To NIH: Neither Ethical, Scientific nor Currently Lawful to Expand Taxpayer Funding for Human Embryonic Stem Cell Research

Washington, DC—Along with DO NO HARM: THE COALITION OF AMERICANS FOR RESEARCH ETHICS, numerous stem cell researchers, doctors, patient and family groups and other public interest legal organizations, Advocates International, through its legal counsel, Gibson, Dunn & Crutcher, has filed extensive legal and scientific comments (the "DO NO HARM et al. Comments") urging the NATIONAL INSTITUTES OF HEALTH (NIH) not to issue as a "final rule" its proposed draft GUIDELINES FOR HUMAN STEM CELL RESEARCH issued for comment on April 23, 2009 (74 Fed. Reg. 18578) in response to President Obama’s EXECUTIVE ORDER 13505 of March 9, 2009 (74 Fed. Reg.10667). Contrary to the general guidance expressly set forth in President Obama’s Executive Order, the DO NO HARM et al. Comments demonstrate why the NIH’s proposed expansion of human embryonic stem cell (hESC) lines eligible for taxpayer funding beyond the currently eligible hESC lines are neither ethically "responsible, scientifically worthy, nor permitted by law."

Advocates International has previously expressed its dismay and astonishment when on March 9 President Obama not only ordered the NIH to consider revoking and reversing the ethical administration policy established in 2001 and begin for the first time using federal tax dollars to encourage researchers to destroy living human embryos for stem cell research in violation of existing federal law, but, without explanation, also revoked the previous administration’s Executive Order 13435 (June 20, 2007) authorizing federal funding of stem cell research that produces the same or superior pluripotent stem cells produced by living human embryos without any need to destroy such embryos.

Sam Casey, Advocates International’s General Counsel and one of the attorneys involved in the federal court litigation in 2001 that resulted in the lawful and ethical stem cell research policy President Obama has ordered NIH to review said, "President Obama’s Executive Order is legally limited and only authorizes NIH action ‘to the extent permitted by law.’ As we have thoroughly explained to the NIH in the DO NO HARM et al. Comments filed yesterday, existing law currently bans the expenditure of any federal funds for ‘the creation of a human embryo or embryos for research purposes; or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g (b))."

Casey further noted that the proposed Guidelines are not only illegal, they are "unnecessary and inappropriate due to several advances in scientific research and medical understanding, well-documented in the DO NO HARM et al. Comments, that promise to achieve each of the stated purposes for the proposed Guidelines without violating the legal, scientific and ethical boundaries implicated by the use of human embryonic stem cells."

Casey said that the NIH’s Proposed Guidelines are also "ethically offensive to everyone who understands the undisputed scientific biological fact, as recently affirmed by the Eighth Circuit Court of Appeal, that "during its embryonic age," a human embryo is ‘a whole, separate, unique, living human being, an individual living member of the species of Homo sapiens.’ " See PLANNED PARENTHOOD V. ROUNDS, 530 F.3rd 724, 735-736 (8th Cir 2008). For all who "understand this biological fact and also believe that every human being has intrinsic moral value – the NIH’s proposed Guidelines are clearly unethical," Casey added. "Encouraging the destruction one human life through human experimentation, even in order to possibly help other human beings, is always morally wrong and should not be countenanced by any government. This is particularly so in this case where it is not even necessary, the subject of the experimentation is a living human embryos cannot possibility give his or her consent to the donation of his or her stem cells and, in any event, the persons donating the embryos or benefiting from their donation who are providing or enabling the so-called informed consent have obviously disqualifying conflicts of interest and are not even required to be " fully informed" or "informing" under the proposed Guidelines. It is also ethically wrong to force taxpayers who do honor the dignity of every human being to help pay for research that they believe necessarily involves an immoral taking of innocent human life."

Advocates International agrees that the proposed NIH Guidelines are not only ethical irresponsible, they are fiscally irresponsible from the taxpayers’ point of view. Scientists have been conducting research with both adult and embryonic stem cells for years. Only research with adult stem cells has yielded any successes in the treatment of human disease. Such successes have been numerous. More than 70 diseases and conditions presently are being treated with adult stem cell therapy. Those diseases or conditions include diabetes, heart disease, cerebral palsy, renal failure, liver damage, and hepatitis. Most recently, a patient suffering from Parkinson’s disease was treated successfully with his own stem cells.

Not only has adult stem cell research progressed in recent years, so has human induced pluripotent stem cell ("iPSC") research. This iPSC research provides an ethical alternative to human embryonic stem cell research. Accordingly, even if NIH had reason to believe that research involving human embryonic stem cells would be as valuable from a scientific and medical standpoint as research involving human adult stem cells (which it does not), it would be arbitrary and capricious for NIH to fund embryonic stem cell research when it could achieve the same scientific and medical goals through research involving human induced pluripotent stem cells that does not pose the same legal.

On the other hand, research with embryonic stem cells has been plagued with problems. Specifically, tests – which to date has been limited to animals due to the inherent risks – invariably have ended in failure due to immune rejection and rapid replication of cells leading to cancerous tumors. As fully explained in the DO NO HARM et al Comments, human embryonic stem cells ("hESCs") are not needed for the basic scientific research suggested in the proposed Guidelines and will not lead to safe human therapeutics. Therefore, Advocates International believes it would arbitrary and capricious for NIH to expand taxpayer funding for human embryonic stem research beyond the hESC lines already eligible for such funding under the current NIH practice established in 2001. Advocates International is an international organization of attorneys in over 150 nations, including the United States, who seek to do justice with compassion, including through its Global Task Force on the Law of Life protecting the inalienable and sacred right to human life from biological conception to natural death.