Way back in 2004 I was bouncing off the ideas of Helix Health of Connecticut. My ex-partner and I even spoke of how great it would be to have datasets with genomes, biomarkers, physical exam and medical history data. We posited how great it would be to sell these datasets to pharma.....We even thought about creating a CRO to carry out the genetic integration of pharma testing creating PGx specialized research.
I only mention this because I got a little blasted for tying 23andME with Tuskegee. Well, not really blasting, just a blog post from a really great new blog called Genetic Future.
First, we said "Is this a viable business model?" The answer, a resounding yes
Second we said "Will patients be ok with us giving their data to Pharma companies?" The answer, maybe...but only if they received something back.
Thirdly we said "Is it ethical to sell your patients' data?" We had seen it done. So we went to some notable ethicists....
What occurred during that time? CRO scandals, researcher kickbacks, fradulent studies, all things poised to make physicians look less than hippocratic.
That's when we abandoned the idea of physicians selling this data without EXPLICIT permission of patients. We did not want to revolutionize medicine AND look like profiteers. If we were not to tell our patients EXPLICITLY, we would just be pulling a scam. I couldn't exactly find the words but then...
The term Slel then came across my radar. It was brought up again by Jason Bobe
Slel: To take DNA from someone against his will, to create avatars of him, or perhaps children.
Well Avatars may not being created and it may not be unwillingly, but a profit could be made. I say could, only because it is not being made yet. Data acquisition is going to be required first.
Why do I react so vehemently against this? Because I sit on the Yale New Haven Health/Greenwich Hospital IRB. The US is a little different than those boys across the pond!
What do ethicists feel? Here is a great take.
7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies:
I only mention this because I got a little blasted for tying 23andME with Tuskegee. Well, not really blasting, just a blog post from a really great new blog called Genetic Future.
First, we said "Is this a viable business model?" The answer, a resounding yes
Second we said "Will patients be ok with us giving their data to Pharma companies?" The answer, maybe...but only if they received something back.
Thirdly we said "Is it ethical to sell your patients' data?" We had seen it done. So we went to some notable ethicists....
What occurred during that time? CRO scandals, researcher kickbacks, fradulent studies, all things poised to make physicians look less than hippocratic.
That's when we abandoned the idea of physicians selling this data without EXPLICIT permission of patients. We did not want to revolutionize medicine AND look like profiteers. If we were not to tell our patients EXPLICITLY, we would just be pulling a scam. I couldn't exactly find the words but then...
The term Slel then came across my radar. It was brought up again by Jason Bobe
Slel: To take DNA from someone against his will, to create avatars of him, or perhaps children.
Well Avatars may not being created and it may not be unwillingly, but a profit could be made. I say could, only because it is not being made yet. Data acquisition is going to be required first.
Why do I react so vehemently against this? Because I sit on the Yale New Haven Health/Greenwich Hospital IRB. The US is a little different than those boys across the pond!
What do ethicists feel? Here is a great take.
7 requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies:
(1) value—enhancements of health or knowledge must be derived from the research;
(2) scientific validity—the research must be methodologically rigorous;
(3) fair subject selection—scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects;
(4) favorable risk-benefit ratio—within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks;
(5) independent review—unaffiliated individuals must review the research and approve, amend, or terminate it;
(6) informed consent—individuals should be informed about the research and provide their voluntary consent;
(7) respect for enrolled subjects—subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored.
So I ask 23andME, deCODE, Knome...Who OWNS the saliva and DNA contained therein?
1 comment:
i'm pretty sure knome has already addressed this directly. from their website faq:
http://www.knome.com/FAQ/tabid/51818/Default.aspx
Will I own my genomic information?
Yes. Your genome will be yours. Once you receive your sequenced genome, you are under no obligation to continue using our services or to maintain your genome with Knome.
Are there research benefits to joining?
Your genome is yours to manage as you like. If you choose to participate in medical research, you will have the ability to share your genome with researchers and other medical professionals -- while remaining completely anonymous.
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