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This House Believes the FDA Should Deregulate Direct-to-Consumer Genetic Testing

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In 2010, the United States Food and Drug Administration (FDA) notified 23andMe – and other personal genomics companies – that these tests belong in the category of medical devices, and consequently under the FDA’s regulatory purview. Under continued pressure from the FDA, 23andMe finally removed all health-related information from its genetic reports in late 2013, leaving consumers with only genealogy-related information.

This house believes that the FDA has acted wrongly in classifying 23andMe’s disease-risk genetic tests as medical devices. Exercising the precautionary principle, the FDA claims that false-positive or false-negative test results could distress consumers and cause them to make drastic changes affecting their health. While the need for rigorous quality assurance is undebated, opponents of the decision argue that customers are unlikely to make dangerous lifestyle choices as a result of an incorrect genetic test or an erroneous disease-risk interpretation. In published studies conducted among consumers of personalized genetic tests, researchers showed that only 42% of them did anything at all with their new genetic information. Among these, the vast majority made changes to diet, exercise, or intake of dietary supplements like vitamins, while only 2% made a change to their prescription medications without consulting their doctor. This house believes that, compared to self-diagnosis via WebMD or Wikipedia, the information offered by 23andMe represents a substantial improvement because it is personalized to the individual consumer. Furthermore, the potential risks of rash action are far outweighed by the benefits of empowering consumers to take an active role in their own health management.

As the cost of personalized genome sequencing drops within the reach of millions, crowd-sourcing may soon become a viable driver of medical genetics research. This house believes that people should not only benefit from these advances, but be allowed access to the data they helped generate. Companies like 23andMe are well-poised to facilitate these efforts, but only if the FDA allows them to do so.

Join OBR-Bay as we debate the pros and cons of FDA regulation of direct-to-consumer genetic testing.

Co-sponsored by the Business Club at UCSF.

Make your vote count before the event HERE

In Opposition:

Gianfranco de Feo and Patricia Zettler

In Proposition:

Andro Hsu and Paul Billings

Schedule:

  • 6:00-6:30PM Registration
  • 6:30-6:40PM OBR & Speaker Introductions
  • 6:40-8:00PM Debate and Q&A
  • 8:00-9:00PM Networking Reception w/food

Speakers at this event

andro-hsu

Andro Hsu - Director, Product Marketing at Syapse Inc.

Speaker bio
Gianfranco1

Gianfranco de Feo - VP Marketing, Bina Technologies

Speaker bio
Zettler_Patti_2009

Patricia Zettler - Fellow, Stanford Law School Center for Law and the Biosciences

Speaker bio
Paul-Billings-Headshot.Pic_-221x300

Paul Billings - Chief Medical Officer, Life Technologies Corporation

Speaker bio
San Francisco Bay Chapter Event

When & Where

  • Genentech Hall - Byers Auditorium (GH 106) @ UCSF Mission Bay Campus
  • 600 16th Street, San Francisco, CA 94158, USA
  • Monday, 7th April 2014 @ 6:00pm

Event attendees

    This event currently has 241 attendees, including:

