Debate Begins Over FY 2001 Budget

The second half of the 106th Congressional session will be abbreviated since it is an election year. This shorter session will likely speed the budget and appropriations process but may add to the difficulty of developing a budget. Already, last month Republican leaders fired the first shot across the Administration bow by sending President Clinton a letter with their expectations for next year's budget.

ASCB Public Policy and Joint Steering Committee member David Botstein met with senior officials from the Office of Management & Budget and the Office of the Vice President to reinforce the case for continued strong science funding in the President’s FY 2001 budget, to be released on February 7.

Congressional leaders hope to finish the FY2001 Congressional budget resolution by March 10, well before the April 15 statutory deadline. But first they must determine whether the FY2001 budget will observe the discretionary spending cap set in the 1997 Balanced Budget Act. To maintain the caps, Congress will have to reduce spending by $42 billion, or 3.2%. Residents of Capitol Hill are quietly hopeful that the President will call for the lifting of the caps in his budget, thus diffusing the political risk for Congress, and giving Congress more flexibility to develop its budget. Last year, the Congress appropriated some $30 billion over the caps.

Congressional leadership also intends to have all 13 annual appropriations bills passed by both houses and in conference by July 28, the final day of legislative business before the August recess and the Republican National Convention. This past year, the House completed all but the VA-HUD and Labor-HHS spending bills before the August recess; the Senate was unable to finish six appropriations bills before the summer break, never passing a stand-alone Labor/HHS bill, necessitating that these programs be funded through an Omnibus Appropriations bill.

In December, House Speaker Dennis Hastert and Majority Leader Dick Armey wrote to President Clinton urging him to submit a budget for FY2001 that does not spend the Social Security surplus and contains no tax increases. They also declared their intention to reattempt the passage of another tax cut. The GOP warned that Congress and the President will again fall into the same position they were in in 1999, working within strict budgetary constraints while wanting to fund priority programs. A tax cut would also reduce the amount of funds available for domestic discretionary programs such as the NIH and the NSF.

Strong Support for NIH Doubling Continues

Despite the likely budget battle, there is hope that the strong support for science of recent years will continue with the advocacy of Congressional leaders, including Rep. John Porter and Senator Arlen Specter, who Chair the Labor Health & Human Services and Education Appropriations Subcommittees that fund the NIH. After receiving the second installment on doubling the NIH budget between 1999 and 2003, some are worried that it will prove especially difficult to maintain this momentum in the FY 2001 budget. The resignation of NIH Director Harold Varmus and the impending retirement of Rep. John Porter leave many concerned that the NIH will be left politically vulnerable.

NSF Funding Increase Expected

Following the FY 2000 6.5%, $240 million increase for the National Science Foundation, advocates are making the case for a $4.5 billion budget, a 16% increase over FY2000, in 2001. In December, President Clinton spoke to business leaders about economic growth, stressing the interdependence of the research enterprise and calling for across-the-board support for research: “Advances in health care, for example, are often dependent on breakthroughs in other disciplines — such as the physics of medical imaging technologies,” a message emphasized both by NSF Director Rita Colwell and former NIH Director Harold Varmus.

NIH Draft Stem Cell Guidelines Promising

In an important step forward, the National Institutes of Health published new draft Stem Cell Guidelines for federally funded scientists who want to conduct research on stem cell lines in the Federal Register last month. The guidelines limit the source of stem cells to those “derived from early human embryos that were created for the purpose of infertility treatment and were in excess of clinical need.” The use of fetal stem cells in research is already permissible. The guidelines also call for the creation of an oversight committee, the Human Pluripotent Stem Cell Review Group, which will ensure compliance with these guidelines. The six-page guidelines are posted at www.nih.gov/news/stemcell/draftguidelines.htm. Comments are invited by January 31, 2000 at Stem Cell Guidelines, NIH Office of Science Policy, 1 Center Drive, Building 1, Room 218, Bethesda, MD 20892; fax (301) 402-0280, or stemcell@mail.nih.gov.

