Summary of Remarks
Dr. Albert Wertheimer
Professor and Research Center Director
Temple University School of Pharmacy
“Pharmaceutical Policy and Outcomes Research”
October 4, 2006

Dr. Wertheimer spoke about outcomes research. He listed the three types of outcomes: clinical, humanistic, and financial. The majority of funds go into clinical outcomes research. Much of the need for outcomes research comes from pressure from the FDA.
 
Dr. Wertheimer discussed the Cochrane Collaborative, the Scottish repository of outcomes research, and NICE, the National Institute of Clinical Effectiveness in England. He said these groups are important because most drugs are only effective for 40 to 60 percent of people and ongoing evaluation is needed. 

A major focus of the talk was on post-market evaluation of drugs. Studies that are promised by manufacturers are often not delivered. New drug approvals in the United States do not expire, which reduces pressure to complete the studies. In other countries, such as Japan, drugs must be re-approved every six years, and updated data on safety and efficacy must be submitted.

Dr. Wertheimer sees major changes in protocols over the next few years. In addition, changes to pharmacy practice will affect the need for outcomes research, including customized therapy, pharmacogenomics, and computer assisted prescribing.