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Judge Reverses Paxil Preemption Ruling

A judge has reversed his earlier ruling dismissing a Paxil lawsuit based on the theory of preemption. When he first dismissed the Paxil lawsuit, brought by the family of Father Rick Tucker, US District Court Judge David Hamilton said that Food & Drug Administration (FDA) approval of Paxil prevented claims against its maker, GlaxoSmithKline.

Father Tucker, a 55-year-old Catholic priest, shot himself in the head in 2000 after taking Paxil for depression for less than a month. In his opinion reversing his earlier dismissal of the Tucker case, Judge Hamilton wrote that, in his prior ruling, he “failed to appreciate the significance of the fact that the ongoing ability, authority, and responsibility to strengthen a label still rest squarely with the drug manufacturer.” Hamilton also stated that Glaxo “has acknowledged that the regulations give it the responsibility for proper labeling of Paxil, and that it had the ability to make changes to Paxil’s label when there was “reasonable association” between a serious hazard and a patient’s ingestion of the drug … the FDA’s current position on preemption is not ‘long standing’ but is, in fact, a ‘180-degree reversal’ from its earlier stance … the court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations…. Drug manufacturers have the authority to strengthen warnings without the advance permission of the FDA.

Drug makers and medical device makers have been behind an effort to convince courts that FDA approval bars product liability lawsuits when their products are found to be defective. Earlier this year, in a case involving Medtronic, the U.S. Supreme Court ruled that FDA approval did preempt such lawsuits against makers of defective devices. The High Court is scheduled to hear a similar case involving drug maker Wyeth, and it is expected that the court will rule in favor of drug makers.

Already, a bill is pending in the US Congress that would reverse the Supreme Court ruling and restore the right to bring claims against makers of defective drugs and devices.

Book Shines Light on Paxil Fraud

A new book shines a harsh light on the way GlaxoSmithKline was able to hush up data about Paxil’s suicide risks for so long. In “Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial” details the way Glaxo’s vast financial resources were used to manipulate a Paxil clinical trail.

According to the book, Glaxo discovered a link between Paxil use and suicide in children during one of the clinical trials it funded. But the risk was kept quiet, and Bass contends that the huge payments made to researchers at Brown University who conducted the trial - which included an $800,000 grant - had a lot to do with the cover-up. The Food and Drug Administration (FDA) doesn’t fare much better in the book, as Bass accuses the agency of ignoring irregularities in the trial.

The Paxil-suicide link only becomes known after a few whistle-blowers uncover what’s going on. They are harassed and intimidated, but because of their persistence, Glaxo is finally forced to put a black box warning on the Paxil label about its suicide risk.

Paxil, Other Antidepressants May Up Fracture Risk

Another study has shown that SSRI antidepressants such as Paxil may increase the risk of fractures in the elderly.

Researchers at Group Health, a Seattle-based health plan, discovered that antidepressant use in postmenopausal women—those who averaged around 64 years of age—was linked to an increased risk of fractures of the spine and other sites. The study involved review of data from over 93,000 women enrolled in the large Women’s Health Initiative Observational Study that compared antidepressant use and incidence of fractures. The researchers found that women taking antidepressants experienced a 30 percent increased risk of spine fracture and a 20 percent increased risk of any type of fracture.

The findings echoed an earlier study conducted by the McGill Centre for Bone and Periodontal Research at McGill University in Montreal, Canada. That study looked at over 5,000 randomly selected people, including 137 who took SSRI antidepressants on a daily basis. That research revealed that daily SSRI users had twice the risk of bone fracture as those not taking SSRIs.

While neither study establishes a direct, causal relationship between SSRIs and fractures, the issue does merit further research. In the meantime, patients taking Paxil and other SSRIs should consider seeing their physician to be evaluated for osteoporosis,

Senator Suspects Glaxo Hid Paxil Suicide Risks

Last month, Senator Charles Grassley (R-Iowa) asked the Food & Drug Administration (FDA) to probe whether GlaxoSmithKline knew of Paxil’s suicide risk when it first sought approval for the drug. Paxil was the subject of two suicide warnings in 2004 and 2006, but evidence has emerged that Glaxo had evidence of the risk long before that.

In a letter to the agency, the Senator asked the FDA to review a report by a Harvard psychiatrist who had submitted information as part of several Paxil lawsuits. The report, written by Joseph Glenmullen, found that Glaxo “had to know of Paxil’s suicide risk when it sought FDA approval for the drug,” Grassley’s letter said. Glenmullen found that Glaxo inappropriately inflated the suicide risk of a placebo during clinical trials of the antidepressant, obscuring the increased danger associated with Paxil.

Grassley’s letter also sites a report by British regulators that found that Glaxo knew as far back as 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents.