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FDA Mislead On Asthma Drug By GlaxoSmithKline

Charges have been held against, a London based leading drug company, GlaxoSmithKline for having presented incorrect data regarding an anti-asthmatic drug, Serevent to the U.S. Food and Drug Administration two years ago when the // medicine came up for a review. This became evident last November when The FDA identified Serevent as a drug that needed additional warnings.

The Public Citizen Group has registered a case regarding the issue. The company is said to have manipulated from the so-called SMART trial, which was initiated in 1996. The study was conducted on a group of asthma patients for 28 weeks who received either Serevent, also known as salmeterol, or a placebo. An increased risk of asthma-related death in those who had consumed the drug has been documented.

However, Glaxo is said to have misled the FDA when it submitted six months of post- trial data in July 2003, along with the study's actual 28 weeks of data. There is a belief that the data presented is an underestimated projection of the apparent dangers associated with salmeterol, including asthma related death. The SMART data has never been published.

``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,'' according to those who have filed the case.

The company in response has issued a statement stating that the SMART study data were collected and analyzed by an independent clinical research organization, not by them.

“After discussions with the Data Safety Monitoring Board, Glaxo was provided with unmasked results of the interim analysis and subsequently terminated the study. The SMART trial was stopped on Jan. 23, 2003, a “Dear Healthcare Professional letter'' was delivered overnight to all U.S. doctors who had prescribed salmeterol, and notices were posted on both the FDA and Glaxo websites,'' said Mr. Kathy Rick ard of Glaxo's Respiratory Medicines Development Center in Research Triangle Park, North Carolina.

Salmeterol is a key ingredient in Serevent and is combined with a steroid to make up Advair, both of which work by easing constriction in the lungs of asthma sufferers. Serevent and Advair together outsell competing asthma treatments as well as Glaxo's other products. The drugs' sales last year totalled 2.5 billion pounds (about $4.4 billion.
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