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.

A Possible Soution To Health Canada's Willful Impotence

Yesterday I wrote about the fact that Health Canada has 'convinced' (not ordered) Apotex to stop importing drugs from one of its suspect plants in Bangalore, India. The agency's (and Health Minister Rona Ambrose's) ongoing timid relationship with pharmaceuticals at the expense of our health and safety suggests stronger measures are needed

Writing in The Star, Amir Attaran thinks he might have a solution to this sorry state of affairs. The professor in the Faculty of Law and faculty of Medicine at the University of Ottawa asks,

should we reduce, or nearly abolish, Health Canada’s drug regulatory functions? Could we be safer by trusting in the decisions of larger, better-funded, foreign drug regulators instead of little lame Health Canada?

He looks to Europe for a model:

The 28 countries of the European Union, many of them quite small, long ago decided that it is expensive, inefficient and sometimes dangerously ineffective for each country to have its own drug regulator. Nowadays, most of them have delegated large parts of their drug regulatory functions to an EU-wide organization, the European Medicines Agency.

Attaran is not optimistic that Canada will likely follow suit with a similar co-operative venture:

Here, the Harper government’s asphyxiating control of government scientists and almost childish pride in Canadian sovereignty mean that Health Canada minimally co-operates with America’s FDA just next door. This is dumb: the FDA is more transparent, better resourced and scientifically better equipped than Health Canada will ever be.

He goes on to offer a picture of the FDA's ruthless effectiveness in interdicting suspect drugs:

Consider the case of Ranbaxy, a pharmaceutical company from India. Last year, the FDA successfully prosecuted Ranbaxy for manufacturing adulterated drugs and misleading it with false, fictitious and fraudulent drug testing data — crimes for which Ranbaxy paid $500 million (U.S.) in criminal and civil penalties.

Contrast that decisiveness with Health Canada's feckless dealings with the same company:

Even though former Ranbaxy executives say they are “confident there were problems” with drugs sold here, after the criminal conviction Health Canada refused to ban Ranbaxy’s factories, and instead negotiated with the company to voluntarily pull a few of its medicines off the market for testing; Health Canada won’t say which ones.

According to Attaran, the main reason for this gross disparity of response is not legal, but cultural,

namely the indolent, lapdog attitude of ministers like Ambrose and the public servants at Health Canada, who seem to lack any understanding of how governments should regulate.

Because they refuse to learn from the best practices of bodies like the FDA and the European Medicines Agency, he concludes that

we should in part abolish Health Canada and harmonize our drug regulation with those foreign agencies that are more competent than our own government.

While that might strike many as too drastic a solution, it is clear that major changes are needed if we are to be protected from corrupt and venal pharmaceutical companies that place their profits and their shareholders above the health and safety of Canadians.

Health Canada's Willful Impotence on Tainted Pharmaceuticals

As I have written previously, the scandal of tainted pharmaceuticals continues, and that which should provoke outrage and demands for accountability seems to elicit for the most part only shrugs and mild interest. And were it not for the Toronto Star's ongoing quest, most of us would be totally unaware of the threats to our health that are aided and abetted by Health Canada and Health Minister Rona Ambrose, thanks to a larger media, including the CBC, that have given the scandal absolutely no coverage.

Despite the investigative series conducted by the paper and an excoriating editorial, the only action thus far taken by Health Minister Rona Ambrose and her recalcitrant department has been to 'convince' (not order) Apotex to

stop distribution to Canadian retailers of what Health Minister Rona Ambrose described as “all products” manufactured at one of Apotex’s factories in Bangalore, India.

“The quarantine will allow the department time to verify that products from this facility meet Canadian safety and quality requirements,” Health Canada said in a short release.

I guess that is progress of sorts, since the last time Health Canada made such a request, Apotex refused. However, it is an anemic response given that when the issue first arose, the FDA banned the suspect drugs from entering the U.S.

However, even in Health Canada's putative victory with Apotex, there is less here than meets the eye, as is typical of the Harper regime:

Health Canada has not told the public what drugs are affected by this quarantine.

So even though many Canadians will have been taking these suspect and tainted drugs, they are not permitted to know which ones they are. Undoubtedly, as has been previously discussed, in the warped of Ambrose and her department, that information is considered commercially confidential.

In my next post, I'll discuss a possible way around the protective wall of silence erected by Health Canada to protect the pharmaceutical industry.