NIH Releases Sharing Policy

Just before Christmas, the NIH published the final version of its policy on Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts <http://www.nih.gov/od/ott/RTguide_final.htm>. The policy, which was released for public comment this summer, provides NIH-funded researchers guidance on disseminating and acquiring unique research resources developed with federal funds in compliance with the Bayh-Dole Act and NIH funding policy.

FOIA Controversy Persists

In October 1999, the Office of Management & Budget published the revision of Circular A-110 regulating public access to research data through the Freedom of Information Act (FOIA) (see November, 1999 ASCB Newsletter). Although the guidelines establish the mechanism for obtaining research data through FOIA, the threshold for allowing public access is considerably higher than originally proposed and is expected to present a minimal burden to the research community. Under the new guidelines, FOIA requests are limited to "data relating to published research findings . . . that were used by the Federal government in developing an agency action that has the force and effect of law."

However, federally-funded scientists continue to be vulnerable. The U.S. Chamber of Commerce, an advocate for greater public access to research data, is challenging the guidelines, generating thousands of letters in support of more aggressive OMB guidelines. According the to the Boston Globe, the Chamber is "demanding personal and confidential data from universities and hospitals in an effort to provoke a lawsuit challenging the OMB regulations." The Chamber is targeting two provisions: the applicability only to grants issued after the statute becomes effective, and the limitation to only data used to support federal policies that have the force of law.

The regulations were proposed in response to data produced by the Harvard School of Public Health, Cambridge-based Abt Associates Inc., and other institutions which were cited by the EPA in proposing tougher clean-gasoline and clean-air regulations. In an important twist, the Greater Boston Chamber of Commerce sided with Harvard in the debate over the data, stating, "we are seriously concerned that the U.S. Chamber's position would stifle intellectual inquiry and impede the development of new technologies.'"

In the meantime, the NIH has released guidelines for NIH grantees, at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

CLC District Meeting

On Monday, November 29, two Members of the Pennsylvania Congressional Liaison Committee ("PennCLs") met with Representative William Coyne (D-PA) to discuss the merits of federal funding for biomedical research. The Congressman represents much of Pittsburgh and has helped secure federal funding for many medical and educational institutions in western Pennsylvania since being elected to Congress in 1980.

PennCLs Cynthia Lance-Jones and Carey Balaban meet with Congressman William Coyne (D-PA)

Representative Coyne had met with members of the CLC on previous Pennsylvania Capitol Hill Days when PennCLs traveled to Washington, D.C. A corporate accountant by training, Congressman Coyne is known as one of the House’s quieter Members. His influence is potent, however, as a member of the powerful Ways & Means Committee.

PennCLs Carey Balaban and Cynthia Lance-Jones attended the 45-minute meeting where they thanked the Congressman for recent efforts to increase the NSF’s and the NIH’s budgets, and for his membership in the Congressional Biomedical Research Caucus.

Balaban and Lance-Jones came prepared with district-relevant statistics, notably that 36.6 job are created for every $1 million of grant money that comes into the state. The University of Pittsburgh attracts $300 million annually to the district.

They also noted that the NIH is the second greatest source of federal R&D funds for Pennsylvania, providing $569 million in FY 1995. In the same year, the NSF provided $94 million for the state.

CLC members interested in meeting with their Member of Congress should contact Alec Stone, National Field Coordinator, (301) 571-7781 or astone@jscpp.org.

Varmus Receives Public Service Award

Paul Berg, Chair of the ASCB Public Policy Committee, presented NIH Director Harold Varmus with the 1999 ASCB Public Service Award. Berg's introduction and Varmus' acceptance speech follow.

