Too many drugs allowed on market: MP
A Tory MP who has led a decade-long crusade against Health Canada's prescription drug safety protocols says Canadian lives are at stake during the agency's closed-door talks this week aimed at updating the Food and Drugs Act.
Terence Young, who is one of several people taking part in Health Canada's three days of consultations that began Wednesday, told CBC News he believes the agency is putting lives at risk by approving too many drugs too quickly.
He used his daughter's death 10 years ago as an example.
Health Canada has invited individuals representing stakeholder groups and institutions — including drug companies, patients' groups, physicians, pharmacists and others — to discuss how the agency reviews drugs, approves them and monitors safety once doctors begin prescribing the medication to their patients.
Young, who represents the Ontario riding of Oakville, said he will keep pushing for the creation of an independent drug safety agency, instead of depending on Health Canada, which he said views its role now as "helping the pharmaceutical companies market drugs."
People on all sides of the safety debate, including Health Minister Leona Aglukkaq, agree that the 50-year-old drug law is too old.
"There is a lot of legislation that is outdated," said Aglukkak, in response to a question from CBC News during a news conference Tuesday on measures to improve safety standards for toys.
"[The talks are] about protecting the health and safety of Canadians. The consultation process will always be a part of that and I would encourage Canadians who have concerns with these issues to bring forward those comments."
The fight of his life
In March 2000, Young's 15-year-old daughter Vanessa collapsed at their Oakville home and was rushed to hospital by ambulance. She had been taking a stomach medication called Prepulsid. Vanessa died from a condition that led to heart failure.
The company that marketed the drug at the time was called Janssen-Ortho. It refused to accept blame when questioned by reporters after the coroner's verdict. Witnesses at the inquest testified that the drug was dangerous. Prepulsid was pulled from the market in Canada in August 2000.
Young insisted Vanessa didn't have an eating disorder, but evidence at the coroner's inquest suggested otherwise. The coronor's jury found that Prepulsid, in conjunction with Bulimia, caused Vanessa's death.
Since that inquest, Young has been on a mission to raise public awareness about drug safety, which is one of the reasons the Conservative MP ended up in federal politics.
"It saddens me a great deal to realize that I haven't been able to make a very significant difference," said Young, who has also written a book about his daughter's death and some of the weaknesses he sees in the country's drug-approval process.
He said Health Canada has become beholden to the drug industry, in large part because companies pay fees to the department to have their products reviewed.
"These are very powerful economic forces," he said. "The pharmaceutical industry is one of the top three wealthiest industries in the world. And they're extremely influential."
However, Norman LaBerge, who speaks for an industry lobby group that goes by the acronym Rx&D, told CBC News the fees don't seem to be having an impact on service from the department.
An application to Health Canada currently takes about 545 days on average to be reviewed, LaBerge said. The performance target of Health Canada is 300 days.
"So if you have drugs that would save lives that are stuck in bureaucracy for a year and a half, you will have people dying of a disease needlessly," he said. "This is undue delay in terms of doing the review, which is costing in terms of real life and quality of life issues in the population."
Critics of the pharmaceutical industry dispute the companies' claims that they are trying to save lives. They say many products coming to the market are so-called "me-too" drugs — drugs used to treat non-life-threatening conditions — a view that is partially backed up from a careful review of Health Canada's database that tracks new drug submissions.
When pressed, LaBerge conceded that many drugs coming to market may not be considered life-savers, but argued the kind of drug isn't relevant.
"Some of the drugs are breakthroughs and the review process is applicable to all drugs," he said. " What is relevant is, are we doing what needs to be done to make sure that the safety profile and efficacy profile is satisfactory before we permit the sales in Canada?"
LaBerge said delays would be reduced if Health Canada worked with regulatory agencies in the United States and other countries when reviewing the drugs.
The official name for such co-operation is "harmonization" and it's one of the many areas Health Canada is discussing with Rx&D and others, including physician Joel Lexchin, who teaches health policy at York University in Toronto.
"The take-away message for the public is that there's nothing wrong with trying to co-operate with other agencies to share information," said Lexchin, who also works in an emergency department at a teaching hospital in Toronto and is, by his own admission, one of Health Canada's fiercest critics.
"But it has to be done in a way that doesn't compromise safety," he said.
If Health Canada depends on reviewers from other agencies, such as the U.S. Food and Drug Administration, it could lead to it conducting less independent analysis based on the work of its own scientists, Lexchin said.
But LaBerge argued that, if anything, a harmonized review would be more efficient because all the regulatory agencies will review the same safety data that companies must submit to all of them before their products are approved.
Talks won't compromise safety: Health Canada
David Lee, director of the office of legislative and regulatory modernization in the branch of Health Canada that deals with drug safety, insists safety is not being compromised.
Lee said these consultations are the latest in a number of talks the agency has been hosting before it drafts new regulations that will become part of a more robust food and drug safety law.
"We're trying to reflect a [drug approval] standard that is more responsible and transparent in terms of saying that there are risks with drugs, alongside the benefits," Lee said.
Although Health Canada has been holding these talks for a number of years, there is evidence the government may be closer to updating its drug safety law now than ever before.
Aglukkaq pointed to the government's update of the 40-year-old Hazardous Product Act in December with the Canadian Consumer Product Safety Act.
"We also know that the Food and Drugs Act needs to be reviewed and updated on a regular basis," the health minister said.
Young said he senses goodwill on the part of his minister, the government and opposition parties to improve the law — a process he calls "non-partisan."
Still, he said, he can't help wondering whether the effort will fall short of offering a protection that could have saved his daughter's life, as well as the lives of the thousands of Canadians who die every year from an adverse drug reaction.
"Nothing has changed in the 10 years since Vanessa died," he said.