Expert commentary on the regulatory requirements regarding pharmaceuticals sold in Canada, particularly around product monograph (an owners manual for a drug). Inquiry on why the Pfizer vaccine and other vaccines remain on the market.
Now switching gears, I’d like to announce our next witness, Alan Cassels. Alan, can you please state your full name for the record, spelling your first and last name?
My name is Alan Kenneth Edward Cassels and it’s spelled, A-L-A-N C-A-S-S-E-L-S.
And Alan, do you promise to tell the truth, the whole truth, and nothing but the truth, so help you God?
Now just to introduce you, much of your professional experience has been in studying pharmaceutical policies and reporting on medical evidence [Exhibit VA-3, CV].
You have a master’s in Public Administration. You have worked on over twenty separate pharmaceutical policy studies over the last twenty-eight years and have published dozens of peer-reviewed publications on many aspects of drug marketing, evidence-based medicine, and rational prescribing. Is that correct?
For the last four years, you worked for the BC UBC Therapeutics Initiative, and I’m wondering if you can explain for us what that is.
So the Therapeutics Initiative [TI] is a group at UBC that’s funded by the provincial government, by the Ministry of Health. It’s been in existence since 1994, and I’ve worked for this group on contract many times in the past. I was hired on salary in 2018. They produce probably the best and highest quality drug information of any agency of its kind in Canada and does so sometimes at great cost in terms of criticism from the pharmaceutical industry. When the NDP were campaigning in 2017, the then health critic, a guy named Adrian Dix, said if the NDP took power, they would double the funding of the Therapeutics Initiative, and that’s exactly what happened. And that’s how they got the money to hire me.
Right, but I want people to understand. So this is an initiative that evaluates drugs without pharmaceutical industry influence?
We welcome you back to the National Citizens Inquiry. We were starting with Alan Cassels, and we were discussing the UBC Therapeutics Initiative project, and then the power went out, and our systems went down, and we would have lost a bunch of people following us on the various platforms. We apologize for that. It was an item that was out of our control.
So we’re going to pick up. Alan Cassels is still on the stand. Alan, I’ll remind you that you’re still under oath. Can I ask you again, because we’re not sure where we cut off, if you can describe for us the UBC Therapeutics Initiative?
Yeah, so the Therapeutics Initiative was formed in 1994. It’s funded by the provincial government, the Ministry of Health, through the pharmacare program. It does hard-hitting critical analyses of drug evidence and publishes that information in newsletters that’s distributed to something like 9,000 doctors in British Columbia and pharmacists on a website. It does presentations and does basically pharmaceutical education for physicians and pharmacists.
And just again, so that people fully understand. So this is an initiative that analyzes pharmaceutical drugs to determine their safety and efficacy and whether or not they should be used. And it’s completely independent of the pharmaceutical industry.
And you have participated for four years. Which is just getting back to the fact that you are an expert in evaluating pharmaceutical interventions.
I’ve got a couple slides of my bio if you want me to throw it over.
Oh, sure, sure. So yeah, let’s launch into your slide presentation [Exhibit VA-3a], and then I’ll just ask you questions as they arise.
Right. So are my slides up there? I can’t see.
Your slides are up.
Yeah, so the most important thing you need to know when someone’s talking to you about drugs is where they get their money from. And it’s very important to have a disclosure statement on any presentation. My disclosure: I’m a former employee for the Therapeutics Initiative, and in 29 years of doing this kind of work, I’ve never had any financial conflicts of interest with companies that manufacture pharmaceuticals or sell pharmaceuticals. Currently self-employed, and I do receive some money from the sale of books I’ve written.
Just to add to the brief bio: I graduated from the Royal Military College with a degree in English. I served for 12 years in the military as a Naval Lieutenant, did two peacekeeping tours. I’ve got a master’s degree in Public Administration from the University of Victoria, and I started doing drug policy research in 1994. I’ve probably been involved in more than 20 research studies in that area in Canada and BC independently, usually funded by either CIHR [Canadian Institutes of Health Research] or provincial funding bodies.
I’ve published quite a few pieces, including probably over 400 articles. I was a columnist for Common Ground Magazine for 12 years. And I’ve lectured to university classes in a variety of subjects in journalism, actuarial science. They had a really cool grant that I won about 15 years ago where I travelled to every single journalism school in Canada to give them a workshop on how to report on prescription drugs. And I’m sure those students have lost those lessons now.
One of the things I’m very proud of, in 2012, my Member of Parliament Denise Savoie awarded me the Queen Elizabeth II Diamond Jubilee Medal, and she cited my work as an author and a pharmaceutical policy researcher and a consumer advocate. And those are the books that I’ve written, including The Cochrane Collaboration, the last book.
Cochrane Collaboration, a very important organization, does what I would consider to be gold standard drug evaluation evidence, meta-analyses of high-quality evidence, and try to get the truth out. They’ve undergone a fair bit of controversy in the last few years, though the Cochrane Collaboration researchers, people like Dr. Tom Jefferson and Carl Hannigan, were people that formed part of that book, and they were the ones that were instrumental in doing the major analysis of the masks and determining that masks simply—there’s no evidence that they have any effect.
I’ve written for Reader’s Digest, there’s just an example.
So the thing that I really focused on over the years has been kind of this gap between what the evidence says about drugs and what the marketing says. And usually there’s a large gap.
And there’s almost always controversy regardless of whether you’re talking about a drug or a vaccine because those who create the product want as large a market as they can and those who use it want to be using it in the most appropriate way possible. And those two values conflict with each other.
Let me just say a little bit more about the Therapeutics Initiative. I told you that it critically evaluates drugs. The TI has a history of doing some really important things in British Columbia. For example, the COX-II inhibitors, drugs such as rofecoxib, also known as Vioxx, which came out in the late 1990s, was on the market a number of years. The BC Therapeutics Initiative was probably the first group in Canada to raise the alarm that there were problems with the trials. The trials were fraudulently reported. The BC government subsequently restricted the use of those drugs to a small population in BC, probably saving 500 to 1,000 lives. It’s really important to get the evidence right because people’s lives are at stake.
