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The Mental Health Reform Act of 2016 (SB 2680) Would Be a Huge Step Backwards

On July 6, HB 2646 (the Tim Murphy Bill) passed the US House and was sent to the Senate.

At the present time, a related bill is working its way through the Senate.  This is SB 2680, The Mental Health Reform Act 2016.  It is sponsored by Lamar Alexander (R-TN), Patty Murray (D-WA), Bill Cassidy (R-LA), Chris Murphy (D-CT), David Vitter (R-LA), and Al Franken (D-MN).  The wording of the bill was finalized in March of this year, and it passed out of committee on March 16.

There is a good measure of bi-partisan support for this bill in the Senate, and if it makes it to the floor it could pass.  If that were to happen, it would likely be reconciled with the Tim Murphy House resolution, and a reconciled version would be enacted.

SB 2680 purports to provide desperately needed help to suffering Americans but is in reality a thinly-disguised tool to expand the scope of psychiatric “care”, with all the drugging, death, damage, and destruction that this entails.

On March 16, 2016, the Committee on Health, Education, Labor, and Pensions issued a press release titled:  The Mental Health Reform Act of 2016 will help Americans suffering from mental health and substance use disorders.  Here are some quotes, interspersed with my comments and observations.

“The Senate health committee today passed legislation to help address the country’s mental health crisis and help ensure Americans suffering from mental illness and substance use disorders receive the care they need.”

Note the term “mental health crisis”.  There is indeed a crisis in the mental health business.  The crisis derives from psychiatry’s spurious and self-serving premise that all significant problems of thinking, feeling, and/or behaving are brain illnesses that are correctable by psychiatric drugs.  This false premise, avidly promoted by pharma, is the cornerstone of the psychiatric-pharmaceutical industry, and is the primary reason that psychiatric drug use in America has reached epidemic proportions.

The fact that these so-called illnesses are so vaguely defined makes it easy for pharma-psychiatry to rope in new recruits.  But the maw of greed can never be satisfied, and pharma-psychiatry continues to lobby for more.  Every undrugged person is money down the drain!

For decades, psychiatry has been inventing new “illnesses” and liberalizing the criteria for others, and it is clear that their objective in all this is to make their so-called mental illnesses as prevalent as the common cold:  everyone gets one from time to time, and psychiatry has “safe and effective treatments”.  There’s no need to suffer – just take a pill or a high-voltage electric shock to the brain.  And keep coming back!

Back to the press release:

“‘One in five adults in this country suffers from a mental illness, and nearly 60 percent aren’t receiving the treatment they need,’ said Senate health committee Chairman Lamar Alexander (R-Tenn.).”

It is a logical and mathematical axiom that one can’t quantify what one can’t define.  But even if we set aside the inanity of these oft-touted statistics, it is clear that vast numbers of Americans who could get a “diagnosis” and a prescription for pills at their local mental health center, choose, wisely, I suggest, not to avail themselves of this “service”.  To Senators Alexander, Murray, Cassidy, Murphy, Vitter, and Franken, however, all of whom, incidentally, have received campaign money from the pharmaceuticals/health products industry, this is a national tragedy – a crisis, no less, that has to be corrected through legislative action.

“‘This bill will help address this crisis by ensuring our federal programs and policies incorporate proven, scientific approaches to improve care for patients.'”

“Proven, scientific approach” means more pharma-funded psychiatric research, with ever more opportunities for over-stated conclusions and even out-and-out fraud.

Senator Murray points out that the bill, if enacted, “…would help expand access to quality care, and make sure that patients receive coordinated mental and physical health care.”

Note again the emphasis on expanding care.  Also note the promotion of co-ordination with physical (i.e. real) medicine; read:  a mental health liaison worker in every GP’s office.  The APA has been pushing this idea for years.  The idea is that one goes to see one’s GP for a bad cough, is “screened” for mental health issues, and comes away with an antibiotic for the cough and an antidepressant for some vague psychosocial concerns.

The press release continues in the same vein.  All the old chestnuts are there, e.g.:

“This bill is an important step in the road to recovery for the 44 million Americans who suffer from a serious mental illness.”

“…our broken mental health care system…”

“…we allow those with mental illness to fall through the cracks.”

“…families struggling to get a loved one the help they need.”

“…prevent suicide…”

“…provide mental health awareness for teachers and others…”

“…evidence-based approaches…”

etc.

DISCUSSION

SB 2680 is littered with platitudes, and for this reason, there is a danger that many of its provisions might be seen as benign, and even desirable.

For instance, the bill calls for the identification of

“…strategic priorities, goals, and measurable objectives for mental and substance use disorder activities and programs operated and supported by the Administration, including priorities to prevent or eliminate the burden of mental illness and substance use disorders;”

and

“…to improve services for individuals with a mental or substance use disorder…”

and

“…ensure that programs provide, as appropriate, access to effective and evidence-based prevention, diagnosis, intervention, treatment, and recovery services…”

etc.

All of these proposals seem positive and helpful, but the bill is solidly rooted in psychiatry’s spurious medical model.  Psychiatric concepts and language permeate the text.  The term “mental illness” is routinely used as if it had the same ontological significance as real illness.

To convey the general tone and thrust of the bill, here’s the full text of Sec 502, which pertains to child psychiatry:

SEC. 502. TELEHEALTH CHILD PSYCHIATRY ACCESS GRANTS.

(a) In General.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Administrator of the Health Resources and Services Administration and in coordination with other relevant Federal agencies, may award grants through existing health programs that promote mental or child health, including programs under section 330I, 330K, or 330L of the Public Health Service Act (42 U.S.C. 254c-14, 254c-16, 254c-18), to States, political subdivisions of States, and Indian tribes and tribal organizations (for purposes of this section, as defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b)) to promote behavioral health integration in pediatric primary care by—”

Translation:  The Federal Government may award grants to promote the embedding of psychiatric concepts and practices into pediatric primary care by:

“(1) supporting the development of statewide or regional child psychiatry access programs; and

 (2) supporting the improvement of existing statewide or regional child psychiatry access programs

(b) Program Requirements.—

(1) IN GENERAL.—To be eligible for funding under subsection (a), a child psychiatry access program shall—

(A) be a statewide or regional network of pediatric mental health teams that provide support to pediatric primary care sites as an integrated team;

(B) support and further develop organized State or regional networks of child and adolescent psychiatrists to provide consultative support to pediatric primary care sites;”

Note:  “networks” of psychiatrists advising and supporting pediatricians!  What kind of advice do you think these networks of psychiatrists will provide?

“(C) conduct an assessment of critical behavioral consultation needs among pediatric providers and such providers’ preferred mechanisms for receiving consultation and training and technical assistance;

(D) develop an online database and communication mechanisms, including telehealth, to facilitate consultation support to pediatric practices;

(E) provide rapid statewide or regional clinical telephone consultations when requested between the pediatric mental health teams and pediatric primary care providers;

(F) conduct training and provide technical assistance to pediatric primary care providers to support the early identification, diagnosis, treatment, and referral of children with behavioral health conditions and co-occurring intellectual and other developmental disabilities;”

What kind of training do you think these access programs will be providing to pediatricians?  Facile “diagnostic” checklists?  Treatment guidelines that recommend neuroleptic drugs for 3-year-olds who display temper tantrums?  The thinly-hidden agenda here is to erode whatever resistance remains among pediatricians to psychiatric orthodoxy, and bring them on board the great psychiatric drugging bonanza.

“(G) inform and assist pediatric providers in accessing child psychiatry consultations and in scheduling and conducting technical assistance;

(H) assist with referrals to specialty care and community and behavioral health resources; and

(I) establish mechanisms for measuring and monitoring increased access to child and adolescent psychiatric services by pediatric primary care providers and expanded capacity of pediatric primary care providers to identify, treat, and refer children with mental health problems.”

In other words, the Feds will be checking to make sure that they’re getting value for their money in the form of more children drugged.

“(2) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection, the term “pediatric mental health team” means a team of case coordinators, child and adolescent psychiatrists, and a licensed clinical mental health professional, such as a psychologist, social worker, or mental health counselor. Such a team may be regionally based.

(c) Applications.—A State, political subdivision of a State, Indian tribe, or tribal organization that desires a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including a plan for the comprehensive evaluation and the performance and outcome evaluation described in subsection (d).

(d) Evaluation.—A State, political subdivision of a State, Indian tribe, or tribal organization that receives a grant under this section shall prepare and submit an evaluation to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require, including a comprehensive evaluation of activities carried out with funds received through such grant and a performance and outcome evaluation of such activities.

(e) Access To Broadband.—In administering grants under this section, the Secretary may coordinate with other agencies to ensure that funding opportunities are available to support access to reliable, high-speed Internet for providers.

(f) Matching Requirement.—The Secretary may not award a grant under this section unless the State, political subdivision of a State, Indian tribe, or tribal organization involved agrees, with respect to the costs to be incurred by the State, political subdivision of a State, Indian tribe, or tribal organization in carrying out the purpose described in this section, to make available non-Federal contributions (in cash or in kind) toward such costs in an amount that is not less than 20 percent of Federal funds provided in the grant.

The meaning and intent of Sec 502 is absolutely clear:  if this legislation passes, Congress is going to pour money and resources into providing more psychiatric care to children.

And how do psychiatrists provide care for children?  They drug them.

THE EMPIRE IS FIGHTING BACK

In the past ten years or so, opposition to psychiatry’s medicalization of virtually every human problem has been growing.  As the venerable and prestigious psychiatric leader Jeffrey Lieberman, MD, has lamented on more than one occasion, psychiatry is the only medical speciality that has its own anti group.  And of course, as we all know, there are very good reasons for this.

We also know that American psychiatry as a whole has been extraordinarily unreceptive to any kind of criticism.  Indeed, their response has been to double down – to assert with increasing vigor that their concepts are sound, their research valid, and their practices helpful and benign.

They have also hired a renowned PR firm and have been lobbying hard in political circles.  SB 2680 and the Tim Murphy House bill are the result of these endeavors.

This is the hidden face of psychiatry, using the legal machinery to push its pernicious concepts and practices deeper and deeper into the lives and institutions of the American people, with increasingly disastrous results.

Incidentally, the sponsors of SB 2680 received the following sums of money from the pharmaceutical/health products industry during the current election cycle (source: OpenSecrets.org):

            Lamar Alexander        $452,548

            Patty Murray               $542,778

            Bill Cassidy                 $234,502

            Chris Murphy              $121,876

            Al Franken                  $131,088

            David Vitter                   $7,850

If you live in the US, please ask your Senators to oppose SB 2680.  Tell them that we don’t need any more psychiatric drugging, particularly of our children!

Allen Frances ‘Replies’

BACKGROUND

On June 19, 2015, I published a post titled Allen Frances’ Ties to Johnson & Johnson.  In that post, I set out some very serious allegations against Dr. Frances.  I drew these allegations from a document titled Special Witness Report dated October 15, 2010.  The report was written by David Rothman, PhD, Professor of Social Medicine at Columbia College of Physicians and Surgeons.

Dr. Rothman’s report was produced in the context of a lawsuit filed by the State of Texas against Janssen Pharmaceutica, a subsidiary of Johnson & Johnson.

The allegations against Dr. Frances and two other psychiatrists, John Docherty, MD, and David Kahn, MD, arise from their production of an expert consensus schizophrenia treatment guidelines document.  The essential allegation is that Dr. Frances and his two partners violated, to a marked extent, the ordinary standards regarding conflicts of interest in the preparation and publicizing of the guidelines.

I quoted some passages from Dr. Rothman’s article, perhaps the most telling of which is the following:

“EKS [i.e., Drs. Frances, Docherty, and Kahn] wrote to Janssen on July 3, 1996 that it was pleased to respond to its request to ‘develop an information solution that will facilitate the 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.’”  [Emphasis added]

Paula Caplan, PhD, a clinical and research psychologist, and an Associate at Harvard’s DuBois Institute, had written an earlier article on this topic in Aporia.  Dr. Caplan had titled her article Diagnosisgate: Conflict of Interest at the Top of the Psychiatric Apparatus, and on March 6, 2015, Dr. Frances had published a very weak and ineffective rebuttal titled ‘Diagnosisgate’ Deconstructed and Debunked

. . . . . . . . . . . . . . . . 

Last Sunday, June 21, 2015, Dr. Frances tweeted to  me:  “Setting the record straight on careless claims” with a link to his earlier rebuttal.

So, to set the record straight:

Dr. Frances’s rebuttal did not address a single issue from the David Rothman report, and his tweeted claim that the rebuttal set the record straight is nothing short of fanciful. 

