Health Canada needs to show backbone with drug companies

Posted on September 21, 2014 in Health Delivery System

TheStar.com – Opinion/Editorials – Faced with a drug company refusing to stop importing suspect drug ingredients, Health Canada simply backed down.
Sep 21 2014.   Editorial

Is Health Canada on the side of drug companies or Canadians?

That’s a question raised once again by the latest revelation about how the department deals — or fails to deal — with pharmaceutical companies.

This time we learn that when Toronto drug company Apotex Inc. was asked by Health Canada to stop importing suspect drug ingredients from one of its troubled manufacturing plants in India, it simply refused.

In response to such flagrant disobedience the department did not take Apotex to court or suspend its licence — which would have temporarily shut down its plants — even though it has the power to do both of those things, according to Amir Attaran, a University of Ottawa law professor who researches drug policy.

Instead, as Star reporters Jesse McLean and David Bruser revealed in Friday’s Star, Health Canada chose to back off when the company agreed to do additional quality testing on products from the Bangalore facility.
Worse, for two months the department refused to make public the drugs that were being made with the suspect ingredients — leaving them in Canada’s pharmacies and hospitals.

Health Canada – whose job is to protect consumers — is putting Canadians’ health at risk with its secrecy and overly cozy relationship with the pharmaceutical giants. Its actions, says Attaran, are “feeble, inadequate and incompetent.”

The department’s excuse for not taking action against Apotex?

It determined it was more productive to work with the company “to quickly determine steps to ensure the safety of its products,” rather than engage in lengthy court proceedings.

Contrast that weak-kneed response to that of the U.S. Food and Drug Administration, which simply barred the importation of all but one product from the plant after its inspectors found that Apotex staff had manipulated data, retested samples until they got favourable results, and destroyed records.

“This proves Health Canada is on the side of drug companies, not Canadians,” says Attaran.

For its part Apotex says the company has updated procedures “to ensure all our products remain safe, effective and of the highest quality.”

The latest revelations are not isolated.

Two weeks ago McLean and Bruser reported that some Canadian pharmaceutical companies sold drugs they knew were defective. In that case, Health Canada refused to give out information on the drugs. Instead the reporters had to obtain it from the FDA’s publicly available inspections.

Then this past week the two reported on a pattern of secrecy where Canadian doctors failed to report serious side effects suffered by their test subjects in drug trials. Again, Health Canada does not publicly report details on the inspections that revealed the failures, though the FDA does.

Finally, last June, the two reported on the dangers of doctors prescribing “off-label” drugs — ones given for a reason other than their intended purpose. Though the practice can be extremely dangerous, Health Canada hadn’t made six years of its findings on the practice public. The FDA, of course, had.

Faced with attacks in the House of Commons on its inaction and secrecy this week, Health Minister Rona Ambrose promised the government would post more of its pharmaceutical company inspections online.
It’s a long overdue first step — if it happens — and one that should be accompanied by a much stronger oversight of pharmaceutical companies.

< http://www.thestar.com/opinion/editorials/2014/09/21/health_canada_needs_to_show_backbone_with_drug_companies_editorial.html >

Tags: , , , ,

This entry was posted on Sunday, September 21st, 2014 at 10:39 am and is filed under Health Delivery System. You can follow any responses to this entry through the RSS 2.0 feed. You can skip to the end and leave a response. Pinging is currently not allowed.

Leave a Reply