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Jeffrey Shuren

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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 I’d say there are two broad political-philosophical tracks by which you can approach the issue of regulation of genomic results. The first is one of rights. That is, you have a right to your genomic information. This is a clean and simple intuition, though the reality is that “fundamental rights” are often contested and constrained. So let us contest for our right! The second avenue is one of consequentialism. What are the consequences of D.T.C. personal genomics? I think in my writing on this topic you can infer that I believe a relatively loose regulatory regime for D.T.C. personal genomics at this stage of the industry is justified. This may make some readers nervous, as they believe that loose regulation in other domains has wrought havoc on our society. But to my mind most of the negative consequences of D.T.C. personal genomics being unfettered from specialist interpretation seem rather overwrought in the broader context of other public health issues. There is far more low hanging fruit in terms of efficacy upon which the fiat power of government could be brought to bear, but many of those actions are blocked by the nature of interest group politics. D.T.C. personal genomics as an actionable complement to personal health is not “prime time” yet in any case, and the instinct to restrict & regulate at this stage seems like the precautionary principle gone wild. Yes, 23andMe is not too big to fail, like Goldman Sachs or AIG, but it is small enough that the government can make it fail. In which case the American consumer has been protected from the malevolent intentions of Sergey Brin’s wife, and can look forward to the blossoming of Asian genomics firms which step in to fill the breach.

I can accept that the public in some cases needs to be “protected from itself.” But let us set the bar high.

(Republished from Discover/GNXP by permission of author or representative)
 
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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 her chief of staff is Molly Muldoon. There is a list of the commissioner’s closest staff here and an address search form here.

Dr. Margaret Hamburg
Commissioner of the FDA
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring MD 20993
margaret.hamburg@fda.hhs.gov

Molly Muldoon
Chief of Staff, FDA
White Oak Office Building 1
10903 New Hampshire Avenue
Silver Spring MD 20993
Phone 301-796-9691
molly.muldoon@fda.hhs.gov

More at Chris’ post.

(Republished from Discover/GNXP by permission of author or representative)
 
• Category: Science • Tags: FDA, Genetics, Genomics, Jeffrey Shuren, Personal Genomics 
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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 own damn genome without a doctor standing over your shoulder.” That is my fear. Is it your fear? Do you care?

In the medium term this is all irrelevant. Sequencing will be so cheap that it will be impossible for the government and well-connected self-interested parties to prevent you from gaining access to your own genetic information. Until then, they will slow progress and the potential utility of this business. Additionally, this sector will flee the United States and go offshore, where regulatory regimes are not so strict. BGI should give glowing letters of thanks to Jeffrey Shuren and the A.M.A.! This is a power play where big organizations, the government, corporations, and professional guilds, are attempting to squelch the freedom of the consumer to further their own interests, and also strangle a nascent economic sector of start-ups as a side effect.

You are so much more than your genes. So much more than that 3 billion base pairs. But they are a start, a beginning, and how dare the government question your right to know the basic genetic building blocks of who you are. This is the same government which attempted to construct a database of genetic information on foreign leaders. We know very well then who they think should have access to this data. The Very Serious People with a great deal of Power. People with “clearance,” and “expertise,” have a right to know more about your own DNA sequence than you do.

What can you do? What can we do? Can we affect change? I don’t know, I can’t predict the future. But this is what I’m going to do.


1) I am going to release my own 23andMe sequence into the public domain soon. I encourage everyone to download it. I would rather have someone off the street know my own genetic information than be made invisible by the government. That is my right. For now that right is not barred by law. I will exercise it.

2) Spread word of this video via social networking websites and twitter. The media needs to get the word out, but they only will if they know you care. Do you care? I hope you do. This is a power grab, this is not about safety or ethics. If it was, I assume that the “interpretative services” would be provided for free. I doubt they will be.

3) Contact your local representative in congress. I’ve never done this myself, but am going to draft a quick note. They need to be aware that people care, that this isn’t just a minor regulatory issue.

4) The online community needs to get organized. We’re not as powerful as a million doctors and a Leviathan government, but we have right on our side. They’re trying to take from us what is ours.

5) Plan B’s. We need to prepare for the worst. Which nations have the least onerous regulatory regimes? Is genomic tourism going to be necessary? How about DIYgenomics? The cost of the technology to genotype and sequence is going to crash. I know that the Los Angeles DIYbio group has a cheap cast-off sequencer. For those who can’t afford to go abroad soon we’ll be able to get access to our information in our homes. Let’s prepare for that day.

This is a call to arms, a start. I’ve been complacent about this issue, focusing more on the fascinating aspects of ancestry inference which are enabled by personal genomics. No more. I’ll be doing a lot of reading today. If you have a blog, post the video. Raise awareness. Let’s make our voices heard. If they take away our rights because we’re silent, we have only ourselves to blame. If they take aware our rights despite our efforts, we’ll set up the infrastructure for the day when we can take back what is ours.

P.S. Feel free to post info and ideas in the comments. I just literally woke up to the urgency of this issue in the past 48 hours.

Update: here is Jeffrey Shuren’s email address: jeff.shuren@fda.hhs.gov.

(Republished from Discover/GNXP by permission of author or representative)
 
• Category: Science • Tags: 23andMe, FDA, Genetics, Genomics, Jeffrey Shuren, Select Post 
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Razib Khan
About Razib Khan

"I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. If you want to know more, see the links at http://www.razib.com"