BROOKE GLADSTONE:  A few months ago, OTM Producer PJ Vogt and I decided to dive into our genetic history by sending some saliva to 23andMe, a company that describes its service as “a first step in prevention.” Here’s a clip from a 23andMe TV ad.

  [CLIP]:

WOMAN:  Stuff we might pass onto our kids.

WOMAN:  Foods I might want to avoid.

WOMAN: Hundreds of things about my health.

MAN:  Getting my 23andMe results –

WOMAN:  It really opened my eyes.

WOMAN:  The more you know about your DNA –

MAN:  The more you know about yourself.

  [END CLIP]

BROOKE GLADSTONE:  PJ and I were excited about the results, but not everyone wanted the burden of knowledge. Here’s former OTM Producer Jamie York.

  [CLIP]:

JAMIE YORK:  I don't want to know what's coming. I can, I can rationally understand the argument. I don't have the psychological fortitude to compartmentalize that information.

 [END CLIP]

BROOKE GLADSTONE:  Well, now it’s likely that fewer people will know what's coming. On Thursday, the personal genome service announced that it would, for now, only supply customers with their raw genetic data, without interpretation. This action follows 23andMe’s announcement that it would stop marketing the tests, as ordered by the Food & Drug Administration in a letter sent late last month. The problem? The agency says the company hasn’t proved their product does what it says it does. Russell Brandom is a writer for the website The Verge. He described the FDA’s letter to the company as “a body blow.” How so, Russell?

RUSSELL BRANDOM:  Well, you can really hear in the text of the letter they’re just furious. I mean, I think you kind of get the sense of this very frustrated bureaucrat who's been emailing them and emailing them and trying to get in touch. They hadn’t heard from 23andMe for six months, and so eventually they pushed the panic button and were just like, nope, you can’t keep doing anything if you’re not gonna work with us.

BROOKE GLADSTONE:  23andMe has been operating for six years and routinely ignoring the FDA, so why slap it now?
RUSSELL BRANDOM:  In August, there was this huge new TV ad push that was making all sorts of promises and just promising to bring 23andMe to this whole new range of customers.

BROOKE GLADSTONE:  That was that ad that we heard at the top.

RUSSELL BRANDOM:  Exactly. The FDA said, wait, hold on a second, you don’t have the approval to market this. So it’s one thing to put up a website and people who are excited about it can do it, but it's another thing to buy all these ads about a product that’s not approved yet.

BROOKE GLADSTONE:  To be fair, the FDA has gotten criticized too. The rules are vague. It took them, as we say, a long time to get around to this. And somebody told you that the FDA –

RUSSELL BRANDOM:  Mm –

BROOKE GLADSTONE:  - is like a giant space tractor?

RUSSELL BRANDOM:  This blogger called Mike, the Mad Biologist was describing –

  [BROOKE LAUGHS]

- was describing, you know, it's like one of these huge tractors that NASA uses to move rockets around, where it's really not very maneuverable but once it gets going. it just crushes everything in its path. This is why, you know, if you go to Pfizer, or a company like that, they’ve got whole departments where people’s only job is keeping the FDA happy and making sure everything’s in compliance and everything’s fine, because if they really decide you're doing something that is out of bounds, they can make your life difficult and your business difficult in all sorts of ways.

The big thing is because this is such a new type of thing, people don't know why we’re gonna want to do this or what we’re really gonna find out from it. So I mean, when you did the test, were you imagining that this was going to be something you would take to your doctor? Probably not, exactly. Were you thinking that it was gonna be something that would tell you something about your body more generally and your health more generally? And is that a medical use? A lot of these questions are really still being negotiated, even within 23andMe.

BROOKE GLADSTONE:  Look, I'm sure that any number of the perhaps millions of people who have used products like this have all done them for individual reasons, right? I mean, I wanted to know how Neanderthal - I am.

RUSSELL BRANDOM:  Yeah.

BROOKE GLADSTONE:  And not enough, it turns out.

 [BRANDOM LAUGHS]

I was interested to see if there any red flags, which could prompt a trip to the doctor. The FDA’s concerned that people will act on this information, for instance, if they've inherited certain genes that increase their risk of uterine and breast cancer, that they’ll run in and, and have those things taken out.

