Monday, November 25, 2013

FDA orders 23andMe to Halt "Marketing"??? WHAT????!!!

So I just heard the news that the FDA has ordered 23andMe to halt markeing its DNA kits.  Really??? Seriously?



Personally, I don't care about the health results, but this seems to be waaay to "Big Brother" to me.  We are adults who can decide what we wish to purchase.  And we can decide what we wish to consider when making health decisions.  The FDA has approved every single, horrible, junk food currently on the market, and is now giving 23andMe grief?!  The odds of someone getting a false negative or positive and getting sicker or dying is surely far lower with 23andMe than the odds of getting sick or dying from junk food!   Anyone who does not seek a Dr.'s advice on seriously health results from 23andMe would have to be really stupid IMHO.  Do I think the results are accurate? Sure, I do actually, I think their results are quite accurate.  And I think they could change medicine.  I think that genetic research done by 23andMe could cure diseases in the future.  And I think that this is an issue of $$ that other companies are worried about.  I think that the insurance companies don't WANT you to find out if you have something medically wrong too early, because you will rack up the medical bills trying to *gasp* save your health/life!

I only test at 23andMe for genealogy reasons, but I care about this issue because it will mean less matches for me in the future if they stop marketing, even if only for awhile.  I love getting my new 23andMe matches!

I don't think this will end the processing of kits they have already sold, and I see no indication that they are in fact halting sales, so I intend to continue to order new kits....

Please sign the (US only) petition here: https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB

US and non-US petition here: https://www.change.org/petitions/fda-administrator-margaret-hamburg-don-t-ban-home-genomics-kits

You can read the official FDA letter to 23andMe here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

You can read one news report at http://www.bloomberg.com/news/2013-11-25/fda-tells-google-backed-23andme-to-halt-dna-test-service.html

The official response so far from 23andMe "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

You can read some interesting details on the whole FDA/DTC genetic testing situation at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2948799/