Transcription – English – Deanna McLeod

09. Deanna McLeod.mp4: Video automatically transcribed by Sonix

09. Deanna McLeod.mp4: this mp4 video file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Deanna McLeod:
Well, my name is Deanna McLeod, and I'm a medical researcher. I'm the founder of a firm called Kaleidoscope Strategic. And we're a medical research firm that does guideline development and makes recommendations. We basically work with specialists to evaluate clinical data related to making recommendations in a giving setting. So our firm has been around since 2000 and we've worked with hundreds of specialists in Canada and we've prepared over 40 peer reviewed publications on guidelines. So we are experts in sorting through data, evaluating data, considering the data in context to see what is a good treatment and what's not a good treatment. And there's a very specific process that you go through when you're doing that type of a thing. And since our our firm's expertise is in cancer research and so we have an eye to safety. So whenever you're dealing with cancer, people are already very sick and there's a lot of extensive research that goes into safety data. And so we always come to the data with a special eye for safety. Now my particular background is an immunology and psychology. I studied at McMaster University, which is kind of the home of evidence based medicine. I actually went on to work ten years in pharma, so I've done medical marketing and sales work in pharmaceutical companies, again specializing in the field of oncology. And in 2000, after about a decade of working within pharma, I felt concerned with what I perceive to be a desire to skew information in favor of a vaccine.

Deanna McLeod:
I'm going to say vaccine or a particular agent. So what they would do is they have a way of of minimizing safety issues and emphasizing benefit. And so our team has become very skilled over the years at identifying the ways that they do this. In the medical literature, we always have an opportunity of calling that out and indicate showing that that's the case whenever we're doing an evaluation. And so what I'd like to do today is to walk you through my evaluation of the data for children and COVID vaccine. So let's just move along. So when you're working on any any type of treatment, you really need to answer three questions. The first one is, do they need them? The next one is, do they work in? The final one is are they safe? And whenever you're evaluating a treatment, you basically stop when you get a no to any one of these answers. So the first question, of course, is do they need them? If the answer is no, then you stop. It's a no go. You don't proceed forward with that treatment. And if they did get it to market because sometimes Health Canada will approve things, you don't use it. The recommendation is negative because there's no need and usually that product falls by the wayside. The second one is, do they work? And if they don't work, then you don't use them. It's a no go.

Deanna McLeod:
The final one is, are they safe? And whenever we're talking about children, that one is particularly close to my heart because they have many, many years ahead of them. So I think that one of the concerns that I have in evaluating this and whenever we're discussing the COVID 19 genetic vaccines, is that everybody is coming from the mindset that these are actually traditional vaccines and they are not. Whenever we're thinking about kids, you know, there's pediatric vaccination schedules. And some of these have been the greatest breakthroughs in medicine. They've they've played a role in eradicating many childhood illnesses. And they I think the one thing that we have to remember is that it's an altogether different agent completely. And one of the things that we do when we're starting an evaluation, even before we get to the clinical questions, is you ask yourself, what's the mode of action? How are these things working? And does it make logical sense that this would work? And that's usually the questions that you ask before you even go into clinical trials. So in this particular case, pediatric vaccines in the past, really what they have done is they've altered the virus, so it no longer causes sickness and then they're tested for decades to ensure that they're safe for use in children before they're they before they come out to market. The other thing is that they often remain localized and they produce strong, long lasting immunity.

Deanna McLeod:
So this is something that lasts for a lifetime and as a result, the child's protected from disease, and they can go about their daily activities without a fear of getting ill. So this is the context that we're coming from and that's how those vaccines work. And by and I'm just going to step out of my research role and I'm going to talk about marketing. Pharmaceutical companies were very crafty in their marketing of these vaccines because. What they did is they by calling these genetic agents this genetic material a vaccine, they basically allowed the public to take on the idea that this is just like other vaccines and it is altogether a different type of a thing, although they did say that it's an mRNA vaccine. The moment that you hear the word vaccine, then you actually think, Oh, it's just like what I know. And vaccines are always good and vaccines keep children safe. And so we're all approaching this data with this bias. You know, one of the things that we did look into was, you know, what you do is there's something called a pre marketing campaign when you're going to launch a product. So they had a pre pre marketing campaign for the launch of these vaccines. Interestingly enough, our government spent, I think it was $50 million highlighting the fact that there was a need for these things and that these were these were actually vaccines and just setting setting the whole tone.

