“The Blue Sheet” Vol. 36, no. 8

February 24, 1993

"The Blue Sheet"

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should be allocated to which research; which mechanism
can be used to attract new talent and new creative thinking into the field; what should be done to facilitate the
development of central organizations, such as breast
cancer registries; and which peer review mechanism
should be used to review the DoD grant proposals.
At the first meeting of the IoM committee on Feb.
11-12, Major General Richard Travis told the committee
that DoD does not object to using existing peer review
systems, such as NIH's, for review of the breast cancer
research proposals ("The Blue Sheet" Feb. 17, p. 2).
When responses to the letters are received, Cassells
said, they will be compiled and reviewed by the committee prior to their next meeting, scheduled for March
4-6 in California.
By the end of that meeting, the group expects to
have completed draft recommendations for DoD. The
committee will meet for the last time on April 7-8 in
California, and plans to have the report finished by the
end of April.
DoD's FY 1993 appropriations bill stipulates that
the Army Medical Research and Development Command has the authority to distribute the $210 mil. In a
separate presentation at the Feb. 22 meeting, Travis
discussed the Army's plans for the research program.
Under the program, there will be a full-time staff of
seven to 10 scientists, working at Fort Dietrick in Frederick, Md. The team will be headed by a researcher with
expertise in breast cancer; the leading candidate is a
woman, Travis reported.
The Army plans to solicit grant proposals sometime
this spring. Peer review of the proposals is expected to
occur in September or October and four- to five- year
grants should be awarded sometime between October
1993 and March 1994.
IoM's move to consult numerous sources involved
with breast cancer research prior to formulating any
recommendations will probably find approval with the
advocacy groups. One such influential advocacy group,
the National Breast Cancer Coalition, whose president
Fran Visco is also a member of the President's Breast
Cancer Commission, has a lengthy research agenda
which Visco discussed at the first loM meeting.
NBCC calls for more attention to many research
areas, including: development of a national tumor bank;
characterization of the genetic changes which allow
cellular transformation; investigation of the possible role
of viruses in the etiology of breast cancer; investigation
of possible racial difference in etiology of breast cancer;

investigation of dietary factors which may prevent breast
cancer; and development of a breast cancer vaccine.
SURROGATE ENDPOINTS FOR TUBERCULOSIS DRUGS BEING
EVALUATED BY FDA's ANTIVIRAL DRUGS DIVISION
The use of surrogate endpoints to accelerate review
and approval of tuberculosis drugs is being considered
by the Food and Drug Administration's Antiviral Drugs
Division, Mark Goldberger, a supervisory medical officer for the division, told the Antiviral Drugs Advisory
Committee at its Feb. 19 meeting.
Goldberger was bringing the committee up to date
on how the division has been encouraging drug companies to develop, manufacture, and supply drugs that are
increasing in demand, but low in supply, such as tuberculosis drugs.
Goldberger told the committee that the division is
considering different incentives, such as use of accelerated approval, to get drug companies to develop products that may not be profitable, but for which there is*a
public health need.
Noting that the committee'"has endorsed the use of
CD4 levels as a surrogate endpoint for antiretroviral
drugs, he said that "as far as trials for TB, the endpoint
for these has in the past been...looking at the relapse
rate after therapy has been completed, and this often
required two years or so of follow-up after a treatment
regimen that would be in the range of six to nine
months." The FDAer noted that "the last two TB trials
done in the United States took, I think, five to nine
years to complete."
The antiviral division is considering whether there
is "a way that we can use the accelerated approval
approach to perhaps look at some surrogate that is likely
to predict the ultimate relapse rates," Goldberger said. "I
think one thing that has been talked about is eight-week
sputum conversion rates."
He added that the division is "actively working now
with people from the Centers for Disease Control and
Prevention, NIH [and] a number of other people in the
field of tuberculosis to get a sense of whether there is
the kind of information that might allow this to become
a reasonable endpoint in [a] trial."
To speed up approval of new tuberculosis drugs, the
division also is looking into using targeted drug development studies to determine what treatment regimen the
drug candidate may eventually fit into.
"Something that we're working on a lot right now
with tuberculosis...is the integration of preclinical and
early clinical data," Goldberger said. "Obviously there's

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