Major flaws found in drug approvals, says York study

Health Canada’s approach to drug regulation puts too much emphasis on speeding up drug approvals and too little on following the safety profile of drugs once they hit the market, according to a new report, written by York Professor Dr. Joel Lexchin, that criticizes drug regulation in Canada, wrote The Canadian Press April 21.

The report, published by the Canadian Centre for Policy Alternatives, also suggests the law governing drug licensing offers too few tools to the regulatory agency. As a result, it said, Health Canada cannot compel a manufacturer to undertake additional safety studies after a drug has been approved or demand that it alter safety labels on a product.

"I think that there are a lot of well-meaning people within Health Canada who are trying to do a good job. But I think that at the political level, there is not the will to directly confront the drug companies by making changes that would really make a difference," Dr. Lexchin, author of the report and a longtime critic of the pharmaceutical industry, said in an interview.

The report, titled "Drug Safety and Health Canada: Going, Going… Gone?", suggests the public’s health may be put at risk by a policy aimed at speeding up drug approvals. It also said Health Canada has no way of gauging whether safety concerns it raises – through so-called "Dear Doctor" letters or in statements to the public – have the desired effect.

Lexchin, who has long advocated for more openness in the sphere of drug regulation, criticized the department for treating too much of the data submitted by drug companies as proprietary information. "Within the Canadian drug regulatory system, democratic values such as openness, safety and objective information have been ignored as Health Canada consciously opts instead for a drug regulatory system that reflects the interests of private industry," wrote Lexchin, who teaches in York’s School of Health Policy & Management, Faculty of Health.

Senior Health Canada officials acknowledged some of the shortcomings Lexchin highlighted in his piece, but strongly rebutted a number of others.

Dr. Supriya Sharma, director general of the Therapeutic Products Directorate, said she took offence at the implication in Lexchin’s article that "for whatever reason we would lower standards in favour of a drug company."

Sharma also refuted a suggestion in the report that her division’s funding levels are affected if drug applications aren’t processed within an established time frame.

Dr. Marc Berthiaume, director of the Marketed Pharmaceutical and Medical Devices Bureau, said Lexchin’s figures are out of date when he suggested resources devoted to drug approvals vastly outweigh those directed towards monitoring the safety of drugs once they hit the market. Staffing levels and resources devoted to post–approval safety monitoring have been tripled over the past couple of years, Berthiaume said.

  • A critic of the pharmaceutical industry says Health Canada’s approach to drug regulation puts too much emphasis on speeding up drug approvals and too little on following the safety profile of drugs once they hit the market, wrote The Edmonton Sun April 21.

Dr. Joel Lexchin also says the Food and Drugs Act doesn’t give Health Canada enough tools to deal with safety concerns that arise once drugs are approved for sale in this country. Lexchin, who teaches at York University in Toronto, says Health Canada can’t make a drug company recall medications from store shelves or compel a company to change the safety labelling on an approved drug.

  • Pharmaceutical industry critic Dr. Joel Lexchin said Health Canada’s approach to drug regulation puts too much emphasis on speeding up drug approvals and not enough on checking the safety of drugs already on the market, wrote CBC News April 20 in a story about efforts by Conservative MP Terence Young to introduce legislation for a new drug safety agency. Young’s daughter, Vanessa, died in a hospital in Hamilton in March 2000 and he believes a medication called Prepulsid or cisapride prescribed by their family doctor contributed to her death.

Health Canada said Lexchin’s critique doesn’t take into account the department’s recent efforts to track drug safety after a product has been approved.

Tim Hortons takes heat over Tori

Two residents involved in the search for eight-year-old Tori Stafford say they were shocked to learn that Tim Hortons – a pillar in virtually every Canadian community – would not adopt a provincewide campaign to help find Stafford by posting notices in their store windows, wrote the Toronto Star April 21. [The company eventually did allow posters in the windows of stores in southwest Ontario near where the girl went missing.]

Ashwin Joshi, professor of marketing and director of the MBA program at York University’s Schulich School of Business, says this was a classic case of policy not working on the ground level. "One of the things Tim Hortons does is involve itself in the community. They give money to local hockey teams, for instance," he said. "You can’t have it both ways: To kind of involve itself in the community when it chooses and stand apart from the community when the community is in grief."

Firefighter heart transplant patient tested using York evaluation

Vernon firefighter Brian Parsons underwent heart transplant surgery on Feb. 22, 2008, so his recovery and return to full firefighting duties is nothing short of remarkable, wrote Vernon, BC’s The Daily Courier April 21. The International Association of Firefighters said Parsons is only the second firefighter in North America to come back to frontline firefighting duties following a heart transplant.

Parsons was required to complete a physical fitness test designed by York University to evaluate firefighters’ abilities to deal with the physical stresses and demands of firefighting. His test results are considered to be outstanding to the amazement of his cardiologist and other medical officials.

Corporate elite settles an old score

Sam Gindin, a former Canadian Auto Workers economist who teaches at York University, argues that public ownership may be the answer in the case of the hundreds of auto supply plants that have been shut down in Ontario (and hundreds more facing imminent closure), wrote columnist Linda McQuag in the Toronto Star April 21. Gindin insists Canada can’t afford to lose this productive capacity and proposes that closed plants be expropriated and turned over to a new public corporation.

These plants could become part of an ambitious government-directed project to convert us to a green economy – building the components for expanded public transit systems, redesigned machinery, appliances, electricity grids.

Such ambitious conversions have happened before. Gindin points out that from 1942 to 1944, GM auto plants were overhauled to enable GM to become the world’s largest producer of naval aircraft. After the war, they were quickly converted back to auto production.

But now, faced with the worst economic crisis since the Depression, we’re led to believe the solution lies not in bold initiatives but in rolling back the gains of the labour movement.

League considers checking out

A major hockey league in north Toronto will vote this summer on an across-the-board ban on bodychecking in all of its divisions, wrote the National Post April 21 in a story that cited a York study and a recent interest in non-contact play as factors in the decision.

A recent study led by York University confirms that hitting is a leading cause of hockey injuries, joining other research that has suggested it either be removed from youth hockey, or introduced later.

York tennis coach cautions eager players to go easy

Getting ready for a summer sport takes more than dusting off the clubs, donning sunglasses and darting for tennis balls: experts say it takes a lot of preparation, wrote The Canadian Press April 20. Michael Mitchell, a coach for York University’s varsity tennis team in Toronto, also says the great ambitions of amateur players can lead to injury on the court. “People will get out there after not playing all winter and start swinging full tilt,” says Mitchell, who recommends all beginner players have a fitness assessment before taking up the sport.

On air

  • James Laxer, political science professor in York’s Atkinson Faculty of Liberal & Professional Studies, spoke about Canada’s history of democracy on Victoria, BC’s C-FAX Radio April 20.
  • Howard Black, adjunct professor at York’s Osgoode Hall Law School, spoke about what happens to virtual property after a person dies, on CBC Radio April 20.