Breast cancer overdiagnosis, Sunshine Act sheds light on COI, and harms in drug approval process

July 9, 2015

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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In JAMA Internal Medicine, a new study finds (again) that more widespread breast cancer screening does not actually save lives, but instead leads to more over-diagnosis, as it detects cancers that would not have been fatal or harmful. As noted on Vox, the research, led by Richard Wilson, DPhil, found that more screening was associated with an increased incidence of small breast cancers, but no correlation to lower mortality. But the authors aren’t rejecting mammograms; they suggested screening may benefit women at higher risk than average of breast cancer. Accompanying the JAMA IM piece is a commentary by authors Joann Elmore, MD and Ruth Etzioni, PhD, who point out there are drawbacks to the method Wilson and colleagues used. They conclude, “Sadly we are left in a conundrum. Women will increasingly approach their physicians with questions and concerns about over-diagnosis, and we have no clear answers to provide.” They do, however, advocate for better tools for women to make informed decisions and for clinicians to be more selective with word choices when discussing premalignant conditions, like ductal carcinoma in situ. Shannon Brownlee, MSc, senior vice president at the Lown Institute, and author of Overtreated, Why Too Much Medicine is Making Us Sicker and Poorer, has written often about mammography. Here she opines on the debate.


Federal data released last week from the Centers for Medicare and Medicaid disclose the vast payments that pharmaceutical companies and medical device firms paid doctors and teaching hospitals in 2014 for research, consulting fees, meals, travel and royalties. The Los Angeles Times and The New York Times report that the payments, mandated by the Affordable Care Act and known as the Physician Payment Sunshine Act, amounted to $6.5 billion and were made to more than 600,000 physicians and 1,000 teaching hospitals. Such payments represent potential conflicts of interest that can threaten patient care. On ProPublica, Aaron Kesselheim, MD, from Harvard Medical School, comments that “there’s good evidence that [such payments] affect prescribing practices and physician behavior.” Industry payments were made not only to physicians, but also to dentists, optometrists, podiatrists and chiropractors. Nurse practitioners and physician assistants, many who prescribe drugs in certain jurisdictions, were not included in the data, as NPR indicates.


Donald W. Light, PhD, at the University of Medicine and Dentistry of New Jersey, School of Osteopathic Medicine, illustrates in a Health Affairs Blog piece this week the many biases inherent in the current drug development and approval process. Harm from medications, he admonishes, has propelled prescription drugs to the fourth leading cause of death in the United States. Meanwhile, reviews conducted by independent advisory groups show that nearly 90% of new drugs approved by the U.S. FDA and the European Medicines Agency (EMA) do not offer benefits that outweigh their risks. The FDA division responsible for approving new drugs receives the majority of its funding from companies submitting their drugs for review. Light argues that the current approval system harms patients by shortening the review process, allowing potentially unsafe drugs to be released to the public faster, and permitting drug companies to produce and publish “distorted” evidence of safety and effectiveness. The process must be redesigned to stymie this epidemic of harm.



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