Monday, February 23, 2009
Thanks to an amazing string of commentary on my blog, I think I get it.
Most of the 23andME users don't understand clinically what they are getting. It turns out, what they are getting is in essence unsupervised genetic counseling.
Vincent a commenter notes from my previous set of comments:
"In their actual report to customers, though, their language is much more sane.
E.g.Carrier for the 6174delT BRCA2 mutation.
Lifetime risk of breast cancer for women is increased from 13% to 85% and risk of ovarian cancer is increased from less than 2% to 23%.
May significantly increase risk of prostate cancer in men. There is also an increased risk for breast cancer in men.
That an accurate (as best as I can tell) statement of fact, and one that does not cross the line into the area of clinical diagnosis."
I then clue him into something he may not get and in fact I didn't get it until we talked about it.
SHERPA-"What you said is in their report is EXACTLY what a genetic counselor would tell their patient......."
Which prompts a reasonable conclusion by Vincent, which is absolutely incorrect. Why? Because we assume genetic counselors are autonomous units.
VINCENT-"A doctor or genetic counselor would take the conversation much further, however, and that is the key point I think. A licensed practitioner has the ability and obligation to go far beyond the purely statistical and into the truly clinical. Family history, behavioral factors, prevention options, treatment options, and so forth.
A company like 23andMe does not have that obligation, and it seems like that is part of what drives you bonkers."
He nailed it without realizing he did. When 23andME presents you this information in such a fashion, they are providing exactly how a genetic counselor would. They are probably painstakingly creating reports that are word for word what genetic counselors would deliver.
In addition, he double nails it. 23andME is providing genetic counseling while abdicating any of the clinical responsibility of putting that information out there. This is especially troublesome with highly penetrant tests, such as BRCA.
He triple nailed it by describing the argument 23andME will likely use
Our reports look like Genetic Counseling, But that's NOT Clinical Medicine/Genetics
I saw this attitude when I sat at a roundtable with Ryan Phelan of DNA Direct, Jeff Gulcher of deCode, Dietrich Stephan of Navigenics and Joanna Mountain of 23andME in San Francisco last June.
When asked "What if this genetic information changes? Who is responsible to notify customers/patients of this change?" What erupted was a slew of finger pointing at the table and Ryan Phelan saying "It would be nearly impossible to ask us to recontact customers with that change in information (rough quote)" Dietrich said "We have a subscription service that you pay for to get those updates" Mountain and Gulcher were silent.
But I grabbed the mic and said "If a physician orders a test and the results change, that physician is legally and morally obligated to report that change to you, at no cost and for the rest of the time that patient is under your care"
That is responsibilty. When I say there is a fundamental lack of willingness to accept this accountability at the highest levels, I mean it. I have seen what they have had to say, and they are left lacking.
Some may say, well 23andME is not practicing medicine. But I tell you, what they are delivering smells, looks and feels an awful lot like what any genetic counselor in any town in the United States, UNDER PHYSICIAN SUPERVISION, would be providing to PATIENTS who underwent BRCA testing.
So genetic counselors, if I haven't alienated you and you are still reading the Sherpa......Beware, 23andME is looking to replace you with reports. In addition, they are arguing that what you do isn't technically the practice of healthcare/medicine......
If you let them get away with this argument
1) Their will be a legal precedent which may ruin any argument your group has to be licensed
2) They will erode the patient trust bond with your patients
3) They will unltimately replace you and a physician will be using this service instead of consulting you.
This ball is now in NSGC's court. I hope you can do something about this, before it's too late.
The Sherpa Says: 23andMe's response "Yes our reports look like genetic counseling, but that's not clinical medicine......." Ouch.......