Mitochondrial replacement therapy, an in vitro fertilization process that can prevent mitochondrial diseases, is a complex and much debated technology that is currently prohibited in the US
Diana Bowman examines this topic in her new book “Reproduction Reborn: How Science, Ethics, and Law Shape Mitochondrial Replacement Therapies.” In it, she brings together experts in medicine, genetics, ethics, law and policy to explore the challenges of mitochondrial replacement therapy, or MRT, and the role countries have in governing reproduction.
Bowman is a professor in Arizona State University’s Sandra Day O’Connor College of Law, associate dean of applied research and partnerships and a professor in the School for the Future of Innovation in Society. Her research focuses on the legal and policy issues associated with emerging technologies.
Mitochondrial disease is a debilitating and often fatal illness in which the cell’s mitochondria have difficulty producing the energy needed to sustain life. According to the National Library of Medicine, one in 5,000 people inherits this genetic disease. MRT can stop the cycle of inheriting mitochondrial disease.
During her two years of research, Bowman gathered global case studies of regulatory responses from all over the world, including China, the UK (where the technology is legal) and the US (where it is not). She received $200,000 for her work when she was awarded the prestigious Andrew Carnegie fellowship in 2018.
ASU News spoke with Bowman about her work and this controversial technology.
Editor’s note: Answers have been lightly edited for length and clarity.
Question: For starters, how is mitochondrial disease identified in a family?
Answer: This is not something that is screened for on a regular basis. The cell of a woman who has defective mitochondrial DNA will only know about that because she has had multiple miscarriages or unsuccessful live births — there will be a long history of adverse pregnancies.
Q: How does mitochondrial disease affect a child?
A: Many children with mitochondrial disease will have a very short lifespan because of just how taxing the disease is on the system. They may not be able to chew food. They will potentially have limited mobility and breathing challenges. They will generally be very tired. Many children suffer from blindness or at least some form of vision impairment. And the list goes on and on.
Q: How does the MRT eliminate the disease and the hardships that go with it?
A: Nuclear genetic material from an egg with affected mitochondria is taken out of the mother’s egg and placed into a donor egg, which contains normal mitochondria. The egg is then fertilized with the father’s sperm in a clinic through an IVF technology process. A child born through this process will have the DNA of three people – 99% will come from the biological parents and 1% will come from the donor.
Q: Are there any risks to the procedure?
A: While the technology is still nascent, leading members of the scientific community believe that the risks are likely to be minimal and greatly reduced for the child born as a result of the MRT.
Q: Why is your book, and the advanced technology it inspires, so valuable?
A: These diseases affect every system in the body — the brain, heart, liver, muscles, kidneys and endocrine system. There is no cure for the disease but it can be treated. But treatment is very expensive and many of these children who have mitochondrial disease will have a drastically shortened lifespan.
This technology allows children to avoid pain and suffering, and allows parents to have, for the first time, a biologically related child who is healthy.
Q: Why does the US currently prohibit this technology?
A: It is very easy to put this technology in the same category as cloning. And the devil really is in the details here. I think it’s so easy just to lump these advanced technologies in the same basket and not unpack what is different, new or novel, or what actually has a real potential therapeutic application from the kind of things that are just … ethically challenging for us to deal with.
It is a complex topic and there are multiple debates associated with the use of the technology. There’s a scientific debate in terms of, “Just because we can do this, should we do it?” And that is often the debate around emerging technology.
There are ethical debates around what it means to be a family and what it means to have the DNA of three parents in a child.
And there are economic debates. There was an economic analysis undertaken by the Wellcome Trust that was very influential in the public debates in the UK in 2016. This report suggested that the technology costs about 100,000 pounds per cycle versus the potentially millions of dollars needed to care for a child with this disease.
Q: Can you clarify the basis upon which Congress is rejecting this technology?
A: MRT is prohibited in the US by the rider to the 2016 Consolidated Appropriations Act, which restricts the Food and Drug Administration from considering applications for MRT. The technology cannot be approved by the FDA, and any US clinic that sought to perform the technique would be in violation of the Federal Food, Drug and Cosmetic Act.
Q: Will it be coming up for consideration this year?
A: Great question — we do not know. We hope Congress is willing to revisit this restriction that it has placed on the FDA now that the UK and Australia have both moved forward with regulatory regimes that expressly allow for MRT to be used in a clinical setting.
Q: Why did you write this book?
A: It is a very esoteric topic to do research in — an area that very few people have ever heard of in terms of technology. And we don’t talk much about mitochondrial diseases, although this disease is very prevalent.
I believe that to move the policy needle here in the US, we need to actually bring this into a more mainstream discussion rather than just within a very small sector of the scientific community and a very small group of people in the legislature.
This was an opportunity for me to bring together the leading commentators from around the world to help frame discussions here in the US I’m hopeful that the book is accessible to a wide range of people across different fields and generates thoughtful discussions around an incredibly complicated and layered form of advanced reproductive technology.
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