Image: static.guim.co.uk
So, a drug gets a bad rap - it's allegedly responsible for the death of many thousands. What do the drug regulators do?
Basically, a trial designed to assess the cardiovascular risks associated with the diabetes drug rosiglitazone (AVANDIA) began in May 2009 by GlaxoSmithKline at the request of the FDA. It involves 137 sites in 14 countries, including 19 sites in the U.S. and 34 in Canada. During April 2010, many new sites were added in developing countries, including Chile, Mexico, Colombia, Latvia, Pakistan and India, presumably to compensate for poor enrollment elsewhere. Eighty-three sites are already recruiting subjects for the trial, which has an anticipated sample size of 16,000 subjects and a targeted completion date in 2015.
Read the following letter sent to the FDA from Sidney M. Wolfe, M.D.
It seems we have been down this road before with Seroxat. Remember, Seroxat is banned for use in children. Strange then that GlaxoSmithKline are currently recruiting children for their Paxil NCT00812812 trial
It's a head scratching moment, for me at least.
Here we have two GlaxoSmithKline products in Avandia and Seroxat. Both can be Googled to see how controversial they are - and now both are being tested again in what can only be deemed as a PR spin 'to prove the public wrong.'
It's baffling but hey, it's pharma and they can do as they please regardless of the consequences to the human guinea pigs.
More on the Paxil NCT00812812 trial HERE
And here's what a recent US Congressional hearing had to say about Avandia and the way the FDA handled complaints about it. [LINK]
Fid
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING
No comments: