Yesterday we covered the story of GSK's demand that third world children submit to medical "trials." Their callous intention was to bring out a product. They are hoping the press and world attention will disregard the deaths of 12 babies directly as a result of this "medicine." Today's report was found as I researched GSK a bit more and found this from a blog dedicated to exposing Seroxat/Paxil (see link at the bottom). This time they forced their pills on middle and working class kids here in the USA, striving to succeed in a world of limited opportunities, patience and resources. Send in the pills? Let's think this through first!
This is how Glaxo hid data and fooled us all
March 6, 2008 — admin
Glaxo did hide data from the regulators and the public about Seroxat/Paxil - for those of you that are new to all this here’s what they did and how they did it:
Secret e-mails show that one of the world’s biggest drug companies distorted clinical trial results of their anti-depressant Seroxat, covering up a link with suicide in teenagers. On Monday January 29, 2007, the BBC TV programme Panorama showed shocking footage demonstrating how GlaxoSmithKline’s PR people and marketing department ’spun’ devastating trial results on children which showed serious risk of suicide, self-harm and aggression (violence), and also indicated it was no more effective than a sugar pill. Instead they claimed to doctors that the drug was ‘remarkably’ safe and effective for under-18s, with the support of an ‘independent’ professor of psychiatry who earned $500,000 in fees from drug companies in one year.
Seroxat, marketed in the US as Paxil, [my bold] an SSRI anti-depressant whose active ingredient is paroxetine, was a big success for GlaxoSmithKline (GSK) from its release in the 1990s, earning billions of dollars worldwide for the drug giant. With a strategy of creating new markets for the drug, [my bold] in the mid-1990s GSK began to explore the possibility of obtaining a licence for its use in children (under-18s), and conducted clinical trials on groups of children to provide data proving its effectiveness which would support its application.
However, the trials were a bust, in particular Study 329, the biggest of a series carried out over a period of years in the US. The results of Study 329 demonstrated that Seroxat had no measurable benefit to child patients. As is usual in the so-called gold standard clinical trial approach, the drug was tested on one group while another was administered a placebo, a sugar pill with no active ingredient. Neither group, nor the administrators of the pills, knew which pill they were getting.
The group given the placebo performed just as well, or as badly, as those given Seroxat in terms of the trial designers’ criteria for improvement in their depression.
But the children who were given Seroxat suffered adverse reactions ranging from mild to serious. The serious adverse reactions included self-harm — mostly cutting; aggression — violence to others; and suicidality — suicidal thoughts or actions, meaning actual suicide attempts.
Seven out of the 93 children in the Seroxat group had to be hospitalised [my bold] as a result. That’s almost eight per cent. To independent researchers, that would be a wildly unacceptable proportion of a treatment population.
[...] “This was the point at which GSK should have begun warning physicians who were prescribing the drug to children because not only is it not effective, it’s not safe,” says Karen Barth Menzies, the California lawyer heading the team pursuing a giant class action suit against GSK in America. Menzies possesses previously secret internal memos and e-mails from GSK, obtained as part of the disclosure process for the upcoming trial, which show what actually happened next.
[...] In an internal company memo dated 14 October 1998, they concluded that the drug does not work and that a licence application would be refused: ‘The results of the study were disappointing. The possibility of obtaining a safety statement was considered, but rejected.’ The best they felt they could achieve was a ‘ statement that although safety data was reassuring, efficacy had not been demonstrated’.
[...] So the self-harm, aggression and suicide attempts were kept quiet, the lack of effectiveness filed away. PR people took over [my bold] to implement a new plan: promote Seroxat to doctors as a treatment for under-18s.
[...] So GSK’s plan was simple — persuade doctors that Seroxat was indeed suitable for their child patients. Which they duly put into effect, spinning the exact opposite of what the studies had shown: Seroxat, they said, was ‘remarkably effective and safe for children’.
Enter the academic ps
ychiatrists, notably Professor Martin Keller of America’s Brown University and child psychiatrist Dr Neal Ryan of the University of Pittsburgh, both co-authors of Study 329.
[...] Last year, Professor Keller admitted to lawyers suing GSK that he had not studied the results of Study 329 in full. [my bold] “I reviewed data analytic tables. I don’t recall how raw it [the data] was. [These are] huge printouts, you know, item by item numbers and variable numbers, and don’t even have words on them. I tend not to look at those… I do better with words than I do with symbols,” he recounted in a session recorded on video. In effect, he admitted that his ‘authorship’ of the paper, apart from being written by a PR company’s ghost, was based on at best an inadequate and incomplete scrutiny of the data — hardly the gold standard scientific review we are constantly told validates clinical trials.
[...] But the drug company in question, GlaxoSmithKline, buried the trial data, including data from another, later trial on children which found that the placebos given to the control group of depressed kids ‘worked’ better than Seroxat. And later, forced by US medicines regulator the FDA to re-evaluate the raw data from Study 329, the company admitted to four further adverse reactions in which children became suicidal, raising the number suffering severe reactions to the drug from seven to 11 — a shocking 12 per cent of the total, and representing a 600% increase in events related to suicide.
Memos in the lawyers’ boxes of GSK papers show that company executives clearly told the PR woman who designed their spin strategy that ‘Seroxat may have caused all of these’. Yet the final article, approved by the PR, stated: ‘Of the 11 patients, only headache (one patient) was considered to be related to the treatment’ and concluded that the drug was ‘generally well tolerated and effective’. This was, finally, reviewed by and accepted for publication in the Journal of the American Academy of Child and Adolescent Psychiatry. And it was published relatively unchanged, even though the journal’s peer reviewers objected in these terms: ‘Overall, results do not clearly indicate efficacy. Authors need to clearly note this.’ ‘The relatively high rate of adverse effects was not addressed in the discussion (core portion of an academic paper)’ ‘Given the high placebo response rate, are these drugs an acceptable first-line therapy for depressed teenagers?’ [my bold]
http://seroxatsecrets.wordpress.com/2008/03/06/this-is-how-glaxo-hid-data-and-fooled-the-regulators/
