by Bob Ehrlich, CEO, DTC Perspectives
After rejecting the three most promising obesity drugs in the past year, FDA has finally done something to bring some hope to the obesity category. Orexigen, the maker of Conclave, announced they had reached an understanding on the outcomes FDA expected from a new clinical study needed to get approval. Doing the study does not guarantee approval, but at least Orexigen can have a reasonable expectation that if the heart attack incidence is within study expectations, then the drug might get approval.
Conclave is not a wonder drug. One can expect a loss of perhaps 5% of body weight. In fact none of the drugs rejected are wonder drugs. Therefore FDA is being super cautious in approving these drugs. I understand their reluctance after the Phen-Fen disaster . On the other hand, if FDA wants drug companies to work to solve America’s biggest problem, then they must encourage further development. If one or all of these drugs are approved, at least additional drug R&D will make economic sense. The cure-all drug is not likely ever to be developed without a payback on these early attempts. Let Orexigen, Arena, and Vivus make back some or all of their investment and then we can expect to see a flood of research dollars invested in obesity.
Obesity is not just a cosmetic concern. Helping people lose weight will lower diabetes, heart disease and high blood pressure. FDA, by at least showing willingness to set some endpoint goals with a manufacturer, is acting correctly. They must be willing to approve drugs with some risk, even fatal risk. If we are to challenge our increasing body mass issue in America, we need FDA to recognize that Americans will not diet or exercise their way to health. That would be nice and should be encouraged, but we live in the real world. In that world of food super-sizes we need pills to help curb appetites.
I am sure diet drug DTC will include the mandatory “along with diet and exercise” this pill might help. Consumers want to pig out and remain thin. They want consumption now and pay later. No one says a diet pill is the ideal outcome for a fat society. It is what we need, however, to help reduce our societal bill for all the over-consumption. FDA should approve any efficacious pill even with some risk. We are at a crossroads of obesity research that requires compromise by FDA. Innovation will surely follow and that 5% weight loss now will become 15% in the near future.