By Jeremy Gruber

Last month, the University of California, Berkeley changed course after months of intransigence and made significant changes to their controversial “Bring your Genes to Cal” freshman genetic testing program.  The most prominent modification was the elimination of any individually identifiable analysis of student DNA.  While this change of course appeared abrupt, it was the result of several months of significant and mostly behind-the-scenes work.  The lessons learned from successfully pressuring the University to revise its program can provide a blueprint for future successes in steering the development of biotechnology towards the advancement of public health, environmental protection, equal justice, and respect for individual rights.

In May of this year, the University of California, Berkeley announced that it would be sending incoming freshman a cotton swab with which to send in a DNA sample to be tested for three gene variants that help regulate the ability to metabolize alcohol, lactose and folates as part of a program for the class of 2014 that would focus on genetics and personalized medicine.  The announcement, including rough details of the program, brought swift condemnation from a number of quarters for the lack of due consideration for issues ranging from the privacy protections for the DNA samples and the data generated from them to issues of improper informed consent and conflicts of interest. Noted professors at Berkeley, from Kimberly Tallbear, Troy Duster, Charis Thompson and David Winickoff to Nancy-Scheper Hughes, Paul Rabinow and Laura Nader, as well as academics outside Berkeley, such as Hank Greely at Stanford, George Annas at Boston University and Debra Geenfield at UCLA all organized, and raised their voices within and without the university (and continued to speak out during the course of the summer).  Organizations such as the Council for Responsible Genetics (CRG) and the Center for Genetics and Society issued serious point by point critiques of the program as well as brought public attention to the issue through significant media coverage during the first few weeks following the program's announcement.  Many other members of the public and media spoke out as well.

Unfortunately, as is often the case, the initial outcry was not enough.  While the University met with many of their academic critics, it failed to seriously consider and ultimately rejected their concerns.  The media attention ran its course.  Having weathered the criticism, indeed seemingly enthralled by it, Berkeley became even more dismissive and convinced of the virtue of its program.

And that is where the story would likely have ended, had many critics of the Berkeley program   not urged the Council for Responsible Genetics to dig deeper.  Raising your voice and taking a public position on an issue is the easy part of advocacy work.   Seldom do organizations like ours have the resources to roll up their sleeves and conduct the incredibly time consuming and unglamorous work that is generally required to truly move an issue forward.  Fortunately for us, we had an incredibly bright and energetic intern assisting us for the summer and there was no greater motivating factor than Berkeley's arrogance!

With our charge of halting this highly problematic experiment, CRG began a multi-prong advocacy plan.  We began building a loose coalition of organizations to work on the Berkeley program.  We had learned our initial lesson, that a group of organizations and individuals focused exclusively on biotechnology issues was insufficient to affecting change on its own. This time we recruited a much larger and varied group of organizations, ranging from civil rights and privacy groups such as the American Civil Liberties Union (ACLU), Electronic Frontier Foundation (EFF), Privacy Rights Clearinghouse and World Privacy Forum to consumer protection groups such as Consumer Watchdog as well as more focused organizations such as the Alliance for Humane Biotechnology.

We filed a number of public records requests with Berkeley under California's Sunshine Act, similar to the federal Freedom of Information Act, in an attempt to learn more details about the program, including information regarding the program's undisclosed funding source.  Berkeley often delayed, and in some cases failed to comply with our requests, necessitating us to file a formal complaint with the Fair Political Practices Commission (which had enforcement authority over some of our requests) that resulted in a rare rebuke to the University.  We also sent out a staggered series of press releases to the media with new information as we discovered it, keeping the issue on their radar.

