Direct-to-Customer Genetic Testing: FDA Overreach and Industry Stupidity

What a fabulous combination. This week, Congress has held hearings on the direct-to-customer (‘DTC’) genetic testing industry. It appears, based on previous statements by FDA officials, that they have publicly contradicted themselves–or been willfully ignorant–about the larger scientific benefits from DTC testing. This week’s hearings also seem to have attracted some serious hyperbolic anti-DTC testimony, even by my standards (these companies are “raping the human genome project“? The HGP was made public domain so everyone, including those who work at companies, could have access to the data). If last summer’s hearings are any indication, things look very bad for DTC testing.

Having said that, there’s a lot of stuff like this floating around (emphasis original):

In the very near future you may be forced to go through a “professional” to get access to your genetic information. Professionals who will be well paid to “interpret” a complex morass of statistical data which they barely comprehend. Let’s be real here: someone who regularly reads this blog (or Dr. Daniel MacArthur or Misha’s blog) knows much more about genomics than 99% of medical doctors. And yet someone reading this blog does not have the guild certification in the eyes of the government to “appropriately” understand their own genetic information. Someone reading this blog will have to pay, either out of pocket, or through insurance, someone else for access to their own information. Let me repeat: the government and professional guilds which exist to defend the financial interests of their members are proposing that they arbitrate what you can know about your genome. A friend with a background in genomics emailed me today: “If they succeed in ramming this through, then you will not be able to access your own damn genome without a doctor standing over your shoulder.” That is my fear. Is it your fear? Do you care?

In the medium term this is all irrelevant. Sequencing will be so cheap that it will be impossible for the government and well-connected self-interested parties to prevent you from gaining access to your own genetic information. Until then, they will slow progress and the potential utility of this business. Additionally, this sector will flee the United States and go offshore, where regulatory regimes are not so strict. BGI should give glowing letters of thanks to Jeffrey Shuren and the A.M.A.! This is a power play where big organizations, the government, corporations, and professional guilds, are attempting to squelch the freedom of the consumer to further their own interests, and also strangle a nascent economic sector of start-ups as a side effect.

You are so much more than your genes. So much more than that 3 billion base pairs. But they are a start, a beginning, and how dare the government question your right to know the basic genetic building blocks of who you are. This is the same government which attempted to construct a database of genetic information on foreign leaders. We know very well then who they think should have access to this data. The Very Serious People with a great deal of Power. People with “clearance,” and “expertise,” have a right to know more about your own DNA sequence than you do.

I understand the frustration: when a relative of mine had a life-threatening sepsis infection, not being told what was happening, even though I understood this quite well, was really frustrating. I also think it’s wrong for the government to collect any healthcare information for political purposes (although the FREEDOM! rhetoric is a little overblown. Personally, I’m a little more concerned that habeas corpus seems to be non-binding at this point, but that’s me).

But the DTC industry made a huge–and arrogant–mistake by not listening and not preemptively dealing with legitimate public health concerns.

It’s no accident that when I see this discussed on blogs, the public health and medical people usually argue for some regulation. It’s not an attempt to create a monopoly (I don’t see primary care physicians having a dog in this fight right now), but based on hard earned experience:

First, many well-intentioned people are ignorant about health (and biology in general). They’re not stupid, but they are misinformed. Remember all the parents who didn’t want their kids to get a flu shot? Talk to any MD, you’ll hear some real howlers (provided you have a dark sense of humor). Second, people have a tendency to selectively hear things. Some patients have a tendency to interpret advice in a way that reinforces bad behavior. Keep in mind that much of the genetic testing–and most of the genome-wide scans–have, to date, disproportionately targeted well-educated, often scientifically literate people.

I know plenty of people who would make bad changes to their diet if they were told that they were at low risk for adult onset diabetes or heart disease. Plenty. Hell, I know better, and I could see myself using that as an excuse. Once DTC testing gets beyond ‘vanity genomics’ and becomes widespread, once we get beyond population geneticists and the very scientifically literate (who, nonetheless, are still quite capable of ‘selective hearing’), these results will have to be explained to the larger public–although, once that’s done, if someone wants to have access to it, they should be able to do so.

And it’s not the slightly foolish behavior (e.g., eating poorly) that I’m worried about. When someone reacts badly to the resulting–and this will be a matter of when, not if–fairly or not, DTC testing will own this. It happened with AIDS/HIV*, and it will happen with DTC testing. That it hasn’t happened yet is largely due to the self-selective customer base, and good fortune.

So you have to have a 45 minute meeting with a genetic counsellor. So what? If it prevents idiots from being stupid, it’s worth it. Yet the DTC testing industry never really took these claims seriously–and never investigated with large enough sample sizes across a range of educational backgrounds–to assuage these concerns. They probably could have gotten away with that anyway, but you throw on top all of the libertarian rhetoric (which is a red flag for government regulators based on past experience), and it’s not surprising at all that the climate is anti-DTC testing.

Which is too bad, since I think DTC testing, with appropriate safeguards, is worth having.

*In the early years of the AIDS epidemic, when infection was a death sentence, clinics made sure not to give people their results over the weekend to prevent suicide attempts.

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