• Buying drugs and procedures smartly, cheaply, safely
• Fighting drug price gouging and making drugs more affordable
• Doctors' incentives to prescribe expensive medications
• Generic drugs: overpricing, shortages, and other issues
• Patient assistance programs
• Orphan drugs: The good, the bad, and the greedy
• The dangers of fake and substandard drugs for patients who can't afford real drugs
• 'Right to try' laws, early access, compassionate use of experimental drugs (pro and con)
• Managing pain (now on its own page)
• Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication (blog post)
• The benefits pharmacy benefit managers manage are usually not for consumers
(under Reforming the U.S. healthcare system)
• Substance abuse and recovery
• Decoding health care prices (the need for price transparency)
• Finding prices for medical procedures
• Managing medications, tests, procedures, and treatments
• Questioning drug claims and managing medication side effects
• Medications, tests, procedures, and treatments to question or avoid
• Private screening tests, the truth about
• Genetic testing and gene therapy
• Reducing medical costs
• Reducing medical debt
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, adverse events, bad practices, and other problems with surgery today
Hospitals and hospitalization
Managing pain and pain medications
Tip No. 1: Most physicians do not have a clue how much various drugs cost (and may have an incentive/encouragement 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.
• Understanding Prescription Discount Cards for 2017 (Medicare.net)
• 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."
• WeRx (promoting transparency in retail drug pricing)
• Blink Health (pay for your drugs online, then pick up the prescription at a pharmacy)
• 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.
• 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.
• 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
• 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.
• Drug Compare (AARP) Compare prices on two drugs.
• 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.
• 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
• 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.
• 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.
• 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
Patient assistance programs help low-income, uninsured patients get free or low-cost, brand-name medications. They may be sponsored by drug companies, doctors, patient advocacy organizations, nonprofit organizations, or civic groups.
Prescription Assistance programs• Partnership for Prescription Assistance helps low-income, uninsured patients get free or low-cost brand-name medications,
• NeedyMeds (find help with the cost of medicine)
• RxAssist (directory of Patient Assistance Programs)
• Center for Benefits (Benefits CheckUp, National Council on Aging, NCOA)
• RxOutreach (a nonprofit pharmacy whose mission is to provide affordable medications)
• Patient Assistance Programs for Prescription Drugs (WebMD)
• Prescription Assistance (HealthFinder.gov, US Dept. of Health & Human Services) Use this site to apply for Medicare, find supplemental insurance plans, hospitals, drug plans, doctors, nursing homes, dialysis facilities, and more.
• Caring Ambassadors (help and information for patients with hepatitis C or lung cancer)
• The Assistance Fund (see covered diseases)
• CancerCare (find help by diagnosis or topic)
• 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. We also guide patients through an opaque and ever-changing healthcare landscape, always listening, always responding, always caring.
• 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
• Pharmaceutical Company patient assistance programs (scroll down to find by pharmaceutical firm name or by generic)
• Leukemia & Lymphoma Society (LLS)
• RareCare, National Organization for Rare Disorders (NORD)
• Patient Advocate Foundation (PAF, solving insurance and healthcare access problems since 1996)
• Patient Advocate Foundation Co-Pay Relief. See How PAF Assists Patients with Co-Pay Assistance
• Patient Services Incorporated (a nonprofit 501(c)(3) premium and copayment assistance foundation)
Articles about payment assistance programs
• 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.
• • 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."
• 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]
• 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.
• 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 ill 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).
• 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.
• 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 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 of strategies to extend the exclusivity period of their wares, keeping less expensive alternatives away from patients. Among the shenanigans: Securing new patents that extend old ones. Keeping brand-name drugs under wraps so generic makers can’t copy them. Filing so-called citizen petitions that gum up the FDA approval process for rivals. Negotiating restrictive deals with drug plans that crowd out less expensive drugs.
• Here’s why doctors must know prescription costs (Mark Kelley, MD, Meds, Kevin MD, 1-10-18) New drugs are protected by patents and promoted by aggressive marketing. They command high prices and subsequently drive up the average cost of prescribed drugs. Drugs with expired patents are usually much cheaper for patients. Generic drugs now account for 89 percent of all prescriptions but only 26 percent of all drug expenditures. However, if a large generic manufacturer has little competition, it can act like a monopoly and raise prices on its own terms. A well-publicized example was the dramatic rise in the price of the EpiPen. Generics may no longer be safe bets for low costs. New and more expensive drugs may not be any better than generics. And drugs may have different co-pays, depending on the insurance plan. So doctors and patients MUST communicate. Doctors should know the prices and efficacy of the drugs they commonly prescribe, and patients should ask for the drug prices up front. The market price for most drugs is available via a simple Google search of the specific drug name with the term “price.” If the patient cannot afford the drug, there are organizations such as NeedyMeds that can help with discounts. Also published as Why Prescription Drugs are Expensive and What We Can Do About It (Mark A. Kelley, HealthWeb Navigator, 11-28-17) (See HealthWeb Navigator ("comprehensive reviews by medical professionals" of health websites.)
