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23andme has suspended health-related genetic tests

23andme.com

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Re: 23andme has suspended health-related genetic tests

#41

Post by 001sky »

asdfaoeu wrote: post #40
sanxiyn wrote: post #10

Earlier quoted context omitted.

I agree. Trying noninvasive but inaccurate tests before accurate but invasive tests is just par for the course. 23andMe is certainly noninvasive, and as far as I can tell more accurate than most such preliminary tests.

The accuracy isn't the problem. It's that the accuracy is unknown. And evidently 23adMe haven't been attempting to prove it to the FDA. As far as I'm concerned at that stage you might as well take homeopathy. > and as far as I can tell more accurate than most such preliminary tests. Oh thats good? I'm sure that anecdotal well set the FDA at ease.

As far as I'm concerned at that stage you might as well take homeopathy.

How does this follow? No test is equivalent to ignorane. Using the test as a non-invasive prelim screen may be imperfect, but its hard to say the "null hypothesis" is equivalent. That would require that no information be present, which seems unlikely (if unproven). Or did you mean something else?

Re: 23andme has suspended health-related genetic tests

#42

Post by khomenko »

bengotow wrote: post #33
Steuard wrote: post #25

We can learn a bit more about this dispute from how 23andMe has responded here. Given that 23andMe is still willing to release their raw genotype results, it seems clear that the FDA isn't objecting to that level of their work. That's comforting: evidently at least that is considered more or less accurate. Instead, they've only redacted "23andMe’s interpretation" of the data from their reports to new customers. My ta…

I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.

a) they never marketed themselves as predictors of cancer or told anyone they have major disease b) the criteria for scientific evidence are here https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXre... (from https://www.23andme.com/for/scientists/)

Re: 23andme has suspended health-related genetic tests

#43

Post by asdfaoeu »

cromwellian wrote: post #34
bengotow wrote: post #33

Earlier quoted context omitted.

I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.

So now, people will just export their data and third party companies will provide such interpretation and the FDA won't be able to touch them. How soon until github has an open source project to read and interpret 23andme data-dumps?

Most likely anyone providing such information would also be in a similar boat with regards to the FDA.

Sure you could be overseas providing the data but it's not like the FDA is preventing you from getting overseas treatment.

Re: 23andme has suspended health-related genetic tests

#44

Post by khomenko »

winterswift wrote: post #30
cperciva wrote: post #22

In fact, they've not only suspended health-related genetic tests, but they've done so retroactively . If you signed up for 23andme in the past two weeks, you're not getting what you paid for.

Nearly ordered myself a test before discovering this mess on the day the FDA sent their letter. I would really hope they'd provide some sort of compensation to those who're being screwed...doubtful that'll happen though.

Everyone who has ordered since November 22nd is offered a refund. The details are on the website and will come in the email. Have some faith, dude. Of course they have to do that.

Re: 23andme has suspended health-related genetic tests

#45

Post by khomenko »

bengotow wrote: post #26
daeken wrote: post #12

I bought 23andMe ages ago and haven't sent in my test yet. Because I purchased it quite a while ago, will I still be able to get all the info? If not, I'm gonna be pretty disappointed.

I don't think you'll get your results - at least not soon. The FDA said they needed to back up their claims that their assessment methodologies are accurate, and since they failed to respond to those requests they've been prohibited from performing the genetic tests and giving you the insights that you paid for. Don't think it matters when you bought the kit :-(

"Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had."

Re: 23andme has suspended health-related genetic tests

#46

Post by groupthinker »

Afforess wrote: post #8

This seems to be the nuclear option. As a (now fortunate) previous purchaser of 23andme, I still have my health information. The information is really valuable, and considering the price ($99!) it is cheaper than a lot of standard medical exams and bloodwork. Obviously not a replacement for any of those things, but it's amazing they can offer DNA health results for so little. The FDA seems to be mostly concerned that…

As someone who purchased four kits for xmas gifts three weeks ago - I'm pissed, and expect a refund in full.

Re: 23andme has suspended health-related genetic tests

#47

Post by cromwellian »

asdfaoeu wrote: post #43
cromwellian wrote: post #34

Earlier quoted context omitted.

So now, people will just export their data and third party companies will provide such interpretation and the FDA won't be able to touch them. How soon until github has an open source project to read and interpret 23andme data-dumps?

