QNEXA: Money & Politics v.s. Science & Common Sense

In July of 2010, Qnexa, the first new prescription weight-loss pill in more than a decade, failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds.

The FDA vote was 10 : 6 against Qnexa.

The Feds said no to Qnexa because of the following side effects:

  • Depression,
  • Anxiety,
  • Increased heart rate combined with lowered blood pressure,
  • Increased body acids,
  • Impaired attention span,
  • Psychomotor slowing resulting  in difficulty finding the correct words
  • Impaired memory, and
  • BIRTH DEFECTS.

Not too surprisingly, the FDA asked Vivus (the maker of Qnexa) to go back to the lab and come back with a safer product.

Since that time:

  1. The drug has not been modified
  2. The FDA has been under a ton of pressure from politicians & lobby groups to “re-think” their position on Qnexa.

Fortunately for the American public, the FDA is a little gun shy about approving obesity medications known to have heart damaging side effects ever since the whole Fen-Phen death debacle of the 1990s.

Unfortunately for the American public, it looks like the possibility of a new multi-billion dollar fat drug combined with affordable political influence is beating the hell out of common sense and scientific integrity.

On Feb.22 of this year, a new FDA advisory panel voted 20-2 in favor of the approval of Qnexa. The exact same drug that was turned down a year and a half earlier.

How come?

As a condition for approval of Qnexa, the FDA and the drugmaker Vivus proposed:

  • A restrictive program to stop pregnant women from taking the drug,
  • A Qnexa training program for doctors,
  • Limited distribution to certified mail-order pharmacies.

Also, the drug will likely only be recommended for obese patients who have a body mass index over 30, or are overweight but have weight-related health issues.

And if that isn’t enough for those hard-asses at the FDA, Vivus has offered to start a new four-year trial of the affect of Qnexa on cardiac health….sometime after the FDA votes to grant formal approval of Qnexa.

REPEAT: After FDA approval has been given

They’ve offered to test how their drug affects your heart after you’ve already started your prescription.

WTF!!!

And if this wasn’t stupid enough

Because Qnexa is a combination of two already approved drugs (the stimulant phentermine and the epilepsy drug topiramate), it is possible for doctors to sidestep the whole Qnexa/FDA issue by writing scripts for both drugs and marketing themselves as weight loss gurus.

The only thing holding them back would be that pesky Hippocratic oath.

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NOTE – The FDA is supposed to vote on the approval of Qnexa on April 17, 2012….stay tuned

 

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