For the first time in Canadian drug regulatory history, experts who advise Health Canada queried drug company officials in public yesterday and heard the views of consumers as they prepared to recommend how, or if, controversial painkillers known as cox-2 inhibitors should be used in Canada.
The pharmaceutical giants, forced to withdraw or suspend sales of two of the three former blockbuster drugs over concerns about heart risks and other potentially serious side effects, presented mounds of clinical data supporting their products.
Pfizer indicated it would like to bring back Bextra. Merck was coy about its plans for Vioxx, the biggest seller but the first off the market. And Novartis said it intends to seek regulatory approval for its cox-2, Prexige, if the panel's recommendations are favourable to the drugs.
Spokespeople for groups representing communities of chronic-pain sufferers argued for continued access to the drugs for people with crippling conditions such as rheumatoid arthritis.
But given the hearing's intent -- to allow the public a voice in, and a window on, the drug regulatory process -- there was surprisingly little live input from average pain sufferers or cox-2 users.
While e-mailed comments from 48 individuals were synthesized for the panel, only three of 12 public presentations were from individuals. And the divergence of their arguments underscored the confusion that surrounds the safety of these drugs.
A 28-year-old woman who has suffered from rheumatoid arthritis for half her life said Bextra -- suspended from the Canadian and U.S. markets in early April because of an elevated risk of a life-threatening skin reaction -- made a measurable difference in her quality of life. "I'm constantly faced with the risks associated with these medications, but it enables me to garden, play the piano, cross country ski, swim and live a full life. But this life is dependent on the availability of the right medications, such as cox-2s," Laurie Proulx told the panel.
But Kassandra Poirier, 19, whose mother died of a heart attack while taking Vioxx, pleaded with the panel to blackball the drug for good. "Now that you know this drug is lethal, I would hope you recommend that Vioxx not be put back on the market," she said with anger in her voice.
She offered no proof that the drug contributed to her mother's death.
Michael Hynes, a chronic-pain sufferer who takes Celebrex -- the sole remaining cox-2 currently available in Canada -- said he fears for the continued availability of the drug. "I appreciate Health Canada's concern for my health, but in the final analysis, I should, as an adult, be able to weigh all the risks and decide my own course of action," said Mr. Hynes, 60, who has taken Celebrex for six years, despite having a history of heart disease.
In a piece of ironic timing, the British Medical Journal published two new studies adding to the growing body of evidence suggesting that some of the drugs elevate the risk of heart events -- sometimes fatal -- in some users.
A British study showed Vioxx users were nearly one-third more likely to have a heart attack than people who hadn't taken the drug in the past three years. It also found increased risk for users of two other painkillers, ibuprofen and diclofenac, which are in a class called non-steroidal anti-inflammatory drugs or NSAIDs.
The Health Canada panel has also been asked to look at whether scientific evidence points to risk of heart events from these commonly used drugs.
A second study, by researchers at McGill University, found Celebrex was safer than Vioxx and NSAIDs for elderly patients with congestive heart failure.
A commentary in the journal suggested the findings of both studies should be interpreted with caution, as neither provided clear data on pre-existing risk factors in the patients that might have clouded the findings.
The disparities in the burgeoning scientific literature and the heartfelt and contradictory views of the public highlight the difficulty facing Health Canada's expert panel, which includes cardiologists, rheumatologists and gastroenterologists.
"It is a complex issue," said chair Dr. Andreas Laupacis, president of the Institute for Clinical Evaluative Sciences in Toronto.
The issue is made more difficult by the fact that chronic pain sufferers, for whom the drugs have been a godsend, make up a small portion of those who used cox-2s. Savvy marketing turned expensive drugs originally meant for a small subset of the population into the pain-control drugs of choice for a broad spectrum of society.
Health Canada's options are relatively limited, Dr. Laupacis noted in an interview. Drugs can be ordered off the market or approved with conditions. But once they are on the market, there's no way of controlling how doctors prescribe them. And stern warnings in the product monographs are unlikely to change prescribing practices, he said.
"There ain't going be any one quick fix, that's for sure. Especially since these drugs are so potentially useful in such a wide variety of individuals," he said.
The expert panel meets in camera Friday to start fleshing out its recommendations, which Dr. Laupacis said he hopes will be issued within about three weeks.