Razib Khan One-stop-shopping for all of my content

July 31, 2012

23andMe and the FDA clearance

Filed under: Bioethics,FDA — Razib Khan @ 12:18 am

As they say, read all about it. I’m rather ambivalent. 23andMe has a business rationale to go in this direction, so I don’t begrudge them their decision. The problem, at least from a legal perspective, is that they’re providing medical advice at least implicitly. And I think this medical direction is really where the big money is in any case. There’s no angle standing on principle.

But, I still believe that on a deep level regulatory agencies don’t “get it.” Our own genotype and genome is going to be a cheap commodity in the next few years. Services like Promethease will proliferate to provide people open source information. Is openSNP going to the FDA anytime soon? The main reason that firms like 23andMe will go through regulatory hurdles is that they are, or aim to be, legitimate public entities. In other words this is an artifact of our institutions. Mind you, 23andMe et al. will probably always have slicker user interfaces, and there’s some value in that. But that doesn’t entail FDA oversight, does it?

The shift toward automation and computation are real ones, and I have a difficult time how seeing regulation developed in the 20th century ...

March 29, 2011

Genetic paternalists are very patronizing

Filed under: FDA,Genetics,Genomics,Paternalism — Razib Khan @ 10:17 am

An comment below on my post Genetic paternalism & the F.D.A.:

I came across your inflamed post from March 9th and the more I read the more disappointed I became, especially when I read your comment “following twitter, it seems there may be a distinction between raw sequence and interpretation. it may be the latter where there are “gatekeepers.” probably for reasons of liability, public safety, etc. (ergo, FDA). i see the logic, but from a perspective of utility i don’t think that the regs will improve human well being. though that’s probably not the implicit rationale behind “interested parties.””
The distinction there is ABSOLUTELY CRUCIAL. There is a huge difference between providing your raw genomic information, and providing diagnostic interpretation.

The AMA letter http://www.ama-assn.org/resources/doc/washington/consumer-genetic-testing-letter.pdf clearly stated that it was directed to ” direct to consumer (DTC) genetic tests that make medical claims” and it is “the making of medical claims” that puts certain offerings of DTC genetic testing squarely in the FDA’s domain; uninterpreted DTC genetic test results – the raw sequence – are NOT in the FDA’s domain under current regulations. Medical claims are. And I have not heard the FDA claim that they would even try to ...

March 13, 2011

DTC testing, mailing addresses, contact information, etc.

Filed under: DTC,FDA,Genetics,Genomics,Jeffrey Shuren,Personal genomics — Razib Khan @ 12:10 pm

Chris, and others, have encouraged me to put up some contact information in regards to DTC testing and the . Here is what Chris has gathered….

The Center for Devices and Radiological Health (CDRH) is the division of the FDA that would be responsible for DTC genetic testing. And Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) is the relevant CDRH office. The CDRH director is Jeffrey Shuren. OVID’s director is Alberto Gutierrez, and OVID’s personalized medicine staff are headed by Elizabeth Mansfield. Use the following to contact FDA staff:
• list of CDRH personnel
• contact info search form.

Dr. Jeffrey Shuren
Director, CDRH
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-5900
Fax 301-847-8510

Nancy Stade
Deputy Director for Policy, CDRH
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-5900
Fax 301-847-8510

Alberto Gutierrez
Director of OVID
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-5453
Fax 301-847-8515

Elizabeth Mansfield
Director of Personalized Medicine
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-4664

The Commissioner of the Food and Drug Administration is Dr. Margaret Hamburg. She’s probably busy, but ...

March 9, 2011

Your genes, your rights – FDA’s Jeffrey Shuren misleading testimony under oath

Filed under: 23andMe,FDA,Genetics,Genomics,Jeffrey Shuren,Select Post — Razib Khan @ 12:05 pm

Over the past few days I’ve been very disturbed…and angry. The reason is that I’ve been reading Misha Angrist and Dr. Daniel MacArthur. First, watch this video:

In the very near future you may be forced to go through a “professional” to get access to your genetic information. Professionals who will be well paid to “interpret” a complex morass of statistical data which they barely comprehend. Let’s be real here: someone who regularly reads this blog (or Dr. Daniel MacArthur or Misha’s blog) knows much more about genomics than 99% of medical doctors. And yet someone reading this blog does not have the guild certification in the eyes of the government to “appropriately” understand their own genetic information. Someone reading this blog will have to pay, either out of pocket, or through insurance, someone else for access to their own information. Let me repeat: the government and professional guilds which exist to defend the financial interests of their members are proposing that they arbitrate what you can know about your genome. A friend with a background in genomics emailed me today: “If they succeed in ramming this through, then you will not be able to access your ...

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