Personal Injury Law

It?s Decision Time on Avandia

By Jamie G. Goldstein

A group of medical experts are meeting at an FDA panel this week to vote on whether or not the diabetes drug Avandia, which some studies show poses an increased risk of heart problems for some patients, should be taken off the market. GlaxoSmithKline claims that Avandia's health risks have been taken out of context, but it has recently come to light that the drug manufacturer has known about the danger since 1999 when they conducted their own study against competitor drug Actos. Unsurprisingly, instead of disclosing the results the company chose to protect its bottom line. GlaxoSmithKlein points to its own RECORD study to insist that Avandia is safe. However documents also revealed that the study was poorly executed and possibly inaccurate. Some participants who experienced heart attacks were excluded from the trial's final data outcome, skewing the results more favorably towards Avandia.

FDA scientist Dr. David Graham lambasted the RECORD study's credibility, saying that basing a decision on it involved 'engaging in the willing suspension of disbelief.' The most recent FDA study tracking seniors over the course of 3 years showed that those taking Avandia were 27% more likely to have a stroke, 25% more likely to have heart failure, and 14% more likely to die than those taking Actos for treatment. Others in the FDA insist the Avandia's effectiveness in reducing blood sugar levels is worth the potential risks.

Full post as published by Chicago Personal Injury Lawyer on July 14, 2010 (boomark / email).