Academic journal article Issues in Law & Medicine

A Review of the National Institute of Health's "Guidelines for Research Using Human Pluripotent Stem Cells"

Academic journal article Issues in Law & Medicine

A Review of the National Institute of Health's "Guidelines for Research Using Human Pluripotent Stem Cells"

Article excerpt

The use of federal funds to support human embryonic stem cell research is illegal, unethical, and unnecessary. On behalf of Do No Harm: The Coalition of Americans for Research Ethics, the purpose of this letter is to advise the agencies reviewing NIH's "Guidelines for Research Using Human Pluripotent Stem Cells," 65 Fed. Reg. 51976 ("Guidelines"), of recent scientific developments that further demonstrate the immense potential of stem cell research that does not entail the destruction of human embryos, and of the concomitant absence of any medical need or justification for the federal funding of destructive human embryonic stem cell research.

Since February 22, 2000, the end of the comment period on the draft Guidelines, research using human stem cells not derived from human embryos has confirmed what prior evidence had long suggested: that adult stem cells (and other "post-natal" stem cells) have vast biomedical potential to cure diseases such as diabetes, Parkinson's, heart disease, and other degenerative diseases. This biomedical potential is as great as or greater than the potential offered by human embryonic stem cell research. Simply stated, adult stem cell research is a preferable alternative for progress in regenerative medicine and cell-based therapies for disease because it does not pose the medical, legal, and ethical problems associated with destructive human embryonic stem cell research.

Among the justifications stated in the Guidelines for pursuing human embryonic stem cell research was the allegedly limited potential of adult stem cells as compared to the purportedly enormous, yet speculative, potential of embryonic stem cells. In particular, NIH's response to comments urging the benefits of adult stem cell research highlighted four alleged shortcomings related to the biomedical potential of adult stem cells. 65 Fed. Reg. 51976. The agency stated that adult stem cells (1) had not been found in all cell types, (2) appear in limited numbers and can be difficult to harvest and grow in time for treatment, (3) are likely to pass on genetic defects, and (4) may not have the capacity to multiply as do "younger cells." Id. Recent scientific developments now support the contention, however, that these claims about the shortcomings of adult stem cells are not true, are not relevant to their therapeutic potential, and/or overstate the differences between adult stem cells and embryonic stem cells. Significantly, human adult stem cells can be pluripotent and have the ability to transform from one cell type into another, a fact largely unrecognized by the Guidelines. The scientific record now indicates that the supposed shortcomings NIH perceived in adult stem cell research either are illusory or can be overcome.

Moreover, an impressive volume of scientific literature attests to the fact that human adult stem cells--unlike human embryonic stem cells--are currently being used successfully in clinical trials to combat many of the very diseases that embryonic stem cells only prospectively promise to treat. Animal research strongly suggests that more therapeutic applications of adult stem cell research will follow.

Finally, the potential biomedical application of human embryonic stem cell research faces risks that are unique to embryonic stem cells, such as the tendency toward tumor formation. In addition, embryonic stem cells face the very real possibility of immune rejection, while use of a patient's own adult stem cells is free from this problem. Consequently, adult stem cells have several advantages as compared with embryonic stem cells in their practical therapeutic application for tissue regeneration.

Thus, contrary to the suggestions by supporters of destructive human embryonic stem cell research, federal funding of such research is not a necessary, or even a wise, use of limited federal research dollars. Other forms of stem cell research are more promising, are demonstrably more successful at producing beneficial treatments that are actually in use today, and do not present the significant problems and uncertainties (to say nothing of the ethical and legal problems) posed by destructive human embryonic stem cell research. …

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