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.