This from Pharmalot:
Last week, US Senator Chuck Grassley called for a probe into Glaxo and the FDA over their handling of the Paxil antidepressant. At issue are the long-standing allegations that the drugmaker knew about suicide risks in children for nearly 15 years but obscured evidence.
In demanding the probe, Grassley cited a report prepared by Joseph Glenmullen, a Harvard psychiatry professor, for litigation in federal court in California over Paxil side effects. The report was unsealed earlier this year, but was missing some pages. Last week, those pages became available and include a section that describes in some detail how Glaxo allegedly manipulated so-called placebo suicides.
These are deaths that occur among patients who are taken off other meds so they can participate in a trial. “The rationale from washing out all drugs is to prevent them from confounding the results of the study, so that all patients start out the study in similar conditions,” according to the Glenmullen report, which goes on to maintain Glaxo “improperly” minimized the differences between Paxil and placebo suicide data in order to obtain favorable results.
As a result, the actual suicide risk was eight times its risk for patients on placebo. “Glaxo was aware of this risk, and hid it,” the report states, as The Wall Street Journal noted over the weekend in a story that refers to the previously missing pages. Here is the full report and page 47 offers a summary of Glaxo’s efforts.