The American Psychiatric Association’s Response to 60 Minutes: Where is the Science?

Jonathan Leo, PhD / Jeffrey Lacasse, PhD
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The 60 Minutes segment featuring Irving Kirsch, on the placebo effect in antidepressant research, is causing some reactions. The American Psychiatric Association (APA) has posted a response on their web site. We imagine that many patients taking SSRIs for depression might be confused at this point, and are searching for clarification. To further clarify the scientific basis for their press release, we think the APA should at a bare minimum answer the following questions:

1) The APA quotes psychiatrist Jeffrey Lieberman who says that, “There is abundant evidence that supports the efficacy of antidepressants above and beyond the effects of placebo.” Would it be possible to list the abundant research you are referring to? Keep in mind that Dr. Kirsch also said that this is the case – but he pointed out that for most patients it is clinically insignificant. We assume that you are saying that there is research that shows there is a large difference.

2) Jeffrey Lieberman also states that Kirsch’s “conclusion is at odds with common clinical experience.” Isn’t the APA basically saying that we should discard 20 years of published, peer-reviewed research on antidepressants, and instead, trust the opinions of academic psychiatrists (many who have received substantial payments from the makers of SSRIs over the years)? How is this congruent with the standards of evidence-based medicine? This statement also seems to miss a basic point of Kirsch’s work which was not that people on SSRI’s don’t get better, but that people on placebo also get better- that antidepressants have only a tiny advantage over non-specific generalized helping.  Over the past tweny years there has been a push towards evidence-based medicine, and clinical trials have been used to measure the true medication response.  What was the purpose of these trials if we are going to discard them?

3) In regards to the FDA, the APA states that, “Kirsch’s conclusions were widely discredited by the FDA.” At first look, this seems totally untrue. Could you please mention the publication where this finding was made public? We are not aware of any, and even Thomas Laughren of the FDA said on 60 Minutes that the difference between medication and placebo is modest. Did he misspeak? Dr. Thase and Dr. Kendall also said it was a very small difference. Did they misspeak?

Kirsch has pursued this line of research since the late 1990s, so he was clearly the best choice to feature on 60 Minutes. But, several other scientists that have also confirmed Kirchs’s findings, such as Khan et al, Ioannadis et al. and Barbui et al. These are peer-reviewed publications in the scientific literature, using rigorous methodology. Are these authors wrong?

3) If the medications are only helping a small subset (Thase said 14%) of the people taking them, then a large number of the people taking the medication are not getting any benefit and are being put at risk for the side effects. All medications require informed consent, where a physician informs a patients of the risks and benefits of medication, as well as being well-informed of the alternatives (e.g., exercise, therapy, self-help strategies). What should patients be told about this?

4) But there is a simple way to move on from all of these arguments. You clearly disagree with Kirsch, stating that he is wrong about the difference between medication and placebo- but you don’t say what the true difference really is. In science, researchers simply don’t believe assertions of others without compelling scientific data to back it up. Putting Kirsch aside, would it be possible for the APA to simply state what they believe the medical literature shows is the true difference between medication and placebo (and to cite the evidence)?

To illustrate the example of the placebo effect and how these studies are conducted, take the second of two trials which was submitted to the FDA to get Prozac approved for children. On the prospectively defined primary outcome, 69% of the children had a beneficial response.  Granted this seems like a signifcant number, however 53% of the children on placebo also improved, which leaves a very small difference between the two groups. In fact, it was non-significant. It was only by looking at other measures that clinical significance was found; on the patient- and parent-rated scales there was no advantage to Prozac, but on one of the clinician-rated scales there was a slight advantage to Prozac. Although Russell Katz of the FDA wrote, “one could argue that this post hoc choice of primary outcome is inappropriate,”the FDA accepted the post hoc change and approved Prozac for children in January 2003 (Center for Drug Evaluation and Research, 2002, p. 13). It was the only antidepressant that the FDA ever approved for use in childhood depression…

Perhaps the most frustrating part about the APA’s response is that they don’t talk about  science or mention any scientific evidence, really.  They simply quote experts who think Kirsch is wrong. Thankfully, 60 Minutes did not do this. The great thing about the 60 Minutes piece was that millions of people got a close look at the actual science behind these medications. Granted, what they saw is not pretty. But at this point, the cat is out of the bag. As much as the APA might dislike this information being disseminated, there is no going back now. And, in terms of informed consent, we think depressed patients deserve to know the facts about these issues- and to hear them from people who understand the science- not to hear reassurances from authorities, statements that we believe starkly contradict the scientific studies.