Again, I was hired as a communications director in the last four years. And I can tell you, not being able to say anything sitting at my desk while COVID was unrolling was very difficult. One thing that I really found personally quite difficult was the language that journalists and neighbours and friends would use against people that weren’t vaccinated, using language that I would consider to be quite bigoted and discriminatory. And so I wrote a letter to the editor of The Globe and Mail, and this is part of my story because it might have been the reason why I got fired. It was 142 words long, and I’m going to read it to you, and it goes like this. I was responding to an editorial that was entitled “Driven by Misinformation,” the thrust of that being that people who were vaccine hesitant or otherwise questioning the value of COVID vaccines were ignorant and moronic.
Responding to The Globe stance, I said:
I don’t see my unvaccinated friends, neighbours, or colleagues as misguided, misinformed ignoramuses who spout conspiracy theories and propagandistic clichés. Maybe I don’t get out enough.
They are mostly highly educated, a class that includes university professors, engineers, researchers, doctors, librarians and even some journalists. I find that these are intelligent people with nuanced interpretations of science who spend a lot of time reading the annoying small print of research studies and asking awkward questions. I therefore find it tiresome when they are labelled as misinformed ignoramuses who don’t “follow the science.”
And I end this by saying:
In the drug-safety world, there’s a truism: Drug safety never leads, it always follows. It is a sentiment that might be best summed up by a line from the singer Tom Waits [who said]: “the large print giveth and the small print taketh away.”
So that is the simple three paragraph letter to the editor where I was talking about how The Globe was characterizing our unvaccinated friends as being stupid ignoramuses.
This is what happened next to me. Several days later, I was called into the office of my bosses with very stern and dour looks on their faces, and they said, “You can’t be out there publishing letters like this critical of government policy.” To which I said, “Excuse me, but I don’t know if you’ve read my letter. I didn’t talk anything about government policy. I didn’t mention Adrian Dix or Bonnie Henry or anything about vaccine mandates or any other things. I mentioned The Globe stance, their bigotry against unvaccinated people, the same kind of bigotry that we see expressed by even politicians, such as our own prime minister.” And I was told specifically, “This could jeopardize our funding.” And I sat back and said, “Wow, these are crazy times we live in if that’s the case.”
So the way that I read your reply, is really you were replying to what in normal times we would have considered hate speech, and you were saying, “No, this isn’t appropriate.”
And you actually are getting sanctioned for that from your employer.
And I don’t know how they could have made the leap between me criticizing The Globe and Mail and me criticizing government drug policy, but you know this crazy world that we live in. Anyways, three months later I was told to pack up my desk, hand in my keys, hand in my computer, and I left the building. And so I’ve never worked for those guys again. Unfortunate. And I was never really given a proper reason why. Because this is called fired without cause: they don’t have to tell you why.
So let’s get on to my talk. What does the research say? And I realize that you’ve got some very smart people presenting here. I’m going to stick to a very specific thing that I know a little bit about, probably more than other people. And that is the regulatory requirements when it comes to information about a pharmaceutical that’s granted a licence for sale in Canada. First of all, I’ll talk about Health Canada’s product monograph. This is a really important document.
So what is a product monograph? In a nutshell, a product monograph is like the owner’s manual for your drug. When you buy a new car and you open the glove box, you get an owner’s manual; it tells you everything about it. A product monograph does the same thing about your drug: It tells you the properties, the claims, and the indications. These are essentially the conditions of use that may be required for the optimal safe and effective use of the drug. Very important. We call it a product monograph in Canada; in the U.S., they call it the approved product label. It’s a very hefty document. The approved product label for the Pfizer COVID vaccines is about 83 pages long, a significant document.
The most important word, in my opinion, in a product monograph is the word “indication”: Indication means, what is the drug used for? What is the approved use of that drug for treating a particular disease? So if the regulator, Health Canada or the FDA, determines there’s enough evidence to approve a drug for the indication, that is the treatment of the disease, the indication becomes a labelled indication. They’ve essentially determined that there’s enough evidence to suggest that the indication will have some help in a particular type of patient and that the drug company is able to market their drug with that information. For example, if they say this drug is used to treat toenail fungus, that’s the indication, toenail fungus. They cannot go on to say, “We think this drug is good for lowering cholesterol.” That’s a non-approved indication. That’s a really important distinction.
So the manufacturers are not allowed to market their drugs for indications for which they have not been approved in Health Canada.
I’m going to give you an example. This drug—this also happens to be a Pfizer drug—but it’s now generic, made by many generic manufacturers. And this drug, by the way, was probably the world’s biggest blockbuster drug ever produced. As you know, Pfizer is the world’s biggest drug company. This drug made the company billions of dollars over the years. It has a very, very specific indication, and I’m going to show it to you.
It looks like this. It’s a 56-page document. This is on Health Canada’s website, the “Product Monograph—Atorvastatin/Lipitor.” So there’s the three indications. Just to be clear, it’s indicated to reduce the risk of myocar — Let me translate this. It’ll reduce the risk of having a heart attack in adults, not kids, that have high blood pressure, hypertension but not clinically evident coronary heart disease, but with at least three other additional risk factors for coronary heart disease: such as you’re over 55; you’re male; you have abnormalities on ECG, et cetera. And it’s also indicated for patients with type 2 diabetes and hypertension, without clinically evident coronary heart disease. And it’s indicated to reduce the risk of myocardial infarction in patients with clinically evident coronary heart disease.
