Not Science Fiction: FDA Evaluating 3-Parent Embryo Creation


In James S.A. Corey’s 2011 sci-fi novel Leviathan Wakes, James Holden, one of the book’s two main characters, finds himself being questioned by Martian authorities about his non-traditional upbringing on Earth:

“Your file says you were the only child of a family co-op,” Lopez said, acting as though they’d never stopped talking about Holden’s past.

“Yes, five fathers, three mothers.”

“So many parents for only one child,” Lopez said, slowly unwrapping another lozenge. The Martians had lots of space for traditional families.

“The tax break for eight adults only having one child allowed them to own twenty-two acres of decent farmland. There are over thirty billion people on Earth. Twenty-two acres is a national park,” Holden said. “Also, the DNA mix is legit. They aren’t parents in name only.”

“How did they decide who carried you?”

“Mother Elise had the widest hips.”

As an avid fan of the genre, I’ve come to expect the presentation of such oddball concepts as part of the future cultural landscape. Science Fiction authors dream big, and like to challenge assumptions. The book is a rousing space opera that begins a thrilling trilogy, and at the time I read it I filed away the multi-parent situation in whatever part of my brain handles those kind of weird details until I need them for later use.

Evidently, that day is today.

The Associated Press reports that the US government has taken a proposal not altogether different than the one I excerpted above under consideration:

Federal health regulators will consider this week whether to green light a provocative new fertilization technique that could eventually create babies from the DNA of three people, with the goal of preventing mothers from passing on debilitating genetic diseases to their children.

The Food and Drug Administration has framed its two-day meeting as a “scientific, technologic and clinical” discussion about how to test the approach in humans. But the technique itself raises a number of ethical questions, including whether the government should sanction the creation of genetically modified humans.

The FDA panel will hear from several prominent critics who oppose any human testing of the approach, arguing that it could be a slippery slope toward “designer babies,” – in which parents customize traits like eye color, height and intelligence.

But the field’s leading U.S. researcher will be on hand to explain and defend his work, which he describes as “gene correction,” rather than “gene modification.”

“We want to replace these mutated genes, which by nature have become pathogenic to humans,” says Dr. Shoukhrat Mitalipov, who will present on Tuesday. “We’re reversing them back to normal, so I don’t understand why you would be opposing that.”

The FDA meeting was prompted by Mitalipov’s research at Oregon Health & Science University in Portland, where he and his staff have produced five healthy monkeys using the DNA-replacement technique. He is seeking FDA approval to begin testing in a handful of women who carry defective genes that can lead to devastating diseases in children, including blindness, organ failure and epilepsy.

Things like this always begin for such seemingly noble scientific reasons, don’t they? But they rarely stop there. And of course in addition to creating tri-parent offspring, which creates ethical and genealogical nightmares in its own right, virtually every instance of embryonic modification involves a slew of violations of the moral law, from in-vitro fertilization to the destruction of fertilized human embryos — human life — deemed imperfect or unnecessary to achieve the desired outcome.

What is the likelihood that the FDA would approve such a procedure? More likely than you think.

[M]any experts expect the FDA to eventually sign off on testing the technique. They note that regulators in the U.K. found broad public support for the research there, with no evidence that it would endanger mothers or their children. The U.K. has significantly more regulations surrounding in vitro fertilization than the U.S., where fertilization clinics are essentially a self-regulated industry.

And before the FDA considers the philosophical implications of genetically modified children, its first concern is the safety of any patients enrolled in experiments. In documents posted ahead of this week’s meeting, the agency said it will seek public input on how to monitor the safety of women who undergo the fertilization process. The agency also wants to hear proposals for long-term follow-up of any children produced via the process.

Stanford University Professor Hank Greely says the FDA is taking the right approach by focusing on the immediate safety concerns, rather than speculating on whether this could lead to a “Brave New World” scenario of biologically engineered humans.

“We constantly live on slippery slopes and it’s our job as moral humans to hold a good position on the slope,” said Greely, a law professor who studies medical ethics. “If you’re worried about genetically engineered monsters or superheroes then you try to stop that, you don’t try to stop medically useful interventions because you’re worried that 17 steps down the line it will turn into something we don’t like.”

