Health Canada Mandate: Protect Pharmaceuticals' Profits Instead Of Canadians' Health

Health Canada continues to extend a metaphorical middle finger to average Canadians. As has been clearly established by an ongoing Toronto Star investigation, the protectorate persists in placing the fiscal health of the pharmaceutical industry above that of Canadians.

Today's Star reports:

Canada’s biggest pharmacies are selling allergy pills made with ingredients from a drug facility in India that hid unfavourable test results showing excessive levels of impurities in their products, a Star investigation has found.

Recently, the Star purchased packs of over-the-counter desloratadine tablets from Toronto-based Shoppers Drug Mart, Rexall, Walmart and Costco stores.

One month before, on Dec. 23, Health Canada had announced these antihistamines — made by Pharmascience — were under quarantine after serious problems were unearthed during an inspection of the company’s drug facility in India. Inspectors found unsanitary conditions at the facility, including high growth of bacteria and mould.

Despite the fact that these data were uncovered by inspectors in 2012, the quarantine only applies to products made in the last month and a half.

“How can a medicine be too dangerous to import but safe enough to consume? This makes no sense,” said Amir Attaran, a law professor and health policy expert at the University of Ottawa.

By not ordering a recall, Attaran said, “Health Canada is knowingly leaving adulterated medicines on the pharmacy shelves.”

For their part, the pharmacies are hiding behind the fact that Health Canada has not ordered a recall of the products currently on the shelves, the same subterfuge that Pharmascience, the manufacturer of the drugs, is using.

This should be cold comfort indeed (no pun intended), given what FDA inspectors uncovered in the Indian plant where the ingredients come from. In addition to finding problematic test data being deleted from hard drives, they

also raised concerns about the water used to manufacture the drug ingredients. A probe of the microbiology lab found “significant growth of both bacteria and mold, and appeared to be TNTC (too numerous to count).” The company’s data used for detecting worrisome trends did not mention the problem, inspectors found.

Equally chilling,

the facility failed “to have adequate toilet and clean washing facilities supplied with hot water, soap or detergent,” inspectors found.

Asks the University of Ottawa’s Attaran,

“The cheapest greasy spoon in Toronto would be shut down if it had these conditions, but the pharmaceutical company sending stuff to Canada is allowed?” he said.

He questions why the government is allowing products originating from the facility to remain on pharmacy shelves, considering Canada’s Food and Drugs Act prohibits the sale of any drug manufactured under unsanitary conditions.

“The law is very clear on this,” he said. “We have evidence here that the product was manufactured under unsanitary conditions, and they’re selling it.

“What more does Health Canada want?”

These are questions all concerned Canadians should be demanding answers to. Given that an election is pending, perhaps our government will stop treating us, even temporarily, in such a contemptuous and cavalier manner?

Tainted Pharmaceuticals: Health Canada's 'Feeble Response'

The Toronto Star has recently been conducting some fine investigative work on tainted pharmaceuticals and the fact that Health Canada has been shielding the guilty companies from public scrutiny. The issue finally rose to a degree of national prominence this week when the issue was raised in the House. The 'answers' provided by Health Minister Rona Ambrose, however, were hardly comforting or reassuring. The bolded parts have been added for emphasis:

“Whenever there is a dangerous product identified, Health Canada inspectors act immediately. In the case of a drug produced by Apotex, Health Canada inspectors asked the company to remove it from the shelf and it refused,” Ambrose said in question period this week in response to questions spurred by a recent Star investigation.

This somehow reminds me of the boy with the sign on his back that says, Kick Me.

In fact, the Canadian government, unable to force the company to recall the drug, twice asked Apotex to “stop sale and cease imports” from the Bangalore facility, Health Canada spokesman Gary Holub said in response to further questions from the Star.

Apparently a believer in the old adage that you can catch more flies (an apt metaphor in this case, given the filthy conditions of Apotex's Bangalore plant) with honey than vinegar, our national health protector changed tacks:

“Although Apotex refused Health Canada’s initial request, it was determined that a more productive course would be to work with the company to quickly determine steps to ensure the safety of its products, over engaging in lengthy court proceedings with no immediate mitigation measures,” Holub said in an email.

Amir Attaran, a University of Ottawa law professor who researches drug policy, called Health Canada’s response “feeble, inadequate and incompetent.”

In the house, Ambrose claimed that she needs stronger legislation to act definitively and decisively against the offending companies:

“It will require tough new fines for companies that are putting Canadians at risk. Most importantly, it will give me the authority to recall unsafe drugs when I need to,”

This claim of legislative impotence surely rings hollow, and does not explain the fact that Health Canada refuses to publish the names of companies contravening drug safety practices nor the names of the offending drugs.

Professor Attaran succinctly sums up the real problem: “This proves Health Canada is on the side of drug companies and not Canadians”.

I have nothing to add to his assessment.

More Indifference From Health Canada's Towards Canadians' Health

Health Minister Rona Ambrose really has no reason to smile.

