Psst ! Wanna buy a bridge?

Nov/26/2007 09:17 Filed in: HCP Marketing
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Cardiologists have been awaiting the results of the trial, called Enhance, to learn how well Zetia and Vytorin work. If they are not as effective as other cholesterol medicines, patients taking them may be putting themselves at unnecessary risk of heart attacks. Of particular concern in this case is that Merck and Schering-Plough said yesterday that they had changed the trial’s “primary endpoint” — the main medical result being measured. The companies now say that they will use only partial results to assess the trial’s success in deterring the formation of plaque that can cause artery blockages and lead to heart attack according to the New York Times. This is about as transparent as a block of steel.



When a drug company says that they will release data from a major study on one of their drugs then not only postpones the data but changes the endpoints you had better believe that someone is trying to sell you the Brooklyn Bridge at a discounted price. What is so puzzling here is why a company would do this full well knowing that it is going to create a lot of doubt in the minds of physicians who prescribe the drugs.


The statin market is very lucrative and in 3-4 years the biggest product in pharma history, Lipitor, is coming off patent. A clinical trial therefor of new drugs within this class could go a long way to pick up some sales from Lipitor or generics if the data clearly shows that their is a benefit of branded products over generics soon to include Lipitor. I talked to a couple of thought leaders and asked them about changing "end points" and most said that it was in fact highly unusual but there is a lot of money to be made if the data can be "manipulated" to show positive outcomes.


What Merck and SP have done here is created doubt in the mind of their target audience which is the opposite of what they wanted to do with this clinical study in the first place. Now, even if the data supports Vytorin, some physicians may be skeptical about the products claims because they have not had a chance to review ALL the data. One wonders how a drug company could make such a misstep but then it's about the stock price and ROI not about which medication is best for patients. It's easy to distrust big pharma and with moves like these it gets easier everyday.
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