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The new thin pill: pg 4

NEW YORK (Wired, October 2006):

75 million Americans may have something called metabolic syndrome. How Big Pharma turned obesity into a disease – then invented the drugs to cure it.

The cholesterol analogy is apt in many ways. For 50 years, high cholesterol was simply one of several risk factors for heart attack and stroke, along with high blood pressure, smoking, and stress. You treated it by changing your lifestyle. But the discovery of statins in the mid-1990s gave physicians a way to control cholesterol levels, and high cholesterol became more like a disease (now called hypercholesterolemia). Today, statins are the biggest drugs in the pharmaceutical industry; Lipitor sales alone will hit $13 billion this year. Metabolic syndrome is in a similar position today. Should the right drugs come along, the metabolic syndrome market "promises to be as big or bigger" than cholesterol, Pharmaceutical Executive magazine predicted a couple of years ago. And rimonabant, also known by its brand name, Acomplia, may well be the first of those drugs. JP Morgan analysts predict that rimonabant sales could hit $5 billion a year.

That potential has spurred Sanofi, the third largest pharmaceutical firm in the world, to launch a two-tiered campaign. First the company is promoting the drug itself, spreading the word about rimonabant in the medical and financial communities. (The company has drawn criticism by announcing its rimonabant results at industry conferences rather than in academic peer-reviewed journals.) But instead of offering rimonabant as just the latest obesity drug, Sanofi is laying the groundwork for the medical community to recognize metabolic syndrome – a disease that just happens to be treatable with rimonabant. The company's education program includes sponsoring conferences, funding research, and providing certification courses for physicians. In the exhibit hall at this summer's American Diabetes Association conference, for instance, Sanofi set up a multimedia display on the endocannabinoid system, complete with polarized glasses and a 3-D movie. There was plenty of literature on cardiometabolic risk and metabolic syndrome on hand, but there was no mention of the drug that might treat it. "Being the first one to come out, the burden of education is on us," a Sanofi spokesperson says.

Sanofi's campaign was supposed to culminate this year with the FDA's approval of rimonabant to treat obesity, and perhaps this new disease, metabolic syndrome. But in February, Sanofi announced that while the FDA had found rimonabant "approvable," the agency had additional questions and conditions before rimonabant could actually be approved. The company and the FDA won't comment, but there's speculation that the drug's reported depressive side effects might be a concern. In early August, the company told financial analysts it remains "hopeful and confident" that rimonabant will be approved in the US (it went on sale in Europe this summer). But that's unlikely to happen until 2007.

In the drug industry, finding disorders like metabolic syndrome is known as "developing new disease markets" or "branding a condition." Industry critics have their own term for it: "disease mongering," they say, shaking a finger at pharmaceutical firms for devising treatments for normal conditions of life – menopause, anxiety, obesity. But as tempting a villain as the drug industry makes, it's not so clear that obesity is, in fact, a normal part of life. Blame corn subsidies or videogames or PepsiCo, but obesity has transformed our nation in the past 30 years. Diet and exercise? It's easy to recommend, and it's good in theory, but there's surprisingly little proof that lifestyle intervention actually works as a weight-loss strategy. In the late 1990s, the Centers for Disease Control and Prevention initiated its Diabetes Prevention Program, a $174 million study hoping to prove that behavioral changes can induce weight loss. To make the point, the program went to extremes. The 3,000 participants received gym memberships and personal trainers, had their food provided, and were coached with daily phone calls from nutritionists – all for two years or more. After all that hand-holding, patients lost an average of 7 percent of their body weight.

The CDC hailed the study as proof that diet and exercise work, but it just as readily proves the opposite. After all, how likely is the average American to stick with – let alone be able to afford – such an intensive program? "It's very easy to point the finger and blame people for not exercising enough," says Aronne. "But we're beginning to understand that there are metabolic issues going on."

"THE FUTURE OF OBESITY IS DRUGS." So proclaims Richard Atkinson, pathologist at Virginia Commonwealth University and president of the American Obesity Association, a drug industry-supported advocacy group. Atkinson is among the increasing number of scientists and physicians convinced that the body's propensity to store fat isn't something mere diet and exercise can correct. "We don't consider obesity a disease because it's easy to see," he says. "But obesity is biochemistry, and drugs change biochemistry." Obviously, the emphasis on drug therapies is a huge boon to the pharmaceutical industry, which has more than 350 obesity and metabolic drugs in the pipeline, many far along in clinical trials. Pfizer has CP 945598, its own cannabinoid antagonist. Manhattan Pharmaceuticals has a drug known as OE, which induces weight loss and matches up favorably with the components of metabolic syndrome. Eli Lilly has half a dozen drugs in Phase I trials. And so on. "The trouble is, it is extremely expensive and difficult to get an obesity drug to market," Atkinson says, pointing the finger at the FDA, among others.

That could be about to change. For several years, the drug industry has been lobbying the FDA to make it easier to get obesity drugs to market. In 2003, the agency started to relent, announcing it would revise its Guidance for the Clinical Evaluation of Weight-Control Drugs, the agency's checklist of standards for developing obesity drugs. First issued in 1996, the guidance has long vexed the drug industry, starting with the title itself ("weight control" implies a lifestyle problem, rather than a public-health issue). When the FDA invited public comments in 2004, 17 companies and two trade groups offered critiques of the guidance. (The American Obesity Association rewrote the entire guidance, line by line.) Almost unanimously, the industry called on the FDA to redefine obesity as a disease. "Obesity is a chronic disease, which may require pharmacotherapy," Pfizer's director of global R&D wrote. Others, including Merck and PhRMA, the pharmaceutical industry's lobby group, went further, urging the FDA to recognize metabolic syndrome as a disease, too. "Given the association of Metabolic Syndrome with obesity, and the clear link with increased cardiovascular morbidity and mortality," Merck's vice president of global regulatory policy wrote, the company "proposes that FDA consider an indication for this syndrome." The FDA has yet to issue its new guidance, saying only that it's still under review.

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