Drugs, surgery, procedures, and tests and medical care (costs and quality)
• Buying drugs, devices, and procedures smartly, cheaply, safely
• Patient, payment, and prescription assistance programs
• Patient advocate programs
• Generic drugs: overpricing, shortages, market manipulation, inferior quality control, and other issues
• ***High costs, surprise medical bills, adverse events, bad practices, and other bad healthcare practices***
• Who's responsible for high drug prices and who (and who not) benefits from them
• Fighting drug price gouging and making drugs more affordable
• Managing pain and pain medications
• Managing medications' side effects
• Orphan drugs
• Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication (blog post)
• Faulty medical devices: what you should know
• Questioning drug claims
• Doctors' incentives to prescribe expensive medications
• The dangers of fake and substandard drugs for patients who can't afford real drugs
• Resisting--or detecting--overdiagnosis, overtesting, and overtreatment--and often misdiagnosis
•'Right to try' laws, early access, compassionate use of experimental drugs (pro and con)
• The benefits pharmacy benefit managers manage are usually not for consumers
(under Reforming the U.S. healthcare system)
• Substance abuse and recovery (a full page of its own, with sections on addiction to opioids and psychoactive drugs, alcoholism, addiction treatment and recovery, culprits in the opioid crisis, fraudulent practices in addiction treatment, needle exchange programs, reversing overdoses, the war on drugs, and more)
• Decoding health care prices(the need for price transparency)
• Finding prices for medical procedures
• Managing medications, tests, procedures, and treatment
• Medications, tests, procedures, and treatments to question or avoid
• Private screening tests, the truth about
• Genetic testing, gene therapy, and other genetic advances
• Reducing medical costs
• Reducing medical debt
• Surgery (miscellaneous)
• What to know and do before undergoing surgery
• How to research a surgeon and hospital
• How to help children prepare for surgery
• Brain surgery
• Heart surgery
• Knee and hip replacement surgery
• Memoirs and reflections of surgeons and about surgery
What's wrong with the 21st Century Cures Act (Norman Bauman's blog post)
Culprits in the opioid crisis
Substance abuse and recovery
Addiction, treatment, and recovery
Addiction to opioids and psychoactive drugs
Depression and other forms of mental illness
Hospitals and hospitalization
Tip No. 1: Most physicians do not have a clue how much various drugs cost (and may have an incentive to prescribe the pricier ones), and don't know how drug prices to the consumer are affected by varying forms of insurance coverage. Let them know what you know and what you can afford and are covered for.
Tip No. 2: Don't be a patient with uncritical confidence in drugs. Don't be fooled by what you see from drug companies, who spend billions of dollars on direct-to-consumer advertisements and provide doctors with samples (and sometimes incentives to prescribe their products).
• Understanding Prescription Discount Cards for 2017 (Medicare.net) "GoodRx Gold beats out everyone on pricing."
• GoodRX Stop paying too much for your prescriptions. Compare prices at pharmacies and find coupons to save up to 80%. Likely to save you most on generic drugs. See especially GoodRX Gold Pharmacy Discount Card "More than 1,000 prescriptions are less than $10 with GoodRx Gold. That’s a savings of up to 90%. Gold prices can even be lower than your insurance copay." Manufacturing pricing plus discounted pharmacy pricing.
• PharmacyChecker.com Compare drug prices among reputable online pharmacies.Find the best drug prices from verified overseas online pharmacies, vetted by the physician who runs it for quality. Order no more than a three-month supply
• ProPublica's Prescription Checker The Doctors and Drugs in Medicare Part D. (H/T Paul Burke for many of these links.)
• OptumRx Low-cost prescription mail service. Order 90 days' worth at a time.
• Clear Health Costs ("Your Source for Finding Health Care Prices"). See, for example, this Range of costs for cholesterol screening and this range of costs for CBC blood test.
• WeRx (promoting transparency in retail drug pricing)
• Blink Health (pay for your drugs online, then pick up the prescription at a pharmacy).
• Drug Compare (AARP) Compare prices on two drugs.
• Can a phone app help you find cheaper drugs? (Consumer Reports, Aug 2013) "We compared 4 and found 2 that worked well."
• Healthcare Bluebook "Never overpay for healthcare again. Join the fair price revolution." Find out what you should expect to pay for healthcare services (specific tests or procedures) in your area with their free search tool.
• No More Secrets: Congress Bans Pharmacist ‘Gag Orders’ On Drug Prices (Susan Jaffe, KHN, 10-10-18) For years, most pharmacists couldn’t give customers even a clue about an easy way to save money on prescription drugs. But the restraints are coming off. When the cash price for a prescription is less than what you would pay using your insurance plan, pharmacists will no longer have to keep that a secret. President Donald Trump was expected to sign two bills Wednesday that ban “gag order” clauses in contracts between pharmacies and insurance companies or pharmacy benefit managers — those firms that negotiate prices for employers and insurers with drugstores and drugmakers.
• Shopping Abroad For Cheaper Medication? Here’s What You Need To Know (Bernard J. Wolfson, KHN, 8-22-19) "People familiar with the practice say you generally can pass through customs without much hassle if you have no more than three months’ worth of a medication, you declare it to customs agents and you show them a doctor’s prescription or a personal note attesting it is for personal use, along with contact information for your physician....Ordering drugs online from foreign pharmacies also tends to go largely unchallenged. Legally, the FDA can refuse entry of the package at an international mail facility. “That does happen from time to time,” but not often, says Levitt....Countries with well-regulated pharmacies include Canada, New Zealand, Australia, much of Western Europe and Turkey."
• Mail Order Sales of Prescriptions Drugs by Payer and by State (Kaiser Family Foundation) For 2019.
• Medicare Provider Utilization and Payment Data: Part D Prescriber (CMS.gov) The Part D Prescriber Public Use File (PUF) provides information on prescription drugs prescribed by individual physicians and other health care providers and paid for under the Medicare Part D Prescription Drug Program.
• Medications: What Your Pharmacist Won’t Tell You (David Belk, MD, True Cost of Health Care) by the author of The Great American Healthcare Scam: How Kickbacks, Collusion and Propaganda Have Exploded Healthcare Costs in the United States "How did we get here and why is this so hard to fix?"
• Medicine Use and Spending in the U.S. IQVIA reports on wholesale and retail costs and number
• Express Scripts articles on drug pricing and 11 billion prescription records (paid access)
• How and when the FDA seeks outside advice on drug approvals (Kerry Dooley Young, Covering Health, AHCJ, 9-23-22) The U.S. Food and Drug Administration could bolster public trust in medicines through greater transparency about its decisions on when to seek expert feedback and its instructions to its advisory committees, argue members of a group that monitors the agency closely. Recent papers from Harvard’s Program On Regulation, Therapeutics And Law (PORTAL) can help journalists who want to dig more deeply into the question of when and how the FDA seeks advice on drug approvals.
• National Average Drug Acquisition Cost (NADAC. Open Data, Data.Medicaid.gov) Explained here: NADAC Pricing for Medicaid Pharmacy Claims (A West Virginia explainer) The National Average Drug Acquisition Cost (NADAC) is based on the retail price survey and focuses on the retail community pharmacy acquisition costs. CMS has mandated that Medicaid pharmacy programs reimburse the actual acquisition cost (AAC) of drugs plus a professional dispensing fee. (H/T: Tom Mirga)
• Smart Shopper This site is dressed to look like a Blue Cross site, and says it lets you "compare the costs of common medical procedures based on price and location," but it is owned by various insurance companies instead, and when I filled out its form and was turned over to a person online, it began not to pass the sniff test for me. If you know otherwise, let me know.
• Tip No. 3: The pulse oximeter measures two things: oxygen saturation in arterial blood (SpO2, which should register between 95 and 100--and 90 or below presents danger of hypoxemia) and heart rate (HR, which would be 60 to 100 per minute in a healthy heart). It's easy to confuse the numbers and think you're ready for the hospital. See Pulse Oximeter | How to Use It? How does Pulse Oximetry Work? An excellent 10-minute YouTube explanation.
• Price of a Brace Brings Soccer Player to His Knees(Paula Andalo, Bill of the Month, KHN, 3-26-19) After a sports injury, Esteban Serrano owed $829.41 for a knee brace purchased with insurance through his doctor’s office. The same kind of braces sell for less than $250 online, he says. Knee braces fall into a category of products called “durable medical equipment,” whose prices can vary widely. Doctors and hospitals that dispense and prescribe such equipment for patients to take home almost always bill for them and add hefty markups that can catch patients unaware. Braces and other products “are often marked up two or three times what the cost is, and unfortunately, that is the standard practice,” said Dr. Matthew Matava, an orthopedic surgeon and chief of sports medicine for Washington University Physicians in St. Louis.
• FDA Repays Industry by Rushing Risky Drugs to Market (Caroline Chen, ProPublica, 6-26-18) As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits. "Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication....The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease."
• To Lower Your Medicare Drug Costs, Ask Your Pharmacist for the Cash Price (Susan Jaffe, Shots, NPR, 5-29-18) "A simple question at the pharmacy could unlock savings for millions of Medicare beneficiaries. Under a little-known Medicare rule, they can pay a lower cash price for prescriptions instead of using their insurance and doling out the amount the policy requires. But only if they ask. That's because pharmacists say their contracts with drug plans often contain 'gag orders' forbidding them from volunteering this information.…. " Some states are banning the gag order.
• Patients Overpay for Prescriptions 23% of the Time, Analysis Shows (Sydney Lupkin, Kaiser Health News, 3-13-18) As a health economist, Karen Van Nuys had heard that it’s sometimes cheaper to pay cash at the pharmacy counter than to put down your insurance card and pay a copay. So one day, she asked her pharmacist how much her prescription would cost if she didn’t use her health coverage and paid cash.“And sure enough, it was [several dollars] below my copay,” Van Nuys said....The practice of charging a copay that is higher than the full cost of a drug is called a “clawback” because the middlemen (pharmacy benefit managers) that handle drug claims for insurance companies essentially “claw back” the extra dollars from the pharmacy.
• When Buying Prescription Drugs, Some Pay More With Insurance Than Without It (by Charles Ornstein, ProPublica, and Katie Thomas, The New York Times, 12-9-17) As insurers ask consumers to pay a greater share of their drug costs, it may be cheaper to pay cash than use your insurance card. One expert estimates that consumers could be overpaying for as many as 1 in 10 prescriptions.
• Consumer beware: Drug discounts may contain catch (Katie Wiedell, Dayton Daily News, 2-4-17, part of an excellent series on pharmacy benefit managers). Critics say coupons and other discount programs mask rising prescription prices. With "many of the coupon options available, there was a catch. In order to get the discount price, consumers must purchase their drugs outside of insurance. The consumer pays less out-of-pocket, but the money doesn’t count toward any insurance deductibles. “The biggest threat to drug manufacturers’ extraordinary earnings is an uprising by consumers over drug prices,” Cahn said. “Manufacturers are doing all they can to reduce — or eliminate — copays and deductibles by the widespread distribution of coupons and discount cards.” Tips on discounts, manufacturer coupons, patient assistance programs, third-party discounters, nonprofit foundations. "There are a number of foundations that offer grants to under-insured patients to help with prescription costs. Some of these organizations openly work with drug makers, some get donations from drug makers, and some are completely independent with no drug-maker funding. The best way to find these is to search by a particular disease."
• Prescriptions May Be Cheaper Without Insurance (Lester Holt, 10-16-17) An NBC News investigation found that a wide variety of generic drugs on certain insurance plans are actually cheaper when you pay out of pocket, but a gag order can prevent some pharmacists from telling patients when they are overpaying. Ask: Is this the cheapest price I can get? Is there a better choice for me?
• Use Pro Publica's Dollars for Docs search tool to see if your doctor receives money from drug or device companies (which might influence prescribing a more expensive drug over an equally or nearly equally effective cheaper drug)
• Prescriber Checkup (ProPublica) Medicare’s popular prescription-drug program serves more than 42 million people and pays for more than one of every four prescriptions written nationwide. Use this tool to find and compare doctors and other providers in Part D in 2015. See High-dollar Prescribers Proliferate in Medicare’s Drug Program (Charles Ornstein and Ryann Grochowski Jones, ProPublica, 11-17-16)
• New Online Tools Offer Path to Lower Drug Prices (Katie Thomas, NY Times, 2-9-16)
• Medicare Part B Drug Average Sales Price (Centers for Medicare & Medicaid Services) Manufacturer reporting of Average Sales Price (ASP) data. Price information for certain drugs covered under Medicare Part B, administered in a doctor’s office, hospital, or clinic (e.g., chemotherapy drugs to treat cancer, infused drugs for osteoporosis, steroid injections for joint pain and vaccines. Medicare typically reimburses doctors for the ASP plus about 6 percent. (H/T Association of Health Care Journalists)
• Generic Drug Prices Are Declining, But Many Consumers Aren’t Benefiting (Charles Ornstein, ProPublica, and Katie Thomas, New York Times, 8-8-17) Outcry has been building over the rising cost of brand-name medications, but the price of generic drugs has been moving in the opposite direction. The stock prices of generic manufacturers have tumbled, but many consumers aren’t paying less at the pharmacy counter.
• The Myth of Drug Expiration Dates ( Marshall Allen, Pro Publica, 7-18-17) Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital (or that they routinely give you way more than you need). Meanwhile the FDA has long known that many remain safe and potent for years longer. Part of Pro Publica's Wasted Medicine series.
• CR's Best Buy Drugs campaign (Consumer Reports)
• Facebook Live: The Prescription Drug Pricing Pipeline (video, Kaiser Health News, archived 30-minute conversation with knowledgeable journalists). Who contributes to what you pay at the pharmacy? Why are prescription drugs so expensive in the United States? In this Facebook Live, KHN’s Julie Appleby talks with Stephanie Stapleton and answers readers’ questions about the prescription drug pricing pipeline and the industry stakeholders who have a role in what you pay.
• Tracking Who Makes Money On A Brand-Name Drug (Julie Appleby, Kaiser Health News, 10-6-16) A diagram of what Julie and Stephanie discuss in previous entry.
• Sounds Like A Good Idea? Regulating Drug Prices ( Julie Rovner and Francis Ying, Kaiser Health News, 7-11-16)
• Save Money on Meds: 9 Tips for Finding the Best Prescription Drug Prices (Consumer Reports, 3-8-17) Prices can vary widely from store to store, even in the same town. The trick is to shop around. Look at the price comparison chart.
• Buying Cheaper Drugs Online (Anahad O'Connor, NY Times, Ask Well, 11-11-13)
• Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication
• Hearing Amazon's footsteps, Walgreens unveils new digital platform to connect patients to doctors (Lisa Schencker, Chicago Tribune, 7-27-18) "Walgreens has unveiled a new digital platform to connect customers to medical services, just weeks after its stock dove on news that Amazon is expanding into the pharmacy business. Deerfield-based Walgreens’ new Find Care Now platform, available online and on the pharmacy chain’s app, allows patients to schedule appointments at its in-store Advocate clinics, talk with doctors and therapists through telehealth company MDLIVE, and schedule online dermatology appointments through online dermatology service DermatologistOnCall. Patients can also get second opinions through the NewYork-Presbyterian health care system and make eye and hearing appointments at Walgreens stores. In other parts of the country, Walgreens has partnered with a number of other regional health care providers. "
• How A Bone Disease Grew to Fit the Prescription (Alex Spiegel, All Things Considered, 12-21-09) How did osteopenia change from a category for public health researchers into a condition that millions of women swallow pills to treat?
• Ten Medications Older Adults Should Avoid or Use with Caution (HealthinAging.org tip sheet)
• 6 Medications That Can Harm Your Hearing (Michelle Crouch, AARP, 9-23-22) More than 600 drugs have been linked to hearing loss and tinnitus, including over-the-counter pain relievers.
• Medications & Older Adults (HealthinAging.org) Download tip sheets (in English or Spanish) on Alternatives for Medications on the Beers Criteria, Avoiding Overmedication and Harmful Drug Reactions, My Medication Diary, What to Do and What to Ask If a Medication You Take is Listed in the Beers Criteria. The AGS Beers Criteria identify medications with risks that may be greater than their benefits for people age 65 and older.
• Dry mouth (symptoms & causes) (Mayo Clinic) and diagnosis & treatment. How to avoid dental problems as a result of dry mouth.
• Medicare Seeks Comment On Ways to Cut Costs of Part D Drugs (Sarah Jane Tribble, Kaiser Health News, 11-16-17) "Noting that the true price of a drug is often hidden from consumers, Medicare officials requested comments late Thursday on how to use discounts and rebates to help decrease what enrollees pay for prescriptions. The proposal request, buried in hundreds of pages, ...asked for public comment on how to share the rebates and discounts that are negotiated by manufacturers, pharmacists and insurers. Insurers and pharmacy benefit managers, or PBMs, administer Medicare’s Part D drug program and negotiate behind-the-scenes fees and discounts that are often hidden from public view. Noting that the true price of a drug is often hidden from consumers, Medicare officials requested comments late Thursday on how to use discounts and rebates to help decrease what enrollees pay for prescriptions. Supporters of a rule change say they want the fees disclosed and for them to be applied to what enrollees pay for their drugs. However, there are questions about how the rule would work and whether it would drive up premium prices for Medicare Part D plans.
• CR Price Reports (Consumer Reports' "bluebook" surveys of national and local fair prices for brain MRI, breast augmentation, breast reduction, chest x-ray, colonoscopy, complete blood count, comprehensive metabolic panel, fetal ultrasound, hip replacement, hysterectomy, knee arthroscopy, knee replacement, laminectomy, lap-band surgery, laparoscopic cholecystectomy, liposuction, rhinoplasty, septoplasty, tubal ligation, TURP (transurethral prostatectomy), and vasectomy.
• An Arm and a Leg (Radio Public podcast series) "A podcast. Because we need to talk about the cost of health care."
• CVS Health Is Sued Over 'Clawbacks' of Prescription Drug Co-Pays (Jef Feeley and Jared S Hopkins, Bloomberg, 8-9-17) CVS Health Corp. was sued by a California woman who accused the drugstore operator of charging customers co-payments for certain prescription drugs that exceed the cost of medicines. CVS, the largest U.S. pharmacy chain, overbilled consumers who used insurance to pay for some generic drugs and wrongfully hid the fact that the medicines’ cash price was cheaper. Woman says she paid $166 for medicine that actually cost $92. Chains worked with benefit managers on billings, suits say.
• I Got the Wrong Drug. And a $2,500 Band-Aid. (Josh Max, Opinion, NY Times, 7-15-17)
• Why I Won’t Take These ‘Safe’ Drugs (Christiane Northrup, MD, July 2016) The four: statins for heart health; bisphosphonates for bone loss; Premarin, Prempro, and all other synthetic hormones (as opposed to bioidentical hormones); and proton pump inhibitors, or PPIs, to treat heartburn, acid reflux, gastroesophageal reflux disease (GERD), or peptic ulcers.
• 5 signs your doctor might be an overprescriber (Consumer Reports, 9-28-16) Too often, patients get unnecessary medication.
• Finding the Right Pharmacy (Consumer Reports, Jan. 2014) 10 reasons why you may want to switch drugstores
• Costco’s Prices for Generic Medications as of October, 2013
• Buying Prescription Drugs From Canada: Legal or Illegal? (ElderLaw Answers)
PLACES AND PROCEDURES
• A Tale Of Two CT Scanners — One Richer, One Poorer (Alison Kodjak, NPR News and KHN, 4-9-18) "Benjamin Hynden had pain and discomfort in his abdomen, so he scheduled a CT scan at a nearby imaging center. He paid $268 for the test. When his abdominal pain returned months later, he underwent a second CT scan, this time at a local hospital. He left without a definitive diagnosis and a bill of $10,174.75....Healthcare Bluebook, a health care pricing tool, says the range for an abdominal CT scan with contrast, like Hynden had, in Fort Myers is between $477 and about $3,700. It pegs a fair price at $595." This is a monthly feature from Kaiser Health News and NPR that will dissect and explain real medical bills in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs.
• Healthcare Bluebook. "Never overpay for healthcare again. Join the Fair Price Revolution."
• ClearHealthCosts. Read about how to help bring transparency to health care costs.
• Ratings for hospitals, doctors, surgeons, home health agencies, nursing homes (Pat McNees's roundup of ratings resources in those categories)
• Compare Hospitals (Leapfrog Group)
• Hospital Compare (Medicare/Medicaid)
• New Choice Health. Save money on common medical procedures.
• I started collecting ER bills. The American Hospital Association started warning its members. (Sarah Kliff, Vox, 10-26-17) Hospital and urgent care prices are often kept secret. Vox is trying to change that. Links here to the many stories in this series, including case studies.
• Costs of Care (Twitter thread). See especially GODMeDS
• Need a Medical Procedure? Pick the Right Provider and Get Cash Back ( Julie Appleby, KHN, 3-5-18) "Laurie Cook went shopping recently for a mammogram near her home in New Hampshire. Using an online tool provided through her insurer, she plugged in her ZIP code. Up popped facilities in her network, each with an incentive amount she would be paid if she chose it. Paid? To get a test? It’s part of a strategy to rein in health care spending by steering patients to the most cost-effective providers for non-emergency care....Lawmakers in nearby Maine took the idea further, recently enacting legislation that requires some private insurers to offer pay-to-shop incentives, part of a movement backed by a conservative foundation to get similar measures passed nationally."
• Attention, Shoppers: Prices For 70 Health Care Procedures Now Online! (Jay Hancock, Kaiser Health News, 2-25-15).
• VIPPS (VIPPS information and verification site of the National Association of Boards of Pharmacy) Enter a site's URL to verify if it meets industry standards.
• Find a VIPPS online pharmacy (National Association of Boards of Pharmacy)
• A Failed Cure for Health Care Costs (Helaine Olen, Slate, 1-9-17) Online price-comparison tools were supposed to cut our medical bills. Here's why they often fail: "researchers at Harvard Medical School discovered that not only did few use them, their spending actually increased after the tools designed to encourage comparison-shopping were introduced." (Sometimes we think "more expensive" means "better quality.") "Comparison tools work by allowing people seeking nonemergency health care like hip and knee replacements, MRIs, physicals, and lab work—and even more mundane services like earwax removal—to compare the cost of the care at different practitioners and determine what their co-payment will likely total based on their insurance and whether they’ve met their deductible....But do you really pick your doctors the way you bargain shop for electronics on the web? Of course not."...about half of us turned to friends and relatives for recommendations when seeking a new primary care doctor. "When the AP–NORC poll asked people what traits made for a high-quality doctor, “affordable” and “accepts my insurance” were the two least important qualities, outranked by more than a dozen other traits including attentiveness, office environment, and bedside manner. Yet another survey, this one by Healthgrades, found many patients prioritizing location over co-pay and quality ratings when they needed a hospital." And pharmaceutical giants set the prices for their drugs. End up in an Emergency Room? You're likely to get a medical bill.
• Online Tools to Shop for Doctors Snag on Health Care’s Complexity (Reed Abelson, NY Times, 6-17-16) "Even when people have access to the newly available information, they may not use it. And when they do, they may not rely on the insight. It is impossible to know, for example, whether a dermatologist who costs twice as much as another can more successfully diagnose skin cancer." Why so far “the potential gains from the consumer price shopping aspect of price transparency efforts are modest.”
• Ratings for hospitals, doctors, surgeons, home health agencies
• Tell ProPublica About Your Experience With Life-Sustaining Medical Devices (ProPublica) Do you or someone you know have a pacemaker, defibrillator, implanted prosthetic, or other lifesaving device? Do you work with or in the medical device industry? Help ProPublica report.
• “Get This Thing Out of My Chest” (Neil Bedi and Maryam Jameel, ProPublica, 12-20-21) A life-sustaining heart pump known as the HVAD was taken off the market after years of problems and FDA inaction. Thousands of people are now stuck with it embedded in their hearts. "I was not informed about the issues, deaths or even the recall of the pump," says Alicia Warren, a 44-year-old who has had the pump since 2018. See also Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous (Neil Bedi, ProPublica, 8-5-21) Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.
• 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. (Editorial, NY Times, 5-4-19) Patients suffer as the F.D.A. fails to adequately screen or monitor products.
• Medical Devices Harm Patients Worldwide As Governments Fail on Safety (International Consortium of Investigative Journalists, or ICIJ, 2018) A global investigation reveals the rising human toll of lax controls and testing standards pushed by a booming industry. See also Implant Files (part of the same award-winning series from the International Consortium of Investigative Journalists, Avrotros, NBC, AP and more than 50 media partners, 2018) Health authorities across the globe have failed to protect millions of patients from poorly tested implants, the first-ever global examination of the medical device industry reveals. A year-long investigation revealed regulators bowing to industry pressure to rush approvals, lower safety standards and cloak critical information, and the consequences: a string of grisly accidents that have left hundreds of thousands disfigured, disabled or dead. They found "artificial hips that corrode flesh and poison blood, spinal-cord stimulators that shock and permanently injure and surgical mesh that cuts into tissue, causing chronic pain and bleeding — all greenlit through a FDA approval pathway known as 510(k) that allows manufacturers to launch new devices based, not on human testing, but on their similarity to older products." See Key Findings (left side), including: "Some of the highest-profile controversies in recent years involve products marketed to women, including contraceptive coils, vaginal mesh, and breast implants."
• Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices (Christina Jewett, Kaiser Health News, 3-7-19). The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark. KHN’s “Hidden Harm” series on the FDA’s secret database of malfunctioning medical devices was honored on Oct. 2, 2019, with the prestigious Barlett & Steele Award for Investigative Journalism.
• FDA challenged over metal implants ‘public health travesty’ (Sasha Chavkin, International Consortium of Investigative Journalists, 11-14-19) The ICIJ reported extensively on hip implants and Essure as part of its global Implant Files investigation. Some of the most forceful testimony came from Dr. Stephen Tower, an orthopedic surgeon who suffered severe cobalt poisoning from his own hip implant, and has since dedicated himself to researching metal poisoning by hip implants. "This is not a metal-on-metal problem. We are seeing this with many popular hip designs," he said.
• Readers from 50 countries share medical implant stories (Amy Wilson-Chapman and Agustin Armendariz, ICIJ, 11-16-19) ICIJ heard from people with hip implants, pain pumps, ankle implants, spinal cord stimulators, breast implants, heart devices, mesh and more. Look at the charts.
• FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request (KHN, 7-23-19)
• Report Medical Device Fraud (Whistleblower Justice Network) WJN has pages on fraud associated with Medicare & Medicaid, durable medical equipment, ambulances, pharmaceticals, PBM & Pharmacy, hospitals, hospice, nursing homes, home healthcare, sleep centers, and a "program of all-inclusive care for the elderly (PACE) fraud.
• Medical Devices and DME Fraud (Constantine Cannon) "Government healthcare programs are susceptible to losses through the fraudulent prescription and dispensing of medical devices and durable medical equipment and supplies (DME). Medical devices include a wide variety of equipment—everything from bedpans to x-ray machines—used to prevent, diagnose, or treat diseases or other conditions. DME encompasses devices used in patient homes, such as wheelchairs and walkers, oxygen supplies, blood glucose monitors and test strips, devices to treat sleep apnea, and prosthetic limbs. Through Medicare and Medicaid, the government pays for a variety of medical devices, including DME prescribed by a doctor who deems the DME medically necessary. Medical device and DME fraud can constitute a violation of the False Claims Act (FCA) and other federal and state laws. Such fraud comes in many forms, including: Illegal payment arrangements, off-label marketing, defective devices, unnecessary DME, unlicensed technicians, unlicensed facility.
• Florida is key player in medical device fraud scheme described as one of largest in U.S. history (Katie LaGrone, ABC News, Tampa, 4-9-19) Medicare; taxpayers robbed of nearly $1 billion, feds say. A massive telemedicine scam preyed on Medicare recipients and bilked taxpayers out of nearly $1 billion, according to the federal authorities. The federal investigation, dubbed “Operation Brace Yourself,” was a national crackdown on a complex telemedicine scam that put unwanted and unnecessary orthopedic braces and other devices in the hands of hundreds of thousands of Medicare recipients. Doctors who signed bogus prescriptions for the braces so Medicare would reimburse DME companies for the devices would also get kickbacks.
• Avoid Medical Equipment Scams (AARP, 2019) Scroll down for Warning Signs and Do's and Don'ts. For example, your quarterly Medicare Summary Notice (MSN) or an explanation of benefits (EOB) from your health plan lists medical equipment you did not order or receive. Report that to Medicare.
• Medical device scam still targeting seniors, and we’re all still paying for it (Katie LaGrone, WPTV, West Palm Beach, 4-8-19) Telemedicine is helping to fuel a multi-million dollar fraud scheme, feds say. here’s how telemedicine fraud works: A medical supply company pitches Medicare patients medical supplies the patient doesn’t need or want. The same company will also hire doctors who have no relationship with the patient, but are willing to rubber stamp prescriptions for those supplies — up to $150 per signature. Patients get the goods and taxpayers foot the bill.
• Are women more likely to be harmed by medical device failures? (Ben Hallman, International Consortium of Investigative Journalists, 12-17-18) A year-long investigation of the $400 billion medical device industry reveals how lax regulation has allowed under-tested devices to flow into the market, and to remain there, even after grisly problems emerge. Women were disproportionately harmed in many of the scandals that have plagued the industry in recent years. An ICIJ analysis of this data identified more than 83,000 deaths and 1.7 million injuries linked to medical devices. Yet the FDA won’t make gender information public. “Significant” issues concern medical disasters that have wrecked the lives of tens of thousands of women: Vaginal mesh, breast implants, essure coils as sterilization devices. But even many devices used by all genders appear to harm women more often than men.
• ICIG's International Medical Devices Database . Explore more than 105,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.
• FDA to End Program That Hid Millions of Reports on Faulty Medical Devices (Christina Jewett, Kaiser Health News, 5-3-19) The Food and Drug Administration announced it is shutting down its controversial “alternative summary reporting” program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public. The agency has for years allowed makers of breast implants to report hundreds of thousands of injuries and malfunctions out of the public eye, federal records show. FDA spokeswoman Angela Stark said the agency will also end “alternative summary reporting” exemptions still in place for makers of implantable cardiac defibrillators, pacemakers and tooth implants. The FDA has said the program was originally designed to allow for more efficient internal review of well-known risks.... The agency said it began winding down the program in mid-2017, revoking many reporting exemptions, including those for saline breast implants and for balloon pumps used inside patients’ blood vessels....The FDA for years reached agreements with makers of about 100 devices, allowing them to cease public reports of certain types of problems. Going forward, device makers will be required to file individual reports describing each case of patient harm related to a medical device....The FDA has not said it will stop allowing device makers to file other types of device-harm exemption reports that are withheld from the public...The FDA had granted Covidien, now a division of Medtronic, a long-standing “alternative summary reporting” exemption for its surgical staplers, a device used to cut tissues and vessels and quickly seal them during a variety of surgeries....The device has been subject to numerous lawsuits over patient deaths and grave harm. [Emphasis added for devices mentioned. Read full article for the full story!
• Five Things We Found In The FDA’s Hidden Device Database (Sydney Lupkin, KHN, 6-27-19)
1. Blood glucose meters for patients with diabetes had more unique incidents than any other device in the database, logging 2.4 million reports over the past 20 years.
2. There were 2.1 million reports for bad dental implants. And 114,200 were reported last year.
3. There were 176 deaths reported through the alternative summary reporting system.
4. Surgical stapler-related malfunctions accounted for more than 66,000 previously hidden incidents since 2001.
5. Breast implant injuries and malfunctions accounted for nearly half a million unique reports over two decades, including implants that leaked, deflated or migrated.
• More Than Half of Surgical Stapler Malfunctions Went to Hidden FDA Database (Sydney Lupkin and Christina Jewett, KHN, 5-30-19) See also FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers (Christina Jewett, KHN, 3-8-19)
• Device-Safety Experts to FDA: Make Data Public (Christina Jewett, KHN, 3-27-19) Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices. A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices. One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible to doctors, medical researchers or the public. FDA needs to open the data on scores of other devices, which have included surgical staplers, mechanical ventilators, and pacemaker electrodes. “The FDA absolutely should be making all of this information available,” said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA about device safety. Among the devices involved are implantable defibrillators and the staplers, which in 2016 were linked to under 100 public reports of harm, even as nearly 10,000 malfunction reports were filed discreetly within the FDA. “The FDA isn’t so capable that they can afford to hide data,” says Dr. Alan Shapiro, an associate professor at the New York University School of Medicine who has used the agency’s public device-safety database, called MAUDE, in his research. Paring down patient-safety data and keeping it in-house is the wrong move in the current era of artificial intelligence and automation. Among the benefits of greater transparency would be the peer pressure among device makers — stripped of reporting exemptions — to make their products safer.
• The Safety of Medical Devices (Christopher Nemeth, PSNet/Patient Safety Network, June 2011) Eleven years after the Institute of Medicine report To Err is Human, there is ample evidence to indicate that issues with device safety remain substantial and widespread. Without data on human cognitive performance in health care and how technology affects it, we have no information on what the real world of health care is like, and any efforts to improve it are just a collective guess.
• Use Pro Publica's Dollars for Docs search tool to see if your doctor receives money from drug or device companies (which might influence prescribing a more expensive drug over an equally or nearly equally effective cheaper drug or device)
• Reports Of Patients’ Deaths Linked To Heart Devices Lurk Below Radar (Christina Jewett, KHN, 12-24-19) The Food and Drug Administration continues to file thousands of reports of patients’ deaths related to medical devices through a reporting system that keeps the safety data out of the public eye. Device makers say the registries strip key data they need to fully investigate each death, most of them related to heart valves threaded through a catheter and implanted in faulty hearts. Such a heart valve made by Medtronic called CoreValve amassed the most reports, with more than 5,800 death incidents reported since 2014, according to Medtronic. The device was initially approved for patients too sick for open-heart surgery.
• List of potentially harmful (defective) drugs and devices (DrugDangers.com) This law firm's site lists and posts info on devices (and drugs) that have harmed people, who have sued. Devices listed: DaVinci robot, IVC filters,Mirena IUD, Essure birth control, Power Morcellator, transvaginal mesh, talcum powder, hip replacement, metal on metal hips, Depuy hip replacements, Stryker hip replacements, Stryker ABGII, Stryker Rejuvenante, knee replacements, Zimmer hip replacements, Zimmer NexGen, Zimmer Persona Knee Replacement. See also List of defective drugs.
• Consumer Safety Guide Recent information on the most popular prescription medications and FDA-approved medical devices that could be endangering your health or putting your loved ones at risk.
• Dialysis Industry Spends Millions, Emerges as Power Player in California Politics (Samantha Young, KHN, 12-10-2020) The two giants of the dialysis industry, DaVita and Fresenius Medical Care North America, have spent about $212 million over the past four years to influence California’s voters and politicians, out of a total $233 million in industry giving. Most of the money funded the defeat of two union-backed ballot measures that would have regulated dialysis clinics — and eaten into their profits.
• How big pharma keeps drug prices high (Priti Krishtel and John Arnold, Pitchfork Economics, 1-7-2020) The American pharmaceutical industry is rigged to make a handful people fabulously wealthy while everyone else gets screwed over. Because of intricate patent laws, we pay double what people in 29 other rich countries pay. Experts and change-makers Priti Krishtel and John Arnold join Nick and Jasmin to explain how we got into this mess (Monopolies! Patent law!), and what we can do about it. Pharm companies are fighting to double the length of patent terms and to squeeze out generics. H/T to Pitchfork for several links below.
• How Big Pharma Reaps Profits While Hurting Everyday Americans (Abbey Meller and Hauwa Ahmed, Center for American Progress, 8-30-19) Pharmaceutical companies receive substantial U.S. government assistance in the form of publicly funded basic research and tax breaks, yet they continue to charge exorbitant prices for medications. Among all Americans suffering from diabetes, at least 1 in 45 have said that they engaged in insulin rationing—a tactic of using less insulin than is needed in order to make the doses last longer—as a direct result of the skyrocketing price of the drug.Among all Americans suffering from diabetes, at least 1 in 45 have said that they engaged in insulin rationing—a tactic of using less insulin than is needed in order to make the doses last longer—as a direct result of the skyrocketing price of the drug. A vial of insulin, which is the only life-sustaining option for Type 1 diabetics, retails at around $300. A 2018 study commissioned by the Congressional Diabetes Caucus found that the price of insulin has doubled since 20127; in the 10 years prior, the price of insulin nearly tripled. Despite taxpayer subsidies, prescription drug prices are increasing at an alarming rate. "Drug companies also benefit from patents, which give them monopoly power for their on-patent products. These patents ensure that prices remain high by reducing competition. Drug patents last for 20 years after the filing date. Pharmaceutical companies have also employed tactics such as evergreening and thicketing to prolong a drug’s exclusivity."
• How a billionaire couple greased the skids for Nancy Pelosi’s drug pricing bill (Lev Facher, Stat, 11-26-19) In September, a prominent former lawmaker contracted by the couple’s advocacy arm vocally endorsed House Speaker Nancy Pelosi’s marquee drug pricing legislation. And in 2019 alone, at least eight researchers and advocates funded by the Arnolds have testified on Capitol Hill, urging lawmakers to move forward with legislation to slash the cost of prescription drugs. Billionaires John and Laura Arnold have focused on four lines of attack: direct political advocacy; funding researchers and academics critical of high drug prices; a public opinion blitz featuring op-eds and Democratic pollsters; and state initiatives that have led to major, if unheralded, drug pricing reforms.
"One group, Patients for Affordable Drugs, became a drug pricing heavyweight virtually overnight thanks to $13 million in funding from Arnold Ventures and the Action Now Initiative, another Arnold-funded nonprofit. For the last two years, the organization has worked to change Washington’s attitudes toward drug pricing through lobbying, political advertisements, and reports highlighting perceived drug company profiteering....
"In the eyes of the drug industry, however, the Arnolds’ deadliest sin comes in the form of grants worth $19.1 million to the Institute for Clinical and Economic Review. The Boston nonprofit’s empirical value assessments have called into question the high price tags on a number of new drugs — and many pharmaceutical industry figures view those empirical value assessments as a gateway to more direct price-setting."
• A Humira Prescription Costs $38,000 A Year Because Our Patent System Is Being Abused (Priti Krishtel, HuffPost, 10-28-18)
• It’s Time for Pharmaceutical Companies to Have Their Tobacco Moment (Editors, NY Times, 2-24-19) Elected officials have made a lot of noise about the cost of prescription drugs. Now they must demand answers from pharmaceutical companies.
• A Supreme Court victory for lowering drug prices (Priti Krishtel, The Hill, 4-28-18) A recent Supreme Court decision on patents — Oil States v. Greene’s Energy Group — marks an understated victory, with far-reaching consequences that will positively impact families and communities across America. This case has deep implications for basic economic fairness, with the judiciary recognizing the importance of keeping critical checks in systems that have become far too imbalanced.
• Millions in U.S. Lost Someone Who Couldn't Afford Treatment (Dan Witters, Gallup, 11-12-19) More than 13% of American adults -- or about 34 million people -- report knowing of at least one friend or family member in the past five years who died after not receiving needed medical treatment because they were unable to pay for it, based on a new study by Gallup and West Health.
• Congress wants these 7 drug company CEOs to testify about prices (Lev Facher, STAT, 2-4-19) The seven invited to testify February 26, 2019: AbbVie, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., Pfizer, and Sanofi. Of the seven companies invited, five are already the subject of a separate investigation being conducted by the House Committee on Oversight and Reform. “Patients and taxpayers deserve to hear from leaders in the industry about what’s behind this unsustainable trend and what can be done to lower costs.”
• Pharma: Greed, Lies, and the Poisoning of America by Gerald Posner. Posner traces the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and uncovers how those once entrusted with improving life have often betrayed that ideal to corruption and reckless profiteering - with deadly consequences. Pharmaceutical breakthroughs such as antibiotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on prescription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry.
• How Much Does Medicare Spend on Insulin? (Juliette Cubanski, Tricia Neuman, Sarah True, and Anthony Damico, KFF, 4-1-19) Medicare Part D spending on insulin increased 840 percent between 2007 and 2017, far outpacing growth in the number of beneficiaries using insulin therapy, according to a new KFF analysis. The findings come at a time when the cost of prescription drugs is a major focus for policymakers in Washington, with rising prices for insulin drawing particular scrutiny, including from members of Congress. Three companies—Eli Lilly, Novo Nordisk, and Sanofi—manufacture most insulin products, and there are no generic insulin products currently available, despite the fact that insulin was discovered in the 1920s.
• The Drug That Is Bankrupting America (Jeffrey Sachs, HuffPost,2-16-15) Synopsis by Norman Bauman: Sofosbuvir (Sovaldi), is a cure for hepatitis C (HCV). The original research was done at Emory University by Raymond Schinazi, with major grants from the NIH and Veterans Administration. He set up a company, Pharmasset Inc., to develop his research into a useful drug, and spent $62.4 million on sofosbuvir R&D, including $45 million from an IPO. Then Gilead Sciences bought Pharmasett for $11.2 billion, of which Schinazi got $440 million. Gilead did Phase 2 and Phase 3 trials, with ~1,000 patients, which should have cost $100 million. After FDA approval in 2013, Gilead set the price at $84,000 for a 12-week treatment. In 2014, Gilead had $12.4 billion in sales of Solvadi. Much of that was from Medicare, Medicaid, and the VA. So, says Sachs, private investors got a good deal. They spent ~$300 million in R&D, and got a company worth $11.2 billion, with $12.4 billion in sales. The federal government got a bad deal. They paid for Schinazi's early research, and (under the Bayh-Dole Act) gave him and Emory the patent rights. Then the government had to pay back most of that $12.4 billion a year to use the drug that was developed from that research that the government paid for, says Sachs. A lot of HCV patients still can't afford it."
• A Better Treatment for Hepatitis C (Celine Gounder, New Yorker, 12-9-13) "Grounder credits Michael Sofia, who joined Pharmassett after Schinazi founded it, as the inventor of sofosbuvir (and doesn't mention Schinazi). There's some justification for crediting Sofia. First, sofosbuvir was named after him. Second, he's on the patent. And third, he got a Lasker Award for it."
---King of the Pills (Jon Cohen, Science, 5-8-15) Vol. 348, Issue 6235, pp. 622-625; DOI: 10.1126/science.348.6235.622) "A more complicated story, profiling Schinazi, and interviewing Sofia too. Cohen says, "Schinazi's precise role in sofosbuvir's discovery is ... contentious." This story explains Schinazi's role in nucleotide and nucleoside analogs."
