Money to Burn?
Investment in obesity research and development is a scarce resource. There’s no supply of money to burn. So the news of the termination of a large, expensive cardiovascular outcomes trial of naltrexone/bupropion (Contrave) is sad news indeed.
This was the inevitable result of a mistake involving premature release of interim data from this study. As we predicted when it happened, this mistake has proven to be very costly to Orexigen, the company that released the data. Their stock, which rose at first, has now lost all of that gain and more. The company will now have to do an additional study costing millions of dollars, and their partner, Takeda, has put Orexigen on notice that they don’t intend to cover any of the costs of the second study.
But perhaps the worst outcome is the loss of trust that this has caused. Clearly, FDA is annoyed and FDA has a long memory. Steven Nissan, lead investigator for the study at the Cleveland Clinic, issued a press release outlining the problems with the study and said:
Patients were misled, investors were misled. It is so critically important that investors and other people understand why early data in a trial are unreliable or unstable.
Trust is hard to build and easy to destroy.
Click here to read more from Reuters and here to read more from Forbes.
Money to Burn, photograph © Adam Cohn / flickr
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