Originally published February 26 2006
FDA panel speaks out about Alli's performance as a diet drug
by Mike Adams, the Health Ranger, NaturalNews Editor
Reuters talks with FDA panel members Dr. Ruth Parker and Dr. Alastair Wood about their opinion of GlaxoSmithKline's weight loss drug Alli, which was approved for over-the-counter sale.
The first diet drug aimed at helping the growing number of fat Americans lose weight without seeing a doctor moved one step closer to U.S. approval on Monday after a health advisory panel endorsed the idea.
Called Alli, GlaxoSmithKline's low-dose version of the prescription drug Xenical is generally safe and effective for adults when used for six months, the U.S. Food and Drug Administration's advisers said.
The FDA will consider the panelists' advice as it decides whether to allow easier access, but usually follows their recommendations.
Panel chairman Dr. Alastair Wood said risks with the drug were low, and people would be better off taking Glaxo's drug than any of the countless, unapproved dietary supplements on the market.
"I don't think there's been any long-term effectiveness shown," said panelist Dr. Neal Benowitz, a professor of medicine, psychiatry and biopharmaceutical sciences at the University of California in San Francisco.
Glaxo bought U.S. rights to Xenical from Roche Holding AG last year and hopes to sell a 60-milligram dose of the 120-milligram prescription version.
That process can cause gastrointestinal problems such as oily stools, rectal discharge and excess gas, and about half of all patients experience them.
"There is no magic pill for weight loss, and orlistat is definitely not a magic pill," John Dent, the drugmaker's senior vice president for research and development, said.
"Orlistat is a tool that will help people control their calorie intake and modify their diet."
George Quesnelle, president of GlaxoSmithKline's North American consumer unit, said nonprescription sales could boost that, reaching five to six million Americans each year.
Mehta Partners analyst Shaojing Tong said he was skeptical that over-the-counter status would jump-start sales, given the side effects and lack of insurance coverage for nonprescription medicines.
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