After FDA Objections, 23andMe Won't Offer Health Information 146
sciencehabit writes "The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was 'to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process,' the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation." It would be great to see a secondary market in this kind of analysis emerge.
Re:good riddance (Score:5, Insightful)
Perhaps this is why the FDA put the kabosh on it
The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.
For example, one of the things that 23andMe can tell you is how well you might respond to one drug versus another, because of your specific genetic makeup. If you take that advice and change the dosage of your medication or switch to a different medication without discussing the issue with your doctor, you could cause yourself serious harm.
On the far end of the scale, "false positives" for some diseases could be catastrophic -- say, if a woman was erroneously told she had a high chance of contracting a certain type of breast cancer and decided to have a double mastectomy, like Angelina Jolie had done.
23andMe claimed that all it was doing was giving people information. But really, the way the information was structured and presented to the customer made it clear that it was designed to be diagnostically relevant and that they should use it to make decisions about how to proceed with health care. Any service that performs that function clearly falls under the jurisdiction of the FDA, IMHO.
Re:good riddance (Score:4, Insightful)
How could that possibly be within any legitimate government's domain? Using the same rational they could shut down wikipedia or rxlist.
They sure would shut down Wikipedia or RXList if those services allowed you to make an appointment to consult them for medical advice. Even campus health nurses have to be licensed.
What Wikipedia offers now is pretty much the same thing as reading information out of a book. You can't stop people from doing that, and there's no law against it.
What 23andMe does is market a product that you use to extract unique information about your own body, which is then presented to you in the form of suggestions about what health measures you should take -- in other words, medical advice. Very different.
The science is open.. (Score:4, Insightful)
Just need to link the science (published) and the genotype. It's all open.
Next up is banning people from sequencing their own genomes without a MD.
The real story here is who's the loser - it's not you; your DNA is your DNA, and the sequences are there or they aren't. The insurance industry are the ones who are actually worried about these tests - all of a sudden you have data they don't, and they can't apply their actuarial models anymore. Hilarity ensures.
May we all live in interesting times.
Re:23andMe is just plain bogus (Score:3, Insightful)
What's your definition of "useful conclusion"? Because I'm pretty sure it's different than what 23andMe was peddling and what all of us satisfied customers expected. Most 23andMe reports are equivocal on their face, in a good way. Some, like markers for Parkinson's or Alzheimer's, are also pretty clear. They tell you in plain English that the lack of a marker does not mean you're free from risk. If a marker is present, they give you a risk factor. But in no way did they diagnose you with Parkinson's.
Everybody thinks that they're smarter than most other people, and people like you just assume that most other people can't comprehend this stuff. Well, 1) we can and 2) it doesn't matter because 23andMe reports are of a different type entirely than what a professional genetic counselor would possess.
Show me one person who was duped by 23andMe? Even my own mother, who is quite naive about science-related topics, consumed her reports with a grain of salt, and without needing any warnings from me. Everybody understood that 23andMe is to professional genetic counseling as Walgreens is to The Mayo Clinic. In other words, professional and trustworthy in so far as a commercial vendor can be, but not in the same league as a real healthcare provider.
In an age where people obsess over stuff like HFCS and juice fasts, 23andMe cut through all the crap with hard data and reports which, despite all the inherent limitations, were damn interesting, if not in the rare case positively life changing. People understood the limitations, even the science-deficient anti-HFCS and organics crowd.
What the FDA did was pounce on some lofty marketing language. Big whip. The FDA just wants to shutdown the commoditization of genetic counseling, period. And it's ultimately going to cost all of us a ton of money.
Re:good riddance (Score:5, Insightful)
The FDA was very clear about why they stopped it. It wasn't necessarily that the information was misleading, but that it would lead patients to make decisions about their own care without necessarily consulting a doctor, which the FDA thinks is not a good idea -- and I totally see their point, frankly.
The FDA made them stop because doctors dislike being cut out of the loop, and insurance companies like being cut out of the loop even less than the doctors, and they would prefer to have you get the data through a disclosure mechanism which gives your insurance company better actuarial information. "Having a Dr. explain the information to the patients one on one" is just a place to hang that hat.
For example, one of the things that 23andMe can tell you is how well you might respond to one drug versus another, because of your specific genetic makeup. If you take that advice and change the dosage of your medication or switch to a different medication without discussing the issue with your doctor, you could cause yourself serious harm.
Yeah, in case you wondered, people can not self prescribe non-over the counter medications. So that excuse doesn't fly, either, since your doctor will be involved in writing the script for the new medication, and your insurance company will be paying for it, and like mine did, probably try to give you a cheaper generic version of a similar drug in place of the one your doctor actually wrote the script for, and then called it "equivalent". I've had that pulled on me, and been given "generic allergy medication" containing a cornstarch binder in place of the other one - when corn products were why I taking the damn stuff in the first place.
Re:good riddance (Score:5, Insightful)
Does anyone else find it upsetting that the local CVS is packed with whole aisles of homeopathic "remedies" with no proven efficacy (or worse, disproven), but some company can't tell you what your genes might mean? Apparently the FDA is about protecting what goes in your eyes than what goes in you mouth?