Study 329’s Authors: Should Those Who Live in Glass Houses Throw Stones?

Jonathan Leo, PhD

For the past several years whenever a critical essay has come along examining the work of Irving Kirsch and his colleagues I have made an effort to examine the validity of the proposed arguments.  Kirsch and his colleagues used the Freedom of Information Act to gain access to the unpublished trials of antidepressants and then pooled the clinical trial data – both published and unpublished ─ and analyzed it as a single data set. It is common for pharmaceutical companies to only publish those studies that find their products effective, and to withhold the negative studies, making it difficult to reach accurate conclusions by examining only the published data.  Kirsch and his colleagues have reported that in the company sponsored clinical trials, the SSRIs only marginally outperform placebo, with the difference being statistically different but not clinically significant.

This past February, 60 Minutes devoted a segment to these studies (Kirsch, Deacon et al. 2008). Following the 60 Minutes piece, the internet lit up with chit-chat and blog postings about the Kirsch studies. One blog posting in particular caught my attention because it seemed to be more of a personal attack than a discussion about the actual evidence.  The blog titled, Overstating the Placebo Effect, was written by Harold Koplewicz, the founder of the Child Mind Institute.

The blog posting did not seem overly significant at the time it was published, but following the recent headlines about GSK’s three billion dollar fine and the role that Study 329 played in that fine, I think his essay can be seen in a different light.  The DOJ’s complaint stated that Study 329 misstated facts and made false claims about Paxil’s efficacy. Dr. Koplewicz is on the byline of Study 329.

The goal of the following discussion is to not to revisit the entire debate about the Kirsch studies but to examine Koplewicz’s statements about the clinical trial process and the efficacy of antidepressants in light of the DOJ’s comments on Study 329.

He starts off with a shot right across the bow: “The argument put forth by Dr. Kirsch and others like him is an ideological one, with  no basis in science. ”

This is a strong statement about Kirsch, but is it really accurate?  No basis in science? Consider that: Kirsch examined the clinical trial literature which the companies performed and submitted to the FDA; Kirsch’s paper in PloS Medicine is one of their most downloaded papers; even the FDA and MHRA representatives largely agreed with him on the 60 Minutes piece; the pharmaceutical companies largely agree with him, and furthermore even his critics stated on the same show that they found his work significant.  It is certainly acceptable to disagree about the FDA data, and some have, but the fact remains that Kirsch has published several important scientific papers in the field.  Can someone really say with a straight face that an examination of the FDA database of clinical trials is not a scientific enterprise?

Koplewicz devotes little space to the heart of the argument but he does touch on three problems that he sees with the Kirsch study:

1)      the clinical trials didn’t use a strong enough dose in the trials,

2)      they only included people with moderate depression,

3)      the trials themselves were not conducted very well.

In the comment section of his essay, one of the responders addresses all of these points: “Interesting blog post. A few comments: (a) there is no dose-response relationship with antidepressant efficacy in the FDA trials – higher doses do not work better, (b) almost all FDA trials were conducted with severely depressed patients, which makes it all the more telling that half of these trials failed to demonstrate a significant antidepressant effect, (c) if the FDA trials were poorly conducted as you suggest they are inadequate to demonstrate efficacy and the drugs should not have been approved.”  The comment goes right to the heart of his essay and leaves Koplewicz’s argument on shaky ground.

But even more to the point, these criticisms are nothing new.  In 2002, following his Prevention and Treatment paper Kirsch addressed almost all these comments, and others, in a formal response.  The first line of his response was, “We are very heartened by the thoughtful responses to our article. Unlike some of the responses to a previous meta-analysis of antidepressant drug effects, there is now unanimous agreement among commentators that the mean difference between response to antidepressant drugs and response to inert placebo is very small.”   One of the responders to his 2002 paper, Steven Hollon, stated, “Many have long been unimpressed by the magnitude of the differences observed between treatments and controls—what some of our colleagues refer to as ‘the dirty little secret.’”

Keep in mind that Kirsch only analyzed pharmaceutical company trials, thus many of the criticisms directed at Kirsch are really directed more to the pharmaceutical companies who conducted the trials and the FDA who approved them.  If the trials were faulty is it appropriate to blame Kirsch?  Peter Kramer also took the tack of blaming the trials in his New York Times essay.  It would be one thing if Kramer and Koplewicz were consistent in finding fault with the trials, but there was little condemnation from them back in the 1980s and 1990s (at least that I am aware of)  when the trials were being used to support FDA approval ─ the trials were the talk-of-the-town back then. But, apparently, now that a more detailed analysis of the trials is published showing their flaws, we are supposed to ignore the trials?

