This Month's News
AMA opinions form ethical cornerstone for interface with industry
At its founding in 1847, members of the fledgling American Medical Association revolutionized medicine through unanimous adoption of the world's first national code of professional medical ethics.
Today, with increased scrutiny of physicians' relationships with the medical drug/device industry, the AMA has three specific opinions that form the cornerstone of ethical guidance for industry interactions that impact medical education and practice:
- Opinion 9.011 - Continuing Medical Education
- Opinion 9.0115 - Financial Relationships with Industry in CME
- Opinion 8.061 - Gifts to Physicians from Industry
All three opinions have been adopted or updated since 2011, in light of the need to ensure independence, transparency and accountability in CME and in interactions with industry. For example, updates to Opinion E-8.061, which was originally issued in 1992 and updated in 1998, were adopted at the AMA's Interim Meeting in November 2013.
As noted in the Council on Ethical and Judicial Affairs' report calling for updates to E-8.061, "Medicine-industry relationships have evolved significantly since E-8.061 was last updated in 1998 and so has public and professional unease about the possibility that gift relationships between physicians and pharmaceutical, medical device and equipment, and biotechnology companies will have inappropriate effects."
These concerns were reflected in the federal Physician Payments Sunshine Act, which went into effect last August. (A similar initiative is underway in the European Union.)
This legislation has had an impact not only on physicians but on the medical industry as well, as reported in The New York Times: GlaxoSmithKline is phasing out its practice of paying physicians to speak about its products or about diseases targeted by drugs the company manufactures. Also, the firm will no longer pay doctors to attend medical conferences.
At the same time, a recent study in JAMA raises concerns about medical communication companies and their role in CME. An accompanying editorial asks whether such companies are "clouding the sunshine," and states, "Continuing medical education that is tainted by promotion is marketing masked as education."
From the physician perspective, the AMA has developed an online toolkit to help physicians navigate the parameters of the Sunshine Act. The AMA is also continuing to monitor the act's implementation to ensure that it is not unduly onerous to physicians and does not inadvertently undermine quality of care efforts.
In addition to ensuring high ethical standards in industry support of continuing medical education, the AMA also is working to ensure that medical students are made aware of the Sunshine Act and its implications for their future practice.
Further, AMA policy encourages all medical school faculty to "model professional behavior to students by disclosing the existence of financial ties with industry, in accordance with existing disclosure policies at each respective medical school." A new report from the Pew Charitable Trusts provides guidance to academic medical centers in this regard; it contains 15 recommendations intended to protect the integrity of education and training and the practice of medicine within the academic medical center while not impeding research and scientific inquiry.
The AMA has been a pioneer in turning physicians' attention to the ethical concerns posed by gifts from industry. Today, it continues to be proactive in addressing these concerns and ensuring that ethics, not external regulation, is the bedrock upon which physician professionalism is built.