Kathy Hudson, The Johns Hopkins University - “Public Policy Challenges in Genomics”
Challenges: getting enough evidence is difficult: Analytic validity, clinical validity.. etc etc
Personal value is there theoretically – but will it work?
Two different approaches: who offers them, and then who makes the tests?
Types: either performed with or without consent. Results returned.. or not. There are now a large number of people offering tests for a wide number of conditions.
Are the companies medical miracles, or just marketing scam? Are the predictions really medically relevant. FTC is supposed to stop companies that lie... but for genetic testing they just put out a warning.
Role of states in regulating: States dictate who can authorize a test. However, in some states anyone can order it, not just medical personel.
How they're made:
Two types of tests: Lab tests and (homebrews) test “kits”. The level of regulator oversight is disparate. Difference is not apparent to people ordering them, but they have different types of oversight.
[flow charts on who regulates what] Lab tests are not under FDA (done through the CMS)... and it makes no sense to be there. you can't get access to basic science information through CMS, whereas in FDA, that's a key part of mandate(?)
Example about proficiency testing – which as poorly implemented in law, and is still not well done. The list is now out of date – and none of the list of diseases being tested have genetic basis. CMS can't give information on what the numbers in the reported values mean (labs get 0's for multi-year tests, but CMS can't explain it.)
FDA regulation of test kits are much more rigorous.
Genentech started arguing that the two path system should not be there. Should be regulated based on risk, not manufacturer. Obama-Burr introduced genetic medicine bill in 2007, and something more recently by Kennedy. (Also biobanking?)
Steps to effective testing:
1.level over oversight based on risk
2.tests should give answer nearly all the time
3.data linking genotype to phenotype should be publicly accessible
4.high risk tests should be subject to independent review before entering market
5.pharmacogenetics should be on label
6.[missed this point]
Privacy: should it be public? Who percieves it as what?
More people are concerned about financial privacy than medical privacy. 1/3 think that medical record should be “super secret” : and what part of it they thought should be most private, most people thought it was social security number! Genetic test and family history is way down the list of what needs to be protected.
People trust doctors and researchers well, but not employers. Genetic information nondiscrimination act is a consequence of that trust level. (not a direct result?)
The new Privacy Problem? DNA snooping. Who is testing your DNA? (Something about a half-eaten waffle left by Obama that ended up on ebay... claiming it had his DNA on it.)
Many actions: testing, implementing lawas, modernizing laws, transparency, better testing
My comments: It was a really engaging talk, with great insight into US law in genetics. I'd love to see a more global view, but still, quite interesting.
Personal value is there theoretically – but will it work?
Two different approaches: who offers them, and then who makes the tests?
Types: either performed with or without consent. Results returned.. or not. There are now a large number of people offering tests for a wide number of conditions.
Are the companies medical miracles, or just marketing scam? Are the predictions really medically relevant. FTC is supposed to stop companies that lie... but for genetic testing they just put out a warning.
Role of states in regulating: States dictate who can authorize a test. However, in some states anyone can order it, not just medical personel.
How they're made:
Two types of tests: Lab tests and (homebrews) test “kits”. The level of regulator oversight is disparate. Difference is not apparent to people ordering them, but they have different types of oversight.
[flow charts on who regulates what] Lab tests are not under FDA (done through the CMS)... and it makes no sense to be there. you can't get access to basic science information through CMS, whereas in FDA, that's a key part of mandate(?)
Example about proficiency testing – which as poorly implemented in law, and is still not well done. The list is now out of date – and none of the list of diseases being tested have genetic basis. CMS can't give information on what the numbers in the reported values mean (labs get 0's for multi-year tests, but CMS can't explain it.)
FDA regulation of test kits are much more rigorous.
Genentech started arguing that the two path system should not be there. Should be regulated based on risk, not manufacturer. Obama-Burr introduced genetic medicine bill in 2007, and something more recently by Kennedy. (Also biobanking?)
Steps to effective testing:
1.level over oversight based on risk
2.tests should give answer nearly all the time
3.data linking genotype to phenotype should be publicly accessible
4.high risk tests should be subject to independent review before entering market
5.pharmacogenetics should be on label
6.[missed this point]
Privacy: should it be public? Who percieves it as what?
More people are concerned about financial privacy than medical privacy. 1/3 think that medical record should be “super secret” : and what part of it they thought should be most private, most people thought it was social security number! Genetic test and family history is way down the list of what needs to be protected.
People trust doctors and researchers well, but not employers. Genetic information nondiscrimination act is a consequence of that trust level. (not a direct result?)
The new Privacy Problem? DNA snooping. Who is testing your DNA? (Something about a half-eaten waffle left by Obama that ended up on ebay... claiming it had his DNA on it.)
Many actions: testing, implementing lawas, modernizing laws, transparency, better testing
My comments: It was a really engaging talk, with great insight into US law in genetics. I'd love to see a more global view, but still, quite interesting.
Labels: AGBT 2009
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