Adopted by the Council of the American Society for Pharmacology 
And Experimental Therapeutics, October 8, 1999

The American Society for Pharmacology and Experimental Therapeutics (ASPET) supports the efforts by the NIH’s Center for Scientific Review on recommendations for change to the peer review system. ASPET represents 4,500 pharmacologists in academia, industry and government. The CSR  “Boundaries” report is to be commended for soliciting input and public comment from a diverse scientific community. This review is needed as the biomedical research enterprise moves rapidly forward with major advances in our understanding and treatment of many diseases. 

Our review of the Boundaries report is mostly favorable. Overall, ASPET’s Council believes many of the recommendations could better serve the interests of the biomedical research community. ASPET does however have some general concerns, several of which are specific to pharmacological research. 

ASPET is pleased to see great emphasis of support for translational research. Basic pharmacological research over the decades has been largely responsible for the success of the pharmaceutical industry. Pharmacologists have been in the forefront of developing systematic approaches to drug design and assessing safety of drugs. Moving basic research to practical clinical application to the bedside should be encouraged throughout the proposed IRGs and implementation in Phase 2. 

From a pharmacological perspective there are several omissions in the Boundaries report that ASPET believes should be addressed. 

Pharmacology offers a contemporary post-genome perspective that will directly benefit patients. However, Pharmacogenetics does not appear to be represented among the IRGs. The study of how an individual’s genetic profile determines how effectively a drug becomes available and then works has major clinical applications and impacts virtually all human disease. Similarly, no mention is made of herbal medicine in spite of the fact that plants and plant-derived drugs play key roles in therapy of many human diseases. Additionally, the only mention of therapeutic drugs is when there is a clear public demand such as in oncology and HIV. This apparent narrow focus does not seem consistent with the Boundaries report emphasis on translational
research. 

ASPET agrees that basic and clinical researchers sitting on these new review groups should have flexibility to move among different study sections.  ASPET agrees with the Boundaries report that this would help promote more ambitious and interdisciplinary research proposals across a wide range of study sections. These peer reviewers need to be pharmacologists or scientists working in pharmacology and who know and understand the underpinnings of many of the biological, biophysical and chemical processes. ASPET believes that while scientific discipline should only be one of the critical factors in deciding study section composition, it is critical that some peer reviewers in each study section know pharmacology. 

ASPET also recommends that peer reviewers be allowed modified tenure with split appointments if desired. This will allow the NIH to draw from a larger body of scientists who are otherwise overwhelmed with other professional demands or intimidated by serving on study sections. This would be particularly helpful in bringing new perspectives from non-senior scientists. The use of external advisory groups as recommended by the Boundaries report should also contain scientists who may offer broader scientific perspective. 

The Boundaries report allows ASPET and other organizations and individual scientists an opportunity to address many of the fundamental questions involving research focus and peer review. ASPET hopes that, as Phase 2 moves forward, NIH will continue to seek broad scientific opinion on how these study sections should be constituted. More details will need to be explained and explored. ASPET looks forward to constructive ongoing involvement in
this important plan.