In Secrecy We Trust
Part 1: A wide-ranging interview with psychiatrist and anti-depressant expert Dr. David Healy about the hazards of ‘following the science’ in an age of drug data secrecy
“Companies and doctors are now using clinical trial data, or the lack of it, as a drunk uses a lamppost — for support rather than illumination.” — Dr. David Healy
In 1999, Dr. David Healy, a professor of psychiatry at Bangor University in Wales, accepted the post of director of the mood and anxiety disorders programme at the University of Toronto’s Centre for Addiction and Mental Health (CAMH). With the lucrative position and professorship set to begin in 2001, Healy delivered a lecture in November 2000 to some of his colleagues in which he criticized psychotropic drugs, arguing that selective serotonin reuptake inhibitors such as fluoxetine (Prozac), manufactured by Eli Lilly, could lead to suicidal thoughts and were probably being overprescribed.
Two weeks later, Healy’s offer of employment was rescinded. Healy was informed of the abrupt decision in an email from Dr. David Goldbloom, the Physician-in-Chief at CAMH. Goldbloom writes:
“We believe that it is not a good fit… this view was solidified by your recent appearance at the Centre in the context of an academic lecture. While you are held in high regard as a scholar of the history of modern psychiatry, we do not feel your approach is compatible with the goals for development of the academic and clinical resources that we have.”
According to the British Medical Journal, the executive director of CAMH at the time, Paul Garfinkel, said that several of Healy’s colleagues were “deeply shocked by the extreme nature of [Healy’s] views.”
Many at the time felt the university was violating academic freedom to safeguard funding from drug companies, including Eli Lilly, which manufactures Prozac, but also donated funds to CAMH.
Healy decided to sue the university. The suit was settled, and Healy went on to be a visiting professor in the university’s Faculty of Medicine until 2005. 1
Healy went on to hold a number of professorships including most recently in the Department of Family Medicine at McMaster University in Hamilton. His main areas of research are clinical trials in psychopharmacology, the history of psychopharmacology, and the impact of both trials and psychotropic drugs on our culture.
Healy has also been involved as an expert witness in homicide and suicide trials involving psychotropic drugs—a subject we’ll return to in Part 2 of this series—and in bringing problems with these drugs to the attention of American and European regulators.
About twelve years ago, Healy founded RxISK, described as “a free, independent drug safety website to help you weigh the benefits of any medication against its potential dangers.” Healy tells me that the platform serves as a place where people can report adverse drug events.
“We can see the comments that come in and this process has led us to discover things about the antidepressants that no one else seems to know,” he says. For instance, among the early posts the site received was from a woman who believed the antidepressant she was on was causing her to drink. Everyone she spoke to thought she was crazy, says Healy, but a recent paper published in the Canadian Medical Association Journal indicates that her hunch was right. Certain kinds of antidepressants can drive some alcohol users to drink more. The CMA study found:
The [Canadian Alcohol Use Disorder Guideline Committee] identified that polypharmacy was common among people with AUD [alcohol use disorder] and that these patients are routinely offered pharmacotherapies that may be ineffective and potentially worsen AUD outcomes…case series and several RCTs [randomized controlled trials] have demonstrated that certain serotonergic medications may worsen AUD outcomes in some patients.
“What people don't seem to realize is that when these drugs come on the market, the pharmaceutical industry gives the impression it's been designed by science and we know all about what you're going to take. In actual fact, we know nothing,” he tells me.
In early 2020 Healy also started the Samizdat Health Writer’s Co-operative:
The pandemic confirmed the fact that we're in a strange world, which is everything's black and white, you're either terribly pro drugs and vaccines and healthcare interventions or are terribly anti them, and the middle ground is simply vanishing.
Samizdat provides space for writers who are having difficulty being published by the academic lay press, but whose books present a more complex, contextual, and nuanced picture of a variety of health-related subjects.
I reached Healy in Dublin, Ireland, where we spoke via videolink.
[This transcript has been edited for length and clarity.]
Linda Pannozzo (LP): Back in 2000, you gave a talk at the University of Toronto where you said that fluoxetine, which is also known as Prozac, could lead to suicidal thoughts and was probably being overprescribed. For saying this, your appointment as the director of the Mood and Anxiety Disorders Program at the University’s Center for Addiction and Mental Health was rescinded. What did you base those comments on at the time?
David Healy (DH): At that time, I had been aware for probably ten years that fluoxetine and other SSRIs [selective serotonin reuptake inhibitors] could cause some people to become suicidal because I had a number of patients that I put on this drug. I put them on the drug probably earlier than most people in the UK did because I worked on the serotonin system so I was interested to know a little bit about what drugs that acted on the serotonin system would do to people, and they can do useful things, but they can also make you suicidal.
