A recent headline in the United Kingdom’s Independent shouts that the first genetically modified human embryos could be created in Britain in just a few weeks. 

The article by Steve Connor reports that scientists have submitted a proposal to the Human Fertilization and Embryology Authority (HFEA), the government’s fertility regulatory body, asking to edit the genes of “leftover” IVF embryos to try to treat infertility. Just today it was announced that the researchers have been given permission to move forward.

The Independent headline is meant to shock and surprise, but if you are someone who is even remotely following recent advances in genetic engineering, this headline should leave you scratching your head. The “first” genetically modified human embryos?

Even if you don’t follow genetic engineering research, you may have seen a headline from 2014 claiming that the first genetically modified babies are now graduating from high school, or an article from 2001, titled “World’s First GM Babies Born,” that made its way around social media in 2012.

So which is it? Are the first genetically modified embryos about to be made? Or has that genie already escaped the bottle?

It depends on how you define “genetically modified.”

Many people are unaware that not all of our DNA is inside the nucleus of our cells. We have DNA outside the nucleus in organelles called mitochondria. Mitochondria are responsible for the energy production of the cell. Our mitochondria have their own DNA called mtDNA. We inherit our mtDNA from our mothers because sperm mitochondria are destroyed at conception.

Make no mistake — mtDNA is still DNA, and any modifications to an organism’s mtDNA would make them “genetically modified.”
Also, any alteration to a human being at the embryo stage would be considered a germ-line modification, one that would be inherited. So germ-line modifications not only affect the embryo who is altered, but every generation after.
Nearly two decades ago, Dr. Jacques Cohen of the Institute for Reproductive Medicine and Science of St. Barnabas in New Jersey genetically altered the eggs of infertile women and created around 30 genetically modified children. Cohen used a technique called “cytoplasmic transfer” to “rejuvenate” an infertile woman’s eggs by injecting the cytoplasm of another woman’s healthy egg. Factors inside the cytoplasm helped the infertile woman’s egg in fertilization. 

When Cohen injected the cytoplasm of the healthy egg, it contained mitochondria from the donor egg. Those mitochondria have the mtDNA from the woman who donated that egg. So after the hybrid egg was fertilized, the resulting children had DNA from one man and two women. 

In 2001, alongside Cohen, as many as eight other IVF clinics were offering cytoplasmic transfer to their patients.

Cohen described the technique as “the first case of human ... genetic modification resulting in normal, healthy children.” 

These are the genetically modified babies who are now graduating from high school. Two of them are confirmed with genetic testing to have genetic material not from their parents.

It remains to be seen how “normal” and “healthy” these children are, since they haven’t reached adulthood or had children of their own. We do know that two of the fetuses had Turner’s syndrome, one miscarried and the other was aborted, and one child was diagnosed with “pervasive developmental disorder” at 18 months of age.

In 2002, Washington Monthly did an in-depth story on cytoplasmic transfer and Cohen, which reported that the Food and Drug Administration (FDA) ordered Cohen and other fertility clinics to stop performing cytoplasmic transfer for safety reasons.

That seemed to be the end of creating genetically modified children — until “mitochondrial replacement,” also called the “three-parent embryo” technique, came along recently as a way to “prevent” the inheritance of mitochondrial disease caused by mutations in the mtDNA. 

Mitochondrial replacement (MR) is a more invasive technique where, instead of simply injecting cytoplasm into an egg to help with fertilization, the egg is taken apart. The nucleus of an egg with defective mitochondria is removed and placed into an egg with healthy mitochondria. That radically altered egg is then fertilized. Like cytoplasmic transfer, this creates an embryo with the genetic material from three people.

There have been plenty of genetically modified embryos made with MR in both the United States and the United Kingdom. In fact, in an attempt to “treat” mitochondrial disease caused by mutations in mtDNA, the U.K. government has given the go-ahead to fertility clinics to use MR to create children with three genetic parents. 

So how can a headline in a U.K. newspaper claim that the “first” genetically modified embryos have yet to be made?

It begins with a deception worthy of a George Orwell novel. The U.K. has a law against genetically modifying embryos intended for reproduction. To allow MR to move forward to the IVF clinic, the law would have to be changed.

But instead of changing the law, the government quietly changed the definition of “genetic modification” to exclude MR. Buried in a nearly 50-page report by the U.K.’s Department of Health is a statement that alterations to mtDNA are not considered to be “genetic modification.” Now the Department of Health only deems changes to the DNA in the nucleus to be “genetic modification.”

So this is how the headline can claim the “first” genetically modified embryos are still to be created. The January 2016 article by Connor is about altering the DNA in the nucleus of IVF embryos using new gene-editing techniques. 
Abracadabra! By changing the definition, the U.K. can now ignore all the genetically modified humans who have come before and pretend this is all brand-new.

Not everyone is fooled, however. When it was discovered that the government had changed the definition of genetic modification, many scientists cried foul. An Independent article, also written by Steve Connor back in July 2014, exposes the deceptive sleight of hand. Lord Robert Winston, an in vitro fertilization specialist and MR supporter, stated: “Of course mitochondrial transfer is genetic modification, and this modification is handed down the generations.”

What is particularly disturbing is that Connor writes about genetically altered babies using MR in 2014 and then writes in 2016 that genetically modified embryos have yet to be made. Does he have amnesia or is this a real-life example of Orwell’s “Ministry of Truth,” where the government decides what is true and the media just blindly report it?

It seems that in the genetic-engineering arena, you just have to redefine what the public might find objectionable and all is forgotten. 

This does not bode well for the future.

The scientists who will edit the nuclear DNA of “spare” IVF embryos to try to manipulate the genes responsible for implantation are clear that all modified embryos from their research will be destroyed. To implant them would be against U.K. law. But for how long? 

The researchers insist there is no slippery slope. These same techniques will not be used to make “designer babies.” The head of the team, American researcher Dr. Kathy Niakin, told the Independent: “Because in the U.K. there are very tight regulations in this area, it would be completely illegal to move in that direction. Our research is in line with what is allowed … in the U.K. since 2009, which is purely for research purposes.”

Considering those “tight restrictions” have been easily redefined before, many are skeptical. David King, director of Human Genetics Watch, commented on the U.K. government regulation: “Although we are always told that the HFEA is there to make sure that crucial ethical lines are not crossed, in reality, the HFEA exists precisely in order to manage and facilitate these transitions and to make sure that the slope stays slippery.”

If all it takes is a simple redefinition to legalize “new” genetic-engineering techniques, then the human genetic-modification slope is more slippery than a greased watermelon.

There is some good news, however. To date in the United States, modifying IVF embryos has fallen under the umbrella of the FDA. Congress has passed language as part of the latest funding bill, which prevents the FDA from approving “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” Dr. David Prentice at TownHall.com, calls this only a “pause,” not a permanent solution.

If America is going to stop sliding down the slope toward designer babies, what is needed in the U.S. is some legislation regulating germ-line genetic engineering in human embryos: legislation that has a clear and correct definition of “genetic modification” that cannot be quietly revised with each new genetic-engineering advance.

Otherwise, we may be living in a high-tech version of Orwell’s 1984, where every year there is a new headline that claims the genetic tinkering of the past never occurred — and today is the first time scientists have altered our genetic makeup.

 

 

 

Rebecca Taylor is a clinical laboratory

specialist in molecular biology.

She writes about bioethics

on her blog, Mary Meets Dolly.