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.
At this point, as far as I can tell, getting your overall genome scanned is mostly for hobbyists, such as people interested in their genealogies. Scanning technology has gotten much, much cheaper, but it turns out that so many genes influence most of the traits we're highly interested in that most of the medical advice flowing from findings that your genome makes you, say, 3% more likely to have a heart attack than the average person is stuff like: Quit smoking and get more exercise!
Eventually, this stuff might be highly medically useful, but it will take a lot more hobbyists having their genomes scanned to figure out what all those genes do and how they interact.
Eventually, this stuff might be highly medically useful, but it will take a lot more hobbyists having their genomes scanned to figure out what all those genes do and how they interact.
As in any business, especially a new one, there are some scamsters in the personal genomics business, but they can be dealt with under laws against scams in general. Imposing onerous medical regulations on this fun little industry will just slow the growth of genetic knowledge and be a boon for the economies of less regulated Asian countries that welcome American personal genomics firms.
Posts
30 comments:
I'm sure there'll be public outrage over this.
Blogspot really needs a sarcasm tag, btw.
Word, Steve. And Libertarians will welcome the chance to defend genome rights on the rhetorical battlefield of civil liberty rather than gay marriage.
“it turns out that so many genes influence most of the traits we're highly interested in”
Clinical physicians who work with genetics do a lot of work in the diagnosis of congenital diseases in pediatrics, as well as counseling for malignancies like breast cancer and ovarian cancer. Some diseases have very important individual genes.
Completely agree. Strict regulations here will only drive businesses outside of the US. Nothing prevents me from sending a mouth swab and a credit card to Singapore, Vancouver, or Mexico City, for that matter.
The benefit of leaving as is right now is that the hobbyists can actually accomplish some things. They can find some dead ends, some leads and so forth, without the costly investments. This is a great time for the government to do nothing.
A very scientific study (OK, ten seconds of Google Fu for "liberal beliefs") revealed these statements in order:
"Pro-choice advocates argue that whether or not to continue with a pregnancy is an inviolable personal choice, as it involves a woman's body, personal health, and future."
Errr, wait.
"Civil liberties are rights and freedoms that provide an individual specific rights such as the right to life, freedom from torture. . . the right to privacy, freedom of conscience, freedom of expression, freedom of assembly and association, and the right to marry and have a family."
Hmmm. No.
"Broadly speaking, liberalism emphasizes individual rights."
Not so much.
"Liberals won't try to force their religions down your throat, and believe people are able to think for themselves."
Well now.
There are already a few genes known where sequence is very important to traits that are expressed in people. For the moment, for the most part, "sequence" means Single Nucleotide Polymorphisms (SNPs). That's the information available from 23andMe and other providers, today, for a couple hundred bucks.
If you want food for thought, Google "ApoE genotype Alzheimer's Disease".
The recent advisory committee meeting again leaves the impression that, to the FDA, the answer is More Regulation.
...What was the question, again?
Let's hear from folks who have been genotyped. (Note to the uninitiated: I've had "only" ~600,000 base pairs read and recorded, hence my use of the word "genotyped", as opposed to "sequenced".
I'm at 23andme.com. 23andme has a great community interface where anyone can easily start a comments board on a genetics topic. The interest is overwhelmingly about ancestry and genealogy.
This might come as a surprise to outsiders, who consider hypochondria a virtue but think that good boys and girls should never ponder their identity, ancestry, or race.
Glad to see Razib slam the AMA. I've seen physicians excoriate unions in the newspaper, while obliviously signing their name with their Organized Medicine-bestowed title, as if they earned a PhD.
Steve you gotta embed the video:
youtube.com/watch?v=YI-m2Cucdoo
Steve here is a note I sent to the FDA a week or two ago.
"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."
Eventually, this stuff might be highly medically useful, but it will take a lot more hobbyists having their genomes scanned to figure out what all those genes do and how they interact.
Correct. Just like the HomeBrew Computer Club. In the late 1970s, everyone was like "what does the average person need with a personal computer"?
The freedom to tinker and trade answered that question a 1000 times over.
Remember that when people ask "what does the average person need with a personal genome"?
Getting my genome scanned is something, like getting a big fancy flat-screen TV, that I have put off for years because the price is dropping by 25% a year.
I can wait.
Also I don't feel like doing the price and service comparison research since each company only scans certain but different areas. A full scan still costs several thousand and it might be best to wait for this to become cheap.
For years I've heard Leftists rail about corporations copyright genes and owning our own chromosomes. Who knew they were upset about who owned them:they preferred the government own them.
I've done 23andMe with their new chip. Pretty cool for 200 bones. But who would want some MD to act as a gatekeeper for this information? F them and their monopoly. I'll go to freaking China or Mexico instead.
Big deal. We'll just fly to Korea or Thailand or India or a dozen other places, saving so much money that it will pay for the plane tickets. Or would this kind of thing be a felony for Americans as well?
