Robert Whitaker has written some of the most dystopian, disturbing, and fascinating stories of evil unleashed that I've ever read.
Unfortunately for us, he's not a fiction writer. Instead, he reports on the psychiatric industry.
In his 2010 book, Anatomy of an Epidemic, which won the Investigative Reporters and Editors' 2010 book award, Whitaker showed how the story told by the American Psychiatric Association – that mental illnesses were caused by known chemical imbalances in the brain, and modern wonder drugs were safe and effective – was a deadly lie.
Instead, we find an epidemic of mental illness erupting just as the drugs that are supposed to treat these conditions become widely prescribed. The only reasonable answer, based on correlation, known mechanisms of action, and clinical data, is that the drugs themselves are destabilizing our brains and creating the very imbalances they purport to address.
His latest book, Psychiatry Under the Influence, co-written with Lisa Cosgrove, puts the psychiatric greed and fraud in a framework of institutional corruption. Rather than blaming bad apples, they indict the entire barrel.
I heard Robert speak in November 2015 at a Wellness Forum Health conference, and was struck by the clarity, integrity, and importance of his message. With up to 1/3 of all Americans medicated for mental illness in any given year, this is a topic that is of utmost importance to all of us.
And with mass shootings going on daily, and gun control not on the table, it's an especially crucial message when our politicians and media want to address the problem of public violence through greater access to psych meds.
I believe this interview will save lives. In it, we talk about:
- the fundamental importance of a valid and reliable diagnostic manual – and why the DSM-III and its successors are neither
- how to design drug trials guaranteed to show benefit and hide harm
- how to lie with statistics in case your best efforts at manufacturing data still aren't enough
- the Prozac fraud – how there's no evidence that Prozac is more effective than placebo in the short term, and plenty of evidence to show worse outcomes in the long term
- why the “chemical imbalance” theory of mental illness actually increases stigma, rather than lowering it
- the selling of Risperdal through sleight of hand
- how drug companies and the FDA buried the 0.7% death rate from atypical anti-psychotics during drug trials
- how consumers can become informed
- the need for a revolution in psychiatry to prevent further harm
- and much more…
Enjoy, add your voice to the conversation via the comment box below, and please share – that's how we spread our message and spread our roots.
Mad In America – Robert's website about science, psychiatry, and community
The Emperor’s New Drugs: Antidepressants and the Placebo Effect: Awesome, entertaining, and startlingly convincing lecture by Irving Kirsch, one of the researchers who proved that SSRIs (Prozac and its competitors) showed no improvement over placebo (it's free to watch; you just have to register for the course)
Howard: Robert Whitaker has written some of the most dystopian, disturbing, and fascinating stories of evil unleashed that I have ever read. Unfortunately, he is not a fiction writer. Instead he reports on the psychiatric industry. And in his 2010 book, Anatomy of an Epidemic, which won the investigative reporters and editors 2010 book award, Whitaker showed how the story told by the American Psychiatric Association - you know, the one that mental illnesses are caused by known deadly chemical imbalances in the brain, and modern wonder drugs are safe and effective in treating those illnesses, and that that was a deadly lie.
And, instead, we find an epidemic of mental illness erupting just as the drugs that are supposed to treat these conditions become widely prescribed. And Whitaker argues that the only reasonable answer, based on correlation, known mechanisms of action, and clinical data, is that the drugs themselves are destabilizing our brains and creating the very imbalances they purport to address.
His latest book, Psychiatry Under the Influence, which was co-written with Lisa Cosgrove, puts the psychiatric greed and fraud in a framework of institutional corruption. In other words, rather than just pointing their fingers at bad apples, they indict the entire barrel.
I heard Robert speak in November 2015 at a Wellness Forum health conference and was just struck by the clarity, integrity, and importance of his message. With up to one-third of all Americans medicated for mental illness in any given year, this is a topic that is of utmost importance to all of us, and even if you yourself don't suffer from what the psychiatric industry calls a mental illness, and even if there's no one in your family or no one you know - you know what? - there are mass shootings going on on a regular basis, and gun control is not on the table. And so, this is an especially crucial message when our politicians and media want to address the problem of public violence through greater access to psych meds.
I believe this interview, if you listen to it carefully and share it, will save lives.
So, without further ado, Robert Whitaker, welcome to the plant yourself podcast.
Robert Whitaker: Thank you for having me. It's a pleasure to be here.
Howard: I've been reading your book, “Anatomy of an Epidemic” with my son who's 16 and he told me to ask you, it's like a dystopian, teen fiction novel. He really wants to know how it's going to end.
Robert Whitaker: Ha ha.
