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.”In a country that prides itself on its medical system, this cannot be deemed acceptable by anyone.
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.
As someone who had been involved with medical research, I believe the reports are just the tip of the iceberg.
ReplyDeleteNot mentioned in the report is that some scientists have either formed their own companies, or partnerships with drug companies, and there are potential financial gains if the drug(s)/ treatments/ technologies they are testing are approved for clinical use.
As the only way for these drug(s)/ treatments/ technologies to be approved for human use is through clinical trials like those mentioned in the TO Star report, there could be a lot of motivation to present only the positive results from the clinical trials, or even to bury adverse events or results.
Incidentally, some of these scientists are also receiving grants from the public funding agencies, which means that public funds are being used for basic research which, if proven useful, could then potentially be hived off to their own companies or those of their partners.Frequently, there are also financial incentives for the institutions which employ these scientists as well. In some institutions, scientists whose work have potential financial implications are significantly more valued than those whose work are more basic.
Currently, as far as I know, public funding agencies only review the grants that are submitted to them for competitive funding only on the basis of their scientific merit.
I suspect many people really do not understand the financial gains that some scientists or their institutions could potentially make if their drug(s)/ technologies become standard clinical use.
I should add that not all scientists have formed their own companies or partnerships with business, so people should do their due diligence before they donate.
I should also add that despite potential financial gains, some scientists and/or drug companies are actually very ethical and would not compromise their values for financial gain. Unfortunately, it is those that are more concerned with financial gain that are the issue.
And of course it is the job of the FDA and Health Canada to monitor and ensure that clinical trials are properly reporting efficacies and adverse effects of new drugs, treatments or technologies.
By refusing to give the public information, as reported in these TO Star articles, Health Canada would seem to be failing badly in one of its most basic roles.
Many thanks for the additional insights your comments have provided, Anon. And one indeed has to wonder about how Health Canada sees its role, given its patent failure to ensure adequate protection for us.
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