In my article, I challenged Dr. Frances to respond to two questions:

  1. Are the allegations against him and his EKS partners that are set out in detail in the David Rothman report accurate?
  1. Are the quotations in that report that are attributed to Dr. Frances accurate?

This challenge still stands.

The allegations against Dr. Frances are extremely serious, and in my view, comparable misconduct in reputable professions would result in censure, or even expulsion.  But with very few exceptions, the silence from psychiatry on this issue has been deafening, even though the David Rothman report has been in the public arena for almost five years.

At the present time Dr. Frances is presenting himself as the champion of moderation, and he routinely lays the blame for the overuse of psychiatric drugs on pharma marketing and on general practitioners.  But he has never, to the best of my knowledge, acknowledged that in the preparation and dissemination of the Tri-University Guidelines, he and his partners formed what they described as a “strategic partnership” with Janssen, and expressed a firm commitment to “helping Janssen succeed in its effort to increase its market share…”  And to guard against any misunderstandings, the issue here is not that Dr. Frances helped Janssen increase its market share.  The issue is that he did this in the guise of producing an objective treatment guidelines document.

Why aren’t psychiatrists screaming in protest?  Where is the outrage and censure?  Is psychiatry truly so intellectually and morally bankrupt that they will turn a blind eye to virtually anything, provided it expands psychiatric turf?

Allen Frances’ Ties to Johnson & Johnson

INTRODUCTION

I recently came across an article titled Diagnosisgate: Conflict of Interest at the Top of the Psychiatric Apparatus, by Paula Caplan, PhD.  The article was published in Aporia, the University of Ottawa nursing journal, in January 2015.  Aporia is “a peer-reviewed, bilingual, and open access journal dedicated to scholarly debates in nursing and the health sciences.”

Dr, Caplan is a clinical and research psychologist, and an Associate at Harvard’s DuBois Institute.  She worked as a consultant to the DSM-IV task force in the 1980’s, but resigned from this position after two years.    Here’s a quote from her February 2014 post on Mad in America The Great “Crazy” Cover-up: Harm Results from Rewriting the History of DSM:

“In the late 1980s, I was a consultant to two committees appointed by DSM-IV Task Force head Allen Frances to decide what DSM-IV should contain. I resigned from those committees after two years because I was appalled by the way I saw that good scientific research was often being ignored, distorted, or lied about and the way that junk science was being used as though it were of high quality . . . if that suited the aims of those in charge. I also resigned because I was increasingly learning that giving someone a psychiatric label was extremely unlikely to reduce their suffering but carried serious risks of harm, and when I had reported these concerns and examples of harm to those at the top, they had ignored or even publicly misrepresented the facts.”

Dr. Caplan has also written a brief synopsis of the Diagnosisgate article here.

PSYCHIATRISTS FOR HIRE

The central theme of Dr. Caplan’s 2015 article is that in 1995, Allen Frances, MD,  and two other psychiatrists (John Docherty and David Kahn) received grants of about $515,000 from Johnson & Johnson to write “Schizophrenia Practice Guidelines” which specifically promoted Risperdal (a Johnson & Johnson product) as the first line of treatment for schizophrenia.  The guidelines were called the “Tri-University Guidelines” in recognition of the fact that Dr. Frances worked at Duke, Dr. Docherty at Cornell; and Dr. Kahn at Columbia.  Subsequently, the three psychiatrists formed Expert Knowledge Systems, and from that platform, actively assisted Johnson & Johnson in the implementation and marketing of the guidelines.  For these latter services, J & J paid EKS a further $427,659.

The role of the three psychiatrists came to light because in 2004, the State of Texas filed a lawsuit against Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, alleging that  company officials “targeted Texas Medicaid with their sophisticated and fraudulent marketing scheme” (here) to ensure that Risperdal was included in the state’s preferred drug list.

During these proceedings, an expert witness report was presented to the court by David Rothman, PhD, professor of Social Medicine at Columbia University College of Physicians and Surgeons.  The report is titled simply “Expert Witness Report” and is dated October 15, 2010.  The report, which can be found here, runs to 86 pages, and is meticulously detailed.

Here are some quotes from Dr. Caplan’s article:

“Allen Frances, arguably the world’s most powerful psychiatrist, spearheaded a massive, million-dollar project using psychiatric diagnosis to propel sales of a potent and dangerous drug by pharmaceutical giant Johnson & Johnson (J & J). Frances began the initiative in 1995, but his involvement has been little known, despite a court document written in 2010 that revealed what its author [David Rothman, PhD], an ethics specialist, called serious deception and corruption in that project.”

“According to the court document, Frances led the J & J enterprise that involved distortion of scientific evidence, conflicts of interest, and other illegal and unethical practices.”

“Rothman reported that, in 1995, the very year after DSM-IV appeared, Johnson & Johnson had paid more than half a million dollars (USD) to Frances and two of his psychiatrist colleagues to create an official-seeming document as the basis for promotion of one of their drugs. The following year, the drug company paid them almost another half million dollars to continue and expand the marketing campaign.”

“According to the Rothman report, Frances and his colleagues wrote guidelines that were designed specifically to persuade physicians to prescribe J & J’s drug Risperdal as the first line of treatment for schizophrenia.”

Here are some quotes from David Rothman’s report:

“In 1993, GTFH Public Relations echoed what State and Federal Associates [another PR company] had recommended the year before.  It, too, emphasized the need [for J & J]to cultivate state officials along with members of the psychiatric community…GTFH also emphasized that J&J should be convening Expert Task Force Meetings: ‘Formulate position and draft guidelines for consensus…Use: ‘Personalized invitational campaign to maximize participation.’…Finally, it counseled J&J to ‘Form exclusive partnership with growing advocacy group,’ citing NAMI as one case in point. J&J should help establish chapters and co-sponsor educational programs on patient issues…”(pp 13-14) [Emphasis added]

Note that one of GTFH’s recommendations was to “…draft guidelines…”

“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 [Texas Medication Algorithm Project] algorithms, giving a market edge to the J&J products in Texas.” (p 14)

The production of the practice guidelines involved polling a selected sample of expert psychiatrists, and collating their questionnaire responses.

“The guideline team [Drs. Frances, Docherty, and Kahn] 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 [John Lloyd, J&J’s Director of Reimbursement Services]:  ‘We are moving into the back stretch and thought you would be interested in seeing the latest draft  of the guidelines project….Please make comments and suggestions.‘  (Italics added).  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”  (Italics added)…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.’…” (p 15)

“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.” (p 15)

“EKS [i.e., Drs. Frances, Docherty, and Kahn] wrote to Janssen on July 3, 1996 that it was pleased to respond to its request to ‘develop an information solution that will facilitate the 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 the 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 implementations,’ 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 [Risperdal] 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.’…” (p 15-16) [Emphasis added]

Back to Paula Caplan’s article:

“On August 30, 2012, Texas Attorney General Abbott issued a press release to announce that Texas and 36 other states had together reached a settlement in which Janssen was to pay the states a total of $181 million because of its ‘unlawful and deceptive marketing.’  Here there appears another mystery: Interestingly, nowhere in either the filing or the press release did the names of Frances, Docherty, or Kahn appear, although their deceptive guidelines were the foundation for the enterprise, nor did they include the names of the other psychiatrists whom Janssen had hired to carry out the deceptive acts. Furthermore, they did not include information about harm done to the individuals who had been prescribed Risperdal.”

“Papers impelled by J & J were published in scholarly journals and, as Rothman reports, ghost-written by individuals selected by J & J, with high-profile names affixed as first authors after the articles had been written. These papers helped promote use of Risperdal 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. Subsequent to the production and marketing of the Tri-University Guidelines came the FDA approval of Risperdal to treat adults and then children diagnosed with Bipolar Disorder, and finally children diagnosed with Autism.”

And another quote from David Rothman:

“J&J turned the guidelines into a powerful marketing tool.  The slides presented at a CNS National Sales Meeting in March 1997, instructed employees to use the guidelines to convince its ‘Primary customers: P & T members [Pharmacy and Therapeutics committees], Formulary Decision Makers and Psychopharmacologists’ – those who made purchasing and reimbursement decisions – that they should use the guidelines to justify making Risperdal the drug of choice.…J&J also wanted the guidelines to promote the product’s use among ‘Secondary Customers,’ namely ‘Physicians who are not convinced of RISPERDAL’s 1st line status.’  So 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[al] APS [antipsychotics] and other atypical APS.’  To make certain the customers got the message, the ‘Full Supplement [of the guidelines publication] should be left behind.’  J&J also funded CME offerings to publicize the guidelines, including a ‘Free ½ Day Seminars, Earn Up to 8 Hours of CE/CME.’  The panel of experts included Frances, Docherty, and Kahn, and also John Rush (who would play a key role in TMAP).  http://web.archive.org/web/19961106071503/www.ibh.com/expert1.htm” (p 17)

. . . . . . . . . . . . . . . . 

What’s particularly noteworthy in all of this is that since about 2010, Dr. Frances has been critiquing the obviously expansionist agenda of DSM-5, and the corruptive role of pharma in disease-mongering, and in the increasing over-use of psychiatric drugs.

In this context, he presents himself as the defender of moderation and scientific integrity, but, to the best of my knowledge, he has never publicly acknowledged his marketing role  with J & J in the creation of the Tri-University Guidelines.

ALLEN FRANCES REPLIES

On March 5, 2015, Dr. Frances did respond to Paula Caplan’s “Diagnosisgate” article.  Here are some quotes from this response, which appeared on the Huffington Post blog.  The quotes are interspersed with my comments.

“…in her usual dramatic and distorted way, Dr. Caplan feels she can score points and gain public attention by exposing a supposed, creatively named, ‘Diagnosisgate.'”

It is my general perception that when people respond to criticism with this kind of personal attack, they have something to hide.

. . . . . . . . . . . . . . . .

“Dr. Caplan, as always, is careless with facts, quick with misinterpretations, and filled with wild accusations. I will first debunk what is simple nonsense in her claims and then discuss the issues that do have a factual basis.”

“It is nonsense to state that my participation in guideline development was in any way a conflict of interest with DSM IV or affected in any way its preparation. The guideline project occurred several years after DSM IV was already in print. The term ‘Diagnosisgate’ is no more than Dr Caplan’s misleading attempt to attract an audience and has no connection to reality.”

There is no suggestion in Dr. Caplan’s article that Dr. Frances’s participation in the guideline development was a conflict of interest with DSM-IV.  In fact, Dr. Caplan notes that J & J’s first payment to Drs. Frances, Docherty, and Kahn occurred the year after DSM-IV was published.  What’s stressed in both Paula Caplan’s and David Rothman’s reports is the fact that Dr. Frances and his two co-founders of EKS actively collaborated with Johnson & Johnson in the marketing of Risperdal, and that the guidelines that they created were clearly designed for this purpose.

. . . . . . . . . . . . . . . .

“It is nonsense to imply that I made a great deal of money from DSM IV sales, which Dr. Caplan states totalled $100 million.”

There is no reference, or even implication, in Dr. Caplan’s article, that Dr. Frances made a great deal of money from DSM-IV sales.  Dr. Caplan mentions the fact that sales of the manual “earned more then $100 million”, but there is no suggestion that Dr. Frances shared in these profits.  Again, what’s stressed in both Paula Caplan’s and David Rothman’s articles is that Dr. Frances and his colleagues made about $900,000 from J & J for producing and marketing the Tri-University Guidelines.

. . . . . . . . . . . . . . . .

“It is nonsense for Dr. Caplan to claim there was ‘data distortion’ in either DSM IV or in the guidelines. Both efforts were the result of completely transparent and forthright processes. Both efforts had very clear and published methodological rules of the road that were conscientiously followed every step of the way.”

The phrase “data distortion” occurs in a sub-heading in Dr. Caplan’s synopsis article, but the phrase does not occur in her main article in Aporia.  So I’m not sure exactly what she had in mind.  But the notion that following one’s own “clear and published methodological rules of the road” guarantees validity and lack of bias is a little naïve.  All that Drs. Frances, Docherty, and Kahn would have to do to skew the results is, firstly, select questionnaire recipients whom they knew favored risperidone, and secondly, word the questions in a way that would tend to elicit the kind of responses that would promote risperidone.  In the published guideline document, the authors state that questionnaire participants were selected from several sources:

“…recent research publications and funded grants, the DSM-IV advisers for psychotic disorders, the Task Force for the American Psychiatric Association’s Practice Guideline for the Treatment of Patients with Schizophrenia, and those who have worked on other schizophrenia guidelines.” (p 2)

From this – obviously very large group – Dr. Frances and his partners selected 99 psychiatrists, 87 of whom responded to the questionnaire.  I can find no information as to how the 99 psychiatrists were selected.

