Healthy Skepticism Library item: 6147

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Publication type: news

Mittelstaedt M.
Report reveals flawed drug system
The Globe and Mail 2006 Sep 25
http://www.theglobeandmail.com/servlet/story/LAC.20060925.DRUGS25/TPStory/?query=flawed+drug+system

Full text:

Report reveals flawed drug system
MARTIN MITTELSTAEDT

TORONTO — A new report that calls for a major overhaul of the way prescription drugs are regulated and monitored by the U.S. Food and Drug Administration also has applicability to Health Canada, medical experts say.

The report, released Friday by the Institute of Medicine, part of the National Academy of Sciences in the United States, recommends that consumer alerts be put on the labels of all new drugs for a two-year period. Other recommendations include a mandatory re-evaluation of the safety and efficacy of new drugs within five years of their approval for use.

Neither step is followed by Health Canada, although regulators in Europe have taken such measures to try to reduce risks posed by new drug therapies.

“A lot of the things they speak of are very similar to the situation in Canada. In fact, they are worldwide issues,” said Bob Nakagawa, an assistant deputy minister of health in British Columbia and a member of the Health Council of Canada, a body that monitors the revamping of Canada’s health-care system.

Health Canada says it will examine the report.

“The report’s recommendations will be carefully reviewed to see whether they are applicable to the Canadian context,” said Jirina Vlk, a spokeswoman for Health Canada.

The U.S. report also called for the banning of drug advertisements directed at consumers for the first two years that a medicine is on the market, a moratorium that would allow the drugs to be monitored for the emergence of unanticipated risks. Canada prohibits direct marketing to consumers, but the regulation is not vigorously enforced.

Regulators and health-policy experts are becoming increasingly concerned about weaknesses in the oversight system for new drugs, a problem that was highlighted when Vioxx medication to treat arthritic pain was pulled from pharmacy shelves in 2004 after the discovery that it doubles the risk of heart attack. Before its withdrawal by drug maker Merck & Co. Inc., Vioxx was one of the biggest-selling medications in the world.

Vioxx was originally tested in a clinical trial that focused on gastric bleeding, not heart disease.

The removal of the drug by its manufacturer, rather than through vigilant government action, has led to calls for changing how new medicines are regulated, a process that is similar in the United States and Canada, where Health Canada evaluates and monitors new medicines.

Joel Lexchin, a professor in the School of Health Policy and Management at York University in Toronto, said clinical trials for new drugs often do not discover the full range of possible adverse effects of the medications. These tests are typically done on a relatively small number of people, usually adults between 18-64, who are taking only one medicine.

This means drug reactions on the elderly, children and patients being treated for multiple conditions might not be adequately assessed. “It’s a real crap shoot in terms of figuring out if there will be safety problems in those people,” he said.

Unexpected problems with the safety of drugs are common in Canada. Dr. Lexchin published a research paper last year that estimated that 41 drugs were withdrawn from the Canadian market for possible safety reasons from 1963 to 2004, one of few efforts to measure the magnitude of the problem.

Health Canada rarely takes the high-profile step of ordering a drug off the market, but usually negotiates with manufacturers to reach voluntary deals to end distribution of the product.

Dr. Lexchin said another regulatory weakness in the current drug-testing system is that Health Canada doesn’t have the authority to demand new safety trials once a drug has been approved, and monitors adverse reactions only in a passive way through reports made by doctors.

“I think that there is a recognition in Health Canada that things are not adequate at this point,” Dr. Lexchin said.