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Weight-loss drug development is not for the faint of heart.

Three companies — Orexigen, Arena and Vivus — had promising candidates before the FDA last year. All walked away empty-handed. Orexigen said earlier this month it was suspending U.S. development of its own candidate, Contrave, because the bar set by the FDA was impossible to clear. Arena and Vivus are pushing ahead to provide the agency with the information it has requested.

Ken Fujioka thinks the current state of affairs is a shame. He’s a diabetologist and internal medicine specialist who directs the Center for Weight Management at the Scripps Clinic-Del Mar. (He’s also conducted clinical research with “multiple companies” working on obesity drugs.)

In an op-ed that ran in the Washington Post this week, Fujioka calls for a “reasonable conversation about what kind of medication risks doctors and patients should be willing to accept in return for benefits that hold the potential to fight this disease.”

In his view, obesity is such a difficult problem to solve — lifestyle changes are “starting points,” but used alone, “not a realistic solution” for most of his patients — that the framework for assessing possible drug treatments has to change. The possible health risks of weight-loss drugs need to be considered in light of the actual risks of obesity, such as diabetes, heart disease and degenerative joint diseases, he writes.

Fujioka wants the FDA to establish guidelines for acceptable risks, “talk to doctors and patients about what is at stake in the battle over obesity” and “hold drug makers responsible for quantifying those risks, after approval.” (We’ve contacted an FDA spokeswoman to see if the agency has a response, and will update if we get one.)

The FDA is planning an advisory committee to publicly discuss the cardiovascular safety angle in particular, an agency spokeswoman told Dow Jones Newswires in early June.

Bonus: Why One Stock Research Firm Won’t Cover Obesity Drugs

Image: iStockphoto

Here is the original: 
Weight-Loss Doctor: My Patients Need Effective Drugs