Despite evidence, only 1 FDA Committee Member argued for Withdrawal of Avandia

GlaxoSmithKline continues its streak of marketing drugs with deadly side effects. Now it is not just psych drugs. See also the testimony of Dr Sidney Wolfe before the FDA on Avandia. the following is via Bloomberg

GlaxoSmithKline Plc convinced a U.S. regulatory panel this week to keep its best-selling diabetes drug, Avandia, on the market. Now comes the hard part: persuading doctors to use a medicine linked to heart attacks.

The U.S. Food and Drug ['Trust us - we know whats good for you!'] Administration committee of advisers said this week that the diabetes pill should carry new warnings about cardiovascular risks. Glaxo shares had their biggest gain in two years yesterday after the advisory panel decided not to recommend the withdrawal of Avandia, which brought in $3.3 billion in 2006 for the London-based company, Europe's largest drugmaker.

To hold onto even a portion of that revenue, Glaxo will have to spend more on marketing a product that analysts had estimated would generate $6 billion by 2011. Glaxo shares may resume a two- month decline that began in May as the company struggles for enough Avandia sales to keep profit growing.

``Glaxo will probably receive a black-box warning and the sales will probably not recover to the previous level,'' Pascale Boyer Barresi, an analyst at Bordier & Cie in Geneva, said in an interview.

Avandia sales ``will probably recover 10 to 15 percent, but the decline was so far I think once doctors have changed their patients, they will not switch back,'' he said.

A black-box in the drug's prescribing information is the FDA's sternest. While some of the advisers called for the high alert, the committee didn't vote to recommend it. The agency usually follows advisory panel rulings.

The FDA committee voted 22-1 to keep Avandia on the market and 20-3 that evidence shows the drug adds to the risks of heart attacks. The panel was seeking to resolve questions raised by a May 21 report in the New England Journal of Medicine that linked the medicine to a 43 percent increased risk of heart attacks.

Glaxo shares were unchanged at 1,255 pence in London, after closing at a two-year low of 1,215 pence on July 30, the day of the hearing. The share decline since the May report has cut 12.3 billion pounds ($25.1 billion) from Glaxo's market value.

Advisory committee members said they weren't convinced evidence from studies supported pulling the drug off the market, even if the pill increases a patient's chances of heart attacks. They said heightened warnings should help doctors.

Two FDA safety officials argued for removing Avandia from the market. They said the treatment raised cardiovascular risks for diabetics, whose chances of developing heart complications are already elevated. The officials also said continuing studies would probably never remove doubts about the product.

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