What Glaxo Says About The Senate Avandia Probe
7 CommentsBy Ed Silverman // February 25th, 2010 // 8:04 am
The drugmaker has issued a 30-page rebuttal to the 342-page report issued last week by the US Senate Finance Committee, which concluded GlaxoSmithKline minimized and hid data about the safety of its Avandia diabetes pill and, in the process, intimidated some docs who were critical of the drug.
For those curious to know what Glaxo has to say, the drugmaker argues the Senate report doesn’t present “an accurate, balanced, or complete view of the currently available info…mischaracterizes and distorts the efforts that Glaxo took to continue to monitor the safety and efficacy of (Avandia). The (Senate) report repeatedly cites documents out of context.”
“Most glaringly, the report does not include discussion of the final results of studies cited in the Report, such as ADOPT, DREAM, and RECORD, nor does it mention numerous other studies reported since the Senate Committee began its inquiry that support the cardiovascular safety of Avandia. The report doesn’t include final discussion of the final results of studies cited, such as ADOPT, DREAM and RECORD.” Glaxo says these have been available for months and, so, the report is incomplete.
“Finally, the report suggests that GSK did not work to actively monitor the safety of Avandia or inform the FDA of its investigations. That suggestion is fundamentally flawed and contradicted by the record of extensive, on-going interactions between GSK and the FDA and the FDA’s on-going review of Avandia in light of all the information available to the agency.”
Read it here and then, if you wish, glance at the Senate report. Meanwhile, the American Heart Association and the American College of Cardiology Foundation issued this advisory.
Lisa Van Syckel
Hello GSK,
Does Paxil Study 329 ring a bell? You promoted your antidepressant, knowing full well, that thousands of children were being harmed, and many, had died, you knew your drug was not effective. To this day, you have not apologized to the families, for the harm your drug brought onto their children. Your drug has destroyed the reputations of countless children.
It is time to behave like responsible adults, only immature children blame others for doing something wrong, so your 30 page attack on on Senator Grassley and his staffers is childish.
I commend Senator Grassley and his staffers, not just in protecting our Nation’s Children, due to your irresponsible behaviour, but for protecting the American Consumer.
You are a Company that cannot be trusted, you become the lowest of the low when you jeopardize the life of a child for the sake of profits.
So, you can take your 30 page rebutal, and put it where the sun doesnt shine!!!!
Justice in MI
What I found interesting in the Senate report is that they use the last paragraph to talk about the big off-label busts in recent years–Lilly, Pfizer, et. al.. However interpreted, whoever wrote it clearly wanted to put the Avandia story in a wider context.
Of course, as finance committee, ripping off Medicare, etc. is their bailiwick.
john
like said in another post, why is it called a white paper?
Lisa Van Syckel
John, the term white paper, is used to grab the attention of state and federal legislators, the white paper is usually only a few pages in length, and, that is because politicians want an issue, no matter how complex, summed up quickly, GSK is aware of this, and I find it soooo unusual that they took up 30 pages. No doubt their 30 page white paper will probably find its way into numerous trash bins.
john
thanks lisa. thought it was weird as well. white paper?
yea the 30 pages were nonsense. need a pretty big trash bin if you have a couple of those white papers.
pharmavet
Here is the fallacy of this entire paper chase. In order for GSK to have prepared a 30 page point-by-point rebuttal of the Senate paper within 5 days, they must have had a leaked copy of the report just like they got a leaked copy of the Nissen paper. This is a game of leaks, counterleaks and intrigue, and he who gets the last leak may have the last laugh. This all reminds me of a column in Mad Magazine entitled “Spy versus Spy”, where each spy was trying to keep at least two steps ahead of the other, and in the end they basically neutralized each other. Or use global thermonuclear warfare or tic-tac-doe from the movie “War Games”. It is an endeavor that has no clear winners or losers.
Lisa Van Syckel
Pharmavet,
It is quite clear to me, the losers, are the patients.