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182. Manufactured Evidence-The Systematic Fraud Behind Adolescent SSRI Prescribing · Radically Genuine

• Roger K. McFillin, Psy.D, ABPP (00:01.506) Welcome to the Radically Genuine Podcast. I am Dr. Roger McFillin. If you're a clinician or prescriber who is convinced you are acting within the evidence base for recommending SSRIs as both effective and safe, especially for children, adolescents and young adults, this episode will be critical for you. In fact, I would argue it's our ethical duty to have working knowledge about what we are going to discuss today because today we're going to deep dive into the murky intersection of science, medicine, and profit with a researcher who spent decades pulling back the curtain on how pharmaceutical industry practices corrupt medical literature. Professor John Giordini is a child psychiatrist with training in philosophy, critical appraisal, and psychotherapy, who leads the Critical and Ethical Mental Health Research Group at Adelaide University in Australia. His deconstruction of industry sponsored clinical trials has exposed how pharmaceutical companies manipulate data, employ ghostwriters, and cultivate academic figureheads to create an illusion of scientific consensus around their products. Through painstaking analysis of data, court documents, and internal communications, Professor Giridini has revealed how medications prescribed to our most vulnerable populations, children and adolescents, gained approval. based on studies that were fundamentally misrepresented in the scientific literature. If more people knew what we're going to discuss today, there would be such moral outrage that the wave of rebellion against the widespread practice of prescription psychiatric drugs, and we would have a greater moral reflection about what the consequences of this treatment is. In his groundbreaking book, The Illusion of Evidence-Based Medicine, which exposing the crisis of credibility in clinical research, co-authored with Lehman McHenry, he demonstrates how commercial interests have hijacked the evidence base that clinicians rely on, compromising patient care in the process. His work raises profound questions about the integrity of published research and challenges us to reconsider the foundations of modern medicine. And he's internationally renowned for his investigations and critical. Roger K. McFillin, Psy.D, ABPP (02:20.928) analysis. Professor Giordini, welcome to the Radically Genuine Podcast. Jon Jureidini (02:25.506) Thanks very much for having me. Roger K. McFillin, Psy.D, ABPP (02:28.172) Your work exposing misleading clinical trials and corporate influence in psychiatry has made you a powerful voice against scientific misrepresentation. While we're going to dive into these issues today, I'm curious, I'm sure my audience is curious, if there's been any personal journey that led you to become such a determined advocate for truth in medical science. Jon Jureidini (02:51.278) No, not really. Just I think I've got a kind of disposition to spot what's wrong with a scene. It can be a disadvantage in nature because there'll be a beautiful scenery and I'll be looking at the one bit of rubbish that's in the edge of my eye line. So I kind of have a sort of native... capacity to see things that aren't right. And I guess I was introduced to psychiatry in a slightly unusual way in that I did two years of child psychiatry before I went into the adult system. And so although I did get sucked into the whole heavy prescribing business, I came to it with quite a strong therapeutic background. And I never really took to the idea of medicating children. wasn't something that I liked right from the start. And so I was always looking for chinks in the armour of those who were promoting medication for children. Roger K. McFillin, Psy.D, ABPP (04:07.532) Dr. John Ioannidis, he's a Stanford professor and medical researcher. He asserts that as much as 90 % of the published medical information that doctors rely upon is flawed. And he openly asserts that the published scientific literature is so flawed and riddled with conflict of interest that doctors are relying upon an illusion of scientific consensus that drives decision-making. In your book, The Illusion of Evidence-Based Medicine, you argue that evidence-based medicine has been hijacked. Can you explain like what you mean by this and how it happened? Jon Jureidini (04:47.788) Well, the stamp of evidence based is what gets treatments accepted in psychiatry. so what happens is that the preferred methodology of the randomized controlled trial is therefore the arbiter of whether something is evidence based. And so if you're a pharmaceutical company wanting to sell your drug, then you don't need to think about whether your drug actually works. What you need to do is demonstrate that it can beat placebo on a randomized controlled trial. And instead of doing what's scientific, is setting the most stringent possible test that's likely to catch your idea out, you do exactly the opposite. set the circumstances most likely to support your favorite idea. And it's relatively easy to do that within the constraints of apparently robust methodology in a randomized controlled trial. So for example, either choosing a very high dose of a comparative drug so that it You can guarantee it will cause lots of side effects, which makes your drug look safer or choose a very low dose of a comparative drug so that it's likely that your drug will look more effective. And there are some of the more obvious tricks, but there are literally tens of ways in which you can carry out a well-conducted randomized controlled trial. then Even if the methodology is sound, the way in which you report it and publish it and spin it offers real opportunity. And all of that is knowingly or unknowingly supported by regulators like the FDA, who do things probably from a good place like... Jon Jureidini (07:05.964) offer an extra six month patent extension for doing research in children. So then there's an incentive to carry out trials that are meaningless and not looking at the truth, but merely ticking a box in order to make another half a billion or a billion dollars from their drug, which is threatened with patent expiry. Roger K. McFillin, Psy.D, ABPP (07:30.774) In the United States here, we're in a bad place. We have what can only be constituted as a mental health crisis where there's high utilization of mental health