Howard: One of the reasons I wanted to talk to you, your work, in kind of uncovering the hidden underbelly of how studies are done in medical practice and turned into practice guidelines or turned into treatments. It's quite chilling. And first I'd like to have you just describe how you got into this field of study in the first place. How did you start sleuthing around what's going on in psychiatry?
Robert Whitaker: Sure, it was all very accidental. So, I had been a newspaper journalist for a long time covering medicine back all the way to the 1980's. And then in 1998 I was doing a series for the Boston Globe, co-writing a series for the Boston Globe. So I was just looking at abuses of psychiatric patients in research settings. And I had a completely conventional understanding of psychiatry at that time.
I thought we were discovering, or I thought psychiatry had discovered, the biological causes of these disorders, that they were due to chemical imbalances in the brain,
and we had drugs that fixed those chemical imbalances, and we were making all this great progress. So, a completely conventional understanding.
And in that series we actually, one of the things we looked at were studies in which anti-psychotic medications had been withdrawn from schizophrenia patients in studies. And we said, well, that's unethical. You would never withdraw insulin from a diabetic, so why would you withdraw an anti-psychotic from someone diagnosed with schizophrenia.
Anyway, what happened at that time, though, was, while I was doing that research, I came upon a couple studies that belied what I knew to be true. And one was that the World Health Organization had twice compared outcomes of schizophrenia patients in 3 poor countries (India, Columbia, and Nigeria), with longer term outcomes in the US and rich countries, and each time they found that the outcomes were much better in the poor countries. And I thought, well, why would that be?
And then, when I looked at the study, they noted that in the poor countries, they used the anti-psychotics very differently. They used them short term, but not long term. And now this quite surprised me, because I thought that medications were supposed to be so essential to long term care. So that was the beginning of my beginning to question.
And then second, when I was doing that same research, I found studies, a study done by Harvard University, which reported that outcomes for schizophrenia patients today were no better than they had been in 1900 (longer term outcomes). So that belied that story in progress. So this began my questioning of what I thought I knew to be true.
And then also, going back to that Boston Globe series, one of the things we wrote about was how, when the new atypical antipsychotics were brought to market (these are drugs like Zyprexa, Risperdal, Seroquel), we wrote about how, in the scientific literature, you could read about how safe and effective these drugs were. But then I used the freedom of information request to get the reviews of the studies done by the food and drug administration.
And there the reviews told of people who had died in the trials, of how the drugs weren't any more effective than the older drugs. Then, so, all of a sudden there was this big gap, between what the scientific literature was saying (in other words the academic psychiatrists being paid by the pharmaceutical companies to run those trials), what they were reporting in the medical literature, and what the FDA's review of those same trials was.
There was just such a big gap.
And that's where I really began looking at how the influence of pharmaceutical money and the influence of psychiatry's own guild interests was leading in essence to, was leading in essence for the American Psychiatric Association and academic psychiatrists to be telling a story to us, about what was known about psychiatric ailments (you know - what is the cause, what the drugs do, how safe and effective they are), and start looking at how the story that they tell us, and the story even that is sometimes in the medical literature, is actually belied when you get into, you know, what the studies are actually showing.
Howard: So after reading Anatomy of an Epidemic, I walked around with the zeal of a new convert, and tried to, like, tell everybody how terrible these drugs were, and I was, I was met mostly by 2 responses:
One is, everyone knew of someone who was on a med and it helped them, or they themselves said, you know, the anti-depressants I was taking helped me, or I have a cousin who's psychotic, and if he gets off of his meds, it's terrible.
And the other was a sort of politically correct, knee-jerk, that I was somehow saying that these weren't real illnesses. Because the way the pharmaceutical industry has framed it, these are brain illnesses due to chemical imbalances, therefore, it’s nobody's fault. And the fact that the drugs exist, kind of, you know, symbolize the fact that it's not anybody's fault, and there shouldn't be any stigma. How do you talk to people when you hear those things?
Robert Whitaker: Yeah, well, let's start with the disease model -that these are diseases of the brain, and that they're due to chemical imbalances. Well, now you want to see, has scientific research really validated that claim, that there are some known pathologies behind these disorders, or that the drugs fix chemical imbalances? And what you find is that the whole chemical imbalance story arose when researchers back in the 60's began to understand how the drugs act on the brain.
So, for example, the SSRI's block the normal re-uptake of serotonin from the synaptic cleft, (that gap between neurons). So, since the drugs up serotonurgic activity, the hypothesis was, well, maybe depression is due to too little serotonin. And that's where the chemical imbalance theory of mental disorders came from, (from an understanding of how the drugs act on the brain, and not from investigations or discoveries made about people so diagnosed).
And then they began investigating that in the 1970’s. And by 1983 you can find that the NIMH (National Institutes of Mental Health) was saying, hey, we're not finding that low serotonin is a problem in people diagnosed with depression before they go on these drugs. We're not finding abnormalities in the serotonergic system.
