By Leah Ramsay

The House of Lords in the United Kingdom voted to allow fertility clinics to  apply for licenses to perform “mitochondrial donation” IVF procedures on Tuesday. The UK is the first nation to explicitly allow the procedure, which it had previously banned; the resulting child would have genetic material from her parents and also from a donor of mitochondrial DNA (mtDNA), with the aim of avoiding transmission of debilitating mitochondrial disease from mother to child. The procedure has never been performed in humans.

Meanwhile, in the United States, the Food and Drug Administration (FDA) is considering clinical trials to test the procedure in humans, and is conducting inquiry into safety as well as ethical and social policy considerations.

The procedure is considered controversial because some say it would cross the “germ line,” or make a permanent, engineered change to the DNA that is passed down from mother to child. Previously this has been seen as an ethical line not to be crossed, but recently scientists and ethics scholars have come out in favor of its potential to allow women to have genetically related children even if they are a carrier of mitochondrial disease.

Bioethics scholars at the Johns Hopkins Berman Institute of Bioethics have been working with journalists to explain the science and related ethical issues.

“One of the reasons it is controversial is that you would be modifying the genetics of future generations who do not have the ability to make a decision about it,” Debra Mathews, Assistant Director of science programs at the Berman Institute, told Voice of Russia radio.

“It will be important to emphasize what the consent form looks like so it’s very clear what the potential future rights of all the different people are,” Berman Institute faculty member Michelle Huckaby Lewis told HealthDay. “The potential benefits are huge, but the potential harms are also huge.”

Pediatrician and Berman Institute faculty member Margaret Moon agrees, saying that just as children who are enrolled by their parents in bio-banking (cord blood) studies should be re-consented at an age of maturity, so should any children that result from these gene transfer clinical trials the FDA is considering. “I imagine there will be a lot done to encourage them to stay in the research program until they reproduce.  Their offspring will be the point of much interest,” Moon says.

Travis Reider, a Hecht-Levi fellow at the Berman Institute, is concerned about the drive to develop the procedure in the first place. He writes in Wired: “My worry is that demand for this technology is driven by a problematic genetic fetishism, and that we should try not to enable this attitude. Not procreating does not equal not starting a family; one could adopt one of the millions of orphans in the world who need a family. However, adoption is often seen as a last resort option.”

Reider also addresses common misrepresentations of the issues in the media, guided by some experts advocating for the procedure to move forward: “…this technology is not life-saving, and it will not prevent cases of mitochondrial disease. Mitochondrial replacement IVF (mtIVF) is not a treatment for an individual with a mitochondrial disease; it is a method for creating a new person with healthy mitochondria… That means that there would not be a single person who would otherwise have been sick, and who will, as a result of the technology, be healthy.  Nor would there be anyone alive who otherwise would have died. There will simply be different people born.”

For Moon and others, the concern that if the FDA allows for germ line modification to prevent passing on conditions like Leigh’s disease through mtDNA, it will open the door to allowing other methods of genetic engineering for custom-made children with selected traits like a certain height, eye and hair color.

At the other end of the spectrum, there could be considerable debate as to which conditions are classified as “debilitating” enough to be engineered out of the gene pool; the deaf community, for example, includes some who object to the classification of their condition as incapacitating and even prefer to have deaf children.

“If we stop a particular avenue of science in its track and say ‘this may not go forward,’ we don’t know what the opportunity cost is,” Mathews told Voice of Russia. “We may think what we’re doing is preventing this particular application that we’re quite concerned about, which may be a legitimate concern, but we sometimes fail to realize there may be opportunity costs with not allowing that science to move forward.”

In addition to conditions like blindness and epilepsy, some propose that the new technique could also be used to treat age-related infertility, as other IVF treatments do. This application would widen the potential pool of patients beyond women carriers of mitochondrial conditions to include millions of women wanting to conceive.

Researcher Shoukhrat Mitalipov, who pioneered the technology in experiments with monkeys, wants to conduct human clinical trials with both women who carry mitochondrial diseases and who are infertile.  However, there is disagreement as to whether the technique would even be effective.

The procedure could have unintended health consequences both for newborns and for future generations, as the genetic tinkering reverberates through time, Lewis told HealthDay.

Mathews agreed, telling the Washington Post that many of the concerns relate to safety, in part because the impact of tinkering with cells at that level may not be completely evident for years or even generations.

In addition, Lewis says the technique raises troubling questions of parental rights and family structure.

“When you use a technology in a new way like this, it really challenges our notions of what it means to be a parent and what it means to be a family,” Lewis said.

(Updated Feb 26, 2015. Originally posted Mar 4, 2014)

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