When Corporate Ties Cause Universities to Compromise
Nancy Olivieri, Professor of Pediatrics and Medicine at the University of Toronto, Ontario, Canada, doesn't fancy herself as Frances Oldham Kelsey. But for many of the people who hear Olivieri's story, the parallels are unmistakable with the so-called "heroine of thalidomide," who, in the early 1960s, kept the deformity-causing compound out of the American market of prescription drugs available for pregnant women.
Olivieri's saga began in 1993, when administrators at the university's Hospital for Sick Children obtained funding from Apotex, a Canadian drug company, for her clinical research on thalassemia, a genetic blood disease. In 1996, a drug produced by Apotex began to show life-threatening side effects in some of her young patients.
Olivieri informed the company that she felt obliged to alert her patients. But Apotex, which had placed a no-publishing clause in the contract funding Olivieri's research, threatened her patients anyway.
"Not to have told them would have been a gross violation of ethics," she says. In August 1998, Olivieri published her findings in the New England Journal of Medicine, sparking further criticism of her by administrators of the university.
Robert Prichard, president of the university, has led a heavily publicized campaign to procure a multi-million-dollar gift from Apotex. In defending his stance against Olivieri, Prichard cited long-term fallout with funders that might jeopardize the hospital's research program and patient care.
For the past three years, Apotex has dropped repeated hints of a lawsuit, and, as the university has sought to distance itself from her, Olivieri has become a poster child for consumer protection from dangerous drugs.
Olivieri's tale of a research relationship gone awry and recrimination from her university has helped rally colleagues to her cause. Yet, while Kelsey, a U.S. Food and Drug Administration officer, won kudos for her work and even prompted legislation in 1962 to mandate more diligent testing of a drug's side effects prior to approval, Olivieri faces hefty legal bills and lingering hostility from administrators after her high-profile challenge. On top of this, the drug produced by Apotex has gone forward for licensing in Europe.
She sees an ominous message emerging from her case. "I think this is a signal," says Olivieri. "It means that if you persist in trying to get an unproven drug through and can get a university to go along with you, you can win." Echoing those who say that the increasing ties of corporations to campus projects and curricula lend undue credibility to the corporate sponsors, Olivieri adds, "This company needs the university far more than the university needs it."
Besides traditional ethics of patient care, Olivieri points out, corporate-campus liaisons in medical research may prove dangerous to academic freedom. On January 6, 1999, she was dismissed from her job as director of the hospital's blood disorders clinic. But sustained pressure from faculty and other leading health experts – including Sir David Weatherall, of Oxford University in the United Kingdom, and David Nathan, head of Harvard University's Dana-Farber Cancer Institute, both of whom flew to Toronto to confer with Prichard on her behalf – helped Olivieri gain reinstatement.
Despite the sour residue on her campus, Olivieri sees some positive impact from recent media coverage of her cause, as research contracts and the role of corporations in medical education come under greater scrutiny by academics and the public. "In 1996, I was this lone voice saying I'm concerned about these kids." Now, she explains, "The dots are being connected and a very disturbing pattern is emerging."