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Monday, March 31, 2014

Bioethics Students Tackle New Fertility Treatment—Mitochondrial Transplants

The procedure under consideration by the FDA combines the genetic material of three people to create a baby free of certain mitochondrial defects.
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Fertility specialists can now implant mitochondria into a human egg, creating a baby with three biological parents.

Welcome to the age of precision medicine and new efforts to minimize birth defects and disease. These ripped-from-the-headlines miracles are the perfect fodder for law students struggling to grasp the complexities of health law.

UC Hastings Adjunct Professor Patricia Davidson’s bioethics class spent a recent Friday morning debating the guidelines for a new technology that is being used to reduce certain birth defects associated with damaged mitochondria.

Mitochondria is the engine that powers the cell, allowing it to use and produce energy effectively. Mitochondrial DNA, or mtDNA, is maternally inherited. Mitochondria defects, however, can be passed from mother to child and can cause a range of health issues, some minor, some serious. In some babies the symptoms are immediately evident and systemic. Others do not show up until patients are adults. And in some, the defect does not trigger automatic illness or injury. Some scientists also believe that damaged mitochondria may be to blame for the puzzling panoply of symptoms that has been dubbed Gulf War Syndrome.

Such defects affect a small percentage of the population. But for at least a decade, scientists have been able to take the mtDNA from one woman, and implant it into the egg of a woman whose mtDNA is damaged. The resulting child, in effect, has three biological parents. One woman who provided the mitochondria, one woman whose mitochondria has been replaced in the egg but whose DNA establishing height, eye color, and other traits remains, and the genetic contribution from the father.

What Laws Govern “Genetic Tinkering?”

One leading researcher acknowledged this “genetic tinkering to promote health” has a host of medical, ethical and legal issues that touch areas of law that are not cut-and-dried. Judging from the wide-ranging small group and class discussion in Davidson’s class, today’s law students agree.

Such mtDNA transplant procedures were allowed until the Food and Drug Administration halted them in 2001. The FDA is currently considering whether to allow the procedure again, and in what circumstances. Thus far, more than 17 babies have been born in the U.S. using this treatment.

The procedure is under consideration in the United Kingdom, and will be regulated by the Human Fertilisation & Embryology Authority (HFEA), which oversees the use of gametes and embryos in fertility treatment and research. The procedure has broad support there. HFEA issued proposed draft regulations and guidelines for its use in 2013.

“Mitochondrial DNA donation has the potential to change the lives of couples who might have been otherwise unable to have their own healthy biological children,” said 3L Amanda Hamilton. “Our class discussed the ethical and legal implications of the UK guidelines.”

“Bioethics is a particularly valuable class in the Health Law curriculum because it allows students to delve into topics that inspire passionate dialogue and deep discussion. I appreciate being exposed to these topics, as it makes me a more well-rounded practitioner,” Hamilton said.

Bringing Medical and Legal Minds Together

Like Hamilton, many of Davidson’s students are taking the Health Law Concentration. Some are MSL students who work in the medical field, such as Nerissa Segovia, who works as an emergency room nurse at San Francisco General Hospital and wants to go into health policy. Others have extensive experience in healthcare, having worked as clinical psychologists or social workers.

Others are JD students like 1L David Roth, who studied philosophy in undergrad and worked in the UCLA Health Systems Ethics Center before entering law school. Several students are associated with the UCSF/UC Hastings Consortium on Law, Science & Health.

“The value of today's collaborative exercise is that it pushed us to examine bioethics issues that we will have to deal with by the time we begin to practice,” Roth said. “Being able to look at something as complicated as mitochondrial DNA donation under the guidance of an experienced professor, and with the input of relevant medical professionals from our consortium with UCSF, is an experience that will help elevate UC Hastings students above their competitors.”

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