COSSA Washington Update, Volume 19, Number 22

· Congress Returns: Budget Battles Ahead

· Senate Debates Social and Ethical Issues in Stem Cell Policy

· House Panel Discusses OERI Reauthorization

· IOM Examines IRB System

· Satcher Calls for More Research on Lifestyle Factors to Eliminate Health Disparities

· COSSA News

· Announcements

· Sources of Research Support

CONGRESS RETURNS: BUDGET BATTLES AHEAD

After more than a month when the President and Congress were on retreat from Washington for vacations and politicking, the annual autumn battle over spending has commenced. With pronouncements from the Office of Management and Budget and Congressional Budget Office indicating the practical demise of non-Social Security-based budget surpluses, the rhetoric of budget making has escalated.

The political commotion over not spending the Social Security Trust has put both the President and the Congress in a bind. Senate Budget Committee Ranking Republican Pete Domenici (R-NM) has tried to talk some sense by admitting what most economists know, that although spending the social security surplus for education and defense may have political consequences, its economic impact is marginal.

There are 13 appropriations bills for Fiscal Year 2002 (which begins October 1, 2001) that need enacting. Everyone agrees that Congress will once again need to pass Continuing Resolutions to keep the government operating, since the spending bills will not be passed by then. Five of the 13 are at the conference committee stage, having passed both houses of Congress. This includes the VA, HUD, Independent Agencies bill that funds the National Science Foundation (NSF). Four others have passed the House, including Commerce, Justice, State (CJS), and Agriculture. The full Senate will consider the CJS bill the week of September 10.

However, not much activity is occurring in the conference committees since the Administration and the Congress are playing a waiting game with the two largest appropriations bills C Defense; and Labor, Health and Human Services (HHS), and Education. The respective House appropriations subcommittees have tentatively scheduled the markup for both bills the week of September 10. The Senate will continue to wait for the outcome of the conference on the reauthorization of the Elementary and Secondary Education Act and the passage of the Defense Authorization bill before moving these two appropriations. On the Labor-HHS bill the question is how much spending on education and the National Institutes of Health (NIH) will increase. The President has requested a $2.7 billion boost for the latter, while NIH supporters want $3.4 billion. On defense, the issue is whether the President will get the entire $18.3 billion supplement above his initial budget request, including all of his requested funds to begin building a missile defense system.

The President has vowed to veto spending legislation that exceeds the budget resolution. At the same time, he wants the increases for defense and education. There is some talk about across-the-board cuts that would adversely impact agencies like NSF and possibly NIH. Budget gimmickry is also about to make its annual appearance. The President continues to rail against earmarking and pork, but with Democrats recently taking the reins of Senate committees after six years, they seek to make their constituents happy. How this plays out will once again keep budget watchers busy, probably until at least Thanksgiving. Are the words “government shutdown” about to re-emerge?

senate Debates Social and Ethical Issues in Stem Cell Policy

On September 5, the Senate Health, Education, Labor, and Pensions Committee convened to discuss the guidelines for federal funding of research on embryonic stem cells that President Bush announced in an address to the nation on August 9. While the senators struggled to grasp the complex scientific issues involved, they were more clearly able to articulate the social and ethical concerns that have shaped their views on the guidelines. On these matters, the committee heard testimony from two ethicists from academia, whose positions differed considerably and reflected the passionate divergent views held by Americans on this emotional issue.

Senator Edward Kennedy (D-MA), Chairman, began the hearing by praising Bush for opening the door to some research on embryonic stem cells, but he added, “the question before the Congress is whether the door is open wide enough.” He then asserted that embryonic stem cell research holds “the greatest promise of hope for millions of Americans who face” myriad diseases. Ranking Minority Member Judd Gregg (R-NH) used his opening remarks to rhetorically ask, How does the President’s policy “address the issues of life” which are so significant to the people of this nation? And Senator Tom Harkin (D-IA) sustained the theme by stating, “we are all concerned about the ethical guidelines surrounding this research.”

The first panel featured two members of Congress, Senator Arlen Specter (R-PA) and Representative Jim Langevin (D-RI), who is the first quadriplegic to serve in Congress. Specter made clear in his testimony that he has serious concerns about the limiting nature of the President’s guidelines, saying, “science should have the full range of opportunity.” He brought home his point by relating the story of one of his constituents who suffers from Parkinson’s disease and carries an hourglass “to mark the sands of time that are slipping away.” Langevin told the senators of his personal struggles to deal with his condition and his hope that embryonic stem cell research will unlock a cure to his paralysis.

