Are You Ready for the New Diet Drugs?

By now, most people are aware of the obesity statistics. Thirty-four percent of US adults are obese, 34 percent are overweight and more than a third of children are either obese or overweight. The average American man weighs 194 and the average woman, 165--a trend that brings to mind an old New Yorker cartoon in which a doctor tells a fat patient "according to this chart you should be seven feet and two inches tall."

Not everyone agrees on the reasons for the ballooning American physique--is it inactivity? Overeating? The wrong foods? Environmental factors?-- but few dispute that excess weight is linked to coronary heart disease, stroke, Type 2 diabetes, cancer, high blood pressure, liver and gallbladder disease and osteoarthritis. One statistical report says obesity is actually more harmful than smoking, drinking or poverty. And that's assuming the overweight aren't afflicted with those conditions too....

But despite the 200 million Americans who could use a diet pill and the $60 billion a year such a pill represents to Pharma (more than the statin market, $25 billion a year and erectile drug market, $5 billion a year combined!) the FDA has not approved a new diet drugs in 13 years. Worse, the last diet drug it approved, orlistat, found in the prescription drug Xenical and over-the-counter version, Alli has been a disappointment and the "butt" of jokes.

Orlistat causes weight loss by blocking the body's absorption of fat, putting users at risk of "fatty/oily stool, oily evacuation, increased defecation and fecal incontinence," says its prescribing information. Soon after the drugs' approval, comedians let fly one liners like, "With Allies Like This, Who Needs Enemas?" and "Free coupon for Depends." Scat and splat jokes aside, weight loss is also only modest with the fat blockers and in 2010 the FDA added warnings of "severe liver injury" to them.

So it is no surprise that overweight people, the doctors who treat them, Wall Street and Pharma are heartened by the FDA's approval this summer of two new diet drugs. Qsymia, made by Mountain View, CA-based Vivus and Belviq, made by San Diego-based Arena Pharmaceuticals were both turned down by the FDA in 2010 but reconsidered and approved this year when more safety data were presented. Both are expected to hit pharmacy shelves before the end of the year.

Qsymia combines the diet pill phentermine (also known as Fastin, Adipex and Ionamin) with topiramate, the active ingredient in the seizure drug Topamax known to suppress appetite. Even though both ingredients are already on the market and could be prescribed without Qsymia's approval, the FDA rejected the combo pill two years ago over   concerns about depression, memory-loss and birth defects risks. (Months after Qsymia's 2010 rejection, the FDA added birth defect warning to topiramate.)

Belviq is lorcaserin, a never-before-approved antidepressant-like drug similar to two drugs withdrawn from the market for deadly heart valve problems in 1997. The FDA rejected Belviq in 2010 because of tumors in rats given the drug causing Arena to lay off 66 employees and prompting a petition to the FDA charging that, "The dramatic elevation of concern over rat cancer," could "result in irreparable damage to the bio-technology and pharmaceutical industry as a whole."

Of course dangerous diet drugs have also caused "irreparable damage to the bio-technology and pharmaceutical industry," which is why the FDA has been so gun shy in approving a new diet med. Fen-Phen, which combined phentermine (found in the just-approved drug Qsymia) and dexfenfluramine or fenfluramine (similar to the just-approved Belviq) was withdrawn as a combination drug in 1997 for causing primary pulmonary hypertension (PPT) and heart valve deaths. The drug's lethal side effects were especially embarrassing to the FDA since its own reviewer had predicted them if the two drugs were combined but his veto was overridden and the drug was approved anyway. Oops.

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