The FDA Will Finally Let You See Your Genetic Information

FDA head Scott Gottlieb overturns Obama's ban on direct-to-consumer genetic testing.

23andMe

Food and Drug Administration (FDA) head Scott Gottlieb is reeling in his agency's outrageous four-year ban on direct-to-consumer genetic testing.

Under the Obama administration, the FDA sent a letter to the genetic testing company 23andMe warning that the company was "marketing the 23andMe Saliva Collection Kit and Personal Genome Service…without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act." The letter noted that the company's tests had been providing "health reports on 254 diseases and conditions," including categories such as "carrier status," "health risks," and "drug response." But not anymore: The folks at 23andMe had little choice but to knuckle under to the agency's demands and stop testing new customers.

The company was eventually permitted to offer genetic test information on customers' ancestry and on genes associated with traits like the length of their toes. In early 2015, the agency allowed the company to provide users with results from a trait carrier test for Bloom Syndrome. Prior to the FDA's ban, the company's $99 genomic screening test package had included results from 53 trait carrier tests.

In April of this year, the FDA finally allowed the company to supply customers with genetic health risk information for 10 different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease, and hereditary thrombophilia (harmful blood clots). Before the ban, the company had been providing its users with some genetic insights with regard to all of those health risks and about 140 others.

Gottlieb's statement dramatically loosens his bureaucracy's stranglehold on direct-to-consumer genetic testing. After genetic health risk test manufacturers have passed through a one-time FDA review ensuring that they meet the agency's requirements for accuracy, reliability, and clinical relevance, any subsequent additional health risk tests will not need to undergo further review. "The floodgates for direct-to-consumer genetic tests are swinging wide open," declares the STAT science new service. Let's hope so.

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

Comments

[Fist of Etiquette]

Looks like a certain company cut a secret check to a certain Hitleresque agency head.

[Microaggressor]

When will the authoritarianism of the Trump regime come to an end?

[Chipper Morning Truthjammer]

Do they test for the libertarian gene?

[Bra Ket]

Gives a new meaning to "libertarian purity test".

[BestUsedCarSales]

As the only true Libertarian here, I have frequently claimed we need more loyalty oaths. A blood test would be a logical extension of this

[vek]

I think that one is mostly just directly related to IQ, that's why libertarians are all white/Jewish men. Doesn't explain the lack of Asian men though...

[Don't look at me.]

It's great that you can get the information, but I'm not sure I would want to know.

[Bra Ket]

By the way those tests are a perfect example of the awesomeness of the healthcare system. If you pay out of picket they charge $99 or whatever. If you have insurance that covers it, they bill your insurance something like $1200.

[Eric Bana]

*If you pay out of packet...

[Arcxjo]

Which is why we need Obamacare to cover it, you poor-hater.

[SIV]

FDA head Scott Gottlieb overturns Obama's ban on direct-to-consumer genetic testing.

MAGA

Yet Matt Welch said Hitlery would be "less worse".

[BigT]

Damned anti-science Republicans allowing useless 'genetic' testing. Should be figuring degree of separation from angels and configuration of bumps on people's skulls.

[John]

It was reasonably common in the pre civil rights era South for people who were mixed race to pass as white. That means there are likely a good number of people in this country who consider themselves to be "white" to have a significant percentage of their DNA actually be black or Native American or Hispanic. So when these people get their DNA tests and find this out, what is to stop them from checking "black" or whatever other minority DNA they find? How could you say that someone isn't "black" when they can pull out a DNA test showing that they are 10% or whatever black?

When that happens, the entire race based entitlement system falls on its ass. I don't see how you could ever overcome that problem short of having people be irreversibly marked at birth as some race.

[Stoic]

The opposite happens as well -- folks who identify as black do the test and find out that they have a substantial percentage of white ancestry. So they could check the "black" box when it is advantageous, but then check the "white" box in other situations. Or just check all applicable boxes. In any case, I do hope the end result is less emphasis on race as a primary eligibility requirement for services/scholarships/etc.

[CE]

There shouldn't be any boxes for race on federal forms. The 15th Amendment effectively prohibits the government from even asking.

[Duke of url]

"........Amendment effectively prohibits the government from even......"

Hahahaha!

[SIV]

Native American DNA means nothing to legal identity in the US. Their race is defined culturally and/or what their ancestors were marked on the census.

[John]

Elizabeth Warren has a tenured position at Harvard that says otherwise. You have to be on the rolls to get the tribal benefits. But there is no requirement for you to be on the rolls to check the block and claim the identity and affirmative action benefits.

[BYODB]

There is a labyrinthine process to be confirmed as Native American to receive those benefits, and from my understanding it mostly relies upon convincing the tribes or having the proper paperwork which is...mostly impossible. At least that's my understanding after talking with a few people who have tried to prove they have ancestors in their bloodline that were so-called Natives.

