London, UKGlaxoSmithKline has labeled the allegations made in a Panorama television program that said the company had suppressed the results of clinical trials that showed Paxil was ineffective and caused children to become suicidal "defamatory."
According to the January 30, 2007, Guardian, an official at the company said Glaxo had looked into taking legal action, "but that there wouldn't be much to gain from taking action against the BBC".
The Guardian also reported that Glaxo "utterly rejects any suggestion that it has improperly withheld drug trial information."
This is not news. Glaxo has falsely denied these assertions probably 100 times in the past from one end of the globe to the other. If Glaxo files a lawsuit against the BBC, it might as well file a worldwide class action against all the other "defamers" who for some reason or another repeated the exact same allegations.
The BBC has broadcast several Panorama programs on Glaxo's marketing of Paxil for children even after the company's own research showed the drug to be ineffective and dangerous with children. The latest program titled, "Secrets of the Drug Trials," was broadcast on January 29, 2007.
Glaxo's worn-out declarations of innocence can only be adequately responded to by highlighting a few of the historical moments in Paxil's never-ending trail of misery.
A good place to start is Wyoming in the year 2000, with the trial involving the case of Donald Schell, who had been on Paxil just two days when he killed his wife, daughter and infant granddaughter before killing himself.
His surviving son-in-law, Tim Tobin, brought a wrongful death lawsuit against Glaxo.
Prior to the trial, an expert for the plaintiff, Dr David Healy, a well-recognized expert on selective seratonin reuptake inhibitor antidepressants (SSRIs), was given access to Glaxo's files on the Paxil studies.
He spent two days reviewing several hundred thousand documents looking for reports on the trials conducted on "healthy volunteers." Healthy volunteer refers to study participants who were not depressed or mentally ill to begin with before taking a drug. If it was shown that suicidality was evident in health volunteers it would disprove Glaxo's theory that suicide was caused by the underlying illness of depression.
Dr Healy was interested in these trials because he knew of recent studies that had surfaced on another SSRI, Pfizer's Zoloft, that showed the drugs could trigger suicidality in healthy volunteers. When he finally found the right files, Dr Healy told the BBC:
"It seemed clear that some people that went on the drugs had no major problems, but equally clear that others who went on the drug ended up more restless, in a state of mental turmoil, complaining about dreams, nightmares and a range of things like this. These don't seem to have been explored further in any great detail."
Dr Healy discovered that one in 4 healthy volunteers suffered this mental turmoil even when they were on normal doses of Paxil and had only been taking it for a few days.
In addition, he found the agitation was worse when the dose was increased and cleared up when Paxil was stopped, only to reemerge when it was started again. There had also been a suicide in the program, and in one healthy volunteer study, Paxil was linked to withdrawal effects in around 85% of subjects.
After hearing the testimony of Dr Healy, the Wyoming jury awarded Mr Tobin more than $6 million in damages in the first jury verdict against a drug maker for the psychiatric side effects caused by an SSRI.
Going up against SSRI makers on behalf of SSRI victims has cost Dr Healy plenty. In 2000, he accepted a position at the University of Toronto, but in the wake of a lecture at the University in November 2000, in which he mentioned that there had been an almost complete lack of research on the risk of suicide associated with SSRIs, Dr Healy was informed that he had lost his job before it even began.
The next historical moment worth noting in the Paxil saga took place in June 2004, when New York's attorney general, Elliot Spitzer, filed charges of consumer fraud against Glaxo and alleged that the company had "repeatedly" concealed damaging information in Paxil studies conducted on children.
The complaint stated that, "starting in 1998, GSK engaged in a concerted effort to withhold negative information concerning Paxil and misrepresented data concerning Paxil's safety and efficacy when prescribed for depression in children and adolescents."
It also alleged an internal 1999, document showed that the company intended to "manage the dissemination of data in order to minimize any potential negative commercial impact.''
