Yale Report Stirs Concerns About Conflict

Newark Star Ledger: TICKED OFF

Yale report stirs concern about conflicts

By Edward R. Silverman

Star-Ledger staff

Business Section, Page 4

May 21, 2000

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The controversy over the Lyme disease vaccine is extending into another contentious arena -conflicts of interest generated by the red-hot intersection of industry and academia.

Last month, two Yale University researchers published a review paper in a prestigious medical journal, the Annals of Internal Medicine, in which they summarized facts and theories about the Lymerix vaccine sold by SmithKline Beecham Plc.

The researchers, Robert Schoen and Wendy Thanassi, concluded their discussion by stating no evidence exists to suggest the vaccine causes an autoimmune arthritis or is responsible for any unexpected safety problems.

What the researchers didn't say is that their employer, Yale University, holds a patent on the vaccine and is paid an undisclosed sum in annual royalties by SmithKline based on the amount of vaccine sold.

A Yale spokeswoman confirmed the arrangement, but added that neither Schoen nor Thanassi were among the Yale researchers who are listed on the patent, which was issued in 1998 to the university, and, therefore, don't share in the royalties.

Nonetheless, the episode troubles medical ethicists because it comes at a time when concerns are rising that the pharmaceutical industry is unduly influencing academic research and that conflicts of interest aren't being disclosed.

In a sharply worded editorial last week, The New England Journal of Medicine warned that growing conflicts of interest are tainting science, and that medical schools have struck a "Faustian bargain" with the pharmaceutical industry.

''A conflict of interest isn't confined to situations where a researcher does research and gets money," said Arthur Caplan, who heads the University of Pennsylvania's Center for Bioethics. "It also exists when researchers write evaluations and the institution gets money.

''Should medical journals and, ultimately, the public understand when that kind of cross-support exists? Yes. But because of growing university and industry ties, we need a more complicated set of rules to handle more of these twists and turns."

In this instance, the issue isn't merely academic. Several lawsuits have been filed against SmithKline by individuals who claim they were harmed by Lymerix, fueling a controversy over the vaccine's safety.

In footnotes, the review paper cited dozens of other papers or scientific abstracts as supporting material, including one that was co-authored by Schoen and Dennis Parenti, the group director for adult vaccines at SmithKline, among four others.

An editor at the medical journal said authors are required to disclose "dual commitments" that represent a potential conflict of interest for individual authors. In this case, she said there was nothing disclosed about SmithKline payments to Yale.

''There were two separate opportunities for these authors to disclose any potential conflicts of interest," said Christine Laine, a deputy editor at the Annals of Internal Medicine. "It would have been nice to know about that."

Neither Schoen nor Thanassi responded to telephone messages left for them. A SmithKline spokeswoman referred all questions about the patent and royalties to Yale.

Article Here- http://www2.lymenet.org/domino/news.nsf/UID/Ledger21-May-2000-2