What Really Drove 23andMe And The FDA Apart

http://www.fastcompany.com/3022891/innovation-agents/exclusive-what-really-drove-23andme-and-the-fda-apart

by jerryhuang100 • 13 years ago

26 51 13 years ago

kghose• 13 years ago

This is a fairly even and well thought out piece but the author does seem to be a fan of 23andme: the author suggests that the FDA should have contacted 23andme semi-formally before because 23andme has a high turnover and their senior management is having a tough personal time. This is a bit funny. The author is basically suggesting that the management of 23andme is incompetent and the FDA needs to make allowances for this incompetence.

Otherwise the article nicely lays out the tensions between consumer advocacy, scientific rigor and sales.

AsymetricCom• 13 years ago

It's clear that 23 thinks that the FDA is incapable of enforcing their mandate and is daring them to do something about it in the media. This is just more BS spin to try to justify their bold and reckless PR maneuvering, under the guise of super-important and helpful medical technology being held back by big bad careless government regulation. I hope 23 continues to pretend like it does nothing wrong in the boardroom, while playing the media through their Google trumpet.

fudgekludge• 13 years ago

It seems as though the author may be making up for some embarrassment on the part of the editors for putting 23 on the cover of fast company recently.

macspoofing2• 13 years ago

Fastcompany and its editors are not at fault here. It's up to 23andMe to be prepared.

macspoofing2• 13 years ago

23andMe is incredibly naive.

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.

wtbob• 13 years ago

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.

tptacek• 13 years ago

Sure. While we're at it, let's get rid of meat inspections too.

smacktoward• 13 years ago

Not all "freedoms" are alike. As the saying goes, your freedom to swing your fist ends at the tip of my nose. And your freedom to make unproven medical claims for a product you're selling ends at my freedom to buy medical products with confidence that they are safe and will do what they claim to do.

001sky• 13 years ago

Medical false-claims have a higher standard of due care for good reasons. Not only are there issues with potential non-reversal, but the search and diligence costs are un-economic for individuals to verify acting in isolation. That's doesn't justify anyone's bad behaviour, but dismissing the problem out of hand is not really helpful.

HarryHirsch2• 13 years ago

23andMe is incredibly naive.

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.

rayiner• 13 years ago

23andMe is incredibly naive.

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.

jbigelow76• 13 years ago

    >The FDA has been asking 23andMe for specific studies on the reliability and efficacy

Who has time for reliability and efficacy, there are markets to disrupt!

digitalsushi• 13 years ago

Every modern car as an 'ODB2' connector under the dashboard, which allows anyone with 99 dollars to monitor the statistics of their vehicles - engine temperature, fuel efficiency, air pressure, et al.

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.

eli• 13 years ago

I don't think anyone here is saying the concept of personal genetic testing is bad.

booyaa00• 13 years ago

I would. The only use case I can see for it is if you're adopted and so don't know family history. Other than that, it can only lead to bad things.

aroch• 13 years ago

Changing your driving habits from "slam the accelerator" to "accelerate slowly and evenly" or "brake hard to stop at the last moment for that stop sign" to "come to gradual stop" is hardly as reckless as "Stop taking as much Warfarin as you are because our tests (with no proven reliability) says you could take a lower dose".

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

aestra3• 13 years ago

No it isn't a metaphor. Not a good one anyway.

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.

ChuckMcM• 13 years ago

I wonder if there was a bit of 'tech' clash with old school 'medicine' clash. Basically tech folks take the position of move forward and fix things that break, rather than wait until you are 99.999% nothing will break and then move forward. If that were the case, I could imagine a product manager getting incentivised to get the kits out the door and testing ramped up in spite of FDA reservations because 'hey it isn't like its something people take or anything.'

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 :-)

cube13• 13 years ago

I wonder if there was a bit of 'tech' clash with old school 'medicine' clash. Basically tech folks take the position of move forward and fix things that break, rather than wait until you are 99.999% nothing will break and then move forward. If that were the case, I could imagine a product manager getting incentivised to get the kits out the door and testing ramped up in spite of FDA reservations because 'hey it isn't like its something people take or anything.'

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

micro_cam2• 13 years ago

There is a somewhat proud history of Doctors self experimenting:

http://en.wikipedia.org/wiki/Self-experimentation_in_medicin...

Crito• 13 years ago

I doubt the FDA would find the time to care if the people at 23andMe were just sitting around diagnosing themselves like a bunch of hypochondriacs. Their interaction with the public is what has gotten the FDA's attention.

There is a rather shameful history of doctors experimenting on others in an improper fashion.

tvladeck2• 13 years ago

This really got me:

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.

dnautics• 13 years ago

You've never had to deal with a three letter agency as a corporation, have you? It's very difficult to ascertain when they want you to take a proactive step to "initiate outreach" and when you're supposed to contact them. And when there's a delay, who knows.

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?

lingben• 13 years ago

Who contacts who? the party that has less power contacts the party that has more power.

that is the way of the world, always has been, always will be

tvladeck2• 13 years ago

I must confess that your first sentence aggravates me. It comes across as an accusation that I am not qualified to have made the comment that I did. With that in mind, yes, I have.

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.

EpicEng• 13 years ago

That's why, when you are about to step into the FDA's purview, you hire people who have experience running a quality system which adheres to FDA guidelines or, at a minimum, a consultant with similar experience. Ignorance is not a defense, and in practice, it doesn't really matter; they can shut you down, you can't do shit about it.

patrickmay• 13 years ago

This is another example of why the FDA should be privatized and operate more like Underwriters Labs. If a company chooses not to seek FDA certification and still has customers willing to pay for its products, the bureaucrats should butt out.

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.

tijs2• 13 years ago

yeah man. Because people act completely rational when their terrified of dying and would certainly take the utmost care to vet every 'solution' offered to them.

aestra3• 13 years ago

I don't understand why naive people won't understand there is real potential to do harm here.

micro_cam2• 13 years ago

To me (software engineer working genetic research) the biggest issue is that 23andme is being represented as a cutting edge genomic tech while offering a test on an simplistic, outdated tech (a genotype array).

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...

huherto• 13 years ago

What about the ancestry information? Is that more useful?

tijs2• 13 years ago

Nope. Me and my Dad did tests at 23andme and a British university lab and according to the 23andme test i'm not a family member of well.. myself (nor my dad). If a test is not good enough to predict family members or even the same person i would not hold any of their other 'conclusions' in high regard either.

tensafefrogs• 13 years ago

? This link now seems to redirect to an unrelated article[1]... very confusing...

[1] http://www.fastcodesign.com/node/1840715

japaget2• 13 years ago

Article has apparently been taken down; the link redirects to a fastcodedesign.com article on Bitcoin. Does anyone have a copy of the original article on 23andMe?

mdturnerphys2• 13 years ago

http://webcache.googleusercontent.com/search?q=cache:http://...

japaget2• 13 years ago

Article has moved; new link at http://www.fastcompany.com/3022891/innovation-agents/exclusi...

mdturnerphys2• 13 years ago

It looks like the article may have been taken down. Here's Google's cached copy: http://webcache.googleusercontent.com/search?q=cache:http://...

What Really Drove 23andMe And The FDA Apart

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