Biederman J & J Risperdal Documents

The New York Times reports (below)

"Dr. Biederman’s work helped to fuel a 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children. Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions in the world."

An early e-mail (dated 1999) states: "Dr. Biederman is not someone to jerk around.  He is a very proud national figure in child psych and has a very short fuse."  A 2001 e-mail refers to university-based clinical trial programs as "growth opportunity" exercises similar to "money on the table" exercises.

A Feb. 5, 2002 email related to the Johnson & Johnson Pediatric Research Center established at Harvard’s Massachusetts General Hospital, states that:

Dr. Biederman "approached Janssen multiple times to propose the creation of the [center]  to generate and disseminate data to support the use of risperidone in this patient population."

"Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events."

A 2002 annual report for the J&J funded Mass General Children’s Center stated that an "essential feature" of its research is to "move forward the commercial goals of J&J."

Dr. Biederman is the researcher whose "science" the FDA said it was leaning upon when it decided that pediatric bipolar disorder was a valid diagnosis back in July.

The Wall Street Journal notes (below) that the Center’s research work–as described in the annual report–appeared to focus exclusively on Risperdal.

In 2001, Dr. Biederman began a three-year study on the use of Risperdal in 4- to 6-year-olds. That work, the WSJ reports, appears to have violated rules at Harvard and Mass General forbidding researchers from conducting clinical trials of a drug if they receive payments of more than $20,000 a year from a drug maker.

Dr. Biederman and colleagues have published dozens of favorable studies on the drug. For example, a 2005 study concluded that "risperidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder."

The commercial value of academic psychiatrists is acknowledged in a March 22, 2002 e-mail describing Dr. Biedeman’s persuasive skills in convincing 1,000 psychiatrists about the validity of pediatric mania and the utility of Risperdal: 

"I think this is a clear example of the utility of partnering with a group such as MGH, who has the potential of reaching and having a significant impact upon the field of child and adolescent psychiatry with these types of professional activities in non-sponsored venues." 

The Times quotes a June 2002 e-mail from Dr. Gahan Pandina, a Johnson & Johnson executive, to Dr. Biederman which included a brief abstract of a study of Risperdal in children "diagnosed" with disruptive behavior disorder. The study was intended to be presented at the 2002 annual meeting of the American Academy of Child & Adolescent Psychiatry.

One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly, "so, if you could, please give some thought to how to handle this issue if it occurs."

The draft abstract that Dr. Pandina included in the e-mail, however, misrepresented the actual findings:
the abstract stated that only the children given Risperdal improved, while those given placebos did not.

According to the e-mail, when asked to sign a form listing himself as author so the company could present the study to the conference, Dr. Biederman responded: "I will review this morning. I will be happy to sign the forms if you could kindly send them to me."
The documents do not make clear whether Dr. Biederman approved the final summary of the brief abstract or asked to read the longer report on the study.

The WSJ reports that the emails suggest that the company’s marketing staff were involved in creating the institute and that company officials helped to write and vet research work done by Dr. Biederman and his associates. The WSJ further reports that a Harvard spokesman, said the university is not directly involved in the child psychiatry center at Massachusetts General Hospital.

However, the MGH website proudly states: "over the last 30 years we [psychiatry department] have been offering educational programs in Boston through Harvard Medical School’s Division of Continuing Education which have drawn thousands of colleagues to learn a broad range of topics…" and "17 faculty members [of MGH psychiatry department] have achieved full professor rank at Harvard Medical School, the highest number in any department at the MGH."

The e-mails were part of a group of documents submitted by plaintiff’s attorneys seeking a judge’s order to require Dr. Biederman to be deposed under oath were obtained by the Alliance for Human Research Protection after they became public.
Dr. Biederman is scheduled to be deposed in Boston on January 30, 2009.

These internal emails validate the view that partnerships and financial ties between drug manufacturers and academia undermine the integrity of medical research and, by extension, the practice of medicine.

The absence of independent checks and balances in medicine, the absence of trustworthy government gatekeepers to guard against corrupt practices, millions of American children are being forced to ingest unsafe, toxic psychotropic drugs for unvalidated scientifically unsupportable "conditions." 

Drug manufacturers are hardly the only ones to blame–American children are being victimized by a consortium of influential psychiatrists at prestigious academic institutions–a list of about 30 KOLs (key opinion leaders in
psychiatry) is contained in one of the J & J Risperdal documents; psychiatry’s professional associations lend their "authoritative" support to this crime–as do a bevy of industry-financed patient "advocacy" groups. As if that were not enough, government agencies that were established to protect the public health and the scientific process have also come under the influence of industry.

