Canada's biggest science controversy in years appears set to continue, this time on the pages of a new book. The book in question is The Drug Trial, by Miriam Shuchman, which puts a new face on the Olivieri case.
It's a face the author labels "controversial" and the main character calls "defamatory".
The Drug Trial relives a scientific war that broke out on August 13, 1998. In the midst of this war a doctor and scientist named Nancy Olivieri became a celebrated whistleblower for standing up against a pharmaceutical company who didn't want to publish negative results about a drug it was making.
But, five years in the making, Shuchman's new book suggests a much more complicated picture, one in which Olivieri is a less than prefect heroine and the biggest losers are the patients themselves, which may be dying in greater numbers due to a lack of an experimental drug at the center of the original controversy.
At stake in the controversy are the reputations of Olivieri and Shuchman. Certain methods of journalism are suddenly under intense scrutiny, as well. Was it fair to publish an account based on so many unnamed sources, and can such a book ever yield a usefully authoritative record of events?
Miriam Shuchman was there right at the beginning.
A psychiatrist and medical ethicist at the State University of New York at Buffalo, Shuchman is also a medical reporter who hooked onto the Olivieri case earlier in the spring of 1998. In fact, she was one of the first to report on it for CBC radio. Originally, Shuchman says she saw the story as a case of a pharmaceutical company unethically pushing around a respected scientist.
At the time, Olivieri, a high-profile scientist working at Toronto's Hospital for Sick Children, was studying an experimental drug (L1 or deferiprone) on people with the rare blood disorder thalassemia. The drug was being made by Apotex-Canada's largest pharmaceutical company-who had Olivieri under a research contract that required her not to discuss scientific results. So, when Olivieri saw serious problems with the drug and warned her patients without approval, Apotex cancelled her research and publicly questioned her science.
"There wasn't any question that the company [Apotex] was behaving as a big bad goliath," Shuchman told The Tyee as she passed through Vancouver. And Shuchman wrote her original stories for CBC as such, relying on lengthy interviews with Olivieri and volumes of documentation provided by her (which would later be used to write The Drug Trial.)
But, soon enough, Shuchman's view of Olivieri began to change. "What I found out while writing the book is that she wasn't a David who had done everything right," says Shuchman. What began to emerge for Shuchman, as she outlines in her book, is a doctor who went to great lengths to clear her name.
Around this time, Olivieri and Shuchman stopped talking.
Shuchman went on to re-construct what she saw as a more complex story than simply a whistleblower fighting against corporate interests. To do this, she talked to the patients and doctors involved in the Olivieri case, while also relying on the documentation Olivieri originally gave her.
The Drug Trial outlines the history of deferiprone, and details aspects of the relationships between the people involved, focusing mainly on Olivieri herself.
Suchman's version plays out as one of rivalry and revenge in a small scientific field. For example, the book talks about how Olivieri cut collaborators out of her research without telling them, sometimes failed to inform Apotex of drug results, and brought down Graham Sher -- then director of the Sick Kids thalassemia program -- with scientific misconduct charges only to replace him as director.
The most striking suggestion in the book is that thalassemia patients in North America are dying at higher rates than in countries where L1 is currently approved.
"There are studies that have been presented but haven't been published, which make it look like people are living longer in the U.K. and Cyprus-places where people are taking this drug [L1]," says Shuchman.
In Toronto, where the controversy largely played out, more than a dozen thalassemia patients have died in the last few years. A press release from the Thalassemia Foundation of Canada states that "many of these deaths were avoidable." Although it is not clear yet why these patients are dying (as Shuchman points out), the The Drug Trial does finger the Olivieri Case as the reason L1 is not yet approved in Canada.
'Standing up for the patients'
But why are we talking about the approval of L1 if it has serious problems as Olivieri originally suggested? As the book details, further research on L1 has failed to confirm Olivieri's original concerns and instead it appears that the drug is a good alternative to standard treatments for thalassemia. "In the end, in 2005, most of the data shows that the drug is working," says Shuchman.
In Shuchman's mind, the fact that L1 now looks effective reveals how the patients really got lost during the controversy.
"No one in this story was really standing up for the patients," says Shuchman, "the patients got lost when there was a fight between Olivieri and the hospital…they got lost when there was a fight between Olivieri and the drug company, because a lot of patients wanted to keep taking this drug." In this respect, The Drug Trial really does take a detailed look at how patients were affected, many of which are presented in the book to feel left out in the cold.
