In Secrecy We Trust
PART 2: An interview with psychiatrist Dr. David Healy about how SSRI antidepressants can trigger violent behaviour
Part 1 of my interview with Dr. David Healy focuses on how little we actually know about the drugs we’re prescribed. The advancement of science requires that clinical trial data be made public for independent scientists to review, but the opposite is true. Even government regulators are not privy to the entire data trove, and clinical trial study “authors”—those most of us assume are intimately involved in the trials they purport to be writing about— are often not involved at all, have not met a single participant, and have nothing to do with the actual writing of the journal paper.
This lack of transparency and scrutiny allows drug manufacturers to design studies to achieve the results they want, hide serious adverse reactions using “tricks” and “loopholes,” and through a ghostwriter, communicate the results in ways that conceal information about potential harm and jeopardize the health and safety of patients.
It's a system in desperate need of an upheaval.
During his career, Healy has paid particular attention to selective serotonin reuptake inhibitors (SSRIs)—a class of antidepressant drugs that currently account for the largest share (>57%) of the global market.1 According to Global Market Insights, in 2020 the global antidepressant market exceeded USD $13.5 billion and was projected to increase to USD $22 billion in just seven years. The largest players are Pfizer, GlaxoSmithKline, and Merck.
Healy is a psychiatrist and author or co-author of 27 books, as well as 240 peer-reviewed journal articles. He’s held a number of professorships including most recently in the Department of Family Medicine at McMaster University. His main areas of research include clinical trials in psychopharmacology, the history of psychopharmacology, and the impact of both trials and psychotropic drugs on our culture.
Since 1997, Healy has been retained as an expert witness in 21 legal cases involving homicide —the focus of the interview that follows—and has brought the problems with these drugs to the attention of American and European regulators.
In 2006, Healy and two of his colleagues published the first independent quantitative analysis linking antidepressants to violence. After reviewing available clinical trial data and drug safety studies on a number of SSRI drugs and outlining a number of “medico-legal” cases involving antidepressants and violence—Healy and his colleagues concluded there are causal links between the drugs and violent behaviours, where the drugs may have induced the behaviour. They call for more transparency and more data about adverse outcomes to be made available, and worry that it may fall to the courts—"faced with cases of violence associated with the use of psychotropic drugs”—to demand access to the data.
Healy and his colleagues point out that for there to be a link between antidepressant use and suicide and/ or violence there needs to be “a plausible clinical mechanism through which such effects might be realized.” They say there are several mechanisms linking the treatment (rather than the condition) to “adverse behavioural outcomes,” such as suicide or violence, including “akathisia, emotional disinhibition, emotional blunting, and manic or psychotic reactions to treatment.”
In other words, “there is good evidence” that SSRIs can cause these reactions, and that these reactions “might lead to violence.”
I reached Healy in Paris, France, where we spoke via video link. Parts of the following interview also took place through email correspondence.
[This transcript has been edited for length and clarity]
LP: You were one of the people, along with a number of other scientists and researchers including Peter Doshi, petitioning for access to the clinical trial data that Pfizer relied on to license the mRNA vaccine. What can you tell us about that?
DH: The material that has come out of the slow trickle of stuff has been interesting but not killer material. There have been all sorts of things in plain site that have been more interesting--the excess deaths on the vaccine was in a public domain FDA document. Among the most interesting things were Augusto Roux's medical documents which he provided,and interviewing another clinical trial participant, Brianne Dressen.2
The point behind Augusto and Brianne and these other cases is they are in plain sight—no one needs to go searching for material we are not allowed see—sometimes called data. People are the data in clinical trials. Pfizer's data is a bunch of figures often badly collected and without the context of being able to speak to the person, so pretty meaningless.
The astonishing thing is so many people have been so clearly injured by the vaccine but yet have ended up being told by their doctors that this has nothing to do with the vaccine. It’s a bit like being told, ‘Ukraine is safe place to go on holidays—there's nothing much happening there.’
Still, I and a colleague Peter Selley have written about some of the things the Pfizer 'material' has shown in posts on davidhealy.org.
LP: What are the implications of companies hiding the harms that drugs can cause?
