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.

.

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

 

Reference

Bye Bye Healthy Lifestyle : Hello Qnexa

Woooo-hoooo!!!!

No more exercise, no more vegetables, no more fish, no more paleo, no more carb/insulin control, no more protein shakes, no more mindfulness, no more healthy anything…

Qnexa is here and as soon as I get my prescription filled, I am gonna lay a beating on the nearest “all you can eat” restaurant I can find.

Because today is the day that the FDA released their review of  Vivus‘ new anti-obesity drug – Qnexa.

And in that 248 page review, the FDA notes that drug trial participants taking Qnexa lost significantly more weight than those taking a placebo, and that those taking the highest doses of Qnexa lost the most weight.

They also noted that there are concerns about Qnexa side effects – which include depression, anxiety, impact upon heart rate, increased body acids, impaired attention span, impaired memory, impaired attention span, language problems and various risks for pregnant women.

But, who cares about a few side effects?

  • I want my cake
  • I want to eat my cake
  • and I want a six pack

Who cares that Qnexa is the offspring of that old-school diet drug “fen-phen“.

Who cares that by replacing the appetite suppressant phentermine with the anti-seizure drug topiramate, Vivus is praying for a weight loss pill with the effectiveness of fen-phen but without all those pesky fen-phen side effects – pulmonary hypertension, heart valve problems and death.

  • Who cares that fen-phen passed all of the same FDA tests and trials that Qnexa is now passing with flying colors.
  • Who cares that analysts estimate that Qnexa could rake in nearly $689 million in sales by 2014.
  • Who cares that Vivus stock has already risen 20% on the news of this FDA report.

.I want my six pack and I want it now.

.Qnexa…here I come.

.Update:

As of Friday, July 16, 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.

So, what happens now?

Vivus should have the results of a 2 year Qnexa study by the end of this quarter. If those results are positive, Vivus will take another run at the FDA.

However, things get a bit more complicated for Vivus.

To win FDA approval, Vivus will now have to test Qnexa in as many as 10,000 human patients, at a potential cost of $150 million. And to raise that kind of money, Vivus will probably have to partner up with one of the Big Pharma corps..