There were two early cases I had after the drug had just come out in the UK, who clearly had a bad reaction, who became suicidal. The problem cleared up when you halted the drug and came back when they were re-exposed to the drug, and I didn't re-expose them to the drug per se. I exposed each of them to another serotonin reuptake inhibitor and this is at a point when it wasn't absolutely clear that it was the serotonin reuptake inhibition. It could have been something else about Prozac that actually caused the problems. But no, it turned out they couldn't actually tolerate other serotonin reuptake inhibitors either. So, it became clear that it was a more general problem with this group of drugs.
At the time that this was happening, I wasn't aware that there had been any other reports out there but it became quickly clear during the course of the following year that there were a large number of reports from very respectable places—from Harvard and Yale and elsewhere—saying that, ‘Yes, we've got a bunch of patients that we put on this drug and they've become suicidal and when you take the drug away, the problem goes away. You reintroduce the drug and the problem comes back.’ So, in terms of cause and effect, this was very convincing. It wasn't saying that this drug is going to make all people suicidal. It was saying, ‘It doesn't necessarily suit all people. There will be people that it can be quite helpful for, but there's a bunch of other people who are going to have a bad reaction like this.’
This is where life got very interesting. The company response to this was to say, ‘We've done our randomized controlled trials and they don't show that there's a problem.’ The interesting thing about this was, it’s the kind of puzzle that can be good to get if you've got one bit of evidence, which seems very convincing—the patient right in front of you becomes suicidal, and no other easy way to explain what was going on other than the drug—and then a large body of what looks like clinical trial evidence saying, ‘No, this can't happen.’ The difference between two bodies of evidence is the kind of thing that should move things forward.
Eli Lilly themselves treated me really well when my article came out [in 1991] saying Prozac can make you suicidal. They gave me a consultancy and brought me along to the company headquarters. They made friends with me and introduced me to a group of other academics who they were consulting about issues having to do with, ‘How do we educate people about these drugs?’ and things like that. I also got some media training from them. These are all designed to just make friends so that it becomes harder for you to say anything that your friends aren't really going to want to hear. That was true of most of the pharmaceutical industry.
They didn't particularly mind me having an article saying this drug can actually make you suicidal, partly because—as became clear ten years later, after the Toronto problems, when I was giving a big talk in the UK and this very charming woman came up to me and said she was so pleased to meet me, and that I was doing more for the sales of Prozac in the UK than anyone else! Getting the kind of gritty conversation about Prozac going makes the conversation more interesting to the people listening, and of course, they only remember one thing from the conversation, which is the word Prozac.
About three years before the University of Toronto lecture, I ended up getting involved in a legal case where a man had killed himself and [three others] and the lawyers were looking for an expert witness… I saw a lot of internal company documents about Prozac showing that the company knew the drug caused suicide and they were working on all sorts of ways to hide the problem. 2
So, at the University of Toronto lecture I said, ‘I believe this drug can cause a problem, and I’ve seen things that you can’t see, and it isn’t right that you can’t see them.’ The point I was trying to make was not that the drug causes suicide. The point was, for us to have a conversation, we all need to have [access to] the same material.
LP: So, you decided to sue the university for breach of academic freedom. Can you tell us what happened as a result of that lawsuit?
DH: It seemed a very clear-cut case that the things that I was saying were reasonable and based on evidence, and it was all about trying to keep people safe, so there shouldn't really be a problem with that. At the time, industry and I were reasonably friendly—it's not as though I was anti-industry or anti-pills or anything. So, my interest in the lawsuit was not to get a huge amount of money, because I didn't. The interest was to find out what exactly had happened. It gave me an opportunity to grill some of the people from the university, to get in the same room and ask them what actually went on there. I had a fairly good idea about what went on, but it was getting them to confirm it, was the key thing.
One of the other people at the lecture was Charlie Nemeroff, who was the professor of psychiatry at Emory University and was a very big name in the field back then. Lots of people were kind of scared of him. He did have a lot of influence and power, and he had been at the meeting as well. I knew from a friend … that the day after the lecture Nemeroff was at a meeting of the American Society for Suicide Prevention saying he was in Toronto where Healy gave a lecture and he, Charlie, had organized to get Healy fired. So, I knew roughly what had happened, but I wanted to get the university to confirm it, and they did. We came to an agreement that they accepted they said a bunch of the wrong things and I got an arrangement where they compensated me for the loss of earnings and they invited me over once a year for a week or two to give some talks. It was a reasonably amicable way for things to end. 3
LP: Just to clarify, you say you found out he got you fired, but he got you fired for what?
