Diagnosisgate: A Major Media Blackout Mystery

Paula J. Caplan, PhD
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Remember “Colonel Mustard in the kitchen with the candlestick”?  From the game called “Clue” in which you tried to solve a murder mystery?  There’s a current, all-too-true and serious mystery involving devastating consequences – even death – for uncounted but vast numbers of people, but in this one the culprits are known to a very few, while their motives remain mysterious.

Until their identities are widely exposed, and their motives are known, the full story of the harm will never be known. It is astonishing that despite six stories in the major media — including a recent, groundbreaking Huffington Post series — and the filing of numerous lawsuits, the names and conduct of the culprits have consistently been omitted.

The story that has been called “Diagnosisgate”[1] starts in 1995, when the man widely considered the world’s most important psychiatrist split a payoff of nearly one million dollars with two colleagues in exchange for doing two patently unethical and illegal things that created the groundwork for a major drug company to market falsely one of the most dangerous psychoactive drugs.

Part one: In return for almost half a million dollars, they ignored what was known about the drug in order to manufacture a practice guideline holding up that drug as the best drug among two whole classes of related drugs for treating people who were classified as “schizophrenic,” the other drugs being marketed by other drug companies. This created what is widely considered the “standard of care,” the treatment that therapists are supposed to follow and that they can use in the knowledge that they are well protected from lawsuits if they follow it and their patients are harmed. The very foundation of the guideline, that it was about “Schizophrenia,” is illegitimate, because – though this will surprise many people – that category has been shown to be unscientifically created and indeed has been called a wastebasket for a wide variety of feelings and behavior, many of which are caused by psychiatric drugs.[2]

Part two: After the triumvirate received a bonus of $65,000 for creating the guideline speedily, their top psychiatrist  wrote to the same drug company, announcing that the three had constituted themselves as an entity that was prepared, in return for about another half million dollars, to create a marketing plan for the drug. The details included finding “key opinion leaders” (KOLs), who were prominent professionals in powerful positions – such as heads of state mental health or prison systems – and having them teach the Continuing Education courses that professionals are required to take, the ultimate message of those courses being that that particular drug was the best one to prescribe. Another section of their marketing plan was to have a great many articles published in what are considered scientific or medical journals, all concluding that that drug was effective and should be prescribed.

It is not clear whether the three psychiatrists were directly involved in choosing the content of the journal articles, but the plan to produce such articles was carried out, leading to publication of pieces recommending use of the drug to treat not only Schizophrenia but also Childhood Onset Schizophrenia, Schizo-affective Disorder, Bipolar Disorder in Children and Adults, Mania, Autism, Pervasive Developmental Disorder other than Autism, Conduct Disorder, Oppositional Defiant Disorder, Psychosis, Aggression Agitation, Dementia, below average IQ, and disruptive behavior. Thus, a staggering array of psychiatric categories – many of which are as scientifically sketchy as Schizophrenia – was used to promote the drug. This massive marketing campaign proceeded despite the many major negative effects of Risperdal, including drowsiness, dizziness, nausea, vomiting, diarrhea, constipation, heartburn, dry mouth, increased saliva production, increased appetite, weight gain, stomach pain, anxiety, agitation, restlessness, difficulty falling asleep or staying asleep, decreased sexual interest or ability, vision problems, muscle or joint pain, dry or discolored skin, difficulty urinating, muscle stiffness, confusion, fast or irregular pulse, sweating, unusual and uncontrollable movements of face or body, faintness, seizures, Parkinsonian symptoms such as slow movements or shuffling walk, rash, hives, itching, difficulty breathing or swallowing, gynecomastia in male children,  painful erection of penis lasting for hours…and death.

Who are the characters in this mystery? Janssen Pharmaceuticals, a division of Johnson & Johnson, is the drug company, and Risperdal is the drug in question. The marketing term for Risperdal and similar drugs is “anti-psychotic,” but the accurate term is “neuroleptic,” reflecting the mechanism of suppressing the brain’s activity as a powerful tranquilizer. Dr. David Rothman, who wrote the expert witness report for one of the lawsuits about the marketing of Risperdal, revealed after scrupulous examination of vast numbers of internal emails between Janssen staff and the representative of the three psychiatrists, is a specialist in medical ethics and the Bernard Schoenberg Professor of Social Medicine at Columbia College of Physicians and Surgeons, the medical school of Columbia University. He is also director of the Center for the Study of Science and Medicine at Columbia and at the time of writing his expert witness report was president of the Institute on Medicine as a Profession.  Rothman stated in his report that the guidelines were constructed “in disregard of professional medical ethics and principles of conflict of interest,” and that they “subverted scientific integrity, appearing to be a purely scientific venture when it was at its core, a marketing venture for Risperdal.”