These commercially-driven stakeholders are condemning children to a life of drug dependency and drug-induced disabling chronic physical and mental illnesses.

If the new administration is serious about healthcare reform–a suggestion to protect children from harm and save (literally) hundreds of millions of taxpayer dollars.

First, Medicaid should not pay for off-label use of drugs for unvalidated non-life-threatening conditions.
Secondly, doctors prescribing psychotropic drugs for children should be registered, and the prescriptions monitored for abuse by the DrugEnforcement Agency.  

See, several internal J & J documents posted on the WSJ website:
Discussions about the Children’s Center

A breakdown of J & J’s goals and budget for the Center research

posted by Vera Hassner Sharav

~~~~~~~~~~~

THE NEW YORK TIMES
November 25, 2008
Research Center Tied to Drug Company
By GARDINER HARRIS

When a Congressional investigation revealed in June that he had earned far
more money from drug makers than he had reported to his university, Dr.
Joseph Biederman, a world-renowned child psychiatrist, said that his
"interests are solely in the advancement of medical treatment through
rigorous and objective study."

But e-mails and internal documents from Johnson & Johnson made public in a
court filing reveal that Dr. Biederman pushed the company to fund a research
center at Massachusetts General Hospital whose goal was "to move forward the
commercial goals of J&J," the documents state. The documents also show that
Johnson & Johnson wrote a draft summary of a study that Dr. Biederman, of
Harvard University, was said to author.

Dr. Biederman’s work helped to fuel a 40-fold increase from 1994 to 2003 in
the diagnosis of pediatric bipolar disorder and a rapid rise in the use of
powerful, risky and expensive antipsychotic medicines in children. Although
many of his studies are small and often financed by drug makers, Dr.
Biederman has had a vast influence on the field largely because of his
position at one of the most prestigious medical institutions in the world.
Johnson & Johnson manufactures Risperdal, also known as risperidone, a
popular antipsychotic medicine. More than a quarter of Risperdal’s use is in
children and adolescents.

Last week, a panel of federal drug experts said that medicines like
Risperdal are being used far too cavalierly in children and that federal
drug regulators must do more to warn doctors of their substantial risks.
Other popular antipsychotic medicines, also referred to as neuroleptics, are
Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by
Pfizer; and Abilify, made by Bristol-Myers Squibb.

Thousands of parents have sued Johnson & Johnson, AstraZeneca and Eli Lilly,
claiming that their children were injured after taking the medicines, whose
risks the companies minimized, the parents claim. As part of the suits,
plaintiffs’ attorneys have demanded millions of documents from the
companies. Nearly all of those documents have been provided under judicial
seals, but a select few that mentioned Dr. Biederman became public after
plaintiffs attorneys sought a judge’s order to require Dr. Biederman to be
interviewed by plaintiff attorneys under oath.

In a motion filed two weeks ago, attorneys for the families argued that they
should be allowed to interview Dr. Biederman under oath because his work has
been crucial to the widespread acceptance of pediatric uses of antipsychotic
medicines. To support this contention, the lawyers included more than two
dozen documents, including e-mails from Johnson & Johnson that mentioned Dr.
Biederman. That interview request has yet to be ruled upon.

The documents offer an unusual glimpse into the delicate relationship that
drug makers have with influential doctors. In one November 1999 e-mail, John
Bruins, a Johnson & Johnson marketing executive, begs his supervisors to
approve a $3,000 check to Dr. Biederman in payment for a lecture he gave at
the University of Connecticut.
"Dr. Biederman is not someone to jerk around," Mr. Bruins wrote. "He is a
very proud national figure in child psych and has a very short fuse."

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson
rejected a request that Dr. Biederman had made to receive a $280,000
research grant. "I have never seen someone so angry," Mr. Bruins wrote.
"Since that time, our business became non-existant (sic) within his area of
control."
Mr. Bruins concluded that, unless Dr. Biederman received a check soon, "I am
truly afraid of the consequences."
A series of documents described the goals behind establishing the Johnson &
Johnson Center for the study of pediatric psychopathology, for which Dr.
Biederman still serves as chief.

A 2002 annual report for the center stated that its research must satisfy
three criteria: improve psychiatric care for children, have high standards
and "move forward the commercial goals of J&J," according to court
documents.
"We strongly believe that the center’s systematic scientific inquiry will
enhance the clinical and research foundation of child psychiatry and lead to
the safer, more appropriate and more widespread use of medications in
children," the report stated. "Without such data, many clinicians question
the wisdom of aggressively treating children with medications, especially
those like neuroleptics, which expose children to potentially serious
adverse events."

A February 2002 e-mail from Georges Gharabawi, a Johnson & Johnson
executive, stated that Dr. Biederman approached the company "multiple times
to propose the creation" of the center. "The rationale of this center is to
generate and disseminate data supporting the use of risperidone in" children
and adolescents, the e-mail stated.
Johnson & Johnson gave the center $700,000 in 2002 alone, documents show.

A June 2002 e-mail from Dr. Gahan Pandina, a Johnson & Johnson executive, to
Dr. Biederman included a brief abstract of a study of Risperdal in children
suffering disruptive behavior disorder. The study was intended to be
presented at the 2002 annual meeting of the American Academy of Child &
Adolescent Psychiatry, the e-mail stated.
"We have generated a review abstract, but I must review this longer abstract
before passing this along," Dr. Pandina wrote. One problem with the study,
Dr. Pandina wrote, is that the children given placebos and those given
Risperdal both improved significantly, "so, if you could, please give some
thought to how to handle this issue if it occurs."

The draft abstract that Dr. Pandina included in the e-mail, however, stated
that only the children given Risperdal improved, while those given placebos
did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as
author so the company could present the study to the conference, according
to the e-mail.
"I will review this morning," Dr. Biederman responded, according to the
documents. "I will be happy to sign the forms if you could kindly send them
to me." The documents do not make clear whether Dr. Biederman approved the
final summary of the brief abstract in similar form or asked to read the
longer report on the study.

Drug makers have long hired professional writers to compose scientific
papers and then recruited well-known doctors to list themselves as authors.
The practice, known as ghostwriting, has come under intense criticism
recently, and medical societies, schools and journals have condemned it.
In June, a Congressional investigation revealed that Dr. Biederman had
failed to report to Harvard at least $1.4 million in outside income from
Johnson & Johnson and other makers of antipsychotic medicines.

In one example, Dr. Biederman reported no income from Johnson & Johnson for
2001 in a disclosure report filed with the university. When asked by Senator
Charles E. Grassley, a Republican of Iowa, to check again, Dr. Biederman
said he received $3,500. But Johnson & Johnson told Mr. Grassley that it
paid Dr. Biederman $58,169 in 2001.

On Monday, David J. Cameron, a Harvard spokesman, said the university was
still reviewing Mr. Grassley’s allegations against Dr. Biederman. He added
that they had not seen the drug company documents in question and that the
university is not directly involved in the child psychiatry center at
Massachusetts General Hospital.

Calls to Dr. Biederman were not returned. Johnson & Johnson did not
immediately comment or make executives available for comment.

Copyright 2008 The New York Times Company
~~~~~~~~~~ 

