NIH Guidelines Promote
Destruction of Life

By Richard M. Doerflinger

Waiting until Congress had left town for the year, the National Institutes of Health (NIH) on December 1 issued long-awaited draft guidelines for so-called stem cell research that depends on the killing of human embryos.

Just two days before, President Clinton had signed a final budget bill for fiscal year 2000 that prohibits federal funding of "research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death." Such protective language has been in effect since 1996, despite the Clinton Administration's vocal opposition.

In a breathtaking act of political cynicism, that Administration has now issued guidelines filled with detailed instructions on how researchers can evade the law President Clinton just renewed!

The NIH guidelines authorize federal grants for researchers who want to kill human embryos to obtain their "pluripotent stem cells." These are very versatile and unspecialized cells that may someday be used for transplants to generate all the different kinds of cells and tissues in the human body. Until now, however, Congress's refusal to fund destructive embryo research has prevented the NIH from supporting and directing experiments which use stem cells obtained by killing embryos.

The new NIH guidelines claim to advance such research without violating federal law, by requiring that private funds are used for the actual "derivation" of stem cells (that is, the specific act of destroying human embryos). Federal funds can then be used for all other aspects of a research project which relies on the killing of human embryos for its very existence.

But, as pro-life critics such as Congressman Chris Smith (R-NJ) immediately pointed out, "these proposed Clinton guidelines are a sham." Current law does not simply ban funding for the act of embryo destruction - - it bans funding for any part of "research in which" human embryos are destroyed.

The real problem is that the authors of these guidelines have a very different view of human embryos themselves than Congress has. For example, in telling researchers how to obtain so-called "spare" embryos from in vitro fertilization clinics, the NIH guidelines require that the embryos' parents be told "that early human embryos donated will not be transferred to a woman's uterus, will not survive the human pluripotent stem cell derivation process, and will be handled respectfully, as is appropriate for all human tissue used in research" (emphasis added). Surely, insisting that an embryo be dissected alive and not given any chance to live is an odd way to show "respect"! In fact the NIH guidelines openly describe these embryos as just another form of "human tissue."

This is no isolated slip. In explaining the alleged benefits of stem cell research that requires the destruction of human embryos, the guidelines declare that these cells can be used to test drugs for "safety and potential efficacy" so that fewer " laboratory animals" will be needed for testing. According to these guidelines, a live human embryo is literally just a blob of tissue, ranking lower in status than a laboratory rat.

This approach is impossible to reconcile with federal regulations protecting unborn children in the womb. Since 1975 these regulations have treated embryos at this same stage of development as "human subjects" to be protected from harmful experiments.

The Clinton/Gore Administration has repeatedly argued that funding research on embryonic stem cells is not the same as funding "embryo research," because stem cells are not embryos but only a kind of human tissue. Now the NIH guidelines describe the embryos themselves as nothing but "tissue"! Thus a central distinction used to justify the NIH's legal approach self- destructs. Clearly, the Clinton/Gore Administration simply opposes current laws protecting human embryos, and will use any ploy it can think of to evade them.

Further ironies and contradictions abound in these guidelines. For example, to show that only "spare" embryos will be destroyed in this program, the NIH says that no federal funding will be allowed for "research in which" stem cells are taken from embryos specially created solely for research purposes. But in order to evade current law against funding "research in which" embryos are destroyed, the NIH guidelines define this phrase so narrowly as to make it meaningless.

In other words, unless it wants to give the phrase "research in which" completely different meanings in different sections of the same guidelines, the NIH will have to allow funding for research in which embryos are specially created solely in order to be killed (so long as private funds are used for the specific acts of creating and destroying them).

Other sections of the guidelines nonetheless insist that the NIH does want researchers to use only "spare" embryos - - that is, embryos that were created by in vitro fertilization clinics for reproductive purposes but are now "in excess of clinical need." The argument here is that the parents would probably want to discard these embryos anyway, so the government is not doing extra harm by helping to destroy them for research.

But this is exactly the argument that Congress has rejected in the case of embryos in the womb. Since 1985, Congress has required that the unborn child slated for abortion be given the same protection in federally funded research as the child intended for live birth.

Parents seeking abortions may think their unborn children are "in excess of clinical need," but this has not given any new mandate to our government to ratify and support the killing - - until now.

How can the NIH involve our federal government so intimately in setting standards for destructive embryo research while claiming that it is not funding such research? This is done by what NIH officials call a "reach-back mechanism."

Since under the guidelines NIH will not directly fund the process of obtaining and destroying human embryos, it would ordinarily have no authority to regulate how such privately funded activities are performed. But it sets forth detailed requirements that researchers "should have" fulfilled if they want a federal grant for research on the resulting stem cells.

Thus the process for obtaining informed consent from the doomed embryos' parents "should have" included "a statement that the early human embryos will be used to derive human pluripotent stem cells for research, that the human pluripotent stem cells will be derived and used following these NIH guidelines, and that the cells may be used, at some future time, for human transplantation research" (emphasis added).