services in the United States. So much so that we're really pushing out mental health counselors who don't really have a strong understanding of the research base and have to make recommendations. More so by you know, what is push to them in academic settings. So for example, like when a licensed professional counselor has to take some final exams, it's very clear that they're to refer to psychiatrists for SSRIs when they see an adolescent who's identifying with clinical depression. In primary care centers, there's these standards of care where pediatricians administer PHQ9A, these screening measures that again push more kids to drugs and it's in their guidelines that these are safe frontline evidence-based treatments. So for context for today's discussion, I want to alert my listeners to a 2004 landmark study which still is utilized today as reference. for why antidepressants are effective for youth. It's called the TAD study, which is the Treatment of Adolescents with Depression study. And it evaluated the effectiveness of fluoxetine, which is Prozac, cognitive behavioral therapy, and our combination for treating what they identify as major depression in adolescents. And when this TAD study was first published in 2004, the practice of prescribing SSRIs to children was under intense scrutiny and for lack of a better word, taking an evidence-based beating. And in that same year, the FDA held a hearing on increased suicide risks with SSRIs in youth, which ultimately led to a black box warning. During that hearing, an FDA official reported that 12 of the 15 pediatric trials conducted prior Roger K. McFillin, Psy.D, ABPP (09:49.848) for fluoxetine in the treatment of children failed to outperform placebo. And I think there was like two or three positive trials that were used for its ultimate approval here in the United States. And despite the criticisms and concerns around SSRIs for pediatric use, the TAD study provided what is identified as the key piece of evidence. And it's widely cited right now supporting medicating depressed youth with drugs like Prozac. Psychiatrists, pharmaceutical companies point to these TADS conclusions that the combination of these drugs with another therapy is the most effective way to treat teens who are presenting with depression. TADS has been instrumental in creating a climate in which the use of antidepressants in minors is not only accepted but actively encouraged despite growing concerns for limitations and harms. John, I want to hand it over to you. I see you as an expert in evaluating this study. What can you tell us about this study? Jon Jureidini (10:55.95) In a way it was two studies because there was a blinded trial of fluoxetine and placebo. That is there were one group of about 200 kids who didn't know whether they were getting fluoxetine or placebo. And there was another group of about 200 kids, half of whom got fluoxetine and CBT and half of whom got CBT. And that was unblinded. That is everybody knew exactly the treatment they were getting. And the meaningful difference in outcome was between the group who got fluoxetine and placebo and CBT knowingly and the group from the other study who received placebo. And those two groups should never have been compared because they weren't subject to the same conditions. When you look at the valid comparison, which is between fluoxetine and placebo, so the half of the study that was blinded. There's actually on two measures, on the most robust measure, it didn't reach statistical significance. On the less robust measure, it only just did. And the differences in outcome for the drug group and the placebo group were meaningless clinically. And nevertheless, it's been promoted as showing the effectiveness. Even more worryingly, I think the TADS authors published about 10 or 12 papers about the outcome from the TADS study. none of them, even though one was allocated to talk about adverse events, none of them honestly reported the adverse events that occurred. And we conducted a reanalysis of the study under the riot scheme, restoring invisible and abandoned trials, which was promoted by the BMJ and PLOS several years ago. And while our effectiveness measures, effectiveness analysis wasn't that different from what had been published, it was a little bit less favorable towards, even less favorable towards FOXATAN. Jon Jureidini (13:18.068) our analysis of the adverse events was quite dramatic. So there were many more suicidal attempts in the fluoxetine group than there were in the placebo group. And remember, children are only being followed for about 12 weeks in this study. And so you've got very few patient years of exposure to the drug and very few people who are having the experience of going on the drug and going off the drug, which are the two dangerous times. And so if you're finding even a hint of increased, serious adverse events, then that should be reported first and foremost, rather than massaged out of the description of the, of the way in which the children have responded to the drug. So, very serious concerns about the misrepresentation. The conclusion should be that fluoxetine is a largely ineffective and dangerous drug. be used in children. Roger K. McFillin, Psy.D, ABPP (14:22.186) Yeah, one thing that I think is really important to report is that there was a follow-up paper, I'm trying to get this gentleman's name, I think it was Goran Holberg, and I think this significant increase in suicidal events for the teens taking fluoxetine compared to placebo was 11 % versus 2.7%. Now that is dramatic. I mean, you're talking about a five-fold increase. and then you start to extrapolate that to larger populations. Why do you think this crucial safety signal went unreported? Jon Jureidini (15:00.326) I think because the authors genuinely don't believe it. They go in with such a strong preconception that fluoxetine and drugs in general are what's needed in psychiatry that they turn a blind eye to anything that doesn't fit with that preconception. I can't think of any more generous interpretation of the apparently willful turning of a blind eye to very worrying data. And also they're comparing it, those that are still in any kind of clinical practice are comparing it to their clinical experience, which is that antidepressants work. It's the same clinical experience that antibiotics work for the common cold because... If you give antibiotics to somebody who's got a cold, by the time they come to see you, they're at