Koplewicz also says, “The conclusions look damning, but in this case appearances are deceiving. To understand why, we need to talk about placebos – and depression.” He then devotes two paragraphs to the placebo effect but never explains why an understanding of the placebo effect should overturn Kirsch’s results.  If anything, he seems to be confirming the importance of conducting randomized trials to tease out the placebo effect.  He even points out that, “people diagnosed with the disorder may get better on their own,” which is just one more reason to determine the true drug effect.

The problem with being so dismissive of the FDA data is that even within mainstream psychiatry it is now fairly well-acknowledged that the difference between placebo and antidepressant drug effect is minimal. The current state of the SSRI debate amongst Prozac’s proponents is as follows: At one end of the spectrum, some, such as Michael Thase, a clinical trial researcher and medication proponent, says that for every ten people taking an antidepressant the drug helps one person. At the other end of the spectrum there are those who argue that it helps three people. The debate comes down to the significance of these low efficacy numbers. Or put another way: Are SSRIs effective for 10% or 33% of the patients that receive them?

While providing no evidence in support of his statement that Kirsch is an ideologue, and little substantive evidence to counteract the idea that there is a significant clinical difference between medication and placebo, he does cite his personal observations.  He assures his readers that he has seen the medications work:  “As a child and adolescent psychiatrist, I have also seen the lives of many children turned around by psychotropic medications. I have seen it help kids who were so acutely anxious they were afraid to speak, and I have seen it help teenagers who were so depressed they were ready to take their own lives.”

Anecdotes are fine to note, and they might be of some interest to some people at some point in time, but at this point in time the debate is about the evidence, and not about one person’s observations.  This is why clinical trials are conducted in the first place– to test these types of observations.  To charge Kirsch with being non-scientific, and then in the same breath use a non-scientific argument to overturn the data from the trials does not seem like a valid strategy.  Kirsch is not making an argument based on anecdotes. I am not naïve enough to think that the debate about the efficacy of antidepressants is over, but citing anecdotes does not seem the way to go about overturning the FDA data.

Moreover, the issue of anecdotes opens a can of worms, and potentially leads the discussion in a direction that I am not sure he wants to tread.  There have been children on SSRIs who have committed suicide, and some of these parents have testified at various FDA hearings about their children’s lack of suicidal ideation prior to starting an SSRI.  In the face of these testimonials, the overall message from the child psychiatry profession has been that these are just anecdotes and that what matters is the clinical trial literature, and in the clinical trials no children committed suicide.  If anecdotes are important for judging efficacy, then why aren’t they good for judging side effects?  The error in logic seems obvious:  You can’t use one set of anecdotes to support your thesis, and then dismiss the anecdotes that don’t support it.

As an aside, Kirsch is not the first person who Dr. Koplewicz has chastised. In a September 2001 blog posting titled Why We Need Psychoactive Meds he took great exception to Dr. Marcia Angell’s article, The Illusions of Psychiatry which has been published in the New York Review of Books. His essay on Angell took the same arrogant and dismissive tone, but again provided little in the way of data to justify his claim that Angell is misguided.  You can sense Dr. Koplewicz’s frustration with the media for covering Kirsch and Angell.  But aren’t reporters supposed to write about science?  For some of the millions of people taking these drugs they work and that is good news. But what is wrong with an adult being told all the facts about a medication? Imagine a media outlet that decided to ignore a study showing that in the clinical trials responsible for FDA approval there was only a slight difference between the medication and placebo groups?

At one point Koplewicz states: “To evaluate efficacy as well as safety, the FDA started testing new medications in the 1960s. Unfortunately, there are many problems with how these clinical trials are conducted.” The irony of his comment is that a study he co-authored, and was soon going to make headlines news, provides the best citation in support of the idea that there are problems with the trials.

