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

March 24, 2011

Genetic paternalism & the F.D.A.

Filed under: F.D.A.,Genetics,Genomics,Jeffrey Shuren,Personal genomics — Razib Khan @ 1:54 am

It’s been over a week since I’ve addressed the “F.D.A. D.T.C.” controversy. I plan on getting back to the issue in more detail later, but right now I thought I’d point you to Robert Verbruggen’s article in National Review. It’s titled ‘The FDA’s Genetic Paternalism’. Robert contacted me for my take on the issue, and you get a few choice quotes from yours truly. It being National Review you can guess the general tenor of the objections from that quarter. Over the past few weeks tracking inbound links and Twitter mentions it does look as if the coming possible restrictions on direct-to-consumer personal genomics have triggered more suspicion and opposition from the political Right. Even with that said, my friends Michelle and Zack, who I think are accurately characterized as on the political Left, also both expressed great reservations about the thrust of Jeffrey Shuren’s comments. Nor do I think that the Genomes Unzipped crowd are all Right-libertarians. Even those who assert the need for regulation and some intermediation between genomic results and the patient/consumer are unhappy with the way the government and some pro-regulation activists have been approaching the matter.

Overall ...

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
jeff.shuren@fda.hhs.gov

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
nancy.stade@fda.hhs.gov

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
alberto.gutierrez@fda.hhs.gov

Elizabeth Mansfield
Director of Personalized Medicine
White Oak Office Building 66
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone 301-796-4664
elizabeth.mansfield@fda.hhs.gov

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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