DH: Charlie was at the meeting and the university folk were there as well and over drinks afterwards, my understanding was, he gave them the impression that the money they had from the pharmaceutical industry would dry up, which it really wouldn't have done. They were a little naive to get as worried as they did and they should have called his bluff. That's not the way the industry works.
Charlie was very much the kind of person who threw his weight around and I'm not sure that the pharmaceutical industry would have necessarily wanted him to do this. I think he was a loose cannon. I'm sure he knows that the pills can cause problems, but his view was just there’s a lot of money to be made out of these pills by saying that they worked wonderfully well. He had threatened me before this. He and I had been at a meeting in the UK and I had a poster about the risks of the pills: I had a healthy volunteer trial where we gave an SSRI to a bunch of healthy volunteers and some of them became suicidal. So, this was interesting and we reported it and Nemeroff came up to me and said, ‘Look, this is going to ruin your career. The pharmaceutical industry is going to roll all over you,’ by which he meant he was going to roll all over me and that he had been retained as an expert witness to the case on the opposite side to one that I was involved in.
As it turned out, when the fuss blew up and became front page news, Nemeroff was no longer an expert witness in the case. It was just inconvenient for industry to have him as one of their experts. So, I think it was just Charlie throwing his weight around. I doubt if any of the companies would have particularly asked him to do it. He was just the kind of man who felt he could do these kinds of things.
LP: You just mentioned that ‘that’s not how industry works.’ How does industry work?
DH: Pharma don't like their fingerprints on things. Charlie was too publicly linked to them and said the wrong things. They prefer you just don't get invited to things or don't get published, or lose jobs without any link to them.
LP: I wanted to ask you a few questions about what's known as Study 329, which was published in 2001—around the same time that you were dealing with the UofT. 4 It portrayed an SSRI called Paroxetine or Paxil as an effective and safe treatment for children and adolescents with major depression. The study was industry sponsored, that is, paid for by the manufacturer, GlaxoSmithKline. It had 22 authors but was in fact ghostwritten, we find out later, by Sally Laden, who worked for the company. First, can you talk about the prevalence of ghostwriting in the scientific literature?
DH: Articles on all of the drugs that we use in health care, not just mental health drugs but across the board, anything industry brings to the market—for heart problems, for breathing problems, gut problems or nervous problems—will be ghostwritten. For instance, the Pfizer vaccine trial paper in the New England Journal of Medicine, this is what I would call a ghostwritten article because the 29 authors or thereabouts, none of them wrote the article. They haven't seen the data. They know nothing about it, but their names are all there. The ghostwriter is mentioned at the end in the “acknowledgements”—Sheena Hunt from New Zealand.
Because her name is mentioned in the small print, a lot of academia will say to you, ‘Well, we don't have a ghostwriting problem anymore because previously, her name wasn't mentioned. But her name is mentioned now, so there is no issue, nothing to worry about.’ The problem is, she does all the writing, and the people whose names are on the authorship line—who are the ones most people look at, and who are from some very distinguished places like Harvard and Yale and that helps sell the product—they haven't seen the data, they haven’t seen a single patient in the trial. They didn't write anything. They often didn't write the letter to the journal saying, ‘Please accept my article.’ That's been written by the ghostwriter as well. So, that's true of all of the drugs we use.
Here’s a key point about the case of Study 329: it was published in the best journal in the field of child and adolescent psychiatry; the journal with the highest impact factor in 2001. At the time, GSK [GlaxoSmithKline] and Pfizer and the other companies weren't sure that FDA were going to approve the use of any of these drugs for children. The trials were dodgy and they really didn't show the drug worked well. What GSK did was—they actually put it in an internal company document—they said, clearly, ‘We're going to take the good bits of this study and we're going to publish those.’ And it appeared in a really good journal with a very distinguished authorship line and tons of teenagers were put on Paxil.
Then a year later they said, ‘Well, let's see if FDA will approve our drug [for children].’ They had begun to think that even if the trials were negative, that FDA would still approve it. So, they sent three trials [involving] children who were depressed to the FDA— all three were negative trials, and this was a year after their article had come out.
You have to recognize what FDA and Health Canada do. They just look at the drug company adverts and if the drug company is claiming in the adverts that this is good for children, then FDA will say, ‘Well, you haven't been approved to make that claim.’ The FDA don't approve drugs, they approve claims. So, a company gets the right to use the phrase ‘antidepressant for children.’ Even if the trials are negative – and FDA don’t approve the drug – what they are not approving is the company right to claim the drug works and is safe – but academics can still make these claims and FDA won’t have a problem with this.