Overstating Efficacy: GSKs Three Billion Dollar Fine and the Role of Study 329

Six-months after his essay on Kirsch was posted, GSK was fined three billion dollars by the Department of Justice (DOJ). Not Three million, but three billion. The fine involved several medications, such as Avandia, Wellbutrin, Advair, and Paxil. Regarding Paxil, the DOJ’s complaint mainly focused on Study 329, which examined the use of Paxil for pediatric depression.  While the DOJ treats GSK as the sole author of Study 329, only two of the named authors were actually GSK employees. All of the other named authors, one of whom was Dr. Koplewicz, were affiliated with universities.  In their complaint about Paxil and the role of Study 329 the DOJ did not mince words: “The United States argues that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.” They also note that:”GSK published an article that misstated Paxil’s efficacy and safety for children and adolescents.”

The DOJ report is just the final nail in the coffin for a paper that academic medicine was unable to put to rest. Study 329 was published in 2001, and it didn’t take long for critics to point out the problems with the study. Right after it was published John Jureidini wrote a letter to the editor, and then followed up with several peer-reviewed papers about Study 329. Alison Bass, a health reporter for the Boston Globe, extensively documented problems with the study in her book Side Effects.  For example, she pointed out that the study miscoded several suicidal teenagers as noncompliant when they were really suffering from suicidal ideation. Several years ago, the editors of the Lancet stated that the, “The story of research into SSRI use in childhood depression is one of confusion, manipulation and institutional failure.”  According to the blogger Boring Old Man, “There is probably no single icon for the corruption of the modern psychiatric literature so paradigmatic as Glaxo-SmithKline’s Study 329.”

At one point in his essay Dr. Koplewicz says, “Some people are simply opposed to treating psychiatric disorders with medication.”  But is it really accurate and fair to portray someone who went through the trouble of analyzing the FDA database as “simply” opposed to medication?  But there is a flip-side to his statement:  Given that the DOJ has just stated that Study 329 overstated efficacy, one could say that, there are some people who will say that treating psychiatric disorders with medications is appropriate, even if the clinical trial data says there is no benefit.

In his essay on the FDA trials he also brings up some issues of the clinical trial process which he believes support his viewpoint, but if anything, especially in light of 329, seem to hurt his case.  Koplewicz states: “Rather than taking the time to determine a correct clinical dose, it’s cheaper to do lots of studies and throw out the ones that don’t get results.” It is unclear what exactly he means by the term “throw out” but how this idea of not reporting negative data is supposed to be seen as a defense of the medications is confusing.  Some people might take the term “throw out” to be a euphemism for “to not publish the results that put our drug in a negative light.” The DOJ apparently felt that this was how GSK was looking at it.

The DOJ report notes that besides Study 329, GSK conducted two other double-blind, placebo-controlled studies of Paxil for pediatric and adolescent depression: Study 377 and Study 701, and the results were never published. In the DOJ’s words: “Like Study 329, both studies failed to demonstrate any statistically significant difference in efficacy between Paxil and the placebo on any pre-specified primary or secondary endpoint.”  The fact that negative studies are apparently “thrown out” is one reason Kirsch looked at the unpublished data. And these “thrown out” studies of Paxil in children were apparently a source of consternation for the DOJ.

There is absolutely nothing wrong with disagreeing with Irving Kirsch or Marcia Angell, but shouldn’t the disagreement be about the data? And it does seem a tad hypocritical for any of Study 329’s authors to criticize another study – especially when it comes to how they reported efficacy – given the fact that they have not commented on their own involvement with Study 329. I am not aware of any of the author’s addressing the DOJ’s statement that, “In publishing Study 329, GSK falsely claimed that it demonstrated Paxil’s efficay in treating depression in patinets under 18.” And the authors’ silence is not for want of media outlets as many of them are regularly interviewed by the nightly news, and some even have their own blogs.

In 2010, at the same time the DOJ was investigating Study 329, The New York Times featured Dr. Koplewicz in a column titled “Ask a Psychiatrist.”  The column’s introduction stated that he “will be responding to readers’ questions about the myths and stigma surrounding psychiatric disorders of children and adolescents.”  Instead of the readers asking questions, shouldn’t the Times reporters have been the ones asking the questions about Study 329?  For instance, did the named authors simply sign their names to an already completed paper written by a company employee? Or what was their role in the intellectual framework of the paper, such as planning the study, analyzing the results, or writing it? These seem like legitimate questions about a paper which has become part of what the justice department has called the largest health care fraud settlement in US history.

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  1. Like so many psychiatric drug apologists, Dr. Koplewicz is very light on logic. It’s almost cruel to whale on him, Dr. Leo.

    Paradoxically, I also believe Kirsch overstates the placebo effect, but not for Dr. Koplewicz’s reasons. Part of the difference Dr. Kirsch attributes to the placebo effect is due to misdiagnosed withdrawal syndrome.

