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Response to “That’s Just Boilerplate” comment

A commenter “Anon” writes in response to The Clinical Applications of DTC Genomics:

Nonsense. For example, 23andme tests “whether or not you are a carrier for Cystic Fibrosis”. You can take action based on these results, such as getting your wife tested to see if she is a carrier too and if so having your fetus tested by your doctor.

Information on Parkinson’s and Alzheimer’s (through browse raw data) diseases can be very useful too. For example you can plan to save more money or get better health insurance in preparation for potentially higher long term health care costs.

That they put boilerplate language in their contract doesn’t change this. I don’t get why you deny these facts when you obviously know them. I understand that their contracts annoy you, but that’s a problem with the legal system, not the DTC companies.

Originally posted as a comment by Anon on Think Gene using Disqus.

In the absence of explicit demonstrably proven clinical application for these DTC genomic tests, the clinical application of today’s DTC genomic tests (23andMe, Navigenics, Coriell) is by the judgment of physicians who are professionally, morally, and legally liable for their medical advice. I would assume it would be good professional judgment not to recommend or use a test to provide medical advice if the test explicitly states not to use it to provide medical advice.

But you’re right, if a physician (or you) judge otherwise, you are welcome to act however you wish for any reason. However, if you were a physician, you would be liable to defend your judgment both to your professional peers and to whomever would be interested in your legal liability.

“It was boilerplate” is not an acceptable professional defense in medicine of which I’m aware.

I’m not refuting the science. The science is what it is, and as for 23andMe, it’s good that they make that science transparent.

Further, I think the future of medicine is in software and automated systems —systems biology. That has no baring on the facts of this situation today regarding DTC genomic testing.

Can you present a compelling general argument why consumers or physicians should knowingly violate a contract for a test that explicitly states that it is not to be used to provide medical advice or to influence any health-related decision —particularly when alternative and often superior medical tests exist? Can you present a compelling general argument why a genomic testing company should imply that its tests are medically applicable but explicate that they are not medically applicable?

But yes, special case solutions for consumers, physicians, and genomic testing companies can be contrived, just as I’m confident that while landing a passenger jet on the Hudson river has no compelling general argument, special case solutions can be contrived.

Medicine isn’t open source software. You can’t just read the source code or try it yourself to know that it works. DTC genomic tests are a loose collection of weak correlations with almost no scientific understanding of the underlying biological mechanisms and with almost no ability to casually verify.

Genomic tests should, are, and will continue to be used in medicine. I’m saying that the tests that disclaim that they should not be used in medicine… should not be used in medicine.

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  1. If Somebody Came to Your Physician Practice with a 23andMe | Think Gene
    January 21, 2009 @ 10:55 pm

    [...] and Raymond McCauley regarding “The Clinical Application of DTC Genomics” and “Response to ‘That’s Just Boilerplate’ comment” (note: please use your names, or at least more identifiable [...]

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