Star Readers Respond To Health Canada's Fecklessness

While "Let them swallow tainted pharmaceuticals" seems to be the motto of both Health Minister Rona Ambrose and Health Canada, always-vigilant Star readers take issue with such deference to the corporate agenda. Here is just a small sampling of their reactions:

Good thing we have the FDA and the Star to look after our best interests with regards to clinical drug trials. Health Canada appears to just run diversion tactics for the medical profession and big pharma.

Richard Kadziewicz, Scarborough

I really appreciate all of the hard work that David Bruser and Jesse McLean are doing to enlighten and inform us about the irresponsible practices of Health Canada. I’m sure it has been next to impossible to obtain salient information from the government organization that is in place to supposedly protect its citizens but instead have to rely on the FDA.

It begs the question as to why. Are they under-staffed or are they protecting the corporations known as Big Pharma? Like the majority of Canadians I resent and abhor that the products we consume are being produced offshore with apparently little or no quality control. At our peril, the corporations’ only consideration is profit. The eroding job market and our health is of little consequence when their insatiable greed is paramount. It’s obscene.

As a citizen, I don’t know how we fight for accountability. Health Canada exists because of our taxes, this practice is unacceptable. Or are the corporations really the body governing our country?

Vivien C. Buckley, Burlington

Looking at the failure of Health Canada to inform Canadians of the shortcomings of part of our pharmaceutical industry, one comes to two conclusions about Health Canada: it was putting the health of Canadians at risk; and it might as well not have done their regulatory work at all. Exactly the same might be said of the Canadian government agency in charge of inspecting meat processing plants.

How about the work of government scientists studying forestry, fisheries, climate, water quality, economics, environment, national statistics, etc? The Harper government appears to have suggested that their work was solely to inform cabinet decisions. If so, that may explain why the “Harpies” do not allow government scientists to speak publicly about their work.

From my point of view, the tax-cutting Tories would be well advised to close all our scientific establishments. Since they largely ignore the scientific work available to them, and will not let the public see the results either, why do it at all?

Clearly, one should never let the facts trump a good ideology.

Peter Bursztyn, Barrie

The Star has informed its readers of the incompetence by Health Canada in keeping the results of their investigations into pharmaceutical companies a secret from the taxpayers they work for.

Health Canada has become another whore in the Harper government, playing along with again a secret policy of giving information to the public only if it is of benefit to federal government.
......

When the next Prime Minister replaces this dictatorship after the next election, I hope that he would fire every single manager at Health Canada, no matter what the management rank is, and replace them with contractors hired from the FDA. It seems that only then will we get what we are paying for.

Robert Knight, Toronto

As well, the Star has an editorial in today's issue that offers a good overview of this scandalous issue.

More On Health Canada's Depraved Indifference

I entitled yesterday's post "All Canadians Should Be Outraged." Now I somehow doubt that all Canadians will get the chance, outside of those who read The Star. To my knowledge, no other news organization nor political party has weighed in on the issue of the secrecy practiced by Health Canada, secrecy that could cost people their lives. Given the potential of the issue to affect all of us, I find that deeply disappointing.

Nonetheless, today's Star editorial continues with the paper's quest for accountability.

Entitled End secrecy around prescription drugs: Health Canada needs to clean up its shameful cult of institutional secrecy and make findings public as the American Food and Drug agency does, the piece sums up the dangers lurking in our midst in just a few short sentences:

It’s a prescription for disaster.

Some Canadian pharmaceutical companies have sold drugs they knew were defective — putting patients at possible risk.

Others have hidden, altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe, or not reported side-effects suffered by consumers taking their drugs.

That’s scary enough.

But more worrisome is this: Star reporters David Bruser and Jesse McLean could not get this information from Health Canada. Instead, they had to rely on detailed notes from the American Food and Drug Administration’s inspections of Canadian companies.

That’s because in addition to conducting inspections of Canadian prescription drug manufacturing facilities around the world, the FDA also makes its findings available on its website for public scrutiny.

And it once more addresses what I found one of the most disturbing aspects uncovered in its investigation:

Health Canada also said it would take months to decide whether it would release information about 30 drug inspections the FDA had conducted on Canadian company manufacturing sites that had resulted in objectionable findings.

In some cases, it said, it would have to consult with the inspected Canadian drug companies before publicly disclosing the information.

Pardon?

Canadian taxpayers, who pay for Health Canada inspections, don’t have the right to know the results — without the approval of the self-interested pharmaceutical companies? Or even be reassured that the drugs they are taking are safely manufactured, as American consumers can easily confirm?

