On August 24, 2012, a three-judge panel ruled that the government had properly interpreted a law that bans the use of federal funds research that destroys human embryos. Many legal observers, however, opined that this ruling will not end the controversy over this issue, and one of the judges on the three-judge panel importuned Congress to clarify what the government could and could not do with respect to human embryos.
This ruling upholds the dismissal of the case by the US Court of Appeals for the District of Columbia Circuit. The case, Sherley v. Sebellius, 11-5241, sought to prevent the US Department of Health and Human Services from using federal money to fund human embryonic stem cell research. The plaintiffs contended that funding human embryonic stem cell research would violate the Dickey-Wicker Amendment, which was passed as a rider to other legislation in 1996.
Predictably, biotechnology companies interested in embryonic stem cell-based treatments and other more academic embryonic stem cell researchers were quite pleased with the ruling. For example, Gary Rabin of Advanced Cell Technology said: “This court ruling should be of considerable benefit to our embryonic stem cell-based clinical programs. It effectively removes major speed bumps for the National Institutes of Health in terms of approving the several stem cells lines that we have submitted for their consideration for funding. We expect that a number of our embryonic stem cell lines will be approved for funding in coming months.”
The plaintiffs in this case were: a) James L. Sherley, who is a former a former member of the MIT faculty, but presently works as a senior scientist at the Boston Biomedical Research Institute; b) Theresa Deisher, who is the founder, managing member, and research and development director of AVM Biotechnology; and Nightlight Christian Adoptions, which is a non-profit, licensed adoption agency dedicated to protecting and finding adoptive parents for human embryos conceived through in vitro fertilization; c) the Christian Medical Association, a non-profit association of doctors dedicated to improving ethical standards of health care in the United States and abroad.
The main argument put forward by the plaintiffs in this lawsuit is that the present NIH Guidelines for the funding of embryonic stem cell projects violate existing federal law that bans the use of federal funds for the destruction of human embryos. Because the NIH created and sent its guidelines with a preconceived determination to fund human embryonic stem cell research and without considering scientifically and ethically superior alternatives, the guidelines are invalid regulations that violate the federal Administrative Procedure Act and, therefore, should be struck down.
With respect to the merits of the plaintiff’s case, it seems rather obvious, to me at least, that the NIH guidelines violate federal law. The Dickey-Wicker amendment was sponsored by former Congressman Jay Dickey (RAK) and Senator Roger Wicker (R-MS) who was then a member of the House of Representatives)], and applied to every Health and Human Services (“HHS”) appropriations bill governing the National Institutes of Health (NIH) since 1995. The bill states, “None of the funds made available by this Act may be used for . . . 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 C.F.R. § 46.204(b) and section 498(b) of the Public Health Service Act (42 U.S.C. § 289g(b).” Even for lawyer-speak, that seems pretty clear to me. Embryonic stem cell research includes the derivation of new embryonic stem cell lines from human embryos. The derivation process destroys the embryo, which is precisely the thing that the Dickey-Wicker amendment prohibits the NIH from funding with federal money.
However, the federal judges did not see it that way for one reason: funding for embryonic stem cell research also includes work on already established embryonic stem cell lines. These lines are already in existence that the decision to kill the embryos has already occurred. Therefore, the judges thought that the Dickey-Wicker amendment was simply not specific enough on the matter to merit stopping all funding for embryonic stem cell work.
While this argument has merit, it dodges the fact that embryo-destroying research will be funded by the NIH because of this ruling and some of this research will include laboratories that destroy embryos to make embryonic stem cells. This is clear, since several sources have noted the increase in embryonic stem cell lines approved for NIH funding. For example the Nature Medicine blog had this to say: “Since the beginning of the month, the NIH has quietly kept adding ES cell lines to its registry, bringing the total tally up to 128.” Thus the NIH funding policy has definitely led to the destruction of more embryos.