the height of their illness and they're going to get better tomorrow anyway. And you give them antibiotics and they get better. So you believe that it's the antibiotics that cured them. Now, fortunately with antibiotics, we've got science that can decide definitively whether or not antibiotics work for viral infections. And we have some hope of countering bad practice based on ignoring evidence or being sucked in by misrepresented evidence. The same thing doesn't apply with depression and antidepressants because we don't even know what depression is. And it isn't a thing. It's a description of a pattern of behavior and experience that gets miscast as an explanation. And so... Roger K. McFillin, Psy.D, ABPP (16:40.589) Yeah. Jon Jureidini (16:52.014) It's such fertile territory for bad science and more importantly, bad medicine. Roger K. McFillin, Psy.D, ABPP (17:03.852) One of the more interesting papers I've read in a long time was your published paper last year with Joanna Moncrief, Julie Clow, Natalie Bustate, and Melissa Raven. And this is the treatment guesses in the TADS study. So you did a good job of setting it up how there was a blinded group who didn't know what they received. Can you tell us a little bit about this published paper? Jon Jureidini (17:28.588) Yeah, so one of the things that the TADS authors or researchers did was to ask the children themselves, their parents, the people providing their assessment and the people medicating them to guess which treatment they were on. And they were asked to do that at six weeks and 12 weeks. And so we were able to look at And there was data collected for, think about 70 % of people had completed that. So it was a reasonable sample. And we were able to look at the, whether they guessed correctly, which they did more than chance. And that's not surprising because it feels different to take the drug than to take a placebo. But what was more striking was that the drug that the treatment that the patient guessed they were taking was more of a determinant of outcome than what they were actually taking. So children and adolescents who took placebo but believed they were taking fluoxetine did better than young people who were taking fluoxetine and thought they were taking placebo. So this suggests that Even the small effects that appear to accrue from the medication might be explained away by some kind of expectancy effect that if you think you're being treated with the drug and, and, you know, TADS couldn't have been better designed to exploit expectancy because the people who were getting the fluoxetine plus CBT openly knew what they were getting. They were told that this was a gold standard treatment. The people who are either on fluoxetine and placebo were pretty much informed that they were getting a lesser form of treatment. They've missed out on the best random, being randomized to the best group. And of course the CBT people knew that they were getting half of the so-called good treatment, but they were missing out on the other half. Jon Jureidini (19:55.106) So if you didn't get a positive outcome for fluoxetine and CBT in those circumstances, you are never going to get it. Roger K. McFillin, Psy.D, ABPP (20:04.494) Do you think that was deliberate, the way they set that up? Jon Jureidini (20:07.64) Well, there's been questioning over the years, why wouldn't you have a fluoxetine and CBT and a placebo and CBT group to compare? And they would at least then be blinded for which, whether they were on medication or not. And they've said it was too expensive or methodologically difficult. And I've never been able to understand why that wouldn't have been quite possible to do. I it was an expensive study anyway. I don't know that it would have significantly added to the cost of the study to do that. So whether that was thought out in advance or whether it was a happy accident, I don't know. Roger K. McFillin, Psy.D, ABPP (20:53.964) And was the TADS study funded by NIMH, the federal government in United States? Were there conflicts of interest with those who ran the study that you were able to identify? Jon Jureidini (21:00.621) Yes. Jon Jureidini (21:10.476) Yes, many of the authors had entrenched relationships with industry and had contributed to some of the previous papers about antidepressants that were used to get the FDA approval for them. Roger K. McFillin, Psy.D, ABPP (21:31.864) So this is a very familiar pattern for you where they design a study that creates the higher likelihood that it'll be favorable to the product they're trying to prove is efficacious. Jon Jureidini (21:44.074) Exactly. mean, the motivation for doing studies, the other motivation is a familiarity trial. This is where there's no real scientific question to be answered. The main purpose of the study is to get your drug into as many centres as possible. So for example, when I was a very junior psychiatrist, we were approached by one of the SSRI manufacturers to participate in a trial of antidepressants for social anxiety, which was big at the time as a newly created disorder to sell drugs. so what was required of me as a potential chief investigator in this study was to provide a few patients for them. didn't really care how many. What they wanted was for their drug to be our drug with all of the competition for different antidepressants. If we were researching a particular drug, we were likely to develop a favorable attitude towards it, particularly because the drug company offered me a chief investigators meeting in Florence as part of the package of what they were offering. So, you know, here's a trial. And most antidepressant trials are not initiated by the scientific branch of the company, they're initiated by the marketing branch. So the emphasis is very much on sales rather than science. Roger K. McFillin, Psy.D, ABPP (23:27.63) And you mentioned this earlier, especially when we're talking about adolescents, they've kind of market this like there's this medical condition called major depressive disorder. And it never looks that way in clinical practice. It's not like one kid looks the same towards another kid. Like it's this really objective, objectified disease state that we can identify. But from what I remember, in some evaluations of the TAD study is a lot of these teenagers, came with many different presenting problems. And then in the cognitive behavioral therapy group, CBT usually has these targeted treatment interventions based on these diagnoses. So CBT