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Over the past few days some friends have started receiving their results from 23andMe’s last sale (others have put me on notice to inform them of the next discount window). This brings me to thinking about direct-to-consumer genetic testing, and the legal and technological framework in which we live. In relation to the former thanks to Daniel Vorhaus the F.D.A. has reopened the public docket on this issue, until May 2nd. So Monday. The best way to submit is online: http://www.regulations.gov, and reference docket ID FDA-2011-N-0066. I believe this direct link to the submission page should work as well. You obviously know my opinion. Here are some sample submissions. You can also see the submissions so far at this address. Some of them are quite succinct: “FDA let people access their genetic information since it’s one of basic right of human being.”

Dr. Daniel MacArthur has more sage commentary, as usual.

Have a good weekend!

(Republished from Discover/GNXP by permission of author or representative)
 
• Category: Science • Tags: F.D.A., Personal Genomics 
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It’s Mischa Angrist and some medical geneticist M.D. offering their opinions in The Los Angeles Times. You know what Mischa is going to say, so what’s the good doc’s opinion? It’s the first and last paragraph which are really interesting to me:

The kind of regulation I would like to see on direct-to-consumer genetic tests would require the involvement of medical professionals who understand the testing information, its limitations and its applications, and who can interpret the information in a way that makes sense to each person.

At this point in time, we as a society are also sharing the burden of paying for healthcare. So when someone goes through direct-to-consumer testing and subsequently seeks expensive follow-up testing, it has an impact on the resources of society as a whole. Personal genomic testing is, therefore, not just a matter of personal freedom; its use intersects with the needs of the community.


As revealed on previous threads there are hardly any medical professionals who “understand the testing information, its limitations and its applications, and who can interpret the information in a way that makes sense to each person.” Those who might dispute this characterization can be very patronizing and contemptuous when their turf is impinged upon. Fair enough. I don’t back down from this characterization. Of the half a million physicians and surgeons in the United States very few are qualified to interpret genomics results to genuinely introduce a “value add” to their patients.

Seeing as how our medical system in the United States is scaffolded with all sorts of regulations, and by some estimates more than 50% of the money now has some government origin (Medicare, Medicaid, etc.), I accept that the reality is that talking about this in an individualistic context runs up against the structural facts that whether you like it or not many of the steps are already de facto socialized. Therefore, some democratic debate is going to occur, because the money comes out of the public kitty.

If the debate ends up on a position where these medically relevant tests must be conditional upon a professional being able to interpret them, we are simply not going to have much personal genomics at all. Right now I don’t think that dense marker genotyping is “prime time” in any case, but in a few years we’ll have full sequences as well as (hopefully) a lot more research utilizing the new data sets. If a gatekeeper is necessary to protect the public from itself there’s going to be a lot of latency because of the time which medical education and retraining will take. Additionally, I really don’t think it would be worth it for a physician or genetic counselor to devote 15 minutes to a set of results. If you are paying for these services (or the government is) you better have a very thorough job done so that there’s no error or oversight. On the other hand, if you just want a low bar of idiot-proofing, you can simply mandate informational display which is bold and clear enough that even the idiots could comprehend the details (I’m thinking use of different colors and facing).

Unlike Mischa and some of the other anti-paternalists I’m frankly not that admiring of the intelligence of the American public, or the broader world public. Most humans are good, ethical, people, but they are not good at probabilities, and there’s a lot of “irrationality” baked into the cake of their behavior. Rather, my position is that in the broader context of the need for innovation and economic growth there are only so many things we can “protect” the public from. We could, for example, enforce a healthy lifestyle on the American public by massive regulation or bans on various processed foods. We could also ban diet books, quacks, etc. There’s a lot of low hanging fruit out there, but ultimately we focus on domains where there is a clear and present danger. I assume that the anti-D.T.C. crowd think they’re “getting ahead” of an impending disaster of excessively personalized medicine. I think don’t think that that disaster is in the offing. We already have a lot of personalized medicine. Go to any bookstore and you’ll see a whole lot of advice on what you should eat, how much you exercise, etc. Then you can walk across the street and go to the supplement store. The key is not to banish personalized medicine, it is to make it better. I think D.T.C. personal genomics has that medium term promise. That promise will be realized more quickly if experimentation, innovation, and decentralized trial & error are allowed to do their work.

(Republished from Discover/GNXP by permission of author or representative)
 
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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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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"