After the Lacuzong case was resolved, at GSK's insistence, the report was sealed under a protective order. However, in the more recent case against the company, Moffett v Glaxo SmithKline, in Mississippi the protective order was lifted and the report was entered in the public record. Dr Breggin has also made it available on his web site at www.breggin.com.
"The publication of a previously sealed report is rare," he says, "the first in my experience."
According to Dr Breggin, drug companies settle almost all lawsuits out of court in order to seal incriminating scientific data. "This deprives the FDA, medical profession and public of critical information on drug safety and efficacy," he says.
In March, 2006, Baum Hedlund's leading SSRI attorney, Karen Barth Menzies, filed another class action lawsuit against GSK, in federal court in the company's hometown of Philadelphia, this time on behalf of patients under the age of 18, who attempted suicide while on Paxil, and on behalf of the family members of children who committed suicide while taking the drug.
Its important to note that Paxil has never been approved by the FDA for any use with children, and so therefore, every prescription written for the children involved in this lawsuit was for off-label use.
One suicide in the case involves 11-year-old Trevor Blain who was prescribed Paxil for "separation anxiety disorder" by his pediatrician in October 2000, and immediately began having trouble sleeping and exhibited angry outbursts. His family knew nothing about the connection between Paxil and these adverse events and so Trevor continued to take the drug.
In early November 2000, Trevor hanged himself with his dog's leash in the family laundry room and although he initially survived the suicide attempt, he remained in a coma for several weeks before he died on December 7, 2000.
Another plaintiff in the case, is 17-year-old Tonya Brooks whose family doctor diagnosed her with "social anxiety disorder" and prescribed Paxil in 2004. While taking the drug, Tonya became agitated, aggressive and had difficulty sleeping.
She first attempted suicide by taking an overdose of Paxil and sleeping pills. After surviving the first attempt, 2 days later Tonya gouged a hole in her leg with a pair of scissors and was hospitalized for several days.
Recounting the horror when she found her daughter sprawled on the bathroom floor after her second suicide attempt, with blood everywhere, Tonya's mother, Cheryl Brooks, says, "no parent should have to go through what we did."
According to Attorney Menzies, this is another case where GSK concealed information to protect profits. "Through our Paxil litigation," Ms Menzies states, "we've obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children."
"That's about as reprehensible as you can get," she adds.
"Governmental regulators around the world have now analyzed the actual data from the clinical trials, not GSK's version of it," she notes, "and have found an increased risk of suicidality."
"We wanted to make sure the rights of all of these kids," she says, "are protected by filing this lawsuit."
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