 

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29 COMMENTS

  1. I always get upset by how the APA responds to these. Like the time they responded to Tom Cruise with something like “Well, he’s wrong… And most people would disagree with him.” and now it’s an argument from authority, “We’re the APA, and he’s wrong because we say so. The FDA and EMA thinks he’s wrong too, so there!”

    It amazes me that they cant be sued over this. They have knowingly been supporting bad science that has harmed millions of people. One would think that their dishonest little head games would have to come to a stop soon else they (and should) face legal consequences.

  2. I find it disheartening that the APA is not able to reply with a more serious and rigorous rebuttal (if one can be made). I found the same to be true of Anatomy of an Epidemic. Most of the critiques were superficial and snide. I struggle every day with trying to determine when neuroleptics should be used and, if started, when they can be stopped. We need studies using active placebos and it would be nice if those who have the influence to determine how research funds are allocated would address some of these questions in a more rigorous manner.

  3. The APA is playing for keeps people. They know that if they are fully exposed that a lot of psychiatrists can lose their jobs or be sued. Also, the 60 Minutes interview was far from a hit piece. No more than a year ago you would literally have to watch a 3 second Pfizer advert before watching clips on the 60 Minutes website. If they did do a hit piece (talking to family members of suicide, those who have brain damage etc.) then the outrage, assuming there is some, would be ten fold. So of course they are going to lie, because they know the repercussions of a serious grass roots movement to expose them if not file criminal charges against them. And let’s get this straight, this whole SSRI scam has been a crime. A big one at that with the FDA, APA and numerous pharmaceutical companies at the center of it.

  4. This analysis is incomplete, as in the APA’s. However, you are attempting to define the science and have failed to understand ‘placebo’. 53% of children in the study quoted responded to the placebo….You make no attempt to understand that, nor put it into the context of the anti-depressants you are criticizing. Placebo is a real treatment, it is the context of the clinic, the assumed expertise of the physician, the deep belief structures we have about medicine, the purchase of the medicine from the pharmacy, the relief we are given when we are told we have a condition/disease that can be treatedI with medicine, etc.
    Comparing placebo to SSRIs is like comparing 2/3 of a glass of milk to a full glass. ALL anti-depressants work about 60% of the time, but SSRIs are preferred because of the side-effect profiles. Other anti-depressants cause cognitive impairments, both objectively and subjectively. SSRIs have their own side-effect issues, but subjects prefer them in multiple studies.
    SSRIs aren’t significantly more effective than placebo? Duh, either is any other anti-depressant. But ‘medications’ for depression are significantly more effective than doing nothing, which is often all depressed people can do.

    • Are you a psychiatrist by some chance? Why do you feel it necessary to be a shill for the APA and the FDA? SSRI’s are killing people, numbing people, shrinking the frontal lobes of people, taking away the creativity of people, and on and one. Why are you defending these toxic drugs? They are not medications, they are toxic drugs on the same level as street drugs.

  5. This analysis is incomplete, as is the APA’s. However, you are attempting to define the science and have failed to understand ‘placebo’. 53% of children in the study quoted responded to the placebo….You make no attempt to understand that, nor put it into the context of the anti-depressants you are criticizing. Placebo is a real treatment, it is the context of the clinic, the assumed expertise of the physician, the deep belief structures we have about medicine, the purchase of the medicine from the pharmacy, the relief we are given when we are told we have a condition/disease that can be treatedI with medicine, etc.
    Comparing placebo to SSRIs is like comparing 2/3 of a glass of milk to a full glass. ALL anti-depressants work about 60% of the time, but SSRIs are preferred because of the side-effect profiles. Other anti-depressants cause cognitive impairments, both objectively and subjectively. SSRIs have their own side-effect issues, but subjects prefer them in multiple studies.
    SSRIs aren’t significantly more effective than placebo? Duh, neither is any other anti-depressant. But ‘medications’ for depression are significantly more effective than doing nothing, which is often all depressed people can do.

