23andMe bows to FDA, drops all medical information from new tests

http://arstechnica.com/science/2013/12/23andme-bows-to-fda-drops-all-medical-information-from-new-tests/

by Jtsummers • 13 years ago

36 64 13 years ago

arstechnica.com

imjoshdean• 13 years ago

Well, this makes the fact that I asked for this for Christmas awkward AND useless...

jedberg• 13 years ago

I found the ancestry information for more interesting than the medical part. So all may not yet be lost.

bananacurve• 13 years ago

Unfortunately the differences genetically between different groups, aka ancestry, is less than the differences between individuals in the same group, so the medical part is what is interesting.

gwern• 13 years ago

My sentiment exactly. 2 days ago I put it on my wishlist, reasoning that even if they weren't marketing, the results would still be interesting. What if I get a kit now? Do I manually look up everything in SNPedia or something?

sitkack• 13 years ago

I have an unused kit from the 99$ sale years ago... Crap. Will they still provide all of the data? One could create a 3rd party service to give the same analysis?

cema2• 13 years ago

No need to do it manually: use promethease, for instance. Still, it's quite inconvenient.

mbreedlove• 13 years ago

I heard about a service called Promethease[1] that will apparently give you some in-depth reporting as well as risk levels for disease. It may be of interest to you.

[1] https://promethease.com/ondemand

jonlucc6• 13 years ago

I think it's interesting that they are still selling the kits at the $99 price point. They also haven't removed the health tab from their site. I'm guessing what they are doing is buying themselves time to prepare and discuss with the FDA. They might continue to run all the same SNPs on their already-designed chips and just try to justify to the FDA that those SNPs are medically relevant in the ways 23andMe says they are.

baddox3• 13 years ago

Obviously most of the blame goes to the FDA here. The only problem I have with 23andMe's handling of the situation is that they continued to sell kits after November 22 promising that health information would be available and then retroactively removing that part of the service. I ordered the kit one day before they announced this, so I guess as soon as it arrives it's going back in the mail for a refund. They should have immediately removed the promise of health information on November 22.

ceejayoz• 13 years ago

Why does most of the blame go to the FDA? From their complaint:

More than five years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the [testing service]," the letter states. It also says that in January 2013, 23andMe claimed that it was doing further testing for its approval application, testing that would take several months to complete; nearly a year later, it never submitted the results of the testing.

fennecfoxen• 13 years ago

Because the FDA is the one who ultimately wants this removed, and because by default most of society operates without seeking permission from the government to do anything.

And maybe because the FDA is stupid and thinks that the risk of people maybe finding out something inaccurate and going crazy with it is higher than the reward of people finding out something accurate and taking action to preserve their health based on this information. Ignorance is the only safe option!

baddox3• 13 years ago

When I said "the FDA," I really meant the entire legal and regulatory system that puts these silly limitations on a harmless product like 23andMe's DNA test.

maratd2• 13 years ago

Why is the Food and Drug Administration sticking it's nose into what is essentially a novelty product? Are you kidding me?

If only 23andme had a pair of balls ... this should really end up in court where we can clearly draw a line the FDA can't cross.

jrkatz• 13 years ago

I purchased and sent in my kit before they removed medical information from their website. However, it hasn't processed yet. I expected that medical information (even though I knew not to trust it). What an awkward position.

jonlucc6• 13 years ago

If they continue to not process the health information, I bet they will offer some sort of plan to mitigate the horrible PR from the nightmare that would ensue if they don't. I heard a seminar from one of the VPs and she made it seem like they don't run those chips at a very high margin, so this might set them back a bit, but I think the future is in their favor.

RyanGWU82• 13 years ago

I'm in the same position, although I returned my kit before the November 22 cutoff date. I figure I could probably request a refund given the new FDA situation -- given their regulatory situation, they'll probably loosen their refund policy to avoid compounding matters. But I don't think my kit should have any less information than before, so I figured I'd let it play out and see what the results look like. Obviously if my results don't include health data, then I'll certainly ask for a refund, because that was the main reason I enrolled.

dmazin4• 13 years ago

For what it's worth, my info is still visible so it might be possible that it'll be up for you too by the time sequencing is done.

throwaway0094• 13 years ago

Yeah, me too. The primary reason I purchased this is that I know I have 50% odds of having a BRCA mutation (1 of my parents does). I was really looking forward to that test.

streptomycin4• 13 years ago

This is exactly why the FDA is acting correctly here!

Dig deep on the 23andme website and you'll find that they test for a few BRCA mutations, but not all. It's far from comprehensive, and it's not at all equivalent to a normal test that you would get from a doctor. From https://customercare.23andme.com/entries/23241132-Does-the-2... "The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer."