Harold Varmus (left) receives the Public Service Award from ASCB Public Policy Chair Paul Berg

Good evening and welcome to the presentation of the sixth annual American Society for Cell Biology Public Service Award. One of the perquisites of being Chairman of the Society's Public Policy Committee is to oversee the selection of the awardee; even more valued is the pleasure and privilege of introducing our chosen one, Harold Varmus, Director of the National Institutes of Health. I am also delighted to welcome Harold's wife, Connie Casey, to this occasion.

In his six years at the National Institutes of Health, Harold Varmus elevated the influence of the NIH Director to a new level. He leveraged an unprecedented period of scientific advancement to instill new momentum and energy at the world’s preeminent biomedical research institution. He inspired Congress with a new vision for the promise of medical research and gained their support for expanded resources to fulfill that opportunity.

Harold mobilized the nation’s biomedical enterprise to ensure that these expanded resources would be invested in our boldest and brightest and in the infrastructure so essential to maintaining top level science. In doing this, he energized all of us, researchers on the Bethesda campus and throughout the country. Harold's legacy as Director will resonate well beyond his tenure, for the institutes are stronger and more secure as they confront the great opportunities and challenges of the coming decades.

By his own reckoning, Harold Varmus is one of us: an ASCB member, a cell biologist and a comrade in purpose. Six years ago, when he was being considered for the NIH Directorship, we lobbied Congress shamelessly, all the while assuming, but also questioning, whether he could translate his effectiveness as a scientist to leading the mammoth National Institutes of Health. There were those who were promoting other favorites making much of his meager — virtually non-existent — managerial track record.

But Harold disappointed them and delighted us. His commanding intellect, cloaked by a patient and unprepossessing manner, emboldened NIH's Congressional allies — Congressmen John Porter, George Gekas and Senator Arlen Specter — to make doubling the NIH budget in five years the centerpiece of their powerful influence in Congress. Today, the biomedical research enterprise, as well as all those individuals whose diseases plague their existence, are in Harold Varmus' debt.

Harold frequently invokes the role of serendipity in science, probably because his own life and career have been so marked by it. "Scientists who begin this kind of work," he noted, "can never be sure where it will lead, or how important their work will turn out to be: often the results that prove most valuable are not the ones that the scientists expected to discover." All of us know, however, that luck is only part of the equation. He also has the gift of vision, enhanced by his wide-ranging intelligence.

Harold was born in 1939, grandson of Polish and Austrian immigrants: his father was a family physician and his mother was a psychiatric social worker. Once he facetiously contrasted his "humble beginnings" growing up on the less pretentious South Shore of Long Island with the decidedly upscale surroundings of the island's North Shore where the scientist he was chiding, David Baltimore, was raised. Although Harold wasn’t entirely sure what he wanted to do, he settled on attending Amherst College where he majored in English. He was especially fond of English literature and went on to Harvard to earn a master's degree in this subject, intending to become a professor of English. But several friends who were at the Harvard Medical School persuaded him to give medicine a go.

The record shows that Harold applied to Harvard Medical School twice, and was turned down each time, I suspect because interviewers could not fit him to the Harvard style. Undaunted, he returned to New York to attend Columbia College of Physicians & Surgeons, where after completing medical school and house officer training, he chose research instead of clinical medicine. To pursue that goal, Harold did a two-year stint with Ira Pastan at the NIH working on cAMP regulation of the lac operon before moving to San Francisco in 1970 to work in Mike Bishop's lab. Their partnership prospered because of matching intellects, mutual respect and a common driving passion for science. The success of their collaborations culminated in 1989, when he and Mike shared the Nobel Prize in Physiology or Medicine for their discovery that normal cells contain genes capable of becoming cancer genes. Seeking the evolutionary origins of the SRC gene, which en-dowed the Rous Sarcoma virus with its cancer-causing property, they discovered that the virus Oncogene had been derived from normal cells by a form of genetic recombination. The discovery of the cellular origin of the SRC gene sparked a spec-tacularly successful assault on the genetic origins of cancer that continues to this day.