---This drug costs $84,000. And there's nothing the US health-care system can do to stop it.(Sarah Kliff, Vox, 12-2-14) "This story further clarified the role of Schinazi and Sofia in creating the drug, how Gilead paid $11.2 billion in a bidding war, and more insight into why the US pays more for the same drugs than other developed countries."
Here's Norman's conclusion: "The federal government paid for the basic and developmental research on nucleoside and nucleotide analogs, including Schinazi's. Schinazi used that research to create a company, Pharmasett. Schinazi started to develop sofosbuvir, and then left it to others. Sofia developed the molecule into a usable prodrug. Schinazi got $440 million out of the deal. The investors, officers and employees of Pharmasett got similar amounts when Gilead bought it. Pharmasett originally expected to charge $36,000 to $72,000 per patient. Gilead got into a bidding war, and paid $11.2 billion, because they knew they could charge any price, and Medicare was required by law to pay for it. (Gilead did the Phase 2 and Phase 3 trials, which according to Sachs, shouldn't have cost more than about $100 million.) They're like one of those hedge funds that finds [companies] charging too little for their product (like Rayban sunglasses), buys them up, raises the prices, and makes their money back. But for a unique, life-saving drug, they can charge anything. This means that if you discover a life-saving drug, and it only costs $100 to make, you should instead charge $84,000, because Medicare has to pay for it. And if you don't charge $84,000, your investors will kick you out and replace you with someone who will. It's an artificial rise in prices, not justified by any social benefit, the way New York City real estate prices are inflated without social benefit. So this raises a strong argument for Medicare negotiating prices, as Kesselheim advocates.
"The big question for the representatives of the pharmaceutical industry is, how can you justify a price like this which makes the drug unaffordable to many Americans (whose taxes helped pay for its development)? The drug companies have many answers, and Kesselheim lists and rebuts each one in turn."
"Medicare should be able to negotiate lower costs for patients. Right now Medicare has to accept the price dictated by the drug company. Medicare can’t say no—no matter the cost. That must change so Medicare can use its purchasing leverage to negotiate for patients. -- Patients for Affordable Drugs
• As Drug Prices Rise, Is Boston’s Prosperity Based On A Moral Crime? (Dr. Vikas Saini, CommonHealth, WBUR, 1-31-19) "The pharma sector, the pride of Massachusetts, is a bubble fed by astronomical, obscene profits. It’s not the innovative ideas, though there are many of those, nor the “best and the brightest” young scientists, though they can be dazzling in their smarts, that are making the biotech sector boom. It’s the recent access to cheap capital and even cheaper hype. And predatory pricing. The companies that have put down roots here to take advantage of our educated elite – Sanofi, Eli Lilly, Novartis and scores of others – have continued the pattern made famous by Martin Shkreli, the CEO who dramatically hiked the price of several drugs, and is now serving jail time for defrauding investors. Companies today are setting prices to whatever the market will bear, no matter the damage...what kind of economic miracle routinely depends on the FDA to approve cancer drugs that are unproven when it comes to prolonging life, yet cost more than $100,000 for a course of treatment? What kind of economic miracle leads to people dying because they can’t afford an essential medicine like insulin, which has been around for almost a century? Antavia Lee Worsham, Alec Raeshawn Smith, Shane Boyle and Jesse Lutgen, four people with type 1 diabetes, died because they couldn't afford insulin."
• Drugmakers Play the Patent Game to Lock In Prices, Block Competitors (Sarah Jane Tribble, KHN, NPR, 9-28-18) "The patenting of a small change in how an existing drug is made or taken by patients is part of a tried-and-true pharmaceutical industry strategy. Drug companies typically have less than 10 years of exclusive rights once a drug hits the marketplace. They can extend their monopolies by layering in secondary patents, using tactics critics call “evergreening” or “product-hopping.” When Abbott Laboratories faced multiple generic lawsuits over its big moneymaker Tricor, a decades-oldcholesterol drug, it lowered the dosage and changed it from a tablet to a capsule to win a new patent. And Forest Laboratories stopped selling its Alzheimer's disease drug Namenda in 2014 after reformulating and patenting Namenda XR to be taken once a day instead of twice. Another common strategy is to create what Food and Drug Administration Commissioner Scott Gottlieb calls "patent thickets," claiming multiple patents for a single drug to build protection from competitors. AbbVie's rheumatoid arthritis drug Humira has gained more than 100 patents, for example.
• Lawsuit Details How the Sacklers, Family Behind OxyContin, Made More Than $4 Billion (Christine Willmsen and Martha Bebinger, CommonHealth, WBUR, 1-31-19) "...when profits dropped in the fourth quarter, the family allegedly supported the company’s intense push to increase sales representatives’ visits to doctors and prescribers. Purdue had hired a consulting firm to help reps target "high-prescribing" doctors, including several in Massachusetts. One physician in a town south of Boston wrote an additional 167 prescriptions for OxyContin after sales representatives increased their visits, according to the latest version of the lawsuit filed Thursday. It claims Purdue paid members of the Sackler family more than $4 billion between 2008 and 2016....While the company settled lawsuits in 2009 totaling $2.7 million brought by family members of those who had been harmed by OxyContin throughout the country, the company amped up its marketing of the drug to physicians by spending $121.6 million on sales reps for the coming year. The Sacklers paid themselves $335 million that year."
• The latest roadblock to Trump’s plan to put drug prices in ads: House Republicans (Nichols Florko, STAT, 9-13-18) "President Trump’s splashiest idea for lowering the cost of prescription drug prices was to force pharmaceutical companies to include the prices of their products in TV and other advertisements. In a bipartisan effort, Sen. Dick Durbin (D-Illinois) and Sen. Chuck Grassley (R-Iowa) proposed a bill that would give the Food and Drug Administration $1 million to help get the ball rolling on making those drug prices transparent. House Republicans opposed the measure. The FDA might not need the extra funding to carry out the regulatory work.
• The High Cost of Hope: When the Parallel Interests of Pharma and Families Collide (Emily Kopp and Jay Hancock, The Daily Beast) Desperate for help finding a lifesaving drug for a genetic disease, these families banded together to raise money for research into a new medication for cystinosis. But then they were priced out of the resulting drug. Procysbi is an “orphan drug,” under FDA rules, giving its makers an extended monopoly and the opportunity for big profits because it treats a disease affecting only about 500 Americans.
• Insulin's High Cost Leads To Lethal Rationing (Bram Sable-Smith, NPR, Shots, 9-1-18) Insulin is an unlikely symbol of America's problem with rising prescription costs. Diabetic ketoacidosis is a terrible way to die. It's what happens when you don't have enough insulin. Your blood sugar gets so high that your blood becomes highly acidic, your cells dehydrate and your body stops functioning. Diabetic ketoacidosis is how Nicole Smith-Holt lost her son. Three days before his payday. Because he couldn't afford his insulin....The price of insulin in the U.S. has more than doubled since 2012. That has put the life-saving hormone out of reach for some people with diabetes...especially if they lack the appropriate insurance and have high deductibles....For Nicole Holt-Smith, as well as a growing number of online activists who tweet under the hashtag #insulin4all, much of the blame should fall on the three main manufacturers of insulin today: Sanofi of France, Novo Nordisk of Denmark and Eli Lilly and Co. in the U.S. The three companies are being sued in the U.S. federal court by diabetic patients in Massachusetts who allege the prices are rising at the expense of patients' health.
• The Latest Culprit in the High Drug Price Blame-Game: The Pharmaceutical Rebate (KHN Morning Briefing, 7-30-18) The drug rebate is similar to any other rebate on a product you're buying -- but instead of you getting to keep the money, it’s the insurer or employers who usually reap the benefit. There's been a lot of movement lately, both from the pharma industry and the White House to eliminate the system. Meanwhile, Democrats are eyeing an unusual ally in their fight to let Medicare negotiate drug prices.
• Meet the Rebate, the New Villain of High Drug Prices (Katie Thomas, NY Times, 7-27-18) An increasingly popular culprit in the debate over high drug prices is the pharmaceutical rebate, the after-the-fact discounts that form the heart of the nation’s arcane — many would say broken — market for prescription drugs. Now, a growing chorus wants to get rid of them, or at least change the way they are applied after drug companies have already set their prices. Rebates, critics say, have pushed up the list price of brand-name drugs, which consumers are increasingly responsible for paying. Insurers generally get to keep the rebates without passing them along to their members.
• The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. (AS Kesselhelm, JAvorn, and A Sarpatwari, JAMA, 8-23-16) CONCLUSIONS AND RELEVANCE: "High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits. The most realistic short-term strategies to address high prices include enforcing more stringent requirements for the award and extension of exclusivity rights; enhancing competition by ensuring timely generic drug availability; providing greater opportunities for meaningful price negotiation by governmental payers; generating more evidence about comparative cost-effectiveness of therapeutic alternatives; and more effectively educating patients, prescribers, payers, and policy makers about these choices." Government Efforts to Reduce Drug Prices: "Government Efforts to Reduce Drug Prices" In theory, the most effective way for a government to reduce drug prices would be for it to set them for the entire marketplace, as central governments do in countries such as Sweden, or to engage in international reference pricing and set prices at levels similar to those of other countries. Taking such a step in the United States would have major marketplace ramifications and is not at present politically feasible, in part because of the power of the pharmaceutical lobby in Washington, DC. Nonetheless, the US government can still take steps to help control excessive drug prices[142,143] by re-assessing some existing unusual and overly permissive policies."
• The data showing drug pricing games (Bob Herman, Axios, 8-1-18) Data analyses from 46brooklyn Research, a new firm started by two people with experience in the pharmacy industry, outline historic trends of drug prices and costs in Medicaid programs across the country in an open, transparent format. The bottom line: These datasets are the clearest examples yet that show specifically how some states are getting bad deals on prescription drugs — and how middlemen like pharmacy benefit managers manipulate the current drug pricing system for their own gains. The spread between what PBMs charge state Medicaid programs for certain drugs and what those drugs cost pharmacies is the profit that PBMs and other middlemen collect.
• PillPack and Capsule expand their digital pharmacy toehold (Mark Brohan, Digital Commerce 360, 5-9-17) Online pharmacies such as PillPack Inc. in Manchester, N.H., and Capsule Corp. in New York are rolling out new digital services they contend will make filling prescriptions online quicker and easier. But they are being held back by pharmacy benefit managers. See The benefits pharmacy benefit managers manage are usually not for consumers
• Use Pro Publica's Dollars for Docs search tool to see if your doctor receives money from drug or device companies (which might influence prescribing a more expensive drug over an equally or nearly equally effective cheaper drug)
• Prescriber Checkup (ProPublica) Medicare’s popular prescription-drug program serves more than 42 million people and pays for more than one of every four prescriptions written nationwide. Use this tool to find and compare doctors and other providers in Part D in 2015. See High-dollar Prescribers Proliferate in Medicare’s Drug Program (Charles Ornstein and Ryann Grochowski Jones, ProPublica, 11-17-16)
• The Cost of Cancer Drugs (Leslie Stahl, 60 Minutes, CBS, 10-5-14--you can listen or read transcript.) Dr. Leonard Saltz: "We're in a situation where a cancer diagnosis is one of the leading causes of personal bankruptcy." "... we as a society have been unwilling to discuss this topic and, as a result, the only people that are setting the line are the people that are selling the drugs." Dr. Peter Bach: "Medicare has to pay exactly what the drug company charges. Whatever that number is." "The challenge, Dr. Saltz at Sloan Kettering says, is knowing where to draw the line between how long a drug extends life and how much it costs." "High cancer drug prices are harming patients because either you come up with the money, or you die." Gleevec as a life-saving drug that makes patients a slave to it and its high cost. Dr. Leonard Saltz: " I don't know where that line is, but we as a society have been unwilling to discuss this topic and, as a result, the only people that are setting the line are the people that are selling the drugs." "Dr. Kantarjian says one thing that has to change is the law that prevents Medicare from negotiating for lower prices."
• Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication
• Dems court conservative firebrand in Medicare drug fight (Mike Lillis, The Hill, 7-29-18) The North Carolina Republican, Freedom Caucus Chairman Mark Meadows, a conservative firebrand and close ally of President Trump, has built a political career around efforts to shrink government and promote free markets. But he also supports the notion of empowering Medicare to negotiate pharmaceutical prices on behalf of seniors — an idea Republican leaders have devoutly rejected since they enacted the Part D drug benefit in 2003.
• Congress May be to Blame for Higher Drug Prices, Experts Say (Ricardo Alonso-Zaldivar, NBC News, 9-29-16) In the last 13 years, Congress passed major legislation that expanded taxpayer-financed coverage for prescription drugs but lacked explicit mechanisms for dealing with costs, instead relying mainly on market forces. Lawmakers look like unwitting enablers in the eyes of some experts.
"Passed in 2003 under President George W. Bush, Medicare's "Part D" prescription benefit provided drug coverage to seniors. Medicare was forbidden to negotiate prices. Instead, private insurers and pharmacy benefit managers would keep costs in check. For a while it seemed to be working amid greater use of generic drugs. But expensive new "specialty" drugs and price increases for some older medications changed things. A feature of the program that protects beneficiaries from "catastrophic" costs has allowed drugmakers and insurers to pass the bill for very expensive medications on to taxpayers.
"Enacted in 2010 under President Barack Obama, the Affordable Care Act, or ACA, expanded coverage for the uninsured. It made prescription drugs an essential benefit, and barred dollar limits on insurance coverage. The drug industry supported the legislation and, according to documents released by House Republicans, got a White House commitment not to seek Medicare rebates opposed by drugmakers. The administration helped defeat an attempt to let patients import lower-cost drugs from abroad.
"It's not clear to what extent Part D and the ACA may have directly caused the very large increases in drug prices in the last five years or so," said Rick Foster, formerly Medicare's chief actuary, or number-cruncher. "Having said that, it wouldn't surprise me if the significant increase in insurance coverage — and especially the catastrophic protection — contributed to the drug price increases."
• The culprits behind high drug prices (Jim Maravelias, Daily Times, 5-15-18) Little-known middlemen called Pharmacy Benefit Managers, or PBMs, are benefiting from high drug prices. "For example, the list price on a medication is $100. The pharmacy first collects the patient’s co-pay of, say, $40 and then collects $60 from the insurance company. Here’s where the funny business comes in: The PBM retains part of the rebate for itself and then gives part of it to the insurer. It doesn’t give any to the patient, who still pays the $40 copay, regardless of the rebate. In the end, the patient ends up paying more than the insurer did. And the PBM makes a profit."
• Klobuchar Wants To Stop ‘Pay-For-Delay’ Deals That Keep Drug Prices High (Emmarie Huetteman, KHN, “We can stop this horrible practice where big pharmaceuticals pay off — they literally pay off — generics to keep the prices and the competition off the market.”
Patient assistance programs help low-income, uninsured patients get free or low-cost, brand-name medications. Copay coupons and copay assistance programs may be sponsored by drug companies, doctors, patient advocacy organizations, nonprofit organizations, or civic groups. See also
Prescription assistance (medication assistance) programs
• How to Find and Use Financial Assistance Programs (GoodRx Health) Excellent links to specific resources and other useful information.
• Center for Benefits (Benefits CheckUp, National Council on Aging, NCOA)
• CancerCare Co-Payment Assistance Foundation
• Co-Payment Assistance Programs (PAN Foundation)
• Medicare: Find a Pharmaceutical Assistance Program for the drugs you take Some pharmaceutical companies offer programs to help pay for prescriptions for people in a Medicare Drug Plan (Part D) .
• GoodRx's Database for Copay Savings Programs and Patient Assistance Programs lists 800 manufacturer discount programs and 1,300 patient assistance programs for more than 1,600 drugs. Get a GoodRx prescription discount card.
• Healthcare and Medical Assistance U.S. Department of Health and Human Services (HHS) maintains this state-by-state list of more than 100 financial assistance programs across the country
• HealthWell helps underinsured people with chronic or life-altering diseases
• Leukemia & Lymphoma Society Co-Pay Assistance Program provides help with out-of-pocket costs for people with medical insurance and a blood cancer diagnosis.
• Medicine Assistance Programs (American Heart Association)
• Medicine Assistance Tool PhRMA’s search engine designed to help patients, caregivers and health care providers learn more about the resources available through the various biopharmaceutical industry programs. See also Worried About Affording Your Medicine? MAT Is Here to Help. PhRMA’s Medicine Assistance Tool (MAT) can help connect families to potential cost-saving resources. MAT is a search engine designed to help patients, caregivers and health care providers learn more about the resources available through the various biopharmaceutical industry programs. MAT is not its own patient assistance program, but rather a search engine for many of the patient assistance resources that the biopharmaceutical industry offers. Not to be confused with Medication-Assisted Treatment (also MAT), used to treat substance use disorders as well as sustain recovery and prevent overdose
• NeedyMeds Find help with the cost of medicine--including info about patient assistance programs and an up-to-date list of drugmaker discounts. Details vary from program to program.
• PAN Foundation helps underinsured people cover copays, health insurance premiums, and transportation costs related to treatment
• Partnership for Prescription Assistance (PhRMA) helps low-income, uninsured patients get free or low-cost brand-name medications
• Patient Advocate Foundation Co-Pay Relief. You can sign up to get notices of co-pay relief programs
• Patient Assistance Programs (GoodRx Health) Sponsored usually by pharmaceutical manufacturers as a “safety net” (financial assistance) for Americans who have no health insurance or are underinsured, to help these patients access drugs for little or no cost. For example:
---Gilead's Advancing Access Program
---GSK for You
---Lilly Cares Foundation
• RxAssist (directory of Patient Assistance Programs)
• RxOutreach (a nonprofit pharmacy whose mission is to provide affordable medications)
• Patient Assistance Programs & Prescription Assistance Programs (Paying for Senior Care)
See List of pharmaceutical companies' patient assistance programs.
• RareCare, National Organization for Rare Disorders (NORD)
• United Healthcare Children’s Foundation provides grants to cover medical expenses for children whose primary insurance coverage is provided by a commercial health plan.
• U.S. federal government programs that help with healthcare coverage Medicaid and CHIP (Children's Health Insurance Program); Social Security and Medicare; Medicaid for Adults
Buying drugs, devices, and procedures smartly, cheaply, safely (a full section on this website)
Criticism of prescription assistance and medication assistance programs
• ***Is My Drug Copay Coupon a Form of Charity — Or a Bribe? (Elisabeth Rosenthal, KHN, 4-21-22) Drug copayment assistance is a form of profitable charity — and, yes, that’s an oxymoron. Amid skyrocketing drug prices, it's understandable that patients desperately need help affording medicine, especially when their health is on the line. But these programs create a mirage that perpetuates our health care system’s reckless spending.
The federal government generally considers manufacturers’ copay coupons and copay assistance programs to be illegal kickbacks, inducing patients to use and doctors to prescribe more expensive drugs when cheaper ones might do. So it severely limits the use of such assistance to patients covered by government insurers, a particular financial hardship for patients on Medicare.
The purpose of patient copays is to make sure patients (and indirectly, their doctors) have “skin in the game” — that they understand that their treatments have a cost, and that it’s sometimes a lot — encouraging them to be more discriminating in the medicines they use and prescribe. It should make them think about whether they can use a drug that’s cheaper but would work as well.
• Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?' (Emily Kopp, Sydney Lupkin, and Elizabeth Lucas. KHN, 4-6-18) KHN launches “Pre$cription for Power,” a groundbreaking database to expose Big Pharma’s ties to patient groups. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the patient advocacy groups. Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures....Recipients of donations from pharmaceutical firms include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.
• Nonprofit Linked To PhRMA Rolls Out Campaign To Block Drug Imports (Emily Kopp and Rachel Bluth, KHN, 4-19-17) A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerhouse lobbying group that includes Eli Lilly, Pfizer and Bayer.A PhRMA senior vice president, Scott LaGanga, for 10 years led the Partnership for Safe Medicines, a nonprofit that has recently emerged as a leading voice against Senate bills that would allow drug importation from Canada. Not a patient's friend!
• • Drug Companies' Patient-Assistance Programs — Helping Patients or Profits? (David H. Howard, PhD, New England Journal of Medicine, 7-10-14) "None of these programs has an income limit, though trastuzumab's copay-card program imposes a $9,000 benefit cap for patients in households with incomes of more than $100,000. Assistance programs are a triple boon for manufacturers. They increase demand, allow companies to charge higher prices, and provide public-relations benefits. Assistance programs are an especially attractive proposition for firms that sell particularly costly drugs. Faced with high out-of-pocket costs, some patients may decide against taking an expensive medication. Patient-assistance programs can convert such patients from nonusers to users. Programs must incur costs for patients who would have used the drug even in the absence of a program, but manufacturers can afford to pay a lot of $25 or $50 copayments in return for even a small increase in the sales of a $50,000 drug. Although many patients and physicians view patient-assistance programs as a financial lifeline, Medicare and other payers take a dim view of efforts to subsidize patients' out-of-pocket costs. They worry that patient-assistance programs discourage patients from using generic drugs and other less costly alternatives to new, patent-protected therapies."
• Prescription Drug Costs and Health Reform: FAQ (WebMD)
• The Assistance Fund (TAF) (see lists of covered diseases)
• CancerCare (find help by diagnosis or topic)
• Caring Ambassadors (help and information for patients with hepatitis C or lung cancer)
• Fund Finder (PAN Foundation) helps you quickly find financial assistance from charitable foundations.
• Good Days (effective compassion). Supports those with life-altering conditions, from chronic to terminal, in part by helping patients pay for costly treatments insurance won’t cover in their entirety. Guides patients through an opaque and ever-changing healthcare landscape.
• HealthWell Foundation (when health insurance is not enough--Helping the underinsured afford critical medical treatments because no one should go without essential care) See Disease Funds
• Leukemia & Lymphoma Society (LLS)
• Patient Advocate Foundation (PAF, solving insurance and healthcare access problems since 1996)
• Fake Drugs Are a Major Global Problem, WHO Reports (Rae Ellen Bichell, WBUR News, 11-29-17) 'In a report released this week, WHO estimates that "1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified." That includes pills, vaccines and diagnostic kits. "We have reports from all over the globe, from countries rich and poor, and reports on all types of products, both innovative or generic, expensive or not," says Suzanne Hill, who directs WHO's department of essential medicines and health products.'
• Prince's death: Superstar didn't know he was taking fentanyl; no one charged with a crime (Maria Puente, USA Today, 4-19-18) 'Music superstar Prince died two years ago because he thought he was taking the common painkiller Vicodin when, unbeknownst to him, it was laced with deadly fentanyl. "He thought he was taking Vicodin and not fentanyl," said Carver County Attorney Mark Metz...Metz, the top prosecutor in the suburban Minneapolis county that is home to Prince's studio/home complex Paisley Park, told reporters the results of a "painstaking and thorough" two-year investigation found that Prince did not know he had become addicted to fentanyl and neither did anyone around him.'
• Bitter Pills: The Global War on Counterfeit Drugs Muhammad H. Zaman. "The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters..." Zaman is interviewed for this story: Why Counterfeit Drugs Are a Global Problem With No Foolproof Solutions (Karen Weintraub, WBUR News, 4-20-18) "In one terrible month spanning late 2011 and early 2012, more than 650 heart disease patients turned up in hospitals around Lahore, Pakistan, with darkening skin, vomiting and uncontrolled bleeding. Over 150 died. It turned out the medicine they were given to reduce their high blood pressure was contaminated with an anti-malarial drug....That same year, more than 800 Americans were sickened and 76 killed in a meningitis outbreak caused by the New England Compounding Center in Framingham."
• Fake Malaria Drugs Fuel Rise Of Drug-Resistant Disease (Jason Beaubien, WBUR News, 12-19-12) "Counterfeit drugs are a growing scourge around the world. They're generating millions of dollars in revenue for organized crime and fueling the rise of drug-resistant parasites. Anti-malarials are among the most popular drugs to fake. But these faux pharmaceuticals are particularly dangerous because malaria can kill a person in a matter of days."
• Fake Medicines Do Real Damage: Thousands Die, Superbugs Get Stronger (Emily Sohn, WBUR News, 4-24-15) "The global battle against malaria, tuberculosis and other deadly diseases faces plenty of obstacles. Among them: a pandemic of fake and poor-quality medicines....When patients unknowingly take bad drugs, they don't just fail to get better. If a drug contains just a little but not enough of the active ingredient, it can also help breed superbugs that become more resistant to the real stuff."
• Counterfeit Medicine (U.S. Food and Drug Administration)center>[To Top]
• A Supreme Court victory for lowering drug prices (Priti Krishtel, The Hill, 4-28-18) A recent Supreme Court decision on patents — Oil States v. Greene’s Energy Group — marks an understated victory, with far-reaching consequences that will positively impact families and communities across America. This week’s SCOTUS decision affirmed that the Patent Trial and Appeal Board (PTAB) can continue its role in ensuring that monopoly rights given through a patent can be reversed. Why is this important for ordinary Americans? Abuse of the patent system is directly tied to skyrocketing drug prices.
• **** The claim that the U.S. government already has the power to lower drug prices (Glenn Kessler, Opinion, Fact Checker, Washington Post, 9-8-21) “HHS should consider using march-in rights when drugs face limited competition or market practices have failed to ensure an affordable price, ensuring that prescription drugs invented with taxpayer dollars are reasonably priced and affordable.” This is a classic Washington story: a deep-in-the-weeds battle over the meaning of a few words in a 40-year-old law, with implications that could upend the pharmaceutical industry. There’s a section of the law that gives the federal government, under certain conditions, the power to “march in” and license patent rights to another manufacturer. Some lawyers, health care experts and lawmakers believe this provision offers a mechanism for the federal government to act to lower the cost of expensive drugs originally created with federal funds.
• Related story: Leading money-in-politics data nonprofits merge to form OpenSecrets, a state-of-the-art democratic accountability organization (Press release, 6-2-21) The Center for Responsive Politics and National Institute on Money in Politics launch combined organization to integrate federal, state and local data.
• Healing an ailing pharmaceutical system: prescription for reform for U.S. and Canada (Adam Gaffney, instructor in medicine, Harvard; Joel Lexchin, professor emeritus, York; US, Canadian Pharmaceutical Policy Reform Working Group, British Medical Journal, 5-17-18) "Our pharmaceutical systems are broken, and only fundamental reform can ensure universal access to safer, more innovative, and more affordable drugs....Our proposal rests on six principles:
---Medical needs, not financial means, should determine access to medications
---Drugs must be affordable to society
---Drug development should be geared toward real innovation that maximizes population health
---The human right to health must take precedence over intellectual property rights (patents)
---The safety and effectiveness of medications must be independently and rigorously evaluated
---Comprehensive and unbiased information on drugs should be available to prescribers and patients." Here is the full proposal as published in BMJ. ~From Physicians for a National Health Program (PNHP)
• California’s New Transparency Law Reveals Steep Rise In Wholesale Drug Prices (Barbara Feder Ostrov and Harriet Blair Rowan, California Healthline, 10-11-19) Drugmakers fought hard against California’s groundbreaking drug price transparency law, passed in 2017. Now, state health officials have released their first report on the price hikes those drug companies sought to shield. Pharmaceutical companies raised the “wholesale acquisition cost” of their drugs — the list price for wholesalers without discounts or rebates — by a median of 25.8% from 2017 through the first quarter of 2019. Generic drugs saw the largest median increase of 37.6% during that time. By comparison, the annual inflation rate during the period was 2%. [Emphasis added]
• Ten Charts on Proposals to Lower Prescription Drug Costs (KFF, 12-11-19) A primer on prescription drug proposals introduced by the Senate Finance Committee, House Democrats and Republicans, and the Trump Administration.
• Drug pricing bill faces uphill climb in an impeachment-focused Congress (Liz Seegert, Covering Health, AHCJ, 10-2-19) "The Pelosi-backed The Lower Drug Costs Now Act (HR 3) would allow the government to negotiate the price of up to 250 brand name drugs on behalf of Medicare beneficiaries, the New York Times reported. Manufacturers also would have to offer these prices in the private insurance market, a provision that has many Republicans up in arms but has received some support from President Trump in the past....HR 3 limits the maximum price for any negotiated drug to the average price in similar countries....The amounts would be pegged to the costs of the same drugs in other countries, which are generally much cheaper, under an “international price index.” It would also levy steep fines — starting at 65 percent of the gross sales of the drug — on drug companies that refuse to engage in negotiations and limit how much drug costs can go up...Additionally, the bill creates a new $2,000 out-of-pocket limit on drug costs for Medicare enrollees. Currently, Medicare Part D plans have no out-of-pocket cap on drug costs."
• Our drug policy often prioritizes eliminating rare disease. One researcher asks: Is that the right goal? (Nicholas Florko, STAT+, 11-26-19) "When it comes to big drug pricing policies, are we thinking big enough? And no, I don’t mean prioritizing middleman profits over patient savings, or prioritizing a higher cost biologic over a biosimilar. Think much bigger: What if we are investing far too much in breakthrough research, and not enough in persistent and growing problems like poverty and suicide? “Are we sure even that the right intervention is more drugs for rare diseases rather than more money back in poor people’s pockets?...When we talk about new drugs we often talk about drugs that improve quality of life but don’t increase longevity, or we talk about drugs that increase longevity on the order of months, maybe years,” Bach explained. “If you’re talking about a quarter of a state’s population having ten years less of life expectancy, you’re not going to be able to develop enough rare disease drugs to make up for that” That was the theme of a whirlwind talk at last week’s STAT Summitt from Peter Bach, the Sloan Kettering researcher who has made a name for himself by systematically, and sometimes scathingly, critiquing the U.S. drug pricing system.
• How a Democratic president could reduce drug prices without Congress (Dylan Scott, Vox, 11-25-19) Two obscure laws provide an opening for a Democratic president to slash drug prices. March-in rights, explained. The “march-in” provision allows the federal government to license a new patent to another entity under certain circumstances. The first, and most important, condition is that the invention (the medication, for our purposes) depended on government support. That would arguably apply to almost any drug that comes on the market: As STAT reported in 2018, every one of the 210 prescription drugs approved from 2010 to 2016 relied directly or indirectly on research funded by the National Institutes of Health. USC 1498, explained. The government can authorize the production of cheaper versions of patented drugs so long as they pay the company that owns the original patent a fair price.
• How a billionaire couple greased the skids for Nancy Pelosi’s drug pricing bill (Lev Facher, STAT, 11-26-19) When House Democrats pass legislation next month that would slash prescription drug spending to the tune of $1 trillion, they’ll have John and Laura Arnold to thank. The Texas billionairesin recent years have used their wealth to turbocharge America’s drug pricing debate, bringing their advocacy to a peak as Congress edges closer to enacting drug-price reforms. Amid a broader tide of anti-pharma sentiment, the pharmaceutical industry isn't pleased that Arnold Ventures has helped push the drug pricing narrative so dramatically against the industry. But nobody can deny they've been effective. Ben Ippolito, an American Enterprise Institute health care researcher, put it this way: “This moment is ripe for somebody like John Arnold to pour more gasoline on the fire. And he’s got a lot of gasoline.” Thanks to their roughly $60 million drug pricing push, the Arnolds have quietly accumulated more clout on the issue than perhaps any entity besides the pharmaceutical industry itself.
• Health Insurance Hustle: The confounding way we pay for care (Propublica/NPR series) Americans pay insurance companies to make sure their medical needs are covered — and at a cost they can afford. But games, side deals and hidden incentives often result in higher costs, delays in care or denials of treatment.
• Anatomy of a 97,000% drug price hike: One family's fight to save their son (Wayne Drash, CNN, 6-29-18) At 7 months, Trevor was diagnosed with infantile spasms, a rare and catastrophic form of epilepsy. The diagnosis was devastating, forcing the family to cancel an overseas move and fight for their son's life. It also thrust them into the unregulated world of America's drug prices. Trevor's doctors said he needed a "miracle drug" known as Acthar. But between Trevor's birth and diagnosis, the price of the drug had shot up from $1,600 a vial to more than $23,000 a vial -- making him one of the first children caught up in one of medicine's most controversial price hikes. Trevor would need at least five vials....Questcor Pharmaceuticals had paid a mere $100,000 for the rights to the drug in 2001. The company first raised the price from $40 to $750 a vial shortly after acquiring it. The price doubled over the next few years. Then, on August 27, 2007, the price shot up overnight from $1,600 to $23,000 a vial. The hike was so dramatic that the Epilepsy Foundation, the American Epilepsy Society, the American Academy of Neurology and the National Association of Epilepsy Centers fired off a letter demanding answers.
• FACEBOOK POST ON INSULIN: In 1923 Frederick Banting & Charles Best won the Nobel Prize for the discovery of insulin. They decided to give away the patent for free because they wanted insulin to be available to diabetics at no charge. When Banting and Best turned over the patient for production, they agreed to receive only $1 each in compensation. Since then drug companies monopolized the insulin market and now charge diabetics $500 a month to survive.
• Today’s insulin isn’t what Banting and Best developed. It’s far, far better (John LaMattina, STAT, 11-14-19) "The insulin that Banting and Best first administered to a patient in 1922 was isolated from the pancreas of an ox. It was short-acting, and had to be administered multiple times a day.... People with diabetes are no longer using preparations derived from animals. We have new insulins that can closely mimic natural physiological conditions, and which are safer than the older agents....Walmart sells Novolin, a human insulin made by Novo Nordisk, for a mere $25 per vial (a vial can provide about 10 days of therapy) — and you don’t need a prescription for it. Novolin can be viewed like a generic in that it’s an older version of human insulin that does not afford the benefits of the newer insulin analogs in terms of 24-hour control, but is 10 times less costly." [Still, there is no question that there is price-gouging.]
• Selling a Lifetime of Insulin for $3 (Craig Idlebrook, Insulin Nation, 8-7-15) 'Frederick Banting, Charles Best, and James Collip, the team that first discovered and refined insulin therapy, agreed to receive $1 each in exchange for giving their patent rights to the Board of Governors of the University of Toronto in 1923.The patent was supplied royalty-free to pharmaceutical companies worldwide....It wasn’t long before drug companies had figured out a way to turn a good profit on insulin, even by possibly illegal means. By 1941, Eli Lilly and Company and two other pharmaceutical companies were indicted for an alleged insulin price-fixing scheme at the time, according to a Chicago-Tribune article; it was a charge that Lilly would settle in a “no contest” agreement. The price of insulin began to climb sharply once drug companies devised how to make synthetic insulin in the late seventies, and there has been little relief since that time.'
• It’s the insulin, stupid: How drug pricing’s simplest case study became a top issue for 2020 Democrats (Lev Facher, STAT, 1-28-2020) Even in a primary dominated by broader health care issues, insulin has emerged as particularly alluring campaign fodder for Democrats. Unlike more perplexing topics like health insurance reform or the cost of drug research, candidates have a plain and simple rallying cry for insulin: That it’s corporate profiteering.
• Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban. Eban reveals how generic drug makers not only help ensure that some of the worst quality drugs enter the least regulated markets but also take extreme measures to avoid regulatory scrutiny. The story of generic drugs connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings?
• Price of Snakebite Drug Is Sky High, But New Competitor Unlikely to Lower Costs (Carmen Heredia Rodriguez, KHN, 8-8-19) In a case reported by Kaiser Health News and NPR (a 9-year-old hiker snakebitten at dusk on a nature trail), an Indiana hospital last summer charged nearly $68,000 for four vials of CroFab. CroFab faces competition from a snake antivenin called Anavip. But few experts who study drug laws and drug prices expect this competition to reduce the cost for patients. Legal wrangling, the advantageous use of the patent system and the regulatory hurdles in creating cheaper alternative drugs stymie any serious price competition. Indeed, the antivenin is a case study of why drug prices are so high. Head-to-head competition between brand-name medicines may not meaningfully reduce prices. “When we allow a system of perverse incentives to flourish, this is the result we get,” said Robin Feldman, a professor at the UC Hastings College of the Law in San Francisco who specializes in pharmacy law.
• Outrageous medical bills (examples and case histories) "Bill of the month" (the Kaiser Health News and NPR series), Sarah Kliff's series of exposes on Vox, and other examples of bad $behavior.
• Tylenol For Infants And Children Is The Same. Why Does 1 Cost 3 Times More? (Selena Simmons-Duffin, Shots, NPR, 3-27-19) If you've ever had a little one at home with a fever, you might have noticed two options for Tylenol at the store. There's one for infants and one for children. They contain the same amount of medicine — 160 milligrams of acetaminophen per 5 milliliters of liquid — but the infant version costs three times more.What gives? It turns out, there's a backstory. And here's a dose table for infants and children for acetaminophen (Tylenol).
• Truecostofhealthcare.org (David Belk MD's site is a "treasure trove of information and analysis for journalists and highly regarded by academics as well" (Randy Barrett, AHCJ, Spring 2019) Hover over the heading "healthcare" and dig deep into material under subheads: Medications, Pharmaceutical Industry, Billing, Medicare, Hospitals, etc.
• Americans Ready to Crack Down on Drug Prices That Force Some to Skip Doses (Jay Hancock, KHN, 3-1-19) Large majorities of Americans from both major parties support steps to control prescription drug costs such as showing prices in ads, removing barriers to generics and letting patients get less expensive drugs from Canada, a new poll shows. By a 9-to-1 ratio, Republicans, Democrats and independents favor making drug companies show list prices in their advertising. Although Republicans tend to frown on government control over commerce, 8 in 10 Republican respondents said they support giving negotiating power to the $700 billion Medicare program in order to lower drug prices for seniors. More than 70 percent of all respondents back importing drugs from Canada and capping out-of-pocket Medicare costs. More than 80 percent said they favor making it easier for less expensive generics to compete with brand-name drugs.
• Drug Prices Will Soon Appear in Many TV Ads (Glenn Thrush and Katie Thomas, NY Times, 5-8-19) The Trump administration for the first time will require pharmaceutical companies to include the price of prescription drugs in television advertisements if the cost exceeds $35 per month. The move, announced on Wednesday by Alex M. Azar II, the health and human services secretary, is the most visible action the administration has taken so far to address the rising cost of prescription drugs. It has been a key issue for American voters and one that both Republicans and Democrats have vowed to address.
• Justice Department alleges more drug copay kickbacks (Bob Herman, Axios, 4-4-19) "Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals are paying a combined $122.6 million to the federal government to settle allegations that they funded outside charities that covered patients' copays for the specific drugs they sell. Why it matters: It's illegal for pharmaceutical companies to directly or indirectly pay for patients' medications, because the payments are "masking the high prices those companies charge for their drugs,” U.S. Attorney Andrew Lelling said in a statement. Yet, copay kickback allegations continue to pop up.
• Should the Government Use Its Monopsony Power to Reduce the Price of Drugs? (Richard Posner, The Becker-Posner Blog, 12-27-09) "Because beneficiaries of government health-care subsidies do not pay the full cost of health care, including the full cost of drugs, health care is overproduced from the standpoint of economic efficiency. This overproduction is exacerbated by the immense marketing expenses of the drug industry, which appear to exploit the ignorance and desperation of the sick. Particularly objectionable in my opinion is television advertising of prescription drugs, which is designed to bypass physicians’ exercise of professional judgment by appealing over the heads of the physicians to the patients, who pester their physicians to prescribe drugs that the patients have seen advertised on television....An objection likely to block any such measure is that it amounts to government’s rationing medical care. It does. But if government is to be the (indirect) provider of care, it has to ration it; otherwise the costs of medical care will strangle the economy." Posner explains monopsony power.
• Watch: Big Week For Drug Pricing Debate Featured On C-SPAN (3-1-10) Watch online.
• Pharma Execs Dig In for a Fight Against Outraged Senators (Emmarie Huetteman and Jay Hancock, Kaiser Health News, KHN, 2-26-19) Senators got their first opportunity Tuesday to prod drugmakers about the wallet-emptying prices they charge for prescription drugs. Almost in unison, the executives expressed support for eliminating rebates that flow to industry middlemen instead of patients; for increasing transparency about how they set prices; for shifting to a more value-based pricing system, in which outcomes are rewarded. Together they demurred when asked to commit to lowering list prices on drugs like insulin and the blockbuster rheumatoid arthritis drug Humira. The drugmakers — AbbVie, AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, Merck, Pfizer and Sanofi — appeared before the Senate Finance Committee as lawmakers mull how to best control rising drug prices. Sen. Ron Wyden of Oregon pointed out that all but one of the drugmakers represented Tuesday were among the top 10 profit-makers. “Your profits are outsized compared to others in the industry, you get a massive portion of your revenue from American taxpayers, and you bear none of the consequences of high drug prices,” Wyden said. Here are five key takeaways from the hearing: (1) Targeting Rebates and PBMs. Each of the seven executives said they support eliminating rebates, or discounts negotiated by pharmacy benefit managers that lower the cost of drugs for those footing the bill — generally, insurance companies or larger employers. PBMs keep a portion of the rebate as payment, but patients are often the only ones who don’t benefit.
(2) Debating List Prices. Wyden had little patience for the executives’ emphasis on rebates, which he dismissed as “window dressing.” He was unequivocal: List prices set by the drugmakers are the real problem. The list prices are unaffordable.
(3) Applauding The CREATES Act. All seven executives pledged support for the CREATES Act, which is designed to stop what Food and Drug Administration chief Scott Gottlieb calls “shenanigans” perpetrated by brand-name companies to block competition. Pharma firms often refuse to supply makers of generics with needed samples to develop rival, less expensive products or abuse safety rules as another way of hindering competition. (See Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions (Sydney Lupkin, KHN, 5-23-18)
(4) Flap Over Prices Overseas. Senators hammered executives on price disparities between the United States and elsewhere, extracting admissions that the companies make money even in markets where prices are much lower. “How is that not gouging the American consumer with high prices even though you’re giving other people, Western, industrialized countries, a better deal?” Wyden asked.
(5) Friction Over Patents. AbbVie, the maker of the top-selling rheumatoid arthritis drug Humira, came under especially intense — and notably bipartisan — scrutiny for its use of patents to thwart competition. Sen. John Cornyn (R-Texas) pointed to the decades-long grip AbbVie has on Humira since it secured multiple patents on the drug without making changes to it, as well as the drugmaker’s lawsuit to block another company, Amgen, from creating a cheaper, biosimilar version. Perhaps the Senate Judiciary Committee should also investigate AbbVie as a matter of anti-competitive behavior, Cornyn said, turning to Grassley, who is also on that committee. Grassley agreed.
