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

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