Glaxo Fights Against Public Paxil Trials

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By Evelyn Pringle (about the author) Page 2 of 7 page(s)

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During the January 18, 2008 oral argument on the preemption motion, Judge Damrell himself pointed out that a finding of an increased risk of suicidality in adults would logically apply to children. He specifically stated:

"As a practical matter, if I see there was an association of suicide ideation with anybody and enough of it, the last person I want to see using it is a child. That may not be scientific, but I'm just talking as a grandfather and human being."

However, in his order, Judge Damrell seems to say the exact opposite:

"That later clinical studies ultimately led to a clear signal of pediatric suicidality, and that these studies arguably reflected the initial data in 1989 and 1991 of similar associations among adults, simply does not provide 'reasonable evidence' of the association of pediatric suicidality in February 1997."

"It is difficult to reconcile Judge Damrell's statements during oral argument with his ruling," says senior trial attorney, Ron Goldman of Baum, Hedlund, Aristei & Goldman, the law firm representing the Bratt family.

Baum Hedlund has roughly 30 lawsuits on file involving Paxil-induced suicides and suicide attempts. Over the past 18 years, the firm has handled more than 3,000 cases involving antidepressants, including Glaxo's Paxil, Eli Lilly's Prozac and Pfizer's Zoloft.

The first study Glaxo conducted on children was called Study 329. The study was started in 1994, three years prior to Benjamin's suicide, and was completed in 1998, nine months after his suicide.

Judge Damrell bought Glaxo's argument that, because Study 329 wasn't completed until after Ben Bratt's death, the company could not have warned of a risk in children prior to that. But, during the four years the study was ongoing, Glaxo received numerous reports of suicidal behavior occurring in children taking Paxil.

Coupled with the risk evident from the adult clinical trials since 1989, the Bratt family argues that Glaxo could have and should have warned of the risk for all people taking the drug long before Benjamin ingested Paxil.

Coincidentally, when the study 329 was finally published, the authors stated that, "The adverse-effect profile of paroxetine in this adolescent population was concordant with that reported in studies of adult patients with depression."

The Bratt family argues that, the question of whether reasonable evidence of an association existed between Paxil and suicidality in any population at the time of Benjamin's death is one for the jury.

The question of what Glaxo knew and when Glaxo knew it is also a question for the jury. Glaxo's attempt to continue the parade down this rabbit trail is simply an attempt to divert attention away from the core issue here. The decisive question in a preemption context for the Court to determine is, "was GSK ever prohibited by the FDA from issuing a warning" thus creating a direct and positive conflict. The answer is unequivocally "NO."

Judge Damrell also held that, if Glaxo had warned about a suicide risk for kids prior to 1997, such a warning would have been subject to a misbranding action by the FDA.

According to Mr Goldman, "Under no circumstances, given the regulatory scheme, can a drug be considered 'misbranded' if the science supports a truthful warning of the risk of suicidality."

"Under the law," he says, "it is a drug manufacturer's duty to warn of risks known or reasonably scientifically knowable."

"A drug company that fails or refuses to conduct necessary analyses in a scientifically acceptable manner," he states, "shirks its legal, not to mention ethical and moral, duty to the medical profession and the public."

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