DH: If I'm being put on a pill, there are trusted sources that you or I would go to, to find out about the drug. Here's what the company says on the one hand, but what are the trusted sources saying? If you look at what we know about the SSRI group of drugs, the single commonest thing they do is to make you genitally numb within 30 minutes of your first pill. But if you look at what the trusted sources say about these things, they don't mention any impact on your ability to make love at all. And if you ask them, ‘Why not?’ they say, ‘Well, we don't want to deter people from getting the benefit of treatment.’
So, between the ghostwritten articles and all of the trusted sources we have, the possibility of us having informed consent about any of these pills is close to nil. And that means, in essence, that everybody from heads of state to the regulatory apparatus to the trusted sources to the Pope, they're part of the system that gets you to live the life that Eli Lilly and Pfizer and GSK want you to live, rather than a system which is informing us in ways that mean that we can use these company products to live the life that we want to live, which is what most people figure we ought to be doing.
We're being conditioned to fit into what the company wants for us. There are very stark choices here. With the SSRI group of drugs, [if I’m on the pill] I can have a problem— maybe unable to make love or maybe I’m thinking about trying to commit suicide. But my partner may have a problem too because I'm unable to make love. She may be killed or other people may be killed because these pills may make me homicidal.
But the other thing that's happening is if you go on these pills as a man, your sperm counts fall, and as a woman, you're going to become less fertile, and there's a huge risk that any embryo that's conceived isn't going to implant. Quite apart from that, once you do have a pregnancy, there's a much higher risk of miscarriage, but there's also much higher risk that you're going to have a voluntary termination and that's partly because these pills disinhibit. I'm sure lots of women, when they're pregnant, every so often think, ‘God, I wish this was just over,’ but when you’re on a pill that disinhibits, you're more likely to act on this wish.
LP: Can you tell us more about the connection you just made between the SSRIs and homicidal behaviour, and some of your experience over the years as an expert witness?
DH: I'm actually here in France and the reasons I'm here are interesting. Two years ago, I got contacted by a couple in France—he a university lecturer in higher mathematics and she a computer scientist and they had two children, charming children, one boy, one girl, and somewhere around three years ago now, when the boy was 16, he became slightly obsessed as a teenager can with issues about weight, eating the right food and things of that nature. He was slightly fussy, but nothing serious. They went down the talk therapy route but it didn't really seem to be getting anywhere so they went to a doctor who put the young man, Romain [Schmitt], on an SSRI, on Paxil.
Over the course of a few months, after he’d gone on the pills, the young man who hadn't much of a problem to begin with, is more agitated than he was before and shortly after that, when he goes back to the doctor, the doctor puts the dose of the pills up. The next time he goes back to the doctor, he's worse than he was before, and the doctor puts the dose of the pills up again. He goes back to the doctor. Clearly at this stage things are a good deal worse in terms of what they’re seeing at home. He is actually saying things to his father like, ‘I don't know what's happening in my mind.’ The doctor puts the pills up again and Romain throws himself in front of a train.
First of all, the case is clear in the sense of you've got a young man who gets put on the pill and whatever problem he has, it gets worse, and the dose gets put up [several times] and he’s dead. You don’t need to know a thing about what these drugs do to the brain, you don’t even need to know what the pills are, anyone looking at that should be able to say, ‘Well it looks like the pill caused it.’
Once the dose was put up twice, at that stage, you can either halt the pill and see if things clear up, which would indicate that it was the pill, or you can put the dose up and see if it gets worse. He kills himself, and it’s pretty well for certain the pill caused it.
LP: Sorry to interrupt but, when you say, ‘Take him off the pill and things should clear up,’ I have read that if you take patients off SSRIs after they've been on them for a while, it can make things worse. Is that right?
DH: When people go on a treatment and become suicidal in most cases—I'd say 9 out of 10 for sure—stopping the drug or reducing the dose clears the problem or at least eases it. The people who become suicidal on stopping [the drug], in most cases, have been fine on the drug and on it for weeks or months or years—so these are 2 different groups.
But there is a notional risk that if you become suicidal going on the drug and are only on it a short while this may not be minimized by reducing the dose.
I've seen it happen in people going on the drug like Romain but I have seen it happen in people who were on the drug a long time and are trying to taper. You may be badly agitated and we put the dose back up or reinstate the drug and things get worse.
There is an old adage that applies - treating and stopping is not the same as not-treating.
