CMDA's The Point

Real Regulation of Human Embryo Experiments

July 8, 2021
Oil Bubbles July 31, 2018

by David Prentice, PhD

As we expected, the International Society for Stem Cell Research (ISSCR) issued its revised guidelines on stem cells and embryo experiments at the end of May 2021, and as expected, the ISSCR recommendations are rife with proposed experiments on young human beings.  The new guidelines discard the 14-day limit on human embryo experiments in favor of no limits whatsoever, and they allow virtually unrestricted manufacture of human-animal chimeras of any type, as well as creation of genetically altered human embryos and lab constructed human embryo “models.” Very little is left in the category of “currently not permitted.”

The ISSCR overreach is telling when bioethicists with widely-divergent views on embryo research ethics label the new recommendation for no limits a “grave omission,” and when well-known supporters of human-embryo research say they are “troubled by the recommendations,” especially removal of the 14-day limit. The ISSCR’s self-serving guidelines even reminded a senior scientist of a letter written long ago, with currently-applicable sage advice about experiments: “If it is dangerous, or wrong, or both, and if it doesn’t need to be done, we just ought not to do it.

While ISSCR advocates for human embryo exploitation, we do need to remember that this is a self-appointed group of scientists, acting without public input, proposing self-regulation for other scientists. Of course, the real purpose of these guidelines is that they are trying to fend off any government regulations or public outcry that could hinder their research desires. But as the letter writer mentioned above notes: “the right experiment to do should not be determined by scientists alone.”

In the United States, a key federal law has provided a barrier against a great deal of human embryo exploitation: the Dickey-Wicker amendment. This annual prohibition passed by Congress prevents taxpayer funds from being used for life-destroying embryo research.

The Dickey-Wicker amendment is named for the two Congressmen who sponsored it in 1995: Rep. Jay Dickey (Arkansas) and Rep. Roger Wicker (Mississippi). First passed by Congress in July 1995 and signed into law by President Clinton in January 1996, it prohibits federal funding under the Labor, Health and Human Services budget for:

  1. the creation of human embryos for research purposes, or
  2. research in which human embryos are destroyed, discarded or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero.

A human embryo is also defined, to include “any organism, not protected as a human subject under 45 CFR 46…that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.”

In short: No federal funds for creating, destroying or risking harm to human embryos for research experiments.

The language comparing research on embryos to “research on fetuses” and defining embryos as humans “not protected as a human subject under 45 CFR 46” comes from the fact that federal regulations define, and protect against research on, young human beings in the womb, but do not protect younger human beings who are not in the womb. This despite the fact that the beginnings of human life and embryological stages of human development (Carnegie Stages) have been accepted since 1942 and reaffirmed by leading embryologists since then. Hence the great need for the Dickey-Wicker amendment, to protect these very young and most vulnerable humans. Moreover, the language anticipated the ever-increasing ways to create human embryos using laboratory techniques (more on this below.)

The Dickey-Wicker amendment was originally put in place in response to proposals to allow human embryo experimentation. The story sounds hauntingly familiar to the situation today. The NIH Human Embryo Research Panel (HERP) was appointed in 1994 (in lieu of a formal Ethics Advisory Board) supposedly to debate the ethics of human embryo research. But at the first meeting, the panel chairman announced that the panel’s mission was not to debate embryo research but to recommend types of experiments for federal funding. He went on to tell the group that anyone who disagreed with that goal had been appointed by mistake and should resign. The biased panel proceeded to lay out a series of recommendations for taxpayer funding of various experiments using human embryos, including creation of human embryos specifically for destructive research. But while praised by scientists and administrators at NIH, even President Clinton rejected the proposals from the panel. Passage of the Dickey-Wicker amendment was a stern repudiation of the overreach of scientists who considered human embryos nothing more than experimental resources to be used and discarded.

Since 1996, the Dickey-Wicker amendment has been passed and signed into law every year, by both Republican and Democrat Congresses and Presidents. This demonstrates a consensus that taxpayer funds should not be used for controversial research with embryos, despite debate on the propriety of the research itself. Denying access to the large cache of federal funds weighs against such research and dissuades scientists from pursuing embryo-destructive experiments.

The role of the Dickey-Wicker amendment in regulating the uneasy tension regarding funding controversial embryo-destructive research has come to the fore in regard to embryonic stem cell (ESC) research. Human embryonic stem cells were first successfully cultured in the lab in 1998 and excited the imagination of many scientists due to the flexibility of the cells to form the range of body cell types (termed “pluripotency”), but deriving ESC requires destruction of young human embryos. When pushed to allow federal funding of the research, the General Counsel of Health and Human Services in 1999 issued a memo that parsed the words of Dickey-Wicker to a new interpretation: while federal funds could not be used to create or destroy embryos, once the embryos were destroyed, federal funds could be given for research with embryonic stem cells from disaggregated embryos. NIH developed guidelines for funding such research and issued a call for grant proposals late in 2000. However, when the grant proposals were about to be reviewed and funds given in spring 2001, a lawsuit citing Dickey-Wicker was filed that created a moratorium on ESC research funding. This forced NIH to withdraw the Clinton-era guidelines and led to President Bush’s first address to the nation, on August 9, 2001, on the topic of stem cell research. Funding of ESC research proceeded but under tight restrictions.

