August 14, 2010
UC Berkeley Students Denied Genetic Test Results
The state of California, in its infinite wisdom, has decreed that incoming freshmen at UC Berkeley can't see the results of free genetic tests that were offered as an educational experience.
The University of California, Berkeley, wonít tell about 700 students the results of genetic tests performed on their saliva, after the state health department barred the institution from proceeding.
The claim: genetic testing must be done by certified laboratories. Safety Nazis? Or power and control freaks? My reaction: How dare they.
The 3 genes to be tested all have dietary implications.
Students were to receive information about three genes relating to their ability to break down lactose, metabolize alcohol and absorb folates.
The UC Berkeley students are basically being told "You can't handle the truth". An interesting message to send to incoming college freshmen.
Are genetic testing results educational or clinical information? I say the results are both a dessert topping and a floor wax.
At a late afternoon meeting yesterday, the California Department of Public Health (CDPH) said that the genetic information that participating students would receive constitutes clinical testing, and therefore canít be released to students outside of a clinical setting. Program organizers, however, argue that the testing is educational, not clinical.
The phrase "outside of a clinical setting" means information provided by someone who is not part of the medical priesthood. I liken this to the Medieval Catholic Church saying that only priests should read the Bible. The masses can't be trusted with the truth uninterpreted by specialists. Who knows what conclusions they might draw and what actions they'll take in their personal lives or political platforms they'll support as a consequence?
California Department of Public Health says "You can't handle the truth".
These (unfortunately powerful) bureaucrats are standing in the way of a very large and healthy trend: huge flows of freely available information. Biological information about our own bodies should flow to our minds without bureaucratic hindrance.
Think about the long term trend with genetic testing and sequencing: Babies will be fully sequenced at birth. Will their full genetic sequence results reside only at a doctor's office? Or will the parents be allowed to take the data home? If the parents take the data home then when baby grows up into a teenager the kid will want to see the data and will likely first see it without a medical doctor around.
Full genome sequencing will provide so much information (a few billion genetic letters at once) that visits to a doctor become completely inadequate as settings for explaining the results. We will have cheap full genome sequencing for decades before the subtle meaning of all the genetic variants become known. You will get sequence results and then meaning will come out gradually over time. Should various subsets of the results be hidden from you until a government agency decides that all the significance of their variations become known?
I am going to watch with interest to see which countries end up allowing easy unfettered access to genetic testing and sequencing results. At some point it could become worth it to get your genome sequenced while on a vacation trip abroad.
Update: FDABlog, which has great posts critical of FDA policy, has a post about the FDA offensive against genetic testing companies.
WASHINGTON - The US Government invested more than
three billion dollars in the Human Genome Project, in part on the expectation that the investment would create jobs for American scientists and engineers. Over the last decade this expectation was largely met, as the vast majority of pioneering companies in the sector ó including innovators like ABI, 454 Biosciences, and Illumina ó were based in the United States. That may be about to change. From Silicon Valley to San Diego to Boston, academics, entrepreneurs, scientists, and venture capitalists have begun to look overseas in the wake of what they call a heavy-handed crackdown by Congress and the FDA on the nascent personal genomics sector.
A lot is at stake here. The explosion of biotechnology enabled by making smaller devices (just like with microprocessors and computer memory) has the potential to revolutionize medical testing and treatments. But if the FDA keeps the existing slow and ponderous drug and test equipment approval process in place and extends it to new biotech industries then progress will be slowed by decades.
What's at stake if progress is slowed by decades? Your life. The development of rejuvenation therapies would happen much faster if various biotech sub-industries could bring their products and services to market without any regulatory barriers.
Look at genetic testing. There's no need to regulate it. Genetic sequence data is information. The quality of the information can be tracked and demonstrated to the public by sending the same test samples to different suppliers and then publishing the results. Let people know what the quality is on the tests and otherwise regulators should stay out of the way and let the public decide when to opt for genetic tests and genetic sequencing.
Update II: The current regulatory regime is incompatible with the future of personalized biotechnology. For example, sensor technology using nanodevices will make it technologically possible for us to wear sensors and/or have sensors embedded in us. We should be able to get alerts about our biochemical status on our smart phones. "Stop eating candy since your blood sugar is going too high" or "You are now about the legal driving limit for blood alcohol" or "You are impaired in your driving ability and general thinking ability due to sleep deficiency. See details".
