Healthy Skepticism Library item: 211

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Publication type: news

Munro , M .
UBC broke drug-trial rules for years, documents show
CanWest News Service 2004 Feb 25

Full text:

UBC Hospital was among research centres reviewed.

The University of B.C. for years broke federal ethics rules and failed to warn patients of all the dangers and side-effects associated with its medical experiments and drug trials, CanWest News Service has learned.

Federal officials were so concerned about the breach, which was not fully resolved until late last year, they threatened to freeze funding and suspend patient enrolment for many of the affected projects at UBC and its affiliated hospitals, according to documents obtained in response to an Access to Information request.

In all, 523 projects, funded variously by industry, non-profit agencies and Canadian and U.S. government agencies, and involving treatments for everything from dementia to cancer, were not properly approved before they went ahead.

The federal agencies now say they are satisfied that UBC “recognized the significance of the breach,” and in the end no trials — most of them in the faculty of medicine — were shut down.

But officials at the Canadian Institutes of Health Research (CIHR) and the Natural Sciences and Engineering Research Council (NSERC), the country’s two largest research-funding agencies, were so concerned when they learned of the problem they threatened to freeze funding for the 44 projects they were financing if UBC did not respond to their concerns “within two weeks.”

Meanwhile, Health Canada was pressing UBC to quickly review projects involving new drugs, most of which were industry funded.

“Should this review not be conducted, Health Canada will be required to contact clinical trial sponsors to stop further enrolment in the approved trials at the UBC clinical trial site,” Dr. Robert Peterson, a Health Canada official, told UBC on May 21, 2002. He gave the university six weeks to complete the reviews.

UBC had discovered a year earlier, in May 2001, its research ethics board had been cutting corners for years, but did not notify Ottawa for 10 months.

The board, which must approve projects before they can start, tended to only look at brief project summaries.

The practice violated federal rules that say ethics boards must review detailed project protocols, which can run for more than 100 pages. The protocols are considered key because they often reveal problems with experiments and risks for patients.

Dr. Indira Samarasekera, UBC vice-president of research, said in a recent interview the university acted quickly once the problem was discovered. It revamped its ethics review process and dug out the full protocols to determine if any risks had been missed.

She says she waited 10 months to inform then- health minister Anne McLellan because it took time to determine how many projects had not been properly reviewed.

Federal officials didn’t buy it.

“Although I acknowledge that the workload must have been huge, the argument for not informing us earlier is not convincing,” NSERC official Isabelle Blain wrote in an e-mail to colleagues at CIHR shortly after Samarasekera informed McLellan of the breach.

Samarasekera says in the end only 399 trials needed to be re-reviewed for risks — “side-effects like a headache or a rash,” she said. No studies had to be cancelled. But consent forms needed to be amended in 37 studies. In only two cases did patients have to be “reconsented,” says Samarasekera, who said she did not know the specifics of the two cases.

Of the 399 projects re-reviewed, 215 were deemed to have “potential ethical issues.” The most common problem, found in 126 studies, was “missed risks.”

Most of the studies were no longer enrolling patients, so in only 37 cases did consent forms have to be amended.

Seventeen studies had potential long-term risks — “cancer etc.” — that might occur even after the intervention had stopped. UBC’s re-review committee decided that in only two studies did patients need to be asked to sign a revised consent form.

In one study, which appears to have been an experimental cancer treatment, patients had not been told the drug might cause “some forms of cancer.” In another study, patients were not told an experimental drug had the “potential to produce fertility problems.”

Samarasekera’s March 7, 2002, letter to McLellan generated a blizzard of paper in Ottawa, as officials at Health Canada, the CIHR and NSERC tried to decide what do about the “most serious” breach.

Officials at the research councils seemed dismayed at the approach taken by UBC, which receives more than $300 million worth of research grants each year, much of it from federal agencies and industry.

“You learned of the noncompliance issue in late August 2001. Why did you not inform us until March 2002?” CIHR and NSERC officials asked in a letter sent to UBC shortly after they learned of the problem.

They added: “Have you considered informing the subjects involved in the trials? If not, why not?”

The federal documents also raise serious questions about UBC’s re-review.

They show UBC was in such a hurry to try to fix things it continued to break federal rules until Nov. 1, 2001, six months after the problem was discovered.

This is because UBC failed to include two people “with broad relevant research experience” on the ethics board that reviewed the projects, as required by federal regulations.