23AndMe issues statement on FDA smackdown


#1

[Permalink]


#2

For six months 23AndMe ignored FDA requests for information. This just Silicon Valley “move fast and break things” and “safety regulators are bad” libertarian arrogance.

Shut down the Google playing.


#3

You could leave out the word “libertarian” and possibly get some libertarians to agree with you. The jab was unnecessary.


#4

why would you WANT libertarians to agree with you? Except on some very very specific issues, having libertarians agree with you on something is usually a bad sign.


#5

Disagree, Drew. On some things the libertarians wrap around far enough to agree with the liberals. I don’t insist that folks agree with me on everything before I’m willing to work with them on the things we do agree on.

As always, beware of judging a group by their loudest members.


#6

That they ignored the FDA for 6 months when provided direction and assistance on how to handle their concerns blows my mind.

Did they really think nothing would happen? Maybe they wanted the media fallout for free publicity? Perhaps their offering doesn’t pass accuracy/consistency tests? Perhaps their results aren’t informative? Bribed the wrong people? What the hell were they thinking? Occam’s razor fails me. By no means did the FDA have an unreasonable request; 23 does not in any way have the higher ground based on how they handled the situation.

In any case, the FDA served their C&D to cause the maximum amount of pain.


#7

I’m kind of boggled by Boing Boing’s general response to this issue. I get that you like the product but it also needs to be regulated. I want to trust it more than I do some box of herbal supplements.

She says on the blog:

In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.

In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.

They failed to complete their applications and now people are surprised that they don’t get to advertise a non-approved product.


#8

What surprises me is that whatever sort of Legal they have (whether external or in-house) didn’t kick and scream about the goodness of this plan… Team Tobacco provided a truly elegant example of how to keep the FDA off your back (and various other industries and individual outfits have adopted similar tactics) and it isn’t letting them nail you on trivial procedural stuff. If anything, the opposite is true, you want that rules-lawyer asshole who nobody could stand to play D&D with doing a bad-faith interpretation of every last procedure, filing, appeal mechanism, comment period, and every other crufty chapter, verse, and appendix of every conceivably relevant thing.

Just going silent and hoping that they go away is about the weakest conceivable strategy: even legal processes that are trivial to game tend to have penalties (sometimes even automatic ones, summary judgements, etc.) that kick in if you don’t show up, don’t file by the deadline, or what have you. I’m not enough of an expert in the relevant regulations and caselaw to know if their situation was winnable or not; but I’d stake a substantial sum of money on the assertion that it wasn’t so unwinnable that they couldn’t have thrown some paperwork in the gears and kept operating for a meaningful additional slice of time.


#9

Perhaps. It was a late addition to the comment, but in my experience libertarians --especially the silicon valley ilk – have no love government safety regulators. After all, there is no market for lemons.


#10

It seems like a pretty good idea to have a regulator to make sure food and medicines are safe. I certainly don’t want to have to do my research every time I ingest something. So that’s a good use for government.
But why does a genetic test need to be regulated? Even if it is wrong and misleading, it isn’t going to kill me. There are plenty of other ways I can purchase wrong and misleading information without it being regulated, so what’s special about the results of a genetic test? How are they different from some cranky “better diet will change your life” book?


#11

Here’s an aarogant libertarian response:
http://vark.blogspot.com/2013/11/the-fda-has-banned-new-sales-by-23andme.html


#12

They changed their marketing strategy to one that (falsely, among other things) claimed to diagnose genetic disorders and illnesses.

The truth is, some of the SNPs they test for have known medical information, but we’re talking risk factor in almost all cases, not “you have (or will develop) X disease”.

They’re trying to double their customer base, because they make a lot of money selling off the data (in aggregate) to other companies.

So anyway, that’s why the FDA got involved. The company started making public claims that pushed their product into what is technically known as a “medical device”…but they did that to themselves.


#13

Genetic tests are just one kind of home testing kit. Think of the implications if home testing kits were not under any kind of regulation to at least ensure they are safe and accurate; home HIV tests, for instance, might make people falsely believe they weren’t infected and further spread the disease. False positives could result in people making rash decisions, including attempting suicide. While genetics results probably wouldn’t result in the same level of immediate potential harm, there are consequences. At a minimum, an inaccurate result might lead to thousands or tens of thousands of unnecessary doctor visits that end up costing millions of dollars.

I’m not saying 23&me is inaccurate, or that personal genetic testing shouldn’t be allowed, I’m just saying that if the testing is offered it should be proven to be accurate to certain standards and should come with appropriate information about how to use the data. And somebody like the FDA needs to be on top of that, because for every “upstanding” company like 23&me there are a thousand hucksters who are happy to make a buck providing inaccurate and dangerous products.


#14

Yes, but I might buy a book which told me that if I had a black spot on my arm, that might be cancer. This could cause me to worry, unnecessarily visit my doctor, or even get suicidal. Come to think of it, I could get suicidal listening to Joy Division. Should books and music also be regulated?
What’s the difference between some opinion that references a genetic marker, and some opinion that references a visible symptom? They could both be wrong and damaging…


#15

You’ve completely missed my point. The issue is not whether a test might make someone upset but whether something is effective for the purpose for which it is marketed. An accurate HIV or pregnancy test is likely to make some people upset, but at least it is effective as a test.

One could argue that Joy Division is unlikely to actually bring anyone joy, and therefore is mislabeled, and I’d happily take on that debate. But we are referring to medical products and the FDA, which does not regulate music. Yet.


#16

I’m not sure I have missed your point. I agree with you that in an ideal world, all products would be effective. However, in reality this is clearly not the case, and yet we don’t regulate everything. So my point was, given that the test is not a matter of direct safety (i.e. it won’t kill you, since it only requires that you spit in a tube), why should the FDA be involved at all? It’s not a food, it’s not a drug, and only by stretching the definition is it a medical instrument, since it doesn’t participate in any medical procedure. If it was used in a hospital to determine whether drug A should be administered instead of drug B, then fair enough, it needs to work. But for home use?


#17

Well you and I will just have to agree to disagree; I think home diagnostic tests should be regulated to ensure they are both safe and accurate, and that genetic tests fall in to that category. The FDA already regulates pregnancy tests, HIV tests, glucometers, and a number of other home diagnostics and I don’t see why this should be any different.


#18

When intentionally or negligently false information is published in a book or magazine, the author and publisher are often liable for damages and possible criminal penalties. I’m not sure we’re living in quite the consequence free, devil-may-care society you propose.

Your Joy Division analogy is pretty far afield from what’s going on with 23andme right now, but it’s true that they don’t bring a lot of joy, and I’m pretty sure they’re not even really a Division, and on those grounds I propose a class action suit. Who’s with me?


#19

Speaking as libertarian, my reaction to leftist allies is: “Do we have to depend on crackpots to defend civil liberties? … I suppose we do.”


#20

Totally off-topic here, but it’s come up a couple of times now…

Do people not realize what the term Joy Division refers to?