As I’ve mentioned on this board before (possibly even this thread), I am a genealogist who uses DNA as part of the research process. Thus, I am a 23andMe customer…both for myself and for all the people I work with.
Right now, on 23andMe’s Community Board, there are at least a dozen threads started about this issue. Why? Because a lot of people do not bother to look at what other threads are current before starting their own. A significant percentage of the comments either 1) get the facts of the situation wrong because they either haven’t read any of the actual information or they’ve misread/misunderstood; 2) blame Obamacare and/or liberals (often in all caps); and/or 3) are panicked this means the FDA is going to take their genome away from them (yes, really). Meanwhile, there are always at least another dozen threads going about how the test is completely unreliable in every way because some customers get a specific result telling them they have a “likelihood” of some particular physical trait that they don’t have. Busted, right? sigh
In other words, it is quite astonishing how many 23andMe customers and potential customers really are ignorant enough to not understand the parameters of what is being tested and what the results signify. They want what they’ve been promised.
Meanwhile, on the company’s end, they have been noticeably less than professional in many ways. Here’s a perfect example: about a year ago, their customer service phone number disappeared from the site. It is no longer possible to call them to ask any questions. There’s a byzantine online path to follow to send a message, and the response rate – while occasionally timely – is usually in the several months to never range. Can you think of any reputable company which does not have a phone number for customers to call?
They’ve been openly questioned about this (and many other examples) on public threads by many customers and they refuse to respond. Total silence…not even excuses. You cannot get answers from this company once you’ve given them your money and your spit. They have what they want, and they literally refuse to support paying customers once that has happened.
Long story short: the FDA is right to question the promises 23andMe is making in its advertising to attract new customers, because many customers really ARE that stupid, and is also right to keep pushing the company instead of letting things slide because the company has shown itself to be unprofessional in multiple ways.
At least in part, that’s because shooting at cars may be legal.
I don’t suspect that the FDA’s ‘actual science’ team much likes it; but homeopathy was written in to the Food Drugs and Cosmetics act, and there isn’t much they can do about it unless a given ‘homeopathic’ product is prepared under grossly unsuitable standards or demonstrably injuring people (eg. Zicam, which was homeopathic for the purposes of the law; but was atypically non-diluted, enough that it was causing anosmia in some cases, and which the FDA did get withdrawn. The stuff by that name now on the shelves is either the oral stuff, which didn’t show any of the same issues, or a reformulation that probably is just spraying expensive water up your nose).
The ’ Dietary Supplement Health And Education Act’ carved out a similarly alarming exemption for anything that felt like calling itself a ‘dietary supplement’ and sticking to absurdly strong insinuations, rather than explicit claims.
I’d assume that most unwise-cessation advice from assorted witch doctors is similarly licit because the FDA only has jurisdiction over medicine, not over bad advice to stop taking it. They might get somebody stupid enough to claim (in writing, on TV, or persistently enough to get investigated in person) that coffee enemas or whatever are a cure for cancer; but (even if they did have the resources, and they don’t) your local naturopathic guru telling you that ‘chemotherapy is poison and you should embrace natural healing’ isn’t really actionable within the scope of the FDA’s remit, though I’d imagine that most of their people wince when they hear things like that.
This isn’t a medical test or a medical device. It is not used to treat, cure, or diagnose anything. The service provides recommendations based on markers for potential issues.
IMO, no governmental agency should be able to tell us what we do with our bodies
[What We Do][1]
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
[1]: http://www.fda.gov/aboutfda/whatwedo/
As far as I can tell, this all began with the end of buyer beware and the creation of the AMA. Somehow, the medical community convinced the government (with cash) that they are the only ones qualified to decide what you can put in your body. I never bought in to that BS. Then again, somehow suicide is illegal as well. I suppose we don’t really own our bodies.
As the sages said, never allow the people to learn anything, it will only lead to civil disorder. Their simple minds will lead them into unhappiness and self harm; they are best left unspoilt by the twin burdens of knowledge and wealth, and the former always leads to the latter.
It’s the same argument for at least 2300 years now.
Once upon a time there was a country that turned the old argument on its head, and enshrined the wisdom of the masses; that country became a model for the world… until it fell.
Aside from whether or not medical tests should be under the FDA’s purview, what is the subtle distinction between ‘a medical test’ and a ‘a service that provides recommendations based on [genetic] markers for potential issues’? I’m pretty sure that’s exactly what a ‘test’ does, albeit possibly with a better warranty.
