|Is GSK boss, Andrew Witty, about to break his promise?|
Just going through the complaint made by UNITED STATES OF AMERICA, et at, ex rel
GREGORY W. THORPE and BLAIR HAMRICK, Plaintiffs, Vs SMITH KLINE BEECHAM, INC., and GLAXOSMITHKLINE PLC d/b/a GLAXOSMITHKLINE, Defendants.
The Paxil section, page 18, is interesting to say the least, particularly sec 58.
58. However, the bulk of Paxil and Paxil CR sales stemmed from GSK's unlawful promotion for off-label uses in adult patients for such diverse disorders as premature ejaculation and general social phobias, anxiety, ADHD, shyness, and bipolar disorder. As part of this scheme, GSK concealed that Paxil is highly addictive.
Now, we've always known about Paxil's addictiveness and we've always heard Glaxo spokespersons deny this.
It would be interesting to see if any exhibits produced in the above case showed that Glaxo hid evidence that Paxil is highly addictive. It would certainly open the creaky door to the UK Seroxat litigation. Although the wheels seem to have grinded to a halt on the UK litigation, it is still live, despite misinformed individuals making statements that the case has collapsed.
Anyway, the full complaint against GSK can be downloaded here. The Paxil section reads as thus:
Paxil [Known as Seroxat in the UK]
Paxil (paroxetine hydrochloride) was initially approved by the FDA on December 29, 1992 for the treatment of Major Depressive Disorder in adults. Thereafter, the FDA approved the drug for other uses, however neither Paxil, nor its extended release formulation known as Paxil CR, has been approved for any use whatsoever in patients under the age of 18.
Nevertheless, GSK has aggressively promoted Paxil and Paxil CR as a safe and effective treatment for a litany of mental issues for children, including, depression, anxiety, ADHD, shyness, and bi polar disorder, among others.
GSK's off-label marketing for pediatric use was particularly egregious because GSK knew no later than November 1998 that Paxil was ineffective in this age group and, even worse, that depressed pediatric users of Paxil were up to three times more likely to commit suicide or engage in other self-harming conduct. GSK not only knew these seminal facts, but withheld its own clinical study data that proved them to be true from the medical community and the public to protect pediatric Paxil sales.
However, the bulk of Paxil and Paxil CR sales stemmed from GSK's unlawful promotion for off-label uses in adult patients for such diverse disorders as premature ejaculation and general social phobias, anxiety, ADHD, shyness, and bipolar disorder. As part of this scheme, GSK concealed that Paxil is highly addictive.
Finally, GSK aggressively promoted Paxil as safe and effective for use during pregnancy. This marketing scheme rivals the contemptibility of its pediatric scheme. GSK characterized Paxil as having treatment benefits that outweighed the risks, when in fact GSK knew the opposite to be true. GSK knew that the drug substantially increased the risk of severe congenital birth defects, particularly holes in the heart of the fetus. The drug is now also known to cause Persistent Pulmonary Hypertension of the Newborn. When information about Paxil's link to birth defects finally became public in December 2005, the FDA reclassified the drug as Category D. Category D classification is reserved for drugs with a proven link to birth defects when used during pregnancy.
Paxil is the only SSRI with a Category D designation. GSK's concealment of evidence of birth defects deprived physicians and expecting mothers of the ability to make informed choices about the risks of its use during pregnancy. Had GSK disclosed the truth, undoubtedly the use of Paxil during pregnancy would have been severely curbed, which is exactly what GSK endeavored to avoid. This is particularly true of off-label use of Paxil, where safer alternatives would have been available.
Andrew Witty, Glaxo's CEO on the $3 billion settlement made by his company:
"“Today brings to resolution difficult, long-standing matters for (Glaxo). Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of (Glaxo), I want to express our regret and reiterate that we have learnt from the mistakes that were made,” [LINK]
The UK Seroxat [Paxil] litigation is based upon withdrawal and that the claimants, in the litigation, had difficulty withdrawing from the Seroxat.
Now, I'm no Albert Einstein but I'd say that a drug being highly addictive would cause severe withdrawal problems, wouldn't you?
It will be interesting to see if Witty sticks to his word, more so to see if he and his company really have learnt from the mistakes that were made.
I'm assuming that they [GSK] and their lawyers, Addleshaw Goddard, won't be contesting the claims against them in the UK then?
A pig has just flown past my window... I'm sure it had a French accent.
Plus ça change, plus c'est la même chose.
GlaxoSmithKline are a British Company that have been successfully sued by American attorneys on numerous occasions.
With Glaxo's CEO being part of British Prime Minister's Business Advisory Committee and with the British Drug regulator, the MHRA, having two ex- Glaxo employees on their staff, is it any wonder that it's easier for the UK man/woman in the street to split an atom then it is to get justice from GlaxoSmithKline.