The second panel featured testimony from Health and Human Services Secretary Tommy Thompson. The Secretary began his defense of Bush’s policy by asserting that “the President wants to usher in this research under sound moral guidelines.” He then explained that the National Institutes of Health has identified 64 stem cell lines in five nations that were developed prior to the President’s speech on August 9 and therefore meet the guidelines for Federal funding. Several members of the committee, both Democrats and Republicans, raised questions about the 64 line limit; most of the senators’ queries related to the viability and accessibility of these lines and issues relating to the combination of the lines with mouse “feeder cells,” which could cause conflict with human clinical trial regulations set by the Food and Drug Administration.

Throughout the question and answer session, Thompson stuck to his line that the President’s policy will allow basic research to go forward and that scientists will now be able to search out cures for diseases and compare embryonic stem cell research to less controversial studies involving adult, placenta, and umbilical cord stem cells. He went on to say that this basic research could take anywhere from three to eight years to complete and that he was hopeful Congress would allow Bush’s guidelines to be carried out in their present form. Senator Harkin pressed the Secretary, however, saying, “we have to be able to adapt to new science . . . I’m not going to take the position that the President’s policy is the end-all be-all.”

The final panel featured a series of experts from academia, including ethicists James Childress of the University of Virginia and Kevin FitzGerald from Georgetown. Childress remarked that federal funds should be allowed for research on stem cell lines under the same ethical guidelines derived after the August 9 deadline as that date is arbitrary. He went on to say that respect is needed for a wide diversity of views on the status of human embryos, but closed by asserting that “we must not unduly restrain research.” He backed this viewpoint by explaining that mankind has a strong moral duty to undertake efforts that may lead to the easing of human suffering. FitzGerald took an opposing tack, saying that there are other avenues of research that do not destroy human life (embryos) but still offer enormous potential. He also stressed that leaders should not promise the public amazing cures from embryonic stem cell studies yet as what will result from the research remains uncertain.

It is also difficult to judge what will come of Bush’s guidelines. Congress could rewrite them through legislation, but the President has promised to veto any measure that extends the limits laid out in his address to the nation. Senator Gregg pointed out that this hearing was merely “an entry level discussion of the topic.” Congress is sure to consider the issue in much greater detail in the near future. As Senator Hillary Clinton (D-NY) pointed out at the hearing, “this is not a decision that will be made by political leaders cutting a deal in the back room; this is society’s decision.”

house panel discusses oeri reauthorization

The House Subcommittee on Education Reform met on July 17 to discuss the federal government’s role in education research, evaluation, data collection, and dissemination. The hearing, “From Research to Practice: Improving America’s Schools in the 21^st Century,” is the first in a series of hearings of the 107^th Congress on education reform.

The witnesses, all researchers and practitioners in education, addressed issues pertinent to reauthorization of the Office of Educational Research and Improvement (OERI), started by the last Congress but never completed. Although it will get little attention until the Elementary and Secondary Education Act is reauthorized (see Update, June 18, 2001), Chairman Mike Castle (R-DE) shared his hope that reauthorization of OERI will be completed in the first session of this Congress. He noted that both President Bush and Secretary Paige have expressed strong interest in moving legislation forward.

In his opening statement, Castle promised that his bill “will be a departure from the status quo,” and will seek to insulate research from partisan influences. In formulating this legislation, he said, “improving student achievement – not protecting the current research structure – should be our main objective.”

Addressing common frustrations with the results of education research, Castle began, “Some may say that 30 years of federally funded research, assistance, and evaluation has had little or no significant impact on educational policies and practices. To the extent that this is true, I believe this is due to the fact that there has not been enough value placed on the need for scientifically-based education research as a means to drive good policy, effective instruction, and, most important, student achievement.”

From the research community, Frank Newman, Professor of Public Policy and Sociology at Brown University, testified before the panel. Calling current research in education “grossly inadequate,” Newman remained optimistic about the future of education research. “It is in research that the federal government plays the leading role and thus this committee can have the greatest impact.”

Newman, former president of the Education Commission of the States, expressed his belief that much of the published research represents opinion buttressed by anecdotes. His staff at the Commission, he said, seldom read any of the 980 journals in education. He attributed the success of research in other fields to the “American system of organizing research – university researchers as the responsible parties; peer-reviewed competitive grants; multiple federal agencies as the grant makers.” Newman contrasted this with the system used in education, “which depends more on block grants. Block grants, even to universities, are much less effective.”

Newman called for a different approach to education research, suggesting an institute modeled on the success of the National Institutes of Health and the National Science Foundation, “an institute shielded from political pressure, adequately funded, primarily utilizing peer-reviewed competitive grants, and capable of a long-term perspective.”