So the NIH guidelines' effort to "comply" with current law amounts to this: NIH will not give federal funds to "derive" these cells (that is, to destroy embryos) - - but a researcher who "derives" them in certain ways specified by NIH will receive a reward of federal funds for doing so!

The Clinton/Gore Administration's supposed guidelines on "stem cell research" devote little attention to standards for stem cell research. In fact they chiefly deal with how to obtain and destroy embryos in order to be eligible for grants in stem cell research!

The only good thing one can say about these guidelines is that they are not final. The draft guidelines are open to 60 days of public comment before the NIH can prepare final guidelines, and begin dispensing our tax dollars to researchers who will kill human embryos for research purposes.

A massive outpouring of protest now may slow down the process, and give Congress the courage it needs to stand up for human life and for the rule of law. (See "Letters Needed,"below.)

Mr. Doerflinger is associate director for policy development at the Secretariat for Pro-Life Activities, National Conference of Catholic Bishops.



Clinton-Gore Administration Proposes Federal
Sponsorship of Experiments That Kill Human Embryos

Under guidelines proposed by the National Institutes of Health (NIH), "For the first time, human embryos would be deliberately killed under the sponsorship of the federal government," said NRLC Legislative Director Douglas Johnson.

"This proposal would result in federal sponsorship and funding of experiments in which living human embryos are dissected and killed--a clear violation of federal law and of ethical standards governing non-consenting human subjects," said Johnson.

On December 1, the NIH posted on its website proposed "guidelines" for funding embryo-destructive research involving human stem cells, which were formally published in the December 2 edition of the Federal Register. The proposal will be open to public comment through January 31. (See www.nih.gov/news/stemcell/draftguidelines.htm.)

Many medical researchers utilize stem cells taken from adults or umbilical cords, to which there is no pro-life objection or legal barrier. "We strongly encourage federal funding of research on stem cells obtained in ways that do not kill living members of the human family," Johnson said. However, NIH guidelines concern the very different question of research using stem cells from human embryos. Human embryos are killed by the act of removing the stem cells.

Since 1996, federal law (the "Dickey-Wicker Amendment," extended through FY 2000 by Public Law 106-113) has prohibited federal funding of any "research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death . . . "

Yet, under the NIH proposal, a researcher would seek and receive from NIH advance approval for an experiment in which the researcher specifically says that he will obtain and kill living human embryos. Indeed, the NIH proposal specifically requires parents to be informed that the embryos "will not survive the human pluripotent stem cell derivation process." (See "informed consent" requirement vii.) After receiving NIH approval and funds, the researcher then will make arrangements with an infertility clinic to obtain living human embryos--pursuant to detailed federally dictated guidelines. The federally funded researcher then will kill the embryos, harvest the stem cells, and proceed with the rest of the federally sponsored experiment.

"Everything that precedes and follows the killing of the embryos is federally approved and federally funded, and it is a transparent and shameful pretense for the Administration to claim that the killing itself is not federally sponsored," said Johnson.

NIH's proposal reflects an earlier political decision by the Clinton-Gore Administration to evade the prohibition on federal sponsorship of experimentation harmful to human embryos. NIH is proceeding under cover of a "legal opinion" issued in January, 1999, by Harriet S. Rabb, general counsel of the Department of Health and Human Services (DHHS), based on work done by her deputy, Marcy Wilder-- whose immediate previous position was as legal director of the National Abortion and Reproductive Rights Action League (NARAL). The Rabb-Wilder memo says that federal funds can be used for experiments using embryonic stem cells because those cells are not themselves a "human embryo" protected by the Dickey-Wicker law. This red-herring analysis evaded the undisputed fact that an embryo is killed by the very act of removing the stem cells, and that a research protocol that requires the killing of embryos clearly falls under the law's prohibition on funding of "research in which" embryos are harmed.

For information on medical advances in stem cell research that does not require the killing of human embryos, see www.nccbuscc.org/prolife/issues/bioethic/index.htm. For further commentary on the Administration's ongoing effort to evade the law prohibiting federal funding of embryo-destructive research, see http://nrlc.org/news/1999/NRL699/doer.html and http://nrlc.org/news/1999/NRL899/doer.html.



LETTERS NEEDED

The draft guidelines can be found on the National Institutes of Health web site: www.nih.gov/news/stemcell/ draftguidelines.htm.

They are also printed in the December 2 issue of the Federal Register, which has an online version: www.nara.gov/fedreg/.

Public comments can be mailed, faxed, or e-mailed by January 31 to "Stem Cell Guidelines" at the National Institutes of Health:

Stem Cell Guidelines

NIH Office of Science Policy

1 Center Drive

Building 1, Room 218

Bethesda, MD 20892

Fax: (301) 402-0280 E-mail: stemcell@ mail.nih.gov

Any comments should also be shared with our elected representatives in the House and Senate, with a cover note urging them to rescind the NIH guidelines on embryonic stem cell research and end this mockery of life and law. Remember the deadline is Jan. 31.