For the love of money is the root of all evil: which while some coveted after, they have erred from the faith, and pierced themselves through with many sorrows.
—1 Timothy 6:10 (KJV)
Almost everywhere you turn these days, there’s talk of increasing transparency and eliminating conflicts of interest with regard to relationships between healthcare professionals and the pharmaceutical industry and medical device manufacturers. Whether it’s the news, Congress, patients, hospitals or academic institutions, or even pharmaceutical representatives, conversations flourish about the implications (real or perceived) of physicians’ financial ties with industry. The basic premise of these conversations is that any financial association creates a potential bias, a perceived lack of self-determination by the physician. More recently, concerns have been raised about the potential for partiality when industry provides funding for the activities of professional medical associations. No matter what your perspective, all agree that we will be navigating a future environment where relationships between physicians, professional medical associations, and the pharmaceutical and medical device industries are heavily scrutinized and discussed. Because of the ACR’s commitment to transparency, we welcome these discussions.
Many Opinions on Conflict of Interest
Fueled by the fervent interest on the part of both patients and the public, several trade publications have recently made headlines in the public press, including the revised “PhRMA Code on Interactions with Healthcare Professionals,”1 which took effect January 1, 2009, and the “AdvaMed Code of Ethics on Interactions with Health Care Professionals,”2 taking effect on July 1, 2009. These codes, instituted by the industries themselves, guide pharmaceutical and medical device–manufacturer relationships with medical professionals. They are voluntary codes of conduct, and as such are subject to interpretation and are not otherwise regulated. The standards set out in these documents call for increasing transparency, eliminating non-educational gifts to physicians, limiting the costs of educational items given physicians, and distinctly separating medical education activities from promotional activities. In addition, meals provided to healthcare professionals must be modest and incidental and provided in a workplace setting combined with an educational component. Overall, the revised codes are intended to increase the transparency of physician–industry interactions by focusing these interactions on education rather than promotions.
The federally proposed “Physician Payments Sunshine Act” would require companies to report a variety of payments made to healthcare professionals or businesses owned by these professionals that exceed $100 annually. Payments that are to be reported include those in the areas of consulting fees, charitable contributions, grants, honoraria, and research. The bill outlines how the reporting is to be implemented via electronic submission to the Department of Health and Human Services, and there are penalties—steep ones if the omission is found to be intentional—for failure to report. Additionally, the language of preemption enables states to add any regulatory laws they deem suitable. Several states, including California, Maine, Massachusetts, Vermont, and Washington, D.C., have requirements for the annual reporting of gifts to healthcare professionals that exceed dollar amounts anywhere from $25 to $100. I believe that these regulations are the first wave of a movement that will permanently change the landscape for physician–industry relationships.