Tuesday, January 20, 2015

Health Canada Fails Us Yet Again

On this blog I have frequently extolled the fine investigative journalism practised by The Toronto Star. Whether on issues of municipal, provincial, or federal significance, The Star, as it frequently proclaims, "gets action."

From the standpoint of average Canadians, probably one of its most important investigations in recent times has been into Health Canada and its all too cozy relationship with the pharmaceutical industry, an industry protectorate seems to treat more as an equal than as an activity to be regulated. its relationship with the generic company Apotex is especially troubling.

Despite previous avowals by Health Minister Rona Ambrose that things would improve, it seems that business as usual prevails at Apotex. Yesterday, The Star reported that problems have again been uncovered, this time at its Brantford palant, information that, as in the past, comes not from Health Canada, but the U.S. Food and Drug Administration:
At the Brantford facility in November, FDA inspectors found the company launched an internal review in 2013 to ensure it was effectively cleaning the equipment used to make drug products. Three swab tests of the equipment found unacceptable levels of contamination.

But Apotex shelved its internal review “until (an) effective cleaning procedure is developed,” according to an Apotex memo reviewed by FDA inspectors.

Then, in September 2014, the company made multiple batches “using the same equipment cleaning methods that failed the cleaning validation,” FDA inspectors found.

The company then released the drug products “based on a less stringent” quality-control requirement.
What were the possible contaminants?
An industry expert said the most common contamination from improperly cleaned equipment would be bacteria or trace amounts of another drug or antibiotic made using the same machines.
So where was Health Canada in all of this?

The agency, which had conducted its own inspection in July with similar discoveries, tagged along with the FDA in its November inspection. But that's where common ground diverges. While the FDA made the result of the inspection publicly available, Health Canada says it is still finalizing the report from its July inspection.

A hard-hitting editorial in today's Star makes it abundantly clear that this kind of cavalier foot-dragging is unacceptable:
That’s not good enough. It’s January and drugs that could possibly be contaminated are on the market.

Health Canada must move a lot more quickly to ensure consumer safety. And it clearly needs to take a much more rigorous look into Apotex’s manufacturing practices. The company has a long history of safety issues at its plants.
The editorial ends with sentiments that few Canadians could disagree with:
In the end, consumers are dependent on Health Canada — not the FDA — to ensure that drugs on the Canadian market are safe and effective. Health Canada should immediately identify the drugs in question and issue its report on Apotex’s Brantford plant. And it needs to have a good hard look at all of Apotex’s manufacturing practices.

Consumer safety is at stake.
That, strangely enough, does not seem to be a priority with Health Canada.

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