Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy

April 10, 2015 by Bob Yirka report
Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy
Diagram of mitochondrial gene replacement therapy proposed by Oregon Health & Science University researchers. The nuclear DNA from a patient’s egg carrying mitochondrial DNA mutations is removed and transplanted into an egg donated by a healthy donor which has also had its nuclear DNA removed. The reconstructed egg cell (oocyte) is then fertilized with the partner's sperm and an embryo is transferred to a patient. The baby will be free of risk from maternal mitochondrial mutations, but yet the biological child of the parents. Credit: Oregon Health & Science University

(Medical Xpress)—Glenn Cohen, with Harvard University, Julian Savulescu, with the University of Oxford and Eli Adashi with Brown University have together written and published a Perspectives piece in the journal Science, describing the differing approaches being taken regarding mitochondrial replacement therapy (MRT) in the U.S. versus Britain, and offer their opinion on how things should change in the U.S.

MRT was developed as a means to help prevent mutant mitochondrial syndromes in babies—it involves taking out a defective part of the mitochondrial DNA in a fertilized embryo and replacing it with healthy mitochondrial DNA from a donor. This has led to it sometimes being described as a way for a child to have three biological parents and as a form of abortion because part of the embryo is destroyed in the process. In their article, the three authors outline the history of research and regulation surrounding MRT, and highlight what they see as positive progress in the U.K. (where it was recently legalized) and slow progress in the U.S. This can be ascribed to four main causes they propose: The way it is regulated, abortion issues and, pubic versus private debate and national pride.

In the U.K. MRT is regulated by a special agency called the Human Fertilization and Embryology Authority (HFEA)—their charter is to review the effectiveness and safety of the procedure In the U.S. on the other hand, regulation falls to a division within the FDA called the Office of Cellular, Tissue and Gene Therapies of the Center for Biologics Evaluation and Research, which has thus far seemed to lean towards classifying MRT as a therapy that must pass clinical trials before being used, none of which have ever been considered by the group. The authors also believe that ethical issues related to abortion are also holding up MRT research in the U.S. They also suggest that public opinion and national pride are playing a role—the British people speak proudly of the work done by research facilities in their country and do not seem to see a connection between MRT and abortion—they have also played a role in debating the issues that surround the technology. Meanwhile, in the U.S., public debate has been minimal and talk of abortion has been magnified by the press.

The authors conclude by suggesting that perhaps it is time to move oversight in the U.S. from the FDA to a new authority and to perhaps begin a national conversation on the procedure, as it appears that MRT is coming, whether it happens in the U.S. or not.

See also: Is UK evaluation of reproductive tech a model for US?

Explore further: Science shows ethical questions remain unanswered with 3-person IVF

More information: Transatlantic lessons in regulation of mitochondrial replacement therapy, Science 10 April 2015: Vol. 348 no. 6231 pp. 178-180. DOI: 10.1126/science.aaa8153

Mutant mitochondrial DNA (mtDNA) gives rise to a broad range of heritable clinical syndromes (1). A cure for those affected remains out of reach (1). However, recently developed mitochondrial replacement therapy (MRT) has raised the prospect of disease-free progeny for women carriers (2–4). Moreover, the feasibility of replacing mutant oocytic or zygotic mtDNA with a donated wild-type counterpart in humans has now been firmly established (2–4). In the United Kingdom, legislation regulating the clinical application of MRT, now 10 years in the making, has recently been approved by the House of Commons (5) and the House of Lords (6). The regulatory vetting of MRT in the United States, under way for a year, remains a work in progress (7). Here, we compare and contrast the regulatory history of MRT in the United Kingdom and the United States and examine potential lessons learned.

Related Stories

Science shows ethical questions remain unanswered with 3-person IVF

February 2, 2015
Diseases caused by genetic mutations in the mitochondria – the powerhouses of the cell – can be disabling, or even deadly. That is why mitochondrial replacement therapy (MRT), otherwise also known as three-person IVF ...

Stirring the simmering 'designer baby' pot

March 13, 2014
From genetic and genomic testing to new techniques in human assisted reproduction, various technologies are providing parents with more of a say about the children they have and "stirring the pot of 'designer baby' concerns," ...

What can magnetic resonance tractography teach us about human brain anatomy?

September 26, 2011
Magnetic resonance tractography (MRT) is a valuable, noninvasive imaging tool for studying human brain anatomy and, as MRT methods and technologies advance, has the potential to yield new and illuminating information on brain ...

Key dates in embryonic research

February 3, 2015
Britain's House of Commons votes Tuesday on allowing the use of donated DNA to create so-called "three-parent" babies to overcome mitochondrial diseases—disorders handed down along the maternal line.

Strong magnetic fields for new insights into the brain

May 13, 2011
Siemens will install three powerful, high-field magnetic resonance tomographs (MRT) at the University of Maastricht, The Netherlands, and thus provide entirely new insights into the human brain. The MRTs are to be dedicated ...

Recommended for you

Women exposed to smoke while in womb more likely to miscarry

July 13, 2017
Women exposed to cigarette smoke while in their mothers' wombs are more likely to experience miscarriage as adults, according to new research from the University of Aberdeen.

Lack of a hormone in pregnant mice linked to preeclampsia

June 30, 2017
(Medical Xpress)—A team of researchers from Singapore, the Netherlands and Turkey has isolated a hormone in pregnant mice that appears to be associated with preeclampsia—a pregnancy-related condition characterized by ...

Aspirin reduces risk of pre-eclampsia in pregnant women

June 28, 2017
Taking a low-dose aspirin before bed can reduce the risk of pre-eclampsia, which can cause premature birth and, in extreme cases, maternal and foetal death.

The biology of uterine fluid: How it informs the fetus of mom's world

June 22, 2017
A developing fetus bathes in a mixture of cellular secretions and proteins unique to its mother's uterus. Before fertilization, the pH of uterine fluid helps create a conducive environment for sperm migration, and afterward, ...

New clues in puzzle over pre-eclampsia and cholesterol regulation

June 21, 2017
Scientists studying a mystery link between the dangerous pregnancy complication pre-eclampsia and an increased risk of heart disease in later life for both mother and child have uncovered important new clues.

Are maternal hormones different when carrying a boy or a girl?

June 15, 2017
With advances in prenatal testing it's now possible to find out whether a pregnancy will result in a male or female baby as early as eight weeks' gestation.


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.