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We are heading toward a slippery slope. The United Kingdom is moving closer to allowing scientists to create genetically modified children – something no country in the world currently authorizes.

I posted in December about how the United States and the U.K. were going down a dangerous road. The Human Fertilisation and Embryology Authority (HFEA), the key U.K. regulator on these matters, recently issued (on very short notice), a “Call for evidence” on issues of safety and efficacy, with a deadline of today, March 21, 2014.

HFEA has released draft regulations that would allow clinical trials of techniques that would create “three-person embryos.” These methods are proposed as a way to help a very small number of women with certain mitochondrial diseases to avoid passing those diseases on to genetically related children. The draft notes that “the Government has decided to proceed with regulations. However, before taking the decision to submit regulations for the scrutiny and approval of Parliament, we will…reconvene the Expert Panel a further time to provide an updated assessment of the safety and efficacy of these techniques.”

It’s deeply troubling that the U.K. would rush to develop regulations for the use of experimental procedures to genetically modify babies without ensuring that the procedures are safe and effective. My mother’s common sense tells me that you attend to those issues first, and only then, do you craft enabling regulations –carefully, with broad-based public input. But that’s not what’s happening.

HFEA’s “Call for evidence” was apparently posted quietly on March 7, with no notice to the general public. People who are concerned about the safety and efficacy of methods that would be used to genetically modify children, and who, by chance, learned of the “Call,” were given only 14 days to submit comments. The HFEA schedule is a tight one. It calls for: 1) a meeting on April 4, 2014; 2) review of all the evidence by April 25; and 3) submission of a final report to the Department of Health in May, 2014.

The HFEA is proceeding at a fast clip.  But all the evidence says it should slow down.

Last month I posted about the then-forthcoming U.S. Food and Drug Administration Advisory Committee meeting on the scientific, technological, and clinical issues raised by these biotechnological procedures. The meeting took place on February 25 and 26.  I was there and laid out my concerns. I was expecting the scientific experts to be relatively sanguine about the safety and efficacy issues. But the worries of the members of the public who spoke at the meeting--all in opposition to human clinical trials--did not fall on deaf ears.

Even the briefing document prepared by the FDA prior to the meeting spoke to the many known and unknown risks that would be imposed on any resulting children--and their descendants.  During the meeting, members of the Committee expressed serious concerns about the use of these methods in humans, citing the limited scientific understanding of mitochondrial disease and the insufficiency of the pre-clinical evidence gathered so far.

Dr. David Keefe, an obstetrician-gynecologist at New York University’s Fertility Center, cautioned that “there are things we know, there are things we don’t know, and there are things we don’t know we don’t know.” He warned that allowing the use of these techniques could lead to a “very, very slippery slope.” In summarizing the Advisory Committee’s views, the chair, Dr. Evan Snyder, noted that “there is no question that there is overall great concern for the well-being of children.” He concluded that “there was a sense of the Committee that at this particular point in time there is probably not enough data either in animals or in vitro to conclusively move on to human trials without… answering a few additional questions,” on both the basic science and pre-clinical data.

It is simply too early to know the long-term effects of these methods on animals--let alone human beings.

These procedures would also involve an unprecedented level of experimentation on non-consenting human subjects--in this case, future generations.  Just imagine.  Scientists adjust the genes of the future child, and those changes are passed from one generation to the next.  Not a single one of those children would have the opportunity to consent. And the changes would be irreversible.

That should be reason enough not to allow human clinical trials.  

But there is more.  As the FDA recognized, these safety issues are also inextricably intertwined with a wide range of ethical and social policy questions. Allowing these procedures could open the door to further genetic manipulations, so that we would wind up treating children like “manufactured products.” In fact, in discussing how human clinical trials might be designed, Committee members actually talked about the “manufacturing controls” that would be needed to minimize the risks to the “products” – by which they meant the manipulated embryos.

Committee member Dr. Renee Reijo Pera, Vice President for Research at Montana State University, acknowledged that since the cloning of Dolly, there has been, in effect, a global pact prohibiting genetic modification of human embryos. A decision to end that de facto moratorium  should not be made unilaterally by the HFEA, the FDA, or any one agency or nation.

That’s why I added my name to a letter urging the HFEA to take additional time to: (1) extend the deadline for responses to the “Call for evidence” to allow for greater input on this crucial matter; and (2) thoroughly explore the safety and efficacy issues raised by the FDA  Committee. If you agree, weigh in by emailing a note to the HFEA at mitochondriareview@hfea.gov.uk, including a link to our letter and letting them know that you share our concerns. Even if we are past the deadline, we should make our views known.

The FDA Committee members were right to counsel caution, and Britain’s HFEA should pay attention.


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