Wednesday, June 5, 2019

Pfizer Hiding Valuable Info?

My friend Mike Greene sent me a  Washington Post article highly critical of Pfizer for not sharing information about an arthritis drug that might prevent AD.  The theme of the article was that Pfizer had stumbled on a statistical correlation between the use of the drug Enbrel and reduced incidence of AD, but Pfizer didn't share information about it outside their company.  The Post contended that they didn't go forward with the information because they couldn't make money on it.  The Alzheimer's Association was also very critical.

Enbrel was near the end of its patent and would soon be available in generic form.  So investing in more research was not in Pfizer's financial interest.  Pfizer's critics say Pfizer should have at least shared what they knew more widely, so that someone else could have run with it.  There are academic institutions, foundations, and governmental institutions that may have done just that.

The mechanism of action for the drug is to reduce inflammation, and inflammation plays a role in AD.  There has been interest over the years in treating AD by reducing inflammation in the brain.  As we discussed in our post of April 16, the idea that an anti-inflammatory drug could effectively treat AD has been discounted by recent research.  But this was not known in 2015 when the correlation was identified or in 2018 when Pfizer made its decision.  On the other hand, Pfizer believed they knew at the time that Enbrel could not penetrate the blood-brain barrier and so shouldn't be able to reduce inflammation in the brain.  The correlation might then have simply been a statistical anomaly found in data of questionable quality.  The data was found in Medicare records that are considered essentially anecdotal for research purposes.  Some have suggested that Pfizer was worried about damaging their reputation by suggesting anyone rely on such data.

What do we make of this?  Well, Pfizer has probably figured out that they should have shared the information!  Regardless of PR considerations, did Pfizer make a reasonable calculation that the correlation would not lead to an effective treatment?  Considering the gravity of the situation, if they weren't going to pursue it, was it their decision to make; the decision that they shouldn't share it because they were certain no one else would be able to show it was an effective treatment?  

I wonder if the belief that Aducanumab or some other amyloid strategy was certain to solve AD before they could follow through with Enbrel played a role in their decision.  At the time, that seemed inevitable.

I'm also wondering if there aren't any other ideas, tucked away in a file somewhere, that if rolled out might not be equally provocative.

Something to watch is whether anyone begins an AD trial for Enbrel.  And if they do, what does it show?  Others may look carefully at the data and agree with Pfizer that it's a dead end, or they may think it's worth a serious investigation and go after it. 


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