Testifying at a hearing before the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee on March 19, Elias Zerhouni, the Director of the National Institutes of Health (NIH), stated that our nation would be better served if federally-funded scientists had access to new embryonic stem cell lines for research. Separating himself from the Bush Administration’s position on this issue, Zerhouni testified:
“It’s not possible for me to see how we can continue the momentum of science and research with the stem cell lines we have at NIH that can be funded…. [F]rom my standpoint as NIH director, it is in the best interest of our scientists, our science, and our country that we find ways and the nation finds a way to go full-speed across adult and embryonic stem cells equally.” (Testimony before the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee, March 19, 2007).
As Dr. Zerhouni asserts, the great promise of human embryonic stem cell research is being impeded by President Bush’s stem cell policy. Under this policy, federal research funds can be used on only a small number of existing embryonic stem cell lines, a restriction that excludes newer and more promising stem cell lines. These limitations are slowing research progress and establishing major roadblocks on the path to developing therapies.
Embryonic stem cell research is about curing diseases and saving lives. The isolation of human embryonic stem cells in 1998 was a major breakthrough in biology and opened a new frontier in medical research. These cells have the unique ability to develop into virtually every cell and tissue in the body. Harnessing this ability could enable researchers to one day cure disease and save lives. Millions of people with debilitating diseases and disabilities could one day benefit from embryonic stem-cell therapy. The possibilities of this research are giving hope to those with Parkinson’s disease, diabetes, spinal cord injuries, autoimmune diseases, osteoporosis, cardiovascular disease, and cancer.
President Bush’s current stem cell policy is impeding embryonic stem cell research and the search for cures. Under the President’s stem cell policy, federal funds cannot be used to support research on embryonic stem cell lines derived after August 9, 2001. Fewer stem cell lines meet this criterion than the Bush Administration once claimed, and this arbitrary cut-off date excludes newer and more promising stem cell lines from federal research funds. Moreover, the President’s policy creates tremendous financial and administrative burdens on research institutions, including universities across the country, that receive federal funding and wish to pursue research on the newer stem cell lines.
- While the Bush Administration once said that 78 embryonic stem cell lines would be eligible for federally funded research, the actual number now available to scientists is only 21, and scientists say an even smaller number of those stem cell lines are actually useful.
- According to top scientists at the NIH, scientists have had difficulty gaining access to the eligible stem cell lines, the limited number of eligible stem cell lines has hindered progress, and additional stem cells lines would help expedite research. (Washington Post, April 7, 2005; and statements to the Senate Appropriations Labor-HHS-Education Subcommittee, January 19, 2007)
- All of the stem cell lines that meet the President’s criteria were cultured in animal feeder cells, which have contaminated them and could make them unsuitable for use in human therapies. (Associated Press, January 23, 2005) Scientists are now developing ways to grow embryonic stem cell lines without animal feeder cells, but these new stem cell lines are not eligible for federally funded research.
- Scientists have learned that embryonic stem cells lines accumulate unwanted mutations over time. Yet only older stem cell lines, which are more prone to mutations, are eligible for federally funded research under the President’s policy. (Washington Post, September 5, 2005)
- The genetic diversity of the 21 stem cell lines eligible for federally funded research is limited, which could limit the people who could benefit from therapies developed from these stem cell lines. (Ruth Faden and John Gearhart, Johns Hopkins University, Washington Post, August 23, 2004)
- The Bush Administration’s policy forces states and research institutions that want to use the newer, better stem cell lines to waste valuable time and resources on duplicative infrastructure and equipment, as well as training, so as to avoid running afoul of the Bush Administration’s prohibition on using federally funded buildings and equipment to conduct research on ineligible stem cell lines. Research has shown that 86 percent of state funding for stem cell research has gone to building infrastructure, purchasing equipment, and training scientists – not to actual research. (Center for American Progress, October 23, 2006)
The Bush Administration’s misguided policy hurts our nation’s competitiveness and hinders research efforts. Many countries have fewer restrictions on embryonic stem cell research than the United States. We cannot compete globally without the full support of the federal government, which is the primary source of funds for basic biomedical research. Other sources of funding, such as private and state-based funding, are beneficial, but they cannot compensate for the current limits on federally funded research.
Moreover, the Administration’s restrictive policy hinders international research by making it harder for U.S. and foreign scientists to collaborate. While the United States has traditionally been an important research hub, the federal stem cell policy makes it difficult for the United States to work with other countries, where scientists are using newer lines that are ineligible for federal funding. The federal government should be supporting and encouraging our scientists, not tying their hands behind their backs
- In his recent testimony before the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee, Dr. Zerhouni asserted, “It is important that the NIH lead this [embryonic stem cell] research effort, because no other entity in the world has the same scientific prowess and because it has a strong track record of implementing safeguards in areas of breakthrough research….” (CQ, March 19, 2007)
- A Stanford University study published in the April 2006 issue of Nature Biotechnology found that human embryonic stem cell research has been accelerating at a faster pace internationally. The study found that in 2002, roughly one-third of the published articles involving human embryonic stem cell research were from U.S. research groups. By 2004, U.S. groups accounted for only one-quarter of the publications.
- In a July 13, 2006 letter to Senator Harkin, Dr. James F. Battey, Jr., Chair of the NIH Stem Cell Task Force, asserted, “The more cell lines available for study, the more likely a cell line will be maximally useful for a given research, and potentially clinical, application. For this reason, the scientific community would best be served by having a greater number of [human embryonic stem cell] lines available for study.”
