Paxil Makers Release Studies
Showing Suicide, Hostility, etc.
From Ann Blake Tracy, Ph.D.
Executive Director, International Coalition For Drug Awareness
Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare
And audio tape on SAFE withdrawal:
"Help! I Can't Get Off My Antidepressant!"
The Daily Mail in the UK has just released an article [below] entitled: "Shamed Glaxo's u-turn on 'suicide' drug" detailing information on the studies on children just released by the makers of Paxil.
On June 2, 2004 the New York State Attorney General, Elliot Spitzer, filed a suit for fraud against the makers of Paxil because they had not disclosed the information they had on the damaging and potential fatal effects of Paxil upon children. He sued them for hiding these studies since at least 1998.
Today the makers of Paxil (Seroxat) posted those studies kept from the public and regulators for years. They demonstrate an increase in suicide, hostility, emotional irritability, insomnia, tremors and dizziness over placebo. As you will see in the British article below, suicide was at least double, and suicide attempts far higher - in one study six on Paxil attempted suicide while only one on placebo attempted.
Also it is very important to keep in mind that "hostility" in this context means "homicidal". An article from the Guardian by Sarah Bosley states: "Just as with Seroxat [Paxil], the GlaxoSmithKline drug banned in June, studies have shown that Efexor can cause children to have suicidal thoughts or to become hostile, a word which in the context of clinical trials can mean homicidal.",3604,1045902,00.html
And Dr. David Healy, who has personally viewed the internal company documents on Paxil, made an absolutely shocking statement on October 12, 2003, at a debate on the SSRI antidepressants in Australia. (Dr. Healy had the opportunity to review these documents while acting as an expert witness in the Wyoming Paxil-induced mass murder/suicide case of Donald Schell where Glaxo paid out $6.4 million in damages.) He stated that these internal company documents indicated a ten times greater rate of "hostility" in those under 18 who were taking Paxil as opposed to those taking placebo. Then he went on to explain what the company meant by the word "hostility":
"From the unpublished data that the company has put into the public domain, children appear on Aropax [Paxil] to be 10 times more likely to be hostile than children taking placebo."
"I wouldn't have guessed what this word might have meant any more than any of you will have guessed, but in actual fact hostile doesn't mean children saying "Hey Mum, get lost". It means children who may have engaged in homicide, may have engaged in a homicidal act, may have been suffering from homicidal ideation [persistent thoughts of killing someone or designing various plans to kill someone], or may have engaged in aggressive behaviour of one sort or the other."
The studies released by Glaxo can be found at the following web address:
In the interest of public safety I encourage you to carry this story along with VERY STRONG warnings about the dangerous withdrawal associated with this drug. Withdrawal MUST be VERY GRADUAL - as Eli Lilly has implimented in their own clinical trials, now taking almost half the amount of time on the drug to withdraw. The steroid effect of these SSRIs is too great to withdraw more rapidly.
Shamed Glaxo's u-turn on 'suicide' drug
Daily Mail 08:49am
15th June 2004
Britain's biggest drugs firm has caved in dramatically and revealed research which shows a leading anti-depressant can cause children to attempt suicide. In an astonishing u-turn, Glaxo-SmithKline finally published full details of nine scientific studies and two clinical reviews which expose the dangers posed to under-18s who take Seroxat.
Children on Seroxat are twice as likely to have suicidal thoughts than those on a dummy pill, it emerged.
Alarmingly, one study showed six youngsters on Seroxat wanted to kill themselves, compared to just one taking a placebo pill. The drug was also linked to distressing side effects including hostility, insomnia, dizziness, tremors and emotional irritability.
Damning findings
Campaigners say the damning findings were suppressed for up to a decade while thousands of teenagers and children as young as six continued to be given the pills to ease depression.
At one point, doctors had even hailed Seroxat as a "wonderdrug" to help people overcome shyness.
The firm is facing a major lawsuit amid allegations that drug regulators were duped into thinking Seroxat - which is worth £2billion a year to Glaxo - was safe for children.
A number of youngsters are known to have committed suicide while taking the drug, but it was not until last year that doctors were banned from prescribing it to under-18s because of the suicide risk.
Some estimate that more than 50,000 under-18s in the UK were prescribed Seroxat between 1990, when it was licensed here, and last year when the ban was imposed by Government medical regulators.
Anguished parents
Anguished parents have complained that their children became suicidal while on Seroxat then showed horrendous withdrawal symptoms when they tried to come off it.
A civil lawsuit has been filed against Glaxo in the US by New York State attorney general Eliot Spitzer, who claims the firm suppressed at least four studies on the drug.
More than 3,000 UK families have also started legal action against Glaxo seeking compensation for their ordeal. They include a number of parents whose children committed suicide while on
Seroxat. Full details of the controversial studies were published on the Internet only after the medical establishment turned on Glaxo.
In an unprecedented attack, the respected Lancet medical journal last week accused the drugs giant of losing touch with its basic humanity over the Seroxat scandal.
'Suicidal thinking'
In an editorial, the journal said: "GSK appears to be floundering in the semantic depths.
"While it has been earnestly parsing the meaning of 'suicidal thinking' and 'publicly', it appears to have forgotten what lies behind those words - people. The time has come for these matters to be revealed in a bright and public light."
The Lancet said the safety and efficacy of Seroxat in children had been tested in "at least five studies sponsored by GSK, only one of which has been published".
It revealed that, although the results of this trial were mixed, they were heralded in a memo as showing "remarkable efficacy and safety in the treatment of adolescent depression".
The Lancet also poured scorn on Glaxo's argument that trials data was made public. This was done at scientific meetings attended only by specialists and published in the letters pages of medical journals.
Medical authorities here are investigating whether Glaxo complied with legal requirements to make all relevant clinical trial data on the drug available.
Too little too late
Last night. a leading consultant psychiatrist who was among the first to question the safety of Seroxat, said the publication of the Glaxo-funded Seroxat studies was too little, too late.
Dr David Healy, of the University of North Wales, said: "If the data had been out there from the start, we could have avoided some of the problems we have seen with Seroxat.
"If people had been aware of the evidence from the trials and seen the risks, they could have reduced the risks of adverse events happening. Parents could have been told to keep a closer eye on their children."
The nine studies were made available to the Government's regulators, the Medicines and Healthcare Products Regulatory Authority, only in May last year.
The details lay behind the decision to ban doctors from prescribing Seroxat to under-18s. A spokesman for GlaxoSmith Kline last night said it had already communicated the trials data to the medical community in the normal way through meetings, letters and papers over the last decade.
Medical regulators
Medical regulators were also given the data as soon as the risk of suicidal thoughts became clear.
But he added: "We thought in the interest of transparency and given the interest in this area that we would publish all the documents on the website.
"We have made no attempt to hide results or mislead regulators or the medical community. Studies individually show no consistent evidence of a problem in terms of the safety issue.
"It really was not until the nine studies had been completed and we had combined it with further review in 2003 that we saw there was a potential signal."
This story first appeared in the . For more great stories like this, buy the Daily Mail every day.
Ann Blake Tracy, PhD
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Office: 801-282-5282
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E-Mail: atracyphd1@aol.



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