June 2016: European Meeting Re: Psychiatry in Crisis?

Dr. Richard Smith

Dr. Richard Smith

In his article in the BMJ, Psychiatry in crisis? Dr. Richard Smith, former editor of the BMJ (British Medical Journal) summarizes the message delivered by several speakers at a meeting also convened in June 2016. This meeting took place in Leiden, the Netherlands; it focused on some of psychiatry’s serious failings and it was attended by an international group of 400 medical professionals. This meeting was boycotted by the national Dutch organization of psychiatrists.

Dr. Smith begins by citing Professor Gøtzsche, a leading researcher who heads the Nordic Cochrane Centre, the Scandinavian arm of the Collaboration, an independent medical research and information dissemination center. Among his achievements is forcing the European Medicines’ Agency to open up their clinical trial data to independent examination. (Read Access to Clinical-Trial Data, Workshop Report, European Medicines Agency, November 2012)

Professor Peter Gotzsche

Professor Peter Gotzsche

In his recent book, Deadly Psychiatry and Organised Denial (2015), Dr. Gøtzsche strips away the layers of deception about the claimed value of psychotropic drugs; citing published and unpublished data demonstrating that these drugs have caused far more harm than any perceptible clinical good – psychotropic drugs killed 500,000 Americans and Europeans in 2014. Therefore, he contends, “our current usage of psychotropic drugs could be reduced by 98%.

Dr. Gøtzsche’s criticism is buttressed also by a consistent finding over some 40 years: the placebo response in psychiatry’s clinical trials has been getting stronger and the effect of the psychoactive drug weaker, which means the drugs’ efficacy is no better than a placebo. Thus, the significant risks and adverse effects are not justified.

Dr. Smith notes that
Gøtzsche’s attack on psychiatry is profound. The research base of psychiatry is unreliable and corrupted by the pharmaceutical industry. There is little evidence that psychiatric drugs, particularly antidepressants, actually work, and yet the drugs kill through making suicide more likely. The clinical expertise of psychiatrists is unreliable, with psychiatrists not agreeing on diagnoses; and the patients are not listened to–worse they may be locked up against their will. Psychiatry is also guilty of creating “fictitious diseases” like ADHD (Attention Deficit and Hyperactivity Disorder).”

Dr. Smith summarizes the views presented by two European speakers: Jim van Os, a Dutch professor of psychiatric epidemiology, who summarized the evidence base of psychiatry in 25 minutes, beginning by pointing out the absence of any established link between a brain abnormality and a psychiatric diagnosis.  Trudy Dehue, a historian, sociologist, and philosopher of science who pointed out that those who criticize the diagnoses and treatments of psychiatry are not dismissing the suffering of the patients.

Dr. Allen Frances, emeritus professor of psychiatry at Duke University and chair of the committee that produced the DSM IV (issued in 1994) garnered the most favorable consensus at the meeting, having reinvented his role by eradicating his responsibility in accelerating the number of people captured by psychiatry’s web of diagnostic and prescribing practices in accordance with the DSM-IV.

Allen Frances 2It was under Dr. Frances’ stewardship that the DSM-IV vastly increased the number of diagnostic categories from 297 (in 1987) to 374; and the DSM-IV launched three diagnostic epidemics — Autism, Attention Deficit Disorder (ADHD), and childhood Bipolar Disorder. As a result, millions of mostly healthy children have been subjected to psychiatry’s dubious psychotropic drug regimens that have produced serious harm, in many cases, irreversible harm.

Furthermore, an expert witness report commissioned by the Attorney General of the State of Texas and submitted to a federal court (2010) reveals that at the very same time that the DSM-IV was issued, Dr. Frances spearheaded a massive multi-million dollar project calibrating psychiatric diagnoses to propel blockbuster sales of Risperdal, a powerful and dangerous psychotropic drug marketed by Johnson & Johnson.

Since the beginning of 2009, Dr. Frances has assumed the role of a staunch advocate for high scientific standards of research methodology in psychiatry and accuracy in the presentation of its research findings. He began to voice criticism against the DSM-5 task force by contrasting its shortcomings with what he described as the scientific rigor of his DSM-IV and DSM-IV-TR task force. However, the newly fabricated image that Dr. Frances has painted of himself is sharply contradicted by the eye witness report by Dr. David Rothman, Professor of Social Medicine and Director of the Center for the Study of Science and Medicine, Columbia University College of Physicians and Surgeons., a specialist in the ethics of collaborative relationships between medicine and industry. Dr. Rothman relied on internal, confidential J&J documents that shed light on the corrupt practices not only of J&J but of prominent academic collaborators.

