Futile: serving no useful purpose : completely ineffective
Last Thursday GlaxoSmithKline vice-president, John Kraus, was called as a witness by defendants, GSK.
On the subject of akathisia and whether or not it was a precursor to suicide, Kraus told the jury that GSK carried out its own study and found that akathisia was not associated with an increased risk of suicide or suicide-related adverse events.
This was basically all Kraus had to say. Bayman went over and over the same points. So, according to GSK's own vice president, the FDA were informed about the link between Paxil and adult suicides, but the FDA never acted on this information. Further, according to Kraus, akathisia is just a condition that "is some of the internal sense of feeling agitated, but it's accompanied by kind of a physical manifestation. This can include inability to sit still, moving up and down, things of this nature."
Kraus was not asked by Bayman whether or not he thinks Paxil caused Stewart Dolin to kill himself, neither was he asked his general opinion about adult Paxil-induced suicides. Hardly surprising given that Kraus testified in a previous adult Paxil suicide lawsuit that, "GSK could not definitively state that any increased risk would end at a particular age." (see Vanderwerf Vs SmithKline Beecham)
Yesterday Kraus was asked by Andrew Bayman why GSK never requested a meeting with the FDA to discuss possible Paxil label changes relating to the adult suicide link. Kraus somewhat flippantly, replied, "It would've been futile." He based this answer around GSK's supposed previous attempts to change the label specifically for Paxil. Kraus claimed the FDA preferred a class labeling, a system whereby the FDA prefer to group all SSRIs together. Kraus also stated GSK could not add an adult suicide warning to the black box on the Paxil labeling, citing this was up to the FDA. Kraus also asserts GSK could not add an adult suicide warning in the 'indication and usage section' of the label because it "wasn't appropriate" to add a warning to this particular section of the label. Kraus claims there was no place on the label that was appropriate to add an adult suicide warning.
In fact, claimed Kraus, there was nowhere on the label that was appropriate for an adult suicide warning.
Nice to see GSK have the consumer at heart, huh? So, according to Kraus and GSK, suicide prevention is "futile", correct?
Brent Wisner was quick to point out to Kraus that the FDA does not prohibit GSK from adding warnings to Paxil labeling. When discussing GSK's refusal to meet with the FDA to address the specific Paxil labeling, Wisner asked who was it that made the decision not to meet with the FDA. Kraus admitted it was ultimately his decision.
On speaking of the two apparent placebo suicides that occurred during the Paxil clinical trials, Wisner asked Kraus if this was a lie. Kraus told the jury (under oath) that this was not a lie, suggesting instead that it was just "inaccurately written."
Wisner also asked Kraus if GSK purposely withheld crucial adult suicide data from the FDA for 10 years because during those 10 years GSK had exclusive rights to sell Paxil. In other words, as long as GSK had the patent, nobody else could sell Paxil in its generic form. Kraus told the jury he didn't know because he was not a patent expert.
The subject of Paxil's promotion was raised, in particular how GSK reps used a published paper (Montgomery and Dunbar) that suggested Paxil reduced suicidality in adults. The paper was based on the two apparent placebo suicides. An internal memo to GSK's sales reps was read to the jury:
"In the analysis from controlled studies and open extension studies of Paxil calculated by patient year of exposure, there were 2.8 fewer suicides in the Paxil-treated group compared with active control and 5.6 times fewer compared with placebo. Clearly, very positive results."
The above was to be disseminated to doctors throughout the United States to alleviate concerns that Paxil did, indeed, induce suicidality in adults.
We know now, and even GSK has admitted, that the two suicides among the 544 placebo patients in Montgomery and Dunbar's 1995 publication actually occurred during single-blind placebo run-in. However, GSK has made no effort to retract the published paper by Dunbar and Montgomory, and neither have either of the authors. (Dunbar's video testimony can be seen here.) Once GSK realized they had a problem, an email was sent out by GSK's head of marketing, Barry Brand. The letter to GSK executives implied that anything submitted to the FDA regarding adult suicide would "be setting us up for potential problems." Furthermore, GSK's marketing head was named, once again, in another email shown to the jury. This email showed how GSK had concerns about raising the suicide issue with the FDA because, at the time, there was already litigation regarding SSRIs and suicide.
Wisner also showed the jury an email from GSK's Pamela Barrett who had raised this issue about adding GSK's Paxil studies into a pool. Barrett wrote that the inclusion of studies 057 and 106 in the suicidality analysis would have "skewed the data." Despite this, GSK still included studies 057 and 106 which watered down the actual number of suicides in the Paxil arm during GSK's clinical trials.
Cross-examination continues today.
Exclusive new 'In Da Paxil Club' video featuring...
John Kraus (GSK)
Andrew Bayman (King & Spalding)
Todd Davis (King & Spalding)
Andrew Witty (Former GSK CEO)
JP Garnier (Former GSK CEO)
(Opens in new browser)
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