July 27, 2001
+++++++++++++++++++++++ POLICY HEADLINES +++++++++++++++++++++++ A biweekly report exclusively for members of the Dana Alliance for Brain Initiatives

1. NIH Reviewing Grantees' Conflict-of-Interest Policies
2. Senate Proposes 5.6% Increase for NSF
3. NIH Budget Not as Large as it Looks
4. Stem Cell Debate Seems No Closer to a Conclusion
5. Information Office and You

1. NIH REVIEWING GRANTEES' CONFLICT-OF-INTEREST POLICIES The National Institutes of Health (NIH) will review conflict-of- interest policies at grantee institutions. Six years ago, NIH determined that institutions would be free to set their own conflict- of-interest policies. An article in the November 30, 2000 issue of the Journal of the American Medical Association, however, raised concerns when it reported that rules vary widely amongst institutions and that fifteen of NIH grantees have no such policy at all. NIH began gathering copies of its grantees' policies earlier this year and plans to review them this summer.

Last year the agency began a series of site visits to examine some universities' approaches to complying with federal regulations including conflict-of-interest. Officials at NIH stress that such visits are not conducted as "check-ups" to discover violations; their purpose is to make each side aware of the other's perspective, thereby reducing administrative trouble spots. The agency has no plans to return to compulsory conflict-of-interest regulations. It hopes to identify common problems in this summer's review and post them to the Office of Extramural Research's web site as a way of sharing information.

2. SENATE PROPOSES 5.6% INCREASE FOR NSF The Senate Appropriations Subcommittee on Veterans' Administration, Housing and Urban Development, and Independent Agencies (VA/HUD) proposed a FY 2002 budget of $4.67 billion for the National Science Foundation, a $246 million (5.6%) increase over the budget for 2001. The increase is $200 million more than President Bush's suggested funding but is $167.6 million less than the budget proposed by the corresponding House committee. Neither the House nor Senate has voted in full on the measures.

While the Bush Administration's proposed FY 2002 budget for the National Institutes of Health is a $2.8 billion increase over last year, the agency would have to give up at least $374 million to other agencies within the Department of Health and Human Services. An additional $95 million would be transferred to the international fund for fighting AIDS, malaria and tuberculosis.

The practice of transferring funds within a department is commonplace; the HHS Secretary is empowered to move 1% of funds allocated to agencies within the department to areas in need. Because its budget is the largest, NIH typically is compelled to share the most. This year's request, however, is so large it might require Congress to approve a 2% re-direct. Last year, HHS re-programmed funds primarily to provide additional money to the Agency for Healthcare Research and Quality (AHRQ) and to the National Center for Health Statistics (NCHS). This year, the Administration would like to continue that funding and broaden the transfers to include funds for data collection at the Substance Abuse and Mental Health Services Administration (SAMHSA) and for work at the HHS Office of Policy Research.

4. STEM CELL DEBATE SEEMS NO CLOSER TO A CONCLUSION The stem cell debate continues. On Wednesday the National Institutes of Health released a report requested earlier in the year by Health and Human Services Secretary Tommy Thompson. In it, NIH says that it is not yet possible to determine definitively whether adult stem cells will prove as useful in application as those derived from embryos. The report, "Stem Cells: Scientific Progress and Future Research Directions," concludes that "the answers clearly lie in conducting more research."

In last week's hearing in the House Government Reform Committee's Criminal Justice, Drug Policy, and Human Resources Subcommittee, patients with debilitating diseases argued in favor of the controversial research that might save their lives while parents who had adopted children as embryos from fertility clinics held their babies up as examples of why no embryo should be destroyed for research purposes. Gerald Fischbach, former director of the National Institute of Neurological Disorders and Stroke, and a Dana Alliance member, testified that "it is irresponsible to think that adult cells are superior to embryonic cells in their ability to proliferate or in the diversity of their descendants." Fischbach, now the vice president of health and biomedical sciences at Columbia University, also dismissed the compromise being discussed by the White House. The Administration suggested that research on embryonic stem cells be funded by the government as long as only existing cell lines were used, an idea backed by Senator Bill Frist (R-TN), the Senate's only physician and a trusted advisor to President Bush regarding medical issues. Frist said that he would support a proposal for federal funding of the research with the existing cell lines and lasting for only five years. Frist suggested that a finite period of research with strong federal oversight would provide an adequate test for whether adult or embryonic stem cells would prove more useful. Fischbach and others have suggested that using only existing cell lines will be an insufficient test of the potential of stem cells.

Meanwhile, President Bush met this week with Pope John Paul II in Rome. The Pope spoke about the issue in a public address after his meeting with the President, condemning "evils such as... proposals for the creation for research purposes of human embryos." This statement appeared to give President Bush some room to maneuver on the subject. Yesterday, the Vatican clarified its position, specifically stating that the destruction of any embryo, created in any way and for any purpose, constitutes "an absolutely unacceptable act."

The University of San Francisco is moving its human embryonic stem cell research, all privately funded, to an off-campus location in an effort to ensure that no federal funds are contributing to indirect costs. Roger Pederson, a stem cell researcher at the University, reportedly has decided to move his work to the UK, where such research receives government funding. Earlier this year, Parliament also approved the derivation of stem cells.

NIH's report, "Stem Cells: Scientific Progress and Future Research Directions," including an Executive Summary, may be viewed online at [http://www.nih.gov/news/stemcell/scireport.htm].