Glaxo reels over US lawsuit

DRUGS giant GlaxoSmithKline faces another day of turbulence on the stock market after it was accused in New York of fraudulently concealing studies showing that its anti-depressant Paxil may cause suicidal behaviour in children.

New York Attorney General Eliot Spitzer has filed a civil fraud suit against the firm saying Glaxo conducted at least five studies on the use of Paxil in children and adolescents but published only one of them.

Even that had mixed results, he said. '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,' Spitzer said.

This amounted to 'repeated and persistent fraud,' he said.

Glaxo denies all charges. Spokeswoman Mary Ann Rhyne said the company disseminated information about all its trials either in medical journals or at public scientific meetings as well as to regulatory agencies.

Paxil, which is marketed as Seroxat in the UK, is approved in the United States only for adults, but doctors are still allowed to prescribe it for children.

Regulators in the UK and the US, however, have warned against its use for patients under 18 years because of concerns over apparently higher suicide rates.

Spitzer claims that Glaxo's actions prevented doctors from exercising proper judgment in deciding whether to prescribe Paxil for children.

The court papers lodged in the New York Supreme Court in Manhattan, cite an internal Glaxo memo from 1999, which said Glaxo intended to 'manage the dissemination of the data in order to minimise any potential negative commercial impact'.

But Rhyne dismissed this evidence, saying the 'memo is inaccurate, inconsistent with the facts, and did not express the overall company position'.

Spitzer also alleges that Glaxo misrepresented the results of its research to its sales representatives, saying the drug had 'remarkable efficacy and safety in the treatment of adolescent depression'.

The attorney general demands that Glaxo give up all profits from the sale of Paxil in New York and is seeking unspecified damages for affected users.

Paxil‘s worldwide sales last year were £1.8bn.

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