Tag: F.D.A.

Make your voice heard on genetic testing

By Razib Khan | April 30, 2011 1:19 am

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 onlinehttp://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!

CATEGORIZED UNDER: Personal Genomics

Two opinions on D.T.C. personal genomic testing

By Razib Khan | April 17, 2011 11:38 am

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.

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CATEGORIZED UNDER: Genomics, Personal Genomics

Genetic paternalism & the F.D.A.

By Razib Khan | March 24, 2011 2:54 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.

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CATEGORIZED UNDER: Genetics, Genomics, Personal Genomics
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Gene Expression

This blog is about evolution, genetics, genomics and their interstices. Please beware that comments are aggressively moderated. Uncivil or churlish comments will likely get you banned immediately, so make any contribution count!
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