When Dr. Mark McClellan sat for an in-depth 30-minute question-and-answer session at an April health policy forum, the audience was filled with top researchers, advocates and Capitol Hill staffers eager to hear what insight the former head of the Food and Drug Administration would dispense.
He did not disappoint.
In response to a question about how competition might drive down the cost of new drugs made from living cells, McClellan said, “That is a great example of where more clarity from FDA about what exactly is required could potentially open up more biosimilar competition.”
McClellan is director of the Margolis Center for Health Policy at Duke University, the academic position by which he’s commonly identified. But he frequently has not disclosed another position he’s held since late 2013: He earned $285,000 last year on the board of pharmaceutical giant Johnson & Johnson, a company accused of blocking the sale of Pfizer’s Inflectra biosimilar, which competes against J&J’s blockbuster Remicade, a rheumatoid arthritis drug.
According to corporate financial filings, McClellan has been compensated with more than $1 million in cash and stock awards since taking that post.
McClellan also receives compensation as a member of the advisory board of privately held Alignment Healthcare, which employs doctors and provides chronic-care management for Medicare Advantage plans in three states. Alignment Healthcare declined to disclose his compensation.
The issue of conflicts of interest has become more pressing in recent years as drug prices soar and health care companies reach out to the academic and policy community for advice — often with generous payments attached, ethics experts say.
Sen. Claire McCaskill (D-Mo.) introduced a bill in June that would require drugmakers to report payments to patient advocacy groups and professional societies. If passed, it would toughen the Sunshine Act, which requires pharmaceutical companies to report payments to teaching hospitals and physicians, detailing how much was paid annually to doctors for travel, speaking and food.
As a board member to these for-profit health care companies, McClellan has a fiduciary obligation “not to injure them” when writing articles and speaking, said Stephen Bainbridge, law professor at UCLA.
And while there is no legal requirement to disclose board memberships when writing for journals or speaking, Bainbridge and other experts agreed there is an ethical obligation.
“There’s certainly a potential conflict of interest there,” Bainbridge said, adding that while serving on the board of Johnson & Johnson “you are dealing with an enormous company that has fingers in a lot of different pies.”
McClellan said in an emailed statement that he provides specific disclosures on topics on which his interests might give the appearance of conflict, including in medical journals and at speaking engagements.
“My board memberships are public information and are broadly known within the field, and I stand by the independence and integrity of all my work,” McClellan said.
Ellen de Graffenreid, director of communications at the Duke-Margolis Center, said it was “clear that Dr. McClellan disclosed his position on the Johnson & Johnson Board when a potential conflict of interest existed — that is, when the publication mentions drugs or devices that may intersect with J&J’s business.” She said that while he serves on the J&J board, he “does not advocate for any positions on behalf the company.”
McClellan is a prolific writer and speaker about how the U.S. health care system operates. He left his work at the Brookings Institution to become the founding director of Duke-Margolis in 2015. He ran the FDA from 2002 to 2004 and served as administrator of the U.S. Centers for Medicare & Medicaid Services from 2004 to 2006 before joining Brookings.
In a majority of the articles McClellan wrote for the Journal of the American Medical Association, he did not disclose his corporate connections when he filled out forms concerning potential conflicts of interest. Of 15 papers he wrote since 2013, McClellan disclosed his relationship with Johnson & Johnson three times.
Johnson & Johnson is a Fortune 500 health care giant, with more than $76 billion in annual sales and a range of products including pharmaceuticals, medical devices and consumer products that include brand names Aveeno, Tylenol and Neutrogena.
“I don’t think there’s any reason to cover up or ignore those [corporate] relationships,” said Arthur Caplan, a professor of bioethics at New York University School of Medicine. “In general … I would say disclose more.”
Journals, conferences and policy forums generally ask contributors to list their potential conflicts of interest — financial relationships that might in some way sway their opinion or color the audience’s perception of information they relay. But the experts themselves decide which connections to list.
At the April forum addressing high drug prices, which was hosted by Kaiser Permanente’s Institute for Health Policy, neither the forum’s agenda, nor the speaker’s introduction at the event mentioned McClellan’s Johnson & Johnson role. (Kaiser Health News is not affiliated with Kaiser Permanente.)
Kaiser Permanente’s John Nelson said speakers at the forums typically have extensive backgrounds and “thus we only provide abbreviated biographies when introducing them.” Kaiser Permanente declined to say whether they knew of McClellan’s corporate roles.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, said he favors disclosure of corporate roles and thinks “many [people] would argue that it should be for the reader and not the author” to determine whether there is a conflict of interest.
The question of when to disclose industry or nonprofit funding has been debated for decades, said Dr. Sandro Galea, who wrote about conflicts of interest and schools of public health last year in JAMA.
“There are public and private actors and both importantly shape the environment in which we are in,” Galea said, adding that it has been “relatively standard practice” for those in academia to determine for themselves whether there is a conflict to disclose.
Bioethics professor Caplan said he could understand why some authors would choose not to disclose a board membership in every article, particularly if the article wasn’t directly related to the company or its products. Caplan serves as an unpaid chair of a compassionate use advisory committee based at New York University and funded by Janssen, which is a division of Johnson & Johnson.
“Just because you have a connection to a company, in my opinion, you don’t necessarily generate a conflict for everything that you do,” Caplan said. “We have to get more sophisticated” about conflicts of interest, though he advocates personally for full disclosure.
Elite medical journals, including JAMA and the New England Journal of Medicine, have streamlined the conflicts of interest question by using a standard disclosure form created by the International Committee of Medical Journal Editors.
JAMA media relations manager Deanna Bellandi declined to release McClellan’s ICMJE forms and said, “We publish what authors provide.”
The New England Journal of Medicine publishes the ICMJE forms with its manuscripts. McClellan disclosed his role at Johnson & Johnson in a 2015 letter to NEJM about the 21st Century Cures Act, a sweeping law that increases funding for disease research and alters the regulatory system for drugs and medical devices. But he did not disclose any corporate roles in two recent articles for NEJM Catalyst, a separate publication that requires authors to fill out a separate disclosure form. Those 2017 articles focused on payment reform and private-sector entrepreneurship in health care.
When completing the standard ICMJE disclosure form, an author fills out a series of sections. Section 3 notes: “You should disclose interactions with ANY entity that could be considered broadly relevant to the work.” And it tells the author 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.”
The Duke-Margolis Center and McClellan have been at the forefront of discussions on the merits of using real-world evidence, a somewhat controversial topic that could alter the way drugs are regulated and approved. The idea is that once a drug is on the market, the patients’ experience might in part supplant rigorous and expensive clinical trials.
Johnson & Johnson, whose executives are open proponents of the use of real-world evidence, did not respond to requests for comment.
McClellan did not disclose his J&J board membership in a 2017 white paper about real-world evidence, which was funded in part by the FDA. In September 2017, McClellan’s role at J&J was not disclosed during a public event done in coordination with the FDA. In December, Duke-Margolis announced a Real-World Evidence Collaborative, which is funded by pharmaceutical companies including Johnson & Johnson.
In May, a $4.2 million FDA grant was reposted for bids after concerns that Duke-Margolis was the sole bidder listed on the grant. The grant focuses on the drug approval process and research initiatives in the 21st Century Cures Act, including the potential benefits of using real-world evidence to analyze whether a drug works instead of rigorous and expensive clinical trials.
“Billions of dollars ride on the evidence that the FDA will accept for whether or not a drug is safe and effective,” said Avorn, whose center does similar research on drug pricing.