Health Care Reform

Revelations About Potentially Dangerous Drug Highlight Need For Impartial Research Provisions in Health Reform Legislation

WASHINGTON–(ENEWSPF)–February 24 – A consumer watchdog group argued on Wednesday that the recent revelations about the diabetes drug Avandia underscore the need for the strong drug research provisions contained in the health care reform legislation being considered by Congress.

Last Saturday, the Senate Finance Committee issued a report that claims Avandia’s manufacturer, GlaxoSmithKline, knew their drug posed possible heart attack risks for years, but kept that knowledge from the public. (Download Finance Committee report and letter here – PDF)

“Instead of coming clean with doctors and patients, drug company execs tried to undermine the studies that showed that their product was dangerous,” said Larry McNeely, Health Care Advocate for the U.S. Public Interest Research Group (U.S. PIRG).

“There’s nothing new about drug companies using their clinical trials for public relations,” continued McNeely. “That’s why U.S. PIRG worked with Reps. Waxman (CA) and Dingell (MI) and Senators Kennedy (MA) and Grassley (IA) to pass a law requiring greater transparency for these studies in 2007. Now, the Food and Drug Administration should take a closer look at Avandia’s risks and benefits.”

The Finance Committee report found that GlaxoSmithKline may have attempted to intimidate doctors who reported the dangerous side effects, registering complaints with their employers and threatening litigation. The drug company also rushed out preliminary results from its own internal clinical trial of the drug to rebut independent research finding that Avandia created a heart risk.

On Wednesday, GlaxoSmithKline said the report had errors of “fact, omission, and inference.” Their rebuttal (PDF) again cited many of their own clinical trials in support of their argument.

The most important factor in preventing injuries and deaths from unsafe drugs is independent research, according to McNeely.

“Doctors need access to unbiased research into drugs, their effects, and their side-effects, when they’re treating their patients,” concluded McNeely. “Both the House and Senate health reform bills will encourage these kinds of studies, so that family doctors won’t have to rely on cherry-picked data from the drug companies when helping patients make decisions.

“Health reform can lower costs and make patients healthier – promoting unbiased, independent research is a key way to make that happen.”