The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 17 No. 9 • October 2014

Another GREAT IDEA From the FDA

According to the 7 August 2014 Nature (pg. 11), the FDA announced on 31 July of this year that it will regulate the development of diagnostic tests and genetic tests by hospitals and laboratories in the United States. The regulations, to be phased in over 10 years, will bring “scientific rigour to a field that has become unruly,” according to the Nature editorial on pg. 5 of that issue. We think it would have been more appropriate to say the regulations will usher in a new era of “scientific rigor mortis.”

We are seriously alarmed at the welcome offered by the ignoramuses at Nature to the FDA’s acquisition (by self-proclamation independently of Congressional authorization) to be the sole authority on diagnostic and genetic tests. “Such guidance should be welcomed,” the editorial exhorts, “not resisted.” Oh, really? The historical record of the FDA offers no support for such confidence in the FDA’s scientific expertise. Rather than the “unruly” nature of freedom to innovate that fosters a diversity of ideas for diagnostic testing and for genetic testing (some of which will be good ideas, some will not be so good), we will have the dead hand of the FDA determining (with all the scientific authority of a loaded gun pointed at your head) what test you may use. This is what the federalies have done to 23andME — and it is resulting in poor health planning that could have been avoided if 23andMe could have supplied truthful information about current understanding of genetic risks to their customers.

(Incidentally, the email message sent to customers by 23andMe celebrating their “progress” in “negotiating” with the FDA to receive the agency’s approval to offer genetic information is simply pathetic — no progress was in evidence — they might as well celebrate the fact that the loaded gun pointed at their head had not been used to shoot them so far, so there’s some real progress there! What the company seems to fail to realize is that by the time years have gone by and they have not gotten the FDA’s approval to offer genetic information, competitors outside FDA’s authority (such as those located in other countries) will be cleaning up selling the information. 23andMe would be better off, in our judgment, to hire Jonathan Emord and vigorously sue the agency for violating their First Amendment rights. They might be very surprised at the speed with which the agency decides to reconsider their current censorship of 23andMe.

Just another good reason to seek medical services such as individual testing kits from outside the U.S. This is good news for Hong Kong and India, though. Just mail a bit of your spit to Hong Kong or Mumbai …

Another good reason to RESIST FDA tyranny!

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