The Food and Drug Administration will meet with Oregon Health and Science University Portland Wednesday and Thursday to discuss a procedure on newborns that has thus far only been used on monkeys, reports Bloomberg Sustainability.
This procedure combines the DNA of three people — the mother, the father and a donor – and changes genetic code by replacing the genes in the mother that have a genetic disease with “disease-free genes from a donor,” Bloomberg Sustainability reports.
“Pre-birth manipulation” could lead to ethical issues of designing babies to fit a mold.
The procedure would allow the baby to keep its physical characteristics from its parents because of the specificity of the genetic code, but the DNA would still be present with the child from all three people for the rest of the child’s life.
Jeremy Gruber, president of the Council for Responsible Genetics, told USAToday that this procedure goes too far, having “implications not only for the offspring, but future generations of that offspring.”
Gruber said he thinks the FDA is acting “outside the public interest” and shouldn’t be holding these hearings.
The procedure could prevent mitochondrial diseases, which occur in one in about 5,000 children with defective DNA, the Daily Mail reports. Mitochondria regulates the amount of energy produced in every cell of the body, except red blood cells.
Vamsi Mootha, professor of systems biology and medicine at Harvard Medical School in Boston, studies mitochondrial disorders and told Bloomberg Sustainability that this isn’t just a procedure to repair disease, but to “offer a woman who’s a carrier for disease more options.”
From 1997 to 2003, “about 30 children worldwide were born” with this procedure. The year of the first baby born from this procedure was reportedly 1997, Bloomberg Sustainability reported.
The New York Times reports that 17 babies were born this way in the U.S. The FDA told researchers they would have to get “special permission from the agency” to continue this procedure, so the study has since been performed only on animals.
Shoukhrat Mitalipov is the lead researcher over the Oregon team’s work and told USAToday that the work is “gene correction” — not “gene modification.”
“We want to replace these mutated genes, which by nature, have become pathogenic to humans,” said Mitalipov to USAToday. “We’re reversing them back to normal, so I don’t understand why you would be opposing that.”
Dr. Alan Copperman, director of the division of reproductive endocrinology and infertility at Mount Sinai Medical Center in New York, told the Times that this meeting will “prepare for this genetic revolution.”
“Every time we get a little closer to genetic tinkering to promote health — that’s exciting and scary,” said Copperman. “People are afraid it will turn into a dystopian brave new world.”
Four monkeys born from this procedure were reported as healthy at age three by a 2009 report by the Oregon researchers in the journal Nature.
Nature again published reports in October 2012 that scientists tested the procedures in human egg cells, half of which developed normally.
The Wednesday meeting with the FDA will determine if these embryos can be implanted in women based on FDA permission.