  • Adam LaPrad
  • Adriana Tajonar, QB3
  • Adrien Burch
  • Akash Datwani, CNS Therapeutics
  • Akhil Merha, UCSF
  • Alan Cheng, Amgen
  • Alan Leung, Stanford
  • Alex Lovejoy, Stanford
  • Alice Rathjen, DNA Guide
  • Alicia Shiu, Stanford
  • Alison Leaf, UCSF
  • Alizée Malnoë, UC Berkeley
  • Allison Green, frog design
  • Ambika Bumb, Bikanta
  • Amy Sherborne, UCSF
  • Andelka Philllips, University of Oxford
  • Andrew McKay, Stanford University
  • Ania Gheyara, UCSF
  • Anne Cocquyt, Genentech
  • Arun Wiita, UCSF
  • Aryaman Shalizi, stanford university
  • Bertram Koelsch, UC Berkeley / UCSF
  • Bhairavi Tolani, SRI International
  • Bonnie J Preston, Health an Human Services, Gov
  • Brandon Bunker, UC Berkeley
  • Briana Fitch, UCSF
  • Brigit Riley
  • Brigitte Ganter, enlightenbio
  • Brittany Anderton, UCSF
  • Bruce R Conklin, Gladstone Institutes
  • Cara Skon
  • carl crott, black-glass sytems
  • Carlos Atico Ariza
  • Carlos Solorzano, UCSF/OBR
  • Carolyn Wang, WCG
  • Charles Greenberg, UCSF
  • Charvi Shetty
  • Cheuk Ka Tong, UCSF
  • Chia Hwu, Qubop
  • Chris Foo, UCSF
  • Chris Ott, Seattle Genetics
  • Christina Abundis, UCSF
  • Christine Baek, UCSF
  • Christine Ott, Seattle Genetics
  • Claudia Catalanotti, Carnegie Institution
  • Cynthia Schaffer, CIRM
  • Dalga Surofchy, UCSF
  • Dan Erlanson, Carmot Therapeutics, Inc.
  • Daniel Clemens, UC Berkeley
  • Daniel Perez, Oxford
  • Datta Nadkarni, DattaNadkarni.com
  • David Burkhardt, UC San Francisco
  • David Butterfield
  • David Carrick
  • David Cohen, CohenSciences
  • Deepika Arora, University of California
  • Desiree D. Dudley, MIT
  • Dhiren Belur, Novartis
  • Diana Kim
  • Diane Longo
  • Dianne Holmes, UCSF
  • DOR KEYVANI, UCSF
  • Dorn Carranza, Coalesce Corp.
  • Elaine Lee
  • Elena Bekerman, Stanford university
  • Elijah Martin, UCSF
  • Elizabeth Costello, Stanford University
  • Elyse Stratton, Cambridge MBE
  • Emily Crawford, UCSF
  • erica elford
  • Erick Lee, UCSF - ITA
  • Erik Jonsson
  • Erika Stanzl, Stanford
  • Esteban Mendoza, UCSF - ITA
  • Everett Meyer, Stanford University
  • Florie Charles
  • Gary Loeb, Counsyl
  • Geetha Mohan, UC San Francisco
  • Geoffrey O'Donoghue, UCSF
  • Girish N. Vyas, UCSF-TheraBiol
  • Graham Heimberg, UCSF
  • Grant Ognibene, Stanford University
  • Gregory Parks, SRI International
  • Hania Koever, Stanford University
  • Heather Hamilos, Charles River Laboratories
  • Henny Bennett, Stanford University
  • Hildegard Mack, UCSF
  • Isabel Nocedal, Ucsf
  • Jackie Lin, Santa Clara University Law
  • Jacquelyn Cafasso, No
  • James Vowles, California Institute of Technology
  • Jamey Kain, Machaon Diagnostics
  • Jamie Kitano, Shook Hardy & Bacon LLP
  • Jason Fernandes, UCSF
  • Jaysen Rajkomar, Stanford
  • Jean Neel, UCSF
  • Jeffrey Axup, Sense6 Design Inc.
  • Jeffrey Yunes, UCSF
  • Jennifer Johnston, Stanford University
  • Jennifer Rauch, UCSF
  • Jennifer Schroeder, Alameda County DNA Laboratory
  • Jeroen Blokhuis, Stanford/OBR
  • Jesse Spaulding
  • Jessica Cortez, UCSF
  • Jessica Lao, UCSF
  • Jessica Lyons, UC Berkeley
  • Jingwei Zhang, UC Berkeley
  • Jita De
  • Joan Zape, UCSF
  • Joanne Greenberg, Amgen
  • John Hawkins, UCSF
