Stem Cells and Executive Order 13435

Recasting the Federal Debate on Stem Cells

Bush Administration Revisits ESC Stance by Encouraging Funding for Pluripotent SCs

GEN JULY 2008 page 8-9
Joseph R. Sollee

Stem cells are one of the most promising areas of R&D in biotechnology today but also one of the most politically divisive. Scientists believe that stem cells offer the potential to cure or mitigate a host of pervasive and debilitating diseases and conditions such as multiple sclerosis, Parkinson’s, Alzheimer’s, and diabetes. They also believe that stem cells can be used to repair or replace damaged tissues or cells caused by injuries to organs, limbs, and the spinal cord. Yet despite these potential benefits, research on stem cells in the U.S. has suffered in recent years. This is due to religious, moral, and political concerns that have in particular affected studies associated with the harvesting and use of embryonic stem cells (ESCs). In April, federal funding of stem cell research took a major step forward with the announcement that the DOD is “embarking on the next generation of research that is going to redefine the face of Army medicine” with the creation of the Armed Forces Institute of Regenerative Medicine (AFIRM). This federally funded institution will focus on the development of clinical treatments for battlefield trauma and severe injuries utilizing stem cells and other tissue-regeneration technologies. The stem cell community has applauded the government’s commitment of significant resources through AFIRM and the breakthroughs that it is expected to bring to the clinic in the near term. With initial funding in excess of $250 million, AFIRM will work in consortium with academic centers, led by Wake Forest Institute for Regenerative Medicine and the University of Pittsburgh’s McGowan Institute for Regenerative Medicine. Many scientists and stem cell advocates are skeptical of the AFIRM announcement, however, viewing it as further evidence of President Bush’s policy to steer funding away from human ESC research and toward somatic stem cell technologies. Given AFIRM’s stated focus on technologies that are close to the clinic, it is expected that AFIRM-sponsored investigations will be directed primarily toward therapies and technologies utilizing somatic stem cells, as these are more advanced than human ESC technologies. Within the stem cell community, the Bush Administration’s seven-year ban on human ESC funding is a controversial issue that has created deep and perhaps permanent divisions, pitting scientists engaged in somatic stem cell research against ESC investigators. Despite a growing and increasingly broad spectrum of public support to lift this moratorium, the Bush Administration has held firm on its policy. This past summer, when President Bush issued his second veto of a Congressional bill providing expanded federal funding for human ESC (hESC) research, many stem cell advocates decided that the only remaining course was to wait out the Bush presidency in hopes of a more supportive future administration. Regardless of one’s position on the Bush Administration’s hESC policy, resolution of the issue is not as simple as merely ending the ban on federal funding. Any future administration that intends to lift the funding ban will need to interpret and address the myriad of existing rules and regulations that would apply to ESC research. The basis for federal legislation and policy applicable to current ESC research dates back to the mid-1970s (more than 25 years prior to the first successful isolation of a human ESC), when Congress limited federal funding of research on human fetuses following the Supreme Court’s Roe v. Wade decision. In addition, since 1995 Congress has appended a rider (known as the Dickey-Wicker Amendment) to each NIH appropriations bill prohibiting the use of federal funds for the creation of human embryos for research or for any research in which human embryos are destroyed, discarded, or subject to a greater than minimal risk of injury or death.

Executive Order 13435

Executive order 13435, issued by President Bush in June 2007, may provide important insight into the future of stem cell policy if the federal funding moratorium is lifted. This order has largely been overlooked since it was issued concurrently with the President’s veto of the ESC Congressional bill. Though many characterized the order as a symbolic measure intended to blunt the inevitable criticism arising from the veto, closer scrutiny yields several potentially important steps taken by the Bush Administration in favor of expanded stem cell research. The operative provisions of the order represent a shift in focus away from the source of the stem cells toward the key attributes of the stem cells in question, such as pluripotency. Additionally, the order directs the NIH to rename the “Human Embryonic Stem Cell Registry” as the “Human Pluripotent Stem Cell Registry” to appropriately capture human pluripotent stem cells (PSCs) that may be created or derived from sources other than embryos. The order contains a broad description of types of PSCs that will be considered as pluripotent for the purposes of the Administration’s policy, including cells that are capable of producing all (pluripotent) or almost all (multipotent) cell types in the developing body. The order directs HHS and NIH to ensure that all types of ethically produced human PSC lines will be included in the NIH stem cell registry and be eligible for federal funding. In addition to nonembryonic sources of PSCs like amniotic fluid, cord blood, and dedifferentiated somatic stem cells, the order directs HHS to support research on sources of PSCs that “take into account techniques outlined by the President’s Council on Bioethics (PCOB).” The PCOB’s 2005 White Paper considered several potential methods for deriving PSCs from embryos (See Insert). The order recognizes that “the Nation should move forward vigorously with medical research” and directs the HHS and the NIH to conduct, promote, and intensify research in the derivation of human PSCs (hPSCs) from a variety of alternate sources. Though no specific funding commitment was attached to the order, it directed HHS to issue a funding implementation plan. In summary, although the Bush Administration hasn’t abandoned its position on the inviolability of nascent human life, the policies enumerated in the executive order are based in part on the same scientific framework employed by advocates of broader stem cell research funding. The Administration may have come to the realization that for certain of the alternate sources of human PSCs supported by President Bush to be acceptable, its stem cell policy must recognize the complexities of early human life. The Administration’s willingness to recast the debate at the scientific level may, in the long run, be the most important aspect of the executive order.

Alternative Sources of PSCs

The President’s Council on Bioethics (May 2005) White Paper identified four alternate techniques for deriving PSCs: 1. Organismically Dead Embryos: by extracting cells from embryos already dead 2. Preimplantation Genetic Diagnosis: by nonharmful biopsy of living embryos 3. Altered Nuclear Transfer: by extracting cells from artificially created nonembro nic but embryo-like cellular systems (engineered to lack the essential elements of embryogenesis but still capable of some cell division and growth) 4. Somatic Stem Cells: by dedifferentiation of somatic cells back to pluripotency

Joseph R. Sollee is an attorney in the life sciences practice at Kennedy Covington. He currently serves as general counsel for Oncomethylome Sciences. Web: www. kennedycovington.com. Email: solleejr@gmail.com.