. . . . . . . . . . . . . . . .

“She enjoys being the center of controversy and will always do her best to stir a tempest in a thimble.”

Ah!  That explains everything.

. . . . . . . . . . . . . . . .

But then, Dr. Frances acknowledges some retrospective misgivings:

“But in retrospect, there are two things about the project I much regret. Firstly, it was very unwise to do guidelines with drug industry funding. Even though they were fairly done, accurately reported, and contained built in methodological protections against industry-favorable bias, the industry sponsorship by itself created an understandable appearance of possible bias that might reduce faith in the sound advice and useful method contained in them. It was an error in judgment on my part that I apologize for. I have learned from my mistake and hope others do as well.”

So, there was absolutely nothing wrong with the guidelines, but the acceptance of pharma money may have created an appearance of bias.  And although no such bias existed, Dr. Frances is apologizing for creating this appearance.  But remember the EKS commitment quoted earlier:  “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.”  This is a clear statement of  bias.  It’s not an appearance of bias; it’s not possible bias.  It is out and out, unmitigated bias.  They express commitment, not to some improvement in client outcomes or welfare, but to increasing Janssen’s market share.  Drs. Frances, Docherty, and Kahn were hired to market Risperdal.  They were well paid, and they delivered what their employer expected of them.

And incidentally, despite his misgivings, there’s no indication that Dr. Frances has refunded his share of the $900,000 from J & J.  “May one be pardon’d and retain the offence?” (Hamlet, Act 3, Scene 3)

. . . . . . . . . . . . . . . .

“Secondly, I did not at the time anticipate, nor did the experts, that the atypical antipsychotics would be so frequent a cause of obesity and of the serious complications that follow from it. The considerable risks involved in using these new medications, and ways of avoiding these, were then unknown and not covered in the guideline.”

So, he assumed without evidence that the drug was safe unless proven dangerous, when in fact, good practice would be the opposite:  assume that the drug is dangerous, until it’s proven safe!  But, in any event, it wasn’t Dr. Frances’s fault.  After all, who could have known?

PUBLICATION OF THE GUIDLELINES

In 1996, the EKS’s Treatment of Schizophrenia guidelines were published as a 58-page supplement in The Journal of Clinical Psychiatry.  It’s an interesting document, and it certainly does promote the use of Risperdal (risperidone).  But of even more interest is this statement in the preface to the supplement .  It was written by Alan Gelenberg, MD, Editor in Chief of the journal.  Dr. Gelenberg begins the Preface with some words of praise for the guidelines, but also advocates caution with regards to pharma-funded projects:

“…in conditions such as bipolar disorder and schizophrenia, where the primary treatments are medications, industry is a looming presence.  Pharmaceutical companies devote enormous sums to academic departments and individual faculty members who consult, conduct research, and teach under the auspices of the company.  These then are the experts who create consensus guidelines.  While few of us sell our opinions to the highest bidder, fewer still are immune from financial influence.” [Emphasis added]

So Dr. Gelenberg could see these issues very clearly in 1996, when the guidelines were published; but Dr. Frances, despite his mea culpa in the Huffington Post last March, still hasn’t grasped the issue.  In that document, from which I quoted earlier, Dr. Frances contends that the guidelines “…contained built in methodological protections against industry-favorable bias…”.  But as Dr. Gelenberg so clearly points out, the expert consultants on whose opinions the guidelines were based were already subject to industry influence by the very fact of their status within the psychiatric community.  So, in fact, industry-favorable bias was actually built in.

Page 2 of the supplement lists the 87 expert psychiatrists on whose questionnaire responses the guidelines were based.  The list is in alphabetical order, and I checked the first fifteen names for links to pharma.  Two of the fifteen are deceased.  Of the remaining thirteen, nine have disclosed that they have received payments from pharmaceutical companies, and eight of these have received payments from Janssen Pharmaceutica/J & J.

I have no way of checking if these financial links were present in 1995/96 when the guidelines were produced, but the extent of these individuals’ involvement with pharma today suggest that Dr. Gelenberg’s concerns were probably well founded.

. . . . . . . . . . . . . . . .

On the supplement’s sub-cover there is a brief acknowledgement of Janssen’s funding:

“This project was supported by an unrestricted educational grant from Janssen Pharmaceutica.”

The term “unrestricted” has a very specific meaning in this context.  It means that the recipients of the grant are not required to produce any particular result.  Essentially there is an expectation that both grantor and recipient will take steps to keep one another at arms’ length.  The term “unrestricted” is, in a sense, a warranty to the reader that the document in question is free from funder bias.

In the light of the material quoted above, it strikes me that the description “unrestricted” in this case was at best misleading, and possibly a blatant deception.

A CHALLENGE TO DR. FRANCES

If Dr. Frances really wants to put this matter to rest, he needs to answer these questions publicly and unambiguously:

  1. Are the allegations against him and his EKS partners that are set out in detail in the David Rothman report accurate?
  1. Are the quotations in that report that are attributed to Dr. Frances accurate?

If the answer to both of these questions is No, then I suggest that Dr. Frances start devoting his time and energy to addressing these matters, and clearing his name, because the allegations are very serious.

But if the answer to one or both of these questions is Yes, then I respectfully suggest that Dr. Frances exit the stage with whatever dignity he can muster, and resume his well-earned retirement.

AND INCIDENTALLY

Mickey Nardo, MD, has also posted David Rothman’s report on his website, 1 Boring Old Man.  Dr. Nardo has also written a post on this topic.  The post is titled detestable.

. . . . . . . . . . . . . . . .

I have quoted from David Rothman’s report in this post, but I’ve confined my attention to material concerning Dr. Frances and EKS.  In fact, the report covers a lot more ground, and gives a great deal of detail on the pharma-psychiatry corruption that has marred the landscape in this field for so long.  It’s well worth reading.

For instance, here’s an insightful little gem from page 21:

“Shon [Steven Shon MD, Medical Director of the Texas Department of Mental Health and Mental Retardation] was also considered a pivotal figure by another J&J employee, Percy Coard…After thanking his colleagues for attending a Shon presentation, he listed all the reasons why J&J wanted a ‘strategic alliance’ with him.  As Coard explained, Shon was a KOL [key opinion leader], influential in the public sector, where ’85 Percent of all anti-psychotic dollars come from;’ he has influenced and supported the use of new drugs in TMAP [Texas Medication Algorithm Project], and a proactive approach to him ‘to support/partner with his current and future projects in the public sector arena will continue to position Janssen as a true partner in public mental health initiatives.'”

Such a sense of civic responsibility!

. . . . . . . . . . . . . . . .

Robert Whitaker discusses EKS and the Tri-University Guidelines in his latest book, Psychiatry Under the Influence, p 149-150.

FINALLY

And for anyone who has any doubts concerning the effectiveness of pharma-psychiatry’s marketing machine, here’s a graph produced by the Agency for Healthcare Research and Quality (AHRQ), a division of the US Department of Health and Human Services.

AHRQ fig 1 on antipsychotics

So between 1997 and 2007, total expenses for neuroleptic drugs in the US went from $1.7 billion (corrected to 2007 value) to $7.4 billion.  This is an increase of $5.7 billion over and above any increase due to inflation.

The cost of these extra sales in terms of reduced life expectancy and quality of life is psychiatry’s legacy to humanity.

Pharma-funded Research

On August 20, 2014, Psychiatry Advisor published an article on its website.  The article was written by Leslie Citrome, MD, a professor of psychiatry at New York Medical College in Valhalla, NY, and a member of the Board of Directors of the American Society of Clinical Psychopharmacology.  The article is called Is Bias Against Pharma-Funded Research Fair?  This is an interesting title, because bias, by its very definition, is unfair.  So the very wording of the question begs the question – which strikes me as unfair.  But let’s put that aside. 

Dr. Citrome begins by introducing the term “pharmaism” (anti-pharma prejudice).  He tells us that:

“Pharmaism includes the implicit belief that people associated with pharmaceutical companies are more likely to be intellectually and morally dishonest than others.”

He provides two examples of pharmaism:

The fact that medical journals insist on independent statistical analyses of research submitted by pharmaceutical companies.

“…the lay media singling out health-care professionals who earn money by contracting with pharmaceutical companies for professional services…”

Dr. Citrome predicts, with apparent misgivings, that the media’s activities in this area will increase when the Physician Payments Sunshine Act’s provisions take effect on September 30.

So, as you can see, the article is off to a good start.  Medical journals that insist on independent statistical analyses of pharma-conducted research are displaying prejudice against pharmaceutical companies.  And we even have a name for this prejudice – “pharmaism,” akin, presumably to racism.

But, wait!  There’s an important difference.  Racism refers to prejudice or discrimination against another person, or group, based solely on race or skin color.  But medical journals that insist on independent statistical analyses of pharma-conducted research are basing this policy decision on the fact that, in a compellingly large proportion of cases in the past, the statistical analyses of pharma-funded research was flawed.  And, by an extraordinary coincidence, was always flawed in a direction favorable to the company!

What Dr. Citrome is trying to do is rescue both pharma and the psychiatrists who accepted their largesse, from the consequences of their venality.  Psychiatry maintained its corrupt relationship with pharma for decades.  The dynamics were simple.  Pharma provided the money; psychiatry provided the fraudulent research, the medical licenses, and the prescription pads.

But now the hoax has been exposed, and corrective measures have been taken.  And Dr. Citrome is crying:  foul!  You people are just pharmaists!  A nice piece of spin, which, incidentally, in prison populations is called “flip the script”.

To find a psychiatrist using a ploy that is popular among prison inmates is not all that surprising to me.  But, you see, I’m a pharmaist – so what can you expect?

Incidentally, the term pharmaism was actually coined by Dr. Citrome, himself, and James Karagianis, MD.  Here’s a quote from the June 2014 issue of The International Journal of Clinical Practice editorial Pharmaism: a tale of two perspectives, by L. Citrome, et al.

“The term ‘pharmaism’ (or ‘pharmism’) has been used informally by two of us (JK and LC) and we were both surprised and pleased that another person has used it in an editorial…and to the best of our knowledge, marks 2013 as the year that this word has first been used in a scholarly publication.”

So Dr. Citrome and Dr. Karagianis are clearly pleased with themselves for this lexicological invention, and, presumably, with the verbal chicanery that it entails.  Or perhaps they’re blinded by truthism, a prejudicial aversion to facing facts.

Incidentally, Dr. Citrome’s and Dr. Karagianis’s full definition of pharmaism is given in the IJCP document quoted earlier.  Here it is – read carefully:

Pharmaism, definition

1

: a belief that being associated with a pharmaceutical company is the primary determinant of human traits and capacities regarding scientific discourse and that not being associated with a pharmaceutical company produces an inherent superiority regarding moral and intellectual standing free from bias

2

: prejudice or discrimination

This is doctoral level spin, without a doubt.  They begin with the notion that many people are distrustful of pharma-funded/conducted research.  They convert this distrust, which incidentally is well-deserved, into a prejudice, and – and this is the rabbit in the hat – they give it a name and a definition.  But note how the phenomenon of warranted distrust has morphed into something truly obnoxious by the simple expedient of inventing a word and a definition to go with it.  Warranted and appropriate distrust has now become a belief,

“…that being associated with pharma is the primary determinant of human traits and capacities regards scientific discourse…”

Has anyone on this side of the debate said this, or anything even remotely like this?  What we do say is that pharma influence and money has in the past corrupted a great many psychiatrists, in both academia and clinical practice, and that it is prudent to be cautious and skeptical of pharma-funded research and advertizing.  Note that Drs. Citrome and Karagianis don’t dispute this.  Instead, they create this inane caricature of our position, and critique that, as if it reflected the position on this side of the issue.

And the second part of the definition is even worse:

“…not being associated with a pharmaceutical company produces an inherent superiority regarding moral and intellectual standing free from bias”

Again, has anyone said this, or even suggested it?  Certainly pharma’s deep pockets, and their willingness to spread largesse, has created an environment in which a great many psychiatrists have been corrupted.  But the notion that a lack of contact with pharma will produce the opposite result is simply absurd.

But back to the Psychiatry Advisor article.  Dr. Citrome concedes that:

“Some of the attitudes behind pharmaism have origins in the sins of the past. This includes the deliberate withholding of data, questionable promotional tactics, and rewarding high-volume prescribers. Despite substantial changes in how pharmaceutical companies do business, there is much in the way of lingering suspicion that deceptive practices continue unabated.”

Let’s take a look at that last sentence and the embedded link.  Despite “substantial changes in how pharmaceutical companies do business” there is still suspicion of deception.