    Dr. Kirsch could not include incidence of withdrawal syndrome in his statistical analysis because NONE of the studies he analyzed differentiated between withdrawal syndrome and relapse. Although incidence ranges from 20%-80%, not a single case of antidepressant withdrawal syndrome was reported in all of those studies. Those cases were counted as relapse, going in the plus column for antidepressant efficacy.

    (In fact, I’ve found only one study of antidepressant efficacy that had a protocol to identify withdrawal syndrome. None of the others, including the STAR*D study, which switched 4,000 people on and off drugs, had such a protocol, instead using only a depression questionnaire.)

    Dr. Kirsch analyzed this plus column, but could not account for withdrawal syndrome because the numbers were absent. Some of the pluses he attributes to placebo were actually withdrawal.

  2. Jon, thanks for penning this fantastic commentary! You hit many nails on the head here and your awareness of the larger context and how many seemingly disparate happenings fit together is much appreciated. I hope this story will soon be told to a broader audience, and you would be a great person to do just that.

    Altostrata, you should know that Dr. Kirsch has not analyzed the types of studies you mentioned in his research. I was a co-author with Kirsch and colleagues on the 2008 paper Dr. Leo mentions and I can tell you that only short-term efficacy studies (4 to 8 weeks) were included. Patients were not withdrawn from their medications in any of these studies, thus relapse and misattribution of withdrawal symptoms was not an issue.

    You are absolutely right to criticize relapse prevention studies for obvious methodological flaws. In these studies, patients initially assigned to a drug and followed through the acute phase (4-8 weeks) are subsequently assigned to either continue the drug or switch to placebo. These studies are seriously flawed for two reasons. First, those who get switched to placebo may experience withdrawal symptoms which are mischaracterized by the researchers as a return of the disorder being treated. Second, switching a patient from drug to placebo would seem to produce an obvious breaking of the blind in which the cessation of familiar drug “side effects,” and/or the presence of new physiological symptoms associated with drug withdrawal, make it clear to the patient that he or she had the misfortune of being assigned to the sugar pill condition. As a result, the patient would have lower expectations of improvement which in turns leads to relapse. As a result of these problems, relapse prevention studies are of extremely limited value in assessing the longer-term benefits of medications despite the fondness of biomedical proponents like NIMH’s Thomas Insel for them.

  3. Dr Harold Koplewicz, like Dr. timothy Wilens of Mass General Hospital. have published books that promote the use of psychotropic medications in children, stating *by virtue of their authority* alone, that psychiatric illnesses are physiological diseases that respond to medication.

    In his book “It’s Nobody’s Fault”, Dr. Koplewicz stated that “depression is the most common brain disorder in America …” He was the star of the first ever White House Conference on Mental Health, June 7, 1999; gushed over by both hillary Clinton and tipper Gore as he capitalized on the Columbine tragedy by leading the charge for prevention through early identification and psychiatric treatment. So captivated by his *take charge* attitude, Hillary Clinton commented during Dr. Koplewicz’s presentation: The goal,she said must be to “identify and get help to children who need it, *whether or not they want it or are willing to accept it*.”

    I don’t think Koplewicz’s arrogance can be appreciated outside of the context of the power and authority granted him by Pres. Clinton during that quickly arranged conference, just 6 weeks after the Columbine story shook parents and teachers across the country. It was a fear-based easy sell. Thirteen years later, no one can hold any of the major fear mongering propaganda specialists accountable. Prominent physicians can write books that have no scientific citations— and promote the use of dangerous drugs for fabricated diseases–in CHILDREN. Koplewicz has study 329 to his credit. Wilens pocketed a couple of million from PHARMA and did not lose his golden boy status at MGH or Harvard Medical School.

    The mere fact that Koplewicz is still commanding an audience for anything he has to say, is a reflection of our society’s judgment on the value of children. As our kids become increasingly angry and hostile over their less than human station, Dr’s Koplewicz and Wilens make up more psychiatric illnesses for which psychotropic drugs are ALWAYS the first line treatment.

    • I think this is a very valuable article.

      But I believe it leaves out a very important conclusion. These psychiatrists are criminals. They know what they’re doing (promoting the products of the drug companies who pay them). And there is no way they can’t know the damage such drugging does to the people who are made to consume the drugs.

