The LA Times took the temperature of some of the leaders in the obesity and weight-loss field and found they were running a high fever when it comes to the FDA's review of new drugs designed to spur people to shed pounds. Coming off two advisory panel votes against Arena and Vivus and a tepid endorsement of Orexigen's Contrave, a number of high-profile experts say that the agency's cards are stacked against developers--and the long-term consequences could be severe.
"Every big company is going to get out of the game, and venture capitalists are not going to invest in the smaller companies to develop drugs," said Dr. Donna Ryan, past president of the Obesity Society, recently. "Everybody in the obesity field is upset. There is a lot of anger.
UC Davis' Judith Stern tells the Times that the FDA is "not taking (obesity) seriously as a disease, and I have no clue why. We have a problem that affects over 65 percent of the adult population... the FDA should be jumping through hoops to give approval."
Needless to say, the FDA has been doing anything but jump through hoops to hand out quick approvals. The Contrave vote was the panel's first recommendation for a weight drug in 13 years. And recently there has been a raft of new safety concerns that has triggered fresh worries about cardiovascular side effects. One of the problems that has plagued the developers is that in clinical trials these new drugs have often only barely managed to beat the FDA's standard for success. If a safe diet and exercise regime could accomplish the same results, why run the risk associated with a therapeutic?
- here's the article from the Los Angeles Times