For far too many years, GlaxoSmithKline “and its predecessor, SmithKline Beecham, marketed Paxil as an antidepressant that would reduce the risk of suicide in depressed patients.”1 After their clinical trials wrapped, the drug makers presented their findings to the FDA and suggested that Paxil was actually safer than a placebo. However, thanks to documents made public from a lawsuit filed against Glaxo, that wasn’t the whole story (I know, shocking that a drug company would lie).
RELATED ARTICLE:
In her suit, Wendy Dolin alleged that paroxetine, a generic of Paxil, contributed to the suicide of her husband: 2
“Back then, the company reported that among nearly 3,000 patients treated with Paxil in the worldwide clinical trials, five committed suicide — a rate of about one in 600. By contrast, there were two suicides in a much smaller group of 554 patients randomly assigned to take a placebo pill — a rate of about one in 275, more than double that of the Paxil group.
Ms. Dolin’s lawyers argue that the documents show the two suicides in the placebo group occurred during the “wash out” or “run-in” period, when patients about to enter a new clinical trial are weaned from prior medications — before the new trial officially got started and before “randomization,” when trial participants are randomly assigned either to the placebo group or the drug group. That transition period is known to be an especially risky time for patients.” 3
(Once again, rather than be totally transparent and do what’s best for patients, the drugs manufactuers were looking to make a buck. Regardless of who they hurt. Or killed.)
RELATED ARTICLE:
Early reports to the FDA saw these suicides notated with an asterisk and a footnote specifying they had occurred during the run-in period, but in later reports they were absent.
May 2006 would see Glaxo adding a warning label and letter to health care providers cautioning that adults of all ages with major depressive disorder had a higher frequency of suicidal behavior, 6.7 times higher, compared with placebo- but nothing happened. By June of 2007, that warning was replaced by the standard black box warning label that the FDA requires all antidepressants to carry.
RELATED ARTICLE:
Glaxo officials testified that they asked the FDA FOUR TIMES about adding “Paxil-specific information to the label”4 but the agency said nothing addtional was necessary.
Playing pass the buck. Again, something we are used to seeing. Shame, shame, shame.
We will monitor this story. I imagine this is going to be the first of many lawsuits.
