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107th Congress
Session I | Session II
Report: The National Institutes of HealthInvesting in Research
to Prevent and Cure DiseaseHearing Before the House Energy and Commerce Subcommittee on HealthJune 6, 2002
Members Present
Michael Bilirakis (R-FL), Chairman; Sherrod Brown (D-OH),
Ranking; Steve Buyer (R-IN); Lois Capps (D-CA); Nathan Deal
(R-GA); Charles Norwood (R-GA); Charles Pickering (R-MS);
John Shadegg (R-AZ); Bart Stupak (D-MI); and Ted Strickland
(D-OH).
Witnesses
- Claude Lenfant, Director of the National
Heart, Lung, Blood Institute (NHLBI)
- Audrey Penn, Acting Director of the National Institute
of Neurological Disorders and Stroke (NINDS)
- Robert Bonow, President Elect, American Heart Association
- Eric Hargis, President and CEO, The Epilepsy Foundation
- Edward Sanchez, Commissioner, Texas Department of Health
- Daniel Jones, Vice Chancellor, University Medical Center,
University of Mississippi.
Summary
This hearing was the first of a series to examine how NIH
as a whole and, specifically, how the ICs are managing their
large annual increases as a result of the doubling of the
agency's budget. This hearing was to focus on research efforts
at NHLBI and NINDS, respectively. H.R. 3431, the Stroke Treatment
and Ongoing Prevention Act of 2001, sponsored by Representative
Capps, was also supposed to be a major focus of discussion.
However, most of the questions were trans-NIH, such as the
mission of NIH; how NIH makes funding decisions (including
funding proportionate to prevalence of disease); the percentage
of NIH research conducted intramurally and extramurally; coordination
efforts among NIH ICs, DHHS agencies and other Government
entities; and the role of NIH as a public health agency. Other
questions related to technology transfer, antimicrobial resistance,
vaccine research, the side-effects of drugs and how they were
monitored.
Opening Statements
Representative Bilirakis opened the hearing by thanking Drs.
Lenfant and Penn for appearing before the committee and stated
that he looked forward to their testimony on their perspective
Institute's research efforts. He mentioned how Congress has
demonstrated its commitment to scientific research by its
five-year effort to double NIH's budget.
Representative Brown was interested in learning how NIH
responds to medical needs not being addressed by the private
sector, for example, the development of new classes of antibiotics
for diseases such as tuberculosis. He commented that there
is insufficient antibiotics to replace those that have lost
their effectiveness. He stated that his other area of interest
was the role NIH plays in economics and allocation of health
care and how NIH's technology transfer polices have a direct
bearing on taxpayers return on investment. He cited the high
cost of prescription drugs and stated that NIH has the power
to "break the patent" on drugs developed with Federal funding.
He questioned the drug industry's claim that it costs $800
million to develop a drug and that NIH had the information
to counter that claim. Later on in the hearing, he mentioned
that he would be submitting a question for the record regarding
eligibility for the extramural clinical research loan repayment
program.
Statements of Witnesses
Dr. Lenfant's testimony focused on coronary heart disease,
stroke, congestive heart failure and blood diseases and disorders.
He explained how heart disease death rates have declined as
a result of decades of research. Even though there has been
marked progress on reducing heart disease, Dr. Lenfant informed
the committee that there are still hurdles to overcome. He
then went on to describe specific research and education efforts
at NHLBI. Dr. Penn emphasized the Institute's commitment to
developing safe and effective treatments for all forms of
stroke. She explained how NINDS has committed more funding
to stroke research than any other single disease or disorder
within the Institute's mission. After explaining various types
of strokes, she described the Institute's research and research
planning efforts, as well as the public education initiatives
sponsored by NINDS.
Questions
Representative Bilirakis started the questioning by asking
if NIH coordinates with other agencies; if there was duplication
of effort; and, if so, was that duplication necessary. Dr.
Lenfant explained the formal and informal communication that
takes place within NIH and between agencies and disease groups,
such as the American Heart Association. He also described
how the various ICs seek input from the academic community
and the public regarding new initiatives and programs. Dr.
Penn added that the type of disease can drive with whom the
ICs collaborate, and she explained how investigators across
the Federal Government work together.
