The facts go something like this. In 1996 Nancy Olivieri, a haematologist working at the Hospital for Sick Children in Toronto, came to believe that an experimental iron chelating drug (deferiprone) that she was trialling in patients with thalassaemia was losing efficacy and causing serious adverse effects. Apotex, the company that made the drug and that was partly funding the trial, disagreed. When Olivieri indicated that she intended to inform participants of her concerns, Apotex terminated the trials and withdrew financial support. They invoked a confidentiality agreement in the research contract and threatened legal action if she made the findings public. Undeterred, Olivieri presented her results at a scientific meeting and submitted them for publication.
Figure 1.
Miriam Shuchman
Random House Canada, $C34.95, pp 464 ISBN 0 679 31084 3 www.randomhouse.ca/
Rating: ★⋆⋆⋆
Shuchman retells the story from a worm's eye view, dwelling on the personalities involved, what they said about each other, who was sleeping with whom
Events after the dispute between Olivieri and Apotex showed deep divisions and personal animosity within the academic community in which she worked. Many of her colleagues were, to say the least, unsupportive. An internal inquiry set up by the hospital authorities found her to have been at fault in the way she handled events after the termination of the trial. (The inquiry was later judged to be flawed in the evidence it heard and in the conclusions it reached.) She was fired from her position as director of the haemoglobinopathy research programme and referred to the medical licensing board of Ontario for research misconduct.
All this is well known. The affair was widely covered in the news media and the medical press. The usual version of the story casts Olivieri as heroine, a plucky whistleblower who, regardless of her own interests, did the right thing. Apotex is cast as the villain: a capitalist monster. The University of Toronto and the Hospital for Sick Children have been seen as afraid that, if they supported Olivieri, a multimillion dollar donation to create a biomedical research facility that they were negotiating with Apotex would fall through.
Olivieri's supporters mostly take the view that the central issue is one of academic freedom: that it doesn't matter whether she was right or wrong or whether she was a congenial or disagreeable colleague. The important thing was that she was concerned enough about the safety of the drug to convey her doubts to a scientific meeting and to a peer reviewed journal so that members of the medical community could judge for themselves. Some people reckon that the main lesson to be learnt is that if academic freedom is to be maintained then collaborations between industry and universities need to be better managed. Researchers and their institutions need to examine the conditions under which funding is provided, to think about potential conflicts, and to set up ways to resolve them before they happen. They may well be right. Indeed, it is hard for an outsider to avoid thinking that had an independent data monitoring committee been in place the whole business might have been avoided.
In a commentary published in the Canadian Medical Association's journal (CMAJ 2001;165: 783-5), Steven Lewis and colleagues memorably described the negotiation of contracts between industry and universities as dancing with a porcupine—something to be undertaken only with prudence and the right precautions—but perhaps unavoidable in circumstances where few universities can afford to turn down commercial partnerships. Others believe the roles of university and industry to be in fundamental conflict: one is, or at least ought to be, concerned with the pursuit of knowledge, while the other's business is making money for shareholders. These aims are irreconcilable, and universities should realise that when commercial companies make substantial donations they are likely to expect to gain substantial influence.
The Olivieri story raises other questions too. Why are whistleblowers treated so badly by the institutions in which they work? What is it about the structures, vested interests, or collective psychology of these institutions that leads, at best, to whistleblowers being marginalised and often to them being vilified and dismissed? Another is about the failure of research ethics committees to consider how the financial and legal arrangements between researchers and pharmaceutical companies impinge on the safety and rights of trial participants. And, most fundamental of all, how should society fund biomedical research institutions and biomedical research?
It is disappointing that Schuchman's book hardly touches on these issues. Instead, it retells the story from a worm's eye view, dwelling on the personalities of the peopleinvolved, what they said about each other, who was sleeping with whom, and the tricks they got up to to blacken each other's reputations. At the beginning the author tells us that while researching the book she discovered information that made her abandon the idea that she was telling a straightforward story of the machinations of a powerful company exposed by a whistleblower. But 400 pages later she ventures no conclusion more dramatic than that Olivieri still wants deferiprone banned, despite accumulating evidence that her anxiety over its toxicity was an over-reaction.