We conducted a significant amount of legal research in our attempt to stop the program from moving forward, evaluating every facet of the Berkeley's plan to look for opportunities for a legal or regulatory challenge. This research resulted in an extensive memorandum outlining Berkeley's potential regulatory and legal breaches and the opportunities for legal action,   ranking them in terms of likelihood of success.  The strongest opportunity for challenge that we identified was in the California Business and Professions Code which regulates clinical laboratory licensure. Genetic tests, the results of which are reported back to the individual, are considered clinical laboratory tests by the California Department of Public Health (DPH) pursuant to the Code. Therefore, any lab conducting such tests must first obtain a license from the DPH.  Through our public records requests, we determined that Berkeley had plans to conduct genetic testing of incoming students at the Genetic Epidemiology and Genomics Lab at the School of Public Health.  We discovered that neither the lab (nor its Director or technicians), had any clinical laboratory licenses from the DPH.  We further determined that in fact the only lab certified for this work was the campus health clinic which was insufficiently equipped to perform this type of testing.  We further determined that no licensed medical professionals were involved in the program, as is also required by the Code.

In the course of researching our memorandum, we had obtained copies of letters sent by the DPH to several in state direct-to-consumer genetic testing companies a couple of years earlier that warned them of the requirement of proper clinical lab licensure.  As the letters were signed, it was relatively easy to identify the appropriate individual to contact at the Department of Public Health with our findings.  While the DPH confirmed that our analysis was a correct interpretation of the regulatory requirements, the Department seemed wary of making public comments before having an opportunity to fully investigate. Given that the University would only violate California law upon the actual testing—not yet performed at that time—it was too early for us to argue Berkeley was operating illegally.

Then we caught a lucky break.  Assemblyman Chris Norby, a moderate Republican in the California legislature, introduced a bill (AB 70) that, if enacted, would essentially shield the state from any lawsuits as a result of Berkeley's (or any other public universitys') genetic testing program.  The costs of any lawsuit would be borne by the individual university's general funds.  While highly unlikely to pass, the bill proved an invaluable tool to renew media and public attention on Berkeley's program.  We formed a close relationship with the sponsor's incredibly dedicated staff and began working closely with them on both substance and strategy. 

With this new platform, we drafted multiple organizational sign-on letters with the help of our coalition partners both in support of AB 70 as well as urging the legislature to force a more general accounting of the Berkeley program.  With these letters in hand, the ACLU became an essential ally in using its deep connections in the legislature to open doors for multiple meetings between themselves, CRG and EFF with staff in both the Senate and Assembly. Both the ACLU and EFF also assisted in broadening our analysis.  The meetings created the necessary pressure to hold a hearing on the Berkeley program.  The Alliance for Humane Biotechnology used its connection with the chairman of the committee holding the hearing to weigh in as well.  CRG worked closely with staff to identify those individuals who could provide testimony beyond that narrowly offered by the representatives from Berkeley including Professors Greely and Scheper-Hughes.  Lee Tien from EFF and myself representing CRG also testified at the hearing.  Perhaps most importantly, the California Department of Public Health was called to testify. The added pressure on the agency was the final piece we needed.

Just prior to the hearing, the Governor's office contacted the DPH and ordered them to issue a statement at the hearing, rather than testify.  Nevertheless, their statement reflected our initial analysis and the hearing elicited a promise from Berkeley, still unconvinced that the DPH was serious, to abide by the agency's interpretation.  A meeting between DPH and Berkeley later that day convinced them that the agency was indeed serious.  Berkeley hastily called a press conference the next day to announce significant changes in the “Bring Your Genes to Cal” program, bringing a media firestorm even larger than the one initially covering the announcement of the program.  While some elements of the program have proceeded, it's safe to say that most institutions considering a genetic testing program in the future will remember Berkeley and invest far more effort into crafting an ethical and legally compliant protocol.

We learned many things from this small success.  We learned that a successful advocacy effort requires many hands and diverse talents and that to actually be effective on our issues we need to continue to build relationships and alliances with organizations that do not exclusively work on biotechnology issues, ranging from the civil rights and privacy communities to the organized labor, disability, patient, consumer protection and environmental communities, to academia and beyond.  We need to build strong relationships with legislators and other policy makers as well as the media.  We learned that legislation, even when unsuccessful, can provide a valuable tool to bring attention to and impact our issues.  And most importantly we learned that there is no substitute for rolling up your sleeves and doing the type of hard work that often goes unnoticed and is usually unsuccessful.  With hard work (and a lot of luck!) we can successfully steer biotechnology development toward advancing the public interest.                                        


Jeremy Gruber, JD, is the President of the Council for Responsible Genetics.

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