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.
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?
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.