Regulation: The FDA is overcautious on consumer genomics

Green, Robert C; Farahany, Nita A.

doi:10.1038/505286a

Cited by 84 publications

(39 citation statements)

References 8 publications

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“…[4][5][6][7][8][9][10] Although the scientific studies conducted so far have indeed shown no evidence of adverse effects, they all had serious limitations that hampered the proper interpretation and generalizability of the findings.…”

Section: Commentarymentioning

confidence: 99%

“…Many researchers and professional societies have expressed concerns about the unclear predictive ability and clinical utility of the tests; [1][2][3] others showed no evidence of adverse psychological or behavioral consequences. [4][5][6][7][8][9][10] Although the scientific studies conducted so far have indeed shown no evidence of adverse effects, they all had serious limitations that hampered the proper interpretation and generalizability of the findings.…”

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confidence: 99%

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The hidden harm behind the return of results from personal genome services: a need for rigorous and responsible evaluation

Janssens

2015

Genetics in Medicine

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CommentaryWhether the delivery of genetic test results directly to consumers has harmful effects has been the subject of scientific debate since the first personal genome services became available. Many researchers and professional societies have expressed concerns about the unclear predictive ability and clinical utility of the tests;1-3 others showed no evidence of adverse psychological or behavioral consequences. [4][5][6][7][8][9][10] Although the scientific studies conducted so far have indeed shown no evidence of adverse effects, they all had serious limitations that hampered the proper interpretation and generalizability of the findings.Many studies were conducted among "early adopters" of personal genome services, who were most often white, better educated, and in better physical and mental health. [4][5][6][7] The largest study of its kind (n > 2,000) concluded that these early adopters may better understand the minor impact that genes have on the development of common diseases. 4,5 However, regarding the generalizability of their findings, the authors wrote that "given that [our sample] is quite homogenous (e.g., highly educated, high income), our conclusions may not be applicable to other groups of individuals should the market expand, or to the general population. " 5In a study reported in this issue of Genetics in Medicine, Hartz et al.8 investigate a population that is virtually the opposite of the early adopters. Of their population, 66% had levels of depression above clinical thresholds, all were nicotine-dependent smokers, and more than half were African American, did not have a college education, were unemployed, and had no health insurance. So far, so good. However, although the authors concluded that "even in an underserved population … subjects responded positively to personalized genetic results, " upon close analysis their results suggest that participants may not have understood the tests: The observed increase in smoking cessation attempts was unrelated to receiving test results of increased risk, and 95% of the participants considered their test results useful while they all received risks that were predicted for Caucasians, also the African-American customers.A major and unavoidable limitation of studies of consumer experiences with personal genome services is that tests for common diseases still have limited predictive ability.2 Most people have probably received risk estimates that were only slightly higher (or lower) than the average risk for a disease, and these were not sufficiently alarming to increase anxiety and distress. The findings of such studies can be generalized to other personal genome tests with limited predictive ability but not to tests that yield very informative test results.That even the return of results from highly predictive tests may not increase harm is often evidenced by citing the REVEAL study, 11 which investigated responses to receiving APOE results for the risk of Alzheimer disease. The study was conducted in children of patients with Alzheimer disease, ...

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Section: Commentarymentioning

confidence: 99%

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confidence: 99%

The hidden harm behind the return of results from personal genome services: a need for rigorous and responsible evaluation

Janssens

2015

Genetics in Medicine

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“…This rapid growth has sparked controversy regarding the regulation of direct-to-consumer testing companies, [1][2][3] leading the Food and Drug Administration to order 23andMe to remove health-related interpretations from its services in 2013 4 before 23andMe adopted offerings to meet regulations in 2015. 5 Studies on the behavioral implications of direct-toconsumer genomic testing are warranted to inform current policies.…”

Section: Introductionmentioning

confidence: 99%

Implications of Personal Genomic Testing for Health Behaviors: The Case of Smoking

Olfson

Hartz

Carere

et al. 2016

NICTOB

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Introduction: Direct-to-consumer personal genomic testing has the potential to influence health behaviors, including smoking. Critics of this testing highlight limited evidence to support positive behavioral benefits and caution that genomic results may provide false reassurance, leading to unhealthy behaviors. This study investigates interest in genetic risks of smoking-related diseases and changes in smoking behaviors among genomic testing consumers. Methods: From 2012 to 2013, a longitudinal series of web surveys was conducted. A total of 1464 customers of 23andMe and Pathway Genomics completed a survey prior to viewing genomic test results, of which 1002 participants provided data on smoking behaviors 6 months after receiving results. Results: At baseline, 64% of participants were never smokers, 29% were former smokers, and 7% were current smokers. Most baseline current smokers were very interested in genetic risk results for lung cancer (65%) and heart disease (72%). For lung cancer, this interest was significantly greater than former (50% very interested) and never smokers (37% very interested) (p < .0001). Even though participants were interested in smoking-related disease genetic risks, 96% reported the same smoking status at baseline and 6-month follow-up. Importantly, only 1% (n = 13/916) of former and never smokers became current smokers at 6 months and 22% (n = 14/64) of current smokers reported quitting. Conclusions: Overall, smokers show a high level of interest in genetic risks of smoking-related illnesses. The experience of receiving direct-to-consumer genomic health risks does not appear to have obvious harms related to smoking behaviors, with some potential benefits. Implications: In the setting of ongoing controversy surrounding direct-to-consumer genomic testing, this study provides evidence that consumers are interested in genetic risk results of smokingrelated diseases. Receiving genomic testing results does not lead to smoking initiation among never smokers or reinitiation among former smokers and may be associated with a higher quit rate among current smokers at 6-month follow-up than the general population. These findings ease concerns that direct-to-consumer genomic testing could lead to false reassurance and unhealthy behaviors related to smoking.

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“…The US Food and Drug Administration's efforts to regulate DTCGT firms as manufacturers of medical devices have been characterized by some ELSI scholars as premature (Prainsack et al 2008), unnecessary (Wright, Hall, and Zimmern 2011) or even an infringement of constitutional rights (Green and Farahany 2014). These regulatory skeptics question whether there is evidence of harm, and some suggested that further empirical research was needed to identify the impact of DTCGT on consumers.…”

Section: Regulationmentioning

confidence: 99%

A market in the making: the past, present and future of direct-to-consumer genomics

Hogarth

Saukko

2017

New Genetics and Society

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Regulation: The FDA is overcautious on consumer genomics

Cited by 84 publications

References 8 publications

The hidden harm behind the return of results from personal genome services: a need for rigorous and responsible evaluation

The hidden harm behind the return of results from personal genome services: a need for rigorous and responsible evaluation

Implications of Personal Genomic Testing for Health Behaviors: The Case of Smoking

A market in the making: the past, present and future of direct-to-consumer genomics

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