• California Adds Its Clout to States Battling High Drug Prices (Katie Thomas, NY Times, 1-11-19) "Gavin Newsom dived into the highly charged debate over prescription drug prices in his first week as California’s governor, vowing action on a topic that has enraged the public but has proved resistant to easy fixes. His idea: Find strength in numbers. Within hours of taking office on Monday, Mr. Newsom signed an executive order proposing a plan that would allow California to directly negotiate with drug manufacturers. The state would bring to the bargaining table not just the 13 million beneficiaries of Medi-Cal (California’s version of Medicaid), but also other state agencies that purchase drugs, including coverage for state workers and prisoners. Down the road, the plan could possibly allow private insurers and employers to join in the savings."
• How PhRMA finally lost: the inside story of the group’s biggest lobbying failure in years (Nicholas Florko, STAT News, 1-2-19) "The drug industry’s storied lobbying group isn’t accustomed to bad news...[On Feb. 7] Congress had just laid out a plan to force drug makers to pay far more into Medicare — a policy change none of pharma’s lobbyists had seen coming....STAT spoke with key members of Congress, congressional staffers, experts, and lobbyists both within the drug industry and outside it to piece together the inside story of how the drug industry finally lost — big — in Washington....Unbeknownst to PhRMA...some of those Republicans had been working alongside Democrats for weeks, endeavoring to hammer out a tiny policy change with massive consequences for pharma. Slipped into less than half a page of the 250-page bill — the whole section is only 168 words — the new policy requires drug makers to pay a larger share of a Medicare beneficiaries prescription costs when that person is in something known as the “donut hole.”... Even now, months later, Washington hasn’t coalesced around a single explanation for McConnell and Ryan’s decision to give pharma that “haircut.” Several sources inside and outside the government suggested Republicans were fed up with the industry and ready to send a message they weren’t invincible anymore. Others say Republican staffers didn’t know quite how big a policy change they were putting forward. Many pointed to the high-pressure budget negotiations and the need to find something — anything — to pay for February’s spending deal."
• In Montana, a Tough Negotiator Proved Employers Don’t Have to Pay So Much for Health Care (Marshall Allen, Health Insurance Hustle, ProPublica and NPR, 10-2-18) With its employee health plan in financial crisis, Montana hired Marilyn Bartlett, a former insurance insider who pushed back against industry players with vested interests in keeping costs high. She proved, essentially, that bargaining down health care prices works. "Bartlett understood something the state officials didn’t: the side deals, kickbacks and lucrative clauses that industry players secretly build into medical costs. Everyone, she’d observed, was profiting except the employers and workers paying the tab....The way health care works in America, most employers cede control of health care costs to their health insurers, to the hospitals that treat their employees and to the companies they pay to manage their benefits. The costs are a dense thicket that few employers feel equipped to hack through. So, they don’t."
• You Snooze, You Lose: Insurers Make The Old Adage Literally True (Marshall Allen, ProPublica and NPR, 11-21-18) Millions of sleep apnea patients rely on CPAP breathing machines to get a good night’s rest. Health insurers use a variety of tactics, including surveillance, to make patients bear the costs. Experts say it’s part of the insurance industry playbook.
• Your Medical Devices Are Not Keeping Your Health Data to Themselves (Derek Kravitz and Marshall Allen, ProPublica and NPR, 11-21-18) CPAP units, heart monitors, blood glucose meters and lifestyle apps generate information that can be used in ways patients don’t necessarily expect. It can be sold for advertising or even shared with insurers, who may use it to deny reimbursement....the makers of the Fitbit step counter, for example, say they never sell customer personal data or share personal information unless a user requests it; it is part of a legal process; or it is provided on a “confidential basis” to a third-party customer support or IT provider. That said, Fitbit allows users who give consent to share data “with a health insurer or wellness program,” according to a statement from the company.
• Why Your Health Insurer Doesn’t Care About Your Big Bills (Marshall Allen, Health Insurance Hustle series, ProPublica and NPR, 5-25-18) Patients may think their insurers are fighting on their behalf for the best prices. But saving patients money is often not their top priority. Just ask Michael Frank. Frank’s insurance company agreed to pay a high price to the hospital where he had his hip operation. Neither the hospital or his insurer would justify the costs to him, no matter how hard he pressed."Widely perceived as fierce guardians of health care dollars, insurers, in many cases, aren’t. In fact, they often agree to pay high prices, then, one way or another, pass those high prices on to patients — all while raking in healthy profits....The Affordable Care Act kept profit margins in check by requiring companies to use at least 80 percent of the premiums for medical care. That’s good in theory but it actually contributes to rising health care costs. If the insurance company has accurately built high costs into the premium, it can make more money....Wonks call this a “perverse incentive.” That's just a taste of this long article.
• Health Insurers Are Vacuuming Up Details About You — And It Could Raise Your Rates (Marshall Allen, Health Insurance Hustle series, ProPublica, 7-17-18) Without any public scrutiny, insurers and data brokers are predicting your health costs based on data about things like race, marital status, how much TV you watch, whether you pay your bills on time or even buy plus-size clothing.
• With new drug pricing legislation, Grassley and Wyden hint at the next steps for a powerful Senate committee (Ike Swetlitz, STAT, 12-4-18) "A powerful, bipartisan pair of lawmakers introduced new legislation Tuesday that would give the government more power to make sure drug companies play by the rules of the Medicaid program. It’s the first sign of how the duo, Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) intends to use their respective perches at the Senate Finance Committee to lower drug prices. Grassley will chair the committee beginning in January, and Wyden is already its top Democrat. The committee has jurisdiction over Medicare and Medicaid, including oversight of most of the Trump administration’s work to date on the issue of drug prices."
• The Drug That Is Bankrupting America (Jeffrey Sachs, director of the Center for Sustainable Development and Sustainable Development Solutions Network, HuffPost, 2-16-15) America is the land of breakthrough science — and health care scams. There is no question that Solvadi is a lifesaver for millions of Americans infected by Hepatitis C. Yet Solvadi is also the poster child of a U.S. health care system that is being bankrupted by greed, lobbying and indefensible policies on drug pricing. "In December 2013, the Food and Drug Administration approved Sovaldi, and another formulation, Harvoni, which is sofosbuvir used in combination with another drug. Gilead set the price for a 12-week treatment course of Sovaldi at $84,000, amounting to $1,000 per pill. Gilead set the price of Harvoni at $94,000. According to researchers at Liverpool University, the actual production costs of Sovaldi for the 12-week course is in the range $68-$136. Indeed, generic sofosbuvir is currently being marketed in India at $300 per treatment course, after India refused to grant Gilead a patent for the Indian market. In other words, the U.S. price-cost markup is roughly 1,000-to-1!...With a rational U.S. drug pricing system, private investors would expect to earn a reasonable multiple of their R&D for a highly successful drug, perhaps even 5 to 10 times the R&D outlays, in order to reflect the long time horizons and high uncertainties surrounding drug development. Yet at a treatment course of $84,000, the multiple for Sovaldi looks to be around 40 times or more....Sovaldi shows how publicly financed science easily turns into arbitrarily large private profits paid for by taxpayers. The challenge facing the U.S. is to adopt a rational drug pricing system that continues to spur excellent scientific breakthroughs while keeping greed in check."
• At the heart of the Solvadi story is Raymond Schinazi, about whom John Cohen wrote an article in Science: King of the Pills (5-8-15). I link here to a summary. "Raymond Schinazi, an unusual academic/entrepreneur hybrid, has had his hand in the development of five lifesaving drugs that have come to market...which treat HIV and hepatitis B and help cure hepatitis C. He specializes in nucleoside and nucleotide analogs that trip up viruses, a strategy once dismissed by many drug developers as too dangerous." The story explains Schinazi's role in nucleotide and nucleoside analogs and Cohen says, "Schinazi's precise role in sofosbuvir's discovery is ... contentious." (H/T Norman Bauman)
• Searching for Savings in Medicare Drug Price Negotiations (Juliette Cubanski and Tricia Neuman, Kaiser Family Foundation, 4-26-18) Allowing the federal government to negotiate drug prices for Medicare beneficiaries is supported by 92 percent of the public, including a majority of Democrats (96%), Republicans (92%), and Independents (92%). This issue brief provides a short history of the concept of allowing Medicare to negotiate drug prices, describes various approaches, and assessments of their potential savings from the Congressional Budget Office (CBO), and considers the prospects for action in the future.
• Something Happened to U.S. Drug Costs in the 1990s (Austin Frakt, The Upshot, NY Times, 11-12-18) Two decades ago, the costs began rising well beyond that of other nations, and in recent years have shot up again. What can explain it? 'Though Americans take a lower proportion of brand-name drugs, the prices of those drugs are a lot higher than in other countries. For many drugs, U.S. prices are twice those found in Canada, for example. Prices are a lot higher for brand-name drugs in the United States because we lack the widespread policies to limit drug prices that many other countries have. “Other countries decline to pay for a drug when the price is too high,” said Rachel Sachs, who studies drug pricing and regulation as an associate professor of law at Washington University in St. Louis. “The United States has been unwilling to do this.” For example, except in rare cases, Britain will pay for new drugs only when their effectiveness is high relative to their prices. German regulators may decline to reimburse a new drug at rates higher than those paid for older therapies, if they find that it offers no additional benefit. That, by and large, explains why we spend so much more on drugs in the United States than elsewhere. But what drove the change in the 1990s? One part of the explanation is that a record number of new drugs emerged in that decade....
"A U.S. Department of Health and Human Services issue brief estimated that 30 percent of the rise in drug spending between 2000 and 2014 could be attributed to price increases or greater use of higher-priced drugs. Coverage expansions of the Affordable Care Act also contributed to increased drug spending. In addition, “there has been a lowering of approval standards,” Dr. Bach said. “So more of these new, expensive drugs are making it to market faster.”
“As in the earlier run-up in drug spending, we’re largely uncritical of the price-value trade-off for drugs in the U.S.,” said Michelle Mello, a health law scholar at Stanford. “Though we pay high prices for some drugs of high value, we also pay high prices for drugs of little value. The U.S. stands virtually alone in this.” '
• Three Ways to Fix the Drug Industry's Rampant Dysfunction (Michele Cohen Marill, Wired, 9-10-19) Big Pharma has come under fire for mislabeled drugs, price spikes, and life-threatening shortages. Now a handful of startups hope to clean up the industry. "Dysfunction in the drug industry has triggered outrage over contaminated generics, massive price increases, and life-threatening shortages of cheap but vital products. Outrage is a catalyst of entrepreneurship, and now Valisure is one of several startups seeking to solve some of the industry’s most glaring problems. Among them are Civica Rx, which aims to eliminate the frequent shortages of dozens of medicines, and Capital Rx, which wants to make drug pricing less opaque."
• 6 reasons why prescription drugs are so expensive (Linda A. Johnson, AP, Business Insider, 9-25-15). 1. No price controls. 2.Lengthy patents. 3. Limited competition. 4. Small markets. 5. Development and production costs. 6. Fewer new generics. Read the details.
• The Secret Drug Pricing System Middlemen Use to Rake in Millions (Robert Langreth, David Ingold and Jackie Gu, Bloomberg, 9-11-18) "As he compared the newspaper notice with his own records, and then with the county’s, Frahm saw that for a bottle of generic antipsychotic pills, CVS had billed Wapello County $198.22. But South Side Drug was reimbursed just $5.73. So why was CVS charging almost $200 for a bottle of pills that it told the pharmacy was worth less than $6? And what was the company doing with the other $192.49? Frahm had stumbled across what’s known as spread pricing, where companies like CVS mark up—sometimes dramatically—the difference between the amount they reimburse pharmacies for a drug and the amount they charge their clients. It’s where pharmacy benefit managers (PBMs) like CVS make a part of their profit. But Frahm says he didn’t think the spread could be thousands of percent.
• Finding Solutions (Patients for Affordable Drugs) "We have to break the monopoly pricing power of the drug corporations and demand transparency from pharmacy benefit managers who run drug insurance programs. The drug corporations try to scare us. It’s like extortion. They say that if we don’t pay their outrageous prices, they won’t develop new drugs. But the fact is that they are making so much money and wasting so much on marketing and advertising, we can have both innovation and lower prescription drug prices. And then we need to stop the secret deals by pharmacy benefit managers—the corporations that run prescription drug insurance programs—so we can be sure patients are being protected." Read on for a to-do list of changes needed in the present U.S. health care system.
• The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. (Kesselheim AS, Avorn J, Sarpatwari A, JAMA via PubMed, 8-23/30-16) "High drug prices are the result of the approach the United States has taken to granting government-protected monopolies to drug manufacturers, combined with coverage requirements imposed on government-funded drug benefits." (Read Conclusions and Relevance)
• Insulin prices could be much lower and drug makers would still make healthy profits (Ed Silverman, STAT, 9-25-18) As prices for diabetes treatments continue to roil consumers, a new study suggests that manufacturers could make both human and analog insulins at low costs and still pocket a profit. The study estimated the cost of production for a vial of human insulin is between $2.28 and $3.42, while the production cost for a vial of most analog insulins is between $3.69 and $6.16. “Pharmaceutical companies cannot justify charging governments $532 per person per year in the U.K. and $1,251 in the U.S., let alone similar amounts in low- and middle-income countries.”
• Everyone seems to want lower drug prices. 5 reasons why that hasn’t happened (Erin Mershon, STAT, 1-26-18) "An assortment of interest groups spoke out loudly and passionately on the need for action, from hospitals to doctors to insurers to generic drug makers to patients themselves....Instead, congressional efforts to lower drug prices are at a total standstill. In interviews with STAT, lobbyists, lawmakers, and congressional staffers, Republicans and Democrats alike, said the most powerful health industry players conspicuously disagree about exactly how to move forward. Every group pushes its own priorities and strategies — a cacophony that makes it unlikely that crushing drug prices will change any time soon." Five factors keep the broader health care industry from agreeing on how to make drugs more affordable:
1. Health care lobbyists are stuck playing defense.
2. Congress isn’t jumping to act. "It hasn't shown great appetite to tackle drug pricing."
3. Each industry has very different priorities, even when they do agree.
4. All the major players have a stake in the status quo.
5. There’s no silver bullet.
• Senate passes bill to stop pharmacy 'gag clauses' that boost drug prices (Sabrina Eaton, cleveland.com, 9-18) The Senate passed a bill to block "gag clauses" that keep pharmacists from telling customers if their drugs would cost less if they pay out-of-pocket instead of using their insurance. (Elise Amendola, Associated Press) The bill would make it illegal for insurance companies to keep pharmacists from telling customers how to save money by paying out of pocket for medicines instead of going through their insurance companies.
• The benefits pharmacy benefit managers manage do not usually benefit consumers (a round-up of articles on the topic)
• Pharma Companies Jack Up Drug Prices When People Need Them The Most, Report Claims (Science Alert, Charlotte Hu, Business Insider, 9-20-18) During drug shortages, a study found, on average the prices of drugs increased more than twice their usual rate. No clear reasoning was found behind why the prices increased so drastically, but researchers suspect that manufacturers were exploiting shortages to charge more for drugs in high demand. The study also found that prices rose even faster for drugs where there was less competition. Doctor William Shrank, an author on the study, said there was no obvious rationale behind the price hikes. Unless there are serious issues with the material or production facility that requires higher costs, Shrank thinks that there should be a cap to control the pricing on these drugs. "The price of drugs is rising faster than all other sectors of the healthcare economy, and we're spending more on drugs than we are on hospital care."
• This brand-new advocacy group is an unapologetic defender of high drug prices (Nicholas Florko, STAT, 10-4-18) The Alliance to Protect Medical Innovation says its goal is to “help educate policymakers and the public about medical breakthroughs developed by the biopharmaceutical industry.” ..."The group’s website includes pharma-friendly answers to a number of hot-button drug pricing questions....Whoever is behind the group also seems to have a grudge against the Laura and John Arnold Foundation, which funds drug pricing watchdog groups like the Institute for Clinical and Economic Review, Patients for Affordable Drugs, and I-MAK."
• Antibiotics May Soon Become Useless. Now What? (Maryn McKenna, Wired, 12-18-18) Antibiotics were one of the great innovations of the last century. "Yet if we don’t change how we find, finance, and support them, antibiotics may not make it to their 100th birthday, just 25 years from now....Two decades is a long span to wait for a return on any investment, but antibiotics are in a special category because their effectiveness—and market viability—is fleeting. As soon as a drug debuts, bacterial resistance against it begins to emerge....Without a change in tax credits or federal reimbursement for hospital drug purchases, some of the small biotechs now trying to bring new antibiotics to market will be out of business within a few years. Solving this problem isn’t just a matter of finding new funding. It requires that we change how we think about antibiotics—not as products we purchase but as infrastructure we share.... Accepting that antibiotics are infrastructure would change our relationship to the drugs, forcing us to recognize that medicine requires long-term planning. It might allow users to guide drug development in ways that a free market won’t allow. And it makes explicit a thing that has always been true, but never really articulated: The continued availability of antibiotics is as fundamental to the health of society as intact roads and reliable electric generation and robust sewage processing."
• Drug executive: It's a 'moral requirement' to charge patients the highest price (Michael Hiltzik, LA Times, 9-11-18) Nirmal Mulye, the chief executive of drug company Nostrum Laboratories: “I think it is a moral requirement to make money when you can ... to sell the product for the highest price.” 'Mulye was responding to questions posed by the Financial Times about his quadrupling the price of an essential antibiotic to $2,392 per bottle. The drug, nitrofurantoin, is used to treat urinary tract infections. It has been on the market since 1953 and is listed by the World Health Organization as an essential medicine for “basic healthcare systems.” In his interview with the Financial Times..., Mulye defended Martin Shkreli, the former drug company CEO who became the face of the industry’s profiteering in 2015 when he jacked up the price of a generic anti-parasitic drug needed by HIV patients by more than 5,000%. “I agree with Martin Shkreli that when he raised the price of his drug he was within his rights because he had to reward his shareholders,” Mulye told the FT. (Shkreli is currently serving a prison term on fraud charges unrelated to the price hike.)
• How to Stop Drug Price Gouging ( Tim Wu, NY Times, 4-20-17) The government can create a means for pharmacies to get supplies from trusted nations overseas at much lower prices. Doing this would not only save Americans a lot of money but also deflate the incentive to engage in abusive pricing in the first place....The F.D.A. is already regulating imported drugs. It might as well use those powers to fight price gouging. Mr. Trump could also declare a war on abusive pricing, if he chose to.
• Pharma chief defends 400% drug price rise as a ‘moral requirement’ (David Crow, Financial Times, 9-11-18) A pharma executive has defended his decision to raise the price of an antibiotic mixture to more than $2,000 a bottle, arguing there was a “moral requirement to sell the product at the highest price.” Last month, Nostrum Laboratories, a small Missouri-based drugmaker, more than quadrupled the price of a bottle of nitrofurantoin from $474.75 to $2,392, according to Elsevier’s Gold Standard drug database. Nitrofurantoin is an antibiotic used to treat bladder infections that was first marketed in 1953, which appears on the World Health Organization’s list of essential medicines. It comes in a tablet form as well as a liquid version that Nostrum makes
• A pharma exec raised the price of antibiotic by 400 percent — and the government can’t do much about it (Ike Swetlitz and Nicholas Florko, STAT, 9-11-18) The bold words from both sides illustrate just how little has changed in the debate over drug prices, despite the Trump administration’s attempts to scare drug makers away from hiking their prices. “We’ve seen that public shaming doesn’t work. It didn’t work for Daraprim. It didn’t work for EpiPen. It’s not a long term solution for our drug pricing problem,” Rachel Sachs, associate professor of law at Washington University, said.
• The Price They Pay (Katie Thomas, NY Times, and Charles Ornstein, ProPublica, 3-5-18) ProPublica and The New York Times have partnered to tell the stories of Americans living daily with the reality of high-cost drugs. There are millions of others just like them. Drug makers have raised prices on treatments for life-threatening or chronic conditions like multiple sclerosis, diabetes and cancer. In turn, insurers have shifted more of those costs onto consumers. Saddled with high deductibles and other out-of-pocket costs that expose them to a drug’s rising list price, many people are paying thousands of dollars a month merely to survive.
• Drug Price Gouging Laws May Become a New Trend (Shawn Radcliffe, HealthLine, 10-10-17) Maryland has permission to go after prescription drug price gouging. A federal judge gave the go-ahead last week. Drug makers had attempted to block the state’s first-in-the-nation law targeting extreme increases in generic drug prices. Maryland is the first to go after price gouging of pharmaceutical drugs, but other states are trying to lower drug costs in other ways.
BUT WILL THE FEDERAL GOVERNMENT ALLOW STATE REGULATION OF DRUG PRICES?
Will Courts Allow States to Regulate Drug Prices? (Christopher Robertson, New England Journal of Medicine, 9-13-18) 'In 2017, Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential off-patent or generic drug.” But in April 2018, a panel of the federal Fourth Circuit Court of Appeals overturned that statute.'
• State Legislative Action to Lower Pharmaceutical Costs (National Academy for State Health Policy, 2017) Categories: Pharmacy Benefit Managers, Importation, Transparency, Study, Volume Purchasing, Rate Setting, Price Gouging, and Other.
• Louisiana explores a new way to deal with sky-high drug prices (Julia O'Donoghue, NOLA.com/The Times Picayune, 7-25-18) The Louisiana Department of Health is working on a new strategy to expand access to a hepatitis C cure, one that involves the state agreeing to pay a drug company for medication for several years in exchange for unlimited access to treatment. If a deal is worked out, Louisiana's Health Secretary Rebekah Gee said the state would be able to make substantial progress toward eliminating hepatitis C from Louisiana. The arrangement between the state and drug companies would also likely be the first of its kind in the country.
• 10 Top Expensive Medications in Medicare Part D (Carol Marak, Aging Alone, Senior Care, 7-5-18) "Researchers at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego found the cost for the 10 "highest spend" medications in Medicare Part D rose almost one-third between 2011 and 2015. In the same time period, the number of patients treated with at least one of these medications also declined 32 percent. The highest spend list in 2015: the top 10 drugs and conditions
---Lepidasvir/Sofosbuvir (hepatitis C)
--- Insulin glargine (diabetes)
---Rosuvastatin calcium (cardiovascular disease)
---Fluticasone/Salmeterol (asthma and chronic obstructive pulmonary disease)
---Tiotropium bromide (chronic obstructive pulmonary disease)
---Sitagliptin phosphate (diabetes)
---Lenalidomide (blood cancers)
---Esomeprazole magnesium (dyspepsia, gastroesophageal reflux)
---Pregabalin (epilepsy, neuropathic pain, generalized anxiety disorder)
--- Adalimumab (arthritis, Crohn's disease)
For individuals without the benefit of subsidies, the average out-of-pocket cost for 1 of these 10 medications increased from $375 in 2011 to $1366 in 2015, noted the researchers.
• Humira’s Best-Selling Drug Formula: Start at a High Price. Go Higher. (Danny Hakim, NY Times, 1-6-18) "Humira is the best-selling prescription drug in the world....The price of Humira, an anti-inflammatory drug dispensed in an injectable pen, has risen from about $19,000 a year in 2012, to more than $38,000 today, per patient, after rebates, according to SSR Health, a research firm. That’s an increase of 100 percent....'People are skipping doses, people are rationing, people are going into bankruptcy because of this drug,' said Ben Wakana, a former Obama administration spokesman who became executive director of Patients for Affordable Drugs, an advocacy group, because his younger brother couldn’t afford Humira without the financial support of their parents."
• Skyrocketing Drug Prices: Year One of the Trump Administration (PDF, Democratic Staff Report, Committee on Oversight and Government Reform, House of Representatives, 5-11-18) It examines detailed prescription drug price data in three key ways based on an analysis of changes in Average Wholesale Prices (AWP) from December 31, 2016, to March 1, 2018: Prices increased for the best-selling drugs in America (16 of the top 20 best-selling drugs in the United States increased significantly in price in the first year of the Trump Administration, mostly by double digits); Prices increased for drugs that cost most for Medicare; Prices increased for the biggest U.S. drug companies ( the three largest U.S.-based drug companies—Pfizer, Merck, and Johnson & Johnson—increased the prices of eight of their nine best-selling drugs in the first year of the Trump Administration, and they increased the prices of seven of these drugs by double digits).
• Medicare spending on Mallinckrodt drug tops $500 million (Angela Mueller, St. Louis Business Journal, 12-27-16) Medicare spent an average of $162,371 for the 3,100 beneficiaries using Mallinckrodt's H.P. Acthar Gel, according to New York Times' reporting on the 2015 Medicare Drug Spending Dashboard. H.P. Acthar is used to treat a variety of conditions, including acute cases of multiple sclerosis and rheumatic disorders. The cost for Acthar increased from $40 a vial in 2001 to $38,000 in 2016. This price increase came at a time when the Senate's Special Committee on Aging was taking a close look at price gouging among prescription drug companies, releasing a report focused on four companies — Retrophin, Rodelis Therapeutics, Turing Pharmaceuticals and Valeant Pharmaceuticals International.
• Price Check on Drug Ads: Would Revealing Costs Help Patients Control Spending? (Julie Appleby and Sydney Lupkin, KHN, 6-6-18) President Donald Trump wants to control spending on drugs. One of his big ideas: include prices in advertisements, just like warnings about side effects. We wondered how drug prices pinned to ads might look, hypothetically." KHN provides monthly drug costs on the top 10 most-advertised drugs by spending...: Humira, Lyrica, Xeljanz, Eliquis, Keytruda, Taltz, Chantix, Trulicity, Cosentyx, and Entresto.
• ‘Pharma Bro’ Shkreli Is In Prison, But Daraprim’s Price Is Still High (Shefali Luthra, KHN, 5-4-18) "t was 2015 when Martin Shkreli, then CEO of Turing Pharmaceuticals and the notorious “pharma bro,” jacked up the cost of the lifesaving drug Daraprim by 5,000 percent. Overnight, its price tag skyrocketed from $13.50 a pill to $750. Shkreli is now serving a seven-year prison term for securities fraud (unrelated to Daraprim). Turing has renamed itself Vyera Pharmaceuticals. But Daraprim, which costs pennies to make and is used to treat the parasitic infection toxoplasmosis — which is rare in the United States — still retails for more than $750 per pill."
• Prescription Drug Prices: An investigation into costs and processes (Katie Wedell, Dayton Daily News) Consumers are kept hidden from this secret world of drug pricing, which is shrouded in layers of complexity that often confound the principles of basic economics.
• The Flow of Money Through the Pharmaceutical Distribution System (Neeraj Sood, Tiffany Shih, Karen Van Nuys, and Dana Goldman, USC Schaeffer Center for Health Policy & Economics, 2017) Manufacturers have higher gross profit margins for branded drugs and intermediaries have higher gross profit margins for generic drugs. Gross margins on generic drugs are lower for manufacturers (50%), and much higher for pharmacies (43%). More than $1 in every $5 in spending on prescription drugs goes towards profits of firms in the pharmaceutical distribution system. While the current analysis cannot say definitively whether any sectors make excessive profits, greater scrutiny of pricing policies of each sector and more competition throughout the distribution system is warranted."
• Who’s really controlling your drug prices? 5 things to know (Kate Wedell, Dayton Daily News, 2-6-17) "While high-profile stories of price increases for life-saving prescription medications have earned negative attention for pharmaceutical manufacturers, many in the public are unaware of the role played by a less visible piece in the drug supply chain — pharmacy benefit managers...critics of these middlemen say their opaque tactics are actually the driving force behind some of the price increases vexing consumers. Pharmacy benefit managers — or PBMs ...determine which drugs are covered or excluded by health plans, which pharmacies patients can use, and play a major role in determining the price everyone along the supply chain will pay....there’s one PBM out there that’s bigger than Pepsi, Coca-Cola, and Home Depot combined, yet nobody really knows what a PBM is. Three PBMs — Express Scripts, CVS Health and Opitmum RX, a division of UnitedHealth Group — control about 70 percent of the market. See Explaining complex world of pharmacy benefit managers led to series for this data journalist (Katie Wedell, AHCJ, 5-29-18)
• Mother, wife, million-dollar patient (Carolyn Y. Johnson, WashPost, 4-25-18) Keeping Loukisha Olive-McCoy alive is a full-time job for her entire family — and good business for drug companies. She has hereditary angioedema (HAE), a life-threatening disease so rare that many doctors have only read about it. Fortunately, cutting-edge drugs can keep the swelling at bay and treat the attacks that break through....For a time, Olive-McCoy couldn’t afford or qualify for health insurance. But once her HAE was diagnosed and she was put on a newly approved rare-disease drug, she entered a pocket of the health-care system that drug companies use to ensure that rare-disease patients can afford their expensive medicine....Without help from a charity funded by a drug company, Olive-McCoy could turn to Medi-Cal, her state’s health plan for the poor. But health experts said that Medi-Cal would not automatically cover her specialists and that, crucially, reimbursements to drug firms are typically less generous than with private insurance because Medi-Cal is entitled by law to deep discounts... Some health policy experts and insurance companies argue that charities, a small but critical part of a sprawling U.S. health-care system, increase sales and shield drug companies from the pressure to lower their prices that might come from publicity about patients unable to afford expensive lifesaving medication. Insurers have raised concerns that the charities could be acting in their donors’ financial interests, for example by paying for health plans that pay the drug companies more in reimbursements." "If she had been on Medi-Cal, Olive-McCoy would have had access to “all covered medically necessary services and FDA-approved drugs,” said Carol Sloan, a spokeswoman for the California Department of Health Care Services. In practice, however, patients on public insurance often face barriers to getting the drugs they need and the specialists they want..."
• It’s time to empower generic drug makers to bring down prices (Patrick Leahy and Chuck Grassley, STAT, 3-16-18) "Prices continue to skyrocket as companies making brand-name drugs restrict competition by refusing to share samples of their drugs with companies aiming to make generic versions or refusing to negotiate a shared safety protocol. This is an abuse of government regulations that are intended to protect patients and ensure drug safety. To rein in spiraling prescription drug prices, we can start by cracking down on abuses by companies making brand-name drugs that engage in tactics to artificially delay the development of generic alternatives. (Read this article and speak up!)
• Drug copay groups: Critical patient charities or fronts for drug makers? (Jayne O'Donnell, David Robinson, Ken Alltucker and Liz Freeman, USA Today, 4-26-18) "Copayment assistance groups, created to help patients with the increasingly higher price of drugs to treat medical conditions, are under investigation by federal authorities for possibly skewing the cost of health care to favor drug companies. The investigations, noted by several drugmakers in their regulatory filings, are slowing contributions to at least two of these assistance groups, charities that sometimes pay top executives salaries of $300,000 or more. Critics of these groups, such as Patients for Affordable Drugs founder David Mitchell, say they drive up the cost of health care by masking the price of drugs and forcing higher costs on the insurance companies that pass them along to consumers and employers. The money to pay for the groups’ support of patients comes almost entirely from the drug companies themselves or other charities they fund. "These groups are a marketing arm of pharma, and the fact that patients are caught in the middle of all this is disgusting," Mitchell says. "Patients shouldn't have to live month to month, at the mercy of the drug companies."...As he prepares to retire April 30, Dana Kuhn, 65, is in Washington this week lobbying for legislation that would protect copay and premium assistance from insurers who have been prohibiting its use in plans purchased on the Affordable Care Act (ACA) exchanges. His story and that of the other groups in investigators and insurers' crosshairs illustrate a little-understood twist on how Washington really works....The government accused UT of paying kickbacks to Medicare patients through a charity, Caring Voice Coalition (CVC), "that held itself out as an independent charitable foundation....This practice, the HHS inspector general said in a statement, could harm patients, the government and taxpayers because people might take pricey drugs instead of cheaper ones."
• Drug makers deserve to be publicly shamed for thwarting competition from generics (Ed Silverman, STAT+, 8-7-17) STAT+ is the subscription version of STAT.
• How Private Claims Data Can Power the Paradigm Shift to Price Transparency (Robin Gelburd, AJMC Managed Markets Network, 5-24-18)
• Buried in spending package: a big win for a small drug company (Erin Mershon, STAT Plus, 3-21-18) Toward the end of the sprawling, 2,232-page spending package congressional leaders unveiled late Wednesday are "five pages detailing a complicated policy that represents a major win for Omeros, the Washington state-based company behind the cataract surgery drug Omidria. In fact, the language is painstakingly worded to ensure the policy affects Omeros and its product and almost no other drug companies." So the "tiny eye drug company is about to walk away from Congress with a great big win: an extra two years of charging Medicare higher prices for its cataract surgery drug."
• New Patient Group to Raise the Issue of Drug Prices in Midterm Elections, Congress and State Houses (Patients for Affordable Drugs Now, 2-1-18)
• Poll: Americans think Big Pharma has even more political clout than the NRA (Rachel Bluth, Kaiser Health News, 3-23-18) More than the National Rifle Association or even Wall Street, it’s the pharmaceutical industry that Americans think has the most muscle when it comes to policymaking. A poll from the Kaiser Family Foundation found that 72 percent of people think the drug industry has too much influence in Washington —outweighing the 69 percent who feel that way about Wall Street or the 52 percent who think the NRA has too much power. Only the large-business community outranked drugmakers.
• Bill Of The Month: For Toenail Fungus, A $1,500 Prescription (Shefali Luthra, KHN, 3-16-18) During Anne Soloviev’s semiannual visit to her dermatologist, a physician assistant diagnosed fungus in two of her toenails. The PA called a prescription into a specialty pharmacy with mail-order services, which would send medication to Soloviev’s home. It seemed like an easy fix to an inconsequential health issue. Then the bill came: $1,496.09 for Kerydin, a topical medication that treats toenail fungus. Read: Nail fungus (American Academy of Dermatology), which lists less expensive options (both medicine applied to your mails and medication taken by mouth).
• Bill of the Month This crowdsourced investigation by Kaiser Health News and NPR dissects and explains your medical bills every month in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs. Do you have a medical bill that you’d like us to see and scrutinize? Submit it here and tell KHN the story behind it. Check out the other examples of Bills of the Month.
• Of ‘Miracles’ And Money: Why Hemophilia Drugs Are So Expensive (Jenny Gold, Kaiser Health News, 3-8-18) The U.S. market is flooded with 28 different medications for just 20,000 patients with the hereditary bleeding disorder. Yet intense competition hasn’t worked to bring costs down. Medications to treat hemophilia cost an average of more than $270,000 annually per patient, according to an Express Scripts report--more if there are complications. Sales amount to $4.6 billion annually in the U.S.
• Big Health-Care Players Are Turning Their Partners Into Prey (Robert Langreth, Bloomburg, 3-12-18) In the chain of drug suppliers, there is pressure on each slice of profit. Pharmacy benefit managers and insurers have pushed out smaller pharmacy partners. 'The interest by insurers and PBMs in the pharmacy business has risen in parallel with the growth of high-cost “specialty’’ medicines that need delicate handling or careful counseling of patients. Handling those drugs can be a profitable sideline....The markups are in the single digits now, Komoto said, but specialty pharmacies still get a spread on costly drugs, and may also get fees for their services or for selling data."
• Express Scripts 2015 Drug Trend Report (March 2016)
• The first target on drug prices: pharmacy benefit managers (Bob Herman, Axios, 3-12-18) But analysts say squeezing PBMs won't solve some of the fundamental problems that drive high drug spending. Nice outline of the issues and competitors for your health care dollar.
• LOWER DRUG PRICES TODAY. Join the fight. (Patients for Affordable Drugs Now) Eight years ago, David Mitchell was diagnosed with multiple myeloma and, as he approached retirement last year, the former head of a public policy advocacy firm in Washington, DC, decided to take on a cause — drug pricing, devoted to injecting patient voices into the complicated and raucous debate. See The Cancer Patient Taking On High Drug Prices (Sarah Zhang, The Atlantic, 9-6-17) David Mitchell, 66, has multiple myeloma, a blood cancer that is incurable but treatable. To stay alive, he takes $440,000 worth of drugs a year. . Now he’s founded a nonprofit to make drugs more affordable. Read transcript of interesting interview.
• Here are 6 of the top reasons why prescription drugs are so expensive (Linda A. Johnson, Associated Press, 9-25-15) (1) No price controls. (2) Lengthy patents. (3) Limited competition. (4) Small markets. (5) Development and production costs. (6) Fewer new generics. "For many drugs, there isn't enough competition to hold down prices. Many older generic drugs were priced too low to be profitable, so some drugmakers stopped making them. Once only one company or two companies make a drug, the price usually shoots up. For older, brand-name drugs that treat conditions too rare to attract multiple manufacturers, the sole maker has a de facto monopoly....large backlog of generic drugs awaiting US regulatory approval means that for some off-patent drugs, only one or two generic versions have been approved. That limits reductions from the brand-name drug's price....Scores of drugs, mostly older, once-cheap generics, have been in short supply over the last decade. Reasons include raw material shortages and manufacturing deficiencies involving dirty factories, pills containing the wrong amount of an active ingredient and other serious problems, particularly at factories in India. Those trigger production shutdowns or temporary bans on their sale in the US. Also, several drugmakers have recently been buying rights to older drugs, then hiking the price, as Turing did with Daraprim."
• Everyone seems to want lower drug prices. 5 reasons why that hasn’t happened (Erin Mershon, STAT, 1-26-18) So why can’t the broader health care industry agree on how to make drugs more affordable? Here are five factors. 1. Health care lobbyists are stuck playing defense. 2. Congress isn’t jumping to act. 3. Each industry has very different priorities, even when they do agree. 4. All the major players have a stake in the status quo. 5. There’s no silver bullet. "Mitchell, along with a spokesman for the Association of Accessible Medicines, which represents generic manufacturers, also pointed to growing consensus behind smaller, targeted policies that would keep branded drug manufacturers from “gaming the system” — policies like CREATES and other changes to the patent system that could garner broader support."
• The High Cost of Cancer Drugs and What We Can Do About It (Mustaqeem Siddiquia and S. Vincent Rajkumarb, Mayo Clinic. Proc. on PMC, Oct. 2012) As long as we have a for-profit system involved in the manufacture of lifesaving drugs, we will always run the risk of high costs. An extremely well-funded philanthropic foundation could, in theory, either create a nonprofit generic manufacturing company or purchase established generic manufacturing companies and, as lifesaving cancer drugs become generic, make generic cancer drugs available at a very low cost because they would have no motive to profit from such a venture. Or they could facilitate FDA approval of companies that legally manufacture generic cancer drugs in other countries for a fraction of the cost at which the drug is sold in the United States. Few philanthropic foundations in the world have the resources to do any of this, and the idea is far-fetched, but if someone stepped forward, as happened in the case of providing drugs to treat human immunodeficiency virus and other diseases in Africa, we might able to provide a segment of patients with accessible and affordable cancer drugs. The existence of nonprofit generic companies might also help prevent or deal with drug shortages.
• Fed Up With Drug Companies, Hospitals Decide to Start Their Own (Reed Abelson and Katie Thomas, NY Times, 1-18-18) The idea is to directly challenge the host of industry players who have capitalized on certain markets, buying up monopolies of old, off-patent drugs and then sharply raising prices, stoking public outrage and prompting a series of Congressional hearings and federal investigations....A group of large hospital systems plans to create a nonprofit generic drug company to battle shortages and high prices. Hospitals have also struggled to deal with shortages of hundreds of vital drugs over the past decade, ranging from injectable morphine to sodium bicarbonate (the medical form of baking soda), shortfalls that are exacerbated when only one or two manufacturers make the product. The Veterans Administration may become involved. "While she said the agency is able to negotiate good prices for veterans, “we don’t necessarily control supply” and have experienced many of the same shortages, including the recent lack of saline fluids, as the other health groups."
• Angered by high prices and shortages, hospitals will form their own generic drug maker (Ed Silverman, Pharmalot, 1-18-18) Angered by rising prices and persistent shortages of generic drugs, four of the nation’s largest hospital systems are forming a new, not-for-profit manufacturer.
• Pharma Has Another Reason To Look Out -- Healthcare Systems Now Plan To Make Their Own Drugs (John Nosta, Forbes, 1-18-18) Intermountain Healthcare is leading a collaboration with Ascension, SSM Health, and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form the company. The five organizations represent more than 450 hospitals around the U.S. "The new company intends to be an FDA approved manufacturer and will either directly manufacture generic drugs or sub-contract manufacturing to reputable contract manufacturing organizations, providing patients an affordable alternative to products from generic drug companies whose capricious and unfair pricing practices are damaging the generic drug market and hurting consumers."
• Why Prescription Drug Prices Are So High in the U.S. (Sydney Lupkin, Kaiser Health News, Time, 8-23-16) The “most important factor” that drives prescription drug prices higher in the United States than anywhere else in the world is the existence of government-protected “monopoly” rights for drug manufacturers. Researchers at Harvard Medical School found that the problem has deep and complicated roots. The five key findings in their JAMA review of studies: 1. Drug manufacturers in the U.S. set their own prices, and that’s not the norm elsewhere in the world. 2. We allow “government-protected monopolies” for certain drugs, preventing generics from coming to market to reduce prices. 2. The U.S. patent system allows drug manufacturers to remain the sole manufacturer of drugs they’ve patented for 20 years, but sometimes drug companies deploy questionable strategies to maintain their monopolies. 3. The FDA takes a long time to approve generic drugs. 4. Sometimes, state laws and other “well-intentioned” federal policies limit generics’ abilities to keep costs down. 5. Drug prices aren’t really justified by R&D.
• Why Our Drugs Cost So Much I(AARP Bulletin, May 2017) Nothing stops drug companies from charging the highest price the market will bear.
• The Loopholes Drug Companies Use to Keep Prices High Cynthia Koons and Robert Langreth, Bloomberg, 12-20-17) Bob Kelsey can’t afford a cancer drug that could save his life. The retired firefighter, 53, needs Revlimid to stay healthy. Celgene Corp. has raised the price 88 percent over the past seven years. The drug doesn’t have substantial competition from a less expensive generic version, and probably won’t for another eight years. Celgene has worked hard to make sure of that. Celgene got 61 patents on Revlimid, many granted years after the drug was first approved. They could make Celgene the dominant manufacturer for 20 years. Drugmakers are using a variety
• British Columbia considers forcing drug companies to disclose payments to doctors (Kelly Grant, Globe & Mail, 6-24-18) British Columbia is planning to join Ontario in forcing pharmaceutical companies to reveal their payments to physicians, patient groups and other health-care organizations. Consultations are set to begin in Vancouver and Victoria next month on a potential health-sector transparency program, one that could compel the makers of drugs and medical devices to disclose what they pay individual physicians for delivering speeches, sitting on advisory boards, travelling to conferences and other work. payments from pharmaceutical companies are not necessarily a bad thing, but disclosing them would be helpful for patients who want to know if their doctors have a potential financial conflict of interest when they recommend a drug or procedure....Last fall, Ontario became the first province to pass legislation inspired by the Physician Payments Sunshine Act, a U.S. law that makes public a searchable database of all drug-company payments to doctors worth $10 or more."
