Wednesday, March 17, 2010

How can MDVIP use Navigenics Test for Medicine?

I have been harping on this say what you mean. Say what you do. Theme lately.

I am a board certified doctor who practices personalized medicine. I see patients and apply the principles or pharmacogenomics, risk prediction and prevention tailored to each individual patient. I do this by taking a 3 generation pedigree, using current clinical risk models and pharmacogenomic or other genetic tests when indicated. That's me.

I have this nagging pain about MDVIP, Ed Goldman and Navigenics.

Some MDVIP members are using Navigenics tests for medical risk prediction. Navigenics is ok with this because hey, they're doctors.

The contents of our Site, including any risk estimates or other reports generated by the Services (collectively, "Your Report") and any other information, data, analyses, editorial content, images, audio and video clips, hyperlinks and references (collectively, "Content"), are for informational purposes only and are not intended to substitute for professional medical advice, diagnosis, or treatment.

The part I want to focus on is "Are for informational purposes only and are not intended to substitute for professional medical advice, diagnosis or treatment"

It seems to me that this will be the more popular language in a Terms of Service for DTCG.
Notice that nowhere does it say, "This report is not intended to diagnose or treat"

I think that while it is nice to not say that, when in fact people are using it to diagnose, it is even goofier to say that it is not intended to substitute for a professional's diagnosis. Ok, so are you saying

1. This is not to be used for diagnosis/medical advice
2. This is to be used for diagnosis, but the professional's diagnosis trumps ours
3. This test is meant to be used by professionals to aid them in diagnosis and treatment

I am really confused here. Is this a medical test or not. Just come right out and say it!

The Sherpa Says: Say what you do, do what you say you do. Isn't that what the Common Framework of Principles is About?


Scott said...

Are you board certified in genetics and do you currently employ board certified genetic counselors?

Steve Murphy MD said...

I am a board certified Internist. I use genetic counselors when needed. Dr Lubin who I work with is an Internal Medicine Geneticist.

Most of these genetic tests and risk stratification tools weren't taught in my genetics fellowship.

In fact, the "Board Certified" geneticists knew so little about internal medicine and Adult Diseases that it made my head spin.

This was at a MAJOR academic center BTW......

So, MDVIP could use these tests. But they,

A. Are not clinically validated
B. Have little clinical utility

I suggest that these companies turn medical and offer these as "medical tests" the CYP 450 testing is worth its weight in gold......


Don Rule said...

There are significant limitations in the SNPs that are tested by whole genome chips. I did a quick applet here: that looked at the SNPs in PharmGKB and compared which companies offered them (Affy being a proxy for Navigenics and deCode and 23andMe a proxy for Illumina. I don't know how useful this is but I found it interesting.


Don Rule said...

I was curious about what SNPs the DTC companies offer so I wrote a little applet ( to compare them to the SNPs in PharmGKB. It turns out the the Cytochromes are particularly sparse.

Don Rule
Translational Software