BETHESDA, MdRepresentatives from government, industry, and
aca-demia met for a day and half to discuss the barriers that limit
more rapid development of imaging techniques needed by cancer
researchers and physiciansand possible ways to overcome them.
Richard D. Klausner, MD, director of the National Cancer Institute,
which organized the meeting, said it was the first in a continuing,
long-term discussion on imaging issues and that the format of the
meeting would serve as a model for resolving other problems in
developing new tools against cancer, including drug development.
Dr. Klausner and Robert E. Wittes, MD, director of the NCIs
Division of Cancer Treatment and Diagnosis, reported on the imaging
meeting to the National Cancer Advisory Board (NCAB).
Attendees at the imaging meeting included officials from the NCI,
Food and Drug Administration, and Health Care Financing
Administration; representatives from a variety of medical device
companies; cancer researchers; and Capitol Hill staff members, Dr.
Klausner told the NCAB members.
The NCI designated imaging technology as one of its
Extraordinary Opportunities for Investment in 1996. These
are areas of discovery with exceptional promise for achieving
pivotal advances in our knowledge about cancer, Dr. Klausner
said. Then the Institute moved forward to gain the cooperation and
participation of the imaging industry.
In talking with business executives, NCI staff found that many lacked
a clear idea of what devices cancer physicians and researchers think
they need. So the Institute began thinking of holding a scientific
conference to clarify the question of what researchers need.
However, further discussion made it increasingly clear that
that was only the tip of the iceberg, Dr. Wittes said. Major
issues for business executives included regulations governing FDA
approval of new imaging techniques and concerns about whether
third-party payers would provide adequate reimbursement to make their
The Health Care Financing Administration is the
governments own insurance company, and what we found in these
discussions was an overwhelming concern with the unpredictability of
the reimbursement situation for emerging technologies, Dr.
Wide-ranging discussions at the meeting covered many topics, and both
Drs. Klausner and Wittes professed satisfaction with the exchanges
and the pledges to continue discussions and work on solutions. Dr.
Klausner called the effort an interesting experiment that we
would like to expand.
A Continuing National Forum
Dr. Wittes noted that a great amount of effort must go into creating
a continuing national forum to address and resolve issues that limit
the development and approval of advanced imaging devices. As an
example of what this might accomplish, he cited working with
the FDA to do things like make approval steps as defined,
predictable, and rational as possible, as well as very public
so that companies can do better calculations of financial
However, Dr. Wittes made it clear that progress will not come easily.
We are under no illusion how difficult this could be, he said.