Tags: Heart Disease | FDA | fertility | three parents | birth defects

FDA Debates Three-Parent Babies

By Melissa Clyne   |   Wednesday, 26 Feb 2014 11:55 AM

Scientists, ethicists, and religious organizations have weighed in on an experimental procedure known as three-parent in-vitro fertilization, which takes DNA from the mother, the father, and a third woman to create an embryo without inherited diseases.

A Food and Drug Administration panel met in Maryland this week to discuss whether lab experiments of three-parent IVF should progress to human testing, The Washington Post reported.

If successful, the procedure would allow prospective parents the opportunity to guarantee their child would not inherit diseases such as muscular dystrophy, epilepsy, and some heart and liver conditions.

However, safety concerns as well as ethical dilemmas present an obstacle for many who argue that genetically modified embryos are tantamount to playing god or creating designer babies, where parents might choose eye or hair color.

"Every time we get a little closer to genetic tinkering to promote health — that’s exciting and scary," Dr. Alan Copperman, director of the division of reproductive endocrinology and infertility at Mount Sinai Medical Center in New York, told The New York Times.

"People are afraid it will turn into a dystopian brave new world. The most exciting part, scientifically, is to be able to prevent or fix an error in the genetic machinery."

The technology, pioneered by developmental biologist Shoukhrat Mitalipov of Oregon Health & Science University, has been tested on rhesus monkeys from three parents who are now more than 4 years old, The Scientist reported in October.

The U.K. Human Fertilisation and Embryology Authority – the country’s independent regulator overseeing the use of gametes and embryos in fertility treatment and research – has approved human trial testing, but Parliament still has to make its decision before such testing can commence.

Mitalipov has said he will pursue testing in whichever country approves it first.

The FDA is concerned only with the science of the testing, not the ethical issues, according to Fox News, which reported that at the conclusion of this week’s hearings some committee members raised safety concerns, suggesting that just because testing on animals had been safe, it may not be so for women and children born by the procedure.

The FDA is not required to follows its panels’ recommendations, according to the Post.

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