What Really Drove 23andMe And The FDA Apart
fastcompany.com
fastcompany.com
>The FDA has been asking 23andMe for specific studies on the reliability and efficacy of its DNA test results as well as specific clinical analysis regarding health claims (for example, the risk of developing a condition that is associated with a genetic marker).
Makes sense. You're making certain medical claims, you darn better have something to back it up. What's their answer? Well:
>23andMe says it is working on satisfying those mandated requirements and admits it wishes its efforts were farther along.
Well, then you can't make those claims!!! What the heck did you expect the FDA to do!? Give you a break? Just this one time?!
> At the same time, 23andMe contends that the reliability of its test kits and data adheres to the highest standards, that its process matches that of a DNA test one would get through a physician.
PROVE IT! The reason why they haven't, I'm sure, is because it's expensive and time consuming. And possibly because the regulations around commercial DNA testing is out of date, maybe, but it is what it is.
>Last spring 23andMe began to ramp up the marketing efforts behind its DNA kits. This included TV and video ads and a direct-marketing campaign.
Of course that would be a problem. How you market your medical product factors greatly in whether or not you're going to be audited! Is this surprising to anyone at 23andMe !?!?
>Given the long history of dialogue with the FDA, you might imagine that 23andMe would have sought feedback about these initiatives--to see if any concerns surfaced or tweaks were requested
The FDA doesn't works like that. You're not going to get an a priori go ahead from them. The way it works is YOU have all YOUR homework done and ready, then go and market, and then if you get audited (and the FDA reserves the right to audit you anytime) the onus is on you to prove that your claims are sound and backed-up by proper evidence, that your quality system is in place and that your product is correctly classified and registered. If you don't have that, you get shut-down, and possibly more.
>The FDA, in turn, took no steps in the wake of this marketing wave to reach out to 23andMe and suggest caution or areas of concern.
The FDA is not your personal auditor or adviser. They don't work on your schedule. They aren't there to hand-hold 23andMe while they take their product to market.
Sometimes when you release a product in a new category, it may take the FDA a long time to come up with the right procedures and to amend the proper regulations, but them's apples. You don't go out, do what you want, and then be surprised when you get shut-down.
That's how it _ought_ to be in a free republic.
I am an adult, I paid for 23andme with my money, and I understand the limitations of their data. If I'm worried about something in particular I'll go to the doctor, since they spell it out all over the place that none of this stuff is final (not to mention the fact that the only thing they even ever tell you is like "1% elevated risk"). I don't need mama government stepping in and making sure I'm not being mislead (which is hilarious because it is on the other hand 100% legal to be a fortune teller and tell someone not to worry since that pesky cancer won't be terminal according to these tarot cards).
You're not allowed to make medical claims in advertisements that you can't back up. Cheerios famously got into trouble for claiming it's heart-healthy or some such.
The FDA was started because companies were making medicines that either didn't work or weren't safe and people were relying on them. Consumers lost faith in the health care industry, so we have a much higher standard of care. I understand that it's expensive, difficult and time consuming to fulfill this higher burden of proof, but the alternative applied across the entire market really just shifts those costs to the consumer while degrading confidence in the market for medical services overall.
Hate to break it to you, but this is already the case, and it had nothing to do with the "precedent" of 23andme. Go walk into a church of scientology or go read "The Secret" and tell me that's not what they're offering. Sure, they don't use the word "medical", but it doesn't matter. You are suffering from an educational bias, your worldview is completely divorced from that of the people you are trying to "protect". Most people don't understand that the term medical is no a mere colloquialism, nor do they understand that the lack of that term is a negative implication on the substance at hand. I speak from experience, my aunt died because she went to see quacks instead of a real doctor, despite all the information in the world available to her. Its perfectly legal to tell someone that doctors are full of shit and crystals are the real way to cure something. And you know what? At some point you need to just be OK with that. If not its just white man's burden all over again rebranded as "rich man's burden".
> The FDA was started because companies were making medicines that either didn't work or weren't safe and people were relying on them.
Hilarious. You want further proof of what I'm talking about? Go to the supplements isle at a grocery store. All that stuff is bullshit and often even specifically says "not approved by the FDA". Guess what? Its still a billion dollar business, and there are people who swear by that stuff and don't trust doctors. No one notices, cares, or understands. Again, your problem is that you are attacking this from a rational position and think that that is how other people operate as well, its not. You are kidding yourself if you think the FDA has succeeded in this goal.
> I understand that it's expensive, difficult and time consuming to fulfill this higher burden of proof
Ah and now we reach the best part about the FDA: that it effectively makes even educated people worse at making decisions. Despite the fact that the FDA has repeatedly been shown to be corrupt or in bed with certain companies, "approved by the FDA" is still a considered a trusted metric not requiring much further thought. Its not. The FDA has no competition and, like any government agency, incredibly rarely suffers consequences for being corrupt or making mistakes. Most people don't know "the burden of proof" required (and if you read about how bad doctors are at understanding statistics you wouldn't trust that burden of proof anyways).
The FDA would love to regulate the supplement market. They simply can't.
Also, "approved by the FDA" isn't a trust metric that anyone relies on. It's a very basic, fundamental requirement for all medical drugs, devices, and procedures.
