FDA

I Want My 23andMe or, The FDA Took My DNA Away!

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I've got a new piece up at The Daily Beast that riffs off the recent, sad, insulting, and doomed attempt by the Food and Drug Administration to put the kibosh on "personal genetic services" such as the one offered by 23andMe.com, which Ronald Bailey wrote about yesterday.

Here's my column's opening:

In its infinite wisdom, the Food and Drug Administration (FDA) has forbidden the personal genetic testing service 23andMe from soliciting new customers, claiming the company hasn't proven the validity of its product.

The real reason? Because when it comes to learning about your own goddamn genes,the FDA doesn't think you can handle the truth. That means the FDA is now officially worse than Oedipus's parents, Dr. Zaius, and the god of Genesis combined, telling us that there are things that us mere mortals just shouldn't be allowed to know….

The FDA is seriously claiming that you might learn you have a possibility of developing breast cancer and then insist on having the potentially cancerous body part lopped off. And that you'll be able to find a doctor or hospital or taxidermist who will do any or all of that without doing further tests and followups. They don't provide a single instance of this happening nor do they specify any possible medical world in which this might happen, but that's enough to shut down 23andMe for the foreseeable future. (The company has issued a short statement about how they will work to meet the FDA's demands.)

The FDA is now apparently taking policy cues from The End, a 1978 comedy starring Burt Reynolds and Dom DeLuise. In that groaner, Burt is convinced he is going to die soon and sets about offing himself. Spoiler alert: Hilarity doesn't ensue. It's a Burt Reynolds-Dom DeLuise showcase after all….

Read the whole thing here.

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  1. I wonder if my genetic makeup predisposes me to appreciate a state that gets between me and the decisions I try to make.

    1. It’s called “Oppositional Defiant Disorder”

  2. Someone was angry that their monopoly on expensive DNA tests was about to go boom and they found a few donkeys to help make sure that was not gonna happen. Don’t blame the people or korporashuns doing this: blame the politicians that have rigged the game to allow it so they could rake in the cash.

    1. 23andMe was going to go into decline unless they started doing whole genome testing. The cost in both time and dollars for doing whole genome has been dropping rapidly (I believe it’s at about $5k for a human) and the next generation tech is a hell of a lot faster and cheaper. 23andme does SNP testing, which is fast, but not all that thorough. Unless 23andme ups its game, it’ll be left in the past fairly soon anyway.

      1. So, they start offering whole genome sequencing — different, non-banned tech, right? Maybe they called down the FDA on their old, useless tech. Like how DuPont happened to see classic Freon banned as their patents were expiring and newer refrigerants were coming online commercially.

        1. What?!! Active rent seeking?!

          UN. Possible.

      2. Companies will innovate or die. They have said for a while they will do whole genome testing. In fact subscribers like me (they run a service that updates your genetic risk profile as more discoveries are made) are supposed to get it at reduced price.

        1. I figured they’d originally switch over to whole genome there’s no way SNP testing will remain viable with the falling cost of whole genome. I was an early adopter and then had to pay for their newer chip (that annoyed me a bit). I haven’t seen anything about them offering whole genome, but I haven’t paid that much attention.

          1. I forget where I saw the “upgrade to full genome sometime in the future claim,” but they are at least pointing in the whole-genome
            direction.

            If they start offering that service, maybe Reason will figure out how to offer this service: http://www.youtube.com/watch?v=l3Ya6z-NlDo

      3. Companies will innovate or die. They have said for a while they will do whole genome testing. In fact, subscribers like me (they run a service that updates your genetic risk profile as more discoveries are made) are supposed to get it at reduced price.

      4. Companies will innovate or die. They have said for a while they will do whole genome testing. In fact, subscribers like me (they run a service that updates your genetic risk profile as more discoveries are made) are supposed to get it at reduced price.

        1. Yikes. I am genetically predisposed to enjoy the company of squirrels.

      5. 5K is a long way from $99.

  3. officially worse than […] the god of Genesis […], telling us that there are things that us mere mortals just shouldn’t be allowed to know

    Whoa now. Can you really blame the god of Genesis for wanting his playthings to be simple? It’s bad enough we have to feed, water and give attention to pets, what if we had to deal with them plotting and building monuments to their hubris?

    I for one support the Semitic Thunder God’s attempts to keep his pets docile.

