NPC, PMC to explore comparative effectiveness research for effective health care treatments

NPC-PMC Conference to Focus on Science, Policy and Business Implications

As Congress continues its efforts to reform the health care system, the National Pharmaceutical Council (NPC) and the Personalized Medicine Coalition (PMC) will host a conference tomorrow to explore a key topic in the debate: using comparative effectiveness research (CER) to determine which health care treatments are most effective while improving the quality of patient care through personalized medicine.

"Understanding how CER and personalized medicine may be aligned with each other and putting them into practice will have policy, science, and business implications for years to come. Health care stakeholders recognize that getting it right, by fostering a sound environment for innovation, will help to pave the way for effective cures for diseases in the future," said NPC President Dan Leonard.

"Unless CER is done properly with attention to the latest developments in molecular biology, it will not help patients because it will not account for individual variation," said Edward Abrahams, Ph.D., PMC's executive director. "CER usually asks what works best for most while personalized medicine asks what works best for whom."

Earlier this year, the federal government allocated $1.1 billion for CER, which compares available treatment options utilizing a range of research methods. Although the goal of CER is to inform health care providers and patients, and further enhance the quality and value of patient care, there is a concern that CER will not be effective unless it takes into account the genetic makeup of patients. Evidence has shown that patient subgroups may respond differently to therapeutic options based on demographic characteristics, genetic variation, and coexisting medical conditions, and such differences can have a big impact on how well a medicine works for them. The health care reform legislation approved by both the Senate Health, Education, Labor and Pensions Committee and the Senate Finance Committee acknowledge these concerns to differing extents. Similarly, an Institute of Medicine committee also highlighted the need for CER to be used to "improve health care at both the individual and population levels."

The conference, "Comparative Effectiveness Research and Personalized Medicine: Science, Policy and Business" will feature leading government, business and science stakeholders, including Dr. Janet Woodcock, Director of the Food and Drug Administration's Center for Drug Evaluation and Research; Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality; Dr. Amy Abernethy, Associate Director of the Duke Comprehensive Cancer Institute; Dr. Robert Epstein, Chief Medical Officer, Medco Health Solutions; Dr. Newell McElwee, Executive Director of U.S. Outcomes Research for Merck & Co.; and Adolph Falcon, Vice President for Science and Policy at the National Alliance for Hispanic Health, among others. In their comments, speakers will examine how CER has been conducted in the past; how it needs to change; and what the implications are for pharmaceutical and other medical companies.

The conference also will highlight a report from The Lewin Group that systematically examines the intersection of CER and personalized medicine and defines key issues to address in developing a policy to advance the two together. Copies of the report brief are available online at ${tempString} and PM Issue Brief.pdf.