Editor’s Note: The following guest post was written by Marilyn Mann, a lawyer with a keen interest in health policy. Members of her family have familial hypercholesterolemia (and have been treated by Steve Nissen), which may account for her particular interest in cardiology and this debate.
Last week I attended the American Heart Association Quality of Care and Outcomes Research conference in Washington, DC. I’m a lawyer, and I’ve attended my share of legal conferences over the years, which tend to be on the dry side, to say the least. This conference was much livelier, and one of the highlights was a debate between American College of Cardiology CEO Jack Lewin and Steve Nissen of the Cleveland Clinic, on the topic of “Controls on the Influence of Commercial Interests.”
As background, Steve Nissen was one of the authors of a 10-point proposal set out in an editorial in JAMA last year that argued that professional medical associations (PMAs) should work toward a complete ban on pharmaceutical and medical device industry funding, except for income from journal advertising and exhibit hall fees. The JAMA editorial, among other things, also argued that PMAs should pool any industry funds for CME and not permit industry to fund specific programs. Explicit in the JAMA editorial is the view that although accepting advertising and exhibit hall fees “might possibly bias the activities of PMAs, officers and members can easily distinguish these marketing activities from educational presentations and are free to ignore them.” (You can read more on the JAMA editorial here.)
Lewin, on the other hand, supports the ACC’s current approach to relationships with industry, which was recently revised in response to congressional hearings and investigations. The ACC has also signed on to the new Council for Medical Specialty Societies (CMSS) Code for Interactions with Companies. (Click here to read Daniel Carlat’s critique of the code .) According to a recent story in heartwire, the ACC’s new policy includes tougher rules with respect to participation in guideline writing groups — 50% of the writing group, plus the chair, can have no relevant ties to industry.
In their presentations, Nissen and Lewin had certain points of agreement. Both agree that industry has an important role in developing new therapies. They also agreed on the need for clear disclosure of industry ties and sponsorship, both by individuals and organizations. (Lewin mentioned that the ACC supports the Physician Payment Sunshine Act because it will make it easier to check the adequacy of disclosure.) However, Lewin focused primarily on disclosure as a way of managing conflicts, while Nissen argued that disclosure was not enough to ensure both the fact and appearance of independence of PMAs from undue industry influence. In addition, Nissen emphasized the problems with industry-funded CME, “where excessive industry influence may distort the benefits and risks of treatments, raising healthcare costs and compromising quality of care.”
With industry spending $1 billion a year on CME (over 50% of all CME spending), this is not a minor issue. According to Nissen, companies spend this money not for philanthropic reasons but because it results in increased sales of their products (an annualized return on CME spending of 350%, according to a study cited in one of Nissen’s slides). In addition, Nissen argues that if industry money were pooled (an idea being tried at the next AHA annual meeting), so that companies could not choose the topics being funded, “the money will dry up.”
Lewin agrees with Nissen that industry has “business motives” for funding CME, but argues that industry funding for CME is a necessity because there is no other source of funds adequate to the educational needs of physicians in the context of an explosion of medical knowledge. He also believes “industry relationships can be managed effectively,” through disclosure and editorial review. Yet, Lewin concedes that this hasn’t always worked well in the past, with the AFibProfessional.org website (previously described on CardioBrief here and here ) being an example of inadequate disclosure and content that was “not unbiased.” (Lewin says the ACC has improved their process for reviewing non-CME as a result.) Lewin also criticized some of the authors of the JAMA article, including Steve Nissen and Catherine DeAngelis, for accepting industry money for research or journal ads while criticizing industry funding for PMAs and CME.
Whatever your views on whether physicians and PMAs can maintain their objectivity while accepting large amounts of industry cash, it seems clear that media coverage of such funding (see examples here and here ) can create a perception of impropriety. In my opinion, it is likely that the trend will continue to be toward increased disclosure of and restrictions on such relationships over the next few years.
— Marilyn Mann