FDA

Genetically-modified humans are already walking among us

Wednesday, May 15, 2013 by: Ethan A. Huff, staff writer
Tags: GM babies, FDA, human genome

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(NaturalNews) An undated article discussing the invention of genetically-modified (GM) human beings that was published by the U.K.'s DailyMail at least 10 years ago is gaining fresh attention from the online community these days. And even though the heinous practice, which is known as cytoplasmic transfer, is technically illegal in the U.S., the current regulatory framework offers little in the way of enforcement capacity against those that breach this moratorium.

Because the DailyMail article is not dated, some have mistakenly taken it to be current, and have adopted the position that GM babies may potentially become the next big thing in reproductive medicine. But it appears as though this is not actually the case, as the U.S. Food and Drug Administration (FDA) apparently banned this form of genetic manipulation back in the early 2000s after declaring it to be under its regulatory jurisdiction.

According to the original DailyMail article, Jacques Cohen, a former employee at the Institute for Reproductive Medicine & Science of Saint Barnabas in New Jersey, came up with a way to blend the genes of multiple mothers into a single egg that can then be fertilized with sperm from a male. The end product is a child with a genetic blueprint from three different parents, a process of human manipulation known as "germline" alteration.

This unscrupulous discovery, which only further taints the natural order of life with man-made genetic modifications, reportedly led to the development of at least 15 GM babies at that time, which are presumably still alive and now progressing through their adolescent years. And according to the original report, any children born to these GM individuals will also bear these modified GM traits, as they are inherently passed down from generation to generation.

"The fact that the children have inherited the extra genes and incorporated them into their 'germline' means that they will, in turn, be able to pass them on to their own offspring," wrote Michael Hanlon for the Daily Mail back at that time. "Altering the human germline - in effect tinkering with the very make-up of our species - is a technique shunned by the vast majority of the world's scientists."

GM babies are a 'biological product,' which puts them under FDA jurisdiction

This is admittedly a very frightening development, as it has the potential to unleash untold horrors on the human genome. But what is not clear from the original DailyMail article is when it was actually written, and if the procedure is still taking place today. As explained in a later paper published by the Washington Monthly in 2002, it appears as though GM babies did not necessarily take off as some believe, and this is due to FDA prohibitions.

"Since 1998, the Food and Drug Administration (FDA) has argued that genetically manipulated embryos are a 'biological product,' and therefore subject to regulation, just like medical devices and drugs," wrote Shannon Brownlee for the Washington Monthly. "FDA sent warning letters to six fertility centers threatening 'enforcement action,' and asserting its regulatory power over 'therapy involving the transfer of genetic material by means other than the union of [sperm and egg]'."

But some of the biotechnologists working in the field have since challenged the FDA's authority on the matter, arguing that the agency's perceived dominance is "a stretch." Does this mean that GM babies will soon become mainstream? It is difficult to say, but at this time, there does not appear to be any clinics in the U.S. actively performing such procedures in violation of the FDA's orders.

Sources for this article include:

http://www.dailymail.co.uk

http://www.lifenews.com

http://www.washingtonmonthly.com/features/2001/0203.brownlee.html

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