Richard Hynes, Paul Berg, Elizabeth Marincola, Maxine Singer, Harold Varmus and Connie Casey listen as Randy Schekman opens the Public Service Award ceremony

At the 1993 Annual Meeting of ASCB, when Harold was assuming the NIH Directorship, he spoke to us about his view for the future of the NIH. The institute's intramural activities were being severely criticized, the clinical center was falling apart and morale among young investigators was at an all-time low. The extramural program was bedeviled by insufficient funds to support the expanding number of biomedical scientists and burgeoning opportunities. He reflected on an article published that year by Mike Bishop, Marc Kirschner and himself in which eleven goals were articulated. These included: "generating a comprehensive plan for the best use of federal funds for biomedical research" and "instituting a mechanism for the periodic evaluation of peer-review procedures."

Today more grants are being funded than ever before, a new clinical center will be completed in 2002 and while there are still serious challenges facing young investigators, their prospects and enthusiasm have been revitalized, providing cause for optimism for the future of biomedical research. Despite his reputed lack of management experience, Harold has overseen sixteen thousand employees in twenty-five institutes and centers at the NIH. He has presided over the largest increase in NIH funding in history, which in the millennium year will reach a fantastic $18 billion, two-thirds more than the $11 billion budget when he arrived. Harold’s scientific and personal credentials brought new blood to help manage the institutes, although he recently questioned how much longer that would be possible if the number of institutes continues to increase. We hope that the secretary of HHS, the President and Congress can appoint a comparably outstanding scientific leader to succeed him.

Harold revealed a previously unrecognized talent at managing the Washington political landscape. He had to confront the political pressures ranging from indirect costs rates for research facilities to research misconduct; there was also the clamor over setting NIH research priorities, human cloning, fetal tissue research and most recently human stem cell research. He is one of those rare scientists who while serving as a political appointee could pursue the broader goals of the administration but never lost sight of his main purpose, the advancement of science. One symbolic indicator of the admiration he won in Washington was his perch next to Hillary Rodham Clinton at the annual State of the Union address last year. Indeed, Harold's tenure as NIH Director may be the most important legacy of the Clinton Administration.

I'm sure that Harold would not resent it if I mentioned his athletic prowess. One could say that he is health conscious, or even a little health obsessed. He often rides his bike from his home in the Cleveland Park neighborhood of Washington to scull on the Potomac River before proceeding by bike out to Bethesda. He has even been known to run in the ASCB road race; we know he gets special satisfaction from competing against his scientific colleagues. I learned during a visit to Umea University in the far north of Sweden that on an earlier occasion before his lecture Harold had to settle for skating on a nearby lake to make up for the lack of snow which frustrated his plan for cross-country skiing.

Harold's departure from the NIH is, of course, a loss to the scientific community — at least to that segment that does not reside at Sloan Kettering. But his reemergence as a private citizen also makes him eligible to rejoin the Joint Steering Committee for Public Policy, of which he was one of the founders. Also, to ease his withdrawal from the congressional biomedical scene, Congressman George Gekas summoned Harold to help celebrate the first ten years of the Biomedical Research Caucus which Harold served as first Scientific Advisor.

Harold Varmus is the rare person who is well-versed in literature, poetry and the arts while also enjoying the distinction of being one of the world’s most eminent researchers. This breadth of knowledge and diversity of interests are seldom seen, especially in our world of increasingly narrow specialization. He cares deeply about the public welfare, as evidenced not just by his contributions to government service but also by his participation in a grassroots DNA education program for San Francisco high school students and spending a day on the set of “ER” to pitch ideas to producers.

Harold, there's been no greater national leader of biomedical research, and there is not one here among us, not in this city nor in this world, who is not in your debt. It is my privilege to present to you the ASCB Public Service Award, the Society's highest recognition for public service. The citation reads:

For his extraordinary accomplishments as a scientist, outstanding leadership of the National Institutes of Health and for inspiring congress with a new national vision for medical research.