More generally, America is being left behind by the human genomics revolution--the biggest sequencing effort to date is taking off in Hong Kong and across the border in China, a project that would be impossible to carry out in the US due to regulations. PC on the left, the religious fundamentalists on the right... not a pretty picture.
With China's history of stealing intellectual property, I'm not sure I want to send them my DNA.
Don't make this a partisan issue. It's not clear to me how much Dr. Shuren, the FDA official testifying, represents the views of "the Obama administration," and congressman Latta, who makes some of the most alarming statements in the video, is a Republican from Ohio.
We need Obama voters on our side here. This could be framed as a civil-liberties issue.
Oops, I guess the congressman making the outrageous statements was not Latta, but former D-turned-R congressman Parker Griffith, who is now out of office.
The doctor's lust for control is impressive.
Under the Uniform Parentage Act, donor insemination or a surrogacy contract are only authorized if you have a doctor in the loop.
The sperm deposit must employ a doctor with his "turkey baster".
Which is extremely odd. For the doctor is not "treating" either party for a "disease".
If applying sperm from a healthy fertile male to the reproductive organs of a healthy fertile female is a "medical treatment" then every man in my family is guilty of practicing medicine without a license.
Talk of the risk of genome-related activities "moving offshore" isn't speculative.
The Beijing Genomics Institute (BGI; Shenzen, Beijing, & Hong Kong) is already a powerhouse in the next-generation sequencing arena. They have deep pockets and big plans (list of announced projects).
"Additionally, this sector will flee the United States and go offshore, where regulatory regimes are not so strict."
Naturally, the paleos will blame free trade and low salaries of Chinese geneticists. Immigration will be somehow involved, too.
Of course, I have to wonder whether this is motivated solely by the medical mafia attempting to preserve its profits, or whether maintaining the idea that "race does not exist" (by keeping rather simple proof to the contrary out of the hands of ordinary people) is also a factor.
Legally, the situation is a bit more complex. Back in summer 2010 when the Congress held hearings on this matter, they asked if 23andMe was doing any research. After these hearings, the FDA dropped plans to regulate a narrow type of testing in favor of reviewing a broader regulation of diagnostic testing. (This is what the state of New York does--no blood tests, etc, without an MD prescription.) The point of the question about 23andMe's research was to determine if genetic testing companies could be exempt on some basis from regulation of all diagnostic tests. This is what's coming down the pipeline. But there is no evidence genetic testing is harmful, and the industry could easily move overseas and be available to consumers there (just as I can send my bloodwork by driving over the border to Vermont).
I had a set of allergy blood tests done. I paid a large sum for the tests, and then I had to pay a doctor to read them to me, since they are not released directly to patients.
He basically just read what was written on the report to me, gave a few platitudes about avoiding allergens and sent me on my way (although, to his credit, he gave me a copy of the test results to read myself).
Obviously, Obama doesn't want us using cheap genomic sequencing to figure out the 5 million people who are most genetically similar to us. After all, that would provide a work around to rabid opposition to white nationalism: new implicit identity groups for whites based on genomic sequencing.
At last, an opportunity for everyone to be a persecuted minority genotype.
Remember that when people ask "what does the average person need with a personal genome"?
When people say "what does the average person need with" I'm already pondering whether they deserve the front of the hand, or the back.
But yeah, you obviously make a good point. But I don't think TPTB & the MOTU want the same outcomes you do.
>Nothing prevents me from sending a mouth swab and a credit card to Singapore, Vancouver, or Mexico City, for that matter.<
Every time I order something from overseas, my credit union freezes my bank account. Even if the amount is less than $20. Reason given: Fraud Prevention. Just a few years ago the reason given was: National Security - sorry, they are making us do this!
"Who is they?" I asked.
"Homeland Security. These are Homeland Security regulations."
"Where are they published? Are they law?"
"Sure they're published: I'm currently telling you what they are."
A nightmare it was trying to reestablish access to my account. Has happened three times.
Maybe we should all give up trying to buy things from overseas, eh?
As to the genome crackdown: we are apparently not to know any more than the government thinks we ought to know, even about ourselves. The reign of ignorance, enforced by the police power.
But why? Because people might trace (are now tracing) their racial heritage...and race is not supposed to exist, in a Western-Liberal democrazy. So, the data are to be effectively suppressed. They must go down the Winston Smith hole, just like breakdowns of index crime by race.
The government is a quirky follower of the Bible. "If thine eye offends it, it will pluck it out..."
Possible motivations:
1. monopoly creation and protection
2. preserving universal neurological equality orfthodoxy
3. Stopping do-it-yourself eugenics.
In order of importance (imo):
3-2-1 or 2-3-1.
I had to jump to through a surprising number of hoops to get tested for Huntingtons Disease.
"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."
A hideous prospect. The *interpret* part is what really gets me.
Post a Comment