The most interesting of the documents above is the one marked:
"Court docs re GSK paxil data analysis suggesting that suicide risk was obscured for 15 years.
http://www.ssri-uksupport.com/GSKsuicidewashoutPaxildata.pdf "
Just as with other pdfs here, the same documents and memos can also be found at various other sites. And like the video in the first post of this thread, the more sites that hold evidence, the better.
Here's a few extracts from the pdf. If there are typos, thats due to my copy typing, not the original:
Page 31
...Thus, GlaxoSmithKline's own CEO [J-P Garnier] acknowledged that side effects should only be counted after the washout phase is complete and the official study has begun, when patients are randomly assigned to either be on placebo or the drug...
Page 32
...Completed studies that occured in the wash-out phase were counted as though they occurred in the placebo group...In other words GSK only disclosed half the problem - the improper suicide attempts counts and not the improper completed suicide counts - to the FDA....
Page 33
...If GSK had presented its new analysis of the correct data on suicide attemmpts the same way it had presented the inaccurate data for years, the correct data would have shown that Paxil increases the risk of suicide and suicide attempts more than eight-fold, as we have seen. But GSK's new way of presenting the data obscured the problem again....
...Note that GSK's admission that only one patient on placebo attempted suicide and the FIVE other suicide attempts previously counted against placebo had now been "excluded from the figures" only appears as a footnote to the table in the report. Note also that GSK continues to report patient-years exposure (PYE) calculations, which as we discussed earlier are inappropriate because the risk of Paxil-induced suicidality is not evenly distributed over time...
Page 34
...The 40 Paxil suicide attempts in 1991 would be the same in 2002, but the 6 placebo suicide attempts in 1991 would be down to 1 in 2002. The significant different would be instantly recognizable: a Paxil suicide attempt rate of 1.3% versus a placebo rate of 0.18", representing a statistically significant more than seven-fold increased risk of suicide attempts for patients on Paxil...
Page 35
...As we have seen in the combined suicidal behaviour Table 10 on page 13, the full tally is 45 Paxil suicides and suicide attempts to only one placebo suicide attempt. Had GSK compared the complete, correct counts, the data would have shown that Paxil causes a statistically significant, greater-than-eight-fold increased risk of suicidal behaviour for patients put on the drug. Instead, GSK's new way of presenting the data again obscured the problem.
...
Page 37
...The linchpin of Spitzer's case was a secret, internal GSK report dating to October 1998 saying the studies showed Paxil "failed" to be more effective than placebo pills in depressed children. The secret memorandum urged company executives to "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact" that might "undermine the profile" of Paxil. In other words, the position paper raised concerns that the damaging information might affect Paxil's global sales, which approached $5 billion a year. How did the report propose to "effectively manage" the potentionally damaging results? By selectively publishing the few "positive data" that would appear to make Paxil look good.
To accomplish this goal, GSK turned to the psychiatrists who originally conducted the studies fof the company. Headed by Dr Martin Keller....a group of more than twenty leading academic psychiatrists published the selected Paxil data in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. In stark contrast to the 1998 secret, internal GSK memo, Keller and his colleagues used highly selected pieces of positive data to glowingly conclude in 2001: "Paxil is generally well tolerated and effective for major depression in adolescents"...
...Kellers misleading 2001 report in the JAACAP was highly influential and widesly used to promote Paxil to children. After its publication, the use of antidepressants for children skyrocketed. But 2 years later, in June 2003, on the basis of the same data, the British introduced their virtual ban on Paxil for children...
End Extracts