The answer therefore is complex and cannot be simplified. Managing it cannot be done by a book—it needs a close relationship. The most important thing is telling the patient these are almost certainly drug effects and do not stem from some condition they have. You need to put on the table for them that this may be the pill that's causing the problem. Simply knowing it’s the pill can help. It’ll stop you from thinking, ‘It’s me that’s the problem.’
This is particularly the case for teens. If you’ve got a 16-year-old boy or girl who gets put on an SSRI—and there’s nothing in the instructions for this pill that says the first thing that's going to happen within minutes of your first pill is you will become genitally numb. How do you talk about that to your parents? You don’t! And there’s very little information out there. So, it's the kind of thing a doctor really should lay out: these are the things that can happen, if they happen you need to know it’s the pill, it has nothing to do with you. What if [the patient] does find information on the internet and learns he’s got PSSD [Post-SSRI Sexual Dysfunction] and that maybe the rest of his life is ruined?
So, in the case of Romain, the parents are university academics, they should be able to work out what’s going on. So how come the parents didn’t recognize this and insist ‘We think it’s the pill that’s causing the problem’? The answer they give you is, ‘Well, you’ve got to trust your doctor. Yes, retrospectively it looks like the pill. But in the middle of it, you figure, I’m not the expert at this, he is, and he should know what he’s doing.’
The other interesting aspect to this case was that after their son dies—and they’re trying to pick up the pieces and work out what went on—they begin to think it was the pill, and try to find a French expert to get involved in the case, but they aren’t able to find one, and end up coming to me. This is the same as what happened in the first [Bill Forsyth] case I had in the United States. The lawyers were looking around and couldn't find an expert to give a view on a terribly obvious case.3 [3]
LP: Is there a lawsuit?
DH: Yes, there is.
LP: Are the parents suing the pharmaceutical company or the doctor?
DH: Well, at this stage, the lawyer working with them would love to have a French expert—and I’m due to meet him tomorrow afternoon—and it's probably the doctor in the first instance, that’s likely to be sued.
There’s a whole range of other interesting things about this case, but I’m putting it on the radar for you for a reason that we’ll get to later.
Let me tell you about an early homicide case that I was involved in, and again, a bunch of lawyers from the United States got in touch with me because they couldn't get any expert in the United States.
The case involved a 60-year-old man named Donald Schell, who was an oil man from Wyoming, who had trouble getting to sleep. So, he went to his primary care doctor who put him on Paxil, and 48 hours later, he shoots his wife and his daughter and his granddaughter and himself. 4
His son in law wasn't there, so he was able to take an action against SmithKline Beecham [GSK], not the doctor. In the case, the chief safety officer for GSK, Ian Hudson, said, ‘We at GSK practice evidence-based medicine, we do controlled trials and this gives us the truth about what drugs do and these controlled trials show that Paxil can’t cause you to commit suicide, can’t cause you to commit homicide, in fact, it doesn't cause any adverse effects at all.’
The jury were a bunch of plain people who were faced with this argument that the drug can't cause any problems at all, and they took what I would call an evident-based approach, which was that it's obvious the pill caused it, there's no other way to explain it.
GSK had the opportunity in court to find out everything about this man, and to tell the court every bit of dirt to cast doubt on the kind of man he was, and it didn't make any difference. They actually weren't able to find much about him. He was just a plain, average guy. There was no way to explain what happened other than the pill had caused the problem.
So, the jury found GSK guilty. But the key point about this from my point of view is, a jury can do that if they don’t have to let the man who has killed others walk out of court free. If they do have to let the person walk out of court free, it's a different thing.5
BBC documentary about James Holmes, “A Prescription for Murder” aired in 2017. Reporter Shelley Jofre reports on the “rare but possibly devastating side effects of SSRI antidepressants that can lead to psychosis, violence and even murder.” It appears the episode is no longer available.
About twelve years after the Schell case, James Holmes, usually referred to as the ‘Batman killer,’ went to the premiere of The Dark Knight Rises movie in Aurora, Colorado, had a bunch of guns, went into the movie theatre and shot and killed 12 people and severely injured 72. This is unusual in that he didn't kill himself, but the cops caught him before he could kill himself. [Holmes] was at university there, but he didn't come from a wealthy family, and his parents couldn't afford a good lawyer, so he got the state lawyer, a public defender, and they got in touch with me.