Deanna McLeod:
And in that was a lot of money, you know, tens of millions of dollars that went into managing disinformation. So I think that that's actually kind of interesting that our government was in on this pre marketing campaign for these particular vaccines and they were already setting the stage. And all the while these are actually traditionally what you call gene therapy. So I'll get into that a little bit more. But right now what we want to do is look at do they need them? And Dr. Payne did a fantastic job of highlighting some of that. But one of the things that I would really want to do is, again, we look at the mode of action and we look at how they actually work. So with children, they're not easily infected by SARS-CoV-2 is they have very low levels of receptors in their upper airways. That's why kids don't get infected. If you if the virus can't get in, you're not infected. If you can't get infected, it doesn't replicate. If it doesn't replicate, you don't get sick and you don't transmit. So this is just basic introductory logic. They have very strong innate immune systems, which means that they can stop the virus in their tracks and they can clear the virus. As a result, they have really mild symptoms or no symptoms at all. The stats that we pulled was about 70% of kids are asymptomatic. So if a child is asymptomatic, they don't even suffer from it.

Deanna McLeod:
Then there's no need to treat. So there is no need for a vaccine. In this case, they're at very low risk of experiencing severe illness. I know Dr. Payne was talking about I mean, the statistics are incredibly low. But again, even in the early days when we were actually monitoring COVID 19 hospitalizations and they did report some instances in children, we now know that some of those were actually not due to COVID 19. They were actually kids that were in hospital for other reasons with COVID 19. And so we've got inaccurate counting going on that's creating this false perception that they're at risk of severe illness. And then again, because they don't actually the virus doesn't have a chance to replicate within them. It doesn't actually have a chance to transmit or a lower level than adults to transmit the disease. So, again, all these concerns about children, children being viral vectors and all this business actually isn't really supported by some of the basic science. I think the other thing that we all need to remember as well is that that a lot of these clinical trials were done when we were COVID 19 or SARS-CoV-2, naive, meaning we hadn't been exposed to the virus and we hadn't had a chance of developing immunity. And this is the CDC report talking about children in the United States. And what they're finding is for children 5 to 11 or 12 to 17, there's a 75% of them have antibodies circulating, meaning they've actually experienced COVID and recovered from it.

Deanna McLeod:
So the whole idea of developing immunity or needing a vaccine is to develop immunity. So if they've already immune, then there is actually no basis for treatment. So they weren't at risk to begin with and now they're already immune. So why are we moving forward with this vaccination campaign? So based on our clinical evaluation, we would have basically said product not needed, move on. I guess let's talk about whether they work or not. Now. In in whenever, whenever you're a pharmaceutical company and you really want to emphasize the benefit of your treatment, what you'll do is you'll do a relative risk evaluation. You'll you'll compare one agent to the other. And they'll say, relative to this particular agent, I'm doing better or worse. And you can sometimes really get fantastic numbers when you do that. So some of the numbers that we've heard related to these particular injections are about 90% effective. But one of the things you really have to remember is what and this is something that we always drill down and look for is what's the net benefit. So with these particular vaccines and I'm just talking about mild disease because that's the only thing that they actually measured. And it wasn't even an endpoint. A primary endpoint in the trial was there's only a net benefit of about 2% reduction in mild disease because nobody gets it and because the kids aren't sick, if you give the vaccine versus not, there was only about four or five patients different or kids different between the vaccine arm and the placebo arm.

Deanna McLeod:
So again, I wouldn't say that that's a really big benefit. And then there's a principle called the minimal intervention treatment, the principle of minimal intervention. And what it means is that if you can take care of this in another way, then you never go and treat a whole group if you can just treat the person. So if this person gets sick and you can treat them, then you treat them. You never put the burden of care on a wider group if you can evaluate it or if you can do it directly. And so again, I would say if only 2% of kids are actually benefiting from this, then this or then basically we wouldn't we wouldn't go ahead with it. So the other thing, too, is in these clinical trials, there were absolutely no events of severe disease reported. So, you know, we know that children are at risk of COVID 19 in general, and some say that we want to prevent severe disease. But there were actually no events of severe disease in these trials. Therefore, there's absolutely no ability for them to be able to say anything or to support any statement related to its ability to reduce severe disease. It wasn't an endpoint in the trial. No kids actually had severe disease.