He offered the subcommittee several recommendations for developing a first-class research program: 1) create large databases constructed with care; 2) focus on issues of importance; 3) follow the research over a long enough period of time to provide meaningful data; 4) replicate encouraging results; 5) learn from what has worked, or failed to work, elsewhere around the world; and 6) spend more on research in education.

IOM EXAMINES IRB SYSTEM

On August 21 - 22, the Institute of Medicine (IOM) Committee on Assessing the System for Protecting Human Research Participants, one of four entities looking at the issue of human participant protections in research, held its fifth meeting to examine the structure, function, and performance of human subject protection activities with a focus on clinical and biomedical research (see Update, January 29, 2001). Daniel Federman is the Committee’s Chair. The meeting examined IRB (Institutional Review Board) administration and operations.

The IRB process is a system overwhelmed, declared Tom Puglisi, invited by the Committee to discuss IRB administration. Puglisi, from Pricewaterhouse-Coopers, is the former director of the Human Subject Protections in OHRP (formerly the Office of Protections from Research Risks). He outlined major challenges to the IRB system.

The IRB system is marked by increased volume, complexity, and expectations coupled with insufficient resources and expertise, said Puglisi. It is being supported by volunteers who are doing work on their own time, out of their own generosity, and with no systematic training.

Citing several medical studies that have received negative attention, he emphasized that the attention paid to these studies make people believe that research is unsafe and unregulated and that volunteers are guinea pigs.

Echoing the National Bioethics Advisory Commission (NBAC) recommendation that all research, both privately and federally funded, be subjected to IRB review, Puglisi called for universal coverage of all research. He also endorsed NBAC’s call for a single federal agency to enforce that requirement and the establishment of data safety monitoring boards (DSMBs).

There is also a need to think about how IRBs conduct their oversight. The present system, said Puglisi, is “labor and paper intensive but not very effective. IRBs spend too much time doing the wrong thing and not asking the right questions,” he noted.

Puglisi called for a clarification of the definition of research, as well as what is not considered research but should be subject to review. He also called for a better definition of “minimal risk,” specifically in a social science context. Noting that the level of review should correspond to the level of risk, Puglisi advocated a rapid, non-labor intensive review of all minimal risk research. “Social science research can be risky, horrendous, and morally objectionable, but all of it does not need the kind of review that it is currently undergoing,” said Puglisi.

Human subject protection is the cost of doing business, said Puglisi, echoing other entities reviewing human participant protection. He called for an increase in resources dedicated to human research participant protection by government, industry, and research institutions. He also recommended resources be dedicated to the ongoing education of IRB members and the research community, and to an increase in the number of IRB members and to better documentation of the IRB process.

Finally, Puglisi called for more public education about research and the attendant risks and benefits, and endorsed the need for more public participants on IRBs.

Crisis of Confidence

Robert Levine of Yale University, a member of the National Human Research Protection Advisory Committee, echoing Puglisi, asserted there is a crisis of confidence surrounding the human subjects protection system. The most significant consequence, Levine declared, is the loss of motivation by researchers to serve as IRB members.

Levine observed that while IRBs have been doing well over the years, they are presently overburdened. The current public perception of IRBs is that, in addition to being overburdened, they are incompetent and primarily concerned with protecting the institution and promoting self-interest. Levine recommended that IRB members focus on important matters that match their skills; he also called for accreditation of IRBs.

He concluded that “in this season of rapid change in national leadership and policy, there is an opportunity to reevaluate and revise policies and practices regarding human subject protection.” He recommended that the IOM committee reevaluate and restate charges to IRBs.

satcher Calls for More Research on Lifestyle Factors to Eliminate Health Disparities

A major challenge in the U.S., according to Surgeon General David Satcher, is bringing science to bear on the issues we face and the policies we create. Satcher made his remarks at the 7th Annual John W. Diggs Lecture at the National Institutes of Health (NIH) on July 23, where he called for more research on lifestyles and behavior that contribute to health disparities.

Six of the ten leading causes of death in the U.S. and most developed countries are behaviorally-based. “Quite clearly, whether we are talking about saving lives or eliminating disparities in health, we have to deal with lifestyles aggressively – much more aggressively than we have done before,” Satcher urged. To that end, he called for greater investment in health promotion and disease prevention.

Healthy People 2010, he said, is about ensuring that the policies we make reflect the science. The initiative offers a prescription for building the next generation of healthy people, improving the science, and nurturing today’s scientists while developing those of tomorrow. It also presents a list of ten leading social health indicators, and discusses the challenges and opportunities surrounding the elimination of health disparities.