One thing you should know is that high cholesterol is not a disease. High cholesterol may be a risk factor for a disease, but thanks to the marketing genius of the pharmaceutical industry, they’ve taken high cholesterol and turned it into a disease in and of itself. However, that does not mean that the company’s able to market this drug
beyond the indications that are in the product monograph. So you’ve got an 85-year-old man with high cholesterol but no history of heart disease. Should he be able to take Lipitor? How about a 70-year-old woman who has normal blood pressure, smokes, and has high cholesterol? How about a 50-year-old male bricklayer who has a stent in his heart, et cetera? A 27-year-old pregnant woman or a 32-year-old woman who has toenail fungus? Again, the answer to this, this is one of my skill-testing questions, is that none of these patients are indicated to take that drug.
I can tell you if we have a hundred people in this room over the age of fifty, probably forty of you are going to be either on a cholesterol-lowering drug or have been offered a cholesterol-lowering drug in your life to reduce your risk of a future heart attack. And if you don’t have coronary heart disease and never had a previous heart attack, the drug is doing nothing for you. You’re wasting your money and you will have no effect of lowering your cholesterol. If you have had a heart attack and you fit the description in the indication, you might have a risk reduction of about three per cent. That’s the best that we’ve seen cholesterol-lowering drugs perform, which is to say that of the 100 people that get prescribed the cholesterol-lowering drug, 97 of them will have no effect. They will have wasted their money. Three per cent might have a reduction in a future heart attack.
So most important point here, companies cannot market their drug for off-label purposes—purposes for which it hasn’t been studied or approved. So why don’t they market their drugs for off-label? You can imagine if you’re a drug company, you want as much stuff in the label as possible. You want your drug not just for adults who have coronary heart disease and high cholesterol and hypertension. You want it to be used for everyone. That’s where the market is. It’s for everyone. You want it to be used in pregnant women, in kids, because that’s what grows the market. And the way it was described to me, an official at a pharmaceutical company once said to me, we go to war for the label, which means that’s the make or break. We get as much stuff into the label as we can because that determines how big our market can be. Because if it’s not in the label, they can’t market for that, but they do.
And here’s an example of, okay, I’m not picking on Pfizer, but this just happens to be Pfizer again was caught illegally off-label marketing a number of drugs: Bextra, Geodon, an anti-psychotic, an antibiotic, and several other treatments. Ended up paying the largest healthcare fraud settlement in history. This is a criminal fine of more than two billion dollars. You might say, “Well, that’s a pretty big fine for a drug company,” but if you realize how much they made off even the sale of one of those drugs, it would be like getting a parking ticket for you.
So let’s look at the vaccine. The product monograph, and I’m just going to use the example of the Pfizer vaccine because it happens to be handy here. Again, it’s an 83-page document. Strange though, the product monograph didn’t hit the streets until September of 2021. I’m not sure when they started actually injecting this drug into the arms of Canadians, but I’m pretty sure it was before September 2021. Which is to say, none of the physicians, nurses, or anybody administering this vaccine had actually read the product monograph, and certainly none of the patients getting injected could have read the product monograph to know what it was indicated for.
So can I just interrupt? So for informed consent, physicians and nurses, if they’re administrating a treatment, are supposed to be able to tell the patient about risks and benefits and the like. And that’s the information that would be in the product monograph.
And so basically, without that even being available, physicians and nurses administrating this vaccine—
What were they administrating, on the basis of what? I don’t know. I can’t answer that. But they certainly weren’t doing it on the basis of the product monograph. They might have had an interim something that was provided by Health Canada, maybe. But let’s look at what the actual product monograph for this vaccine says. By the way, if my slides are available, every document I’m talking about is linkable in the slides.
I can tell you that the slides have been made an exhibit in these proceedings. So they’ll be available to both the commissioners and the public.
And I believe it’s [Exhibit] VA-3a, it will be your slide presentation.
Okay. So this vaccine—I don’t even know how to pronounce this, this is weird. Comirnaty, something like that, is that how you pronounce it? Anyway, let’s call it the Pfizer vaccine. It’s “indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 [SARS- CoV-2] in individuals 6 months and older. Page five of the monograph sets out in black and white what this drug, and I’ll call it a drug, is indicated for. So the primary endpoint, you have to actually go further into the product monograph to figure out what do they mean by “active immunization,” what is the actual endpoint. And the primary endpoint on page 62 is defined as any symptomatic COVID-19 case confirmed by the PCR test. So you have to have two things: You have to have a symptom, and the symptoms are listed in red, one of these symptoms—fever; new or increased cough; new or increased shortness of breath; chills, et cetera. And you have to have a positive PCR test. That’s basically the case. And that is what the product is indicated for.
So my question to you is, if someone is out there saying this product is good for toenail fungus, what are you going to say? You’re going to say, “Well, is it in the product monograph? Has it actually been tested to treat or prevent toenail fungus?” Well, no, it’s not in the product monograph. “Does it prevent hospitalizations? Does it prevent deaths? Heart attacks, strokes, cancer? Does it prevent viral transmission?” And the answer, of course, is no. It did none of those things. The product monograph states that all it does is reduce symptomatic COVID with these kinds of symptoms and a positive PCR test.
And this is what drives me crazy because the public health people are saying things that the pharmaceutical companies are not allowed to say. They would get criminally charged for saying those things. But yet, you’ve got people telling me, “This vaccine is going to keep you out of hospitals; it’s going to prevent deaths; it’s going to prevent heart attacks, strokes, et cetera; and it’s going to prevent viral transmission.” And I really want to focus on the viral transmission because I think that’s probably the most important part of my talk. And it’s the most important part of what transpired in COVID. It has to do with transmission.
You know, I looked at the flu vaccine more than 15 years ago. And I can tell you, if the flu is any indication of what this disease became, none of the flu vaccines are approved to prevent transmission. To actually prove that your vaccine prevents transmission, you would have to have a massive trial, enroll hundreds of thousands of people and take several years. It’s just not going to happen. It’s way too costly. You’re never going to be able to do it. So transmission is definitely a non-starter.
