Top policy expert's ties to giant drugmaker often go unstated

Mark McClellan, MD, a former leader at both FDA and CMS and now director of Duke University's Margolis Center for Health Policy, epitomizes the growing ethical debate over conflicts of interest in the pharmaceutical industry. As a top commentator on the U.S.

Mark McClellan, MD, a former leader at both FDA and CMS and now director of Duke University's Margolis Center for Health Policy, epitomizes the growing ethical debate over conflicts of interest in the pharmaceutical industry. As a top commentator on the U.S. health care system, McClellan's ties to drug giant Johnson & Johnson often go unmentioned in published articles and at speaking engagements. He has earned more than $1 million in compensation since accepting a board seat with the firm 5 years ago—a dual role that may raise eyebrows in some, but not all, circles. "Just because you have a connection to a company, in my opinion, you don't necessarily generate a conflict for everything that you do," argues Arthur Caplan, a bioethics professor at New York University School of Medicine, who says the industry must "get more sophisticated" about the issue. Caplan personally leans toward full disclosure, something that might no longer be an option in the future. Sen. Claire McCaskill (D-MO) recently proposed legislation that would oblige drugmakers to report payments to patient advocacy groups and professional societies. If passed, it would bolster the Sunshine Act, which requires pharmaceutical firms to report payments to teaching hospitals and physicians. In the meantime, prestigious medical journals are handling the dilemma by using a standard disclosure form created by the International Committee of Medical Journal Editors. It stipulates: "You should disclose interactions with ANY entity that could be considered broadly relevant to the work," going on urge authors to report "all sources of revenue paid (or promised to be paid) directly to you or your institution on your behalf over the 36 months prior to submission of the work."