And now Prozac comes to market in 1998. And we hear more and more about how the new SSRI's, you know, fix a low serotonin problem that's behind depression. But the research never showed that to be true. And, say, in 1998 the American Psychiatric Association textbook actually says that, you know, this is where the hypothesis came from. We didn't find it to be so. And it was really a pretty lame hypothesis from the beginning.
Because there's no reason to think that, you know, if you're using a drug that has a certain mechanism of action, that the pathology is the opposite of that mechanism of action. But, so, even while science was not showing the chemical imbalance theory to be true, and even as research was not identifying the pathology of mental disorders, what was the story told to us by the American Psychiatric Association, by the drug industry, and really by academic psychiatrists?
Well, what they told us is that science was showing that these drugs, these disorders, were due to chemical imbalances. In other words, this is the problem that you're running into. It's, there's been, our society has organized itself around a false story. It's a story that has served commercial purposes. But it's really quite easy, if you dig into the research, to show that it's just not true.
And now, maybe some of your listeners are going, now, oh, this is crazy. This is the same thing, that, you know, when you said this, people responded. Well, the chemical imbalance theory has fallen apart totally. So, we have Tom Insel, the former director of the NIMH, saying, you know, that's an outdated model. It didn't turn out to be true.
We have Kenneth Kendler, co-editor and chief of Psychological Medicine, who spent years investigating chemical imbalances saying this, “We have hunted for big neurochemical explanations for mental disorders and have not found them.”
And we have Ronald Pye, who's the former editor and chief of Psychiatric Times, even writing, saying, “The story of chemical imbalance was always a kind of urban myth, never a theory seriously proposed by well informed psychiatrists.”
So think about this. You begin saying this, you know, you know, questioning this story out there, and people say to you, “come on, we know that these are diseases of the brain, and we know that it's nobody's fault, and it reduces stigma.” And what does the science really show?
A. We don't know the pathology of these disorders.
B. The drugs in fact induce chemical imbalances, but people do not have any known pathology beforehand.
In other words, we don't know what causes these disorders.
I mean, obviously there can be psychological things that can cause depression and anxiety. But we don’t, there's been no information discoveries of the type that is usually used, is usually seen as validating or proving that something is a brain disease.
It's just a marketing story at this point.
And as far as reducing stigma, the irony is, all the surveys show that the more the public becomes convinced that these are brain diseases and chemical imbalances, the stigma increases. Because what happens is, you now begin to say, the public says, look, that person has a disordered brain and they can't do anything about it, and that actually makes us more afraid of that person.
So, and again, what the proponents of this disease model have said is it reduces stigma. It's nobody's fault, etc. And, but my point is, that's a marketing slogan. It's not even shown in science.
So that's the first half of it.
The second half, when people say anecdotally, hey, I know someone that's been very helped by this, or I've been helped by this, you know that's true. There are many people are helped by the drugs.
But when we say, “Are the drugs effective over the long term?”, what you're really asking is this: Compared to what is the natural course of whatever the disorder might be, (depression, anxiety, psychosis, etc)?” does long term use of the drugs improve outcomes in the aggregate over a long period of time or not? And what you see quite clearly in the research is that the medications increase the likelihood that a psychiatric disorder will run a chronic course.
In other words, meaning that the person who is depressed today will still be suffering from depression 10 years later. Or the person suffering from psychosis will still be suffering from psychosis 10 years later. It's higher in the medicated group.
And in addition to that sort of increased chronicity of the very symptom you're trying to treat, you'll see, on the whole, increased rates of functional impairment, increased rates of disability, increased physical problems, that sort of thing, in the medicated group.
So, just to finish this up, let's imagine that the natural course of depression (and this is really pretty true), that 80% of people who come down with a depressive episode will be better within a year, in other words, the depression will have lifted.
Now, if you have a drug treatment in which 50% of the people are better within a year, you can have a lot of people saying, look, the drugs helped me. I'm doing great. But actually, the recovery rate is now much less than it was before. And that's a lot about what we're talking about.
Howard: Hmm, So, I have to say that if you'd hooked me up to a stress test while I was reading the book, probably the Ronald Pye's quote on page 59 would have spiked it the highest.
Robert Whitaker: (laughing) Right. It's remarkable, right?
Howard: Which is, whose, you know, this is like, the lady protests too much me thinks. I am not one who easily loses his temper, but he gets upset when someone says, well, psychiatrists tell us that it's a chemical imbalance theory, when, you know, the audacity of that sort of claim is just ridiculous.
