A Congressional investigation led by Sen.
Charles Grassley revealed in June that a world-renowned Harvard University
child psychiatrist and two of his colleagues failed to declare millions of
dollars in consulting fees from drug manufacturers to university officials.
Dr. Joseph Biederman, known as one of the
most prominent advocates of diagnosing bipolar disorder in children, was
accused of failing to disclose more than $1 million in payments from drug
companies. Harvard
Medical School
is investigating the case.
An e-mail from an employee of Johnson &
Johnson revealed that Dr. Biederman’s intention was to create a joint center
for bipolar disorders in children. The hospital said in a statement that its
grant specified the purpose of the center was scientific and educational, not
to promote J&J’s products.
A spokesman for Boston-based Harvard Medical School
said Harvard isn’t involved with the center at Massachusetts General.
The allegations “have raised significant
questions and concerns about the implementation of those agreements,” a
statement from Massachusetts
General Hospital
reads. “The grant agreements stated that the center was for scientific and
educational purposes only and not for purposes of promoting, directly or
indirectly, the products of Johnson & Johnson and its affiliates,” the
statement said.
According to newly disclosed court
documents submitted to the FDA panel last week, the Johnson & Johnson drug
Risperdal, also known as risperidone, is increasingly being prescribed to
children for unapproved uses. A government study published online by the
American Journal of Psychiatry found no major differences between older and
newer antipshychotics in treatment outcomes, but found significant differences
in side effects among youths taking the drugs. The study has found that
children who took newer antipsychotics, such as Zyprexa from Eli Lilly and
Risperdal from Janssen experienced weight gain and increases in total
cholesterol, LDL “bad” cholesterol, insulin and liver enzymes. Other side
effects may include muscular tics and increased risk of diabetes. The
newer-generation drugs were developed to avoid the side effects of older drugs,
which can produce Parkinson-like symptoms, such as involuntary movements,
rigidity and even permanent physical disabilities.
Thousands of parents have
sued Eli Lilly and Johnson & Johnson, claiming that their children were
injured after taking the medicines. Lawyers for the families argued that they
should be allowed to interview Dr. Biederman because his work has contributed
to the widespread acceptance of pediatric use of antipsychotic medicines.
The psychological condition known as
bipolar disorder, formerly known as Manic-Depressive Illness, is characterized
by episodes of significant disturbance in mood and the individuals affected
experience manic and depressive episodes. Bipolar disorder also carries a high
risk of suicide. Experts say that in the long term, those affected by the
condition may experience depressive symptoms three times longer than manic
symptoms. People diagnosed with bipolar disorder receive medication such as
mood stabilizers, anti-psychotic and antidepressants.
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