THE WALL STREET JOURNAL     
NOVEMBER 25, 2008
J&J Emails Raise Issues of Risperdal Promotion
By DAVID ARMSTRONG and ALICIA MUNDY

Johnson & Johnson planned funding for a research institute to focus on use
of the antipsychotic drug Risperdal by children well before the treatment
was approved for patients that young, according to internal emails produced
in a lawsuit against the company.

The 2001 and 2002 emails, which circulated in the drug maker’s Janssen unit,
raise issues of whether the company helped promote, through the institute,
an unapproved use of Risperdal, which wasn’t cleared by the Food and Drug
Administration for widespread use in minors until 2007.
Doctors may prescribe FDA-approved drugs as they see fit, but companies
aren’t permitted to market them for uses that aren’t approved by the agency.

Documents
.    J&J email describing discussions about the institute
.    A breakdown of J&J’s goals and budget to support work on Risperdal
for children and adolescents
Risperdal, which had sales of $4.9 billion last year, is the focus of a
growing debate over whether antipsychotic drugs are overused in children. At
the center of the controversy is a Harvard University psychiatrist, Joseph
Biederman, who proposed and ultimately headed the institute that J&J funded
— the Johnson & Johnson Center for the Study of Pediatric Psychopathology,
at Boston’s Massachusetts General Hospital.

