Public involvement a “first” for Health Canada: Expert Advisory Panel reviews COX-2 evidence

Health Canada opened up one of its drug review Expert Advisory Panels to the public in Ottawa on June 9. It’s Expert Advisory Panel and Public Forum on the selective COX-2 inhibitors was the first time that an Expert Advisory Panel has heard and questioned pharmaceutical drug company presentations in public. It is also the first time that Health Canada has invited public input to be part of the evidence that the Panel will consider. The 13-member Panel included two patients: Pam Montie of Chilliwack, BC and Linda Wilhelm of Kings County, NB. Both are active in CAPA and in other arthritis organizations.

The mandate of the COX-2 Panel is to provide Health Canada with advice on the risks and benefits of these drugs and on how to ensure their appropriate use. The Panel was also asked to recommend additional clinical trials or observational studies needed to further evaluate all non-steroidal anti-inflammatory drugs (NSAIDs).

Much of the June 9 event was given to the pharmaceutical companies to present the evidence for their products. The companies summarized extensive reviews of studies comparing gastrointestinal and cardiovascular side effects of different COX-2s with each other, with placebo and with traditional NSAIDs. There was minimal mention of effectiveness, although the outcry at the loss of Vioxx and Bextra would seem to demonstrate, at least anecdotally, their value to consumers/patients.

While Merck Frosst was evasive about whether it intends to seek Health Canada approval to re-introduce Vioxx, Pfizer indicated that it would like to bring back Bextra; Novartis said that it might seek Canadian approval for its Lumiracoxib, if the Panel’s recommendations are favourable to the COX-2s. You can access the presentations themselves, as well as written public submissions and a variety of background information, by visiting the Public Forum website at: http://www.hc-sc.gc.ca/english/protection/cox2/index_e.html .

Kassandra Poirier, whose mother died of a heart attack while taking Vioxx, made a passionate plea for the permanent removal of the drug. CAPA member Laurie Proulx, a 28-year-old woman who has suffered from the effects of Juvenile Arthritis for half her lifetime, eloquently defended her right to weigh the risks of a treatment against the difference it can make to the quality of her life.

Ann Qualman spoke on behalf of CAPA and asked that the COX-2s be made available along with full, balanced, easily understood information; the choice of treatment should rest with the patient in consultation with their physician. Click (here) for Ann's presentation. Health care providers, the Arthritis Society, other presenters and Health Canada’s summary of written submissions echoed these themes.

The scientific challenge facing the Expert Advisory Panel, and Health Canada, is daunting. How relevant to an RA patient is a study that compares a COX-2 to placebo? How relevant to a 25-year-old is the relative prevalence of cardiovascular (CV) events in a sample of elders with Alzheimer’s disease? Does low-dose ASA taken as a cardio protective measure increase or decrease adverse effects of COX-2 therapy for OA? What has been the contribution of traditional NSAIDs to the incidence of cardiovascular disease? And how does the CV risk of COX-2 treatment stack up against the risk of a sedentary lifestyle due to inadequate pain management? These are only a few of the questions that the Panel will be debating as it formulates its recommendations through the month of June.

Overall, Health Canada’s Public Forum was a major step forward in openness. The Forum would have been even better if more of the day had been devoted to discussing practical risk management. How can Health Canada move beyond the traditional regulatory options of label warnings and patient monographs? Will the Expert Advisory Panel be influenced by the Public Forum and the Panel's consumer advocate members? It remains to be seen - CAPA Voices will keep you informed as the COX-2 saga continues to unfold.