NAS proposes prudent US policy on 3-person IVF

3-parent babyA new report from the National Academies of Sciences, Engineering, and Medicine here in the US recommends a policy significantly more cautious on first read for 3-person IVF than that in place now in the UK.

My initial take on this new 164-page report is that it is very well thought out and the recommendations are both appropriate and prudent. I’m still reading the report so it is possible I may feel differently at the end or that others may point out concerns that I missed, but so far my impression is positive.

Keep in mind that 3-person IVF also goes by the monikers mitochondrial transfer, 3-parent IVF, and mitochondrial replacement therapy (MRT, the term used by the Academy).

Alta Charo Mito TransferNotably, the Academy committee explicitly stated that MRT is a form of human genetic modification and human germline therapy. Some proponents of MRT in the UK and even in the US had mysteriously claimed otherwise.

While the Academy committee wrote in the report that 3-person IVF is ethically permissible in theory, in practice the depth of their concern about the risks of this technology was reflected in the array of conditions that they detailed must be met first.

These conditions include, but are not limited to the following as taken in some cases verbatim from the report or the Academy press release:

  • initial MRT clinical investigations should be limited to women who are at risk of transmitting a severe mitochondrial genetic disease that could lead to a child’s early death or substantial impairment.
  • Only male embryos should be permitted to be used for pregnancy. This would avoid transmission of the donor mitochondria should something go wrong.
  • initial safety is established and risks to all parties directly involved in the proposed clinical investigations are minimized, although minimizing risk to future children should be of highest priority; (note, my interpretation of this is that more preclinical data are needed)
  • the likelihood of efficacy is established by preclinical research using in vitro modeling, animal testing, and testing on human embryos as necessary;
  • if the intended mother at risk of transmitting mitochondrial disease also desires to carry the pregnancy, it is determined by professional opinion that she is able to complete a pregnancy without significant risk of serious adverse consequences to her health or the health of the fetus;
  • clinical investigations are limited to investigators and centers with demonstrated expertise in and skill with the relevant techniques; and
  • FDA has reviewed the science surrounding matching the mitochondrial DNA subtype of the egg provider with that of the intended mother and if compelling, has considered such matching as a means of mitigating the possible risk of incompatibility that could arise from combining the egg provider’s mitochondrial DNA with the nuclear DNA of the intended mother.

I’m largely in agreement with the Academy on this policy recommendation. It seems wise and frankly more appropriately cautious based on the science than what is now allowed in the UK.

The policy recommendations were summed up by the committee Chair in this way:

“In examining the ethical, social, and policy issues associated with mitochondrial replacement techniques, we concluded that the most germane issues could be avoided if the use of these techniques were restricted by certain conditions, rather than prohibiting them altogether,” said Jeffrey Kahn, chair of the committee and the Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy at The Johns Hopkins Berman Institute of Bioethics in Baltimore.  “Although MRT would not treat a person with a mitochondrial disease, its pursuit could satisfy prospective parents’ desire to bear genetically related offspring with a significantly reduced risk of passing on mitochondrial disease.  The limitations on MRT that we propose focus on protecting the health and well-being of children born as a result of the techniques.”

Now it will be interesting to see how and to what extent the FDA implements these policy recommendations as well as the response in the scientific community. I would predict that some proponents of MRT may view this policy as too restrictive. Perhaps some might interpret it as a green light, but so far in my reading I don’t see it that way.

The other fascinating thing is to compare this report on 3-person IVF to the organizer’s closing statement from the NAS Meeting on Human Gene Editing from December. Some of the issues raised in the new report on 3-person IVF seem to directly apply to human gene editing as well.

I appreciate that the committee was cognizant of larger issues such as transparency, access, and public discourse.

Here is the committee roster.

Jeffrey Kahn, Ph.D., M.P.H. (chair)

Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy Berman Institute of Bioethics

Johns Hopkins University

Baltimore, M.D.

Jeffrey R. Botkin, M.D., M.P.H.

Chief

Division of Medical Ethics and Humanities, and

Professor of Pediatrics

University of Utah School of Medicine

Salt Lake City, U.T.

David Chan, M.D., Ph.D.

Professor of Biology

California Institute of Technology

Pasadena, C.A.

R. Alta Charo, J.D.1

Warren P. Knowles Professor of Law and Bioethics

School of Law and Department of Medicine and Public Health

University of Wisconsin at Madison

Madison, W.I.

James F. Childress, Ph.D.1

University Professor and John Allen Hollingsworth Professor of Ethics

Department of Religious Studies

University of Virginia

Charlottesville, V.A.

Alan H. DeCherney, M.D.1

Associate Clinical Director and Branch Chief

Intramural Program in Reproductive Endocrinology and Gynecology

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Institutes of Health

Bethesda, M.D.

Marni Falk, M.D.

Assistant Professor of Pediatrics

Division of Human Genetics

Children’s Hospital of Pennsylvania

University of Pennsylvania Perelman School of Medicine

Philadelphia, P.A.

 

Jonathan Kimmelman, Ph.D.

Associate Professor in Biomedical Ethics

Biomedical Ethics Unit

McGill University

Montreal, Canada

Anna C. Mastroianni, J.D., M.P.H.

Professor

University of Washington School of Law

Seattle, W.A.

Vamsi K. Mootha, M.D.2

Investigator

Howard Hughes Medical Institute, and

Professor of Systems Biology and Medicine

Harvard Medical School

Boston, M.A.

Laurie Strongin

Founder and Executive Director

Hope for Henry Foundation

Washington, D.C.

Keith Wailoo, Ph.D.1

Townsend Martin Professor of History and Public Affairs

Department of History

Woodrow Wilson School of Public and International Affairs

Princeton University

Princeton, N.J.

STAFF

 

Anne B. Claiborne J.D., M.P.H.

Responsible Staff Officer

Rebecca English, M.P.H.

Program Officer

Morgan Stathem, M.S.

Associate Program Officer

Michael Berrios

Senior Program Assistant

_________________

1Member, National Academy of Medicine

2Member, National Academy of Sciences

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