Are Pharmas Addicted to Lifestyle Drugs?

Drugmakers are eager to spiff up your sex life and hairline, even as their lucrative products face mounting safety questions

by Arlene Weintraub

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At a storefront exhibit in New York to promote the new weight-loss pill Alli, four slender young women gather around a computer terminal to learn about the drug that some have called a miracle remedy for America's obesity epidemic. But not one of the women appears to be overweight, let alone obese.

That raises a question: Will Alli (pronounced "ally") become the next lifestyle drug—a magic pill for a quick fix? Might it serve those who want to shed pounds before a big event, such as a wedding, or, worse, women who yearn to be as stick-thin as runway models?

It is, after all, the first FDA-approved weight-loss product to be sold over the counter. Steven Burton, vice-president of the weight control division for GlaxoSmithKline Consumer Healthcare (GSK), which markets Alli, cringes at the term "lifestyle drug." He's also nervous about the hype. After a tour of the exhibit, he says: "People have to understand this is not about losing 30 pounds in three weeks."

Try as they might to distance themselves from the lifestyle drug sector, pharmaceutical companies can't seem to kick their addiction to these lucrative products. Even as consumers and government regulators grow more alarmed over drug safety, an examination of four popular lifestyle categories—weight loss, hair loss, sleep, and sexual dysfunction—shows that the pharmaceutical industry is by no means shying away from this controversial territory.

This is a surprising trend for several reasons. Lifestyle drugs are defined loosely as products used to treat conditions that are not life-threatening. Yet because people take these drugs over long periods of time, sometimes on a daily basis, it can be difficult for companies to persuade the Food & Drug Administration that the medicines will cause no harm in the future. On June 13 a panel of FDA advisers voted unanimously that regulators should not approve a weight-loss treatment called Acomplia, from Sanofi-Aventis (SNY), and most experts believe the FDA will follow the advice of its panel when it reaches a decision later this summer.

For manufacturers of lifestyle drugs, the Acomplia example offers a cautionary tale. Analysts originally pegged the product, now called Zimulti, as a surefire blockbuster, with potential sales of $4 billion a year. It is already on sale in 37 countries.

But the FDA is concerned that some patients in clinical trials have experienced depression, and a number of them have been troubled by suicidal thoughts. The drug seems to achieve its desired effects by blocking biological receptors in the brain that cause food cravings. But by intervening in this pathway, it may also unleash anxiety, phobias, and other psychiatric disorders, according to statements the FDA released when it first reviewed this drug in 2006.

A Bulging Epidemic

Obesity occupies a special place in the lifestyle arena. Most experts argue the condition is, in fact, life-threatening over the long run, because it can lead to heart disease and diabetes.

A drug such as Acomplia, if it is eventually approved, will face a restricted market—if only because it will require a doctor's prescription. But Alli, which costs about $60 a month, is a different matter. Its over-the-counter status virtually guarantees that it will attract fans well beyond those who are dangerously obese.

And for many, the potential benefits are as much about cosmetics as they are about health. "Losing weight helps my self-esteem and well-being," says Stephanie, a 38-year-old beverage company executive who asked that her last name not be revealed. She has lost 20 pounds in the past year by exercising and changing her diet, and she plans to add Alli to her weight-loss plan. "Looking good makes you feel better."

Glaxo's Burton says it's hard to estimate the potential market size for Alli. But he adds that the market for weight-loss pills that are not FDA-approved is about $1 billion a year. Add in diet foods and programs such as Jenny Craig, and you end up with a $40 billion-plus market.

Burton believes Alli's limitations will dissuade people from using it as a shortcut to a quick trim-down. The drug prevents the body from digesting about a quarter of the fat in a person's diet. Those who eat too much fat while taking the medication can experience unpleasant side effects, such as diarrhea. That will effectively force patients to stick to a low-fat diet while they are on the drug.