23 Skiddoo to “23andme” chromosomal screening

A couple of weeks ago the FDA came down, hard, on the “do it yourself” “Personal Genome Service” tests offered by Google-affilliated “23andme.com”, effectively shutting down their sales.
Their concern was that the company was marketing the kits “in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act)” as the company (per the FCC letter) “… markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention””.
This is one of those greyish areas between Big Gov’t as Big Nanny, but also with a company promoting a product as promising way above any scientifically valid data.
When even Forbes is on the side of the FDA… my head hurts. But I know better than to take acetaminophen… Oh, and make sure to read the Sci-Am article and comments.
The FDA’s letter: http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm
Forbes’ article:http://www.forbes.com/sites/davidkroll/2013/11/28/why-the-fda-cant-be-flexible-with-23andme-by-law/
And from what’s left of Scientific American:

http://www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda

5 responses to “23 Skiddoo to “23andme” chromosomal screening

  1. Of course, *nobody* would ever consider stockpiling data that could conceivably used in the future for eugenics. That would be as silly as, say, recording and storing every text and telephone connection made in the country to analyze later for ‘subversive activity.’

  2. Eyup. That’s _exactly_ the point made in the Scientific American article.

  3. When will these regulators start making sense? To Wit:
    1. I can buy “Natural Vitamins” to enhance my:
    a. Prostate Health
    b. Testosterone
    c. Memory
    d. And many many more, too numerous to number.
    But the FDA does nothing.

    2. Chiropractors try to treat diseases form Anaphylaxis to Zenker’s diverticulum, and many others in between some known only to them. (Once I had a patient in cardiac arrest on a Chiropractors manipulation table suffering from V-Fib and said he had a manipulation that would resolve it. I told him he had just a few seconds till the defibrillator charged to remove his hands from the patient or he would be launched across the room. He let go.)
    But the FDA does nothing

    3. They allow Homeopathic remedies that are nothing but dihydrogen monoxide, with even marginal placebo effectiveness to be sold. These hucksters draw people away from Evidence-based medicine remedies.
    But the FDA does nothing.

    I could continue but we all know it would never end.

    Now, they shut down a company that gives suckers information of dubious use, and places portion of their genome into a database? That data sure is better than the worthless and sometimes dangerous practices above. So let’s stop harassing the ants walking across red square, and start working where would really made a difference.

  4. So, only the government approved organizations can sell snake oil now?

  5. Just wait. There is a politically-connected competitor who will start marketing “approved” DNA kits, which will probably cost twice as much and be even more useless.
    That is how our current government works.

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