Robert Whitaker: You know, you're quoting from the last book I co-wrote with Lisa Cosgrove, Psychiatry Under the Influence. It just shows the incredible, I don't even know how to put it. Of course, it's cognitive dissonance on Pye's part, but it's also so disingenuous. Obviously, psychiatry's been telling people for decades they had chemical imbalances.
And to pretend that the profession never told this, when it's easy to show where the presidents of the association told this to the public. I mean it's just really remarkable. But I think it does show how psychiatry now is in a bind, because you're not supposed to lie to people. You're not supposed to tell your patients they have some known biological problem, when the research hadn't shown that to be true. And so, given that, you know, moral, you know, failing, in essence, and since the chemical imbalance story has fallen so completely apart scientifically, what is psychiatry trying to do now?
Well, we never lied to our patients.
But in order to do that, you have to have these extraordinarily ridiculous comments like Pye is saying that they never said it.
Howard:Yeah, boy, I just wish there was medication that could help them.
Robert Whitaker:(laughing) Yes, well, I'm not sure what we would call it. What, the truth telling serum, or something. I'm not sure.
Howard:Yes, so let's say, I'm really enjoying Psychiatry Under the Influence. In a sense it's scarier than Anatomy of an Epidemic, because you frame it under, this isn't bad people, you know, it's not bad apples, it's a bad barrel in which —
Robert Whitaker: Right
Howard: and I found myself thinking, if I had been one of those marketing executives of a drug company, or if I had been a PR firm hired to ghost write scientific papers, that I probably would have done the same things those people did. And, you know, even to the point where you're suppressing adolescent suicide. Like, it seems like such a slippery slope that I really, you know. I read Anatomy of an Epidemic feeling superior to all these A-holes.
Robert Whitaker: Right
Howard:But I read Psychiatry Under the Influence kind of humbled by, you know,
the things that I might have done myself, just like, one step after another, on a kind of a road to a banality of evil.
Robert Whitaker: Yeah, you know, I think this, I mean first of all, what. In Anatomy of an Epidemic, you know, I really focus on long term outcomes and there is actually, saying, well, how easy it is to be unaware of these long term outcomes, because you don't see it in the, you don't see big aggregate outcomes in your clinical practice and that sort of thing, and the betrayal there was really limited to the fact that the psychiatric establishment, every time it got one of these studies showing better outcomes for the long term, over the long term for the unmedicated patients, they basically didn't publicize that.
So, there is that betrayal.
But with Psychiatry Under the Influence, it's basically like this. The corruption is so thorough. I mean it's at every step of the way. You find that, you know, the story about the disease model and that these are diseases of the brain, you find that, and that science supports that story, and you find that that's not true.
Then you find that the construction of the DSM III, and this whole disease model, was so arbitrary. And, you know, basically, and then once we get DSM III in 1980, you can see the money going to people to expand the boundaries to increase the market for drugs. Then you can see new drugs coming in. And you can see that the story told to the public about the safety and efficacy is absolutely out of sync with the data sent to the FDA.
Then you can see the clinical practice guidelines that are meant to support this commercial enterprise, and so forth and so on. And so, it's so pervasive in which the public is betrayed in all these steps in terms of what we expect from a medical specialty.
But, now, let's go to your point. You have to ask yourself, well, what would I have done? And what you realize is that psychiatry operates something like a tribe. In other words, it forms a certain belief system that everybody is supposed to adhere to and even forms like, ok, and this is what we're going to tell the public, and somehow you convince yourself it's good to tell the public this, and within pharmaceutical companies, you know, you somehow convince yourself that, you know, you're bringing good important new drugs to market. And then, if you're the PR firm, you're saying you're helping publicize this.
And so, what you do see here, is that these, you know, these different organizations, they form a belief system that is conducive to their financial interests. And then, once that happens, people make sure their beliefs are sort of in sync with that commercial interest regardless of what the science says.
And I think what's so, there are just so many things revealing about this. One is that, this disease model we have of psychiatric disorders, and how we've organized ourselves around this disease model, we think it's a scientific thing. But, in fact, it's just a commercial story.
Now, when we switch to modern capitalism, it's pretty easy to see how industries creates stories for us. And then we organize ourselves around those stories. So, the psychiatric story fits within that commercial sort of corporate environment we've all existed in in the last 30 years.
And the next thing you know, I think, and then the question becomes, Yeah, you can see, it's not just the A-holes, as you said, but it's this bad barrel problem, where even good people within that barrel can lose sight of, you know, what they should be doing. And then we have to say, well, what do we as a society have to do to clean up that bad barrel? And that's a really tough question.
Howard: Let's dive a little bit into the different elements. You have the DSMs, (the diagnostic and statistical manuals). You have the study, you know, the developments of the drugs, the studies to prove their efficacy. You have the expansion of disease, the clinical guidelines.
It all starts with the DSMs. From a very broad perspective, help us understand why is a diagnostic and statistical manual important?
