- Many Well-Known Hospitals Fail To Score High In Medicare Rankings (npr.org)
The federal government released its first overall hospital quality rating...slapping average or below average scores on many of the nation's best-known hospitals while awarding top scores to many unheralded ones....The Centers for Medicare & Medicaid Services rated 3,617 hospitals on a one- to five-star scale, angering the hospital industry, which has been pressing the Obama administration and Congress to block the ratings...Hospitals argue that the government's ratings will make teaching hospitals and other institutions that treat many tough cases look bad. They argue that their patients are often poorer and sicker when admitted, and so are more likely to suffer further complications or die, than at institutions where the patients aren't as sick...Rick Pollack, president of the American Hospital Association, called the new ratings confusing for patients and families..."We are especially troubled that the current ratings scheme unfairly penalizes teaching hospitals and those serving higher numbers of the poor."..."Hospitals cannot be rated like movies," Dr. Darrell Kirch, president of the Association of American Medical Colleges..."We are extremely concerned about the potential consequences for patients that could result from portraying an overly simplistic picture of hospital quality with a star-rating system that combines many complex factors and ignores the socio-demographic factors that have a real impact on health."
- More than half of adults misuse medications, study finds (washingtonpost.com)
More than half of adults and 44 percent of children who were drug-tested by a national clinical laboratory last year misused their prescription medications, according to a study...by Quest Diagnostics...Misuse of medications can mean that patients were either taking too much, too little or none of their medications. It also can mean test results showed they were using other drugs that had not been prescribed, including illicit drugs -- as 45 percent of adults were doing...The rate of misuse identified by the study might skew higher than what would be found in the general U.S. population. Some patients were tested because their health providers determined there was a "high probability" of them mismanaging medications...The study also identified the drugs most often misused by patients depending on their age: amphetamines for youth 17 and under, but benzodiazepines and anti-anxiety medications for adults 25 and older, followed by opioid painkillers.
- Medical groups push to water down requirements for disclosing industry ties (statnews.com)S. 2978: Protect Continuing Physician Education and Patient Care Act (govtrack.us)OpenPayments (cms.gov)
Nearly 100 national and state medical societies from around the United States are backing a Senate bill (Protect Continuing Physician Education and Patient Care Act, (SB 2978) that would exempt drug and device makers from reporting payments made to doctors for receiving continuing medical education...sessions, medical journals, or textbooks. Among them are the American Medical Association and the American College of Cardiology...The move is the latest push in a long-running effort to roll back requirements for reporting such payments to a federal database, which tracks financial relationships between companies and physicians. Known as OpenPayments, the database was launched...in response to concerns that financial ties between drug firms and device makers and doctors may unduly influence medical practice and research. It was included in the Sunshine Act provision in the Affordable Care Act. A recent analysis found that payments can affect prescription rates...
- Facing thousands of Accutane claims, Roche wins appeal of $18M jury verdict (fiercepharma.com)
Roche won another reprieve in its fight against Accutane safety claims. The...drugmaker persuaded a New Jersey appeals court to overturn an $18 million jury verdict in favor of two Accutane (isotretinoin) plaintiffs...Appellate Division ruled...that the trial court judge "seriously erred" in allowing some revelations in court while restricting others. The judge’s mistakes were weighty enough to warrant a new trial...It’s the latest in a series of victories on appeal for Roche...The lawsuits are among 3,000 assigned to multicounty litigation in New Jersey. The plaintiffs allege that Roche’s acne drug, pulled from the market in 2009, triggered their inflammatory bowel disease...Accutane once was a blockbuster med for Roche and a staple therapy for acne sufferers. Roche pulled Accutane for "business reasons"...long after the drug went off patent and generics hit the market. The company already was facing hundreds of liability lawsuits at the time
- The best drug to fight Zika may already be approved and out there, study suggests (statnews.com)
Several teams of scientists are racing to develop a vaccine for the Zika virus. But what if a drug that already exists could stop an infection in its tracks?...According to new research, it’s not a totally crazy idea...A group of researchers has identified two dozen Food and Drug Administration-approved drugs that have shown some ability to block Zika from infecting human cells in the lab, according to a paper published...in the journal Cell Host & Microbe. Some of these drugs — which treat infections, cancers, and even depression— also showed potential to prevent infection in certain cells tied to fetal defects in pregnant women...the next steps in testing the drugs against Zika, and added that scientists should consider using some of the drugs together because they work in different ways...The candidate drugs don’t all share certain characteristics...While some have shown past hints that they can fight flaviviruses — the virus family that includes Zika — others had never before shown any antiviral ability, according to the study...
