FDA Shuts Down Genetic Testing Company, Says Consumers May 'Misunderstand' Results

[James Madison]

Ronald Bailey|Nov. 25, 2013 12:42 pm

For a couple of years, I have been warning all my friends and colleagues to purchase $99 personal genome testing from 23andMe before the Feds banned it. Well, now the Food and Drug Administration has banned it sending the genome testing company a warning letter:

The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

The FDA says it is concerned that consumers would misunderstand genetic marker information and self treat. For example, the agency cites the company for testing for versions of the BRCA gene that confers higher risk of breast cancer worrying that women might get a false positive test leading "a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions....

What the test results would actually lead patients to do is to get another test and to talk with their physicians. The FDA also cites the genotype results that indicate the sensitivity of patients to the blood-thinning medication warfarin. Again, such results would be used by patients to talk with their doctors about their treatment regimens should the time come that they need to take the drug. In fact, in 2010 the FDA actually updated its rules to recommend genetic testing to set the proper warfarin dosages for patients.

It is notable that the FDA cites not one example of a patient being harmed through the use of 23andMe's genotype screening test. Nevertheless the agency orders that...

...23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization for the device.

The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous.

For more background, see my 2011 Reason article on my own genetic testing experience here and go to SNPedia here for even more information on my genetic flaws.

H/T Mike Riggs and Andrew Mayne.

http://reason.com/blog/2013/11/25/fda-shuts-down-23andme-outrageously-bann


This is relevant:

…Marthe Kent, OSHA’s director of safety standards program and head of the ergonomics effort, couldn’t be happier at her job. ‘I like having a very direct and very powerful impact on worker safety and health,’ she recently told The Synergist, a newsletter of the American Industrial Hygiene Association. ‘If you put out a reg, it matters. I think that’s really where the thrill comes from. And it is a thrill; it’s a high.’ Later in the article, she adds, ‘I love it; I absolutely love it. I was born to regulate. I don’t know why, but that’s very true. So as long as I’m regulating, I’m happy.

http://www.lewrockwell.com/lrc-blog/inside-the-incredibly-repellent-mind-of-a-bureaucrat/

 

[angelatc]

Oh this sucks! I was going to get my son one of these for Christmas!

 

[Acala]

I used the service and found the results very interesting. If only I had known how unsafe it is I probably wouldn't have done it. Barely escaped with my life, I'll wager.

 

[Keith and stuff]

Horrible news. What would be even worse is if the Feds steal all of the info. That's my fear and why I never took the test.

 

[MRK]

So when a company takes on a huge risk by pioneering a brand new and unknown market capable of saving lives, that company gets shut down when it makes mistakes? Wouldn't this company be in a superior position to not make those mistakes again versus another company, given that it has learned from them first hand?

Why would new businesses and industries want to come to the US again?

 

[Anti Federalist]

Horrible news. What would be even worse is if the Feds steal all of the info. That's my fear and why I never took the test.

Oh, you can pretty much count on all the records and info being seized by the FedCoats.

And put into their database.

 

[FindLiberty]

Looks like they are winning the war on tests faster than the war on (some) drugs.

 

[fr33]

This is so outrageous. The US Govt is the #1 enemy of humanity.

 

[Barrex]

Oh this sucks! I was going to get my son one of these for Christmas!

Well if you get him one now and tell him to be careful because it is illegal he will be even more excited.

 

[Quark]

I bought a kit from them for $300 when I was 16, four years ago, and a kit for my mother for $99 last year. I've had zero problems with their service, and it's benefited me. The FDA is an inhibitor of "progress" not a catalyst.

 

[AngryCanadian]

The FDA Running people's lives.

 

[angelatc]

Well if you get him one now and tell him to be careful because it is illegal he will be even more excited.

Ha!

He just wanted to know his ancestry. My father's mother's family traced 1 guy back to Wales, but that's all we have. My husband's mother's family's story changes depending on who you ask.

 

[Acala]

Oh, you can pretty much count on all the records and info being seized by the FedCoats.

And put into their database.

And then what? Are they going to clone me? Use my DNA to frame me? It's not like I haven't had a thousand blood draws in my life, each providing ample opportunity to snatch my DNA. I even had a colonoscopy a few years ago. They probably snipped some tissue and sent it to the Secret Service and then implanted a chip up there. Who was that man in black sweeping up my hair at the barber shop? What ever shall I do?

