Further response to Barry Blackwell’s reply by Donald F. Klein


Donald F. Klein’s further response to Barry Blackwell’s reply to his comment

I believe there is more agreement than disagreement here. All agree that transparency is needed. I believe that requires access to patient level data as the EMA has held. Tom emphasizes that there are major legal problems in gaining such access. Therefore, as scientists, our focus should be on developing more homogeneous diagnostic sub-groups that will allow a better understanding of pharmacological interaction with pathophysiology.  This leads to better specificity of prescription and accuracy of prognosis. Certainly I agree, but must simply point out that such scientific development and legal/economic modification are not mutually exclusive goals. 

My emphasis is that the current parallel group, placebo controlled, extensive design actually is problematic, since it gets in the way of improving homogeneity by confounding response due to specific drug benefit with improvement due to non-specific factors, e.g., "spontaneous" remission, anti-demoralization, etc.

The approach that may lead to more homogeneity in medication response is the "intensive" approach, basically double blind placebo substitution in apparent medication responders. This was previously discussed in the INHN comments on Bech’s Clinical Psychometrics.


Donald F. Klein

September 17, 2015