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 Harper Acquiescence To The Corporate Agenda

As much as it is said that the Harper regime is planning to buy votes for the 2015 election by giving income-splitting to families, the reality is that Canadians are increasingly being called upon to aid and abet its agenda of 'starving the beast' while at the same time subsidizing corporate profits.

As reported in The Globe and Mail, our Finance Department has quietly shelved plans to crack down on so-called “treaty shopping” by multinationals. The surprise move suspends a long campaign by Ottawa to stop what it says is rampant “abuse” of international tax treaties by companies seeking to duck Canadian taxes.

Treaty-shopping was most recently in the news when Burger King engineered a merger with Tim Hortons so it could pay a much lower corporate tax rate that Canada offers. Despite the fact that the late Finance Minister Jim Flaherty wanted to curb the practice, 'Uncle' Joe Oliver is embracing it:

Facing intense lobbying from resources companies and their tax advisers, Mr. Oliver apparently bought the argument that curbing treaty shopping would put a chill on foreign investment in places such as the Alberta oil sands, leaving Canada at a competitive disadvantage.

In other words, the argument goes, the rapacious appetite for massive corporate profits, along with the refusal to accept any responsibility to the country that makes those profits possible, is the business imperative that must be yielded to:

In a prebudget submission to the House of Commons Finance committee, Deloitte & Touche LLP had this to say:

“To attract foreign capital, Canadian projects generally must support higher potential yields than comparative investments located in the home country of a capital source,” Deloitte tax policy leader Albert Baker said in the submission. “This is a particular issue for the energy and resource sector.”

The flip side is that not squeezing corporations means individual Canadians must bear a disproportionate share of the country’s tax load. Unlike companies, ... hard-working Canadians can’t use complex offshore tax structures.

The message therefore seems to be that all other Canadian taxpayers – you and I – should subsidize the inflated profits of offshore oil sands investors.

So much for the rhetoric and propaganda the Harper regime fosters about its concern for 'working families.'

Is That The Pitter Patter Of Little Feet I Hear?

Sorry. False alarm. Turns out it was the sound of Ontario NDP leader Andrea Horwath doing a fancy dance as she practices her routine for the November leadership review she is facing.

In Toronto this past Saturday, more than 200 members of the party's provincial council were witness to the reborn Horwath expressing her allegiance to essential party principles, principles that were decidedly absent in the provincial election she forced last June that saw her party lose the balance of power it had held.

Averred the rechristened leader:

“We believe in fighting each and every day for a more equal society,” ... We believe in a strong and active role for government, because there are many things that are more important than making a buck in the marketplace.”

As reporter Adrian Morrow observed,

The soaring rhetoric was a major change from last June’s election, when the NDP campaigned on a platform of small-ball populism, pointedly abandoning ambitious policies such as a provincial pension plan.

Despite those facts, Ms. Horwath tried to remind her audience of the party's proud history without mentioning how she herself had sullied it:

In a speech that bordered on liturgy, she rhymed off example after example of progressive values – from universal health care to fighting poverty to better pensions to public transit – that she would embrace over the next four years.

She went on to channel her inner Jack Layton:

“Love is better than anger, as a good friend reminded us a few years ago. We are the party of hope. We are the party of optimism".

While all of that may be true, some cannot forget that the party of optimism currently seems to be headed by a leader of opportunism.

Perhaps also significant is this:

MPP Cheri Di Novo, who has criticised the last campaign for moving away from the NDP’s traditional focus on social justice, wouldn’t say whether she thought Ms. Horwath deserved to remain.

“I’m going to leave that to the party, the party makes that call,” she said.

The party will get that chance in November.

Since the future of her leadership rests on making a good impression, perhaps she can take some instruction from Christopher Walken on how to make a grand entrance at the review:

On Harper's True Loyalties

In response to yesterday's post about Stephen Harper's boycott of a major climate change summit hosted by UN Secretary General Ban Ki-moon in New York on September 23, Anon wrote the following, and offered this video which, I think you will agree, is a most appropriate choice:

Harper, early on, seemed to care about human rights and UN initiatives:

"'I think Canadians want us to promote our trade relations worldwide, and we do that, but I don't think Canadians want us to sell out important Canadian values,' Harper said.

Chinese President Hu Jintao won't meet with Prime Minister Stephen Harper in Hanoi, which is being seen by some as a snub over Canada's criticism of China's human rights record. 'They don't want us to sell that out to the almighty dollar.'"

After that crazy talk, I think Harper's sponsors sat him down in a boardroom in Calgary and explained the facts of life to him. The fact that he always was, and always would be, an Imperial Oil mail room clerk. I imagine that meeting would have gone something like this:

No Surprise Here

Rather typical, wouldn't you say?

UN Secretary General Ban Ki-moon is hosting a major climate summit in New York on September 23, “to mobilize political will” towards reducing global emissions.

U.S. President Barack Obama will be attending, as will U.K. Prime Minster David Cameron.

In fact, 125 heads of state will be there.

Canadian Prime Minister Stephen Harper, however, will not.

And please remember:


This message not brought to you by the Committee to Re-elect Stephen Harper.

Israelis Of Conscience

I reproduce the following story without comment, except to state the obvious. It is a testament to the courage and integrity of those described therein, who will likely face all manner of vitriol at home for their principled decision:

Forty-three reservists from Israel's elite army intelligence unit have announced their refusal to serve, accusing the military of "abuses" against Palestinians, in a letter published on Friday.

The letter, circulated to Hebrew-language media and addressed to Prime Minister Benjamin Netanyahu, referred to the army's intelligence work in the occupied Palestinian territories, including targeted assassinations and intrusive surveillance of civilians.

The soldiers and officers from the elite unit, known as 8200, which works closely with Israel's security services, declared they no longer wanted to "continue to serve in this system, which harms the rights of millions of people" and refuse "to be tools to deepen the military regime in the occupied territories," according to daily Yediot Aharonot.

Soldiers in 8200, the army's largest unit, are responsible for collecting and intercepting telephone calls, texts, e-mails and faxes among various populations, the daily reported.

"We call all soldiers serving in the unit or who are going to serve, and all Israeli citizens to make their voices heard against these abuses and work to put a stop to it," the paper quoted the letter as saying.

In their letter, the reservists said that information their unit gathered was used against innocent Palestinians and created division within Palestinian society, including aiding in the recruitment of collaborators.

"Contrary to Israeli citizens or citizens of other countries," continued the letter, "there's no oversight on methods of intelligence or tracking and the use of intelligence information against the Palestinians, regardless if they are connected to violence or not."

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.