By Kris Hundley, Times staff writer
In Print: Tuesday, October 19, 2010
Excerpt from the online version
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Regulators giving closer scrutiny to proposed weight-loss drugs
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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