Favoring Innovation in Obesity
For people favoring innovation in the treatment of obesity, we passed an important milestone last week. A headline in the Financial Times yesterday made it unmistakable:
“U.S. More Open to Obesity Drugs”
That headline summarizes an interview with Lars Sorensen, CEO of one of the largest pharmaceutical companies in the world, Novo Nordisk. Last week an expert advisory committee voted by an overwhelming margin of 14-1 to recommend approval of a Novo Nordisk drug, liraglutide, for obesity treatment. Next step for this drug will be a final ruling by FDA, which is due in October.
Reflecting on the significance of last week’s hearing, Sorensen said:
Obesity was seen as a behavioral problem. That is changing. Regulators are seeing that obesity is a problem that must also be addressed pharmacologically.
Looking back just three years, the change has been dramatic. At that time, FDA had rejected every new drug that had come before it to treat obesity. In a New York Times report back then, a veteran advocate for obesity innovation, Morgan Downey, was quoted as saying:
The FDA has decided that the most significant threat to public health will not be treated by any drug. In the current environment, tap water could not be approved.
At the 2010 Cleveland Clinic Innovation Summit on Obesity, Sanofi CEO Chris Viehbacher said:
As long as we’re so worried about obesity being a lifestyle choice — that anyone can choose to be fat or thin — then I don’t think we’re going to have an ability to develop drugs. I don’t think right now we have a regulatory environment, a risk/benefit environment that would allow me as a CEO to take the risk of developing a drug for obesity.
The change we have witnessed has come through the concerted work of diverse organizations united as the Obesity Care Continuum: the Obesity Action Coalition, the Obesity Society, the American Society for Metabolic and Bariatric Surgery, the American Society of Bariatric Physicians, and the Academy of Nutrition and Dietetics. In 2012 representatives of these organizations participated in the development of a consensus report with leadership from the George Washington University School of Public Health and Health Services. The report called for a new approach in evaluating the risks and benefits of drugs for the treatment of obesity.
That report was one of many important efforts to shift the framework for reviewing innovative obesity treatments. The progress is as gratifying as it is unmistakable. Yet much work remains. Drug treatments offer really good efficacy for relatively few people with obesity. More options are needed. A deeper understanding of the disease is needed to generate more and better options for both prevention and treatment.
Renewed private sector investment in obesity research will help. Momentum is building to tackle obesity through research and evidence-based interventions that will make a difference.
Click here to read more from Reuters and here to read more from the Financial Times.
3D Bright Idea, image © StockMonkeys.com / flickr
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