ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
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
psychiatrys diagnostic manual the DSM-IVwhich determines the criteria for
issuing diagnosesand psychiatrys 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 psychiatristswhose
influence has succeeded in popularizing a previously unaccepted diagnosis
in childrenBipolar (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 organizations 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
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
"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. Grassleys
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 Grassleys 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
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.
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 parents 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 doctors potential conflict of interest.
Lawyers are bound to disclose potential conflicts of interest because they
may compromise the lawyers 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
Exec. Dir., Child and Adolescent
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?
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 16s 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 everyones 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 familys entire life with results that can be
When will todays 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
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