It didn't sound from what they told me that the drug had caused the problem, but they were kind of insistent that they wanted to tick the boxes and get me to meet [Holmes] and see what I thought. So, I met [him] in jail and was convinced – and when I say I was convinced, he didn't figure the drug caused the problem; he didn't really know why I was there. But I think it was very clear when you look at the record of what actually happened to him, and the way he was responding to my questions, I thought a very strong case could be made that the drug likely had caused the problem.
LP: Briefly, can you tell me what it was about what happened to him, and his responses to you that made you think the drug was responsible?
DH: At the interview, he gave very clear descriptions of genital and emotional numbing—the two go hand in hand—he was not to know this. He also described akathisia in a diary. He told the psychiatrist treating him that if he told her the thoughts going through his head, she would have to lock him up. She didn't ask him what they were, just said he'd have to take responsibility for them. His behaviour became disinhibited. He was put on the drug for being shy, but he began to ask women out—the ones that would have been out of his reach usually.
He only bought guns and went to shooting ranges after going on the drug. He was later [after the shootings] re-exposed to an SSRI and became suicidal. His parents, not knowing what had happened to him with meds were put on SSRIs and had agitation and problems. I interviewed them as well.
There was more, it was all very convincing, and as mentioned the lawyers had no hint that there really might be a case.
Holmes was facing the death penalty. I wrote a report and made it clear that I thought the drugs had caused the problem and included in the report a lot of other material like Pfizer had known ten years before Zoloft came on the market—which was the drug [Holmes] was on—that it could cause problems like this. They had given it to healthy volunteers and they had become aggressive and violent.6 I also made it clear that the FDA and Pfizer had known this when the drug got licensed, and made it clear that the literature on this drug was ghostwritten and concealed the problem.
At the time the events happened, Holmes was 24, which meant that he was in the age range that the black box covered.
Black box warning for Prozac
LP: Tell us more about the black box warning for SSRIs.
DH: The risks are not clearly stated. The fact is the drug can be linked to mental deterioration, but the [black box warning] does not clearly tell most people or doctors that it causes mental deterioration, or that it can cause suicide, aggression and homicide. The wording has been written by pharma with armies of people working on the text, and to most doctors and the public it conveys a message that early in the course of treatment or linked to stopping the treatment, things can go wrong. In the absence of an unequivocal statement that the drug is a likely cause of this, this is read by most doctors and the public that it is the illness that is causing things to go wrong not the drug, and the dose needs to be increased.
The [black box] warning is not read by most people as unequivocal, in the way that saying that healthy volunteers in healthy volunteer trials have committed suicide is. It does not say ‘caused’ and does says depression is ‘associated with increased risk of suicide.’ It used to more clearly link the problems to changes in dose, which for someone like me does hint strongly at cause, but doesn't do that for most people, and is now gone. 7
Holmes’ defence team was initially enthusiastic about my report but decided not to use it, and my hunch is they did a deal with the prosecution, where the prosecution agreed there would be one juror who would say they have doubts about this case so, James Holmes would be found guilty, but would not be executed. From the defence team point of view, that's a victory. It's not a victory from James Holmes’ point of view because he ended up [receiving a sentence] of 3,300 years.
Unlike the Donald Schell case, the jury would have had to let a man who killed 12 people and injured a load of others walk out of court free. His legal team, I'm sure, were thinking that to find him innocent—in the sense that he didn't do it of his own free will—you've got to find the institutions guilty. The FDA, the New England Journal of Medicine, Pfizer, lots of academics, lots of doctors, the doctor who put him on the pills and put the dose up and didn't listen to him when he told her, ‘Look, I'm having the strangest and weirdest thoughts and if you knew what I was thinking, you’d lock me up.’ She didn't ask what the thoughts were.
A lot of legal teams would say, ‘We can't get a jury to go there. It’s like getting a committed Christian to renounce their faith there and then, and you just can't do it.
Christopher Pittman and his grandfather Joe Pittman, 2001. Source
I was reminded of another case this week—one I also got involved in—of Christopher Pittman, who [in 2001] was a 12-year-old boy, who preferred to be with his grandparents than with his father. He and his father had a falling out and Christopher ran away from home to the grandparents and somewhere in the mix, was picked up by the cops and brought to a mental health unit where he was put on the SSRI Paxil. The grandparents came to pick him up, took him back to their house, and he was thrilled to be with them. They brought him to the doctor who said, ‘Oh, I don't like Paxil. Let's put him on Zoloft.’