Healthy People 2010 targets populations that suffer disproportionate rates of death and disease. It is a real test, Satcher observed, of our research, our health care system, and our public health system. The two goals of the program are increasing the length and quality of healthy life and eliminating racial and ethnic health disparities.

The intent of the ten leading health indicators, devised with the help of the Institute of Medicine, Satcher explained, was to come up with a finite number of indicators or areas of broad public health importance that were measurable and could be followed over a ten-year period.

The indicators, which all relate to lifestyle, environment, health systems, and/or research, are: physical activity, overweight and obesity, tobacco use, substance abuse, responsible sexual behavior, access to care, mental health, injury and violence, environment quality, and immunization. For each of these there are at least two measurable objectives, said Satcher.

Two recent studies indicate the effects of lifestyle choices and the potential health benefits of prevention. The Surgeon General cited a Harvard School of Public Health study, which revealed that physical activity results in a 20 - 25 percent reduction in the risk for breast cancer, and a Duke University study, which found that physical activity in conjunction with pharmacological interventions is more effective than pharmacological interventions alone in treating depression.

Satcher pointed out that such results reveal the need to invest more time and money in learning how to get the American people up and moving, because we pay a great price when we don’t, he said. One of those prices is overweight and obesity.

Satcher pointed to some health impacts of obesity, which include: higher body weights associated with higher death rates; increased risk of high blood pressure, elevated cholesterol, Type 2 diabetes, heart disease and stroke, gall bladder disease, arthritis, sleep disturbances, and problems breathing; increased risk of hip fractures, endometrial, breast, prostrate and colon cancers; and social stigmatization, discrimination, and lowered self-esteem.

Satcher also noted a “very strange happening” at the societal scale. The rate of overweight and obesity in children, he said, has doubled over the last 15 - 20 years. Furthermore, there has been a dramatic increase in the number of Americans who are overweight or obese, and this has occurred just as we have been making strides (over the last 40 - 50 years) in reducing deaths from cardiovascular diseases.

Not all groups are at equal risk for obesity, and differences in lifestyles are a significant factor, Satcher concluded. Conceding that it will not be easy to eliminate disparities in this and other health problems, Satcher urged the audience to take on such tough issues all the same.

COSSA NEWS

· The American Statistical Association has named William B. Smith as its new Executive Director. He replaced Ray Waller, who is retiring. Smith is currently a program director in the Division of Mathematical Sciences at the National Science Foundation. He received his Ph.D. from Texas A&M in 1967 and has been on the faculty of the University’s Statistics Department ever since. He has also served as Associate Dean of the College of Science. For nearly ten years, Smith was Editor-in-Chief of Communications in Statistics. He has owned a statistical consulting business and has won a university-wide teaching award.

· The American Psychological Association has appointed Kurt Salzinger Executive Director for Science. Salzinger replaces Richard McCarty, who is now the Dean of the College of Arts and Science at Vanderbilt University. Salzinger, who has been a member of the COSSA Board of Directors, is a Professor of Psychology and Director of the Ph.D. Program in Clinical Psychology at Hofstra University. He has served as President of the New York Academy of Sciences, a program officer at the National Science Foundation, and chair of the Cambridge Center for Behavioral Studies. His Ph.D. is from Columbia University.

· Catherine Rudder, Executive Director of the American Political Science Association (APSA), has announced she will be leaving on October 1 to join the School of Public Policy at George Mason University in Fairfax, VA, where she will direct the Master’s program, conduct research, and teach. Rudder, with APSA since 1981, and Executive Director since 1987, has also served as an Administrative Assistant to former Congressman Wyche Fowler and as a member of the Board of Trustees of Emory University. She is currently Chair of the National Humanities Alliance. She has a Ph.D. from the Ohio State University. APSA Deputy Director Robert Hauck will become Acting Executive Director. A national search will be conducted for Rudder’s successor.

announcements

Schoolkids to Learn About Behavioral and Social Sciences: Lesson Plans Needed

The newest program of the Decade of Behavior is Exploring Behavior Week, a project to capture the imagination of young students, increase the knowledge and visibility of the social sciences, and encourage the flow of talent into the future-scientist pipeline.

University and college faculty and students will introduce behavioral and social sciences to 8^th to 10^th graders, based on a lecture template and accompanying slides. The Decade of Behavior seeks collaboration in developing a lesson plan in your discipline. Materials for psychology have already been developed (see www.apa.org/science/ ebw.html). Please contact dob@apa.org for more information.

The Decade of Behavior is a multidisciplinary initiative to focus the talents, energy, and creativity of the behavioral and social sciences on meeting many of society’s most significant challenges (www.decadeofbehavior.org).

Volume 20, Number 16 Celebrating 20 Years of Advocacy September 10, 2001