It has recently occurred to me that a state of chronic paranoia depends on at least two persistent delusions.

The first delusion is a grossly exaggerated impression of the capability of whoever it is you think is after you. So let's get this straightened out right now. The government is nearly ALWAYS incompetent. Healthcare.gov is not an anomaly, it is SOP. The only reason it gets headlines is because it is so huge. But it is no different in character than virtually everything government does. Government is almost entirely composed of the inept, the lazy, the stupid, and the corrupt. They are not cunning. They are not tenacious. They are not effective. They bungle EVERYTHYING. Edward Snowden, bless his heart, is PROOF of just how incompetent is the government even in its super-secret whiz bang black heart of hearts. Any DNA database operated by the government will be a disaster of mismanagement and will be virtually useless.

Through circumstances that are not relevant, I once had close, informal contact with a homicide detective. He told me something very interesting. When his office investigated a murder and found the unmistakable signs of a professional "hit", they called off the investigation and filed it. Why? Because they knew they would never solve it and learned long ago not to waste their time. So with all their forensics, ballistics, DNA databases, fingerprint databases, and technological shock and awe, the only murderers they ever catch are the ones that were either drunk, angry, or stupid. And those are the ones they would have caught a hundred years ago. The rest is just Hollywood.

The second delusion is a grossly exaggerated impression of self-importance. The reality is that nobody cares about me. I am not even on the radar screen. And, no offense, but neither are you. There are real intellectual and moral giants in the liberty movement - people like Ron Paul, Robert Higgs, Stephen Molyneux, and many others - who are really making a change. And yet, nobody is dragging them off in the night or darting them with polonium or sending mind-controlled zombies to assassinate them. Adam Kokesh, as brash and radical as he was, had to nearly break IN to prison. I am nothing compared to them. Why on earth would I think that I would be a target when they are not? I'm not a target and neither are you.

I can assure you that the chronic stress from believing that you are under threat from every direction will kill you LONG before any government agent even cares that you exist.

Now the day may come when the government decides that thought crime, no matter how insignificant, must be stamped out. But when that day comes, it will be a neighbor or co-worker who fingers me, not some database of spit or NSA spy network.

 

[Cleaner44]

Oh this sucks! I was going to get my son one of these for Christmas!

23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization for the device.

It looks to me that you can still purchase the product, they just are supposed to stop marketing it. Place your order and see what happens.

 

[puppetmaster]

Ha!

He just wanted to know his ancestry. My father's mother's family traced 1 guy back to Wales, but that's all we have. My husband's mother's family's story changes depending on who you ask.

Lol I have the same changing answers from my moms side also....

 

[axiomata]

I used the service and found the results very interesting. If only I had known how unsafe it is I probably wouldn't have done it. Barely escaped with my life, I'll wager.

Wow, I too survived this dangerous service. What are the odds.

 

[kuckfeynes]

Nanny state strikes again. Hopefully they continue the service and just try to make the marketing and analysis more compliant. What many people don't understand is that just because one has a specific polymorphism linked to this or that health issue doesn't necessarily mean it is expressing; it is merely an indicator. And 23andme's internal analysis doesn't do much to combat this misconception.

While a lot of people get it done just for the novelty of it, it has actually been a huge leap forward for people with cellular level issues (methylation, sulfation, krebs cycle, etc) from chronic fatigue to autism spectrum disorders to gain a deeper level understanding of their problems and approaches to address them. Before 23andme, similar testing cost 5 times as much for a tiny fraction of the data. It has also probably saved several people going under the knife from potentially life-threatening anesthesia paralysis.

Mainstream medicine still considers a lot of this pseudoscience and the researchers on its forefront "quacks," but there is no arguing with empirical evidence and success stories. Google Amy Yasko for more background. Many doctors who are naturally curious professionals and not just pill-pushing agents of the healthcare state are coming around. There is enormous potential in the field of epigenitics and we've only begun to scratch the surface. The only problem is getting peer-reviewed studies published in scientific journals costs millions, which typically come from Big Pharma, which we all know is more interested in drug sales than actual cures.