I can think of countless other automated alerts driven by embedded sensor data such as warnings of micronutrient deficiencies or signs that your kidneys are not working well or early signs of a viral or bacterial infection. Imagine a sensor system that alerts you when you are incurring an aerobic exercise deficit or that lets you know that you ought to go to sleep within 2 or 3 hours.
This information should be immediately available and therefore should not first go thru review by a doctor. Yet America's highly entrenched and very powerful regulatory apparatus stands in the way of our direct use of our own biological information in real time.
RP: "Safety Nazis?"
No. Safety FROM Nazis.
There is no room anywhere in the world for anything that might have disparate impact for Nazis. Carpet bomb any country that lets this infection fester within its borders.
You can't hide from the facts forever. As much as this sucks, there are people who, at conception, have an advantage over others. People who you might even say are "more valuable" than others. This could destroy a society whose founding principle is that all men are created equal.
Given that, I think the reaction, no matter how ineffectual against the coming tide, is reasonable. When the truth comes out... Well, I just hope I'm far away from certain... areas.
I work for a government administrated program that provides medical insurance to those who can't afford it. I deal with these people daily. They are incurably stupid. No matter how many times you try to teach them things, simple things that we do every day, like remembering addresses, dates, and phone numbers, they will never grasp it. They can't remember the name of a doctor that they've been visiting all their lives... And they are so belligerent. Especially annoying are the mothers, with three to five children, all with different surnames, going to OBGYN appointments to keep their junk cranking. How can these people ask for so much when they contribute so little? There are times I just can't see the point of the government paying to help these people stay alive.
They're adjusted to life on the veldt. Their numbers spike when there's a enough food so that at least some of them survive the inevitable coming famine.
But once it's undeniable what kind of creatures they really are, and that they just can't help it... Can we tell them that they are just never going to be as happy or fulfilled as us in our world? What will we do with them?
The facts are nauseating.
Personally I think the scientists who done this testing should just publish the information on the internet if they have the consent of the students in question. The first amendment issues here are quite staggering to say the least.
This is also a serious blow to the citizen science movement where an increasingly larger amount of serious science is being done outside the ivory towers of traditional academia. I doubt that these citizen scientists will allow government to prevent them from continuing their work and it seems that we as a nation no longer have the money to imprison them.
What are these health departments going to do when people start using the $1000 genetic testers and electron microscopes they have purchased in their garage and start posting results of research done on the internet on open source research sites protected under the creative commons laws?
I am just going to post some related sequelae
a) The voltage from a small 9v battery applied to the head for more than 3 minutes appears to improve memory
b) the principal investigator resigned with Zhang Cui's LIFT/GIFT therapy and there is no reason for justification to the public because accountability isn't a matter of who is right but who is blamed; no reward for correcting false theory when it's safer to not try.
c) philosophical masturbation is another name for bioethics
Links would help. You mean
Zheng Cui and GIFT versus cancer? Who was the principal investigator if not him? Why'd he resign? What's the state of GIFT research?
I thought you said you were moving politically leftward. Yet your observations about the lower classes are taboo on the Left. Your comments remind me of how
Heather Mac Donald explained in an interview that her experiences with dysfunctional lower classes helped turn her rightward Taking up journalism in the early 1990s exposed me to the total disconnect between liberal dogma about the underclass poor and the reality of their self-defeating behavior. I still have no idea how New York Times reporters can visit the same homeless shelters and welfare offices that I have and remain confident that the "clients" of those facilities are the victims of racism, rather than their own bad decisions. So I would say that reporting on social problems provided the coup de grace for liberal pieties. (I write about my political evolution at greater length in a forthcoming book of essays by various journalists called
Why I Turned Right)
"The facts are nauseating."
I think that's just a stage everybody goes through at first when they become acquainted with the HBD picture. Stay focused on the goal: there's no way out except to uplift all of humankind.
BTW, I wish we had an HBD wiki. Even just a concise collection of links to the materials that seem to form the backbone of the current HBD picture, like the material from Cochran & Harpending, Gregory Clark, and Bruce Lahn, and also the work of folks like Richard Lynn and J. Philippe Rushton that, at the end of the day, really is irreplaceable. My understanding was built from years of reading the excellent writing by Steve Sailer and the GNXP authors, but as long as there's no concise collection of such materials, we can't expect people to have much familiarity with HBD.
Also, it's been years since I was a regular reader of Sailer & GNXP, so I'm sure my understanding is no longer quite up-to-date.
mmm... as far as I know HBD means "here be dragons" ... I really don't think that's what you meant
>>I thought you said you were moving politically leftward.