Varmus Address

Thank you all very much. I appreciate the nice crowd showing up; I’ll even try to believe it’s not for the food. I want to thank Randy Schekman for his kind remarks. Paul, I very much appreciate your adulating my athletic accomplishments. And Elizabeth, thanks for helping to get me here today and the many things you do on behalf of the scientific community through this organization. I also want to say a word of thanks to those at the NIH, the Department, the Society, the Administration and in the Congress, especially Mr. Porter, Mr. Specter and Mr. Harkin and others, for the help they gave me in the last six years.

I'd like to say a few words about how I got to this podium. Some are born public servants; some (like me) have public service thrust upon them. For most of my career, I minded my own business (and that of my trainees and UCSF colleagues). Then, exactly ten years and two days ago, the King of Sweden passed a magic wand over my head and Mike Bishop's. It was like receiving both a magnet to attract invitations and a megaphone to amplify our voices.

Varmus talks with Richard Hynes at the ASCB Public Service Award presentation

Soon thereafter, Bruce Alberts said, "you must come and speak at the National Academy about success rates for young investigators" (something I really knew nothing about), and Marc Kirschner said, "you must join the Joint Steering Committee on Public Policy," again to consider issues I knew almost nothing about. The NIH said, "you must come and talk to us about indirect cost rates," something I knew even less about. And then Donna Shalala said, "you should come to D.C. and serve as NIH Director."

So why did I do this? What was I hoping to achieve as NIH Director? As you've already heard from Paul, my colleagues and I had already written a prescription for what I should do as NIH Director. In January 1993, just as Clinton and Gore took office, Science published the advice to the new Administration that four of us — Bruce Alberts, Mike Bishop, Marc Kirschner and I — had composed, although only three of us (not Bruce) had signed. The piece included the famous eleven directives about Federal biomedical research policy.

Almost a year later, only 19 days after being sworn in as NIH Director, I had a chance to revisit that advice at the ASCB meeting in New Orleans. Rereading that speech, it is sobering to see how the wings of our ambitions seem to have been clipped by economic, bureaucratic, and political realities.

Now, only 19 days before leaving the NIH (I need an expert in the Kabbaleh to understand the significance of these symmetries), I look back and see that we have made a lot of progress towards the most important goals of the manifesto we wrote in 1993: Increasing the NIH budget at 15% per year (admittedly after a several-year lag). Engaging the scientific community in the planning of research initiatives. Reevaluating the peer review system. Encouraging technological development. Protecting basic biological research. Hiring savvy leaders of science agencies, independent of political considerations. Normalizing indirect cost policies, including the costs of animal care. Giving greater attention to science education and research infrastructure.

Some other good things, not mentioned in our Eleven Theses, have also happened. Clinical research has been strengthened. Sensible policies on misconduct in science have been codified. Science has contributed importantly to tense public debates about cloning and stem cell research, topics that weren't even on the table in '93.

So what is next? Yesterday I received a letter from Eric Lander, the current chairman of the Joint Steering Committee, informing me that I have been on leave for six years and would now be expected to rejoin the group. I am pleased to say that I am officially accepting that invitation. But the invitation has prompted me to think about the kinds of things that the Joint Steering Committee — hereafter known as the JSC — ought to do. In a sense, it has prompted me to compose another brief manifesto — one, you'll be glad to know, with fewer recommendations than the eleven imperatives we came up with before, only five. In doing this, I am conscious of things left undone or unfinished at the NIH; things that I began working on too late; and even mistakes that I made as NIH Director.

1) Continue to Fight for the NIH Budget.

Doubling in five years is finally off to a good two-year start, and many are committed to finishing it. But some think the NIH has had its good time at the trough and has prospered at the expense of other worthy social and educational goals. We need to explain the disastrous practical consequences of turning off the scale-up after only a couple of years, and we need to outline a sensible adjustment to more modest budgets after the doubling is achieved. At the same time, we must continue to advance our most powerful arguments: that our science produces important results each year, that our engines of discovery can run harder and faster with more fuel, that our management of money and science is rigorous, and that the public wants what we have to offer — science that improves health.

