It’s no secret that money from drug manufacturers can influence policymakers and researchers. But the scope and effects of industry payments in medicine are, perhaps, poorly understood.
That is changing, however, in part thanks to the US Sunshine Act (also known as Open Payments), a transparency statute included in the Patient Protection and Affordable Care Act of 2010 (“Obamacare”).
The Sunshine Act requires drug and medical device manufacturers — as well as companies producing biologic agents — to report payments made each year to physicians and teaching hospitals, contributing to a spate of recent studies on pharmaceutical industry money and the influence thereof.
In recent months, JAMA Internal Medicine and The BMJ have published several studies detailing pervasive industry payments and how they can affect clinical research, prescribing decisions, social media activity, and patient advocacy groups.1-5
The studies’ authors conclude that more transparency is needed.
“Financial relationships between physicians and the pharmaceutical industry are prevalent, and it’s important for regulators and researchers to identify and call attention to situations when those relationships lead to potentially problematic outcomes,” said Michael S. Sinha, MD, JD, MPH, a postdoctoral fellow in the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital in Boston, Massachusetts.
Conflicts of interest in the clinical trial space are “likewise troubling,” Dr Sinha said, citing one of the recent studies, which linked industry payments to primary clinical trial investigators and positive study results.1
“What troubles me about such conflicts of interest in oncology is the vulnerability of the patient population and the possibility for therapeutic misconception — the mistaken belief that the clinical trial is intended to treat the condition,” Dr Sinha told Cancer Therapy Advisor. “A principal investigator who is vested financially in the outcome of a trial may foster such a misconception in the patients he or she enrolls, overemphasizing benefit while minimizing risk.”
The new studies “show that financial ties to the pharmaceutical industry are very common and widespread, both in medical research and among patient advocacy groups,” said Barbara Mintzes, MSc, PhD, senior lecturer in the faculty of pharmacy and a member of the Bias and Research Integrity Node at the Charles Perkins Centre, University of Sydney in Australia. Dr Mintzes recently coauthored a systematic review on industry funding and clinical study outcomes, which found that industry-sponsored drug and device studies is associated with more favorable outcomes for the studied products.6