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Biederman et al get Protective Shield from Harvard-Mass General Hospital

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    ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYI To
    Message 1 of 1 , Jun 17, 2008
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      Promoting Openness, Full Disclosure, and Accountability
      http://www.ahrp.org and http://ahrp.blogspot.com


      To appreciate the culture of corruption that undermines medical institutions
      that fail to protect the integrity of medical research from the undue
      influence of industry, see the statement (below) issued by Dr. Peter L.
      Slavin, Mass General president, and Dr. David F. Torchiana, head of Mass
      General Physicians Organization, in support of Dr. Joseph Biederman and his
      two colleagues, Drs. Timothy Wilens, and Thomas Spencer whom the statement
      describes as "pioneers in the field of child mental health."

      These prominent child psychiatrists have been caught lying about $4.2
      million they received from pharmaceutical companies whose drugs they have
      aggressively promoted for use in children, and their conduct has sullied the
      reputation of Harvard University and its hospital affiliate, Massachusetts
      General. The adulatory statement published in the Boston Globe describes the
      three as "beloved and trusted by thousands of grateful children and families
      who have counted on them for treatment, counseling, help and hope. We know
      this is an incredibly painful time for these doctors and their families, and
      our hearts go out to them."

      One can only speculate whether Mass General will continue to rally round Dr.
      Biederman and the other so-called “pioneers” who failed to disclose their
      considerable pharmaceutical income should the National Institute of Health
      revoke its grants to the institution as a consequence of their violation of
      federal conflict of interest rules.
      To appreciate the magnitude of pharmaceutical influence on American
      psychiatry, one needs to look at the documented evidence showing that
      psychiatry’s diagnostic manual the DSM-IV—which determines the criteria for
      issuing diagnoses—and psychiatry’s prescription guidelines (e.g., TMAP) have
      been formulated by industry-funded psychiatrists whose integrity is a matter
      of debate. “Recent investigations revealed over 50% of authors revising the
      Diagnostic and Statistical Manual of Mental Disorders (DSM) had financial
      ties to the pharmaceutical industry….Within the ‘Mood Disorders’ and
      ‘Schizophrenia and Other Psychotic Disorders; panel, 100% of members had
      financial ties.” See: Oregon DUR Board Newsletter, Feb. 2007

      And one needs to examine the unabashed promotional hype that has been passed
      off as “research” by the foremost company-financed child psychiatrists—whose
      influence has succeeded in popularizing a previously unaccepted “diagnosis”
      in children—Bipolar (a.k.a. Manic Depression) a rare condition in adults.

      It is instructive to review the following:

      1. The website describing the Pediatric Psychopharmacology Program at
      Harvard-affiliate, Massachusetts General Hospital:

      “Founded just twenty-five years ago, the Pediatric Psychopharmacology
      Program is the largest research program in the Department of Psychiatry, and
      its researchers are among the most prolific and respected child
      psychiatrists and psychologists in the world. Under the leadership of
      renowned child psychiatrist and founder, Joseph Biederman, MD, the program
      has “changed the face of child psychiatry…"

      2. A bevy of supportive letters to The New York Times from organizations
      that have considerable vested interests in promoting pediatric Bipolar
      Disorder which is hugely profitable for their pharmaceutical company
      See: letters from the American Medical Association and the Association of
      American Universities; the American Psychiatric Association, the Child and
      Adolescent Bipolar Foundation, and the Pediatric and Adolescent Advisory
      Council at Massachusetts General Hospital.

      Though the spokespersons for these organizations espouse support for
      disclosure, they all fail to mention their organization’s own substantial
      pharmaceutical financial ties.

      An unpublished letter to the Times by Dr. Nathaniel Lehrman follows below.

      3. Honesty in medical education is hard to come by. So, Dr. Daniel Carlat a
      psychiatrist who is not “on the take,” who publishes both the Carlat
      Psychiatry Report, a peer-reviewed, non-industry biased, CME publication,
      and the Carlat Blog, is trustworthy. In the Carlat Blog, Dr. Carlat
      expresses his (admittedly) very biased opinion, “formed as a result of
      participating in many CME activities, that allowing pharmaceutical companies
      to sponsor accredited medical education leads to many bad things, including
      biased education, corrupt physicians, and, ultimately, harm to our patients.
      So, if you are interested in the tangled politics and economics of CME, read
      [The Carlat Report is at: http://www.thecarlatreport.com/