Robert Whitaker: Yeah, everything starts with the DSMs. Because the DSM becomes the manual that guides societal thinking about this, you know, part of our lives, this psychiatric part of our lives. And we entrust in the medical specialty to, you know, to set, to tell us what is the problem, (why are you suffering from depression, why are you suffering from mania, why are you suffering from psychosis?) So, the very conception that is the support or that underlies the manual is going to be so important.
And so, in 1980 the American Psychiatric Association published the third edition of its diagnostic and statistical manual. And when it does so, it reconceives of what medical and psychiatric disorders are. Before, we have a lot of psychological, even Freudian, explanations saying that are, you know, responsible for depression, anxiety, etc.
But now, the American Psychiatric Association says in DSM III, “no, these are diseases of the brain”. Now, in fact, that they hadn't found that to be so, but this is the new conception that is presented in DSM III, and they say, if you have these symptoms of a disease, like, let's say, depression (you're not sleeping enough, or you're not eating, etc.), those aren't symptoms of a psychological state you're in, but those are symptoms of a disease.
So, it gives you the conception, and the manual describes what is normal and what is not normal. It describes the boundary lines of disease, so to speak. And what they did in DSM III, they made these boundary lines as big as possible. And there's something like 290 disorders, I forget.
But, and, the idea is with these boundaries, is they're going to be big enough to provide a diagnosis to anyone who comes into their office with whatever complaint. And then, since they're conceptualized as diseases, insurance companies will reimburse for them.
So, the DSM establishes the conception of the disorders. And then, once you have the conception, it's really going to drive the treatment, because, if you conceive of them as diseases, well, what's going to be a front line treatment? It's going to be a drug that can reduce the symptoms of that disease. And effectiveness is not going to be looked at as
are you working, are you enjoying life or any of the things that maybe, you know, your functionality.
Effectiveness of the drug, now, is going to be just, does it in some ways diminish the symptoms of the disease (sleeping, eating, that sort of thing) a little bit better than placebo?
So, my point is, the DSM is what tells us, as a society, how to think about mental disorders, and in that conception it tells us how are we going to organize ourselves to treat those disorders.
And DSM III and the disease model gave us the idea that these are diseases, drugs should be the first line treatments, and they also gave us diagnoses that, you know, extended to a wide part, a big part, of the population, such that, now, you know, they say that 25-30% of the population is “ill” each year.
So it changes how we as a society think about psychiatric problems, about normal life, about the behavior of kids. It's a really profound thing.
Howard: Now the DSM, and any diagnostic manual has to be a little bit reductionist, right? And we accept that the cost of that reductionism (of taking someone's whole complex life and reducing it to these symptoms) is there's a benefit there (that it's easier to diagnose, and we can agree upon diagnosis, and we can agree upon and that different practitioners using the same manual get the same results). So, how did the DSM III do in terms of validity and reliability?
Robert Whitaker: Yeah, this is really important. So, for any diagnostic manual to be useful in medicine, it needs two qualities. It needs to be reliable and it needs to be valid.
Now, reliability means that if I'm a patient and I go to one doctor, I'll get a diagnosis and then I go to a different doctor with the same symptoms, I'll get the same diagnosis, ok? The manual allows us to group people with like problems into these categories.
And then validity means that the category is real. In other words, if you say (let's just use the very category we think is the realest, and that's schizophrenia.), and you say, ok, there's a real discrete disorder called schizophrenia, and it has this sort of long term outcome. Here's the biology, and this is why everybody in that category needs to be treated in the same way.
But, if we really put these two questions - the DSM - Is it a reliable manual? And you'll find that it isn't. You'll find that there's all sorts of differences between, if you go with the same symptoms to one psychiatrist and to another, in terms of which diagnosis you get.
And, of course, many people will talk about how their diagnosis changes constantly depending on who they see. So the DSM does not meet the standard of reliability.
And as for validity, going back to the DSM III in 1980, the diagnoses in that manual were considered hypotheses by the American Psychiatric Association, and the hope was that research would then validate these hypotheses (meaning they would find the pathology, they would find a characteristic course, they would find genetic markers and genetic links).
And in 2009 or 2010 there was a round table of experts in the DSM (psychiatrists). And they asked this question: “Have we validated the disorders in the DSM?”
And they said, “No, we don't have that information.”
And then let's go back to our example with schizophrenia. What we really know now is there's no such discrete thing as schizophrenia, and even the biological people will say, really, what we may have is a group of “schizophrenias” and there may be many different causes of what we call schizophrenia (many very distinct disorders within that).
