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Commentary | Health Features

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Victoria double-cross on pharma watchdog

Recently, we saw two very different examples of how we collectively show our gratitude to those who protect us. Newspapers across the country displayed a picture of Canada’s newly unveiled Victoria Cross, a medal for “extraordinary valour and devotion to duty while facing a hostile force”. Although the Canadian version of the British award was established in 1993, it took us 15 years to decide on the inscription for Canada’s most coveted bravery honour. Regardless of what you think of military service, you can’t argue against showing some gratitude to people who put themselves in harm’s way to save the lives of others.

Back here, there are also people who show exceptional valour in the face of formidable foes and display a disregard for danger to protect the lives of others. I’m thinking of a number of whistle blowers who have sounded alarms on toxic chemicals, dangerous drugs, or environmental threats, people who soldier ahead in obscurity, usually facing scorn and disparagement from the industries they defend us from. There are no medals for their battles.

In my estimation, the academic physicians and pharmacists at UBC called the Therapeutics Initiative are such a group. The TI’s job is to educate B.C. physicians and policymakers on the evidence concerning new drugs—both the benefits and harms. In the past 14 years, their assessments of pharmaceuticals have likely saved more lives than almost anyone currently wearing a medal in the Canadian Forces. I say that with some inside knowledge: I have three medals myself—two for peacekeeping, and a Canadian Forces Decoration for 12 years of military service—but, alas, none for bravery.

Funded by the B.C. Ministry of Health, the Therapeutics Initiative has sometimes been a lifesaver to frontline clinicians who are at risk of drowning in a sea of pharma spin. Its recommendations for caution and safety regarding the use of new drugs are consistently shown to be prudent. Yet the thanks it gets is more like a cross-examination by Victoria politicians, the pharmaceutical industry, and their surrogates than a medal.

At about the time the new Victoria Cross was launched, the Therapeutics Initiative was being torpedoed by the provincial government’s endorsement of its own Pharmaceutical Task Force report. To the surprise of those of us who watch such things, Minister of Health George Abbott said he “accepted” all 12 recommendations of the task force, including one that advised the Liberals to consider the TI’s “replacement”.

Can he be serious? This nine-member task force—which had a mandate to find ways to “maximize value” for patients and money and to “improve the pharmaceutical approval process”—included the top Canadian lobbyist for industry association Canada’s Research-Based Pharmaceutical Companies (Rx&;D), plus five other people with ties to the drug industry. Established in November 2007, the task force spent four months doing its work, consulting almost exclusively with drug-industry-friendly groups, including two major “patient” groups in Canada that are known to work on pharma’s dime.

Imagine the uproar if the government established an environmental task force at the urging of big U.S. oil companies, stacked it with their top lobbyists, and then had its environment minister accept all its recommendations. York University professor and MD Joel Lexchin, probably the most knowledgeable drug-policy researcher in Canada, scoffed at the task force’s report in an e-mail: “Why did they bother with a task force? They could just have asked Rx&D to write the report. It would have been quicker and less expensive. What a pile of horse manure.”

Facing criticism in the legislature, Abbott later relented somewhat. According to Hansard, he told the house: “We are endorsing all 12 of the recommendations, so if the decision is to maintain Therapeutics Initiative, it will be maintained in an enhanced form that does speak to the issues of inclusiveness—that is, the expanded registry of qualified scientists who can deal with this and having additional transparency around the evidence base for the decisions that it makes.”

This is code for allowing the drug companies to put their own people on B.C.’s drug-review committees—an idea that will please big pharma but should make the rest of us fear the pharmacy even more.

The task force leaves us with a report that is singularly unhelpful: an opinion-based review of an evidence-based organization. They didn’t even attempt to estimate the number of lives saved by the Therapeutics Initiative.

Let’s consider one example of the TI’s lifesaving prowess. Back in 2001-02, the Therapeutics Initiative looked closely at both published and unpublished studies of Vioxx and Celebrex, the first of a new class of anti-inflammatory drugs called COX-2 inhibitors. Its researchers dug through the website of the U.S. Food and Drug Administration to find unpublished trial results that indicated the COX-2 inhibitors were associated with an increase in serious adverse events. The TI concluded that the published trials of these two drugs did not include the full serious-adverse-event data and, hence, the conclusions were misleading to physicians, who were only getting half the story. Thankfully, BC PharmaCare brought in coverage policies that were very restrictive, whereas Ontario and Quebec covered COX-2s with few or no restrictions. As a result, according to a study comparing B.C. and Ontario, COX-2 use was much lower in B.C. After Vioxx was withdrawn because of its association with higher rates of heart attacks and strokes compared to similar drugs, scientists estimated that B.C.’s cautious prescribing and coverage policy likely saved about 500 lives.

Those who show undue gallantry in saving the lives of fellow Canadians when threatened by foreign forces surely deserve medals for bravery. Wouldn’t it be great if health ministers similarly awarded medals for health-care excellence? The Canadian Victoria Cross reads “Pro Valore”, meaning “For Valour”, and the inscription on my peacekeeping medal for serving in Cambodia reads: “In the Service of Peace”. For protecting us from the COX-2 fiasco, the Therapeutics Initiative’s medal should state: “For Saving the Lives of 500 British Columbians”.

And that’s only one class of new drugs. There have been many battles fought, and there will be many more campaigns. New drugs are mostly widely marketed before their long-term benefits and harms are known, and many people die needlessly.

We need the TI for our own safety.

Alan Cassels is a drug-policy researcher affiliated with the University of Victoria’s School of Health Information Sciences.

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