      Contact: Vera Hassner Sharav

      Psychiatrists under fire supported by Mass. General by Elizabeth Cooney June
      11, 2008

      Three Harvard psychiatrists facing a US Senate inquiry got a vote of
      confidence from their hospital as "beloved and trusted by thousands of
      grateful children and families." Senator Charles Grassley is looking into
      the doctors' failure to report payments of more than a million dollars in
      consulting fees from drug makers from 2000 to 2007.
      A memo from top officials at Massachusetts General Hospital obtained by the
      Globe praised Drs. Joseph Biederman, Timothy Wilens, and Thomas Spencer as
      "pioneers in the field of child mental health" while also endorsing "closely
      managed" collaboration with industry and promising a review of
      conflict-of-interest policies.
      "They are beloved and trusted by thousands of grateful children and families
      who have counted on them for treatment, counseling, help and hope. We know
      this is an incredibly painful time for these doctors and their families, and
      our hearts go out to them," Dr. Peter L. Slavin, hospital president, and Dr.
      David F. Torchiana, head of Massachusetts General Physicians Organization,

      The three psychiatrists received money from companies that made the
      medications they researched and recommended. Biederman's work is widely
      linked to a steep rise in bipolar diagnoses among children.
      On Sunday Biederman told the New York Times “my interests are solely in the
      advancement of medical treatment through rigorous and objective study.”
      The full Mass. General memo follows:

      As you may know, the Sunday New York Times contained a page 1 article
      regarding ongoing inquiries of the US Senate Finance Committee, led by Sen.
      Charles Grassley of Iowa, focusing on relationships between drug companies
      and physicians and academic institutions. This story, which was picked up by
      the Boston Globe and other media outlets, described Sen. Grassley’s
      inquiries into the financial disclosures of three MGH psychiatrists, Joseph
      Biederman, MD, Timothy Wilens, MD, and Tom Spencer, MD, all pioneers in the
      field of child mental health. During this process, the committee raised a
      number of questions about our institutional policies for interactions with
      industry and about the information provided by the physicians about the
      payments they received from certain pharmaceutical companies. We wanted you
      to be aware of a number of issues related to this situation.

      First, we want to state that MGH firmly believes that appropriate and
      closely managed collaborations between academia and industry are important
      in the ongoing quest to discover treatments, cures and preventions for
      diseases that afflict millions of people worldwide. The innovative work of
      scientists at institutions like the MGH provides the intellectual and
      scientific foundation for so many of the therapies that industry has
      developed, tested, manufactured and carried to the marketplace to benefit
      Second, we want to emphasize that the three MGH physicians being reviewed
      have all been vital players in such productive collaborations with industry.
      Their impressive body of academic work, backed up by significant data and
      rigorous science, has earned them reputations as international leaders in
      the understanding and treatment of serious pediatric psychiatric disorders.
      Perhaps most important, they are beloved and trusted by thousands of
      grateful children and families who have counted on them for treatment,
      counseling, help and hope. We know this is an incredibly painful time for
      these doctors and their families, and our hearts go out to them.
      You also should know that MGH has cooperated fully with Sen. Grassley. We
      have provided the disclosure forms requested as well as information about
      our conflict-of-interest processes and systems for disclosing relationships
      with and income from industry. As a recipient of significant public research
      funds, the MGH embraces its obligation to not only uphold science that is
      rigorous and sound, but also to conduct research according to the highest
      ethical standards and in compliance with rules and regulations designed to
      ensure quality, objectivity and accuracy.

      Finally, we want you to know that the MGH takes Senator Grassley’s concerns
      regarding financial disclosures very seriously and has undertaken a thorough
      internal review of all the issues raised by him. Harvard Medical School is
      likewise doing the same with respect to compliance with its policies. In
      addition, the MGH is participating in a senior administrative commission
      initiated by Partners HealthCare that aims to re-examine all of our policies
      relating to our interactions with industry to ensure that they appropriately
      address all issues in the relationships between Partners institutions and
      its physicians and industry.

