AAMC Testifies at House Hearing
on Clinical Research
March 26, 2004 - The House Energy and Commerce Subcommittee
on Health March 25 held a hearing on re-engineering clinical
research. Much of the focus of the
hearing was on the Roadmap initiative put forward by National
Institutes of Health (NIH) Director Elias Zerhouni, M.D. Testifying
on behalf of the AAMC, Eugene Braunwald, M.D., Hersey Distinguished
Professor of Medicine at Harvard Medical School and chairman
of the TIMI Study Group at Brigham and Women's Hospital, focused
on the role of academic medicine in clinical research and
where there is room for improvement. Also testifying at the
hearing were Hal Barron, M.D., chief medical officer of Genentech,
Inc., and Robert Beall, Ph.D., president and CEO of the Cystic
Fibrosis Foundation.
Dr. Zerhouni's testimony began with an explanation of why
the clinical research enterprise needs to be re-engineered.
He cited evolving public health challenges such as the aging
population and health disparities, and the need to transform
medicine for the 21st century. He argued that the Roadmap
would explicitly address the roadblocks to accelerating basic
research findings and translating those findings into clinical
practice. In the context of clinical research, Dr. Zerhouni
noted the Roadmap's goal of integrating clinical research
networks, essentially creating inter-operable networks of
networks. The question and answer period addressed a number
of issues of interest to Subcommittee members including human
subjects protections, reasonable drug pricing, genetic non-discrimination,
and the participation of minorities in clinical research.
Dr. Braunwald told the subcommittee that both the opportunities
and challenges in clinical research are greater now than at
any time during his professional career. He noted the landmark
discoveries made in recent years due in part to NIH-funded
research, but that a "lack of coordination of the clinical
research enterprise has led to a fragmented cottage industry
of investigators each going in their own separate directions."
He cited several reasons contributing to this lack of coordination,
including an enormous regulatory burden, information technology
systems based on billing needs rather than clinical research
needs, a need to foster increased integrity in the research
process, and the shrinking pool of well-qualified clinical
investigators. Dr. Braunwald called for a tripartite system
of clinical research including the federal government, academic
medicine, and industry, because "each partner has a stake
in the success of the others." He concluded with the
statement "if we have a stable clinical research system,
the ultimate winner will be the public." In response
to questioning from the panel, Dr. Braunwald expressed academic
medicine's support for the NIH Roadmap initiative. He also
noted that the recent small increases in the NIH budget are
having a deleterious effect on the morale of young investigators
who see a career path in clinical research as being more and
more difficult as funding becomes more unstable.
Information:
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525
Get Washington Highlights
in your Inbox!
|