GSK said to FDA, ‘Look, we've done three trials and they’re all negative,’ and FDA’s letter back to GSK says, ‘We're happy to approve this drug for teenagers even though we agree with you, all three trials are negative, and we're also not going to mention the fact that these are negative drugs. We're not going to let the world know about this.’
Now, the thing is, if FDA had made a big deal of it and had a public letter or included in the label of the drug that actually, the trials that were done in children were negative, then GSK could have been sued for fraud. As it turns out, they did get sued for fraud, when their own internal documents came out. 5
What's clear now is that all of the anti-depressant literature in children and a large proportion of the adult literature as well are reporting negative trials as positive, and the FDA aren't doing anything about it and Health Canada aren't doing anything about it because they say, ‘Well, it isn't our job to police the medical literature. It's other people who have that job.’
LP: If Paxil wasn’t approved for use in children, how was it prescribed for children? Doesn’t it have to be approved before being prescribed by doctors?
DH: The FDA or Health Canada don't approve drugs for use in children, or adults. They approve company claims—'this is an antidepressant’—so, once that happens it can be given to children even if a specific claim can't be made about children. You wouldn't want a child not to be given an anticonvulsant if fitting even though few if any are or were approved for children.
LP: In terms of ghostwriting, how does it actually work? And why would the authors want to do it? What would be the incentive?
DH: Back in the late 1990s and early noughties, I think a lot of academics might have thought that it's safe enough or it's okay to have their names put on this because the company writers are going to be responsibly reporting the results from the trial. That was kind of naive, wishful thinking. ‘If the claim is that the drug worked, then, it's probably [accurate] that it did.’ It’s only since 2004 that we know for sure this isn't the case. Before 2004, yes, if you have your name on articles, you get paid for it, and if you're the kind of person who goes along with what that company wants, you get brought to meetings to be in the audience or as one of the people actually doing the speaking, and you get paid for that as well. So, it's a comfortable life. You get flown business class as opposed to economy class. You do hear a lot of tales about extras that some of these key opinion leaders ask for, and I think probably get. It works for the big names in the field, it works for the company, and to some extent, up until about 2004, people could have done it reasonably naively. After that, most [authors] should know what the score is and should be more wary.
LP: What happened in 2004?
DH: 2004 is when GlaxoSmithKline was charged with fraud by New York State for having written Study 329, claiming the drug worked well and was safe, but internally having a piece of paper [memo] that said the drug didn't work and wasn't safe. Part of the problem is proving fraud. You've got to show an intention to mislead people, and this [memo] showed an intention to mislead people. But that's the standard company procedure. In all instances they intend you to think the drug is actually better than it is and is free of the problems that it has.
LP: You were among the international group of researchers that re-analyzed Study 329 and eventually in 2015 published a study in the British Medical Journal called “Restoring Study 329” that came to a very different conclusion than the original study. Can you tell us about that? 6
DH: Study 329 led GSK to be charged with fraud, and as part of the resolution of that, GSK agreed to put more of the details of the trials they had done on kids up on the company website than you would usually get, or that FDA or Health Canada would usually see. So, this gave a few of us the opportunity to look more closely at the data.
It was five or six years later that one of my colleagues got in touch with the Attorney General in New York to say, ‘You know, GSK have put a lot of material up on their company website—their report about what the trial actually showed—but if you read the report, it says it's got Appendices A, B, C, D, E, F, G, and H, and they didn't put those up. Could New York ask them to do so?’ And New York asked them to do so and they did. They put up appendices A to G, but not H. This gave a lot more detail than the regulators usually see and it gave us the opportunity to begin to work on the material and to try and work out, if you're going to faithfully represent these data, what would the article look like?
When you get access to the raw data, you find that it's greyer than you usually think. It's not a case of black and white. It will often raise questions that you didn't think about beforehand. If you look at the material with interest you find there’s all sorts of interesting things this drug is doing that I didn't know about. It isn't just the fact that the original study was ghostwritten. It's written in a style which says, ‘We know what this drug does. Here's the report on it and it's the doctor's job now to just prescribe it without asking any more questions and it's the patient's job to take the pill.’
Whereas when you get the raw data and have a chance to move it around and think about things, you end up realizing it’s much more the case of, ‘Well, here's this trial and here are the issues that fall out of it, and actually we've got more questions now than answers.’
As the scientific literature actually stands, it's a bunch of commandments. It's religious. It's biblical. That's not what good scientific literature should look like. It should be much more a case of, ‘Well, there's all sorts of strange things going on here and if you get put on this drug, maybe odd things will actually happen to you also.’
LP: What did your re-analysis conclude based on looking at the raw data?
