Poor Andrew gets his health information friom a magazine.

By...............................

GlaxoSmithKline

http://www.oag.state.ny.us/press/2004/jun/jun2b_04.html

Department of Law
120 Broadway
New York, NY 10271
Department of Law
The State Capitol
Albany, NY 12224

For More Information:
(212) 416-8060
For Immediate Release
June 2, 2004

MAJOR PHARMACEUTICAL FIRM CONCEALED DRUG INFORMATION
GlaxoSmithKline Misled Doctors About the Safety of Drug Used to Treat
Depression in Children

State Attorney General Eliot Spitzer today announced a lawsuit against one
of the world's leading pharmaceutical companies for concealing important
information about the safety and efficacy of an anti-depressant drug.

The lawsuit, filed today in New York State Supreme Court in Manhattan,
alleges that GlaxoSmithKline (GSK) engaged in repeated and persistent fraud
by concealing and failing to disclose to physicians information about Paxil,
a drug used to treat depression. Paxil has been approved by the FDA for the
treatment of depression in adults, but not in children. Prozac is the only
antidepressant that has been approved to treat depression in children.
Physicians, however, have professional discretion to prescribe Paxil for
treatment in children, a so-called "off-label" use.

"Doctors should have access to all scientifically sound information so that
they can prescribe appropriate medication for their patients," Spitzer said.
"By concealing critically important scientific studies on Paxil, GSK
impaired doctors' ability to make the appropriate prescribing decision for
their patients and may have jeopardized their health and safety."

The lawsuit alleges that, starting in 1998, GSK engaged in a concerted
effort to withhold negative information concerning Paxil and misrepresented
data concerning Paxil's safety and efficacy when prescribed for depression
in children and adolescents.

Specifically, GSK conducted at least five studies on the use of Paxil in
children and adolescents. However, GSK only published and disseminated one
of these studies, which showed mixed results on efficacy. The lawsuit
alleges that the company suppressed the negative results of the other
studies, which failed to demonstrate that Paxil is effective and which
suggested a possible increased risk of suicidal thinking and acts. GSK is
also alleged to have failed to disclose this information in "Medical
Information Letters" that it sent to physicians.

An internal GSK document from 1998 shows that GSK intended to "manage the
dissemination of (the) data in order to minimize any potential negative
commercial impact."

The lawsuit also alleges that GSK misrepresented the results of its research
on Paxil as a treatment for children and adolescents to its sales
representatives who promote Paxil to physicians. The company portrayed the
drug as having "remarkable efficacy and safety in the treatment of
adolescent depression."

In fact, GSK's studies did not demonstrate that Paxil is effective in
treating children and adolescents with major depressive disorder and showed
the possibility of increased risk of suicidal thoughts and acts in
adolescents. In documents submitted to the FDA and similar agencies in the
United Kingdom and Europe, GSK admitted that its studies "all failed to
separate [Paxil] from placebo overall and so do not provide strong evidence
of efficacy in this indication."

Through these and other acts, GSK deprived physicians of the information
they needed to evaluate the risks and benefits of prescribing Paxil for
children and adolescents and deprived these youngsters of the benefit of
their physicians' professional judgment.

The lawsuit seeks disgorgement of all profits obtained by GSK as a result of
the conduct alleged in the suit.

Barry Perlman, M.D., President of the New York State Psychiatric
Association, said: "The relationship between a doctor and a patient must be
based on a sense of trust. In order to hold true to that principle,
physicians must have access to all relevant medical information regarding
treatment. Any obstacle placed in the way of full and complete communication
with our patients undermines the trust upon which the doctor-patient
relationship is based and prevents us from providing the best care we can to
our patients."

Arthur Levin, Executive Director, Center for Medical Consumers, said: "The
fact is that published drug studies are hugely biased towards good news -
the drug works and is safe - and that studies reaching the opposite
conclusion are likely never to see the light of day. The ability of drug
companies to pick and choose the research they provide doctors in support of
their product is an outrageous conflict of interest and puts us all in
harm's way."

More than two million prescriptions for Paxil were written for children and
adolescents in the United States in 2002. Nearly 900,000 of these
prescriptions were for youngsters whose primary diagnosis was a mood
disorder, the most common of which is depression. Prescriptions for Paxil to
treat mood disorders in children and adolescents translated into US sales
for GSK of approximately $55 million in 2002 alone.

In the last year, the use of Paxil for children and adolescents for the
treatment of major depressive disorder has come under scrutiny by the FDA
and regulatory agencies in the UK, Ireland, Europe and Canada. The FDA has
advised caution in prescribing Paxil in children and adolescents for the
treatment of major depressive disorder and is currently conducting an
analysis of the data related to the use of Paxil and the possibility of
increased suicidal thoughts. Regulatory agencies in the UK, Europe, Ireland
and Canada have recommended that Paxil not be prescribed for adolescents and
children with depression.

GSK is based in the United Kingdom with subsidiaries in the United States
and several other nations.

The investigation was handled by Assistant Attorneys General Rose Firestein
and Shirley Stark, under the supervision of Thomas Conway, Chief of the
Consumer Frauds Bureau, and Joseph Baker, Chief of the Health Care Bureau.

You quoted from a magazine and not the official mouthpiece of
alternative medicine that some posters just love....

http://prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-18-2007/00
04609767&EDATE=

Now it is credible.

Hope this helps.