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.
Wolfe maintained that the FDA relied heavily on testimony by a panel comprised of pharmaceutical company representatives. But that is only part of the difficulty, he said. The side effects were embarrassing, dramatic and distasteful enough to cause orlistat to lose popularity.
"The RX (prescription) drug's popularity went down, because it caused all sorts of acute problems, mainly gastrointestinal," Wolfe said. "Twenty-five percent of people got oily spotting (from the rectum), because the fat is going in one end and coming out the other. You definitely wouldn't want to take it while on a first date."
Wolfe said some people also experienced gas, loose or more frequent stools, and inhibition of fat-soluble vitamins. "We wanted the FDA to ban the RX version," he said. "It should never have been approved for over-the-counter sales."
But the FDA denied Public Citizens' petition.
This is precisely why GlaxoSmithKline is strongly recommending that a person adopt a low-fat diet when using alli. "These unwelcome side effects will only occur if people eat too much fat while taking the weight-loss drug, Cadle said. "And if they eat too much fat, then they're not following the program."
Cadle said alli will be sold in drugstores, mass market retailers such as Wal-Mart and Target, club warehouse stores, and some grocery stores.
The FDA has a location on its Web site outlining the approval process for alli®.
SOURCES: Joe Cadle, marketing director, GlaxoSmithKline Consumer Healthcare, Pittsburgh, Pa.; Vidhu Bansal, Pharm D., director, medical affairs, GlaxoSmithKline Consumer Healthcare, Parsippany, N.J.; Sidney M. Wolfe, M.D., director, Public Citizens' Health Research Group, Washington, D.C.