I suggest that most people reading this would presume that the “changes” mentioned were of the cleaning-up-one’s-act variety.  And, I further suggest that most people on opening the link would expect to find some account of this clean-up, e.g. publishing the results of all trials, rather than cherry picking those with favorable outcomes, making all relevant data available to outside scrutiny, etc…

But actually, this is not the case.  The link is to a brief article in HealthDay News titled Pharma Sales Reps Finding Access to Physicians Increasingly Difficult (author unnamed).  The gist of the article is that according to a report from ZS Associates, a New York-based marketing consulting firm, there has been a steady decline in drug reps’ access to physicians.  The only changes on the part of pharmaceutical reps mentioned in the article is greater reliance on  “digital communication channels.” Rather than on face-to-face visits, which were the norm in the past.

In particular, there is nothing in the article that might be expected to allay the lingering suspicion concerning pharma-funded research.

So what Dr. Citrome has done is imply that pharma has cleaned house, pretended to provide a supporting reference, and then directed criticism at us pharmaists for retaining – in typically bigoted fashion – our lingering suspicions concerning the integrity of pharma researchers and those psychiatrists who sup at the same table.

And then the Crown Jewel:

“Separating the facts from the rhetoric takes some effort…”

Dr. Citrome, that is, indeed, the case!

He then refers us to “…an excellent summary of the issues…”  This links to an article by Thomas Stossel, MD, et al in the June issue of The International Journal of Clinical Practice, After 20 years, industry critics bury skeptics, despite empirical vacuum.  Dr. Stossel is a professor of clinical medicine at Harvard, and a division director at Brigham and Women’s Hospital.

Here’s the conclusion section of that article, quoted in full:

“As this review reveals, the conflict of interest movement has failed to substantiate its central claim that interactions between physicians, researchers and the medical products industry cause physicians to make clinical decisions which are adverse to the best interests of their patients. After 20 years of impugning the motives of industry and demeaning the professional judgment of physicians, the instigators have failed to produce solid evidence of harm commensurate with their extravagant allegations. At the same time, they have diverted resources away from more worthwhile pursuits, such as basic and applied medical research, clinical care and medical education towards onerous compliance exercises and obtrusive laws and regulations. They have propagated an availability cascade that projects the superficially plausible message that the medical products industry is coopting patient care by corrupting physicians and researchers. Perhaps worst of all, they have made it respectable to ignore the epistemological foundations of medical science, diverting attention away from the scientific merit of the information presented and focusing it instead on the identity and motives of those who present the information.”

A full critique of this article would take us too far afield, but the essential points of the piece are:

  1. The conflict-of-interest (COI) movement has not proven that physician ties to industry have actually harmed patients.
  2. The COI movement has created an environment where information is judged more by the motives of the presenter than by its actual merits.

It’s an interesting, if one-sided, article.  Note  some of the language in the conclusion:

  • the “instigators” [in the COI movement];
  • their “extravagant allegations”;
  • “onerous” compliance “exercises”;
  • “obtrusive” laws and regulations;
  • the “superficially plausible” message.

And the image of the COI movement “diverting attention away from the scientific merit of the information presented” is a far cry from the reality – at least in the psychiatric field –where an eminent researcher at a prestigious university is actually on record as promising a pharmaceutical company a positive result for their drug if they would pony up at least $700,000 for a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.

And incidentally, according to an Editorial in Endocrine Practice, November/December 2009:

“Dr. Stossel is a founder and director of, consultant to, and owns stock options in Critical Biologics Corporation to which his employer, Brigham & Women’s Hospital, has licensed his inventions; he is a director of and owns stock options in Velico Medical Corporation to which Brigham & Women’s Hospital has also licensed his inventions; he currently serves as a consultant to Pfizer.”

But getting back to our psychiatrist, Dr. Citrome, it is clear that he loves the article and he finishes with an upbeat quote:

“Consulting for and collaborating with industry to facilitate the development of new treatments, informing practitioners about new treatments, assisting in conducting clinical trials are all activities that can ultimately benefit patients.”

DISCUSSION

The most notable feature of Dr. Citrome’s article is the fact that it got written at all.  Psychiatry’s corrupt relationship with pharma has been a dominant feature of the profession for the past 40 years.  It is a legacy of the most profound shame and ignominy, which psychiatry made no attempt to correct, until outsiders such as Senator Chuck Grassley, of Iowa, who is probably a pharmaist, began to expose these practices.  Pharma-psychiatry corruption was widespread, and existed in both academia and in clinical practice.  Deliberately tainted pharma research was promoted, not just in professional circles, but also to the general public.  Tawdry pharma adverts in psychiatric journals and in the general media promoted the chemical imbalance lie, and turned dangerous psychiatric drugs into blockbuster products.  For instance, between 1997 and 2007, the number of Americans taking neuroleptic drugs increased from 2.2 million to 3.9 million, bringing the promise of brain shrinkage, tardive dyskinesia, akathisia, and an assortment of other adverse effects to an additional 1.7 million people!  Most of this increase was the result of cooperative psychiatric researchers “discovering” new uses for these products, especially among children and older people.

As in so many areas, psychiatry has no answers to the criticisms it faces. So it resorts to spin; in this case, vilifying the conflict-of-interest movement.

For decades, psychiatry went unchallenged.  Those few of us who drew attention to the spuriousness of its concepts, and the destructiveness of its “treatments” and its corrupt ties to pharma, were marginalized and ridiculed.  We were parodied, and asked if we also believed in witches!

Psychiatry had the backing of pharma dollars, and seemed unassailable.  They neither listened to, nor cared about, voices of dissent.  Theirs was the arrogance of the true believers, and they had the pharmaceutical cash register receipts to prove that they were correct.

Then something happened.  The bubble burst.  The scales fell from the eyes. The Emperor’s nudity was recognized, and psychiatry has no response other than spin. And that’s what we’re seeing in Dr. Citrome’s article:  the COI movement is doing more harm than good!

And, incidentally, at the end of the article, the disclosure states:

“In the past 36 months, Citrome has engaged in collaborative research with, or received consulting or speaking fees, from: Alexza, Alkermes, AstraZeneca, Avanir, Bristol-Myers Squibb, Eli Lilly, Forest, Forum, Genentech, Janssen, Jazz, Lundbeck, Merck, Medivation, Mylan, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Reviva, Shire, Sunovion, Takeda, Teva and Valeant.”

And just to make my epistemological position clear, I do recognize that a person could have all these ties with pharma and still be objective on these issues.  That’s logic 101.  But I also recognize that there are strong incentives not to bite the hand that feeds us.  That’s psychology 101.  Actually, it isn’t even that.  It’s just common sense.

 

The FDA:  The Fox Guards the Hen House

In their Fall 2013 issue, the Journal of Law, Medicine, and Ethics published a symposium of papers by members of the Harvard’s Edmond J. Safra Center for Ethics.  The symposium was called Institutional Corruption and Pharmaceutical Policy.

The symposium focuses on pharmaceutical products generally, but all the material is relevant and important in the context of psychiatric drugs.

In this post I will highlight one of these papers:  Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs, by Donald W. Light, Joel Lexchin, and Jonathan J. Darrow.

Here are some quotes:

“An extensive range of studies and lawsuits already documents strategies by which pharmaceutical companies hide, ignore, or misrepresent evidence about new drugs; distort the medical literature; and misrepresent products to prescribing physicians…”

“It is our thesis that institutional corruption has occurred at three levels.  First, through large-scale lobbying and political contributions, the pharmaceutical industry has influenced Congress to pass legislation that has compromised the mission of the Food and Drug Administration (FDA).  Second, largely as a result of industry pressure, Congress has underfunded FDA enforcement capacities since 1906, and turning to industry-paid ‘user fees’ since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages.  Finally, industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.”

“Despite the small number of clinically superior drugs, sales and profits have soared as successful marketing persuades physicians to prescribe the much more costly new products that are at best therapeutically equivalent to established drugs…  Both an American and a Canadian study found that 80 percent of the increase in drug expenditures went to paying for these minor-variation new drugs, not for important advances…  Companies claim that R&D costs are ‘unsustainable.’  But over the past 15 years, revenues have increased six times faster than has investment in R&D.…”

“…allowing companies to test their own products has led them – as rational economic actors – to design trials in ways that minimize detection and reporting of harms and maximize evidence of benefits…”

“…companies have created what can be characterized as the trial-journal pipeline because companies treat trials and journals as marketing vehicles.”

“Furthermore, companies are much less likely to publish negative results, and they have threatened researchers who break the code of secrecy and confidentiality about those results… Positive results are sometimes published twice – or even more often – under different guises.  This further biases meta-analyses – a method of statistically combining the results of multiple studies – and clinical guidelines used for prescribing.  The result is ‘a massive distortion of the clinical evidence… For decades the FDA has kept silent about these practices and about the discrepancies between the data submitted to the FDA by companies and the findings published in journal articles, to the detriment of patients but much to the benefit of the companies.”

The authors offer five suggestions for restoring institutional integrity in this field.

  1. “…while research companies play important roles in discovering and developing superior drugs, they should play no role in testing them.”
  2. “…the FDA needs new leadership to restore public trust and build a new culture focused on safety through enforcement of its existing rules.”
  3. “…user fees must end, and the FDA must be entirely funded by taxpayers-as-consumers. The FDA should be entirely clear about whom it serves.”
  4. “…while approval criteria should allow for a sufficient number of therapeutically equivalent drugs in a class to give clinicians a range of choices…they should also require patient-relevant evidence of superiority.”
  5. “…Congress needs to restore trust by creating a National Drug Safety Board with adequate powers, funds, and mandates to independently investigate and report on drug safety issues.”

This is a meticulously written and well-referenced article.  I urge readers to take a look.  The authors have pulled together all the compelling issues in this matter, and have presented them in a cogent and condensed format.  The article provides excellent material for developing responses to psychiatry’s exaggerated claims, and for lobbying politicians with regards to the obviously much-needed reforms.

According to OpenSecrets.org, the pharmaceutical/health products industry spent $226 million lobbying US politicians in 2013.  By contrast, the defense aerospace industry, popularly regards as a heavy lobbyer, spent $58 million.

Sluggish Cognitive Tempo – A New Diagnosis?

On April 11, 2014, journalist Alan Schwarz (brief bio here) published an article in the New York Times on this topic, titled Idea of New attention Disorder Spurs Research, and Debate.  Alan has written extensively on the rising rates of the condition known as ADHD, and on the abuse of the drugs that are used to “treat” this condition. He has drawn a good deal of criticism from psychiatry’s believers.

In the NY Times article Alan draws attention to the fact that sluggish cognitive tempo (SCT) is being promoted as a new disorder  “… characterized by lethargy, daydreaming and slow mental processing.”  He makes the obviously valid point, that the formalization of such an entity  “… could vastly expand the ranks of young people treated for attention problems.”

The NY Times article was prompted by the fact that the Journal of Abnormal Psychology featured this emerging “diagnosis” in its January 2014 issue.  The issue contained eleven articles on the topic.  These articles addressed questions like:

  • Is SCT a sub-domain of ADHD?
  • Is SCT a disorder in its own right?
  • What are the symptoms of SCT?
  • What are SCT’s co-morbidities?
  • In what ways does SCT differ from ADHD, inattention type?
  • How does SCT differ from depression and anxiety, etc.?

It is a central theme of this website that mental illnesses/disorders, including ADHD and SCT, have no ontological or explanatory significance, are not a helpful way to conceptualize human existence, and in fact are intrinsically disempowering and stigmatizing.  The fact that these so-called illnesses are adduced by their psychiatric inventors to legitimize toxic treatments adds to their destructiveness.  The details of these critiques need not be repeated here.

HISTORY OF SCT

Sluggish cognitive tempo is not a new concept.  ADHD has long been criticized, even by psychiatrists, as embracing two very different kinds of presentations:  inattentiveness, on the one hand, and hyperactivity/impulsivity on the other.  DSM-III-R (1987) acknowledged this problem and created the new “diagnosis” 314.00 Undifferentiated Attention-Deficit Disorder (p 95).  The manual describes this condition as follows:

“This is a residual category for disturbances in which the predominant feature is the persistence of developmentally inappropriate and marked inattention that is not a symptom of another disorder, such as Mental Retardation or Attention-deficit Hyperactivity Disorder, or of a disorganized and chaotic environment.” [Emphasis added]

DSM-IV (1994) also acknowledged this issue, and split ADHD into three distinct “diagnoses.”

  • ADHD Combined type
  • ADHD Predominantly inattentive type
  • ADHD Predominantly hyperactive-impulsive type

DSM-IV-TR (2000) created the “diagnosis” 314.9  Attention –Deficit/Hyperactivity Disorder Not Otherwise Specified

“This category is for disorders with prominent symptoms of inattention or hyperactivity-impulsivity that do not meet criteria for Attention-Deficit/Hyperactivity Disorder.  Examples include:

1.  Individuals whose symptoms and impairment meet the criteria for Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type but whose age at onset is 7 years or after.

