Why Health Canada Cannot Remove the mRNA COVID Vaccines Before the US does
Adderall XR: A cautionary tale
A long time ago, seems like another life, a very brave Director General of Health Canada removed a drug from the market. I remember this, because I had just started working in government in drug pricing, and we sue or restrict a drug sale based on price and this case was very relevant to an ongoing case we had.
Dr Bob Peterson MD becomes head of the Therapeutic Drugs Directorate at Health Canada
Dr Robert (Bob) Peterson, MD received a MD and a PhD in pharmacology from Yale University in 1974. He completed a Master’s of Public Health at Harvard University’s School of Public Health in 1996. He has authored numerous papers and chapters in pediatric clinical pharmacology and toxicology.
He has been Director, Pediatric Clinical Pharmacology at the University of Colorado, Professor of Pediatrics and Pharmacology and Chair of the Department of Pediatrics at the University of Ottawa’s Faculty of Medicine, and also Director of the Children’s Hospital of Eastern Ontario Research Institute.
In 2000 he became the Director General of the Therapeutic Products Directorate at Health Canada.
Health Canada Directorates and Organization
Health Canada is divided into about Directorates shown below. The Biological and Radiopharmaceutical Drugs Directorate cover vaccines and gene therapies. The Marketed Health Products Directorate (MDD) covers post-authorization safety and effectiveness of authorized health products that come onto the market in Canada.
The rest is self explanatory.
When Dr Peterson started, his responsibilities also included post-authorization safety now covered by the MDD. The MDD didn’t really become a self-standing Directorate until about 2014, though it was established in 2002.
February 10, 2005 Dr Peterson suspends the sale of Adderall XR in Canada
Adderall XR a combination of amphetamine salts, was approved for use in Canada in January 2004 for the management of Attention-Deficit Hyperactivity Disorder in children. Clinicians in the field welcomed the addition of a 12-hour amphetamine product to compliment the other medications which were currently available.
In a news release dated February 9th, 2005 Health Canada suspended the market authorization of this medication, based on issues of safety. They had conducted a review of 20 cases of sudden death in patients taking Adderall or Adderall XR. These data were from the U.S. Food and Drug Administration (FDA). None of the 20 deaths occurred in Canada. The deaths were not associated with overdose, misuse or abuse. Fourteen of the deaths were in children, six were in adults.
"Adverse events are very rare but they are also catastrophic," Dr. Robert Peterson, director general of the therapeutic products directorate at Health Canada, said yesterday in explaining the move.
He said the benefits of the drug, improving attention span, had to be balanced against the risk, possible death. Given currently available information and the fact that there are many other ADHD drugs on the market, the continued sale of Adderall XR could not be justified, he said.
Health Canada asked Shire Pharmaceuticals for a volutary withdrawal.
Shire officials refused, reiterating their belief Adderall XR was a safe therapy. This was the first time that a drug company actually refused to comply with a directive of Health Canada.
The fallout was huge.
February 11, 2005. The FDA pushes back
The FDA issued a statement stating, “FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse event reports, and the FDA’s own knowledge and assessment of the reports received by the agency”.
In fact, Senator Grassley said the FDA pushed for HC to keep Adderall XR on the market
The US Media wrote several article saying “who was right?”
And as seen below in the Carlat Psychiatry Report, is was TEAM USA!
From The Carlat Psychiatry Report
Daniel Carlat, MD Dr. Carlat has disclosed that he has no significant relationships with or financial interests in any commercial companies pertaining to this educational activity.
On February 9, 2005, Health Canada (HC) announced that it was suspending sales of Adderall XR in Canada because of concerns that it might lead to sudden death and stroke. The FDA, however, has begged to differ.
Both agencies claim to have analyzed the same data, yet according to their respective health advisories, their numbers look different. HC reported 20 sudden unexplained deaths (“SUDs”) linked to Adderall from 1999-2003, while the FDA reported only 12. What gives?
+++++++++++++++++++
Ultimately, The Carlat Report sided with the FDA in this inter-agency skirmish. Any connection between Adderall and death is probably spurious. After a series of high profile embarrassments, it appears that Team FDA has finally gotten its numbers right.
TCR VERDICT: Adderall and death? No connection.
Shire Pharmaceuticals Trigger the Appeals Process
The appeal process consists of a three-person panel, one selected by Health Canada, one selected by the pharmaceutical manufacturer, and a third person agreed to by the other two parties.
This panel was chaired by Dr Mitchell Levine, but the other members have not been disclosed. (Full transparency, I know Dr Levine personally but have never discussed this case with him. I didn’t even know he chaired the panel).
