NEWS
ARTS&CULTURE
IDEA to IPO Class
Charlie Varnon in Feisty Old Jew
Training the new science entrepreneur » PAGE 8
IN THIS ISSUE
News Briefs » PAGE 3 Journal Club » PAGE 5 Puzzles » PAGE 11
Synapse Storytelling from the stage » PAGE 11
The UCSF Student Newspaper
Thursday, May 22, 2014
synapse.ucsf.edu
Volume 58, Number 32
NEWS
NEWS
By Tina N. Tran Contributing Writer
vs. The Right to Know
Congratulations to the School Regulating Direct-toConsumer Genetic Testing of Pharmacy Graduates
L
ast Thursday, beloved families, friends and faculty joined 123 Doctor of Pharmacy (PharmD) graduates at Davies Symphony Hall in an event we had all been anxiously waiting for—the UCSF School of Pharmacy Commencement Ceremony. Dean B. Joseph Guglielmo, PharmD, known to the Class of 2014 as “Dean Joe,” opened the ceremony with a warm welcome speech. As he read aloud a few excerpts from our entrance essays, those written just four years ago about our challenges, hopes, dreams and the kind of pharmacists we were all inspired to become, we couldn’t help but think to ourselves: “Four years have flown by in the blink of an eye! It is hard to believe, but we finally did it!” Ryan Beechinor and Gary Lau, our elected student speakers, delivered two personal reflection speeches on their experiences
By Benjamin Cohn and Dalga Surofchy Staff Writers
F Photo courtesy of Tina Tran/P2014 Tina Tran is a member of the the School of Pharmacy, Class of 2014.
as student pharmacists at UCSF as well as their perspectives on the future of pharmacy. These reflections highlighted the qualities that make up the unique student body at the UCSF School of Pharmacy: diverse, authentic, caring, compassionate, innovative, resource-
PHARMACY GRADUATES » PAGE 3
or about $100, customers can have DNA from their saliva analyzed by the genetic testing company 23andMe for hundreds of gene variants thought to be linked to traits ranging from ancestry and earwax type to warfarin sensitivity and Alzheimer’s disease. While 23andMe gives customers access to their raw genetic data, some would say the real value of their product lies in the interpretation packaged with these data. For gene variants linked to health and disease traits, however, , the U.S. Food and Drug Administration has taken notice as 23andMe has yet to provide them with premarket assurance that these interpretations are clinically validated and accurate. The FDA argues that using 23andMe’s service this way qualifies it as a medical device, and ordered the company to cease marketing their kit as a health management tool until these assurances were met. How should the direct-to-consumer (DTC) genetic testing industry respond to the FDA?
NEWS
Paying it Forward: Sutro Stewards Volunteers Keep Our Mountain Accessible By T. Booth Haley Staff Writer
M
t. Sutro is the most amazing backyard any urban university could ever want. Right in the middle of San Francisco, students and neighbors can enjoy 61 acres of eucalyptus forest, replete with rocky outcrops, a summit meadow, miles of trails and even a seasonal creek. The mountain has experienced many changes throughout the last 150 years, including being owned by two different San Francisco majors, but only recently has it truly become the sparkling emerald of the San Francisco park system. The current set of trails that hikers and bikers enjoy today has been greatly improved in the last seven years, almost entirely due
SUTRO STEWARDS » PAGE 8
The Sutro Stewards help maintain the hiking trails of Mt. Sutro.
Photo by Mason Tran/D4
Last month, the San Francisco Bay Area chapter of Oxbridge Biotech Roundtable (OBR) convened experts at UCSF to debate the FDA’s recent decision to bring DTC genetic testing under its regulatory authority. This decision marks the most recent chapter in five years of largely unproductive communications between the federal agency and 23andMe, culminating in December, when the FDA ordered the company to “immediately discontinue marketing the Personal Genome Service (PGS) kits until such time as it receives FDA marketing authorization for the device.” Arguing in favor of the FDA’s actions were Gianfranco de Feo, VP of Marketing at the Redwood City-based computational genetics company Bina Technologies, and Patricia Zettler, a fellow at the Stanford University Law School Center for Law and the Biosciences. In opposition were Andro Hsu, Director of Product Marketing at Syapse, Inc., a Palo Alto-based data management software company, and Paul Billings, Chief Medical Officer for Life Technologies. They were joined by Glenda Anderson, CEO and cofounder of the healthcare IT company Farsight Genome Systems. A medical device? If a medical device calls to mind images of heart stents and CT scanners, it might seem surprising that the FDA wants to regulate 23andMe’s DNA testing service under this classification. The distinction is worth thinking about, however, because it relates to the type of service 23andMe claims to be offering. Here’s an excerpt from the official FDA definition for a medical device: “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” (http:// www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm) Patricia Zettler argued that 23andMe’s test unambiguously satisfies the FDA definition because it was marketed as a way to prevent and diagnose disease. Last year, 23andMe ran a television spot which promised—or at least strongly insin-
GENETIC TESTING KITS » PAGE 4