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Saturday, January 25, 2003GlaxoSmithKline said yesterday that Serevent, one of its popular asthma drugs, might pose a risk of death and serious asthma-related illness in some patients. The company said it was halting the study it had been conducting since 1996 to evaluate Serevent's safety because the study was unlikely to be conclusive. GlaxoSmithKline said it would work with regulators to design further studies to address concerns about Serevent's safety. While the results of the study were not statistically significant, they suggested that people who use Serevent, particularly African-Americans, might be at greater risk for life-threatening attacks or deaths associated with their asthma. People who use Serevent without also taking inhaled steroids to control their asthma may also be at increased risk. My express letter said basically the same thing, but left me scratching my head. Why would they go to the trouble and expense to send me news about findings that weren’t even statistically significant? If they aren’t statistically significant, then they could just be due to chance. The cynic in me suspected they just wanted to scare me into switching everyone over to their more expensive product, Advair, which combines Serevent with an inhaled steroid. The Times account does nothing to assuage my cynicism: Although the preliminary analysis of the study suggested additional risks, they were not statistically significant because of the small number of deaths and other serious effects, said Dr. Kate Knobil, a research physician at GlaxoSmithKline. The company would soon make public the number of these cases, she said, but was still compiling the information. The increased risk appears to be driven by the lack of inhaled steroid use, Dr. Knobil said. Despite medical recommendations that patients use inhaled steroids or some other medication, many patients in the study were not being treated with additional medicine. Less than half, or 47 percent, of the patients used inhaled steroids. Whether or not a patient was using an inhaled steroid was determined by that patient's doctor, not the company You would think from reading that excerpt that the only anti-inflammatories available were inhaled steroids. But, in fact, for people who have asthma attacks more than twice a week, but not daily, it’s still considered appropriate to use drugs other than inhaled steroids, drugs such as cromolyn sodium or mast-cell stabilizers such as Singulair. In teenagers and children, these alternatives are preferred because they don’t run the risk of slowing growth that is seen to a very small degree in chronic use of inhaled steroids. (Children with daily asthma attacks, however, should take an inhaled steroid. Their asthma poses a far greater risk to their well-being than the small risk of growth slow-down with steroid inhalers.) GlaxoSmithKline didn’t give the details of the study to the media or in their express letter to physicians, which makes it even harder to evaluate. According to the Times, though, financial motives aren’t likely: Analysts played down the significance of the study while acknowledging that it gives GlaxoSmithKline's competitors some advantage in promoting their own drugs to treat asthma. "It's a little marketing nudge here and there," said Todd Lebor, an analyst with Morningstar Inc. in Chicago. While the asthma franchise, which includes Advair, is important, Mr. Lebor said, it is a small part of GlaxoSmithKline's nearly $30 billion in revenue. "They don't have a blockbuster portfolio," he said. For the nine months ended Sept. 30, the company sold $574 million in Serevent, with $327 million coming in the United States. Advair sales reached $1.7 billion, of which $925 million were in the United States. But if they get doctors and patients nervous enough about Serevent, won’t they switch to the costlier Advair to avoid using Serevent, even thouigh it may be used with another anti-inflammatory? Of course they would. Especially when you consider that using the combined product eliminates the risk of patient non-compliance with the anti-inflammatory. But my inner cynic is probably wrong. It probably isn’t profit, but fear of litigation that’s motivating them. After all, companies have been sued for less. After all, the FDA is taking the finding seriously and looking into it further. What does it say about us, though, when findings that aren’t statistically significant send a company running away from its product? posted by Sydney on 1/25/2003 08:15:00 AM 0 comments 0 Comments: |
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