Canada panel to review Vioxx, Celebrex, Bextra, Mobic
Canadian Health Minister Ujjal Dosanjh has announced that the Public Forum on selective COX-2 inhibitor non-steroidal anti-inflammatory drugs (NSAIDs) will be held in Ottawa on June 9th and 10th, 2005. The FDA in the US held a similar panel in February this year and based on the deliberations, it decided to ban Bextra and put a black box warning on Celebrex. While Vioxx and Bextra have been recalled worldwide, the decisions are not yet final. Both Pfizer and Merck want to fight these decisions despire overwhelming evidence against the safety of these drugs and mounting number of class action lawsuits. (Related article: Bextra recall lawsuits in Canada)
While Celebrex and meloxicam are still available in Canada, on September 30, 2004, Merck Frosst Canada Inc. voluntarily withdrew Vioxx. Pfizer voluntarily discontinued sale of Bextra in Canada along with other countries in the world on April 7, 2005, as a result of information that suggested the reported rate of serious skin reactions among Bextra users was greater than for those using other selective COX-2 inhibitor NSAIDs.
The Expert Advisory Panel is a panel of independent experts, convened by Health Canada, that will review evidence and scientific data, consider questions posed by the Department and provide advice on the safety of selective COX-2 inhibitor NSAIDS. Expert panels are frequently convened by Health Canada to access special expertise and to bring a multi-disciplinary approach to issues that require it. The panel will be made up of specialists from a number of fields that may include rheumatology, cardiology and gastroenterology, experts in biostatistics and epidemiology and representatives of patient and consumergroups. Panel members will be selected based on their expertise in areas relevant to the issues to be considered, such as the treatment of arthritisand rheumatoid arthritis, a knowledge of cardiovascular and digestive side effects and patient concerns.
A similar panel constituted by the FDA got into a big controversy after it was disclosed that panel members had financial ties to the drugmakers under review. Almost everyone did not trust the recommendations of the panel because the FDA failed to disclose the conflicts of interest. Accordingly, Health Canada is taking precautions right away. (Related article: Americans lose trust in the FDA after its mishandling of Vioxx and Bextra recall)
Health Canada says that given the relatively small size of the research, medical and patient advocacy communities in Canada, the Department recognizes the reality that panel members of this stature may have done research or had other involvement with a drug manufacturer. Where the independence of a panellist's advice could be questioned because of such involvement, Health Canada says that it has established a rigorous process to assess any potential conflict of interest. In the case of the Expert Panel, potential members have been requested to declare any material and financial interests related to selective COX-2 inhibitor NSAIDS (such as membership on any advisory groups; travel or conferences paid by a manufacturer; or shares) and any research or other ties that may affect their objectivity (such as acting as the principle investigator for any manufacturer's study). Health Canada is assessing these declarations and determining whether any conflict exists, how it could be managed (for example, by excluding the member from certain portions of the deliberations) or whether a replacement member must be invited. A summary of this information will be shared with the public at the time of the panel meeting.
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