Health Canada/Provinces Goof 7. No Data Transparency
Show ALL the data and documents regarding decision making
The clinical research environment has changed, that is it has improved, since I started my career in the late 70s. There has been a move towards more transparency and sharing of data. Many clinical trials and protocols are now registered or published in advance so that these could be compared with the final published trial results. This is just one of the checks and balances that exist to ensure as much reliability as possible in the search for the truth. No where during COVID is this more important than with the mRNA drugs or vaccines. There is way too much at stake. These have been administered to hundreds of millions of people - the largest scaled experiment in human history. Now, in some jurisdictions at least, there is pressure to administer these products to every younger children. Some countries recommend this and yet looking at the same data, others do not. We, as citizens, parents, and grandparents have the RIGHT to know EVERYTHING about these products. Full transparency.
The COVID pandemic has been unprecendented. I keep hearing politicians say that COVID has caused all these problems. No, the virus is a neutral entity. It has been the response to COVID, no matter how well intentioned, that has lead to the devastating effects. Policies are being scaled back to different degrees (after all they are all following the same science) in each province of Canada, and yet our Federal government is doubling down on policies that are in no way based on science and at this point seem purely punitive. Our Prime Minister, like so many politicians, is unable to admit making errors or overreaching. Next best option, do what is stupid (see previous Newsletter) and do it faster.
Clinical Trials
Medical researchers would likely agree that transparency is always important if not critical, but especially so critical during a pandemic. Decisions have to be made quickly by the health care elites, as they must be feeling the pressure to do the right thing. Doing something is often perceived to be better than sitting on their thumbs as at least they can say that they tried. OK, I get that, but when things are not working it is incumbent on them to course correct. They are loathe to do that as that would mean that they are flip-flopping - I guess changing one’s mind is a mortal sign in politicianstan.
Physicians and scientists relying on the published literature is better than nothing but this leaves a wealth of information unexamined. I find it amusing that the public is so enamoured with ‘peer review’ as if this was a guarantor of the best science. No, medicine is a club and you have to go along to get along. Do you really think that the fact that Dr. Fauci controls a phenomenal amount of research money that he could not subtly influence other researchers, scientists or journal editors? Money talks. And that is also true with the undue influence big Pharma has on the regulators, who they help fund. In what sane world does that make sense?
I guess what I am saying is that critical appraisal of impactful clinical trials by a few people is not only insufficient for journal publication but no where near enough for professional and governmental institutions. There should be free and unfettered access to ALL clinical trial data (with individual person data eliminated); this would allow for independent and informed assessment. This would be a perfect ‘crowd sourcing’ exercise and given the large numbers of competent researchers could be done in a short period of time. This would be further supplemented by having the original trial protocols, minutes of any trial meetings, and modifications available as well. Meta-analyses would be greatly improved as often granular detail of trials is not included in published reports.
At present, with regard to the mRNA drugs there is really no availability of these trial documents and data. There is some summary data on the Health Canada website. The FDA wanted to release the data they held in slow tranches over the next half-century or so. The US District Court for the Northern District of Texas would have none of that and in early January 2022 issued an order requiring the FDA to release 12,000 pages of documents by January 31 and an additional 55,000 pages per month thereafter, until the release of the nearly 400,000 pages of documents is complete. We are still waiting for the first data dump.
It is not clear to my why the public places so much trust in big Pharma. As another example of this, while Pfizer claims to support the disclosure of the above documents, it is now back in court and stated: “[S]eeks leave to intervene in this action for the limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court’s order.” The Pfizer attorneys claimed that while they were not asking the court to reconsider the initial order, it would consider challenging the order at an unspecified later date.
These drugs have been administered world wide, without full data transparency and with what now appears to be moves to obstruct the release of the data by Pfizer. Nothing to hide I guess.
How does this not raise serious concerns over the rational use these drugs? Especially in children!
Regulatory Bodies
The FDA was apparently integrally involved in the design of the original Pfizer trial(s) and even in the selection of the primary endpoint - laboratory confirmed COVID-19 or in the case of children antibody levels; many experts had originally believed the trials were designed to study a reduction in hospitalisation, need for intensive care and death (due to COVID or all-cause mortality). This is what matters most to the public. It appears that since the FDA was complicit in the design that if the protocol was adhered to, emergency use authorization would be granted. As a result, the clinical trial was way to small to show strong evidence of the mRNA drug on the important clinical endpoints either individually or as a combined endpoint. Despite the belief among experts that follow-up for treatment and placebo arms would be continued for up to 2 years, alas this did not happen. Unblinding occurred after a few months so that true long-term controlled data comparisons will never be available.
All the documents related to these decisions involving the FDA and Health Canada should be released. In Canada there are typically press conferences where decisions are rendered, at times with a power point presentation. As with the clinical trial data, all regulatory documents produced by Health Canada and the Provincial regulators should be made available so we can see the scientific review documents, analyses of the trials and the discussions about the authorization of these drugs. These should be considered as a complement to, and not a substitute for, trial data.
The same types of data should also be released for all other medications or products considered but disqualified for use (or outright banned) in the COVID pandemic.
This transparency would give the public a great deal of insight into the decision making processes and the hierarchy of outcomes considered. Moreover, it would allow the public to assess the consistency of criteria, or at least a sense as to what threshold is required for different types of treatments.
It is, after all, about eliminating the appearance of bias or undue political influence. All financial information on big Pharma and Health Canada or the groups making these decisions should be fully disclosed.
Professional Medical Bodies
Professional bodies and academic organisations in Canada might also play a large role in promoting transparency. Public statements that convey the unacceptability of sharing data over decades after the fact. So far, apart from promoting these drugs I have seen very little criticism of the process. Nor, I might add, have they made any statements about silencing contrarian medical opinions. When did that become a problem in an open and free academic environment.
Aren’t we all trying to get at the truth?
Bottom Line: Transparency in such situations is not ‘nice to have’, it is critical to ensure that there is adequate oversight of decision making that, in the case of these mRNA drugs, have been injected (and multiple times per person) on a scale that was unthinkable 2 years ago. In addition, if the information recently leaked by Project Veritas is accurate - Pfizer is hoping to make these jabs a yearly subscription for all age groups. Society needs complete and transparent access to all data immediately. Again, it is the appearance of bias or influence or worse.