Firm accused of manipulating drug data

October 07, 2005|By NEWSDAY

NEW YORK -- A consumer watchdog group has accused the makers of a popular asthma drug of manipulating safety data submitted to the FDA two years ago to create the impression that the drug Serevent is safer than it is.

GlaxoSmithKline officials vehemently denied the charge, made by Public Citizen's Health Research Group in a letter in this week's issue of the British medical journal The Lancet.

"Throughout this process, GlaxoSmithKline communicated ... with a sense of urgency, to ensure that healthcare professionals and patients had access to the results of the study as they became available," a GlaxoSmithKline statement said.

Serevent or salmeterol, known as Advair when combined with the steroid fluticasone, carries a black box label warning of a small but significant increase in asthma-related deaths among patients who use it.

But officials with the Health Research Group, which has Serevent on its list of "Do Not Use" drugs, say the labels aren't enough.

The controversy surrounds a large 28-week trial involving tens of thousands of patients, called the Salmeterol Multicenter Asthma Research Trial, or SMART. The trial was initiated in 1996 because of concerns about possible health risks associated with Serevent, a long-acting beta agonist used to help open airways by relaxing muscles during an asthma attack.

"They were just adding noise," said Dr. Peter Lurie, co-author of the letter in Lancet. "And in each case, the addition of the post-study data noise reduced the apparent risk of the drug."

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