      Our ultimate hope is that after such a comprehensive review, our processes
      will be further enhanced, strengthened and streamlined. We will no doubt
      learn a great deal from this experience – as difficult as it may be – and we
      must be willing to share the insights and perspectives we gain to improve
      conflict-of-interest processes not just here, but at academic institutions
      Peter L. Slavin, MD, President, MGH

      David F. Torchiana, MD, Chairman and CEO, MGPO

      Comments so far...
      1. The drugging of children for profit. Did they promote this agenda to
      help children, or line their pockets. There are very strict disclosure rules
      on this type of thing.
      Posted by Kevin June 11, 08 05:25 PM

      2. This sounds quite a bit like the 50's when MD's at MassMental fed
      disabled children oatmeal laced with radioactive isotopes - never bothering
      to disclose the nature of the research being conducted to the families.
      American "medicine" today is simply the user interface of the
      Insurance-Pharma-Industrial Complex.
      These "healers" prove the rule rather than the exception. Corporate
      platitudes and goobleygook from other MDs written by PR flacks in their
      employ ring hollow indeed.
      Posted by terrence mckenna June 11, 08 06:05 PM

      3. For so highly regarded an institution, MGH has released a statement
      not unlike those disseminated by college football coaches after a star
      halfback gets caught cheating on his exams.
      The physicians charged with inappropriate behavior related to money big
      enough to pay for swanky places on the Cape are "beloved and trusted." Being
      fingered for failing to comply with requirements to report exceptionally
      lucrative arrangements has created "an incredibly painful time for these
      doctors and their families, and our hearts go out to them." The accused are
      "vital players" and "international leaders."

      Given the tone of this statement, I think that that I can predict the
      outcome of the "thorough internal review of all the issues raised." Rather
      than being fired for embarrassing the institution for what what may be
      kindly called inappropriate behavior, my hunch is that these guys will stay
      in the starting MGH lineup. Just as in big-time college football, there is
      too much money at stake for an honest consideration of ethics and integrity.
      Appropriate consequences are for those that don't play the game seriously.
      To adapt the "haec olim meminisse iuvabit" passage from the Aeneid to this
      circumstance: "Some day they will look back upon this time and laugh about
      it over gin and tonics on the Cape."
      Posted by octoberjazz June 11, 08 07:12 PM ~~~~~~~~~~~~~~ THE NEW YORK TIMES
      June 16, 2008 Letters Doctors, Research and Drug Payments Re “Researchers
      Fail to Reveal Full Drug Pay” (front page, June 8) and “Hidden Drug Payments
      at Harvard” (editorial, June 10):

      The first obligations of those who conduct lifesaving research at American
      medical schools, teaching hospitals and research universities are to protect
      the safety of patients and assure the integrity and objectivity of science.
      Researchers and their institutions must reveal to research participants
      potential financial conflicts of interest and comply with reporting
      Our associations’ recent report, “Protecting Patients, Preserving Integrity,
      Advancing Health,” urges our medical schools and research universities to
      require clinical research faculty to report all outside income directly or
      indirectly related to professional responsibilities.

      The report also strongly urges our institutions to develop and carry out
      rigorous oversight policies for institutional conflicts of interest.
      The public must be assured that scientific results are honest and that
      patient safety is not compromised for financial gain. We are committed to
      these principles and hope to work with Senators Charles E. Grassley and Herb
      Kohl in their legislative effort.

      Robert M. Berdahl
      Darrell G. Kirch
      Washington, June 11, 2008
      The writers are presidents of, respectively, the Association of American
      Universities and the Association of American Medical Colleges.
      The public deserves to have access to information about relationships
      between medicine and the pharmaceutical industry (“Hidden Drug Payments at
      Harvard,” editorial, June 10), just as the public should be aware of
      relationships between legislators and lobbyists.
      Once we know about relationships, we can consider whether any potential
      conflicts they pose affect our own interests.
      These relationships can have positive outcomes. Financing for much of the
      research that has allowed rapid advances in diagnosing and treating
      illnesses comes from the same pharmaceutical companies and device makers
      that profit when the research is successful. Often medical schools depend on
      income from this industry-backed research to educate the next generation of

      The American Psychiatric Association supports and encourages the full
      disclosure of relationships between physicians and pharmaceutical companies
      and any other possible sources of conflicts of interest. Transparency helps
      to protect medical education, research and care.
      But for real solutions, we have to look even further to ourselves and to our
      government to pay for the kind of medical education and research that has
      for decades provided new and better treatments for medical conditions.

      Nada Stotland
      Chicago, June 11, 2008
      The writer, a medical doctor, is president of the American Psychiatric
      While it is good news that there is a bill introduced in the Senate that
      would require “drug and device makers” to disclose payments to doctors that
      exceed $500 annually, such disclosure should also be easily accessible to
      parents and other consumers.
      In New York, a parent’s informed consent is required before a doctor can
      administer nonemergency psychotropic drugs to a child. In order to make a
      fully informed choice, parents must be aware of all the relevant
      information, which should include a doctor’s potential conflict of interest.
      Lawyers are bound to disclose potential conflicts of interest because they
      may compromise the lawyer’s professional integrity. Doctors should be held
      to the same standard, especially where the lives of children are at stake.