for anxiety is gonna look different than CBT for depression. And if there are these behavioral manifestations or externalizing disorders, then the treatment's primarily behavioral. But you can't do that when you're setting up a trial and you're not gonna have these great CBT experts, have to standardize this. Can you tell us about the type of kids that generally were in this study and did they fit some clear criteria for major depressive disorder? Jon Jureidini (24:38.548) well, firstly, the, assessment was only interested in whether they met criteria for depression. So, there's no attempt to formulate a case as you would in clinical practice and to work out, what's going on for the particular child. we weren't, nothing was made available to us that told us anything very interesting about the kids who were coming into the trial. There were exclusion criteria, but we didn't have access to any details of the young people who were excluded from the trial. And so, but the CBT, was a standard package. And so it's not a test of psychotherapy, which by its nature should be individually attuned to the needs and an understanding of the individual. Roger K. McFillin, Psy.D, ABPP (25:52.908) Yeah. So what that means out there for the lay audience who's listening, there could be a kid who's depressed because his parents are getting divorced. There could be a kid who's depressed because he's being bullied in school. kid could be depressed because he has like horrible social anxiety. There's all these reasons why someone feels a certain way. And that's not what they're interested in in the study. It's not a formulation of why, and then targeting that individually. It's just mass application. of these very almost oversimplified interventions. So, John, I'm really interested in the ethics of my profession, especially around informed consent and medical freedom. And informed consent is illegal, it's an ethical imperative. And I find what is happening in our culture is both therapists and prescribing doctors really fail to be able to have in-depth conversations with families of teens who are struggling about risks, benefits, and alternatives. And so now we're blindly following guidelines. so given what you know about SSRIs for youth, I'd just be curious to know how you would provide informed consent to a family who is considering taking this drug. Jon Jureidini (27:24.809) So, just a kind of general principle before I answer that. You've probably spoken to Joanna Moncrief over the years and some of your listeners will be familiar with her concept of drug-centred prescribing, that every time we prescribe, we need to treat it as a trial because we don't know what the impact of a drug is going to be on any individual. even after the millions of prescriptions that we've given for psychiatric drugs. And the only reason for giving a drug is if the predictable effects of that drug provide a good match for the range of symptoms that the patient has. And if we think that there is a good match and that the benefits are likely to outweigh the harms, then it's a responsible decision to prescribe to that person. So part of informed consent is an acknowledgement of the fact that this is not like giving an antibiotic for a streptococcal throat infection where we've got every reason to believe that we're giving a specific treatment that will cure the problem. So, and that doesn't mean, I mean, clearly, There's no point in giving a treatment and saying to the patient, don't really think this is going to work. So you don't have to go to that extent, but you do have to share with the patient the level of uncertainty about whether a drug is going to be effective or not. And then you need to inform with antidepressants, you need to inform them of the likely and unlikely adverse effects of the drug, the harms that come from the drug. It's very likely that the drug will interfere with sexual functioning. Now, so far as I'm aware, none of the studies that have been done in adolescence have looked at sexual functioning as an adverse effect, as a specific question about that. It's like it's morally OK to give people mind-altering drugs, but it's not OK to talk about sex with adolescents. So we won't ask them about that. And we know from adult studies, and we've got no reason to believe it would be different for adolescents. Jon Jureidini (29:50.424) that something like half of people will have disabling sexual side effects. If you think about the place in which sexual thinking has in adolescence and the impact having sexual dysfunction, even for somebody who's not interpersonally sexually active, the impact that might have on depression and anxiety and all the other things that the young person is going through. then a part of informed consent must be to talk about sexual functioning. The other thing that has to be spoken about is akathisia, a rare effect, but a potentially fatal one because some of your listeners will have experienced restless legs, which is not an uncommon symptom to have. Akathisia is like having that very much exaggerated and throughout your body, but more importantly in your mind. And so there's a incredible sense of restlessness and agitation. And people for some reason don't recognize that that's an effect of the drug. It feels to them like this is something that is part of them. And this appears to be the experience that leads to those tragic cases where somebody behaves completely out of character and kills themselves or kills somebody else when taking these drugs. So that needs to be warned about even though it's rare. The other thing that needs to be warned about is the difficulty of withdrawing from the drugs. So people who take these drugs for any length of time, an important minority of them will have real difficulties coming off the drugs. And that will often be mistaken for a recurrence of the depression, but it's not. It's now been demonstrated that it's a quite distinct phenomenon and it can be crippling. And so all of those things need to be shared with families before antidepressants are prescribed. But the culture is still the one from the sort of Prozac Nation days that these are harmless Jon Jureidini (32:17.23) drugs suitable for cosmetic medicine, know, why not feel better than good? Those kinds of messages are still in the background, I think, and they kind of trivialise the significance of a mind-altering drug in young people. Roger K. McFillin, Psy.D, ABPP (32:42.318) So given the risks that you just spoke about, as well as the questionable, at best, efficacy, are there any scenarios in which you would recommend a depressed young person try an SSRI? Jon Jureidini (32:59.422) in my practice, no, but there are people whose practice I respect who would sometimes use antidepressants, provided it's, it's done as a, as a trial and, with properly informed consent, then, I still don't think it's a good thing to do. but it's not, it's not medically irresponsible to do it if it's done properly. But that would be a fraction, a tiny fraction of anybody's practice. So in almost all cases, it's inappropriate that young people are prescribed antidepressants. Roger K. McFillin, Psy.D, ABPP (33:46.252) Yeah, statistically speaking, we're approaching near 20 % of adolescent females being prescribed an SSRI. That's the level to which it's being prescribed. so, although scientifically, I can't really identify any valid reason why that should be recommended, I always accept that there could be an extremely small percentage of people who are suffering to such an extent. that their willingness or openness to try something, especially when they might have a belief that there's something physically or medically wrong with them. You know, when we talk about the power of belief and adopting this idea that you might need a drug just to feel okay. I think humanely, there's the openness to say in those very rare occurrences, it's a tool or it's an option to use. But the overwhelming majority of people who are prescribed these drugs, we don't have sound scientific data. to support their value. And we have just to such an extent a growing understanding of the harms that are created from these drugs. And you were mentioning all the ranges of adverse effects that we should be open about when it comes to informed consent. You know, I can... very bluntly stated, I wrote some articles on this recently, is this is a period of mass experimentation. This is a critical developmental period for adolescents, especially around sexuality. And we have this bi-directional relationship with serotonin and sex hormones. And so we really don't know what's happening when you interfere with nature to the degree that we're interfering with nature. These are chemically constructed drugs made in a factory that are interfering and influencing human development. in ways that we still can't say we know what they're doing because the brain is so complex, the human body is so complex, and we'd have to acknowledge that we are experimenting on human beings. Jon Jureidini (35:46.218) Yeah, but we do know something about the drugs and we know that they're emotional numbing agents and that's what they should be called really. They're not antidepressants. They don't take depression away. What they do is numb people emotionally and for people in certain circumstances being emotionally numbed, although it involves a loss of agency and autonomy and selfhood, is a better state. Just like being hospitalized and placed in a know, coma in extreme circumstances is something that is life-saving for when it's appropriate, but when it's not appropriate, it's taking undue risks. Roger K. McFillin, Psy.D, ABPP (36:30.498) John, I do have some questions about ethics for you. And I've been around long enough now, 25 years in this field, where you see that there's always the new drug that's being promoted here in our country. We're one of two countries who have direct to consumer advertising. Right now the drug is Lexapro, esitalopram, which is widely prescribed right now in primary care settings. have extraordinary amount of young people who are taking Lexapro. In 2023, the FDA approved Lexapro for children as young as seven with anxiety. And this raises serious questions about pharmaceutical influence in research because there was, you know, very clear conflicts with the authors. And this study clearly identified there was a six increase in suicidality among children who were prescribed Lexapro compared to the placebo group. And the authors of the study described Lexapro as quote unquote, well tolerated. So my question then for you is how is that ethical and how is that legal? Jon Jureidini (37:58.764) Yeah, there's an Australian author who talks about weasel words. And that's a good example of that. it's true that the clear majority of patients in that study didn't have adverse effects, significant adverse effects from Lexapro. And so you can say that and not end up in court. But you're manipulating the truth in order to do that, in order to sell drugs. so, you know, this is an equation that happens in company boardrooms. It's not a psychiatric drug, but Vioxx, the arthritis drug. Merck, which had a reputation as being one of the most ethical drug companies, apparently debated whether it was when they knew that their drug was causing cardiac deaths. They did the sums and worked out if we keep selling it for as long as we can, we'll make more money than we'll lose in the litigation that happens afterwards. In that calculus, the death of all those people doesn't form part of it. Capitalism. Roger K. McFillin, Psy.D, ABPP (39:25.39) True. And there's a story, I started looking into the history of Lexapro, eventually found myself to your work, the CIT MD-18 study, which was a clinical trial conducted by Forrest Laboratories between 1999 and 2002 to test the efficacy and safety of citalopram, which is marketed as Celexa, compared this to to placebo for treating depression in children and adolescents. Now this study is important because it has been leveraged for regulatory approval of SSRIs for children and adolescents and has a connection to the drug Lexapro, which is esetalopram in adolescents. And when you look at the molecular structure of the drugs, they're not very dissimilar. So, I'm going to open it up to you if you could tell us a little bit about that CIT MD 18 study. Jon Jureidini (40:29.112) Before I do just the relationship between Sitalopram and Sitalopram. So Sitalopram is just the active ingredient of Sitalopram, active part of Sitalopram. So it's an identical drug, not a similar drug. Effectively, it's identical and it's a strategy used for when a patent's running out. You engineer, you basically modify the drug to make it different enough. Roger K. McFillin, Psy.D, ABPP (40:45.378) Okay. Jon Jureidini (40:58.488) to allow you to take out a new patent. So anybody who's taking S-Cetalopram could achieve the same effect with double the dose of Cetalopram. It's just