23andme has suspended health-related genetic tests
23andme.com
23andme.com
The FDA seems to be mostly concerned that the results of 23andme could be misinterpreted, or wrong. As far as I am aware, 23andme was advertising the health assessment as the first step in prevention - not a one stop shop for diagnosis. I am not very impressed with the FDA.
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.
So let's go back to the FDA, is it so effective? Here is the FDA authorizing a drug that killed lots of people http://www.undergroundhealth.com/fda-approved-prescription-d... Also, the time the FDA takes to approve a good drug can take more than 10 years, how many people die because of this unseen consequence? http://en.wikipedia.org/wiki/Criticism_of_the_Food_and_Drug_... Not to forget its reluctance to approve drugs for political reasons (canabis).
So let's see, many people die because of wrongly approved drugs and many die as it takes too long to approve good ones because of the FDA. Now let's imagine a world with no FDA, many people would still die, but at least they'd have the choice to do so on their own decision and not have to wait on a nanny state bureaucracy to tell them what's good or bad for them and many times wrongly so. Why not let people freely decide what they can do to their own body when not doing so still kills a lot of people too? Plus, allowing so would make it much faster to detect when a drug works or not and save way more lives. If you don't even own your own body, what do you own?
Yeah, we have things called "clinical trials" that pretty much put an end to the bad old days of patent medicine. Guess who enforces that stuff?
The rest of your post is a straw-man. Does the FDA make mistakes? Sure. That doesn't invalidate the need for the agency. Is it your right to do stupid things with your body? See previous comment.
> Yeah
No, we don't. I said "en masse", that is to say, do we have a massive amount of people taking arsenic everyday to cure boldness? No we don't, and yet anyone can read about it on the web.
> Does the FDA make mistakes? Sure. That doesn't invalidate the need for the agency.
Yes it does, I've just explained that the FDA is responsible for more death than if we had no FDA while taking away people's freedom do cure themselves the way they want.
> Is it your right to do stupid things with your body? See previous comment.
Well, according to you, only if the FDA approves so, the same FDA responsible for countless deaths. No thanks.
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-...
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.
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?
Is there a more comprehensive and maybe configurable export feature available?
If you do strenuous exercise several times a week and adopt a healthy diet, your risk will drop dramatically. Was it because you already do these things?
I wanted to know if I have awesome genetic material and it was true ;)
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 take on this is that the FDA wants some sort of rigorous demonstration that 23andMe isn't making errors in its interpretation of medical data. I'm thinking specifically of stories like this one: "My deadly disease was just a 23andme bug" https://news.ycombinator.com/item?id=6796219 It's hard to know (as a simple consumer) how common that sort of error might be: I rely on folks like the FDA to set and enforce quality standards on such things.
Similarly, I honestly don't have a great sense of how well 23andMe's interpretations reflected the full current state of known science. For instance, my memory is that they were only able to test for a few of the known breast cancer risk factor genes because others are still covered by patents. How clearly did their interpretation pages convey those gaps in what they were presenting?
I hope that 23andMe finds a way to get fully back online before long. But honestly, I'd be happiest if they manage to satisfy the regulators that they really are getting things right. Someone needs to verify claims like that for the rest of us!
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 over a product that is advertised or marketed as intended to "diagnose, treat, or cure any disease." Notice how the manufacturer explicitly disclaims that exact verbiage on all those sorts of products? That's because anything that is marketed that way is immediately subject to a much higher degree of FDA jurisdiction, under which they can literally shut you down overnight.
When 23andMe runs your genome and sees a genotypic match for an arbitrary disease, and then tells you that you have that disease, they're diagnosing you. When they tell you that you're 72.3% Northern European, or give you a ginormous CSV (or however they encode their data dumps), they aren't.
That's the only thing I think you can meaningfully read from this situation: they're changing the way their product is marketed, and the services they provide, so as not to be subject to the FDA's nuclear option.
1. https://www.23andme.com/you/download/
2. http://www.snpedia.com/index.php/Promethease (non-pro version)
Sure you could be overseas providing the data but it's not like the FDA is preventing you from getting overseas treatment.
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?
- 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.
http://www.change.org/petitions/fda-administrator-margaret-h...
https://petitions.whitehouse.gov/petition/overrule-fdas-deci...
See: most things on Change.org.
Unlike buying medicine from foreign soil that can be interdicted, this is all electronic: shipping spit, and getting back HTML.
People really need to get over paranoia over this and focus on what matters: laws against discrimination based on genetics.
Anyone have any idea how useful the health data is without the 23andme interpretation? I'm guessing it will be basically useless.
European regulation is supposed to be harsher than US one, so it is highly unlikely, but I didn't found the information on the website.
But fuck it. Libertarian nerd rage. Disrupt!! There is a reason people outside your bubble think you are assholes.