CLEVELAND, June 5, 2009 (GLOBE NEWSWIRE) -- Mass tort trial lawyer Ben Anderson of Anderson Law Offices says "junk science" is the basis for a new study sponsored by London-based GlaxoSmithKline (NYSE:GSK) about the side effects caused by the popular diabetes medication Avandia.
Mr. Anderson represents thousands of former Avandia users who suffered heart attacks and other heart problems after taking the medication. The study published today represents the culmination of six years of research paid for by GlaxoSmithKline to purportedly determine whether Avandia causes heart problems at a higher rate than other diabetes medications. The study results are being presented today at the American Diabetes Association's 69th Scientific Sessions in New Orleans, the world's largest diabetes conference.
Among the many problems cited by Mr. Anderson and medical professionals who have reviewed the study's methodology is that there was an insufficient number of study participants to produce statistically valid results. Another flaw is that the study tested Avandia in combination with other drugs rather than determining the effects of taking the drug alone.
"This study is a classic example of the fox guarding the hen house," says Mr. Anderson. "GlaxoSmithKline bought and paid for the results of this study which could easily mislead thousands of prescribing physicians and tens of thousands of diabetic patients into thinking that Avandia does not increase a patient's risk of developing cardiovascular disease and heart attack."
The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes, or RECORD, study is based on information collected from diabetes patients who live in Europe. The RECORD study was initiated after a 2007 report in the New England Journal of Medicine revealed that Avandia users suffered a 43 percent increase in heart attacks and a 64 percent increase in cardiac deaths.
The U.S. Food and Drug Administration responded in 2007 by requiring GlaxoSmithKline to include an updated "Black Box" warning on Avandia prescriptions about the potential increased risk of heart attacks. "Black Box" warnings are the most serious warnings required by the FDA, and are used only when a drug presents a significant risk of serious adverse side effects.
Although the RECORD study indicates no statistically significant difference in heart problems among users of Avandia and other diabetes medications, Mr. Anderson and other medical professionals who have reviewed the methodology say the results are unreliable.
"The FDA's own researchers criticized this study over two years ago indicating that it should not have even been conducted because it couldn't produce scientifically reliable or valid results," says Mr. Anderson. "By using junk science and publishing this study, GlaxoSmithKline is disregarding the safety of thousands of diabetes patients and continuing to put the Company's profits ahead of patient safety."
Anderson Law Offices represents clients in courtrooms around the country in mass tort and medical malpractice cases. The firm is composed of outstanding trial attorneys with decades of experience handling cases involving pharmaceutical liability, medical device litigation, medical malpractice and catastrophic injury.
For more information on Avandia, please visit the Anderson Law Offices Web site at http://www.andersonlawoffices.net . To interview Mr. Anderson, please contact Larry Peskin at 888-589-0256 or larry@andersonlawoffices.net.