By Kate Resnevic
The Food and Drug Administration (FDA) has just made it even easier for people to obtain a risky weight-loss drug that has embarrassing – as well as some potentially life-threatening – side effects.
In February, the FDA approved an over-the-counter version of the diet drug orlistat, sold as Alli, and marketing began in June. (The prescription version’s brand name is Xenical.) The greater availability of this drug may seem exciting because Alli is the only FDA-approved over-the-counter diet drug. But it is also the first over-the-counter medication approved by the FDA that is known to cause pre-cancerous lesions.
Even before the drug was approved for over-the-counter use, Public Citizen had been trying to stop the widespread marketing of it.
In January 2006, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, and Elizabeth Barbehenn, a health researcher at Public Citizen, testified before a meeting of FDA advisory committees, opposing a switch from prescription to over-the-counter status.
And in April 2006, Public Citizen filed a petition asking the FDA to remove orlistat from the market because the drug can cause pre-cancerous lesions in the intestinal lining. The FDA chose not to take Public Citizen’s recommendations – much to the benefit of drug manufacturer GlaxoSmithKline’s pocketbook. The drug maker reported $153.5 million in sales to stores (including stockpiling) from Alli for the period between its June 15 launch and the end of that month.
Alli has been shrouded in clever marketing as an “innovative weight-loss program” that includes online support for users with menus, meal plans and shopping lists; links to help users find licensed dieticians; customized action plans; lessons about meal planning, managing hunger, dealing with setbacks, and making food and lifestyle changes; as well as message boards that connect Alli users.
“The diet and exercise program advocated by the Alli marketing team is great,” Wolfe said. “In fact, the only thing wrong with the Alli program and packaging is the drug itself, which is unsafe, ineffective and overpriced. The FDA’s decision to approve this drug for over-the-counter sale was reckless.”
Drug’s dangerous side effects are not pretty
Alli prevents enzymes in the gastrointestinal tract from breaking down the fat in food into smaller molecules that can be absorbed by the body. Thus, absorption of fat is decreased by about 30 percent. Unfortunately, as the undigested fat is washed away, it takes with it fat-soluble vitamins (A, D, E and K) and beta carotene, and patients using the drug must take a supplement that contains these vitamins. Vitamin deficiencies can ensue.
The undigested fat is also the cause of a number of unpleasant gastrointestinal symptoms for which the product already has gained notoriety. These include oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. Oily spotting and flatus with discharge occurred in about a quarter of the patients using the drug, according to the drug’s label. Wolfe contends that this is one more reason that the use of the prescription version of the drug, Xenical, has rapidly declined. (By fiscal 2006, prescriptions had dropped 79 percent from peak sales in fiscal 2000.)
It is amusing, then, but not surprising, that Alli’s Web site tells users: “Until you have a sense of any treatment effects, it’s probably a smart idea to wear dark pants and bring a change of clothes with you to work.”
Drug doesn’t work very well
The health risks associated with Alli would be unacceptable even if the drug worked, but the drug’s efficacy is minimal at best. Alli has made quite a media splash, but in terms of effectiveness, this has been much ado about nothing.
In clinical trials lasting for one year, patients taking the drug lost an average of only 13.4 pounds, compared to 5.8 pounds with placebo. That means that, after taking the drug up to three times daily for a full year, enduring serious restrictions on fat intake and all the unpleasant and sometimes dangerous side effects, patients will still lose only an average of 7.6 pounds.
This hardly seems worth it, especially because a 30-day supply (90 capsules) of Alli costs $59.99 at a major pharmacy chain. Refills for 40 days cost $69.99 at the same pharmacy. That means Alli users pay roughly $2 a day for the first 30 days, and $1.75 a day after that, to lose only moderately more weight than with diet and exercise alone. For those who do not discontinue Alli because of the obvious and embarrassing side effects, the drug does help people lose some weight. But there is no evidence that weight loss from this or any diet drug will reduce the risk of premature death or illness associated with long-term obesity. And there is no evidence that weight loss from this drug is sustainable in the long term after people stop taking it.
The safest, healthiest way to lose weight is the old-fashioned way: with a healthy diet and frequent exercise – no dark clothes required.
Kate Resnevic is an administrative assistant with the Health Research Group at Public Citizen.