We’ve long written that the relationships and finances exchanged between industry and researchers points to a medical bias in which patients are often not the prime concern.
Now, in a recently sent letter to the White House, Charles D. Rosen, MD, former president and co-founder of the Association for Medical Ethics, along with other physicians, is seeking action on the Physicians Payments Sunshine Act (PPSA), which was part of the Affordable Care Act passed in 2010.
The Act is being delayed from enforcing the law mandating public disclosure and transparency of the financial relationships between physicians and drug and medical device companies. According to the letter, “three years later, we are disappointed that the PPSA has yet to be implemented—especially in light of reports that the final rules are being held up at the White House Office of Management and Budget.”
Dr. Rosen was one of the signers to the letter addressed to Jacob Lew, Office of the Chief of Staff. Marcia Angell, MD, Senior Lecturer in Social Medicine, Harvard Medical School and Former Editor-in-Chief, New England Journal of Medicine; Jerry Avorn, MD, Professor of Medicine, Harvard Medical School; Jerome Kassirer, MD, Distinguished Professor, Tufts University School of Medicine; Steve Nissen, MD, Professor of Medicine Cleveland Clinic Lerner School of Medicine also signed the letter.
The letter also states that, “The administration should implement the Act without any further delay so that it can begin, as soon as possible, to rein in the undue and harmful influence of money on medicine.”
The Association for Medical Ethics collaborated with Senators Charles Grassley (Republican) and Herb Kohl (Democrat) supporting the Act. Dr. Rosen testified before Congress in 2008 for the Act and, again, in September 2012 for the Senate Special Committee on Aging Roundtable “Let the Sunshine In: Implementing the Physician Payments Act.”
Physician payments information was meant to be made publicly available this year. A strict timeline was to have been set by Congress for a final rule by October 2011 followed by the drug and medical device companies collecting and submitting their physician payments by March of 2013. Implementation of the rules of PPSA are now 15 months late, which means that the information will likely not be made public until 2015.
“I think the letter highlights that this law has been held up from implementation, in my opinion, by Big Pharma and medical device companies who are trying to gut the teeth of the Act in a couple of ways,” Dr. Rosen said. “They are trying to change the rules of the law so foreign subsidiaries of companies paying money to American doctors don’t have to be reported. Also, they are trying to change the rules that medical devices or pharmaceuticals going through FDA Clinical Trials don’t have to reveal payments to authors/researchers until after its approved. In my opinion, medical device pharma companies are making the Act less transparent by not revealing the millions of dollars going to its physician researchers.”
As we previously wrote, a prior New York Times review revealed that about 25 percent of all physicians have accepted cash from drug and device makers and about 2/3rds have accepted meals in exchange for advice and speaking engagements. Most significantly, the Times also revealed that physicians receiving money from drug makers tend to practice medicine in different ways than physicians who do not accept industry gifts, and that doctors working with industry also tend to prescribe medications in riskier and unapproved ways.