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

By: Biology to the masses | Biology News by Biologged

Biology to the masses | Biology News by Biologged — Wed, 25 May 2011 18:32:17 +0000

[...] 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. [...]

By: DKB @ NYU

DKB @ NYU — Sun, 13 Mar 2011 14:37:47 +0000

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.

By: Dr Mike

Dr Mike — Sun, 13 Mar 2011 03:42:32 +0000

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.

By: Undead Astronauts » You are too dumb to view your own genetic code

Undead Astronauts » You are too dumb to view your own genetic code — Fri, 11 Mar 2011 19:01:00 +0000

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

By: The FDA cracks down on genetic testing | Conservative Heritage Times

The FDA cracks down on genetic testing | Conservative Heritage Times — Fri, 11 Mar 2011 14:54:58 +0000

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

By: FDA to deny us right to our own DNA | Tea Party News .NET

FDA to deny us right to our own DNA | Tea Party News .NET — Fri, 11 Mar 2011 05:37:50 +0000

[...] 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. [...]

By: George

George — Fri, 11 Mar 2011 05:31:07 +0000

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/

By: Jeff

Jeff — Fri, 11 Mar 2011 01:31:45 +0000

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.

By: The False God

The False God — Thu, 10 Mar 2011 21:59:35 +0000

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.

By: Polybius

Polybius — Thu, 10 Mar 2011 21:20:08 +0000

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.

By: L

Thu, 10 Mar 2011 20:28:50 +0000

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.

By: Luke Lea

Luke Lea — Thu, 10 Mar 2011 10:33:30 +0000

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

By: Chris

Chris — Thu, 10 Mar 2011 02:18:20 +0000

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.

By: jeffrey shuren's conscience

jeffrey shuren's conscience — Wed, 09 Mar 2011 20:47:12 +0000

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?

By: Henry Harpending

Henry Harpending — Wed, 09 Mar 2011 20:44:33 +0000

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.