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FDA Tells Google-Backed 23andMe To Halt DNA Test Service
Hugh Pickens DOT Com writes "Bloomberg reports that 23andMe Inc., the Google-backed DNA analysis company, has been told by US regulators to halt sales of its main product, the Saliva Collection Kit and Personal Genome Service, or PGS that tells users whether they carry a disease, are at risk of a disease and would respond to a drug because the kit is being sold without FDA's marketing clearance or approval. 'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.' 23andMe was founded six years ago by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions. 23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews but the FDA said the company failed to address 'the issues described during previous interactions'."
I figure that a product which makes claims about its ability to predict (note that they won't say diagnose) your potential for developing certain diseases later in life should fall under the FDA's purview. I've been interested in 23andme for a long time. The first time I heard about them, the test and resulting reports ran something like $500. I added it to my "wish list" way back then and nobody bit. It's apparently down to the $99 mark now and is being marketed on television in time for the holiday season.
I'm a fairly intelligent individual and I'd be absolutely sure to take anything they reported about my genetic profile with a grain of salt. However, the FDA exists to protect your average Joe out there, who believes those TV commercials that say taking Penalis will give you a raging boner, and that lady who was on "Las Vegas" really does have an amazing non-surgical facelift procedure that will remove 20 years from your face.
A lot of these products get away with using a very blatant disclaimer that "these statements have not been evaluated by the FDA" etc. I'm not entirely sure why 23andme can't just put that disclaimer in there as well, and be all good. But the fact is, FDA has been trying to work with them for several years to get them into whatever is considered to be FDA marketing compliance, and the company apparently hasn't cooperated.
If they'd not put commercials on TV, they probably wouldn't be in any trouble. I just checked their site and can't immediately find the old list of stuff that they said they'd test your DNA for (and there was a big list). Not saying they've taken it down, but I didn't see it with a quick glance.
All of that said, the 23andme spit-and-get-results thingy is still on my wish list.
Thanks to the War on Drugs, it's easier to buy meth than it is to buy cold medicine!
My brother is working for a company that is in the prototype stage for something similar, but for use in non-developed countries.
Their test you first create a cartridge that has the dna sample doped with a radioactive substance you want to match against. You insert the patients test sample, it gets treated by different chemicals in the cartridge, and if the dna is a match the radioactive substance is released and a faint glow occurs which the machine reads giving you a nearly instant result to let you know if that dna sequence shows up in the patients sample.
It is not ready for use at this time, but you can be damned sure they will cross every single t and dot every i when they are ready to get approval for their system.
I believe that's exactly what the problem is. 23&Me is selling the test but never submitted evidence to the FDA that it works. Why should they just assume it's good because they said so?
I think likely the test is fine, but they haven't shown it to be so, so why should the FDA approve?
So there just *might* be someone who electively undergoes invasive, serious, expensive medical treatment without getting a second opinion (viz. diagnosis) and that is somehow the responsibility of 23andMe? Is that what the FDA and you are claiming? Are you also claiming that FDA approved channels *never* make mistakes and therefore people obtaining those results can completely trust them and should not seek a second opinion (viz. diagnosis)?
No, this smacks of the FDA wanting to be expansive and control everything - possibly even an expensive competitor using the FDA as a way to quash competition. This also smacks of a huge number of people not understanding that *I* am responsible for my own body and get to seek information and treatment for it through any and every channel I deem useful.
You and the FDA are tyrants for trying to tell me how to treat my body and taking away useful tools for doing such.
P.S. It is quite coincidental that the capta text for submitting this is "rights". How apropos.
If doctors were actually using these mail-order tests to make medical decisions, that would be a concern.
I don't think it's realistic to expect that anybody would for example get a double mastectomy/ovarectomy on the basis of this test. No licensed doctor in the US would operate on a woman on that basis.
(In fact, a doctor in Australia wrote an article about that in the New England Journal of Medicine. A woman had gone to a "free screening" at a "health fair" and the "alternative medicine practitioner" told her that she had cancer, and sold her a few thousand dollars worth of "alternative medicines" to treat it. This woman went to this real doctor, an oncologist, demanding to be treated for cancer. The oncologist kept telling her, "but you don't have cancer!")
Similarly, I can't follow the FDA's argument that this test could affect a patient's use of warfarin (although I give them credit for trying to make a case).
The FDA seems to give a free hand to companies selling some dubious tests http://www.hairanalysiskit.com/glink/1a.htm?gclid=COTshpbjgLsCFQbNOgodGUMAbQ so there are some legitimate questions.
Regulators protecting us from dangerous health fraud? Or jack-booted thugs restricting our freedom? You decide.
At the rate things are going it is likely to soon become cost effective to sequence everything for what 23andMe is charging now and simply hand customers a DVD with their fully sequenced DNA.
When that happens the cat is out of the bag all you need is software to do analysis for any and all aliments you want using nothing more than software which can be downloaded and used freely by anyone. Software no government is going to have much luck restricting people from getting their hands on it.
I am all for FDA regulations but they need to evolve or they will find themselves on the loosing end of a war they cannot win (See also drugs, smokes and alcohol)
A couple of suggestions:
1. Carve a space in regulatory regime allowing for speculative technologies provided any test outcomes must be validated by an FDA approved method before actionable decisions are made by a doctor. e.g. what is most likely to happen currently anyway as a result of any 23andMe diagnosis.
2. Setup a scoring framework and information system allowing people to get statistical information on the accuracy of tests as results are confirmed so they can make up their own minds whether tests are worth their time. Enabling the market to drive accuracy is a win for everyone.
The Founding Fathers never imagined or desired a federal government that regulates every aspect of our lives and runs 25% of the economy. They certainly did not imagine or want anything like the FDA, DEA, or other such institutions. The federal government is supposed to defend the nation and make sure that nobody interferes with free trade between the states, that's all.
Yes, and health care, education, drug laws, etc. should not be national matters.
And it's high time that we kick representatives with that kind of arrogant attitude out of office.