There he is at the Bacara Resort & Spa in Santa Barbara, California, talking up Paxil CR. Here him chat at the Peninsula Grill in Charleston, South Carolina, the Monterey Fish Grotto in Pittsburgh or Ruth’s Chris Steak House in Birmingham, Alabama. No destination was too far from Atlanta…because Glaxo was paying.
Investigation of Glaxo's Paxil widens: paper June 20/08
A U.S. Department of Justice investigation into whether GlaxoSmithKline PLC withheld data about the suicide risks of the antidepressant drug Paxil is widening, the Wall Street Journal reported on Friday.
Thyroid drug users urged to contact Centre for Adverse Reactions Monitoring. The Adverse Reactions Centre want to hear from Eltroxin users who have suffered side-effects since the thyroid treatment drug was reformulated by GlaxoSmithkline.
An inappropriate analysis of clinical trial data by Glaxo researchers obscured suicide risks associated with Paxil for 15 years, writes The New Scientist, citing court documents that were recently unsealed by a federal court in California.
Two years ago, Glaxo alerted the public to an increased risk of suicide associated with its pill. However, an analysis of internal Glaxo memos and reports suggests the drugmaker had data demonstrating an eightfold increase in suicide risk as early as 1989.
Harvard University psychiatrist Joseph Glenmullen, who studied the papers, tells the mag it was “virtually impossible” Glaxo misunderstood the data. The drugmaker calls that “absolutely false.” He reached his conclusion after reviewing documents obtained by lawyers who have filed about 30 cases against Glaxo over Paxil and suicides or suicide attempts.
The analysis focuses on the so-called washout phase preceding a trial, when subjects stop taking most or all meds to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or a placebo, side effects can’t be attributed to the trial and so are seldom, if ever included in final results, New Scientist notes.
Chuck Grassley of the Senate Finance Committee has just written Glaxo seeking nine pages that weren’t made available with the unsealed documents.
However, Glaxo researchers submitted data to the FDA in the late 1980s and early 1990s that included suicides and suicide attempts from the washout period in the results for the placebo arms, or portions of the trials, but not from the Paxil arms. Glenmullen alleges these extra “placebo” suicides negated suicides attributed to Paxil, making the pill appear safer. He argues that if the washout results had been excluded, the data would have shown Paxil posted an eightfold increase in the risk of suicidal behavior in adults.
Glaxo spokeswoman Mary Anne Rhyne tells the mag that including 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 randomized.” She adds that even without the washout data, paxil still came out as safe as the placebo in the trial. And she accused Glenmullen of incorrectly analyzing the data to reach the opposite conclusion, but she ddidn’t respond the the mag’s request for numerical proof that his conclusion was incorrect.
For his part, Glenmullen suggests the FDA would have acted differently had the washout data been used more explicitly. Rhyne says that documents still under court seal show the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Becher, the FDA staffer who reviewed Paxil safety data, as agreeing during a pre-trial hearing that the use of washout data was “scientifically illegitimate.”
VANCOUVER/CKNW(AM980) March 1, 2008 - The suit alleges Glaxo-Smith-Kline failed to notify pregnant women about the risks associated with the drug (Paxil) and suggests the company targeted pregnant women, who are often susceptible to depression.
Here are some reports compiled from the Health Canada website – for some reason there are no ARs after 2002 – makes one wonder why - Paxil ARs stick out like sore thumb. Also Prozac has an active metabolite norfluoxetine considered to be nearly as active a 5-HT reuptake inhibitor as the parent compound fluoxetine – the combination of long half-life and active metabolite seems to be the reason why Prozac is safer for discontinuation – and the FDA still approves it for children & adolescents. Paxil has the shortest half-life with no active metabolites – very dangerous indeed when trying to discontinue.
GlaxoSmithKline Documents Delivered To FDA - Use of Paxil or Paxil CR in Pediatric Patients
Interesting that they do not date their documents – this is one that the FDA mandated that they put up on their website.
Below are just some of the negative findings buried amongst much gobelygook:
QUOTES FROM DOCUMENT
“In the 3 GSK studies for the treatment of major depressive disorder (MDD) in pediatric patients, treatment with Paxil was not statistically superior to placebo with respect to efficacy (Table 1). “
“In pooled analyses of the pediatric placebo-controlled trials, a difference, on adverse event reporting, was seen between Paxil and placebo in suicidal thinking and suicide attempts. The incidence of adverse events possibly related to suicidal behavior while on therapy (treatment phase plus taper phase) was 2.4% (18/738) and 1.1% (7/647) for Paxil and placebo, respectively; and was 3.4% (25/738) in the Paxil group and 1.2% (8/647) in the placebo group 30 days after therapy. Please refer to Table 5 for incidence of events by disorder. “
“The pooled results of these 5 trials found a significantly greater incidence of suicide-related events occurring in the paroxetine group (22 of 642, 3.4%) compared to placebo (5 of 549, 0.9%) (OR, 3.86; 95% CI, 1.45 – 10.26, P = 0.003). “
“An analysis of placebo-controlled trials of adults with psychiatric disorders showed a higher frequency of suicidal behavior in young adults (prospectively defined as aged 18-24 years) treated with paroxetine compared with placebo (17/776 [2.19%] versus 5/542 [0.92%]), “
An Interview with Paxil Lawyer Karen Barth Menzies
Karen Barth Menzies is a partner of the Los Angeles based law firm of Baum, Hedlund, Aristei, Goldman & Menzies and heads the firm's Pharmaceutical Antidepressant Litigation Department.April 2007
Suppressed Paxil Suicide and Stimulation Data Released
By Dr. Peter Breggin
Dr. Breggin stated, "The drug companies settle almost all legal cases brought against them in order to seal incriminating scientific data. This deprives the FDA, medical profession and public of critical information on drug safety and efficacy.
According to Irving Kirsch in Prevention & Treatment , “there is now unanimous agreement that the mean difference between response to antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents. The small difference between the drug response and the placebo response has been a "dirty little secret". It was not known to the general public, depressed patients, or even their physicians
This website is intended for educational purpose only, and as such any material on this site, under copy write protection, is in no way authorized for reproduction.This website is not intended to provide medical advice and is not maintained by medical practitioners.
