December 15, 1998: Robert Branch, University of Pittsburgh Medical Center
Response to AHRQ on CERTs
This letter provides comment to the AHCPR/FDA initiative to fund regionally-based Centers for Education and Research on Therapeutics (CERTs), and represents collective views from a multidisciplinary group at the University of Pittsburgh.
The original intent of the CERTs concept in the following statement published by Dr. Raymond Woosley in his article "Centers for Education and Research in Therapeutics" (Clin Pharm Ther 55:249-255, 7 994) describes the CERT as having two primary missions:
(1) Conduct the essential research on drugs and therapies that is not being performed by the pharmaceutical industry; (2) Establish and communicate to practicing physicians therapeutic guidelines incorporating the most effective, safe, and least expensive therapies.
As you know, the CERTs concept was originally proposed in the Kennedy era and has been followed by intensive work by clinical pharmacologists, most notably Dr. Raymond Woosley, and supported by the American Society of Clinical Pharmacology and Therapeutics. We strongly endorse these initiatives.
The contribution of this proposal should be to promote rational therapeutic interventions for diseases, thus improving therapeutic outcomes in patients. CERTs are clearly a primary mission of academic medical centers and properly trained clinical pharmacologists are uniquely qualified to engage in these efforts.
These Centers should be based within academic clinical pharmacology, incorporating multidisciplinary working groups among physicians, pharmacists, health service researchers, bioinformatic specialists and biostatisticians. CERTs funding should encourage an investigator's existing extramural funding, as well as local institutional funds supporting pharmacy practice and cost-effective drug utilization. The leadership of each Center should also establish networking links among the CERTs to respond quickly to immediate needs from constituent groups with respect to drug safety issues as they become identified, with recent examples such as the FIAU hepatotoxicity, Seldane cardiotoxicity, Fen-Phen and valvular heart disease, and Mibefridil with its drug interaction profile.
Robert Branch, MD
Director, Center for Clinical Pharmacology
University of Pittsburgh Medical Center
623 Scaife Hall
200 Lothrop Street
Pittsburgh, PA 15123-2582
Fax: (4l2) 648-1837