Leave 23andMe Alone

The FDA should stop obstructing consumer-driven genetic testing.

In November the Food and Drug Administration (FDA) warned the direct-to-consumer gene testing company 23andMe to stop marketing its $99 genotype screening test. The FDA's letter gave 23andMe 15 days to respond, warning that if the agency didn't like what it heard, the potential results could "include, but are not limited to, seizure, injunction, and civil money penalties."

Two weeks later, evidently to fend off further regulatory ire, 23andMe announced that it was suspending its Personal Genome Service for the duration of the FDA's review process. There will be no new DNA-testing customers until the federal government says it's OK.

The FDA worries that purchasers of 23andMe's personal genome services will do something dangerously stupid in reaction to what they learn. The letter suggested, for example, that customers could be misled by the results of a test for BRCA breast cancer genes. "If the BRCA-related risk assessment for breast or ovarian cancer reports a false positive," the agency argued, "it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

Researchers around the world use the same biochip that 23andMe employs-the Illumina OmniExpress-and find that it provides highly accurate results. Still, all diagnostic tests produce false positives and false negatives, so the question becomes: What is unique (and uniquely dangerous) about patients obtaining this information through 23andMe?

First of all, the company clearly states on its website that it screens for only three of the more prevalent BRCA breast and ovarian cancer mutations, and emphasizes that there are hundreds of potentially carcinogenic mutations in the BRCA1 and BRCA2 genes for which it does not test.

But suppose a customer tests positive for one of the BRCA mutations. What is she likely to do next? FDA bureaucrats seem to think she will immediately search for a surgeon to remove her breasts or start gobbling tamoxifen pills to ward off cancer. But those scenarios are ridiculous. The most likely outcome is that the customer would first consult with her physician about the results and then get another, more comprehensive genetic test. That is exactly what Huffington Post blogger Jill Steinberg did when her 23andMe results came back showing that she carried one of the BRCA mutations. Her subsequent test confirmed the 23andMe finding, and she eventually decided to have a preventive double mastectomy.

What if the 23andMe test missed one of the three mutations it's designed to detect? In that case, a customer might indeed wrongly assume that she is not an especially high risk for breast cancer. But let's put that error in context. Consider, for example, the OraQuick at-home HIV test, an FDA-approved product that the agency acknowledges produces "about one false negative result out of every 12 tests performed in HIV-infected individuals." A person who wrongly relies on the negative HIV result, like the person with an incorrect negative BRCA result, may be harmed by not seeking appropriate medical care.

The FDA does warn users of the HIV test that it is "important never to use a negative test result to decide on whether to engage in behavior that puts you at risk for HIV infection." Similarly, 23andMe explains to its customers, "The absence of these mutations does not rule out the possibility that a person may have another genetic variation that increases the risk of these diseases." Why should one test be permissible and the other not?

In 2013, 23andMe researchers conducted a peer-reviewed study of how customers reacted to their BRCA results. It found that those who tested negative "did not report inappropriate actions, such as foregoing cancer screening." The study also noted that "all but one of the 32 mutation-positive participants appreciated learning their BRCA mutation status." Similarly, a 2009 Genetics in Medicine study analyzing how patients responded to the results of a suite of eight genetic vulnerability tests reported, "We found no evidence that those who considered or sought testing were inclined to overestimate the contributions of genetics to common health conditions or to underestimate behavioral risk factors."

The FDA also suggested a scenario in which 23andMe customers would learn how sensitive they are to the blood-thinning drug warfarin and then use the results to "self-manage their treatments through dose changes," producing dangerous blood clots or bleeding incidents. As it happens, my 23andMe results indicate that I have increased sensitivity to warfarin. Fortunately, I don't have to use the drug right now, but I certainly would let my physician know these results in the event that I needed such treatment.

23andMe tests for the same variants relevant to warfarin sensitivity that tests approved by the FDA do. (By the way, stand-alone warfarin sensitivity tests cost between $200 and $400, while 23andMe's warfarin sensitivity results are included in its $99 fee.)

In any event, I seriously doubt that 23andMe customers who are not using warfarin will suddenly start anti-coagulant therapy for the fun of it. Nor are those currently on warfarin likely to stop listening to their doctors and begin to self-treat by swallowing d-CON pellets. 23andMe itself offers this advice at the top of the webpage reporting my warfarin results: "Only a medical professional can determine whether warfarin is the right medication for a particular patient. The information contained in this report should not be used to independently establish a warfarin regimen, or abolish or adjust an existing course of treatment."

23andMe has not always behaved prudently in this perhaps-inevitable conflict. The FDA's letter noted that the agency "has not received any communication from 23andMe since May," although the company rolled out a big new marketing campaign for its personal genome service in the fall. It is not very smart for a company to snub the regulators who have the power to shut it down at a whim.

But when it comes to the company's relationship with its customers, it's hard to find fault. So far, nearly 500,000 people have purchased 23andMe's genotype screening tests. The FDA's warning letter does not mention any substantial customer complaints about the service.

The development of all new technologies involves a social learning process in which some early adopters try it out, explain to others how it works, and find its flaws, which newer innovators then fix. The genetic testing companies that tease out and explain useful information about disease risks and pharmaceutical interactions will be the ones that succeed. Despite the FDA's parade of horrible hypotheticals, the bigger risk is that increased regulation will slow down the progress of beneficial genetic testing and treatment.

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  • ||

    The FDA worries that purchasers of 23andMe's personal genome services will do something dangerously stupid in reaction to what they learn.

