Paula J. Caplan Ph.D.
October 30, 2015
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” 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.
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, 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.
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Read More At: MadInAmerica.com
 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
 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.