DH: It concluded the drug didn't work and it concluded that roughly one in six of the children taking Paxil had a serious behavioral event on it, which is kind of shocking. GSK had found creative ways to make people disappear, that FDA don't seem to know about because—and this was 30 years ago—you can see company trials to this day using the same tricks GSK used back then to hide problems from FDA, who don't seem to be interested in trying to close the loopholes that are there.
LP: You recently gave a talk to the annual meeting of the International Society of Ethical Psychology and Psychiatry, and you introduced the topic of randomized controlled trials (RCTs) with the subject of the now infamous drug thalidomide, which was introduced in the 1950s as a sedative and was found to lessen morning sickness in pregnant women but ended up causing severe birth defects. How does thalidomide illustrate how our faith in randomized controlled trials is misplaced?
DH: It was the first drug, where in a placebo-controlled trial before its launch, it worked awfully well and was free of hazards. It has side effects—it can cause you to become suicidal, it can cause you to be unable to make love, and it can cause peripheral neuropathies—but none of these things showed up in the clinical trial. When the thalidomide crisis happened, the response from the system was to say, ‘We should try to get companies to prove the drugs work and get them to use RCTs. But thalidomide had sailed through a placebo-controlled trial without a problem in sight. So, we put in place a mechanism to stop thalidomide-type problems happening again, that it had sailed right through. So, we made a bad mistake.
The 1950s was a period during which we got the very best drugs we have: the best antidepressants, antipsychotics, antihypertensives, hypoglycemics. They’re just too old and cheap and don't get used as much these days but they all got put on the market without a randomized controlled trial in sight. Doctors and patients and everybody who was on them was able to see they worked.
One of the things about randomized controlled trials is you can show a drug that barely works at all, is a drug that works in the sense of it works statistically. We can get the numbers to line up so that we can make the claim, ‘This drug works.’ But the SSRI group of drugs don't as obviously work as the older drugs we have worked. So, what people forget is that the randomized controlled trials, when they were introduced, were all about taking drugs that we were not sure worked, and trying to see if there was any evidence that they work? [RTCs] weren't designed to be applied to drugs that clearly work.
RCTs give the industry an opportunity to bring weaker and weaker drugs on the market. You're told that the scientific apparatus with RCTs is ensuring that the drugs we have are much better than the older drugs we have. That isn't the case. The thing that brings it out the most is the change of climate that has me kind of worried.
LP: What do you mean by that?
DH: Back in the late 1950s, when the first antidepressants came out, doctors were able to say these are great drugs to have, but some people react and can become suicidal and they can also interfere with your ability to make love. If you look at the situation today where people have been given SSRIs and they come back to the doctor and say, ‘I'm feeling suicidal,’ the response is to this day—even though there are black box warnings—most doctors don't believe the drugs can make you suicidal. Today, if you come back and talk about the sexual problems you’re having while on these drugs, you'll be told that's your illness, that's the depression, not the pills.
Doctors today—with weaker drugs that they shouldn't be hugely enthusiastic about—are now in a strange world where they don't recognize any of the problems the drug could actually be causing.
David Healy: For me, it's like I'm in a war zone and there's a war going on, bombs going off, and I report back to the radio station that there's a war here, there’s bombs falling, people have been shot, and the response is, ‘We don't believe you.’
Patients are not being believed now in a way they once were. Thirty or forty years later, the system will deny that the pill is actually causing the problems that you're absolutely sure it's causing you, and that's because of RCTs. RCTs are designed not to pick up the problems that the drug may be causing either. This happens because the trials are designed so that the problems that the company knows can happen, aren't going to show up. Or if they do happen, the ghostwriters are briefed to maybe say that a few odd and incidental things happened, but we've got no reason to believe that the drug is linked to them.
We now operate in a virtual reality that is increasingly mad. It's very hard to know how we turn this around.
Dr. David Healy
LP: One of the things you’ve said is, “It is not science if you can't see the data.” One would think that in the interest of advancing science, clinical trial data would be made public along with the published studies. But it isn't. In the US, the FDA don't even see the data. How can any of us trust that study findings or results are in fact true?
DH: We can't. Doctors are in a position to go on strike. They could say to companies, ‘Look, we're not going to use your pill until we see the data. We've got lots of other pills. We've got older pills that are probably better, and are certainly cheaper than your new pill.’ But we don't go on strike and we're shooting ourselves in the foot because there are cheaper prescribers than doctors. There are nurses and pharmacists and increasingly the prescribing is being done by them and others. So, doctors are going out of business and we need to wake up and smell the coffee and say, ‘Look, if we’re going to get the pay that we figure we deserve, we’ve got to have a bit of moral backbone. If we’re going to sell our soul we need to sell it for a higher price than we're selling it at the moment.’
LP: During the pandemic, Pfizer's clinical trial data for the mRNA shots were not accessible to other scientists for independent review, but they are now being released as a result of a lawsuit. What can you tell us about the data that are becoming public? 7
DH: First of all, it was clear that the Pfizer vaccine trial was ghostwritten. Secondly, it becomes clear pretty early on that there were more people that died on the vaccine than on the placebo in the trial, despite all the hype and the claims that millions of lives have actually been saved. So, it's very much a case of what you're seeing with the vaccine trials is totally consistent with what you see with the SSRI trials and other trials of all other drugs that we use.8
One of the intriguing issues about the vaccines is lots of people, even the most skeptical of the pharmaceutical industry thought, ‘Well, when it comes to vaccines, they're going to have done things properly.’ But the [industry] has a playbook that works beautifully and there was no reason for them to change it and they haven't.
Pfizer shows you the name of the ghostwriter at the end of the article. You can read the material that's with the FDA and can get a grip on [the data] that you don't have to have a lawsuit for, and see that more people have died on the vaccine than on the placebo. 9 [Industry is] saying, ‘We can show you that our vaccine didn't work and is harming people and the stuff is all ghostwritten, and we still know the government and everybody else is going to force you to take it.’ It’s kind of strange.
LP: Strange is one word for it. I wanted to touch on the issue of the vaccine mandates. They were imposed in many countries around the world, including here in Canada. Public health officials and policy makers said that they were “following the science,” but the real-world evidence was showing that the vaccines did not prevent infection or transmission of the virus. They were also making these claims without access to any of Pfizer or Moderna's original clinical trial data. Absent these, what were the vaccine mandates based on?
DH: No, it's very hard to know what it was based on. They certainly weren't following the science. They certainly weren't following the data [because] they didn't have it. Insofar as they made any efforts to get it, it would have said to them, ‘We shouldn't have mandates. We should leave it for people to make up their own mind if it's good to have it or not.’
The mandates were one of the most extraordinary things that I have ever seen. I had a strange experience with all this. I had an article in the BMJ, before the vaccines came out, saying we need to see the data, and I’ll be very unhappy if people mandated me to have the vaccine without access to the data. And of course, they did mandate me at McMaster University to have the vaccine without access to the data, and that contributed to the university and me parting ways. 10
LP: People were essentially forced to get a vaccine or lose their jobs, or not be able to participate in civic life, while at the same time we had no evidence or data supporting this. How did that happen?
DH: It's very hard to know. I think it's going to take us all a while to look at how it happened. One of the oddities about the whole drug/ vaccine thing is it's generally been conservative parties who've been more skeptical and more inclined to hold pharmaceutical companies to account. The left—the progressive parties—have been more inclined to think it’s not a fair world if people who aren't well-off can't get access to the kinds of treatments that people who are wealthy can get. So, we want to level people up, and this means to a great extent, the left may argue about the price of drugs and things like that, but if they do succeed in being able to bring the price of drugs down, that just means that lots of us may be put on more drugs. What they don't think about is [the need for] a judgment call about how many drugs we should be on, or how many vaccines we should get.
Today, women who are pregnant are getting seven vaccines while pregnant. So, polypharmacy is beginning in utero.
There's a lack of judgment. With the vaccines, to some extent, you've got the progressive point of view gone mad. There is this threat, the threat of the virus is real, it does cause problems, it turns out not to have been as bad as we thought it might be, but it does cause problems and it can kill people, and you have people who are progressive generally, leaping in and saying, ‘We're not just going to ensure you have access to this, we're going to ensure everybody gets it.’ The apogee of all that is the progressive parties are totally pro the pharmaceutical industry and the benefits that it can offer us.
LP: I also wanted to touch on the role of regulators because, theoretically, they are meant to act in the public interest and are supposed to keep vested interests, in this case, the pharmaceutical industry, honest. But they don't appear to be doing that. Here in Canada, for example, 75% of the cost of regulating human drugs is paid for by the industries that are being regulated. What are your thoughts about the role of government when it comes to regulating big pharma?
DH: I think people are misinformed about what regulators do. Regulators are just bureaucrats who decide if a company can use the word ‘chocolate’ or ‘butter’ or call a drug an ‘antidepressant.’ In terms of the safe and proper use of foods and drugs, regulators don't have a place in it. Their role is pretty minimal, but because the world’s a risky place, we all want a father figure who's going to look after us. It used to be doctors, once upon a time. And even doctors think regulators are looking after them, ensuring the drugs are absolutely safe, but they're not. Regulators aren't scientists, they’re just bureaucrats saying, ‘Yes, we can tick a box. You've met the criteria for use of this particular word, antidepressant, antihypertensive or whatever.’ But in terms of the use of those drugs, regulators don't have any part to play. It's doctors generally, who should be, as a professional body, ensuring that they're actually using the right drugs for us and doing all they can to keep us safe. But they've deserted the playing field and it's really down to us these days now to be a lot more cautious about these things than we have been inclined to be.