    • I think the ethics of placebo are still out. No one denied that people get better due to placebo (and when they do, are often better off than the people who took meds to get better). The dilemma is whether it is ethical to sustain a what I believe is a deeply unjust, non-science based, profit driven, and often harmful psychiatric pharmaceutical industry in order to provide the mechanisms for placebo response that benefits drug makers, doctors, and insurance companies at the expense of patients wallet and autonomy. Ultimately, I don’t think it is worth it, especially if there are cheaper, effective, evidence-informed and minimally risky ways to support people’s mental well-being.

      Having a nice doctor’s office with a diploma on the wall helps clients assume expertise, but is that ok if the prescribing doctors actively ignore or disregard the science or psychotropic medications (which is what they are supposed to be experts in?)

      Having faith in medicine and a strong belief in its effectiveness is based on people’s belief that medical practitioners, researchers, and medicines have been shown to be effective. Is it ok to continue to ask patients to rely on that belief while the scientific base for the medicines they are being given are unfounded? If it is, how long will people continue to have faith in Medicine of there is a continued disconnect between what doctors tell their patients to believe and what the science indicates?

      Is it ok that the process of patients having to go to a specialized doctor for a prescription, go to a pharmacy, and pay a lot of money for medications which have chemical properties that alleviate their symptoms, cause side effects, and possible unknown harms?

      Is it ok to tell people they will get relief because they have a diagnosis (with little validity) and access to pharmaceutical treatments (with little evidence of effect) so that some of those patients may get relief, even if they and others aren’t likely to experience it and be exposed to harm?

      Ultimately, I think it is better for everyone’s mental health, the health of people seeking treatment, and Medicine and psychiatry, if doctors and patients make decisions based on evidence, and not relying on stacked up falsehoods. Recognizing and taking responsibility for perpetuating lies about antidepressants (serotonin balancing theory, new SSRIs are better drugs and worth the great costs, diagnoses and medications are often for forever, there is little risk in taking meds, there is no harm in getting off them, etc.) will probably make the placebo response less strong. This may reduce efficacy of people’s current treatments. However, it will actually allow for rigorous science and inquiry to take place, rebuild trust in mental health professionals and psychiatry especially, and allow for better treatments. And if people agreed to these treatments/medications without being informed that 1) they are clinically meaningless, 2)based on an understanding of depression that is unfounded, 3)prescribing doctors know this, and 4) risk of discontinuation problems and other risks known that are often not shared, then they did not really have informed consent to be using the medications in the first place.

    • “…the context of the clinic, the assumed expertise of the physician, the deep belief structures we have about medicine, the purchase of the medicine from the pharmacy, the relief we are given when we are told we have a condition/disease that can be treated with medicine, etc….”

      What the contemporary history of psychiatry is telling us is that all the above is a delusion.

      Our once well-founded belief in medicine and doctors has been hollowed out by cynical exploitation for vast pharma profit and personal gain for psychiatry’s leaders.

      Jack, if you find this difficult to accept, blame the psychiatrists who keep on publishing these compromised studies, not statisticians who reveal the flim-flammery.

    • I wasn’t aware that people were suggesting that we do nothing, what they are suggesting is that we do something other than put toxic substances into someones body and tell them that they are correcting some mythical chemical imbalance in the brain. There are much cheaper, healthier and more productive ways to treat these conditions. What differs is that they are not cost effective for the doctors who are in bed with the makers of these drugs. That you have no problems at all with the side effects and pain and suffering that these drugs cause people says more about you than anyone else.

      When I seek help from a doctor I expect to be given evidenced based advice. That does not happen. I am told I have a brain based disease which is diagnosed sitting four feet away from me with a pen and paper and I am further told that I will have this brain based disease for life and need to take these medications that make me feel like shit for life. Again where is the evidence of that. Why did no one bother to ask me or anyone else, why we were feeling so down. Why did no one bother to give us any advice about improving our diets and exercising, about simply doing things we enjoy, about seeking some counselling or the like.

      As for the drugs being so effective, then WHY are the only results that are positive found in doctor reports and not patient or parent/carer reports. HOW can any doctor decide if a person is not depressed without talking to them. Provide the tests to assess this brain based disease that do not require talking to someone and I will consider listening to what doctors say, but since we all know that will never happen it is time to start listening to the people.

      And of course if the evidence is there to prove that these drugs are as effective as you claim, then provide that evidence. The same response given here is what is said in relation to anatomy of an epidemic. Doctors no longer care about patients, the oath of do no harm does not apply to doctors anymore, all they do now is make money, and if a few million die along the way, well it is just a slight side effect and not of any real concern to them. When did doctors and especially psychiatrists stop understanding any of there basic medical training.

