FDA Denies Safety Approval for Anticipated Anti-Obesity Drugs

By Emily Butcher

The FDA’s advisory committee has a recent history of exercising unusually high safety standards for new pharmaceuticals aimed at treating obesity, but that didn’t prevent the shock many expressed that the three most promising drugs poised to hit the market, backed by Arena Pharmaceuticals, Vivus, and Orexigen Therapetics, were not approved due to insufficient data presented on effectiveness, as well as potential risks shown by the detection of tumors found in rats who had received high doses of one of the drugs. The pharmaceutical industry has yet to find an effective weight loss drug and has run into a list of complications and setbacks, including the infamous fen-phen scare of the ‘90s; weight loss drugs have been blamed for side effects ranging from damage to heart valves to depression and suicidal thoughts. This is not entirely surprising since the brain-body link is arguably one of the reasons it can seem nearly impossible to shed pounds; many prospective drugs have negatively affected hormones and neurotransmitters associated with cognition, information processing, and emotions.

Despite these upsets, the implementation of an effective weight-loss drug could not only generate billions in revenue, but also save a staggering amount in healthcare costs each year – a study conducted partly by the federal Centers for Disease Control and Prevention estimated that treating obesity and obesityrelated diseased totaled nearly $147 billion in 2006 in the U.S., accounting for 9% of overall healthcare spending. Once considered strictly a Western, affluent affliction, the ripple effects of the disease are quickly spreading to countries like Japan, India and Brazil. Besides the potential lucrative gains, increased quality of life could affect a large percentage of the global population who now struggles with the effects of being overweight or obese.

Despite millions of potential users, obesity drugs are rarely covered by insurance companies, and doctors are often hesitant to prescribe them, stressing that diet and exercise are the most effective longterm solution to maintaining a healthy weight. Furthermore, experts point out that some non-obese users may choose to buy the drug, finding a quick fix to drop those last five pounds. To combat these fears, the companies emphasize that their products are not meant for cosmetic purposes, but aim to control and prevent diseases such as diabetes, cardiovascular disease and high blood pressure, among other related conditions.

Undoubtedly, pharmaceutical companies will continue to push forward with new medicines and work to tackle existing problems, but the decision may ultimately lead to heightened support for alternate therapies, such as the increasingly supported theory that any effective form of weight loss management includes at least some form of behavior modification. Weight Watchers, aimed at maintaining long-term behavioral changes, was found to be the only effective weight-loss program of eight popular programs evaluated by the Annals of Internal Medicine in 2005.

These landmark decisions will likely foster support for a combination of approaches and treatment. The FDA seems to favor bridging the gap, and asked Arena Pharmaceuticals to submit more information on studies using the drug in combination with behavioral health modifications. So for now, the search for the “magic pill” continues and for the time being, some old-fashioned sweat may prove to be the most effective treatment.

Emily Butcher                                                                                                        Interactive Media Institute                                                                                             U.S.A.                                                                                                   ebutcher@vrphobia.com                                                                         www.vrphobia.com