Mark Lanier disses RECORD

Avandia Attorney Says Study Based on 'Useless Trick Science'

Today's announcement hurts thousands of Avandia patients, counsel says

HOUSTON, June 5 /PRNewswire/ -- Noted Houston trial lawyer Mark Lanier of The Lanier Law Firm says "useless trick science" is the basis for a new study being unveiled today in New Orleans by drug maker GlaxoSmithKline (NYSE: GSK) about the side effects caused by the company's diabetes medication Avandia, which reportedly has been linked to heart problems in thousands of patients.

Mr. Lanier represents many former Avandia users who suffered heart attacks and other heart problems after taking the drug. The study released today follows 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 at the American Diabetes Association's 69th Scientific Sessions, the world's largest diabetes conference.

Among the many problems cited by medical professionals who have reviewed the study's methodology is that not enough participants were included to produce statistically valid results. The study also used Avandia in combination with other drugs rather than determining the effects of taking the drug alone.

"This study is a prime example of getting what you pay for," says Mr. Lanier. "For six years, GlaxoSmithKline has been pouring money into this study to get the results they wanted, and that's exactly what's happening today."

The Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes, or RECORD, study is based on information from diabetes patients who live in Europe. The study results follow a 2007 report in The New England Journal of Medicine, which 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 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.

Preliminary results from the RECORD study showed no statistically significant difference in heart problems among users of Avandia and other diabetes medications, but Mr. Lanier and others who have reviewed the methodology say the results are unreliable.

"One of the FDA's own researchers said two years ago that he didn't think this study should have been conducted because it couldn't produce scientifically reliable or valid results," says Mr. Lanier. "By using tricks as science and publishing this study, GlaxoSmithKline is disregarding the safety of thousands of diabetes patients in the company's pursuit of the almighty dollar."