2. Individuals with clinically significant impairment who present with inattention and whose symptom pattern does not meet the full criteria of the disorder but have a behavioral pattern marked by sluggishness, daydreaming, and hypoactivity.” [Emphasis added]

DSM-5 has two residual categories in this area:

  • Other Specified ADHD (314.01)
  • Unspecified ADHD (314.01)

These “diagnoses” do not mention sluggishness, daydreaming and hypoactivity specifically, but these attributes are clearly embraced by the definitions.  This is particularly the case in that practitioners working with DSM-IV-TR would have become accustomed to conceptualizing this particular presentation as a “sub-diagnosis” of ADHD and, in addition, DSM-5 did not repudiate the SCT example given in DSM-IV-TR.  DSM-5 offers no examples of the residual diagnoses, the most reasonable interpretation of which is that the older examples are still to be considered valid as well as any others that individual practitioners encounter/invent as they go about their work.

It is noteworthy also that the DSM-5 main entry on ADHD contains the phrases: “mind seems elsewhere” and “may include unrelated thoughts.”  These phrases did not occur in the DSM-IV-TR main entry, and are clearly intended to embrace the notion of daydreaming.

So it is clear that the APA’s notion of ADHD (predominantly inattentive type) has long embraced daydreaming and lethargy, and it was probably inevitable that psychiatry, with its ever-expanding agenda, would eventually begin to conceptualize this as a distinct “illness.”  So today we have sluggish cognitive tempo emerging as a “diagnosis” in its own right, and attracting comment and attention.

CURRENT STATUS OF SCT

Earlier this year, Catherine Saxbe MD, a psychiatrist, and Russell Barkley PhD, a psychologist, wrote a paper reviewing the history of research on sluggish cognitive tempo.  The paper, The second attention disorder? Sluggish cognitive tempo vs. attention-deficit/hyperactivity disorder: update for clinicians, was published in the Journal of Psychiatric Practice.  Here’s a quote:

“Sluggish cognitive tempo (SCT) refers to an impairment of attention in hypoactive-appearing individuals that first presents in childhood. At this time, it exists only as a research entity that has yet to debut in official diagnostic taxonomies. However, it seems likely that a constellation of characteristic features of SCT may form the criteria for a newly defined childhood disorder in the foreseeable future, provided limitations in the extant findings can be addressed by future research.”

The authors expressed the belief that sluggish cognitive tempo is an unfortunate name for the disorder  “…since the term sluggish is associated with connotations of being retarded, slow-witted or just plain lazy.”  They remind us that

“More than semantics is at stake here.  The nosology reflects the way we conceptualize a disorder, view our patients, and how they understand themselves.”

They suggest that “concentration deficit disorder” or “developmental concentration disorder” or “focused attention disorder” would be better names for the problem, and appear to be entirely blind to the fact that the negative effects of referring to a child as “sluggish” pale to nothing compared with the stigma and disempowerment inherent in the notion that he is a “patient” with a “mental illness” (regardless of the name given to this illness).  In addition to which, of course, must be reckoned the destructive effects of the “treatments.”

Here are some more quotes from the Saxbe and Barkley article:

“No large-scale medication trials have examined response to stimulants specifically in SCT, but one recent investigation shows promise for the potential use of atomoxetine.”

and

“This is an exciting finding and warrants further investigation as it is the first published report to show improvement in SCT with any medication.”

and

“Given the overlap of SCT with anxiety and depression, perhaps selective serotonin reuptake inhibitors (SSRIs) might be [another] possible treatment.”

The study in question is Wietecha L. et al., titled Atomoxetine improved attention in children and adolescents with attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute, randomized, double-blind trial.  This appeared in the November 2013 issue of Journal of Child and Adolescent Psychopharmacology.  The paper is a study of the efficacy of atomoxetine in the “treatment” of various attention problems including SCT.  Atomoxetine is a selective norepinephrine reuptake inhibitor (NRI) marketed as Strattera by Eli Lilly.  The study (Wietecha et al.) found that:

“The atomoxetine-treated ADHD-only subjects significantly improved from baseline to Week 32 on…all K-SCT [Kiddie-Sluggish Cognitive Tempo Interview] subscales…”

and

“This is the first study to report significant effects of any medication on SCT.”

All of this is particularly interesting because:

  1. Ritalin, which is now off patent, and other stimulants, are reportedly ineffective in the “treatment” of SCT “symptoms.” (Saxbe and Barkley, 2014, p. 47)
  2. Atomoxetine, which is still on-patent, is now “proven” effective in this area.
  3. Linda Wietecha works as a Clinical Research Scientist for Lilly USA, LLC
  4. According to Dollars for Docs, the following co-authors on the study have also received money from Eli Lilly in the period 2009-2012: Bennett Shaywitz, MD, $963,003; Stephen Hooper, PhD, $16,540; David Dunn, MD, $56,886; and Keith McBurnett, PhD, $5,000.
  5. Russell Barkley, PhD, co-author of the article cited earlier, received $120,283 from Eli Lilly for consulting, speaking, and travel between 2009 and 2012 (Dollars for Docs), and as recently as February of this year gave a lecture tour in Japan sponsored by Eli Lilly.

All of which raises the interesting question:  is SCT disorder being promoted at the present time by Eli Lilly’s paid hacks as a way of increasing sales of atomoxetine (Strattera) while it is still on patent?

PSYCHIATRIC CREDIBILITY

Interestingly, and sadly, most of the research and promotion of SCT has been done by psychologists rather than psychiatrists.  This fact prompted Jeffrey Lieberman, MD, President of the APA, and very eminent psychiatrist to  tweet on April 11 “no credible psychiatrist takes this [SCT] seriously” in response to Alan Schwartz’s article in the New York Times.  Dr. Lieberman seems to be unaware that in DSM-IV-TR (2000), the APA created a specific “diagnosis” for the sluggishness/daydreaming/hypoactivity presentation (using those exact words), and that this “diagnosis” has been clearly retained in DSM-5 (though without those specific words).  I’ve never been aware of any great outcry from organized psychiatry, or from individual practitioners, on this matter.  So, if we are to take Dr. Lieberman at his word (and why would we not do that?), there must be an enormous dearth of “credible psychiatrists” within the APA’s ranks.

In this context, it is also noteworthy that the Wietecha et al. article was published in the Journal of Child and Adolescent Psychopharmacology, which suggests – at least to me – that the journal takes SCT seriously.  The editor-in-chief is Harold Koplewicz, MD, psychiatrist, founding member and President of the Child Mind Institute.  Dr. Koplewicz has held many prestigious positions, and has received numerous awards, including the 2009 American Psychiatric Association McGavin Award for lifetime contributions to child psychiatry.  But alas, he must now be considered a psychiatrist with no credibility.

And

The Saxbe and Barkley article was published by the Journal of Psychiatric Practice, the editor of which is John Oldham, MD, Senior VP and Chief of Staff at the Menninger Clinic, and a psychiatry professor at Baylor College of Medicine.  Dr. Oldham is a past President of the APA (2010-2011), and of the American College of Psychiatrists (2010-2011).  He has also been President of the International Society for the Study of Personality Disorders, and was a member of the DSM-5 Personality Disorders workgroup.  But, here again, no credibility!

The general point here is that psychiatry has embraced the concept of medicalizing daydreaming. Dr. Lieberman either doesn’t realize this, or is trying to conceal the fact.

DISCUSSION

It would be easy to get distracted by this recent attempt to promote childhood daydreaming as a mental illness.  As mentioned earlier, daydreaming, or to use psychiatric terminology, “the persistence of developmentally inappropriate and marked inattention,” has been a specific “mental illness” since DSM-III-R, 1987, (p 95).

The fact is that any human presentation can be considered a mental illness.  All that is needed is the APA’s say so.  And the APA made their position absolutely clear in the foreword to DSM-II (1968).  In the paragraph where they discuss what “diagnoses” should be included in the manual, they state:

“The Committee has attempted to put down what it judges to be generally agreed upon by well-informed psychiatrists today.” (p viii)

In other words:  if we say it’s a mental illness, then it’s a mental illness!

In subsequent editions of the manual, they offer a definition of a mental disorder, which when stripped of verbiage boils down to:  any significant problem of thinking, feeling, and/or behaving.  And who decides something is a problem?  A psychiatrist, of course.

Sluggish Cognitive Tempo (or concentration deficit disorder, as Drs. Barkley and Saxbe would prefer to call it) is more psychiatric nonsense.  But that’s all it is – more of the same; another inevitable result of psychiatry’s fundamentally flawed, spurious, and destructive medicalization of human existence.  Psychiatry continues to expand its net of entrapment into all aspects of life and into every corner of the globe.

By all means let’s speak out against this latest encroachment, but let us not lose sight of the corrupt and spurious engine that has been driving this endeavor since the 1950’s, or of the trail of human suffering and destruction that it has left, and continues to leave, in its wake.

Nor let use lose sight of the fact that many of the greatest writers, scientists, and artists were chronic daydreamers.  We can only imagine how much better the world would be today if these individuals had received the benefits of modern psychiatric treatment. We can also look forward to a better future – a future where daydreaming will be routinely recognized as the illness that it is, it’s victims will be “treated” appropriately with psychiatric drugs, and this plague, that has beset humanity since pre-historic times, will finally be eradicated.

* * * * * * * * *

There is absolutely no facet of human existence that psychiatry will not pathologize in the pursuit of its own self-serving agenda.

Revitalizing Psychiatric Therapeutics?

In January of this year, Steven Hyman MD, former Director of NIMH and currently a leading psychiatric researcher at MIT and Harvard, published Revitalizing Psychiatric Therapeutics in Neuropsychopharmacology.  The article is in the journal’s commentary section and is essentially an opinion piece.  Here’s Dr. Hyman’s summary:

“Despite high prevalence and enormous unmet medical need, the pharmaceutical industry has recently de-emphasized neuropsychiatric disorders as ‘too difficult’ a challenge to warrant major investment.  Here I describe major obstacles to drug discovery and development including a lack of new molecular targets, shortcomings of current animal models, and the lack of biomarkers for clinical trials.  My major focus, however, is on new technologies and scientific approaches to neuropsychiatric disorders that give promise for revitalizing therapeutics and may thus answer industry’s concerns.”

Dr. Hyman is a key figure in the promotion of bio-psychiatry.  His opinions carry weight, and I thought it might be useful to examine what he has written.

Dr. Hyman begins with a brief look at the psychopharmacological “revolution” of 1949-1957, during which lithium, chlorpromazine, iproniazid and imipramine were introduced.

“These serendipitously recognized drugs gave rise to a large number of related compounds in each therapeutic class that in aggregate produced enormous benefit to patients while fundamentally changing the scientific and clinical landscape of psychiatry.”

and

“Later, beginning with clomipramine, serotonin-selective antidepressants were found to exhibit a degree of efficacy for obsessive-compulsive disorder.  These discoveries not only improved many lives but also motivated significant advances in both basic science and clinical investigation.”

Dr. Hyman’s enthusiasm for the drug revolution in psychiatry is clearly evident, and there’s little or no recognition that the drugs he mentions may have done, on balance, more harm than good.  He does concede some toxicity concerns but assures us that the drugs developed in the last 50 years are less toxic than their forerunners.  He acknowledges, however, that they are no more effective.

“What has not happened for five decades across the range of psychiatric drug classes is any significant improvement in efficacy.”

Dr. Hyman attributes this lack of improvement in efficacy to the fact that

“…the molecular targets of all of today’s widely used psychiatric medications are the same as the targets of their 1950s prototypes.”

Dr. Hyman notes that

“…the past 4 years have seen the industry significantly decreasing its investment in psychiatric disorders while investing in other areas.”

He attributes this reduction in investment to pharma’s perception that the “scientific underpinnings” of psychiatry are “less mature” than in other medical fields.

This, he tells us, has “enormous negative consequences for patients with psychiatric disorders and their families” because “…discoveries that may come from academic labs in the near term…” will not result in marketable products without pharmaceutical funding.

So, according to Dr. Hyman, pharma is distancing itself from psychiatry because psychiatry’s scientific underpinnings are less mature than other fields.  Specifically, Dr. Hyman mentions:

1.  “poor understanding of disease mechanisms”
2.  “significant disillusionment with animal models”
3.  “a phenomenological diagnostic system and a lack of biomarkers for diagnosis or ascertainment of treatment response”

With regards to the third item, Dr. Hyman is fairly blunt about psychiatry’s current diagnostic categories.

