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23andMe Wins a Second Life, Raises $115M

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Re: 23andMe Wins a Second Life, Raises $115M

#91

Post by dekhn »

Karunamon wrote: post #71
lfuller wrote: post #44

Earlier quoted context omitted.

23&Me was using a medical test to give users data regarding their risks of certain diseases without sufficiently proving to the FDA that that data was accurate. It's not a stretch to imagine someone acting on that information with potentially dangerous results; taking extra unneeded supplements, having elective surgery, dramatically changing their lifestyle to reduce the risk of some condition, etc.

I'm so happy the FDA was there to prevent this company from doing the things with my genetic information that I asked them to do. Thank god for government.

Nobody prevented me from having Illumina sequence my genome (they gave me a hard drive with all the files along with medical interpretation).

The difference is that Illumina did things legally (including hiring clinical genetics analysts who pored over the details and made a number of calls about what was significant).

23&Me did not. They were doing something that they would have known was illegal. The FDA explained this to them, and 23&Me blew them off. Failing to respond to an accusation from the government is an amateur move and 23&Me deserved what they got. They only went back and negotiated afterwards.

You're complaining the government was restricting your freedoms but we have more than adequate evidence that 23&Me was acting irresponsibly.

Re: 23andMe Wins a Second Life, Raises $115M

#92

Post by dekhn »

refurb wrote: post #20
billions wrote: post #13

Earlier quoted context omitted.

The FDA put a stop to crowd-DNA research via the 23AM law suit. Prior to the lawsuit 23AM had a large user base completing questionnaires effectively mapping health risks, traits and allergies to genes. Not sure what the Food and Drug administration has to do with my genes other than regulatory overreach.

It has to do with the FDA protecting the public from crappy medical devices and drugs. IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound. The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusio…

Their disclaimer said: The genotyping services of 23andMe are performed in LabCorp’s CLIA-certified laboratory. The tests have not been cleared or approved by the FDA but have been analytically validated according to CLIA standards. The information on this page is intended for research and educational purposes only, and is not for diagnostic use.

Re: 23andMe Wins a Second Life, Raises $115M

#93

Post by dekhn »

jamesblonde wrote: post #54
rodneyfool wrote: post #24

Earlier quoted context omitted.

I've used 23andMe, and it told me I have twice the risk of developing Alzheimer's disease when I'm older. Considering that I've lost a few family members to Alzheimer's, it worries the hell out of me. Regardless, this has triggered me to research a bit about the disease and ways of potentially reducing the risk. It does make you anxious, but when you have that knowledge, you feel the need to do something about it.

I mentioned this to another person in the thread. Worth repeating. Take lots of curcumin every day for the rest of your life. It has been shown to bind to a-beta protein and get cleared from the brain. The overproduction of a-beta causes alzheimers. India, where they consume lots of turmeric (curcumin is an extract from turmeric) has significantly lower incidence (very very low) of alzheimers. You'll be fine.

This is an absurdly irresponsible thing to claim.

Re: 23andMe Wins a Second Life, Raises $115M

#94

Post by heygrady »

dekhn wrote: post #15
mmanfrin wrote: post #6

Earlier quoted context omitted.

Other than that, all the things I've seen are marginally useful at best. Part of it is that the FDA successfully sued 23AM from showing things like health risks.

That's not correct. The FDA made them stop doing something they were doing illegally. Their genetic test is a medical device and they didn't have federal approval. Further, when the FDA informed them they needed approval, they didn't respond. The FDA finally had to invoke the law. Also, I don't think 23&Me's test results have enough medical value to be used for evaluating health risks. Further, 23&me's database has s…

Relevant news report from when the FDA took regulatory action.

http://www.cbsnews.com/news/fda-warns-23andme-tells-genetic-...

Re: 23andMe Wins a Second Life, Raises $115M

#96

Post by malyk »

allsystemsgo wrote: post #8

This would make me anxious. I remember reading about someone who learned from 23andMe that they had a terminal disease or something like that, and it drastically altered their life. I'd rather just live in ignorance.

There's an interesting Freakonomics episode about testing for Huntington's disease. Turns out some people want to know and some people don't. Me, I'd absolutely want to know. If I had a good chance to get it then I'd adjust my life to make the most of it before ~55 instead of planning for a long retirement...as one example.

http://freakonomics.com/2013/06/20/do-you-really-want-to-kno...

Re: 23andMe Wins a Second Life, Raises $115M

#98

Post by refurb »

dekhn wrote: post #92
refurb wrote: post #20

Earlier quoted context omitted.

It has to do with the FDA protecting the public from crappy medical devices and drugs. IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound. The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusio…

Their disclaimer said: The genotyping services of 23andMe are performed in LabCorp’s CLIA-certified laboratory. The tests have not been cleared or approved by the FDA but have been analytically validated according to CLIA standards. The information on this page is intended for research and educational purposes only, and is not for diagnostic use.

Thanks for pulling that. As I said, I would be fine with it. The FDA isn't.

Re: 23andMe Wins a Second Life, Raises $115M

#100

Post by refurb »

SilasX wrote: post #89
refurb wrote: post #20

Earlier quoted context omitted.

It has to do with the FDA protecting the public from crappy medical devices and drugs. IF you want to sell a genetic test, you need to prove to the FDA: (1) that your test is accurate and reproducible, (2) that whatever conclusion you draw from the test is scientifically sound. The issue was that 23&Me was saying "you have this SNP, that means your risk of X is increased by Y%". The test, the result and the conclusio…

>That said, I'm fine if people want that info anyways, but 23&Me would need to add a disclaimer that says "Your genetic test results and the risks attributed to them may or may not be accurate." But they FDA doesn't allow it, even under this condition. I think it's ridiculous that the FDA considers this okay: A) "1,2,3-methyl dethyl has been proven in clinical research to make your life suck less. (This statement not…

You are correct, the FDA doesn't allow it.

"1,2,3-methyl dethyl has been proven in clinical research to make your life suck less. (This statement not evaluated by the FDA blah blah blah)"

I'm assuming you saw that on a dietary supplement? That would never fly for an approved drug. Take a look at the FDA website to see what kind of promotion they crack down on. There was a ADD drug company that had an ad with a kid studying and the slogan "He can finally get his homework done". The FDA came down hard on them and said "where is the clinical trial showing that academic performance improves?".

As other posters have stated, 23&Me got busted, submitted a 510(k) (approval of medical device) and then when the FDA came back with questions, they failed to reply. You can find it all in the numerous FDA warning letters.[1]

[1]http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...

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