The Canadian Acaemy of Child and Adolescent Psychiatry and the Canadian Psychiatric Association are NOT Happy
On March 7th, 2005 these organizations wrote a letter to Dr Peterson to state there was no comprehensive, advanced notice strategy to physicians. Many doctors and patients became aware of this withdrawal through reports in the media. Oh, and that expert physicians were not consulted. Keep in mind that Dr Peterson was a PEDIATRIC PHARMACOLOGIST. I think he was quite capable of making a decision. He quit the day after he made the decision to withdraw Adderall XR from the market.
They ask:
A number of serious questions remain concerning this withdrawal:
Why was the medication withdrawn in Canada based on data collected by FDA, when a careful review by FDA did not cause particular concern?
Health Canada appears to have no mechanism for, or even interest in, timely consultation with treating professionals or their professional Associations. It is uncertain as to how internal decisions are made and a general lack of transparency.
It was unacceptable to physicians that they found out about this withdrawal from reports in the media.
Are these specialist physicians or not? Can they not handle a simple reassessment of medication therapy? Where is this pushback coming from?
The Globe and Mail reported (Andre Picard, BTW)
Pam Eisen, a Toronto-area mother of a severe ADHD sufferer, said she is troubled and unsure what she will do if the 14-year-old can no longer get Adderall. "My son has gone from not being interested in school at all, and being really disruptive, to being one of the most-improved students."
Ms. Eisen said David was taking Ritalin for five years but it was never as effective as Adderall. "I would definitely keep using it if I could because nothing else has worked."
Dr. Umesh Jain, a child and adolescent psychiatrist and administrator of the Canadian ADD Resource Alliance, also had high praise for Adderall XR.
This sounds like a press release, doesn’t it?
There was quite a media storm and it is instructive to read these reports. They are much better written than today as well.
What was the Outcome of the Appeals Process?
Well, what do you think. Of course the Health Canada decision was reversed.
And it only took 5 months for the reversal.
A very complete article on the whole debacle can be found here, that I highly recommend all to read.
What Happened to Dr Peterson?
As mentioned earlier, he quit the day after he announced the suspension of Adderall XR from the Canadian market. I believe he had death threats and that the government itself was not a happy camper, likely due to the pressure from special interest groups (ie the docs, and patient groups) and the FDA.
Currently, Dr Peterson is working in British Columbia
What Lessons did Health Canada Learn?
Better let the FDA know everything you are doing. Independent assessment does not go over well. Thus these “cluster” meetings of HC with the FDA and EMA on on various topics including the covid vaccines. The pediatric cluster meetings were initiated in 2007
Drug companies mobilize their special interest groups of physicians and patient groups (many which get some funding from pharma like say the Arthritis Society, Canadian Diabetes Association, etc, etc) which provides pressure to Health Canada.
Compliant media amplify concerns
Never act unilaterally and you must give the pharma lots of time and notice regarding your concerns. Pharma has many tricks up their sleeves.
Good, ethical and thoughful physicians/scientists will be sacrificed by the machine, government, media etc.
Corporate memory in government is long. I believe that the Marketed Drugs Directorate for POST-authorization safety and efficacy concerns is now separated from the initial approval at the Pharmaceutical Drugs Directorate, partly because of this case. Currently, the Covid vaccines, this means the MDD monitors the safety and efficacy of the Covid vaccines together with PHAC. A shared responsibility (or a plausible deniability??)
This is why the call2halt19.ca team is also writing to the FDA to halt the Covid vaccines. Pressure on the FDA is also coming from Australia. However, I feel the Health Canada can still act unilaterally for children, pregnant women and other groups as countries in Europe and elsewhere has. Keep up the pressure!
Let me know what other observations and conclusions you may have on this cautionary tale.
Oh and pray the rosary.
PS. I believe our sights should be on public health as well. Maybe even more so than the regulatory agencies.
Poor Dr Peterson doing his job and acting from a place of concern regarding the safety of drugs, he observes a rare potentially catastrophic problem of Adderall XR which could end, under certain circumstances, in loss of life so he brings it to the fore. What he did not see or know was the protective forces marshalling from the pharmaceutical industry that did not place the same regard for loss of life against the use of a drug already in the public market. You can see the ruthless tactics used against him at that time, one being "death threats", he probably was being used as an example of what would happen to any official who went against the mighty forces of the pharmaceutical industry.
He certainly showed himself as one of the last independent officials working from a place of ethical responsibility to the public, he was a dying breed that no longer exists in today's world.
As a Canadian, I truly see a lack of transparency in the information that the public is given. I was one of a number of Canadians, that questioned the covid inoculation. I am angered by the intentional misleading or withholding of important information regarding the side effects and necessity of taking the inoculation. At this point, I see the mRNA inoculations as harmful to health. I see the harmful global initiatives the World Health Organization was trying to thrust on everyone. I see the CBDC that the Bank of International Settlements wants to impose on people. I see the bold faced lies the media tells. I see the tyranny being imposed.