Should we open the door to genetically modified babies?

As the genetically modified food wars wage on, another bombshell has been quietly waiting to drop: We could soon start genetically modifying people.

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There has been a lot of confusion around this controversial issue, but as we are now facing a historic crossroads, it is important to set the record straight.

Over a decade ago, scientists at St. Barnabas Hospital in New Jersey announced that they had created genetically modified babies with a technique called ooplasmic transfer. They described this as "the first case of human germline modification," which means that they had changed the genes not only of the immediately resulting children, but also of any children they might have, on through the generations.

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Ooplasmic transfer involved injecting part of a fertile woman's egg "white" into an infertile woman's egg. The U.S. Food and Drug Administration stopped the practice because there was no pre-clinical data about its safety, and because several fetuses created with the technique showed genetic anomalies. The FDA told the researchers that they would need to apply for approval in order to continue, and it seems that none of them ever did.

Ooplasmic transfer has largely been forgotten, but an undated Daily Mail article about it, which was apparently written in 2001, continues to cause a great deal of confusion. It begins with the provocative statement, "The world's first genetically modified humans have been created, it was revealed last night." Many people come across it, and are understandably led to believe that this is something happening now.

In fact, 45 countries around the world have considered the legality of human germline modification (more commonly known as inheritable genetic modification or IGM), and all have determined that it must be prohibited because of the Pandora's Box of problems it introduces. IGM is additionally prohibited by the Council of Europe's Convention on Human Rights and Biomedicine, and considered to be "contrary to human dignity" in UNESCO's Universal Declaration on the Human Genome and Human Rights.

But this widespread international agreement may soon be greatly tested.

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The United Kingdom is one of the countries that prohibits IGM, but it is considering changing its law to allow a heavily funded technique similar to ooplasmic transfer. Its Department of Health recently announced that it hopes such a move will put the UK at the "cutting edge of medical techniques."

Similar research has also been considered in the United States. An FDA committee charged to gauge these techniques' safety met in February, and concluded that significantly more animal and preclinical research would be needed before human trials would be acceptable. It was also pointed out that there is no medical need for such a biologically extreme technique, since safer alternatives are already available.

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Governmental bodies in the UK have referred to the new technique under consideration as mitochondrial donation, replacement, or transfer. In fact it is not the mitochondria (organelles outside the cell nucleus), but the nuclear genome itself that would be transferred from one woman's egg or embryo into another's. This process will result in a child that has not only been genetically altered, but that has genetic material of three different people in every one of its cells. (That's why "3-person IVF" is yet another term used.)

The technique's stated goal is to allow a woman who has mutated mitochondria, which can lead to an array of disorders, to have a child who inherits another woman's healthy mitochondrial DNA, but who still inherits her nuclear DNA.

Mitochondria contain a small number of genes, but they are replicated hundreds or thousands of times in every cell of our bodies. And they are in constant interaction with our nuclear DNA, providing necessary energy for every activity in our body. No one knows what the impact of combining mitochondrial and nuclear DNA from two different women will be.

Scientists have pointed out that nuclear-mitochondrial incompatibility is a real concern, as is epigenetic harm caused by the invasive procedure of removing and reinserting a nucleus into a new environment.

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Despite these serious safety and efficacy concerns, the prospect of violating a long-respected international policy consensus, the ethical dilemma of turning children into medical experiments, and the health risks to young women who would have to supply the eggs — not to mention the lack of public support in its own country — the UK is pressing forward.

Proposed regulations drafted by the U.K. Department of Health will be put before Parliament this fall. If proponents have their way, the technique could be attempted in U.K. fertility clinics by next spring, without any required follow-up of the resulting children.

In what can only be understood as a concerted effort to assuage public opposition, the U.K. Department of Health has recently declared that it does not believe this particular technique actually results in genetic modification. Given the vehement critiques of GMOs in Europe, it's perfectly clear that this terminological maneuver is aimed at minimizing the drastic nature of the manipulations.

But any child born following this procedure will inherit 37 genes they would not otherwise have had. For comparison, a tomato is considered to be genetically modified if even a single foreign gene has been introduced into its genome.

I would agree with several scientists recently quoted in The Independent, who said that the government's redefinition of a commonly used term is both "dishonest" and "clearly political."

In 2001, the researchers who tried ooplasmic transfer were described as trying to bring inheritable genetic modification in "through the back door." With the U.K. on the verge of writing human germline modification into law, the issue is now definitively at our front door. But unfortunately it seems that backdoor tactics have endured.

For now, it seems that the U.S. is taking the more responsible route. Stem cell biologist and FDA Committee Chair Evan Snyder told USA Today that the FDA is unlikely to consider clinical trials until more animal research has been completed. And perhaps it will determine that human genetic modification is simply not worth the risks. Committee member and cell biologist Renee Reijo Pera noted "I just don't think that this is an avenue that we should pursue in humans."

Jessica Cussins is a project associate at the Center for Genetics and Society, a nonprofit information and public affairs organization working to encourage responsible uses and effective societal governance of human genetic and reproductive technologies. She is a regular blogger at Biopolitical Times, Psychology Today, and the Huffington Post. Follow her on Twitter @JessicaCussins.