souped up same drug. So what a couple of interesting things about the Cetalopram trial that you're talking about. First is it's a really good example of ghost management. So ghost writing, is a problem for, from a kind scientific ethical point of view, if somebody else writes a paper and I put my name on it, that's plagiarism. And, you know, I'm unfairly competing in the career stakes. But provided the science is accurately represented in the article, that doesn't harm patients. Some would even argue that a medical writer so-called would do a better job of writing up a research study than I would. so patients are better off if we use medical ghost writers rather than having busy clinicians write papers. But the problem isn't ghost right from the patient's point of view. The problem isn't ghost writing, but ghost management. That is the control of what goes into the paper, not how it's written up. And so... Roger K. McFillin, Psy.D, ABPP (42:25.955) Mm. Jon Jureidini (42:27.896) The satelipram trial was a really good example of that. for example, the secondary outcomes in the study reflected poorly on satelipram. So the strategy was to target a journal that had brief reports where it wouldn't be expected that you'd have to report on the secondary outcomes. And so the ghostwriter was instructed to construct an article that would fit for a particular journal. that would have high level of exposure, but wouldn't bring out the bits of the study that they didn't want brought about. And there's a particularly cynical bit of email correspondence in which the medical writing company, the ghost writing company says, we haven't decided who's going to write it yet. And then in brackets, as opposed to who the author is going to be, close brackets. So The whole article is prepared before they've asked, in this case, Dr. Wagner, who went on to become president of the American Academy of Child and Adolescent Psychiatry, to put a name on an article and until then she'd never seen. So, again, all of that doesn't matter to the patient if the science is accurately represented. But the main scientific problem with this paper was that there was unblinding. Several of the drugs were sent, or a whole batch of the drug was sent out with the wrong packaging on it, and it was clear which was the drug. And rather than abandon the trial or manage the statistics differently, those cases were included in the analysis, which just pushed the drug into statistical significance. You take them out and it doesn't. And there's been argument in the literature about how it should properly have been handled. But the unequivocal, unethical thing, it was never declared. We had to go looking through papers that were discovered through legal action in order to identify that this sleight of hand had happened. Jon Jureidini (44:54.166) And so it was, you know, it's not the case that somebody might accidentally have done the wrong thing or followed an incorrect methodology. It's a quite clear conscious decision to hide a deficit in the trial. And the knock on effect, as you point out, is this then goes to licensing. And once the drugs on the market, nobody cares about the science anymore. It just, and that's why our scientific rebuttal of these studies, I think has very little effect. mean, nobody's stopped prescribing these drugs because we've produced scientific evidence that they don't work and they're dangerous. So the decision-making is happening on a different level from that. And it's a sad fact that that producing scientific refutation of these claims has very little impact on practice. Roger K. McFillin, Psy.D, ABPP (46:07.254) which makes us the illusion of science, because as you know, science requires replication, debate, continued evaluation, and which I have to question whether psychiatry is a viable and trustworthy medical specialty given the clear misrepresentation of scientific data by key academic opinion leaders who are hired by the pharmaceutical industry, and they shape medical training and public perception. to such the extent it almost seems to, you know, appears more of a religion than anything that medical students have to blindly follow that you see when you want to enter into some critical analysis, when you want to present your work, for example, there's a defensiveness that occurs where they're so closed off and not even open to the possibility that, the drugs efficacy and safety is completely misrepresented to them. Jon Jureidini (47:08.578) Yeah. When you talk about the difficulty of getting critical views published, our riot reanalysis of peroxetine, the infamous study 329, which was eventually published in the BMJ. We, that process of pub from submission to publication took a year. rather than the standard page or two of reviews, there were 27 pages of peer review that we had to deal with. So the bar that's set for critical discourse in psychiatry is so much higher than what's required to put the bad science out there in the first place. And, you know, as a critic, if you make one mistake, You're disqualified. As the person putting out the bad ideas in the first place can be riddled with errors and you have an opportunity to correct them. So it's a very uneven battle. Roger K. McFillin, Psy.D, ABPP (48:21.09) And the way that it's represented, if you do have critical analysis and you really do believe in the scientific process, and that's a high ethical standard, you're deemed anti-psychiatry for questioning any of the evidence. I mean, it feels very similar to how other people are discredited when they have opposing views to... what is the majority? It's you become kind of discredited as a, as a, as a person and, not your, your critical analysis or your findings or, you know, anything around your, your, your opinions or beliefs that you want to share aren't really argued. It's just as ad hominem attack. Jon Jureidini (49:07.67) Yeah, I went to a conference on truth decay. It was about, you know, the my kind of stuff about misrepresentation. But it was interesting because one of the presenters was talking about conspiracy theories. And one of his conspiracy theories that he put up for discussion was that antidepressants are ineffective and dangerous. Roger K. McFillin, Psy.D, ABPP (49:35.714) Yeah, I mean, it's such a powerful machine. And I do see that there's movement, know, certainly, you know, post COVID, there's a certainly a distrust in the public authority, the medical authority, which is valuable because