NIH Issues Guidelines Restricting Embryonic Stem Cell Research

United Press International, April 17, 2009

In response to President Obama's March 9th Executive Order, the U.S. National Institutes of Health (NIH) have issued the first draft of a set of guidelines suggesting how federal funds should, and should not, be used for human embryonic stem cell research. The scientific, medical and religious communities have eagerly awaited the release of these guidelines, which have been highly anticipated, and debated, by all.

Specifically, the guidelines state that federal funds may now be used for research conducted on any human embryo that is "stored" at an IVF clinic and which is considered to be "spare", "left-over", or "orphaned", after having been originally created at an IVF (in vitro fertilization) clinic for reproductive purposes. In other words, researchers may now apply for NIH grants to pay for such research - NIH grants being one of the primary, though certainly not the only, source of biomedical research funding throughout the United States. Nevertheless, contrary to public misconception, the NIH guidelines still prohibit the use of federal funds for research conducted on human embryonic stem cells derived from human embryos that were created by other means and for other objectives, such as, for example, somatic cell nuclear transfer, parthenogenesis, therapeutic cloning, and in vitro fertilization specifically designated for research or experimental, not reproductive, purposes.

It has been estimated that approximately 500,000 human embryos are currently frozen in a state of perpetual "limbo" in freezers at IVF clinics throughout the U.S., and many people, including the legal parents of these frozen "orphaned" embryos, are wondering what should be done about the situation. If any of the embryos were to be implanted into the uterus of an adult human female, many of the embryos would develop into a normal fetus and would ultimately be born as a human child, although some percentage of the embryos would either fail to implant properly or would fail to develop normally and would therefore not result in a healthy birth. When a woman solicits the services of an IVF clinic, usually for reasons pertaining to infertility, in order to be implanted with an embryo that was created through in vitro fertilization, it is standard procedure for the doctors of the IVF clinics to create multiple embryos with the IVF technique, precisely because of the fact that not every embryo will successfully implant and develop into a normal, healthy birth. The consequence of this routine, unquestioned practice is the creation of an unseen population of approximately half a million human embryos that nobody wants and which are destined either to be frozen indefinitely, discarded as biological trash, or now, as a result of the new NIH guidelines, deliberately destroyed in the process of embryonic stem cell research. The ethical can of worms that has been unleashed merely by the fact that these "orphan", frozen human embryos exist, is beyond the scope of this news article to address, and possibly even beyond the scope of NIH to address. However, certainly one of the topics which NIH has yet to define precisely are the legal terms and conditions of the consent forms that parents of these frozen embryos must sign before their embryonic offspring can be officially designated for laboratory research and destruction.

Regardless of the specific legalities, embryonic stem cell scientists will now be allowed to receive federal funding (i.e., from NIH) for research which they may now perform on any of these "orphan" human embryos that are available from IVF clinics, all of which were originally created for reproductive purposes in the hopes of creating a human child, but which are "no longer needed for that purpose," according to NIH acting director Dr. Raynard Kington. Although there are approximatley half a million orphaned human embryos frozen in IVF clinics across the U.S., it has been estimated that only approximately 700 new stem cell lines from those embryos would now be available for human embryonic stem cell research. Certainly 700 represents a significant increase from the number of human embryonic stem cell lines that were initially available in 2001 for federally funded research under the Bush administration, which originally had been estimated in the 60s but later proved to be numbered in the 20s. It is a common misperception, however, that President Obama has made broad, sweeping changes that will suddenly allow for any type of human embryonic stem cell research, as this is not the case, or at least not yet. The creation of human embryos specifically for research, not reproductive, purposes, is precisely what embryonic stem cell scientists covet the most, yet the federal funding of this type of research still remains illegal under the Obama administration, at least so far. Many proponents of adult stem cell research fear, however, that even this policy may, in time, change.

The new NIH guidelines allow for federal funding to be used for the very thing that is banned by the Dickey-Wicker Amendment, namely, research in which the health or life of a human embryo is threatened or destroyed. Although many people expect the Dickey-Wicker Amendment to be formally overturned at some time during the Obama administration, these NIH guidelines represent a concrete and immediate step in that direction. If Congress does, in fact, rescind the Dickey-Wicker Amendment, then the legalization of therapeutic cloning and other scientifically dangerous as well as ethically controversial procedures are seen as the logical next step. According to bioethicist Wesley Smith, "The political campaign has begun to destroy the Dickey Amendment. Should that happen, it would be legal for the Feds to fund human cloning, the making of embryos for research, and just about anything 'the scientists' wanted to do in this regard. Once that happens, the NIH would likely revise these guidelines to permit funding for those activities... Expect the struggle over Dickey to erupt within the next few years during the annual budgetary process. And if a bill passes sans the Amendment, there is no question in my mind that Obama would sign it."