This is a false statement.
See the Dietary Supplement Health And Education Act of 1994 which is a failure of government to protect citizens best interests in favor of the industry.
The strategy of 23andme is to collect genomic data and correlate it with phenotypic data to get a handle on variations. They will sell the data, either to pharmcos or themselves; if they do it themselves they will need to do trialing to ensure that their test does measure what they say it measures.
This stunt serves to hollow out the FDA and get an end-run around clinical trials.
Meat inspections are under the purview of the USDA thanks to the Federal Meat Inspection Act.
>The FDA has been asking 23andMe for specific studies on the reliability and efficacy
Also, what is their lawyer doing, allowing them to make statements like "23andMe contends that the reliability of its test kits and data adheres to the highest standards, that its process matches that of a DNA test one would get through a physician" in the middle of this sort of agency action? Maybe the author's paraphrase is wildly wrong, but in this sort of situation, you don't really want to go on the public record doubling down on your position that your product is as good as what you'd get through a doctor, while arguing that it shouldn't be regulated as a medical test.
Naive? To cynical me this dustup is a PR stunt, they want exposure and to put public pressure on the FDA to be allowed to continue just as they did in the past.
Otherwise the article nicely lays out the tensions between consumer advocacy, scientific rigor and sales.
> or a recognition from the FDA that, given turnover at 23andMe (and Wojcicki’s distraction due to her public separation from husband Sergey Brin), the task of initiating outreach fell to them.
That's laughably ludicrous.
In registering my nonprofit with the IRS, I sent in my 1024s, and promptly got a letter back, "we will get back to you in 90 days." It's been 180-ish days. Static. What now? Who contacts whom?
But that's irrelevant.
Anyway, you missed my point. My comment did not imply that it was obviously not the FDA's responsibility to make contact. (Nevermind the fact that at the end of the day, it was in fact the FDA that did reach out to 23andMe.) I did imply, however, that turnover at 23andMe and Anne's marital issues were ludicrous reasons for it to have been the responsibility of the FDA.
that is the way of the world, always has been, always will be
Even intelligent, technically minded people get taken in thinking they have "had there genome sequenced" when they are getting tested for a small number of single nucleotide polymorphisms (SNPs).
The scientific reality is that, while there are some well established correlations between SNPs and disease, the explanatory power of such simple tests and validity of studies based on them is in question [1].
Getting a genotype for 99 bucks is a cool service but I worry that the marketing that goes along with it is doing more to misinform than educate. I wish they had pushed more towards offering actual sequencing to consumers as prices fall.
[1] http://en.wikipedia.org/wiki/Genome-wide_association_study#L...
It would make an interesting short story (fiction of course) of a Doctor who invents a cure for cancer and starts giving it to people in his family who have cancer, and curing them but gets thrown into jail by a regulator, whose spouse dies of cancer during the clinical trials. The character conflict of someone who is doing the right thing at great personal cost, compared to someone who did the wrong thing for personal benefit, vs the overall 'right vs wrong' of the entire system. If someone picks up this story line add a thank you to me in the forward :-)
Replace "product manager" with "marketing exec", and I think you have it right here. The FDA's problem with 23AndMe isn't with the tech, it's with the marketing. The FDA has asked for studies proving that 23AndMe's marketing is correct, and so far, 23AndMe has not produced the results of the studies.
This isn't anything new, too. Here's what the FDA said to General Mills about their Cherrios advertising in 2009: http://en.wikipedia.org/wiki/Cheerios#2009_Drug_Claim
http://en.wikipedia.org/wiki/Self-experimentation_in_medicin...
There is a rather shameful history of doctors experimenting on others in an improper fashion.
Thought experiment: If everyone all of a sudden had all this information on their dash tonight, how many would change their natural driving habits because of the visible information, even if no metric was any different than the every day before it?
I won't speculate. It's just a metaphor.
Medical screening tests are a costs benefits analysis. Science does this.
There is a cost for everything. If you have a disease that isn't causing any symptoms, do you treat it, even though it will probably never cause symptoms? There is a risk in all treatments, some more than others. There is a study that most prostate cancers don't show symptoms, ever and our super sensitive cancer diagnostics tests are causing more harm than good. More diagnostics does not mean more good. That's why we no longer do the Prostate-Specific Antigen (PSA) Test. It finds too many cancers that aren't going to cause harm and then people get unneeded treatment that causes side effects. (Source in: http://en.wikipedia.org/wiki/Prostate-specific_antigen)
For example, it used to be recommended that all women perform a breast self exam every month, then data showed us this didn't prevent cancer and actually caused harm because it lead to needless surgeries and biopsies. (Sources here: http://en.wikipedia.org/wiki/Breast_self_exam)
We just don't throw more diagnosis and screening at patients and assume that is a good thing.
Almost all the metrics you'd get out of of an ODB port would tell you to be gentler in your driving. Very few people feel comfortable in messing about with the guts of their car. Whereas many patients are more than happy to disobey their doctor's orders on a whim
If 23andMe is making demonstrably fraudulent claims, that's an issue for the courts. Otherwise, the government shouldn't be using force to interfere with voluntary transactions that harm no one else.