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. Hes a diabetologist and internal medicine specialist who directs the Center for Weight Management at the Scripps Clinic-Del Mar. (Hes 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.
Karen Riley, an FDA spokeswoman, tells the Health Blog in an email that the agency has always been clear with companies developing weight-loss products that we will weigh the drugs potential benefits with the potential risks. We have been actively involved in the drug development process providing guidance to these companies on ways to design clinical studies in people to determine how safe the product is and how effective a treatment may be.
The FDA is in the early stages of planning an advisory committee to publicly discuss the cardiovascular safety angle in particular, she said.
Bonus: Why One Stock Research Firm Wont Cover Obesity Drugs
Update: This post was updated with FDA comment.
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