Is it medicine, or is it not?
In May, the University of California, Berkeley unveiled its “Bring Your Genes To Cal” program. The idea was, Berkeley’s 5,500 or so incoming freshman would have the option to have their DNA tested for three particular characteristics: Their metabolism of folate, tolerance of lactose, and metabolism of alcohol. Though the program was limited, it raised privacy hackles. And now the State of California has ruled: This is a medical test, and Cal can’t do it unless it’s in a clinical setting.
Mark Schlissel, UC Berkeley’s dean of biological sciences and an architect of the DNA program, said he disagreed with the state Department of Public Health’s ruling that the genetic testing required advance approval from physicians and should be done only by specially-licensed clinical labs, not by university technicians. The campus could not find labs willing to do the work and probably could not afford it anyway, Schlissel said. He also contended that the project deserved an exemption from those rules because it was an educational exercise [Los Angeles Times].
If you’ve been following this summer’s stories about personal DNA tests, this probably sounds familiar. The simmering question of whether or not they are “medical,” and therefore how they ought to be regulated, began to reach a boil after Walgreens announced its intention to sell DNA tests in its brick-and-mortar stores. In June, the FDA stepped in and said the tests are medical, and therefore it has the right to make the rules for them.
The Cal program’s leaders say they got about 700 samples returned as part of the voluntary program before the state clamped down on it. Because of the state’s ruling, the university can’t return individual results to students, but the researchers can analyze the samples to present the entire group as a data set—and then they must incinerate them.
Revealing himself to be a true teacher at heart, Berkeley geneticist Jasper Rine says the short-lived program was a success anyway because it provided a learning experience.
“Most of the benefit of this program has already been had,” Rine told reporters – “Every single student who opened the envelope had to make a judgment for themselves” regarding whether or not to get tested. The two biologists also said that the Berkeley program would undoubtedly raise wider issues of how universities around the country use genetic information, for both educational and research purposes [Nature].
A teachable moment may be all the Berkeley scientists get for a while. The experiment has shown that even a testing program with a limited scope can’t escape vexing questions about handing over the keys to individuals’ DNA.
Critics had raised questions about how the genetic information, even seemingly innocuous, could be misinterpreted or misused. For example, students who learn they metabolize alcohol well may mistakenly think they can overindulge without consequence [San Francisco Chronicle].
And given the authority relationship between a university and its students, allowing the school access to its students’ DNA invites the possibility of abuse, no matter how benign the intention or how detailed the legal papers.
Related Content:
Not Exactly Rocket Science: How I Got My Genes Tested
Discoblog: Welcome, UC Berkeley Freshmen! Now Hand Over Your DNA Samples
80beats: Government Sting Operation Finds Problems With Personal Genetics Tests
80beats: FDA: We’re Going To Regulate Those Personal Genetics Tests, After All
80beats: 5 Reasons Walgreen’s Selling Personal DNA Tests Might Be a Bad Idea
Image: Wikimedia Commons
August 13th, 2010 at 3:51 pm
“…the researchers can analyze the samples to present the entire group as a data set—and then they must incinerate them.”
This seems a little like I’ll tell you, but then I’ll have to kill you.
August 14th, 2010 at 7:11 am
Chapter 1. The Good
You mentioned genetic testing being a good thing.
It can be.
Say you’re an orphan, or know of some genetic defect in your family, or are worried that something may be hiding that you could benefit by knowing about. Maybe you decide the $1000.00 is worth spending to have the test done. That information could help you protect yourself by taking certain precautions.
Chapter 2. The Bad
Now say you decide that you may be able to benefit by having me tested. You’ve paid for the test and you’ve got the results. Now maybe protection for you is to see that I am not able to see the specialist or have certain test that could cost you down the road.
Chapter 3. The Ugly
And now to get really deep and on a different slant on the topic.
Say the government has convinced you that it is a good thing for them to do the test for you.
They pay for it. They get the results. What are their motives?
And to top it off. They have no money to pay for it. They print it up out of thin air and devalue the money you have with inflation.
See it’s like say you have all the money in the world. Say it’s a Brazillian dollars. They print up a Brizillion dollars to do the testing and all of a sudden your Brazillion is worth only half as much.
That is what counterfeiting does.
That is what they have been doing.
That may be why so many people can’t keep up with them and can no longer afford to work.
August 14th, 2010 at 10:30 pm
StokeyBob that makes no sense at all…..Its like your trying to imply there is some sort of conspiracy and your trying to relate it to the article but you didn’t understand what the article was about or how conspiracies work…
your stupidity compelled me to write a comment
August 14th, 2010 at 11:03 pm
I object to that! As someone who is skeptical about everything dealing with government, for instance, the FDA. Its in cooperation with government no doubt for the safety of the people, now what I don’t understand is, why is almost every ad’s for FDA approved drugs include such lengthly lists of side-effects including “heart attack, stroke, or even death”. Or why the DEA is in a war on drugs while our FDA approved oxycontin has so many people addicted to and or dieing from? Who’s the real bad guys. Because it is legal doesn’t make it right. I believe big brother wants control over this for further reference on peoples vulnerability and ultimately how to dimished population. If it were left in our hands -which it should-we would live longer, not necessarily something big brother wants sadly.
August 15th, 2010 at 10:25 pm
All those side effects yet they frown on weed…..
August 16th, 2010 at 11:20 am
First, to Stokey Bob. Please take your poorly disguised political views to a political website. This article has nothing to do with who pays for DNA testing and who doesn’t. This article sheds further light onto the question of whether DNA is medical or not. As much as I agree with Eric H and his opinion about the FDA, in this particular case (the sampling, testing and monitoring of DNA) I would have to agree with the government agency. DNA testing should be in a clinical setting.
Now, if the tests ARE completed under clinical testing rules, the results should also be known to the individuals who provided their DNA. The whole ‘present to the entire data group then incinerate’ is crap. The government and the international community are being very VERY careful with DNA testing, mapping, gene splicing etc etc etc because of all the ethical issues surrounding such work. As for the students who volunteered to be tested, I would wager that 99.5% of them did so in the hopes of discovering that they had a higher tolerance for alcohol!!!
August 17th, 2010 at 2:13 am
I think everyone is blowing this out of proportion. Those students were given the option to give a sample of their DNA, not required to. I think the idea is a great way to stimulate interest in genetics and gives the chance for students who choose to give DNA to learn more about their own genetic profiles.
It’s a shame that something that could have been beneficial is being shown in such a negative light. Any such idea can have negative results if people- like those in our government for instance, those who seem to thrive on searching for the downside to every situation- choose to take the idea and run in a negative direction.