Originally published February 26 2006
Big Pharma expects Alli to be a blockbuster drug
by Mike Adams, the Health Ranger, NaturalNews Editor
GlaxoSmithKline, maker of weight loss drug Alli, told the FDA that it expects between five and six million Americans to use the drug, which would put annual sales somewhere between $2 to $5 billion dollars.
The battle against obesity in the US took a significant turn today when a federal scientific panel endorsed the first-ever sale of a powerful weight loss drug without a prescription.
If federal regulators agree, the drug orlistat, currently sold by prescription as Xenical, would be marketed as Alli by GlaxoSmithKline Consumer Health, a division of the London-based drug giant.
Orlistat blocks the body's absorption of dietary fat by up to 30 per cent, resulting in average weight loss of five per cent for almost all users over about six months, the recommended regimen.
Patients, health experts and the drug industry have chased the tantalising prospect of a safe and effective diet pill for years, despite false starts and recalls.
Two advisory boards to the US Food and Drug Administration, after a daylong hearing, put aside concerns about orlistat's unpleasant side-effects - incontinence and diarrhoea - and voted 11-3 to recommend non-prescription sale to people 18 and over.
The advisory committees' votes are nonbinding but tend to carry great weight with FDA officials.
Some experts fear normal weight people obsessed with losing weight may abuse or misuse the drug, which will be relatively easy to buy at US pharmacies.
But Caroline Apovian, a Boston University School of Medicine professor speaking on behalf of GlaxoSmithKline, played down the concerns by noting that orlistat needs several weeks to take effect.
"This is not something a teenage bulimic is going to continue using, because the day after they take it, they're still not going to get their desired weight loss," Apovian said.
Concerns about the defecation side effects apparently were one reason orlistat's prescription sales lagged behind hopes after Hoffmann-La Roche Inc launched the drug in 1999.
GlaxoSmithKline told FDA advisers they predict between five million and six million Americans would buy over the counter Alli, at between $16 to $33 a week.
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