Originally published Sept. 24.
By Turna Ray
The Government Accountability Office and the US Acting Comptroller General Gene Dodaro this week appointed19 members to the board of governors for the Patient Centered Outcomes Research Institute, some of whom may represent the interests of personalized medicine stakeholders.
PCORI is a private, non-profit institute created by the Patient Protection and Affordable Care Act of 2010 with the charge to develop and fund comparative effectiveness research. The institute's aim is to help patients, clinicians, purchasers, and policy-makers make "informed health decisions" by conducting research on the quality and effectiveness of medical treatments, GAO said in a statement announcing the appointments.
The members of the board (see full list below) represent the pharmaceutical and device industries, academia, non-profit organizations, and the payor community.
According to a post on the GAO's website, the GAO accepted nominations for PCORI's governing board until June 30. The directors of the Agency for Healthcare Research and Quality and the National Institutes of Health — entities that received funds for conducting CER under the American Recovery and Reinvestment Act — will also be on PCORI's board, bringing the total number of members to 21.
"The decisions made by this first PCORI board will have a significant impact on the future of CER and its utility for health care decision makers," said National Pharmaceutical Council President Dan Leonard in a statement. "After all, this board, along with the methodology committee, will be setting the framework for determining CER priorities, developing sound standards and methodologies for data and research, and translating research results in a useful and understandable way."
Since PCORI's research has the potential to significantly impact healthcare priorities in the US, there is the danger that the bulk of CER projects will be directed toward treatments for the general population. Before PCORI was formed, personalized medicine proponents were not pleased with the scant number of genomics projects proposed under the CER priorities issued by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research.
However, converging CER with personalized medicine has advocates in high places. Janet Woodcock, director of the US Food and Drug Administration's Center for Drug Evaluation and Research; Carolyn Clancy, AHRQ director; and National Institutes of Health Director Francis Collins have all spoken out on the importance of CER to factor in how differently treatments can behave in genomically defined subpopulations of patients (PGx Reporter 11/04/09).
Whether personalized medicine strategies will feature prominently in CER going forward remains to be seen. For the time being, personalized medicine stakeholders are content that their interests appear to be represented within PCORI's board.
One board member with expertise in genetics is Eugene Washington, dean of the David Geffen School of Medicine at the University of California, Los Angeles. Washington's research focus is on assessing medical technologies and national health policy for prenatal genetic testing, cervical cancer screening and prevention, health care quality, as well as racial and ethnic disparities in health outcomes. He will serve as the chair of the PCORI board of governors.
Another board member, Freda Lewis-Hall, chief medical officer of Pfizer's medical division, was nominated by the Personalized Medicine Coalition, which has strongly advocated for CER to take into account the varying degrees of effectiveness in genomic subpopulations of patients. According a statement from PMC, the organization nominated Lewis-Hall for her "commitment to and knowledge of both comparative effectiveness research and personalized medicine."
A year ago, PMC and the Lewin Group Center for Comparative Effectiveness Research released a report recommending ways to align genomically guided personalized medicine strategies and comparative effectiveness research (PGx Reporter 10/28/09).
Other medical industry representatives on the board include Harlan Weisman, chief science and technology officer for medical devices and diagnostics at Johnson & Johnson; and Richard Kuntz, senior VP of Medtronic.
J&J has said it is investing in genomic research to personalize treatments in its pipeline. Medtronic is developing technologies for the delivery of RNAi-based therapies.
PCORI's board members are appointed for a maximum of six years and may be reappointed for an additional six years. The terms of the PCORI board members are staggered, with the first set of appointments made this month set at two, four, and six years.
PCORI board members whose first term will expire in September 2016 are:
o Eugene Washington, dean, David Geffen School of Medicine, University of California Los Angeles; Washington will serve as the chair of the PCORI board of governors.
o Steven Lipstein, CEO, BJC Health Care; Lipstein will serve as the vice chair of the PCORI board of governors.
o Christine Goertz, vice chancellor for research and health policy, Palmer College of Chiropractic and Palmer Center for Chiropractic Research
o Sharon Levine, associate executive director for the Permanente Medical Group of Northern California
o Ellen Sigal, founder of Friends of Cancer Research
o Harlan Weisman, chief science and technology officer, medical devices and diagnostics, Johnson & Johnson
o Robert Zwolak, vascular surgeon, Dartmouth-Hitchcock Medical Center.
Board members whose first term will expire in September 2014 are:
o Lawrence Becker, director, strategic partnerships and alliances, Xerox
o Arnold Epstein, chair, Department of Health Policy and Management, Harvard University School of Public Health
o Andrew Imparato, CEO, American Association of People with Disabilities
o Robert Jesse, health and national program director for cardiology, US Department of Veterans Affairs
o Freda Lewis-Hall, chief medical officer, Pfizer Medical Division
o Grayson Norquist, chairman, Department of Psychiatry and Human Behavior, University of Mississippi Medical Center
Board members whose first term will expire in September 2012 are:
o Debra Barksdale, associate professor, University of North Carolina - Chapel Hill, School of Nursing
o Kerry Barnett, executive VP of corporate services, the Regence Group
o Allen Douma, CEO, Empower LLC
o Leah Hole-Curry, Program Director for the Health Technology Assessment (HTA) program, Washington State Health Care Authority
o Harlan Krumholz, Harold H. Hines, Jr., professor of medicine and epidemiology and public health, Yale University School of Medicine
o Richard Kuntz, senior VP, Medtronic