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Brave New World: Making baby with the DNA of 3 people FDA weighs new technique


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Making baby with DNA of 3 people: FDA weighs new technique

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.

WASHINGTON —

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.

An estimated 1 in 5,000 U.S. children inherit such conditions because of defective DNA in their mitochondria, small energy-producing organs found in the cell. Unlike most DNA -- located in the nucleus of the cell -- mitochondrial DNA is passed along only by the mother, not the father.

The experimental technique, if approved for use, would allow a woman to give birth to a baby who inherits her normal nucleus DNA but not her defective mitochondrial DNA.

To accomplish this, researchers would remove the nucleus DNA from a healthy female donor's eggs and replace it with the nucleus DNA of the prospective mother. After fertilization, the resulting child would inherit the mother's nucleus DNA -- which contains most inherited traits like eye color and height -- but the donor's healthy mitochondrial DNA.

The technique initially made headlines as a way to create babies with three parents, but scientists say that's an overstatement, since the child would have only trace bits of DNA from the donor.

No matter how it's described, the technique faces opposition from a broad spectrum of critics who say it presents serious medical, ethical and societal dilemmas.

Chief among these concerns is that the genetic changes created using the technique would be passed down to future generations, potentially spreading unintended health consequences throughout the population.

In a letter to the FDA, the Center for Genetics and Society points out that more than 40 countries -- including Germany and France -- have laws banning human gene modification that is passed on to future offspring.

The group's director says mitochondrial replacement would help only a tiny fraction of patients affected by such disorders, and they have other options like egg donation to create healthy children.

"It does initially look like something you would want to support," said Marcy Darnovsky. "But the safety concerns and the social and ethical concerns are really overriding."

Still, many 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."

http://seattletimes.com/html/health/2022983612_apx3parentembryosfda.html

Fear of ‘Designer Babies’ as F.D.A. Weighs Fertility Procedure

GAITHERSBURG, Md. — The Food and Drug Administration is weighing a controversial fertility procedure that involves combining the genetic material of three people to make a baby free of certain defects, a therapy that critics say is an ethical minefield and could lead to the creation of designer babies.

The agency has asked a panel of experts to summarize current science to determine whether the approach – which has been performed successfully in monkeys by researchers in Oregon and in people more than a decade ago– is safe enough to be used again in people.

The F.D.A. meeting, which is being held Tuesday and Wednesday, is meant to address the scientific issues around the procedure, not the ethics. Regulators are asking scientists to discuss the risks to both the mother and the potential child, and how future studies should be structured, among other questions. The meeting is being closely watched. The science of gene therapy has advanced dramatically in recent years, and many scientists are urging federal regulators to ease requirements for study in humans.

The procedure in question involves mitochondria, the power producers in cells that convert energy to a form cells can use. It replaces mitochondria with defects that could be passed to a fetus with healthy mitochondria from another woman. This is done either before an egg is fertilized, or after.

Scientists have already experimented with combining genetic material from cells of three people. In 2001, researchers in New Jersey did so using material from the cytoplasm, the material that surrounds the nucleus of the egg and directs its development after fertilization, from healthy women into the eggs of infertile women. More than 17 babies have been born this way in the United States.

The practice sparked controversy and eventually led the F.D.A. to tell researchers that they could not perform such procedures in humans without getting special permission from the agency. Since then, studies have been confined to animals.

26baby_part-superJumbo.jpg Dr. Alan Copperman, director of infertility at Mount Sinai Hospital, in his office in New York on Tuesday. Credit Damon Winter/The New York Times

But a researcher in Oregon, Shoukhrat Mitalipov , has performed the mitochondrial procedure in monkeys successfully and has said it is ready to try in people.

Such genetic methods have been controversial in the United States, where critics and some elected officials ask how far scientists plan to go in their efforts to engineer humans, and question whether such methods might create other problems later on.

“Every time we get a little closer to genetic tinkering to promote health — that’s exciting and scary,” said Dr. Alan Copperman, director of the division of reproductive endocrinology and infertility at Mount Sinai Medical Center in New York. “People are afraid it will turn into a dystopian brave new world.”

He added that the current meeting and discussion was an attempt at “putting together a framework for us to prepare for this genetic revolution.”

“The most exciting part, scientifically,” he said, “is to be able to prevent or fix an error in the genetic machinery.”

http://www.nytimes.com/2014/02/26/health/fda-meeting-considers-controversial-fertility-procedure.html

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Just skip to the last paragraph of the linked Seattle Times article, that's all you need to read.

"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."
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Just skip to the last paragraph of the linked Seattle Times article, that's all you need to read.

I don't know what to think of this. I am mean its good because future generations could become resistant to certain diseases and illness but on the other hand it opens up a can worms for other things. I guess its a wait and see kind of thing.

I think we should embrace our unique individual quantities more then ever now... Things like looks or IQ could be possessed my many people now in the future in the form of designer babies.., but mostly likely wealthy people.

Imagine if somehow designer babies become the norm in like 100 years or so? and having regular birth was reserved for poor people. Humans have sure screwed up good things in the past...

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I don't know what to think of this. I am mean its good because future generations could become resistant to certain diseases and illness but on the other hand it opens up a can worms for other things.

Except consider the consistency at how this is stated for every technology that causes warnings of some slippery slope. Designer babies are already possible with IVF, and are hardly ever done anyways, so I'm not sure where this alarmist perspective comes from.

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Except consider the consistency at how this is stated for every technology that causes warnings of some slippery slope. Designer babies are already possible with IVF, and are hardly ever done anyways, so I'm not sure where this alarmist perspective comes from.

Scientists fear mongering for government funds. :lol:

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Guest Gumballthechewy

Imagine if somehow designer babies become the norm in like 100 years or so? and having regular birth was reserved for poor people. Humans have sure screwed up good things in the past...

"We must purge our cities from the filth of those genetically inferior to ourselves! Are we not the pinnacle of the human race? Why should we share this planet with those who are so inferior to ourselves, those who could muddy our genes with their filth? I imagine a world where the genetically superior live free from the trash!"

~ Unknown Designer Baby c. 2112

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"We must purge our cities from the filth of those genetically inferior to ourselves! Are we not the pinnacle of the human race? Why should we share this planet with those who are so inferior to ourselves, those who could muddy our genes with their filth? I imagine a world where the genetically superior live free from the trash!"

~ Unknown Designer Baby c. 2112

Captain Kirk will save us......as usual

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Guest Gumballthechewy

Can you design me a mix of the following

Mila Kunitz

Scarlette Johanssen

Natalie Portman

Hayley Atwell

Jamie Alexander

K thanks I would really appreciate it before I am to old for that to be enjoyable

I'd have to be dead before I'm too old for that to be enjoyable. :P

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