Yale Daily News

Although Yale School of Medicine Dean Robert Alpern’s failure to fully disclose his ties to a pharmaceutical company Tricida, Inc. only became public in December, Yale’s Institutional Conflict of Interest Committee had already met on Oct. 25 to discuss his ties to the biomedical industry.

According to an individual with knowledge of the situation, the committee advised Alpern to notify the Clinical Journal of American Society of Nephrology — where he published a co-authored study examining the effectiveness of a new treatment developed by Tricida — that he served on the pharmaceutical company’s board of directors and owned shares of its stock. The individual requested anonymity because the proceedings of the committee are confidential.

“You see people from major academic institutions on the boards of major pharmaceutical companies. That’s pretty standard,” the individual said. “The issue with [Alpern] was not that he was on the board of pharmaceutical companies. It was that … he didn’t report [that] … he was on the board of a startup [called Tricida] that was commercializing technology that he was an inventor of… [The committee] told [Alpern] to issue an amendment to the journal [clarifying his ties].”

In December, the New York Times reported on Alpern’s “erroneous disclosure” and revealed that Tricida, which is developing treatments for chronic kidney disease, had funded Alpern’s clinical trial. That same month, the News reported that Alpern received over $500,000 from pharmaceutical companies such as AbbVie and Abbot Laboratories, where he previously served on the board of directors. But according to the individual close to the matter, Yale’s Institutional Conflict of Interest Committee did not take issue with these payments. Instead, the individual emphasized that the University often encourages its faculty members to participate in sponsored research and added that broadly criticizing Alpern’s ties to pharmaceutical companies would be “guilt by association.”

Chair of the Institutional Conflict of Interest Committee and Management and Sociology professor Olav Sorenson declined to comment.

In an email to the News, Alpern said he believed his initial disclosure — that he was a consultant for Tricida — was sufficient. All the disclosures related to the study were submitted by “one of the authors” of the study, and those disclosures “made it clear that significant financial interests existed,” Alpern said.

Following the Institutional Conflict of Interest Committee’s October meeting, Alpern notified the journal about his additional ties to Tricida. According to Alpern, while the journal responded that his existing disclosure “was sufficient” at the time, it later decided that all authors’ disclosures should be supplemented. Per the Times report, the journal’s editors said the article would be amended after the Times and Propublica inquired about the disclosures. On Jan. 10, the journal issued a correction.

“The authors and editors have determined that the disclosures of potential conflicts of interest provided by the authors at the time of initial publication were incomplete and not aligned with the disclosure policy for the journal,” the correction stated.

It remains unclear why or how Alpern’s ties to the industry were brought up in the October Institutional Conflict of Interest Committee meeting.

According to University spokeswoman Karen Peart, Yale requires all full-time faculty members, senior leaders and researchers to disclose “all relevant significant financial interests at least annually” to the University.

“The university reviews each disclosure to determine if an individual’s financial interest could conflict with any of their Yale activities, including research, administration, teaching, and clinical care,” Peart said. “If a conflict of interest is identified, the university will determine by what means — such as modifying or monitoring the individual’s university activities or requiring the individual to relinquish some or all of the financial interest in the external activity — the conflict will be managed or eliminated.”

Peart added that according to Yale’s policy, a conflict of interest exists when “an individual has a significant financial interest that could directly and significantly affect their university activities.”

According to an individual close to the matter, Yale is planning to announce changes to its conflict of interest policy. Peart did not specify what the changes will be but clarified that the University is not in the process of making “significant changes” to the policies.

In a statement to the News, Alpern emphasized his commitment to “advancing the care of … patients” and said his involvement with the industry has been beneficial for companies, Yale and patients. Per the anonymous source, the Institutional Conflict of Interest Committee never “questioned the presumption that [Alpern] was acting ethically.”

“The majority of the funds spent on medical research are provided by industry and most if not all drugs require a significant role of industry before they can be brought to patients,” Alpern stated. “If Tricida is successful in bringing their drug to market, it could transform the lives of kidney patients. However, I also understand that these multiple roles create a potential conflict of interest that must be carefully managed. I believe the university has robust policies and practices for managing conflicts of interest and I am committed to following these policies and practices.”

According to the Yale website, the Institutional Conflict of Interest Committee oversees “relevant significant financial interests of University Leaders,” which includes members of the Yale Corporation, officers of the University, senior non-faculty administrators, faculty administrators and members of research compliance committees.

Serena Cho | serena.cho@yale.edu