  6. So but your own argument we should be prescribing Glucose over SSRI’s but retaining the, “context of the clinic, the assumed expertise of the physician, the deep belief structures we have about medicine, the purchase of the medicine from the pharmacy, the relief we are given when we are told we have a condition/disease that can be treatedI with medicine, etc” Also the side effects of Glucose are consistently preferred by “Subjects” or people over SSRIs in the vast majority of studies. Thanks for the confirmation Jack!

    • Kirsch notes findings of several studies that show that people, when told they are being given an inert “placebo” medication, and that taking placebos can be helpful for depression, they do get better with few side effects and more cheaply. I think prescribing placebos is totally ethical if people are informed that they are being given a placebo. Many people would prefer taking <20% cut in benefit from their antidepressants to avoid side effects, alleviate fears of being on meds, and to save some money.

  7. I struggle with this almost daily. It is not news to me that antidepressants, let alone a number of other medications often used to enhance their effects, are of limited efficacy and I have been having this discussion with people for years. However, I have many patients who continue to insist on taking them (sometimes in the face of having derived limited benefit in that past). One could argue that what one individual doctor says is drowned out by the overwhelming cultural messages but people have been looking for medicinal cures for a very long time. When an individual experiences relief from taking a drug, and is then told that the improvement may be due to placebo, this can leave a person feeling invalidated. I have found it hard, at times, to explain that improvement from a placebo is as important and “real” as improvement from anything else.

  8. Wow. Interesting that they didn’t include NICE in their rebuttal, oh wait, that’s right…the NICE in the UK actually agree (with Kirsch et al)…

    My favourite part of the APA rebuttal is: that 60 Minutes has “provided its viewers with highly misleading information, and I encourage everyone taking antidepressants to talk with your doctor.”

    No wonder they’re upset with 60 Minutes, providing misleading information is their raison d’etre, no?

    • Could not agree more. If the information is so highly misleading then WHY do they not provide any evidence to prove how it is highly misleading?? Surely it would be as simple as Whitaker and others are saying, just show us the scientific research to support what they are saying. But they can’t do that. Instead they accuse others of doing what they do on a day to day basis. The inability of psychaitry to admit their limitations is there biggest failure. It is also what is going to see them ultimately die. If they were willing to be honest and admit the limitations and to consider the full ramifications of what they are currently doing, people might have some respect for them, but the more they put there heads in the sand, the worse they look.

      • The problem is they are in too deep. To admit failure now would hurt the little credibility they have left. The psychiatric community is no longer fighting for professional integrity, they are fighting for their livelihood. As of right now 11% of Americans over the age of 12 are taking anti-depressants. This is mind blowing. Up until this point psychiatry has been good in whitewashing their abuses (ECT, Lobotomy, etc.) We can not let them do it this time around. As much as i do not like constantly bashing psychiatry and essentially beat a dead horse, the amount of damage they have done is just too big to ignore. They are in very serious trouble, and they know it.

      • All of these posts, except for Jack’s, give me real hope that maybe someday we will be able to take down the large drug companies and their psychiatrist shills and parrots. Most psychiatrists I’ve dealt with are nothing but flim flam people selling their snake oil to the public. We are beginning to pull the curtain back, even as the Wizard screams to pay no attention to the man behind the curtain! I for one, took myself off of these toxic drugs and refuse to chemically lobotomize myself any more with them.

        • Thanks guys.

          The absolute refusal to even acknowledge that there is any debate on the subject is what I find infuriating. I was hospitalized last year, my Doctors were adamant to my family that my condition was a chemical imbalance, and just like a diabetic needs to take their insulin, I should agree to take antidepressants for the long term, if not for the rest of my life.

          It became clear very quickly to myself and my family, that to get out of the hospital I had to play the game (yes sir, no sir, three bags full sir). They seemed to get very upset if you questioned anything they said. For example, when I stated that the chemical imbalance theory seemed overly simplistic, my Doctor really didn’t seem to know how to deal with that. All they could say was that it was statistically proven. The phrase “lies, damn lies and statistics” seemed lost on them also…

          How any clinician can think giving misinformation to patients is ethically justified, or in any sense therapeutic is beyond me…

          But it seems, that they have to cling to the perceived need to medicate patients, because without any tangible form of treatment being provided, alas, they would have no legal/ethical justification for locking people up and treating them against their will.