Where did this legal battle originate? It began in 1994, during the presidency of Bill Clinton. Before 1994, there was a ban on human embryo experimentation. The Clinton Administration took steps to reverse this ban, and allow embryo-destructive research on donated embryos left over from fertility clinics while still prohibiting research that created its own embryos for research purposes.; This policy shift was in response to the recommendation of an advisory committee known as the Human Embryo Research Panel (“HERP”). This was an ad hoc committee formed to address the question of embryo research. The phrase “ad hoc” is a Latin phae that means “for this.” It simply means that this committee was formed for to address this particular question. In testimony before the House Appropriations Committee, NIH Director Varmus stated that NIH would have funded six out of nine applications for grants involving embryo-related research “if the NIH had been able to proceed according to the recommendations and the President’s directive.” Varmus also stated that he “firmly agree[d]” with particular sections of the HERP report, and further told the Committee that NIH was currently deciding whether to go forward with funding embryo-destructive research on donated human embryos.
However, before NIH was able to approve any grants that funded embryo-destructive research, Congress passed the Dickey-Wicker Amendment for the first time. Opponents of the amendment argued that prohibiting federal funding of embryos research would push such research into the dark recesses of private industry where it would not be properly regulated. Also, the understanding of the amendment was universal throughout Congress: it would prohibit ALL federal funding of embryo-destructive research. Democratic senator from California, Barbara Boxer, understood the Dickey-Wicker Amendment as creating “a total prohibition of Federal funding for human embryo research,” and Republican Congressman John Porter understood the amendment in this way as well. In fact Porter tried to pass an alternative rider to the Dickey-Wicker Amendment that would have prohibited federal funding for only creation of new embryos, but not other types of embryo-destructive research with donated embryos, but his rider was defeated.
Even more significantly, the NIH understood the amendment that way from 1996-1999 when they enforced it. DNA research with DNA from human embryos that did not necessarily kill the embryos was prohibited from receiving federal funding under the NIH’s understanding of the Dickey-Wicker Amendment. In a 1996 letter (October 10) to Georgetown University Medical School researcher Mark Hughes who was using federally funded equipment to conduct tests on DNA derived from embryos, NIH “clarif[ied] . . .the NIH position on embryo research.” The agency explained that “analysis from DNA derived from a human embryo” violated the federal prohibition on research involving embryos and that NIH equipment “may not be used for embryo work of any kind.”
However, four years later, the NIH altered its position and issue Guidelines authorizing the funding of human embryonic stem cell research (65 Fed. Reg. 51976, Aug. 25, 2000). Before the 2000 Guidelines were published, then-HHS General Counsel Harriet S. Rabb issued a memorandum on January 15, 1999, that supported the National Institutes of Health (NIH) claim that the Dickey-Wicker Amendment ought to be re-interpreted to ban federal funding of the derivation of embryonic stem cells – the procedure by which human embryos are destroyed to harvest their embryonic stem cells – but not research utilizing the derived embryonic stem cells. This is in direct contradiction to the clear understanding of the Dickey-Wicker amendment put forward by Congress.
To remedy this reinterpretation of the Dickey-Wicker Amendment (DWA), seven senators sent a letter to then Secretary of Human Health and Services, Donna Shalala. In that letter they stated that “Congress never intended for the National Institutes of Health to give incentives for the killing of human embryos for the purpose of stem cell research.” The warnings of the senators and the comments from many dissenting parties were ignored by the NIH.
When President Bush took office, he rescinded the Clinton rules and upheld the original interpretation of the DWA. This ended when Barak Obama became president in 2008. President Obama revoked President Bush’s Executive Order 13435 (June 22, 2007) and ordered NIH “support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.”
This was the reason for the lawsuit filed by Sherley and his co-plaintiffs. They wanted the Federal government to simply recognize the law as it was originally written and interpreted. Unfortunately, the judges ignored all that and went with their own shtick. This is sad, and it should be remedied, but for now the situation seems to be that Congress’ laws do not mean what they originally say.