LP: What do you see as the alternative to RCTs?
DH: Well, if the drugs work well, you don't need RCTs so we need to get back to a position of having drugs that work well, which companies don't have an incentive to produce. They've got an incentive to have drugs that are used very widely, rather than a drug which works wonderfully well for a niche condition because the company isn’t going to make a vast amount of money because there aren't a huge number of people who have this—problems that you wouldn’t think of as being niche, like multiple sclerosis. From a company point of view, that’s niche, it’s not a big market. Epilepsy is not a big market. If they're going to bring an anticonvulsant on the market, they’ve got to sell it for something else as well, like mood disorders. That's where the money is.
We could save a lot of money by getting companies to make drugs that really work even for a niche condition and paying them a vast amount of money more than we do for a treatment that really worked for a relatively rare condition, provided they agreed to stop making all the rest of us ill by saying to us we're depressed or we’re bipolar, when we're not. They actually make their money out of persuading us to think the way they want us to think.
You can ask, are they not doing good science these days? And the answer is they are doing good science and applying really good science, but it's about propaganda techniques: the science of how to control the population rather than the science of how to make a chemical that is really going to cure a condition that we need a cure for.
LP: It's been more than 20 years since you had that appointment at U of T rescinded for something you said in a public lecture. What has happened, do you think, in the intervening years to academic freedom and the integrity of science?
DH: I think things are much worse than they were, and it's very hard to see any hope for the future. But I guess it's bit like the Berlin Wall. Things are so rotten now that you figure that they have to collapse sometime.
[Stay tuned for Part 2 of my interview with Dr. David Healy, where we continue this discussion and pay particular attention to the potential for SSRIs to cause homicidal behaviour.]
Around the time of the Healy lecture and subsequent law suit, I was working at Dalhousie University as the Executive Director of the Nova Scotia Public Interest Research Group, spending a lot of time researching the new alliances that were forming between industry and universities. The new “partnerships” were becoming ubiquitous features of campuses across the continent and were not only a threat to academic independence but also to unimpeded inquiry. In a piece I wrote in 1999 titled, “Masters of the University,” I interviewed fisheries scientist, Jeffrey Hutchings, who said, “The greater we entwine ourselves with industry, the greater the degree we potentially subvert academic freedom, the freedom to critically examine or analyze the workings of industry and government.” The piece—“Masters of the University”—was published in Missing Pieces: An Alternative Guide to Canadian Post-Secondary Education, by the Canadian Centre for Policy Alternatives. Versions of that article were also published in The Coast, and Highgrader Magazine.
In 1998 Donald Schell killed himself, his wife, his daughter and his granddaughter after taking Paxil. Healy was an expert witness in the wrongful death civil suit brought forth by Schell’s son-in-law and sister. This case will be discussed in further detail in Part 2 of this series, but suffice it to say here that in June 2001, the jury decided the drug maker was 80 percent to blame for the homicides and that Paxil could cause someone to commit suicide or homicide and was “a proximate cause of the deaths” in the Schell murders/ suicide. SmithKline Beecham (which became GlaxoSmithKline) was ordered to pay $8 million to Schell’s relatives.
Charles Nemeroff is recognized as a leader in psychiatric research, but has also been criticized for his close ties to the pharmaceutical industry. He resigned from his position at Emory University in 2008 when he was found in violation of policy for not disclosing payments received from drug makers. A piece in the New York Times reported in 2008 that between 2000 and 2007 Nemeroff earned more than $2.8 million from consulting arrangements with drug makers but failed to report at least $1.2 million of it. A Congressional inquiry into the conflict-of-interest disclosures of university researchers found that universities are “incapable of policing their faculty’s conflicts of interest.” Nemeroff went on to become chair and professor of psychiatry at the University of Texas in Austin Dell Medical School.