The psychiatrist who spearheaded these efforts is Dr. Allen Frances, who the year before teaming with Janssen oversaw the publication of the fourth volume of the “Bible” of hundreds of categories of mental illness, Diagnostic and Statistical Manual of Mental Disorders, sales of which topped $100 million as a result of marketing by the lobby group called the American Psychiatric Association, which published it.  By virtue of this position, he has been called the world’s most important psychiatrist. At the time, he was also Chair of the Department of Psychiatry at Duke University. The two psychiatrists who with Frances shared the nearly $1 million in payments from Janssen are Dr. John P. Docherty, who was then Professor and Vice Chairman of Psychiatry at Cornell University at the time, and Dr. David A. Kahn, who was Associate Clinical Professor of Psychiatry at Columbia University.

Now back to the mystery: Despite five individual stories in major media outlets in 2011, 2012, and 2014 about two huge Risperdal court cases filed by the state of Texas and joined by many other states, neither a single writer of any of these stories nor even the papers filed for the court cases named Frances, Docherty, or Kahn or described the fundamental roles played by their Practice Guideline and their marketing plan in the scandal. The mystery is deepened, because the authors of the media stories and the court documents did name and describe the roles of some of the KOLs, who assuredly were guilty of unethical conduct but whose participation was conceived of by Frances and his colleagues. And some of those who reaped huge financial profits from Risperdal’s false marketing – most notably Harvard University’s Dr. Joseph Biederman, who created an empire based on claims that “Bipolar Disorder in Children” had been woefully underdiagnosed and untreated – have been royally outed for the enormous sums they earned. But even respected investigative journalist Steve Brill, who recently completed a unique, 15-part story of the Risperdal scandal for Huffington Post, and who described in detail many of its players and some of the patients who suffered terrible harm from the drug and who elegantly described the way that Janssen covered up data about some of the harm, left out the essential roles the Frances triumvirate played.  Activist Vera Sharav of the Alliance for Human Research Protection published an online article about the Rothman Report and included the names of Frances and those two colleagues, her article was apparently picked up by only two or three bloggers and none of the major media reporters who read what she posts.

The Rothman Report has for some years been available online,[3] and information from many of the major media articles came from that report, so their blackout of information about Diagnosisgate is all the more puzzling. Indeed, it is difficult to read about the Risperdal scandal without coming across the Rothman Report, where Rothman’s scrupulous documentation of the Diagnosisgate portion appears on pages 14-17 of the 86-page document, so it is hard to miss.

It has not been possible as yet to determine the reason for the blackout, but it is alarming, given the powerful, influential positions held by Frances, Docherty, and Kahn, and in the interests of not only their own patients and trainees but also of anyone who hears the claims they make about treatments, as well as for anyone who enters the mental health system and is subject to being diagnosed as mentally ill. It is also alarming that the vast majority of therapists are far less likely to know about Diagnosisgate – and thus about the shocking extent to which conflicts of interest have driven diagnosis and drug marketing – than to have read the massive number of journal articles in which Risperdal is recommended for a wide array of “indications.”

Brill goes to great lengths – in 15 chapters published one per day – to document a vast amount of the Risperdal story, so it is perplexing to try to imagine whether he might have missed those crucial pages near the beginning of the Rothman Report or whether something else happened. And if it is the latter, what could it possibly be? Because I am a psychologist, people often believe that I can read their minds, but of course I cannot. I do not even wish to speculate about what maintains the blackout. What is clear is that the effect it has is to keep from the public some of the most crucial information about how those who promote and benefit from the widespread use of psychiatric labels have sometimes worked hand-in-glove with Pharma, riding roughshod over the truth – especially information that is harmful to patients, ignoring professional ethics and good scientific methodology, and after all that, not being held accountable, not to mention liable, for the harm they cause. No matter how or why the blackout has been created and has persisted, it is time for it to end.

