Now the FDA in the U.S. has joined the U.K.’s Human Fertilisation and Embryology Authority in being very close to approving trials of human genetic modifications that would create three parent babies. Both countries have formal and informal rules that forbid germ-line modification where embryos have their DNA modified and the alterations can be passed on to future offspring.
Fortunately, even if the Authority in the U.K. approves the trials, the issue will have to be debated and approved by Parliament before it can move forward. This is not the case with the FDA in the U.S. FDA approval is the only requirement to begin the trials.
Many ethicists believe this is the beginning of a trend toward designer babies. This is where prospective parents decide what characteristics they want their offspring to have and genetic modifications are made to order.
In an August 2013 post entitled Chimeras for Transplant and Third Parent Immunity, we raised the issue of genetic modification of a woman’s egg with genes from a second woman’s egg with the resulting egg being fertilized by a man. This was identified as the newest approach to protect babies where the biological mother had mitochondrial disease.
The framing of the proposal is that it allows a woman with mitochondrial disease to have children without any fear of passing on mitochondrial diseases. This creates a very sympathetic public reaction. Ethicists and geneticists point out however that no one knows what effects there will be on future generations from having the additional genes of the third parent.
According to Dr. Marcy Darnovsky, Executive Director of the Center for Genetics and Society in Berkeley, California, the concern is that the genes involved “have pervasive effects on development and metabolism. And the permissive record of the UK regulatory authorities raises the prospect that inheritable mitochondrial changes would be used as a door-opening wedge towards full-out germ-line manipulation, putting a high-tech eugenic social dynamic into play.”
The fear is of unpredicted outcomes in the children whose genes have been modified or in subsequent generations of direct descendants. Also, Dr. Darnovsky stated these trials would be “the first time a government body had okayed genetic changes for humans and their descendants.”
Even researchers who are generally supportive of the procedure have their doubts about proceeding to human trials. An article issued by Reuters said that Dr. Evan Snyder of the Sanford/Burnham Medical Research Institute in La Jolla, California, who chaired one of the committees queried by the U.S. FDA, said “there was probably not enough data in animals…to move on to human trials without answering a few additional questions” about safety.
The United States has a long history of supporting genetic engineering and modification. This would be its first experiment approved with human beings but the precedent has been set with its long history of approving and giving worldwide support to genetically modified plants and crops.
The FDA’s support has typically benefitted the U.S. agribusinesses that have commercialized these products and have strong lobbies. It appears there is not an organized lobby that would put pressure for approval of these trials.
For this reason, public pressure, domestic or foreign, might work to halt a positive decision to go ahead. I would recommend that readers who oppose germ-line modifications contact their congressmen or senators if they are U.S. residents. Opponents, in other countries should send correspondence directly to the U.S. FDA at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 or call 1-888-INFO-FDA (1-888-463-6332). Unfortunately, approval by the U.S. will be used as an example of ‘international competition’ to spur the UK to approve as well.
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