Deanna McLeod:
And these trials. So anything that they're saying related to its ability to prevent severe episodes is complete conjecture. The other thing, too, is that the benefits, according to the six month data in adults are very short lived. They basically last two months and then they start to fade. I believe it's after two months they peak and then at 6% fade after that every two months. And in the trials, transmission wasn't even assessed. So basically one of the things we've heard is that it's the best way to protect yourself and others. But if it actually was never this transmission was never studied, then there's no basis for saying that as well. So I guess overall, when we're thinking about kids, we've already talked about the fact that it's not needed, but then the studies actually didn't even show the ability to reduce mild disease was minimal. It didn't actually show any benefit with respect to severe disease. The actual benefits that it did show in the mature data was fleeting and it wasn't able to stop transmission. So in my mind, I don't find any basis for the need for this. So we've already said they don't need them. And now I would I would basically say, based on this data, that it doesn't work. Now I'm going to I've pulled up some of the data for the toddlers trial, and I know that Dr. Payne talked about the fact that this was a disaster.

Deanna McLeod:
And I just want to walk you through some of the data, particularly related to this one. So now just to come back, the FDA recently voted to approve this particular these injections for children six months to four years. And so what we've done is we've pulled the toddler data, which is 2 to 4 years old. And I've just pulled this particular cohort because I think it's actually really interesting if we walk through it. So in the bottom right hand corner, you see that there's a number related to symptomatic cases and that's that wonderful relative risk change. That's the thing that pharmaceutical companies love to emphasize. So it's an 82% reduction in COVID 19 symptomatic cases. So then the news headlines would say it's an 82, it's 82% effective. But if you actually look at the number in the injections arm, there's two in the vaccine arm and then in the placebo arm there's five. So there's only a difference of three cases, right? So that's a total of three cases different. And so we're going to inject or vaccinate the whole pediatric population for a difference in three mild cases, which could, according to this definition, be a headache and a runny nose. Right. So this is really what we're going to do. And again, I want to highlight the fact that there were no severe cases. And then on the right, you can see that the absolute risk change was only 2% because three cases is only 2% different.

Deanna McLeod:
Now, what I'm going to do is this is an interesting trial because the trial was actually run where they the protocol was to give two doses and then test after seven days to see what the differences were. And I recall hearing that the test, the trial was negative. And so I thought, well, thank goodness they're not going to move forward with this. But what they did was they adapted the trial to add a third dose eight weeks later and then and then test it after that. And so that's the number that we're actually getting. That's three doses, seven days, eight, the third dose, eight week out, and then seven days later, they're getting this injection. So they're measuring and that's the 82%. So what we wanted to do is we wanted to say, well, what happened to these children after the first dose? Right. Because what they're doing is they're just coming along and they're just taking this slice in time and that's what they're advertising. So we wanted to know, you know, what does it look like from the beginning? So of all of the children that were enrolled in this particular trial, there was 1673 in the vaccine arm in 834 in the placebo arm. What happened with them? And when we actually look at the data and you can see something that's really interesting, you can see that there's actually more symptomatic cases that occur in the vaccine arm than in the placebo arm.

Deanna McLeod:
So that's more instances of COVID from the beginning when they get the first shot all the way through to just before they did that last measurement. You can also see that there's more episodes of multiple cases. Right, and also severe cases. This means that these studies, what they're saying is that you get your shot and then all this time later, three after your third dose and seven days later, you know you're going to get this type of result. But if you actually look at what's happening to these children between the time that they get their first dose and when they make this measurement, there's they're actually creating more instances of symptomatic cases of COVID. They're actually getting more disease. They're getting multiple cases of disease and they're getting more severe disease. And that's like a difference of 6 to 1. So we were celebrating these vaccines with an 82% effectiveness rate because there was a difference in three cases of mild disease. And yet in the vaccine arm, there is a difference of five cases, six versus one, that the arms are imbalanced. But that's 199% increase in severe disease and 149% increase in multiple cases of COVID 19. So these things are doing the furthest thing from what we think that they're doing. And that's by cherry picking. Well, they they they went on a fishing expedition and they adapted their trial to so that it would be positive.

