Healthy Skepticism Library item: 3672

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Publication type: news

Henderson D.
Glaxo plans sales curbs for diet pill
The Boston Globe 2006 Jan 13
http://www.boston.com/business/healthcare/articles/2006/01/13/glaxo_plans_sales_curbs_for_diet_pill/

Notes:

Ralph Faggotter’s Comments:

We are increasingly seeing chemical solutions being proposed as solutions to cultural and behavioural problems.

In the long run, therefore, they are doomed to fail.

Full text:

Glaxo plans sales curbs for diet pill

By Diedtra Henderson, Globe Staff | January 13, 2006

WASHINGTON — Popping a diet pill to fulfill a New Year’s resolution to lose weight may become easier this year, but perhaps only for people who can prove they’re old enough.

GlaxoSmithKline Consumer Healthcare wants to sell a low dose of its prescription diet pill Xenical over the counter, but purchasers may be asked to flash a driver’s license, just as they do to buy cigarettes or alcohol. The sales restriction would allay governmental concern that adolescents could misuse the pill.

The prescription waiver, if approved, would arrive as the nation struggles with a growing obesity epidemic.

Xenical, known generically as orlistat, helped overweight patients lose 5 percent of their baseline weight within four months in a clinical trial led by a University of Kentucky professor. That’s roughly the same weight loss achieved by obese patients who spent two years controlling food portion sizes in a federal study.

A spokesman for GlaxoSmithKline, which markets Xenical in the United States, said it had not been formally asked for a plan to prevent misuse by teenagers if Xenical is sold over the counter. But when federal advisers discuss the Xenical application Jan. 23, Glaxo will have a plan ready.

‘‘We don’t know if this is going to be a requirement,” said Brian Jones, a Glaxo spokesman. ‘‘If we do have to do it, we intend to have our preparations in place.”

Stores are unlikely to use a single approach to monitor purchases. Jones outlined one strategy they could use: When Xenical is rung up at the register, a computer prompt could prod cashiers to ask for proof of age. Until a valid date of birth is entered, the sale cannot be completed. Some retailers use this technique in handling the over-the-counter sales of GlaxoSmithKline’s nicotine-replacement gum Nicorette.

Xenical accounts for less than $100 million in sales annually in the United States, said Zach Wagner, an Edward Jones analyst. Over-the-counter sales of diet pills tallied $637 million in 2004, the latest available data yesterday from Marketdata Enterprises, a Florida market-research firm. Sales of prescription diet drugs were $413 million in 2004.

Eliminating the need for a prescription could help Xenical break through a crowded field of diet remedies.

‘‘It’s an effort, obviously, by them to boost sales of the product,” Wagner said. ‘‘Will it have a substantial impact? It’s hard to say.”

Many companies are working on a pill to help people lose weight and keep it off. Still, a recent National Institutes of Health study found that swallowing a diet pill is not enough. Obese adults lost the most weight when they combined a diet drug with such lifestyle changes as a healthier diet and exercise.

About two-thirds of American adults, or approximately 130 million, are overweight or obese. People are described as obese based on height and weight. For example, someone 5-feet, 4-inches tall who weighs 175 pounds or someone 6-feet tall who weighs 222 is obese. The condition is linked to diabetes, heart disease, and some cancers.

It is not the first time the FDA has struggled with over-the-counter sales of a drug that could be purchased by young people.

The agency sparked a congressional investigation and raised the ire of abortion rights activists last year by delaying a decision on whether to permit over-the-counter sales of an emergency contraceptive, known as Plan B. In August, Former FDA Commissioner Lester M. Crawford said the agency needed more time to resolve ‘‘difficult and novel policy and regulatory issues,” such as how to restrict over-the-counter Plan B sales so the drug is only sold to women 17 years and older.

Last month in New York, a federal judge said the Plan B matter had ‘‘all the earmarks of an administrative agency filibuster” and denied the government’s request to dismiss a lawsuit that seeks over-the-counter sales.

With Xenical, the wild card for the FDA is whether young people would abuse it the same way they do laxatives and diet pills.

According to the Centers for Disease Control and Prevention, 7.3 percent of Massachusetts high school students took diet remedies without physician oversight in 2003, the most current figures available. And 6.1 percent said they vomited or used laxatives to lose weight or to avoid gaining weight.

‘‘There is a potential for abuse,” said Dr. David L. Katz, director of the Prevention Research Center at the Yale University School of Medicine.

Katz said students more likely to misuse the diet pill include young women with eating disorders, wrestlers trying to make weight, and gymnasts who fear gaining weight.

‘‘People will be tempted to try it,” Katz said.

The drug does not produce the buzz that other diet pills do when taken at double or triple their regular dose, said Dr. James W. Anderson, a University of Kentucky professor of medicine who led a recent Xenical clinical trial.

Also, the pill can trigger an embarrassing and sudden loss of control over bowel movements.

‘‘These are things that would be unpleasant and socially not acceptable,” Anderson said.

Diedtra Henderson can be reached at dhenderson@globe.com.
© Copyright 2006 Globe Newspaper Company.