THE FOOD and Drug Administration made headlines on Monday when a panel of federal health advisers made the first-ever formal recommendation that a weight-loss pill be offered to consumers without a prescription. This decision has many negative implications in a nation where obsession with health and weight loss is on the upswing. Few can remember a time when we were more concerned with fitness and health than we are now: Although they have always been especially hot topics, dieting and weight loss have garnered excessive media attention of late, as new fad diets are springing up at a rate which appears to be one every few days. The FDA should be wary about approving over-the-counter sales of the new drug, as to avoid suggestion that weight problems can be solved with a pill. The administration risks advocating an unhealthy mentality among Americans, though it assuredly does not intend to.
The drug in question, which was first made available by Roche Pharmaceuticals in 1999 as "Xenical," is now on the brink of being sold over-the-counter by GlaxoSmithKline Consumer Healthcare, just as Roche's patent on it has expired. It is taken before mealtime, and functions by blocking the body's absorption of about one-quarter of all fat consumed -- typically 150 to 200 calories from fat per day. GlaxoSmithKline plans to market the drug at half the dose of the prescription variety.
Although the FDA has yet to give its final go-ahead -- that could take months -- many health care professionals are already warning of the negative consequences we face if it is approved. There is danger, for instance, that the drug will be looked towards as a quick fix for the obesity epidemic. Americans are constantly faced with pressure to lose weight quickly, and to keep it off -- most notably a function of the media. But this drug is not designed to achieve quick results. Nor will the results last without accompanying behavior modification. Simply, it may be used for the wrong purposes without a physician's direction.
GlaxoSmithKline readily admits that its reincarnation of Xenical, called "Alli," is only effective when combined with diet and exercise regimens. Even with that, Glaxo's Steve Burton describes the weight loss achieved by Alli as "gradual and modest." However, many consumers are not likely to take this into consideration.
Instead, consumers ought to focus on taking steps to modify their attitudes towards eating and their behavior. When these steps are taken in conjunction with Xenical or Alli, weight loss may be jump-started. But because the drug is not an appetite suppressant, it is largely ineffective for those who lack the self-discipline to control their calorie intake. When the one takes the drug under a physician's supervision, however, it is much more likely that the patient would receive the guidance and support necessary to maximize its benefits.
Without this guidance, consumers may resort to more drastic measures to ensure rapid weight loss, such as overdosing on the drug in order to heighten its effects. What these consumers may not realize is that this behavior puts them at an increased risk of vitamin deficiencies, already a primary concern of the FDA. Xenical is currently prescribed for use in 6-month intervals in order to minimize the chances of such deficiencies, but without a mechanism for regulating its use, it is possible that bulimics and binge-eaters using the drug may develop serious health problems after taking it for extended periods of time.
There is not only potential for abuse by those looking for a quick fix, but also by those who are misinformed about guidelines for the drug's use. For instance, supplemental vitamins must be consumed within two hours of its consumption, as it blocks the absorption of fat-soluble vitamins by the body. However, the FDA's own trials revealed that half the patients failed to heed these directions. Additionally, there is a long list of consumers which the FDA has deemed the drug unsuitable for, including diabetics, patients taking blood thinners and many who have received organ transplants.
Because no dietary supplement or drug for weight loss purposes has been approved for over-the-counter sale by the FDA to date, this move is surely cause for concern, as it has the power to change the face of American dieting regimens in the future: Rather than focusing on modifying our behavior, we might instead look to a pill for the solution. Is this mentality safe or healthy? There is a good chance that it is just the opposite. Weight-loss drugs should only be turned to when all other safe measures have been exhausted, lest they be abused in desperation. And while the average consumer is not equipped to make this decision, physicians are able to do so. The FDA must me more cautious, as it verges on making a dangerous mistake.
Todd Rosenbaum's column usually appears Wednesdays in the Cavalier Daily. He can be reached at trosenbaum@cavalierdaily.com.
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