In this editorial, Williams questions the over-the-counter sale of an anti-obesity drug, orlistat. In 2006, the American Food and Drug Administration granted GlaxoSmithKline (GSK) approval to sell orlistat (Alli) over-the-counter, and GSK recently applied to the European Agency for the Evaluation of Medicinal Products to sell Alli over-the-counter throughout Europe. Several clinical trials have shown orlistat to be safe and effective. However, in a clinical trial context, participants are motivated and well supported by medical staff, who emphasize lifestyle modifications to increase the likelihood of permanent weight loss. If this support is not offered, Williams questions how Alli will perform. It is most likely that obese people, who often have very high expectations, will not persevere to experience the drug’s benefits. In addition, obesity is a multi-factorial clinical condition that cannot be fixed by using an over-the-counter drug alone. Rather, healthy eating and physical activity must remain the cornerstones of obesity management. It may therefore be necessary to advise people who are taking orlistat without medical supervision that they may not achieve the same weight loss observed in clinical trials if they do not include lifestyle changes in their drug strategy.
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