The Wall Street Journal reports (below) that US Justice Department prosecutors met with plaintiffs' lawyers, Karen Barth Menzies and George "Skip" Murgatoyd of Baum Hedlund, representing families suing GlaxoSmithKline. The lawyers indicate that last year they were asked in detail about information they had collected for lawsuits about "what Glaxo told the FDA about Paxil's potential risk of suicidal behavior, between 1989 and 1992, while the drug's approval was pending."

The attorneys "were also asked "if they had information about any activities by company representatives involving the promotion of Paxil's safety and efficacy for teens and children." Prosecutors wanted to know about the research Glaxo did --and whether the claim that "there were no suicidality problems" was a true reflection of what the data really showed.

Prosecutors seek "information, documents and depositions concerning Paxil's potential link to suicidal behavior in adolescents and adults, and how the company portrayed that risk to doctors and to the Food and Drug Administration."

Of note, a recently unsealed court document, an expert report by Harvard psychiatrist, Joseph Glenmullen, MD, reveals that GSK knew as early as 1989 that there was an 8-fold increased risk of suicide for patients taking Paxil. [Link] and [Link] Yet, the company did not acknowledge a suicide risk to the public until 2006 after its concealment of evidence was the focus of a lawsuit by New York State Attorney General. [Link]

Dr. Glenmullen's analysis of data in FDA's possession, focuses on GSK's misattributing suicides and suicide attempts that occurred during the "washout" phase (prior to randomization to drug or placebo) to the placebo. The hazardous effects occurring during the drug washout phase are attributable to the effects of drug withdrawal --not to placebo. GSK thus misrepresented the true findings. Shouldn't FDA officials have caught the misattribution of suicides to placebo--just as Dr. Glenmullen did?

The WSJ reports that "Glaxo hasn't allowed Baum Hedlund's lawyers to share with the FDA the same sealed information that the company gave the Justice Department. Glaxo's outside counsel wrote, "If the FDA wanted additional information, such as the internal documents you propose providing it, they could have requested them from GSK..."

Why did FDA officials look the other way --even after GSK's deceptive practices were uncovered by the BBC (2003), and after GSK's internal (1998) memo revealed that GSK-sponsored reports in medical journals deliberately misrepresented the pediatric safety - efficacy data? [1]

The UK medical authority (MHRA) convened a criminal investigation, finding GSK had failed to submit suicide data. Why then, did FDA officials fail to use the agency's authority to demand the company's clinical trial raw data--so that the Paxil link to suicide could be independently evaluated?

GLAXO's criminal conduct led US Senator Charles Grassley to ask the FDA to investigate the company's marketing of Paxil and its failure to disclose the truth. AHRP urges the Senator to investigate FDA officials who were clearly derelict in failing to carry out their responsibility. Indeed, time and again, FDA officials have demonstrated a lack of interest in protecting the public by warning physicians about lethal risks linked to widely promoted drugs.

For well over a decade, FDA officials denied evidence linking SSRI antidepressants (Prozac, Paxil, Zoloft etc) to an increased suicide risk. Similarly, FDA officials defended COX 2 painkillers (Vioxx, Celebrex etc) despite evidence of a fatal cardiac risk--which the agency's own safety officer warned about. FDA officials ignored a petition from 22 neurologists who asked the agency not to approve Fen Phen (fenfluramine), the lethal diet drug.

And FDA officials are irresponsibly issuing pediatric approvals for exceedingly toxic antipsychotic drugs (Zyprexa, Risperdal, Seroquel). These drugs' debilitating, life-shortening risks are a matter of public record whereas no scientifically valid evidence of these drugs' clinical benefits exist. FDA's unsupportable action will result in accelerating the number of children harmed from exposure to these toxic drugs that are prescribed primarily to controls behavior--i.e., as chemical restraints.

Reference
Clinical trials and drug promotion: Selective reporting of study 329 by Jon N. Jureidini, Leemon B. McHenry, Peter R. Mansfield, in The International Journal of Risk and Safety in Medicine, Volume 20, Number 1-2 / 2008, Pages 73-81