And that's the problem, if you have a diagnostic manual that's saying, oh, think of everything as when you have this certain sort of constellation of symptoms as schizophrenia, as a discrete illness, when in fact you might have 5, 6, many different causes of whatever the person is experiencing, that's going to be a diagnostic manual that blinds you to what is happening to your patients, and blinds you to the fact that, maybe, rather than one size treatment fits all, you need treatments of many, many different kinds, and, sort of, patient centered treatments, etc.
So, if you have a manual that is neither reliable nor valid, that manual, in fact, rather than lead to insight into what's going on with patients, and rather than lead to good treatment, it's very likely going to lead to delusions about what's going on with people, and actually to recommendations of treatment that often so not right for that individual person.
Howard: So, you would expect, if the manual is neither reliable nor valid, that you did trials of the drugs that were supposed to cure these discrete or treat the symptoms or ameliorate or remit these discrete diseases, that the results would be terrible.
\And we find out that in drug trials, in reported drug trials, that make it both to psychiatric journals and to mainstream media that these SSRIs, the atypicals, the anti-, the, like, all this stuff is doing really great.
And I'd like to talk about just some of the ways in which studies are pimped (I can't think of another word) to make it seem like these chemicals that are, you know, these pills are good for us, when, in fact, there's very little evidence to that effect.
Robert Whitaker:So, let's go back to Prozac. It gets introduced in 1988. And if you look at what was told to the public, we hear about, it's so much safer and effective than the old drugs.
We hear about how it fixes a chemical imbalance in the brain. And then, we also hear that, in fact, it can, maybe, make people feel better than well. So, this is a miracle drug, a breakthrough drug for depression.
Now, you go to the actual studies that were submitted to the FDA. And one of the first things that you find that is so surprising is that fluoxetine wasn't actually tested as a stand alone agent for depression.
And the reason for this is that, early on in the trials, many people treated with fluoxetine became manic, or they became agitated. They suffered from something called akathisia. So, the trials were amended, so that people who experienced that effect on fluoxetine, could be given a benzodiazepine.
So in the studies of Prozac, what you're really seeing, is a combination of benzos, of a benzodiazepine plus Prozac, as a treatment for depression compared to placebo.
Now what were the results?
Well, if you look at the trials, many of the trials failed to find that Prozac was any better than placebo. And then, if you look at all the data that was sent to the FDA, you pool all that data and you compare it to placebo, collectively, and you find that the reduction in symptoms on Prozac as compared to placebo is basically exactly the same.
Now what happened was, there was one or two studies in which Prozac was better, and that's why the drug got approved. But you look at all the data, the reduction in symptoms on the Hamilton scale was only one point different between the 2 groups, which is absolutely clinically meaningless.
So, you began this question saying that, listen, if the thing's not valid, you wouldn't expect the drugs to be very effective, because people might have a lot of different things going on. And that's precisely what the Prozac trials found.
And you see that with the other SSRI trials, as well. Now, let's go back to an antibiotic trial. If you have an antibiotic that's effective against a bacteria, you will see a dramatic difference between those with that bacteria.
You know, you begin with the people who have a bacterial infection. Those given the antibiotic are going to do so much better than those, (if the antibiotic is effective) than those on placebo. Because that's a discrete disorder, and it's going to be a marked difference.
Here we did not see that with the SSRI's at all, OK? So that actually reflects the fact that what we're calling depression, undoubtedly, is many different things, and we don't have a specific treatment for it. And that maybe SSRI's are good for some small group of people, but for the vast majority of people with depression, they're really no better than placebo, even over the short term; and over the long term, in fact, I think there's plenty of evidence that they increase the chronicity of the disorder.
And, by the way, just to finish this up, when they've tested SSRI's in “real world” populations (because in industry funded trials, you're testing them in a very select group of patients), the results were horrible.
In the first NIMH study of this sort, only 26% of real world patients even responded to an SSRI anti-depressant (meaning they had some reduction in symptoms). And at the end of one year, only 6% of the patients initially treated were in remission (meaning that their depression had gone away).
So that's a story of a drug class that is very ineffective in real world populations.
Now let's move on to the atypicals for a story about how studies are biased by design to make the study drug look better. So take this study. Take the trials of Risperdal. How were they conducted?
There was no placebo group actually in those studies. What they did is they took people who were somewhat stabilized, you know, doing ok on anti-psychotics, and they randomized them to a group.
One group was abruptly withdrawn from the medication.
The other group was, just then, either randomized to an old drug, or randomized to one of the new drugs. And the group that was abruptly withdrawn and kept off the medication becomes your placebo group.
Now, the problem with that is that we know that abrupt withdrawal actually often leads to serious symptoms (a sort of a serious relapse state). And that's because your brain has adapted to the presence of the drug.
So, we're going to have a placebo group (a group labeled placebo that isn't true placebo, but is in fact a drug withdrawal group), and that group can be expected to do horribly.