  • John Kratz, California Digital Library
  • Julia VanderMeer
  • Jun Axup
  • Karen Lee, UCSF
  • Karen Shaff, Applied Stemcell, inc
  • Kate Woronowicz, UCSF
  • Katie Nishimura, UCSF
  • Keerthana Devarajan, Stanford University
  • Kelly Zalocusky, Stanford University
  • kelsey sivick gauthier, uc berkeley
  • Kenneth Burke, UCSF
  • Kimberly Wemmer
  • Kirk Willmarth
  • Krista kaasik, Ucsf
  • Kristen Aramthanapon, Sylvatex
  • Krystal St. Julien
  • Kurt Burgess, Jon Block Group
  • Kyle Barlow, UCSF
  • Lara Skwarek
  • Laura Hodges, UCSF
  • Laura Sasportas, Stanford University
  • Laura Walsh, UCSF
  • Lauren Murray Sassoubre, Stanford University
  • Lauren Popov, Stanford University
  • Lawrence Lin, UCSF
  • Leah Makley, UCSF
  • Lesley Luginbill, Genentech
  • Li (Jin) Sajo, Stanford University
  • Li Tai Fang, OBR - San Francisco Bay
  • Liliana Fernandez, UCSF
  • Lucien Caillaud, sup'biotech Paris
  • Luke Lightning, LAUNCH
  • Marcel Alavi, UCSF
  • Marco Ellwanger
  • Margaret Elvekrog
  • Maria Cho, Fujifilm Diosynth
  • Marie Perrine Durot, PRIME
  • marta wegorzewska, ucsf
  • MEEJ KIM, CHORI
  • Melanie Mahtani, Apprisa
  • Melina Mathur, Stanford University
  • Melody Lee, UCSF
  • Merce Padro, UCSF
  • Michael Barrientos, Syapse
  • Michael Sachs, UCS
  • Michael Sullivan
  • Michael Todhunter, UC San Francisco
  • Mikel Shybut, Plant & Microbial Biology, UC Berkeley
  • Monica Lin, UC Berkeley/UCSF
  • Monya Baker, Nature Publishing Group
  • Namrata Prasad, UCSF
  • Nathan Davis, Wedbush Securities
  • Nick Mordwinkin, OBR
  • Nina Riehs, UCSF
  • Noushin Nabavi, UCSF
  • Olivier Allegret, Paris Region Economic Dvpt
  • Pao-Chen Li, Gladstone Institutes
  • Parham Mirshahpanah
  • Parisha Shah, Stanford University
  • Paul Li, Gladstone Institutes
  • Paula Gitis, WCG
  • Peter Mulligan
  • Philip Jeng
  • Pin Xiang, UCSF
  • Pingyang Liu, UCSF
  • R W
  • Ramya Akula Suresh Babu
  • Rena Mizrahi
  • Richard Kao
  • Robert Bernstein, Consultant
  • Robert Calderon, UC Berkeley
  • Robin Kageyama, UCSF
  • Robin Kutner, Genentech
  • Roeland Hancock, UCSF
  • Rowena Mittal, PhD, .
  • Ryan Honaker, Stanford University
  • Sam Oh, UCSF
  • Samantha Ancona Esselmann, UCSF
  • Samantha Pearlman, Crescendo Bioscience
  • Sarah Denny, Stanford University
  • Sarah Reiff, UCSF
  • Sasha Brophy, Ariosa Diagnostics
  • Satyan Pai
  • Saumitra Rahatekar
  • Saurabh Srivastava, 20n Labs, Inc.
  • Shea Thompson, UC Berkeley/UCSF
  • Shira Lee, Zyomyx
  • Shirley Recipon, Recipon Consulting
  • Sneha Gupta, Stanford University
  • Stephanie Piecewicz, Bell Biosystems
  • Stephen Popper, Stanford University
  • Steven Karp, BayBio
  • Stuart Hwang
  • Sunanda Marella, Stanford University
  • Susie Lee, Stanford
  • Sylvain Costes
  • Tara Friedrich, UCSF
  • Tatiana Ecoiffier, University of California Berke
  • Thomas Deschamps, Exogen
  • Tiffany Ho, Ph.D., UCSF
  • Toby Freedman, Synapsis Search
  • Travis Kupp
  • Tushar Vasisht, Blue Shield
  • veronica shim, TPMG
  • Victoria Whitehill, Genentech
  • wei zhang, ucsf
  • Xiao Peng
  • Xiaoyan Ge, ucsf
  • xinyuan lu, UCSF
  • Yana Khalfin, Genentech
  • Yedida Rissman
  • Yu Liang

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