The grandparents did the usual thing that they did with Chris. They brought him to church with them, and when he was in church, he was clearly very, very restless and couldn't keep still and they were saying to him afterwards, ‘You won't be able to come to church again if you're going to be as restless as that.’ This clearly appears to have been drug induced akathisia.
There were probably a few more episodes like that and they end up saying, ‘Look, we're going to have to send you back to your father if you don't settle down.’ So that was probably not the kind of thing Christopher was going to cope with very well in the state of mind he was in—and I would say, because of the drug he was on. One evening shortly after that, Christopher went into his grandparents’ bedroom with a shotgun and shot them both dead in the bed and then set the house on fire and pinched [stole] their car. This is just a 12-year-old boy! He drove off and got picked up by some guys in the woods who called the cops, and he gave them a tale about how a black man broke into the house and tried to kidnap him and he actually escaped.
It took years for the case to go to court, so he ends up being tried as an adult, and one of the unfortunate things about it was that when Christopher was 12—at the time the event happened—he was small [in stature]. But when the court case happened four years later, he was six foot tall.
I thought there was a very clear case that it was the drug that did this, and the prosecutors argued [Pittman] was a ruthless murderer who planned this. I thought that was totally implausible, but the jury semi-bought it. They bought the argument that the drug played a part, but they didn’t know whether it fully excused him so that he should be let walk free from court.8
But the interesting thing about it—and this is why I began this interview with the story about Romain—the judge in the [Pittman] case said something along the lines, ‘There's something about this case that is troubling me a lot. If you can't depend on a prescription drug and what we’re being told about a prescription drug, it seems to turn everything on its head.’ 9
That comes back to the issue of trust and what Romain’s parents said about trusting your doctor. Or you trust medicine. In the Pittman case, you have the judge saying much the same thing, which is, you can't trust the academic literature and it gives him a legal problem. The question is, how do you move forward from here?
The Pittman case came back to me this week, as a release from jail date 22 years later, since the age of 12, has just been announced.
Marilyn Lemak, after she killed her children and tried to kill herself. Image taken from RxISK.org
DH: Marilyn Lemak was a high-powered nurse in a Chicago hospital, very highly thought of, married to a doctor, they looked like the ideal couple. They had three children. After the birth of her second child, she became depressed, was put on Prozac and it didn't help at all. One of the issues was she had put on weight and might not be as attractive to her husband as she had been before. When she was put on the weight loss drug, she actually recovered quite quickly. Prozac didn't do a thing for her but the weight loss drug helped. So, after her third child, she became depressed again and thought her husband was falling out of love with her and she was worried that they were going to get divorced. She went to the doctor, talked about this, and it's clearly the kind of problem that you shouldn't have a pill for, and that's what he told her.
[The doctor] ended up seeing her for about a half a year during which things weren't any better and a potential divorce situation was still looming large, and he said, ‘Well, pills aren't the answer, but we can try Zoloft and maybe it’ll help.’ Over the course of the next few months, he put the dose up because each time she came back things were a bit worse. She's now not sleeping as well and the situation at home with her husband is getting worse. At some point in the middle of all this, her husband does declare that he's having an affair. Her doctor—in the face of the evidence that a pill is not the answer to these problems—puts the dose up again, and again, and each time he does, she's worse. So, it's a very convincing case that the drug is causing the problem.
Figuring that her husband would be better off if she and the kids weren't there, she kills the three children and tries to kill herself, cuts her wrists, but doesn't die. Chicago is stunned because when it hits the news, what they play is the recording of her phone call to the ambulance service saying, ‘I think I've killed my children and you need to get over here.’ It's all very eerie.
She goes to court and at that stage in Illinois—this is the late 1990s—the idea that a drug might have caused you to do something like this is not a defence you're permitted. That’s changed. So, the defence team played the mental illness card, and for the prosecution, it was a no brainer. It was the easiest job in the world to say to the jury, ‘This is not a mentally ill lady.’ So, they found her guilty, and the judge said, as they often do in these cases, ‘I hope you rot in jail and spend every single day thinking about your children.’ It was as brutal as that.
