GlaxoSmithKline will face accusations in court that the company misled US doctors about the safety of prescribing its antidepressant Paxil to children, a lawsuit having now been filed by New York State Attorney General Eliot Spitzer who claims important information was concealed.

Mr Spitzer claims the company engaged in "repeated and persistent fraud" by concealing and failing to disclose information on the drug, known as Seroxat in the UK.

In March this year, the FDA told all manufacturers in the SSRI market to carry warnings about worsening depression or the emergence of suicidality, but said there was no conclusive evidence the drugs were causing these and other side effects.

An investigation by the EMEA came to a similar conclusion, while the UK's own inquiry which sparked international concerns concluded that only fluoxetine (Lilly's Prozac) should be prescribed to children under sixteen.

Controversy has surrounded the issue for several years, with a handful of campaigners accusing GSK and other companies of a cover-up or alleging incompetence among regulators.

Adding its voice to such claims, the New York State lawsuit alleges that GSK conducted at least five studies on the use of Paxil in children and adolescents, but only published and disseminated one, which showed mixed efficacy results.

The lawsuit alleges the company suppressed negative results from other studies, and even cites an internal GSK document from 1998 which it quotes as saying, aimed to "manage the dissemination of data in order to minimise any potential negative commercial impact".

"Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients," Mr 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 seeks to seize all profits earned by GSK as a result of the alleged conduct, which the state says amounted to $55 million in 2002 alone.

The company has rejected all the claims, saying in a statement that it has acted responsibly in conducting its trials and disseminating data, and that all paediatric studies have been made available to the FDA and regulatory agencies worldwide.

Regarding the apparently damning internal 1998 memo, the company said: "It is inconsistent with the facts and does not reflect the company's position."

Paxil/Seroxat was GSK's biggest selling drug in 2002, but loss of its original US patent has hit sales, despite the launch of new patent-protected extended release formulations.

In the UK, the ongoing special inquiry into the drug and the SSRI class seems to have seriously undermined confidence in the drug: GSK's 2003 sales in England falling more than 25% to £64.3 million.

Earlier this year, GSK lost its UK patent exclusivity following a challenge from generic companies, opening up the company to further revenue losses.

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Thursday , April 01, 2004

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