Vioxx may be sold in Canada again
In a bizarre development, a panel of Canadian expert is recommending that Vioxx, the drug that is estimated to have killed as many as 50,000 Americans and caused 140,000 injuries in the US, be allowed back on the market. Merck voluntarily recalled the drug in September last year after a study showed that it increased the risk of heart attacks and strokes. Since then, Merck is being sued by tens of thousands of Vioxx victims and States of Texas and New York have filed lawsuits for fraud.
A panel constituted by the FDA in February this year made similar recommendations but its recommendations were widely criticized and completely ignored after it was pointed out that several panel members were essentially agents of drug firms like Pfizer and Merck. While Merck announced that it will try to bring Vioxx back on the market, it is highly unlikely that it will happen any time soon as Merck gets bogged down in courts. The first of the Vioxx lawsuits is scheduled to go on trial next week.
Health Canada, the FDA counterpart in Canada, acknowledged the panel’s view that, as a group, selective COX-2 inhibitors are associated with an increased risk of cardiovascular events, a risk that is similar to those associated with most NSAIDs. The panel noted that this risk is present for all patients taking anti-inflammatory agents and that it increases with longer-term use and when other risk factors, such as cardiovascular disease, are present.
Health Canada also acknowledged the panel’s findings that certain drugs in this class are effective anti-inflammatory agents and that the use of these drugs should be left to informed patients, advised by their well-informed health care providers.
In the case of Vioxx, which is not currently authorized for sale in Canada, the panel reported that available data justifies the marketing of Vioxx in Canada because the risk of cardiovascular incidents from Vioxx appears to be similar to that of most NSAIDs. In order for VIOXX to be marketed in Canada, the manufacturer is required to submit a new drug submission to Health Canada. The submission would be carefully reviewed to ensure it meets safety data requirements, with particular attention to the safe labelling issues raised by the panel. Merck has vowed to do the same in the United States.
Immediate actions Health Canada will take include:
- Manufacturers of all NSAIDs currently on the market in Canada will be requested to provide updated patient safety information for these products. This would include Celebrex, which is currently available in Canada by prescription, and ibuprofen products (Advil, Motrin, etc.) currently available over-the-counter.
- Health Canada will continue its assessment of whether Bextra should be returned to the Canadian market after sales were voluntarily suspended in April 2005. The recommendations from the panel will be a key factor in the Department’s final decision, which is expected in the coming weeks. While the FDA forced a recall of Bextra, Pfizer has promised that Bextra will be back on the market in the US and worldwide.
- Health Canada will be conducting further analysis and communicating to provincial health regulators the panel’s recommendations on current over-the-counter availability of some ibuprofen products, in particular to address the possibility of inappropriate, long-term use of these products. FDA has already issued a similar warning about the risks of all NSAIDs. In another study, it was shown that diclofenac also may be as dangerous as other OTC paikillers like Aleve and Mobic.
- Such a recommendation by the expert panel in Canada is bound to hurt the FDA expert Dr. David Graham, who has continued to fight against Vioxx. He even proved that Vioxx was so dangerous a drug that it should have never been approved by the FDA. The Association of Certified Fraud Examiners (ACFE), the world’s leading provider of anti-fraud training and education, today announced that Dr. David Graham will receive its 2005 Cliff Robertson Sentinel Award. Graham’s ongoing crusade for drug safety, despite intense pressure from supervisors and drug manufacturers, earned him this prestigious award.
- Since last August, Graham says that the FDA has not involved him in any new drug safety issues, even though he is its most senior and experienced drug safety researcher. He believes that he has not been fired only because of the personal intervention of Senate Finance Committee Chair Chuck Grassley (R-Iowa). “Because of inherent structural and economic conflicts of interest it is my opinion that the FDA’s Center for Drug Evaluation and Research (CDER) views the pharmaceutical industry as its client and ally. As a result, I believe the public and the nation are virtually defenseless against new drug safety disasters. Unless Congress acts to reform FDA, history teaches us that there will be many more disasters in the future,” says Graham. It is not clear if Health Canada is also as closely aligned with the drug industry as the FDA but it would be no surprise since it caved in under pressure from the drug industry to stop import of prescription drugs from Canada by poor Americans.
Merck Frosst, the Canadian affiliate of Merck & Co. did not release a statement on the developments.
Recommended article: Merck wants to improve its image after Vioxx crisis
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