Deerfield, IL, October 23, 2008 – Opponents of Michigan’s stem cell research initiative – Proposal 2 – launched an ad yesterday using the tragic and universally reprehensible Tuskegee Experiments as a basis for comparison to stem cell research. This ad is replete with myths and misinformation. The distortions about the nature and regulatory environment of stem cell research are many, and it is important to set the facts straight.
First, examine Proposal 2 itself. The proposal explicitly states that, "All stem cell research and all stem cell therapies and cures must be conducted and provided in accordance with state and local laws of general applicability, including but not limited to laws concerning scientific and medical practices and patient safety and privacy”. Thus, the proposal itself provides for state regulation of this area. Opponents of Proposal 2 appear to have intentionally ignored and under-played this fact in an attempt to scare people.
In addition to the potential for state regulation, there are also federal laws that would prevent unethical research in this potentially medically important arena.
First there is federal law that would prevent unethical stem cell experiments from being performed on human subjects. Under this law, Institutional Review Boards must approve any stem cell research involving human subjects, including clinical trials as well as the donation of embryos for the derivation of new embryonic stem cell lines. These review boards must approve patient consent documents and the research methods, to ensure that the scientific goals are ethical and beneficial.
Secondly there are Embryonic Stem Cell Research Oversight (ESCRO) Committees that have been set up under guidance from the National Academy of Sciences to oversee all aspects of embryonic stem cell research. This includes research conducted in laboratory dishes, in patients, and in animals, as well as providing an additional layer of oversight covering the derivation of new stem cell lines. ESCRO committee approval is therefore required for all experiments performed with embryonic stem cells. These oversight committees (IRB and ESCRO) are composed of scientists, physicians, ethicists, lawyers, and members of the community.
Next, the U.S. Food and Drug Administration (FDA) regulates all research done at private companies toward the development and testing of any medical product, and imposes similar regulations to ensure that such research is performed ethically.
The International Society for Stem Cell Research, an organization of the world’s leading stem cell researchers, stands firmly for the belief that the use of stem cells will transform the lives of patients and offer new treatments for diseases that are currently incurable. Opponents of Proposal 2 have tainted that vision with claims that lead people to incorrectly conclude that such research is unregulated. This is simply not correct.
“It is preposterous that opponents of Proposal 2 have tried to link stem cell research with the Tuskegee Experiments, one of the most despicable episodes in American medical history,” said Dr. George Q. Daley, ISSCR past-president and associate director of the Stem Cell Program at Children’s Hospital Boston. “The ad distorts and misleads. The people of Michigan should reject this cynical misinformation. Michigan scientists have much to offer in this important area of biomedical research, and it is a shame that they would be kept out of the game if this proposal passes.”
Proposal 2 offers other protections to ensure the ethical conduct of regulated research by putting in place numerous restrictions of its own, including the following:
- Prevent stem cells from being taken from embryos more than 14 days after cell division begins;
- Prohibit the purchase or sale of human embryos, and;
- Assurance that research conducted in Michigan follows all existing and future federal laws.
The proposal would involve only embryos that could not be used for fertility treatment, and that would otherwise be discarded if not donated for research. The embryos would also have to meet the following requirements:
- They were created for the purpose of fertility treatment;
- They were not suitable for implantation or surplus to the clinical need;
- They were donated with the informed consent of the patient;
- Planned to be discarded unless used for research.
Proposal 2 is about one thing. It is about accelerating medical research in Michigan to develop new treatments for currently incurable diseases.
“People need accurate information to make responsible decisions,” said Dr. Daley. “Voting in favor of Proposal 2 is to vote for reasonable, regulated research in hopes of curing illness and alleviating human suffering.” The ISSCR believes that research must continue with all types of stem cells.
The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.
Posted October 11, 2010