Representative Brown stated that NIH is a public health agency
in the sense that it responds to health demands in terms of
basic research. He then went on to say that pharmaceutical
companies will not conduct research on diseases to develop
drugs that would not be profitable, such as malaria and river
blindness that occur in third-world countries. He described
how the Walter Reed Army Institute of Research was proactive
in developing antimalarial drugs and asked Drs. Penn and Lenfant
if they saw NIH fulfilling this kind of need, especially in
the area of antibiotics. Dr. Penn described the mission of
NINDS and how the Institute's researchers look at scientific
opportunities that can be translated into clinical applications.
Dr. Lenfant explained that NHLBI conducts clinical trials
in areas that the drug industry avoid and how there are significant
benefits for the public. When Representative Bilirakis asked
if Dr. Lenfant was speaking for NIH as a whole, Dr. Lenfant
responded that he was aware of a large development program
at NCI and that if the industry did conduct research in the
area, it would negate the need for the program at NCI. Representative
Brown stated that if NIH's budget is being doubled, the agency
needs to think about its ultimate goals.
Representatives Deal and Norwood asked very basic questions
such as the percentage of the research conducted extramurally
versus intramurally, the grant awarding process, and the mission
of NIH. Representative Norwood was also interested in whether
there was enough emphasis on basic research, and if NIH defines
itself as a public health agency. Dr. Lenfant explained that
on average, 11 percent of NIH's research is intramural and
that this percentage varies among the ICs. At NHLBI, he explained,
it was about 6 percent of a $2.7 billion budget, which is
significant. He then explained the peer review process at
NIH. Dr. Penn described how intramural research is reviewed
at NIH. Representative Deal also asked what oversight NIH
grantees received. Dr. Penn briefly explained how scientific
experts review the progress of grants.
After commenting that NIH is required to transfer new biomedical
technologies to the private sector for further research and
commercialization and that Congress intended that NIH-supported
efforts would lead to diagnostics and vaccines, Representative
Stupak asked how far NIH goes in developing new vaccines.
Dr. Penn explained that, except in a few circumstances, vaccine
development fell within the purview of NIAID. Representative
Stupak asked if NIH's Office of Technology Transfer (OTT)
worked with drug companies to develop vaccines. Dr. Penn answered
in the affirmative and briefly explained OTT's role. Representative
Stupak also asked about vaccine clinical trials, and then
he asked if NIH was involved in post-marketing on drugs. Dr.
Lenfant explained that, regarding clinical trials, the NIH
works very closely with the FDA, and any event that may occur
during the trial is reported to that agency. Representative
Stupak then said that the FDA does not conduct post-marketing
surveillance on some drugs and asked if NIH did this task.
Dr. Lenfant stated that NIH does not have the authority to
conduct post-marketing surveillance. Although Representative
Stupak acknowledged Dr. Lenfant's answer, he added that NIH
is a public health agency and, if it is involved in producing
vaccines or drugs, then it should have an interest in following
up. He then mentioned that NIH helped to develop an antimalarial
drug called Lariam (this drug was actually developed by Walter
Reed as Mefloquine), which has some negative side effects.
Representative Stupak commented that neither the FDA nor NIH
was conducting post-marketing surveillance.
Representative Capps mentioned how she and Representative
Pickering were working on H.R. 3431, the Stroke Treatment
and Ongoing Prevention Act. She expressed her interest in
the Report of the Stroke Progress Review Group and
wanted to know how much it would cost to implement. Dr. Penn
replied that it would be implemented within the context of
the budget. Representative Capps was also interested in how
women's health would be addressed. She mentioned a letter,
signed by 80 of her colleagues, addressing the fact that research
on stroke and heart disease has not kept pace with the NIH
doubling. Dr. Penn reiterated how NINDS spent more on stroke
research than any other of the Institute's major disorders
and that the review group prioritized promising areas of research.
Representative Capps was also interested in stroke research
at NIH as a whole and asked about efforts at other ICs. Dr.
Penn explained that NIH ICs, as well as other agencies, are
working together on this effort.
Representative Pickering commented on the importance of H.R.
3431 and asked for recommendations on the legislation. He
also wanted to know what impact the bill could have if enacted.
Dr. Penn stated NINDS is already engaged in activities consistent
with H.R. 3431. Representative Pickering asked how much was
being spent on stroke research. Dr. Penn responded that NIH
spent $239 million in FY 2001, and NINDS spent $117 million
in the same period. Representative Pickering then asked if
stroke research could be categorized in the top five priority
research areas at NIH. Dr. Penn stated that she would get
that answer for the written record; however, for NINDS, stroke
research was a priority. She reminded the congressman that
there are other priorities such as AIDS and diabetes, to which
he responded that resources and priorities should be put in
the context of medical and economic impact. Dr. Lenfant added
that NHLBI spent approximately $60 million on stroke research.
He also mentioned that high blood pressure is a risk factor
and that $120 million was spent on research and public education.
Representative Green commented that NIH funding is not proportionate
with the burden of disease, using diabetes as an example.
He added that NIH is probably the only agency that Congress
is reluctant to micro manage because they do not have the
expertise; however, it seemed to him that NIH should be emphasizing
those diseases that have the largest burden. Dr. Lenfant stated
that although diabetes research, per se, does not fall within
the purview of his Institute, NHLBI research is of great importance
to patients with diabetes as many of them suffer from cardiovascular
disease. Dr. Penn explained how research in one area can have
an effect on the progress of research on other diseases. She
added that it is not necessarily how much money is spent on
research on a disease; a variety of factors come into play,
such as training more scientists and researching the genetic
underpinnings of disease.
Representative Buyer commented that the way Dr. Lenfant answered
some of Representative Deal's questions seemed "capricious."
He expressed his displeasure that Dr. Penn would not directly
answer what NIH's top five research priorities were and went
on to say that if Congress is doubling NIH's budget, it is
not being unreasonable to expect answers to these questions.
After Dr. Lenfant listed NHLBI's top five research priorities,
Representative Buyer asked what percentages of applications
received funding. Dr. Lenfant responded, that for NHLBI, the
success rate is between 30 and 33 percent.
Referring to an American Stroke Association chart, Representative
Buyer stated that he could understand the increase in cancer
research spending as a result of the doubling, but he could
not understand the huge increase in AIDS funding relative
to stroke and heart disease. He then asked if Dr. Lenfant
could compare the death rates of cancer, AIDS, heart disease
and stroke. Dr. Lenfant responded that half the people in
the hearing room would die from heart disease. However, he
was not in a position to answer why the budget of cancer and
AIDS is higher than heart disease. Representative Buyer said
that, given this statistic, why isn't there more funding for
heart disease research than for AIDS research. Dr. Lenfant
explained that there is a steady increase in the incidence
of cancer death rates, whereas there is a steady decline in
cardiovascular disease. He added that the decision-makers
probably see the increase in cancer as an emergency which
influences their determinations of where to allocate funding.
Dr. Lenfant said that since AIDS is a world-wide infectious
disease, it is also considered an emergency. Before yielding
back to Representative Bilirakis, Representative Buyer stated
that NIH
needed more scrutiny.
Representative Bilirakis thanked Drs. Lenfant and Penn for
their testimony.
Panel Two
The witnesses on the second panel described the mission of
their perspective organizations and some of the collaborations
with NHLBI and NINDS. Questions to the panel focused on the
types of collaborations these various organization had with
NIH and whether they were productive. Specifically, Representative
Bilirakis asked Dr. Bonow to describe how NIH translates research
to the public and also to describe the relationship between
advocacy groups and NIH as reflected in public programs. He
asked Mr. Hargis to submit his answer to the same question
for the record.
Representative Pickering asked Dr. Jones whether, without
passage of H.R. 3431, the University of Mississippi could
achieve their objectives in reducing stroke. Dr. Jones said
they could not and that reducing the incidence of stroke requires
a partnership and resources to raise awareness. The discussion
then briefly turned to discussion of another bill to limit
malpractice suits which could keep neurosurgeons from leaving
Mississippi.
Before adjourning the hearing, Representative Bilirakis stated
that the panel was welcome to submit additional information
for the record.
Prepared by: Patricia Brandt Hansberger/OLPA/June
11, 2002
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