Glaxo Fights Against Public Paxil Trials

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According to the US Supreme Court, preemption applies (1) where it is impossible for a private party to comply with both federal and state law; and (2) where the state law stands as an obstacle to the accomplishment and execution of the full purposes and objective of Congress.

"When carefully analyzed, there is absolutely no evidence showing that it would have been 'impossible' for Glaxo to warn of this very serious risk, an absolute requirement in cases where conflict preemption is raised," Mr Goldman contends.

"To the contrary," he says, "such a warning is in perfect harmony with the FDA regulations and the overarching purpose of the FDA: to promote health and safety in prescription drugs."

In their brief filed in opposition to summary judgment, the Bratt Family stated: "GSK would like to convince this Court that it is merely a 'puppet' when it comes to labeling its multi-billion dollar blockbuster drug, Paxil."

"According to GSK," the brief notes, "it is hapless and at the mercy of the FDA when it comes to the content of Paxil's label."

Glaxo claims it needed the FDA's prior approval to issue a warning. However, the attorneys in the Paxil cases point out that Glaxo itself changed the label and sent out a Dear Doctor letter warning about the suicide risk in May 2006, with no prior approval from the FDA. The FDA never objected to the letter or the strengthened warning label.

The FDA, in its amicus briefs, has asserted twisted logic in these cases because the FDA cannot force a company to add a warning to a label. On March 1, 2005, the FDA's deputy director for the Office of New Drugs, Dr Sandra Kweder, testified at a hearing before the Senate Committee on Health, Education, Labor and Pensions, that the FDA does not have the authority to require a specific label change and that the agency has to negotiate with the companies about how things should be worded, placement, those kinds of things.

During oral argument in SSRI suicide cases, industry attorneys claim that the reevaluation of the suicide risk of all the pediatric studies on SSRIs occurred after Glaxo "voluntarily" offered up the studies to the FDA.

For instance, on December 10, 2007, during oral argument in a case in a federal court in Philadelphia, a Pfizer attorney, Malcolm Wheeler was asked by the court: "What was the tipping point then for the change in position with respect to adolescents and then later extending that to young adults up to age 24?"

Mr Wheeler replied: "The tipping point was because GlaxoSmithKline voluntarily went forward and informed the FDA of some study results and said here are these results."

"And what the FDA did as a result of that," he told the court, "was to conduct a new analysis, pooling the data from nine different drugs, not just SSRIs, but nine different antidepressants, to say when we pool all the data from these various antidepressants, does it indicate any signal that suggests that we ought to do something other than what we've done in the past?"

However, that is a gross misrepresentation of what actually happened. The truth is, according to FDA documents obtained in litigation, that the European Medicines Agency (EMEA) contacted the FDA in mid-2003 to alert officials about the hidden suicide risk in the pediatric Paxil studies.

According to a June 2, 2003, FDA email written by Dr Russell Katz to Dr Andrew Mosholder, the FDA was notified in May 2003, that suicide events were hidden under the term "emotional lability." Dr Katz's email states:

"We have recently become aware of a presumed association between Paxil and suicidality in pediatric patients. We received a call from the EMEA a little over a week ago.

A Dr. Raines told us that the company (GSK) had submitted data that demonstrated that use of Paxil in kids was associated with increased suicidality compared to placebo, and that the company proposed labeling changes.

"I believe she also said that it was in the news, and it was a big issue. Tom and I told her that the company had not informed us of any of this, and we agreed to look into it."

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