23andme has suspended health-related genetic tests • Hacker News Board

Re: 23andme has suspended health-related genetic tests

#61

Post by Steuard » Fri, Dec 06, 2013, 2:34 PM UTC

rosser wrote: post #36

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…

That's comforting: evidently at least that is considered more or less accurate. I'm not sure you can safely draw that conclusion from the way this has played out. I think it's equally, if not more likely, that 23andMe is able to continue offering raw and ancestry data simply because those things are outside the FDA's purview. Consider, by analogy, the dietary supplement industry: the FDA has incredibly more power ove…

That's a really good point. Rats. So only if they go back to advertising health information after FDA approval will we be able to be confident that their actual genotype results meet FDA standards (as well as their interpretive text).

Re: 23andme has suspended health-related genetic tests

#62

Post by tokenadult » Fri, Dec 06, 2013, 3:16 PM UTC

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…

"The SNP chip method that 23andMe uses was never very good at providing useful genetic information. Its advantage has been its low cost. But as sequencing gets cheaper and cheaper, SNP chips have already largely become obsolete for most genetic testing."[1]

Basically, 23andMe has always oversold the results available from the crude SNP chip technology they were using as a hook to have people PAY to send them DNA samples that would make them "members" of 23andMe. Then the members are reminded to send in personal health history information to be put into the 23andMe database so that 23andMe can data-mine that and try to figure out what the DNA actually means[2]--which no medical geneticist knows to any precision at the moment. That business model of suckering in paying clients today for the promise of an unknown amount of actionable information in the future is why 23andMe was trying to stonewall the FDA while marketing what was plainly a direct-to-consumer medical device. It's not surprising (see first link here) that the FDA is not going to let 23andMe get away with that.

[1] http://venturebeat.com/2013/12/03/why-the-fdas-anvil-dropped...

[2] http://www.fastcompany.com/3018598/for-99-this-ceo-can-tell-...

Re: 23andme has suspended health-related genetic tests

#63

Post by jonlucc » Fri, Dec 06, 2013, 7:20 PM UTC

tokenadult wrote: post #62

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…

"The SNP chip method that 23andMe uses was never very good at providing useful genetic information. Its advantage has been its low cost. But as sequencing gets cheaper and cheaper, SNP chips have already largely become obsolete for most genetic testing."[1] Basically, 23andMe has always oversold the results available from the crude SNP chip technology they were using as a hook to have people PAY to send them DNA samp…

I'd like to add that 23andMe also wants to be a resource for finding patients for studies. They boast being able to find a large number of people with a certain condition in a short amount of time (a real benefit in human studies) because of the health information they have.

Re: 23andme has suspended health-related genetic tests

#64

Post by kingkawn » Fri, Dec 06, 2013, 7:34 PM UTC

Afforess wrote: post #5

kingkawn wrote: post #3

Earlier quoted context omitted.

Their interpretations were based on poorly proven associations between genes and disease-outcomes. I bet with the info you could look up on wikipedia/google scholar much of what you needed to know. But it depends on the format of this data dump.

No, that is pure FUD. 23andme provides a confidence assessment for the associations and risks. Here is a screenshot from their site: https://dl.dropboxusercontent.com/u/49805/confidence.png

All well and good that intervals of confidence exist in medical research. But good understandings of these associations have been reached with very few genes. The categories alone do not prove that they apply broadly enough to justify the product.

Re: 23andme has suspended health-related genetic tests

#65

Post by [deleted] » Fri, Dec 06, 2013, 7:37 PM UTC

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/ )

[deleted]

Re: 23andme has suspended health-related genetic tests

#66

Post by streptomycin » Fri, Dec 06, 2013, 7:57 PM UTC

billpg wrote: post #54

Great. How about the FDA deal with the claims made by homeopaths next?

They would love to, but they are limited in the scope of their authority. Homeopathy companies tend to label their products as "dietary supplements" so they don't fall under FDA drug regulations. When they slip up with their marketing, the FDA does get involved http://news.discovery.com/human/health/homeopathy-takes-hits... (see "Skirting Drug Regulations").

Re: 23andme has suspended health-related genetic tests

#67

Post by winterswift » Fri, Dec 06, 2013, 9:52 PM UTC

khomenko wrote: post #44

winterswift wrote: post #30

Earlier quoted context omitted.

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.

Ah, well that's good then.

Re: 23andme has suspended health-related genetic tests

#68

Post by infocollector » Mon, Dec 16, 2013, 4:03 PM UTC

Afforess wrote: post #19

infocollector wrote: post #16

Earlier quoted context omitted.

And no one has problems with their privacy policy?

Your DNA is pretty much public domain anyway. You drop tons of it all over the place.

Thankfully I do not label it with my name ;)