Dr. Rothman reported that in 1995, the very year after DSM-IV was disseminated, J&J had paid more than half a million dollars to Dr. Frances and two of his colleagues to create a seemingly official document as the basis for promoting the company’s new drug, Risperdal (risperidone). The following year, the drug company paid them almost another half million dollars to continue expanding the marketing campaign.

Dr. David Rothman, Professor Columbia University, Pres. Institute of Medicine as a Profession

Dr. David Rothman, Professor Columbia College of Physicians & Surgeons, Pres. Institute of Medicine as a Profession

Dr. David Rothman Report:

“As one of its first activities, and in disregard of professional medical ethics and principles of conflict of interest, in 1995, J & J funded a project led by three psychiatrists at three medical centers (Duke, Cornell, and Columbia) to formulate Schizophrenia Practice Guidelines. From the start, the project subverted scientific integrity, appearing to be a purely scientific venture when it was at its core, a marketing venture for Risperdal. In fact, the guidelines produced by this project would become the basis for the TMAP algorithms, giving a market edge to the J&J products in Texas.”(emphasis in original)

Three psychiatrists, Dr. Allen Frances, Chairman of the Department of Psychiatry, Duke University, Dr. John P. Docherty, Professor and Vice Chairman of Psychiatry, Cornell University, and Dr. David A. Kahn, Associate Clinical Professor of Psychiatry, Columbia University, took the lead in designing and developing the Tri-University guidelines.

Dr. Frances negotiated the agreement with J&J (November 1995), to set forth the Schizophrenia Practice Guidelines. The project would employ three questionnaires to establish the guidelines: one went to academic experts, one to clinicians, and one to policy experts. [..] Dr. Frances wrote J&J: “This is new to us and requires additional discussion. The panel members would include mental health commissioners, community mental health directors, state hospital directors, managed care medical directors, pharmacy directors, NAMI representatives, experts in pharmoeconomics, and so forth.”

These were precisely the constituencies that J&J was eager to influence. J&J was the exclusive supporter of the project, dividing an “unrestricted” grant of $450,000 among the three schools. It further agreed to a $65,000 bonus incentive payment if the team was timely with its product. The team met the requirement, requested the additional payment, and received it.

The guideline team promised wide distribution of its product, including publication in a journal supplement. The team was prepared to have J&J participate in its work, not keeping the company even at arms length. With a disregard for conflict of interest and scientific integrity, the group shared its drafts with J&J. On June 21, 1996, Frances wrote Lloyd [J&J Director of Reimbursement] : “We are moving into the back stretch and thought you would be interested in seeing the latest draft of the guideline project… Please make comments and suggestions.” So too, the group was eager to cooperate with J&J in marketing activities. Frances wrote without embarrassment or equivocation: “We also need to get more specific on the size and composition of the target audience and how to integrate the publication and conferences with other marketing efforts.”

Indeed from the start J&J had made it apparent to the team that this was a marketing venture. In a letter to Frances, Lloyd set forth what he called an “aggressive time line” for the project, and added: “There are a number of other Treatment and Practice Guidelines for schizophrenia being developed or published during this same period that may well serve our marketing and implementation needs at a substantial lesser cost.”

“Not only were Frances, Docherty, and Kahn ready to violate standards of conflicts of interest in mixing guideline preparation with marketing for J&J, but also in publicizing the guidelines in coordination with J&J. The three men established Expert Knowledge Systems [EKS]. The purpose of this organization was to use J&J money to market the guidelines and bring financial benefits to Frances, Docherty, and Kahn.

EKS wrote to Janssen on July 3, 1996 that it was pleased to respond to its request to “develop an information solution that will facilitate implementation of expert guidelines.” It assured the company: “We are also committed to helping Janssen succeed in its effort to increase its market share and visibility in the payor, provider, and consumer communities.” Now that the “first phase” was completed, with guidelines created, “EKS is now ready to move forward in a strategic partnership with Janssen.” The strategy will allow Janssen to influence state governments and providers… Build brand loyalty and commitment with large groups of key providers around the country.”

EKS also promised “rapid implementation,” with particular attention to having an impact on Texas decision making. “It is our intent to work with the State of Texas immediately in implementing this product in a select number of CMHC’s with the assistance of A. John Rush, MD.” Again, EKS emphasized: “It is essential for Janssen to distinguish Risperidone from other competitors in a timely and creditable way.” In its Summary of the document, EKS wrote: “Your investment in the development of state of the art practice guidelines for schizophrenia is already beginning to pay off in terms of positive exposure in the Texas implementation project.”

