Misleading medical device marketing, huge price hike for EpiPens, and reprimanded doctors’ industry ties

August 25, 2016

In order to bring you more of the news you want to read, RightCare Weekly summarizes and interprets three important articles and provides headlines linking to the many other articles and editorials you’ll find interesting. As always, RightCare Weekly presents articles related to moving our healthcare system toward the right care for all patients.

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STAT reported earlier this month that device maker Medtronic went too far in pushing the off-label and potentially dangerous use of one of its premier products, a spine implant called Infuse. Jerome Lew had cervical (neck) spine surgery in 2009 at UCLA involving a Medtronic implant that led to life-altering complications and recurring pain. Medtronic had gained approval for an earlier Infuse device, which was tested for use in the lower spine. A modified, smaller version was later cleared by the agency without requiring the company to submit results of any clinical testing for use in the cervical spine. Yet, Vikas Saini, MD, Lown Institute president, told STAT, “everything about [the new devices]…makes it clear that they were meant to be and were used in the cervical spine,” where they caused problems. Under current FDA regulations, doctors are allowed to use devices and medications “off-label” on patients for whom the product has not been specifically approved—and often not even tested. This device is unusual in that the off-label use is what it appears to be intended for, and Medtronic’s marketing appeared to recommend it for that use. The Justice Department had been investigating off-label use of Medtronic spinal implants as early as 2008, according to the Wall Street Journal. At that time, Medtronic said it had “fully complied with federal laws.” Eight years later, the question remains: How many more patients will suffer needlessly before Congress empowers the FDA to do its job and regulate products more effectively?

For people with potentially life-threatening allergies and asthma, EpiPens are a necessity. A decade ago, a two-pen set of Epi, the primary treatment that prevents anaphylaxis, the airway closure that can occur in people with severe allergies or asthma, cost pharmacies about $100. Today, that same set costs more than $600, according to The New York Times. Aaron Carroll in Upshot, says epinephrine, the drug in EpiPen, costs less than a dollar a dose. So why the price hike? Mylan, the maker of Epi, has followed the leads of other drug makers, raising prices because it can, reports Vox. While copays and drug coupons offset a portion of the cost for some, families who don’t have insurance or who have high deductibles are going without or cutting back on the number of pens they must buy not only for home, but also for schools, camps, and grandma’s house. Adding to the problem is that more than one dose may be required for some reactions, and the drug degrades in a short period of time. Taxpayers are affected, too, as schools are required to stockpile the drug. Naomi Shulman’s 12-year-old daughter needs the drug. “It’s gouging parents about their children’s lives…It’s life or death,” she told the Times. A group of senators is demanding an investigation into why Mylan raised the drug’s price by 400 percent. We hope they also demand an explanation for why Mylan’s CEO compensation went from $2.4 million eight years ago to $19 million today.

Doctors with records of severe misconduct received payments from pharmaceutical and medical device companies for consulting, speaking, and travel, according to a recent ProPublica analysis. Despite previous industry promises to screen potential consultants and speakers thoroughly, drug and device companies paid more than 2,000 physicians with disciplinary records between 2013 and 2015. Hundreds of these doctors had been previously reprimanded for major offenses such as improperly prescribing addictive drugs, sexual misconduct, and fraud. While disturbing, these findings are not surprising to those who study the effects of industry influence on medicine. “Their [drug and device companies’] fiduciary duty is not to educate physicians and make public welfare better. It’s to sell a product,” said Charles Rosen, MD, co-founder of the Association for Medical Ethics. The ProPublica analysis comes on the heel of efforts by medical societies to further limit disclosure of industry payments to doctors. The societies are attempting to amend the Physician Payments Sunshine Act to exempt industry from disclosure requirements for payments to doctors for continuing medical education and copies of medical studies. In an opinion piece for STAT, Paul D. Thacker, a former investigator on the U.S. Senate Finance Committee, describes how industry funding turns education courses into marketing sessions and transforms medical studies into endorsements. These payments “guided doctors toward more expensive and less-tested products,” he said.


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