When President Obama discarded restrictions on ESC research and his NIH put forth new, loosened guidelines on ESC research, another lawsuit (Sherley v. Sebelius) citing Dickey-Wicker shut down all federally-funded ESC research. Eventually the legal stay on funding the research was lifted, based not on congressional intent or a clear reading of Dickey-Wicker language but on NIH’s interpretation of the meaning of “research in which” an embryo is destroyed, and the Supreme Court declined to weigh in to clarify the law. Nonetheless, the Dickey-Wicker amendment still prevents taxpayer funding of embryo-destructive experiments.

The new ISSCR recommendations present new challenges, and Dickey-Wicker will play an important role again against unethical research. A plain reading of this prohibition suggests that most, if not all, of the embryo research experiments allowed by ISSCR could not receive federal taxpayer funds. As the previously-mentioned letter noted, it should help determine “the right experiment” apart from the scientists’ desires.

Ethical research alternatives do exist, such as adult stem cells, and these alternatives are already helping patients, while the embryo-destructive research has failed.

Sen. Roger Wicker (Mississippi), testifying at a stem cell research hearing on September 16, 2010, pointed out the realities of the critical need for continuing the Dickey-Wicker amendment:

“I am proud to say that for a decade and a half, the Dickey-Wicker amendment has protected life. This debate involves profound ethical and moral questions. This is a matter of conscience for me, but more importantly, it is a matter of conscience for millions of Americans who are deeply troubled by the idea that their taxpayer dollars may be used to destroy another human life when there are other proven techniques available.”

According to a Talmudic saying: “Whoever saves a life, it is considered as if he saved an entire world.” The Dickey-Wicker amendment has saved millions of worlds.

David Prentice, PhD

About David Prentice, PhD

David A. Prentice is Vice President and Research Director for the Charlotte Lozier Institute. He is also Adjunct Professor of Molecular Genetics at the John Paul II Institute, The Catholic University of America and was a Founding Advisory Board Member for the Midwest Stem Cell Therapy Center, a unique comprehensive stem cell center in Kansas that he was instrumental in creating. In 2020, he was appointed by the Secretary of HHS to the federal Human Fetal Tissue Ethics Advisory Board. Dr. Prentice has over 40 years’ experience as a scientific researcher and professor, including previous service as senior fellow for life sciences at the Family Research Council, Professor of Life Sciences at Indiana State University, and Adjunct Professor of Medical and Molecular Genetics, Indiana University School of Medicine. He established Stem Cell Research Facts, an educational website providing scientific facts and patient-centered videos about adult stem cells, and is a founding member of Do No Harm: The Coalition of Americans for Research Ethics, and an advisory board member for the Center for Bioethics and Human Dignity. He has provided scientific advice for numerous medical professionals, legislators, policymakers and organizations at the state, federal, and international levels. Dr. Prentice received his Ph.D. in biochemistry from the University of Kansas, and was at Los Alamos National Laboratory and the University of Texas Medical School-Houston before joining Indiana State University where in addition to his research and teaching, he served as Acting Associate Dean of Arts and Sciences and Assistant Chair of Life Sciences. He was recognized with the University’s Caleb Mills Distinguished Teaching Award and Faculty Distinguished Service Award. He has taught courses ranging from non-majors biology to advanced and graduate courses including developmental biology, embryology, cell and tissue culture, history of biology, science and politics, pathophysiology, medical genetics, and medical biochemistry. Several of his courses were also taught on-line. He received the 2007 Walter C. Randall Award in Biomedical Ethics from the American Physiological Society, given for promoting the honor and integrity of biomedical science through example and mentoring in the classroom and laboratory. Dr. Prentice’s research interests encompass various aspects of cell growth control, cell and developmental biology; one major focus is adult stem cells. He has reviewed for various professional publications including The Journal of the American Medical Association. He is an internationally-recognized expert on stem cell research, cell biology and bioethics, and has provided scientific lectures and policy briefings in 40 states and 21 countries, including testimony before the U.S. Congress and numerous state legislatures, the U.S. National Academy of Sciences, the President’s Council on Bioethics, European Parliament, British Parliament, Canadian Parliament, Australian Parliament, German Bundestag, French Senate, Swedish Parliament, the United Nations, and the Vatican. He was selected by President George W. Bush’s U.S. President’s Council on Bioethics to write the comprehensive review of adult stem cell research for the Council’s 2004 publication “Monitoring Stem Cell Research.” Dr. Prentice has published numerous scientific and bioethics articles, including a recent review of stem cell science and adult stem cell treatments published in Circulation Research. He has also published numerous commentaries and op-eds, and travels nationally and internationally to give frequent invited lectures regarding stem cell research, fetal tissue research, gene editing, cloning, embryology, cell culture and vaccines, bioethics, and public policy. He has been interviewed in virtually all major electronic and print media outlets, including CNN, ABC, NBC, CBS, Fox, CSPAN, Reuters, AP, NPR, USA Today, BBC, The Washington Post, The Los Angeles Times, and The New York Times.