The night before Merck & Co. officials pulled Vioxx off the market last September, after their popular painkiller was found to double the risk of heart attack and stroke, they called a small, trusted group of scientists for advice.
Claire Bombardier was one of them. Director of rheumatology at the University of Toronto and holder of a prestigious Canada research chair in the field, Dr. Bombardier has been a consultant to Merck on Vioxx since 1997.
That night, Merck officials described fresh evidence that Vioxx increased heart risks. Dr. Bombardier agreed the data confirmed the problem. Still, she told them, it would be a shame to lose it given that it was a matter of weighing benefits and risk. "It was a good drug," she told them. Patients, she said, would miss it: "I was on the fence."
It was a careful answer, as befits a physician who is both research scientist and drug-company consultant -- and someone who is a key figure in one of medicine's biggest drug controversies.
Dr. Bombardier headed the 1999 Merck-sponsored drug trial that first provided evidence of the alarming heart risks of Vioxx, and she was the lead author of the resulting study published in the New England Journal of Medicine.
That study is now under attack for the heart-risk data it did not include. Critics say the full information from the study should have prompted the drug company and drug regulators to take swift action against Vioxx five years ago.
This week, a special panel of the U.S. Food and Drug Administration held hearings into the safety of Vioxx, and the new generation of painkillers to which it belongs. The hearings are just one of several investigations and legal actions surrounding the drug, and Dr. Bombardier says she must be careful about what she says, since she might find herself on a witness stand. As she puts it: "If you are in the car when there is a car accident, you have to testify."
The FDA panel voted to allow the possible return of Vioxx, provided it carries a black-box warning of heart-attack risks and faces other severe restrictions that make people aware of its dangers. FDA whistleblower David Graham, who earlier warned of the Vioxx risks, said those measures are "five years too late."
A Globe and Mail investigation involving internal Merck documents, congressional testimony, files made available through the FDA and interviews, paints a disturbing picture about the way public safety seemed to have taken a back seat on the road to turning a vaunted new drug into a blockbuster marketing hit.
While Vioxx became one of the fastest-selling drugs in history -- with sales of more than $2.5 billion (U.S.) -- behind the scenes, serious concerns about whether it might be harming, even killing people were raised steadily.
Documents show Merck fighting a war on a number of fronts: against its chief competitor, Pfizer, and its drug Celebrex; against outside scientists who questioned the drug's safety; and against drug regulators who seemed to have been unable or unwilling to compel the company to do all the investigations it wanted.
Marlene Gauthier, a spokesperson for Merck Frosst Canada, said due to the ongoing legal proceedings against the company it could not respond to questions about its actions at this time.
In the United States, the Vioxx saga has triggered not only government hearings, but a criminal investigation and an inquiry by the Securities and Exchange Commission. At least 700 lawsuits have been filed against the company.
In Canada, where the drug was invented and where pharmacies dispensed roughly three million prescriptions a year, 30 class-action lawsuits have been filed, though not all have been certified.
There has been no public airing here of the events surrounding the withdrawal of Vioxx, nor how Health Canada, which has also been named in lawsuits, dealt with the drug. Health Minister Ujjal Dosanjh called this week for public hearings into its class of medication and for greater transparency. Due to the legal proceedings against it, Health Canada officials would not answer key questions for this article.