Is it just me, or does it seem as though most times someone publishes the opinion of someone with the word “ethicist” in their title, they turn out to be someone promoting just the opposite of ethics? (Maybe I’m just still thinking about this.)
It’s too early to tell what comes next with research of this nature, but genetic manipulation is poised to be a growth industry in coming years, and genetic testing and embryonic manipulation are already making waves. Look no further than the case of Amanda and Bradley Kalinsky, published earlier this month:

Her first thought after she heard the news, after she screamed and made her mother and boyfriend leave the room, was that she would never have children. Amanda Baxley’s doctor had just told her, over a speakerphone in her psychiatrist’s office, that she had the gene for Gerstmann-Straussler-Scheinker disease, or GSS, which would inevitably lead to her slow and terrible death.

This rare neurological disease had stalked her family for generations. Her father, 56, was even then in its final throes.

On the spot, Ms. Baxley, 26, declared she would not let the disease take another life in her family line, even if that meant forgoing childbirth. “I want it stopped,” she said. The next day, her boyfriend, Bradley Kalinsky, asked her to marry him.

But the Kalinskys’ wedded life has taken a completely unexpected turn, one briefly described on Monday in The Journal of the American Medical Association Neurology. Like a growing number of couples who know a disease runs in the family, they chose in vitro fertilization, and had cells from the embryos, created in a petri dish with her eggs and his sperm, tested first for the disease-causing gene. Only embryos without the gene were implanted. The Kalinskys are now parents of three children who will be free of the fear of GSS.

Yesterday, a friend quipped in a Facebook post: “Brave New World was a warning, not a roadmap.”
Evidently, the scientific community didn’t get that memo.

Categories:Abortion Health Care Pro-Life

  • Mito Adult

    If Catholics stand a chance of gaining respect in defending against this agenda, we must use scientific empirical data, otherwise our voice against abortion and IVF is just background noise in the public, like Charlie Brown’s parents. Absolutely this is a germ-line modification, hands down. But what needs to be brought into this debate is “why”? Is it truly needed, and why were the scientist/researchers who are so closely related to cloning given such a loud voice in the debate. The 1:5000 babies that is being reported as the number of children born with a mitochondrial disease is misleading, and is being used by those advocating this technique to gain public favor. What is not being reported by the secular press, and the Catholic media needs to jump all over it is the fact that 1 in 5,000 represents those who may develop a mitochondrial disease in their life-time. Mitochondrial diseases can arise from nuclear DNA (nDNA) or in the mitochondrial DNA (mtDNA) or in the communication between the nucleus and mitochondria. Most mitochondrial disease that present in infants and children are due to mutations in the nDNA. This technique addresses ONLY mutations in the mtDNA and does not address mutations in the nDNA. The actual number of babies born with a mitochondrial disease at birth if far less than the reported 1 in 5,000. Keep in mind, that number represents folks like me, who developed the disease in later decades of life, and not at birth. For me, it became debilitating in my 5th decade. The manipulation of data needs to be brought into the light for this debate. When you understand that the ground this debate was won on in the UK was because the proponents used data that many children would be spared great suffering, when in fact that number is far less. Which begs the question, if they are going to make a recovery on their financial investment of this technology, where is that going to take place? Its a Trojan horse to usher in accepted gene modification in my humble opinion.

  • William Foster

    All this is absolute nonsense.
    It is not playing God. Merely enabling a woman whose Mitochrondria have faulty DNA to have a healthy child. Mitochondrial DNA is not really part of the genotype of the fetus. In no way is this interfering with the DNA of the fetus.
    Suggest you people go to a library & learn some basic biology. Like what a Eukaryote cell is. Before opening mouth or writing strong opinions at least learn something about the issue about which you have such strong opinions

  • TCL

    I have to admit this is one of those areas I lose the ability to articulately explain my sense of outrage. Simply, where’s the respect for human life? We are now gods.

  • Eric Johnson

    Oh Steve. You have such little faith in the human race.

    • Brian

      Oh, Eric. you have too much.

      • Steve Skojec

        I wish we had a “like” button on comments.

      • Eric Johnson

        Brian, we are God’s greatest creation and I have great trust in His creations.

  • Rebecca Taylor

    One of the most compelling arguments against this technique that you do not mention is that this creates a germ-line modification; one that will be passed onto to future generations. Dozens of technologically advanced countries have laws prohibiting such modifications because they are experimentation on generations that did not consent.

    Research on mitochondrial disease needs to stay focused on treating patients; not on the germ-line genetic engineering of future generations.

    • Steve Skojec

      Thanks, Rebecca. This was cited in the original article I linked. Due to space and my decision to prioritize other ethical concerns, I chose not to highlight this. I’m glad you brought it up though.



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