Americans spend tens of billions of dollars each year to lose weight — gym memberships, Weight Watchers and other programs, operations, nutritional supplements and whatever the latest diet fad might be.
But the first new prescription weight-loss drug to reach the market in 13 years is having a hard time winning even a tiny slice of that huge market, despite an apparent need.
Sales of the drug, Qsymia (pronounced Kyoo-sim-EE-ah), have been minuscule since it went on sale last September. Sales totaled only $4.1 million in the first quarter of this year, even as Vivus, the manufacturer, spent $45 million on marketing, sales and administrative expenses.
Vivus's stock price has plunged to $12.41 from $29 on the day after Qsymia was approved last July. And the company's largest shareholder, saying the drug's introduction was horribly botched, is battling to oust the entire board and top management at Vivus's annual shareholder meeting on July 15.
More than a corporate drama, however, the slow start of Qsymia raises questions about what role prescription drugs really can play in combating the nation's epidemic of obesity.
While there are some problems unique to Qsymia, it is also facing barriers that are likely to confront other weight-loss drugs as well, including Belviq, a drug from Arena Pharmaceuticals and Eisai, that went on sale last month. Another drug, Contrave from Orexigen Therapeutics, is in advanced clinical trials.
These obstacles include lack of insurance reimbursement, modest weight loss, safety concerns, the troubled history of diet drugs, and a feeling on the part of many doctors and obese people themselves that excess weight is a lifestyle issue best addressed by more willpower, rather than a disease that requires medical treatment.
"You've got this turning of the battleship to change how the medical community views obesity," said Dr. Barbara Troupin, vice president for scientific communications and risk management at Vivus.
The attitude is turning at least a little. Last month, the American Medical Association, the nation's largest group of doctors, declared obesity a disease. In April, the American Association of Clinical Endocrinologists included weight-loss drugs in its diabetes treatment guidelines.
Given that one-third of American adults are obese and another third merely overweight, an effective and safe diet pill would seem like the path to instant riches. Jack Lief, the chief executive of Arena Pharmaceuticals, said in 2009 that sales of obesity drugs could eclipse those of statins, the cholesterol-lowering pills like Pfizer's Lipitor, which had peak annual sales of about $13 billion before falling to generic competition.
Yet no prescription drug for obesity has ever reached annual sales of even $1 billion, the lower boundary of what the pharmaceutical industry considers a blockbuster.
While it is estimated that more than two million people take weight-loss drugs, the vast majority using the old generic appetite-suppressor phentermine, that is still only a tiny fraction of the 70 million or more obese adults.
And patients typically give up on the drugs quickly. An analysis of prescription data by the Food and Drug Administration found that only one quarter of people kept using a drug for at least three months, and only 10 percent for at least 180 days.
One reason is that many people don't lose much weight. The clinical trials showed that those taking the recommended dose of Qysmia lost an average of 7.8 percent of their weight after a year. At that rate, a 250-pound person would end up at about 230 pounds.
Some people can do better than average, however. Marty McNamara, who started taking Qsymia in November, said he had dropped from 424 to 332 pounds as his appetite has virtually disappeared. Mr. McNamara, a 6-foot 5-inch highway maintenance worker from Ridgecrest, Calif., said he now eats only fruit for lunch.
"It's amazing, because I like food," he said, but quickly corrected himself. "I used to like food."
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