"There are many sides to this story," says James McCormack, Professor of Pharmaceutical Sciences at UBC, who has served on the UBC ethics committee for various clinical trials in Canada. "It's a very legitimate take that the whole affair was handled poorly," he says, "and painting Olivieri as the martyr in this whole thing and everyone else as the bad guys is probably not the balanced view point."
Margaret Munro, a veteran science reporter at CanWest News, says that Olivieri was a darling of the media. "But it [the Olivieri case] is still held up by the international community as a case of the problems researchers can run into," says Munro. This is still the most important issue, she adds.
Olivieri weighs in
Nancy Olivieri considers The Drug Trial to have numerous errors and be a personal attack against her.
Responding to a review of Shuchman's book in Maclean's, Olivieri writes in a letter to the magazine that "for any physician, the most damaging accusation is that you've killed people, as Miriam Shuchman suggests I have in Maclean's…this latest attempt to discredit me is based on gossip, innuendo and falsehood."
Although Olivieri was not available to talk by phone due to her traveling, she did respond to questions from The Tyee via an email, commenting that despite the past extent of the controversy over deferiprone, she was still surprised by the content of the book.
"Shuchman was anything but fair," writes Olivieri in her email. "Shuchman and her publisher clearly adhere to the view that they can defame me with impunity," she adds. When asked what she thought the book got wrong, Olivieri writes in part that "Shuchman falsely accuses me of responsibility of deaths it is well documented were solely the responsibility of others." Olivieri further adds that "she [Shuchman] repeats in great detail the false allegations made against me in the past, and gives no details on why these were proven wrong by independent inquiries."
In her letter to Maclean's, Olivieri also brings up concerns about the use of "unnamed sources and anonymous quotes." Indeed, The Drug Trial does rely on the use of confidential sources and is unusual in having "a note on sources" positioned at its front.
Shuchman explains that there were a lot of lawsuits during the course of the case and people were fearful. "In this book, when people said I have to be concerned that I could be sued…I had to accept that," says Shuchman. Nevertheless, Random House, who published the book, knows who all the sources are and has fact checked it, says Shuchman.
But, at least one critic of the book, Rick Salutin, a self-described friend of Olivieri, has questioned the use of unnamed sources. In the Globe and Mail on May 6th, 2005, Salutin wrote "The book relies mainly 'on unnamed sources and anonymous quotes' because people 'were worried about being sued.' Why didn't they just say: Don't quote me, I may be lying."
Salutin appears quite angry by the suggestion that Olivieri neglected her patients, writing "I've heard her speak soulfully and anxiously about patients and say that what gave life some meaning during the mauling she took in the corridors of power…was her work with them."
Stephen Ward, Professor of Journalism Ethics at UBC, says "that any book that comes out using mainly anonymous deserves to be looked at with great scrutiny, but I would not say to disbelieve it." However, the book does find itself in a period of overuse of confidential and anonymous sources, says Ward, which has gotten some journalists in trouble for fabricating.
"If you are going to use confidential sources, the standard rule is that at least one senior editor has to exactly know who this person is," says Ward, "and then make a judgment call to whether this person's quotes are valid." In The Drug Trial, Shuchman says exactly this was done.
"Without allowing people the possibility of being confidential sources we wouldn't be able to tell the story," says Shuchman. As a result, the book was kept very hush-hush as it was being written.
The bigger picture
Even with the use of confidential sources, Shuchman says the story was worth telling. This is because the story speaks to where things stand in science and clinical trial research today in Canada, and how the ties between academia and industry must be closely examined. This examination partly must fall on the contracts researchers sign with companies to ensure that negative results can be freely published.
Shuchman, Munro, and McCormack, all agree that the most important points of telling this story is to call into question how well we are able to monitor the state of an ongoing clinical trial, protect patients, and be forthcoming with information. "It's the whole issue of transparency," says McCormack.
Nevertheless, "the book is controversial," says Shuchman. "But I'm glad it's out there to debate," she says, adding that she expects L1 to be approved in Canada at some point in the future despite the controversy.
Olivieri appears not to be convinced that L1 will be approved in Canada soon, according to her letter in Maclean's.
But, in her email to The Tyee, she does relate several life lessons from the whole process. Namely, that:
(a) Very few people are prepared to offer effective support to those who risk their careers in order to protect the public interest;
(b) The personal and career costs of defending the public interest have turned out to be far greater than it even did after the first five years of this decade-long ordeal;
(c) It is very important for individuals to be active in democratic mutual support organizations such as faculty associations and trade unions.
David Secko is on staff of The Tyee with a focus on science.
Editor's note: Dr. Nancy Olivieri has written a response to this Tyee article. To see her response, click here.