107th Congress

Report: The National Institutes of Health—Investing in Research to Prevent and Cure Disease—Hearing Before the House Energy and Commerce Subcommittee on Health—June 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