Pharma, Heroes, and Ethics in Publishing

This is a messy posting about a messy topic. It’s about an unflattering review of an unflattering book about a whistleblower.

Here’s the brief version of the long, messy story, for those unfamiliar with it:
Dr. Nancy Olivieri is a specialist in the treatment of thalassemia, an inherited blood disease. She works at the Hospital for Sick Children in Toronto. In 1996 she came to believe that the experimental drug she was studying, called deferiprone, was having serious side effects on the children she was treating. She decided to inform patients and their families. Apotex, the copmany that makes deferiprone, didn’t like that. They stopped the trials, withdrew funding for the research, and reminded Dr. Olivieri that she had signed a confidentiality agreement. Then, basically, everybody sued everybody. The Hospital and the University of Toronto (with which the hospital is affiliated) didn’t back Olivieri, and some think that had something to do with a large donation the university was expecting from Apotex. Olivieri was hailed as a hero, a whistleblower, protecting her patients by standing up to powerful corporate interests. A report was commissioned by the hospital; it was critical of Olivieri, but this report was itself later demonstrated to be based on misinformation. An indepedent inquiry sponsored by the Canadian Association of University Teachers exhonerated Olivieri, but was highly critical of Apotex, the University, and the Hospital.

OK, fast-forward a few years.

Miriam Shuchman (a psychiatrist and medical journalist) publishes a book called The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children. The book is highly critical of Olivieri.

Fast forward another year or two. Philosopher Arthur Schafer publishes a review of Schuchman’s book in the scholarly journal, Bioethics, called “Science Scandal or Ethics Scandal: Olivieri Redux” (subscription required) The review is devastating. According to Schafer, the book manifests a clear bias against Olivieri: it focuses on the woman’s alleged character flaws, and papers over those of her critics. It also unfairly (and unrealistically) blames Olivieri for the deaths of patients who didn’t get access to deferiprone. Further, Schuchman relies extensively on quotations from anonymous sources — nothing wrong with the odd anonymous source, of course, but it’s a dodgy way to build a case. And some of the sources she does cite explicitly are people who have already been thoroughly discredited. Finally, Schafer notes a number of serious factual inaccuracies in Schuchman’s book, including at least one instance in which a quotation is wrongly attributed to Schafer himself.

I haven’t read the book myself (nor do I plan to), but if even half of Schafer’s criticisms are valid (and he’s a thorough scholar, so I suspect it’s all valid), there’s a serious problem with the book having been published at all (by Random House Canada…).

But what concerns me most about the book, and about the decade-long controversy, is the focus on one person, on Olivieri. For Shuchman to focus on a single individual might have been good from the point of view of selling books, but from the point of view of understanding the ethics of the case, it was a mistake. It might even be a mistake to lionize Olivieri as a hero. This shouldn’t be a story about heroism. Personally, I have great respect for Olivieri (though I know her only by reputation), but the point is that this case isn’t about her. It’s about sick children, the institutions that are supposed to be dedicated to helping them, and the standards and procedures that smart, well-intentioned, compassionate people put in place for reviewing novel medical treatments.
Update: Arthur Schafer says that people who want to see his article may feel free to contact him by email. Schafer asked me to add that — as he notes in his review — Shuchman also accuses Olivieri of being wrong about the science in this case, but that Shuchman does a poor job of defending that claim.

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