President Obama's March 9th Executive Order directed NIH to submit guidelines addressing both the scientific and the ethical concerns of human embryonic stem cell research, within 120 days of that Executive Order, and NIH has issued this eagerly-awaited first draft in slightly over a month. According to NIH acting director Dr. Kington, "We considered the range of ethical issues and we believe this policy will allow the substantial research that is ethically responsible and scientifically worthy. We believe this is our best judgment now about a reasonable policy at this time."

Apparently, a number of people disagree with Dr. Kington, such as, for example, Tony Perkins, president of the Family Research Council, who states, "The NIH draft guidelines demanded by the President will do nothing to advance stem cell research that is showing near-term benefit for suffering patients. Instead of funding more embryo destructive research, the government should fund research using adult stem cells that are on the cutting edge of treating patients for diabetes, spinal cord injury, heart disease and various cancers. Unfortunately, this draft guidance only diverts limited federal resources to unethical stem cell research that has not successfully treated a single person for any disease."

Although embryonic stem cell proponents like to think that Obama's policy on expanding embryonic stem cell research is a sign of "progress", already Obama's embryonic stem cell policy would appear to be outdated. It was nearly two years ago, on September 21st of 2007, that Dr. James Thomson was quoted in the Boston Globe as stating, "The world has changed. Over time, these [iPS] cells will be used in more and more labs. And human embryo stem cell research will be abandoned by more and more labs." Dr. Thomson, of course, was the first person ever to isolate an embryonic stem cell in the laboratory, first in 1995 from a nonhuman primate and then in 1998 from a human. The entire field of embryonic stem cell research exists, therefore, purely as a result of Dr. Thomson's achievements, and his name is revered in stem cell laboratories throughout the world. If anyone would understand the future direction of embryonic stem cell research, it would be Dr. Thomson. By sharp contrast to embryonic stem cells, the recently developed iPS (induced pluripotent stem) cells hold much greater research and clinical potential than do embryonic stem cells. Furthermore, since iPS cells can be created without involving an embryo at all, let alone destroying an embryo, iPS cells do not involve any of the ethical dilemmas that are inextricably entangled in embryonic stem cell research. Additionally, Dr. Ian Wilmut, who created the world's first cloned mammal, Dolly the sheep, was quoted in Time magazine in December of 2007 as stating, "Changing cells from a patient directly into stem cells has got so much more potential", once again referring to the advantages of iPS cells when compared to embryonic stem cells. Along those same lines, Dr. Shinya Yamanaka, who first developed iPS cells, was quoted in the December 11th, 2007 issue of the New York Times as stating, "We can't keep destroying embryos for our research. There must be another way." Apparently, neither President Obama nor the distinguished scientists at NIH have sought the advice of any of the world's foremost leading authorities on embryonic stem cell research, cloning, nor iPS cells.

As stated on the website of the NIH, "The purpose of these draft Guidelines is to implement Executive Order 13505 on March 9, 2009, as it pertains to extramural NIH-funded research, to establish policy and procedures under which NIH will fund research in this area, and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH research involving human stem cells." This first set of guidelines by NIH is only a draft, which will be published next week in the Federal Register where public comments from the general population will be accepted for the next 30 days. As also stated on the NIH website, "The National Institutes of Health (NIH) is requesting public comment on draft guidelines entitled 'National Institutes of Health Guidelines for Human Stem Cell Research' (Guidelines)." Apparently, members of NIH believe that it is possible for scientific and bioethical matters to be decided democratically, by majority opinion. Based upon the input of these public opinions, NIH is then expected to issue a final set of guidelines by early July.

(Please see the related news articles on this website, entitled, "Former Director of NIH Explains Why Embryonic Stem Cells are Obsolete", dated March 4, 2009; "Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect", dated March 9, 2009; "Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research", dated March 10, 2009; "Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research", dated March 11, 2009; "A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama's Policy", dated March 13, 2009; and "Members of The President's Council on Bioethics Object to Obama's Stem Cell Policy", dated March 26, 2009).