TUESDAY, May 22 (HealthDay News) -- Pharmaceutical giant GlaxoSmithKline isn't wasting any time.
On Monday, about a month before its over-the-counter (OTC) weight-loss drug alli® will actually be on store shelves throughout America, the company opened a multimedia exhibit in the much-shopped and often congested Union Square area of Manhattan.
This "look, learn, but don't buy" preview of the only weight-loss medication currently approved by the U.S. Food and Drug Administration and available without a prescription is getting the same sort of advance media play that kicked off campaigns for prescription drugs such as Viagra and the sleeping aid Lunesta.
But is alli being over-hyped? GlaxoSmithKline doesn't think so.
"We're positioning alli as an honest voice in a category known for hype," said Joe Cadle, marketing director of GlaxoSmithKline Consumer Healthcare. "The alli experience will teach people the difference between alli and the rest of the weight-loss category." The OTC dosage of alli (orlistat) is 60 milligrams (mg), a dilution of the prescription amount. Orlistat is not a new weight-loss drug; the FDA approved it in 1999.
Cadle said that people currently spend $1 billion a year on ineffective weight-loss products that make unrealistic claims. "alli is much more than just pills in a bottle," he said, adding that GlaxoSmithKline was offering a companion book called Are You Losing It? Losing Weight Without Losing Your Mind and other weight-loss material.
But the magic question seeking the magic answer for millions of overweight Americans is, "Does it work?"
Not surprisingly, Cadle said it does, but not by itself. "alli is not a magic pill," he said. "You have to eat a reduced-calorie, low-fat diet and be willing to do the work. If you do, you can lose 50 percent more weight. If you lose 10 pounds without taking alli, you could lose 15 when taking it."
Marketed to overweight adults over age 18, alli is expected to cost between $1 and $2 a day. It works by blocking the body's absorption of fat.
It's designed not to have an adverse effect on the cardiovascular system as did other weight-loss products such as ephedra, Cadle said. The FDA banned ephedra after medical evidence indicated it increased heart attack risk.
Alli is not without its critics, however, chief among them Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., who has spoken against orlistat's side effects before.
When another pharmaceutical company, Roche, marketed orlistat in prescription strength as Xenical, Wolfe spoke out. "Animal studies done by Roche show that rats developed aberrant crypti foci, ACF, precancerous lesions in the colon from Orlistat, which put them at higher risk of colon cancer," Wolfe said in a recent interview. "An independent study by researchers in 2006 found the same thing."
But another expert said Wolfe's concerns are unfounded.
"There are more than 100 clinical studies, including 30,000 clinical trial patients, and nine years of post-marketing surveillance with more than 29 million patient treatments, all showing no such risk with orlistat use," said Dr. Vidhu Bansal, director of medical affairs for GlaxoSmithKline Consumer Healthcare. "The FDA concluded the same in their recent review," she added.