Now, how about the comparison between the new drug, say Risperdal, vs the old drug, Haldol?
Well, what they did in the Risperdal trials is they randomized people to different types of dosages (1 higher, 1 medium, 1 low), which gave them 3 different groups. And they compared that to a group of patients randomized to, you know, put on Haldol at very high doses.
Now, the reason they wanted to use a high dose of Haldol is because they knew that, when they compared a low dose of Risperdal to a high dose of Haldol, that there would be a lot more adverse events in the high dose of Haldol, and they could say, look, our drug is so much safer.It has, you know, it causes so many fewer problems than Haldol.
But that's not a characteristic of the drug. That's a finding that results from how you designed the study. So we heard in the scientific literature how Risperdal was a breakthrough drug, so much better than Haldol and Thorazine.
But what did the FDA say when they reviewed the data?
They said, listen, these trials are biased by design. There's no evidence that your new drug is any better than the old drug, and, in fact, we should expect all sorts of adverse effects of a different sort — the drug has a bit of a different mechanism of action) — to pop up.
So, the very claim that was being made to the public, of a breakthrough medication, and being made in the scientific literature, when you actually get to the FDA review, they're saying, this is just a story that results from biased study design, meant to make the new drug look better.
So, that's a very long winded answer. To go back to your question about, well, if these disorders aren't validated, and you might have people with a lot of different problems in one category, wouldn't you expect the drugs to not do so well? And, in fact, that's what you find in the data that was submitted to the FDA.
You actually, by the way, don't find those new atypicals much more effective than the drug withdrawn group. That's a surprise. And in the trials of Zyprexa, the FDA actually said that the phase III trial showed no, provided no meaningful efficacy data.
They approved Zyprexa based on a phase II, a smaller phase II study. So, that's a long-winded answer. But, in fact, this is one of the reasons that it may be so hard for companies now to bring new drugs to market, because you have lumped together people with problems, undoubtedly, of many different types.
Howard: Right. And you may think it's a long-winded answer, but it really barely scratches the surface of the manual of dirty tricks.
Robert Whitaker: Yeah, you know again, now, if we look at that, why do they design trials this way? Well, the pharmaceutical companies design trials this way because they're trying to have trial data that helps their new drug be a success in the marketplace.
Then you have to ask, well, why did the academic psychiatrists agree to biased designs like this, and why did they sign their names on studies that reported, you know, results without mentioning the biased designs?
What happened as this went on, is that academic psychiatry got captured by the pharmaceutical industry. The pharmaceutical industry began paying academic psychiatrists huge amounts of money to be their consultant speakers and advisors.
Once that happened, that really influenced how they looked the other way when they were, you know, investigators on studies that had biased trial designs. When they reported the outcomes, they hid adverse events. So, for example, in the atypicals, there actually were a lot of deaths.
When I was writing that series for the Boston Globe, I looked into this. And I think it was roughly 1 in every 135 people who entered those studies died. And yet, when you look at the reports in the medical literature, there's no reports of any deaths.
Howard: Hmm. Well, you know, I have a career in marketing. And so, there's a part of me that really has grudging admiration for the brilliance of the way the results are. Even when the study is badly designed, sometimes you find that the data don't support the drug, or they show terrible safety profiles, or not better than placebo, and yet, even after the data's all in, the writers and ghost writers find a way to down play the harm and make it seem, you know, just the language is breath taking in its diabolical brilliance.
Robert Whitaker: Yeah, well, first of all, of course, sometimes they'll hide adverse events or they'll recast, say, suicidal attempts as emotional lability or headaches. That's one of the things you saw in one of the trials.
And they'll also poke through the data until they find something that makes the drug look good. Yeah, I mean listen, and from a commercial, PR, marketing point of view, yeah, it has been brilliant, absolutely.
And, listen, think about this. As a country we spent $800,000,000 in psychiatric drugs in 1987. That was the market at that time. Now, as a country, we spend more than $40 billion a year on psychiatric drugs. That's a 50 fold increase.
And now a little bit more than 20% of Americans take psychiatric drugs on a daily basis. Well, from a commercial, marketing, PR point of view, that is a story of extraordinary success.
Howard: So, what do we do about it? And I want to ask the question first on behalf of individuals who are, you know -One in 3 of us is likely to voluntarily come across the mental health system and be offered a drug. You know, not to say nothing about the people who are forced into it by the judicial system. So what do individuals do?
And then what's the prescription for fixing the barrel or creating a new one?
Robert Whitaker: Yeah, well, the first thing is what are individuals to do? Well, I think it becomes what we really need is, we have a society that's misinformed, right?
So, the question is, can individuals somehow make this science better known? Can they help stir the discussion where we can really look at what the science is saying?