      Diane Goldstein Temkin
      New York, June 10, 2008
      The writer is a lawyer with the Mental Hygiene Legal Service, a state agency
      that protects the rights of the mentally disabled.
      The Child and Adolescent Bipolar Foundation supports full disclosure of
      pharmaceutical company payments to physicians and researchers. Parents and
      doctors need all the information to evaluate research on treatments,
      including information about potential conflicts.
      Families living with pediatric bipolar disorder face challenges few others
      can imagine. Their children may be suicidal or explosive and unable to
      function in school or at home.
      Early treatment saves lives and improves the long-term prognosis, but
      diagnosis typically trails onset by a decade. We cannot allow controversy or
      confusion to further harm children yet undiagnosed.

      Complex psychiatric conditions like pediatric bipolar disorder require more
      well-designed, large-scale and long-term studies. These studies should be
      federally financed, so researchers will be less reliant on pharmaceutical

      Susan Resko
      Exec. Dir., Child and Adolescent
      Bipolar Foundation
      Wilmette, Ill., June 8, 2008

      June 17, 2008
      I am writing as the parent of a child who suffered from early-onset rapid
      cycling Bipolar II as well as many other illnesses.
      It is astounding to me the kind of outrageous attacks Senator Charles E.
      Grassley has maintained against Dr. Joseph Biederman in particular and
      pediatric psychiatric research in general.

      There is no one more dedicated or concerned for the vast numbers of children
      suffering from these devastating illnesses than Dr. Biederman and the
      extraordinary group of doctors he has assembled into a world-famous team to
      try to save them. If these doctors were looking to make fortunes, they would
      not be in research; perhaps they would not be treating these most difficult
      cases, which demand their attention 24 hours a day.
      Perhaps it would serve the taxpayers better if their hard-earned dollars
      were spent delving into the huge amounts of corporate greed and lack of
      accountability rather than constantly attacking these courageous pioneers.

      We should be paying special homage to this group of incredibly dedicated,
      brilliant and caring doctors who make even the most fleeting stability
      possible for children who suffer from unfathomable demons and terrors.
      It is all too easy to accuse in this country. And after reputations are
      dirtied, no matter how innocent one is, who is there to shout out for
      innocence and excellence?

      Lynn Tesher
      New York, June 8, 2008
      The writer is on the Pediatric and Adolescent Advisory Council at
      Massachusetts General Hospital

      Copyright 2008 The New York Times Company

      To the Editor:
      The forty-fold increase between 1994 and 2003 in children diagnosed with
      “bipolar disorder” (news story, June 8, but not mentioned by June 16’s four
      official “letters to the editor”) is at least as important as the hidden
      drug payments to psychiatrists involved in this epidemic. The increase
      results from psychiatrists’ labeling children and then drugging them, rather
      than helping parents teach youngsters self-control through appropriate
      limits on temper tantrums and other mood-swings – as mental health
      professionals did routinely before biological psych¬iatry took over the

      Such excessive swings are part of almost everyone’s growing up. Parents
      have controlled them from time immemorial by setting firm, warm, consistent
      limits. But when parental authority is undermined – when the swings scare
      the parents, or the latter are divided on how to handle them - the cycles
      may continue and even worsen.

      Calling such mood-swings “bipolar disorder” aggravates them further by
      defining them as “illnesses” beyond the capacity of either child or parents
      to control. This undermines parental authority still more. And when
      physician-prescribed drugs are relied on to control such swings, the swings
      can become the focus of a family’s entire life – with results that can be

      When will today’s biopsychiatrists recognize that substituting drugs for
      competent child-rearing creates tragedies like that of Rebecca Riley? She
      died at age 4 after being started at 28 months (also called the Terrible
      Twos) because of “bipolar disorder” on powerful prescribed medications
      (unapproved for children) by a university psychiatrist, who pre¬scribed
      similarly for her two older siblings.

      Nathaniel S. Lehrman, M.D.,
      10 Nob Hill Gate, Roslyn NY 11576; 516/626-0238.
      Former Clinical Director, Kingsboro Psychiatric Center NY; former Assistant
      Clinical Professor of Psychiatry, Albert Einstein and SUNY Downstate College
      of Medicine.

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