Back in February of 2009 23andMe/Serge decided to do testing for genetic founder mutations.........
Yet they claimed it wasn't medicine and should not be used for medicine.
BRCA Ashkenazi Jewish founder mutations offer information that can confer an elevated risk of Breast, Ovarian, possibly melanoma, Pancreatic and maybe blood cancer.
There really isn't any other thing that these tests can be used for other than medical decision making and diagnosis. The diagnosis would be Genetic Risk for Cancer. There is a medical code for it in the International Classification of Diseases 9th Edition. In fact there are multiple codes. The v84.0 super family of codes.
Granted this presentation was a bit manic and the iPhone volume control was horrible (turn down your speaker volume). But the point is clear. Either founder mutation testing is a medicine or it is not.
You cannot have it both ways. Say what it means. If that means your state requires physician consultation or ordering, do it.
If it doesn't, well, I strongly recommend you receive that healthcare provider service.
Friday, March 12, 2010
........DTC Genomic Medicine?
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Same Test.
23andMe is medicine.
http://www.thinkgene.com/same-test-brca-is-23andme-is-myriad-is-medicine/
Interesting video? Does this person/character require a MD advice to use this information? What is required for supervision-diets? http://www.youtube.com/watch?v=mSRMCDCVg6Y
23andMe vs. Myriad Trial
Dear "Dr" Murphy,
In the video you appear to be conducting a human experiment on a single patient subject to compare the results and methods of 23andME genomics and Myriad Genetics BRCA screening test. Under the Declaration of Helsinki- Principles for Medical Research Involving Human Subjects Article 15 you must have an independent ethical review to do such an experiment. US laws, both state and federal, support the Helsinki principles and require that you register your trial with clinicaltrials.gov. A quick scan of clinicaltrials.gov did not show that you registered your study. Being a licensed medical doctor does not in any way exempt you from these rules and their accompanying laws.
Perhaps the Helsinki principals are inappropriate in this case? I would no more want to see you lose your license for violation of the law than I want my right to my DNA restricted by laws written for a different time and a different problem.
I believe the principal of freedom of speech also applies to the information in my own genome. It is a book about me that I can and should be able to read or share without restriction. Books were once and are still considered dangerous by many. What you often advocate is as absurd as requiring a doctor’s permission to read a book. The laws that restrict my access to books are now gone, as will soon be the laws that restrict individual access to the contents of their DNA or in fact any measure of their biological or molecular status.
Obviously 23andME is “Practicing Medicine” by some legal definition just as you are obviously “conducing a clinical trial” by some legal definition. The problem here is the definitions.
How did the definition of practicing medicine go beyond actually doing something (an action) as opposed to learning something (discussing information)? You are licensed to perform actions to others that could cause harm; procedures, prescriptions, etc. You are not licensed to limit information. The American founding principal that all are created equal did not create a special class called “doctors”. Contrary to what you advocate, you have no right to restrict my rights. New technologies always challenge the meaning and rules of law. My guess is that when push comes to shove the Constitution will win and you will be out of the inhibition of speech business.
I am a customer of 23andMe and I understand the limitations of what they are doing. I also believe in what they are doing. They are pursuing a future where we all have access to information about some of the variables (our genetics) that affect our health and lives and are building a platform to learn about it. This is a moral, democratic, empowering mission that supports self-determination.
I think you are an excellent scientist and an innovator ahead of your colleagues. I love your vicious and fearless critiques of each genetic advance and interpretation. These are the skills the revolution needs. Your frequent focus on semantics and the use of law for purposes they were not intended limit your impact and value.
We both agree that genomics should be done to rigorous scientific standards. We should also both agree this is not a test that the “practice of medicine” meets now. I assume you would not propose shutting down all of healthcare until we meet that standard. I suggest that we let genomics evolve. Perhaps non-doctors will surprise you and individuals might begin to make personalized medicine a reality. It is not likely they can make it worse than it is now.
-Jamie Heywood
PS: I really do love your blog – its one of the few I read regularly. I also think this would make a fun panel at a genomics meeting. Lets do it - Drinks on me.
@molecular
That really is the holy grail. Now if we can only trust the algorithms are scientifically valid and not just based on the highest marketing.....
Jamie,
I am honored to have you as a reader. Andrew is a patient of mine. As evidenced in this video. He is under my clinical care. There is no experiment. He wished to have the same test from his salvia and from his lymphocytes.
As a clinician, I saw no clinical contraindication to performing this tests.
There was no research here, it was clincal care. About 2 hours of counseling were cut out of the video.
I don't see how you can set up such a red herring. The laws were set up to prevent the same sort of chicanery that happenned decades ago from happening again. They have appeared to failed in some aspects.
Speech is something you express Jamie, not intrinsic code. Do you have a "right" to your sodium level? what about a CT scan of your brain?
But the genome book is no more than a few scattered sheets of paper, hardly a story right now. If you want that scan, go to a state that lets you have it on your own.
Again Information is not Speech. Chemical levels in your body are not Speech.
I am glad you understand the limitations of what 23andMe is doing. Many people do not. Were you aware of the non-limitation of the clinically valid DNA test they are running on BRCA1/2?
I cringe when physicians misinterpret the BRCA testing. But at least you can sue them for malpractice when that happens. Who takes responsibility over at Google-Plex?
No one, that's who. I saw it in 2007 when they all adamantly refused to claim legal responsibility to notify patients/customers when results had changed or meant something different. I took that responsibility.
Maybe you want to too. Maybe people need to be responsible for themselves. Heck, you can defend yourself in court right?
But that often ends up on Extra or some darwin award.......
My point is simple. If you want to hack your health, go ahead, but in doing so, don't demean or downplay what matters to the public.
Maybe if you don't know what matters, you shouldn't be playing? Maybe you should? I am not here to say who should or should not. I am here to lead you the right way up the mountain of PM, currently the DIY path is dangerous and confusing....
-Steve
p.s. Will take you up on that Beer. Murphy's Irish Stout please.
Jamie,
How about these DNA rights?
http://www.wired.com/threatlevel/2010/03/obama-supports-dna-sampling-upon-arrest
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