Recently, I was required to complete disclosure and conflict-of-interest information for Partners Health Systems; a separate request also came from Harvard Medical School. For the former, I was provided an online “tutorial” explaining in detail the definitions and requirements for the myriad categories that reflect my involvements. For the latter, I was mandated to first complete a 30-minute educational program culminating with a multiple choice examination. Almost simultaneously, the American Academy of Orthopaedic Surgeons (AAOS), in conjunction with a solicited chapter for the AAOS, required that I complete a program regarding ethics in publications, also highlighted with a multiple choice examination.
Despite the requirements for comprehensive data regarding disclosures and conflicts-of-interest, one can only be amused by the wide variation in the mandated “disclosure” slide preceding any lecture or conference, ranging from “no disclosures relative to this subject” to a slide containing an exhaustive list of all disclosures and conflicts-of-interest from all members of the speakers department—both usually shown for no more than a few nanoseconds.
Much of this can be traced to the 2009 report of the Institute of Medicine entitled “Conflicts of Interest in Medical Research, Education, and Practice” in which the committee recommended that all medical institutions, academic institutions, professional societies, patient advocacy groups, and medical journals establish conflict-of-interest policies that require disclosure. It ultimately led to the Sunshine Act introduced in 2010 as part of the Patient Protection and Affordable Care Act requiring payments and gifts of >$100 to be reported to the Department of Health and Human Services. This includes consultation fees, honoraria, research funds, stock options, and travel costs.
We live in the era of the “Medical-Industrial Complex,” a term first introduced in the 1971 book “The American Health Empire” by Ehrenreich1 and soon promoted by thought leaders such as Arnold Relman, MD, when he became editor of the New England Journal in the early 1980s. This is not surprising given the fact that Americans spend upward of 2.5 trillion dollars annually on health care, and in some parts of the country health care delivery is the number one employer. As pointed out by Margaret Wente in an article in the Toronto Globe and Mail in July 2011 “…rewards for high-tech medicine and “breakthroughs” are extremely high. Medical corruption, influence-peddling, and inflation of research are serious problems.”
It is not surprising that the ever-increasing disclosure requirements, insidious incremental numbers of regulations, and the looming change in the delivery of health care are unsettling. In an article in the Wall Street Journal dated August 21, 1995 entitled Medicine’s Industrial Revolution, JD Kleineke noted “many physicians are understandably threatened by this watershed in the history of medicine, this challenge to 2500 years of clinical hegemony. From unquestioned GOD to accountable production worker is a long way to fall in a few short years.”
Yet, some might well argue that the term “conflict-of-interest” is not appropriate as it might introduce a specific bias that may impede open discussion. Perhaps we should pay more attention and become more familiar with the work of Thomas P. Stossel, MD, Professor of Medicine at the Brigham and Womans Hospital in Boston and cofounder of the Association of Clinical Researchers and Educators, a not-for-profit association that advocates the value of physician-industry collaboration. In a key note address at the industry breakfast at the 97th Annual Clinical Congress for the American College of Surgeons, he stated “We have gone from bad to worse. We have immense regulatory issues and massive confession where we disclose our relationships to industry and these are used to initiate a whole variety of inhibitors in freedom of speech, freedom of association, and rewards for excellence.”