Trust me... Where I am now is a leftward move from where I was. And I only use those terms in a relative sense anyway... I'm not dumb enough to identify with a political party, especially not an American one.
The biggest leftward move for me has been away from white/asian/ashkenazim superiority and anarcho-capitalism. I believe that universal healthcare's biggest failure in the US is that it tries to support people who don't produce anything but babies. If they could just control their numbers (abortion and birth control are huge progressive issues) then they could probably still stay on the dole and live out their lives as happy as they are capable of being. I think it's our obligation, as people who are capable of basic thought to try and reduce human suffering as much as possible. It's really not these people's fault that the behaviors that come naturally to them are extremely maladaptive.
That they really have no business breeding is just inescapable common sense.
In the end, almost any political system would work if society was made up of people who could think.
One of the things I learned when I trained in HIPAA (not that they come out and say this explicitly, but it becomes clear if you start out looking for it) is that patients *do not* have a right to their medical information. There are a lot of restrictions on who it can be released to, how and why, but nothing that says a patient must be given it on request. Nice bit of lobbyist handiwork, there.
Get your genes tested and download the raw data now before the government stops you and it will. The question is how soon and I predict really soon.
Strictly speaking, BBartlog, what you learned is that right is routinely
Of course we aren't permitted direct access to our medical information. Take me, for instance: I had prostate cancer, I get a quarterly PSA done. My doctor would get HALF as many visits from me, if I wasn't required to see him face to face, and pay for an office visit, in order to learn that my PSA is still zero. The financial incentive for doctors to remain medical test result gatekeepers is immense. This is just a routine example of regulatory capture.
AB, at current prices, you'd probably save money by waiting until the price dropped, and taking a nice vacation abroad to have the test done, and the results handed to you outside the FDA's jurisdiction.
The UC Berkeley students are basically being told "You can't handle the truth". An interesting message to send to incoming college freshmen.
I'm not sure about that. An error in a test for alcohol tolerance could lead to nasty outcomes if the subject performed a "practical exercise", and I'll bet that the decision not to release the results was at least halfway driven by the univeristy legal department wanting to avoid liability in this suit-happy society (aka, lawyers justifying their salaries as defense against other lawyers).
No, the decision came because the California Department of Public Health told UC Berkeley they can't release their results.
Otherwise, UC Berkeley could have just released the results from the other 2 tests.
The issue is not liability. The issue is overreaching regulatory agencies that want to control what information you have access to.
I see the genetic testing issue as part of a much larger issue: Access to biological testing results, including future real-time access. The real-time access will be made technologically possible with nanosensors. But if the FDA has its way we won't be able to use those cheap and embeddable sensors to watch our own metabolism in real-time.
>>But if the FDA has its way
you seem to be hinting at a larger purpose behind all of this suppression. up until now i always thought that it was almost entirely a racism thing. are you saying there's a political reason?
I say that the results were clinical in nature regardless of where they were tested and as a consequence they fall under HIPPA. As a consequence the university may not deny the students access to their records under the act.
"All men are created equal" is a claim about status, not about ability. We all have equal inalienable rights, not equal bodies or equal brains.
1) The FDA and Cal Dept of Public Health do not want us getting medical test results except thru a doctor.
2) The FDA wants to control what tests are even available for a doctor to provide with large regulatory hurdles for getting new tests approved.
3) The reasons are mostly the same as for non-genetic tests. The main angle here is not something to do with genetic information.
4) If the government has the power to restrict which tests we can get done then they certainly will find lots of reasons to restrict tests that will depend on circumstances around each test. Some of those circumstances might involve social agendas and the desire to get the masses to think politically correct thoughts. But lots of other reasons will be found as well.
The bottom line is they do not recognize your right to know. They want the flow of knowledge restricted and doled out by a priesthood. I find their position offensive and harmful to our best interests. Hope you see it the same.
There is no conspiracy here.
Any lab tests you get in the U.S., you have a right to see the results. They're just saying these tests weren't done in a certified lab. It would be the same if UC Berkeley had done blood tests on the students.
The issue is not whether or not you can have access to your genetic testing. The debate is who and what companies or organizations will give these tests - and how or whether or not those giving the tests will be regulated.
If I have to go to a doctor to get a test ordered then:
- The doctor will charge me for his time twice.
- The doctor will not let me choose between test providers.
- Since he'll take a cut and choose providers I'll pay more for the actual test.
- The doctor could say no.
Certified labs: Again, this comes down to reducing my choices. If the FDA decides some test results are not useful then the FDA could just decide not to let this information be gathered.
