Well, sure. That's because dispositive results are valuable to their customers. It's not a marketing problem: they have someone (some) people want. Saying that it would be "better" that they not provide this service seems to be an odd usage of "better".
The liability concern is real: they aren't perfect, they'll goof up tests, and in some measure (though IMHO largely overstated -- the real risk here is a little fear and a needless diagnostic procedure) people will suffer when they do. But that doesn't seem to me to be insoluble. If no one insures that kind of thing right now then maybe they could be induced to, or 23AndMe could work up something on their own via investors.
But arguing that the only viable solution is to shut down a comparatively cheap and (full disclosure: I'm a customer) really quite entertaining service seems wrong to me. It's a net good; some people (hi!) like it.
> But arguing that the only viable solution is to shut down a comparatively cheap and (full disclosure: I'm a customer) really quite entertaining service seems wrong to me. It's a net good; some people (hi!) like it.
That's not what's happening. You're not stupid, and I'm surprised you see it this way.
23andMe are being asked not to market their product in the way they are marketing. Or, if they want to continue to market like they are they have to have the same level of regulation as all other medical device suppliers.
Neither of those stop you from using their product.
OK, the language was inflammatory and I apologize for that bit. But the point stands: it's not a "marketing" problem that they are providing pseudo-diagnostic results. That's what the market wants, because they can't get it from the existing products under the existing regulatory structure.
One way to see this is yours and the FDA's: it's a fairness issue, and they need to play by the same rules. The other is the liberstartuptarian line that the regulatory structure is the thing actually at fault here. In this case, I tend to agree with the latter.
I mean, I had fun with this service, and I wasn't fooled by its marketing: they told me in essence that they'd give me their best guess at my traits and disease risks and drug susceptibilities, etc... And I bought it. A product that just gave me a bunch of genes and markers I could look up on wikipedia wouldn't have gotten my money.
So what's the answer here? Where's the regulatory answer for those of us who want to spit in a tube and get a fun HTML5 experience out of it? It doesn't seem like the FDA has one.
> That's what the market wants, because they can't get it from the existing products under the existing regulatory structure.
The market can have that, all 23andMe has to do is stop selling their product as a diagnostic test.
They sell it as being able to predict your risk of some diseases. They're not a tiny little startup battling against the industry, they have some pretty big money.
They need to either sell it as a novelty ("Not designed to treat or diagnose any medical condition") or step up and get regulated.
They could slap on a disclaimer saying 'Results for entertainment purposes only. This service has not been evaluated or approved by the FDA.' I'm no expert on regulatory law but I suspect this would immunize them from most oversight...but I also suspect it would have a deleterious effect on sales.
I think they would have to remove much of the product too. The FDA is involved because they consider the product to be "intended for use in the diagnosis of disease." I doubt they could say, "our data shows you have disease X but this is for entertainment purposes only."
Nobody is arguing that it should be "shut down"; even the FDA doesn't appear to be doing that, and is demanding that they cease marketing only after years of effort trying to alter the product's marketing message.
That's exactly right. There is, at this time, no such thing as "medical genomic information", of the sort which 23andme purports to provide. There is a great deal of data, but that's not the same thing, and distilling that into information is an entire field of study -- complex, subtle, enormously recondite, and extremely refractory to the layman.
The liability concern is real: they aren't perfect, they'll goof up tests, and in some measure (though IMHO largely overstated -- the real risk here is a little fear and a needless diagnostic procedure) people will suffer when they do. But that doesn't seem to me to be insoluble. If no one insures that kind of thing right now then maybe they could be induced to, or 23AndMe could work up something on their own via investors.
But arguing that the only viable solution is to shut down a comparatively cheap and (full disclosure: I'm a customer) really quite entertaining service seems wrong to me. It's a net good; some people (hi!) like it.