Regulating DTC testing is common sense

by jeeg 23. June 2010 01:35

Mike the Mad Biologist thinks regulating DTC testing is common sense.  On his blog he says:

This post might put me at odds with much of the science bloggysphere, but I think a lot of the concern over congressional and FDA hearings over whether 'over-the-counter' genetic screening and genome sequencing should be regulated is overblown. Maybe my feelings are influenced by my concerns about the misuse of antibiotics--in the case of cefquinome, the FDA did the right thing (and I only wish they had acted sooner).

Consider this article which was recommended by a ScienceBloging, the crux of which is:

The controversy here rests on a single assumption: That the typical Walgreen's customer, and by proxy the typical American, isn't prepared to learn about their DNA. Unless a physician guides us, the argument goes, we can't handle the truth. We'll quit our jobs, we'll divorce our spouses, we'll panic. Without a doctor, we're told, information can be more than mystifying -- it can be downright dangerous.

Now let's examine the source of this article:

The Huffington Post.

Have you ever checked out its "Wellness section?" This is the same Huffington Post that routinely publishes altie woo in every form imaginable (my favorite is the claim that cancer is a fungus, although the enema fetish is nice too). My point is not to discredit by association those opposed to regulation--I like the Huffington Post's political reporting. But let's return to this:

The controversy here rests on a single assumption: That the typical Walgreen's customer, and by proxy the typical American, isn't prepared to learn about their DNA.

I won't make claims about the typical Walgreen's customer*, but the typical Huffington Post Wellness section reader is a fucking moron. Having worked in public health, I see serious potential for bad outcomes; public health workers, though hard-earned experience, have learned that even seemingly simple things can go very wrong.

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. As we move to the broader population, well....

Enemas. Nuff said.

Third, doctors need to learn about this stuff. I don't mean to disparage MDs, but, in my job, I collaborate with a lot of MDs, and these are MDs who are researchers interested in genomics. If they're the leading edge (and they are smart people), then most doctors are going to need a lot of training and supplemental materials to be able to explain this to their patients and to use this information appropriately (again, this isn't a slam against MDs--how they reliably know so much different stuff amazes me, especially when getting it wrong isn't an academic exercise). But most people aren't population geneticists/genomicists. Fourth, while I think blaming some things on irrationality is stupid, people do have a hard time assessing risk when it's expressed in mathematical terms; sadly, not everyone is a statistician in the rough.

Finally, we regulate all sorts of diagnostics (and we should)--why should this be any different?

The point is that I can see some downsides without regulation, and it doesn't hurt to examine if and what regulation would improve this technology for patients and doctors.

*I regularly shop at CVS, and I doubt, on the whole, we're any smarter than Walgreen's customers.

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