Most likely anyone providing such information would also be in a similar boat with regards to the FDA. Sure you could be overseas providing the data but it's not like the FDA is preventing you from getting overseas treatment.

I doubt it, since those people aren't making any medical devices. Moreover, the SNPedia can be used by anyone, so an open source tool can be written and deployed as an app. I highly doubt the FDA will be able to stop that.

Trying to stop someone from analyzing their health data dump is about as useless as trying to stop bitcoin transactions. About the only thing the government can try to do is to stop the public from being able to use DNA microarrays, but how long is it going to be before a cheap, consumer grade version of such chips can be made and sold in a way that the FDA can't regulate them?

Re: 23andme has suspended health-related genetic tests

#48

Post by cromwellian »

I wonder if another nuclear option is to just move the whole shebang to say, the Cayman Islands, China, or some jurisdiction outside the reach of the FDA and European regulators. Re-incorporate as a non-US entity.

Unlike buying medicine from foreign soil that can be interdicted, this is all electronic: shipping spit, and getting back HTML.

Re: 23andme has suspended health-related genetic tests

#49

Post by timr »

Afforess wrote: post #8

This seems to be the nuclear option. As a (now fortunate) previous purchaser of 23andme, I still have my health information. The information is really valuable, and considering the price ($99!) it is cheaper than a lot of standard medical exams and bloodwork. Obviously not a replacement for any of those things, but it's amazing they can offer DNA health results for so little. The FDA seems to be mostly concerned that…

Here's the deal: you have a report. You have no way of knowing if the information in the report is correct, or not. You may have paid $99 for something that's completely fictional. You just don't know.

Is that your "right"? Sure, to some extent. A sucker is born every minute, and if you desperately want to be one of them, the US Government is mostly content to let it happen. We'll even let companies do patently absurd things like sell you pills that are supposed to make your dingus larger. We just limit what they can say when they're selling them to you, to protect the most credulous among us.

Like it or not, our society has decided that certain forms of charlatanism are so egregious that we act proactively to prevent them. Medicine is one area where we are strict, because our country has survived a rather nasty era where unfettered "medical innovation" was allowed to kill large numbers of people. I have a vintage Merck manual sitting on my desk, and it recommends such wonderful treatments as oral arsenic for hair loss (to be fair, you probably care a lot less about being bald when you're dead...) and vinegar (via injection!) as a cure for cancer. That's "medical innovation" without regulation to enforce safety and effectiveness, and I don't particularly want to go back to it. Maybe you do.

The FDA is doing its job rationally here, it is well within its mandate, and as far as anyone who knows what they're talking about can tell (including the leaders of the company), 23andMe is just clearly in the wrong on this issue. So if you don't like the laws we've set up to protect consumers against medical malpractice, I guess that's your opinion, but it's obviously dumb to blame the FDA for doing exactly what it's supposed to be doing.

Re: 23andme has suspended health-related genetic tests

#50

Post by bengotow »

khomenko wrote: post #42
bengotow wrote: post #33

Earlier quoted context omitted.

I agree - Here's a company that built a complex software system, loaded it with "if" statements pulled from research papers, and started marketing itself as a predictor of cancer and disease. How did they do their research? What is their threshold for determining if scientific evidence is conclusive enough to merit telling the world they could have a major disease? The FDA wants to know, and so do I.

a) they never marketed themselves as predictors of cancer or told anyone they have major disease b) the criteria for scientific evidence are here https://23andme.https.internapcdn.net/res/pdf/HIC-SXIYiYqXre... (from https://www.23andme.com/for/scientists/ )

Hmm - thanks for the link! Good stuff. I think the complaint I have is that in their advertising (https://www.youtube.com/watch?v=JTIY310FGBU&list=TLdNSueMINq...), they feature:

- An individual for whom 23andMe correctly identified a heart issue that he later had.

- An individual who caught his prostate cancer early because 23andMe told him he was likely to have it.

In both cases, 23andMe successfully identified the condition before it occurred. That's about as close to marketing yourself as a predictor of disease as you can get. Granted, the word for word text in the video references "elevated risk", but the overall story they're selling to the public is that 23andMe predicts diseases you'll have. At least, that's my impression. Really interested to see how all this pans out.

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