it's leading people to advocate and question and take control of their own health. That's kind of the positive of all this. Obviously, there's always downsides to when the trust in public institutions becomes less credible. And I think we're going through that challenging and difficult time. You my question to you is how do we restore trust back into the scientific process? I mean, what can be done in our culture and at the federal level to ensure scientific integrity? Jon Jureidini (50:29.8) Yeah, I think can only come about through government intervention, which is not likely, but I think the public pay for all of the research that pharmaceutical companies carry out. So the argument that only the pharmaceutical industry can afford to do this research is spurious because we subsidize them. to do the research, whether it's in Australia through government prescription scheme or in countries where individuals pay for their medication. there's a, you're paying not only for the science, but you're paying much more for the marketing that the company does. So it could be taken away completely from the pharmaceutical industry and all drug research. only drug research that's carried out by independent authorities would be counted for licensing of drugs. A less ambitious approach would be for to eliminate, to largely eliminate journals from the process, that what would be required of people who carried out research would be to publish their data, maybe not available to the whole public, but available to Roger K. McFillin, Psy.D, ABPP (51:51.566) Mm. Jon Jureidini (51:55.436) suitably qualified people. And then anybody could make their analysis of what the data shows. And that would be what's published in journals and so on. That the government employ health technology agencies to properly analyze data. But, know... conflict of interest will find its way into all these areas. If you look at it, you've talked about guidelines. I guidelines are almost always conflicted. And the view is that the experts inevitably have entanglement with industry because industry is after the best people and the best people attract industry sponsorship. So if you exclude people with industry sponsorship, then you're not going to have the best people making the decisions. And that's a spurious argument. You mentioned before about doctors being hired by industry. We're not mostly hired. And in fact, when we are hired, that's not so bad. If I'm employed by a company, then there's a clear contract. Excuse me, it's overt that I'm working in the interests of the company. Much more problematic is the creation of key opinion leaders who are people who honestly believe that they're independent and probably think they're taking the drug company for a ride. know, look at these people. They're giving me all this money to do stuff. I don't even always prescribe their drug. I'm much smarter than they are. mean, know, the drug companies are really good at playing into our arrogance as doctors. think. Roger K. McFillin, Psy.D, ABPP (53:31.566) Mm. Jon Jureidini (53:49.486) We're the cleverest in the pack. And they've got these huge billion dollar marketing companies made up of people who are really very clever and they're outwitting us every step of the way. So, you know, there's no such thing as an equal partnership between somebody who's very rich and somebody who's got modest means. So that... You can have an ethical relationship in which you're employed by somebody very rich, but you can't have an ethical relationship in which you are subjected to the illusion that you're in a partnership with somebody very rich because they're pulling all the strings and whether you know it or not, you're a puppet. Roger K. McFillin, Psy.D, ABPP (54:28.558) you Roger K. McFillin, Psy.D, ABPP (54:37.358) That's a really good point. Well said. I think the only option we have is complete transparency. If the scientific method is our protection of bias and it's our process towards truth, really, it's those people who are really passionately seeking out truth which drives scientific investigation, those who are meeting a high ethical standard would welcome the debate. Jon Jureidini (54:47.649) Ahem. Roger K. McFillin, Psy.D, ABPP (55:06.231) they'd welcome replication. But you know, what happens, think, unfortunately, is your career becomes tied to certain findings. Your research labs are funded based on that your whole career, in its essence becomes very connected to positive research, you know, things that that show some some effect that we're not really, you know, open to all that the important research that shows, hey, no, this doesn't work, or under these conditions, it doesn't work. And we need to have that back into our culture again. And I think we have to train critical thinking and critical analysis. I mean, that's the challenge that exists in the American healthcare industry right now is there's really the loss of the independent doctor. So no longer are we, you know, meeting with our local physician, somebody we trust who's serving their community and has an independent practice. Most of them have gotten bought up by these large scale hospital networks. And it is really profit driven medicine. They're following these industry funded guidelines from major medical organizations. And if they deviate from that standard of care, then they open themselves up to liability. And so they're afraid to take the risk. They have to follow that standard. As one pediatrician told me, he said, listen, even if I believe what you're saying, Roger, is true that these drugs can be really dangerous to a teenager. And I'm aware of the black box warning. If I prescribe this drug to a teenager who's reporting suicidal thoughts, or if I fail to prescribe this drug to a teenager who's experiencing suicidal thoughts, and then they do end their life, I'm liable. If I prescribe the drug and they end their life, then I'm not liable. So there's the illusion of evidence-based medicine right there. We're prescribing drugs to suicidal kids, a drug that's going to increase the likelihood that that teen is going to develop. increase suicidal ideation or even act on it. So that doesn't meet scientific evidence right now. And if you're handcuffed as a, as a physician and you can act independently and you can't critically evaluate, then really you just become somebody who's on an assembly line and, does this protocol medicine. And that's where, you know, you really see the, the American