One of the authors of ghostwritten Study 329 was Dr. Stan Kutcher, professor emeritus in Dalhousie University’s department of psychiatry. In 2018 he was appointed to the Senate of Canada. Back in 2011, he was running as the Liberal candidate for Halifax in the federal election, when Coast writer, Tim Bousquet, wrote a piece about Kutcher’s involvement in Study 329. The 800-word piece appeared just a few days before the election, and Kutcher’s lawyers threatened to sue The Coast for libel unless they issued a retraction. Bousquet’s piece was immediately retracted (the next day) and Coast editor, Kyle Shaw issued an apology. According to a piece by Justin Ling of the Halifax Media Coop, unlike many of the others who were listed as authors, Kutcher was actually involved in writing Study 329, along with ghostwriter, Sally Laden. Ling also reveals that Kutcher was involved in another study—Study 377—which also showed dismal results for Paxil, but did not see the light of day until the New York district attorney’s office forced GSK to release it. “377 discloses each author’s involvement in the pharmaceutical industry,” writes Ling. “Of Kutcher, it lists he had been a paid consultant for GlaxoSmithKline. It also says that he had ‘received research grants from, has been a consultant for, or participated on advisory boards’ of pharmaceutical heavy-weights GSK, Pfizer, Eli Lilly. He disclosed nine drug companies in total.”
In 2020, during the pandemic, Kutcher, along with Timothy Caulfield, a professor of health law and science policy at the University of Alberta, came up with the idea for ScienceUpFirst, an organization that claims to combat misinformation.
For more on the Study 329/ Stan Kutcher story, go here, here, and here.
As reported in 2004, the law suit arose when a confidential GSK memo was leaked to the media which indicated that Study 329, a 1998 clinical trial found that paroxetine (Paxil) had no beneficial effect in the treatment of adolescents. The New York State Attorney General filed a consumer fraud lawsuit against the company for engaging in “repeated and persistent fraud by concealing and failing to disclose to physicians, certain information about Paxil” and that the concealed information “impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized public health and safety,” stated Attorney General Eliot Spitzer. The suit was settled in 2004 and obliged GSK to maintain an online clinical trial registry with summaries of its sponsored trials. Trial results are to be posted within 10 months of the drug being marketed.
A separate Department of Justice suit against GSK was settled in 2012 and the company was fined $3 billion for bribing doctors with kickbacks, like lavish vacations, for agreeing to write extra prescriptions to help increase drug sales: “Psychiatrists and their partners were flown to five-star hotels, on all-expenses-paid trips where speakers, paid up to $2,500 to attend, gave presentations on the drugs. They could enjoy diving, golf, fishing and other extra activities arranged by the company,” reports The Guardian. “GSK also paid for articles on its drugs to appear in medical journals and "independent" doctors were hired by the company to promote the treatments, according to court documents.”
Peter Doshi is a pharmacy professor at the University of Maryland School of Pharmacy, and senior editor at the British Medical Journal. He and others re-analyzed the Pfizer clinical trial data and published a study that appeared in 2022 in the journal Vaccine. The data were not made public when the vaccines were first authorized for emergency use and deployed. It was only through a court order in response to a Freedom of Information request by a group of doctors and scientists, including Doshi, that the US Food and Drug Administration was ordered to release the 450,000 pages of data it relied on to license Pfizer’s vaccine. The US government wanted to review and release 500 pages a month, which would have taken 75 years to complete. After re-analysis, Doshi says the Pfizer and Moderna data show a combined 1 in 800 chance of having a Serious Adverse Event (SAE), which the companies define as landing you in hospital. Doshi says this is vastly higher than other vaccines that have an elevated risk of a SAE of about 1 or 2 per million vaccinated.
Go to page 23 to see there were more vaccine deaths than placebo deaths: https://www.fda.gov/media/151733/download
See this 2021 British Medical Journal news piece which reports: “During the blinded, controlled period of the study, 15 vaccine recipients and 14 placebo recipients died. In the open label period, three Pfizer recipients and two original placebo recipients who received Pfizer after unblinding died.” The news report goes on to say that Pfizer’s investigators “concluded that none of these deaths was considered to be related to the vaccine.”
In the BMJ article, David Healy and Peter Doshi conclude: “Before any covid-19 treatment or vaccine is made widely available, study protocols should be in the public domain, along with statistical analysis plans, clinical study reports, patient level data, and copies of the correspondence with regulators and other key stakeholders. Data transparency is not a “nice to have.” Claims made without access to the data—whether appearing in peer reviewed publications or in preprints without peer review—are not scientific claims. Products can be marketed without access to the data, but doctors and professional societies should publicly state that, without complete data transparency, they will refuse to endorse covid-19 products as being based on science.”
I'd be curious to hear if Dr. Healy knows of any research that's been done, or his opinion on whether there is a link between kids being on these psychiatric medications and school shootings...
Anybody that takes prescription medicines or vaccines should read this. Looking forward to part 2 and hope you will delve into why Dr. Healy left Canada. Also very interesting to read the note about Senator/Dr. Kutcher’s conflicts-of-interest and his involvement in the more recent censorship efforts.