California Berkeley Summer Assignment for Students: Genetic Testing

Voluntary summer assignment for incoming freshman wrongfully draws a great deal of criticism.

College is supposed to be one of those places where young people can discuss controversial topics in an open and intellectual manner. As for controversial topics, perhaps none has greater implication for our future as the issue of genetic testing.

But while the topic is a hot one on campus, we now see where one of the premier state university’s in America, the University of California, Berkeley, is about to take the controversial topic one step further. Roughly 5,500 incoming freshman will receive DNA test kits designed to analyze some of the genes that help control the body’s responses to alcohol, dairy products and folic acid.

It seems that Berkeley wanted to take the assigned summer reading concept to a different level. By offering students the voluntary test kits, the school sought to engage students directly in a dialogue about the growing field of personal genomics.

The school was not interested in helping students learn of their likelihood for any specific disease. Instead, the university saw the assignment as possibly creating a more lively vehicle for discussion as compared to assigning a book or an article.

Immediate Criticism

Once announced, the school has been universally hammered for the idea. First for the critics, there is the issue of the technology itself and the notion that it is still largely unproven.

Many saw the Berkeley move as sending the students a specific message, that the gene-testing kits that claim to predict the risk of future health problems have been proven to do so. In reality, these tests rely on studies that use statistics to determine how likely a particular gene variation is to be connected to a specific disease.

Others saw the idea of the school sending out kits as one of endorsement, i.e. the school supporting the notion that young adults should consider taking genetic tests to see what those tests reveal.

Both sentiments were very troubling for the group of individuals who have noted that the kits’ manufacturer never submitted the product to the Food and Drug Administration for review, a requirement for medical devices. The failure to receive FDA approval has recently led two national chains, Walgreens and CVS to renege on their initial commitments to sell the test kits.

Great Idea

When it comes to the theory, the move by Cal Berkeley borders on genius. First, the school carefully chose genes for testing that were not related to serious health issues. The goal was to pick tests that were easy to understand and non-threatening which would then produce results that might mirror knowledge students had of themselves already.

Given that genetic testing is about to change the world in ways we could never fathom, the idea of having students receive free kits certainly would get conversations started. Just the decision as to whether to participate or not would have students thinking about the topic in ways they never thought about it before. And once opting to be tested, they would no doubt begin to think about this technology and the implications it has for them moving forward.

Most importantly, students were to be given the details of the science behind the tests. Upon arrival in the fall, students were to also be invited to a presentation of the data for the entire incoming class with a specific focus on learning what the results mean.

Lastly, the school was taking strong steps to preserve anonymity among students. All tests were to be collected privately and a barcode utilized for students to review their individual results. No student would be stigmatized as to their willingness to be tested or based upon their results unless that student chose to share such information. In addition, upon conclusion of the tests, the remaining DNA submitted was to be incinerated.

A Halt for Now, But

Given that the FDA has not given clearance it is understandable that both Walgreens and CVS have put a halt on selling the kits. That temporary hold also demands Cal Berkeley temporarily reconsider its plans to move forward with their concept.

The company producing the kits, Pathway, believes it is in compliance with federal regulations. That may be so and if they are deemed to be in compliance in time for Cal Berkeley to still implement the plan we think it should go forward.

With such tests being able to assess the risk of serious health concerns such as the risk for Alzheimer’s disease or breast cancer, there will no doubt be hundreds of thousands of kits being sold to the public. Educating college students as to what these tests can and cannot do is one of the best ways for the greater public to have a better understanding of what genetic testing is all about.

Because the test kit will be relatively inexpensive ($20 and $30), many will likely consider purchasing it. But the first thing to learn is that the basic kit does not cover the full cost of all testing results. According to reports, kit buyers interested in Drug Response info will need to shell out $79. The “Pre-Pregnancy Planning” or “Health Conditions” test results will set a person back $179. A total look at all areas will cost $249.

Perhaps most importantly, genetic counseling does not come with the aforementioned prices. All counseling will carry extra fees with the expected rates at $40 for a call of up to 20 minutes and $99 for an hour.

Of course, there in lies the greatest issue for the future; these test results demand counseling follow ups. There is little doubt that specific outcomes could be particularly troubling to those receiving the results.

That development has been likened to providing people information without providing them the knowledge to understand the info provided. Genetic risk for disease, of course, is not the same as having the disease. The reality is that anyone tested is going to find that he or she is at risk for one condition or another.

But if the FDA provides clearance, we agree with one of the plan’s sponsors, Mark Schlissel, Berkeley’s dean of biological sciences, that the voluntary tests of this year’s freshmen represent a teachable moment.

There is little doubt we are moving towards the world of personalized medicine. The best place to teach young people about the positives and negatives of that world is on our college campuses.

And there is no better way to provide students the requisite knowledge than to immerse them directly in the process.

 

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