The lawsuit charged that Glaxo conducted at least 5 studies on Paxil with children, but only published one. A study referred to as Study 377, noted that some children exhibited suicidal behaviors and attempts to commit suicide. Referring to that study, and also Study 329, the complaint alleged, an internal Glaxo memo acknowledged that Paxil "failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures."
Glaxo might want to add Mr Spitzer as a defendant in the worldwide class action for his "defamatory" remarks, made in print no less. According to a June 2, 2004, press release by Mr Spitzer, by concealing negative studies, Glaxo made out like a bandit in 2002, with more than 2 million pediatric prescriptions for Paxil written in the US. "Prescriptions for Paxil to treat mood disorders in children and adolescents," Mr Spitzer said, "translated into US sales for GSK of approximately $55 million in 2002 alone."
The lawsuit also alleged that Glaxo misrepresented the results of the company's own research to its sales representatives who promoted Paxil to physicians and portrayed the drug as having "remarkable efficacy and safety in the treatment of adolescent depression," when in fact, the studies did not demonstrate that Paxil was effective in treating children and showed the possibility of increased risk of suicidal thoughts and acts in adolescents.
The suit further alleged that Glaxo failed to disclose this information in "Medical Information Letters" that it sent to physicians, and thus deprived physicians of the information needed to evaluate the risks and benefits of prescribing Paxil for children and deprived children of the benefit of their doctor's professional judgment.
In August 2004, to settle the charges that were based on the same allegations made during the Panorama program that Glaxo now claims are "defamatory," Glaxo agreed to pay $2.5 million and to publicly disclose all clinical studies.
Glaxo's largest clinical trial on the use of Paxil with children was conducted in the US in the 1990s, and was called Study 329. Child psychiatrist, Dr Neal Ryan, of the University of Pittsburgh, was paid by Glaxo and was listed as co-author of the study.
In 2002, Dr Ryan also gave a talk on childhood depression at a medical conference sponsored by Glaxo and said that Paxil would be a suitable treatment for children. He later told Panorama reporter, Shelley Jofre, that Paxil had probably lowered rather than raised suicide rates.
But an internal company email penned by a public relations executive working for Glaxo describes Study 329 differently. "Originally we had planned to do extensive media relations surrounding this study," it said, "until we actually viewed the results."
"Essentially the study did not really show it was effective in treating adolescent depression," the email stated, "which is not something we want to publicise."
However, the manipulated results from Study 329 were in fact published in the Journal of American Child Adolescent Psychiatry in 2001, with the positive spin stating, "Paxil is generally well tolerated and effective for major depression in adolescents."
Another publication that Glaxo might want to add as a defendant in its class action against the world would be the Canadian Medical Association Journal. In March 2004, the Journal printed excerpts from an internal Glaxo memo to illustrate how the company had withheld studies from regulatory agencies that showed the ineffectiveness of Paxil with children which stated in part: "It would be unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine".
A television program in the US could be added to the list of "defamers" as well. Back in December 2004, ABC's "Primetime Live," also said it had obtained hidden Glaxo studies and reported that some children in the studies showed the same types of suicidal thoughts and behaviors that parents had for years claimed their children were exhibiting.
According to these documents, Primetime said, internal studies showed Paxil had little or no effect in treating depression in children and adolescents and as far back as 1997, the company was aware of suicide related behaviors in young patients taking the drug.
In spite of this information, Primetime reported, Glaxo distributed a memo to its sales force in 2001 touting the drug's "remarkable efficacy and safety in the treatment of adolescent depression."
And last but not least, another "defamer" would appear to be the US Congress. It too claimed that Glaxo hid negative studies in the name of profits. "This is about money," said Representative, Henry Waxman (D-CA), who was on a congressional committee investigating SSRI makers at the time.
"This is not about science," he stated, "because what they're doing is withholding the scientific information, suppressing the studies that could have a negative impact on their sales and their profits."
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