RUSSELL BRANDOM:  Yeah.

BROOKE GLADSTONE:  Like they can do that, without a doctor.

I have to say that I agree a little bit here with Richard Epstein, who you quote in your piece. He’s a law professor who wrote about the case for the conservative Manhattan Institute. And he told you the FDA has a terrible culture:  “Every time I read them, they’re protecting me and they're assuming that I'm an idiot.”

RUSSELL BRANDOM:  Any patient who comes into a doctor's office with the 23andMe result, the absolute first thing the doctor is gonna say is, well okay, we’re gonna get you tested again and within our system in a more reliable test. I think everyone knew that that was the case. And so, a lot of that objection is sort of ringing hollow. In many ways, the FDA didn't want to have to make that case. It’s just that you look at the results page and you see, oh, I've got 18 percent increased risk of heart disease, is that actually helping me mitigate my risk of heart disease?

BROOKE GLADSTONE:  Is it hurting you? If the FDA is saying, don't make these claims you can’t support, that’s fine. But when the FDA makes an objection that is just as overblown as the claims it says 23andMe are making, then the whole thing feels like a bunch of strawmen battling it out.

RUSSELL BRANDOM:  Really, their objection is just the claims. But then it gets to this question of if 23andMe isn’t gonna market itself as a medical device, then why is it telling us anything about those diseases at all? They're looking at it as if you're selling these cholesterol-lowering pills, right, and if you put cholesterol-lowering pills on the bottle, they want to make sure it's really lowering your cholesterol.

BROOKE GLADSTONE:  Mm-hmm.

RUSSELL BRANDOM:  So what exactly is the promise that 23andMe can make? If they're making a promise that it'll help you manage your health or help mitigate the disease, they really have to back that up. And it’s not clear that they can. And so, if they can’t, then what’s their pitch for why you should do this?

BROOKE GLADSTONE:  Just – information?

RUSSELL BRANDOM:  Yeah, but I mean, I've got too much information already. [LAUGHS]

BROOKE GLADSTONE:  Well, tell me. You’ve done 23andMe, right?

RUSSELL BRANDOM:  Yeah, yeah.

BROOKE GLADSTONE:  And, how’d it go?

RUSSELL BRANDOM:  The ancestry stuff was really interesting. There were a lot of really puzzling things where I think I had a had a higher risk of drug addiction, and I remember thinking, well, what does that mean? How am I going to live my life differently, now that I know this?

BROOKE GLADSTONE:  When we first looked at this - and listeners can go back and hear this - we had another geneticist come in, and he talked about which results you can rely on and which you can't. And the ones that have to do with cognition and behavior are particularly dubious. But it's even marked in the test. They  rank the validity of the findings that they provide.

RUSSELL BRANDOM:  Okay, so there’s the bit where you say it and the bit where you take it back.

  [BROOKE LAUGHS]

They’re like, well okay, here’s this thing but don't trust it at all.

BROOKE GLADSTONE:  Mm-hmm.

RUSSELL BRANDOM:  We’re just putting it out there? I think a lot of the medical profession is really uncomfortable with that ‘cause they just don't know – they look at it and they say, well, what do I do with this?  

BROOKE GLADSTONE:  Are you sorry you did it?

RUSSELL BRANDOM:  Well, I got a good article out of it, so I’m not sorry. [LAUGHS]

  [BROOKE LAUGHS]

But I don’t think it harmed me in any way. But I do think you can sort of look back and think, well, what was I really buying here?

BROOKE GLADSTONE:  Well, you can say that about any purchase, practically! It’s information. Process it. Don’t process it. Put it on the shelf. Consider it a horoscope, whatever you want. People pay for those too, you know, and sometimes considerably more than 99 bucks.

RUSSELL BRANDOM:  Yeah, no but they have to be careful how they advertise, though. [LAUGHS]

BROOKE GLADSTONE:  [LAUGHS] Fair enough. Russell, thank you so much.

RUSSELL BRANDOM:  Oh, thanks for having me.

BROOKE GLADSTONE:  Russell Brandom is a writer for the website The Verge.