FDA-Approved Diet Drug to Get Big Sendoff

(April 30, 2007) -- One million copies of a book titled "Are You Losing it?" will go on sale nationwide Tuesday. The small, square volume is an introduction to alli -- the first weight-loss drug approved by the federal Food and Drug Administration for over-the-counter sales. GlaxoSmithKline Consumer Healthcare will follow up in mid-June by putting 3.5 million starter kits for the drug onto shelves at 40,000 stores and supermarkets nationwide.

"Given the scale and the unprecedented way we are approaching this launch, it is probably going to be one of the largest investments made in any over-the-counter brand in the last 10 years," said Steve Burton, vice president, weight control for Glaxo's consumer division in Moon.

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Alli could generate $200 million a year in sales for the U.S. consumer unit of British-based Glaxo, according to one financial analyst. Alli is the nonprescription form of the fat blocker orlistat, which about 28 million consumers have used since its arrival in prescription form eight years ago.

GlaxoSmithKline is serving its messages about the drug's potential benefits with a big helping of caution.

That's the idea behind introducing the book six weeks before the pills go on sale.

"Probably the worst thing a consumer can do with alli is to make an impulse purchase," said Joe Cadle, Glaxo's marketing director in Moon. "There is a lot you have to know about this drug and how it works."

"Are You Losing It?" will sell for $5.99 in weight loss aisles, with profits going to programs that fight childhood obesity, Glaxo says.

The book is a quick primer that explains the drug is for overweight adults committed to eating low-calorie, low-fat meals and exercising.

"If they do make that commitment," Cadle said, "they will lose 50 percent more weight than with dieting alone. So instead of 10 pounds, they'll lose 15."

Motivational tips, dietary lessons and recipes fill most of the 140 pages, along with warnings about side effects.

"With a medication like this, if you eat too much fat, you will suffer the consequences," said Dr. Terrence Starz, chairman of the Allegheny County Medical Society and its obesity task force.

"It does work. It is not a cure-all, but it is a way to help guide our diet choices," he said.

Madelyn Fernstrom, director of the University of Pittsburgh Medical Center's Weight Management Center and a contributor to the book, said alli could work for someone reluctant to see a doctor for a weight loss prescription.

Fernstrom said alli's complications would tend to discourage improper use by people with eating disorders. The book advises alli users to wear dark clothing and keep a change of clothes handy until they know how the drug will affect them.

Dr. Sidney M. Wolfe has fought to ban orlistat in his role as research director with the consumer advocacy organization Public Citizen. Its release in nonprescription form, he said, is "a massive mistake on the part of the FDA and GlaxoSmithKline. We urge that nobody use this product."

He said orlistat has no known health benefits, users regain weight rapidly when they stop taking it and the range of health risks includes precancerous colon lesions.

Linda Bannister, an analyst with Edward Jones, projected alli will generate about $200 million in annual sales for Glaxo, a global company that relies on prescription drug sales.

"We are a society that is very focused on the need to lose weight. There will be a lot of consumer interest in this," she said.

But problems with past dietary supplements might make some consumers wary of alli, Bannister said.

Americans spend about $1 billion annually on weight loss supplements.

GlaxoSmithKline officially will introduce the alli brand May 21 in New York City. The drug won't be available, but consumers can pick up promotional materials and a copy of the "Losing It" book, said Jeff Schuldt, the consumer division's director of promotions and alliances.

The company won't put an exact date on the drug's availability because production is under way.

In thousands of stores, alli will be sold from free-standing displays featuring phones with a 30-second, prerecorded message about the drug's benefits and drawbacks, along with brochures.

The consumer division's strategy of promotion, tempered with caution was developed years before the FDA gave its final approval for the drug in February.

"The risk is if it just shows up on the shelf one day and you hear it is FDA approved, there could be a stampede," Glaxo's Cadle said. "We don't want a stampede. We want people to think about this."

By: Kim Leonard
Source: Tribune-Review

Last updated: 04/07

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