* * * * *

References:

[1] Caplan, Paula J. (2015). Diagnosisgate: Conflict of interest at the top of the psychiatric apparatus. APORIA:The Nursing Journal 7(1), 30-41. http://www.oa.uottawa.ca/journals/aporia/articles/2015_01/commentary.pdf

[2] See Caplan, Paula J. (1995). They Say You’re Crazy: How the World’s Most Powerful Psychiatrists Decide Who’s Normal. Reading, MA: Addison Wesley, and Poland, Jeffrey, & Caplan, Paula J. (2004) The deep structure of bias in psychiatric diagnosis. In Paula J. Caplan & Lisa Cosgrove (Eds.), Bias in psychiatric diagnosis. Livingston, NJ: Jason Aronson.

[3] For instance, at http://psychrights.org/States/Texas/exrelJonesvJanssen/ David_Rothman_Expert_Report_300dpi.pdf

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34 COMMENTS

    • In my opinion these drugs have never been successful at anything other than brain damage. Brain damage shouldn’t seen as success because this was easily achievable through visible means in the middle ages.

      I think the only real and recorded recovery has been through the avoidance of neuroleptics and the use of normal and reasonable means.

  1. What an awesome article. As survivor of this drug, I am grateful, and I love the way story was told. I believe I was on it from around 1993 until 2011, usually taking 6 mg., along with the rest of the cocktail I never needed. I went off cold turkey from 3mg no problem, and by all means felt better! Damages included lost menstrual periods resulting in osteoporosis and a fracture in 1999 (which confirmed the bone problem), breast milk, a close call with Tardive Dyskenesia (started in one hand, my right), and god knows what else, possibly neuro irregularities and part of my heart enlarged, one of the aortas, not sure. I was a Clozaril guinea pig, put on it for no reason but told, “You’re getting special treatment so quit being a pest,” and maybe a year later switched to Risperdal, when they told me “It’s better.” For what, I have no clue!

  2. Thank you for your community service; this is a pointed and articulate article exposing details about the unethical relationship between the powerful pharmaceutical industry and psychiatry. This unethical relationship fosters a rationalization for unrestrained greed; more importantly, it harms community mental health.

    Best wishes, Steve

  3. Thanks for this very important and truly informative article. I’d say Allen Frances is mostly an MIA blogger in name only. He must be aware he doesn’t really belong among the critics of his profession. He isn’t naturally a critic of that profession, and I’m thinking there is some kind of ulterior motive involved in his present criticism. Here his deception has been exposed. Elsewhere that deception (or duplicity) continues. Why hasn’t the mainstream press sniffed this story out? You tell me. Why does the media routinely ignore the books written by critics of psychiatry in favor of those books written by apologists for the profession? One reason, given ‘direct to consumer advertising’, is that the supposedly impartial media must have its own conflict of interest issues. You’ve got this attitude… “Oh, those things don’t happen any more.” Oh, yes, they do. The chief architect of the DSM-IV wants to come across as the chief critic of the DSM-5. He suggests that if only the people behind the DSM-5 did matters differently, they’d come up with a more reliable bible, er, manual. Think again. This is a media illusion. Anybody in the know, knows better.

  4. Dear Dr Caplan,

    I support what you say about “schizophrenia”, and quite a bit of it being caused by the neuroleptics.

    Years ago in Ireland when I found myself in hospital after attempting to come off depot ‘cold turkey’ – I got talking to a psychologist who practically guaranteed the option of drug free recovery.

    Ultimately, this did become available to me through careful taper and the Talking Treatments.

  5. I, too, thank you for exposing the fraud, Paula. And I appreciate your pointing out the reality that “schizophrenia” is a scientifically unproven ‘”wastebasket” of a disease category, as are all Frances’ made up DSM “mental illnesses.” Although it does seem his DSM teams did a stellar job describing the symptoms of the iatrogenic (not GENETIC) “serious mental illnesses,” that result from the use of the psychiatric drugs.

    I also appreciate your mentioning that Risperdal is a nerve seizing major tranquilizer, a neuroleptic, that does not actually have the false marketed “antipsychotic” properties, at least not for most people. And I do so hope the psycho / pharmaceutical industries learn that false advertising is technically illegal in the US.

    Since, I too am a Risperdal survivor. I was suffering from the common symptoms of antidepressant discontinuation syndrome, worsened by the common adverse effects of what I later learned was a synthetic opioid and a NSAI, and these adverse drug reactions were DSM-IV-TR misdiagnosed as “bipolar,” although it’s my understanding this might be a proper diagnosis, according to the DSM5 today. This resulted in my being prescribed a child’s dose of Risperdal, and this additional drug actually caused a first episode “psychosis” in me, at the exact point the drug was to “kick in.”