• Dollars for Docs search tool (Pro Publica). Use this to see if your doctors receive money from drug or device companies (which might influence which drugs and devices they prescribe)
• Rapid flurry of new drug pricing leaves no room for public debate (Dr. Kevin A. Schulman, The Hill, 10-16-17) In August, Novartis announced the price of their CAR-therapy — a form of treatment primarily for blood cancers like leukemia and lymphoma — was $475,000 per patient based (although they may offer a refund for patients who do not benefit from the therapy).
What is the unique in the pharmaceutical market is the lack of outcry from hospitals and physicians over these unprecedented prices. In any other industry, if the cost of your core technology faced astronomical price increases, you’d quickly see a backlash. Unfortunately, in health care, the federal government has developed a pricing program that make many hospitals a beneficiary of this aggressive pricing strategy on the part of pharmaceutical manufacturers. You see, hospitals buy drugs at a significant discount from the list prices under a program called 340B, and then are able to sell them at above the list price to Medicare and private health insurance plans. This markup on drug costs is now the largest profit center of many of these hospitals.
• TransUnion, Equifax and Experian Agree to Overhaul Credit Reporting Practices (Tara Siegel Bernard, NY Times, 3-9-15) "The three companies will also establish a six-month waiting period before reporting medical debts on consumers’ credit reports, providing more time for consumers to resolve issues that might amount only to a delayed insurance payment or another dispute. The credit agencies will also remove medical debts from an individual’s report after the debt is paid by insurance." "“Too many people are surprised to learn of medical billing problems only after having a bill sent to collection and being forced to deal with damaged credit,” said Mark Rukavina, a longtime consumer advocate and principal of Community Health Advisors, a consultancy that works with nonprofit hospitals on billing and collection issues. “Having the agencies finally agree to remove medical debts that were reported and subsequently paid by insurers is long overdue.”
• Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication. A roundup of articles and analysis on the subject. For example: (a) It doesn't matter if a cheaper (often generic) version may be available if doctors don't pay attention to costs and consumers believe the more expensive drug is probably more effective. Moreover, doctors who do pay attention to costs have an incentive to prescribe the more expensive version of a drug, not the generic version. (b) Step therapy ("fail first" protocols insist that a patient start with a traditional lower-cost drug and advance to a newer, more expensive drug only if the first drug fails to produce the desired results. For new drugs that are clearly more effective, this means doctors and patients have to jump through hoops to get patient to the more effective drug, in order to get insurance coverage." (c) Why do drug companies charge so much? Because they can. (d) The United States does set medical prices for the 50 million elderly Americans who rely on Medicare. The Republican plans put the burden of high prices more squarely on patients. (e) 'It’s sort of embedded in the health care system that the price is never the price, unless you’re a cash-paying customer,' Mr. Fein said. 'And in that case, we soak the poor.'”' And so on.
• Want to see how problematic Medicare pricing is? Look to ophthalmology (Max Ehrenfreund, Washington Post, 4-9-14) "...doctors also receive commissions of 6 percent to cover their own expenses. The commission a doctor collects on each dose of Avastin would be only about $3, as opposed to $120 on each dose of Lucentis. Congress and the courts have refused to allow Medicare to save money by scrutinizing doctors' decisions."
• Doctors Often Receive Payments From Drug Companies (Neal Conan, Talk of the Nation, NPR, 9-13-11) A Pro Publica investigation shows that many doctors are being paid by the same drug companies whose medicines they prescribe. By 2013, all doctors must report any payments from pharmaceutical companies to the federal government, and those records will be available to the public.
• Prescriptions. No room to negotiate. The Soaring Cost of a Simple Breath (Elisabeth Rosenthal, NY Times, 10-12-13) Part 4 of Paying Till It Hurts In her series on the cost of health care, Elisabeth Rosenthal interviews patients, physicians, economists, hospital and industry officials to examine the high price of health care. Her book: An American Sickness: How Healthcare Became Big Business and How You Can Take It Back . And read the series here--including the readers' comments (from both patients and doctors).
• Pay to Prescribe? Two Dozen Doctors Named in Novartis Kickback Case (Theodoric Meyer, ProPublica, 5-3-13)
• Dollars for Docs How Industry Dollars Reach Your Doctors (Eric Sagara, Charles Ornstein, Tracy Weber, Ryann Grochowski Jones and Jeremy B. Merrill, for ProPublica, Updated 3-3-14). See if Your Health Professional Has Received Drug Company Money.
• As Full Disclosure Nears, Doctors’ Pay for Drug Talks Plummets (Charles Ornstein, Eric Sagara and Ryann Grochowski Jones, ProPublica, 3-3-14) As transparency increases and blockbuster drugs lose patent protection, drug companies have dramatically scaled back payments to doctors for promotional talks. This fall, all drug and medical device companies will be required to report payments to doctors.
• Medicare Drugs Turn Doctors into Millionaires (Walter Russell Mead & Staff, The American Interest, 4-10-14)
• Prescribing Under the Influence (E. Haavi Morreim, Markkula Center of Applied Ethics, Santa Clara University)
\• Why do drug companies charge so much? Because they can. (Marcia Angell, Washington Post, 9-25-15) "Unlike every other advanced country, the United States permits drug companies to charge patients whatever they choose. ...Drug companies say high prices are necessary to cover their research and development costs" but most drugs "are invented not by the companies that sell them now but by someone else. Then, like big fish swallowing little fish, larger companies either buy small firms outright or license promising drugs from them. Very often, the original discovery occurs in a university lab with public funding from the National Institutes of Health (NIH), then licensed to a start-up company partly owned by the university and then to a large company. There is very little innovation at the big drug firms. Instead, their major creative output is trivial variations of top-selling medications that are already on the market (called “me-too drugs”), to cash in with treatments just different enough to justify new patents." Pharmaceutical companies are among the most profitable and "they spend more on marketing and administration than on R&D." ... "Congress has blocked Medicare from negotiating the price of drugs or creating a formulary for patients. It’s time that we, too, move to stop price-gouging by the pharmaceutical industry — even when no one notices."
• ‘Conservative diagnosis’ means judicious testing to avoid potential harm (Liz Seegert, Covering Health, AHCJ, 11-7-18) 'Balancing the challenges of underdiagnosis (missing or delaying important diagnoses) and overdiagnosis (labeling patients with diseases that may never cause suffering or death) can feel like walking across a canyon on a tightrope. Diagnostic errors occur in an estimated 10 percent to 20 percent of cases and will affect most Americans at least once in their lifetime. They are the leading cause of medical malpractice claims, harming more than 4 million people at a cost of more than $100 billion....“What we’re striving for in all cases is the appropriate, conservative diagnosis. One that is smarter, safer, thoughtful, rational and honest.” To get there, Schiff says doctors should keep some core principles at the forefront of every diagnostic decision.
• Ten Principles for More Conservative, Care-full Diagnosis (Patient Safety Research) Promoting a new model for caring; Developing a new science of uncertainty; Rethinking symptoms; Maximizing continuity and trust; Taming time; Linking diagnosis to treatment; Tests: more thoughtful ordering and interpreting; Safety nets: incorporating lessons from diagnosis errors; Addressing cancer: fears and challenges; Transforming specialists and ED physicians into conservative diagnosis stewards.
• Patient's Toolkit for Diagnosis (free download. PDF) A resource for patients, by patients, from the Society to Improve Diagnosis in Medicine. Download here.
• A Medical Detective Story: Why Doctors Make Diagnostic Errors (Laura Landro, WSJ, 9-26-15) Hardeep Singh investigates why things go wrong and what can be done to avoid problems
• Without Context Or Cushion, Do Online Medical Results Make Sense? ( Sandra G. Boodman, WaPo, 3-17-18) “I think getting [test results] online is great,” said Laura Devitt, who says she wishes she had been spared days of needless worry waiting for her doctor’s explanation. “But if it’s concerning, there should be some sort of note from a doctor.” A recent study by Singh and his colleagues found that, like Devitt, nearly two-thirds of 95 patients who obtained test results via a portal received no explanatory information about the findings. As a result, nearly half conducted online searches. Many with abnormal results called their doctors.... The push for [patient] portals has been fueled by several factors: the widespread embrace of technology, incentive payments to medical practices and hospitals that were part of 2009 federal legislation to encourage “meaningful use” of electronic records, and a 2014 federal rule giving patients direct access to their results. Policymakers have long regarded electronic medical records as a way to foster patient engagement and improve patient safety. Studies have found that between 8 and 26 percent of abnormal lab results were not communicated to patients promptly. Are portals delivering on their promise to engage patients? Or are these results too often a source of confusion and alarm for patients and the cause of more work for doctors because information is provided without adequate — or sometimes any — guidance?"
• Improving Diagnosis in Health Care (Institute of Medicine report, 2015, as reported in Covering Health, AHCJ) Most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. The committee defines diagnostic error as “the failure to establish an accurate and timely explanation of the patient’s health problem(s) or communicate that explanation to the patient.” It often results from multiple causes: inadequate collaboration and communication among clinicians, patients and families; a system poorly designed to support the diagnostic process; and a culture that discourages transparency and disclosure of diagnostic errors.
• Reducing medical errors (a separate section on this website)
• 25-Year summary of US malpractice claims for diagnostic errors 1986–2010: an analysis from the National Practitioner Data Bank (Ali S Saber Tehrani, et al., British Medical Journal) "Among malpractice claims, diagnostic errors appear to be the most common, most costly and most dangerous of medical mistakes."
• Differential diagnosis (CMPA's Good Practices Guide) The diagnostic process is a complex task, involving several steps. Generating a differential diagnosis — that is, developing a list of the possible conditions that might produce a patient's symptoms and signs — is an important part of clinical reasoning. It enables appropriate testing to rule out possibilities and confirm a final diagnosis.
• How A Bone Disease Grew To Fit The Prescription (Alex Spiegel, All Things Considered, NPR, 12-21-09) Increasingly, bone scientists like Cummings say Fosamax — and drugs like it — are not a necessarily a win for most women with osteopenia. While Fosamax and similar drugs reduce spinal fractures, the drugs may not reduce other types of bone fractures that are more common in women who have osteopenia. Cummings says treatment should start only when fracture risk is significant, bone density is low, or someone already has a spine fracture.
• Concern Is Growing That the Elderly Get Too Many Medical Tests (Sandra G. Boodman, KHN, 9-12-11) Critics say there is little evidence of benefit — and considerable risk — from common tests for colon, breast and prostate cancer, particularly for those with serious problems such as heart disease or dementia that are more likely to kill them. “It’s not always in your best interest to do more or to keep looking. But we never seem to talk about the downside of testing.”
• Doctor’s Rx For A Stiff Knee: A Prescription For 90 Percocet Pills (Michelle Andrews, KHN, 11-21-17) Following minor surgery, KHN’s consumer columnist sees how easily doctors offer pain pills, fueling epidemic of opioid addiction.
• So Much Care It Hurts: Unneeded Scans, Therapy, Surgery Only Add To Patients’ Ills (Liz Szabo, KHN, 10-23-17)Overtreatment of breast cancer and other diseases is pervasive, burdening patients and the health care system with enormous costs and needless suffering.
• Overtreatment Is Common, Doctors Say (Nicholas Bakalar, NY Times, 9-6-17) “We’re told that there are too many operations done for narrowed blood vessels in the legs. Spine surgeons say that a quarter of all spine surgery may not be necessary. Half of stents placed may be unnecessary. These are significant opportunities to improve quality and lower costs.”
• Some Older Patients Are Treated Not Wisely, but Too Much (Paula Span, 11-6-15) Evidence is accumulating that older adults with diabetes, hypertension and other conditions should be treated less aggressively than they commonly are. “Deintensification,” the Michigan researchers have named this approach.
• Underactive Thyroid: Is Yours Being Overtreated? (Cleveland Clinic) Overtreatment for hypothyroidism places you at risk
"Acetaminophen [Panadol, Tylenol] is the most common cause of acute liver failure in the United States. Half of all patients with liver failure, and one-fifth of all patients who need a liver transplant, sustained their injury using this common over-the-counter medication."---Was This a Virus, or Something More Dangerous for Her — and Her Fetus? (Lisa Sanders, Diagnosis, NY Times Magazine, 11-16-17)
• Genetic testing fumbles, revealing ‘dark side’ of precision medicine (Sharon Begley, STAT: Reporting from the frontiers of health and medicine, 10-31-16) 'Enthusiasm for precision medicine, from the White House down to everyday physicians, is at an all-time high. But serious problems with the databases used to interpret patients’ genetic profiles can lead to “inappropriate treatment” with “devastating consequences,” researchers at the Mayo Clinic warned on Monday....“This is the proverbial dark side of genetic testing and precision medicine,” said Ackerman. Because databases that companies use to interpret DNA tests are riddled with errors, “we’re starting to see a lot of fumbles,” with patients told that a DNA misspelling is disease-causing when it actually isn’t....That raises the very real concern that some people treated with “precision” approaches will be misdiagnosed and given useless or even harmful treatment.'
• It’s Hard for Doctors to Unlearn Things. That’s Costly for All of Us. (Aaron E. Carroll, NY Times, 9-10-18) Procedures live on even after they’ve been proved ineffective. It can lead to harms and wasted resources. "In 2016 alone, studies were published that showed that we still recommend that children consume commercial rehydration drinks (like Pedialyte), which cost more, when their drink of choice would do. We give antidepressants to children too often. We induce deliveries too early, instead of waiting for labor to kick in naturally, which is associated with developmental issues in children born that way. We get X-rays of ankles looking for injuries we almost never find. And although there’s almost no evidence that hydrolyzed formulas do anything to prevent allergic or autoimmune disease, they’re still recommended in many guidelines." (From a JAMA report) Among studies about adults: "MAKE THEM STOP? It's Not Easy. In 2001, a study recommended that doctors use tight glycemic control in patients admitted to I.C.U.s. The practice rose steadily. Eight years later, another study advised doctors to stop, but the practice showed no signs of slowing.
• Why American doctors keep doing expensive procedures that don’t work (Eric Patashnik, Vox, 12-28-17) The proportion of medical procedures unsupported by evidence may be nearly half.Our system is "market-based," not evidence-based, which means insurance still reimburses for procedures known to "work no better than a placebo", including stents inserted in patients with heart disease to keep arteries open (costing from $11,000 to $41,000 in US hospitals)
Atul Gawande observes, “Millions of people are receiving drugs that aren’t helping them, operations that aren’t going to make them better, and scans and tests that do nothing beneficial for them, and often cause harm.” And "a common knee operation, performed on millions of Americans who have osteoarthritis — an operation in which the surgeon removes damaged cartilage or bone (“arthroscopic debridement”) and then washes out any debris (“arthroscopic lavage”) — worked no better at relieving pain or improving function than a sham procedure. Those operations can go for $5,000 a shot....Other operations that have continued to be performed despite negative research findings include spinal fusion (to ease pain caused by worn disks), and subacromial decompression, which in theory reduces shoulder pain....Choosing Wisely...examined seven procedures that have widely been shown to be ineffective, including imaging tests for “uncomplicated” headaches, cardiac imaging for patients without a history of heart problems, and routine imaging for patients with low-back pain."
• Genetic test costs taxpayers $500 million a year, with little to show for it (Casey Ross, STAT, 11-2-16). Unnecessary medical care is estimated to cost the United States between $750 billion and $1 trillion dollars a year, accounting for nearly a third of its overall spending on health care. Wasteful testing is one of the primary drivers of those costs. In the case of inherited thrombophilia, said Dr. Christopher Petrilli (a University of Michigan hospitalist who coauthored the study cited), doctors appeared to be complicit in the waste — possibly due to fear of litigation or simply a shared desire to get the answers for their patients. “You can explain to them that getting a test is not going to change therapy and that it’s just going to lead to more anxiety, unclear results, and more testing,” said Dr. Nitin Damle, president of the American College of Physicians.
• Pros and cons of various medical tests, treatments, habits for cardiovascular problems
• The cold facts about colds and flu (Consumer Reports article on the difference between a cold and the flu and how best to treat them)
• A Prescription for Confusion: When to Take All Those Pills (Paula Span, NY Times, 12-18-15)
• Preventive Care (Publichealth.org). Under Resources , find curated links to journals, open courseware, research and professional organizations, and awareness campaigns on addiction, aging, cancer, environmental health, heart disease, HIV/AIDS, infectious disease, maternal and child health, mental health, nutrition, obesity, poverty, and sexual abuse.
• Maybe You Should Rethink That Daily Aspirin (Maanvi Singh, Shots, NPR, 4-27-15) "Aspirin thins the blood and can help prevent blood clots that can clog blood vessels and cause strokes and heart attacks. But long-term use of the drug also increases the risk of ulcers, gastrointestinal bleeding and bleeding in the brain. "Everyone agrees that for people who have already had a cardiac event, the benefits outweigh the risk," pharmacologist Craig Williams says. But for most other people, the chance that aspirin will prevent a first heart attack is about equal to the chance that it will cause harmful side effects, research suggests."
• Dental amalgam or resin composite fillings? (helpful Delta Dental explanation)
• Autism and the Agitator (Frank Bruni, NY Times Op Ed, 4-21-14) For much of the past decade, Jenny McCarthy has been the panicked face and intemperate voice of a movement that posits a link between autism and vaccinations. "When did it become O.K. to present gut feelings like hers as something in legitimate competition with real science?"
• When More Medicine Isn't Better (Leana Wen, Huff Post blog, 8-11-13)
Have you noticed that the price for your vitamins and supplements has been rising? The Food and Drug Administration (FDA) does not regulate the safety and sale of nutritional supplements. Because they're classified as food products, not medicines, they aren't regulated by the strict standards governing the sale of prescription and over-the-counter drugs.
• Risky stimulants turn up — again — in weight loss and workout supplements (Rebecca Robbins, STAT News, 11-8-17) "The ingredients, apparently new, were popping up on the labels of dietary supplements marketed for weight loss and workouts. Sometimes the label said DMHA. Sometimes, Aconitum kusnezoffii. Or other, even harder-to-parse names... Octodrine did indeed show up in one of the products Cohen analyzed. But the others contained three different stimulants, with unknown or potentially risky side effects. They could speed up heart rate and raise blood pressure. And none, including octodrine, has gone through the process required by the FDA to be included as ingredients in dietary supplements...The new findings also highlight just how hard it has been for the FDA to keep potentially unsafe supplement ingredients off the market. For example, regulators warn that the best-known of these stimulants, called DMAA, can cause cardiovascular problems ranging from shortness of breath to a heart attack."
• Knowing What’s Worth Paying For in Vitamins Lesley Alderman, NY Times, Patient Money, NY Times, 12-4-09) Use only what you need: "Popping too many vitamin pills is not only a waste of money but can be bad for your health. Talk to your doctor about what added vitamins or minerals you might require; you can ask for a blood test to learn what you might be lacking." A multivitamin will not provide the level of a vitamin you may be deficient in. If your doctor recommends a specific supplement, like omega-3, ask in what form you should be taking it. Find a reputable source. "Purchase your vitamins from well-known retailers that do a brisk business and restock frequently, whether that’s Costco or Drugstore.com." Price may not indicate quality."ConsumerLab.com says it has found a few patterns that consumers may find helpful. Products sold by vitamin chains tend to be more reliable than drugstore brands, and Wal-Mart and Costco’s vitamin lines are usually worth considering. In a recent test of multivitamins, ConsumerLab.com found that Equate-Mature Multivitamin 50+ sold by Wal-Mart was just as good as the name brand Centrum Silver, but at less than a nickel a day is half the price."
• ConsumerLab.com. Among sources ConsumerLab.com recommends for buying vitamins, supplements, and "natural products" (but check their site!):
Check the price at your local store against prices for the same product on Amazon. They are often notably higher at the vitamin shop I have frequented.
• Supplements Can Make You Sick (Jeneen Interlandi, Consumer Reports, 7-27-16) Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers' health at risk.
• Vitamin B.S. (Cari Romm, The Atlantic, 2-26-15) How people came to believe the myth that nutritional supplements could make them into better, healthier versions of themselves. From an interview with Catherine Price, the author of Vitamania (for which I've seen two different subtitles: "How Vitamins Revolutionized the Way We Think About Food" and "Our Obsessive Quest for Nutritional Perfection").
• What Heart Patients Need to Know About Herbal Supplements (Lauren Friedman, Consumer Reports, 3-2-17) A new study says they may be an especially risky choice for patients taking heart meds
• Liver Damage From Supplements Is on the Rise (Lauren Cooper, Consumer Reports, 5-19-17) Green-tea extract and bodybuilding pills pose a particular risk, study finds
• The Truth About Calcium and Vitamin D Supplements (Lauren Cooper, Consumer Reports, 7-27-16) Consumers take them to strengthen bones and prevent fractures. Do they work? "Taking daily calcium pills can increase bone density in people over 50 years old by 1 to 2 percent—not enough to prevent fractures. That’s according to a review of 59 randomized controlled trials, published last year in the British Medical Journal. “That small gain is not worth the risks, including an increased likelihood of heart disease, kidney stones, and gastrointestinal problems,” Lipman says."
"The best way to get that calcium is to eat calcium-rich foods including milk, cheese, and yogurt. Good sources of vitamin D are mushrooms, eggs, fortified milk, soy beverages, and salmon. Our bodies also make vitamin D when our skin is exposed to sunlight, so our experts suggest getting 10 minutes of sunshine per day. Exercise is important, too. “Weight-bearing aerobic activities, such as walking and dancing, may slow bone loss."
• 15 Supplement Ingredients to Always Avoid (Consumer Reports, 3-21-17) These supplement ingredients can cause organ damage, cardiac arrest, and cancer: Aconite, caffeine powder, chaparral, coltsfoot, comfrey, germander, greater celandine, green tea extract powder, kava, lobelia, methylsynephrine, pennyroyal oil, red yeast rice, usnic acid, yohimbe. A useful chart with "claimed benefits" vs. "risks."
• 4 Supplements to Question After Age 50 (Lauren Cooper, Consumer Reports, 12-16-16) Who might need folic acid, calcium, iron, and vitamin E supplements, do they do what is claimed, and what problems might there be with them (for whom).
• Fish Oil Supplements May Not Help Prevent Heart Disease (Sally Wadyka, Consumer Reports, 3-14-17) Those who already have certain forms of heart disease may benefit, though, a new report finds. "One thing most heart disease experts do agree on: The best way to get the protective benefits of omega-3s is to eat fish rather than take fish oil supplements.Salmon, sardines, mackerel, and other fatty fish, have the highest amount of omega-3s, and are low in mercury. Fish may be protective, says Lipman, not just because of its omega-3 content, but because it is a lean source of protein, low in saturated fat, and rich in other nutrients.:
• ‘Natural’ Sleep Supplements Carry Serious Safety Concerns (Ginger Skinner, Consumer Reports, 12-29-16) There's little research to suggest melatonin and valerian work, plus the popular supplements come with clear risks
• Choosing wisely (Evidence-based advisories on various medical procedures, produced by Consumer Reports, working with the ABIM Foundation). You can download a pdf of all specialty society lists of procedures to avoid. Two examples follow:
• Five Things Physicians and Patients Should Question (American Academy of Hospice and Palliative Medicine, Choosing Wisely, an initiative by the American Board of Internal Medicine Foundation and Consumer Reports, to alert doctors and patients to problematic and commonly overused medical tests, procedures and treatments)
1. Don’t recommend percutaneous feeding tubes in patients with advanced dementia; instead, offer oral assisted feeding.
2. Don’t delay palliative care for a patient with serious illness who has physical, psychological, social or spiritual distress because they are pursuing disease-directed treatment.
3. Don’t leave an implantable cardioverter-defibrillator (ICD) activated when it is inconsistent with the patient/family goals of care.
4. Don’t recommend more than a single fraction of palliative radiation for an uncomplicated painful bone metastasis.
5. Don’t use topical lorazepam (Ativan), diphenhydramine (Benadryl), haloperidol (Haldol) (“ABH”) gel for nausea.
• Five Things Physicians and Patients Should Question (American Geriatrics Society, Choosing Wisely)
1. same as above
2. Don’t use antipsychotics as first choice to treat behavioral and psychological symptoms of dementia.
3. Avoid using medications to achieve hemoglobin A1c <7.5% in most adults age 65 and older; moderate control is generally better.
4. Don’t use benzodiazepines or other sedative-hypnotics in older adults as first choice for insomnia, agitation or delirium.
5. Don’t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present.
• For the Elderly, Medical Procedures to Avoid (Paula Span, New Old Age, NY times, 10-23-13)
• Drugging dementia: Are antipsychotics killing nursing home patients? (David Martin, America Tonight, Aljazeera, 3-11-15) Antipsychotic drugs are approved for patients with bipolar disorder or schizophrenia, not for dementia. They are often given to dementia patients, because when they are zonked out, they are easier to control. A body of research has shown "a correlation between lower staffing levels and higher use of antipsychotics."
• Beers Criteria for Potentially Inappropriate Medication Use in Older Adults (American Geriatrics Society, based on evidence-based recommendations. See additional material.
• Doctor Groups Issue List of Overused Medical Tests (Laurie Tarkan, Well, NY Times, 2-21-13)
• Doctor Panels Recommend Fewer Tests for Patients (Roni Caryn Rabin, Health, NY Times, 4-4-12) Nine medical specialty boards plan to recommend that doctors perform 45 common tests and procedures less often, and to urge patients to question these services if they are offered (for example, EKGs done routinely during a physical, even when there is no sign of heart trouble, M.R.I.’s ordered whenever a patient complains of back pain, and antibiotics prescribed for mild sinusitis
• When Demented Patients Receive Feeding Tubes (Paula Span, NY Times, Health, 5-9-11). Do not use feeding tubes for patients with advanced dementia.
Ratings for hospitals, doctors, surgeons, home health agencies
• Tracking Your Medications (worksheet, National Institution on Aging). "You may be taking many different medicines as well as numerous vitamins and over-the-counter drugs. It can be confusing to keep track of everything! This form can help. Because your medication regimen may change over time, make a copy of the blank form (PDF, 57K) so you will always have a clean copy to use. Try to bring a completed and updated copy of this form to every doctor appointment."
• Do Best-Selling Drugs That Calm Stomachs Damage Kidneys? The Answer’s Unclear. (Sydney Lupkin and Pauline Bartolone, Kaiser Health News, 5-17-17) Recent research has linked proton pump inhibitors, or PPIs, such as Nexium and Prilosec to serious side effects, including chronic kidney disease. The risk of chronic kidney disease is as much as 50 percent higher in people who’ve taken the drug compared with those who’ve not — although no causative link has been proven and manufacturers like AstraZeneca insist they are safe. Although their labels recommend limiting treatment to a few weeks or a few months, it’s not uncommon for patients to take the heartburn pills for years--producing sales worth many billions of dollars a year for pharmaceutical companies.
• 6 Supplements That Don’t Always Mix With Prescription Drugs (Constance Sommer, AARP, 4-6-22) Over-the-counter vitamins, herbs and minerals aren’t without potential risks. Read in this article about potential problems if you take St. John’s wort, Coenzyme Q10 (CoQ10), turmeric, probiotics, Vitamin C, or milk thistle.
• When Drug Side Effects Pose Real Dangers (Jane E. Brody, NY Times, 12-9-19) The rule of thumb in medicine — first, do no harm — has as its corollary that the expected benefits of treatment should outweigh its potential risks. And the sequel: The Hidden Drug Epidemic Among Older People (Brody, 12-16-19) People in their 60s take an average of 15 prescription drugs a year. Combined with over-the-counter products, they may do more harm than good.
• Learning About Side Effects (Food & Drug Administration)
• Biotene (for counteracting dry mouth, a common side effect of many medications). I learned about Biotene not from my doctor but from a friend's brother-in-law, on a cruise of the Mediterranean. You'll know you have dry mouth (a side effect of quite a few medications) when your lips start sticking together. Let me know if you know of another remedy!
• Does Biotene cure dry mouth? (Stephanie Watson, HowStuffWorks, Oral Care Products) Dry mouth, a lack of saliva despite drinking fluids, can be caused by different health conditions and treatments and lack of saliva can leave bacteria on your teeth, leading to tooth decay, bad breath, and other problems. Biotene can relieve dry mouth in some people but is not an effective long-term solution. It is not meant to be swallowed; keep it out of the reach of small children.
• Daily Med (National Library of Medicine, NIH) Go to the Daily Med website, enter a drug name, click on the name when it appears, and scroll down to Adverse Reactions.
• MedWatch Online Voluntary Reporting Form (U.S. Food & Drug Administration) Here is where both doctors and patients can report serious problems with human medical products including drugs.
• What are the possible side effects of a drug and where can I find the most current information about my drug? (FDA)
• What is a Serious Adverse Event (FDA)
• MedShadow (blog about Balancing Drug Risks and Benefits)
• Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance. (BA Golum et al., Drug Safety, on PubMed, 2007)
• Dose of Confusion About 160 Americans die accidentally each year from acetaminophen poisoning — and about the same number use the drug to commit suicides each year. Two-thirds of parents who brought children under 7 into city emergency rooms did not know the difference between concentrated infant’s drops and other formulations of acetaminophen. At certain doses, acetaminophen can damage or even destroy the liver.
• Use Only As Directed (This American Life and ProPublica, Program 505, 9-20-13) One of the country's most popular over-the-counter painkillers — acetaminophen, the active ingredient in Tylenol — also kills the most people, according to data from the federal government. Over 150 Americans die each year on average after accidentally taking too much. And it requires a lot less to endanger you than you may know. We reported this alongside ProPublica. The ProPublica stories (T.Christian Miller and Jeff Gerth, ProPublica, 9-20-13): "The dose that helps is close to the dose that can cause serious harm, according to the FDA. The FDA has long been aware of studies showing the risks of acetaminophen. So has the maker of Tylenol, McNeil Consumer Healthcare, a division of Johnson & Johnson. Over more than 30 years, the FDA has delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen. McNeil, the maker of Tylenol, has taken steps to protect consumers. But over more than three decades, the company has repeatedly opposed safety warnings, dosage restrictions and other measures meant to safeguard users of the drug."
• We need to pay better attention to medication side effects (Marlene Beggelman, MD, Kevin MD, 2-22-17) Clinicians often misdiagnose problems caused by medications, especially when patients take multi-drug combinations. Physicians don't actively report side effects from medications and often deny those patients tell them about. When doctors fail to connect symptoms to medications, not only do they fail to help their patients, but they also fail to report the side effects to the Food and Drug Administration. As a result, the FDA is likely underestimating the reactions, leading other doctors and patients to believe some drugs are safer than they are. "Patients may be the most reliable sources to report side effects. In fact, they are often the only information source about reactions to medications. Their observations deserve serious consideration. Federal money for drug research and safety has declined to the point that pharmaceutical companies now fund over 85 percent of all research, medical journal publications and medical conferences, where physicians receive much of their educational information –- a clear case of the fox guarding the chicken coop."
• How I almost killed my mom with a simple anti-itch pill "Known for her easy smile, great style and a crazy-early bedtime, [my mom] morphed in less than five hours into a hallucinating, night-walking, screaming basket case, all thanks to one anti-itch prescription pill I gave her for her eczema....One of the many secret aspects of aging is that physical symptoms can mutate like aliens, which plays havoc with all we think we know about healing ourselves or our loved ones. For example, once we hit our 70s or 80s, symptoms of urinary tract infection that most women recognize — fever or a burning sensation when urinating — give way to something known throughout Florida — the state with the nation’s highest percentage of the elderly — as “acting strange.” "Anticholinergics include all kinds of mass-market remedies beyond Benadryl (which is known generically as diphenhydramine), such as Nyquil, Sominex, Advil/Tylenol PM, the bladder-control prescription drugs oxybutynin (Ditropan) and tolterodine (Detrol), and neck and back pain drugs such as Flexeril. These are all worthwhile medications — for younger people. My 95-year-old mother’s accumulation of daily prescriptions were classic textbook material, beginning with pills for overactive bladder that she had taken from age 69 to 94. A doctor had prescribed that medication years before — without her even being incontinent."
• Common anticholinergic drugs like Benadryl linked to increased dementia risk ( Beverly Merz, Executive Editor, Harvard Women's Health Watch, on Harvard Health Blog, 5-23-17) "In a report published in JAMA Internal Medicine, researchers offers compelling evidence of a link between long-term use of anticholinergic medications like Benadryl and dementia. Anticholinergic drugs block the action of acetylcholine. This substance transmits messages in the nervous system. In the brain, acetylcholine is involved in learning and memory. In the rest of the body, it stimulates muscle contractions. Anticholinergic drugs include some antihistamines, tricyclic antidepressants, medications to control overactive bladder, and drugs to relieve the symptoms of Parkinson’s disease."
• Magellan Anticholinergic Risk Scale
• When the Immune System Thwarts Lifesaving Drugs (Gina Kolata, Health, NY Times, 5-15-17) "The body’s immune system produces antibodies, blood proteins, in order to attack molecules the body recognizes as alien, often carried on viruses and bacteria. But antibodies also are deployed against other foreign substances, and this may include drugs given to patients." With several serious medical conditions, patients sometimes develop antibodies to the drug that might save them and perhaps to other drugs that the immune system might see as foreign. Understanding the cause of these antibodies would be valuable "if you could say, 'This one patient out of 20 should not take this drug.’” Also, "drugs that might have been abandoned could be developed for the patients who can tolerate them."
• Consumer drug ads: The harms that come with pitching lifestyle over information “Direct-to-consumer marketing is a nightmare,” said Andy Lazris, MD. He believes the ads use imagery and statistics in misleading and potentially harmful ways.The next time you watch a drug ad, "ask yourself if it meets the FDA criteria for backing up claims of benefit with evidence, portraying harms vs. benefits in a balanced way, and being more accurate than misleading. Although some might argue that nearly half the one-minute commercial is dedicated to a listing of side effects and cautions — and that this should fulfill the FDA’s call for accuracy and mentioning harms — this stands in stark contrast to the complete lack of evidence to support the touted benefits."“And if they give you any numbers at all they’re almost always the deceptive relative numbers that look really good, not the more realistic absolute numbers. So the benefits are over-exaggerated, the harms are downplayed or missed, and that’s how patients can get hurt.”
"As we wrote last year, direct-to-consumer marketing of prescription drugs was approved in the U.S. in 1997 (the only other country where this is allowed is New Zealand, where it was approved in 1981) 'before the internet emerged as the most far-reaching marketing tool of our time.'[ According to Kantar media drug companies spent just over $6 billion on DTC advertising in 2017, a 64% jump since 2012."
SOME DRUGS FALL OUT OF FAVOR, FOR VARIOUS REASONS:
• COX-2 inhibitors: a story of greed, deception and death. (PubMed) "In 1999, drug manufacturers introduced a class of NSAIDs called COX-2 inhibitors or coxibs. The drugs were avidly promoted directly to the consumers and became bestsellers from the start. Arthritis sufferers were eager to take medications that eased joint pain with less risk of causing gastrointestinal pain, bleeding and other side-effects. In the year after their introduction, doctors wrote over 100 million prescriptions for celecoxib (Celebrex) and rofecoxib (Vioxx). Celebrex is the sixth best-selling drug, with sales of more than US$ 4 billion since its debut in 1999. Vioxx had sales of US$ 2.6 billion in 2001. However, the coxibs increase the risk of heart attacks and strokes, and their price, in the USA, is obscene. The manufacturers faced a possibly complicit, toothless and bloodless FDA, and used every maneuvering to fleece the patients. We must now reflect on attitudes that we thought only belong to the tobacco industry. Fortunately, safe and active alternatives exist."
• The anatomy of a drug website: 5 pharma tactics to be wary of (Michael Joyce, HealthNewsReview, 5-25-17) In brief: 1) Heavy reliance on patient anecdote videos (ironically, using actors more than real patients); 2) Cherry-picked statistics; 3) A financial saving/support or “Co-Pay Calculator” (implying you don’t have to pay full cost … if you qualify); 4) Quizzes or FAQ sections which encourage you to self-diagnose (at a very low threshold); 5) A call to action = “ask your doctor." "The primary goal of these websites is not hard to spot. They are clearly trying to expand the pool of people who are eligible to be diagnosed with the condition their drug treats." That is, to increase demand for the drug (even among those for whom it is useless).
• Pharma payments to docs in Europe are often inadequately reported or hard to find (Ed Silverman, STAT, 3-20-18) As interest grows in toughening the Sunshine Act in the U.S., a new analysis finds requirements for reporting financial relationships between drug makers and doctors in nine European countries are inconsistent and often inadequate, and the data is also sometimes hard to access.
• Cashing in on emotions: How pharma profits from medicalizing the normal spectrum of feelings (Michael Joyce, HealthNewsReview.org, 5-16-17) Nuedexta is the only FDA-approved drug to treat a condition called pseudobulbar affect, or PBA. The drug has its own website, which is a virtual blueprint for the 5 marketing tools I see most commonly used to hook customers (pharma would likely counter they are 5 tools to “educate”).
• Tips for analyzing studies, medical evidence and health care claims (HealthNewsReview)
"Although generic drugs far outnumber brand names, the latter account for about 80% of drug spending in the U.S."
~ Darrel Rowland, Columbus Dispatch
• Bottle of Lies: The Inside Story of the Generic Drug Boom by Katherine Eban. Today, generics comprise almost 90% of our pharmaceutical market, and the majority of them are manufactured overseas, mostly in India or China where quality control is lax, at best, and impossible to regulate adequately from the US because of understaffing of the FDA. We have been assured that generic drugs are acceptable and less expensive alternatives to their brand-name counterparts, but after reading this book you are unlikely to want ever to take drugs made in India. To make the most profit, the firms investigated for this story make the lowest-quality products they can get away with, and with little US inspection or control that's very low. They "work to make their formulations look perfect on paper, regardless of their actual quality. They jury-rigged the results by fiddling with the tests, retesting already proven batches, or even testing the brand-name products instead."
Until the whistleblower Dinesh Thakur revealed to FDA staff the deception and corruption in manufacturing processes at Ranbaxy, the Indian firm Eban's narrative focuses on, and the inadequacy of FDA quality control abroad when tests are routinely fudged, little could be done to detect dangerous drugs. Moreover, the best-quality generics were shipped to the best-regulated markets, including the US, and the shoddiest drugs were shipped to markets with little regulation (Africa, East Europe, Asia, and South America). A section on totally ineffective drugs shipped to Africa is horrifying. At a certain point you will find yourself recognizing items on your own medication list, and may start insisting on no more foreign-made generics, but then Eban writes about operations in West Virginia at Mylan (manufacturer of EpiPen, the popular auto-injector of shots of epinephrine against a fatal allergic reaction called anaphylaxis), where outrageous price hikes are not the only problem (read "Crashing Files," chapter 25).
Most unsettling for me was the recognition that the only way the FDA could recover its considerable costs from filing a criminal suit against Ranbaxy (the main pharmaceutical villain in this story), after six years of investigation, was to negotiate a settlement with Ranbaxy, which could afford to settle for $500 million only if it retained its (not quite legitimate) claim to have exclusive six-month rights to sell the generic version of Lipitor, the most lucrative drug on the market. Eban's book exposes the deceit behind global generic-drug manufacturing—and the attendant risks for global health. Eban emphasizes how generic drug makers not only help ensure that some of the worst quality drugs enter the least regulated markets but also take extreme measures to avoid regulatory scrutiny. The story of generic drugs connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: What are the risks of moving drug manufacturing offshore, and are they worth the savings?
Listen to The Generic Drugs You're Taking May Not Be As Safe or Effective As You Think (Dave Davies, Listen Fresh Air, NPR, 5-16-19) The 1984 Hatch-Waxman Act changed the generic-drug industry. It simplified the application process, abbreviating the application (requiring clinical studies on fewer patients, because clinical studies for the brand drug had already "proven safety and efficacy of this molecule in the human body"). The act also gave firms an incentive 'called "first to file," [which] said if you are the first company to submit your application — and literally first by the minute or the second — and you get approved, you're going to get six months of exclusivity on the market to be the lead and only generic, and you're probably going to be able to sell your drugs at about 80 percent of the brand-name price.' Hence 'Generic drugs sometimes go to market in the U.S. without proper vetting.' She describes the FDA as "overwhelmed and underresourced" in its efforts to ensure the safety of overseas drug production. Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them. But some consumers may find they are not allowed by their health plan to switch to alternatives, because of cost.'
• Patients for Affordable Drugs: Pharmacies don't always pass along the declining cost of generic drugs to consumers. And pharmaceutical companies manipulate things so that many generics are not available to compete with high-priced pharmaceuticals or are available in inferior versions. "Generic versions of drugs should be available sooner to compete with brand names. Patents and exclusivity protections extend too long. And drug companies game the system to extend them further by making tiny changes and calling it a whole new drug. We must put an end to these practices that hurt patients." Moreover, "We spend billions through the National Institutes of Health and when a drug shows promise, private companies swoop in to acquire the rights and then charge whatever the market will bear. We need to make sure taxpayer funded drugs are priced to maximize public health — not private profits."
• Generic-Drug Giants Accused of Blocking (Cristin Flanagan and Riley Griffin, Bloomberg News, 8-14-19) Lawsuits filed by state attorneys general in 2016 and this year allege a conspiracy among 20 drugmakers to carve up the market and raise prices of more than 100 drugs including commonly prescribed antibiotics as well as medications for reducing cholesterol and controlling seizures. Those actions, authorities allege, cost taxpayers and patients billions of dollars. The prices of some drugs increased by as much as 8,281% between October 2013 and April 2014, according to the lawmakers’ letter made public on Wednesday. The most recent lawsuit included emails from 2014 in which executives at Teva Pharmaceuticals, Mylan, and Heritage Pharmaceuticals planned to respond to congressional inquiries with “polite f-u” letters.