      I don’t use the word “criminal” lightly. But I am an attorney and it is crystal clear to me that what happens in these cases are crimes.

      And how about the very recent case where some Harvard neurosurgeon injected bacteria into people’s brains, after which his victims died? This is first degree murder, recognizable by any first year law student. The surgeon kept his job, with a one-year suspension from doing “research.” I guess Harvard really needs the money the doctor brings in.

      I appreciate the value of projecting an objective tone (sort of). But at some point, people should be pointing out what these corrupt doctors are doing, and not leave it to psychiatric survivors like me.

      The experiment of injecting bacteria into patients’ brains is the sort of thing done by Nazi doctors to the Jews in the concentration camps.

      Why aren’t people saying this?

      • How many lawyers does it take to bring a case to the Attorney General… State or federal level??

        We have laws against making a profit by lying and harming the public— breeching the *public trust*.

        1) The lies?— easy, most of it is in writing!
        2) The harm?— evident especially amongst the child/adolescent population
        3)The profit? all over the news
        4) Breech of trust? The hippocratic oath.

        If i were a lawyer, i would have no time to be posting here!

      • People in the system have no voice for one thing. And if you recover and move out of the system you have no credibility because you are still considered mentally ill by everyone backing the system. People who have no connection to the system gullibly believe anything and everything that the drug companies and the APA put out for consumption.

        I had a friend of 41 years who is no longer my friend at this time. She was a very influential educator in nuclear medicine imaging at a state medical university. Id known her since she was a Junior in high school. Well, after my little experience in the state hospital she constantly battled with me because I wouldn’t accept that I had a broken brain. She threw the “I can show you brain scans of people who are mentally ill and their brains are abnormal.” When I explained this was due to the damaging drugs given to them prior to the scans she went into a fury and pounded her fist on the arm of her chair, all the time screaming at me that I was totally wrong! This was a woman I’d known for a significant part of my life and she was determined that I was ill and always would be. She is well educated and well informed about everything except what is happening to people in the system. She doesn’t want to know. Sadly, we had to part company because I didn’t need her kind of “support.”

        I agree with you; many professionals should be sitting in prison or jail at this very moment but it will never happen unless we can somehow change the attitudes of the general public and for some reason they want to believe the lies spread by the drug companies and the biopsychiatrists at all costs.

        • I understand what you are saying and have realized for awhile that those who have the strongest evidence for indicting these criminals, also have the greatest barriers to speaking out and being heard. That said, I am convinced that the prerequisite public attitude change will follow when we are able to frame this atrocity in the simplest of terms and give it the most concrete from of expression.

          Is there any reason, for example, for the public to assume that MDs will write, teach and diagnose from anything BUT scientific evidence?
          The leading child psychiatrists used all three of these venues to state that mental illness in children is a brain disease that responds to medication. Of course they write and speak with no scientific citations, because NONE exist to back up these statements. They are false. Plain and simple. Then, what does back up these claims that solicit business for them via their appeal to parents, teachers, caregivers? Only their medical licenses and the status they have attained, by virtue of their affiliation with academic medical centers.

          How does a medical license and a professorship at a leading academic medical center authorize false claims that solicit patients/business for these psychiatrists and their consorts? Neither has any special significance outside of the power our society, we the people, ascribe to these titles. We do have a few safeguards in place to protect us from being harmed by the MD who preys on the ignorance of the public for profit- When, for example, the MD makes specific claims that are leading people to seek treatment that can be harmful for disorders that the MD made up— to support the need for his very profitable treatments.

          I don’t think it is fair to even suggest that psychiatric survivors should lead the charge to expose the fraud and harm employed by those from whom he/she barely escaped. No. This would be adding insult to injury. Nor do I think that civil suits, or medical malpractice are the best grounds for changing the attitude of the public. I am suggesting that simple, readily comprehensible evidence be presented to any Attorney General )preferably starting with Martha coakley in MA.) of fraudulent claims that directly solicit patients/children via their *trusting* parents, teachers, care givers for treatment that consists of dangerous pharmaceuticals; the revenue, bringing in big $$$ for PHARMA and psychiatrists who prescribe these dangerous drugs.

          I believe restitution should be sought, but most of all, the naked emperor must be exposed, and it will not require a Harvard degree to spell this out.