    Perhaps, all the psychiatrists need to wake up and realize that their “antipsychotics” can cause “psychosis” in people, so they need to actually listen to and believe their patients regarding adverse reactions to these toxic “torture” drugs and drug combinations. Rather than fraudulently claiming they “know everything about the meds,” while espousing unfettered delusions regarding the scientific validity of their DSM stigmatizations.

    And this is especially important when combining the “four ‘anti’s of antihistamines, antipsychotics, antidepressants, and antiparkinsonian drugs[3] as well as atropine, benztropine, datura, and scopolamine.” Since combinations of these drugs are know to cause anticholinergic toxidrome, aka anticholinergic intoxication syndrome. The central symptoms of which can result in “memory loss, disorientation, incoherence, hallucinations, psychosis, delirium, hyperactivity, twitching or jerking movements, stereotypy, and seizures.”

    And the psychiatrists can’t tell the difference between anticholinergic toxidrome induced “psychosis” and “psychosis” caused by any of the theoretical, and scientifically invalid, DSM disorders.

    Truly, doctors who claim drugs, that the UN states are “torture” drugs, are “safe medicines,” are nothing more than complete hypocrites, and should not be trusted. And it is a tremendous shame the psychiatric industry did not learn from WWII that making up “mental illnesses,” then torturing and killing people based upon these scientifically invalid “mental illnesses,” is unacceptable human behavior.

    I bought Francis’ book, but was unable to finish reading it, because it struck me as filled with hypocrisy.

    • Hi,
      One of the things I keep reading about “antipsychotics” is how bad they are – and that they are only suitable for “Schizophrenics”. This makes me wonder what’s so special about the “Schizophrenics”?

      It is possible for the “Schizophrenics” to come off the neuroleptics and to permanently recover like everyone else (with a little decent help).

      When this happens the community benefits and country saves a lot of money.

  6. Thank you, Paula. I read Rothmans 86 page expert witness document, which I accessed on Jim Gottstein’s Psych Rights web site, after watching your stunning disclosure, which he posted on YouTube. Allen Frances’ key role in the “mess” he now claims was an unforeseen consequence of –EXACTLY what he evidently set out to accomplish, should be headlines in MSM– even if, or especially because Huffington Post has become his safe haven.

    Granted this is a brain squeezer– a real mystery as to why this is a mystery to begin with? But someone has to just speak plainly and to the point. I am grateful that you have stepped up to the plate.

    Unlike the mysteries surrounding the jury rigging of RCTs to favor a drugs chances of getting to market, and even the mysteries around academic psychiatrists who sell their names to expand the market for potentially harmful drugs, there is documented evidence of Allen Frances’ pitch to J&J– proof that he , and Biederman breached both the law and medical ethics for financial gain, requested and received large payments from pharma–; that there is substantial evidence of harm directly related to their reifying both disorders and protocols for treatment AND disseminating the fraudulently contrived *treatment guidelines* via CME courses– which, by the way, accounts for the large percentage of psych drug prescribing that PCPs are doing…

    Refuting the validity TMAP, CMAP treatment guidelines that entrap people at the point of encounter with psychiatry; establishing the basis for stopping just this one abusive, harmful intervention, would be a piece of cake once the criminal actions of the Frances et al and Biederman et al become a focal point for public outrage.

    Rather than continuing to condemn GSK and J&J, who have paid billions and produced whistle blowers that we can thank for the documents they produced for litigation and are now in the public domain; rather than blaming the nefarious pharma reps for hoodwinking doctors, we need to shine the spot light on the *wizards* who have been operating the smoke and mirrors machinery.

    Long overdue!

    Excellent work, Paula!

    Best,
    Katie

    I

  7. Since I knew about Allen Frances’ double-dealing, in terms of profiting from promoting harmful neuroleptics and legitimizing unscientific labels, all the while pretending to be “scientific” and “for the public good”, I never trusted Frances’ newer “reformist” writing. Back in the ’90s Frances was a hardcore promoter of the medical model of mental illness. His promoting of Risperdal for “schizophrenia” caused untold damage in terms of painful side effects and lost opportunities for suffering people to recover their lives. Then, many years later, he was ironically portraying himself as the fairminded one in criticizing others who overdrug and overdiagnose.