• How our health systems are working to prevent hospital drug shortages (Barclay E. Berdan, Scott Reiner, and Terry Shaw, STAT, 8-1-19) Drug shortages are a major challenge for hospitals. Today, 121 key lifesaving drugs are in short supply and 70% of all hospital pharmacists report at least 50 shortages a year. Without these lifesaving drugs on hand, providers may be forced to delay medically necessary care or substitute therapies that may not be as effective. Most shortages occur with generic drugs. Because many of these are low-margin products, too few companies produce them. As a result, many drugs have just one or two suppliers for the entire country, creating a fragile supply chain that isn’t strong enough to handle variable market demand.
• Colorado becomes first state in nation to cap price of insulin (Anna Staver, Denver Post, 5-23-19) Under bill signed by governor this week, diabetics will pay no more than $100 a month for insulin....Insulin has been around for nearly a century, but the price that patients with Type 1 and Type 2 diabetes pay for the drug has doubled since 2012...The cost of insulin can creep up toward $1,000 for those whose health care coverage requires significant cost-sharing." The new law also requires the state attorney general to investigate why drug manufacturers started rapidly raising the price of insulin in recent years, and to report by 2020.
• California Bill Would Fight Deals That Delay Generic Drugs (Ana B. Ibarra, KHN, 8-1-19) California’s attorney general touted a legal victory this week against drugmakers who he said made secretive, backroom deals to keep less expensive drugs off the market. Xavier Becerra also lamented that he didn’t have enough legal tools to go after all the companies that engage in the practice of “pay for delay,” in which brand-name drugmakers pay off generic manufacturers to keep the more affordable generic versions of their medications off the market. He also called on the state legislature to pass a bill that he said would make it easier to crack down on these “collusive” deals. Even if drug companies aren’t making financial settlements, brand-name manufacturers may offer compensation to generic drugmakers in other forms such as sharing knowledge or paying their legal fees.
• Klobuchar Wants To Stop ‘Pay-For-Delay’ Deals That Keep Drug Prices High (Emmarie Huetteman, KHN, 4-26-19) "We can stop this horrible practice where big pharmaceuticals pay off — they literally pay off — generics to keep the prices and the competition off the market,” said Sen. Amy Klobuchar on April 22, 2019 during a CNN town hall for presidential candidates. "She said ending the practice of pay-for-delay, as well as allowing Medicare to negotiate drug prices and importing less expensive drugs from countries like Canada, could help bring down pharmaceutical costs." When these deals include money or “anything of value” transferred from the brand-name manufacturer to the generic, that’s a red flag that the companies are using pay-for-delay tactics, which can violate antitrust laws.
• Why a patient paid a $285 copay for a $40 drug (Megan Thompson, PBS, 8-19-18) "In recent years, the industry has taken a lot of heat from the media and elected officials over a controversial practice called “clawbacks.” This happens when a pharmacist collects a copay at the cash register that’s higher than the cost of the drug, and the pharmacy benefit manager takes most of the difference....Joyce said sometimes pharmacy benefit managers try to push customers to take another medication for which it had negotiated a bigger rebate....Insurance copays are higher than the cost of the drug about 25 percent of the time, according to a study published in March by the University of Southern California’s Schaeffer Center for Health Policy and Economics.... big retailers like Costco sometimes offer deep discounts on drugs through low-cost generics programs." And pharmacy benefit managers sometimes place some generic drugs on a more expensive "tier" than others, collecting a bigger rebate if a patient insists on a different-tier drug. "Websites like GoodRx and WellRx can help consumers find the best prices at local pharmacies." See also Buying drugs and procedures smartly, cheaply, safely.
• Klobuchar Wants To Stop ‘Pay-For-Delay’ Deals That Keep Drug Prices High (Emmarie Huetteman, KHN, 4-26-19) “We can stop this horrible practice where big pharmaceuticals pay off — they literally pay off — generics to keep the prices and the competition off the market.”
• Why Should Americans Be Grateful for $137 Insulin? Germans Get It for $55 (Elisabeth Rosenthal, NY Times, 3-21-19) This month, Eli Lilly and Company announced with some fanfare that it was manufacturing a generic version of its own best-selling insulin brand, Humalog, which it would sell for half off — $137.50 versus $275. Only by the bizarre logic of the U.S. pharmaceutical industry does this drug count as any kind of generic. "If the product being sold was electricity or gas for your car, a price rise of more than 600 percent over 15 years would be regarded as price gouging and wouldn’t be tolerated. And in Germany and many other developed countries, there is no need for a $137.35 vial of “authorized generic” for Humalog. At around $50 a vial, Humalog as Humalog costs far less."
• Generic drugs aren't always favored (Bob Herman, Axios, 4-4-19) "Conventional wisdom says health insurers nudge patients toward generic drugs whenever they can, saving everyone money in the process. That's not always true. How it works: Mylan recently launched a generic version of the popular Advair inhaler at a 70% discount. But Express Scripts, which manages pharmacy benefits for 100 million people, is telling pharmacies to dispense the more expensive Advair brand because it won't cover Mylan's generic....Generics still make up 90% of filled prescriptions. And PBMs make sizable profits off generics through practices like "spread pricing" — in which they charge their clients more for drugs than what they pay pharmacies, and keep the difference." Read the whole piece!
****• Secretive ‘Rebate Trap’ Keeps Generic Drugs for Diabetes and Other Ills Out of Reach (Jay Hancock and Sydney Lupkin, KHN, 1-18-19) In a practice that policy experts say smothers competition and keeps prices high, drug companies routinely make hidden pacts with middlemen that effectively block patients from getting cheaper medicines. The so-called rebate trap joins a long history of efforts by makers of brand-name drugs to stifle generics, including protecting drugs with multiple layers of dubious patents, “pay for delay” deals to keep generics off the market and withholding key ingredients needed for generic production, critics say...Makers of established brands give volume-based rebates to insurers or intermediaries called pharmacy benefit managers. In return, those middlemen often leave competing generics off the menu of drugs they cover, called a formulary, or they jack up the price for patients. The result is that many can’t get the cheaper drugs unless they shoulder a bigger copay or buy them with no help from insurance....In 2015, only 19 percent of generic drugs covered by Medicare were in the preferred formulary tiers with the lowest out-of-pocket costs, found a study last year by consultants Avalere. In 2011, on the other hand, 71 percent of generics had been in the best tier, which helps determine what patients are prescribed.
• AbbVie Is Sued for Using Humira Patent Deals to Block Competition (Ed Silverman, STAT+, 3-20-19) In a novel step, a New York union accused AbbVie (ABBV) and seven other drug makers of anticompetitive behavior for striking deals that resolved patent lawsuits, but also meant that lower-cost biosimilar versions of the Humira treatment would not be available in the U.S. for several years. In its lawsuit, Local 1500 of the United Food and Commercial Workers, which represents grocery store workers, alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar competition” by filing dozens of patents for Humira, its franchise product.
• Climbing Cost Of Decades-Old Drugs Threatens to Break Medicaid Bank (Sydney Lupkin, KHN, 8-14-17) Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. Eighty of the drugs — some generic and some still carrying brand names — proved more than two decades old. Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics. Even after a medicine has gone generic, the branded version often remains on the market. Medicaid recipients might choose to purchase it because they’re brand loyalists or because state laws prevent pharmacists from automatically substituting generics.
• Trump Administration Salutes Parade of Generic Drug Approvals, But Hundreds Aren’t For Sale (Sydney Lupkin and Jay Hancock, KHN, 2-7-19) The Trump Administration has trumpeted a huge increase in generic drug approvals, the result of its actions to streamline a cumbersome process and combat anti-competitive practices. But more than 700, or about 43 percent of those newly approved drugs aren’t being sold in the United States, Kaiser Health News has found, meaning that many patients are deriving little practical benefit from the administration’s efforts....Generics sellers have fought for years against patent litigation and other delay tactics that protect brand-name drugs from competition. In recent years, vast industry consolidation has reduced the ranks of companies willing to purchase and distribute generics. And, in some cases, makers of generics obtain approvals and ultimately make a business decision to sit on them. Without generics to lower drug costs, branded manufacturers can continue to increase their prices, at a rate of roughly 10 percent a year. Manufacturing consolidation has dramatically reduced the production of injectable drugs, which are typically administered in a doctor’s office. This may be why 157 injectable generics that were approved in the past two years haven’t been brought to market. Erin Fox, a pharmacist at the University of Utah who tracks drug shortages, said the KHN analysis of stalled generics “highlights that companies often have a lot of products ‘on the books’ but aren’t really making them.” For some generic manufacturers, there’s money to be made by waiting. Brand-name drugmakers will pay them to keep their products off the market as part of a tactic sometimes called “pay for delay.”
In some cases, Gottlieb said, generic drugmakers wait until they’ve stockpiled a number of newly approved generics and have landed a contract with a purchaser before bringing their medicines to market....They’ll wait until the most strategic time to launch, which could be after the competition shakes out, leaving them as “the last man standing,” Conti said. Then they can launch and hike the price."
• Generic-drug initiative Civica Rx welcomes 12 new members (Alex Kacik, Modern Healthcare, 1-7-19) Utah-based not-for-profit generic-drug company Civica Rx was spearheaded by Intermountain Healthcare, SSM Health, Trinity Health and Ascension, which is no longer part of the endeavor. The venture represents the frustration of the numerous hospitals that must work around persistent shortages of simple but vital drugs. Many health systems have formed internal teams and protocol to manage a seemingly ever-expanding list of pharmaceuticals that are in short supply. Civica Rx (formed by large hospital systems and backed by $100 million from philanthropic organizations) plans to bring 14 hospital-administered generic drugs to market in 2019, likely by sub-contracting with an existing Food and Drug Administration-approved manufacturer. See also 9 things to know about the hospital-owned generic drug company (Alia Paavola, Becker's Hospital Review, 10-4-18) Answers questions about which health system players are involved, what is the governance structure, the financing, etc. The names of the 14 generics to be manufactured are not disclosed.
• Generic drug group sues to block Maryland price-gouging law (Nate Raymond, U.S. Legal News, Reuters, 7-6-17) The main U.S. trade group for generic pharmaceutical companies filed a lawsuit on Thursday seeking to block a recently adopted Maryland law that lets the state attorney general sue generic drugmakers that sharply raise prices. The Association for Accessible Medicines filed the lawsuit in federal court in Baltimore to seek an injunction that would block state officials, including Maryland Attorney General Brian Frosh, from enforcing the law. Does the consumer have a dog in this fight? Yes, and yet: Fourth Circuit appeals court strikes down Maryland’s drug price-gouging law (Oveta Wiggins, WaPo, 4-13-18) "A federal appeals court has struck down a Maryland drug-price-gouging law, a first-of-its-kind measure aimed at lowering the price of off-patent or generic drugs. The U.S. Court of Appeals for the Fourth Circuit said in a 2-to-1 ruling that the 2017 law is unconstitutional because it violates the commerce clause of the U.S. Constitution....Last year, Maryland became the first state in the country to give its attorney general the power to take legal action against drug companies that dramatically increase the price of off-patent or generic drugs. The drug trade group argued that the law was “overreaching” and vague and wrongly gave the state power to regulate interstate commerce and business in other states. The suit also claimed that the measure violated the companies’ right to due process....Maryland Attorney General Brian E. Frosh (D), who had pushed for the landmark drug bill, said the court’s ruling “substantially intrudes on the States’ reserved powers to legislate to protect the health, safety, and welfare of their citizens.’” Stay tuned for news on this David (the consumer) and Goliath (the pharmaceutical industry) fight for reasonable pricing and healthcare consumers rights.
• Hospitals Create Drug Company to Fight High Drug Prices (Shawn Radcliffe, Healthline, 1-24-18) After years of drug shortages and high prices, several health systems have teamed up to form a not-for-profit company to manufacture their own generic drugs.
• Collusion or Coincidence: The Making of a Drug Shortage (David Belk, MD, Huff Post, 8-18-17) Multiple pharmaceutical companies stopped producing a commonly prescribed blood pressure medication (the beta blocker atenolol) at the same time and for no apparent reason. Was this the result of collusion or merely a coincidence? Was this an effort to get patients onto the newer, higher priced nongeneric drug?
• Allergan and a Mohawk tribe ask the Supreme Court to review their controversial patent deal (Ed Silverman, STAT, 1-15-19) After being rebuffed by a federal appeals court last summer, Allergan (AGN) and the St. Regis Mohawk Tribe have asked the U.S. Supreme Court to decide a vexing question that was at the heart of a controversial maneuver to protect a best-selling eye medicine. Their petition has its roots in events that began in the fall of 2017, when the drug maker transferred six patents to its Restasis treatment, which was on track to generate $1.4 billion in sales, to the Mohawk tribe in hopes of thwarting generic competition. At the time, Allergan was facing a conventional patent challenge from several erstwhile generic rivals in a federal court.
• Glaxo's Advair Is the $100 Billion Asthma Drug That Won't Die (James Paton, Bloomberg, 5-4-18) Sharon Bassett tries to stretch a month’s supply of GlaxoSmithKline Plc’s Advair over 60 days to save money on the asthma treatment because the U.S. lacks a cheaper generic version. Eight years after the patent on the drug itself expired and two years since its companion Diskus inhaler lost exclusivity, it remains untouched by competition from generics in the U.S. -- and patients like Bassett pay the price. Brand-name rivals and European generics are invading its space, a new generation of inhalers are poised to replace it, and a generic from Mylan NV is threatening -- finally -- to crack the U.S. market.
• Walgreen Must Face Lawsuit Over U.S. Generic Drug Pricing (Reuters, NY Times, 3-9-18) Walgreen Co to face most of a proposed class action lawsuit accusing the drugstore chain of fraudulently overcharging customers for a decade when they bought generic drugs through private insurance, Medicare or Medicaid. It was accused of wrongly requiring insured customers to pay more than members of its Prescription Savings Club, who for a low annual fee could buy more than 500 widely prescribed generic drugs for $5, $10 and $15 for 30-day prescriptions, and $10, $20 and $30 for 90-day prescriptions. U.S. District Judge John Lee in Chicago said the plaintiffs plausibly alleged that these prices were Walgreen's "usual and customary" prices, and that the company misled their insurers by reporting higher prices when seeking reimbursement.
• Generic Drug Prices Are Declining, But Many Consumers Aren’t Benefiting (Charles Ornstein, ProPublica, and Katie Thomas, New York Times, 8-8-17) Outcry has been building over the rising cost of brand-name medications, but the price of generic drugs has been moving in the opposite direction. The stock prices of generic manufacturers have tumbled, but many consumers aren’t paying less at the pharmacy counter.
• Journalists learn about intricacies of prescription drug pricing (Liz Seegert, Covering Health, Association of Health Care Journalists, 2-27-17) Why are drug costs so high in the United States? This and other questions were addressed at a meeting of the New York chapter of AHCJ. What can justify a "$50,000 cancer drug that extended life for an average of 17 days"? A helpful summary of what several experts explained about how we in the U.S. end up with exploitative prices on some drugs. Among points made: (1) "It’s the doctor, not the patient, who decides what to prescribe. Our current system also rewards doctors for prescribing more expensive drugs. Why prescribe the generic when you can make more money prescribing the brand? (2) Doctors are making those decisions, typically, with little information about cost. Now with more patients in high-deductible plans with a coinsurance model, there’s sticker shock and people are asking questions. (3) Nobody knows if we are spending the right amount on drugs, said Peter Bach, MD, director of the Memorial Sloan Kettering’s Center for Health Policy and Outcome. Moreover, we do not know if we are spending it on the right drugs, either.
• Top Prescription Plan to Offer $1 Alternative to $750 Pill (Andrew Pollack, NY Times, Business Day, 12-1-15) "Turing Pharmaceuticals’ effort to charge $750 a pill for a 62-year-old drug is facing a new headwind: The nation’s largest prescription drug manager plans to back an alternative that costs only $1 per pill....Daraprim, known generically as pyrimethamine, is the treatment of choice for toxoplasmosis, a parasitic infection that can be serious for babies and people with AIDS. While there is no patent protection on such an old compound, there are no generic versions approved for sale in the United States, in part because the market is small."
• 20 States Accuse Generic Drug Companies of Price Fixing (Katie Thomas, NY Times, 12-15-16) The suit’s focus is two drugs, a delayed-release form of the antibiotic treatment doxycycline hyclate, and glyburide, a commonly used diabetes drug. The price of doxycycline has surged in recent years, and it was singled out by members of Congress and others as a prime example of unexplained price increases for generic drugs. See also News of Charges in Price-Fixing Inquiry Sends Pharmaceuticals Tumbling (Katie Thomas, NY Times, 11-3-16) "Drug companies have come under intense scrutiny over the last two years over the prices of their drugs, particularly old drugs that have lost their patent protection but have, in some cases, jumped in price. In the case of doxycycline, an antibiotic, for example, the price went from $20 a bottle in October 2013 to $1,849 by April 2014, according to members of Congress who are investigating drug prices. The same report found that the price of a pill of digoxin, an old heart medicine, rose to $1.10 in 2014 from 11 cents in 2012."
• A new Parkinson’s drug is a long-acting version of a cheap generic. Should it cost $30,000 a year? (Adam Feuerstein, STAT Plus, 8-25-17)
• Pfizer has raised prices on nearly 100 drugs by an average of 20 percent (Ed Silverman, STAT, 6-2-17). That is for subscribers only. See also Reuters story, from Financial Times (also 6-2-17) "Drug pricing has become a contentious issue as a wave of new treatments for cancer and other serious conditions reach the market, some costing tens or hundreds of thousands of dollars. But the row is particularly fierce in the United States, where prices are higher than in Europe and where there have been highly publicized price hikes of some older drugs, such as Mylan's EpiPen."
• Alleged Scheme To Fix Generic Drug Prices Started At Dinners And ‘Girls Nights Out’ (Liz Szabo and JoNel Aleccia and Mark Zdechlik, Minnesota Public Radio, on KHN, 12-22-16) Details emerging from an ongoing investigation show that drug company employees gathered regularly at such swanky locations and conspired to keep prices and profits high....The lawsuit hits home for many middle-class families who have struggled in recent years to pay for generic medications while prices for some drugs soared more than 8,000 percent. The price for a decades-old antibiotic called doxycycline, for example, jumped from $20 for a bottle of 500 pills in October 2013 to more than $1,800 in April 2014. That price hike was the result of secret efforts by generic drugmakers to make as much money as possible, the complaint says. In addition to doxycycline, the companies and executives were charged with fixing the price of an oral diabetes drug called glyburide, which helps control blood sugar. Article includes a chart listing generic drug price increases.
• Hospitals Say They're Being Slammed By Drug Price Hikes (Sydney Lupkin, Kaiser Health News, 10-11-16) The price hikes driving the spending increases “appear to be random and inconsistent from one year to the next,” the researchers wrote. About half of the drug price hikes in the report occurred in drugs with no generic competitors.
• Fed Up With Drug Companies, Hospitals Decide to Start Their Own (Reed Abelson and Katie Thomas, NY Times, 1-18-18) A group of large hospital systems plans to create a nonprofit generic drug company to battle shortages and high prices.
• Generic Drug Marketplace Is a Fragile Place Where Competition Can Quickly Wither Into Monopolies (Kaiser Health News, an entire issue on the subject)
• The generic drug industry has brought huge cost savings. That may be changing. (Carolyn Y. Johnson, WashPost, 8-1-17) "Overall, generic drugs have been a major source of savings to the American health-care system, accounting for nearly nine out of 10 of all prescriptions filled but only about a quarter of the total spending on prescription drugs, according to the Association for Accessible Medicines, a trade group for the industry. But concerns that the market isn’t functioning as intended have been sparked by drug shortages and old drugs that have risen in price. The fading of competition has meant that years after it went generic, the lifesaving emergency drug wasn’t always easily available." "The trajectory of generic Cerebyx shows the limitations of relying on the market alone to bring down drug prices and ensure supply — particularly for hard-to-make injectables or low-volume drugs, which are critical to the people who need them. It’s the flip side of the low prices in the generic industry: Thin profit margins can turn temporary challenges such as active ingredient shortages or manufacturing delays into decisions to discontinue a drug altogether. Companies stopped making fosphenytoin for several reasons, including technical challenges, production problems and decisions to concentrate on producing other drugs."
• Middlemen Who Save $$ On Medicines — But Maybe Not For You ( Francis Ying, Julie Appleby, and Stephanie Stapleton, KHN, 8-2-17) Video. Pharmacy benefit managers — companies that are often unnoticed and even less understood by most consumers — hold an important place in the prescription drug-pricing pipeline.
• 3 In 4 U.S. Prescriptions Are Now for Generic Drugs ( Scott Hensley, NPR News, 4-20-11) As more brand-name drugs lose patent protection, use of inexpensive generic medicines continues to rise. Later this year cholesterol-fighter Lipitor will become available as a generic in the U.S., a change that will add more fuel to the trend. All 10 of the most prescribed medicines in the U.S. last year were generics, led by the defending champion generic equivalents of Vicodin (hydrocodone plus acetaminophen). There were 131 million prescriptions dispensed for the painkiller last year, up 3 million from 2009, according to data released Tuesday by the IMS Institute for Health Informatics. The persistence of Vicodin-like medicines at the top of the chart is one reason why the White House is pushing new approaches to reducing the abuse and misuse of prescription painkillers.
• Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication (blog post, 2-16-16, updated 11-30-17)
• Pfizer has raised prices on nearly 100 drugs by an average of 20 percent (Ed Silverman, STAT, 6-2-17). That is for subscribers only. See also Reuters story, from Financial Times (also 6-2-17) "Drug pricing has become a contentious issue as a wave of new treatments for cancer and other serious conditions reach the market, some costing tens or hundreds of thousands of dollars. But the row is particularly fierce in the United States, where prices are higher than in Europe and where there have been highly publicized price hikes of some older drugs, such as Mylan's EpiPen." See also EpiPen’s Price Hikes Draw Intense Scrutiny, Raise Ire Among Lawmakers (KHN Morning Briefings, 8-24-16) News outlets report on how the maker of the emergency allergy medicine came to raise the treatment's price tag by so much, how this move fits into the broader story of U.S. drug pricing policy and how the ensuing controversy will now play out both in the marketplace and on Capitol Hill.
• Vox: EpiPen’s 400 Percent Price Hike Tells Us A Lot About What’s Wrong With American Health Care The story of Mylan’s giant EpiPen price increase is, more fundamentally, a story about America's unique drug pricing policies. We are the only developed nation that lets drugmakers set their own prices, maximizing profits the same way sellers of chairs, mugs, shoes, or any other manufactured goods would. In Europe, Canada, and Australia, governments view the market for cures as essentially uncompetitive and set the price as part of a bureaucratic process, similar to how electricity or water are priced in regulated US utility markets. (Sarah Kliff, Vox, 8/23)
• Report: Here's What The Feds Can Do To Cut Drug Prices (Alison Kodjak, Shots, NPR, 11-30-17) Drug prices are too high, and we had better do something about it. That is the nutshell conclusion of a 201-page report from the National Academies of Sciences, Engineering and Medicine. The independent advisory group's report lists dozens of suggestions for what U.S. officials could do to rein in those rising prices. Many have been tossed around Washington for years. And given the power of the pharmaceutical lobby — it has spent more than $200 million on lobbying so far this year, according to the Center for Responsive Politics — few of them are likely to be implemented soon. Key recommendations: Allow the federal government to negotiate drug prices and refuse to cover some expensive medications. Speed the approval of generics and biosimilars and ensure patients have access. Shed light on who pays what for prescription drugs. Discourage those endless ads pushing prescription drugs and stop giving patients coupons to try medication. Cut the cost to consumers for their prescription drugs. Take away incentives for doctors to administer high-cost drugs. But even in the dissent, there was some agreements, specifically in the need for greater transparency in how drugs are priced, and how the money flows through the system. The dissenters suggest that pharmacy benefit managers have outsized power and take too much money from the system. (But do read the whole article!)
• CountyRxCard (up to 75% discount on all FDA-approved drugs at 56,000 pharmacies nationwide)
• The Myth of Drug Expiration Dates (Marshall Allen, Wasted Medicine, ProPublica, 7-18-17, co-published with NPR’s Shots blog). Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer.
• Too Few Patients Follow The Adage: You Better Shop Around (Michelle Andrews, Kaiser Health News, 8-18-17) Despite having more financial “skin in the game” than ever, many consumers don’t make any attempt to compare prices for health care services, according to results from a 2015 survey of nearly 3,000 adults younger than 65). Most respondents said they didn’t comparison shop or even ask how much they would owe in copayments or other cost-sharing expenses before they turned up for an appointment. Three-quarters of the study participants said they did not know of any resource that would allow them to compare costs, while half said that if a website showing such information were available, they would use it. “If price shopping is an important policy goal, it will be necessary to increase the availability of information on price and decrease the complexity of accessing the information,” the researchers wrote. Patients trying to figure out pricing information and their share of the cost must often know specific procedures’ billing codes, the difference between professional fees and facility fees, and the details of how their insurance plan is structured. shopping for health care services is nowhere near as user-friendly and intuitive as buying something on Amazon or Expedia. “Maybe right now these tools are so primitive that even though there is a financial incentive to shop, people aren’t doing it,” Sood said. People surveyed were most likely to search out prices before going to a retail or urgent care clinic compared with other care facilities. Consumers who received physical therapy or lab and imaging services were more likely than others to comparison shop for providers, the survey found.
• 5 Tips for Handling Early-Year Medical Expenses (AP, NY Times, 2-5-15) Which refers to:
---Co-Payment Assistance Organizations (Patient Access Network Foundation)
---Partnership for Prescripton Assistance (PPA)
• In Medicine, the care (David Leonhardt, NY Times, 4-6-10) Americans tend to think more healthcare is better healthcare, says Leonhardt, but "it also has big downsides, including the side effects and risks that come with unnecessary treatment." For example, we overuse CT scans (radiation), " \Caesarean births have become more common, with little benefit to babies and significant burden to mothers. Men who would never have died from prostate cancer have been treated for it and left incontinent or impotent. Cardiac stenting and bypasses, with all their side effects, have become popular partly because people believe they reduce heart attacks....unnecessary care causes a lot of pain and even death." (See Berwick on Medical Errors.) So let's start reducing unnecessary care. "Learning to say no more often will be a three-step process."
(1) Learn more "about when treatments work and when they don’t." The Institute of Medicine says the most promising areas for research into what's necessary include prostate cancer, inflammatory diseases, back pain, hyperactivity, and CT scans vs. M.R.I.’s for cancer diagnosis.
(2) Give patients the available facts about treatments. When patients are given information about potential benefits and risks, they can weigh the risks and benefits and may choose the less invasive option.
(3) Change the economics of medicine, to reward better care rather than simply more care -- so "doctors who provide good, less expensive care won’t be financially punished as often as they now are."
• Guroo.com, which "shows the average local cost for 70 common diagnoses and medical tests in most states...based on a giant database of what insurance companies actually pay." Guroo is produced by the Health Care Cost Institute. See KHN story: Attention, Shoppers: Prices For 70 Health Care Procedures Now Online! (Jay Hancock, Kaiser Health News, 2-25-15).
• Estimates Suggest that RX Drugs Will Continue to Represent an Increasing Portion of Overall Health Spending Kaiser Health News analysis estimates that by 2025, 10.8% of total health spending will be allocated to prescription drugs, up from 9.8% in 2016. Explore the full chart collection from the Peterson-Kaiser Health System Tracker.
• A Mexican Hospital, an American Surgeon, and a $5,000 Check (Yes, a Check) (Phil Galewitz, NY Times, 8-9-19) A novel twist on medical tourism to avoid the high cost of U.S. health care saves an employer money and even earns the patient a bonus.
• Bill of the Month (NPR and Kaiser Health News) Journalists from KHN and NPR look at surprising medical bills and figure out what they tell us. For example: Life-Threatening Heart Attack Leaves Teacher With $108,951 Bill (Chad Terhune, Morning Edition, NPR, 8-27-18) An insured Texas teacher, 44, faced a "balance bill" of almost twice his annual salary from an out-of-network hospital's treatment of his sudden heart attack. Shortly after this story was published and broadcast, St. David's said it was now willing to accept $782.29 to resolve the $108,951 balance because Drew Calver qualifies for its "financial assistance discount." This is a series. You may share your medical bill with them (Scott Hensley, NPR, 2-16-18)
• Wasted Medicine (ProPublica series about squandered health care dollars.
• What Hospitals Waste (Marshall Allen, ProPublica, 3-9-17) The nation’s health care tab is sky-high. We’re tracking down the reasons. First stop: A look at all the perfectly good stuff hospitals throw away.
• Seven Ways Patients Can Protect Themselves From Outrageous Medical Bills (Marshall Allen, ProPublica, Wasted Medicine, 11-28-17) Experts in reducing charges for medical services say patients need to push for detailed answers up front about the true costs of their care.
• Cost Conundrum: What a Texas town can teach us about health care (Atul Gawande, New Yorker, 6-1-09)
• CAPHIS 2013 Top 100 List: Health Websites You Can Trust
• PatientAssistance (helping patients get medication). See list of Top 50 drugs
• Be a Prepared Patient Center for Advancing Health, CFAH)
• 6 Ways to Lower a Massive Medical Bill (Lacie Glover, The Fiscal Times, 6-16-14)
• How to Catch Costly Errors on Your Medical Bills (Lacie Glover, The Fiscal Times, 6-8-14)
• 30 Ways to Cut Health Care Costs (Kimberly Laskford, Kiplinger, April 2011) How to pay the lowest price without sacrificing quality.
Ending medical debt (as a chronic national U.S. problem)
• Knoxville’s Black Community Endured Deeply Rooted Racism. Now There Is Medical Debt. (Noam N. Levey, KHN, 10-27-22) In Knoxville, the burden of medical debt reinforces a long history of segregation. When Dr. H.M. Green opened his new medical office building on East Vine Avenue in 1922, Black residents of this city on the Tennessee River could be seen only in the basement of Knoxville General Hospital. They were barred from the city’s other three medical centers. But the health gaps Green labored to narrow still divide this community. And if segregation is less apparent in medical offices today, its legacy lives on in crushing medical debt that disproportionately burdens this city’s Black community. In and around Knoxville, residents of predominantly Black neighborhoods are more than twice as likely as those in largely white neighborhoods to owe money for medical bills.
• How to Get Rid of Medical Debt — Or Avoid It in the First Place Even people with health insurance can land in debt; indeed, one of the biggest problems is that so many people are underinsured, which means they can get hit with huge out-of-pocket costs from coinsurance and high deductibles. Before you get care:
---Get familiar with your insurance coverage and out-of-pocket costs.
---Sign up for public insurance if you qualify.
---If the drug you want isn’t covered by your insurance, ask whether the drugmaker has a patient assistance program; many do, though eligibility requirements vary.
---Get a cost estimate. The federal No Surprises Act, which took effect in January, requires providers to give uninsured patients “good faith” estimates of what planned care will cost.
---Check for other forms of financial assistance.
During treatment or soon after,
---Ask for line items of the costs for every service, prescription, or treatment you receive.
---Check whether providers are in-network
---Check for double billing.
---Negotiate with the hospital directly.
---Prioritize paying for food and shelter over medical bills.
If You Are Already in Debt or in Collections
---Try to qualify, even after the fact, for charity care.
---Dispute your bill if it is inaccurate.
---Contact free legal aid services.
---Do not ignore the issue. Keep advocating for yourself or your family
• Good news about medical debt and your credit report--and how it happened (Dan Weissmann, Arm and a Leg podcast, 5-26-22) with transcript, Credit Where It's Due. Credit reporting bureaus announced in April that they would start taking most medical debt off of people’s credit reports, starting July 1, 2022. Debts under $500 don't come off until March 2023. Once you pay off the bigger medical bills (more than $500) they are supposed to disappear from your credit report completely, like they never happened.
• RIP Medical Debt RIP Medical Debt, a charity, was founded with the mission of seeking out, buying, and forgiving unpaid and unpayable personal medical debt. However, as the group explains, "While we would love to help everyone who needs assistance, RIP Medical Debt cannot abolish medical debt by individual request. We approach the problem of medical debt by acquiring large portfolios of debt to help thousands of people at once. Because medical debt affects so many people who may not have debt accounts in the portfolios we purchase, we have compiled a list of resources that may be able to help in ways RIP Medical Debt cannot. Here's the list: Debt Resources ("RIP Medical Debt is not affiliated with any of them.")
• Equifax, Experian, TransUnion to remove some medical debt from credit reports (Kerry Dooley Young and Joseph Burns, Covering Health, AHCJ, 4-6-22) Starting in July 2022, paid medical collection debt will no longer be included on consumer credit reports, Equifax, Experian and TransUnion said in a joint announcement. The time before unpaid medical collection debt would appear on a consumer’s report will be increased from six months to one year. This happened after publication of the federal Consumer Financial Protection Bureau (CFPB) report last month, Medical debt burden in the United States
• Medical Debt Policy Scorecard The volume of medical debt lawsuits in the civil legal system is staggering—and on the rise, magnified by the COVID-19 pandemic. The Medical Debt Policy Scorecard map features the rankings and composite scores of all 50 states based on their medical debt consumer protection policies.
• The burden of medical debt in the United States (Matthew Rae, Gary Claxton, Krutika Amin, Emma Wager, Jared Ortaliza, and Cynthia Cox, Kaiser Family Foundation, 3-10-22) A new KFF analysis of government data estimates that nearly 1 in 10 adults (9%) - or roughly 23 million people - owe medical debt. This includes 11 million who owe more than $2,000 and 3 million people who owe more than $10,000. See Health System Tracker Chart of medical debt (scroll down).
---Black adults, those in poor health, and people living with disabilities are most likely to carry significant medical debt. Americans likely owe hundreds of billions of dollars in total medical debt.
---People ages 35-49 (11%) and 50-64 (12%) are more likely than other adults to report medical debt. They have greater health needs than younger people on average and aren’t yet old enough to qualify for Medicare coverage, which may protect them from high costs.
---Larger shares of people in poor health (21%) and living with a disability (15%) report medical debt. People in these groups are more likely to need and receive care than people in better health and without disabilities.
---Among racial and ethnic groups, a larger share of Black adults (16%) report having medical debt compared to White (9%), Hispanic (9%), and Asian American (4%) adults.
---Adults who were uninsured for more than half of the year are more likely to report medical debt (13%) than those who were insured for all or most of the year (9%).
• Medical Bills Can Shatter Lives. North Carolina May Act to ‘De-Weaponize’ That Debt. (Aneri Pattani, KHN, 6-21-22) About 100 million people in the U.S. — 41% of adults — have some form of health care debt, according to a KFF poll conducted for a new KHN-NPR investigation. The problem is driving millions of people into bankruptcy, depleting savings and retirement accounts, and leaving black marks on credit scores that make finding housing or employment difficult, the investigation found. Federal protections remain weak. And the widespread burden has spurred efforts by at least a dozen state legislatures to better protect patients. California, Maine, and Maryland have enacted measures that compel hospitals to expand financial aid, crack down on debt collectors, and curb extreme practices such as placing liens on patients’ homes.
Some states with the highest levels of medical debt, such as Texas, South Carolina, and Tennessee, have few protections. Low-income, Black, and Indigenous people in these Southern states are among the hardest hit. But even in more liberal states such as California, the health care and debt collection industries have foiled more ambitious reform efforts. (Map shows hardest hit areas.)
North Carolina lawmakers are debating two measures to tackle the state’s debt problem: one to expand Medicaid, a government insurance program for low-income people, and another to strengthen financial protections for patients.
• Journalists, We’re Sharing Our Tips From Patients With Medical Debt. Want Them? (Maya Miller, Profiting from the Poor, ProPublica, 10-16-19) Stories about aggressive debt collection are leading to real change, and we want to see more of them. Let us give you our leads from across the country. In Coffeyville, Kansas, where the poverty rate is double the national average, we found that at least 11 people were arrested in the past year after unpaid medical bills, and we analyzed more than 30 arrest warrants, some for bills as low as $230. We’re hoping more of you will report on aggressive medical collection practices in the communities you cover. This piece is full of tips and links for journalists.
• 3 reasons to cover new laws on hospital billing and medical debt (Joseph Burns, Covering Health, AHCJ, 2-16-22)
• End Medical Debt Medical debt belongs at the center of every conversation about our broken healthcare system. Everyone knows someone who struggles to pay their medical bills. Millions of responsible Americans confront $1 trillion in medical debt that produces hardships for individuals, families, communities, and our nation as a whole.
Fast Facts about Medical Debt:
Millions of responsible Americans annually exhaust their life savings to pay doctor, hospital and pharmacy bills, including “surprise medical bills” they thought their health insurance would cover.
Medical debt contributes to more than 60 percent of all personal bankruptcies.
Medical debt destroys the financial stability of large segments of America’s most vulnerable communities in every state — the sick, the elderly and the poor.
Medical debt particularly impacts the middle class, driving into poverty many families who already are barely getting by (most families are $400 away from financial hardship).
Fully one-third of all Go-Fund-Me campaigns are pleas for help in meeting medical bills.
Our veterans are not safe from healthcare related bills, collectively shouldering more than $6 billion in “emergent” (ambulance and emergency room) medical debt.
The book: End Medical Debt: Curing America’s $1 Trillion Unpayable Healthcare Debt by Jerry Ashton, Robert Goff, Craig Antico; edited by Judah Freed.
• States Move to Protect Hospital Patients from Heavy Medical Debt (Anna Wilde Mathews, Wall Street Journal, 2-7-22) For subscribers only (but try reading in library). Laws passed in at least 10 states require financial assistance for low-income patients or limit aggressive debt-collection practices See also Hospitals in Wisconsin Pursued Medical Debt Collection Widely but Unevenly, Study Finds (Melanie Evans and Tom McGinty, WSJ, 12-6-21) Some hospitals were more likely to sue over unpaid medical bills than others, and low-income and Black people were disproportionately sued, according to the analysis of state court records.
• End Medical Debt: Curing America’s $1 Trillion Unpayable Healthcare Debt by by Jerry Ashto, Robert Goff, and Craig Antico. “End Medical Debt explains why only Americans risk the probability that medical treatment will be financially inaccessible or that a family will be made destitute from a serious injury or disease.”-- Nancy A. Niparko, M.D., Children’s Hospital Los Angeles
• Hospital Prices Are Arbitrary. Just Look at the Kingsburys’ $100,000 Bill. (Melanie Evans and Tom McGinty, WSJ, 11-28-21) Newly public data reveal how some patients end up paying more at hospitals—and how little control consumers have over the amounts, even with insurance
• Debt Resources ("RIP Medical Debt is not affiliated with any of them.")
• 31 Million People Were Underinsured in 2014; Many Skipped Needed Health Care and Depleted Savings to Pay Medical Bills (The Commonwealth Fund, 5-20-15) New Report Finds Rising Deductibles Likely Factor in Underinsured Rates as Share of People with High Deductibles Relative to Incomes Has More Than Tripled Since 2003. "Credit cards aren’t the way to pay off medical debt, but a third of consumers paid their medical bills by pulling out the plastic in 2014, and 44% suffered a hit to their credit score."--Perrucci
• Resources for dealing with medical Debt (RIP Medical Debt)
• Debt Collection FAQs (Federal Trade Commission, Consumer Information)
• How one reporter explored the impact of medical credit cards on dental debt (Mary Otto, Covering Health, AHCJ, 4-24-2020) The story: Dental patients face years of debt, inflated bills with ‘out-of-pocket’ credit cards (Manuela Tobias, Sacramento Bee, 12-9-19) Legal aid organizations report that low-income Californians are particularly at risk of falling into debt traps with medical credit cards because of ongoing struggles with the state insurance system. Advocates say the terms of medical credit cards are too complicated for most people to understand. They are particularly confusing in high-pressure situations, like the moments of excruciating pain leading up to important dental procedures. If consumers do not fully understand the terms or fall behind on payments, they can end up facing inflated bills and crippling dental debts.
• Americans are drowning in medical debt, so this nonprofit is buying — and forgiving — it (Paul Solman and Judy Woodruff, PBS, 12-12-19) What almost no one knows is that most medical bills can be contested. As many as 80 percent have errors. They can be past the statute of limitations. And then there's the charity care exemption....About 30 percent of the accounts that get placed for collection qualified for charity care. If they make less than two times the poverty level, they get it, no questions asked. But people don't take it.... The bill collector is the enforcer for the financial industry, chasing down borrowers in default, regardless of their ability to pay. If they can't collect, they rely on third parties. And when the third parties (such as hospitals) fail, then they consider selling their debt into the debt market, for a few cents on the dollar. Craig Antico and Jerry Ashton knew all this, as debt collectors. When the Crash of '08 happened, Ashton persuaded Antico to help him start a nonprofit, RIP Medical Debt, that would raise money to buy up and forgive seriously delinquent medical bills.
• TV station buys $1 million in medical debt forgiveness for viewers (Al Tompkins, Poynter, 2-14-18) And the vehicle for doing so: RIP Medical Debt. ("RIP Medical Debt locates, buys and forgives medical debt across America, the only industrialized nation on earth with personal medical debt. We work on behalf of individual donors, philanthropists and organizations who provide financial relief for people burdened by unpaid and unpayable medical bills." Similarly, The Miracle of Medical Debt Forgiveness on HBO’s Last Week Tonight with John Oliver (RIP Medical Debt) Medical debt pursuit, or more precisely, the endless harassment of patients unable to pay their bills (as opposed to unwilling), has gained increasing prominence as a major social issue. Among the more egregious practices in the collections industry is the sale of old medical debt – for pennies on the dollar – to bill collectors who will then aggressively pursue this debt at full face value for an additional two to 10 more destructive years. Thanks to a June 5 airing of the HBO comedy series, Last Week Tonight Show with John Oliver, far more of us now are privy to this collection industry practice, and the debt treadmill it creates. Oliver and his LWT staff investigated the debt buying industry, and then registered a debt-buying company in Mississippi for $50, calling it Central Asset Recovery Professionals (CARP, like the bottom-feeding fish). They located and bought for about $60,000 a medical debt portfolio worth $14.9 million, which they donated to the RIP Medical Debt charity. Read The Patient, The Doctor and The Bill Collector: A Medical Debt Survival Guide by Robert E. Goff and Jerry Ashton
• Nonprofit Christian Hospital Suspends Debt Collection Lawsuits Amid Furor Over Suing Its Own Employees (Wendi C. Thomas, MLK50 and ProPublica, Profiting from the Poor, 7-3-19) Methodist Le Bonheur Healthcare is reevaluating its policy after an MLK50-ProPublica investigation found that it had filed 8,300 lawsuits in the past five years, including against many of its own employees.