    1. He sent you a message, didn’t he? Was it like waking up to a horse head in your bed. Good God, Sarah Jessica Parker, is there no limit to Jahovah’s cruelty.

      1. Was it like waking up to a horse head in your bed. Good God, Sarah Jessica Parker, is there no limit to Jahovah’s cruelty.

        I tried to drown my sorrows in delicious, delicious antifreeze, but He has cursed me with an inability to metabolize it.

        *returns to sobbing softly in the corner*

        1. There, there, Jesse…

          *tries to man-sole Jesse – which is consoling, in a manly way*

          no homo

          1. Side hug. One arm wrap. Manly shoulder clap. If in sports, butt pat, elsewise, walk off.

          2. It’s Jesse, who could blame you even if it did.

            1. Do I get some kind of no homo exemption?

              You guys need to let me know these things so I can maximize my abuse of this privilege.

              1. It’s like that episode of Family Guy where Louis cheats on Peter with Bill Clinton, and he goes to confront Clinton, and winds up sleeping with him. You have Clinton level magnetism and charisma.

                1. er, Lois. You see, I’m all confused about gender identity now!

                  1. Alex Bornstein is a chick!?!?!

                    http://upload.wikimedia.org/wi…..more_3.jpg

                2. I think that’s the first time I’ve been called Clintonesque in a complimentary way.

                  1. The last time was when someone implied that it couldn’t possibly be rape or sexual assault with a man as charismatic and good-looking as yourself, amirite?

                    1. It’s not sexual assault. It’s sensual assault.

                    2. Huh? The chloroform usually prevents them from jibber-jabbering that much.

                    3. *singing*

                      “…take my breath aaaa—waaaaaayyy…”

                      *sees jesse in soft focus…then passes out from chloroform*

                    4. I will never hear that song the same again.

                    5. dreamy, innit?

                      *falls back into dreamland*

    2. Next thing you know its like the 3 Generations of Bridges-guys Outer Limits where Jeff sets the alien crawfish to warring with each other. (Pretty sure this was originally a Ted Sturgeon short story, too.)

      1. He’s lucky them crayfish enver found out there was a Popeye’s right down the road from his barn house or else it would have gone even worse for him….

    3. The cats already plot against us.

    4. Isn’t Mr. Gillespie misrepresenting Jehovah? I presume he is referring to Genesis 2:17, which talks about the only restriction that God saw fit to put upon the first humans: don’t eat from the tree of the knowledge of good and bad. What is the meaning of that? Man doesn’t have the authority to DECIDE what is right and what is wrong – that is my emphasis.

      Misrepresentation can come from anywhere. I think Nick has done so here. If you think what I said is incorrect, feel free to say so.

  4. The FDA is seriously claiming that you might learn you have a possibility of developing breast cancer and then insist on having the potentially cancerous body part lopped off. And that you’ll be able to find a doctor or hospital or taxidermist who will do any or all of that without doing further tests and followups.

    Well, according to the president, doctors just lop off limbs willy-nilly.

    1. Not my 11th finger!

      1. Inigo Montoya can help you with that if the doctors refuse.

    2. “Well, according to the president, doctors just lop off limbs willy-nilly.”

      And they do it for people WITHOUT INSURANCE!

  5. Nick and Ron, your perspective appears to be a gross misrepresentation of what’s going on here. There is no basis for ascribing ulterior motives such as “Because when it comes to learning about your own goddamn genes,the FDA doesn’t think you can handle the truth”. This is a regulatory issue solely related to presentation. If 23andMe wasn’t making specific claims about the medical usefulness of the information, then the FDA wouldn’t have any basis for taking action.

    I can’t say that I have a strong opinion one way or the other about the validity of the medical statements being made by 23andMe. Is the marketing legitimately based on substantiated research? I have no idea. But you two aren’t arguing that point. And I don’t see any evidence here that the FDA is acting outside of the boundaries established for them by Congress. They’re doing what they are charged to be doing.

    Whether Congress should have set these boundaries in the first place is an entirely different argument. But to spin this as an attack on personalized DNA test results in general has no substantial basis.

    1. Ron Bailey posted the FDA letter. I suggest you read it. The FDA concern rests with the risk that supposedly “ignorant” patients might decide their own individual medical destinies.

      1. We certainly can’t have the peasants deciding their own destinies, medical or otherwise!

        They need our….our HELP!