[John]

Your understanding is correct. But I am saying that you don't need to be on a tribal roll or get those benefits to claim to be a native American. You can just check the block and dare someone to question it. And that is exactly what Warren did.

[Bra Ket]

"When that happens, the entire race based entitlement system falls on its ass. I don't see how you could ever overcome that problem short of having people be irreversibly marked at birth as some race."

Oh this is an easy one.

Black people with white DNA are descendants of rape victims.

White people with black DNA are descendants of rapists.

[John]

Sure, but what says I am a white person with black DNA and not a black person with white DNA?

[Bra Ket]

hairdo, clothing (skinny vs baggy), political affiliation.

p.s. "sure"?

[John]

So the black guy in the business suit who plays chess is really "white" while the white guy in dreadlocks with baggy pants who hasn't showered in a week is really "black".

Sadly, that is where this is all headed.

[vek]

Oh God, probably. In all honesty though, I hate wide guys with dreads. It's not because it's cultural appropriation, but it's just lame.

[Dalben]

Color of your skin of course, the color of your parents skin may also matter.

It's not really about science or logic so DNA testing is irrelevant.

[vek]

The Injun blood of my dads side is Seminole, so I've always wondered if there is some black mixed in there as they were famous for breeding with runaway slaves in the everglades or whatever.

I'm going to get a DNA test one of these days, I'm just holding out for them getting to be more specific so I can hopefully get more granular information on my European side. The current tests don't even distinguish between German and French for Christs sake!!! LOL

Since I'm mostly German, it would be cool if they nailed it down to being slightly more regional or something. Like if it could say 1/3 of my German genes were from south eastern Germany/Austria for instance.

[buybuydandavis]

I think you get much more lineage specificity with Y-DNA and mitochondrial DNA testing.

[TJM]

More nanny state roll backs, one of the positive aspects of the Trump admin. But really, why should the FDA be at all involved in genetic testing service? If I am convinced of the value and am willing to pay for a service, whose business is that but mine and the company in question?

[Roger Knights]

"But really, why should the FDA be at all involved in genetic testing service?"

Regulatory creep, abetted by regulatory creeps.

[buybuydandavis]

Medical mafia needs needz moar extracted rent

[BYODB]

In April of this year, the FDA finally allowed the company to supply customers with genetic health risk information for 10 different conditions, including late-onset Alzheimer's disease, Parkinson's disease, celiac disease, and hereditary thrombophilia (harmful blood clots).

So, finally millions of people can confirm that they're really just hipster douche bags and they aren't really allergic to gluten? Sounds like a win, to me, and usually I'm the resident luddite.

[CE]

Their ads are funny though.

"We always thought we were Italian. Turns out grandma slept with some Slavic dude."

[John]

If SNL were still a comedy show, those commercials would be an easy target.

"I always thought I was Italian. But now I know grandma was a whore and the Milk Man was Slovak.".

[BYODB]

That show is still on the air? How droll.

[John]

I am told it is. I honestly couldn't name a single member of the case, however.

[Careless]

South park did it last month

[Unemployed Armenian Tranny]

How soon till 23 will be providing a comprehensive report for its new customers?

[Miner49er]

Its good that THE STATE is sticking its big fat nose less often into consumers' right to know about their health and genetic risks. It is certainly useful information, but the collection procedure is a huge privacy risk. None of these entities can guarantee to keep your info safe, and some of them even sell it. It is discoverable by government, law enforcement or litigants. Also, FANG and all the data merchants are avid to collect (and own) your genetic info. Read the book "Next" by the late Michael Crighton--its one of his best.

How would it feel to be denied a job opportunity or a business loan because "they" don't like your genes? (don't ask how "they" found out, because that, of course will be confidential.) This has already occurred in some workplaces. Or what if your child were denied admission to the college of his or her choice, because "they" don't like your genes.

Read "Brave New World" by Aldous Huxley. (He was an iconoclast, but his brother Julian was a notorious Fabian Socialist (the "nice socialists that still did a great job of screwing things up) during the between-the-wars period.)

[buybuydandavis]

Gottlieb's statement dramatically loosens his bureaucracy's stranglehold on direct-to-consumer genetic testing.

Sounds like freedom, don't it?

What's available to us is determined by the whimsy of proclamations of unelected apparatchiks.

At least this Duke seems more benevolent than the last.

[buybuydandavis]

By the by, you can get a huge report off of your raw data at Promethease.com.

Load your raw data, give them 5 bucks (or a few dollars extra if you have multiple reports to upload), and they run the data versus SNPedia, a wikipedia of genetic data mapped to health issues.