• When Medical Debt Collectors Decide Who Gets Arrested (Lizzie Presser, ProPublica, 10-16-19) Ambulance, Judge, Jail. Welcome to Coffeyville, Kansas, where the judge has no law degree, debt collectors get a cut of the bail, and Americans are watching their lives — and liberty — disappear in the pursuit of medical debt collection. .
• 3 Stories to Report on Medical Debt (Dorianne Perrucci, Business Journalism, 3-25-18) Story ideas from the business desk.
• Occupy Wall St. Offshoot Aims to Erase People’s Debts (Ariel Kaminer, NY Times, 11-13-12) A group of professors, documentary filmmakers, corporate dropouts and others had spent months protesting Americans’ debt burden when a novel idea arose: What if they could just wave a magic wand and make some of it disappear? Rolling Jubilee's first purchase will be medical debt.
• Former Collection Agency Executives Start Charity To Buy And Forgive Medical Debt (Robin Young, Here and Now, WBUR, 8-12-19) Craig Antico and Jerry Ashton, founders of RIP Medical Debt, decided to use their expertise to forgive medical debt instead of collecting it. So far, their company has abolished hundreds of millions of dollars in debt. They want to reach a billion by 2020.
• The Problem of Underinsurance and How Rising Deductibles Will Make It Worse (Commonwealth Fund, 2015)
• 10,000 in Appalachia will see medical debt forgiven, highlighting national issue (Phil McCausland, NBC News, 7-27-19) Two men--Jim Branscome, a former journalist who became the managing director of Standard & Poor’s Financial Services, and author and journalist Bill Bishop--approached RIP Medical Debt in May and said they wanted to focus on Central Appalachia with their personal donation of $100,000. That amount is just a drop in the bucket of the $88 billion of medical debt racked up in the United States over the past year.
and the bad and greedy
• Orphan Products: Hope for People With Rare Diseases (U.S. Food & Drug Administration (FDA)
• List of FDA Orphan Drugs (1-888-205-2311, NIH/GARD--National Center for Advancing Translational Sciences, Genetic and Rare Diseases Information Center)
• GARD Information Navigator
• Saving Mila: How a tailor-made therapy, developed in a flash, may have halted a young girl’s rare disease (Meghana Keshavan @megkesh, STAT, 10-22-18) Mila has Batten disease, an ultra-rare, neurodegenerative genetic disorder. For every child diagnosed, the prognosis has been tragic: Batten is always fatal. It’s part of a family of diseases called lysosomal storage disorders — in which a genetic defect leads to a deficiency of an important metabolic enzyme. This, in turn, leads to a toxic buildup of proteins and lipids in the brain — and those affected end up with degenerative disease. Drug development typically takes several years before a new therapy can even make it into clinical trials. Mila, however, made it from diagnosis to bespoke therapy in just over a year. Her case serves as a proof-of-concept in efforts to rapidly develop and deliver precision medicine — as tailored to a single patient. The drug was designed specifically for Mila’s unique mutation, and it’s not clear whether many more children carry it as well, or will benefit from the therapy.
• Cutting the orphan drug tax credit would take away my day in the sun (Amy Dickey, STAT, 11-21-17) In the Republican-led campaign to reform the U.S. tax code, the tax incentive for making orphan drugs is on the chopping block. The House bill eliminates this credit, while the Senate bill decreases it by about half. Both versions worry me and likely the millions of other Americans living with orphan diseases who are waiting, often in vain, for effective therapies....The Orphan Drug Act has been criticized for creating monopolies by ensuring that companies have seven years of market exclusivity for each orphan drug’s rare disease. Because of this, drug companies have been able to charge astronomical prices. In some cases, companies have even obtained orphan drug designations for medications already on the market, enabling them to charge considerably more for the same drug if used for rare diseases. Abuses of the act’s market exclusivity, however, would not be addressed by eliminating the tax credits of the Orphan Drug Act, which provides drug companies with a tax credit of 50 percent of the cost of research and development....Cutting this tax incentive would almost certainly further slow the creation of new orphan drugs, making the outlook even more bleak for people living with orphan diseases. New legislation to fix the Orphan Drug Tax Act, which the Senate bill calls for, could seek to control abuses of the act’s market exclusivity, rather than eliminating the tax credits."
AND THE BAD AND GREEDY
•**** The Orphan Drug Machine (Video, 6 minutes, Kaiser Health News, 1-17-17) In sum: In 1981, the TV program Quincy M.E. brought attention to the need for drugs for orphan diseases. In 1983, Congress passed the Orphan Drug Act, with incentives for companies to develop drugs for rare diseases (diseases affecting fewer than 200,000 people in the United States). Once drugs are designated as orphans, incentives include a fee waiver, a 50% tax credit for all clinical trials related to the drug's development, and support from the FDA's rare disease program while testing and developing the drug. The firm is also guaranteed 7 years of market exclusivity if the drug is approved--that is that drug will have no competition for treating that disease for 7 years. The ensuing skyrocketing drug prices have created a firestorm. Lawmakers have tried to rein in corporate profits. One proposed law was vetoed by Pres. George W. Bush. Orphans have created a gold rush among pharmaceutical companies. About 450 orphan drugs have been approved, accounting for almost half of all new drugs approved by FDA. Orphans command prices of up to $70,000 a month. Experts worry that orphans are contributing to the rising cost of health care for millions of Americans.
**** Gaming the System: Orphan Drugs Part 3 (Dr. Aaron Carroll, Healthcare Triage, part 3--an excellent video explanation of a major cause of today's drug pricing crisis) There are three ways to game the Orphan Drug Act: Recycling, pushing products for unapproved uses, and "salami slicing." This brilliantly succinct summary of a major problem with the drug industry today is just one part of a broader series (see details below).
(A) Recycling: "Find a cheap drug with lapsed patents that is approved for one indication but is widely used off-label for an orphan disease. Run the drug through clinical trials for that disease and get FDA to approve it for the new indication. You've got seven years of market exclusivity and you jack up the price. The point of the Orphan Drug Act was to reward novel research, not to foster the recycling of existing drugs."
(B) Unapproved uses. "Manufacturers can also secure approval for an orphan drug and exploit their seven years of exclusivity to market their drugs for unapproved uses. This kind of regulatory bait-and-switch may partially explain the paradox that so many blockbuster drugs are also orphan drugs." One study "found that off-label use of orphan drugs is rampant. The lidocaine patch, for example, was approved to treat painful hypersensitivity and chronic pain in post-therapeutic neuralgia. But it's prescribed 83% of the time for different uses entirely. For just 4 orphan drugs from 1999 to 2005, the researchers concluded that state Medicaid programs spent a combined $495 million on off-label uses." The Orphan Drug Law "allows a manufacturer to get a patent for one application and get a chokehold on the market for off-label uses."
If a brand name drug is also an orphan drug, a bioequivalent generic's label must exclude the information about how to treat the orphan disease. It's a "skinny label" because it's no as extensive as the normal label.
(C) Salami slicing. "Many common diseases have subtypes, and manufacturers can seek to approve a drug either for the broader disease or for those subtypes. When some of these subtypes can be characterized as orphan diseases, the manufacturer may be tempted to seek approval for one subtype after another, earning seven years of market exclusivity for each new approval. As a result, a drug that's targeted at a population that is much larger than 200,000 people can call itself an orphan." The narrator provides examples of how certain cancer drugs can be unfairly exploited by drug manufacturers. What's the concern with this salami slicing?
(1) "Granting seven years of market exclusivity for every new disease subset allows manufacturers to extend their drug monopolies."
(2) "A practice of seeking approval for disease subtypes will result in fewer clinical trials on whether a drug works for the disease as a whole. Without those trials, many patients who could benefit from the drug won't receive treatment."
(3) "Phase 3 clinical trials for orphan drugs are less intensive than for conventional drugs, enrolling about one-third as many patients. For true orphan drugs, that's probably okay: Reducing the stringency of FDA approval may encourage their development. But easing up on drugs that aren't actual orphans will mean a general reduction in the quality of clinical trials."
(4) "Salami slicing may enable a manufacturer to maintain market exclusivity for off-label uses, even when the drug is no longer patented. When a cluster of orphan drug designations makes it difficult for a generic to get a toehold, generic manufacturers may lack adequate incentives to bring a competitor to market. And without generic competition, an orphan drug has a lock on the market for both approved and off-label uses."
See also the other three videos in the series -- plus many others on The Incidental Economist podcast (a weekly discussion about health research and policy, co-hosted by Aaron Carroll and Austin Frakt)
• The High Cost Of Hope: When The Parallel Interests Of Pharma And Families Collide (Emily Kopp and Jay Hancock, KHN, 9-7-18) A desperate but determined group of parents raised millions through golf tournaments and cocktail parties to support research for drugs to fight cystinosis, a rare, fatal childhood disease. They were ecstatic when a pill called Procysbi was approved in 2013. The twice-a-day medicine was a breakthrough because it supplanted an existing drug with debilitating side effects that had to be taken every six hours around the clock — a missed dose could permanently damage a child’s kidneys. But the families’ elation dimmed when Raptor Pharmaceutical, which acquired the marketing rights and financed clinical trials for Procysbi, priced the drug: more than $300,000 a year for some patients. Cystinosis families say they are deeply grateful for Procysbi. The medicine would not be on the market without Raptor — which performed clinical trials — and Horizon Pharma, which acquired the rights two years ago, they acknowledge. But they also feel they’ve been used. What began as a desperate search for life-extending medicine, cystinosis parents say, has become a story of corporations profiteering off their children."
• Interactive: How Orphan Drugs Win The ‘Monopoly’ Game (KHN, 1-17-17)
• Drugs For Rare Diseases Have Become Uncommonly Rich Monopolies (Sarah Jane Tribble, Morning Edition, NPR, 1-17-17) "More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored....But the exclusivity is a potent pricing tool. Drugmakers can charge whatever they want by shielding their medicine from competition. The market exclusivity granted by the Orphan Drug Act can be a vital part of the protective shield that companies create. What's more, manufacturers can return to the FDA with the same drug again and again, each time testing the drug against a new rare disease. "What we are seeing is a system that was created with good intent being hijacked," said Bernard Munos, a former corporate strategy adviser at drug giant Eli Lilly and Co. who reviewed the KHN analysis of several FDA drug databases. It's "quite remarkable that it has gone on for so long."
• Orphan Drugs, An Introduction (Healthcare Triage, 4-11-17, on YouTube)
• Orphan Drug Costs (Healthcare Triage, Part 2, 4-17-17)
• CNN investigation exposes inappropriate use of drug in nursing homes (Blake Ellis and Melanie Hicken; Data analysis by Sergio Hernandez, CNN Investigates, 10-12-17) "The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe, a CNN investigation has found. And much of the money is coming straight from the federal government.The pill, called Nuedexta, is approved to treat a disorder marked by sudden and uncontrollable laughing or crying -- known as pseudobulbar affect, or PBA. This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker's own figures, and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig's disease. Nuedexta's financial success, however, is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company, CNN found."
• Healthcare Triage: Orphan Drugs part 4 – Fixing the System (Aaron Carroll, The Incidental Economist, 5-2-17)
• This old drug was free. Now it’s $109,500 a year. (Carolyn Y. Johnson, Wash Post, 12-18-17) 'For decades, Don Anderson of Seattle has been taking the same drug to help control the temporary bouts of immobility and muscle weakness caused by a rare and frightening genetic illness called periodic paralysis. “It's like putting a 50-pound pack on your back and standing up at the dinner table,” Anderson, 73, said. “It's like wearing lead shoes around all the time.” The drug Anderson has been taking all these years was originally approved in 1958 and used primarily to treat the eye disease glaucoma under the brand name Daranide, its price so unremarkable that he can't quite remember how much it cost at the pharmacy counter. But the price has been on a roller coaster in recent years — zooming from a list price of $50 for a bottle of 100 pills in the early 2000s up to $13,650 in 2015, then plummeting back down to free, before skyrocketing back up to $15,001 after a new company, Strongbridge Biopharma, acquired the drug and relaunched it this spring. I'm constantly hearing that public pressure, public shaming will be sufficient to curb these bad actors in these industries. It often feels if you take your attention off of them, even for a second, they'll revert to these old ways,” said Rachel Sachs, an associate law professor at Washington University in Saint Louis. “It’s just another example of how the system has some problems that need to be fixed.” The zigzagging trajectory of the price of Daranide, now known as Keveyis, shows just how much freedom drug companies have in pricing therapies — and what a big business opportunity selling extremely-rare-disease drugs has become. It also illustrates how well-intentioned policy to help spur the development of “orphan” drugs for very rare diseases can have unintended consequences....In a PowerPoint presentation for investors, Strongbridge Biopharma estimated that the annual price of treatment for the drug, Keveyis, would range from $109,500 to $219,000, depending on the dosage the patient took. One slide shows that the drug is covered broadly by insurers.'
• The business of orphan drugs is booming (Suzanne Shelley, Pharmaceutical Commerce, 8-26-15) With competing products and pricing pressure, the rare disease market is starting to resemble the conventional drug market. "Nearly all of this activity is traceable to the Orphan Drug Act of 1983 (ODA). Since then, some 490 new orphan drugs have been approved (including some with multiple indications), more than 3,200 other investigational drugs have received the orphan designation from FDA (allowing them to benefit from the lucrative ODA provisions), and 4,738 orphan drug designation requests have been submitted for consideration....The ODA provisions include annual grant funding and tax credits (to defray the cost of qualified clinical research and testing), assistance in clinical research study designs, seven years of market exclusivity after the orphan drug is approved, and a waiver of the Prescription Drug User Fee Act (PDUFA) filing fees (that fee for FY2015 is more than $1.3 million per application)."
• FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program (Sarah Jane Tribble, The Orphan Drug Machine, Kaiser Health News, 9-13-17) The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases. In a blog post Tuesday, FDA Commissioner Scott Gottlieb said he wants to ensure financial incentives are granted “in a way that’s consistent with the manner Congress intended” when the Orphan Drug Act was passed in 1983. That legislation gave drugmakers a package of incentives, including tax credits, user fee waivers and seven years of market exclusivity if they developed medicines for rare diseases.
• When the Patient Is a Gold Mine: The Trouble With Rare-Disease Drugs (Benjamin Elgin, Doni Bloomfield, and Caroline Chen, BloombergBusinessWeek, 3-24-17) "With a flagship treatment that helps fewer than 11,000 people, how is Alexion making so much money? In the U.S., an orphan drug is defined as one that treats a disease affecting fewer than 200,000 people in the country. Orphan drugs accounted for a disproportionate share, 41 percent, of all medications brought to market in 2014. These drugs have helped millions of people...but have also caused a seismic shift in treatment costs....
"A fraction of a teaspoon of Soliris, administered in a single 35-minute treatment, costs more than $18,000, and patients might need 26 treatments a year for the rest of their lives. With this single drug accounting for almost all its revenue, Alexion has created enormous wealth out of an estimated 11,000 customers." This is an ugly story about drug company marketing practices"....
History: "To address neglected research areas, Congress in 1983 passed the Orphan Drug Act, which gave drugmakers federal grants, tax incentives, and seven years of marketing exclusivity for new rare-disease treatments (vs. three to five years of exclusivity for a more common new drug). In the ensuing 34 years, more than 600 orphan drugs have been approved in the U.S., compared with 10 in the decade before the law was passed. But government-protected monopolies, combined with desperate patients, led to today’s prices." Do your homework. Read this article.
• Insurers Battle Families Over Costly Drug for Fatal Disease (Katie Thomas, NY Times, 6-22-17) Duchenne muscular dystrophy overwhelmingly affects boys and causes muscles to deteriorate, killing many of them by the end of their 20s. Nolan and Jack Willis are twins who took part in a clinical trial that led to the approval last fall of the very first drug to treat their rare, deadly muscle disease, Exondys 51, manufactured and sold by Sarepta Therapeutics. The drug can cost more than $1 million a year even though it’s still unclear if it works. "While insurers once covered drugs for rare diseases as a matter of course, that may be changing now that a wave of expensive drugs have reached the market. The pharmaceutical industry has been in hot pursuit of an increasingly enticing demographic target: An estimated 30 million people in the United States — about 10 percent of the population — are living with one of roughly 7,000 rare diseases. The agency’s approval of Exondys 51, though, prompted a rebellion among some insurers, who are refusing to play along and saying they are concerned about the cumulative impact of such breathtakingly expensive drugs on health care costs."
• Orphan Drug (Wikipedia). Wikipedia cannot be relied on as a primary source, because everyone can contribute to it and can change it. This entry (as of 3-8-17) is a useful overview with links to many publications and resources on the subject. Here's Wiki's opening statement: An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. In the US and EU it is easier to gain marketing approval for an orphan drug, and there may be other financial incentives, such as extended exclusivity, all intended to encourage the development of drugs which might otherwise lack a sufficient profit motive. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development." (3-8-17)
• Drugs For Rare Diseases Have Become Uncommonly Rich Monopolies (Sarah Jane Tribble and Sydney Lupkin, Morning Edition, NPR, 1-17-17, and Kaiser Health News) "More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored. By the drugmakers' calculations, the markets for such diseases weren't big enough to bother with. But lucrative financial incentives created by the Orphan Drug Act signed into law by President Reagan in 1983 succeeded far beyond anyone's expectations. More than 200 companies have brought almost 450 so-called orphan drugs to market since the law took effect. Yet a Kaiser Health News investigation shows that the system intended to help desperate patients is being manipulated by drugmakers to maximize profits and to protect niche markets for medicines already being taken by millions. The companies aren't breaking the law but they are using the Orphan Drug Act to their advantage in ways that its architects say they didn't foresee or intend. "
• Drugmakers Help Turn Patients With Rare Diseases Into D.C. Lobbyists (Sarah Jane Tribble, "The Orphan Drug Machine," Kaiser Health News, 4-10-17) "...behind-the-scenes partnerships between the pharmaceutical industry and advocacy groups may work against lowering the price of high-price drugs. Critics say vulnerable patients are being manipulated and the goals promoted are skewed by the pharma benefactors who want faster government approval for new products and to get insurers or government programs to pay for them, whatever the price tag. Dr. Ezekiel Emanuel, a bioethicist who has studied the issue, said he questions whether patient advocacy groups truly are 'white knights defending the good fight.' He said research suggests that the conflicts of interest that occur when drug companies train and finance patient groups are ';pretty rampant.'” One advocate, the father of three young children with a deadly metabolic disorder, complained that patients and their families had no “involvement drafting, creating or discussing” the messaging delivered to Congress, adding: “It’s like marketing, I’m pushing an agenda by and through a sob story.”
• High Prices For Orphan Drugs Strain Families And Insurers (Sarah Jane Tribble and Sydney Lupkin, All Things Considered, NPR, 1-17-17, and Kaiser Health News) "Cerezyme is an orphan drug, which means it was created to treat a rare disease, one that affects fewer than 200,000 people in the U.S. The orphan drug program overseen by the Food and Drug Administration is loaded with government incentives and has helped hundreds of thousands of patients like Luke feel better or even stay alive. But the 34-year-old program has opened the door to almost unlimited price tags and created incentives for drugmakers to cash in, and to cash in repeatedly, a Kaiser Health News investigation shows. The explosion has burdened insurers as well as government programs like Medicare and Medicaid with drugs that cost up to $840,000 a year that they have almost no choice but to pay for." "AHIP, in a study led by Burns, found that the prices of 45 orphan drugs increased 30 percent, on average, from 2012 through 2014." "Under the law, companies with orphan drugs win some of the richest financial incentives in the regulatory world: a 50 percent tax credit on research and development in the U.S., fee waivers, and access to federal grants. In a 2009 webinar, an FDA official referred to the incentive package as "our 'basket of goodies.' "
• Pricing and reimbursement of orphan drugs: the need for more transparency (Steven Simoens, Orphanet Journal of Rare Diseases, 2-22-11) "There is a need for a transparent and evidence-based approach towards orphan drug pricing and reimbursement. Such an approach should be targeted at demonstrating the relative effectiveness, cost-effectiveness and economic viability of orphan drugs with a view to informing pricing and reimbursement decisions."
• The Economic Power of Orphan Drugs (Laura Gaze, Jennifer Breen, Thomson Reuters, 2012) The revenue potential of orphan drugs may offer greater profitability when considered across their lifetime. Despite the smaller patient pool for rare disease R&D, the economics of orphan drug development shows great potential for commercialization.
• High prices make once-neglected ‘orphan’ drugs a booming business (Carolyn Y. Johnson, WaPo, 8-4-16) Pushed by patients and a popular television show that highlighted rare diseases, Congress passed the Orphan Drug Act. The 1983 law offered drug companies attractive tax credits and monopolies to develop treatments for rare diseases, radically transforming the pipeline of orphan drugs. Pharma companies are offered a perk: a period of market exclusivity that prevents competition for seven years. That has paved the way for drug prices so high that a single year of treatment can cost more than a car or even a house. Since the act passed, the median launch price of orphan drugs for chronic use has doubled every five years. Despite the drugs’ high list prices, patients generally are not on the hook for the full amount, thanks to insurance, secret rebates and assistance programs underwritten by drug companies. As the rare-disease drug business has expanded, though, the high prices could drive up insurance costs for everyone.
• Why the Shift? Taking a Closer Look at the Growing Interest in Niche Markets and Personalized Medicine (Shannon Gibson, Hamid R Raziee, and Trudo Lemmens, World Med Health Policy, March 2015, on PMC). Note: "Some members of the scientific community now argue that 'stratified' medicine is a more accurate term than 'personalized' medicine for describing this new approach which targets patient subpopulations that are more or less likely to respond to a treatment rather than tailoring the treatment specifically for the individual." "While there are many potential benefits associated with targeted therapies and drug development for historically neglected rare diseases, niche market therapies also present evidentiary challenges (e.g., smaller clinical trials and enrichment strategies) that can make approval decisions difficult, and uncertainties remain around the true benefits of many therapies."
How are prices for targeted therapies for rare diseases set and how likely is health insurance to provide coverage? If the drug is FDA approved and the only treatment available for a condition, is an insurer obligated to cover it? Does the system of setting drug prices need to be fixed?
• It’s Easier to Measure the Cost of Health Care than Its Value (Dana Goldman, Amitabh Chandra, and Darius Lakdawalla, Harvard Business Review, 11-16-14) "How can there be no licensed treatment or vaccine for Ebola, a disease with a very high death rate that has caused a global public health emergency? The answer is painful but clear: The profit potential from Ebola treatments was too small to interest large manufacturers. Ebola historically has threatened West African countries that have low standards of living. The small Canadian laboratory that produced an experimental vaccine was funded by the Canadian government, and Ebola was chosen as a research target because it is a good model for other infectious diseases. Ebola may seem remote, but the economics of innovation are the same in Africa and the United States: Innovation subsists entirely on the prospect of substantial rewards earned from the discovery of a new drug." Goldman and colleagues analyze the problem and discuss practical short- and long-term solutions. "The bottom-line principle is that if we reimburse care on the basis of value — rather than price — and preserve access to that care, everyone wins in the end." To stay up on this topic, follow Dana Goldman on Twitter, where he says "There is a reason we develop few new anti-malaria treatments, despite 500K deaths annually around the world." and "People really want to talk Sovaldi! Price will drop when others enter and ultimately when patents expire." "Decouple debate about price from cost. We don't accuse Apple of gouging because iPad costs more than manufacturing cost." Bottom line: "Value drives pricing, not manufacturing costs."
• On the other hand, Goldman has been criticized as advocating on behalf of pharmaceutical companies (through a consulting firm called Precision Health Economics, as a Consumer Reports/Pro Publica reports emphasizes: Big Pharma Quietly Enlists Leading Professors to Justify $1,000-Per-Day Drugs (Annie Waldman, Pro Publica, 2-23-17) As it readies for battle with President Trump over drug prices, the pharmaceutical industry is deploying economists and health care experts from the nation’s top universities. In scholarly articles, blogs and conferences, they lend their prestige to the lobbying blitz, without always disclosing their corporate ties. Check out all the articles in the Pro Publica series Dollars for Docs
• Drug Licenses: A New Model For Pharmaceutical Pricing (Dana P. Goldman, Anupam B. Jena, Tomas Philipson and Eric Sun; Health Affairs, 2008) High drug prices are a major barrier to patients’ access to drugs and compliance with treatment. It is often argued that low drug prices provide inadequate incentives for innovation. Goldman and colleagues propose a drug-licensing model for health care which has the promise of increasing drug use without altering patients’ out-of-pocket spending, health plans’ costs, or drug companies’ profits. In such a model, people would purchase annual drug licenses that would guarantee unfettered access to a clinically optimal number of prescriptions over the course of a year. Using the example of statins, they illustrate how such a model could be implemented. They consider three scenarios: (1) a pure copayment model (the status quo), (2) a drug-licensing model with zero copayment and license fees paid by both the health plan and the statin user, and (3) a mixed model in which a license fee is paid in return for lower, but not zero, copayments.In the license example, statin users pay this amount up front as a license fee, and the copayment is eliminated. Compliance improves.
• What the candidates don't get about drug pricing (Dana Goldman, LinkedIn, 3-16-16) Donald Trump says that he could save $300 billion annually-- quite an accomplishment since Medicare’s total Part B and Part D prescription drug spending is about $140 billion....When the candidates say they will do something about drug prices, what they really mean is that they are going to restrict access to some treatments, either through closed formularies or high cost-sharing with patients. There is no other way to lower prices. And they should be honest with the American people about that....They also need to be honest about what it means down the road. Higher prices in the United States drive pharmaceutical innovation. We know R&D spending is greater in battling diseases where there are large patient populations, widespread insurance coverage, patent exclusivity, and research subsidies. Consider, by contrast, the plight of Africa, where malaria kills more than 400,000 children each year, and yet we have few if any active efforts to develop antimalarials. It takes the beneficence of people like Bill and Melinda Gates to find treatments."
• Myths and facts about specialty drugs (Anupam B. Jena, Dana Goldman, Tomas J. Philipson, American Enterprise System, 11-4-15) "The ongoing debate over specialty drugs — reflecting conflicting motives of buyers and sellers — neglects important insights about the impact of these new technologies, their value to society, and the economics of medical R&D. We here disentangle the facts from the myths surrounding these products."
• Pricing Orphan and Specialty Drugs-Insights from the World Orphan Drug Congress & ISPOR (Health Advances Blog, 6-22-16) Andrew Funderburk interviews Carrie Jones on her recent attendance at the World Orphan Drug Congress and Julia Gaebler and Martha Boylston on the International Society for Pharmaeconomics and Outcomes Research (ISPOR) annual meeting. One popular panel was “The Price is too Damned High, or is it?” From the payer (Medicaid) side, panelist Jeff Myers argued that "there have been a lot of price increases among specialty products without any new innovation," -- for example, for insulin, which is not an orphan disease. From industry came the argument that "price is needed to support innovation, and a large percent of that is coming from the US system, or at least the US payer is paying for a lot of the drug innovation that’s happening in the world today." Dana Goldman often analyzes the cost of Sovaldi for the treatment of hepatitis C: "Even though Solvaldi only prevents what many argue is a small number of high cost liver transplants and cases of liver cancer, standard cost-effectiveness analysis suggests that it’s still cost effective at its high price. But what Dana showed was that if you were to attach a cost to all of the benefits associated with treatment, including a reduction in the prevalence of hep C, brought about by the curative effects of Solvaldi, and increased life expectancy of the current population with Hep C, then what you see is that the costs of treatment are a tiny sliver compared to the value of the benefits....This approach put a dollar value on life extension, and the decline of the prevalence of hep C." However, the government and payers still can't afford it. When a drug comes along that blows out the budget, there is a tradeoff. Said panelist Julia: "Do you treat six CF patients, or do you treat people much more prevalent common diseases? I don’t know the answer to that, but other governments have given more thought to how to make that trade‑off explicit." Said Andrew F.: "We don’t do explicit tradeoffs very well in the US. We tend to bury our head in the sand and hope the problem goes away, which has not been a very successful strategy, traditionally." Julia G.: "In the US we’re scared of the R‑word, rationing. We don’t say that word here." Andrew: "But you [know] it happens, because all health care is rationed in some way."
The FDA refers to such a program as an expanded access program (EAP). ... “Compassionate use” is a more colloquial term that is not generally used by the FDA. Individuals and their physicians can apply for use of an investigational drug using FDA Form 3926, an application form created by the agency in June 2016.
• Expanded Access: Information for Patients (U.S. Food and Drug Administration) Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions-- investigational drugs/devices not yet been approved by the FDA and not yet proven to be safe and effective.
• How State Right-To-Try Laws Create False Expectations (David Farber, Preeya Noronha Pinto, Arthur Caplan, and Alison Bateman-House, Health Affairs blog, 5-22-15) "Federal preemption laws prevent states from creating workarounds that purport to supersede the extensive regulatory scheme enforced by the FDA. Contrary to the hype surrounding them, so-called Right-to-Try laws do not create any additional “rights” for patients."
• Seeking the Right to Try (Kimberly Leonard, U.S. News, 11-18-14) Laws allowing terminal patients to try drugs not approved by the FDA have passed in five states, but experts question their efficacy.
• 'Right to Try' Legislation Tracker (RAPS) ( Alexander Gaffney, Regulatory Affairs Professional Society, 6-24-15) Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for regulatory professionals and patients to keep track of legislation as it moves through various state legislative bodies. Links to states with Right to Try Laws
• Examining Patient Access to Investigational Drugs A hearing was held Tuesday, Oct. 3, 2017, by the Subcommittee on Health of the House of Representatives’ Committee on Energy and Commerce. The subcommittee called on Alison Bateman-House and several other witnesses, including a veteran with ALS, a biotech CEO, a patient advocate, the commissioner of the FDA and the U.S. Government Accountability Office’s director for health care.
• ‘Right-to-try’ law threatens patient safety and rational drug development (Mark Harrington and Ellen V. Sigal, STAT, 3-12-18) "Backers of the right-to-try law would have you believe that the FDA is barring the distribution of all sorts of miracle cures. But many experimental treatments turn out to be totally ineffective. And as it stands, the FDA approves more than 99 percent of the thousand-plus applications it gets each year — usually within days of receiving the application — for access to experimental therapies through an existing program called expanded access or compassionate use. Right-to-try legislation would create a pathway to remove FDA oversight of experimental, unproven therapies. Excluding the FDA from the development and delivery of these therapies will make it harder to gauge their safety and effectiveness.
• ‘Right-to-try’ bill rejected by House, in major blow to GOP efforts ( Erin Mershon, STAT, 3-13-18) "The vote was an embarrassing defeat not only for House Republicans but for President Trump, who had called on Congress to quickly pass right-to-try legislation, and Vice President Mike Pence, a longtime supporter of the effort. It was also a rare misstep from Speaker Paul Ryan, who like most congressional leaders almost never schedules votes on legislation without some certainty that the given measure has the support to pass....Critics, however, including Minority Leader Nancy Pelosi of California, pointed out that the FDA already has a program in place to offer access to terminal patients, and the agency grants some 99 percent of all the requests it receives, often within a short time frame. They also argued that without more FDA oversight of the use of experimental therapies, desperate patients could be vulnerable to bad actors or unsafe treatments."
• I’m the ideal person to support right to try. But I can’t — it’s a disaster in the making (Michael D. Becker, STAT, 2-1-18) Put simply, under the right-to-try bill, a death caused by the use of an experimental drug could not be considered by the FDA in deciding whether to approve or reject the therapy. Not to mention the implications of this for patients.
• Accelerated Approval and Expensive Drugs — A Challenging Combination (Walid F. Gellad and Aaron S. Kesselheim, NEJM, 5-25-17) "[A]t a time when medications can cost hundreds of thousands of dollars per year, accelerated approval can lead to situations in which private payers may choose not to cover a drug because of high cost and lack of evidence of clinical efficacy, thereby thwarting the pathway’s goal of getting potentially important therapies to patients earlier, while major government payers are forced to cover the product, directing substantial tax dollars to drugs not yet shown to have clinical benefit. For public insurers, accelerated approval thus becomes not only a pathway for a new product to enter the market, but also a mandate to pay high prices for an unproven therapy. We propose...First, manufacturers could be required to offer additional price concessions to public insurance programs for drugs receiving accelerated approval until the confirmatory trials are completed....For example, Medicaid is supposed to receive the “best price” the manufacturer offers to other payers, but an additional rebate could be statutorily added for accelerated-approval products; this would last until confirmation of the drug’s clinical efficacy....Alternatively, to address the concern that additional required discounts will simply lead to higher list prices, companies could be reimbursed by government payers only for the cost of manufacturing the drug plus some agreed-on markup, until confirmatory trials demonstrate clinical benefit....Second, we would like to see the FDA do more to ensure that confirmatory trials conducted after receiving accelerated approval are performed in a timely fashion and are designed optimally to limit the period of uncertainty about true clinical effect....Finally, we propose that all drugs that move through the accelerated-approval pathway and cost over $100,000 per year, or some other agreed-on threshold, should be the subject of formal economic impact analyses after 1 to 2 years on the market."
• Will New FDA Regulation On IRB Review Speed Patient Access To Experimental Drugs? (Kelly McBride Folkers and Alison Bateman-House, Health Affairs, 12-11-17) 'For terminally ill patients or those with serious conditions that cannot be successfully treated with the available approved therapies, the ability to access experimental treatments provides some hope. Many of these patients seek spots in clinical trials, but only some will land them. To help patients who might benefit from experimental therapies but who are unable to participate in a clinical trial, the Food and Drug Administration’s (FDA’s) expanded access program provides a pathway for access to drugs, biologics, devices, and vaccines that have not yet been approved by the agency. For single-patient access, this pathway is colloquially known in the United States as “compassionate use.”...Over the program’s three decades of existence, the majority of expanded access requests have been approved. Yet libertarian activists and their allies argue that the process is slow and overly bureaucratic. Galvanized by this claim, the Senate passed a federal “right to try” bill, which, if passed by the House and signed into law, would severely limit the FDA’s role in compassionate use....But to appropriately evaluate new guidance on IRBs—relating either to process or role—it is necessary to have an accurate snapshot of the IRB landscape before making changes. Unfortunately, such baseline data are lacking, which will hinder ongoing efforts to evaluate the impact of this and other possible regulatory changes pertaining to IRBs.' An interesting discussion, which answers questions few may know to ask.
• New FDA Breakthrough-Drug Category — Implications for Patients (Jonathan J. Darrow, Jerry Avorn, and Aaron S. Kesselheim, NEJM, 3-27-14) There has also been little discussion of the implications of approving breakthrough drugs
on the basis of limited data for patients considering therapeutic options and for their physicians. Expedited approval has been championed by patient advocacy groups who think that FDA requirements that delay access to new products infringe on personal autonomy....In Europe, centralized payers serve as a barrier to the widespread use of available but marginally useful clinical therapies. However, in the United States, the greater fragmentation of the insurance market and the greater sense of entitlement to all available treatments make it unlikely that this counterbalance will be as effective....In the next few years, evidence will accumulate to indicate how well the new breakthrough-therapy designation improves the options of patients with serious and intractable diseases and to what extent it facilitates the market entry of treatments that promise more than they can deliver.
• What I Told Congress About Patient Access To Experimental Medicines (Alison Bateman-House, Forbes, 10-17-17) The "de facto purpose of the hearing was to talk about right to try laws. These laws purport to grant terminally ill patients access to experimental medicines outside of clinical trials. In my analysis, what these laws really do is take the current FDA process by which severely ill patients with no other treatment options are able to access these medicines and strip it of vital provisions that benefit patients, adding nothing of value in return....I used my time before legislators to tell them what I and my colleagues in the Working Group on Compassionate Use and Pre-Approval Access (CUPA) have learned after more than three years of intensive study about patient access to experimental medicines. First, there is a widespread lack of knowledge of the FDA’s expanded access program, the existing channel by which seriously ill patients may access experimental medical products outside of clinical trials. Again and again, we found that patients, doctors, reporters and even personnel in the pharmaceutical industry have not known that it is possible to access investigational drugs outside of clinical trials, much less how to do so. They may have heard the term “compassionate use,” but what that is, who it is for, and how to take advantage of it was largely a mystery....On the whole, patient advocacy groups tended to be more familiar with the topic; however, again, there was a vast range in knowledge...
The second issue I raised in my testimony was that of rampant inaccurate, even mythological, beliefs about access to investigational medical products....One such belief is that the FDA can force drug or device companies to make their products available. This is not true. The FDA can merely approve a request to proceed once the relevant company has agreed to it; if the company says no, there is no higher power to which a patient can appeal...Another widespread myth is that the FDA is slow to review and decide upon expanded access requests. This is not true.... (Read on to learn about further myths, and the facts....)..."There is no doubt that some experimental therapies are able to bring patients back from the very edge of death. A well-known example was Gleevec, and a more recent example is immunotherapy. But we’ve seen that immunotherapy can miraculously help a lucky few, yet kill others, and we do not yet know how to predict who will benefit and who will be harmed." "When drugs are tested in clinical trials, meticulous records are kept on patient survival, adverse events, and deaths. But this typically has not been the case in expanded access. Upon receiving experimental drugs to try on their patients, physicians are told to report serious or unexpected reactions and a summary outcome; however, it is widely known that this is not always done. Furthermore, the FDA does not audit these physicians to determine or ensure compliance with this rule. As a result, we do not know how many of those who try experimental products via expanded access are harmed, and, because nobody’s systematically tried to document it, we don’t know how many of those patients are helped or how many experience no effect, either positive or negative."
• How State Right-To-Try Laws Create False Expectations (David Farber, Preeya Noronha Pinto, Arthur Caplan, and Alison Bateman-House, Health Affairs blog, 5-22-15) "Federal preemption laws prevent states from creating workarounds that purport to supersede the extensive regulatory scheme enforced by the FDA. Contrary to the hype surrounding them, so-called Right-to-Try laws do not create any additional “rights” for patients."<
• Expanded Access: Information for Patients (U.S. Food and Drug Administration, or FDCA)
• Expanded Access Navigator (Reagan-Udall Foundation) Expanded Access (EA) may be considered for patients who have exhausted their treatment options and are not eligible for, or able to participate in, a clinical trial.
• From 100 Hours to 1: FDA Dramatically Simplifies its Compassionate Use Process (Alexander Gaffney, Regulatory Affairs Professionals Society, 2-4-15) Before Feb. 2015, patients and doctors had trouble accessing the Expanded Access program. The new form should take under an hour to fill out.
• Characterizing expanded access and compassionate use programs for experimental drugs (Jennifer E. Miller, Joseph S. Ross, Kenneth I. Moch, and Arthur L. Caplan, BioMed Central Res Notes, 7-28-17) Team sought to determine the characteristics of “expanded access” and “compassionate use” programs registered in ClinicalTrials.gov and to determine the percentage of drugs provided through these programs that ultimately received FDA marketing approval. "Most (76%) provided drugs in expanded access programs eventually received FDA approval. Thus, provided drugs in registered expanded access programs are, more times than not, eventually deemed safe by the FDA. Notwithstanding, the fact that nearly 25% of expanded access drugs have yet to receive FDA approval, shows that we cannot entirely eliminate safety and efficacy questions in expanded access and compassionate use programs. It is reasonable to allow the FDA to retain its oversight and approval role for these programs, in order to help mitigate safety risks for patients- especially since it approves 99% of expanded access and compassionate use requests....Expanded access programs raise broader ethical and regulatory questions, including whether (and how much) product manufactures should re-direct investigational products and resources from formal clinical trials to patients requesting expanded access and how to finance these programs."
• Medical ethicist discusses Right-to-Try legislation (Sibyl Wilmont, Covering Health, AHCJ, 12-6-17) "Right-to-Try (RTT) legislation sounds like a no-brainer, promising to improve access to treatments yet unapproved for marketing by the FDA for people with terminal illnesses. But it’s not that simple, according to Alison Bateman-House, Ph.D., M.P.H., M.A., an ethicist and assistant professor at the New York University School of Medicine. In fact, many of its basic provisions make it unlikely to deliver on its promise....Federal legislation, ostensibly aiming to overcome legal challenges to 38 state RTT laws, was introduced in both houses of Congress earlier this year....Proponents of this legislation, led by Phoenix-based libertarian think tank the Goldwater Institute, blame the FDA for “killing patients” and use heart-wrenching patient stories to support their cause. Not surprisingly, families desperate to find help for their critically or terminally-ill loved ones have provided ammunition. This is especially true, says Bateman-House, of people suffering from ALS and supporters of easing regulations on widespread use of stem cells. RTT opponents argue that the legislation does an end-run on regulatory protections and puts Americans at risk. By releasing health care providers and drug companies from their respective mandates to report adverse events (AE) to the FDA, serious complications, drug interactions, and even deaths attributed to investigational medical products could remain closely held secrets. Unlikely opponents to RTT include pharmaceutical, biotech, and medical device companies, who worry that lacking such information could lead to ineffective or dangerous products entering the market, only to be withdrawn after tragic outcomes for families — and, consequently, for their own marketing...the only requests that go to the FDA for approval are ones that the drug companies have agreed to fill: hence, the chief obstacle to obtaining access to investigational drugs is at the company level" .Bateman-House is personally involved in an effort to "use a non-industry, interdisciplinary panel to decide which patients’ requests for investigational drugs to grant and which to decline" (see NYU Department of Population Health: CompAC: The Compassionate Use Advisory Committees.
• The dark side of ‘compassionate use’ of experimental drugs (Ariana Eunjung Cha, Washington Post, 8-31-16) "A powerful report from STAT this week provides a heartbreaking reminder that the reason experimental drugs are not available for anyone to use is because they are just that — experimental. And the chances that things will go wrong are as strong as that they will go right. The report focuses on a highly controversial treatment for rare cancers being promoted by Texas doctor Stanislaw Burzynski and how, from 2011 to 2016, 37 members of Congress wrote to the Food and Drug Administration about his work. Many of those letters asked the agency to give their constituents “compassionate use exemptions” to try his unapproved drugs. But what about the other letters? They were reports about patients having bad reactions — or even dying — from his treatments...These cases should serve as cautionary tales to parents to have realistic expectations about compassionate use and to beware of supposed miracle cures."
