Cat-fight over California

A couple of days ago I mentioned California's regulatory smackdown of direct-to-consumer genetic testing companies, and the triumphant response of Helix Health's Steve Murphy to the news. Steve has long argued that physicians need to play a role in any genetic testing with potential health consequences - unsurprisingly, given that this is exactly what his business model depends on. California's regulatory response struck Steve as exactly what the doctor ordered:

That's right, in order to test, you are soon going to have to document informed consent and evaluation by physician or extender. So anyone not doing what Helix Health is doing will soon find themselves on the wrong side of the law....again.

Well, Steve's tone certainly got him some attention. In the comments to his post, Steve's response to the news was described as "rent-seeking" and "arrogant"; and today, Wired blogger Thomas Goetz criticises Steve's "paternalistic tone" and argues strongly against a physician-centred vision for the future of the personal genomics industry:

Having been tested by both 23andMe and Navigenics, I can say that, yes, it's complicated. But frankly I don't need a doctor, and I don't want a doctor, to facilitate my understanding of what my DNA means.

[...]

This is not a dark art, province of the select few, as many physicians would have it. This is data. This is who I am. Frankly, it's insulting and a curtailment of my rights to put a gatekeeper between me and my DNA.

Deepak Singh from bbgm is similarly outraged by the regulators, given the ignorance of the average medico in matters genetical:

This is my data and it’s my decision. Regardless of what you think about the services and their utility or lack thereof, it’s ludicrous to think that doctors, most of whom know less about genetics than I do, need to make a call on this. It’s a personal decision. [my emphasis*]

I naturally side with the freedom-of-genetic-information folks on this issue. As I said in my last post (in a comment that was echoed by David Ewing Duncan in Wired), what we're seeing here is to some extent a turf war, with the medical establishment trying to use legislation to claw back deference and power that used to be theirs automatically. Unfortunately for them, we're already living in a world in which people justifiably feel a strong sense of ownership over their genetic information; that's not going to change, and doctors will simply have to adapt to the new rules of play.

However, at the same time I want to emphasise the dangers of heading too far in the opposite direction. Three hours reading the 23andMe website and Googling "type 2 diabetes" does not make you an expert on this disease. Seriously - they may not know what a SNP is, but when it comes to diseases doctors know stuff that you can't get from Google.

Now, I don't believe that I should need a doctor's permission to sequence my own genome, and I see no need for laws compelling me to see one afterwards. Nonetheless, it is crucial that readers don't walk away from this discussion feeling that the medical profession is suddenly irrelevant to the shiny, high-technology era of health genomics. Clinicians will be absolutely critical when it comes to making personal genomics medically useful - or at least they will be once the medical establishment stops trying to make itself relevant through legislation, and instead focuses on providing doctors who are capable of engaging with genomic data.

If they manage this, in a few year's time nearly every personal genomics customer will be reviewing their sequence data with a medical professional: not because the law says they have to, but because they want to.

It's unfortunate that Steve's clear conflict of interest undermines his credibility here (as most of his critics have pointed out, some savagely) since his position is not baseless: clinicians do have an important role to play. He just needs to realise that brute legislative force is not the right way to achieve this end.


* It's worth noting that the knowledge of genetics of most of the people commenting on this topic (certainly including Deepak) is waaaaay better than the average personal genomics customer - I think we all need to carefully calibrate our outrage to allow for the fact that the regulators are aiming at people who know much less about this stuff than the typical genetics blogger does. We should still be annoyed; just slightly less than we actually are.


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