Stem Cell Guidelines Still Pending
By Rich McManus
The scorecard at the end of a daylong session of the advisory committee to the NIH director (ACD) on June 3 read something like this: Yes to more computing muscle in biomedicine; great progress in launching the Council of Public Representatives and drafting guidelines for sharing of research tools; a graduate school at NIH? Well, maybe; put the Office of Protection from Research Risks outside NIH hierarchically, but keep its soul in science; keep those Consensus Development Conferences coming, but at a slower and less exhaustive (to panelists) pace; and lastly, regarding guidelines governing human pluripotent stem cell research hang on, folks, we're still deliberating.
"The guidelines are not yet ready," announced Dr. Shirley Tilghman of Princeton University. "It is still a work in progress." She said the human pluripotent stem cell working group is "working on our third, and we hope final, draft." The group's discussions, which NIH director Dr. Harold Varmus noted are "not only arduous, but also (conducted) in the public spotlight," have been "extremely lively," Tilghman reported. "This is not an unopinionated committee."
While it is the responsibility of the National Bioethics Advisory Commission to determine the ethical questions involved in human pluripotent stem cell research (which depends on cells derived from human embryos and fetuses NBAC's report is due June 28-29), the NIH group is charged with determining how to undertake, in a responsible manner, this kind of research if it is approved. Its guidelines will oversee derivation and use of human pluripotent stem cells from fetal tissue as well as use of cells from so-called "spare" embryos created at clinics that treat infertility. Both Varmus and the working group cited the value of the report of a 1994 ACD working group the human embryo research panel which drafted recommendations governing potential use of human embryo cells in federally sponsored research; that report yielded taboos that Tilghman said will stand in the new guidelines: no human cloning, no human-animal chimeras, and no creation of novel organisms.
Biomedical Information Science and Technology Initiative
"It's a given that we need a lot more money we want to answer, 'Why?'," began Dr. David Botstein, professor and chair of the department of genetics at Stanford University, who cochaired the working group on biomedical computing. Virtually all fields of biomedicine, both in academia and industry, need much more computing capacity and staff sophisticated enough in both computation and biology to make useful contributions, he said. "Training is the most important unmet need," he continued. "It's the people, not the actual stuff. Bill Gates isn't going to solve the problem for you, if you don't know what to do." The initiative (available on the Web at http://www.nih.gov/welcome/director/060399.htm) includes five recommendations, the first of which is that "NIH cause to come into being incentives for some 5 to 20 National Programs of Excellence in Biomedical Computing" devoted to all facets of this emerging discipline, said Botstein. His cochair Dr. Larry Smarr, director of the National Center for Supercomputing Applications, labeled these centers, "watering holes." Botstein added, "We need a new field, with people as professional in computing as in biology, just as we once needed people as competent in chemistry as biology."
Noted 1978 Nobel laureate Dr. Hamilton O. Smith, formerly of NIH but now in private genome science, "We're going to be awash in huge amounts of data millions of sequence units per day that needs analysis. I'm predicting that in 5 or 10 years, 25 percent of all research is going to be in the analytical area." Responded Varmus, "I agree with that entirely." He will ask NIH's institutes and centers to propose a variety of initiatives to implement the report, with oversight by a coordinating body.
Research Tools, COPR
Dr. Maria Freire, director of NIH's Office of Technology Transfer, reported that her office has published a "road map" governing transfer of materials; the two-part guidelines have been published in the Federal Register and are open for 90 days of comment ending Aug. 23. NIH's goal is to ensure academic freedom of publication, foment the use, commercialization and access of new tools, and generally minimize impediments to research.
NIH Associate Director for Communications Anne Thomas reported on the successful first meeting of Varmus' Council of Public Representatives (COPR) in April, noting that its 20 members are eager to contribute to many NIH activities. "People really want to be involved in helping manage a $16 billion budget," she said, noting that COPR representatives responded "in a nanosecond" to Varmus' request for COPR participation in a retreat relating to the FY 2001 budget held June 16-17.
NIH Graduate Program
Debate about this proposal, first introduced at last December's ACD meeting, and continuing on campus at a town meeting held May 24 in Masur Auditorium, continues to focus on whether there is a national need for NIH to offer Ph.D.s in subjects where there is both a labor shortage and NIH strength: bioinformatics, clinical research and genomics. Acknowledging that she was the plan's most vocal critic 6 months ago, Princeton's Tilghman remains skeptical. "What other options exist for stimulating training (in the needy fields) beside an NIH grad school?" she asked. Dr. Philip Needleman, chief scientist at Monsanto Co., said the proposal "lacks focus," and is diluted by "900 different mentors. You really ought to do something special that's not done in other places. I don't see that here."
Other ACD members, including Dr. Eric Kandel of Columbia University and Dr. Marc Kirschner of Harvard, said the proposal has more solidity and merit now than it had last December. To get a reading on which direction his advisors were taking him, Varmus asked for a straw poll before the group broke for lunch. Though not everyone voted, a clear majority favored continuing with development of the proposal.
Late in the day, Varmus opened the floor to revisit any topic, and again Tilghman spoke up, but this time she allowed that a pilot, specialized grad school focusing simply on bioinformatics might be acceptable. "Take that as your first challenge, then proceed from there," she said.
"We'll think through some of the options we've heard," said Varmus, "and continue some informal discussion. I saw the (straw) vote as at least a partial vote of endorsement, though clearly there is some opposition and resistance. Obviously there are some crevasses in this terrain; everyone is not equally enthusiastic. I must say that the negative votes here do count pretty heavily."
Working Group on OPRR
Varmus asked a review panel on OPRR to advise him about where the office should be located organizationally, and whether it needs more authority to accomplish its mission. The report (at http://www.nih.gov/welcome/director/060399b.htm) concludes that, to be effective, OPRR should relocate outside NIH to the Office of the Secretary, HHS, reporting either to the Surgeon General or assistant secretary for health. It also urged the department to upgrade the director's status to the Senior Executive Service level. Additionally, OPRR would benefit from an independent advisory committee, and a larger budget, according to the panel.
"All of us at NIH are very comfortable with the report," said Varmus.
Report from OMAR Working Group
For the sixth time in its 21-year history, the Office of Medical Applications of Research's consensus development program came under review; Varmus asked a 9-member working group to identify how Consensus Development Conference processes could be improved to better serve both NIH and the health care system, and to suggest alterations. NIDA director Dr. Alan Leshner chaired the group, which unanimously endorsed continuing the conferences, albeit at a slower, more deliberate pace that he said "targets the moment when the science is there, but the practice is not. We should hold them only when NIH has something to promulgate." The panel urged a departure from the needlessly stressful practice of confining panelists all night before the third and final day of each conference so that a consensus statement can be read to the press the next afternoon. "The compressed time frame was arduous and exhausting," remarked Dr. Christine Cassel of Mt. Sinai Medical Center. Leshner said the conference statement should be separate from the conference itself, appearing some 6-8 weeks later.
"It's good to slow the process down," noted Varmus. "Now we can put the (new) process in place, and seek a replacement for John Ferguson (who is retiring from his post as OMAR director)."
In other personnel-related remarks, Varmus noted that a new NIH associate director for legislative policy and analysis is due July 1 Marc Smolonsky, formerly of the HHS legislative office and a veteran of congressional staff positions. Also, Dr. Constance Battle is the new executive director of the Foundation for NIH; she succeeded Dr. Anne Alexander at the end of May.
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