Experts from the National Academy of Sciences, Engineering and Medicine are advising President Obama's Food and Drug Administration (FDA) to approve mitochondrial DNA replacement techniques (MRTs) to help about a hundred Americans give birth to creatures fabricated in a laboratory using genetic material from three unrelated people. The experts promise that no scientists in the future will misuse the techniques to "play god" and create any Frankenstein babies.
For background, read President Obama's FDA Pushes 3-parent Babies
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Also read Unborn Must Die so Others Can Live, Scientists Say
-- From "Three-parent babies are ok, experts say" by NBC News 2/4/16
Such "three-parent" babies could be a way for people with a high risk of rare, devastating genetic diseases to have healthy children that are genetically their own, the National Academy of Medicine panel said.
And at first, the panel advised, only male embryos should be made this way until it's clear that dangerous mutations would not be passed down to future generations.
The FDA asked the academy, formerly known as the Institute of Medicine, to look at the three-person embryo processes, called mitochondrial replacement techniques (MRT). These are variations of in vitro fertilization, or IVF — the method that creates so-called "test-tube babies."
MRT adds a step [to IVF]: The mother's nuclear DNA would be removed and placed into the egg cell of another woman. The father's sperm would then be used to fertilize that hybrid egg.
The new techniques would be used to prevent the transmission of certain types of diseases that occur at the mitochondrial DNA level, the experts said.
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From "Babies With Genes From 3 People Could Be Ethical, Panel Says" by Rob Stein, WBEZ-FM91.5 NPR (Chicago, IL) 2/3/16
Critics of the research, meanwhile, say the number of women who could benefit from the experiments is so small that it's not worth crossing a line that's long been considered off-limits — making genetic changes that could be passed down for generations.
"The possibility of what you could call 'mission creep' is very real," says Marcy Darnovsky, executive director of the Center for Genetics and Society, a watchdog group based in Berkeley, Calif. "People are talking about going forward not just with this but with the kind of genetic engineering that will produce outright genetically modified human beings."
Once that happens, Darnovsky says, "I think you get into a situation of where some people are genetically enhanced and other people are the regular old variety of human being. And I don't think that's a world we want to live in."
. . . The FDA email praised the "thoughtful work" of the panel and said the agency would be "reviewing" the recommendations. But it noted that the latest federal budget "prevents the FDA from using funds to review applications in which a human embryo is intentionally created or modified to include" changes that could be passed down to future generations. As a result, the email says, any such research "cannot be performed in the United States" at this time.
"I think it's a great step in the right direction," Mark Sauer, a professor of obstetrics and gynecology at Columbia University who is a member of one of the teams . . . "Politics as usual often gets in way of progress," Sauer said in a subsequent email. While the FDA statement would cause "undue delays" in his research, he added that he hoped it wouldn't permanently "necessarily halt the efforts."
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From "Should scientists be allowed to change DNA to prevent genetic disease?" by Daphne Chen, Deseret News 2/3/16
"I think the field has come together to say, 'Let’s think about this together and go forward carefully,'" said Dr. Jeffrey Botkin, a professor of pediatrics and chief of medical ethics and humanities at the University of Utah.
Botkin sat on the 12-person committee that included top bioethics experts from Johns Hopkins, Caltech and Harvard.
"There's not a bright line between where this kicks over into unethical," [University of Utah, Department of Biochemistry Dr. Jared] Rutter said. "The technology that we have is expanding … more rapidly than our sophistication with thinking about how to use it."
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From "Ethicists approve ‘3 parent’ embryos to stop diseases, but congressional ban remains" by Joel Achenbach, Washington Post 2/3/16
The committee, which was convened last year at the request of the Food and Drug Administration, concluded that it is ethically permissible to “go forward, but with caution” with mitochondrial replacement techniques (MRT), said the chairman, Jeffrey Kahn, a bioethicist at Johns Hopkins University.
But the advisory panel’s conclusions have slammed into a congressional ban: The omnibus fiscal 2016 budget bill passed by Congress late last year contained language prohibiting the government from using any funds to handle applications for experiments that genetically alter human embryos.
Thus the green light from the scientists and ethicists won't translate anytime soon into clinical applications that could potentially help families that want healthy babies, said Shoukhrat Mitalipov, a pioneer of the new technique at Oregon Health & Science University in Portland, Ore.
“It seems like the FDA is disabled in this case by Congress," Mitalipov said. “At this point we’re still not clear how to proceed."
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From "Report: It's ethical to test embryos from DNA of 3 people" by Lauran Neergaard, Medical Xpress 2/3/16
The genes that give us our hair and eye color, our height and other family traits—and some common diseases such as cancer—come from DNA in the nucleus of cells, the kind we inherit from both mom and dad.
But only mothers pass on mitochondrial DNA, to both daughters and sons. It encodes a mere 37 genes, but defects can leave cells without enough energy and can lead to blindness, seizures, muscle degeneration, developmental disorders, even death. Severity varies widely, and researchers estimate 1 in 5,000 children may inherit some degree of mitochondrial disease.
Critics have argued that the first such births would have to be tracked for decades to be sure they're really healthy, and that families could try adoption or standard IVF with a donated egg instead. And they say it crosses a fundamental scientific boundary by altering what's called the germline—eggs, sperm or embryos—in a way that could affect future generations.
"It is reckless to proceed with this form of germline modification," said Marcy Darnovsky of the Center for Genetics and Society, an advocacy group.
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