Will New Weight-Loss Drugs Be a Healtcare Disaster?

Not every­one agrees on the rea­sons for the bal­loon­ing American physique. Is it inac­tiv­ity? Overeating? The wrong foods? Environmental fac­tors? The Centers for Disease Control report 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 might 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 drug 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 drug’s 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.”

So it is no sur­prise that some 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 a 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 about 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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