EXECUTIVE SUMMARY

A controversial reproductive technique recently resulted in the birth of a baby with three genetic parents. Some ethical concerns include the following:

  • If limited resources are invested in this technology, other important needs may go unmet.
  • The technology would be of benefit to very few individuals.
  • The technique could be utilized in countries with fewer protections for the research participants and less vigorous oversight than the U.S.

Ethical concerns continue to surround a controversial reproductive technique, further stirred by the recent birth of a baby with three genetic parents.1 The baby is the product of genetic material from three individuals: one male who contributed nuclear DNA (nDNA), one female who contributed nDNA, and one female who contributed mitochondrial DNA (mtDNA).

Lisa Campo-Engelstein, PhD, assistant professor at the Alden March Bioethics Institute and Department of OBGYN at Albany (NY) Medical College, says the birth of the “three-parent” baby shows how quickly technology moves forward — sometimes before there is significant ethical consideration.

“Ethically speaking, this baby provides further evidence that there are multiple ways to understand what it means to be a parent, and that genetics alone does not equate to parenthood,” says Campo-Engelstein. Most would not consider the mitochondrial donor the social or intended mother. “At the same time, however, this baby also shows how important it is to many people to be genetically related to their children,” says Campo-Engelstein.

Françoise Baylis, PhD, professor and Canada research chair in bioethics and philosophy at Dalhousie Medical School in Halifax, Nova Scotia, outlined ethical issues involving creating children with three genetic parents in a recent paper.2

These include harms to egg providers, potential offspring and future generations, harms to specific interest groups, and harms to society. In Baylis’ view, the biggest ethical issue is prioritizing individual reproductive choice over important matters of social justice.

“If our limited resources — time, talent, money, and human eggs — are invested in this technology for the benefit of a very few, then other more important needs will go unmet,” says Baylis.

Some have suggested that the mtDNA donated by one of the two women is somehow not important, and so the person who provided this is not important. “But this is clearly false,” says Baylis. “The donated mtDNA can make the difference between an offspring with a serious illness and an offspring without that illness.”

In addition, if the offspring born is female, her mtDNA will be passed on to all of her children. “So how is it that the mtDNA is not significant?” asks Baylis.

The technology involved in creating children with three genetic parents is only potentially effective for avoiding the births of children with mitochondrial disease when the disease is caused by defective mtDNA. Most mitochondrial disease in children is caused by defective nDNA.

Recent calculations suggest that the maximum potential direct benefit of this technology is 778 healthy births per year in the U.S.3

This number is inconsequential in a country of just over 300 million people. This fact “should raise questions about the value of investing in the science of manipulating human embryos to avoid mitochondrial disease caused by dysfunctional mtDNA,” says Baylis.

Further, Baylis believes this number is a significant overestimate. This number assumes that all women with dysfunctional mtDNA who are at risk of having children with mitochondrial disease will choose to reproduce using egg providers, IVF, and human nuclear genome transfer.

“For a number of reasons, this assumption is very likely incorrect,” says Baylis. Not all women with dysfunctional mtDNA want to become pregnant, not all will choose IVF followed by human nuclear genome transfer, and of those that do, not all will be successful. Baylis recalculated by taking these facts into consideration and came up with her own estimate of a maximum benefit of fewer than 113 births per year in the U.S.

Some clinicians and scientists are arguing the technology should be used to treat older infertile women.4 This might expand the customer base for the technology, says Baylis.

R. Alta Charo, JD, Warren P. Knowles professor of law and bioethics at University of Wisconsin Law School in Madison, believes the technique is unlikely to become commonplace due to the relatively small number of people for whom it is the only, or even the best, option for minimizing the risk of serious disease in their children. “While we are learning more about mitochondrial disorders, only a portion of them are due to problems in mitochondrial DNA,” she explains.

Charo notes the technique, at present, cannot be performed in the U.S. because it is a form of cell therapy that requires an Investigational New Drug (IND) application from the FDA. Congress passed a provision that prevents FDA from considering an application for an IND to begin clinical trials of this technique. “That provision may not be renewed, but is in effect at the moment,” says Charo.

The technique will continue to be developed, however. Charo says this will occur “in the U.K. under strict regulatory oversight, or in other countries that have fewer protections for the research participants and less vigorous oversight to ensure the technical quality of the effort.”

REFERENCES

  1. Hamzelou J. Exclusive: World’s first baby born with new ‘3 parent’ technique. New Scientist 27 Sept. 2016. http://bit.ly/2dwuGoR.
  2. Baylis F. The ethics of creating children with three genetic parents. Reproductive BioMedicine Online 2013; 26, 531
  3. Gorman GS, Grady JP, Ng Y, et al. Mitochondrial donation — How many women could benefit? N Engl J Med 2015; 372:885-887.
  4. Connor S. Scientist who pioneered ‘three-parent’ IVF embryo technique now wants to offer it to older women trying for a baby. Independent. February 7, 2015.

SOURCES

  • Francoise Baylis, PhD, Professor, Canada Research Chair in Bioethics and Philosophy, Dalhousie Medical School, Halifax. Phone: (902) 494-6458. Email: Francoise.Baylis@Dal.Ca.
  • Lisa Campo-Engelstein, PhD, Assistant Professor, Alden March Bioethics Institute & Department of OBGYN, Albany (NY) Medical College. Phone: (518) 262-0239. Fax: (518) 262-6856. Email: campoel@mail.amc.edu.
  • R. Alta Charo, JD, Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin Law School, Madison. Phone: (608) 262-5015. Fax: (608) 262-5485. Email: racharo@wisc.edu.