Culture Clash: Silicon Valley vs. the U.S. Government
HBS Professor John Quelch hosts an online chat to discuss the business and health care implications of genetic testing.
24 Feb 2015   Christian Camerota

Just because you can doesn’t mean you should. This is the point of contention at the crux of a long struggle between genetic testing provider 23andMe and the U.S. government.

Following the finalized sequencing of the human genome in 2003, 23andMe began offering and promoting its personal genome service, a direct-to-consumer diagnostic tool that allowed people to submit saliva samples and, several weeks later, receive a report summarizing their genetically-based predisposition for 53 inherited conditions, 122 health risks, 25 drug responses, and 60 traits, along with genetic ancestry information.

Company founder Anne Wojcicki (profiled in a 2013 Fast Company article) cited two goals for the company and its new tool: to empower consumers to manage their own health by giving them access to genetic information, and to aggregate data from genetic tests into a database that would help researchers and medical professionals develop cures.

The innovation was hailed as Time magazine’s 2008 invention of the year, but along with a flood of positive attention came widespread concern about both companies’ and consumers’ ability to accurately process such complicated data and results. These concerns came to a head in November 2013, when the U.S. Food and Drug Administration (FDA) issued a letter to 23andMe to halt the sale and promotion of its genetic testing kit until it was in full compliance with a rigorous set of standards for medical devices. The standoff spurred lively ongoing debate about the efficacy and morality of genetic testing, involving global players and celebrities like Google, Johnson & Johnson, and Angelina Jolie.

Professor John Quelch chronicles the differences of opinion in depth in his case study, 23andMe: Genetic Testing for Consumers, which he uses as part of his course “Consumers, Corporations and Public Health.” Quelch’s case and his course are taught to Harvard Business School MBA students and Harvard T.H. Chan School of Public Health MPH candidates so they can study the complicated but crucial intersection of corporate and public health roles and regulations in the United States.

Do you think consumers should have access to the test? Was the FDA right in taking action against 23andMe? Will the company survive? Join Professor Quelch for a Twitter chat Friday, February 27, 1:00-2:00 pm, where he will explain key concepts from the case and answer your questions. Follow #HBSChat and tweet to @HarvardHBS to join the conversation.

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