“Newer technologies combined with growing momentum for a ‘cognitive jailbreak’ from the fictive DSM categories that have captured grant making, journal editing, and regulatory decisions for the past several decades suggest that progress may be in the offing for biomarkers as well.” 

The general theme of the rest of the article is that great breakthroughs are at hand – maybe.

“Because of advances in genomic technologies, psychiatry is at the threshold of gaining information about molecular mechanisms of disease.  That said, putting genetic findings to work in the service of understanding the pathogenesis on psychiatric disorders and revitalizing therapeutics poses very difficult challenges.”

SUMMARY

Dr. Hyman’s article is interesting from a number of perspectives.

Firstly, he is clearly wedded to the bio-psychiatric approach and to the notion that psychiatric “patients” have gene-linked neural defects, the identification and remediation of which should be the primary focus of research.

Secondly, he is optimistic that breakthroughs in this area will occur, and that the pharma industry will resume its financial support of psychiatric research.

“The pace of technology development seems only to be accelerating, and should thus give us hope.  Despite the challenges, there is a substantial opportunity to win back industry and to revitalize psychiatric therapeutics by embracing clear thinking and by putting technologies to work.”

But of greatest interest is Dr. Hyman’s claim that pharma is abandoning psychiatric research because the latter has failed to identify precise “disease mechanisms” or biomarkers.

Pharma had been a staunch supporter of psychiatric research for five decades, during which time there were no identified disease mechanisms or biomarkers.  There were hypotheses, of course (e.g. the biogenic amine theory of depression, the serotonin theory of depression, the dopamine theory of schizophrenia, etc.), and these theories were promoted, both by psychiatry and by pharma, with more enthusiasm and vigor than their merits warranted.

It is also the case that psychiatry’s relationship with pharma was riddled with corruption at all levels of the profession, but especially among its leadership.

One facet of this corruption was the routine over-statement of psychiatry’s effectiveness, and, equally routine, under-statement of adverse effects.

And through all of this, psychiatry and pharma remained blissfully hand in glove.

What has changed in recent years is simply that the bubble of deception and profiteering has burst.  The spurious concepts and the destructive practices have been exposed; there is an active, growing, and outspoken survivor movement; and we’re seeing an increasing number of successful lawsuits.

In addition, there is a growing sense that it is only a matter of time before a definite link between psycho-pharma products and the school shootings will be established.

Pharma’s decision to hitch its wagon to psychiatry was never driven by science.  It was driven by business considerations.  Likewise, the decision to unhitch has nothing to do with science.  It’s because the cost of doing business with psychiatry has become unacceptably high.

Sandy Hook Massacre: The Unanswered Question

On December 27, 2013, Connecticut State Police issued a 7,000-page, heavily redacted, report on the massacre that occurred at Sandy Hook Elementary School just over a year earlier (December 14, 2012).  For the record, I have not read the 7,000-page report, but I have read the Wikipedia article Sandy Hook Elementary School shooting, last updated January 4, 2013, and several media reports on the matter, including reports from the New York Times, the Hartford Courant, and the Washington Post.

Obviously there is an enormous volume of material in the official reports and in the various media reports and comments.  But there is still one major unanswered question.  Was Adam Lanza under the influence of a psychopharmaceutical product(s) at the time of the shooting or in the period immediately prior to the shooting?  There is a report in the record that he took Celexa (citalopram) for a short while in 2006, but no reports of psychiatric treatment since that time.  But there are some reasons for doubt.

ABLECHILD’S FREEDOM OF INFORMATION REQUEST

On August 22, 2013, Connecticut Assistant Attorney General, Patrick B. Kwanashie, during a freedom of information hearing on this matter, stated that releasing this information could “… cause a lot of people to stop taking their medications.”  He made his statement in response to AbleChild’s request for Adam Lanza’s medical records, especially with regards to any psychiatric drugs that he might have taken.  The hearing was videotaped.  Here is an excerpt, transcribed verbatim, from Mr. Kwanashie’s response.  The excerpt begins at about 1 hour 4 minutes into the tape.

“Therefore it is simply not sure that if you don’t fall into one of those categories, what you have to advance reasons that you actually do have a real interest in the [unclear] medical records.  The plaintiff, the complainant have not shown any such interest.  The complainant is proposing that they can make generalizations, generalized from one single incident, no matter how the uh outcome of the use of antidepressants, or thee thee thee causal link between the use of antidepressants and the kind of violence that took place in Newtown.  You just can’t, that’s not a legitimate use of information, of that information.  You can’t generalize just from one case.  Even if you can conclusively establish that Adam Lanza, his his uh his murderous actions, were caused by antidepressants, you can’t logically from that conclude that um um in others would uh, would uh commit the same actions as a result of taking antidepressants.  Um, um, so it’s simply not legitimate, and not only is it not the use to which they are proposing to put the information not legitimate, um it is harmful, because you can cause a lot of people um to stop taking their medications, stop cooperating with their treating physicians, um um just because of the heinousness of uh what Adam Lanza did.  As thee, as thee thee material, the FDA material that they submitted show, it would take a lot of studies uh over a long period of time and among, and within various demographic groups to even begin to uh establish causal links between antidepressants and uh uh aggressive actions or suicidal behavior.  And thee thee informed uh uh, the informed opinion has not quite reached that the point to to say definitively that there’s a causal link between uh between uh the use of antidepressants and uh and uh violent behavior.  Having correlations, there are correlations, but to say there are correlations doesn’t necessarily mean there is, the relationship is causal.  And uh uh this is an issue the FDA is still grappling with, and so far it’s been willing to do is is ask the drug makers to put warnings on their on their products and to advise physicians, treating physicians, to follow monitor their uh their  uh patients closely uh uh at the uh the beginning of uh uh the taking of antidepressants.  Um so it’s a complex issue, um and to pretend that you can just based on this one case make uh recommendations as to how people should uh uh how we should make judgment choices is a disservice to the public and illustrates why these types of reports should not be made available, because in the wrong hands they can be the source of the source of mischief.”

The hesitancies make the material a little difficult to read, but I think the message is clear:  AbleChild should be denied access to the documents in question because they are likely to draw and publicize unwarranted assumptions from these documents, and this might induce large numbers of people to stop taking the drugs in question.

Mr. Kwanashie’s statement is extraordinary for three reasons:

1.  The issue on the table was whether or not AbleChild had a “legitimate interest” (as defined by the statute and regulations) in the material.  This was essentially a legal/technical matter, and the complainant’s attorney Jonathan Emord had outlined various legal reasons in support of their right to the information.

What appeared to be expected from the Assistant Attorney General, who represented the State of Connecticut, was a rebuttal also based on legal issues and technicalities.  Instead, he launched gratuitously into these controversial waters, and provided, in my view, a glimpse of what seems to be going on behind the scenes.

It is of note that when he had finished these remarks, the hearing chairperson drew him back to the legal issues and asked him some clarificatory questions on those matters.

2.  Mr. Kwanashie has unquestionably conveyed the impression that there is some information that is being suppressed, and that it is being suppressed for the reasons that he outlined; i.e. so that people would not stop taking their pills.

3.  Mr. Kwanashie was not speaking as a private individual, but rather as the representative of the State of Connecticut.  He had almost certainly been authorized by his superiors to make the statement in question, and presumably the statement reflects the state’s stance on this issue generally, i.e. not just in the Adam Lanza case.

It’s possible, of course, that Mr. Kwanashie was confused or inadequately prepared for the hearing.  But that seems unlikely.  He is 59 years old, has been licensed to practice law in Connecticut since 1988, and draws a salary of $142,000.  Denying a freedom of information request is not a trivial matter, and the notion that he would go to such a hearing unprepared is hard to credit.  This is especially the case in that the Lanza shooting is probably the highest profile case that the State of Connecticut has encountered in decades.

So what we have is a credible indication that Adam Lanza was taking psychoactive “medication” around the time of the murders.  But the State of Connecticut will not release this information because such a release might induce large numbers of people to stop taking antidepressants.

A MINNESOTA TOWN HALL MEETING

A December 13, 2013, article called Newtown One Year Later, The Missing Link on the AbleChild site contained a link to a video.  The video is of a town hall meeting that Minnesota Congresswoman Betty McCollum held with some of her constituents in Oakdale, Minnesota eleven months earlier, on January 26, 2013.  At about 39 minutes and 30 seconds into the video, a member of the audience made the following comments:

“…I agree with Congresswoman McCollum that we need to have a dialogue with what’s going on with these gun issues.  I’m, we’re blindly running into gun control and a violation of the second amendment – but we’re not even sure if we have a  gun control problem.  I’ve been reading things where a lot of these kids – the Sandy Hook kid and the kid up in Red Lake Minnesota and Aurora – they’re all on Prozac and Ritalin and is this a psychopharmaceutical issue that’s causing these kids to do. – I mean – I think we need to have a,  I think we need to bring not only with both sides of the aisle but both sides of the issue together and examine exactly what’s going on here.  Is this a gun problem or is it a – you know – it could be anything.  But I think before we jump into legislating one portion of this we need to examine the entire issue and find out what’s going on.  Thank you very much.”

Here’s Congresswoman McCollum’s verbatim response:

“To that, let me tell you something: that, to quote my grandmother (so I use nice words here), frosted my cookies.  We can’t study, federally – we’re prohibited from studying the effects of some of the drugs that you were just talking about as it relates to people who go out and commit violent acts with guns.  We’re prohibited from studying that.  It’s an NRA square bolt.  That’s why I’d never be at 100%.  I think we have an obligation to study those kinds of issues.  So that’s why we need a dialogue.  It is prohibited from the CDC – the Centers of Disease Control – to study this.  It’s wrong!  And that’s why we need to get the lobbying efforts out of the discussion, just saying here’s your scorecard and they only highlight certain issues.  And they don’t give you everything else that they’re involved in. And that’s why I’m here and that’s why I’m glad you’re here.  So that we can talk and listen to one another.  And so I really am feeling very good that you’re here today.”

In the December 13 article, AbleChild describe their unsuccessful attempts to obtain additional information from Congresswoman McCollum concerning the CDC “rule.”

My interpretation of the Congresswoman’s words in the town hall meeting is that there is some kind of prohibition within the government on researching this topic, and that this prohibition is connected to lobbying – presumably by the pharmaceutical industry.

According to Wikipedia, Congresswoman Betty Louise McCollum is 59 years old, and is the U.S. Representative for Minnesota’s 4th congressional district, serving since 2001. She is a member of the Democratic-Farmer-Labor Party (DFL).  She currently serves on the United States House Appropriations Committee and the following subcommittees:  Subcommittee on Interior, Environment and Related Agencies, United States House Appropriations Subcommittee on Defense.   She also previously served on the House Committee Education and the Workforce; House Committee on Government Reform; House Committee on Resources; and House Committee on the Budget.  So she is mature and not, I imagine, given to flights of fancy.  She appears credible; she seems to have some personal knowledge of the “rule”; and there is nothing to suggest that she is making this stuff up.

Why is the media not all over this?  The town hall meeting was held almost a year ago.  To date the video has had only 307 hits.

WHITE HOUSE PETITION

And let’s not forget that a petition to formally investigate the link between psychopharmaceutical products and violence was removed from the White House petition website in December of 2012 without explanation, even though it was well on the way to obtaining the requisite number of signatures.

Is the US government, or any branch, or agency, of the US government deliberately suppressing research into the widely-suspected link between psychopharmaceutical products and mass shootings?  And if so, is this suppression the result of pharmaceutical lobbying?

If in fact, as many of us suspect, there is a causal link between the mass shootings and psychopharma products, shouldn’t this be a matter of urgent national importance?  Whose interests would be served by the suppression of this information?  Has the constitutional supremacy of We The People been usurped by They The Drug Companies?  By what distorted “logic” can a government collude with the notion of keeping people in the dark concerning a devastating drug effect in order to ensure that individuals keep taking these drugs?  I encourage my readers to check out both videos, and perhaps recommend that your friends and contacts do the same.  Perhaps there’s an innocent interpretation to all this.  If so, I’d be very grateful if someone could explain it to me.

FINALLY

In 2000, Joseph Glenmullen, MD, a psychiatrist, published Prozac Backlash – a critical look at the adverse effects of Prozac and other serotonin boosters.  Here’s a quote from the final chapter:

“We do know, from documented clinical experience and research, that these drugs have led to suicidal and violent urges in some patients.  We desperately need warnings for patients and doctors, together with information on prevention and coping with suicidal and violent impulses when they occur.  Additional research to help us understand the phenomenon is desirable but should not be merely a ploy to delay such warnings and preventive steps.” (p 336)

And that was more than 13 years ago!

