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The 3 Parent Baby, the US, and over-regulation in the globalized world.

Writer's picture: John DarrellJohn Darrell

On April 6, 2016 the first baby created using a new 3 parent technique known as "spindle nuclear transfer" was born. The procedure is pioneered by scientist John Zhang, a New York resident who studied medicine at Zhejiang University School of Medicine in China. The baby, born in Mexico, has DNA from 3 separate people. (2 females, 1 male). The Jordanian mother and father, who received the treatment, had lost 4 children in the past to a genetic disorder known as Leigh syndrome, one of whom survived less than 1 year, and one who lived less than 6 years. Leigh syndrome is a serious genetic disorder that is likely to cause the death of a new child by the time they reach 3 months old.

Although this is not the first 3 parent baby to ever be born, by a strictly genetic definition, it is the first to use Dr. Zhangs technique, which is designed to cure a specific range of genetic disorders, whereas past treatments ("ooplasmic transfer" carried out in the mid 1990s, and banned in 2001) have only been to solve infertility issues.

With this technique, using only the mitochondrial (outer) portion of a donor egg to supplement the original two parents, the baby shares a large majority of it's genetic traits with its original parents. This mitochondrial DNA accounts for only 37 DNA strands, compared to the 20000 or so of the nucleus. Because of this the range of disorders that are curable is limited. But there are still important and devastating disorders which originate in the mitochondrial DNA alone, such as Leigh Syndrome.

Where does this fall into the scope of globalization? Due to government regulation Dr. Zhang was unable to carry out his procedure in the United States. Since the FDA stopped use of the "ooplasmic transfer" technique in 2001 (an IVF method used to bolster weak mitochondria in females, not entirely replace it as with Dr. Zhang's method) they have required approval for any such embryonic technique, and congress continues to ban the procedure. The method has been approved by the UK health administration but clinics have yet to complete a procedure there. Other countries don't even require approval, there simply is no form of regulation for the technique. Earlier this year another 3 parent baby, using the "pronuclear transfer" solution for infertility, was born in Ukraine. Zhang's baby was conceived and born in Mexico, where he did not face regulation.

Zhang says that he applied for FDA approval, and that the administration told him that they did not have a department to even handle his request, and that no further action could be taken.

Norbert Gleicher, a fertility specialist at the Center for Human Reproduction in New York City, explains the obstacles to trying such an experimental procedure—or even applying for approval to offer it—in the United States. Gleicher says he has sought a meeting with the U.S. Food and Drug Administration (FDA) to discuss mitochondrial DNA replacement for U.S. patients, including as a treatment for infertility. “We have not even been able to get an appointment,” he says.

Given the United State's position as a world leader in many facets, it is surprising to me that we would not take a position of leadership in regards to this topic as well. As a global community, advances in science such as this should be supported by all. This is the only way to iron out the various elements of uncertainty and danger which inevitably creep there way into fields such as genetic manipulation. More resources, more awareness, and more support from the government will result in better procedures that are more likely to cure more disorders.

If these procedure are going to happen anyways, why not make them legal in the United States? Wouldn't that set us in a better light among the world community if we showed a guiding hand towards pioneering genetic research? Zhang's clinic. The "New Hope Fertility Center." Is based in Manhattan, NYC. Certainly it would help him and his team to streamline their operation if they had closer contact with medical facilities and would-be regulatory bodies. Less displacement of resources and other types of difficulty involved with coordinating a medical procedure across international borders can only result in a safer outcome for something that is going to happen anyways. Don't we just end up looking like we are standing in the way of progress?

The current picture is: "We've got people out there working hard and actually preventing cases of things like Leigh syndrome, but they aren't welcome to work here, in fact, our bureaucracy is so tangled with itself that we will echo back discouraging an confusing messages when members of the scientific community make requests for change." Not exactly a welcoming message for would be pioneers. I'd go as far as to say that the United States ends up looking foolish when the dust settles given it's current stance. Why push away great achievements, leaving citizens of other countries scratching their heads saying "why is the US so bullheaded and frustrating to deal with?"

Is it really good for anyone for that type of opinion to spread?

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