GSK faces renewed scrutiny over Paxil as unsealed study claims firm "improperly" counted placebo cases

GlaxoSmithKline is under renewed scrutiny over its antidepressant Paxil (paroxetine HCl), after a US study suggested that the UK drug major improperly counted patients taking placebo to minimize the differences in suicide rates between the two groups (Marketletters passim).

A recently unsealed report prepared by Joseph Glenmullen, a professor of psychiatry at Harvard University, and commissioned by plaintiff's lawyers, claims that GSK downplayed the differences in suicide rates by including in the placebo group those who had attempted suicide before the study formally started.

When parts of the study were unsealed last February, GSK issued a statement saying that it was unscientific, using only part of the information available. In a letter dated June 12, Sen Chuck Grassley asked the US Food and Drug Administration to carefully scrutinize information it received from GSK about Paxil. Sen Grassley has also asked the FDA to review findings recently released by the UK drug safety agency which said that the firm had known about suicide risk with pediatric use of Paxil since 1998.