    IGNORANCE IS STRENGTH

  • Steve G||

    then use the results to "self-manage their treatments through dose changes,"

    Oh noes!! Zod forbid people take personal responsibility even though it comes w/ potential risk. I've been "self-managing" my familial history of heart disease by deliberately ignoring the food pyramid/MyPlate for several years and am healthier than all of my peers as a result(40+ crowd).

    What was the name of the 3rd party site/company where you could send your raw 23andMe data for analysis??

  • Steve G||

    I still remember getting handed my copy of "Take Care of Yourself: The Complete Illustrated Guide to Medical Self-Care" years ago from my employer (mil) in their attempts to 'sell' me on the positives of their reduction in primary care (web-based physicals, never seeing a doctor, only PAs, etc). I guess self-care is only okay w/ THEY tell you to do it.

  • VG Zaytsev||

    The FDA worries that purchasers of 23andMe's personal genome services will do something dangerously stupid in reaction to what they learn.

    Why is concern for consumers actions a legitimate purview of the FDA?

  • Doctor Whom||

    Because we're all too stupid to make choices over our own bodies (except on abortion), so we need the nanny state.

    Back when permission to sell (not subsidize, not mandate, just sell) home HIV test kits was an issue, an opponent, who prided herself on being pro-choice, opposed allowing them because, inter alia, government needed to protect poor minorities from abuse. When I asked her whether she thought that poor minorities were too stupid to make choices over their own bodies, you should have seen the smoke come out of her ears.

  • VG Zaytsev||

    Even if that is true (which we both vehemently oppose) why the FDA?

    There's nothing in the laws creating the agency mandating or even allowing that agency to protect consumers from themselves.

  • etavenner||

    There's that, and the failure to tender the proper baksheesh.

  • Mike M.||

    What the government really wants is to get its hands on all of that information.

  • Heroic Mulatto||

    If I remember correctly, 23andMe's business plan is making money by selling the information to 3rd party interests rather than making it through their primary product. Last I read, they priced the kits in a way that they actually lose money on the them in a kind of a lead-loss strategy than enables them to make the money on being the eventual Google of "personal health information". You're a researcher looking for a huge data set in your work in population genetics? For the right price, 23andMe can provide you with that data which has been completely dissociated with identifying characteristics!

  • Almanian!||

    LEAVE BRITNEY ALONE!!

    *sobs*

  • SugarFree||

    The FDA also suggested a scenario in which 23andMe customers would learn how sensitive they are to the blood-thinning drug warfarin and then use the results to "self-manage their treatments through dose changes," producing dangerous blood clots or bleeding incidents.

    You mean like my blood glucose meter that I use to decide my insulin dosage at 7am and 7pm everyday?

    The horror.

  • ||

    "the bigger risk is that increased regulation will slow down the progress of beneficial genetic testing and treatment."

    Government hacks are well aware that they stifle innovation and they see it as a good thing. I have had one tell me so explicitly.

  • pan fried wylie||

    and civil money penalties

    Isn't it called a fine when the gov't does that? What private entity can claim damages in this situation?

  • Neoliberal Kochtopus||

    Fines come after court proceedings. Penalties can be levied without court proceedings.

  • Mark22||

    The controversy has nothing to do with risk to consumers. It's just that established makers of profitable medical tests don't like the competition. 23andMe provides information that's equivalent to conducting lots of patented and expensive tests individually; it's all about money, rent seeking, and government-maintained monopolies.

  • RishJoMo||

    Dude sometimes you gotta roll with it.

    www.Anon-Works.com

  • ||

    AnonBot isn't on top of his game -- just a generic remark, no attempt to parse the headline and make a somewhat relevant gag.

  • ||

    OT: Supreme Court rules against defendants in asset freeze case

    The Supreme Court on Tuesday ruled that criminal defendants facing federal charges cannot challenge a court's decision to freeze their assets before trial.

    By a 6-3 vote, the court said defendants can be prevented from using assets frozen by a pretrial order for their legal defense without a court hearing on the matter.

    [...]

    ----

    That's evil, plain & simple.

  • ||

    OT: More retired NY firefighters, cops arrested in pension fraud probe

    [...]

    Vance said the total amount stolen from taxpayers could reach $400 million.

    [...]

    ----

    A mil here, a mil there, and soon we're talking real money.

  • Adam.||

    i really wish i would have bought one of these before the FDA went all pantswetting on it

  • Riven||

    As do I. Honestly, most of the reason I would want one is simple curiosity. I don't see myself getting less-than-favorable results and falling all over myself to begin early, preventative treatment without at least one more medically validated opinion on the matter.

  • mtrueman||

    " Her subsequent test confirmed the 23andMe finding, and she eventually decided to have a preventive double mastectomy."

    A preventative double mastectomy based solely on tests of her genes, and with no actual symptoms of the disease present? Is that considered the wise choice these days?

  • Riven||

    She's a Huffington Post blogger... What were you expecting?

  • mtrueman||

    The author is not presenting her as someone exceptionally stupid, but as what we can expect in a typical case.

  • Tyler Durden||

    Ron, something that is often forgotten when reporting on liberty from a US perspective: what right does the US FDA have to interfere with my contractual arrangement with 23andme (I've paid an annual subscription for the last three years), when they have no power to regulate the medical advice I receive in my home country from any source? So far I've stuck with 23andme because I benefit from the links to other existing members who are genetically related to me, but a (to me) foreign government taking away my health-risk analysis by executive fiat, forcing me to rely on my memory of it, can only have negative consequences. As a foreigner, who has never resided in the US, I also have no recourse for this unjust taking of my property (my medical records) without compensation, and no standing to dispute this in your courts.

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