• This Shield of Patents Protects the World’s Best-Selling Drug (Cynthia Koons, Bloomberg, 9-7-17) "Humira, a treatment for inflammatory diseases such as rheumatoid arthritis and psoriasis made by AbbVie Inc., is the planet’s best-selling drug. It’s also been around almost 15 years. Those two facts alone would normally have rival drugmakers eagerly circling, ready to roll out generic versions that could win a piece of the aging medicine’s $16 billion in annual sales. Yet last year, when the patent on Humira’s main ingredient expired, not a single competitor launched a copycat version. Figuring out how to manufacture it wasn’t the obstacle. The real challenge was the seemingly impregnable fortress of patents AbbVie has methodically constructed around its prized moneymaker." Over Humira’s lifetime, AbbVie has secured more than 100 patents to prevent anyone from attempting to copy the biologic, with $16 billion in annual sales.
• A Drug Program That Keeps Patients Safe (And Profits, Too) (Cynthia Koons, Bloomberg, 7-26-17) "For generic drug companies, manufacturing low-cost alternatives to brand-name medicines is the easy part. The hard part: getting their hands on the drugs they want to copy. The U.S. Food and Drug Administration plans to take action to address the problem. Regulators say that some makers of blockbuster drugs are using rules designed to warn patients about dangerous side effects to withhold samples needed to make lower-priced generic versions. ...Like most businesses, drugmakers protect their intellectual property zealously. At the same time, the vast majority of medicines consumed in the U.S. aren’t brand names. Generics are used to fill nearly nine out of every 10 prescriptions in the U.S."
• FTC Charges That Shire ViroPharma Inc. Abused Government Processes Through Serial, Sham Petitioning to Delay Generics and Maintain Its Monopoly over Vancocin HCl Capsules (Federal Trade Commission, 2-7-17) Antibiotic is used to treat serious gastrointestinal infection.
• Hearing Amazon’s Footsteps, the Health Care Industry Shudders (Nick Wingfield and Katie Thomas, NY Times, 10-27-17) The latest category alarmed by the specter of competition from Amazon is the pharmacy market....CVS Health is now in talks to acquire Aetna, one of the nation’s largest health insurance providers, a move considered to be partly a reaction to the footsteps of Amazon....“They can at least dip their toe in the water with the cash-pay customers, and learn the business,” said Ana Gupte, an analyst for Leerink Partners. She said cash-paying customers account for 5 percent to 10 percent of the $560 billion prescription drug business....Expanding the pharmacy business without the aid of a major pharmacy-benefit manager would be tough, because the benefit managers serve as gatekeepers to insured patients, deciding which pharmacies they can and cannot use. The benefit managers also operate their own mail-order pharmacies, which might make them less willing to accommodate Amazon."
• 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 article!)
• How Two Common Medications Became One $455 Million Specialty Pill (Marshall Allen, ProPublica, Wasted Medicine, co-published with The Atlantic. 11-28-17) After I was prescribed a brand-name drug I didn’t need and given a coupon to cover the out-of-pocket costs, I discovered another reason Americans pay too much for health care. Vimovo was created using two readily and cheaply available generic, or over-the-counter, medicines: naproxen, also known by the brand Aleve, and esomeprazole magnesium, also known as Nexium. The Aleve handles your pain and the Nexium helps with the upset stomach that’s sometimes caused by the pain reliever. The key selling point of this new “convenience drug”? It’s easier to take one pill than two....You can walk into your local drugstore and buy a month’s supply of Aleve and Nexium for about $40. For Vimovo, the pharmacy billed my insurance company $3,252. This doesn’t mean the drug company ultimately gets paid that much. The pharmaceutical world is rife with rebates and side deals — all designed to elbow ahead of the competition. But apparently the price of convenience comes at a steep mark-up. My insurance company, smartly, rejected the pharmacy’s claim. Since 2014, Vimovo’s net sales have been more than $455 million. That means a lot of insurers are paying way more than they should. "In recent months I’ve looked at what hospitals throw away and how nursing homes flush or toss out hundreds of millions of dollars’ worth of usable medicine every year. We all pay for this waste, through lower wages and higher premiums, deductibles and out-of-pocket costs."
• About $765 Billion Is Wasted Each Year on Health Care. Can You Help Us Find It? (Marshall Allen, Wasted Medicine, ProPublica, 3-9-17) We are reaching out to people who work in health care and have seen money being blown in ways that could be stopped. We’re not talking lost nickels and dimes here — we want the most outrageous and high-profile cases we can find.