healthcare industry and the mental healthcare industry has really taken dramatic steps in the wrong direction. Roger K. McFillin, Psy.D, ABPP (57:30.272) And by every available statistics, you can see it is now creating harm. So I don't understand how, you know, psychiatry in general doesn't do a good enough job of policing their own medical specialty because it's really now at this point with the degree of harm to patients out there, it's such a tidal wave of movement against their ethical practice. I think it's in real jeopardy, which is a shame. because I think the field of psychiatry can continue to advance with everything we know about science, where it could really support people's health physically, which it doesn't, and it's just become an arm of the pharmaceutical industry. I've kept you a while and I really do value your time. I am interested before we conclude today, if there's anything right now that you're working on and like where your focus is in your career. Jon Jureidini (58:20.812) Yeah, so. Jon Jureidini (58:26.828) I guess partly out of disenchantment with trying to achieve meaningful change through the academic system, some colleagues and I are turning our attention to the public discourse about mental health. And we're trying to find ways to get across the message that the message is sort of summarized as not broken. More and more people are encouraged to think that their brains are broken in some way, whether it's ADHD or depression or autism or whatever. And we want people to think more about social needs and social determinants of mental health and how you can make a difference in your own and other people's lives through interpersonal means and more broadly about the social changes that we need to make in order to make a difference to people's lives. One of my I see children and I see children who've had lots of adverse experiences, adverse circumstances in their early life. And the ones who do best have often had a positive experience in a school environment. And that's because, not because somebody in the school environment is smart about mental health or has referred them to a psychiatrist or a psychologist. It's because the school's been functional enough to provide that child with a positive educational and interpersonal experience, which has enabled them to survive and overcome the adversity they're experiencing elsewhere. And yet we invest so little in schooling and I don't know what it's like in America, but you can have a very low Jon Jureidini (01:00:53.772) school achievement and still become a school teacher. It's not a valued or well remunerated profession. So why don't we rather than investing in more and more mental health services and the evidence is quite clear that it's not the case that more of the same makes things better. It probably makes things worse. We've got more. money being spent on mental health in Australia than ever before in real terms. And yet the rates of mental health problems are increasing all the time. So we're funding the wrong things. So I don't know whether in the later part of my career we can achieve some kind of traction in the community to say the language of The medicalized language that we use to talk about people's distress is doing far more harm than good. And that we need to get back to using ordinary language to talk about what people are experiencing and, and recognizing the value of relationships in, in healing. Well, mean, just about every problem I see is interpersonal. It doesn't live in the person's brain. It lives in their relationships with other people. so going looking in their brain and putting chemicals into their brain is just really the wrong place to be doing the work. Roger K. McFillin, Psy.D, ABPP (01:02:32.906) Very meaningful. Yeah, there's this depathologizing movement that I think is absolutely necessary. think we're kind of moving ourselves out of this, you know, 30 to 40 year delusion of which started with trying to identify all human distress as if it's reduced some to simple, you know, brain chemicals that really pushed an entire industry. I would say this, I know you felt like you haven't made great movement academically, but A lot of your work for the past 20, 25 years is becoming more mainstream here in the United States from a critical analysis perspective, because we're only coming out of the delusion, you know, in the past four, five, six years. It's still a minority. I still feel like I'm on an island a little bit, but we're able to speak more intelligently about why these drugs haven't been proven to be effective and why they're unsafe. based on a lot of your analysis and a lot of your work over the years. So I wanna just make sure that you understand how grateful a lot of people are over here in the United States, younger psychologists as well, people who are in this critical movement and able just to read your work and still to use it today. And I'm glad you're still publishing this 2024 paper about the... the unblinding and the influence of outcomes on prediction, think is fascinating because it opens up a greater discussion. I've brought it up on other mainstream podcasts where we talk about the power of what we believe to be true and what we create in consciousness. I mean, that's so meaningful. And if what happens when we start, you know, informing people that their own agency and wellbeing is externalized from them or they somehow, you know, failed the genetic lottery and they're doomed to this life of distress and struggle and how powerful that message is on an individual and how it affects how they cope with their lives as opposed to seeing, you know, emotions as very meaningful signals that are represented, the things that are happening in their lives. And there are also opportunities for them to transcend and to overcome and to grow and to learn. And it's such a meaningful and needed conversation to bring back in to the public discourse. Roger K. McFillin, Psy.D, ABPP (01:04:50.67) And Dr. Professor John Girardina, just want to thank you so much for a very valuable conversation today. There's going to be lot of young clinicians that listen to this episode, people who are practicing and believe that they have to send all their clients to psychiatry or to primary care in order to be on a prescription. And just going through this history is extremely, extremely valuable. So, I want thank you so much for a radically genuine conversation. Jon Jureidini (01:05:18.648) Thank you very much.