NIH/Stem Cells/Etc.


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Posted by Sandy Donchess on February 24, 1999 at 23:00:26:

ADMINISTRATORS TESTIFY BEFORE SENATE ON NIH BUDGET PROPOSAL
TOPICS INCLUDE FACILITIES, STEM CELLS, FUNDING CAPS, GENOMICS

Senate supporters of the National Institutes of Health (NIH) promised Tuesday to seek significantly more funding for the agency than President Clinton requested, noting that NIH Director Harold Varmus has said he potentially could make use of an additional $3.7 billion next year.

But members of the Senate Appropriation Labor, Health and Human Services, Education and Related Agencies subcommittee said to secure more money for NIH, the Clinton administration needs to join them in an effort to lift the caps on discretionary spending. The panel's chair, Sen. Arlen Specter, R-PA, said that if the caps stay in place, the Department of Health and Human Services (HHS), which includes NIH, will face $2.7 billion in cuts.

NIH funding needs were discussed at a subcommittee hearing that featured testimony from Varmus, several NIH institute directors and HHS Secretary Donna Shalala.

In addition to slamming Clinton's proposed $320 million increase for the agency, Senators also focused on the controversy surrounding NIH's decision
to fund research with human embryonic stem cells, the need for core facilities construction at grantee institutions, private sector involvement in human genome sequencing and spending on prostate cancer research.

Specter made a point of focusing on what he said were statements Varmus made to him in a meeting two weeks ago indicating a "desired" FY 2000 budget of $19.3 billion. That's compared to President Clinton's request for $15.933 billion, or a $320 million 2.1 percent increase over the FY 1999 budget of $15.613 billion, which itself was $2 billion above the FY 1998
appropriation.

Varmus was quick to note that the $19.3 billion "is the number you requested as a professional judgment" and one that represents "what we could do under optimal conditions."

"The number we actually submitted to the (White House) Office of Management and Budget was considerably lower," Varmus said, adding that NIH can "operate effectively" under Clinton's proposed funding level.

Specter indicated that he preferred Varmus's "professional judgment" to the administration's request and said the $19.3 billion figure would give the subcommittee a "guidepost" for its FY 2000 deliberations.

As for the FY 1999 increase, Varmus assured Specter that the extra $2 billion is being put to effective use. In an effort to respond to inquiries about how the agency is investing the new money, NIH officials have put together a series of slides, which Varmus included in his testimony, offering a detailed breakdown of how the funds are being applied on a program-by-program basis.

Specter said that following this year's boost with another sizable increase will be "tougher than ever," given the constraints on discretionary spending imposed by a balanced budget agreement. That agreement remains in place even though the federal government is running an ever mounting surplus. (see Washington Fax 2/19/99)

Specter rejected as "highly speculative, to put it mildly" the $18 billion in budget offsets proposed by the administration as way of getting some extra money without lifting the caps. He directed Shalala to "tell me in writing" how she would apply what he estimates would be $2.7 billion in cuts if an agreement is not reached to breach the spending barriers.

"I'd like your expertise on what you would cut if we're looking at a budget of $2.7 billion less," Specter said, adding that he also would "ask for the administration to consider a leadership role in urging that the budget caps be lifted."

President Clinton has stated the caps should stay in place until
Republicans and Democrats agree on a plan to revamp the Social Security system.

Specter and Sen. Ted Stevens, R-AK, who chairs the full Senate
Appropriations Committee, told Shalala they want to know more about $3.1 billion in welfare block grants state governments have yet to spend and would consider it as a possible source of funding for an NIH increase.

Shalala said she expects that figure to fall sharply as states develop plans for spending that money. She also said that some of the unused funding represents money states are saving in "rainy day" accounts to protect them against a downturn in the economy.

Shalala Defends Stem Cell Decision

In terms of science policy, Specter talked with both Shalala and Varmus about the escalating controversy surrounding NIH's decision that a ban on federal funding for human embryo experiments does not prohibit the agency from funding work with embryonic stem cells. Recently, House and Senate supporters of the embryo research ban have sent letters to Shalala protesting the decision, which is based on an HHS General Counsel's legal
opinion that while the ban prohibits funding for research with human embryos, it does not apply to experiments with stem cells derived from them. (See Washington Fax 2/22/99a and 2/18/99)

"That's going to be a real battle ground," Specter said. He discussed with Shalala the possibility of changing the law to "avoid the ambiguity of legal interpretations" by making it clear that NIH could fund research with embryos as long as it involves "excess embryos not to be considered for human life."

"We don't believe a change in the law is necessary," Shalala said. "We believe the general counsel's opinion is consistent with current law (and) we'll continue to rigorously enforce the congressional prohibition on funding for human embryo research. But, as the general counsel has pointed out quite carefully, the law allows stem cell research, and the promise of this research is extraordinary."

Specter asked each institute director to provide him with a written response on what they might "achieve" with stem cell research. He said it would be helpful for proponents of stem cell research to be "armed with specifics from the experts, the research scientists."

Harkin Seeks Additional Funding for Construction

Sen. Tom Harkin of Iowa, the subcommittee's highest ranking Democrat, asserted that any effort to accelerate scientific discovery at NIH will falter unless Congress and the administration invest in construction at grantee or "extramural" research institutes.

He said that many laboratories are "simply inadequate" and "outdated" and need to be upgraded. And he said he would seek legislation this year authorizing an increase in construction funding.

Shalala said "internally and externally" HHS officials "have never been able to make a case successfully" for major investments in infrastructure. She said part of the problem is that "bench scientists will tell you, if they are candid with you, that they would prefer the money for their research and let the universities figure out a way to build the infrastructure."

But she acknowledged that if NIH is going to be the subject of a
substantial build-up, then infrastructure needs will have to be addressed. And she added that, by the same token, beefing up the basic sciences will require more attention to the needs of the Food and Drug Administration (FDA), since many new discoveries by NIH grantees will eventually wind up as drug and device approval applications before FDA.

In addition to discussing infrastructure, Harkin also questioned Varmus about the implications of the private sector firms getting involved in the sequencing--the deciphering of DNA code--of the human genome.

Varmus told Harkin that NIH is currently working with one of the firms, Celera Genomics, to "make the most of different strategies" for producing the genome sequence. He said there is a "potential" to combine Celera's data "with our more systematic approach" to the sequencing effort.

Harkin said he is concerned that private sector involvement in genome sequencing could result in patent claims on the genome that would inhibit biomedical research.

Finally, Stevens, who last year unsuccessfully sought a $175 million earmark for prostate cancer research, quizzed Varmus and Richard Klausner, director of the National Cancer Institute, about the status of a congressionally mandated report assessing the agency's strategy for fighting the disease.

Stevens, a prostate cancer survivor, said he is concerned that prostate cancer is not getting as much attention as other cancers.

Klausner said the report will contain, as requested, the agency's "professional judgment" of scientific opportunities in prostate cancer research and will be finished by April 1 deadline set by Congress.

--Matthew Davis

Slides used by NIH Director Harold Varmus to demonstrate how NIH is spending it's FY 1999 allocation are available on the NIH web site at
http://www4.od.nih.gov/ofm/policies/page1.htm.

The statement of NIH Director Harold Varmus before the Senate
Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee is available at

http://www.nih.gov/welcome/director/022299.htm





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