• What Hospitals Waste (Marshall Allen, Wasted Medicine, 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. Elizabeth McLellan started Partners for World Health when she worked as a nurse administrator and saw her hospital tossing out useful supplies.
• Gilead faces challenge to U.S. hepatitis C patents from advocacy group (Ed Silverman, STAT, 10-26-17) In the latest attempt to attack the cost of hepatitis C drugs, an advocacy group is challenging several U.S. patents for the Sovaldi treatment that is sold by Gilead Sciences (GILD). The group wants to overturn six patents for the drug, which is the oldest of several Gilead hepatitis C medicines, in hopes of spurring lower-cost generic versions to become available sooner than might otherwise be possible. The group contended that U.S. taxpayers can save $10 billion and generics can get to market 14 years faster if it succeeds. (H/T: KHN)
• Gilead’s Patents on Hepatitis C Drug Challenged by Consumer Group ( Susan Decker and Cynthia Koons, Bloomberg, 10-25-17) Gilead Sciences Inc.’s U.S. patents on the blockbuster $84,000 hepatitis C treatment Sovaldi were challenged by a consumer group that’s battled the drugmaker around the world over the pricing. The Initiative for Medicines, Access & Knowledge, a nonprofit focused on how patents affect access to medicine, said that it’s filed petitions with the U.S. Patent Trial and Appeal Board seeking to challenge intellectual-property rights that would keep generic versions of Sovaldi from entering the market. Group says patents have blocked access to life-saving medicine. Pricey hepatitis C treatment has been a top seller for Gilead. (H/T: KHN)
• This cancer patient is devoting his life to making drugs more affordable (Dan Gorenstein, Marketplace, 5-17-17) David Mitchell started a national organization, Patients for Affordable Drugs., to channel the public's growing frustration about high drug prices and campaign to make them more affordable. What makes his organization different to others is that it doesn't take any funding from drug companies. That's significant because most patient advocacy groups do.
• Take the Generic Drug, Patients Are Told — Unless Insurers Say No ( Charles Ornstein, ProPublica, and Katie Thomas, NY Times, 8-6-17) Faced with competition, some pharmaceutical companies are cutting deals with insurance companies to favor their brand-name products over cheaper generics. Insurers pay less, but sometimes consumers pay more. Shire, the maker of Adderall XR, tried a new tactic to sustain market share when generics came on the market: giving ever-larger discounts to pharmacy benefit managers and insurers for preferential treatment over the generics. That did not mean lowering the list price of the drug but rather negotiating rebates that were paid not to the patients, but to insurers and middlemen such as CVS Caremark.
This Is Why Your Drug Prescriptions Cost So Damn Much (Stuart Silverstein, Fair Warning, 10-21-16) “It’s Exhibit A in how crony capitalism works.” When the Republican-controlled Congress approved a landmark program in 2003 to help seniors buy prescription drugs, it slapped on an unusual restriction: The federal government was barred from negotiating cheaper prices for those medicines. Instead, the job of holding down costs was outsourced to the insurance companies delivering the subsidized new coverage, known as Medicare Part D. The ban on government price bargaining,justified by supporters on free market grounds, has been derided by critics as a giant gift to the drug industry. A Kaiser Family Foundation poll found last year that 93 percent of Democrats, and 74 percent of Republicans, favor letting the government negotiate Part D prescription drug prices. It seems an anomaly in a democracy that an idea that is immensely popular — and calculated to save money for seniors, people with disabilities and taxpayers — gets no traction. But critics say it’s no mystery, given the enormous financial influence of the drug industry, which rivals the insurance industry as the top-spending lobbying machine in Washington. A key aim of Part D proponents, Oliver said, was to cover seniors “in a Republican, pro-market kind of way.” That meant including “as much private sector involvement as possible,” which led to insurance companies managing the program. At the same time, it excluded federal price controls, which were anathema to the drug industry.
• The high price of anticancer drugs: origins, implications, barriers, solutions High drug prices harm patients — often directly through increased out-of-pocket expenses, which reduce levels of patient compliance and lead to unfavourable outcomes — and harms society — by imposing cumulative price burdens that are unsustainable. The excessive costs of anticancer drugs have been criticized by >100 experts in
• Best Buy Drugs (Consumer Reports free service to help you make smart drug choices based on scientific evidence and expert medical advice).
• High drug prices: Don’t let industry excuses go unchecked–or patient voices go unheard (Alan Cassels, HealthNewsReview.org, 5-18-17) price gouging is beyond frustrating for David Mitchell, a D.C.-based consumer advocate who started Patients for Affordable Drugs.
• AARP: Why Our Drugs Cost So Much (AARP Bulletin, 5-22-2017)
• Lowering the Cost of Prescription Drugs Is One of the Top Health Priorities Across Parties. That's shown in the chart displayed in this story: Kaiser Health Tracking Poll - Late April 2017: The Future of the ACA and Health Care & the Budget (Kaiser Health News, 4-26-17) Six in ten Americans say lowering the cost of prescription drugs is a “top priority” for President Trump and Congress – including majorities of Democrats, Republicans, and independents. "A majority of Republicans, Democrats, and independents favor most of these policy actions with one exception – encouraging people to buy lower-cost drugs by requiring them to pay a higher share if they choose a similar, higher-cost drug, which is favored by less than half of Democrats."
• Reference pricing for ‘shoppable’ health care services steers consumers to low-cost providers (Joseph Burns, Covering Health, Association for Health Care Journalists, 8-15-16) "Using reference pricing, Safeway saved $2.57 million over the three years of the study (2011 to 2013). Of that amount, $1.05 million (41 percent) went back into consumers’ pockets, and the remaining $1.70 million accrued to Safeway, the study showed. Also, reference pricing led to a 32 percent drop in the average price that consumers paid for 285 different lab tests."
• Why U.S. medical costs are so high
and where the system needs fixing (key articles explaining the high cost of medical care in the United States -- and asking whether we're getting what we're paying for)
• Taking the mystery out of health care prices . A push for transparency in health care pricing.
• 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) If this rings your bell, go to this page: Drugs, Big Pharma, conflicts of interest, and why U.S. patients pay too much for medication. There is no getting around who the main villains are in America's wildly out-of-balance health care $ystem.
• This controversial rule could change how doctors profit from using the most expensive drugs (Carolyn Y. Johnson, Wash Post, 4-11-16) "A controversial effort by the Obama administration to reform how doctors earn money from administering injection drugs would reduce their earnings on the most expensive drugs while making many older generics more lucrative, according to a new analysis. A high-stakes debate exploded last month over the administration's drug payment pilot program, which would test a fundamental change in how doctors are reimbursed for giving chemotherapy and other injectable drugs through Medicare. Medicare has said the pilot would remove a perverse incentive for doctors to prescribe the most expensive drugs, while the drug industry, doctors and disease groups argue it would threaten small cancer practices and seniors' health....Peter Bach, director of the Center for Health Policy Outcomes at Memorial Sloan Kettering Cancer Center...his team also found that just a handful of commonly used, high-priced cancer drugs are driving doctors' and hospitals' income under the current reimbursement scheme. And they argue that the status quo also appears to allow drug companies to steadily increase prices in a way that mutually benefits doctors and pharmaceutical companies." The four high-priced, most-used cancer drugs are trastuzumab, denosumab, bevacizumab and rituximab. (Study this situation if you are in the business of health reform.)
• 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."
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. And pharmacies don't always pass along the declining cost of generic drugs to consumers.
• 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.
• 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?
• 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)
• (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!)
• 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.
• Wasted Medicine (ProPublica series about squandered health care dollars.
• 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.
• 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.
• 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 Power of No (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."
• 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
• CountyRxCard (up to 75% discount on all FDA-approved drugs at 56,000 pharmacies nationwide)
• 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.
• 3 Stories to Report on Medical Debt (Dorianne Perrucci, Business Journalism, 3-25-18) Story ideas from the business desk.
• 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
• The Problem of Underinsurance and How Rising Deductibles Will Make It Worse (Commonwealth Fund, 2015)
• 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. "We regret that RIP cannot forgive medical debt for specific individuals… at this time."
• 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.
• 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.
"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."
• 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 s 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)
• 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): "About 150 Americans die a year by accidentally taking too much acetaminophen, the active ingredient in Tylenol, federal data from the CDC shows. Acetaminophen has a narrow safety margin: 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."
• 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.
• Learning About Side Effects (Food & Drug Administration)
• 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)
• 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
• 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. Some 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)
• 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
• 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)
• 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.
• 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.'
• 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)
• 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. Does this product relieve the symptoms?
• 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)
• 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
• 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)
• 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.
• 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.
• 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.
• 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.
• 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."
• 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.
• 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.
• 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
• 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.
• 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.
• 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.”
• 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.
• 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
• 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.
• 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)
• 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
• 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."
• 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.
• The Open Heart Companion: Preparation and Guidance for Open-Heart Surgery Recovery by Maggie Lichtenberg
• Organ and tissue transplants. See also Donating your body or body parts
• 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)
• 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.
• 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.
• 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 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.
• 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.
High costs, risks, adverse events, bad practices, other problems with surgery
And a few solutions
• 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.”
• 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.
• 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. Consider these alternatives. 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."