While the federal government watches from the sidelines, the states are racing to secure funding for stem cell research. Stem cell research advocates are concerned that this approach is leading to a fragmented and uncoordinated policy, limiting significant progress toward researching one of the most promising areas of medicine. Given the federal government’s lack of leadership on this critical issue, the National Academy of Sciences (NAS) recently recommended guidelines to strengthen oversight of research with human embryonic stem cells.
Stem cells are “unspecialized” cells that have the potential to develop into many different cell types in the body. Medical researchers believe stem cells can be used to generate new cells and tissues for medical therapies, possibly reversing the symptoms of many diseases and leading to cures. It is estimated that 128 million Americans have diseases or injuries that could be treated or cured with stem cell therapies. These devastating medical problems affect a child or an adult in nearly half of all families and result in hundreds of billions of dollars in health care costs annually. (To learn more about stem cells, see Orbit January 2005, “Stem Cell Research: An Overview.” The article is available online at: www.unitedspinal.org/pages. php?catid=179&submenu=252&pageid= 754&styleid=magazine).
The purpose of the NAS guidelines (issued in an April 26 report) is to establish a standard set of requirements for ethical embryonic stem cell research. NAS calls for all research institutions to establish oversight committees to ensure that the new, voluntary guidelines be followed. The oversight committees would be comprised of legal and ethics experts and public members. The report also calls for the creation of a national independent body to periodically review the guidelines and to decide if they should be updated. According to the report, the lack of oversight standards is a major reason why a centralized and federal policy is needed to govern stem cell research.
In August 2001, President Bush announced that the Administration would provide federal funds for embryonic stem cell research provided that such research is performed using only stem cell lines that already exist. In other words, no new embryonic stem cell lines can be produced or used with federal funds. This policy does not have an impact on research performed with private or even state funds. Since its announcement, most stem cell research proponents have said this policy is far too limiting and would prevent meaningful research from advancing because it was believed that only about 60 usable stem cell lines existed at that time. Now evidence exists that all of the lines eligible for federal funding are contaminated which makes them risky for use in medical therapies.
Despite the freeze on federal funding, states are rushing to make money available to meet the needs of researchers.
• California took the lead on Election Day 2004, when its voters approved Proposition 71, a bond initiative that will provide $3 billion to fund stem cell research within California over the next 10 years. The initiative, which passed by a margin of nearly 60% to 40%, is the largest state investment in basic scientific research. Spurred by California, several other states are attempting major funding initiatives, largely to prevent their biomedical research industry and researchers from moving to California and other countries where stem cell research funding is far more abundant.
• New Jersey was the first state to commit public funds to stem cell research, with an initial $9.5 million appropriation approved last year for a new stem cell institute. Acting Governor Richard Codey has also proposed a $380 million initiative for stem cell research and has suggested that New Jersey, Delaware, and Pennsylvania form a regional stem cell research partnership. • Wisconsin Governor Jim Doyle has proposed spending $750 million for biotechnology and stem cell research, including $375 million in public and private funds to build a Wisconsin Institute for Discovery.
• Illinois Comptroller Dan Hynes has proposed a 2006 ballot referendum for $1 billion in bonds over 10 years to fund stem cell research and create the Illinois Regenerative Medicine Institute. Bond debt would be paid for by a 6% tax on elective cosmetic procedures. • In New York, legislation has been introduced that would provide $300 million to fund stem cell research and create the New York Institute for Stem Cell Research and Regenerative Medicine. • Connecticut Governor Jodi Rell has said she will sign legislation to commit $100 million over the next 10 years for stem cell research, if the Connecticut State Legislature approves the bill. The race among states to fund stem cell research will undoubtedly continue and will likely result in a patchwork of individual and uncoordinated state stem cell funding initiatives and state laws unless national research oversight standards are implemented. The National Academy of Sciences recommendations are a good starting point to address this problem, however, their guidelines are voluntary. It is time for the Federal Government to step forward and establish a centralized policy to regulate stem cell research.
At the time of the writing of this article, the U.S. House of Representatives had just passed legislation that would expand President Bush’s stem cell research policy by increasing the number of stem cell lines available for research. But first, the Senate must pass the legislation and then the President must sign it into law. President Bush, however, has said he would veto the legislation. In other words, this legislation has a long way to go before becoming law.
Dan Anderson is assistant director of Legislation at United Spinal.
