Science abandoned for a diet

Once again, the FDA has foregone scientific evidence in approving a diet pill. Today, the FDA announced it had approved an over-the-counter version of Xenical (orlistat) for sale, making it the first prescription weight loss drug to be available without a prescription.

As recently discussed here, medical professionals have expressed concerns over diet drugs, specifically Xenical, for failing to show long-term effectiveness for weight loss, long-term safety or present any evidence that they improve actual health outcomes. Of special note is that Xenical reduces the absorption of essential fat-soluble vitamins, which could have serious adverse outcomes for both young and old adults. An over-the-counter version would also make it more likely for teens and children to abuse it in the same way they do laxatives and other diet pills.

Even the FTC’s scientific expert panel reviewing the evidence for weight loss advertisements, as discussed here, determined that any claims that a weight loss product will cause weight loss by blocking the absorption of fat or calories were false and fraudulent advertising. As panel member Judith Stern noted, even with the prescription strength Xenical, people can’t malabsorb enough fat a day to lose a pound a week and there are limits beyond which significant gastrointestinal problems occur. The panel’s scientific analysis stated: “The biological facts do not support the possibility that sufficient malabsorption of fat or calories can occur to cause substantial weight loss.”

But GlaxoSmithKline, who had paid over $100 million for the U.S. rights to the prescription version made by Roche, had undertaken an intense guerilla marketing campaign. And with good reason; the company told the FDA it anticipated that their over-the-counter version of Xenical, given the cute name “Alli,” would bring in annual sales to the company of $1.5 to $3.9 Billion.

One example of GlaxoSmithKline’s marketing schemes was to finance a series of press releases claiming an organization of obesity experts called the Reality Council had issued a FTC white paper calling for action against competing over-the-counter diet aids and later applauding the FTC for complying. Not a single reporter noted that there was no such white paper on the FTC website or available anywhere online; that the Reality Council has no address or website; and that all of the members listed for it in the GlaxoSmithKline’s press release were members of obesity lobbying organizations or weight loss product spokespersons. For example, co-chair George Blackburn is past president of North American Association for the Study of Obesity, Board member of the American Obesity Association and a trustee of the SlimFast Nutritional Institute. Co-chair Lou Aronne is director of the Comprehensive Weight Control Center in New York City. Other members cited included five past and current presidents, board members, and public affair officers for NAASO and AOA, executives of government obesity programs and program directors for weight loss centers.

It appears the strongest support for any safety record is that few will likely take it for very long. Most patients don’t like the side effects and don’t find they’re worth the small 5% of short-term weight loss with diet and exercise it promises, not to menton the price: $2-3 a day.