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

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Update: Welcome Instapundit readers! Please make sure to follow the very thorough discussion/debate over at Discover Blogs, where this has been cross-posted.

End Update

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 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.

15 Comments

  1. Razib here is a letter I sent to the FDA a week or so ago. Henry

    Dear FDA:
    I am writing to comment on the meeting to be held March 8-9 about direct to consumer (DTC) genetic testing (Docket FDA-2011-N-0066). I am especially motivated to write after reading the plea to you by the AMA that any DTC results of possible medical interest be censored to consumers. Their letter reflects an appalling paternalistic arrogance that would violate basic freedoms and impede public scientific understanding. I presume that if they could they would have you ban bathroom scales on the grounds that body weight must only be revealed in consultation with a “qualified medical professional.”

    The AMA submission has two main themes. The first is that citizens are unable to understand the risks and predicted outcomes that might be reported and that experts are vital to provide guidance. My own experience is that I am perfectly capable of finding empirical risks from current literature, I expect I can do a much better and more thorough job than my personal physician, and even my teenage son can do it with no trouble. My own experience, again, is that only about 1 in 5 medical students know what Bayes’ Theorem is.

    The second theme is that knowledge of potentially medically relevant genotypes can do some unspecified harm to customers. I have spent a total of six or so years on university IRBs, and this kind of worry is ever present. While there is much public loose talk about psychological harm and the like, within the committee room we all understand that the practice of witholding any data from subjects about themselves is nothing but protection from lawyers. I am perfectly free to refuse to participate in research and in clinical trials but I am not free to refuse to participate in federal censorship of knowledge of my own genotype.

    I would urge you to keep freedom of information for consumers at the center of the table when you discuss regulation of the DTC genetic testing industry.

  2. The most effective thing you can do is to email jeff.shuren@fda.hhs.gov directly and demand an explanation.

    Even better, get a bona fide reporter from a real news agency to demand an explanation.

    The press is the only thing that can put a check on the FDA’s power.

    These thugs want to make it so that you can’t look at your *own genome* without a prescription from a physician, a prescription that might not be forthcoming. You might not even be able to take the data out of the examination room. They are locking down genomes like they are heroin, like they are hard core controlled substances.

    I don’t get it. Is this just about raw power? Entrepreneurial bureaucratic activity?

    And why are there more than one hundred places that certify a medical doctor but only one place that certifies a medical device?

  3. Good post and good reply. The issue about bathroom scales is very relevant and applies also to all sorts of freely available information such as body fat calipers and the free blood pressure cuffs found in pharmacies. These aren’t regulated because there isn’t a potential windfall for medical practitioners.

    It looks like this issue must still be in committee. Write your own senators and representatives, but write the committee members, too. Especially ones from the party you donate money to.

  4. Not to worry, this will never pass constitutional muster on 1st amendment grounds — freedom of speech, press.

  5. Here’s the note I sent to my congressman:

    Dear Congressman– The FDA is about to implement a regulation which would require a person to go through a doctor to access information about one’s own genome sequence. To allow the FDA to create such a rule would be a diminution of our liberties. I own my body, and any information about it, not the federal government. This is not just some obscure regulatory issue. People do care. We do not wish to be forced to go through a “professional” to get access to our genetic information. If you wish to have a staffer look into this, the issue is Direct To Consumer (DTC) genetic testing (Docket FDA-2011-N-0066). Thank you for your attention to this.

  6. It would probably be a good thing to inform them that whatever they decide is ultimately irrelevant. If we can’t get access to our own vital health information in the US we can always get it overseas and then they will not get a cut of even running the tests. They need to be informed that everyone understands that this is all about their getting paid and we aren’t falling for any of their attempts to obfuscate the true reasons for their actions.

    If all it takes is licking an envelope then we can send a letter anywhere in the world… and we will if forced to do so. Once again they are irrelevant. What they decide is irrelevant. They are not capable of denying us this information. The only thing they are capable of doing is cutting themselves out of the action and assuring that the US lags in the development of this new and key technology.

    There is nothing bureaucrats hate more than knowing they are irrelevant. But there is nothing they are more in need of hearing. They don’t get to make these sorts of decisions for everyone.

  7. Please, oh please, explain to me how your own genome is either a “food,” “drug,” or “administration.”

    Also, explain to me why a pregnant woman can abort a living thing nearly without restriction or consent of the other party involved in the making of it, but I can’t be trusted with information regarding my own DNA.

    Blatant hypocrisy, without any attempt at roundabout justification, from your government.

  8. Prior to Obama’s election wasn’t there a debate on this very blog about the probability that an Obama Administration would impose restrictions on gene studies? It is easy to infer that the present debate is primarily about money, but we must also consider that our elite has been all to willing to sacrifice national wealth in the name of subverting various truths.

  9. I like L’s idea of contacting your congressman. If you want an easy way to find out who your congressman is you can use the website for the House of Reps here:

    http://writerep.house.gov/writerep/

  10. [...] Harpending Distinguished Professor of Anthropology at the University of Utah posted this over at Gene Expression, here is a letter I sent to the FDA a week or so ago. [...]

  11. [...] noted by Razib Khan and Henry Harpending, the FDA is attempting to crack down on genetic testing.  Khan writes: In the [...]

  12. [...] From Razib’s rare passionate post. [...]

  13. Some of us believe in freedom.
    It is difficult to understand how limiting information is helpful for patients.
    Paternalism should be dead in medicine.
    Your DNA, your data. Not mine or the FDA’s.

  14. That’s what guilds do. But why stop here? There are lots of other guilds you could go after. Maybe we should make a list of the most annoying ones.

  15. [...] When it comes to the mass consciousness aspect I think personal genomics and other consumer biotech will play a large role in demystifying DNA, and in the future making the public more open to the possibilities of bioengineering. Those of us alive today are on the cusp of a new age. I think the medium-term shape of that age is highly sensitive to initial conditions, so we should be both hopefully and vigilant. [...]

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