It took about ten or maybe 15 years in jail for her to even begin to think that the pills might have caused the problems. I think it happened because there was a woman [Janet Lagerloef] who had always been intrigued by her case, who began to visit her in jail and didn't push the drug element, but put it on the table and Marilyn finally came to thinking that maybe the drug did play a part. About a year and a half ago, Janet recruited more than one lawyer to see what could be done about the Lemak case and the legal view was it was better to opt for a clemency hearing before a retrial.
Twice a year, the Governor of the state has an opportunity to release certain people from prison on the basis that it looks like there's some issue and that they really ought not to have been put in jail for as long as they have been. So there was a clemency hearing in the middle of the COVID pandemic, and I couldn't get from Toronto down to Illinois, so I did a video recording of what I would have said to them if I was there in person. There was great hope on our side, but I don't know that I expect much because again, Governor Pritzker, just like a jury, has to agree that Pfizer knew this kind of thing could happen. If [Lemak] gets out, she was such a high-profile case, that these issues are all going to come into the public domain, and the Pritzker family has a long association collaborating with mainstream mental health on health care initiatives. 10
If this fails this time around, I don’t know if her lawyers are going to try to get a retrial.
In 2015, Brian Short killed his wife and 3 children and then himself. The family’s next of kin brought a wrongful death action against the appellants—the mental healthcare provider (Park Nicollet Health Services)—alleging they had provided negligent care, and committed medical malpractice. They are seeking damages. The case is still ongoing.
I probably should tell you one more case, this happened [in 2015] but the court case is still ongoing. Brian Short, who had been a nurse but started a very successful health care business, was having a few nights of poor sleep, went to his family doctor, and the family doctor put him on a sleeping pill. It just knocked him out, and he goes back to the family doctor and said, ‘This is completely knocking me out, I can’t work,’ and the family doctor switched him to a SSRI and said, ‘I’ll refer you along to the local psychiatric unit, which was a private unit, the most prestigious in the Minneapolis area and had 54 psychiatrists in it.
Brian gets put on this drug, gets referred and he has an appointment quite quickly. He’s seen about a week later, and the people seeing him do rating scales and look at the dose of the SSRI he's on—I forget which one it was, might've been Zoloft—and they say ‘Oh you're on a very low dose, we should increase it up and they increase it up. And Brian goes back a week or two later and they do the rating scales again and he fills them out and he's worse—the score is higher. So, they double the dose again and he goes back to them and the usual approach there is to give another rating scale and the score is worse. So, they say, ‘Oh, this isn’t good,’ and they take him off the Zoloft and they put him on [another SSRI] Lexapro.
So, he's withdrawing from the Zoloft and starting another drug at the same time, and he's due back to them in two weeks-time and on the day he’s due to go back, he kills his wife and three children and himself.
There are two interesting features about this case. One is—and this is almost the norm across the United States these days in the public health system or the private system, which is what this was— you're seen by a nurse practitioner, you're not being seen by a doctor. Even though he's getting worse, they don't call in anyone to review what they're doing. The other thing is that during the trial, the hospital is saying, ‘Well, this man killed himself at home. He's not on our premises and we don't have a duty of care to anyone who's not in the hospital. If something like this happens—if they kill themselves at home—that's not our problem, and we certainly don't have a duty of care to anyone else who gets killed by this man. You can't predict violence. It’s awfully sad, but it has nothing to do with us.’
That ends up going to the Supreme Court of Minnesota who decide, ‘Well, actually you do have a duty of care, but not by a wide margin. It was a reasonably close vote, but that case is going forward.11
LP: There have been so many mass murders in the US—and they do seem to be mostly in the US—what's your sense? What role are these drugs playing if at all?
DH: Unless I get to interview the person, I can't really say for sure. These drugs can change your personality and through a range of factors that can cause a suicide, the same factors can cause you to kill others, then kill yourself. But just because a person is on a drug that can do something like this, and they've done something like this, doesn't mean that in that case the drug has caused it.
Given how many of these incidents [mass shootings] there have been, on a probabilistic basis, it's highly likely that some of them are linked to the pills the person was on. But the cases I’ve told you about have all been ones that I've been able to interview all of the key people and see the medical records.
LP: When the person ends up killing themselves or ends up being killed, often by police, the chances are much slimmer for there to be any court case afterwards because they're dead.
