Dr. Olivieri, a leading researcher at the University of Toronto, was working with Apotex, Canada's leading domestic pharmaceutical, on a clinical study of deferiprone, a drug treatment for thalassemia, an inherited group of blood disorders. The study was being performed on children at Toronto's Hospital for Sick Children during the 1990s.
I won't go into the details -- this case has been documented in great details already. Google will provide all sorts of links. In a nutshell, Dr. Olivieri noted nasty side effects, but when she tried to report them to the patients and their families, Apotex argued that the non-disclosure agreement she signed prevented her from discussing these problems. When she ignored Apotex, the hospital and the university came down on the side of Apotex. The case went public, and was fought in the court for years.
Ultimately, Dr. Olivieri prevailed. In at least one report, the hospital and the university were criticized for not supporting their researcher, and it was noted that very large donations from Apotex to both institutions probably played a role in their reaction. To add insult to injury, Apotex then took the support provided by the hospital and the university and used it as evidence in court to show that the company was in the right -- support that Apotex bought and paid for.
One of the recommendations that was made was that Health Canada make it clear the role and responsibilities of researchers, especially when the drug companies have made sizable donations to the various people and institutions involved in these clinical studies.
So what happened?
First, in 2003, Apotex made a large donation to Paul Martin's leadership campaign -- $50,000 -- which easily puts in it in the top 1% of contributors. No other pharmaceutical concern comes close. (Google "paul martin apotek disclosure" -- the file "Paul Martin - 7th Disclosure" has been removed from the government website, along with everything else related to the Ethics Counsellor, but you can view the cached document. The company's name is rendered as "Apotek".)
Then on January 28, 2004, Dr. Olivieri and others sent this letter to Prime Minister Paul Martin:
We are writing you to express our deep concern with your governments proposal to replace Canadas Food & Drugs Act with a new health protection legislative regime. We have noted a series of changes announced by your new government that reflect the commitment to building a 21st century economy. A key element appears to be the redesign of the federal approach to health and safety regulation in order to create an advantage for industry by means of weaker safety standards.Of particular concern are Health Canada's proposals to: a) abandon the Precautionary Principle to a narrow risk-benefit regime; b) shift the burden of proof from industry to the public products are presumed safe unless harm is proven; c) speed up drug approvals; and d) allow direct-to-consumer advertising of prescription drugs.
The letter goes on for some length.
I'm not promoting one side or the other in this particular debate. But I do find it interesting that Apotex had success in paying off the Hospital for Sick Children and the University of Toronto. The people who run this company obviously have excellent instincts when it comes to knowing where to apply financial incentives to their benefit. Curiously, that includes our Prime Minister, Paul Martin.
The question is: are their instincts right about Paul Martin?