Here’s a skill-testing question for the crowd. So how many of the six federally approved COVID-19 vaccines in Canada are indicated to prevent viral transmission? The man at the back has it right with the big goose egg. None are approved to prevent viral transmission. So, in fact, I’ve read through every single one of these product monographs. And it’s a lot of reading. And the word transmission does not even appear in the product monograph or any of its correlates. Did they say viral conveyance or passing it on or anything like that? No, not in the product monograph. Therefore, again, I’m reiterating the point: the manufacturer is prevented by law from claiming that their vaccine prevents viral transmission to other people.
So you ask me, why are you focusing on transmission, Alan? Because I think the key marketing strategy for the vaccine, and I would call it a marketing strategy, the fear was a big thing. My first book, Selling Sickness, was really about the marketing of fear: It wasn’t a marketing of fear for pandemics, it was a marketing of fear of the lipids in your blood; the level of your blood pressure; the score on a test that can test whether you’ve got early signs of Alzheimer’s and so on. Fear is a very important motivator.
As the marketers like to say, “You don’t sell the steak, you sell the sizzle,” in the sense of, if you want to drive your market as big as possible, you have to get people motivated. And one of the main ways that we motivated people to get vaccinated other than— I won’t say this was evil but genuine appealing to people say, “This might actually save you from getting COVID.” You might say, “Well, I don’t care if I get COVID.” “Well, that’s fair enough. Oh, but it’s going to help you protect your grandma because you will not be able to transmit it to grandma.” And it’s like, “Wow, okay, that’s a reason for taking it because it’s going to save grandma.” It’s not true though. None of the vaccines have been studied to prevent transmission and none of them have been approved. So whether you were vaccinated or not made no difference to grandma.
And so we said, “Let’s follow the science: where are the research studies indicating that the COVID vaccines prevent viral transmission?” They’re not available. They don’t exist. Again, why is this important? I think the mandates and the force pressure on the public really caused very deep rifts in our society. I refuse to get a vaccine passport just on the principle of the thing. Because allowing this kind of discrimination in facilities seemed to me just so wrong on so many levels. As I explained to some of my friends: if you lived in Victoria a hundred years ago, they would have signs in restaurants or in saloons that would say ”No Indians or dogs allowed.” It was perfectly allowable at the time, a discrimination of a certain class of people. And that’s exactly what I saw the vaccine passport as. There’s a sign of the royal Simba Club: “No Dogs or Indians” allowed.
So the vaccine passport became a very harmful thing to do. I mean sure, encourage people to get vaccinated, do that, but to say that they can no longer go in to see their parents in a hospital or to go to a movie theatre or go out. In the case of British Columbia, we couldn’t go to restaurants for what was it, seven months, or something like that?
Further on, not just the science that didn’t go into the product monograph, this was kind of reinforced by epidemiological studies. A number of epidemiological studies were done in the U.S. and Germany and Vietnam and Israel, and they basically found that the vaccinated people are equally able to carry the virus as well as the unvaccinated, or should I say that there was no difference whether you had been vaccinated or not. You could still be a vector for the disease. And when I argue with my fiercest critic on this, who happens to be my wife, she says “Yes, but wouldn’t the people who, if the vaccine reduces your symptoms, then wouldn’t you be less likely to pass it on?” And I said, “Yeah, show me the study.” No, there’s no studies. Sounds good in theory, but I’d like to flip that over. What if getting the vaccine is more likely that you pass it on because you can go out into the community and you have no symptoms, and you become the vector for the disease? So this is kind of my main thesis: anything that can help you, can also harm you.
And any theoretical idea such as “the vaccine might prevent some level of illness in the person, therefore it’s going to prevent them from transmitting to others,” that’s a leap in logic that hasn’t been studied. And when we have looked at it through epidemiological study, there’s no difference. My summary: based on my review of the studies of the approved COVID vaccines, there are zero randomized trials that have shown any effect on viral transmission. And this is the kind of thing that I think good journalists would have asked right at the beginning: “Show us the evidence, show us the beef. Where is the research that shows that these vaccines are preventing viral transmission? Because your whole vaccine coercion apparatus—your passports and so on—is based on it preventing viral transmission.”
Something really interesting, I just had to add this in the last few days or so.
This group in the U.S., they call themselves The Coalition Advocating for Adequately Labeled Medicines. They’re concerned that products are on the market, but the regulator, in this case it’s the FDA or Health Canada, don’t actually go back and revisit the label. When you get new information, you should be rewriting the label, so people can stay up to date if they use the product label as something to guide their behaviour. This group, CAALM, had a petition that they sent to the FDA about three months ago, I think it was the end of December—no, in January. And they asked the FDA, “Can you make these amendments to the product monographs of some of the vaccines?” They said, for example, can you “add language clarifying that phase III trials were not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death?” They’re just being nice and say, “Can you just re-write the—because we know this is a true statement and that should be reflected in the label.”
The response from the FDA is hilarious. This guy Peter Marks responds, and this was in the letter that he responds. He basically told this group—he kind of told them in a sense to piss off, “we’re not going to change the label very much.” But he did say, to that point about “Can you add something in there about the vaccine doesn’t prevent viral transmission?” He says, “The vaccines are not licensed or authorized for prevention of infection with the SARS-CoV-2 virus or for the prevention of transmission of the virus, nor were the clinical trials supporting the approvals and authorizations designed to assess whether the vaccines prevent infection or transmission of the virus.”
So he’s essentially saying what I’m saying: there’s no evidence—“We didn’t actually approve these treatments to prevent transmission of the virus.” And he’s right. They didn’t approve. But everyone else from Bonnie Henry all the way up to Joe Biden was telling you, they’re making this claim that these vaccines were preventing transmission.
