Does the FDA think you're too stupid to have access to your own genetic information?

It sure seems so.

The Food and Drug Administration, which bills itself as "the oldest comprehensive consumer protection agency in the US federal government," probably stirs up more emotion among citizens than any other federal agency (save perhaps for the IRS). For good reason. The range of activities into which the FDA is "mandated" to poke its supervisory fingers is vast and includes most prominently the regulation of most types of foods, dietary supplements, medical devices, human and veterinary drugs, vaccines and other biological products, and cosmetics.

And this time it's really gone too far.

On November 22, 2013, the FDA sent a warning letter to the well-known consumer genomics company 23andMe, ordering it to "immediately discontinue marketing" its only product.

For those of you who are not familiar with 23andMe, the company provides a "DNA Spit Kit" and "Personal Genome Service" (PGS) that supposedly reports on 240+ health conditions and traits and helps clients track their ancestral lineage. Basically, you send a saliva sample in via the "Spit Kit," and the company analyzes the sample using a DNA sequencing machine.

It doesn't give you a full readout of your genome, but tests for a custom panel of what are called single nucleotide polymorphisms in order to determine, for instance, if you're a carrier for certain disease-linked mutations like cystic fibrosis or sickle cell anemia. The panel also tests for the three most common BRCA1 and 2 mutations that are associated with breast cancer, among many other mutations associated with other diseases.

So what we're talking about here with 23andMe is information, not a medical device. It's your personal genetic information. And the FDA wants to put the kibosh on one of the only companies providing this service inexpensively—you get your Spit Kit and readout for just $99—to consumers.

This is really a first amendment issue, and the FDA should not be in the business of regulating freedom of speech and information. But considering what the FDA thinks of your intelligence, I'm not surprised they're trying to reach this far.

Consider some of the language from the FDA's warning letter to 23andMe.

"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."

Really? You think that if a woman receives news from a $99 test that she may be at a higher risk for breast cancer due to a genetic mutation that she's going to run out and somehow acquire chemo drugs and start dosing herself, or that she's going to go to some back-alley clinic to have her breasts lopped off? Not to be crude or make light of a very serious situation and condition, but the FDA's implication is insulting, to say the least.

What would actually happen in the real world is that she'd go to a doctor to get herself checked out, perhaps sooner rather than later, which isn't a bad thing even if the 23andMe test showed a false positive. Now, if the test showed a positive for the mutation and she is in fact positive—which would have to be confirmed by a separate test from a doctor anyway before a mastectomy—it is her right to undergo such surgery whether or not it is determined to be "medically necessary." This is precisely what Angelina Jolie recently did.

The false negative argument is maybe a little more plausible, but despite what the FDA might believe, people who are proactive enough about their genetic makeup to seek out a service like the PGS from 23andMe are smart. They know that no test is foolproof or 100% accurate. People receive false negative tests from federally regulated labs and physicians all the time. It's unfortunate, but that's the way these things work. You don't see anybody making a stink that these tests shouldn't be run just because there's a small chance of delivering a patient a false negative result.

In response to the FDA's warning letter, 23andMe has stopped all TV, radio, and online advertising for its PGS, although the service is still being sold on the website. The situation is still unfolding, so whether or not the FDA decides that the company is now in compliance because it's no longer "marketing" the PGS remains to be seen. It could determine that just having the website active is a form of "marketing," which could be the nail in the coffin for the company. We'll have to see. According to the FDA, 23andMe had 15 working days (starting November 22) to notify it of the specific actions the company has taken to address all of the issues raised in the letter.

As expected, an additional consequence of the FDA's warning letter is a class action lawsuit that was filed just five days after the letter was sent. The lawsuit alleges that the test results are "meaningless," and that 23andMe uses false and misleading advertising to promote its services to US consumers. The lawsuit seeks at least $5 million under various California state laws and estimates "tens or hundreds of thousands" of US customers are entitled to damages from the company.

Look, I get that many of you probably think the FDA had every right to do what it did. And I'll admit that its actions probably were legally justified, since 23andMe's advertising campaign did seem to market the PGS "for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease," which falls under the FDA's purview.

I also understand why detractors of consumer genomics companies think the FDA should shut down 23andMe and all its peers/competitors—because people engaging the services of these companies don't get the full picture, and what's going on is much more complex. Only part of a person's DNA is tested, and how to properly interpret the results is still uncertain, since many factors other than a mutation in isolation contribute to disease.

But when do we ever get the full picture? Even a readout of our entire genome is only a small part of the story. A key takeaway from what's known as the ENCODE Project is that much of what was previously thought of as "junk DNA" actually performs regulatory functions—which can be thought of as regions that act like switches attached to a particular gene that determine whether or not they'll be expressed. There are millions of such regions throughout the genome, and they're linked to each other (and to the protein-coding genes) in an extremely complicated hierarchical network.

What's more, the linear ordering of the genome provides a further source of confusion: the three-dimensional folding of the chromosomes inside the nucleus allows promoter regions to maintain a close connection to genes that apparently lie far away on the linear sequence. This explains why so much biochemical activity can be found even deep in the deserts of the alleged "junk DNA."

Many of these promoter regions manifest themselves in the cell as "functional RNA" molecules—types of RNA that are an end product in themselves, rather than merely an intermediate step on the way to becoming a protein, and tha
t play a key role in switching genes on and off.

In truth, we never get the full story, no matter whom we turn to, and there's nothing wrong with bits and pieces of information to help us make decisions along the way (or just to satisfy our curious nature).

And that's really the whole point here. I don't really care if what the FDA did was technically legal or that some people think it makes sense in order to keep others from harming themselves in some way. What matters is that this ultimately boils down to information—personal genetic information. And whether 23andMe does a good job of providing that or not, it's our right to seek out such a service and use it if we so desire.

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