Psychiatry’s Over Reliance On Pharma

I recently read The NIMH-CATIE Schizophrenia Study: What Did We Learn? by Jeffrey Lieberman, MD, and T. Scott Stroup, MD, MPH.  The article was published in the American Journal of Psychiatry 168:8, August 2011.  

Here are two quotes:

“When the CATIE study was designed in 1999-2000, the prevailing opinion of researchers and clinicians alike was that the newer (second-generation) antipsychotic drugs were vastly superior to the older (first-generation) antipsychotic drugs in efficacy and safety. This largely reflected the results of studies sponsored by the manufacturers of the new drugs…, marketing messages of pharmaceutical companies and the hopes of many who wanted better treatments.”

“CATIE helped to demonstrate that, although the introduction of second-generation antipsychotic drugs brought new options for treatment of psychosis, the major advance many had hoped for remains elusive.”

Let’s take a look at the first passage.  Essentially what’s being said is that by about the year 2000, psychiatric researchers and practitioners believed that the second-generation neuroleptics were vastly superior to the older drugs in effectiveness and safety.

The CATIE study debunked these beliefs, as is acknowledged clearly in the second quote.

EFFECTIVENESS AND SAFETY

Here is a list of the second-generation neuroleptics introduced prior to the year 2000 with the main adverse effects associated with the use of each drug as listed in the 2001 PDR.

  • Clozapine, Clozaril (1989).  Adverse effects:  agranulocytosis (black box); seizures (black box); orthostatic hypotension (black box); neuroleptic malignant syndrome; tardive dyskinesia; akathisia, etc… 
  • Risperidone, Risperdol (1994).  Adverse effects:  extrapyramidal disorders; akathisia; aggressive reaction; joint pain; weight gain, etc… 
  • Olanzapine, Zyprexa (1996).  Adverse effects:  neuroleptic malignant syndrome; tardive dyskinesia; akathisia; weight gain; postural hypotension; joint pain; extremity pain, etc… 
  • Quetiapine, Seroquel (1997).  Adverse effects:  neuroleptic malignant syndrome; tardive dyskinesia; orthostatic hypotension; seizures; hypothyroidism; cholesterol and triglyceride elevations; etc… 

Each entry in the PDR is a verbatim copy of the manufacturer’s FDA-approved labeling information and is updated annually.  It is clear, from the adverse effects listed with each of these products, that the respective manufacturer acknowledged clearly that there was a real danger of serious and potentially irreversible adverse effects.

With the exception of clozapine, the manufacturers also acknowledged that their efficacy data was based on very short-term trials.

  • risperidone                  3 weeks
  • olanzapine                   6 weeks
  • quetiapine                    6 weeks 

The entry for olanzapine (Zyprexa) stated explicitly:

“The efficacy of ZYPREXA was established in short-term (6-week) controlled trials of schizophrenic inpatients…

The effectiveness of ZYPREXA in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials.  Therefore, the physician who elects to use ZYPREZA for extended periods should periodically re-evaluate the long-term usefulness of the drug for this individual patient… [emphasis added]

ZYPREXA is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.

The efficacy of ZYPREXA was established in two placebo –controlled trials (one 3-week and one 4-week), with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or, without psychotic features…

The effectiveness of ZYPREXA for longer-term use, that is, for more than 4 weeks treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use ZYPREXA for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient…” [emphasis added]

Against this background, it’s difficult to afford much credence to the assertion of Drs. Lieberman and Stroup that the responsibility for psychiatrists’ false beliefs that these products were vastly superior to the old drugs in efficacy and safety can be laid at the feet of pharma.

It is noteworthy that Drs. Lieberman and Stroup mention not only industry sponsored studies, but also pharma’s “marketing messages.” [emphasis added]

This strikes me as an extraordinary admission.  America is the birthplace of aggressive marketing, and we all know how successful it can be in the selling of cars, vacuum cleaners, etc…  But for a group of people, who routinely claim that they are a bona fide medical profession, to admit that they were duped by tawdry marketing ploys raises serious concerns about their credibility and competence.

Drs. Lieberman and Stroup are defending psychiatry’s overly zealous adoption of the newer drugs by blaming the pharmaceutical companies’ misleading research and commercials.  But the much more fundamental issue is:  why did psychiatrists believe these messages despite the fact that the PDR entries for the drugs in question provided abundant justification for caution and restraint?

It’s difficult to avoid the suspicion that the various largesse showered on psychiatry by the pharma industry might have played some part.

It’s also clear that psychiatrists’ love affair with these drugs and their vulnerability to pharma marketing continue to this day.

In the third quarter of 2013, the second-generation neuroleptic Abilify (aripiprazole), with over $1.5 billion in sales, was not only the best selling neuroleptic drug in the US, it was the highest grossing of all prescription drugs.  It was also the most heavily promoted neuroleptic in 2011 (the last year for which I can find data), and accounted for 38% of neuroleptic promotional spending.

However, there is nothing in the current PDR entry, which is available online, to suggest that it is any safer than the other products.  All the usual second-generation neuroleptic adverse effects are listed, including tardive dyskinesia, akathisia, weight gain, metabolic problems, neuroleptic malignant syndrome, etc…  There are also two black box warnings:  increased mortality in dementia-related psychosis; and increased suicide risk in children and young adults.

In addition, efficacy studies were limited to 6 weeks.

SUMMARY

So in 2011, we had Drs. Lieberman and Stroup blaming pharma advertizing for psychiatry’s misplaced enthusiasm for the newer neuroleptics, while side-stepping the obvious corollary:  that psychiatrists were taken in by these promotions.  Now, two years later, the problem is still with us.  Psychiatrists apparently are still responding positively to the marketing messages; and neuroleptic drugs, which in former times were barely a blip on the sales charts, are now acquiring blockbuster status.

Neuroleptics for Children: Harvard’s Shame

In December 2012, Mark Olfson, MD, et al, published an article in the Archives of General Psychiatry.  The title is National Trends in the Office-Based Treatment of Children, Adolescents, and Adults with AntipsychoticsThe authors collected data from the National Ambulatory Medical Care Surveys for the period 1993-2009, and looked for trends in antipsychotic prescribing for children, adolescents, and adults in outpatient visits.  Here are the results:

Age Increase in no. of antipsychotic prescriptions per 100 population (1993-2009)
0-13 0.24-1.83 (almost 8-fold)
14-20 0.78-3.76 (almost 5-fold)
21+ 3.25-6.18 (almost 2-fold)

 

The authors provide a breakdown of the diagnoses assigned to the children and adolescents during the antipsychotic visits.

Diagnosis Visits %
Children
(0-13)
Adolescents
(14-20)
Schrizophrenia 6.0 8.1
Bipolar 12.2 28.8
Depression 11.2 20.9
Anxiety 15.9 14.4
Dev Disorders 13.1 5.0
Disruptive Behavior Disorders 63.0 33.7
Other Dx’s 18.0 16.8

 

Percentages do not total 100, because some individuals were assigned more than one diagnosis.

It is clear that disruptive behavior disorders are the most common diagnoses used in antipsychotic visits for both children and adolescents.

Thirty years ago, the prescription of neuroleptic drugs to children under 14 years of age was almost unheard of.  It was rare in adolescents, and even in adults was largely confined to individuals who had been given the label schizophrenic or bipolar.

By 1993, the first year of the Olfson et al study, about a quarter of 1% of the national childhood population were receiving antipsychotic prescriptions during office visits.  The percentage for adolescents was about three quarters of 1%.  By 2009, these figures had increased to 1.83% and 3.76% respectively.

The devastating effects of these neurotoxic drugs are well known, and it is natural to wonder what forces might be driving this trend.  The authors suggest that:

“Increasing clinical acceptance of antipsychotics for problematic aggression in disruptive behavior disorders may have increased the number of children and adolescents (especially male youths and ethnic/racial minorities) being prescribed antipsychotics.  The increase in the number of clinical diagnoses of bipolar disorder and autistic spectrum disorders among children and adolescents may have further increased antipsychotic use by youths, particularly by boys.”

They also note that:

“The trend in the prescribing of antipsychotics to youths occurred within the context of a dramatic increase in the clinical diagnoses of bipolar disorder among young people.”

The notion that the increase in the prescription of neuroleptics for children is driven by increased use of the bipolar diagnosis is supported by another study:  Most Frequent Conditions in U.S. Hospitals, 2010,  by Plunter et al, January 2013, published by the Agency for Healthcare Research and Quality (a division of the US Department of Health and Human Services).  This study, which analyzed hospital admission data from 1997 to 2010, found that mood disorder, which in 1997 had been in the fourth place (behind asthma, pneumonia, and appendicitis) was by 2010 the most common diagnosis for children aged 1-17.  In the 13-year period admissions for mood disorders had increased 80%, while admissions for asthma and pneumonia had decreased by 30% and 16% respectively.

Most of the increase in mood disorder frequency was for bipolar disorder.  In the period studied, admissions for children for depression rose 12%, but admissions for bipolar disorder rose 434% (from 1.5 per 100,000 population to 8.2).  For children in the age group 5-9, the increase was 696%! – a seven-fold increase.

So, over the last decade or two, we’ve seen a huge increase in the number of children being hospitalized for bipolar disorder and in the number of children being prescribed neuroleptics in office visits.

HOW DID THIS HAPPEN?

Neuroleptics are probably the most damaging drugs used in psychiatry.  The adverse effects, including permanent and extensive brain damage, are devastating, and occur in virtually all of cases where use is prolonged (Breggin, 2011, p 197).  In former decades, their use was confined mainly to adults who had been labeled schizophrenic or bipolar.  It was routinely claimed by psychiatrists that their benefits outweighed the risks, though this contention is not standing up to the increasing scrutiny that has occurred in the past decade or so.

The increase in the prescription of neuroleptic drugs for children is a direct consequence of the increased use of the bipolar label in that population.  And most of the responsibility for that increase can, in my view, be laid at the door of one person:  Joseph Biederman, MD, of Harvard Medical School and Massachusetts General Hospital.  Dr. Biederman will go down in history as the inventor of pediatric bipolar disorder.

DSM-III-R was published in 1987.  It makes no reference to the existence of childhood bipolar disorder.  The total entry under Prevalence is:

“It is estimated that 0.4% to 1.2% of the adult population have had bipolar disorder.” [emphasis added]

DSM-IV, published in 1994, greatly expanded the concept of bipolar disorder, essentially by removing the requirement of a manic episode or a mixed (manic-depressive) episode.  References to age are vague – e.g.:

“Approximately 10%-15% of adolescents with recurrent Major Depressive Episodes will go on to develop Bipolar I disorder.”

It is not clear whether this “development” might occur in late adolescence or in adulthood. There is no suggestion that bipolar disorder can occur in a pre-adolescent child.

By 1996, however, Dr. Biederman and his colleagues at Harvard were promoting childhood bipolar disorder as an accepted psychiatric diagnosis that needed to be treated with pharmaceutical products, including neuroleptics.  This was accomplished primarily by selling the notion that childhood temper tantrums could legitimately be regarded as symptoms of mania.  This blatant distortion of the traditional concept of mania was facilitated by the “not otherwise specified” (NOS) qualifier which has been a component of almost all diagnostic categories since DSM-III.  The purpose of the NOS diagnoses is to enable psychiatrists to assign the diagnosis in question to an individual even though he doesn’t actually meet the criteria.  The fact that this renders the criteria somewhat pointless is generally lost on psychiatrists, but that’s a different story.

What the Bipolar Disorder NOS diagnosis enabled Dr. Biederman and his colleagues to say was essentially this:

We know that temper tantrums aren’t really an integral component of bipolar disorder as it is traditionally conceived.  But we believe that that’s how bipolar disorder presents itself in young children, and so that’s what we’re going to call it.

This is on a par with dermatologists deciding that pattern baldness is a symptom of psoriasis!  In real medicine, this isn’t how it’s done, but in psychiatry it’s the norm.  The “diagnoses” are fictitious.  They can be created, modified, and eliminated with strokes of a pen.  This is what Dr. Biederman and his Harvard colleagues did, and American psychiatry followed.  The neuroleptics-for-children spigot was opened, and is running freely to this day.

The creation and promotion of pediatric bipolar disorder has been described and critiqued by several writers.  Joanna Moncrieff, a British psychiatrist, provides an excellent account in her book The Bitterest Pills (2013 , p 200-205).  Here are some quotes:

“Although it is the adult market that accounts for the bulk of sales of atypical antipsychotics, it is the use of these drugs in children alongside the emergence of the diagnosis of paediatric bipolar disorder that best illustrated the way in which a severe mental disorder can be morphed into a label for common or garden difficulties, as well as the role that money plays in this process.”

