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DO I HAVE A CASE?

Here Comes Qnexa

     One of my favorite commercials from the Super Bowl was the car commercial… What, you don’t remember a car commercial? Well, I’ll bet you’ll remember it when I describe it.

     A fat dog keeps seeing a car drive by that he wants to run outside and chase. The first time he tries, he can’t get through the opening in the door. So, he sits and looks at himself in the mirror to figure out what to do. He is sad. The violin music is playing.

                                                                                                                                                                          

     Off of a sudden, the voice of James Brown kicks in with, “Get Up Offa That Thing”. Heavy dog decides to go on a massive workout program to lose weight. He throws his ball down the steps, so he has to chase it. He runs on the treadmill. He ignores the food being dropped on the floor: He even goes out to the pool to swim.

   In thirty seconds, you feel a part of the accomplishment. Yes, he is through the door doggy hole and out chasing the VW Beetle. All because he decided to exercise and do it. He takes no shortcuts to weight loss.

  The New York Times did a story on the making of the ad, because so many people picked it as their favorite Super Bowl ad. YouTube even has “The Making of:The Dog Strikes Back” commercial.

     They decided to create a metaphor of “letting ourselves go” by showing Fat Dog. Originally, the director of the commercial was looking for two dogs. But, they decided that “Bolt”; the dog in the commercial, was such a good actor that they would just use special effects to accomplish the weight loss.

     Bolt wore a “fat suit” built out of fake fur. As the reporter of the Times put it, “No animals were harmed in the making of this fat suit”.

     We all can feel a bit challenged by this ad because it ends in accomplishment. Unfortunately, drug companies know that people aren’t inclined to exercise and would rather just take a pill to lose weight. They have been focusing on finding “that pill” and getting it approved for marketing.

      It’s why the diet drug, fen-phen, was so widely prescribed. Then, when it was shown to cause pulmonary hypertension and heart valve problems, the drug was taken off the market; and it led to damage lawsuit payouts of about $13 Billion dollars.

     Other drugs have failed to get approval. Even Qnexa was rejected in 2010. But, maybe enough time has gone by where the effects and dangers of fen-phen are fading from our minds.       

     Last week’s big pharmaceutical news is the potential arrival of  Qnexa to market. Vivus is the Mountain-View based drug company to create it. When the FDA gave tentative approval last week by a 20-2 vote, Vivus stock (VVUS) jumped 98 percent on its first day of trading.  At close on Friday, it is now trading at $22.13 and moved to $22.45 in after hours trading.

     I will briefly describe ingredients and warnings. No need for exercise with what they are touting.   

     In terms of weight loss, Qnexa’s study participants loss an average of 10 percent of their body weight. One analyst predicts that such results will make this drug “the next Lipitor” with millions of prescriptions being written.

     If you analyze the drug, you’ll find that it’s really a cocktail creation. It’s a combination of two previously approved FDA drugs. The first is phentermine, which is really an appetite suppressant. It was the “phen” of fen-phen.     The second part of Qnexa is topiramate, which is an anti-convulsant.  

     Phentermine is already known to have two heart-related side effects: tachycardia, which is an increased heart rate, plus it has been shown to elevate of blood pressure. It has been around for over 40 years.

     Topiramate is the active ingredient in Topamax. It’s side effects include confusion, memory loss, concentration problems and “difficulty in finding the right words” in conversation.

     It appears that the FDA is going to allow this to go to market, because of the positive effect in the war on obesity. The FDA  probably will require additional studies for those that are already at risk from the above two ingredients.

      Warnings probably will include cardiovascular issues. Plus, Topiramate already carries the warnings of depression, mood problems, fatigue and sleeplessness. Plus, there’s that side effect termed as “suicidal ideation”.

     The FDA will make a final determination on approval and required warnings on April 17. Vivus is asking the FDA to allow it to begin a 4-year-trial on cardiac health AFTER the FDA approves it. People will be excited with the weight loss and push to be on the drug longer. Then, history tells us that the drug company will push for a stronger version, for those that really need to lose weight.

     I suspect that you will be seeing more blogs from me on this drug, if it is approved. It would not surprise me, if this law firm becomes very familiar with this drug and drug company.

     For pic o’ day, I thought I’d post something that I think, describes this blog.


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