It's another one of them 'shake your head' moments folks.
The New York Times reported on Friday on GlaxoSmithKline's clinical trials - not Paxil - this time, Avandia.
The Times writes:
Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.
...Dr. Marciniak’s review of the Record study calls that assertion into question. He found one case in which a seizure patient was hospitalized for bleeding in the brain, but all mention of the episode was deleted from records. Another patient was hospitalized for 67 days after a severe stroke, but the study record showed no sign of a cardiovascular problem.
Still another died after being hospitalized for a serious heart problem, but the death was listed as arising from an unknown cause and not heart-related.
Will this be another slap on the hand for GlaxoSmithKline akin to the one given to them by the British regulator, The MHRA, when, after a four year investigation, they found Glaxo had withheld vital information regarding the use of Seroxat/Paxil in children?
This latest just highlights how important it is for pharmaceutical companies to sell its products - forget the side-effects, they are not important. So what if someone's father, mother, uncle, aunt, child, dies.
The Times article sees the reappearance of Glaxo's Mary Anne Rhyne, they write:
Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said the study demonstrated that Avandia is safe and added, “The Record study was conducted according to good clinical practices and the data are reliable.”
Here's what Mary Anne Rhyne said back in 2004 when a lawsuit filed by New York Attorney General Eliot Spitzer accused Glaxo of fraud by withholding negative information and misrepresenting data on prescribing its antidepressant Paxil to children.
"The company has acted responsibly in conducting the studies in pediatric patients and disseminating results. All of our studies have been made available to the (U.S. Food and Drug Administration) and regulators worldwide."
Nobody from GlaxoSmithKline has ever apologised for the Paxil 329 debacle.
I suspect there won't be an apology for this latest Avandia cover-up either.
The FDA Briefing Document, Advisory Committee Meeting for NDA 21071 Avandia, can be downloaded HERE
One of the corporate motto's of GlaxoSmithKline is, "We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer."
In other news:
Humpty Dumpty fell off a wall, the big bad wolf fell down a chimney and Hanzel and Gretel found a house made from chocolate.
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