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  • 14/07/2004

the uk pharmaceutical major GlaxoSmithKline (gsk) is facing a lawsuit in the us for allegedly concealing the information about its anti-depressant drug Paxil. The data pertains to adverse side-effects like suicidal tendencies, which the medicine could have on children. The case, filed in the state Supreme Court in Manhattan by New York state attorney general Eliot Spitzer, charges the company with deliberately withholding information about the drug's trials on children.

gsk conducted nine such trials but the result of only one was published in full. Although the drug is registered for use only for people above the age of 18 years, its off-label prescription for children is quite common.

Responding to the lawsuit, gsk's chief executive, Jean-Pierre Garnier, claimed: "We have a policy of publishing our negative data to the authorities.' But experts say drug companies do not publicise negative studies the same way as the positive or neutral ones. Besides, it is difficult for doctors to keep up with findings filed with the authorities.

The lawsuit demands that the company should return all profits made from the sale of the drug for treating children. This amount works out to more than us $367 million.

Besides, the us Food and Drug Administration (fda) has asked gsk to withdraw its advertisement for the drug since it plays down its known side-effects. A uk parliamentary inquiry is also probing the reactions of this drug and other anti-depressants.

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