2) Develop Stronger Alliances Among Advocates for Research, Especially Between Scientists and Patient Advocates.

Scientists have united to form the JSC, they've united to form FASEB and a number of other organizations. Advocates for research on many different diseases have the Ad Hoc Committee, the National Health Council, and Research!America. But the two worlds of disease-based and science-oriented advocates don’t intersect enough. I have personally taken some heat from certain advocacy groups during the past six years. But there is no doubt that the growth of the NIH budget — as opposed to the budgets of other science agencies or of health science agencies in other countries — is largely due to our active and informed patient-oriented constituencies. Scientists and their societies need to reach out to the advocacy groups more vigorously. The ASCB, for example, should invite patient advocates to attend and speak at annual meetings. Leaders of advocacy groups should be invited to visit your members' labs.

I admit that I was slow to see the potential benefits of such collaborations. But now, having assembled the NIH Director's Council of Public Representatives — called CoPR — and established the CoPR Associates, which is a program of several hundred members, I happily call upon these groups for help with oversight and policy at the NIH, and we all benefit from it. Recently, as a result of a National Research Council workshop on scientific prizes, I suggested that CoPR members and associates consult with scientific societies such as this one to set up even modest awards for achievable short-term goals in medical research. This kind of program could be an effective means to encourage advocates and scientists to work together — and might even achieve some practical health benefits.

3) Help Insure that our Increasingly Sophisticated Science Will Serve the Interests of a Wide Community, Indeed a Global Community, and Not Just the Elite.

The NIH exists to improve public health. As publicly funded scientists, we benefit from the evidence that our research has extended life and reduced disease around the world. Still, as scientists working with public funds, we must continue to recognize that profound differences in health status exist in different parts of the world and even within our own affluent society. Moreover, new technologies, however exciting and beneficial, will not be sufficient marks of success if their benefits cannot be widely shared. We know that there are complex explanations for health disparities, which biomedical scientists can only partially address. But we can help to find better ways to increase the representation of minority groups in American science, we can help to spread the culture of modern science to the developing world, and we can help to bring effective technologies into widespread clinical practice.

4) Rethink the Organization of the NIH.

The NIH is becoming increasingly complex, with a large and still increasing number of Institutes and Centers that differ in age (from one to over 60 years), budget (with differentials of up to one hundred-fold), staff size, and management skills. It is important to remember that the proliferation of new Institutes is a manifestation of public and Congressional enthusiasm for what we do. The decisions that created the current NIH should be revisited with caution and respect. Still, I and many of my colleagues believe that the NIH could become a stronger and more effective organization by a judicious clustering of current Institutes into five or six larger units devoted, for example, to research on the brain, or development and aging, or infectious and environmental diseases. Changes of this sort need a broad consensus that can be achieved only slowly and with the help of an independent, authorized, and widely respected commission. But it is not too early for the scientific community to begin to debate the options.

5) Work with Government to Create Conditions that Allow our Scientists to Do their Best Possible Work.

Budgetary growth encourages us to think about repairing and rebuilding the aging and dilapidated labs in which many of our scientists work. Technological innovations provide powerful tools for discovery to which more of our scientists seek access. The Internet and personal computers allow centralized data deposition and universal data sharing — and could even permit unencumbered access to the full text of the entire scientific literature. I am particularly grateful to this Society's journal, Molecular Biology of the Cell, for its willingness to participate as a charter member of a great new experiment of the NIH, PubMedCentral, our effort to make the biomedical research literature freely accessible over the Internet.

Scientific societies need to engage government on these issues on behalf of their rank-and-file. The ASCB has been especially effective as an advocate for its membership in policy issues of this sort and others. In that sense, it has set an enlightened standard for all scientific societies. To receive a Public Service Award from the scientific society that has itself exemplified public service is a special honor. I’m grateful for it, and I thank you very much.