The United States should pursue both embryonic and adult stem cell research. Most scientists strongly disagree with the claims of the White House and some Republican Senators that adult stem cell research is more promising than embryonic stem cell research. Adult stem cells do not have the intrinsic ability to generate all other types of tissue and have been found in only a few tissues. While adult stem cells are used in some treatments, primarily with blood diseases, it’s important to note that this research has had about a 30-year head start on embryonic stem cell research. (Human embryonic stem cell lines were first derived in 1998, and the first federal grant was not awarded until 2002.) Most scientists, including the directors of the NIH, believe research on both embryonic and adult stem cells is needed.
- A recent article in the journal Science exposed false statements made by one prominent opponent of embryonic stem cell research, Dr. David Prentice. The article examined claims made by Prentice and others that adult stem cells provide treatments for 65 human illnesses and found that only nine conditions on Prentice’s list had actually been approved by the FDA. The authors concluded: “By promoting the falsehood that adult stem cell treatments are already in general use for 65 diseases and injuries, Prentice and those who repeat his claims mislead laypeople and cruelly deceive patients.” (Science, July 13, 2006)
- Testifying before a joint hearing of the Senate Health, Education, Labor and Pensions Committee and the Senate Appropriations Labor-HHS-Education Subcommittee, George Daley, a stem cell researcher from Harvard University who testified on behalf of the American Society for Cell Biology stated, “I believe there are no credible scientific studies which say that we should be studying adult stem cells at the exclusion of embryonic stem cells.” (CQ, January 19, 2007)
Research involving alternative methods for deriving stem cells is not a substitute for embryonic stem cell research. Some suggest that no change in the President’s policy is needed because scientists will eventually discover ways to obtain embryonic stem cells without destroying an embryo. While the development of alternative sources of stem cells would be welcome, this area of research is only in its earliest stages and is fraught with uncertainty. None of the so-called alternative methods has succeeded in producing a pluripotent line of human stem cells, and there is no guarantee that any of them will ever work. Meanwhile, the current method for deriving stem cells – using embryos that otherwise would have been discarded as medical waste – has produced an estimated 400 stem cell lines worldwide, most of which are off-limits to federally funded scientists. The possibility that science may one day discover alternative sources of pluripotent stem cells should not be used as a justification for continuing the President’s restrictive stem cell policy.
- Prominent scientists Paul Berg of Stanford, George Daley of Harvard, and Lawrence Goldstein of the University of California at San Diego have written that proposed alternative approaches for obtaining stem cells “are unproven” and that some “are ethically questionable” and urged Congress to focus instead on changing the President’s current restrictions on federally-funded stem cell research. These scientists assert, “We want to be very clear: The most successful demonstrated method for creating the most versatile type of stem cells capable of becoming many types of mature human cell is to derive them from human embryos.” (Washington Post, July 19, 2005)
- In response to the Bush Administration’s claim that research on newly discovered amniotic stem cells is a viable substitute for research using embryonic stem cells, Dr. Anthony Atala, author of the study cited by the Administration as an example, stated, “I understand that some may be interpreting my research as a substitute for the need to pursue other forms of regenerative medicine therapies, such as those involving embryonic stem cells. I disagree with that assertion… It is essential that the National Institute of Health-funded researchers are able to fully pursue embryonic stem cell research as a complement to research into other forms of stem cells.” (Letter from Dr. Atala to Congresswoman Diana DeGette and Congressman Mike Castle, January 10, 2007)
- In his March 19testimony before the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee, Dr. Zerhouni asserted, “The presentations about adult stem cells having as much or more potential than embryonic stem cells, in my view, do not hold scientific water… I think they are overstated. I think we do not know at this point where the breakthroughs will come from… My point of view is that all angles in stem cell research should be pursued.”
Legislation would provide federal support for research on stem cell lines derived from frozen embryos in fertility clinics that would otherwise be discarded. Earlier this year, the House passed H.R.3, legislation that would expand the number of embryonic stem cell lines eligible for federally funded research. The Senate has introduced identical legislation, S.5, and is expected to consider this issue in the coming weeks. Like H.R.3, S.5 would permit federally funded research only on stem cell lines from embryos that would otherwise have been discarded. The legislation recognizes that in vitro fertilization typically produces more embryos than are needed, that only a very small fraction of frozen embryos have been donated to other infertile couples, and that the overwhelming majority of the approximately 400,000 frozen embryos in fertility clinics will remain frozen or will eventually be destroyed. S.5 specifies that stem cell lines derived from these frozen embryos in fertility clinics would only be eligible for federal research funds if the embryos would never be implanted in a woman and would otherwise be discarded.
Democrats will continue to fight to expand federally-funded embryonic stem cell research. In the 109th Congress, legislation to expand federally funded embryonic stem cell research was approved by bipartisan majorities in both the House and the Senate, with nearly universal support from Democrats and the support of members on both sides of the abortion debate. Despite support for the legislation by the overwhelming majority of Americans, as well as major medical and scientific associations, research universities and institutions, and dozens of patient advocacy organizations, President Bush vetoed the legislation �’ and he threatens to do so again if the 110th Congress passes similar legislation. If enacted, S.5 would advance federally funded research on embryonic stem cells, which have the unique ability to develop into virtually every cell and tissue in the body. Harnessing this ability could one day enable researchers to grow customized cells and tissue that could repair damaged or diseased organs. For the millions of Americans who suffer from diseases or conditions that could be treated with stem cell research, the status quo is unacceptable.