One of the urgent questions to be faced after the provincial election in May is how to rebuild B.C.’s drug-assessment program. For the existing version is well and truly broken.
Before a new drug can be marketed, a licence from Health Canada is required. But the federal government rarely conducts its own tests to ensure the product is safe and effective.
Instead, it relies mainly on trials carried out by the manufacturer. This is an obvious weak point, since pharmaceutical firms have a vested interest in boosting their products. Numerous studies have shown that companies rig drug trials or misreport results to gain licences.
For many years, the provincial government dealt with this problem by funding an independent group of researchers at the University of B.C. The Therapeutics Initiative, as the project is called, conducts followup tests after a drug has been licensed, to see if it performs as advertised.
The group has been credited with saving lives and money by keeping dangerous or overpriced drugs off the shelves. Last week, for instance, it published a study that linked higher-strength cholesterol-reducing drugs to kidney damage. The group’s work has been called “the only source of critical assessment of new treatments in Canada that is not political or partisan.”
That might sound like a compliment. But to drug manufacturers, it’s a call to battle. When the B.C. Liberal party took office in 2001, the industry lobbied strenuously to have the Therapeutics Initiative silenced.
Two years ago, the pressure finally paid off. First, the team’s budget of $1 million was cut in half, leading to staff layoffs.
Then, last September, the remaining funds were frozen. The team hasn’t been paid in six months.
The government linked this latest freeze to concerns that confidential patient files may have been mishandled. Several officials in the health ministry have been fired, and an internal investigation is under way.
This is certainly a serious matter. But what any of it has to do with the Therapeutics Initiative is unclear.
Team members insist they did not receive personalized patient information. The files they get are all stripped of identifying material, such as names, addresses and MSP numbers. This looks more like silencing an inconvenient voice than a legitimate concern about privacy issues.
What, then, is to be done? The government is trying to rebuild the drug-review process around a new council appointed by the health minister.
But this is an invitation to more industry lobbying. Pharmaceutical firms will push to get people appointed who are friendly to their interests.
Even if they are not successful, the council is fatally flawed. Most of the current appointees work for organizations funded by the province. They and their parent agencies are, in that sense, dependent on government goodwill.
But that is a hazardous role. By muzzling the Therapeutics Initiative, the health ministry has already demonstrated what happens to people who cross the pharmaceutical industry.
The only feasible solution is to create a drug-review process that is in every respect independent of government. The best (and easiest) way to do that would be to re-establish the Therapeutics Initiative as a genuinely arms-length agency.
That means giving it a source of funding that cannot be removed at the minister’s whim. Perhaps this could be accomplished through a long-term financial agreement with UBC.
But whatever mechanism is adopted, one thing is clear. Any government that assumes ownership of the drug-review process is putting itself in harm’s way. It will be lobbied to an extent that even the most resolute minister may find daunting.
Ironically, the best way for a new government to deal with this problem is not to own it.
