Senator Grassley goes after GlaxoSmithKline: May have hidden Paxil suicide risk for 15 years.

According to New Scientist, an analysis of internal GSK memos and reports suggests that the company had trial data demonstrating an eightfold increase in suicide risk among adults as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data - a claim the company describes as "absolutely false". It took until 2006 for GSK to add warnings to Paxil about increased rates of suicidal behavior in adolescents; no such warning has been added for adults.

Senator Grassley, ranking member of the Senate Finance committee, and a man who believes light is a good disinfectant, sent a letter to Glaxo today, asking the company to clarify when it became aware of the suicide risks of its antidepressant. The senator also requests the company provide certain pages from Glenmullen's report which remained sealed by the court. (Download Grassley letter and Glenmullen report here.)

Glenmullen's analysis focuses on the "washout" phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself, writes New Scientist. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can't be attributable to the trial and so are seldom if ever included in final results.

However, GSK when submitting data on Paxil to the US Food and Drug Administration included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms.

This threw the results in a tailspin aimed at making Paxil look good.

Glenmullen alleges that these extra "placebo" suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eightfold the risk of suicidal behaviour in adults.

GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data "was intended to present the full picture of events that occurred in all phases of the clinical trials - starting from the time patients were enrolled, before they were randomised". She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn't respond to a request for numerical proof that Glenmullen's verdict was wrong.

No surprises there.

Independent researchers say it was wrong to use washout data as GSK did. "I can't imagine circumstances in which it would be appropriate," says Bruce Psaty of the University of Washington in Seattle.

Neither can BrandweekNRX.

Funny thing is that the wash-out period is used by drug companies to weed out the fast responders; the patients that would easily have responded to placebo. This weakens the placebo reponse in the study, since the quick responders have already been removed, so it makes the antidepressant results look better.

But in this case, that wasn't good enough and GSK decided to included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms.

BrandweekNRX looks forward to Senator Grassley's investigation. And the release of the "missing pages" of Glenmullen's report.

Comments

[Paxil Side Effects]

My name is Michael Smith and i would like to show you my personal experience with Paxil.

I am 40 years old. Have been on Paxil for 5 years now. Please be careful if coming off, i started to wean myself with out doctors help couldnt afford it. I went from 20 mgs to 10 mgs for a month, then 10 mgs to 5 mgs for a month. Because the 20 mgs were way to strong took 20 for 5 years and was always on edge. After about 1 month on 10 felt a little better. I stopped for 7 days completly and man did I feel like shit man I didn’t want to leave the house , shop! I just started back on 5 mgs to get it back in my system. Who know what is the right amount you have to be the test subject on yourself!

I have experienced some of these side effects-
Headaches, tremors, emotional wreck, just the blah's when I 1st started takin wasnt bad, cause I also way taken klonopin.

I hope this information will be useful to others,
Michael Smith