          I don’t find a doctor/patient relationship based on dogmatic misinformaton, and subliminal coercion meaningful. I have only found it to be profoundly traumatic, and in the long run, all it has done is ensured that any future treatment I seek, will not be from the psychiatric industry. Surely that is not the result that Doctors want?

        • They are being exposed and truth and justice are only going to come to the fore through grass roots leg work. We are not going to get any help from the main stream media, Washington, the medical establishment or psychiatry itself. Psychiatry has been a debacle for decades and these entities have done very little, if not nothing, to eradicate or at a minimum curb their abuses. We must remain steadfast and remember that we are on the side of truth and have the moral high ground.

  9. I believe you are on to something when you say psychiatrists believe we are not entitled to any form of redress from their harms. I have a hard time believing all psychiatrists are suffering from a case of ignorance/negligence or cognitive dissonance. To a certain extent i am convinced they have been engaging in a massive field experiment for the greater good of science, coupled with a eugenics operation. Now people get a little queasy when eugenics comes up but the US has a VERY rich history in it. We were the inspiration for the Nazi’s! This fiasco goes beyond dollars and cents in my opinion.

    • I agree, Scott. I’ve said it for years that I don’t believe psychiatrists can really be that stupid, nor can the parents of drugged up children. The evidence that the drugs are bad and brain damaging are right their in front of them. A kid turning from a normal hyperactive defiant child to listless zombie with black rings around his eyes, cottonmouth, drooling and dragging his feet across the floor. Did you see that boy in “the medicated child” on PBS? For crying out loud…

      OF course they know what they are really doing and of course they must have some sort of dehumanizing view of the person to be able to do it, E.G. they are inferior and the world is better off without them.

  10. Is this not something that could be brought as a civil liberties violation case? Could there not be grounds for a class action lawsuit on the basis of unconstitutional involuntary detention and treatment? The U.S. Supreme Court has consistently emphasised (since O’Connor v. Donaldson) that involuntary hospitalisation is a serious curtailment of liberty, which can only be justified in the name of actual treatment.

    If the entire focus of treatment is meds, and the meds are bogus, and the doctors are lying to their patients, then there’s no legal justification for involuntary incarceration, is there?

  11. Oh Anon, I so hope that such a thing does occur. Yes, there’s supposed to be a clear and well understood efficacy when drugs are forced on people via court order. It’s not supposed to be a big experiment. That would not be legally allowed. Doctors have lied to and around the law to force drugs, particularly neuroleptics, on people with the explanation that it (neuroleptics, I’ve never even heard of adults being forced to take antidepressants) works specific to their “disease” and is therefor a valid medical treatment, as opposed to what it really is, a chemical straight jacket.

    Yes, if the truth were fully known and the laws stayed the same, psych drugs couldn’t be forced on people via the courts. However, I’m quite sure that the laws will change as the truth becomes known as to protect the doctors and mental health workers from civil suit as well as to please the NAMI-minded folks who will still demand to forcibly drug others, even if the drugs are just chemical lobotomies.

  12. Organize- but how. After reading up on all these issues it is easy to repeat and reinforce the obvious, but where are the practical solutions that would lead to confronting the drug industries effectively, what with their billions in profits made from hooking people, then treating them for the side effects essentially for life? Plus, the chemical effect of these drugs on the brain effectively neutralizes the patients, turning them into zombie-like, often willing subjects lacking the initiative to escape and not being taken seriously in their drugged state. This destruction of their will to go back once ‘addicted’, strengthened further by the fears the doctors promote to those who would even mildly question getting back to a natural state seems criminal.It should be a crime. It is a trap, and a form of medical corruption where those who benefit the most turn their backs on the moral dilemmas, while they comfortably build their practices with patients they hope to treat for life. Creating the medically ill seems to be a lucrative business – I’ve seen and lamented lots of base corruption in the third world where I work, but this is corruption on an advanced, educated scale that is astounding.

    • Very well said. Telling each other that these drugs suck isn’t going to solve much. However, the information “war” is definitely part of the battle. In this vein, helping start and support seminars/conferences that expose the fraud and offer alternatives can also be a weapon. A little civil disobedience and protests of pharma firms and medical gatherings can be employed. Why not become a single-issue voting block? The NRA has only a couple million people or so but has a lot of sway over legislation. Just a couple of ideas.