Maria Gutschi: Health Canada’s change to the definition of ‘Safe and Effective’ Smells of Big Pharma Intimidation

How can they keep saying “safe” and “effective”?

Because the meaning and standards used were changed

I knew from the very beginning that criticizing the “safe” and “effective” narrative using data and facts were doomed to fail. I have spent many years convincing doctors that their safe and effective drugs are not as advertised but outcome data from studies and trials can be massaged. So you end up in the battle of the experts. So I concentrated on manufacturing, and quality and we did get some traction using this approach.

However, to get at the root cause of this narrative, we need to really understand how the national regulatory authorities actually assessed these products. My colleague David Wiseman has been following the FDA process for 3 years and dissects how the FDA went off the rails. He talks about it here:

David Wiseman on Trial Site News start at 39:45 or thereabouts

I will attempt to do the same for Health Canada.

Safe and Effective is a Term Defined in Law and Regulation

Interim Order

Canada did not have existing legislation that could be applied to authorization of a drug product in the context of a pandemic. The FDA used their existing EUA developed for a pandemic, and the European Medicines Agency (EMA) used a “fast track” or accelerated pathway used many times before and just adaped to the pandemic. I think this is why the EMA’s review is the most complete.

Canada therefore, introduced a temporary emergency authorization as a new legal rule, the Interim Order (IO), for a specific one-year time period, promulgated September 20, 2020. The IO was also designed to support “intellectual property considerations” so that there would be no delay in access to COVID-19 treatments for Canadians.

“Seriously? I think there is another rabbit hole there. I worked for the patent regime in Canada as a scientific officer and this smells of intimidation by Pharma to me.”

Comparison of Interim Order to Notice of Compliance (NOC)

Here I compare in a draft document I am writing how a normal drug is assessed to receive what is called a Notice of Compliance (NOC) in order for the manufacturer to market and sell the product. This is also a ‘full approval.’ Canada does not have a separate authorization for vaccines or biologics vs regular drugs. These are all considered “drugs” under the Food and Drugs Act. The FDA grants a specific biologic authorization for biologics, vaccines and gene therapies called the Biologic License Application or BLA.

 

Do you see it?

In regulations for an NOC in C.08.002(2) you need to establish the safety of a new drug with detailed report (part 2g). And you need substantial evidence of clinical effectiveness (part 2h)

In the Interim Order the Minister MUST approve? Really? Sufficient evidence that the benefits outweigh potential risks. So no standard for establishing safety and efficacy THEN doing a benefit vs risk assessment like we do for a regular approval. Basically if a ham sandwich looked liked it did something, the Minister was required to approve.

Lets look at these terms.

“Substantial Evidence” needed to establish a full approval

Health Canada’s Guidance Document for Priority Review, 2006[1], and note this is an ACCELERATED approval policy, states that “substantial evidence” is…

“evidence of clinical effectiveness … consisting of at least two adequate and well controlled clinical studies, each convincing on its own to establish effectiveness of the drug involved……In some instances, clinical evidence consisting of a single, large-scale, adequate and well controlled study or one pivotal trial and additional clinical evidence may be deemed “substantial.”

“Known Information” for approval

In the 2020 Guidance under Interim Order for market authorization requirements for COVDI-19 vaccines,[1] Health Canada states that…

“Authorization decisions will be based on the overall benefits and risks. We will also consider all of the data available, including the results that have been provided in the rolling submission and the current knowledge about the virus and disease, which will need to be continually monitored following authorization. Sources of knowledge include the scientific literature, public health and surveillance data, and collaborations with our international regulatory partners.” (emphasis added)

So what kind of data does Health Canada count on to make a decision? This is similar to what is known as the “totality of evidence” which is not an objective standard. Its a FEELING it is going to work.

The Requirement for Well-Controlled Data for the Interim Order

Unlike what is required for a NOC under Section C.08.002 of the Food and Drugs Regulation, the is no requirement to establish safety with “substantial evidence” with “well-controlled clinical trials.” Health Canada stated it required…

“robust evidence of the vaccine’s ability to prevent COVID-19 infection from well-conducted phase 3 clinical trials in humans.” [1]

The reference to well-conducted trials suggests controlled clinical trials with randomization or blinding are not necessarily required. “Robust evidence” is usually given to mean the data from controlled clinical trials are persuasive but may still be prone to bias.[2] Thus persuasive or highly significant results from an uncontrolled trial may not represent high quality evidence. What does everyone think? See the word play? Am I wrong?

In its guidance for market authorization requirements under IO, Health Canada required an efficacy assessment with a threshold, normally used for influenza vaccines of

“at least 50% efficacy to be reasonable for COVID-19 vaccines.” “However, even efficacy thresholds that do not reach the minimally accepted 50% efficacy would still be considered for review.”

Yikes!!! So even if we get 30% efficacy (which is almost barely above nothing) this would potentially be approved?

Which is kind of what happened with the boosters etc. Pretty well a ham sandwich.

The willingness to accept data of low quality and efficacy belies the “safe and effective” standard when Health Canada stated [Health Canada News]

“[It]… has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada.”

Rolling Review

Many national drug regulators used a “rolling review” process as an important tool to reduce the time to a regulatory decision given the “urgent public need,” including Health Canada, the European Medicines Agency (EMA), FDA and others. The rolling review process allows a regulator to complete the review of a submission earlier compared to the routine process of commencing the review following the submission of the full dossier since the data is reviewed as it is submitted.