• To help cancer patients, lawmakers pushed access to a controversial doctor (Sheila Kaplan, STAT, 8-29-16) "The treatment, developed by a controversial Texas doctor named Stanislaw Burzynski to treat a rare form of cancer, has never been shown to be successful. Yet, for years, patients have continued to seek Burzynski out, and to ask their representatives in Congress to intervene on their behalf. From 2011 to 2016, 37 members of Congress wrote to the FDA about Burzynski, several of them numerous times, according to documents obtained by STAT under the Freedom of Information Act. Most of the lawmakers asked the agency to grants constituents “compassionate use exemptions” so that they could try his unapproved drugs, or to allow his clinical trials to proceed. Other letters, however, reflect the long-standing allegations against Burzynski, who has been cited by the FDA in dozens of cases in which patients have reported bad reactions to his treatment — a mix of peptides — or even died. In those letters, the lawmakers ask the agency to shut down the doctor’s clinical trials. Lawmakers routinely appeal to government agencies on behalf of constituents in need of medical assistance. But in Burzynski’s case, the doctor’s critics say, the congressional advocacy risks giving the terminally ill and their families a false sense of hope, while also conferring a measure of legitimacy on him that many believe he does not deserve."
• I've heard that compassionate use is a way to get access to experimental treatments. How does it work? (Timothy J. Moynihan, M.D, answers question on Mayo Clinic website)
• After Colorado, ‘Right To Die’ Movement Eyes New Battlegrounds (Melissa Bailey, Kaiser Health News, 11-9-16) Fortified by a solid victory in Colorado Tuesday, a controversial campaign to let terminally ill patients access life-ending medication is moving on to other battlegrounds across the country. An overview of where such campaigns stand.
• Expanded Access: Information for Patients (U.S. Food and Drug Administration) Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions-- investigational drugs/devices not yet been approved by the FDA and not been proven to be safe and effective.
• Seeking the Right to Try (Kimberly Leonard, U.S. News, 11-18-14) Laws allowing terminal patients to try drugs not approved by the FDA have passed in five states, but experts question their efficacy.
• 'Right to Try' Legislation Tracker (RAPS) ( Alexander Gaffney, Regulatory Affairs Professional Society, 6-24-15) Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for regulatory professionals and patients to keep track of legislation as it moves through various state legislative bodies. Links to states with Right to Try Laws
• STAT and Retro Report collaborated on a three-part series of documentary video shorts looking back at the roots of today’s most promising genetic technologies:
---Part 1: Finding the Code The race to sequence the human genome was also billed as a race to end disease. What happened? (12:10 minutes)
---Part 2: Fixing the Code CRISPR — and the promise and pain of gene therapy that came before it. Does the ability to more easily change the blueprint of life mean we’re on the path to repairing the broken bits in our genetic inheritance? Or have we tried this before and failed? (13:07 minutes)
---Part 3: Selling the Code Genetic testing has moved out of the labs into the masses. It’s now easier than ever to peer into your own genetic code. But are all of the new companies out there offering you information about yourself that you can believe? Don't buy into the hype. (10:55 minutes)
• What Is CRISPR, and Why Is It So Important? (Michael Tabb, Andrea Gawrylewski, Jeffery DelViscio, Scientific American, 6-22-21)
• CRISPR Cheat Sheet (Tyler Ford and Jennifer Tsang, addgene blog)
• CRISPR TRACKR (STAT News) Requires subscription.
• Want to stay up to date on the latest CRISPR advances? STAT has created a searchable CRISPR Trackr. (STAT News)
• CRISPR debuted 10 years ago, in a paper hardly anyone noticed. Jennifer Doudna reflects on the DNA scissors’ first decade (Megan Molteni, STAT News, 6-28-22) CRISPR has been used to manipulate the genomes of organisms across every branch of the tree of life, including humans. It’s now being tested to treat dozens of inherited diseases, with companies planning to ask regulators for approval of the first CRISPR-based medicine as soon as later this year.
• CRISPR Cheat Sheet: The Most Important Gene Editing Stories of 2019 (Emily Mullin, OneZero, Medium, 12-24-19) Human trials, bird flu, gene editing in space, and more. Scroll down for links to more articles about CRISPR and for more CRISPR stories.
• CRISPR TRACKR: Follow the latest developments in genome editing (Megan Molteni, STAT+, paid subscription.
• What is CRISPR? (Aparna Vidyasagar, Nicoletta Lanese, LiveScience, 10-20-21) A good, illustrated explainer.p>
• CRISPR coverage (STAT)
• The untold story of how the Golden State Killer was found: A covert operation and private DNA (Paige St. John, Los Angeles Times, 12-8-2020) FamilyTreeDNA let law enforcement set up a fake account using genetic material from a crime scene. After uploading the forensic profile to MyHeritage, a civilian geneticist working with investigators found the close relative needed to solve the case.
• 29 Siblings and Counting (Rachael Rifkin, 23andMe blog, 5-20-19) Shauna Harrison, a San Francisco-based fitness coach with a Ph.D. in public health, got an unexpected twist in her family story when she dug into her 23andMe results. As someone who grew up as an only child and really owned that identity, receiving an email that began “It looks like we are related” was pretty disorienting. Shauna and her donor siblings are “diblings”— siblings with different mothers, conceived using the same donor father. Her dad was a paraplegic but it never occurred to Shauna that he might not be her biological father.
• Three of the World’s Top Ancestry Tests: How Do They Compare? MyHeritage vs 23andMe vs AncestryDNA (Moss Stern, DNA Weekly) He had his DNA tested by all three, so he's in a good position to give you a side-by-side comparison. Thorough, detailed, interesting, and very helpful! Among other questions addressed: Are the DNA Test Kits a good value for the price? How do they compare on various points. What does each of them give you? How many geographical points are analyzed? How much do they follow up with annoying sales pitches? How much help will you get if something goes wrong? And so on.
• Award-winning genetics reporter shares her process (Tara Haelle, Covering Health, AHCJ, 1-8-2020) Saey submitted her DNA to eight different testing companies and then compared the results and their widespread discrepancies. Her five articles explore what consumer DNA testing companies promise and what they actually deliver. She especially delves into the topics of disease risk and ethnicity, but what might have been dry recitation of numbers becomes instead a series of personal stories that illustrate the limitations of such testing.
• Genetic testing goes mainstream (Tina Hesman Saey, Special Report, Science News, 5-23-18) Consumers are jumping on the genetic testing bandwagon. Many don't know what's in store. A multi-part package, which includes:
---Consumer DNA testing promises more than it delivers Here’s what to expect from consumer DNA tests.
---What genetic tests from 23andMe, Veritas and Genos really told me about my health Consumer genetic testing companies offer different levels of DNA analysis, but none offer complete information about a person’s health.
---The history of heredity makes for a fascinating, and chilling, read A review of Carl Zimmer’s book She Has Her Mother’s Laugh, which chronicles how scientists have come to understand genetics.
---Guidelines call for limits to whole genome testing for fetuses Ethical and practical issues dog prenatal whole-genome tests.
---What consumer DNA data can and can’t tell you about your risk for certain diseases Consumers face lots of choices and unanswered questions.
---Privacy and consumer genetic testing don’t always mix Protections are spotty at best and vary by testing company.
---At-home telomere testing is not a reliable marker of aging, researcher says Companies pledge to tell you your cellular age from a drop of blood. Don’t be so sure.
---What I actually learned about my family after trying 5 DNA ancestry tests Results can vary widely.
---What is DNA recombination? (Video, Science News) Explained with lego blocks. Why there’s a chance you don’t share any DNA with your third cousin.
What genetic testing means for solving crimes
---New genetic sleuthing tools helped track down the Golden State Killer suspect Mining genealogy databases to find crime suspects raises privacy concerns.
---Genetic sleuthing again IDs a murder suspect in a cold case Crime-scene DNA let investigators find distant cousins and fill in the family tree.
---Why using genetic genealogy to solve crimes could pose problems Some worry that authorities could violate people’s rights using the method.
---Genealogy databases could reveal the identity of most Americans Keeping your DNA private is getting harder.
• Genetic Counselors For when you want to find a "medical genetic counselor," to help you find information about inherited medical conditions.
• When There’s a Surprise in DNA Results (Amy Johnson Crow, 8-2-19)
• AAAS Kavli Science awards went to these three articles:
---A Young Mississippi Woman's Journey Through A Pioneering Gene-Editing Experiment (Rob Stein, Shots, NPR, 12-25-19) In three stories from NPR’s “All Things Considered,” Rob Stein and his colleagues Joe Neel and Jane Greenhalgh told the story of Victoria Gray, a patient with sickle cell disease who received the first use of a groundbreaking new CRISPR treatment for her genetic disorder. Read
---In A 1st, Doctors In U.S. Use CRISPR Tool To Treat Patient With Genetic Disorder (Rob Stein, Morning Edition, NPR, 7-29-19)
---A Year In, 1st Patient To Get Gene Editing For Sickle Cell Disease Is Thriving (Stein, Morning Edition, 6-23-2020) Gray is the first person with a genetic disorder to get treated in the United States with the revolutionary gene-editing technique called CRISPR.
• A serious new hurdle for CRISPR: Edited cells might cause cancer, two studies find (Sharon Begley, STAT, 6-11-18) Editing cells’ genomes with CRISPR-Cas9 might increase the risk that the altered cells, intended to treat disease, will trigger cancer, two studies published on Monday warn — a potential game-changer for the companies developing CRISPR-based therapies. In the studies, published in Nature Medicine, scientists found that cells whose genomes are successfully edited by CRISPR-Cas9 have the potential to seed tumors inside a patient. That could make some CRISPR’d cells ticking time bombs, according to researchers from Sweden’s Karolinska Institute and, separately, Novartis.
• The US Scientists Who Knew About CRISPRed Babies (Shawna Williams, The Scientist, 1-29-19) When MIT Technology Review and the Associated Press in late November broke the story that a clinical trial in China had implanted gene-edited embryos and yielded apparently healthy babies, the news shocked many, including scientists in the field. Multiple researchers were aware of He Jiankui’s clinical trial before the news became public in November. But in the months since, it’s emerged that several top scientists and at least one bioethicist were not surprised—they’d already known about, and in one case were involved in, researcher He Jiankui&rsquo's plans.
• New details emerge about a U.S. scientist’s obscured role in the ‘CRISPR babies’ scandal (Megan Molteni, STAT+, 3-18-22)
• What Have We Learned? the Scientist, the Twins, and the First Human Gene Edit (Ella Williams, Carre4/Medium, 1-3-21) Two years on from the birth of the world’s first tailor-made babies
• CRISPR scientists are in for the long haul. Wall Street is less patient (Damian Garde, STAT+, 6-11-18) Investors’ bullishness on the potential of gene-editing technologies has turned a trio of startups into multibillion-dollar enterprises. But some unforeseen scientific findings, courtesy of a pair of new scientific papers, provides a jarring reminder to the market: Until this newfangled technology is proved safe in actual humans, investing in CRISPR stocks will remain a head-spinning experience. CNBC's coverage: CRISPR stocks tank after research shows edited cells might cause cancer.
• Genetics 101: From Chromosomes and the Double Helix to Cloning and DNA Tests, Everything You Need to Know about Genes by Beth Skwarecki. (Read about how she wrote it.
• 20 Americans Die Each Day Waiting for Organs. Can Pigs Save Them? (Tom Clynes, NY Times Magazine, The Tech and Design Issue, 11-16-18) A story about genetic engineering. Twenty Americans "die each day waiting for an organ.... Even though 58 percent of adults in the United States have registered as donors, demand still outpaces supply and most likely always will. Thanks to genetically engineered pigs, the donor-organ shortage could soon be a thing of the past....The organs inside this little pig — or perhaps more realistically, those of its progeny — could someday find their way inside me or you or one of our descendants. If so, we will be much the better off for it, even if we cannot say the same for the pig."
• Why Your DNA Is Still Uncharted Territory (Carl Zimmer, NY Times, 9-18-18) Scientists are focusing on a relatively small number of human genes and neglecting thousands of others. It was possible, for example, that scientists were rationally focusing attention only on the genes that matter most. Perhaps they only studied the genes involved in cancer and other diseases. That was not the case, it turned out. “There are lots of genes that are important for cancer, but only a small subset of them are being studied,” said Dr. Amaral. “All the rewards are set up for you to study what has been well-studied. We keep looking at the same genes as targets for our drugs. We are ignoring the vast majority of the genome.” Dr. Stoeger argued that the scientific community should recognize that a researcher who studies the least known genes may need extra time to get results.
• Genetic Testing Is a Hot New Benefit for Employees, But Researchers Say It Might Do More Harm Than Good (Kaiser Health News, 4-16-18) A whole issue on the topic.
• How Genetic Tests Muddy Your Odds Of Getting A Long-Term-Care Policy (Michelle Andrews, KHN, 8-7-18) "The federal Genetic Information Nondiscrimination Act prohibits health insurers from asking for or using your genetic information to make decisions about whether to sell you health insurance or how much to charge. But those rules don’t apply to long-term-care, life or disability insurance....If you get genetic testing after you have a policy, the results can’t affect your coverage."
• Most White Americans’ DNA Can Be Identified Through Genealogy Databases (Heather Murphy, NY Times, 10-11-18) "The genetic genealogy industry is booming. In recent years, more than 15 million people have offered up their DNA — a cheek swab, some saliva in a test-tube — to services such as 23andMe and Ancestry.com in pursuit of answers about their heritage. In exchange for a genetic fingerprint, individuals may find a birth parent, long-lost cousins, perhaps even a link to Oprah or Alexander the Great. But as these registries of genetic identity grow, it’s becoming harder for individuals to retain any anonymity" See also So many people have had their DNA sequenced that they've put other people's privacy in jeopardy (Deborah Netburn, LA Times, 10-12-18) and Study: DNA Websites Cast Broad Net for Identifying People (Associated Press, 10-11-18) About 60 percent of the U.S. population with European heritage may be identifiable from their DNA by searching consumer websites, even if they've never made their own genetic information available, a study estimates. And that number will grow as more and more people upload their DNA profiles to websites that use genetic analysis to find relatives, said the authors of the study released Thursday by the journal Science.
• Swift Gene-Editing Method May Revolutionize Treatments for Cancer and Infectious Diseases (Gina Kolata, NY Times, 7-11-18) Scientists report that they have discovered a way to tweak genes in the body’s immune cells by using electrical fields. "For the first time, scientists have found a way to efficiently and precisely remove genes from white blood cells of the immune system and to insert beneficial replacements, all in far less time than it normally takes to edit genes. If the technique can be replicated in other labs, experts said, it may open up profound new possibilities for treating an array of diseases, including cancer, infections like H.I.V. and autoimmune conditions like lupus and rheumatoid arthritis....Currently, scientists attempting to edit the genome often must rely on modified viruses to slice open DNA in a cell and to deliver new genes into the cell. The method is time-consuming and difficult, limiting its use."
• Staggering Prices Slow Insurers’ Coverage Of CAR-T Cancer Therapy ( Michelle Andrews, KHN, 7-17-18) 'Patients whose blood cancers have failed to respond to repeated rounds of chemotherapy may be candidates for a new type of gene therapy that could send their cancers into remission for years. But the two approved therapies, with price tags of hundreds of thousands of dollars, have roiled the insurance approval process, leading to delays and, in some cases, denials of coverage, clinicians and analysts say. The therapy involves collecting patients’ own T cells, a type of white blood cell, genetically modifying them, and then infusing them back into patients, where they hunt down and kill cancer cells. Known as CAR T-cell therapy, it has been called a “living drug.” Two drugs, Kymriah and Yescarta, were approved last year to treat patients whose blood cancers haven’t responded to at least two other rounds of treatment. Kymriah is approved for people up to age 25 with a form of acute lymphoblastic leukemia, the most common cancer in children. Kymriah and Yescarta are both approved for adults with advanced lymphomas.'
• Carl Zimmer's Game of Genomes (Season 1) (Carl Zimmer, STAT News). Carl Zimmer takes a narrative journey through the human genome — his own. The first journalist known to have acquired the raw data of his own genome, Carl spent months interviewing leading scientists about the latest in genome research to learn more about himself and about human genomes in general. A three-part series, which led eventually to his book She Has Her Mother's Laugh: The Powers, Perversions, and Potential of Heredity.
• ‘Home run’ gene therapy for Duchenne muscular dystrophy: Investor-oriented coverage pitches promise but … (Michael Joyce, HealthNewsReview, 6-25-18) Various analysts dubbed it “spectacular,” a “home run,” and a “game-changer.” Don't be taken in by investor-oriented coverage.
• The Science Behind Babies With 3 ParentsJennifer Barfield, WBUR CommonHealth, 6-15-18) "In 2016, a baby was born to a couple who had struggled with the consequences of mtDNA mutations that cause Leigh syndrome, a progressive neurometabolic disorder. When defective mitochondria of the woman’s egg were replaced with mitochondria from a donor who did not carry the mutation, the resulting child carried DNA from three people: the female nuclear DNA donor, the male nuclear DNA or sperm donor, and the female mitochondria donor. This was the first baby born using this technique. This technique, termed mitochondrial replacement, can be thought of like an organ transplant, or rather organelle transplant. However, there are some significant differences that have created concern among legislators, resulting in a ban on mitochondrial replacement in the U.S.
• Which Anti-Depressant Is Right for You? Your DNA Can Shed Some Light (Lucette Lagnado, WSJ, 5-6-18) McLean Hospital psychiatrists Brent Forester and Ipsit Vahia, are occasionally using genomics to help inform decisions about prescribing anti-depressants. The GeneSight test predicts the effects of more than 50 anti-depressants and anti-psychotics. Based on a patient’s results, drugs are categorized as ones to be avoided, ones that have some drawbacks and ones that can be used “as directed.” An evaluation of the story: Gene test for depression treatment: Realistic patient story helps keep WSJ article grounded (Joanne Rogers, Leah Rosenblum, Elizabeth Russo, HealthNewsReview, 5-10-18) Points out the reality: The Myriad Genetics GeneSight test apparently can improve the chances of getting an effective anti-depressive drug, but the research is all preliminary. See also A Genetic Test Could Help Predict the Right Antidepressant For You (Alice Park, Time, 5-7-18)
• Employees Jump at
Genetic Testing. Is That a Good Thing? (Natasha Singer, Technology, NY Times, 4-15-18) Genetic disease risk screening is becoming
a popular employee benefit. But the tests may not be all that beneficial for the general population, experts say. Levi Strauss & Company introduced a novel benefit for employees at its San Francisco headquarters last fall: free genetic screening to assess their hereditary risks for certain cancers and high cholesterol. Chip Bergh, Levi’s chief executive, hoped that the tests would spur employees to take preventive health steps and in that way reduce the company’s health care costs. But even Mr. Bergh was surprised by the turnout. Of the 1,100 eligible Levi’s employees, more than half took the genetic tests. Now, he wants to extend the benefit to employees in other cities.
• F.D.A. Approves First Home Testing for 3 Breast Cancer Mutations, With Caveats (Roni Caryn Rabin, NY Times, 3-6-18) The agency’s action permits the testing company, 23andMe, to report results as part of its $199 Health and Ancestry product, which uses DNA from saliva samples to inform customers about their families’ countries of origin, along with information on genetic health risks. There will be no extra charge for the additional reports, which should be available in a few weeks to customers who actively opt in and request to see them, company officials said. The three breast cancer mutations are common in Ashkenazi Jews; this gives consumers the ability to initiate testing at home and see results without talking to a doctor or counselor. Even for Jews of Ashkenazi descent, whose families originated in Eastern and Central Europe and who are most likely to test positive for the three mutations, testing negative is no panacea, as they may carry other mutations that increase cancer risk.
• Insurers May Insist On Counseling Before Genetic Tests For Breast Cancer (Michelle Andrews, KHN, 9-13-16)
• My Grandmother Was Italian. Why Aren’t My Genes Italian? (Gisele Grayson, NPR and KHN, 1-29-18) Several companies are offering DNA tests, but "the ways the companies analyze the genes leave lots of room for interpretation. So, he said, these tests “would be most accurate at the level of continental origins, and as you go to higher and higher resolution, they would become less and less accurate,” says Dr. Aravinda Chakravarti who has spent his career studying genetics and human health. “When we talk about the 50 percent that gets inherited from Mom, there’s a chance that you have a recombination that just gave you more of the northwest European part than the Italian part of your mom’s ancestry DNA,” she said. That is also why siblings can have different ancestry results. Elissa Levin, a genetic counselor and the director of policy and clinical affairs of Helix, says, “When we talk about the 50 percent that gets inherited from Mom, there’s a chance that you have a recombination that just gave you more of the northwest European part than the Italian part of your mom’s ancestry DNA.” That is also why siblings can have different ancestry results.
• Moms of Kids with Rare Genetic Disorder Push for Wider Newborn Screening (Anna Gorman, Kaiser Health News, on Scientific American, 10-5-17) Only a handful of states offer such testing.
• Genetic tests help parents avoid passing on serious diseases (Irina Zhorov, The Pulse, Here and Now, 1-26-17) This particular family tested for Huntington's. Labs can now test for more than 6,000 genetic conditions, like Cystic Fibrosis, Spinal Muscular Atrophy, and Huntington’s.
“But the limitation is we don’t have a gene for everything. We don’t have a gene for diabetes, we don’t have a gene for autism, there are so many of these controversial conditions people do want to avoid in the next generation but we can’t offer that because we need a single gene that’s associated with it, not a complex condition,” Dokras said.
• Every Cell in Your Body Has the Same DNA. Except It Doesn’t. (Carl Zimmer, NY Times, 5-21-18) "James Priest couldn’t make sense of it. He was examining the DNA of a desperately ill baby, searching for a genetic mutation that threatened to stop her heart. But the results looked as if they had come from two different infants. “I was just flabbergasted,” said Dr. Priest, a pediatric cardiologist at Stanford University. The baby, it turned out, carried a mixture of genetically distinct cells, a condition known as mosaicism. Some of her cells carried the deadly mutation, but others did not. They could have belonged to a healthy child."
Annual physicals and health care screening tests Physicals, yes--just not annually. Definitely get a physical when something is wrong.
• A Check on Physicals (Jane Brody, Well, 1-21-13) A 'Danish team noted that routine exams consist of “combinations of screening tests, few of which have been adequately studied in randomized trials.” Among possible harms from health checks, they listed “overdiagnosis, overtreatment, distress or injury from invasive follow-up tests, distress due to false positive test results, false reassurance due to false negative test results, adverse psychosocial effects due to labeling, and difficulties with getting insurance.”'
• Barbara Ehrenreich: Why I’m Giving Up on Preventative Care (Lit Hub, 4-9-18) How Contemporary American Medicine is Testing Us to Death. "What could be more ridiculous than an inner-city hospital that offers a hyperbaric chamber but cannot bestir itself to get out in the neighborhood and test for lead poisoning?" She grudgingly agrees to a bone density scan. "The result was a diagnosis of “osteopenia,” or thinning of the bones, a condition that might have been alarming if I hadn’t found out that it is shared by nearly all women over the age of 35. Osteopenia is, in other words, not a disease but a normal feature of aging. A little further research, all into readily available sources, revealed that routine bone scanning had been heavily promoted and even subsidized by the drug’s manufacturer. Worse, the favored medication at the time of my diagnosis has turned out to cause some of the very problems it was supposed to prevent—bone degeneration and fractures."
• Which screening tests are worth getting? , sidebar to story Annual physical exam is probably unnecessary if you’re generally healthy (Christie Aschwanden, Washington Post, 2-8-13).
• Private health screening tests are oversold and under-explained (UK physician Margaret McCartney, The Guardian, 9-17-14) The message in this article for the UK is equally valid for the USA: "Health screening can cause more harm than it prevents, so companies have a duty to provide full information to customers." Life Line Screening markets its for-profit tests without providing fair information and an evidence base for taking them. She provides examples and links, particularly to PrivateHealthScreening: What to Think About When You’re Thinking About Screening Tests. (Click on and read all the links there.) Links below (via Gary Schwitzer) get more specific. Unless your doctor recommends them, there are reasons to think twice about screening tests for which you receive marketing material--say, for aortic aneurysms.
• Screening For Asymptomatic Carotid Artery Stenosis (PDF, Agency for Healthcare Research and Quality, Evidence Synthesis No. 50)
• Screening Asymptomatic Adults With Resting or Exercise Electrocardiography: A Review of the Evidence for the U.S. Preventive Services Task Force (Annals of Internal Medicine, 9-20-11)
• Effect of Screening on Ovarian Cancer Mortality (JAMA, The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial, June 8, 2011)
• The UK NSC policy on Osteoporosis screening in women after the menopause (Systematic screening in postmenopasual women is not recommended.)
• Liver function tests in patients with computed tomography demonstrated hepatic metastases (Springer, 1989) "Although liver function tests (LFTs) (enzyme levels) are inexpensive and simple to perform, they failed to detect a significant number of patients with liver metastases."
• Incidental Findings on Brain MRI in the General Population (New England Journal of Medicine, 11-1-07). "Incidental brain findings on MRI, including subclinical vascular pathologic changes, are common in the general population. The most frequent are brain infarcts, followed by cerebral aneurysms and benign primary tumors. Information on the natural course of these lesions is needed to inform clinical management." See full discussion.
• "Preventive health screenings" that are hardly a Life Line (Dr. Kenny Lin, Common Sense Family Doctor, 2-7-11)
• How Doctors and Patients Do Harm (Tara Parker-Pope, Well, NY Times, 4-20-12). "That was the beginning of Otis Brawley becoming a loudmouth in the prostate cancer screening debate. We’re making promises to patients and making them think we know things we don’t know and making money off of them. There is a subtle little corruption in medicine. We’re selling chemo to people who don’t need it, giving prostate screening when it might save lives, but we make them think it definitely does..."
• Articles about screenings (Covering Health, Association of Health Care Journalists).
• Iowa hospitals drop controversial mobile testing firm (Tony Leys, Des Moines Register, 9-5-14). University of Iowa Health Alliance plans to stop using HealthFair, "a mobile heart-testing company that has been accused of 'fear-mongering' to induce healthy people to undergo scans of their hearts and arteries." This came about after the advocacy group Public Citizen called for an investigation and a halt to recommending tests for most patients. "Such widespread screenings are not recommended by medical experts because each of the six tests either benefits only appropriately selected high-risk patients or has not been scientifically shown to provide any clinically meaningful benefit to anyone.
• ClearHealthCosts (bringing transparency to the health-care marketplace by telling people prices for medical procedures and items -- using crowdsourcing in the few cities where it operates)
• FairHealth. Consumers: Estimate your healthcare costs, dental or medical.
• Healthcare Bluebook. Never overpay for healthcare again. Join the Fair Price Revolution.
• ConsumerHealthRatings.org (providing consumers with information they can use to make better-informed decisions about their health care)
• Medibid (reducing healthcare costs through competitive bidding--a helpful site if you have a high deductible health insurance plan)
• That Surgery Might Cost You a Lot Less in Another Town (Alison Kodjak, All Things Considered, 4-27-16) The average price for a knee replacement in Tucson, Arizona, is $21,976, about $38,000 less than it would in Sacramento, Calif.
• Shop Prices for Health Care on the Web (Christopher J. Gearon, Kiplinger, Feb. 2013)New online tools can help consumers find the best deals on medical care.
• Average Hospital Cost By State (Governing.com, Governing the States and Localities)
• BILL OF THE MONTH: A College Student’s $17,850 Drug Test (Kaiser Health News). The debut of a monthly feature from Kaiser Health News and NPR that will dissect and explain real medical bills in order to shed light on U.S. health care prices and to help patients learn how to be more active in managing costs. Do you have a medical bill that you’d like us to see and scrutinize? Submit it here and tell us the story behind it. Here's the story behind that bill: Pain Hits After Surgery When a Doctor’s Daughter Is Stunned by $17,850 Urine Test (Fred Schulte, KHN, 2-16-18)
• BILL OF THE MONTH: That’s A Lot Of Scratch: The $48,329 Allergy Test (Barbara Feder Ostrov, KHN, 10-29-18) Janet Winston had a rash that wouldn’t go away. The English professor from Eureka, Calif., always had been sensitive to ingredients in skin creams and cosmetics. This time, however, the antifungal cream she was prescribed to treat her persistent rash seemed to make things worse. Was she allergic to that, too? ... Her Stanford-affiliated doctor had warned her that the extensive allergy skin-patch testing she needed might be expensive, Winston said, but she wasn’t too worried. After all, Stanford was an in-network provider for her insurer — and her insurance, one of her benefits as an employee of the state of California, always had been reliable. Then the bill came.
• Taking the mystery out of health care prices
• How much does a colonoscopy cost? From $600 to over $5,400 (Jeanne Pinder, ClearHealthCosts, 7-20-14)
• How much will that cost/did that cost? Part 1 of a series on billing (Jeanne Pinder, ClearHealthCosts, 10-30-16)
• Is it cheaper to pay cash than to use your insurance? Maybe. (Jeanne Pinder, ClearHealthCosts, 12-22-14)
• How much does a mammogram cost? The takeaway on billing, from our WNYC partnership (Jeanne Pinder, ClearHealthCosts, 7-1-13) Mentions resources for those who are not insured.
• Reforming the U.S. system.
• Understanding the issues health care reform should address
• Organizations serious about reforming U.S. healthcare.
What to know and do before undergoing surgery
How to research a surgeon and hospital
How to help children prepare for surgery
Knee and hip replacement surgery
Memoirs and reflections of surgeons and about surgery
High costs, surprise medical bills, adverse events, bad practices, and other problems with surgery today
• Facing Surgery? Here’s How to Prepare. (Melinda Wenner Moyer, Washington Post, 10-20-22) 'The best way to navigate a surgery recommendation is to ask a lot of questions. When Dr. Krumholz and his colleagues interviewed U.S. adults who were candidates for elective angioplasty — a procedure that opens blocked arteries — 70 percent said they believed the procedure would lengthen their life or prevent future heart complications, even though it typically does not. (It usually just relieves chest pain.) When it comes to understanding the risks and benefits of medical procedures, “there’s lots of common misunderstandings.”'
• Should Older Seniors Risk Major Surgery? New Research Offers Guidance (Judith Graham, KHN, 9-28-22)
• What You Really Need to Do Before Surgery (Consumer Reports, October 2013) What you do before an operation can affect what happens after it
• The Patient's Checklist: 10 Simple Hospital Checklists to Keep You Safe, Sane and Organized by Elizabeth Bailey. "A producer of music videos, Bailey was thrust into the role of patient advocate when her elderly father was systematically manhandled by one of New York’s great teaching hospitals. Bravo to her for turning that all too common misery to a constructive end."--Abigail Zuger, MD, New York Times book review
• Surgery: What are you consenting to? (Melissa Crawford, Context Health Communication, 3-5-18) "Stories are more engaging teaching tools than statistics. Instead of telling patients that surgery carries a 20 percent risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes."
• The Talk Seniors Need to Have With Doctors Before Surgery (Judith Graham, KHN, 8-1-19) Before surgery, surgeons should review patients' advance directives — instructions for the care they want in the event of a life-threatening medical crisis — or offer patients without these documents the chance to complete them. Surgeons can help guide discussions that require complex decision-making by asking five questions:
---How does your health affect your day-to-day life?
---When you think about your health, what’s most important to you?
---What are you expecting to gain from this operation?
---What health conditions or treatments worry you most?
---And what abilities are so critical to you that you can’t imagine living without them?
If a stay in intensive care is expected after surgery, that should be made clear, along with the patient’s instructions on interventions such as feeding tubes, dialysis, blood transfusions, cardiopulmonary resuscitation and mechanical ventilation.
• Estimate for Cost Of Hernia Surgery Misses the Mark (Rachel Bluth, Bill of the Month, Shots, NPR, 8-29-19) Wolfgang Balzer did his research and got an estimate. The hospital told him the normal billed rate was $10,333.16, but that Cigna, his insurer, had negotiated a discount to $6,995.56, meaning his 20% patient share would be $1,399.11. The surgeon's office quoted a normal rate of $1,675, but the Cigna discounted rate was just $469, meaning his copayment would be about $94. Balzers were billed $2,304.51, much more than they'd budgeted for. It is a good idea to get an estimate in advance for health care, if your condition is not an emergency. But it is important to know that an estimate can be way off — and your provider probably is not legally required to honor it.
• Never Too Late To Operate? Surgery Near End Of Life Is Common, Costly (Liz Szabo, KHN, 2-28-18) Nearly 1 in 3 Medicare patients undergo an operation in their final year of life. And medical staff may even implant a defibrillator--a medical device to keep them alive by delivering a powerful shock--even if they have signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive them should their heart stop.
• Has Laparoscopy Sung Its Final Song in Cervical Cancer? (Medpage Today, Meeting Coverage, ASCO, 8-2-19) Pedro T. Ramirez, MD, says his study 'defies all of the results that we knew' from previous data. In the recent LACC trial of more than 600 patients undergoing surgery for cervical cancer, the number of disease recurrences after laparoscopic or robotic-assisted procedures was nearly 4 times higher than that of recurrences after open abdominal surgery -- 27 vs 7 -- and significantly more patients who had minimally invasive surgery (both in laparoscopy and in robotic surgery) died during a median follow-up of 2.5 years -- 19 vs 3 with open surgery. Minimally invasive surgery was associated with worse disease-free survival and worse overall survival.
• The Elderly Are Getting Complex Surgeries. Often It Doesn’t End Well. (Paula Span, The New Old Age, NY Times, 6-7-19) Complication rates are high among the oldest patients. Now a surgeons’ group will propose standards for hospitals operating on the elderly. People over 65 represent roughly 16 percent of the American population, but account for 40 percent of patients undergoing surgery in hospitals — and probably more than half of all surgical procedures. Those proportions are likely to increase as the population ages and more seniors consider surgery, including procedures once deemed too dangerous for them.
• Some states fall short on oversight of ambulatory surgery centers (Cheryl Clark, Covering Health, Association of Health Care Journalists, 9-27-19) "Here's a somewhat worrisome report from the Office of Inspector General. Some two-thirds of the ambulatory surgery centers (ASCs) in the nation are supposed to be surveyed for quality and safety issues by their state health agency, according to Medicare rules. But a troubling number of states seem to be ignoring their responsibility.
"Since Medicare reimburses ASCs for certain approved procedures - including some that carry higher risks for complications - federal officials have set requirements for how often and how extensively those state agencies are supposed to inspect those facilities. One could argue, and many have, that stricter standards should be put into place, but this report is just about the compliance of the ones that do exist."
• As Surgery Centers Boom, Patients Are Paying With Their Lives (Christina Jewett, Kaiser Health News and Mark Alesia, USA TODAY Network , 3-2-18) An investigation by Kaiser Health News and the USA TODAY Network discovers that more than 260 patients have died since 2013 after in-and-out procedures at surgery centers across the country. More than a dozen — some as young as 2 — have perished after routine operations, such as colonoscopies and tonsillectomies.
• Lax Oversight Leaves Surgery Center Regulators and Patients in the Dark (Christina Jewett and Mark Alesia, USA Today and KHN, 8-9-18) A Kaiser Health News and USA Today Network investigation finds that a hodgepodge of state rules governing outpatient centers allow some deaths and serious injuries to go unexamined. And no rule stops a doctor exiled by a hospital for misconduct from opening a surgery center down the street.
• Surgery centers don't have to report deaths in 17 states (Christina Jewett and Mark Alesia, Kaiser Health News and USA Today, 8-9-18)
• Thousands of patients possibly exposed to HIV, hepatitis at NJ surgery center asked to take blood tests (Aaron Katersky, ABC News, 12-8-18) More than 3,000 patients of an outpatienht surgery center in Bergen County, New Jersey (HealthPlus Surgery Center), may have been exposed to HIV, hepatitis B and hepatitis C. Most of the patients are from New York and New Jersey.
• ER Wait Watcher (Lena Groeger, Mike Tigas and Sisi Wei, ProPublica, 12-19-14) Use this tool to look up average ER wait times, as reported by hospitals to the federal government, as well as the time it takes to get there in current traffic, as reported by Google.
• For older people, surgery poses risks that aren’t always made clear (Judith Graham, Washington Post, 8-5-19) "New standards meant to improve surgical care for older adults have been endorsed by the American College of Surgeons. All older patients should have the opportunity to discuss their health goals and goals for the procedure, as well as their expectations for their recovery and their quality of life after surgery, according to the standards. If a stay in intensive care is expected after surgery, that should be made clear, along with the patient's instructions on interventions such as feeding tubes, dialysis, blood transfusions, cardiopulmonary resuscitation and mechanical ventilation."
• Going Under the Knife, With Eyes and Ears Wide Open (Jan Hoffman, Health, NY times, 3-25-17) More people are rejecting general anesthesia for procedures, prompting doctors to narrate their steps as they deal with alert patients asking questions. More surgery is being performed with the patient awake and looking on, for both financial and medical reasons.
But as surgical patients are electing to keep their eyes wide open, doctor-patient protocol has not kept pace with the new practice. “For a thousand years, we talked about the operating theater,” said medical ethicist Dr. Mark Siegler,and author of a recent study on surgeon-patient communication during awake procedures, published in the American Journal of Surgery. “And for the first time, in recent years the patient has joined the cast.” "Choosing to watch your own surgery is one more manifestation of the patient autonomy movement, in which patients, pushing back against physician paternalism, are eager to involve themselves more deeply in their own medical treatment." But Dr. Alexander Langerman, "said that a patient’s decision to remain awake during an operation also reflects a growing suspicion, generally, of authority figures. 'The occasional scandals that emerge while patients are sedated continue to erode their trust in us.' But patients are also intrigued by what is being done to them while they are asleep. In choosing to stay awake, added Dr. Langerman, /there’s a curiosity and desire to have control over your experience.”
• If You Smoke Pot, Your Anesthesiologist Needs To Know (Kate Ruder, KHN, 8-2-19) Colorado is on the front lines in dealing with how marijuana use affects surgery. Lessons learned on operating tables and in recovery rooms have prompted calls for more research on marijuana nationwide. “The hypothesis is that chronic marijuana users develop a tolerance to pain medications, and since they do not receive marijuana while in the hospital, they require a higher replacement dose of opioids,” said Dr. David Bar-Or.
• State charges Brazilian butt lift doctor with malpractice — two years after patient died (Daniel Chang, Miami Herald, 5-23-18)
• Some Thyroid Cancer Patients Can Safely Delay Surgery (Liz Szabo, Kaiser Health News, 8-31-17) Freeman said she was shocked by the inside of the operating room at Encore Plastic Surgery, which has changed its name twice since her operation in March 2016 and now goes by Jolie Plastic Surgery. The place was not clean, but "Freeman went through with the surgery, and would live to regret it. She got an MRSA infection, which is an antibiotic resistant bacteria, and was left with deep indentations in her stomach, knotted scars in her waist and an uneven bulge in her hips.
• Inside Job: Surgeons at Work (PDF, excellent Summer 2014 issue of Stanford Medicine)
• Black boxes in the operating room could improve teamwork, patient safety (Karen Blum, Covering Health, AHCJ, 11-15-22) The aviation industry has used black boxes (actually painted orange) to help determine what caused an accident. Some surgeons have now been employing similar technology in the operating room to monitor and improve performance and communication among surgical teams with an eye toward better patient safety.
• ‘Black boxes’ in Stanford Hospital operating rooms aid training and safety (Nina Bai, Stanford Medicine, 9-28-22)
• Unlikely Surgeons (Joseph Forrester, Health Affairs, Nov. 2017) A Surgeon in the Village: An American Doctor Teaches Brain Surgery in Africa, "an invigorating, uplifting, and fast-paced new book by Tony Bartelme, describes one neurosurgeon’s journey to bring neurosurgical interventions to Haydom Lutheran Hospital in rural Tanzania and sustain their use there. Through this example, Bartelme frames a realistic way to help alleviate the daunting burden of conditions treatable by surgery in resource-limited settings....Responsible task shifting of surgery to local health care providers is a profound way to improve access to surgical care and empower the local health care workforce. Given that an estimated one-third of all deaths worldwide are from conditions treatable with surgery, access to surgery must be seen as a global public health priority now more than ever.'
• A Surgeon in the Village: An American Doctor Teaches Brain Surgery in Africa by Tony Bartelme. “A Surgeon in the Village turns the modern philanthropic paradigm on its head. In this inspiring story of cultivating medical sustainability, Tony Bartelme teases out the human dimensions of neurosurgery and illustrates how connection and mentoring have the power to transform entire nations.” —Danielle Ofri, MD, PhD, author of What Patients Say, What Doctors Hear
• When a Scar Is a Choice (Charlee Dyroff, Guernica, 10-12-18) A former athlete reflects on the physical reminders of her years on the court.
• How to Pick the Right Surgeon (Linda Marsa, AARP Bulletin, Sept 2017) Act as if your choice is life or death — because it often is. File this excellent batch of AARP articles and links in your home medical folder! Read the article to put these links in context:
---Federation of State Medical Boards (FSMB). Click on Consumer Resources to get to the free tool, “Learn About Your Physician.”
---Certification Matters (American Board of Medical Specialties)
---Pro Publica. Plug in your zip code and "and you’ll find a directory of local hospitals that perform eight common procedures, along with surgeons on staff who perform them, the number of procedures they’ve done and their complication rates."
---Surgeon Ratings (Consumers' Checkbook) Compares 5,000 surgeons' results for 12 types of surgery). Consumers' Checkbook also rates doctors, hospitals, and dentists.
• Clear Health Costs Helps Consumers Determine if Medical Costs Will Be Just Expensive, or Really Expensive ( Robin D. Schatz, Fast Company, 11-27-13). "Startup Clear Health Costs aims to help consumers comparison shop for medical procedures—after all, why pay $3,500 for a vasectomy when you can get it for $450? The site also shows the Medicare reimbursement rates in a region as a benchmark to help guide consumers.
• Room for Better Safety at Surgery Centers, Survey Finds (Joyce Frieden, MedPage Today, 10-22-19) Leapfrog Group finds gaps in board certification, hand hygiene monitoring. See also Hospitals Cry Foul Over CMS's Surgical Coverage Proposal (Cheryl Clark, MedPage Today, 10-15-19)Do patient-safety arguments mask deeper worries about revenue?
• Clear Health Costs ("Your Source for Finding Health Care Prices"). See, for example, this Range of costs for cholesterol screening and this range of costs for CBC blood test.
• Incremental progress seen in price transparency, but report may rate A+ among journalists (Joseph Burns, Covering Health, Association of Health Care Journalists, 7-28-16) There has been a bit of progress in states giving consumers the information they need to shop for care based on price, though 43 states earned a failing grade to meet even minimum standards. This year, three states earned an A: Colorado, Maine and New Hampshire. Oregon moved from an F to a B. Vermont and Virginia each got a C, and Arizona got a D. Vermont and Virginia each got a C, and Arizona got a D.