And that, some of that is going on now, I think. Because, say, for example, the chemical imbalance story has fallen apart, and people are feeling betrayed, but it is falling apart and that's getting known.
So, I think as individuals the question is, can we really become informed about the science? And remember, by the way, too, the principle about medicine is that it's supposed to be based on informed consent, right?
So, if we don't, you know, if we're deluded, we can all see that that's a problem. In other words, if you go to these people and say, instead of saying that the drugs are no good, you can say, well, how about the information that is told about the drugs?
And once you can see that that has not been accurate (that the chemical imbalance story has been fraudulent), that opens up a discussion. Because, we can all say, like, well, that's not good, if people are misled about the drugs and what they're doing.
And then, what do we do about this as a society? That's the bigger problem.
We think the problem can be solved by just reducing the influence of pharmaceutical companies on psychiatry, and on academic psychiatry, and on the APA.
The problem that is greater here is that this medical specialty really has three products in the marketplace: diagnosis, (in other words, its diagnostic manual), research into the “biology” of these disorders, and then psychiatric drugs.
So, and this is the guild that really has the responsibility in our society as a medical specialty to tell us what is truth, so to speak. So, how is this guild now going to say, after what they've been saying for 35 years, about these are known brain diseases, our drugs are so safe and effective?
How are they going to say that, you know, listen, biology is still unknown, our disorders aren't valid, they've never been validated, our drugs really aren't very effective over the short term, over the long term, it looks like they increase the chronicity of these disorders, so we really have to re-think their use?
How can a guild say that and survive?
I think this is the big challenge - how psychiatry occupies this space as a medical specialty. So, in other words, it has a place of authority in our society. So, how can we question that authority? Because, I don't think we can expect psychiatry to reform itself.
And, somehow, and I don't know how we do this, we just need to have power or authority over this domain of our lives in our society shared by more groups (groups including psychologists, social workers, philosophers), you know, just society as a whole. And we somehow have to take this sort of governing power and authority from this medical specialty.
I think that's the real prescription for reform.
Howard: Yeah, it kind of reminds me of, you know, governments who admitted they were wrong.
Sort of South Africa's Truth and Reconciliation commission, or post-World War II Germany, where you kind of need almost a revolution, you know, new blood to come in and say, OK, we've overstepped, we've hurt people, and we need to come clean.
Robert Whitaker: We need a revolution in the sense that we need a very different paradigm of care which would begin with a different conception of what has been going, that goes on with people, and would, in fact, I think, see that this whole past 35 years, that this disease model has been, you know, it's a false, it's been based on a false story, and it's done great harm to our society.
So, yeah, I think we need to overthrow that, you know, that ruling authority in this domain of our lives. I agree.
Howard: Well, Robert Whitaker, thank you so much. I have so say, you know, both books have been extremely impactful for me, Anatomy of an Epidemic and Psychiatry Under the Influence, but Psychiatry Under the Influence is really, it lays it out so clearly, play by play, from the brilliant deconstruction of the Star*D Trial, to, you know.
I just want to send this to all my doctor friends who still think that there's an iota of truth or integrity in the marketing. So, I'm so grateful for the work that you and Lisa Cosgrove have done to put psychiatry in the context of a natural, human tendency toward guild and money corruption.
Robert Whitaker: Well, thanks. That's what we tried to do, and, you know,
hopefully it does illuminate the problem in a new way.
Howard: Well, thanks again for taking the time.
Robert Whitaker: Thanks so much for having me, Howard. I really appreciate it.
Howard: Be well.
I hope you got a lot out of this episode of the Plant Yourself Podcast. If you're skeptical, which is understandable, or if you'd like to learn more, I recommend that you check out the show notes for this episode, which you can find at http://plantyourself.com/139, because this is episode 139.
You'll find the website http://madinamerica.com, which is Robert's website about science, psychiatry, and community. You'll get links to his books, and also, very interesting, an on-line course taught by Irving Kirsch, who is one of the researchers who proved that the antidepressants are no better than placebo. And Irving Kirsch teaches this course. It's essentially about an hour long video. It's free to register and watch it.
You have to pay, I think, $15 if you want to take a short quiz afterwards for CME credit. I mention this also because I'm happy to announce that Irving Kirsch is going to be the guest on an upcoming episode we recorded last week. It was a fascinating conversation. And look for that coming in the next couple of months.
Download the PDF transcript here (courtesy of Beth Hillman)
The Plant Yourself Podcast theme music, “Dance of Peace (Sabali Don),” is generously provided by Will Ridenour, a kora player from North Carolina who has trained with top Senegalese musicians.
It can be found on his first CD, titled Will Ridenour.
You can learn about Will, listen to more tracks, and buy music on his website, WillRidenour.com.