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UBC Reports | Vol. 50 | No. 11 | Dec. 2, 2004

Can We Trust the Drug Companies?

The Therapeutics Initiative is working to get reliable data to doctors and patients

By Hilary Thomson

Imagine you are a 75-year-old woman who has been taking a daily drug to relieve arthritis pain. You’re shocked to learn the drug just got pulled off the market worldwide and you wonder if you can trust your doctor to know what’s safe.

With the recall in September 2004 of Vioxx®, a top-selling arthritis pain medication that was found to increase cardiovascular problems, and a U.S. Congressional hearing into how the drug’s safety was evaluated, a UBC initiative dedicated to disseminating evidence about drug therapies couldn’t be more relevant.

Under the direction of Jim Wright, a professor in the departments of pharmacology & therapeutics, and medicine, the Therapeutics Initiative (TI) has been providing physicians and pharmacists with up-to-date evidence on the effectiveness of prescription drugs for 10 years.

In fact, the current issue of the group’s newsletter, Therapeutics Letter, (which has a circulation of 10,000) addresses the storm of uncertainty surrounding the class of drugs called COX-2s. Used to treat inflammation, the class includes Vioxx® and Celebrex®.

The newsletter focuses on COX-2’s product monographs -- legal documents written by drug companies to list pertinent data, including potential benefits and harms. The newsletter reported that the monographs do not adequately inform of harms and that they provide insufficient information as to whether COX-2s increase myocardial infarction or other cardiovascular events.

“We’ve been looking at this class of drugs for several years now,” says Wright, a faculty member since 1977. “Our work nearly always surrounds medications, like these ones, that are widely prescribed but which have uncertain therapeutic value. Our efforts frequently put us at odds with drug companies.”

Started in 1994 with a five-year annual grant of $540,000 from B.C.’s Ministry of Health (MOH), the TI is now operating on a three-year, $1 million per annum grant from MOH. The group reviews evidence of effectiveness for drugs prescribed for everything from male pattern baldness to depression in children and adolescents, and is one of only a handful of such groups in Canada.

In addition to provincial work, TI members also complete one-quarter to one-third of the federal government’s common drug reviews, a year-old process overseen by the Canadian Coordinating Office for Health Technology Assessment.

“The main challenge in our work is getting to the truth,” says Wright. “It’s been estimated that about 90 per cent of the published literature is biased by economic interests.”

Dr. Warren Bell, a general practitioner in Salmon Arm, B.C., says he uses the newsletter “for clarifying and interpreting the relentless propaganda of the drug industry” and adds that he has formed a number of prescribing practices directly out of the pages of the letter.

The largest working group in the TI is the drug assessment group, headed by Ken Bassett, a faculty member in the department of family practice and the Centre for Health Services and Policy Research at UBC.

Some of the 30 assessments completed annually are triggered by new drug submissions to PharmaCare, the province’s drug subsidy program. TI researchers review the submissions, evaluate evidence of the drug’s therapeutic advantage and report back to government and, in a summarized fashion, to practitioners via the newsletter. Physicians and pharmacists also learn of critically appraised evidence through annual drug therapy courses and numerous interactive seminars.

The TI’s evaluation group measures the impact of these education efforts on prescribing patterns and assesses how drugs are being used. It also uses provincial health databases to learn the impact of drug prescribing patterns on patient health outcomes.

A challenge for the group is a perception that the TI may not be independent from the provincial government’s interest in decreasing costs of PharmaCare. Wright counters by saying that TI reviews and reports to government don’t include cost data and are limited to evidence of drug benefits and harms derived from clinical trials. PharmaCare includes TI reports as just one of the pieces of information it uses to make funding decisions, he adds.

Internationally, many TI members are actively involved in the Cochrane Collaboration. Named for Archie Cochrane, a British medical researcher, epidemiologist and advocate of rigorous reviews of health intervention evidence, the collaboration is an international organization dedicated to making available reviews of the effects of health-care treatments and therapies.

Wright says it’s currently not possible for groups like the TI and the Cochrane Collaboration to get complete data from all clinical trials conducted worldwide. However, he does have a vision for greater access to reliable and unbiased data.

“What’s needed is to get more people involved in Cochrane, better access to data from all clinical trials, more systematic reviews published and more countries providing universal free access to the Cochrane resource,” he says.

Many countries, such as Australia, Finland, Ireland and England, make the Cochrane Library’s resources available without charge. In Canada, however, only one province -- Saskatchewan -- has paid for the licence. The federal government has balked at a $500,000 annual fee that would make the library freely accessible to all Canadians, says Wright.

For more information on the TI, visit www.ti.ubc.ca.

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Last reviewed 22-Sep-2006

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