The University of California, Berkeley has decided to offer this year's freshmen "the opportunity to find out what they're made of -- genetically speaking -- courtesy of the College's On the Same Page program." The plan is for all freshmen and undergraduate transfer students to be sent, along with other introductory materials, a cotton swab. They can send this back with a little of their DNA, which will be analyzed for three specific genes, variants of which indicate "the ability to absorb folic acid, to tolerate alcohol, and to metabolize lactose."
In other words, students can supposedly find out just how careful they should be about eating their greens, drinking in moderation, and consuming dairy products.
This endeavor is part of a program that, in the past, has assigned incoming freshmen a book to read over the summer, in order to create "a common intellectual experience." This year, they will instead explore "the theme of personalized medicine -- the set of emerging technologies that promises to transform our ability to predict, diagnose, and treat human disease -- with Professor Jasper Rine as our guide."
This idea rapidly became national news. It was covered by the New York Times, Inside Higher Ed, and the wire services. And it provoked a rapid reaction.
The Council for Responsible Genetics sent a letter of complaint [pdf], pointing out that "the American Medical Association, the American Society for Human Genetics and the American Clinical Laboratory Association have all issued strong statements against direct to consumer genetic testing" without proper counseling. The Center for Genetics and Society (which produces this blog) issued a press statement:
"Just last week, the largest drugstore chain in the country halted plans to retail a similar product after receiving a stern letter from the US Food and Drug Administration. If selling genetic tests directly to consumers is a problem in the eyes of federal regulators, how can the University justify pushing them on thousands of eighteen-year-olds? ... This program may be good for the direct-to-consumer genetics industry, but it is an abuse of the trust that thousands of young students should be able to place in the university they've chosen."
The press took notice. These and similar comments were picked up by the New York Times, US News & World Report, San Francisco Chronicle and many other outlets, where they got a lot of attention.
The program does includes some safeguards: The samples are sent back anonymously (the sender keeps an ID key), and "all genetic material will be incinerated after the experiment has been run." But no one seems to have considered the broader implications.
Justifying the program, Jasper Rine told the Daily Californian: "If they have a common allele of aldehyde dehydrogenase, they will then know that they have a deficiency in metabolizing ethanol. This test is an easier and more pleasant way to learn this than by the empirical testing that is common in this age group." To which George Annas of the Boston University School of Public Health replied:
"They may think these are noncontroversial genes, but there's nothing noncontroversial about alcohol on campus. What if someone tests negative, and they don't have the marker, so they think that means they can drink more? Like all genetic information, it's potentially harmful."
Thus far, the University's response has essentially been to stick with the program. One part was discarded -- a plan to give more extensive testing by 23andMe to four students as a prize. A spokesperson explained:
"We suddenly realized that handing an 18-year-old a genetic kit without counseling, there might be something from that test that we don't want to be responsible for."
It is extraordinary that the university did not consider this before. And yet somehow they justify the concept by claiming that the controversy would "add to the dialogue, and dialogue was what we hoped to generate."
Up to a point. It's also true that Rine is a founder of VitaPath Genetics, which "is developing a family of DNA tests to help individuals reduce the risk of serious and life-threatening disease." He is a firm believer in "nutritional genomics" and clearly sees a commercial opportunity there. Rine is not going to make money directly out of this endeavor -- it's unclear what company will do the DNA testing, but it won't be his, nor will it be 23andMe -- but he is clearly invested, literally and figuratively, in the future of this technology.
At least some of the UC Berkeley faculty were surprised by the uproar, notably this member of the 23andMe scientific advisory board. Which is itself really quite surprising, since it came at the same time as Congress began investigating the business of direct-to-consumer genetic testing, following the FDA's intervention that stopped Walgreens selling tests. Yet this entire proposal is predicated on the assumption that "individuals may have to take a more active role in the management of their own health care, informed by their genetics," since there are "far too few genetic counselors to handle the flood of genetic information that is coming."
It has since been reported by GenomeWeb (full text requires sub) that "Stanford University has similar personalized medicine educational plans in the works, but on a much bigger scale." This is a matter of potentially even greater concern. As the CGS press release pointed out about the Berkeley proposal:
This project could fuel common misperceptions about the importance of genetic information, and sets a bad precedent about the way genetic tests should be used. In effect, it puts the university's seal of approval on products that have not been -- and may never be -- approved by federal regulators.