“Moreover, by locating the problem in the brain of the child, it seemingly detaches it from the situation within the family.”

“Academic psychiatry fuelled this craze, with added financial incentive from the pharmaceutical industry…”

“In the 1990s, a group led by child psychiatrist Joseph Biederman, who was based at Massachusetts General Hospital and the prestigious Harvard Medical School, started to suggest that children could manifest ‘mania’ or bipolar disorder, but that it was frequently missed because it was often co-existent with other childhood problems like ADHD and ‘antisocial’ behaviour…  In a paper published in 1996 the group suggested that 21% of children attending their clinics with ADHD also exhibited ‘mania’, which was diagnosed on the basis of symptoms such as over-activity, irritability and sleep difficulties…  A year later the group were referring to bipolar disorder in children as if it were a regular, undisputed condition, and emphasized the need for ‘an aggressive medication regime’ for children with the diagnosis…”

“Neither Harvard nor Massachusetts General Hospital nor any other psychiatric or medical institution has commented on the fact that prominent academics were found to be enriching themselves to the tune of millions of dollars through researching and promoting the use of dangerous and unlicensed drugs in children and young people.  Although some individual psychiatrists have expressed misgivings…academic papers continue to discuss the diagnosis, treatment and outcome of bipolar disorder in children as if no controversy existed, with more than 100 papers on the subject published in Medline-listed journals between 2010 and 2012.  Notwithstanding…the disgrace of Joseph Biederman, the practice of diagnosing children with bipolar disorder and treating them with antipsychotics remains alive and kicking.”

The spurious creation of childhood bipolar disorder has been critiqued also by Mickey Nardo, MD, a retired psychiatrist who blogs under the name 1 Boring Old Man (which, incidentally, he isn’t).  On July 2, 2011, he published a post called bipolar kids: an all too familiar lingo…  Here are some quotes:

“What happened in that second half of the 1990s is that they created a new diagnosis – Pediatric Bipolar Disorder. Looking at these articles…or at the COBY Study [started right around this time], Bipolar Disorder in children was becoming a common diagnostic term, but the diagnostic criteria bore little resemblance to the familiar symptom complexes from the Manic Depressive Illness of old. It was something new masquerading as something old [or vice versa]. These kids weren’t euphoric, they were irritable.”

“…the Biederman-led movement to broaden the category to call all kinds of difficult and disruptive children Bipolar had little to no scientific basis. It felt like a rationalization to use the new atypical antipsychotics to control difficult behavior-disordered kids – a trick.”

“And even without knowing what we know today about what happened, at the turn of the last century there was plenty of reason to smell a rat [named pharma]. The articles had all the tell-tale phrases – “urgent public health problem” “emerging new treatments” “need for more research” – an all too familiar lingo that pointed down a well-traveled yellow brick road. And this time it didn’t lead to Oz, it lead to Harvard University. And the guy behind the curtain was Joseph Biederman …”

Ultimately Dr. Biederman was disgraced – not for the spurious expansion of a diagnostic category.  Diagnostic expansion has been psychiatry’s primary agenda for the past 60 years.  A small minority of psychiatrists might have had reservations concerning Dr. Biederman’s work, but the mainstream psychiatry-pharma alliance embraced the new development with their customary zeal and self-serving enthusiasm.

Nor was Dr. Biederman disgraced because he had deliberately encouraged the exposure of thousands of children to neurotoxic chemicals.  Again, that’s just business as usual.  And in fact, he received awards and accolades for drawing attention to the plight of these tragically “underserved” children.  Here are some of the awards and honors he has received since his ground-breaking work on childhood bipolar disorder:

  • NAMI Exemplary Psychiatrist Award
  • NARSAD Senior Investigator Award
  • ADHD Chair of World Psychiatric Association
  • Outstanding Psychiatrist Award, Massachusetts Psychiatric Society
  • Excellence in Research Award, New England Council of Child and Adolescent Psychiatry
  • Mentorship Award, Psychiatry Department, Massachusetts General Hospital
  • William A. Schonfeld Award for outstanding achievement and dedication
  • Distinguished Service Award, MGH/McLean Child and Adolescent Psychiatry Residency

He was disgraced for under-reporting to his employers at MGH and Harvard the amount of money he was receiving from the pharmaceutical industry for conducting research that was used to promote their products.  Here again, there was nothing particularly unusual in this.  The so-called Key Opinion Leaders (KOL’s) in psychiatry have been awash in pharma money for decades.  But Dr. Biederman’s take ($1.6 million) was on the high side, and came to light at a time when the corrupt psychiatry-pharma alliance was being exposed nationally, largely through the efforts of Iowa Senator Charles Grassley.

Dr. Biederman was also criticized for promising Johnson & Johnson a positive result for their neuroleptic drug risperidone in pre-school children before he had actually conducted the research.  Obviously this makes a mockery of the research, but psychiatric research was hijacked by pharma marketing decades ago.  It has long since ceased to be a source of genuine scientific information, and much of it instead is little more than marketing material bought and paid for by the pharmaceutical industry.  Dr. Biederman’s error in this area was that he committed his promises to writing (in the form of slides that he presented to Johnson & Johnson executives), and these slides and other correspondence came to light during lawsuits against Johnson & Johnson for fraudulent marketing of their products.  These are the same lawsuits that Johnson & Johnson recently settled for $2.2 billion.

The great irony with regard to Dr. Biederman’s premature promise of a positive result for Johnson & Johnson is that he was absolutely correct!  If you give a neuroleptic drug to a misbehaved child, the incidence of misbehavior will indeed decrease.  If you give him enough, he’ll go to sleep and won’t misbehave at all!  That’s why these drugs used to be called major tranquilizers.  Dr. Biederman could accurately predict this result in advance because that’s what major tranquilizers do.  If you conduct a study to see if alcohol will make people drunk you’ll get a positive result.  If you conduct a study to see if major tranquilizers subdue childhood temper tantrums, you’ll get a positive result.  Dr. Biederman couldn’t use this defense, however, because he, like psychiatrists in general, has to play along with the big fiction:  that childhood temper tantrums are a symptom of an illness, and that the drugs are medicines targeting specific faults in neural circuitry or chemical imbalances or whatever.  Dr. Biederman’s proposed study would have produced a positive results for Risperdal in the same way that most industry-sponsored studies obtain positive results:  by limiting outcome criteria to the known effects of the drug, by keeping follow-up times short, and by ignoring adverse effects.

Dr. Biederman’s ethical lapses were thoroughly investigated (for three years) by his bosses at MGH and Harvard, and in 2011 they gave him and two of his colleagues (Thomas Spencer – total take:  $1.0 M, and Timothy Wilens – total take:  $1.6 M) very, very severe slaps on the wrists.  The Boston Globe covered this story.  Here’s a quote:

“The three psychiatrists apologized in their letter for the ‘unfavorable attention that this matter has brought to these two institutions.’  They called their mistakes ‘honest ones’ but said they ‘now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.’

They said the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer ‘a delay of consideration for promotion or advancement.'”

The notion that the ethical lapses of these three psychiatrists were “honest mistakes” is a little hard to credit, given that the total dollar amount was more than $4 M!

Today Dr. Biederman is fully rehabilitated and is back in business. He’s receiving research funding from ElMindA, Janssen, McNeil, and Shire, and is once again churning out research papers on topics such as ADHD and, guess what? – pediatric bipolar disorder.

THE BIG QUESTIONS

The two big questions in all of this are:

1.  Why do Harvard and Massachusetts General Hospital stand for this kind of blatant corruption and deception in the upper echelons of their psychiatry department?

2.  Why does the APA not take a stand against the medicalization and drugging of childhood temper tantrums – a problem that parents of previous generations simply took in their stride as an integral part of normal childrearing?

With regards to the APA, it’s really not much of a question.  Their agenda has always been: more psychiatric drugs for more people, and the neuroleptics-for-children development is really just business as usual.  They have dulled their ethical sensibilities through decades of prescribing benzodiazepines, SSRI’s, methylphenidate, and various other neurotoxins for an ever-widening range of human problems, and prescribing a neuroleptic to a 1½ year old for temper tantrums is a short step.

The APA, however, did express some mild concern about the spurious extension of the bipolar label to children.  In DSM 5 (p 132) they state:

“In individuals with severe irritability, particularly children and adolescents, care must be taken to apply the diagnosis of bipolar disorder only to those who have had a clear episode of mania or hypomania – that is, a distinct time period, of the required duration, during which the irritability was clearly different from the individual’s baseline and was accompanied by the onset of Criterion B symptoms.”

But rather than risk losing the pediatric business, hard-won by Harvard’s psychiatrists, they created a new diagnosis:

“When a child’s irritability is persistent and particularly severe, the diagnosis of disruptive mood dysregulation disorder would be more appropriate.”

The effect of all this is that psychiatrists can go on prescribing drugs for childhood temper tantrums, but instead of calling them bipolar disorder, they should use the new label:  disruptive mood dysregulation disorder – but they can continue to use the bipolar diagnosis also, with a few caveats, couched in the APA’s characteristically vague language.

Harvard’s stance on the scandals is a little harder to fathom.  After all, Harvard is hallowed ground – America’s Oxbridge.  It has acquired an image as a center of learning where educational and research standards eclipse all other considerations.

And in fact, there are legal and medical ethicists at Harvard who clearly recognize the implications of the psychiatric scandals.

Earlier this year, the Journal of Law, Medicine & Ethics (Vol 41, Issue 3) published a symposium of 17 papers written by members of Harvard’s Edmond J. Safra Center for Ethics.  Here are some of the titles:

Here are some quotes:

“The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created.” (Light et al)

“In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests.” (Cosgrove and Wheeler)

“Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behavior and decision-making.” (Sah and Fugh-Berman)

Clearly these papers are addressing important and relevant topics.  But what’s particularly noteworthy, from the present perspective, is that they originated in Harvard – the same institution in which senior psychiatry faculty members were hand-in-glove with pharma in the production of fraudulent research and advertizing.  How are we to understand this contradiction?  How are we to understand the minimal response from Harvard’s management, and incidentally from the other academic departments, given that such a wealth of ethical resources was there on their own campus, presumably available and willing to be consulted on these kinds of matters.

BUSINESS ETHICS VS UNIVERSITY ETHICS

In America, it is becoming increasingly recognized, and even accepted, that big businesses are frequently amoral.  Considerations of right and wrong are routinely subordinated to bottom line accounting.  Many big pharmaceutical companies are perceived in this light.  Indeed, the recent $2.2 B  penalty levied against Johnson & Johnson was discussed in some media outlets quite simply as a “cost of doing business.”  The question of whether it is a good thing to promote the use of neuroleptics for children doesn’t even come on the radar.  The perverse calculus is reduced to the difference between the projected profits from the drugs sales, and the fines and lawsuit settlements that might ensue.

Has Harvard’s Psychiatry Department, in concert with their pharmaceutical allies, crossed this line?  Have they now, implicitly or explicitly, adopted the ethical standards of the business world?  Have they subordinated their sense of decency and shame to considerations of prestige and revenue?

And what of the MGH/Harvard leadership?  Do they actually believe that the sanctions imposed on Dr. Biederman and his colleagues are adequate?  Or do they reckon that the years of past and future pharma revenue are worth the cost?  Have they crossed the line into the shady realm of business ethics?

And as we ponder these thorny questions, let’s not forget that the Johnson & Johnson lawsuit listed psychiatric researchers at other renowned universities, including Johns Hopkins, Stanford, UCLA, University of Illinois at Chicago, University of Texas at Austin, Georgia Regents, University of Toronto, and Dalhousie University.

Meanwhile the destructive prescribing continues, and Dr. Biederman is still at MGH, where he is Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, and at Harvard, where he is a full Professor of Psychiatry, a position, which, by his own account, ranks just below God!

Psychiatry’s primary agenda for the past 60 years has been the expansion of their diagnostic net to embrace an increasing range of ordinary human problems, and the unscrupulous prescribing of more and more psycho-pharmaceutical products to more and more people.  In the final analysis, Dr. Biederman’s problem was that he was particularly good at this job.  He was, in effect, a Model Psychiatrist – the perfect embodiment of everything that the APA stands for.

CLARIFICATION OF TERMINOLOGY

My frequent use of the term bipolar disorder in this article should not be interpreted as an endorsement on my part of the ontological validity of this expression, much less its status as an illness or disease.  I use the term bipolar disorder (and the various other so-called diagnoses) for the sake of readability and linguistic convenience.  What I mean by “bipolar disorder” is:  the vaguely defined and loosely clustered behaviors, thoughts, and feelings that psychiatrists call bipolar disorder.