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When the Goose Lays a Rotten Egg

by William Wells

Most collaborations between industry and academia are positive: companies get research done, and academics get funding. But when results are unexpectedly negative, things can get messy.

Silence of the Boots

In November 1994 Betty Dong of the University of California, San Francisco (UCSF) received word that her manuscript had been accepted for publication in the prestigious Journal of the American Medical Association (JAMA). Dong was delighted — an article in JAMA comes along rarely for even the best medical researchers — and publication was set for January 25 1995.

But then on January 13 1995 JAMA received a letter from Dong withdrawing her manuscript. She cited as explanation an "impending legal action by Boots Pharmaceuticals, Inc. against the University of California, San Francisco and the investigators."

Dong’s withdrawn article contended that one of Boots’ big money-spinners — a thyroid hormone preparation called Synthroid — was biologically equivalent to three competing and cheaper preparations. Over the previous four years Dong had been battling Boots, who funded the study, over the results. She was hamstrung by a contract that she had signed which stated, amongst other things, that any data were "not to be published or otherwise released without written consent" of the company. Such gag orders are forbidden by any sane university, but Dong signed the contract before 1993, the year that administrative review of all such documents became standard practice at UCSF. Now UCSF was unwilling to back up Dong, even as she claimed that Boots was threatening legal action against her personally for any reduction in sales of Synthroid.

Publication was staved off for long enough for the 1995 sale of Boots to Knoll Pharmaceuticals to go ahead successfully. Meanwhile Boots/Knoll came under increasing pressure following a 1996 article in the Wall Street Journal and a series of curt inquiries from the US Food and Drug Administration. The company finally relented and the Dong article, unchanged from the 1994 proofs, was published in April 1997.

But UCSF wasn’t in the clear just yet.


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