THE NEWS THIS WEEK Vol. 44, No. 22 May 30, 2001 NIH Information "Bypass" To Senate Is Suggested By Harkin In Light Of HHS Delays Future transmissions between NIH and the Senate Appropriations/HHS Subcommittee perhaps should be made by way of a "bypass" to prevent the politicization of scientific information, Ranking Member Tom Harkin (D-Iowa) suggested at a May 23 hearing. Harkin made his remark after written documents from NIH evaluating the potential of embryonic stem cells were delayed from reaching the subcommittee due to last-minute revisions requested by HHS. Noting Congress has mandated the direct submission of the National Cancer Institute's budget request to avoid "political interference," Harkin hinted "maybe what we need to do is to ensure that any requests for any letters from any of the heads of any of the institutes...also has a bypass" that would circumvent the channeling through NIH's governing department. "Now, if political people in whatever department or whatever administration want to tinker with it, that's their own business, but at least we should get the unvarnished truth," he said. Chair Arlen Specter (R-Penn.) had asked NIH institute and center directors for their scientific evaluation of the potential applications of human embryonic stem cells in a letter they received May 4. Specter was irritated by the lateness of their responses, delivered to him May 22, but more so by the cause of the delay. As described by HHS Assistant Secretary for Legislation Scott Whitaker, whose office reviewed the documents, revisions were made to some of the original letters altering content "based on some nonscientific speculation" that had gone "beyond the mission" of the individual institutes. NIH Acting Director Ruth Kirschstein, MD, confirmed she had been notified May 22 of the department's concern letters from some directors "were more broad-ranging than focusing on the particular mission of their institute" and did not talk "strictly about the scientific aspects" of the question they were asked to address. Kirschstein convened a same-day meeting with the directors and asked them to consider whether modifications should be made to their documents, all of which – except for NCI's, which was delayed at least a day – NIH had se nt through the agency's executive secretariat for HHS clearance May 14. "Some made changes, some did not," she reported to the subcommittee. Whitaker said HHS issued no specific instructions to NIH regarding amending the letters but "made a generalized request that we thought it would be best that the letters be focused on the science and the science only." He apologized for the delay, telling Specter "there was in no way an attempt on the office of the secretary's part to withhold information or control the information that was sent to the institute." Specter asked Whitaker to supply the panel with the original drafts and an account of the changes made. "I want to see what those responses are, whether they're based on science – or maybe somebody didn't like the answers ," he explained. "At your department, we expect transmission, without editing and alteration," he told Whitaker. "We'll get the details as to what were originally submitted." Harkin endorsed Specter's request and added, "If at any time, you would like to issue a subpoena to go back and get these, you'll have my name on it...if that becomes necessary." He expressed his support for "unbiased, no npolitical interference with scientific research." As he had criticized HHS, Specter similarly reprimanded NIH directors, accusing them of straying from their scientific charge by reportedly including "speculation and personal views" in their original responses – also pos sibly a veiled jab at the department for overly prescriptive editing directions. "You're scientists, and I would expect you to submit answers based on science, and I would be shocked if you didn't, because I know your caliber and your qualifications," he told the NIH panel of witnesses. "If you top flight men and women don't respond to the subcommittee based on science, I have a hard time understanding why we're appropriating $24 bil. toward you," he warned, referring to the NIH proposed FY 2002 budget. "There's no place for politics in the work of your unit," Specter declared. A strong backer of embryonic stem cell research, he said "there's a political fight brewing over this matter and that's going to be decided in th e Congress [and by] the President." Both Congress and the Administration "want to know what the facts are on stem cells," and they "want it unvarnished," Specter said. Yet, because the ban on federally-supported stem cell research remains in place while HHS reviews the policy and because of the lack of published data on the subject, speculation on stem cells' potential is mostly what the directors could have offered beyond extrapolation from animal models – something they were reluctant to do at the hearing. The chair peppered a number of the institute directors with queries about how specific diseases under their purview potentially could be improved through the use of embryonic stem cells. National Institute on Aging Director Richard Hodes, MD, said work in animal models has demonstrated "cells of a variety of sources" may be able to differentiate into functional neurons in the brain, which could be used in preventative therapy for Parkinson's disease. Intramural research at NIH has shown mouse embryonic stem cells can differentiate into islet-like clusters, a finding that may prove useful for patients with diabetes, whose disease results from the abnormal function of p ancreatic islets, National Institute of Diabetes and Digestive and Kidney Diseases Director Allen Spiegel, MD, said. When asked by Specter to compare the value of human adult and embryonic stem cell sources, however, Spiegel declined to make an assessment. "As far as human embryonic stem cell work, obviously it's going on in the private sector, perhaps in foreign countries, but since there are no publications that I'm aware of, I can't really comment," he said. Spiegel did, when pressed by the panel chair, state his desire to have embryonic stem cells available for experimentation. National Heart, Lung and Blood Institute Director Claude Lenfant, MD, spoke of the successes with adult stem cells being used to regenerate damaged heart tissue and to form new valves and blood vessels. Although embryonic stem cells have not been used in this research, Lenfant agreed their ability to differentiate surpasses that of adult stem cells and "needs to be explored." Meanwhile, the scientific community awaits HHS Secretary Tommy Thompson's decision, expected this summer, on whether research on stem cells derived from human embryos should be federally funded. Alan Trounson, PhD, Monash Medical Center, Clayton, Victoria, Australia, has confirmed his is the only application to the NIH Human Pluripotent Stem Cell Review Group to advance to the "final stage," while colleague Martin Pera, PhD, was the other applicant for the first round of grants eligible for NIH support, assuming Thompson upholds the Clinton Administration's decision on the policy ("The Blue Sheet" May 23, In Brief). Since the presidential campaign, President Bush has stated his opposition to federal support for such work. As recently as May 18, in a letter to a diabetes patient advocate, he has said, "I oppose federal funding for stem cell research that involves destroying living human embryos." However, according to the Coalition for the Advancement of Medical Research, a stem cell research advocacy group, Bush's viewpoint is not that of the majority of Americans. A survey of 1,010 adults conducted by CAMR and released May 23 found 70% of those sampled offered their total support for stem cell research and a similar percentage – 69% – of respondents indicated their support of NIH f unding for the research. The survey also found 57% of respondents said they would be more likely to support the President if they knew he endorsed NIH funding for stem cell research, while 34% would be less likely. Respondents also were questioned about their support for research on stem cells derived from excess fertilized eggs resulting from in vitro fertilization, and 77% indicated support while 14% stated their opposition. The coalition is a group of universities, patients' organizations and scientific societies created to support federal funding for research on stem cells from IVF sources and to ensure the preservation of current federal guidelines governing such research. Specter's S 723 would allow federal funds to be used for the derivation of and experimentation on human embryonic stem cells. The legislation was introduced April 5 and has attracted 16 cosponsors. The last Congress' version of the bill, S 2015, only had two cosponsors. Meanwhile a House resolution (H Con Res 17) has attracted 59 cosponsors. http://www.fdcreports.com/bluestory.shtml *********** [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn