FDA Rips Study Favorable to Avandia
Posted on behalf of Phillips Law Group on Jul 13, 2010 in Defective Drug
Avandia is a drug that's manufactured by GlaxoSmithKline, one of the true giants of the pharmaceutical industry. It's used to help patients fight type 2 diabetes, and for years it dominated the market in that regard. However, amidst a large number of reports of serious side effects, Avandia came under intense scrutiny both from the FDA and from Avandia side effects lawyers representing injured clients all over the United States. Tomorrow and Wednesday, a federal panel of experts will discuss whether or not Avandia should remain on the market. In the meantime, a study has been published that's favorable to the drug, but the FDA has ripped this data prior to this discussion.
RECORD - A Study of Avandia Side Effects
The study in question is known as RECORD, and it has been done in furtherance of the decision that's to be made regarding Avandia's place on the market. It was billed as the most extensive study done to date on the drug and its alleged link to Avandia side effects that include heart attacks, strokes and death. RECORD followed more than 4,000 patients in the study and compared Avandia with two older diabetes drugs, metformin and sulfonylurea. The conclusion was that Avandia posed no greater risk to those who used it than those who used the other drugs.
The FDA Pillories RECORD Study
In response to the publication of these findings, the FDA stated that there were several serious problems with its conclusions. At its core, the FDA's position and response was that those who were handling the RECORD study repeatedly submitted sloppy data and failed to follow up on reports of Avandia side effects in patients who were taking part in the study. The FDA even stated that the very design of the study was not only inappropriate, but biased. These are very strong terms to be used by a governmental agency.
How an Avandia SIde Effects Lawyer Can Help
This will be a very big week for GlaxoSmithKline and Avandia, as it could possibly include news of whether the drug will remain available in the United States. Unfortunately, those who have already been harmed by Avandia side effects will not be helped by this decision. If this includes you or someone you love, contact a skilled personal injury lawyer in Phoenix today to schedule a free initial consultation.