On March 25, the House Energy and Commerce Subcommittee on Health held a hearing on clinical research at the National Institutes of Health (NIH).
Pointing out that the NIH has not been reauthorized in over a decade, Chair Mike Bilirakis (R-FL) stated, “I firmly believe that our investment in biomedical research through NIH is probably one of the wisest uses of our limited federal resources. However, it remains incumbent upon us here in Congress to continue to ensure that taxpayer dollars are used in the most effective manner possible.”
In her opening statement, Rep. Diana DeGette (D-CO) voiced her support for human embryonic stem cell research. Referring to President Bush’s decision in August 2001 to allow the use of federal funds for only 78 existing stem cell lines, she cited recent reports indicating that only 12 of those lines are currently available for distribution. Arguing that scientific policy “should not be based on moral and ethical considerations,” Rep. DeGette expressed her disappointment that the available lines may be unsuitable for therapeutic use in humans.
NIH Director Elias Zerhouni summarized the “NIH Roadmap” plan on clinical research entitled, “Re-engineering the Clinical Research Enterprise.” The first part of the plan is intended to facilitate translational research, and Dr. Zerhouni explained that the key to building a strong infrastructure for clinical research “will be the ability to increase the interactions between basic and clinical scientists, and cross-training of basic and clinical scientists in each other’s disciplines, thus easing the movement of powerful new tools from the laboratory into the clinic.” The second part of the plan is aimed at enhancing the nation’s clinical research workforce, and the NIH is implementing a program to train doctoral candidates in clinical research settings that are multidisciplinary and collaborative. Dr. Zerhouni said that the third part of the plan, integrating clinical research networks, is designed “to promote synergy among diverse clinical research activities through the development of linkages among research institutions, medical centers, and existing research networks.” The final part of the plan is to coordinate research policies among federal agencies. Dr. Zerhouni stated that the NIH “is working in concert with regulatory agencies, research communities, and patient advocacy groups to catalyze Federal-wide coordination of policies pertaining to clinical research, to develop better processes, and to standardize requirements for reporting adverse events, human subjects protections, privacy and conflict-of-interest policies, and standards for electronic submission.”
During the question and answer session, Rep. Lois Capps (D-CA) discussed the Human Genome Project at the NIH and asked Dr. Zerhouni whether he felt legislation was needed to prohibit genetic discrimination. He said legislation was required and voiced his support for a bill (S. 1053) approved by the Senate in October (see The Source, 10/17/03). Earlier in the hearing, Rep. Capps expressed her dismay that some Members of Congress were trying to politicize a number of sex-related research grants supported by the NIH. “We should keep politics out of science,” she argued.
Noting that there has been a 30 percent increase in the number of cases of genital herpes, and one out of every four women has the disease, Rep. Steve Buyer (R-IN) asked Dr. Zerhouni whether this would be considered an epidemic. Dr. Zerhouni replied that approximately 65 million Americans have a sexually transmitted disease (STD) and it was of great concern to the NIH. He explained that most of the NIH investment goes toward HIV/AIDS and human papillomavirus research, but medical and behavioral research on genital herpes and other STDs was also underway.
