E-DRUG: New York Times: The Drug Trial
---------------------------------------------
The Drug Trial
Reviewed by Gina Kolata The New York Times
[copied as fair use]
THURSDAY, JUNE 23, 2005
The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children
The story of Dr. Nancy Olivieri, a Canadian whistle-blower, was a reminder of the power that drug companies can wield over the release of unfavorable data. Or so it seemed.
As it was told on national television, in newspapers and in medical journals, and as Olivieri tells it, she was testing a promising treatment for patients with a terrible disease when she discovered that the new drug soon lost its effectiveness and could cause deadly complications. She told the company she was going to report her findings at a meeting and tell her patients.
But the company said she could not breathe a word because she had signed a confidentiality agreement. It removed her as a principal investigator and continued its drug study.
Olivieri eventually told everyone. The company never took legal action, but its threats became known and chilled scientists to the bone. Olivieri was hailed as a hero, winning medals for her courage.
The reality, however, is a bit different, at least as Dr. Miriam Shuchman, a journalist and psychiatrist, describes the case in her new book, "The Drug Trial." Hers is a story of colossal egos and rushes to judgment, of rivalries and revenge, and of character assassination and serious harm to patients, to doctors and to Canada's largest drug company.
(Complete disclosure: A colleague and I spent time in 1999 investigating Olivieri's claims before deciding not to write about them.)
The story begins with the patients, children and young people with thalassemia, a rare blood disorder. As part of their treatment, they had to endure excruciatingly painful injections and infusions of a drug, Desferal. If they neglected the treatment, iron would build up in their hearts and other organs, and eventually the iron overload would kill them. But the treatment was so difficult, so unpleasant and could have side effects so disabling that many patients eventually gave it up, knowing full well the fatal consequences.
Enter L1, [L1 is deferiprone. BS] a pill that might replace the dreaded Desferal. Apotex, a Canadian drug company, wanted to develop it. And Olivieri, who directed the thalassemia treatment program at the Hospital for Sick Children in Toronto, had already started studying L1 and was eager to have the company's support.
Within a few years, she was both a paid consultant for Apotex and director of a study to find out whether L1 was effective and safe.
But soon the company and Olivieri were at odds. Apotex was impatient with Olivieri's tardiness in supplying data and her increasing requests for more assistance, Shuchman writes. Then, according to the book, Olivieri, angry with Apotex's demands that she provide them her findings in a timely fashion, began deliberately withholding data from the company.
In the spring of 1995, Olivieri began to suspect that L1 did not always work and told Apotex she wanted to investigate. The company asked to see her data but she instead pressed Apotex to pay for her proposed new study.
Olivieri shared her data, but Apotex interpreted it differently and terminated its pact with her. Its executive, Dr. Michael Spino, left her a message saying that if she tried to disseminate information from the study, Apotex would "vigorously pursue all legal remedies.'
The battle escalated. Olivieri turned against L1 and claimed that it was not just ineffective, but it was deadly, producing liver scarring and even scarring of the heart.
Meanwhile, The Journal of the American Medical Association took up Olivieri's cause, and, in 1998, The New England Journal of Medicine published her paper on L1, even though its editor at the time, Dr. Jerome Kassirer, later told Shuchman in an e-mail message that he was skeptical.
Today, Shuchman reports, L1 is licensed in 47 countries, although it is not sold in the United States or Canada. It is no panacea and has its own side effects, including a precipitous decline in white blood cells that can be fatal if the drug is not discontinued immediately. The claims about its liver and heart toxicity have not held up. But Olivieri continues to cite them in her crusade against L1.
In her epilogue, Shuchman quotes Olivieri's former collaborator, Dr. Alan Cohen, physician in chief at the Children's Hospital of the University of Pennsylvania, as advising, be "wary of investigators."
As Cohen, she said, put it: "There's a lot of motives out there besides money. There's academic advancement, self-promotion, self-aggrandizement."
Nathan Ford
MSF
London
"Nathan Ford" <nathan.ford@london.msf.org>