Your question about legitimate doctor-patient relationship is a good one, but not a new one. That’s the test the federal and various state governments try to use with respect to “pill mills,” overprescribing drugs that can be abused, and internet-based prescriptions. Taking a history and doing an examination are generally viewed as good rules of thumb for such a relationship. From my (legal) perspective the key is that a physician who claims a legitimate doctor-patient relationship for the purposes of writing a prescription is then on the hook for malpractice liability with regard to at least that prescription. That should make the doctors pay some attention to the results.

If the people at 23andMe know your medical history better than your physician does, you should change physicians. And you should not be confident that the good people at 23andMe (I don’t mean that sarcastically – I disagree with the company’s business model, but I know several of the people and think very well of them) know enough about medicine to help you if a health issue arises.

Hank, how would you determine which doctors have “legitimate” doctor-patient relationships with the individuals (whether you call them patients or consumers)? I think the folks at 23andMe know me and my medical history better than any of my physicians do.

I have a proposed interim solution for the FDA – declare genetic tests “restricted devices” under Section 520(e) of the Act and allow them to be provided only on a prescription from a doctor in a legitimate doctor-patient relationship with the person being tested. It is not a perfect solution, nor (necessarily) a permanent one, but it provides some interim protections while allowing medical uses to go forward. I just posted a longer discusssion of this idea on the Center for Law and the Biosciences blog.

http://blogs.law.stanford.edu/lawandbiosciences/

I’ll be interested in your reaction, and that of your readers. (And, yes, I do expect to get flamed by the libertarians.)

Just wanted to point out that McGowan & Lambrix’s commentary is actually a reply to Amy McGuire and colleagues’ survey of Facebook users’ attitudes toward DTC testing.

http://www.informaworld.com/smpp/content~db=all~content=a911991969~frm=titlelink

That whole issue of AJOB was about DTC testing issues (23andMe wrote the opening editorial).

For my part, I’d prefer that the industry be allowed to develop however it wants, and in the future when we figure out what went wrong, we can send time-traveling robots back to the present day to implement appropriate regulations and legislation.