• How Much Is That MRI, Really? Massachusetts Shines A Light (Martha Bebinger, WBUR and KHN, All Things Considered, 11-6-14) "There are no uniform prices; they vary from one insurer to the next. And you have to read the fine print on these sites to know what is and is not included in the dollar figure you'll see online."
• Clear Health Costs: Cracking the Code Coverage. In April 2017, New Orleans PriceCheck, reporting on and crowdsourcing health prices with partners WVUE FOX 8 Live and NOLA.com/The Times-Picayune, began saving its readers and listeners lots of money by comparing health care prices publicly. Says Jeanne Pinder, "We use shoe-leather journalism, data journalism and crowdsourcing to reveal the mysteries of pricing. The project is on fire, with hundreds of people sharing their stories, commenting, and sending in their EOB's [explanations of benefits]. The hospitals are extremely upset with us, and we have been able to save people hundreds of dollars-- and completely change the conversation in New Orleans about health care. Here's a page with their coverage collected together: https://clearhealthcosts.com/new-orleans-partnership/. Scroll down here for an earlier story about Clear Health Costs, and do watch The Healthcare Industry and the USSR Jeanne Pinder's wonderful talk (YouTube video, Ignite Health Foo 2013).
• Healthcare Bluebook (transforming healthcare with transparency)
• FairHealth Consumer (a national, independent, not-for-profit organization dedicated to bringing transparency to healthcare costs and health insurance information through data products, consumer resources and health systems research support)
• State Health Facts: Hospital Adjusted Expenses per Inpatient Day (KFF, 2017)
• Medicare Provider Utilization and Payment Data . Under the Obama administration, soon after Steven Brill's article came out, in 2013, the Centers for Medicare & Medicaid Services (CMS) publicly posted inpatient prices for hospitals across the country, making public huge variations in cost for the 100 most common inpatient services, 30 common outpatient services, and all physician and other supplier procedures and services performed on 11 or more Medicare beneficiaries.
• Your safer-surgery survival guide Consumer Reports' ratings of 2,463 U.S. hospitals can help you find the right one.
• Hospital ratings by state (Consumer Reports)
• The Pricing Of U.S. Hospital Services: Chaos Behind A Veil Of Secrecy (Uwe E. Reinhardt, Health Affairs, Jan. 2006, vol. 25, no. 1, pp. 57-69. Important article, covering many topics (How hospitals set their prices and how they are paid; Price discrimination by hospitals; Hospital pricing and consumer-directed health care; with invaluable links to other sources.) And the title sums it up: "Chaos behind a veil of secrecy!" "To move from the present, chaotic pricing system toward a more streamlined system that could support genuinely consumer-directed health care will be an awesome challenge. Yet without major changes in the present chaos, forcing sick and anxious people to shop around blindfolded for cost-effective care mocks the very idea of consumer-directed care....The bewildering and sometimes troublesome picture of contemporary U.S. hospital pricing is not entirely of hospitals’ own making. They are part of a wider system of health care financing whose administrative expense now ranks as a major cost component of U.S. health care (as much as 25 percent)."
• Chargemaster (Wikipedia). Excellent links to articles on medical health care costs and billing. "In the United States, the chargemaster, also known as charge master, or charge description master (CDM), is a comprehensive listing of items billable to a hospital patient or a patient's health insurance provider. In practice, it usually contains highly inflated prices at several times that of actual costs to the hospital. The chargemaster typically serves as the starting point for negotiations with patients and health insurance providers of what amount of money will actually be paid to the hospital. It is described as "the central mechanism of the revenue cycle" of a hospital."
• Defending Your Chargemaster (Elizabeth Gardner, Health Data Management, 2013, p. 27 ff.) Experts weigh in on the new rules of the game. See Gardner's "Reporter's Notebook" sidebar, for an overview of the effect of CMS (in May 2013) releasing data on charges for inpatient care. Yes, a hospital with more Medicaid patients may have to charge paying customers more than a hospital with few or no Medicaid patients, but hospitals may now have to change their approach to charges and pricing.
• OpenNotes (evidence suggests that opening up clinicians' visit notes to patients may make care more efficient, improve communication, and most importantly may help patients become more actively involved with their health and health care) “Open notes create partnerships toward better health and health care by giving everyone on the medical team, including the patient, access to the same information.” See Patients and clinicians on the same page (Open Note videos)
• Hospital Prices No Longer Secret As New Data Reveals Bewildering System, Staggering Cost Differences (Jeffrey Young, Chris Kirkham, Huffington Post, 5-8-13) Hospital price disparities made public
• In Health Care, A Good Price (Or Any Price) Is Hard To Find (Jenny Gold, Reporter's Notebook, KHN, 9-14-17) A recent story about why Northern California is the most expensive place in the country to have a baby began as a tip from an obstetrician. Dr. Sarah Azad told me that insurers were paying her just a third of what they pay doctors employed by large hospital systems in her town of Mountain View, Calif. "As it turns out, the vast majority of contracts between doctors or hospitals and insurance companies are subject to a gag clause, which prohibits either party from disclosing negotiated rates. That means it’s almost impossible for consumers, researchers or journalists to find actual, accurate numbers, despite the fact that cost differentials among doctors can be so stark...
“ It’s no accident that data on physician costs are so hard to find. Its inaccessibility allows hospitals to keep raising their prices. It’s simply not in their interest for the public to know how much they’re charging. And insurers don’t want other doctors or hospitals to see the high prices they’ve agreed to pay, for fear they would demand the same....In the end, all of us — through our insurance premiums and our taxes — pay a price for non-transparency."
• Unaccountable: What Hospitals Won't Tell You And How Transparency Can Revolutionize Health Care (listen online to interview on Diane Rehm show, WAMU, with Dr. Marty Makary, surgeon at Johns Hopkins and author of Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care
• Revealing a Health Care Secret: The Price (Tina Rosenberg, Fixes, Opinionator, NY Times, 7-31-13) A new health care approach: Don't hide the price. "Why are health care costs so high? ...only sellers, and not buyers, know the price. If prices are secret, patients can’t comparison shop. There is no way to push prices down, or force providers to compete on price. Price secrecy hides the need for reform. “Getting prices out in the open is crucial to bringing prices down,” said Katherine Hempstead, senior program officer at the Robert Wood Johnson Foundation."
• Elusive Goal: A Transparent Price List For Health Care (Eric Whitney, Morning Edition, Shots, NPR, 2-19-14) Actual prices for a colonoscopy are hard to find and vary greatly from one clinic to another. Colorado is one of eleven states that are starting to make public a lot of health care prices. Since doctors and hospitals generally don't tell people how much services cost beforehand, the best way to figure out the price is to get receipts from the parties that pay the bills: insurance companies, Medicaid and Medicare, mostly. But "claims data is dirty" and takes lots of scrubbing before it can be presented in consumer-friendly formats.
FIND MORE ON THE SUBJECT OF PRICE TRANSPARENCY HERE:
Decoding Health Care Prices
Orphan Prices: The Good, the Bad, and the Greedy
• Understanding the Issues Health Reform Should Address
• Open heart surgery, explained at MedlinePlus.
• The Open Heart Companion: Preparation and Guidance for Open-Heart Surgery Recovery by Maggie Lichtenberg
• Low-Risk Trials Cement a Role for TAVR Alongside—or in Place of—Surgery (Michael O'Riordan, tctMD/the heart beat, 3-17-19) Hotly anticipated new randomized clinical trials testing transcatheter aortic valve replacement in low-risk patients, for whom surgery is standard, provide strong evidence that TAVR has earned its rightful place in this patient population.
Both trials, presented during a late-breaking clinical trials session Sunday at the American College of Cardiology (ACC) 2019 Scientific Session, sh"owed at the very least that TAVR is equivalent to surgery in the treatment of low-risk patients with aortic stenosis....The PARTNER 3 trial, however, exceeded noninferiority expectations, with investigators reporting that treatment with the balloon-expandable Sapien 3 transcatheter heart valve (Edwards Lifesciences) was better than surgery for the prevention of death, stroke, and rehospitalization at 1 year, the study’s primary endpoint."
• Organ and tissue transplants. See also Donating your body or body parts
• The Heart of the Matter (transcript for a video that is no longer available). Karen Carey is a Perth woman who grew up with a simple heart problem. At 13 she was diagnosed with a mitral valve prolapse. She learned the hard way that health care decisions doctors make for profit affect patients' lives. Later in life she had two strokes caused by clots breaking off from a mechanical heart valve and lodging in her brain. She sued and lost and became a consumer health care advocate, advising people to ask doctors these three questions when faced with a medical decision: What are my treatment options? What are the expected outcomes, including the complications? And how likely is it that each of those outcomes will occur, including success and complications? Karen's doctors had not told her about the cumulative nature of the risk, the fact that with heart valve surgery the risk of clotting and stroke is cumulative--adds on each year.
• Recovering From Heart Surgery (For Heart Bypass, Heart Valve Surgery and other Open Heart Surgery Patients) (DVD, RecoverRite)
• Heart surgery (overview, Texas Heart Institute)
• Minimally invasive heart bypass surgery (Medline Plus)
• What Is Coronary Artery Bypass Grafting? (National Heart, Lung, and Blood Institute, NHLBI)
• Cut to the Heart (PBS series on radical but promising new form of heart surgery)
• Cardiovascular disease: Heart and coronary conditions and care
• Nova has useful material online: Map of the Human Heart (images showing bloods flow path through the heart), Troubled Hearts (images, PBS, Nova)
• DNA Links Deadly Germs, Tainted Heart Surgery Devices To German Factory (JoNel Aleccia, KHN News, 7-12-17) Heater-cooler devices made at the LivaNova PLC plant in Munich, Germany, were contaminated during production. Researchers also found that some hospital water systems and Maquet heater-coolers were contaminated, raising concerns about local contamination.
• Treating a Sick Heart (PBS, Nova)
• Narrating and imaging an aortic dissection (Edward Tufte)
• Surgical corrective procedures for congenital heart disease (LearningRadiology)
• The Richer You Are, the Better You May Do After Heart Surgery (Nicholas Bakalar, Well, NY Times, 10-20-15) They have found a relationship between income and survival, but that doesn't mean there is a causal effect.
• More than half a million heart surgery patients at risk of deadly infection (Lena H. Sun, Washington Post, 10-13-16) "More than half a million patients who had open-heart surgery in the United States since 2012 could be at risk for a deadly bacterial infection linked to a device used during their operations, federal health officials said....The device in question is a piece of medical equipment known as a heater-cooler unit, an essential part of life-saving surgeries because they help keep a patient’s organs and circulating blood at a specific temperature during the operation....About 60 percent of these procedures use the German-made model that has been linked to the infections."
• At St. Luke’s in Houston, Patients Suffer as a Renowned Heart Transplant Program Loses Its Luster (Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle, 5-16-18) The hospital and its legendary surgeon Denton Cooley performed some of the world’s first heart transplants back in the 1960s. In recent years, though, it has had some of the worst heart transplant outcomes in the country. Companion piece: A Death in Slow Motion ((Mike Hixenbaugh, Houston Chronicle, and Charles Ornstein, ProPublica, 5-22-18) A heart transplant. A medical mishap. A drawn-out ending. All told on Facebook. And the hospital (except for one person) doesn't tell the family how they screwed up. St. Luke’s has performed an outsized number of heart transplants resulting in deaths or unusual complications, has lost several top physicians and has scaled back its ambition for treating high-risk patients, all the while marketing itself based on its storied past. And then: Supporters of a Famed Houston Surgeon Have Alleged Inaccuracies in Our Investigation. (Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle, 6-29-18) They stand by their story, and say why.
• Switching Course (Julie Greicius, Stanford Medicine, Spring 2014) Untangling a birth defect decades later. When people ask 24-year-old Brooke Stone about her chest scar, she gives them the simplest answer she can: “I tell them I was born with my heart attached backwards.”
• Heart Surgery, Unplugged (Jerome Groopman, New Yorker, 1-11-99). Making the coronary bypass safer, cheaper, and easier
• Top-scoring hospitals for heart surgery in USA (Consumer Reports, June 2014)
• Best Hospitals for Cardiology & Heart Surgery (U.S. News & World Report)
• Mortality rates after surgery for congenital heart defects in children and surgeons' performance (J. Stark et al., Lancet, 18 March 2000.
• Doctors get creative to distract tech-savvy kids before surgery (Jenny Gold, Kaiser Health News, 7-12-16). They called it BERT, short for Bedside Entertainment Theater. It looks high-tech, but the whole thing costs about $900 to build. Here's the video that goes with that story: Distraction (video, Heidi de Marco, KHN). Pre-surgery anxiety is dangerous for kids. One hospital is solving the problem without meds.
• The day of surgery for your child (Medline Plus)
• Black children more likely to die after surgery (Chloe Reichel, Journalist's Resource, 3-2-18) Death after surgery is more than twice as likely for black children than white children. New models indicate which risk factors are most commonly associated with this outcome for both groups...new models could advance health equity by providing black families “accurate information on the surgical risks their children face, not risks based on analysis drawn from predominately white children.” Knowing which risk factors are most strongly associated with death for a particular race and intervening to reduce these risks could reduce disparities."
• Medicare opens new push on hip, knee replacement in effort to follow patients more closely, head off complications (Ricardo Alonso-Zaldivar, AP, in Wash Post, 3-31-16) The idea is to follow patients more closely to smooth their recovery and head off unwanted complications that increase costs.
• Up To A Third Of Knee Replacements Pack Pain And Regret (Liz Szabo, Kaiser Health Network, 12-25-18) Many patients face lingering pain and disappointment after undergoing knee replacement surgery, which costs an average $31,000. And doctors are increasingly concerned that the procedure is overused and that its benefits have been oversold. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while 1 in 5 are dissatisfied with the results. A study published last year in the BMJ found that knee replacement had “minimal effects on quality of life,” especially for patients with less severe arthritis....The younger patients are, the more likely they are to “outlive” their knee implants and require a second surgery. Such “revision” procedures are more difficult to perform for many reasons, including the presence of scar tissue from the original surgery. And revisions are also more likely to cause complications.
• After Knee or Hip Replacement, No Place Like Home (Jane E. Brody, Personal Health, NY Times, 4-24-17) "It may surprise many to learn that, even if joint replacement patients live alone, the overwhelming majority recover equally well and may experience fewer complications if they go home directly from the hospital and get outpatient rehabilitation instead of spending days or weeks in a costly rehab facility....[In one study, S]ix months after their surgery, there was no difference in mobility, pain, function or quality of life between those who got inpatient rehab and either of the two groups that got outpatient rehab....Costs aside, patients who go home directly may be less likely to experience what doctors call “adverse events” – complications like infections, blood clots or worse." "I can also underscore the general futility of some popular efforts to postpone needed joint replacements, including injections of hyaluronic acid and corticosteroids, braces, shoe inserts and opioid painkillers like OxyContin and fentanyl, none of which are recommended by the American Academy of Orthopaedic Surgeons....(The academy guidelines strongly recommend only three of the eight preoperative treatments studied — physical therapy, nonsteroidal anti-inflammatory drugs and the painkiller tramadol.)"
Knee replacement surgery
• An Inside Look at Knee Replacement Surgery (video, WebMD). You can see what happens during surgery.
• Recovery Timeline for TKR: Rehabilitation Stages and Physical Therapy (Healthline)
• Total Knee Replacement Surgery - Hospital and Home (YouTube. This video follows a Spokane orthopedic knee surgery patient through the total knee replacement surgery and recovery process at Sacred Heart Medical Center.)
• What I wish I knew about total knee replacement (video, Dame Judi Dench with Jonathan Monk) Would she have done anything differently? She would have done it sooner. It's not going to get better. It's only going to get worse. A good pep talk.
• A Mexican Hospital, an American Surgeon, and a $5,000 Check (Yes, a Check) (Phil Galewitz, NY Times, 8-9-19) In the United States, knee replacement surgery costs an average of about $30,000 — sometimes double or triple that — but at Galenia, it is only $12,000, said Dr. Gabriela Flores Teón, medical director of the facility. The standard charge for a night in the hospital is $300 at Galenia, Dr. Flores said, compared with $2,000 on average at United States hospitals.
• What Does Knee Surgery Cost? Few Know, And That’s A Problem (Melanie Evans, Wall Street Journal, 8-21-18) The price we pay for health care often has little connection to what it actually costs. One hospital decided to investigate. For nearly a decade, Gundersen Health System’s hospital in La Crosse, Wis., boosted the price of knee-replacement surgery an average of 3% a year. By 2016, the average list price was more than $50,000, including the surgeon and anesthesiologist. Yet even as administrators raised the price, they had no real idea what it cost to perform the surgery—the most common for hospitals in the U.S. outside of those related to childbirth. ... Prompted by rumblings from Medicare and private insurers over potential changes to payments, Gundersen decided to nail down the numbers. ... The actual cost? $10,550 at most, including the physicians. The list price was five times that amount.
• A New Set of Knees Comes at a Price: A Whole Lot of Pain (Jane E. Brody, Health, NY Times, 2-8-05). Total knee replacement may be more painful if your doctor prescribes the minimal dose of opioids, which many do (which interferes with rehabilitation), and if your insurance doesn't cover the amount of rehabilitation you need, you may have to pay out of pocket for it.
• 3 Years Later, Knees Made for Dancing (Jane E. Brody, NY Times, Health, 6-3-08)
• Jane Brody's New Knees (Tara Parker-Pope, Well, NY Times, 6-3-08)
• What Do You Want to Know About Total Knee Replacement? (Samuel Greenguard, HealthLine, 4-30-12) This will take you to a whole set of Q&A pieces about knee surgery (and alternatives).
• Understanding Knee Replacement Costs: What's On the Bill? (Samuel Greengard, HealthLine, 2-23-15)
• Alternatives to Knee Replacement Surgery (Samuel Greengard, HealthLine, 7-19-17)
• Hospitals And Surgery Centers Play Tug-Of-War Over America’s Ailing Knees (Christina Jewett, Kaiser Health News) What felt to Kirschenbaum like a bold experiment may soon become far more standard. Medicare, which spends several billions of dollars a year on knee replacements for its beneficiaries — generally Americans 65 and over — is contemplating whether it will help pay for knee replacement surgeries outside the hospital, either in free-standing surgery centers or outpatient facilities. The issue is sowing deep discord in the medical world, and the debate is as much about money as medicine. Some physicians are concerned that moving the surgeries out of hospitals will land vulnerable patients in the emergency room with uncontrolled pain, blood clots or other complications. Even if a policy change is made, Medicare would still pay for patients to get traditional inpatient surgery. But with the agency also paying for the bulk of outpatient procedures, there would be a huge shift in money — out of hospitals and into surgery centers. Perhaps of equal concern to patients are the financial consequences, because even though less care is given, outpatient procedures require higher out-of-pocket costs for patients. Medicare covers inpatient hospital stays, aside from a $1,288 deductible.
• Runner's Knee (WebMD)
• Regular exercise, healthy diet may help reduce knee pain for overweight adults with diabetes (News-Medical.net, 7-24-15)
• The sound of a knee cracking amplified is the actual worst sound ever (Science Alert, 5-31-16) A team from Georgia Institute of Technology has been investigating ways that will allow them to tell a healthy knee from a bad 'crunchy' knee, without having to open it up or run a bunch of X-rays and scans.
• Joint Pain Alliance on Facebook posts links to news and articles about knee pain and alternatives to knee replacement surgery.
Hip replacement surgery
• What I Wish We Had Known About Hip Replacements Before My Husband’s Surgery (Judy Kirkwood, Third Age, June 2016)
• A New Hip, A New Dance (Judith Sachs, 10-11-14)
• Total hip arthroplasty. (J S Siopack and H E Jergesen, Western Journal of Medicine, March 1995, on PubMed Central)
• The Mysterious Case Of 'Vanishing Bone' And Hip Replacements Gone Wrong (Carey Goldberg, Shots, NPR and WBUR's CommonHealth newsletter, 3-11-18) It all began with a single X-ray. It was 1974, and surgeons had been doing total hip replacements for a dozen years. Soon hundreds of thousands of patients had replacement hips that were being attacked by a bone-eating disease. An interesting medical mystery that required developing new materials for both knee and hip replacement surgeries.
• Vanishing Bone: Conquering a Stealth Disease Caused by Total Hip Replacements by William H. Harris.
• The inspiring story of a female orthopaedic surgeon (Nancy Yen Shipley MD, Kevin MD, 6-10-19) "Not only did I see how orthopaedic surgery could restore function in such a short amount of time, but it impressed upon me just how amazing the human body is, with its capacity to heal after a major surgery like this."
• Klobuchar Wants To Stop ‘Pay-For-Delay’ Deals That Keep Drug Prices High (Emmarie Huetteman, KHN, 4-26-19) “We can stop this horrible practice where big pharmaceuticals pay off — they literally pay off — generics to keep the prices and the competition off the market.” ~ Sen. Amy Klobuchar
• Drugmaker raises the price of an old chemo medicine tenfold amid persistent shortages (Ed Silverman, STAT News, 10-27-22) Areva Pharmaceuticals has begun marketing vials of fludarabine at a wholesale price of $2,736, a much steeper cost than the $272 charged for the same dosage by Fresenius Kabi and the $109 price tag from Teva Pharmaceuticals. Fludarabine is mainly used to treat chronic lymphocytic leukaemia (CLL). It may also be used in trials for low grade non-Hodgkin lymphoma (NHL), hairy cell leukaemia, acute myeloid leukaemia and a type of lymphoma that affects the skin called mycosis fungoides.
• Bitter Pill: Why Medical Bills Are Killing Us Stephen Brill, Time report,4-3-13)
• Nearly half of cancer patients in Medicare Part D don’t take life-saving medication when their prescription costs more than $2,000 to fill. (Leukemia & Lyphoma Society) "Some blood cancer drugs cost Medicare Part D patients as much as $16,000 out-of-pocket each year. That amounts to more than half of the income of the average Medicare patient. Patients who must pay at least $2,000 out-of-pocket for their cancer care are five times more likely to abandon their treatment. We need to cap Medicare Part D costs and let seniors spread their costs throughout the year."
• Investors’ Deep-Pocket Push To Defend Surprise Medical Bills (Rachel Bluth and Emmarie Huetteman, KHN, 9-11-19) As proposals to ban surprise medical bills move through Congress and state legislatures with rare bipartisan support, physician groups have emerged as the loudest opponents. Third-party companies that employ doctors and assign them out to health care facilities have opposed efforts to limit the practice known as balance billing. They claim such bans would rob doctors of their leverage in negotiating, drive down their payments and push them out of insurance networks. These third-party companies are waging well-financed campaigns to stop legislation limiting balance billing. But the force behind this multimillion-dollar crusade is not only medical professionals but also investors in private equity and venture capital firms who have bought and now operate many large physician-staffing companies. But the key to profits is not participate in insurance networks, allowing them to send surprise bills and charge patients a price they set. “They have money to burn,” said a congressional aide with knowledge of the lobbying efforts “They’re in take-the-bill-down mode.”
In some areas, doctors have few options but to contract with a staffing service. The two largest staffing firms, EmCare and TeamHealth, together make up about 30% of the physician-staffing market. Both are owned by private equity firms. Research from 2017 shows that when EmCare entered a market, out-of-network billing rates went up between 81 and 90 percentage points. When TeamHealth began working with a hospital, its rates increased by 33 percentage points.
In many states, balance billing — when a provider charges a patient the difference between their fee and what their insurance company paid — is legal, so physician-staffing services have little incentive to contract with insurance companies and provide in-network doctors. “These physician-staffing companies are benefiting tremendously from the ability to bill out-of-network,” said Zack Cooper. The business models are built on the ability to get profits from balance billing. STUDY THIS ARTICLE if you're part of the fight to end surprise medical bills!
• Three Ways to Fix the Drug Industry's Rampant Dysfunction (Michele Cohen Marill, Wired, 9-18-19) Big Pharma has come under fire for mislabeled drugs, price spikes, and life-threatening shortages. Dysfunction in the drug industry has triggered outrage over contaminated generics (including potentially carcinogenic chemicals found in blood pressure medications), massive price increases, and life-threatening shortages of cheap but vital products.Now a handful of startups hope to clean up the industry. With America's attention on COVID-19, drugmakers are quietly raising US prescription prices (Darrel Rowland, Columbus Dispatch, USA Today, 1-17-2021)
• Health equity: For Whom Does the System Work? (YouTube video, Native American Journalists Association, 3-24-22, 1 hour) The Native American Journalists Association and the Association of Health Care Journalists hosted this webinar on the subject of health equity and how the U.S. health care system works – or doesn’t, depending on who you are and where you live. This roundtable is the second in a three-part NAJA series focused on health equity in Indian Country and the first “Health Care Reporting 101” webinar for NAJA members by AHCJ, both supported by the Commonwealth Fund. Interesting, useful slides accompany the talks.
• Surprise Medical Bills Give Both Parties an Unexpected Opportunity to Agree (Margot Sanger-Katz, NY Times, 5-24-19) A broad campaign against costs is also expected to include an executive order mandating more transparency to patients about the costs of their care. A small number of hospitals use doctors who routinely go out of network. Surprise billing has emerged as a major voter concern, and is showing up in public opinion surveys. Everyone seems to agree it's a problem that must be addressed. Sanger-Katz talks about the pros and cons of various proposed solutions.
• An examination of surprise medical bills and proposals to protect consumers from them (Karen Pollitz, Matthew Rae, Gary Claxton, Cynthia Cox and Larry Levitt Kaiser Family Foundation issue brief, 6-20-19) In roughly 1 of every 6 emergency room visits and inpatient hospital stays in 2017, patients came home with at least one out-of-network medical bill, a new KFF analysis finds. More specifically, 18% of all emergency visits and 16% of in-network hospital stays had at least one out-of-network charge, leaving patients at risk for surprise medical bills. The analysis also finds the incidence of such charges varied greatly by state, for both emergency visits and hospital stays.
• What's wrong with the 21st Century Cures Act (Norman Bauman, blog post on this site, 12-20-16) On the surface, a popular move to speed new drugs along, but in the end a handout to the pharmaceutical industry, weakening the FDA's standards of evidence used to approve drugs, particularly randomized, controlled trials (RCTs). Critics say all the lobbying Big Pharma did to push the bill through is drowning out some warnings about patient safety.
• Bill Of The Month: $4,836 Charge For Laughing Gas During Childbirth Is No Joke (Lauren Weber, Shots/NPR/All Things Considered, 5-28-19) "As hospitals have adopted billing practices common in other businesses, more and more of their services are billed by the minute — for example the time a patient spends lying in the recovery room after surgery, the time a cancer patient spends receiving a drug infusion or the time a patient is hooked up to heart monitoring. A midwife whose own industry would charge $100 for the same amount of nitrous oxide (laughing gas) to dull the discomfort of active labor, breathed it a few times an hour during 11 hours of labor. But she was charged nearly $5,000 for the for the minute-by-minute presence of the equipment in the delivery room. Never hesitate to question such an outrageous charge. They knocked it down to $500, still five times what her own practice would charge.
• Outrageous medical bills (examples and case histories)
• Pulling back the curtain on surprise medical bills
• How to challenge excessive medical bills
• How a push to cut costs and boost profits at surgery centers led to a trail of death (Christina Jewett, Kaiser Health News, and Mark Alesia, USA Today Network, 3-2-18) Some centers have state-of-the art equipment and highly trained staff that are better prepared to handle emergencies. But Kaiser Health News and the USA TODAY Network found more than a dozen cases where the absence of trained staff or emergency equipment appears to have put patients in peril. “It’s important to realize that surgery centers are not hospitals. They have different resources, different equipment.” See also Medicare Reconsiders Paying for Seniors’ Spine Operations at Surgery Centers (Christina Jewett, Simple Surgeries, Tragic Results, KHN, 7-30-18) Medicare is reviewing whether seniors should undergo spine surgeries at same-day surgery centers. A USA Today-KHN investigation found that spinal surgery patients suffered tragic complications in surgery centers or soon after they left.
• Dr. Death (Laura Beil's podcast series, Wondery) A scary story about a charming surgeon, 33 patients, and a spineless system. Christopher Duntsch, an accredited but incompetent Texas neurosurgeon, was convicted of gross malpractice after 31 of his patients were left seriously injured after surgery, and two others died during it. See also Laura Beil Dissects a Criminal Doctor’s Surgical Rampage (Rachel Zamzow, The Open Notebook, 1-22-19)
• At St. Luke’s in Houston, Patients Suffer as a Renowned Heart Transplant Program Loses Its Luster (Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle, 5-16-18) The hospital and its legendary surgeon Denton Cooley performed some of the world’s first heart transplants back in the 1960s. In recent years, though, it has had some of the worst heart transplant outcomes in the country. Companion piece: A Death in Slow Motion ((Mike Hixenbaugh, Houston Chronicle, and Charles Ornstein, ProPublica, 5-22-18) A heart transplant. A medical mishap. A drawn-out ending. All told on Facebook. And the hospital (except for one person) doesn't tell the family how they screwed up.
• A news story’s role in the death of son of Mothers Against Medical Error founder (Joy Victory, HealthNewsReview, 4-24-18) Helen Haskell first learned about the surgical procedure that would ultimately kill her son by reading a local newspaper article, which described the surgery, known as the Nuss procedure, as “a revolutionary type of surgery at the Medical University of South Carolina.” It was being marketed as a new way to surgically correct pectus excavatum, a congenital condition that causes a concave chest. "Haskell’s story shows just how high the stakes are when journalists on health care stories become promoters rather than independent analysts–and how long this problem has been in place. For this reason, we chose Haskell’s story to be our first in our ongoing new series examining patient harm from misleading media messages....In the articles we read, there is little–if any–discussion of the potential harms, even though the procedure involves inserting a metal bar into the chest of a (usually healthy) child, and leaving it there for two years....[In April 2018] the Journal of Pediatric Surgery published a study examining the adverse events associated with the surgery, which it noted are underreported. (Underreporting of bad outcomes is a problem for most surgeries, since no governing body in the U.S. regulates surgery, and none tracks complications in a database.)"
• Mothers Against Medical Error (supporting victims of medical harm)
• Why One California County Went Surgery Shopping (Chad Terhune, Kaiser Health News, 9-1-17) "Fed up with wildly different price tags for routine operations, some private employers are steering patients they insure to top-performing providers who offer bargain prices. Santa Barbara County, with about 4,000 employees, is among a handful of public entities to join them. The county has saved nearly 50 percent on four surgery cases since starting its out-of-town program last year, officials said. The program is voluntary for covered employees. At a Scripps Health hospital in the San Diego area, the county paid $61,600 for a spinal fusion surgery that would have cost more than twice as much locally. "Typically, employers are seeking deals through “bundled payments” — in which one fixed price covers tests, physician fees and hospital charges. And if complications arise, providers are on the hook financially. Medicare began experimenting with this method during the Obama administration. Even as more employers and insurers embrace bundled payments, the Trump administration is applying the brakes.
"Santa Barbara officials try to persuade workers and their family members to participate in its program by waiving copays and deductibles. The county pays about $2,700 in travel costs and still comes out way ahead.
• Taken for a Ride: After ATV Crash, Doctor Gets $56,603 Bill For Air Ambulance Trip (Alison Kodjak, KHN/NPR News, 9-26-18) After an accident in an all-terrain vehicle crushed a doctor’s left arm, he was whisked by air ambulance to the closest trauma center for specialized care. Soon he was fighting over the $56,603 bill.
• A Jolt to the Jugular! You’re Insured But Still Owe $109K for Your Heart Attack (Chad Terhune, KHN, 8-27-18) A Texas teacher, 44, faces a “balance bill” of almost twice his annual salary for a heart attack he never expected to have.
• A Transgender Woman’s ‘Bait-And-Switch’ $92,000 Surgery Bill (Emmarie Huetteman, KHN, 7-26-18) After being promised a significant discount for paying cash upfront and forgoing insurance, a Wisconsin patient gets caught in the middle between hospital and insurer — and feels snookered by a last-minute surprise and billing snafu.
• Physician-Ownership of Ambulatory Surgery Centers Linked to Higher Volume of Surgeries (John M. Hollingsworth et al., Health Affairs, April 2010) Between 2000 and 2007, the number of Medicare-certified surgicenters (non-hospital-based facilities that exclusively furnish ambulatory surgical services--that is, procedures not requiring hospitalization, such as cataract removals, certain knee and ear surgeries, and colonoscopies)--increased by 50 percent. With physician investment in these centers, is there an incentive to do more surgery than needs to be done?
• Inside the renewed push to prevent surgical fires (ABC News video) Something as minor as a mole removal surgery can lead to facial disfigurement from fire on the operating table. Some patients don't need added oxygen and some get more than they need. Mark Bruley, vice president of accident and forensic investigation for ECRI, has been tracking operating-room fires for 30 years. He says these fires happen when oxygen pumped to the patients meets an ignition source, such as a laser. He suggests asking, "Do you really need oxygen on my face or can you get by with air? That is part of the process for eliminating this hazard." Check the website started by a patient: SurgicalFire.org. See also Fires during surgeries a bigger risk than thought (Liz Kowalczyk, Boston.com, 11-7-07) Use of cleaners, pure oxygen adds to danger.
• Surgery Risks (When Seconds Count, American Society of Anesthesiologists)
• Will you die from medical error? Will they know that's why you died?
• The Anatomy of Medical Error (Pat McNees, NIH Clinical Center News, 2006)
• Reducing preventable medical errors
• When routine surgeries go wrong (Jacque Wilson, CNN, 12-19-13)
• Double-Booked: When Surgeons Operate On Two Patients At Once (Sandra G. Boodman, Kaiser Health News, 7-12-17) The controversial practice has been standard in many teaching hospitals for decades, its safety and ethics largely unquestioned and its existence unknown to those most affected: people undergoing surgery. But over the past two years, the issue of overlapping surgery — in which a doctor operates on two patients in different rooms during the same time period — has ignited an impassioned debate in the medical community... Known as “running two rooms” — or double-booked, simultaneous or concurrent surgery — the practice occurs in teaching hospitals where senior attending surgeons delegate trainees — usually residents or fellows — to perform parts of one surgery while the attending surgeon works on a second patient in another operating room. Sometimes senior surgeons aren’t even in the OR and are seeing patients elsewhere. Critics of the practice, who include some surgeons and patient-safety advocates, say that double-booking adds unnecessary risk, erodes trust and primarily enriches specialists. Surgery, they say, is not piecework and cannot be scheduled like trains: Unexpected complications are not uncommon. Indiana orthopedic surgeon James Rickert regards double-booking as a form of bait-and-switch. “The only reason it has continued is that patients are asleep,” said Rickert, president of the Society for Patient-Centered Orthopedics, a doctor group." [Do read the whole article!]
• Stop Knee Pain! 8 steps you can take to avoid surgery (Richard Laliberte, AARP Magazine, Feb/March 2017)
• 4 Surgeries to Avoid (Karen Cheney, AARP Magazine, Aug. 2014) four operations are often overperformed. Some are moneymakers for doctors and hospitals; others are expedient and still others seem to work, at least in the short term. But evidence shows that all have questionable long-term outcomes for treating certain conditions, and some may even cause harm: Providing stents for heart disease patients with stable angina, spinal fusion for spinal stenosis, any type of back surgery, and hysterectomy for quality-of-life concerns, such as heavy bleeding or pain caused by uterine fibroids,
• The lap band for weight loss is a tale of medicine gone wrong (Julia Belluz, Vox, 5-25-17) The lap band for weight loss is a tale of medicine gone wrong. How the lap band works — and how it fails. It doesn’t lead to weight loss and often requires more surgery. Other weight loss surgeries are more effective, but doctors will still keep doing the lap band.
• For Surgeons, Talking About Adverse Events Can Be Difficult: Study (Zhai Yun Tan, Kaiser Health News, 7-20-16) Medical mistakes often happen. National guidelines call for doctors to provide full disclosure about adverse events, and studies have shown that those discussions benefit patients. But new research finds that the act of disclosure, combined with stress from the procedure gone wrong, can be an anxious experience for some doctors — and more training is needed to help them engage in these difficult conversations. “For a long time in the field, people thought that the primary reason that physicians have trouble reporting adverse events is that they were worried about being sued, but there are other barriers that are more important,” said Gallagher, one of the authors of the study.
“This paper helps highlight how embarrassing and upsetting these events are for clinicians … (and) makes it difficult for the physician to admit to the patient, ‘Here is exactly what happened.’”...
"They found that about 90 percent of the surveys showed that doctors said they had disclosed the event to patients or their families within 24 hours, expressed concern for the patient’s welfare, explained why the event happened, expressed regret and discussed with patients steps to treat subsequent problems. But only about half showed the doctors discussed whether the event was preventable and a third reported they talked about how it could be avoided in the future. Just over half apologized to the patient.
"The study also reported that those surgeons who find an event very or extremely serious and who had difficulty discussing that event are more likely to suffer anxiety over the experience. That was also true of surgeons who feared negative reaction from patients, an impact on their reputations, bad publicity or a malpractice suit."
• The Terrible Beauty of Brain Surgery (Karl Ove Knausgaard, NY Times, 12-30-15)
• The Deepest Cut (Christine Kenneally, New Yorker, 6-25-06) How can someone live with only half a brain? At nine o'clock on July 28, 2005, Wendy Nissley carried her two-year-old daughter Lacy into an operating room at Johns Hopkins Hospital to have half of her brain removed. Lacy suffered from a rare malformation of the brain, known as hemimegalencephaly.
• Preparing for neurosurgery (UCLA Neurosurgery, video, English or Spanish)
• Care and recovery after brain surgery (Johns Hopkins Medicine)
• About brain tumors (Johns Hopkins)
• Do No Harm: Stories of Life, Death, and Brain Surgery by Henry Marsh. What is it like to be a brain surgeon? How does it feel to hold someone’s life in your hands, to cut into the stuff that creates thought, feeling and reason? How do you live with the consequences of performing a potentially lifesaving operation when it all goes wrong? Leading neurosurgeon Henry Marsh reveals the fierce joy of operating, the profoundly moving triumphs, the harrowing disasters, the haunting regrets and the moments of black humor that characterize a brain surgeon’s life. See also Admissions: A Life in Brain Surgery
Anatomy of Error (Joshua Rothman, New Yorker, 5-18-15) A review of Dr. Marsh's book Do No Harm: Stories of Life, Death, and Brain Surgery, a review that in itself explains a few things also.
• Complications: A Surgeon's Notes on an Imperfect Science by Atul Gawande
• Better: A Surgeon's Notes on Performance by Atul Gawande
• The Checklist Manifesto: How to Get Things Right by Atul Gawande "Gawande gives a vivid, punchy exposition of an intriguing idea: that by-the-book routine trumps individual prowess. That humblest of quality-control devices, the checklist, is the key to taming a high-tech economy."--Publishers Weekly. In riveting stories, he reveals what checklists can do, what they can’t, and how they could bring about striking improvements in a variety of fields, from medicine and disaster recovery to professions and businesses of all kinds.
• Do No Harm: Stories of Life, Death, and Brain Surgery by Henry Marsh.
• Admissions: A Life in Brain Surgery by Henry Marsh• Do No Harm: Stories of Life, Death, and Brain Surgery by Henry Marsh. What is it like to be a brain surgeon? How does it feel to hold someone’s life in your hands, to cut into the stuff that creates thought, feeling and reason? How do you live with the consequences of performing a potentially lifesaving operation when it all goes wrong? Leading neurosurgeon Henry Marsh reveals the fierce joy of operating, the profoundly moving triumphs, the harrowing disasters, the haunting regrets and the moments of black humor that characterize a brain surgeon’s life. See also Admissions: A Life in Brain Surgery
Anatomy of Error (Joshua Rothman, New Yorker, 5-18-15) A review of Dr. Marsh's book Do No Harm: Stories of Life, Death, and Brain Surgery, a review that in itself explains a few things also.
• When the Air Hits Your Brain: Tales from Neurosurgery (2008) by Frank T. Vertosick Jr.
• Heart Matters: A Memoir of a Female Heart Surgeon by Kathy Magliato (2011)
• Confessions of a Surgeon: The Good, the Bad, and the Complicated...Life Behind the O.R. Doors by Paul A. Ruggieri (2012) From NY Times review: "Dr. Ruggieri, by his own description, is a regular Joe Scalpel: An average student, he graduated debt-ridden in the middle of his medical school class, weathered a grueling old-style residency program, and now works as in private practice at a community hospital....Ask for your surgeon’s complication rate before your procedure, Dr. Ruggieri suggests — you will have to assume the answer is truthful. And if you want to know what really happened while you were asleep, track down the operative report (although even that document may not reflect all the potholes on the trip)....He offers up the requisite anecdotes featuring hapless people impaled by various pointy objects (including the horn of an annoyed rhinoceros), but he is at his best describing his own worst moments, muttering under his breath to a recalcitrant section of intestine, his right eye twitching in anxiety, wondering why he didn’t go for that M.B.A. instead."
• The Patient's Checklist: 10 Simple Hospital Checklists to Keep You Safe, Sane and Organized by Elizabeth Bailey. "A producer of music videos, she was thrust into the role of patient advocate when her elderly father was systematically manhandled by one of New York’s great teaching hospitals. Bravo to her for turning that all too common misery to a constructive end."--Abigail Zuger, MD, New York Times book review.
• Dear Dr. Shumway (Stanford Medicine, Spring 2014) A boy, two frogs, and an airmail letter. Curious little boys do sometimes grow up to be surgeons.
• Were These Enslaved Women Grand Medical Experiments or Guinea Pigs? (Bruce Chadwick, History News Network, 1-29-19) "Doctor James Marion Sims was a giant in American medical history....from 1844 to 1849 he set up a small hospital and conducted a series of operations on fistulas in 17 slave women after they gave birth, some to still born babies. He conducted from six to 30 operations on each. The women were forced to kneel, naked, on their hands and knees for an hour-long operation with no anesthesia. The operations were debilitating. The slave women wound up with dozens of scars, could barely walk and had their lives ruined by his surgeries. Through their surgeries, though, over several years, he found a way to cure fistulas and ever since then millions of women have avoided them in birth, a small miracle....Behind the Sheets is a tragic, and yet beautiful play, about fistulas, Sims and his slave women." Sims became prominent 'by discovering how to cure “fistulas” in slave women, and white women afterwards. A “fistula” is a tear between the uterus and bladder, a hole, through which urine and feces flow into the vagina, causing odors, bleeding, blood poisoning and infections.'