23andMe FDA letter: Premarket approval requirement could kill at-home genetic testing industry.

The FDA Is Poised to Kill the Personal Genetics Testing Industry

The FDA Is Poised to Kill the Personal Genetics Testing Industry

The citizen’s guide to the future.
Nov. 26 2013 12:39 PM

The FDA Could Set Personal Genetics Rights Back Decades

Its letter to 23andMe is foolish and paternalistic.

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The FDA letter ignores all these and other advantages of at-home genetic testing and describes a parade of horribles that are greatly overstated. FDA warns that consumers may engage in risky and perhaps unnecessary prophylactic surgery based on their genetic test results, but there are not many patients in our nation who undergo major surgery without first talking to a doctor, who will undoubtedly consider and confirm the genetic test results before operating on a patient based on those test results. The FDA expresses concern that patients will self-medicate or alter their medication doses based on their genetic test results. It is far more likely that the patient will call the genetic test results to their doctor’s attention, which may provide helpful information the doctor did not have. To give a personal example, I tested positive through 23andMe for a gene variant that makes me more susceptible to bleeding from the drug warfarin, one of the examples the FDA cited in its letter to 23andMe. My mother unfortunately recently had a mini-stroke, and the doctor in the hospital prescribed warfarin for her. She remembered that I had tested positive for the gene affecting warfarin metabolism and mentioned it to the doctor, who then decided a different drug may be better for my mother. It is quite possible that my mother did not give me that gene or the even if she did, that the normal warfarin dose would not have harmed her. But it is also possible that it would have, and my 23andMe test result brought this to the doctor’s attention and allowed him to choose a different treatment option.

There are other benefits to consumers being empowered with genetic test results. Recently, 25 students in my genetics and law class at Arizona State University chose to obtain genetic testing from 23andMe. The students uniformly found the results they received useful and interesting. At least one student tested positive for a cystic fibrosis mutation, which means his children would be at a 1 in 4 risk of having this terrible disease if he happens to marry and have children with a mate also carrying the mutation, present in about 4 percent of the population. He is grateful to have this information and be in a position to avoid risking such a life-changing adverse outcome, another benefit the FDA completely ignores. Genetic information can also motivate consumers to take preventive action. Another of my students found out that she carried the ApoE4 mutation, which significantly increases the risk of late-onset Alzheimer’s disease. There are no proven interventions to reduce such risks at this time, but there is suggestive evidence that exercise, mental stimulation, and perhaps certain vitamins may help reduce the risk, which she is now more motivated to undertake and which will be beneficial whether or not she is destined to develop Alzheimer’s. She again is grateful to have this information and will be closely attuned to any new preventive recommendations that may be forthcoming in the upcoming decades.

To be sure, there are real risks from direct-to-consumer genetic tests. There have been some direct-to-consumer genetic test companies that have tried to swindle consumers by selling “genetically tailored” cosmetics or “complete personality profile” genetic tests. These fly-by-night companies can be immediately detected because they do not provide the information and links to the underlying data and studies that more responsible companies like 23andMe provide. These companies offering unsubstantiated tests should be singled out for enforcement under the deceptive advertising provisions, along with the oceans of other bogus health information flooding the Internet, AM radio, and newspaper ads, rather than banning all at-home genetic testing.


Genetic test results showing major health risks can have significant psychological impacts on affected persons. For example, as the FDA notes, there can be false negatives: Home-based genetic testing does not include all the mutations for a particular health endpoint (e.g., breast cancer), and an at-risk person may falsely assume that he is not at any increased risk if the mutations that are tested are not present in his DNA. But this is all explained on the 23andMe website. Another of my students who also tested positive for an ApoE4 allele is less positive about learning her result than my other student and now preferred that she not know her result. But again 23andMe warns consumers about such risks, and my student does not second-guess her choice to undertake such testing—she just wishes it had come out differently. Studies are showing that consumers are generally not as psychologically devastated by adverse genetic test results than many of the experts anticipated. Arguing that consumers are too vulnerable and unable to manage such information harkens back to the bygone era of paternalism when doctors would not inform patients that they had cancer, out of fear of causing anxiety and stress. Some of these problems—which surely do not outweigh the benefits—could be eased by better genetic education for consumers. 

One thing that is absolutely clear from studies and the experience of consumer genetic testing is that people differ in their preferences about getting genetic information about themselves. Some, like me, want to get any and all the information we can. Others prefer not to know, especially for risks and traits they can do nothing about. The role of the government should be to respect and enable such choices, not to cut off that pathway altogether. Just as no one should be required to get genetic information he doesn’t want, consumers should be able to find out their own genetic information when they so choose. The FDA’s heavy-handed assault on 23andMe will block consumer access to our own genetic information for the foreseeable future. No company could meet the regulatory roadblocks and burdensome costs that the FDA has now imposed. This is particularly unfortunate as we are entering an era where genetic information is increasingly relevant and useful. In such an era of opportunity and understanding, government-imposed ignorance is not bliss.

This article is part of Future Tense, a collaboration among Arizona State University, the New America Foundation, and Slate. Future Tense explores the ways emerging technologies affect society, policy, and culture. To read more, visit the Future Tense blog and the Future Tense home page. You can also follow us on Twitter.