Healthy Skepticism Library item: 945

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Publication type: news

Goar C.
Is drug watchdog on duty for us?
Toronto Star 2004 Oct 11

Full text:

In the mid ’90s, the World Health Organization released a study warning that certain drugs should not be used to treat acute diarrhea in infants and children.

But youngsters who had taken these medications kept turning up at the emergency department of Toronto’s University Health Network, where Dr. Joel Lexchin worked.
This struck him as odd. He couldn’t fathom why Health Canada was licensing products that were not approved for children by the WHO.

Using the Access to Information Act, Lexchin submitted a request to Health Canada, asking for all studies examining the efficacy of the drugs in question – Donnagel, Imodium, Kaopectate and Lomotil – in treating acute pediatric diarrhea.
He waited 21 months. Finally a package arrived containing five pages of one report on Imodium: the title page, the table of contents, two pages of column headings with all the data removed and an empty statistical table.

That launched Lexchin on a four-year investigation into the way Ottawa regulates drugs. His findings, which have just been released by the Canadian Centre for Policy Alternatives, are deeply worrisome. They show that clinical information about the safety and effectiveness of new drugs approved by Health Canada is routinely withheld, not only from the general public, but from doctors and researchers as well.

They show that this secrecy stems from the financial dependence of the Therapeutic Products Directorate, the arm of Health Canada that tests and approves new drugs, on the pharmaceutical industry. They show that Canada’s Access to Information Act is virtually useless in obtaining information about new drugs because it allows public officials to hold back “any record requested under this act that contains financial, commercial, scientific or technical information that is confidential information supplied to a government institution by a third party.” And they how show that four federal attempts to make the drug approval process more transparent have failed or been shelved in the last nine years. “There are valid reasons to protect manufacturing secrets,” Lexchin acknowledges.

“But when it comes to data relating to health and safety, there is no good evidence to show that the interests of (pharmaceutical) companies would be harmed by such disclosure.”
Ottawa’s symbiotic relationship with the brand-name drug manufacturers can be traced back to the deficit-cutting drive of the mid ’90s.

Health Canada, struggling to do more with less, introduced what it called a “cost recovery” model. It started charging pharmaceutical companies user fees to get new drugs approved.
The industry now pays approximately half the cost of operating the Therapeutic Products Directorate (about $35 million out of $70 million.) This, according to Lexchin, allows the drugmakers to call the shots about how much information is made public.

It is in their interest to disclose as little as possible, particularly if there is a problem with one of their products, if they are introducing a drug that has not been extensively tested or if a new medication is found to be no more effective than existing ones.
“When new drugs come onto the Canadian market, the amount of published material is often grossly inadequate to allow physicians to make rational prescribing decisions and consumers to make informed choices,” Lexchin says.

Fortunately, there are other sources of information. The U.S. Food and Drug Administration releases an approval package consisting of a detailed outline of the information submitted by a drug manufacturer plus its own analysis, when it authorizes a new medication. The World Health Organization issues regular bulletins. And various medical journals publish studies on the safety and effectiveness of drugs.
But Lexchin argues that Canada cannot afford to be a free rider. Drug companies sometimes introduce products here before putting them on the U.S. market, he says. Moreover, the medications they submit for approval may not be identical to those sold south of the border.

In a deeper sense, he says, Canadians have a right to look to their own government to protect them against unsafe or ineffective products.
Lexchin is calling for three reforms.

First, he would like to see the Therapeutic Products Directorate break free of its financial dependence on the drug industry. The $35 million cost would be money well spent, he contends.
Next, he would like to see Canada match the U.S. standard of disclosure of clinical information about newly approved drugs.

Finally, he thinks Ottawa should open up the drug approval process to outside medical experts and informed members of the public.
Lexchin is not optimistic. He has been battling the pharmaceutical giants for more than 20 years. His victories have been infrequent and small.

As for the antidiarrheal drugs that triggered his concern, most of them are still on the market. Health Canada does not require any warning that they should not be used for children. Lexchin has no idea when – or whether – the problem will be fixed.