This is an absolutely perfect example of the FDA using the precautionary principle to cause paralysis. Obesity is one of the greatest public health issues facing the American people. There are almost no good treatment options for most people, short of invasive, potentially life threatening and life altering surgery. A new drug (actually a combination of two already approved drugs) approaches the FDA for approval:
The Food and Drug Administration rejected another new diet pill on Thursday, the latest setback in the quest to develop treatments for overweight Americans amid the nation’s obesity epidemic.
The rejected drug, called Qnexa, is the third weight loss medicine to run into trouble this month because of concerns about safety. Last week, the F.D.A. declined to approve another new drug, lorcaserin, because it caused tumors in rats. And earlier in the month it forced the withdrawal of Meridia from the market after 13 years, citing the risk of heart attacks and strokes for certain patients.
Instead of allowing patients, in conjunction with their Doctors, to determine what level of risk they are willing to take in order to combat a problem that they know increases their risk for everything from heart disease to cancer, the FDA doesnt allow any treatment to be approved because there will be side effects; the reasoning distills the essence of bureaucratic paralysis:
Morgan Downey, an advocate for obese people who also consults for pharmaceutical companies, said the F.D.A. appeared to believe that a very effective drug would be used so much that unanticipated side effects would show up, while less effective drugs were not worth any risk. [Emphasis mine-SW]
“The F.D.A. has gotten itself into a real knot,” said Mr. Downey, who describes himself as obese and edits the Downey Obesity Report Web site. “They can’t approve a very effective drug and they can’t approve a modest drug.”