I'm opposed to gatekeepers who can control what information I can get access to. I end up paying more and getting access to less information. Plus, the process becomes less transparent and less predictable.
The whole discussion in the comments is a microcosm of why health care costs are so high.
Let the free market at health care. Costs will halve. Quality will go up.
What is a free market?
1) Consumers pay. That means health insurance is a high deductible exercise, and employers are out.
2) Most of the regulation regarding diagnosis, prescription, delivery and information must go.
3) Information must be freely available. Let's begin with treatment centers and hospitals, and their pricing and effectiveness. That will decrease the cost of health care by hundreds of billions a year. You can not have a market without information.
4) Patient information must also be available. But even without it, number 3 will get most of it.
5) True competition by health insurers, and tort reform.
By the way, I just described how to halve the cost of education as well. If we privatized universities, progressivism would be dead in 10 years. Only a PHD without a real job can believe in such a thing. It's like eugenics.
Plus, if people have to go to a doctor to get DNA tests then:
- We've got to call up to make an appointment and get told when they can come in.
- We've go to take off from work twice: once to provide a sample and once to get results.
Why not be able to just send samples directly? This is what was happening before the California government started making life difficult for the DNA testing services.
As for certified labs in the UC Berkeley case: The school wasn't trying to diagnose a disease. It was just trying to educate students to start thinking about DNA test results and how the information from tests could help them make better decisions.
If lower error rates in test results are the goal then lab certification isn't the way to achieve this goal. Rather, comparing test results from different labs for the same sample sources and then publishing the results would let us make informed choices. Heavy handed regulation is not needed. It serves no constructive purpose. It just reduces choices, increases costs, and introduces inconveniences and and causes wasting of time.
There was a time when all the Ivy League schools persuaded their students, male and female, to have naked pictures taken of themselves with pins in their backs, in the name of posture science and a large genetic sample.
Now it's a large sample of genetic info instead, but the students are still paying a lot of money and being taken for chumps. Nothing much changes.
In quick response to Randall:
There is no requirement that you have to go to a doctor to order a lab test, MRI, X-ray - you name it. Many labs and testing centers require that your test is ordered by a doctor, but they are happy to direct you to facilities that do not. Of course, your insurance may not pay for it but that's nothing new.
Forgot to mention: I have never been to a doctor that required me to take a test at a certain facility. Perhaps some cooperative health plans may have such requirements, I do not know. But that's again more of an insurance issue.
As far as regulation of genetic testing, the technology is entirely portable, so why not just put it aboard a cruise ship?
It comes down to who owns the results and whether anything was agreed between the parties prior to the tests being undertaken.
As an analogy, consider a photographer taking pictures of a busy city street-scape. People are aware of what he's doing as they can see him in plain view. Some people walk around him so that they won't appear in his pictures while others walk right into the frame. A few even strike playful poses and ham it up a little.
Who owns the pictures? Is the photographer obliged to give a copy of his photos (the results) to everyone who happened to be photographed that day? Does the absence of a formal agreement make any difference?
Getting back to the genetic testing situation: Did the students sign a document (such as a agreement or a waiver) prior to being tested. Was there an agreement in place regarding the ownership status and treatment of the results? If so, what were the details of that arrangement? Is this a case where the students have been bilched out of what is rightfully theirs by yet another government interference and failure? Or is this a case where whatever property rights the students may have possessed were voluntarily allocated to other parties and the students retained no property right in the test results?
Moving on, Randall's concerns are serious and demand consideration. If the state of play is that a US subject is to be rendered unable to order and receive medical/genetic/surgical test results without third party control, then that should raise strong concerns. On the other hand, for those who believe the state has any role to play in medicine/surgery/insurance, then it must be accepted as an inevitable step. In the meantime, the lesson for the students is to never place trust in authority.
"This could destroy a society whose founding principle is that all men are created equal."
Which society is that?
Reason I ask is that the "society whose founding principle is that all men are created equal", in the sense that you use that phrase, was not and is not the USA.
CLIA regulations were put into place to ensure that testing was done in an accurate and quality controlled manner (this was often not the case prior to CLIA). Laboratories that have not been certified by CLIA or another regulatory body should not be providing clinical results as they are not ensured to be following good clinical practices or even using accurate tests. This has nothing to do with who owns what data; prove that your test is accurate and that you are performing it correctly and you are free to provide the results to patients. This seems like a good compromise that the students will still be getting an educational benefit by seeing the de-identified data for the class as a whole.