The costs for these various activities included: $250,000 for “educational conferences;” and dissemination of publication at $177,659. J&J agreed to them. So all told, J&J paid at least $942,659 on the production and marketing of the Tri-University guidelines.

On July 18, 1996, as the project was coming to a close, Lloyd [J&J Director of Reimbursement] wrote Frances to express his delight with the way the project had turned out:”How we work together as a team to insure their [guideline] delivery and implementation will be critical…to J&J this was a venture to help Risperdal expand its market. And so t was in all too many ways to the Tri-University leaders. As Frances wrote Lloyd: “We also need to get more specific on…how to integrate the publication and the conferences with other marketing efforts.”

J&J took great credit internally for the Tri-University guidelines…J&J turned the guidelines into a powerful marketing tool…although the front piece for the guidelines described them as ‘suggestions for clinical practice,’ from J&J’s perspective, they provide ‘credibility; Reinforces RISPERDAL’s 1st line status; Differentiates RISPERDAL from convention APA and other atypical APS.’ J&J also funded CME [continuing medical education] offerings to publicize the guidelines, including ‘Free ½ Day Seminars, Earn up to 8 Hours of CE/CME.’ The panel of experts included Frances, Doherty, and Kahn, and also John Rush (who would play a key role in TMAP [Texas Medication Algorithm Project]

The guidelines were published in the Journal of Clinical Psychiatry (1996) Supplement. The Journal acknowledged that the supplement was supported by an unrestricted educational grant from J&J…Tri-University was the first of the guideline strategies that J&J deliberately, and at substantial expense, pursued. J&J next gave funding to [ ] TMAP, again looking to increase the sales of Risperdal…J&J effectively applied both the substance of Tri-University and the tactics that worked so well there to TMAP.”

(Read David Rothman Expert Witness Report. 2010. Available at: PsychRights and 1Boring Old Man; read also, AHRP post (2011)

Hidden in plain sight: But is it a case of “Strategic ignorance”?
This report documents the collaboration between Johnson & Johnson and pivotal prominent academic psychiatrists who were situated in high positions of authority; who used their positions to facilitate the most ambitious, clinically irresponsible, drug marketing scheme ever devised. How is it then that this document has not received attention from either the media or commentators in the medical journals who call for “transparency” and research integrity? Why are some collaborators given a pass after having received approximately one million dollars, without ever being confronted about their role in a prescribing scheme that continues to undermine the mental and physical health of millions of mostly healthy adults and children?

Read also, Dr. Paula Caplan, “Diagnosisgate: Conflict of Interest at the Top of the Psychiatric Apparatus,” 2015; Dr. Frances’ disingenuous response to Dr. Caplan on the Huffington Post in which he never addressed, or mentioned the stinging condemnation his conduct received in the Rothman report.

Read also Phil Hickey, PhD. Allen Frances Names and Shames the Power Players, but Not Himself, Behaviorism & Mental Health, 2015

Richard Smith: Psychiatry in crisis? 4 Jul, 16 | BMJ

Peter Gøtzsche, a Danish physician and researcher, has written a book arguing that 97% of psychiatric drugs cause more harm than good. Allen Frances, emeritus professor of psychiatry at Duke University and chair of the committee that produced DSM IV, says that 70% of Gøtzsche’s book is right but the big problem is that patients with serious psychiatric illness are being abandoned while many people with minor problems are overtreated. Both were speaking at a meeting in Leiden last week to celebrate 50 years of Geneesmiddelenbulletin, a journal that provides independent advice on prescribing.

The Dutch national organisation of psychiatrists boycotted the meeting and emailed their members saying they should not attend because the meeting was antipsychiatry, antiscience, and bad for patients. Yet there were some 40 Dutch psychiatrists in an audience of 400, and two of the speakers were Dutch psychiatrists.

Dutch psychiatrists, it was explained to me, are feeling vulnerable because there are too many of them. They have two treatments to offer–drugs and psychotherapy. But the Netherlands has many clinical psychologists, and they have taken over the psychotherapy. Psychiatrists are left with drugs and anxiety about their future.

Gøtzsche’s attack is profound. The research base of psychiatry is unreliable and corrupted by the pharmaceutical industry. There is little evidence that psychiatric drugs, particularly antidepressants, actually work, and yet the drugs kill through making suicide more likely. The clinical expertise of psychiatrists is unreliable, with psychiatrists not agreeing on diagnoses; and the patients are not listened to–worse they may be locked up against their will. Psychiatry is also guilty of creating “fictitious diseases” like ADHD (Attention Deficit and Hyperactivity Disorder).

