Thursday, July 15, 2010

The FDA Panel and Fat People, No to Qnexa



In an unexpected 10-6 vote (or was it 9-7, it's been reported both ways so far), the FDA's Endocrinologic and Metabolism Drug Panel failed to recommend the approval of the weight loss drug, Qnexa. In today's vote, safety concerns overcame the Committee's acknowledgement of the drug's effectiveness in promoting weight loss. There is no doubt that the product is a useful weight loss agent, especially in the higher dosage form. While safety issues are germane, proper prescribing instructions and warnings could have been appropriate recommendations. Black box warnings are often alternatives for drugs with worrisome side effects.

VVUS, which had closed on the 14th in the high $12 low $13 range, reopened in after hours trading and dipped to a low of $4.85. The share price has moved up into the low $5's at present. Such tumult is part of the Las Vegas like pharmaceutical business.

Considering that Qnexa is a combination of two already FDA approved drugs, phentermine and topiramate, the decision is all the more surprising. When the epidemic nature of obesity in the US is factored into the equation, the Panel's disinclination to give the drug a green light, makes an observer wonder if the panelists have a fat bias. Suppose a disease, infectious or autoimmune, resulted in a higher morbidity and mortality, similar to that of obesity. Further suppose that the risks and side effects of the therapeutic drug for this disorder are the same as Qnexa. There is little doubt, after a risk benefit analysis, that the hypothetical product would be accepted and endorsed. Obesity NEEDS to be viewed as the killer that it is. Being obese cannot be considered a cosmetic problem of weak willed individuals. The incidence of obesity's co-morbid medical problems of diabetes, hypertenson and heart disease are formidable.

As a matter of obvious comparison, Qnexa's safety has to be matched up with the safety of the traditional weight loss remedies of diet and exercise. In an ideal world, diet and exercise are the perfect remedy for obesity, a remedy with minimal side effects. The problem with that analysis is that the majority of the obese population cannot manage their disease with diet and exercise. Indeed, if the obese patient could succeed with diet and exercise, wouldn't they?

The two other diet products presently in the pipeline, Contrave and lorcaserin, will face the same Panel later this year. Of the three of them, Qnexa appeared in studies thus far, to be the most effective in weight loss treatment. It is possible the safety profiles of one or both of the other drugs will be more acceptable to the Panel. Today's opinion set the bar HIGH. Wouldn't it be a shame if effective drugs, such as Qnexa, Contrave and lorcaserin, are ultimately unavailable to the American public. The Panel needs to understand that, in the real world, Americans are suffering and dying from obesity.

Perhaps the FDA will ignore the Panel's advice and approve Qnexa? Perhaps an obese patient can ask his doctor to order phentermine and topiramate independently so that he would be using a de facto Qnexa.? Perhaps, when Canada has Qnexa on its formulary, the patient can fax an Rx north of the border? Perhaps, perhaps, perhaps...

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