The People Of The State Of New York vs. Glaxosmithkline

[Guest guest]

Wow, what a concept, an attorney general who seems to

be actually representing the people.

 

 

> SSRI-Research

> Sun, 15 Aug 2004 17:43:37 -0400

 

> [sSRI-Research] THE PEOPLE OF THE STATE OF

> NEW YORK vs. GLAXOSMITHKLINE

>

>

http://www.oag.state.ny.us/press/2004/jun/jun2b_04_attach1.pdf

>

> SUPREME COURT OF THE STATE OF NEW YORK

> COUNTY OF NEW YORK

> x

>

> THE PEOPLE OF THE STATE OF NEW YORK, :

> by ELIOT SPITZER, Attorney General of the :

> State of New York, Plaintiff,

>

> GLAXOSMITHKLINE, plc.,

> d/b/a/ GlaxoSmithKline,

> SMITHKLINE BEECHAM CORPORATION,

> d/b/a GlaxoSmithKline, Defendants.

>

> x

>

> TO: THE SUPREME COURT OF THE STATE OF NEW YORK

>

> The People of the State of New York, by their

> attorney, Eliot Spitzer,

> Attorney

> General of the State of New York, allege the

> following upon information and

> belief:

>

>

> PRELIMINARY STATEMENT

>

> 1. GlaxoSmithKline, plc and SmithKline Beecham

> Corporation (doing business

> as GlaxoSmithKline and together referred to as

> " GSK " ) are collectively a

> pharmaceutical manufacturer with net income

> (adjusted earnings) in 2002 of

> over $6.9 billion. GSK has engaged in repeated and

> persistent fraud by

> misrepresenting, concealing and otherwise failing to

> disclose to physicians

> information in its control concerning the safety and

> effectiveness of its

> antidepressant medication paroxetine HCL

> ( " paroxetine " ) in treating children

> and adolescents with Major Depressive Disorder

> ( " MDD " ). GSK sells paroxetine

> in the United States under the

> names Paxil and Paxil CRTM. Until 2003, GSK had

> market exclusivity for

> paroxetine in the US.

>

> 2. Paroxetine has been approved by the United States

> Food and Drug

> Administration

> ( " FDA " ) as safe and effective for treating various

> indications in adults,

> including MDD, social

> anxiety disorder, general anxiety disorder and

> obsessive compulsive disorder

> ( " OCD " ).

> Paroxetine has not been approved for any condition

> or illness in children or

> adolescents.

> However, New York, like other states, permits

> physicians to prescribe

> FDA-approved drugs for

> conditions or diseases for which FDA approval has

> not been obtained when,

> through the exercise

> of independent professional judgment, the physician

> determines the drug in

> question is an

> appropriate treatment for an individual patient.

> This practice is referred

> to as " off-label " use, and

> prescribing paroxetine for children and adolescents

> is an off-label use.

>

> 3. Approximately 2.1 million prescriptions for

> paroxetine were written for

> children

> and adolescents in the United States during 2002.

> Nearly 900,000 of these

> prescriptions were for

> youngsters whose primary diagnosis was a mood

> disorder, the most common of

> which is

> depression. It is estimated that one-third of such

> prescriptions are written

> by non-psychiatrists,

> many by family practitioners and pediatricians.

> Prescriptions for paroxetine

> to treat mood

> disorders in children and adolescents translated

> into US sales for GSK of

> approximately

> $55 million in 2002

>

> 4 GSK has misrepresented information concerning the

> safety and efficacy of

> paroxetine for treating MDD in children and

> adolescents. GSK has allowed

> positive information

> about pediatric use of paroxetine to be disclosed

> publicly, but has withheld

> and concealed

> negative information concerning the safety and

> effectiveness of the drug as

> a treatment for

> pediatric MDD. Thus, GSK has prevented physicians

> 'from properly and

> independently

> exercising their professional judgment on behalf of

> their child and

> adolescent patients with MDD.

> GSK's acts have deprived these youngsters of the

> benefit of their

> physicians' independent

> professional judgment.

>

> 5. The Attorney General of the State of New York

> brings this action to stop

> GSK's

> illegal and deceptive actions, to obtain restitution

> for the New York

> children and adolescents with

> MDD for whom paroxetine has~s been prescribed, for

> disgorgement of profits,

> and for all other

> proper relief.

>