In the past six months, the U.S. Food & Drug Administration has considered whether to approve three new drugs for gout, a painful malady once called "the disease of kings" because of its association with rich living. It is an unusual confluence, given that there have been no new treatments for gout for more than 40 years.
But gout, linked with such noted figures as Henry VIII, Benjamin Franklin, and Shakespeare's Falstaff, is on the upswing. So are sleep apnea, infertility, kidney disease, hyperthyroidism, and newer disorders such as metabolic syndrome—a collection of risk factors for heart disease and diabetes barely recognized before the 1970s.
All of these seemingly unrelated illnesses share a common tie: They are among the side effects of obesity, which now afflicts about one-third of U.S. adults, according to some definitions. The Centers for Disease Control & Prevention estimates that medical spending on diseases related to obesity has nearly doubled in the past decade, to $147 billion, 9.1% of total medical spending.
New ToolsThe pharmaceutical industry is, as a result, ratcheting up research into treatments for these once-uncommon illnesses. "I think we're going to see several new drugs for obesity and related conditions in the next 5 to 10 years," says Dr. Caroline Apovian, director of Boston University's nutrition and weight management center. "They won't be panaceas, but they will be valuable additions to the toolbox."
Many adults these days are trying to shed pounds on their own, but drugmakers needn't worry about being carved out of the picture. "Lifestyle modification only gets you so far when you are already obese," says Brian Lasky, consultant with drug market researcher IMS Health. "It's very hard to reboot the body on your own. Better drugs are essential." The market for drugs that treat obesity complications should be worth billions, he says.
Getting such drugs to patients isn't easy, however. One obesity treatment after another has failed in recent years, either on the market or at the FDA, because of such side effects as depression, heart problems, and diarrhea.
Gout medications haven't had a much easier time. The disease is caused by excess uric acid in the blood that accumulates around the joints, causing pain and inflammation. The incidence of gout started rising about 20 years ago along with obesity, and today there are some 5 million sufferers in the U.S. The journal Clinics in Dermatology warned three years ago that "we may be in the midst of the third great gout epidemic of Western Civilization." (The first two occurred during the height of the Roman and British empires.)
Disruptive Snoring Generic anti-inflammatories have been the most common treatment for decades, although they are of limited benefit for many people. In February the FDA approved something new: Uloric, from Takeda Pharmaceuticals. But it took the Japanese company five years to convince the agency that the drug is safe. And on Aug. 2, the FDA delayed another treatment for the disease, Krystexxa from Savient Pharmaceuticals, which was ordered to submit new data on side effects and the manufacturing process.
The problems of obesity go far beyond gout. Sleep apnea, characterized by loud snoring and intermittent wakefulness because of the collapse of the upper airways during sleep, is a common side effect of excess weight around the neck. A recent study by the Irish consultants Research & Markets projects the worldwide market for respiratory devices to double by 2015, to $7.4 billion, because of growing demand from patients struggling with sleep apnea. And while the economic slump has hurt some medical companies, ResMed, a leading maker of sleep apnea devices, saw profits rise to $45.4 million last quarter, 53% up over the same period last year. "The market has remained healthy all during this time," CEO Kieran T. Gallahue told investors.
Drug companies are particularly interested in coming up with treatments for metabolic syndrome, a basket of symptoms that includes abdominal fat, high cholesterol, and high blood sugar. But research is complicated by the fact that the FDA does not recognize metabolic syndrome as a disease. "Until there is a regulatory path to approval, it's hard to move forward," says IMS's Lasky. Nevertheless, Merck and Eli Lilly are both developing drugs for the disorder.