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GlaxoSmithKline Misled FDA about Asthma Drug, Public Citizen Charges

October 8, 2005
GlaxoSmithKline presented misleading results to the Food and Drug Administration (FDA) from a study of the popular asthma drug salmeterol (Serevent, also known as Advair when combined with the steroid fluticasone), Public Citizen writes in a letter in this week’s issue of The Lancet.

In 1996, the Salmeterol Multicenter Asthma Research Trial was initiated to study tens of thousands of asthma patients who received either salmeterol or a placebo. The study lasted 28 weeks and showed an increased risk of asthma-related death for those taking salmeterol.

The results have never been published, although GlaxoSmithKline presented the interim results to the FDA in July 2003, when the drug came up for review before the FDA’s Pulmonary-Allergy Drugs Advisory Committee. The company submitted final study data to the FDA on August 29, 2003.

However, that data included adverse events that were reported six months after the trial ended and were not to be included, according to the original study protocol. The inclusion of the post-study data reduced the apparent dangers of salmeterol with respect to four critical study outcomes, including asthma-related death.

GlaxoSmithKline did not clearly inform the FDA that the final study included data from six months after the trial had concluded until the FDA inquired about the results in April 2004. The FDA had presumed the data were only from the 28-week trial itself, since that was the “period of interest,” according to the FDA.

Since learning of the suspicious reporting of the study results, the FDA’s Pulmonary-Allergy Drugs Advisory Committee on July 13, 2005, recommended strengthening the warning on the labels for both Servent and Advair, but the agency has yet to make a final decision. Public Citizen learned of the misleading data presentation from materials provided to the advisory committee.

“The behavior of GlaxoSmithKline in submitting these faulty data is deplorable,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group and co-author of the letter. “Absent greater transparency at the FDA, we will never know how often this kind of self-serving data analysis occurs.”

Public Citizen listed Serevent as a “Do Not Use” drug in its Worst Pills, Best Pills newsletter in March 2003 because of the interim study results.

Salmeterol was dispensed more than 2.1 million times in U.S. pharmacies in 2004. The combination product, Advair, was dispensed more than 16.1 million times in U.S. pharmacies that year.

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