So another way to say this: They basically said, “Could you revise the label stating that it doesn’t prevent infection?” The guy says, “We never said it. The FDA is not making that claim that the vaccine prevents transmission, but others, you know, high officials in the U.S. health establishment, politicians, media pundits, and so on. So we’re off the hook here.” I found that really interesting because it’s kind of like— Who is doing the marketing for these vaccines? I mean, imagine making a product, and the pharmaceutical industry spends more than a third of its budget on marketing, communications and marketing. It’s very important. They have to sell the drug to the physicians and the pharmacists; they have to spend a lot of time convincing people of the value of the drug.
But in this case, they just have to stand back because all the politicians, the pundits, and the public health people are going out there making claims about their products that aren’t true. So they’re off the hook. They’re not going to face three-billion-dollar fines, and they can stand back and be perfectly innocent. I mean, it’s so crass and savvy at the same time.
Just a little bit about—and I think other speakers are going to go into this in great detail—about the post-market adverse reactions and so on. This is actually in the label, and I don’t think you would have seen it in the earlier versions of the label. This is now in the label that the following adverse reactions have been identified: cardiac disorders, immune system disorders, musculoskeletal conditions, et cetera. Knowing that that’s in the Health Canada approved product label, could you make the statement that these treatments are effective and safe? Well, you would have to have a very interesting concept of the word safe in order to make that statement, given the list of potential serious adverse reactions.
But probably the most important study, and I hope others will be talking about this at your hearing, was this study that was published online in August 2022. They looked at the two mRNA vaccines, so the Pfizer one and the Moderna one, and they combined the results of them and looked at what was the likelihood— Now these are big trials by the way, there’s 40,000 people in the Pfizer trial, and the Moderna trial is equally as big. When the trial is that big,
you know that the risk of the condition is very small and the likelihood of any benefit from the treatment is also very small.
Anyway, they looked at these very closely and found something that we have suspected for quite a while. We suspected this when we first saw the first published trial of the Pfizer vaccine, which was spoken about earlier today, that the adverse events outnumbered the reductions in hospitalizations. For example, in the Moderna trial, they were two and a half times more likely to suffer a serious adverse event from the vaccine than being hospitalized with COVID. This is not Alan Cassels speaking; this is published data in Vaccine, probably the world’s premier peer-reviewed journal in vaccine research. Has anyone ever seen any report in the mainstream media about this? And the Pfizer harm: serious adverse events, 10/10,000 [subjects]; hospitalizations, -2/10,000 [subjects]. So the Pfizer vaccine harm was four times higher than the reduction in hospitalizations.
Can I just stop you there because you’re making a really important point. You’re basically pointing out that Pfizer and Moderna’s own clinical trial data shows that the vaccine caused more hospitalizations than COVID would. But my question is, what was the age population? Could we— And then I want to move to kids because my understanding is that children have basically a zero risk of being hospitalized. And so can you kind of explain how much worse the situation is for us vaccinating children?
Yeah, I don’t know exactly how many children would have been included in this trial. I think it was mostly adults, depending on your definition of child whether it’s five to sixteen, or five to seventeen, so I don’t know the actual answer to that. The principle here is—the only reason you would take a treatment that might have a risk is that you’re at high risk of having the condition in the first place. And we know that children were at very low risk of developing any complications and serious adverse effects related to COVID. Therefore, your risk reduction changes.
So if I’m a 50-year-old guy with high cholesterol, high blood pressure, diabetes, and a bunch of other things, my risk of having a heart attack in the next ten years might be ten per cent, whereas someone who’s my age but is a super-fit cyclist and doesn’t have any of those things might only have a risk of three per cent. So the likelihood of any benefit from whether it’s a drug or a vaccine is different. For the guy who’s got a ten per cent risk, you can reduce that: you might even reduce it down to five; you could cut it in half. Well, the guy whose risk is three per cent or two per cent to start with, he has a very low chance of benefit. And that’s the same principle with children: that if you’ve got a low chance of being harmed by the disease in question, you have an even more infinitesimally smaller chance of having any benefit from the treatment.
And just my last thing, and then I’ll let you carry on. What struck me with that is that the Nuremberg Code does not address just consent. But one of the provisions is that once you are aware that a treatment that you’re testing is causing more harm than benefit,
then you’re violating the Nuremberg Code; you have to stop immediately. So it seems odd that this product wouldn’t have been withdrawn from the market.
Oh, any other product would have been torn off the market in a heartbeat. Because this is not a vaccine. It’s like a whole different sacred territory. I can tell you that there are many drugs that have been taken off the market for much less harm than this, let’s put it that way, okay. Though it’s very difficult to get a drug taken off the market. Often what happens is that they will change the label, and they’ll say, “Well don’t use it in this population; don’t use it in kids anymore.” So they’ll change the label. But actually to withdraw a product off the market, it’s time-consuming. You got to be dedicated to it. And the fact that there are still public health people promoting the life-saving benefits of these vaccines in light of published research like this is, frankly, part of these crazy times we live in.
So I have to comment, and then I’ll let you go on, because you say it’s really hard to take a drug off the market.
I’ve spent 29 years as a lawyer where roughly half of my practice is standing up to Health Canada on behalf of manufacturers and vendors of natural health products, which are drugs and regulated as drugs. And any complaint, however minor, and that drug is off the market immediately with the full force of Health Canada.
That’s because it’s not a level playing field, as you know. Natural health products get treated way differently than pharmaceuticals. Because the pharmaceutical companies will say, “We have double-blind randomized controlled trial evidence that proves the effectiveness of our treatments. Plus, we have lots of money that we give to Health Canada to keep their operation running, whereas you natural health people, you can’t patent your product and you’re a threat to our business model.”
I think you’ve hit the nail on the head in so many ways. And when you say, you can’t patent the product because the new drug approval process is about protecting intellectual property rights.
Yeah. I remember a Health Canada employee once saying, I said something like, “Well, what about the patients at the end of the day?” And her response was, “Well, we’re not in the patient-safety business; we’re in the patent-protection business.” It’s like, oh my God, the truth comes out.