- This startup is using tech to make animal testing in clinical trials more ethical (medcitynews.com)
Dog as man’s best friend...Now a small startup in Philadelphia is making the saying applicable to the pharmaceutical and drug development world...Drugs that are developed by pharmaceutical companies are...tested first in animals to evaluate their safety and how they interact with living tissue. But the typical testing method is to take a healthy animal, give them a certain disease, test the drug, therapy, or medical device, and then kill them...The One Health Company is trying something new by finding dogs (and cats) with naturally occurring diseases that are also present in humans, like bone cancer, and testing new drugs or therapies on them. The goal is two-fold: Provide pro-bono care for pet owners to heal their own pets, while facilitating bringing new drugs to market by collecting data for pharmaceutical companies...The...approach...is notably different. Pets remain with their families, diseases are never induced, and putting a pet down is never considered an option in any of their clinical trials. Families caring for their sick pets as they undergo these trials collect data, via smartphone, on their pets’ behavior and habits using proprietary clinical trial management software...
- How Buprenorphine Implants Help People Fight Opioid Addiction (forbes.com)Implant for Opioid Dependence (req subscription) (jama.jamanetwork.com)
Poor medication adherence can lead to reduced treatment benefits, even death in some cases. Implants are being used by some medical professionals to increase the likelihood of patients “following the doctor’s orders.” Specifically, some clinicians are using these devices in individuals with an addiction to opioids...Even though buprenorphine can be used to treat opioid addiction, its efficacy is limited by the potential lack of adherence to daily, sublingual doses. To...increase...compliance among patients undergoing buprenorphine treatment...the FDA approved the first buprenorphine implant for the treatment of opioid dependence...Called Probuphine, the treatment provides a low-level dose of buprenorphine for six months...This treatment option may also be considered an effective relapse prevention tool. Icahn School of Medicine at Mount Sinai researchers found...
- The Radical Experiment That’s Changing the Way Big Pharma Innovates (fortune.com)
J&J has thrown open its R&D doors — to all comers. Will this uber-open-access strategy work? ...Just five years ago, one of the last places one would have looked for innovation at Johnson & Johnson was in its Merryfield Road lab in La Jolla, Calif...The R&D facility for the healthcare giant, No. 103 on Fortune’s Global 500 list, had become something of a scientific wasteland...These days, the gleaming, state-of-the-art space is teeming with entrepreneurial spirit and cutting-edge science. What’s odd, though, is that these researchers toiling away within J&J’s walls—and making use of J&J’s abundant resources—do not work for the company. Nor do the findings or the discoveries they produce there belong to J&J. Some of these drug scientists even receive funding from J&J’s competitors. As for the venerable, 130-year-old company that’s paying for all this largesse, it claims it wants nothing more out of the arrangement than for its tenants—all life science start-ups—to succeed.
- Medicare safeguard overwhelmed by pricey drugs (toledoblade.com)
A safeguard for Medicare beneficiaries has become a way for drugmakers to get paid billions of dollars for pricey medications at taxpayer expense, government numbers show...The cost of Medicare’s “catastrophic” prescription coverage jumped by 85 percent in three years, from $27.7 billion in 2013 to $51.3 billion in 2015...Out of some 2,750 drugs covered by Medicare’s Part D benefit, two pills for hepatitis C infection — Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir)— accounted for nearly $7.5 billion in catastrophic drug costs in 2015...The pharmaceutical industry questions the numbers, saying they overstate costs because they don’t factor in manufacturer rebates. However, rebates are not publicly disclosed...Medicare’s catastrophic coverage was originally designed to protect seniors with multiple chronic conditions from the cumulatively high costs of taking many different pills. Beneficiaries pay 5 percent after they have spent $4,850 of their own money. With some drugs now costing more than $1,000 per pill, that threshold can be crossed quickly...
- Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant (bloomberg.com)
Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory (Zhejiang Hisun Pharmaceutical Co.) with a history of poor quality controls, or face shortages of treatments for American cancer patients...Food and Drug Administration inspectors had uncovered what the agency later called “broad data manipulation” at the factory, located in Taizhou....Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints...The agency issued an indefinite ban on the factory...one of China’s leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant continue exporting about 15 ingredients for use in finished drugs in the U.S., including nine key cancer medicine components. Hisun says that it takes quality seriously and has complied with requirements.