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Over-the-Counter Fat Fighter Clears First Hurdle: For the First Time, a Federal Panel Has Recommended a Powerful Weight-Loss Pill Be Sold Without a Prescription

Posted on: Tuesday, 24 January 2006, 12:00 CST

By Thomas Ginsberg, The Philadelphia Inquirer

Jan. 24--Americans' battle against obesity took a significant turn yesterday when a federal scientific panel endorsed the first sale of a powerful weight-loss drug without a prescription.

If federal regulators agree, the drug orlistat, now sold by prescription as Xenical, would be marketed as Alli by GlaxoSmithKline Consumer Health, a division of the London-based drug firm with U.S. headquarters in Philadelphia and North Carolina.

An estimated two-thirds of Americans are overweight or obese, with the problem worsening. Patients, health experts, and the drug industry have chased the tantalizing prospect of a safe and effective diet pill for years, despite false starts and recalls.

Alli (pronounced AL-lie) is not new. What is new is its possible distribution over the counter, not by prescription, which experts hope will translate into broader use against a condition they call epidemic.

Two advisory boards to the U.S. Food and Drug Administration, after a daylong hearing, put aside concerns about orlistat's unpleasant side effects -- incontinence and diarrhea -- and voted, 11-3, to recommend nonprescription sale to people 18 and over.

The advisory committees' votes are nonbinding, but they tend to carry great influence with FDA officials. It was not clear when the FDA would make a final decision.

Orlistat works by blocking the body's absorption of dietary fat by up to 30 percent, resulting in average weight loss of 5 percent for almost all users over about six months, the recommended regimen.

At the same time, however, orlistat causes incontinence or oily, loose stools in at least half its users. The problem stops when people stop using the drug, with no lingering serious side effects.

The drug also blocks the absorption of fat-soluble vitamins, leading to nutritional concerns. It has potentially dangerous interactions with the blood-thinner warfarin and the transplant-drug cyclosporine.

And some experts feared that normal-weight people obsessed with losing weight might abuse or misuse the drug, which will be relatively easy to buy at 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., of Nutley, N.J., launched the drug in 1999.

Over-the-counter hopes

Both drugmakers are optimistic, however, that orlistat will prove more popular as an over-the-counter product. Their studies found cost and effectiveness, not side effects, were the main reasons people might stop taking it.

Indeed, the chairman of one FDA panel, Alastair Wood, a Vanderbilt University medical school chancellor, voted for Alli despite what he dubbed its "underwear issue."

GlaxoSmithKline told FDA advisers that they predicted five million to six million Americans would buy over-the-counter Alli, at between $12 to $25 per week. If the sales predictions hold true, Alli would reach annual sales of between $1.5 billion and $3.9 billion, making it a blockbuster drug, which is considered unusual for over-the-counter products.

GlaxoSmithKline, the world's No. 2 drugmaker, told the FDA panels that it would make only modest claims about the drug -- to avoid abuse -- and mount an extensive education campaign, including setting up a Web site where users could track their weight.

"Our message will not be, 'Simply pop a pill, and the weight will fall off,' " Steve Burton, GlaxoSmithKline's vice president for weight control, told the panel meeting in Bethesda, Md. "The message will be, you can do it, and orlistat will help."

Drug alone won't do

GlaxoSmithKline said it invented the name Alli to emphasize that users must ally the drug with exercise and healthier eating.

It said Alli's package would include six pocket-size pamphlets on proper nutrition, exercise habits, and a weight-loss chart. It will include detailed instructions and warnings on side effects. It says people seeking to take the drug again after six months should, instead, contact a doctor about other treatments.

"They show that orlistat is not a magic weight-loss pill," said John Dent, GlaxoSmithKline's senior vice president of research and development. Users "have to make lifestyle changes, too."

GlaxoSmithKline emphasized there was no other genuine weight-loss drug sold without a prescription in the United States. Americans spend an estimated $1 billion a year on dietary supplements and unapproved treatments, but none has FDA approval.

Health experts said the addition of a tested, FDA-approved medication could help counteract the frenzied and often futile search for obesity remedies.

A half-dozen people, including one patient brought to the meeting by GlaxoSmithKline, rose to urge approval. "We need all the help we can get," said Valentine Burroughs, chief medical officer of North General Hospital in East Harlem, speaking on behalf of the National Medical Association, an African American advocacy group.

But Sidney Wolfe, of the consumer advocacy group Public Citizen, cited orlistat's dangerous interactions with other drugs and called on the committees to reject GlaxoSmithKline's "desperate attempt to revive this barely effective drug."

GlaxoSmithKline emphasized that orlistat was not addictive and did not appear to cause more weight loss even if taken in higher dosages.

Contact staff writer Thomas Ginsberg at 215-854-4177 or tginsberg@phillynews.com.

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Source: The Philadelphia Inquirer

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