Inside Drugmakers' War on Fat

(page 6 of 6)

Browse Issues

Browse the BusinessWeek Archive

Related Items

• Debate Room: Diet Industry Lies?
• Online Extra: Fat Fighters
• Take Two of These, and Go to the Gym
• Video: Obesity in America
• Podcast: Behind the Cover

Story Tools

• post a comment
• e-mail this story
• print this story
• order a reprint
• digg this
• save to del.icio.us

GETTING DEPRESSED

Sanofi's drug developers were so concerned about Acomplia's potential mood effects that they excluded depressed patients from the trials. That omission may have been the drug's downfall. Obesity itself can cause depression, and without data on how those people respond to the drug, panel members were at a loss. "How often are obese people thinking about suicide? We never had a handle on it," says FDA advisory panel member Clifford Rosen, a senior scientist at Portland Medical Center Research Institute in Maine. Paul Chew, president of U.S. research and development for Sanofi, says he hopes to "understand it better with additional trials." A current 17,000-patient study includes people with clinical depression.

Taking to heart the warnings about depression during Sanofi's FDA review, Merck tacked an extra year onto a two-year trial of its weight-loss drug so it could gather more data. That move shortened the lead Merck had over rival Pfizer, which is also developing an obesity drug that hits the cannabinoid receptors. But the resemblance between Merck's obesity drug and Sanofi's was too close for comfort. "It's not trivial," says Amatruda, an endocrinologist by training who still sees obese patients once a month at St. Luke's Hospital in New York. "We need to make sure we can define the risk/benefit profile."

After the FDA's negative review of Acomplia, Merck tweaked its research strategy. It went back to the doctors running its clinical tests and instructed them to double up their efforts to locate patients who drop out of their trials. "Some patients just disappear," says Amatruda, because they're unhappy with how much weight they're losing, or they're suffering from side effects that they don't want to talk about. "We are now actively seeking out these patients, calling them, trying to find them. We need to get information about why they dropped out."

On Jan. 8, Merck got a preview of the scrutiny its obesity drug is about to undergo. After it released a small 12-week study, press reports focused on a disturbing revelation: About 30% of patients on the drug reported psychiatric side effects such as depression, vs. 18% who were taking the placebo. Amatruda says the side effects were clearly worse in the patients who took the highest doses of the drug, and that the company has decided not to seek FDA approval for the higher doses. "We obviously took the side effects very seriously," he says. Whether the lower doses produce impressive enough weight loss won't be clear until later this year, when Merck will begin releasing results from its final round of trials.

Merck and everyone else pursuing the irresistible obesity market have grown adept at managing expectations. On Nov. 15, after Amylin announced the results of its weight-loss trial, there were high-fives in the labs and executive suites at Amylin's headquarters. But executives stopped short of jumping into the glassy-blue fountain in the courtyard—a celebratory ritual they established after Amylin got its two diabetes drugs onto the market in 2005. The 25-pound average weight loss in the trials "was astounding," Bradbury says. But he's quick to add, "we don't know what it's going to do long term."

Join a debate about the weight-loss industry.

Weintraub is a senior writer for BusinessWeek's science and technology department.