Jim van Os, a Dutch professor of psychiatric epidemiology, summarised the evidence base of psychiatry in 25 minutes, beginning by pointing out the absence of any established link between a brain abnormality and a psychiatric diagnosis. Frances later said that neuroscience and neurogenetics are exciting areas of science but have not benefited even one psychiatric patient. What we do know, said van Os, is that many people are mentally vulnerable, that there is real need. (Trudy Dehue, a historian, sociologist, and philosopher of science who has been booed by psychiatrists, pointed out that those who criticise the diagnoses and treatments of psychiatry are not dismissing the suffering of the patients.)

Problems arise, continued van Os, when we try to classify the vulnerability. Frances said how when producing DSM IV the task force had adopted a very high evidence hurdle for agreeing a new diagnosis. They had 94 proposals but accepted only two, both of which, he added, turned out to be “disasters.” The DSM V task force started with a blank sheet, which could have been useful if they’d agreed a high evidence hurdle for a diagnosis. Instead, they have created many new diagnoses driven not by the pharmaceutical industry, said Frances, but by the “intellectual conflicts of interest” of the members of task force. By intellectual conflict of interest he means commitment to their own research, theories, ideas, and experience. But once the diagnoses are there the industry moves in fast.

We know, continued van Os, that “one size does not fit all” and there is great heterogeneity among the patients within a diagnosis and in how patients respond to treatment. At a group level almost all psychiatric treatments have a small positive effect, but the group response hides the heterogeneity.

One consistent finding with the evidence is that over some 40 years the placebo response has been getting stronger and the effect of the psychoactive drug weaker, meaning the difference has diminished. This may be because less sick people are being treated and included in trials. Another consistent finding is that drugs plus psychotherapy works better than either treatment alone. The intensity of treatment is also important, with, for example, 12 sessions of psychotherapy being more effective if delivered twice a week rather than once a week. The quality of the relationship between the doctor and the patient is also crucial, with a good relationship meaning not only that talking treatments are more effective but also drug treatments. A placebo delivered in a good relationship may be as effective as an active drug delivered in a poor relationship.

Gøtzsche agrees that psychotherapy can be effective, even, he believes, with severely psychotic patients. Perhaps psychiatry has been diverted by being too concerned with drug treatments, particularly when, as we heard in the morning’s session of the conference, drug companies have pursued a mission of increasing the number of people taking their drugs rather than producing more effective drugs.

Now, said Frances, the worried well are being treated on a huge scale while this is the worst time ever to be severely mentally ill in the US. About a fifth of the population in the US is taking a psychoactive drug but perhaps 4-5% are really sick. The privatisation of services for the severely ill has meant that many, some 300 000 patients, have ended up in prison or on the streets; and in prison it is the psychotic who end up in solitary confinement (the worst thing possible for a seriously ill patient) or being raped. The UK, warned Frances, is going the same way.

Psychiatrists may have forgotten, he suggested, that the brain is the most complicated thing in the universe. Schizophrenia may be a 1000 different conditions, as may Alzheimer’s disease and other psychiatric conditions. Changing diagnostic criteria means, said Frances, that they are getting closer and closer to normal. Some 105 genes have been associated with schizophrenia, but these findings are unlikely to lead to better treatments. Personalised medicine, he said, is a marketing term.

Hippocrates, said Frances, made his statement of “first do no harm” to counter overtreatment and cruel treatments happening elsewhere in Greece. The history of medicine and psychiatry is filled with ineffective and often cruel treatments. A third of patients, he said, will recover without treatment, and another third will not respond to treatment. Doctors must be prognostications and treat the middle third, avoid treating those who will recover untreated, and help as much as possible, perhaps through social support, those who do not respond.

The audience was left with the impression that Gøtzsche may have overdone his condemnation of psychiatry but that his attack needed to be taken seriously. Psychiatry seems to have lost its way, as, I believe, has all of medicine. The response should not be to refuse to listen to criticisms, as the Dutch organisation for psychiatrists advised, but to listen to and use them as a stimulus to deep examination of current practice.

Richard Smith was the editor of The BMJ until 2004.
Competing interest: RS chaired the day’s meeting and had his expenses paid (at least he hopes he will).

Addendum: In light of the effort by child psychiatrists to resuscitate the aggressive TMAP algorithm prescribing guidelines for children; a recommendation which was articulated by the President-elect of the American Academy of Child ad Adolescent Psychiatry at the June meeting of the American Psychiatric Association, I think that those who regard Professor Gøtzsche’s critique of psychiatry’s prescribing methods as “overdone” do not grasp the magnitude of harm those methods produce!