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Emergency Rolling Reviews Replaced Proper Safety Testing

Day 4 · 3:55:04 · Deanna McLeod

  • ⏱️ Products approved after only two months of RCT data via rolling review instead of multi-year safety proof.
  • 📱 Follow-up relied on phone apps; almost no exams or lab biomarkers were required.
  • 📉 Nordic 23-million study confirming youth risk arrived two-and-a-half years later—after mass harm.

Regulatory shortcut turned post-market monitoring into harm detection.

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Transcript

Deanna McLeod · 3:55:04

So on the far left-hand side, you can see that, uh, that's kind of time zero, and that's whenever the, the mRNA product was rolled out. And it was, it was rolled out based on level 1 evidence, which is a randomized controlled trial, but only 2 months of level 1 evidence. It was a fairly large study, but it's very difficult to understand within 2 months if something could be harmful to the heart or not. A little bit longer, so each of those bands afterwards are 6-month intervals. So a little further along, you get the 6-month follow-up data for the randomized controlled trial, specifically for Pfizer. And in that trial, which came out, you know, in September 2021, you have this— if you actually looked and analyzed the deaths, you have 9 cardiovascular deaths in the mRNA product arm and 5 cardiovascular deaths in the placebo arm. So what that tells you— and this was a population of healthy individuals— so there was a signal as early as, you know, 6 months after rollout.

Deanna McLeod · 3:56:04

But I'm just going to pause right now because, um, I just like to explain something about the regulatory framework. So on a normal regulatory framework and standard practice, you a pharmaceutical company would have to prove that a product was safe before it accessed the market. So you prove safety and you do that through rigorous testing. The testing would include clinical examinations, it would include, you know, lab work. You'd look for biomarkers, you do extensive testing. It would take years to complete that trial. And then at the end of the trial, you would look at the results and you would be able to say, is it safe or is it not? And does it meet the standards for regulatory approval. However, during the pandemic, because this was a public health crisis, a new emergency framework was put in place and they were able to conduct approvals based on what they call rolling reviews. And a rolling review basically means that you get to take sneak peeks at the trial, and if there's an early sign of benefit, then you actually get to approve the product based on that early data.

Deanna McLeod · 3:57:06

So these products were approved based on 2 months of data. And if you were to actually consider how carefully they were looking at them, they were basically— the patients had a phone app and they would basically say, did you get this?

Speaker N · 3:57:17

Did you get that?

Deanna McLeod · 3:57:18

Did you not get that? Little clinical examination, no lab marker, no lab reviews. It's not a standard clinical trial. All of that to say is that the 6-month, we see that there's some trouble. They're relying on post-marketing, on pharmacovigilance data. There was a report 3 months later from Pfizer and it basically highlighted that there were Serious cardiovascular deaths worldwide, 1,403 cases and 135 deaths after the rollout. That's within 3 months. So we approve it at 2 months. At 3 months, there's these— this report from Pfizer. They had to hire new staff because there were so many side effect reports from the vaccine rollout. The 6-month data comes out. Still, there's not a lot. The Israeli study, which is a matched cohort study, which is fairly reliable in terms of, you know, maybe moving the needle in terms of people acknowledging a side effect. And then Ontario Public Health comes out and says, oh, myocarditis, there's an alert.

Deanna McLeod · 3:58:23

So we're concerned with the Israeli study because there was more people getting myocarditis with the Moderna than the Pfizer. It's not like don't take it, or let's start risk profiling people, which is what you should be doing. It was take the Pfizer and not the Moderna and you still can't get an exemption for your vaccine. Sorry, don't go to school, don't go to your job or whatever it was. So this is abnormal clinical practice. I've never seen this before. We don't do this in cancer. A little bit further along, Dr. Davidson mentioned the Nordic matched cohort study. It was a very reliable study, fairly well structured, 23 million people. They only looked for 28 days after, so this is a very short time frame right after the mRNA product rollout, and they basically said this— there's a real risk in young people. So I just want to say, by the time they were able to get a properly designed study, it was 2 and a half years later. So what this means is that the product was put on the market, people were harmed for 2 and a half years, because we were negligent in doing our safety testing prior to rollout, and then we acknowledged the harm.

Deanna McLeod · 3:59:35

So this whole idea of rushing a product to market for the good of the people is ridiculous, because what we're actually doing when we do rush a product is we monitor not safety but harm. And the people who witness today are the people who've been harmed by this negligent regulatory practice. Which needs to stop. So I'm just going to zip to another set of slides, and these are ones that we presented in Washington at the President's Council panel in June 2021.