Deanna McLeod:
And then they're also just choosing one point in time that looks favorable and disregarding the continuum of the experience of these children. So I just want to emphasize at that point that this similar pattern was seen throughout all of them so that the maximum benefit that any of the children got was 2% reduction in mild symptoms, which is could be a headache and a runny nose or it could be a fever and a runny nose. Now, the next question is, are they safe? And I just want to take a moment and talk about how they've been manipulating the word safety throughout this pandemic. And I'm I'm extremely concerned about that. So normally you would say that something is safe after considerable testing. You test, you evaluate, you say there was nothing after I've tested and then you did. And then you say I've proven safety. So interestingly enough, in this pandemic, what they've done is they've done something called declaring safety. So basically they say, well, we don't really have very much data or we're not going to look very carefully, but then we're going to basically declare that it's safe and then we're going to give it to everybody and just hope that it was true. Some sort of a thing where we're not going to really do our rigorous testing, we're just going to skip that whole thing and you know. I guess just move along. I'm not sure. So when it comes to children, there's a few real considerations.

Deanna McLeod:
First is we have to consider something called quality life years. And when you're figuring out how much safety testing you should do, you have to say, who's the population? How long are they going to live so that if an injury happens here, how many quality life years have we basically jeopardized? So our children are our future. They have 70 quality life years ahead of us. So if we're ever going to be serious about safety, it would be in those in those children. We need to do more testing. We need to be even more safe. The other thing, too, is that we know in adults that there are rare side effects, like myocarditis, that could have lifelong consequences with these children. So therefore, we need to design our trials and our safety trials and our testing so that we can actually detect things that are like one in 50,000 or one in ten. We know that these things are causing sequelae. So and the other thing too is that it's new treatment. So this is gene therapy. And as Dr. Payne mentioned earlier, this hasn't been actually used in humans. In fact, I was reading through the FDA regulations and maybe there's some instances where it might be used or it's being tested for advanced disease. But generally speaking, the the requirements for safety or the recommendations for safety for the FDA are 15 years of testing if you want to use gene therapy in a broader population.

Trish Wood:
Deanna, we're really low on time. Okay.

Deanna McLeod:
So I'm going to move it along.

Trish Wood:
Sorry.

Deanna McLeod:
Okay.

Trish Wood:
Yeah, well, so I. I can't read that.

Deanna McLeod:
Okay. We're going to move it along. So the bottom line, we're almost done. So that's 80,000. So if we were to do proper testing for this, we'd want to follow these children for 80,000 children for 15 years. That would probably do it in terms of the safety testing. And so what we've done is we've done two months of testing and 2500 kids per age group. So the bottom line is that we're not looking and if you don't look, you don't find and you certainly can't declare and prove safety based on the available evidence. So for any parents who's out there who's listening and they're saying it's safe, it's safe, it's basically a declaration of safety and not evidence of safety because the safety testing hasn't been done.

Trish Wood:
Great. Thank you very much. It's a wonderful presentation and I think it's something for everybody to really seriously think about. But I don't think we have time for questions.

Deanna McLeod:
Okay.

Trish Wood:
So let's just see. Do they need them? No. Do they work? No. Are they safe? No.

Deanna McLeod:
So I'm.

Trish Wood:
Done. Okay. Okay. One quick question. I can't say no to Preston.

Preston Manning:
Who do you do this research for? Does the government itself contract for this type of research?

Deanna McLeod:
So we this is actually pretty interesting. So our our main source of funding is through pharmaceutical companies. So we actually either work directly to for pharmaceutical companies or we get grants that are then applied that are given to different bodies that we could then actually get hired for. So, I mean, some of our clients are pharmaceutical companies and this is the same process for everything. But more recently what we've been doing is we work on guidelines and for instance, BC Cancer Agency would hire us or.

Preston Manning:
Alberta government itself doesn't commission this type of.

Deanna McLeod:
Oh, no.

Preston Manning:
Not not from you.

Deanna McLeod:
Okay. Yeah, that's right. Well, thank you very much.

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