J&J, in a statement, said it helped to fund the center in 2002 "with an
objective to conduct rigorous clinical trials to clarify appropriate use and
dosing of Risperdal in children." It noted that some of those uses were
later approved by the FDA, and it said the company only promotes its
products for FDA-approved indications. Dr. Biederman didn’t return phone
calls seeking comment.

Dr. Biederman has been a leading advocate for wider childhood and adolescent
use of the drug. The emails were provided to a New Jersey court as part of
an effort by patient plaintiffs to force the psychiatrist to testify in
their suit against J&J over alleged harms caused by Risperdal. The company
has said the drug’s side effects are limited, and it has defended
Risperdal’s safety in previous statements.

In a statement Monday, Massachusetts General said "the allegations related
to the Johnson & Johnson Center that were described in various media reports
today have raised significant questions and concerns about the
implementation of those agreements. The MGH takes these allegations very
seriously, and intends to investigate these issues thoroughly."

Risperdal was being prescribed to thousands of teens and younger children
before it was approved in mid-2007 for use in children and adolescents with
bipolar disorder, according to data presented at an FDA panel last week. The
doctors’ panel convened by the FDA said that antipsychotics have been
overprescribed to children and adolescents; nearly 390,000 were given
Risperdal in 2007, and 200,000 of them were under the age of 12.

The diagnoses included attention-deficit disorder, for which the drug isn’t
approved. Risperdal, whose chemical name is risperidone, has been linked to
side effects including serious weight gain and diabetes.

The emails in the lawsuit indicate that Dr. Biederman approached Janssen to
start the institute. A spokesman for Harvard said the institute isn’t
affiliated with the university.

"Dr. Biederman is the pioneer in the area of [child and adolescent] bipolar
disorders," said a 2002 internal email from a Janssen researcher to others
at the company. "He approached Janssen multiple times to propose the
creation of a Janssen-MGH center for C&A bipolar disorders. The rationale of
the center is to generate and disseminate data supporting use of risperidone
in this patient population."

In a 2002 annual report for the institute, one of the criteria listed as an
"essential feature of the center" is moving "forward the commercial goals of
J&J," as well as research to "improve the psychiatric care of children."
The documents don’t indicate if Dr. Biederman profited from the work of the
center or derived any income from it. In the 2002 annual report, he was
listed as director of the center.

Internal J&J records that are part of the plaintiffs’ filing indicate that
Janssen paid, or was requested to make payments, of $500,000 to help start
up the center in 2002, another $200,000 for operating funds in 2003 and an
additional $250,000 for 2004 activities. Janssen declined to comment on
those figures.

Dr. Biederman was receiving direct compensation from J&J during those years,
according to records obtained by Sen. Charles Grassley, who has been
investigating drug-company payments to the Harvard researcher and others at
academic medical centers. In 2001, Dr. Biederman was paid $58,169 by J&J
although he reported to Harvard that he was only paid $3,500, according to
Sen. Grassley. In all, Dr. Biederman received more than $1.6 million between
2000 and 2007 from drug companies while reporting to Harvard receiving only
several hundred thousand, Sen. Grassley’s documents show.

Harvard declined to answer specific questions about Dr. Biederman’s pay,
saying there is an ongoing review of his outside compensation.

The center’s research work, according to the annual report, appeared to
focus exclusively on Risperdal. Dr. Biederman and colleagues have published
many favorable studies on the drug. A 2005 study, for instance, concluded
that "risperidone treatment was associated with a significant short-term
improvement of symptoms of pediatric bipolar disorder."

In 2001, Dr. Biederman began a three-year study on the use of Risperdal in
4- to 6-year-olds. That work appears to have violated rules at Harvard and
Mass General forbidding researchers from conducting clinical trials of a
drug if they receive payments of more than $20,000 a year from a drug maker.

The Janssen emails indicate the company was concerned about maintaining a
positive relationship with Dr. Biederman, who is o chief of clinical and
research programs in pediatric psychopharmacology at Mass General, which
includes the Johnson & Johnson Center. "Dr. Biederman is not someone to jerk
around," a company official wrote in 1999. "He is a very powerful national
figure in child pysch and has a very short fuse."

The emails also suggest that the company’s marketing staff were involved in
creating the institute and that company officials helped to write and vet
research work done by Dr. Biederman and his associates. Dr. Biederman has
been ordered to undergo a deposition as part of the New Jersey case on Jan.
10.

Write to David Armstrong at david.armstrong@wsj.com and Alicia Mundy at
alicia.mundy@wsj.com

Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved

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