I know and let me tell you a funny story. I’m not supposed to give evidence, but I just, I can’t resist. So I’m running a trial where Health Canada has charged a company for selling a natural health product without a drug identification number. And this was before 2004 when we had the NHP [Natural Health Products] regs, so you really couldn’t. And I’ll tell you that the client was found to have contravened the law, but the court acquitted the client, saying it was legally necessary or more people would have died. Because people died, and the court found as a matter of fact that Health Canada restricting this product caused deaths. And in fact, the Canadian Mental Health Association would hold a press conference every time there was a death to shame Health Canada.
But I have a Health Canada inspector on the stand; I think her name was Sheila Wheelock. And I think I’m setting her up for a trap question down the road. And one of the questions, my setup—and I just thought it was “a gimme” because I didn’t understand that it’s not about health at Health Canada—is I said something like, “Well, you know, as a Health Canada inspector, you’re there to protect our health.”
“No.” Like what? And I keep trying to circle around and get her to agree, and she explained to me, quite rightly, “No, we’re there to enforce the law, which is the Food and Drugs Act and Regulations.” And I challenge anyone to find in the Food and Drugs Act or Regulations anything that puts an onus on Health Canada to protect health or actually even the public interest or to have good health outcomes. And would you agree with that statement?
Yes, I think the regulatory capture of our drug regulators, as I can only speak of that with some insight, has been almost complete. When I say regulatory capture, you say to Health Canada, in the drug regulatory side of things, “Who is your client?” You know, anybody in this room—if you ask Health Canada, “Who’s your client?” you say “It’s the population of Canada. The government pays for us to regulate products to keep Canadians safe.” That’s what everyone in this room would say; everyone watching this online is going to agree to that. But no, that’s not the case. Their self-proclaimed purpose is to ensure that the people who are paying them, in this case the pharmaceutical industry, is getting what they want. The pharmaceutical industry is “the client,” right? When you’ve got more than, say, 60 to 70 per cent of the regulator getting its funding from the companies that it is actually regulating—this is an ass-backward situation.
It would be like saying, let’s fund an organization with the major oil companies and we’ll put them in charge of Canada’s climate science regime. That would be great. Or let’s get all the tobacco manufacturers and let them decide which cigarettes should be sold in Canada and how they should be sold. It’s absurd. There’s no way in the world we’d stand for that. But drugs is part of the crazy world.
Anyways, just very briefly, and I’m almost finished here. So there was a very interesting briefing document. This came to light actually this week, but the briefing document, which was released under a FOI,
acknowledged that the rationale for imposing mandates, back in August 2021, [was] kind of questionable. Why? Because there’s emerging evidence that COVID-19 cases, in this case the Delta variant, this was three or four variants ago, in “fully vaccinated people may have similar viral loads than unvaccinated cases.” So I’ll just summarize here: The vaccine mandates were premised on what I would consider to be a faulty and unscientific, untested, and ultimately non-approved indication for the COVID vaccines, and that was the ability to stop transmission.
The pharmaceutical manufacturers were also quite savvy not to promote their vaccine stopping transmission because they could have faced criminal fines for doing so. They just allowed the public health people to do that kind of promotion. And so the public health people took up this banner of “the vaccine will protect your grandma” language, and thus massively deceiving the public. And I believe continue to do so, especially in this province. I guess the point that I would make to all consumers is that if you’re going to take any drug, any drug, read the product monograph. If you don’t understand it, email me or phone; talk to your doctor, say, “Who is this drug indicated for? Am I the patient that is mentioned in this indication for this drug?”
And the other thing you should ask is, “Who is this drug contraindicated for?” Many drugs are contraindicated for use in pregnancy, for example, which is to say they should not be used in pregnant women, though this happens all the time, where either the prescriber or the consumer doesn’t know that the drug is contraindicated, and they use it in an unsafe manner.
So speaking of grandma—that’s my mom. Claiming that the COVID-19 vaccine stopped transmission was unscientific and ultimately damaging. And it affects many people, including a lot of the older people in our lives who were denied the ability to be seen by their family in care facilities and so on.
And I’ll just leave it with a quote from Gandhi here, which is “An unjust law is itself a species of violence. Arrest for its breach is more so.” And I would say that in many ways, citizens in our country who’ve made personal decisions that might have been different than what the public health people wanted them to make, in many ways, have been arrested either through sanctions, through discrimination, really based on an unscientific and a non-evidence-based statement of things.
Before I turn you over to the commissioners for questions, I actually felt optimistic because here we have, you know, these COVID-19 vaccines. So this is the biggest public health issue in our lifetime, and I’m confident that the Therapeutic Initiative at UBC would be evaluating these without pharmaceutical influence. Can you comment on that?
Because I don’t work there anymore, I’m not sure, but we did nothing about the vaccines. Colleagues of ours that work for similar organizations—there’s a group in Spain, there’s one in France—they did some pretty deep dive analyses of the COVID-19 vaccines, very reliable and very respectable. Our group didn’t, and I think the last that I saw, they did an evaluation of the Pfizer drug treatment Paxlovid, which is an expensive, mostly useless drug to treat COVID. I say mostly useless, it’s not completely useless, I’d make that distinction. It might have some use in some patients for some small reasons, but you always have to ask, “compared to what?” So no, the Therapeutic Initiative has not been doing vaccine-related analyses.
And I was being facetious because I knew that they hadn’t, and my understanding was they were even discouraged from doing so.
Yeah, it’s a very interesting question. I can only hypothesize. Yeah, I don’t really know. What bothers me at the moment is that we could do some really weapons-grade research in BC. We have linkable data sets. We have individual personal health numbers that can be linked to— So you have a PHN, that’s your own personal health number: it can be linked to hospitalizations, doctor visits, drugs dispensed, vaccinations,
and then ICD codes, codes for the type of illness you have. All this data is linkable. If we wanted to do a vaccine-harm study, we could do it overnight. We have the resources in place. I know the people that would be working on that study. If the Minister of Health said, “It’s time to release the dam, we could do that research overnight.” Is it being done? I don’t think so. Nobody would touch it.