        /FDA bureautard

      2. Trying again, but who knows what the 3pm squirrel break will do. I think an actress had a pre-emptive double mastectomy based on her genetic profile… and replaced her murderous funbags with the best prosthetics money can buy. Right about the time the old ones were succumbing to the merciless ravages of time.

        1. Angelina Jolie.

      3. The FDA concern rests with the risk that supposedly “ignorant” patients might decide their own individual medical destinies.

        I understand, but this is not FDA’s fault. Look at their enabling legislation, and you see this has been a longstanding concern of Congress, and comes up frequently in regard to OTC dx kits as well as drugs and therapeutic devices. It’s not a stretch on FDA’s part. Blame the legislators (and not just recent ones, but you can blame them too because with all the amendments they haven’t removed this consider’n), because the agency is doing just what the legislators wanted and mandated them to do.

    2. Nicely done, MP. Took you longer to run your mouth ignorantly than to just research the facts.

  6. F’ing squirrels; once more:
    Posted in AM Links, Chron lefty columnist says “Good!”; someone somewhere sold snake-oil:
    http://www.sfgate.com/technolo…..011311.php
    From the comments and I don’t think the comrade is being sarcastic:
    “@talk0underworld
    This is serving the public, by making sure they aren’t spending money on tests that aren’t useful to anyone.”

  7. The comments are what we thought they were.

    koshandeh
    12 minutes ago
    Who paid you to write this advertisement, Mr. Gillespie?

    FlagShareLikeReply
    rob654
    20 minutes ago
    So the real reason can’t possibly be that in fact the company has not proven its product, its testing and its results nor has it received the appropriate clearance before running tests and informing people with what might be completely bogus results?

    http://www.fda.gov/ICECI/Enfor…..376296.htm

    “Good technology tends to win out over time, despite all the attempts by the old guard to stifle it.”

    Agreed, however, we have no proof yet that this “23andMe’ company is providing good technology or good diagnostic results.

    FlagShareLikeReply
    klow
    54 minutes ago
    The National Geographic Society provides the same service except for the disease proclivity as part of its human migration history project. Companies other than 23and me have been providing the exact same service for years. I first investigated this service 10 years ago and decide a year ago to submit my saliva to the National Geographics Society.

    So the FDA is not banning the service but only stopping one company from providing the service on the simple ground that the company is not doing a good enough job. In effect, the FDA is saying that if you want this service, go to another company that is better at providing this service.

    1. Remember, the FDA isn’t banning trans-fats, it is simply informing companies that they will be open to huge punitive lawsuits if they continue selling and/or using them in products.

    2. I’m sorry, klow, but we’re afraid you aren’t doing a good enough job at breathing. Now, we’re not banning breathing, we’re just saying others are better at it. So, until such time as you can provide proof that your breathing is on par with other people’s breathing, we’re going to have to “ask” you to stop.

      1. If nothing else, it’ll stop wasting valuable oxygen.

    3. Agreed, however, we have no proof yet that this “23andMe’ company is providing good technology or good diagnostic results.

      Somebody might not come down with a disease that 23andme said that they might come down with! We can’t have anarchy like this!

  8. I wish you would stop linking to TDB, Nick. I always click the link, and I always feel the urge to read a few of the natives’ articles. Like this masturbatory love letter to Elizabeth Warren.

    And in one of the biggest applause lines of the entire convention, taken straight from Occupy, she thundered that “we don’t run this country for corporations, we run it for people.”

    1. “we don’t run this country for corporations, we run it for people.”

      “America is not an oligarchy? A Republic must answer to the people”

      The latter is from Senator Jeffery Beauregard “Jeff” Sessions III. Either one.

  9. Turns out the Greeks AREN’T infecting themselves with HIV.

    http://www.theguardian.com/wor…..-inflicted

  10. Bill Handle killed Dominick DeLuise. Not literally, but Handle hastened his demise. Handle is the host of LA’s most popular AM radio talk show. Given the traffic congestion in LA that’s big venue. Handle finegl’d the suits at KFI AM640 into getting DeLuise a weekend talk show cooking slot. DeLuise was smart, funny, and a good cook. But he didn’t have a motor mouth. He was devoured by crickets. Just gruesome.

  11. Don’t make more of this story than it appears to be. I’ve no doubt compromises will be reached and data submitted to allow the specimen collection kits to return to market with substantially the same function as they’ve been marketed as. There’s money to be made; this is not the 1st time a diagnostic kit has had to be done over to satisfy FDA.

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