Once the regulator decides that sufficient data are available and deemed complete, the temporary authorization may be granted. However, this type of review is more complex and resource intensive. Ongoing planning, meetings and engagement with the sponsor or manufacturer is needed in order to prepare, initiate and conduct a rolling review submission.

Rolling Review was “quicker but just as safe”

The rolling review process was presented to Canadians as a quicker way to achieve authorization without sacrificing safety. Dr Supriya Sharma, the Chief Medical Advisor for Health Canada, explained that the COVID-19 vaccines,

“went through exactly the same type of review that any vaccine would…..the same amount of data as for any vaccine that would be authorized in Canada….they just do it faster.”

As stated by Dr Gerry Brown, a professor of bioethics and global health at the University of Toronto said at the time,

“…. There is no way they are cutting corners on this. They are looking at all the evidence section by section. I find it very encouraging.” [Global News]

However, Health Canada also admitted, that the standard of evidence required for an Interim Order is lower than required by law

“instead of a company, like Pfizer, providing substantial evidence of the safety and effectiveness of a new drug — as usually required by federal law — the interim order says an applicant can submit the information as it becomes available, allowing for the “rolling review” process. [Global News]

But what could happen, and did, it that data on animal studies for toxicity or biodistribution is being reviewed at the same time as people are being jabbed in the clinical trials. Hmmmmmm talked about being a guinea pig.

Differences in assessment of safety and risk – benefit analysis: NOC vs IO

The lower quality of data comprising “known evidence or totality of evidence” will isn’t what I would call a “rigorous standard.” The 2020 Guidance for marketing authorization of COVID-19 vaccines under IO will grant authorization only if…

“The benefits of the vaccine outweigh its potential risks.”

The risk-benefit analysis will also weigh the uncertainties of the vaccine against “the urgent public health need.” For a conventional approval under the Food and Drug Act, the word “potential,” is omitted requiring:

“(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended.” [Food and Drug Regulations]

Including the word “potential” lowers the quality of evidence acceptable for a risk-benefit analysis under an IO. Since the nature of the threat posed by COVID-19 was poorly understood, assessment of potential benefit relied on speculation and, out of an understandable abundance of caution, yielded an overestimate of the threat posed by the novel pathogen. Secondly, because an entirely new class of therapeutics was being deployed for the first time with limited understanding of its pharmacology and toxicology, their potential benefits and harms were largely unknown.

Lack of complete data and uncontrolled use of drug products approved under Interim Order may not permit differentiation between the safety risks of these products, from the complications and comorbidity of a disease whose natural history is not yet fully understood. This is exactly what we are experiencing.

Granting of “Full Approval” for COVID-19 vaccines and therapeutics under the Food and Drugs Act

Modified Requirements for Safety and Efficacy

In 2021, Health Canada made specific changes/ amendments to the Food and Drug Regulations (FDR) for drugs including vaccines in relation to COVID-19 (March 19, 2021) which were promulgated on September 21, 2021, when the Interim Order (IO) expired.

Under C.08.002 (2.1) a COVID-19 designated drug is granted a final Notice of Compliance (NOC) and is considered in regulations as a “carve-out” specifically for designated COVID-19 drugs, including vaccines, that is of a lower standard for establishing safety and efficacy. However, other non-Covid designated related drugs and vaccines must still meet the higher standards in C.08.002 (2).

Here: See for yourself Food and Drugs Regulation

(2.1) A manufacturer may file, for a designated COVID-19 drug, a new drug submission that does not meet the requirements set out in paragraphs (2)(g) and (h) if the submission contains…

(a) a statement that the submission contains evidence to establish that the requirement set out in paragraph (b) is met; and

(b) sufficient evidence to support the conclusion that the benefits associated with the designated COVID-19 drug outweigh the risks for the purpose and under the conditions of use recommended, with consideration given to the uncertainties relating to those benefits and risks as well as the public health need related to COVID-19.

Do you remember paragraphs (2)(g) and (h)?

2(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;

2(h)substantial evidence of the clinical effectiveness….

Holy Toledo!

So even for full approval they do not have to establish safety and efficacy.

This sleight of hand in which fully approved COVID-19 drugs are assumed to have been assessed to the same standard as other drugs needs to be recognized.

My Conclusion

Health Canada isn’t lying per se when they say it is “safe” and “effective” per se. Just not really telling the whole truth. It is because…

THEY CHANGED THE DEFINITION OF SAFE AND EFFECTIVE, LIKE THEY DID FOR THE DEFINITION OF A VACCINE FOR COVID-19 DRUGS.

What does everyone think? Do you think I have this right? Any legal minds out there?

This Article by Dr. Maria Gutschi (Doctor of Pharmacology) was first published on her Substack at:

https://mariagutschi.substack.com/p/health-canadas-safe-and-effective

Dr. Gutschi testified as an Expert Witness at the National Citizens Inquiry. Her NCI Bio reads in part…

“As a Doctor of Pharmacology and regulatory specialist with extensive experience in analyzing good manufacturing practices, Maria Gutschi is well-equipped to evaluate manufacturing processes. After conducting a thorough review of #Pfizer’s manufacturing documents, she has identified glaring problems that seem to be unsolvable.”