          While publishers of books that are full of this half baked crap are not really concerned about what they put in print, promoted and circulated.. (So far as I have been able to discern thus far). Although book sellers and even librarians are confused by their own concepts of freedom of speech. Although it’s a real challenge to capture the attention of those we tend to think of as caring for the public good, especially children…. I know for a fact that the documented evidence alone is enough to make an airtight case for criminal indicitments. It is against the law to exploit and harm the public for profit— EVEN if you are an MD and a full professor at Harvard Medical School- department of psychiatry.

          Similarly, though not yet enacted, the corrupt research practices and the lack of diligence of federal regulatory agencies is also *illegal*.

          Will thoughtful reflection on this newly framed description of the situation result and motivate doctors and PHARMA execs alike bring about their own self motivated action to rectify their errors and provide for both remedial and preventative care to those damaged and those at risk?? All that prevents this from happening is the fear of civil suits for damages— once their errors are admitted.

          A few years back medical interns and residents were educated about the benefit of making full disclosure of errors to patients, admitting their human flaws. Patients and their families seemed to appreciate this, along with sincere apology and rarely initiated law suits.– the benefit for the doctor was obvious. now when we consider how admission of errors like the ones we all discuss here would look—- or even if apology would be forthcoming, not to mention that the reputation of an entire medical speciality is at stake should this become the new widespread practice of American psychiatrists… There is that discomforting element of uncertainty as to whether these false claims and harmful drugging practices are really the result of human error— or something else. Scary stuff, right? But how does it compare to the certain plight of millions of our youth— a whole generation being sacrificed as lab rats for the preservation of biomedical psychiatry— a specialty that never had even a tiny connection to medical — anything?

  4. What is particularly troubling as one who suffers from depression is that I and so many of my peers find that our treatment continues to be primarily or exclusively medication despite Kirsch’s paper in Plos Medicine and more recently Piggot’s analysis of the STAR-D. I know with each medication change or addition I will be taking an antidepressant or adjunctive medication which affords me on average a two point reduction over a placebo on the HAM-D. (Of course, I have taken Paxil.)

    While government can seek redress how are my peers and I to be made whole? Afterall, we took the antidepressants and adjunctives we were told would significantly decrease our depressive symptoms but too rarely did we enjoy the promised relief. This involved a significant opportunity cost where the medical model prolonged our suffering and served as a barrier to accessing and/or receiving treatment which might have make a difference, ex. CBT.

    We too were defrauded by “the dirty little secret” but we just don’t matter.

    • You’re correct. It’s very difficult to get insurance to pay for talk therapy. It’s also very difficult to find a psychiatrist who even knows how to do talk therapy these days since they are not taught how to do it when they’re in college.

      The toxic drugs are the only treatment of choice and poor you if you speak out agains tthem. I think you’re correct, we don’t matter or count.

  5. A lot of what Koplewicz says publicly about helping children plays well in the media, but is what this guy says really objective or merely masking his own personal agenda in promoting himself and psychotropic drugs for children??

    Check out the Wikipedia article on “Harold S. Koplewicz”. Here are just a few examples about the Koplewicz that pose questions of integrity / conflicts of interest:

    – As noted in this website article, Koplewicz co-authored the widely discredited trial study report (Study 329) of the psychotropic antidepressant drug Paxil in 2001 that was sponsored by GlaxoSmithKline (GSK) and used to market the drug to children as safe and effective. The U.S. Department of Justice (and other state governments) sued GSK for fraud and for using unsound scientific trial results (Koplewicz’s report). To this and other charges, Koplewicz responded by dismissing critics and investigators as “ridiculous” “conspiracy theorists” who impugn the integrity of doctors and a respected industry. (See his Huffington Post blog about Dr. Marcia Angell).

    However, after years of investigation and court evidence by the U.S. Government, and even as Koplewicz attempts to silence his detractors with derision and ridicule, in 2012 his report’s sponsor GSK settled with the US DOJ for a record $3 billion (plus millions more for other cases).

    – He is a well-compensated (shares and financial payments) chairman of a pharmaceutical/medical device company (Delcath Sys) and also receives compensation as a director of another medical tech company (Biosigns Tech).

    – For the past 12 years he has managed (for compensation, assumingly) a “peer-reviewed” psychopharmocology journal owned and published by Mary Ann Liebert, a for-profit entity that invests in bio-chem technologies/research publishing. A quick look shows that Koplewicz’s journal tends to feature articles written by himself and his friends who have the same real or potential conflicts of interests. New definition of “peer-reviewed”?