I am more open to the notion that cheap 'n cheerful non-FDA-approved first-line stuff has its uses, especially since it can be so very cheap, and I accept denial of the FDA, period, as a potentially cogent position (if not necessarily a good idea, given the glorious history of self-regulation); but I’d be wary of conflating dislike of the FDA or FDA approval with assertions that what 23andme is doing is not within the scope of the FDA’s regulatory role, whether you like it or not.
Dancing around the idea that a ‘service that provides recommendations based on markers for potential issues’ is not a ‘medical test’ and does not ‘diagnose anything’ is really edging up on the sophistry of distinction without difference.
If you think that it’s an illigitimate imposition to claim any authority over testing or diagnostics, or even over any aspect of medicine, you’ve got yourself a point to advance; but the distinction you are trying to draw there is spun of rather thin stuff.
About the hypothetical BRCA scenario people keep raising –
I know someone who tested positive for the variant through 23andme, and made an appointment at a specialist medical center where she wound up seeing the head of oncology, as part of its high-risk program. She asked if she should repeat the test for confirmation. He consulted with the center’s board of advisors, and their collective judgement was no. (She also has family history of BRCA cancer, and came back as having the same specific variant as her mother.)
So it’s interesting that the practicing medical authorities are either confident in the test, or their assessment is equally at fault.
Or Facebook posts. I am in the middle of an argument with someone who posted something claiming that courts recently confirmed that the MMR vaccine causes autism.
Your argument is essentially that only rich people should have any access to across the board genetic testing, and that anyone who isn’t rich enough to be able to afford a non-insurance covered doctor visit and a few thousands dollars worth of testing needs to fuck off. You either get cheap testing that is covered in disclaimers saying that no, you really need to talk to a doctor if you find anything scary and accept that there might be some false positives in addition to the actual positives, or you just accept that if you don’t have the gobs of cash to hire a doctor and pay inflated lab fees then fuck off.
I personally will happily take the cheap testing. If I get back an OMG YOUR ARE GOING TO DIE result, I’ll make a doctors appointment and start hemorrhaging the money it takes to get a more professional opinion. As long as it is smeared in disclaimers, it should be my right to take a non-FDA approved non-invasive test that might not be perfect, rather being told to fuck off until I have a few thousand dollars to spare.
Or they don’t believe that the retest has significant value to the patient.
Which may be true. Unless you plan on doing preemptive mastectomy or something similarly major, the things you could/would do in response to a positive result are pretty much all things you should be doing anyway, especially given the family history.
This is why you want someone in the loop who can help you interpret how much the results should actually affect your lifestyle and plans.
My feeling is that if you’re going to pay even a small amount for the test, you can probably afford a comparably small amount for help interpreting it. Yes, it should be cheap. It should also be accurate, and correctly interpreted.
If the cheap testing came with a clear statement that “THIS IS ONLY AN INITIAL SCREENING, DO NOT TAKE IT TOO SERIOUSLY BECAUSE IT MAY BE WRONG IN EITHER DIRECTION”, I would agree that it didn’t need to be regulated. When they start claiming medical benefit, they’ve crossed the line and have to demonstrate that it is accurate enough to have that benefit. Truth-in-advertising laws, if nothing else.
Cheap and misleading is not an improvement over expensive and reliable.
Prophylactic mastectomy and ovarian removal are the typical advice for BRCA patients of her type. She is in her 30s, and the oncologist said she should take preventative measures soon. So these doctors were exactly recommending surgery on the basis of the 23andme result (corroborated by her family history).
It comes with a clear statement that says exactly that. It isn’t fine print. It is big and bold simple words. It is stated multiple times. Seriously, anyone who gets back a result and chops off both their boobs or decide to take up heroine because they are going to die in 5 years is criminally stupid and was likely to die choking when they suffocate eating a bag of chips. You can’t protect extreme stupidity. The people who are not criminally stupid should have to be punished because someone is dumb enough to shove a pencil up their nose despite the big bold letter warning label telling you that that would be really dumb.
“Punished”? All I see is the FDA saying that the company needs to be able to support the claims they make for the product, giving them lots of opportunity to do so, and finally giving them a warning that time is running out.
If your doctor’s going to help you interpret it, and sanity-check it, I have no problem with that. If they want to continue marketing retail, they need to play by the rules… and since (we presume) they’re legit, they really shouldn’t have any trouble doing so.
They tried to take a short cut. It failed. Now they get to go back and do it the way they should have when the FDA first told them the short cut wasn’t acceptable. I’m sorry, I don’t see that as an undue hardship or restraint of trade; it’s simply a cost of doing business in this country.
