Friday, October 29, 2010


The FDA has declined to approve the investigational weight-loss pill Qnexa, marking the second time in a week the agency has rejected a diet drug.

The FDA wasn't expected to approve the medication because a panel of outside experts voted in 10-6 in July against recommending approval for the combination drug -- made by Vivus -- which was shown to be effective in helping obese and overweight patients lose an average of 6-10 percent of their body weight in the company's clinical trials.

At the meeting, one panelist said the drug is "far superior to anything on the market;" however, concerns over psychiatric and cardiovascular issues uncovered in the company's trials ultimately trumped the weight-loss benefit.

Qnexa had been touted by many experts as the most promising weight-loss drug in more than a decade.

One of the key researchers in the development of Qnexa warned that the FDA's negative decision on the drug could have a cooling effect on industry efforts.

"If there isn't any kind of path forward for this drug I think it is going to shut down all obesity drug development for a decade," said Dr. Tim Garvey of the University of Alabama. Garvey conducted two clinical trials of Qnexa and has consulted for Vivus.

"Why would a company put all that investment into developing a drug if the FDA signals they aren't willing to approve it," he said.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.

While I question the constitutionality of the FDA, they actually may be right here.

I have done a lot of research on this subject since this story broke, and it turns out that if you eat LESS and exercise MORE, you will actually lose weight.

Maybe of we all turn off "American Idol," get off the couch, and go for a walk, we'll be better off...

1 comment:

  1. -->...Maybe of we all turn off "American Idol," get off the couch, and go for a walk, we'll be better off...

    Turn off "American Idol"? Alright, man, now that's just a downright, un-American, pro-Commie thing to say.

    What's happened to you?!

    ~ D-FensDogg
    'Loyal American Underground'