DH: Ideally, you have the person who did the shooting. But if there are people around who knew the person had been on the drug for months or years and doing well, then the drug didn’t cause it. But if they've only been on the drug a brief time and if there's anyone around to say, ‘Their personality changed. They did seem to be getting more restless or tense,’ as opposed to seeming to be helped - that can get you a long way. But you do have to have people who knew the person and can talk about a change.
LP: Depression and anxiety seem to be much more prevalent these days than it was in the recent past. Is this an accurate observation on my part or just a function of more awareness and diagnosis of the problem, and if it’s the former—that it’s more prevalent— what do you attribute it to?
DH: If a treatment works the condition disappears, which means wards close and staff is re- redeployed. Depression is now a thousand-fold more common that it was, ditto for ADHD, ditto bipolar disorder. This is marketing: a conversion of variation into illness. There are no more mental diseases now than there were, though there is likely less schizophrenia - but not because the drugs cure it.
The question people have to make up their own minds about is, is distress or stress an illness?
Market share information taken from Global Market Insights. According to Fortune Business Insights, the pandemic was a boon for the antidepressant industry. “The global impact of COVID-19 has been unprecedented and staggering, with depression medications witnessing a positive demand shock across all regions… [and] has led to a rise in stress levels among the general population owing to various factors such as financial as well as emotional burden, stress, anxiety, fear, which has led to rising prevalence of depression. This combined with growth of Telehealth, and rising awareness among general population towards available treatment, has led to higher percentage of patients undergoing treatment.”
David Healy has written about the issue of “how we can tell when a drug, device, or vaccine has caused a problem?” here.
In November 2020, Brianne Dressen volunteered to participated in the “Phase 3” clinical trial for the AstraZeneca COVID-19 vaccine and almost immediately started to experience a serious reaction. Over a period of two and a half weeks her symptoms “cascaded” and included severe tachycardia, tremors, and loss of control of her legs and bladder. AZ did not allow Dressen to receive the second shot, and once unblinded, she learned she had received the vaccine and not the placebo. I’ve interviewed Dressen, and wrote about her injury here. Dressen says her adverse event is missing from the clinical trial report and she has yet to receive a cent from the company – even though it is contractually obliged to pay for her medical expenses because she was involved in a clinical trial.
In 1993, William (Bill) Forsyth Sr. killed his wife and then committed suicide. Forsyth’s surviving children sued Eli Lilly, the manufacturer of Prozac, because they claimed it was the drug that caused the murder/ suicide and that the company did not provide adequate warnings to the physicians concerning the risks associated with the drug’s use. The plaintiffs said the homicide/ suicide was the direct result of these inadequate warnings. Eli Lilly denied the claim saying there was no credible medical or scientific evidence to support it, and that Forsyth killed his wife and then himself because of his depression and other long-standing emotional and mental problems. Eli Lilly won the case. But during the trial, internal company documents were produced that showed the pharmaceutical company had known for some 20 years that Prozac could produce—according to a news article at the time—"a strange, agitated state of mind that can trigger in them an unstoppable urge to commit suicide or murder.”
Details about the Donald Schell legal case, as well as eight others involving violence where antidepressants are believed to have played a part, are provided in the 2006 article, “Antidepressants and Violence: Problems at the Interface of Medicine and Law,” by Healy, Herxheimer, and Menkes. According to the paper, Schell had a history of anxiety/ depressive episodes that “did not involve suicidality, aggressive behaviour, or other serious disturbance.” These episodes had resolved on their own after several weeks, but in 1990, Schell’s depression was treated with fluoxetine (Prozac). “He had a clear adverse reaction to [the drug] involving agitation, restlessness, and possible hallucinations, which worsened over a three-week period despite treatment with trazodone and propranolol that might have been expected to minimize the severity of such a reaction,” write the authors. “After fluoxetine was discontinued, [Schell] responded rapidly to imipramine. In 1998, a new family doctor, unaware of this adverse reaction to fluoxetine, prescribed paroxetine [Paxil] 20 mg to [Schell] for what was diagnosed as an anxiety disorder. Two days later having had, it is believed, two doses of the medication, [Schell] using a gun put three bullets each through the heads of his wife, his daughter who was visiting, and his nine-month-old granddaughter before killing himself.”