Last week, based on a Star Investigation, I outlined the shocking incompetence, indifference and completely unacceptable secrecy within Health Canada that allows for tainted, ineffective, and dangerous drugs to be sold regularly to Canadians. It was only because of the transparency of the American Federal Drug Administration that The Star was able to uncover this wholly unacceptable and outrageous state of affairs.

Unfortunately, the story doesn't end there.

Continuing its investigation, The Star has uncovered, thanks to the FDA database and freedom of information requests that were answered fully and expeditiously by that body, more shocking failures on the part of Health Canada. This one involves clinical trials. Fraud, incompetence and corruption do not seem overly strong terms to describe what they have uncovered:

In 2012, a top Toronto cancer researcher failed to report a respiratory tract infection, severe vomiting and other adverse events.

A clinical trial run by an Alberta doctor reported that patients responded more favourably to the treatment than they actually did.

A Toronto hospital’s chief of medical staff ran a clinical trial of autistic children on a powerful antipsychotic, and he did not report side-effects suffered by four of the children.

The problems uncovered with clinical trial oversight seem to stem from the same factors that allow for tainted and ineffective formulations on the market: inadequate inspections by Health Canada (only a handful of the 4000 clinical trials running at any one time) and the latter's insistence on keeping the problems it covers secret, citing 'proprietary concerns.'

One cannot overestimate the importance of clinical trials: They

are experiments using volunteer subjects to determine whether a drug is safe and effective, as well as what side-effects it may cause. Participants may experience side-effects, which the doctors leading the trials must report.

Unfortunately, such protocols are being circumvented by Canadian doctors. Take the case of Dr. Sunil Verma, who chairs the breast medical oncology unit at Sunnybrook’s Odette Cancer Centre. An FDA inspection uncovered the fact that he failed to report to the sponsoring drug company adverse reactions suffered by five patients, including a respiratory tract infection and severe vomiting that lasted two weeks.

His explanation: “This was purely a clerical issue. This was clearly an oversight on the part of the nurse” .

Interestingly, Dr. Verma is on the drug company's advisory board, which pays him about $1500 each time he gives an “educational presentation” on breast cancer.

Overlapping, or what some might describe as incestuous, relationships between doctors and drug companies do not seem uncommon:

At the University of Calgary, Dr. Remo Panaccione’s has received money for consulting and lecturing from at least 26 different pharmaceutical companies.

Dr. Panaccione conducts research into inflammatory bowel disease. A clinical trial he led in 2007 into a drug designed to treat Crohn's disease was found deficient by an FDA inspection. He failed to report the hospitalization of three patients being treated to the university's ethics board. Like the aforementioned Dr. Verma, Panaccione blamed his staff for the “oversight.”

Then there is the case of Dr. Alexander Paterson, a renowned Alberta researcher, who has the dubious distinction

of being cited for violations in three FDA inspection reports — in 1988, 2002 and 2004 — more than any other Canadian doctor, according to a Star analysis of available FDA data.

During the first inspection, the FDA inspector uncovered a series of problems with the trial, including one the FDA said was “extremely” concerning: Patient information submitted by the pharmaceutical company to the FDA (to get the drug tamoxifen approved to treat cancer) did not match medical records found in Paterson’s possession.

In several cases, the copies given to the regulator suggested the treatment worked better than the doctor’s own progress notes indicated.

The inspection also found “possibly ineligible patients being enrolled in the study . . . and patients being incorrectly dosed.”

In one case, the inspector’s report says, the record submitted by the drug company said the patient’s response to the treatment involved “no change.” This was in direct conflict with the doctor’s record, which “lists the patient’s response as ‘worse.’ ”

Like the two previously mentioned doctors, Paterson had an explanation, blaming the findings on overzealous and out-of-their-depth FDA inspectors.

Errors, I am sure, happen all the time. After all, we are all human. But for me, the most important aspect of this story again is the fact that were it not for the openness and accessibility of FDA data, Canadians would be completely in the dark about these mistakes and coverups, all of which seem invariably to work to the benefit of the drug companies for which the researchers are doing their work. Health Canada seems completely unconcerned.

There is much more in the Star investigation, including a sole study by Hamilton doctors whose tainted data and failure to report serious side effects led to the approval of a drug thinner implicated in stroke, heart attacks and major hemorrhages. I hope you will read the entire report on the Star's website.

I will close with just one more excerpt from the Star investigation that speaks volumes about its indiifference to the health of Canadians:

Over the past 12 years, Health Canada found at least 33 clinical trials had critical problems and were “non-compliant.” In July, the Star asked for details of these and other inspections, and last week Health Canada refused, saying that providing records “would require an exhaustive manual paper file review.”

The regulator also said the release of these clinical trial inspection reports could only come after consultation with third parties, typically the doctors and drug companies.

In a country that prides itself on its medical system, this cannot be deemed acceptable by anyone.

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.