Vioxx recall controversy heats up in Canada
While the validity of FDA panel's recommendation to allow sales of Vioxx to resume in the US is in serious doubt due to conflicts of interest of panel members (10 panel members have financial ties to Merck and Pfizer), Merck is now getting into a row with Health Canada. (Related article: Merck and Pfizer ignored drug safety; focused on profits alone)
According to an interview published in The Globe and Mail, a leading Canadian newspaper, the Canadian Minister of Health Ujjal Dosanjh, has charged Merck of holding back safety data from drug regulators after it voluntarily recalled Vioxx worldwide in September 2004. “I can tell you that I am extremely concerned and disappointed with Merck [Frosst Canada] withholding data from Health Canada, even after it pulled the drug. I think they have an obligation and they have some explaining to do,” Ujjal Dosanjh said yesterday. (Related article: Merck could have found out Vioxx risks earlier)
The Health Minister has shown his frustration with Merck as the company failed to provide the data that was asked of them. It is clear from the interview that Merck dragged its feet on Vioxx safety data both prior to recall of Vioxx and subsequent to that. Health Canada representatives attended the FDA panel discussions in the United States last week. The agency issued an advisory on Cox-2 drugs in December 2004, and according to the transcript of an tele-conference published on its website, the Health Minister has promised to investigate the safety of these drugs. He calls the Cox-2 drug investigation as "one of the most demanding and costly that the department has undertaken in recent years in the area of post-market drug safety." (Related article: Merck knew of Vioxx risks, according to WSJ)
Ten Health Canada scientists and physicians are working full-time on the review of all Canadian and international studies, tests, trials, adverse effects reports, and other scientific evidence. Health Canada has been widely criticized for its poor performance in handling Vioxx recall process in Canada. (Related links: Louisiana Medicaid, Kaiser Permanente, New Zealand, European Union, and Australia limit/ban Cox-2 drug prescriptions) That was one major reason why the agency moved more aggressively in the case of Adderall XR recall despite the pressure by the FDA not to do so.
Merck Frosst, the Canadian operations of Merck, issued a statement today that the Company has at all times and will continue to cooperate with Health Canada in matters concerning Vioxx. "We are perplexed with the comments made to the Globe & Mail by Health Minister Ujjal Dosanjh" said Company spokesperson Marlene Gauthier. "The Company responded in writing to Health Canada's request for information and has offered to meet with Health Canada officials at their convenience. We had not received any verbal or written feedback to our letter until we saw the Minister's comments in the newspaper" she added.
Related developments
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Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra
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