Drugs from A to Z: Alli, Avandia, Acomplia & Zimulti
In the middle of the Avandia blowup, GlaxoSmithKline this week is launching the new over-the-counter diet pill "Alli." The company says it's spending 150 million bucks on the first-year marketing of the formerly prescription-only Xenical from Roche.
A big chunk of that is going toward a multi-pronged educational campaign to convince dieters they have to change their eating habits and exercise if they want to get the maximum benefit from Alli. That's crucial with this drug because the more fat you eat, the worse the gastrointestinal side effects. Clue: Glaxo is telling Alli users to wear dark pants and bring an extra pair to work. The company has gone so far as to set up an exhibit in New York City this week where people can get more information about Alli.
But if the side effects don't sound appealing, dieters can eat less and exercise more and/or wait a couple months. Sanofi-Aventis is waiting for FDA approval of its diet pill formerly known as rimonabant and Acomplia and now being called "Zimulti." That's right... Zimulti.
Apparently, the FDA balked at the proposed name of Acomplia because it sounded either too much like "accomplish" or like an existing drug on the market. How they went from Acomplia to Zimulti (from A to Z), though, is beyond me.
Anyway, the middle of next month, the drug goes before an FDA Advisory Committee. And the FDA is scheduled to make a decision on whether to approve it by the end of July. So far, tests show it helps people lose weight without any nasty gastrointestinal side effects. But questions have been raised about more patients on Zimulti reporting feeling depressed versus those who were on the placebo.
Meantime, there's more news regarding Avandia. The British medical journal, The Lancet, is pooh-poohing the Avandia study in The New England Journal of Medicine. The Lancet writes in an editorial published online today that "...it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses. To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of (Avandia) is needed. Alarmist headlines and confident declarations help nobody."
A meta-analysis is essentially a review of data from a bunch of clinical trials. It is not considered the gold standard in medical research. That said, the Cleveland Clinic's Dr. Steven Nissen, who did the meta-analysis, stands by his findings.
Glaxo is based in the U.K.
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