But we could do it. In fact, the people at the Therapeutics Initiative, the people I worked with for more than 25 years off and on, those people are the experts in doing this kind of drug analysis research. They could do it. They would have to get the call from the Minister, though.
Right. Well, thank you. I’ll ask if the commissioners have any questions of you.
Thank you very much for this very interesting presentation. I have a question about this indication that you mentioned in the description of the Pfizer vaccine, for example. Do we find that indication would specify a certain category of age, or is it something that is usually not specified?
Age, did you say? Yes. In fact, in that monograph, it was for anyone age five and older. So it wasn’t for babies. Though oftentimes it will state the age that the drug is indicated for.
And it’s my understanding, and subsequently, some sort of additional trial has been done to expand the indication.
And this was approved by FDA as an indication—to have it offered to smaller —
I would say, and I don’t know for sure, I would say that if the vaccine is actually being administered to babies, and I don’t know if it is, then that would have to be mentioned in the product monograph, that the vaccine is approved for that age.
So what about contraindication? As you mentioned, some drugs are not recommended for pregnant women. Was that specified on this particular product?
I didn’t see any contraindications. I’m confusing both the Lipitor product monograph and the Vaccine monograph. The Lipitor product monograph is contraindicated for pregnant women. It says it right specifically, and it’s also contraindicated in children. You don’t give children cholesterol-oriented drugs. I mean, children meaning under, I think, the age of sixteen or seventeen. I don’t know about the vaccine. I don’t think it’s mentioned. Does anyone know? No.
So what about the use of any treatment off-label? My understanding from talking to doctors is that a large quantity of drugs are actually prescribed off-label. So why is it that the health authority had made some special policy to prevent the off-label use of some drug, based on what?
Sorry, why didn’t they make—?
In this case, I’m talking about the generic drugs, for example, that have been used in other countries freely, and sometimes encouraged by the government. In Canada, it was prohibited.
Yeah, well, it’s who’s calling the shots here. Let’s say that you wanted to prescribe hydroxychloroquine off-label, which is approved to treat arthritis, but you’re using it to try to prevent a person from having a worse case of COVID. That would be an off-label use. Doctors can prescribe that perfectly legally; they can do that. Though the companies could not market the treatment as being a sort of COVID preventative. So, yeah, you’re right, off-label prescribing happens all the time. I was hoping somebody was going to ask me about this.
Off-label prescribing happens all the time: that doesn’t mean it’s safe, and that doesn’t mean it’s wise. I mean I would prefer that my drug got tested in the kind of patient that I am, for the reasons that I’m taking that drug. If the doctor’s using a drug off-label, saying to me, “Oh, you’ve got toenail fungus,
so I’m going to give you a cholesterol-lowering drug,” you might want to ask some questions. Because if the companies could have got the drug approved to treat toenail fungus, they would have. They go to war over the product label. They want as much stuff in there as they can get.
Sometimes—and this happened when Pfizer faced that huge fine. They were promoting things that the FDA specifically told them not to do. For example, it was about a dosage size, saying this drug is approved, say, in a three hundred and a five hundred milligram dose. Then the company is out there in the community, promoting thousand milligram doses, even though the FDA said to them specifically, you cannot; it’s contraindicated to give a higher dose. Again off-label is a very complicated thing, but I think that most people— So much of prescribing is not evidence-based, the least we can do is to make sure that the treatments that we’re getting is as close to the labelled use as possible. And sure, your doctor might prescribe you a drug for an off-label use. You have to ask some deep questions though—“Where did that information come from? Who’s promoting it as an off-label use? And is there really any evidence of benefit?” Because if there was good evidence of benefit, it wouldn’t be an off-label use. It would be on the label and the company would be marketing for that purpose.
I know I sound a little religious on this topic, but you see so many people harmed by the injudicious use of drugs for stupid reasons. It happens all the time.
So about marketing, you demonstrated that any marketing of a drug off-label can actually be punished by law. But that requires, I guess, that somebody will find a case against that, otherwise it won’t happen automatically.
Yes. That’s right.
So during the COVID vaccination campaign, it seems to me that, at least in Canada, that the company maybe have not formally advertised their product off-label, but it seems that the Health Agency or a lot of people have done it, but they’re not liable for that?
They’re not liable for it, which is amazing. They’re not covered by the same law that the pharmaceutical company is covered by.
Should they be?
Shawn probably knows this better than I do. But what law is there to prevent public health people from saying drugs are good for some purpose when there is no evidence that that’s true? Where is the law that prevents them from basically lying to the public? I don’t know if there is such a law, is there?
Yeah, actually section 9 of the Food and Drugs Act would prevent any fraudulent advertising, and that’s what they would use to go after a pharmaceutical company if they were to go criminally. And you know, the thing that jumped out at me, like we had this relative risk advertising by Health Canada. “The drug is 95 per cent effective,” which conveyed to the public, “Oh, I’ve got a 95 per cent chance of not catching COVID,” is what people would think. Where the absolute risk—the chance that it would do anything for you at all was less than 1 per cent.
It was 0.048 per cent.
If I had a client ever advertising relative risk, I mean Health Canada would be all over them saying, “You know, you stop this or we’re going to charge you.” So it was just ironic to see Health Canada basically violating their own rules.
Talk about a double standard, huh?
I liked how you tied our journalists, our mainstream media, with public health authorities. And I’m just wondering about the bias and inaccurate and false, misleading comments that have been made. And I know there’s a section in the Criminal Code that talks about publishing. If you publish harm, it is against the law. And I’m going to go a little bit further, but my notes are not very good: So he or she who publishes something that “is false and that causes or is likely to cause injury or mischief to a public interest is guilty of an indictable offence and liable to imprisonment” and fines.
