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Regulators giving closer scrutiny to proposed weight-loss drugs

Pat Faulkner, 63, has been on diets and promised remedies for 50 years. She lost 30 pounds after two months on Fen-Phen, but ended up in the hospital with skyrocketing blood pressure. 

MELISSA LYTTLE | Times

Pat Faulkner, 63, has been on diets and promised remedies for 50 years. She lost 30 pounds after two months on Fen-Phen, but ended up in the hospital with skyrocketing blood pressure. 

Here's how desperate people are for a fat-fighting pill:

A couple of years ago, a study of an experimental weight-loss drug was well under way when the 3,200 volunteers were told the pill, called lorcaserin, caused tumors in lab rats.

Did the trial come to a halt because too many people dropped out? No way.

The study, as well as another lorcaserin trial involving 4,000 people, was completed. The data showed people on the drug for a year lost an average of 5.8 percent of their body weight, compared with 2.5 percent for those on a placebo.

Armed with the results, the drugmaker took its case to the FDA. But last month an FDA advisory committee voted against the drug, trademarked Lorqess, and now its future is in doubt. Lorcase-rin's limbo reflects both the desperation for effective diet drugs and the renewed vigor of regulators charged with protecting Americans from potentially dangerous medications.

A safe and effective pill that can help people lose weight is the holy grail of the pharmaceutical industry and sure to be a blockbuster for the winning company. Still, it's a path littered with failures, product recalls and unappealing options.

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Dr. William Dudney, a Tampa psychiatrist who has specialized in weight loss since 1992, said, "There's such a pent-up demand, I think whatever's approved, effective or not, will be very popular. But if it doesn't work, it won't be popular for very long."

Fenfluramine, half of the popular diet cocktail known as Fen-phen, was pulled from the market in 1997 after the combination was found to damage heart valves. Meridia, an appetite suppressant approved in 1997, was withdrawn at the FDA's request earlier this month after it was shown to increase the risk of heart attack and stroke. Diet drugs still on the market are limited to short-term use (generic appetite suppressant phentermine) or have unpleasant side effects (fat blocker orlistat),

This year has seen a string of new weight-loss drug candidates seeking FDA approval. In July, the agency's advisory panel rejected Qnexa, a combination of phentermine and the anticonvulsant topiramate, because of concerns about usage by pregnant women and psychiatric side effects. The FDA will make a final ruling on the drug, made by Vivus Inc., later this month.

In December, the FDA's advisers are expected to review Orexigen Therapeutics' Contrave, a combination of the generics in antidepressant Wellbutrin and Narcan, used to treat drug addition.

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Lorcaserin, which uses a new chemical to suppress appetite, was considered the most likely of the three diet-drug applicants to succeed. In July, the New England Journal of Medicine published results of Arena Pharmaceuticals' two-year trial of lorcaserin and an editorial that was generally favorable toward the drug. Neither mentioned any issue with rat tumors.

The first public disclosure of the FDA's discussions with Arena regarding rat tumors came in the advisory panel's briefing documents, released two days before its meeting Sept. 16. The report said that although the drugmaker blamed malignant tumors on a toxic dosage given to the rats, 17 times the human dosage, "FDA reviewers do not believe that the available data support this hypothesis."

It went on to say there had been no reports of tumors in humans who tested lorcaserin. But the FDA's concerns created enough uncertainty that its advisers voted 9-5 against the drug's approval.

The FDA, which usually follows its advisers' opinions, is expected to make a ruling by Friday.

Arena, a small biotech whose stock reached $8 after the NEJM article, saw its share price plummet 75 percent after the FDA panel's negative vote. Observers were stunned that last-minute concern over animal studies could sidetrack a drug that had completed 18 human trials, all with the FDA's approval. Dr. Christopher Newell, an internist who lives in Orlando and has been involved in clinical studies, blamed both the FDA and Arena for the bombshell.

"You get your animal data wrapped up and if it looks bad, you figure out why. Then you give it to humans," said Newell.

Tamera Norton Smith, who owns a South Carolina company that monitors FDA studies worldwide, said it's unusual for subjects to be told about new risks after a trial is underway.

"These trials are so attractive to people suffering from obesity that you need to do all you can to protect people so they make an informed decision," she said. "That's a lot of risk to take on an obesity trial."

Smith said the FDA's concerns over lorcaserin might stem from changes she's seen at the agency over the past year. "They have new methodologies for looking at the sponsor's data more critically," she said. "They're putting the responsibility back on the manufacturers to prove their drugs are safe and effective."

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Regardless of lorcaserin's fate — or that of other weight-loss drugs in the development pipeline — people who have been on the diet-drug roller coaster aren't expecting any silver bullets.

Pat Faulkner, 63, has been on diets and promised remedies for 50 years. She lost 30 pounds after two months on Fen-Phen, but ended up in the hospital with skyrocketing blood pressure.

Last year, at 360 pounds, she had lap band surgery. She's now 67 pounds lighter, but credits both the procedure and a changed lifestyle. No more trips to buffets or late-night binge eating.

"It would be a wonderful thing if they came up with a miracle drug, but it won't do any good if you don't change your habits," said Faulkner, who lives in Gulfport. "I just wish I could have thought of this 20 years ago."

Kris Hundley can be reached at khundley@sptimes.com or (727) 892-2996.

Regulators giving closer scrutiny to proposed weight-loss drugs 10/18/10 [Last modified: Wednesday, October 20, 2010 4:43pm]

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