The jury in the wrongful death civil suit brought forth by Donald Schell’s son-in-law and sister found that paroxetine “can cause some people to become homicidal and/ or suicidal,” and the drug manufacturer, SmithKline Beecham was found to be 80 percent responsible for the tragic events. The authors state that the evidence in the case included an unpublished company study of “incidents of serious aggression in 80 patients, 25 of which involved homicide.”
According to a paper published earlier this year in International Journal of Risk and Safety in Medicine, Healy and two others reported that while the jury in the wrongful death civil suit brought forth by Donald Schell’s son-in-law and sister (ie. Tobin v SmithKline) found the drug company “culpable for familicide,” the drug company begged to differ. Ian Hudson, who at the time was head of safety within GSK argued that clinical trials had not shown that paroxetine could cause suicidal events. Hudson later became head of Britain’s Medicines and Healthcare Products Regulatory Service (MHRA) and is currently Senior Advisor with the Gates Foundation. The jury verdict came before the 2001 version of Study 329 was published, with its claim that paroxetine was safe and effective in children, and had also provided cause for the company to “pause and consider whether their approach [in Study 329] was appropriate.”
During a healthy volunteer study, there is great cause for concern when more suicide/ suicidal ideation/violent events occur in the treatment group than in the placebo group. For more information go here.
For instance, the black box warning for Paxil reads: “Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of PAXIL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PAXIL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)”
Note: There is no mention of violence, aggressive behaviour, hostility, or homicidal ideation.
According to an article that appeared in the Rock Hill Herald, the Charleston jury in 2005 found Pittman guilty of two counts of murder and “the judge gave Pittman the lowest possible sentence for two murders — 30 years for each to run concurrent.” But the convictions were overturned in 2010 when Pittman “filed a lawsuit against his defense lawyers, which showed that the trial judge, prosecutors and lawyers had discussed plea deals that Pittman and their court appointed guardian were never told about by the defense team despite having the legal right to be told. The judge in that lawsuit ruled the convictions could not stand and a new trial was ordered, but Pittman took a plea deal to voluntary manslaughter and was sentenced to 25 years.”
Circuit Court Judge Daniel Pieper said, “There is no case in South Carolina that addresses involuntary intoxication by prescription drugs…It seems to turn the whole medical system on its side if you can’t rely on the medication your doctor prescribes. It potentially forces you into a situation of lifetime commitment if that drug induces an effect which you are unaware. There’s something disconcerting about that, albeit probably of a legal nature that is troubling me.”
The Pritzker family have been notable supporters of Robert Gibbons—the Pritzker Scholar at the University of Chicago—who is well known for attempting to cast doubt on the idea that SSRI antidepressants cause harm. Gibbons has held that position since 2011. According to this article, in 2004 Gibbons was a member of the FDA panel that voted 15 to 8 in favour of having a “black box warning” for SSRIs, but Gibbons was among those who voted against it, saying that it was not warranted and he has since published a number of articles that dispute the FDA finding that SSRIs increase the risk of suicide and suicidal ideation. Gibbons published at least 8 papers between 2005 and 2011 challenging the use of the black box warning, but his research— linking the black box warning to a decrease in SSRI prescriptions and a subsequent increase in suicides— has been largely discredited for “inappropriate data selection,” “opaque methodology,” “obvious arithmetic errors,” and “deceitful presentation.”
The trustee for the next of kin of the five Short family members brought a wrongful death action against the appellants—the mental healthcare provider (Park Nicollet Health Services)—alleging they had provided negligent care and committed medical malpractice. They are seeking damages. The Hennepin County District Court dismissed the action, concluding that the mental healthcare provider did not have a duty to protect or control Brian, or his family because he was an outpatient (not custodial) and harm was unforeseeable. In a unanimous decision, the Minnesota Court of Appeals reversed the decision and held that the healthcare provider did have a duty of care, and that “genuine issues of material fact existed as to whether the provider's conduct created a foreseeable risk to Brian's wife and children.” The case was remanded back to the district court for trial. Park Nicollet (the healthcare provider) petitioned The Supreme Court of Minnesota to review the Court of Appeals’ ruling. The Supreme Court agreed to review the case and found “a mental healthcare provider owes a duty of reasonable care to its patient, which is not negated by a lack of total control over the patient… [but] the harm to the family was outside the scope of the duty of care and unforeseeable as a matter of law.” The case has been remanded back to the District Court. For more info on the details of the case to date go here.
Wowza. Just wowza.