Obese Expectations Trump Great Data

Great data, VIVUS (Nasdaq: VVUS  ) and Orexigen (Nasdaq: OREX  ) . There's just one problem; I can't see how it's going to get your drugs approved.

Both companies presented data on their obesity drugs at the American College of Cardiology meeting yesterday. After two years on VIVUS's Qnexa, patients reduced their triglycerides, improved their good cholesterol levels, and a reduced the use of antihypertensive medications compared to placebo. Orexigen's Contrave similarly increased good cholesterol and decreased a marker for heart disease.

Sounds great. Both companies were up by double digits at some point yesterday. Unfortunately all the trials seem to do is reinforce the idea that losing weight is good for you and improves heart-related issues. There's no evidence that the drugs are having a direct effect on the cardiovascular system. Instead, the effect seems to be a side effect of losing weight. If you put patients onto a treadmill for four hours a day, you'd likely get the same effect.

And the weight loss from exercise would come without the side-effect worries that come with Qnexa and Contrave. The Food and Drug Administration has requested data from VIVUS about cleft lip seen in babies born to women taking one of the components of Qnexa. And the FDA wants an additional heart study -- oh, the irony -- for patients taking Contrave.

Personally, I think the risks justify the weight loss. I'd just approve them both along with Arena Pharmaceuticals' (Nasdaq: ARNA  ) loracaserin. Heck, bring back Abbott Labs' (NYSE: ABT  ) Merida, and let Pfizer (NYSE: PFE  ) relaunch Fen-Phen if it wants. Just tell patients the potential risks and let them decide for themselves whether they should take the drug.

Unfortunately, I neither work at the FDA nor does the agency share my Libertarian views of drug approvals. It's highly unlikely that the new data will do anything to change the FDA thinks about the risk-benefit analysis of the drugs.

Investors willing to risk putting their portfolios on a diet can go ahead and take a flyer on VIVUS or Orexigen. The rest of us should wait until the side-effect lady sings before jumping on board.

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Pfizer is a Motley Fool Inside Value recommendation. The Fool owns shares of Abbott Laboratories. Motley Fool Alpha LLC owns shares of Abbott Laboratories. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Motley Fool has a disclosure policy.


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  • Report this Comment On April 05, 2011, at 6:23 PM, PhillyDan wrote:

    Great article Brian. I agree that weight loss will improve your cardiovascular system. I just recently underwent a second kidney transplant. After the transplant, I have lost 20 pounds. My blood pressure is the best it has been in years - I do take one heart medication, but a low dosage of that medication.

    My lipid levels are very good. My heart rate is decreased, etc. Thus, I am a good example of the key point of your article.

    Like you, I am in favor of the FDA approving Lorcaserin, Qnexa (mid-level dosage) and Contrave since there are a number of people out there that do need assistance to help them lose weight. My preference is Lorcaserin, since it has the best side effect profile and why I have a large investment in Arena.

    Having all three on the market will provide Doctors with different options for treating their patients. They could start a patient out with one of the drugs, if that appears to be working and the patient is tolerating the drug, then they can maintain that drug for the patient. On the other hand, if the patient is not seeing the weight loss expected or they have a side effect issue, then the Doctor can switch them to one of the other drugs.

    With Lorcaserin, a Doctor could prescribe a low dosage of phentermine to go along with the Lorcaserin. This should provide quicker weight loss than Lorcaserin alone. Once the patient meets the desired weight. Then Lorcaserin would be used as the maintenance drug.

    It already appears that both Vivus and OREX are losing part of yesterday's gain.

    In addition to the data presented in the press releases, was the fact of what they omitted from the press releases.

    Once again, a good article that was spot on.

  • Report this Comment On April 06, 2011, at 8:03 AM, hopjmpoop wrote:
  • Report this Comment On April 06, 2011, at 9:37 AM, Blindnomore wrote:

    I too have a stake in Arena but unfortunately I have now figured out why the FDA will never approve these drugs except after running them through near impossible tribulations with the intent on bankrupting the companies so they just give up their battle to gain approval. Why you might ask? The FDA as well as the drug companies are not desiring an easy way for people to regain their health by losing weight. Weight loss, as pointed out by the article and the first commenter, has huge benefits for the person in several ways. So many in fact I can't can't them all. These reductions in negative health do only one thing. Reduce pharma's profit margin on their other drugs they sell to treat all those health problems aggravated by obesity. It is that simple. The FDA is in league with the big pharma players but try to make it look otherwise because if they did not there would be no need for the FDA. And the FDA employs a HUGE number of so called doctors. Ha- more like on the take, insider trading scam artists is more like it.

  • Report this Comment On April 06, 2011, at 1:05 PM, healey215 wrote:

    brian , everyone is aware that the many health benefits are just a result of losing the weight, if that was your point. whats the difference if as you say, there is no evidence of a direct effect on the cardiovascular system. They are being marketed as obesity drugs. Active healthy lifestyles would certainly cure the epidemic , but look around at your neighbors, sadly way too many do not live that way and would use your treadmill to hang wash on. Changing a inactive culture would be the safest solution, but the reality is, if people are going so far as to under the knife[ dangerous bariatric surgery], many are unable or unwilling to change.

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