    – In 2009 he started and is president of a for-profit clinic (Child Mind Medical Practice PLLC) that specializes in and advocates the controversial practice of widely using psychotropic/psychoactive drugs as the primary means of treating children. He has ownership interest and a salary as president, and charges up to $1000/hour for talking with children and/or parents (NYT 2011). The Child Mind Institute/Foundation (from which he collects yet another salary) and its programs to “help children” serve also as PR covers for fundraising and for Koplewicz and for feeding clients to his medical practice.

    In a very clever scheme, the non-profit foundation raises money from well-intended donors to “help the children” with “financial aid” and then uses much of that money to pay the portions of the large fees (much higher than industry standard) that Koplewicz and his for-profit clinic charge that can’t be afforded by some children’s parents. In other words, for 20% or so of clients, Koplewicz charges as much as the clients can afford, and then has donors (who probably think they are donating to some noble cause of research for children) pay him the rest. To the public this questionable financial conflict of interest is obfuscated in vague financials and accounting sleights-of-hand. CMI ambiguously combines the financials of the for-profit and non-profit in a combined annual report, and refuses to publicly provide any credible accounting of how they actually spend the money they raise from gullible donors, nor do they provide any surveys or analysis of how their programs have actually performed or whom they have actually helped. If you strip away all the marketing hype (“Dr. K saved my children…” [paraphased quote of the owner of Penthouse Magazine and one of Kople investors Marc Bell]) on what basis can one discern what real and quantifiable impact his programs have actually had?

    Interestingly, literally millions of dollars that they raise in donations each year (“to help the children”, of course) are used just to pay the rent of their 24,000 sqft space on Manhattan’s Park Avenue (this little fact seems to be left out of the promo/fundraising material and replaced with photos of smiling children and of Koplewicz appearing with famous celebrities and socialites). Note: avg office space on Park Ave is est. at $79/sq foot per month (according to Morningstar Credit Agency) and is among the most expensive in the world. Hmm….

    – A background check showed that he had his own PR Assistant Brittney Green at NYU’s Child Mind Center and his CMI “Public Education Manager” Caroline Axelrod write flattering articles (e.g., his “vision”, brilliant leadership, transforming lives…) about him in Wikipedia (and of course there was no disclosure of this conflict of interest). Look for yourself where the original articles on “Harold S. Koplewicz”, “NYU Child Study Center”, etc, were written by his PR staff.

    – He introduces himself and is usually introduced as a “leading doctor” (check on how he nearly always refers to himself on Twitter, Facebook, his articles, interviews, etc…) and that he’s been written up in the New York magazine (NYM) as one of New York’s “Best Doctors”. Somehow he fails to mention that the list actually includes nearly 1,200 NY doctors or of his connection with Caroline Miller, editor-in-chief of NYM for eight years, who actually works for Koplewicz and is the creator/manager of his CMI website — no conflict of interest there! Also, along with the NYM mention, Koplewicz and his followers/acolytes rarely fail to tout that he has been recognized by the “Best Doctors” in America website, but somehow fail to mention that this list is actually comprised of the top 47,000 doctors in the U.S., which is hardly the pinnacle of success Koplewicz insinuates.

    – When you investigate press coverage of Koplewicz and CMI, you begin to wonder just how many “journalists” like Ingrid Wickelgren of the “Scientific American” Koplewicz has recruited and cultivated to shill for him and his ventures. Google-search (“child mind institute”, “ingrid wickelgren”) and see for yourself how many articles and blog pieces in different media outlets she churns out, extolling the endless virtues of Koplewicz and his CMI venture… Maybe I didn’t dig deep enough, but it wasn’t obvious to me that any serious journalism or critical thinking was present. Furthermore, do a Google search on “Harold Koplewicz” and you will literally see thousands of references to him that repeat virtually verbatim the same flattering biographical descriptions that originally came from Koplewicz himself and his PR people.

    Try finding independent and primary source verification of other roles he purports to have played (other than the endless copy-pasting of the personal profile that started making the Internet rounds when he was at NYU) and you will probably face the same difficulty I did. If we sneak a peek behind the Wizard of Oz’s curtain, what else will we find that is illusory, inflated or falsely attributed credit that belongs to others?

    Conclusion – I personally have never met the guy, so, after seeing him in the media, reading his articles and those about him and getting second and third hand accounts from people who knew him from the past, I end up wondering who the real Harold Koplewicz is and what part of what he says I should believe…