So I’m just wondering, we’ve sent out summonses to the politicians and I believe also to the chief medical officers: they’re not here. Mainstream media: we’ve been going across the country and they’re not here. So I’m just wondering how does that work? They’ve been publishing for the last three years all these false and misleading statements.
They’ve obviously been biased in their presentation.
What are your thoughts on how we get some accountability towards both of those industries or both of those professions because at this point, here we are in Vancouver, we’ve travelled across the country, all of us, making this point and yet neither are here. Even the politicians who have received summons, the chief medical officers who received summons have not come to tell us their story. What are your thoughts?
Yeah, that’s probably a legal question, not a sort of drug policy question. But you know, policing misinformation to me seems like a very, very slippery kind of slope. Whose misinformation and in whose interest? What I noticed during the pandemic is those who were proclaiming, you know, pointing the finger at misinformation were the misinformers: people who hadn’t actually read the product monograph, people that were making statements that were easily, factually wrong. So I don’t know what remedy there is to try to ensure that, say, politicians or public health people or the media should generally conform to statements of truth. It’s a really tough business. I don’t know. Do you know, Shawn?
I have no comment.
Sorry. Bad answer.
That’s a good answer. Thank you.
So before I thank you, you had indicated, and you showed some books that you’ve written, and you also indicated that you had been writing for several years for Common Ground Magazine. And so for people watching that aren’t from British Columbia, or not even from Canada, won’t understand that Common Ground Magazine is a magazine that’s published in the Lower Mainland that would allow somebody like you to have a forum, and it’s been strong on environmental issues and social justice issues and health freedom. And I just wanted people to understand, when you mentioned Common Ground Magazine, that it’s kind of a gem that would allow somebody like you to have a regular column, and we just don’t find that, very rarely. And I note that the editor, Joseph Roberts, is in the house today so I wanted to do a shout-out for him.
Absolutely. I mean, Common Ground is a real resource and a fabulous sort of thing, Joseph’s labour of love. And yeah, I had a column every month for 12 years. So I’ve got 150, 145 columns, and they’re like mini essays. I mean, I’ve written about— If you went back into Common Ground ten years ago, you’d read all the stuff they wrote about the flu and the stupid policies that were being brought in to protect us from H1N1, the nasty, the last pandemic. You remember that one? Yeah, it was a very good gig and good, strong journalism, independent journalism, and we need more of that in this country.
So Alan, on behalf of the National Citizens Inquiry, I sincerely thank you for coming and sharing with us today.
Final Review and Approval: Margaret Phillips, August 25, 2023.
The evidence offered in this transcript is a true and faithful record of witness testimony given during the National Citizens Inquiry (NCI) hearings. The transcript was prepared by members of a team of volunteers using an “intelligent verbatim” transcription method.
For further information on the transcription process, method, and team, see the NCI website: https://nationalcitizensinquiry.ca/about-these-transcripts/
- 12 years in the military as naval lieutenant including two peacekeeping tours
- Master’s degree in public administration from the University of Victoria
- Worked in drug policy research since 1994
- Worked on 20+ separate pharmaceutical policy studies over the last 28 years.
- Published dozens of peer-reviewed publications on topics including drug marketing, evidence-based medicine, and rational prescribing
- Has been working for the BC-UBC Therapeutics Initiative funded by the BC Ministry of Health, but currently self-employed.
Alan spoke about the regulatory requirements regarding pharmaceuticals that are granted licenses to be sold in Canada. He started with an explanation of Health Canada’s product monograph which in summary is like an owner’s manual for a drug. It provides the properties, the claims and the indications for a drug and these are essentially the conditions of use required for the optimal safe and effective use of a drug.
In Alan’s opinion, the most important word in a product monograph is the word indication. Indication specifies what the drug is used for, i.e. for treating a particular disease. So, if the regulator, Health Canada or the FDA, determine there’s enough evidence to approve a drug for the indication, that is the treatment of the disease, the indication becomes a labeled indication, and the drug company is able to market their drug with that information. The manufacturers are not allowed to market their drugs for indications for which they have not been approved by Health Canada. So, companies cannot market their drug for “off-label” purposes for which it hasn’t been studied or approved. He mentioned that drug companies like Pfizer have been caught in the past with illegally off-label marketing of certain drugs and ended up paying the largest healthcare fraud settlement in history.
The approved product monograph for the Pfizer vaccine is about eighty-three pages long and didn’t get released to the public until September of 2021 even though they started injecting this drug into the arms of Canadians before September 2021. So, it is unlikely that any of the physicians, nurses, or anybody else administering this vaccine had actually read the product monograph, and certainly none of the patients getting injected could have read the product monograph to know what it was indicated for. This means that there was no informed consent about the risks and benefits before administering this vaccine to patients prior to September 2021.
Alan said he read through every single one of the product monographs for the six federally approved COVID-19 vaccines in Canada and none of them were indicated to prevent viral transmission. So, the manufacturer is prevented by law from claiming that their vaccine prevents viral transmission. Yet, the whole vaccine coercion apparatus put in place by government, including the passports and mandates, was based on the vaccine preventing viral transmission. High ranking officials in the US health establishment, politicians, health officials, media pundits, and so on were making these claims about the vaccine preventing transmission. Alan noted that while the pharmaceutical manufacturers were not promoting their vaccines as stopping transmission, they permitted the public health officials to make these claims about their products that weren’t true.
Published data in “Vaccine,” the world’s premier peer-reviewed journal in vaccine research, says that what they saw in the first published trial of the Pfizer vaccine is that the adverse events outnumbered the reductions in hospitalizations. As well, the label for Pfizer has now been amended to identify adverse reactions such as cardiac disorders, immune system disorders, musculoskeletal conditions, etc. Even though these adverse reactions are in Health Canada’s approved product label, Health Canada and public health officials continue to make the statement that these treatments are safe and effective. Alan indicated that any other product with a safety profile like this would have been pulled off the market in a heartbeat, yet the Pfizer vaccine and some of the other vaccines still remain on the market.