    For these reasons Allen Frances personifies the term “two faced”. He’s the living Janus of psychiatry, a man who brings to mind those Wall Street insiders who caused the crash and then profited from it afterwards.

    If Frances wants to clear his name, he should get on here and respond to these allegations. If he lacks the courage to do that, his denial and avoidance should be seen as revealing who he really is.

  8. Psychiatry runs on trends and dogma, not science. My best bet is that Allen Frances “sees the writing on wall” re: scrutiny of psychiatry. Time to update, re-brand, stay current, etc. Hardcore biological psychiatry is evidently quickly becoming passe.

    Risperdal is rough stuff. I was briefly on it while in a psych ward, following heavy, involuntary shock treatments (hey, psychiatrists in the south…its the 50s down here, y’all!). The akathisia was intense, and I was pretty much left to my own devices, so I paced around the ward for hours upon hours each day. I really didn’t see what was so modern or “atypical” about Risperdal…just another mind numbing tranquilizer that clearly creates problems.

    What’s truly upsetting is how psychiatrists have, as other posters pointed out, used resources that could have helped people recover (with or without meds) to push a bio-bio-bio model of distress (“mental illness”) on both the people they label (“patients”) and society as a whole. Of course, psychiatry reflects society, to a certain extent; perhaps we should also be asking what it is about modern culture, particularly in the US, that allows this sort of abuse of power and outright corruption to flourish.

  9. “This massive marketing campaign proceeded despite the many major negative effects of Risperdal, including drowsiness, dizziness, nausea, vomiting, diarrhea, constipation, heartburn, dry mouth, increased saliva production, increased appetite, weight gain, stomach pain, anxiety, agitation, restlessness, difficulty falling asleep or staying asleep, decreased sexual interest or ability, vision problems, muscle or joint pain, dry or discolored skin, difficulty urinating, muscle stiffness, confusion, fast or irregular pulse, sweating, unusual and uncontrollable movements of face or body, faintness, seizures, Parkinsonian symptoms such as slow movements or shuffling walk, rash, hives, itching, difficulty breathing or swallowing, gynecomastia in male children, painful erection of penis lasting for hours…and death. ”

    How are these people really any different than the NAZI war criminals ?

    Nuremberg Case #1 Doctors Trial https://youtu.be/o9Moe5mIRyM

    This is how the Risperdal story should end.

    War Crimes Trials, Nuremberg & Hangings at Landsberg Prison, Germany (May 24, 1946) https://youtu.be/q3lAfGtWomk?t=26s

    I don’t think this comment is over the top.

    Below is the study where they threatened children with injections to test the Risperdal on them.

    “You need some medicine to help you get back in control. Take this medicine or we may have to give you a shot.”

    “A rage outburst was defined as sufficient agitation and loss of control such that the child was unable to “time out” (i.e. sit in a chair for 10 minutes on being told to do so)”

    Gabrielle A. Carlson, MD, Michael Potegal, PhD, David Margulies, MD, Joann Basile, RN, BA, and Zinoviy Gutkovich, MD Liquid Risperidone in the treatment of rages in psychiatrically hospitalized children with possible bipolar disorder Bipolar Disord. 2010 March; 12(2): 205–212.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2990969/#R23

  10. “Media blackout”

    Ask your doctor why the mainstream media blacks out stuff like the Risperdal story wile playing billions of dollars worth of ask your doctor ads for pharmas latest side effects will kill you pills.

    Hi doctor, I know you live in a cave with no TV or cable and never watch the news so I want to ask you about this new pill I saw on TV… Ever heard of it ?

  11. Paula, thanks for this information. Having served on Vera Sharav’s AHRP board, I was and am well aware of all the volumes of information that appeared on the website there that were never picked up by the “mainstream media”.
    When I think about Dr. Frances and his motivation, it reminds me a little bit of a late-life Come to Jesus motive, yet I don’t think this is it….I think he realizes that “our” voices are only going to get louder, and the shame heaped on the profession will only get greater, so the man is trying to escape his fate. Would that such infamy would also come to the pharmaceutical executives who connived to hide the truth for the sake of profits. But it hasn’t in any way so far. For example, Mitch Daniels, who was Vice President of North American Operations for Eli Lilly during its rollout of Zyprexa, went on to become Governor of Indiana and is now President of Perdue University. His role in what resulted in so many deaths certainly hasn’t held him back in his career, at least thus far.
    As for Risperdal itself, the bottom line for me is always to remember poor little Rebecca Riley, dead from it at age four.