HEARING REPORT Summary of Panel 3 Senate Labor and Human Resources Subcommittee on Public Health and Safety Senator William Frist (R-TN), Chairman Date of Hearing: October 9, 1997 Subject: Support Strategies for Clinical Research and Alternative Medicine Research at the NIH Panel 3 Topic: Alternative Medicine Research at NIH Members Attending During Panel 3: Senators Frist and Tom Harkin (D-IA) Panel 3 Witnesses David Eisenberg, M.D. Assistant Professor of Medicine, Harvard Medical School Director, Center for Alternative Medicine Research Beth Israel Deaconess Medical Center Boston, Massachusetts Robert R. Rich, M.D. Representative, Association of American Medical Colleges Distinguished Service Professor of Microbiology, Immunology and Medicine Vice President and Dean of Research, Baylor College of Medicine Houston, Texas James Samuel Gordon, M.D. Director, The Center for Mind-Body Medicine Clinical Professor, Departments of Psychiatry and Family Medicine Georgetown University of Medicine Washington, D.C. In summary at the end of the hearing, Senator Harkin said that the basic items that are important for alternative medicine research at this time are for the Office of Alternative Medicine to have independent grant-making authority and to be able to choose its own reviewers for the peer review of its grant applications. This followed a lengthy discussion between Senator Harkin and the witnesses about the types of peer reviewers who would be appropriate to judge the quality of alternative medicine research applications. The center for complementary and alternative medicine, proposed by Senator Harkin, was supported by Drs. Eisenberg and Gordon and opposed by Dr. Rich. However, the discussions centered more on the need for more research on alternative medicine to be funded and the need to build a science base. Dr. Eisenberg said that $12 million is not sufficient to support definitive clinical and basic science experiments. He also said that: ‘The principal criticism leveled at this fledgling field is that there is not enough responsible science to make sense of it. Implicit in this criticism 1s the fact that there are not enough responsible scientists devoted to this challenge. I fully agree with this criticism....An enhanced federal commitment involving the NIH and, | suggest, the CDC, AHCPR, FDA, HCFA, and HRSA is necessary to improve and stabilize the science so as to navigate based on evidence, not fadism, anecdote or market appeal. In short, if the biggest problem we face is a lack of good science then we must, “Get it the old fashioned way...we have to pay for it.” Figures of $100-$150 million for research were suggested by Senator Harkin and the witnesses supporting the center proposal. During discussion of the increased administrative costs that Dr. Rich noted would be necessitated by Senator Harkin’s proposed center, Senator Harkin responded that no increased cost would be incurred. He explained that, because the institutes already are spending money for grants review and management, with OAM taking over this role, there would be a commensurate saving for the institutes equal to the new expense forOAM. 3_ A277 vu 2: 4 Senator Harkin emphasized the need to have an independent center. One reason cited was that although there was considerable cooperation between OAM, NIMH, and the Office of Dietary Supplements in supporting the study of St. John’s Wort to treat depression, no mechanism is available to OAM to support such studies if the appropriate institute 1s unwilling to participate. Senator Harkin concluded that the OAM has been rebuffed by the institutes, and that it is difficult for OAM to break through the existing structure at NIH. Therefore, according to Senator Harkin, in order to ensure that the public can have answers to questions about alternative therapies, the office must have the ability to review and fund applications within its mandate. Senator Harkin said that NIH historically opposes the creation of any new institute or center (such as the NINR and NIDCD) and that the current opposition of NIH to his proposed center was nothing new and should be viewed in that context. Senator Harkin quoted from an October 6 article in the New York limes, entitled, “Bee Pollen Bureaucracy,” which mentioned that several top scientists (D. Allan Bromley, Yale physicist; Paul Berg, Stanford professor and Nobel laureate in chemistry) had recommended that OAM be abolished. He linked this suggestion to the reduced funding request from NIH for OAM for fiscal years 1997 and 1998. Senator Harkin was especially concerned about the signal this sends to the scientific community. He noted that the reduced funding request had occurred while he had been arguing to double the NIH budget. He also noted that the OAM budget is currently only 1/1000 of the total NIH budget. At the end of the hearing Senator Harkin described an event that he recently had witnessed at NIH while his brother was being treated for terminal thyroid cancer. He emotionally described the pain his brother suffered and a circumstance in which an acupuncturist was brought to NIH to treat his pain. Up to that time his brother had been receiving morphine for the pain. The Senator emphasized that the acupuncture treatment brought his brother complete relief which lasted for 10 hours, without the need for any morphine. Senator Harkin expressed dismay that NIH had not funded any studies of acupuncture for pain relief, when the clinicians at NIH are willing to utilize the treatment. Senator Frist stated his preference for rigorous science, and said he felt most comfortable having scientific research conducted within the institutes where the scientific expertise resides. He also expressed an interest in improving the scientific base of alternative medicine. He acknowledged the need to be able to answer patients’ questions when conventional methods have failed. The Senator also noted that he had just received a letter signed by a number of Nobel laureates who opposed the creation of a free-standing center for alternative medicine at this time. The Nobel laureates said there should be a critical review of OAM before any change in status is undertaken. Prepared by NIH/OLPA on October 9, 1997.