March 09, 2011
FDA's Jeffrey Shuren: Perjury Against Genetic Testing Freedom?

Michael Lee of the FDABlog draws my attention to his post on FDA deception as part of their attempt to regulate direct-to-consumer genetic test. Check out his video Did FDA's Jeffrey Shuren lie under oath about Google-backed 23andMe?

Michael's editorial text interspersed with the video makes great points. The worst statement from Shuren comes at the end where he basically calls for heavy regulation and a market dominated by large cap companies. Large regulatory agencies always end up getting captured by the big players and they work together to protect each other. But it is the small companies that are going to do the most innovation in new areas.

Anne Wojcicki's views are much closer to my own. We can do original and highly valuable science by crowdsourcing. We can get together as groups, pay to collect our own genetic and medical data, and submit the data to data chomping teams that organize on web sites. This approach is a challenge to the traditional gatekeepers and data owners.

The American Medical Association has predictably come out against allowing you to directly go and get yourself genetically tested. They want you to go thru a gatekeeper that has M.D. at the end of their name. I find this infuriating. I believe I have a right to get my full genome sequenced, to own the resulting data, and to get that data analyzed by whoever I want to pay to analyze it. Do you think you have the right to your own design? If so, oppose the FDA, the AMA, and Henry Waxman as they work to take that right away.

Razib Khan shares my fury on this and he says "This is a power grab, this is not about safety or ethics.".

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.

Click thru and read what Razib is going to do about this. Also, read Daniel MacArthur and Misha Angrist.

Also see my post Daniel MacArthur On Freedom Of Genetic Info And Paternalism.

Fellow bloggers: tell your readers about this!

Update: Michael Lee has more:

"The statement, for 23andMe in particular, that 'they are not doing their own research on the genetic profiles,'" said Stanford's Serafim Batzoglou, "is patently false." "Clearly this is false," said Russ Altman, also at Stanford. "I am reviewing [23andMe's paper] in my annual review of translational bioinformatics."

The FDA wants to discredit 23andme in order to make it easier to ban direct-to-consumer genetic testing. The FDA wants to keep us chained to the gatekeepers.

Update II: Here's a letter genetic anthropologist and US National Academy of Sciences member Henry Harpending telling the FDA we do not need the paternalism of the AMA when it comes to genetic information.

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.

The AMA wants to stand between you and your genetic information. I am opposed. How about you? Writing letters to your elected representatives and to the FDA is one way to fight this.

Share |      Randall Parker, 2011 March 09 09:34 PM  Policy Medical


Comments
razib said at March 9, 2011 10:15 PM:

thanks!

Anonymous said at March 10, 2011 8:21 AM:

Wake up and smell the government! To a first approximation, *all* government is a power grab. In those rare instances where it's actually about protecting people, the rule is expensive failure. When these ass hats do take the industry by force, I'll be in my basement sequencing people for a better price than all those M.D.-headed protectionists.

Matthew Fuller said at March 10, 2011 11:37 AM:

"I find this infuriating."

I also find this infuriating. Which state do you live in? I am in texas myself. What are the power relationships between fda, the court system, the judiciary, and states in terms of this issue?

It all sounds very very complex.


thanks for the update btw.

sabril said at March 10, 2011 3:54 PM:

I think it's probably correct that the government can't really stop people from having these tests done. How can you stop people from sending a swab through the mail to an overseas lab and viewing the results over the internet? The only way to deter people is to make it a serious offense like trafficking in child pornography or explosives. But realistically, judges, juries, and prosecutors are not going to send people up the river for accessing their own genetic information.

Alicia said at March 10, 2011 7:10 PM:

Yes, it's infuriating!

I have lived with what physicians and other 'counselors' have to say to their patients after major surgery: you are treated like an 8-year old. The subject of the actual duration of recovery is avoided as if you were a child who cannot take it. I guess the only patients who are told the truth are the terminally ill. So I can just imagine the drivel that would be doled out regarding genetics.

And this Shuren person. What an oppressive weasel; so are the Congresspersons. It's about time the US Congress freed us from their gracious FDA wardship. (I would have to channel Charlie Sheen to fully express my reaction to this video clip.)

Sabril has it exactly right. Let them try to own our genetic code, and if we lose this battle against them, we will simply slip past them.

Chris T said at March 11, 2011 10:03 AM:

As Dr. Harpending touched on, the most infuriating thing about this is the AMA's suggestion that its members are somehow qualified to interpret genetic information by virtue of being medical professionals! How many physicians even know what a Punnett square is?

But realistically, judges, juries, and prosecutors are not going to send people up the river for accessing their own genetic information.

You have way more faith than I.

bmack500 said at March 12, 2011 2:33 AM:

I think You've got it spot on here! Small companies will be the innovators. Some of these Multinationals will protect their profits simply by purchasing politicians, instead of producing great products. Or so it seems to me.

And somebody, whom can point out Whose products are good which ones are snake oil (Perhaps in the model of consumerlab.com)?

Elsie J. Binder said at February 11, 2015 6:50 AM:

Small companies might contributing to the medical science but it is also true that they are still wasting a very big amount just for marketing. Such as giving free gifts to doctors, making agreement with doctors for selling their medicine and so on. These should be stopped too.

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