I've seen several commenters here on HN making the same mistake as you. HN readers are generally smart and skeptical. If we aren't perceptive enough to see through the bullshit, how do you think the general public is going to fare?

mbreese• 13 years ago

Prior discussion from last night...

https://news.ycombinator.com/item?id=6859732

300bps• 13 years ago

I guess I will be making screenshots of all the health information in my 23andme account now. Who knows if they'll be allowed to keep it up there indefinitely?

jonlucc6• 13 years ago

I don't yet have one. Is there not a way to download your information? They should certainly allow some sort of export.

ideonexus• 13 years ago

I have an account. You can export your raw data from the test. I've done so and actually taken my results to other services for additional analyses. You can't, however, easily download their interpretations of your results, which is fair since that's their website. I did actually take the time to go page by page through their analysis and print them to pdfs.

If you're interested, I did a write-up on everything I've learned through personal genomics with resources, etc:

http://ideonexus.com/2012/04/16/adventures-in-personal-genom...

throwaway_yy2Di2• 13 years ago

Next week:

Show HN: Saliva Road -- genomics as a Tor hidden service. We accept Bitcoins!

-DreadPostdocRoberts

AsymetricCom• 13 years ago

Somehow I feel safer with a random pirate having my DNA in a database than Google.

swalsh• 13 years ago

It probably is safer in that, you will pretty much assume it will be use for nefarious purposes eventually. So going in you probably have the right mind set to protect yourself.

throwaway_yy2Di2• 13 years ago

That's an "interesting" idea: Google Ads targeted for your genome.

Crito2• 13 years ago

A hidden service bitcoin accepting DNA service presumably gives their clients anonymity right? So long as the DNA cannot be readily connected to my 'real' identity, I don't see much problem with anybody having it.

I mean, say they straight up sell it to insurance companies... now insurance companies know that some guy, somewhere, has [pre-existing condition here]. So long as they can't disambiguate "some guy", is there a problem for me? I could see myself opting into that sort of situation.

yoloswaggins• 13 years ago

I don't see why they can't just put up a disclaimer that's like "This is only an indication of medical issues you may have. Always consult a doctor." Or something like that.

How come they try to make these guys shut down, but largely leave homeopathy alone? I would say homeopathy is way more damaging than seeing whats in your genes.

Why does the FDA have to be jerks? (that's rhetorical. I know why they have to be jerks. It just sucks.)

potatolicious• 13 years ago

Because 23andMe can't run a disclaimer like that without being either:

- totally disingenuous

- defeating the core marketing angle of their product

Either they are issuing the disclaimer in good faith, in which case their marketing becomes "we don't really know for sure, this is just a for-fun thing, do not base any health decisions off this". This is antithetical to what 23andMe is trying to do.

Or they issue the disclaimer in bad faith - i.e., they claim certainty in their information, they claim reliability, and they market the product as a medical tool, and then slap a shitty disclaimer on the bottom like the small-print of a crappy infomercial purely for legal reasons.

The latter approach is just creative mislabeling, like calling vibrators massagers.

erifneerg• 13 years ago

I was listen to an old episode of Radio lab (http://www.radiolab.org/story/91713-famous-tumors/) and they had an ad for 23andme. The ad most talked about how you can use this information and talk it over with doctor. The ancestry reports was just a side thing mentioned at the end.

pak4• 13 years ago

If you think 23andMe is getting singled out in comparison to homeopathy, that's not correct. The FDA has long considered how to handle homeopathic remedies, and they do regulate them and the conditions under which they can be marketed.

For more information, visit the NIH website: http://nccam.nih.gov/health/homeopathy#hed6

Note that homeopathic medicines cannot be sold over the counter if they claim to treat a serious disease (something that wouldn't resolve on its own, like a cold or a headache). They must be prescribed!

cema2• 13 years ago

Does 23andme claim to treat diseases? Not that I know of.

scotty79• 13 years ago

So... opensource tool for healthy interpretation of raw data from 23andme? Anyone?

pak4• 13 years ago

If Valley folks created this, it would be the holy grail that NIH-funded bioinformatics researchers have been pursuing for the last 20 years. I wish them the best!

In all seriousness, this is exactly the point of most federally funded research in genomics, including the projects of the institute I work for. http://icahn.mssm.edu/genomics

pbreit• 13 years ago

They need to buckle down, work with the FDA and fully recognize the gravity of the information they are presenting to people. I can't imagine that they won't be able to do this.

23andMe bows to FDA, drops all medical information from new tests

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