That attitude is shameful and dangerous.

I blame the Harper regime for setting the tone at Health Canada. The culture of secrecy embraced and promoted by this government, having permeated the bureaucracy, coupled with the elevation of business interests over those of citizens, means all Canadians are being needlessly put at risk.

Citizens are only as powerful as the information they have access to. If you didn't read yesterday's Star exposé, I urge you to do so, and send a link to as many people as you know.

None of us can afford to simply dismiss this as just another sad testament to the decline in care and service we have all been witness and victim to under the current regime.

All Canadians Should Be Outraged

Yesterday I wrote a post on the perspective that age bestows, my point being that the longer one lives, the greater the potential ability to critically evaluate everything that happens. Despite having seen many things during my life, however, I have to confess that didn't prevent me from feeling deep outrage, disgust, and perhaps even mild shock at what I read on the front page of this morning's Toronto Star. It is a story that, in the old days, would have led to howls of outrage from the people, demands for real accountability, and ministerial resignation.

Yet I fear none of that will happen.

The story, resulting from a Star investigation (one of the many reasons I subscribe to the paper), reveals that Health Canada has been purposely hiding from the public the fact that many of the drugs Canadians take are unfit for consumption. These drugs, manufactured both in Canada and abroad, have been rejected for sale by the U.S. FDA because of doctored data, contaminants found at the manufacturing sites and in the drugs, and side effects.

And the worst appears to be that Health Canada has essentially been colluding with the Canadian pharmaceutical companies who have been selling these medicines with knowledge that their products were defective.

Here are but a few of the shocking facts, based on the inspection reports, not of Health Canada, but of the U.S.FDA, which also inspects Canadian plants that sell to Americans:

- Generic drug maker Taro Pharmaceuticals of Brampton kept drugs on the market despite company tests showing batches of the medications deteriorated before the expiry date listed on the label.

- In June, at a facility in Bangalore, India, that makes drugs destined for North America, Apotex employees did not report undesirable test results and doctored bacterial growth test records.

- Cangene Corp., a Winnipeg drug manufacturer, failed to tell authorities of blood clots, fever and other side-effects associated with their products.

Equally disturbing is that the Star investigation was made easier by two facts: the transparency of information thanks to an extensive FDA database accessible to the public, and freedom of information requests that are handled with dispatch instead of the delays and obfuscations common under the Harper regime.

Conditions at some Canadian plants are shockingly deficient. The U.S. regulator has posted online dozens of warning letters to Canadian companies, many of which detail egregious conditions in drug manufacturing facilities.:

A 2010 letter to Apotex revealed details of earlier inspections of its Toronto facilities where U.S. inspectors found the company distributed antihistamine and diabetes tablets made with contaminated ingredients. Apotex recalled more than 600 batches of drugs made at its GTA facilities from Canadian and U.S. markets.

In contrast, Health Canada does not tell the public the number of times it has inspected individual facilities at Apotex or other major drug companies.

Other FDA inspection reports are equally chilling:

- At the Quebec plant of Macco Organiques, after charred, black particles spoiled a batch of a pharmaceutical ingredient, the firm shipped it to the customer anyway. Inspectors saw dead insects and live ones buzzing around production material and areas of the factory covered in “dust and debris.”

- Staff at Taro Pharmaceuticals in Brampton did not respond to six Star requests to talk about the FDA inspections that found the firm kept drugs on the market despite company tests showing batches of the medications failed a quality test or deteriorated before the expiry date listed on the label.

Another contrast:

Under U.S. freedom of information legislation, the Star quickly obtained additional records for more than 30 of these FDA inspections north of the border. Health Canada said it will take months to decide whether it will release similar information.

In several cases, the Canadian regulator said it will first need to consult with the inspected Canadian drug companies before publicly disclosing the information, a practice that strongly suggests commercial considerations take priority over citizens' health and well-being.

It also appears that Health Canada inspects only about 10 foreign sites annually that make products destined for Canadian pharmacies. The FDA, on the other hand, inspected nearly 150 international facilities last year alone.

There is much more to be read in this disturbing report, including doctored data within the offending labs. I hope you will take the time to read it in its entirety.

Rona Ambrose, our current Health Minister, should, of course, resign. Of course, that won't happen, because under the current regime, any admission of error is seen as a weakness. It is therefore up to the Canadian public to send this government, which has progressively raised secrecy to an entirely new level, a strong message in 2015 by resoundingly defeating it at the polls.