Correspondence/Editorial: The direct-to-consumer genetics debate

The Lancet Oncology

 I am employed by 23andMe in the company's communications group.

We read the Lancet Oncology Editorial with interest.¹ Although there are several important topics to debate regarding direct-to-consumer genetic testing, the authors missed an opportunity to address them. Rather, they conflate two separate issues: the regulation of prescription medication marketing, and the regulation of non-diagnostic direct-to-consumer genetic testing.

The Editorial discusses proposed legislation to end tax breaks given to drug companies for marketing prescription drugs directly to consumers. The juxtaposition of this legislation with the discussion on #23andMe suggests a connection between the proposed law and direct-to-consumer genetic testing regulation, when in fact the two are unrelated. Direct-to-consumer genetic testing is subject to regulation by the US Food and Drug Administration (FDA) and various state agencies, and does not receive any tax deduction for marketing.

In addition to decoupling these issues, the Editorial would benefit from painting a more complete picture of the regulatory environment for direct-to-consumer genetic testing. Although 23andMe was not wholly banned from selling its product, it was mandated by the FDA to cease marketing the health portion of its test in November, 2013. 23andMe complied and engaged in a lengthy review process with the FDA, which included thorough validation testing and consumer comprehension studies. As a result, the FDA authorised the marketing of 23andMe's Bloom Syndrome Carrier Status test report, and down-classified carrier status testing as a category of direct-to-consumer genetic testing, therefore exempting carrier testing from premarket review. 23andMe now offers the only direct-to-consumer genetic service that includes reports that meet FDA standards.² Furthermore, 23andMe does not provide information on carcinogenic mutations, as cited in the editorial.

The authors also raise questions about whether information gleaned from genetic testing should be delivered directly to consumers. Although there is always room for debate, evidence has been generated over the past 5 years indicating that most consumers who purchase direct-to-consumer genetic tests do understand the results they are given.³ Additionally, and in direct opposition to assertions in the Editorial, data included in 23andMe's FDA submission showed a more than 90% comprehension rate of key concepts in its reports.⁴ Those results were generated in nationwide focus groups, which were representative of the US population according to age, race or ethnicity, and education.

Although direct-to-consumer marketing of pharmaceuticals and direct-to-consumer genetic testing are two topics that warrant further discussion, they are distinct issues that should be treated as such to ensure the respective facts can be understood, analysed, and debated. Other issues specific to direct-to-consumer genetics raised by the editors, such as consumer privacy and physician comprehension of genetic testing information, should be continually discussed. We welcome these conversations as greater adoption of direct-to-consumer genetic testing continues.

I am employed by 23andMe in the company's communications group.

References

1. The Lancet Oncology. US legislation for direct-to-consumer advertising: paternalism or common sense?. Lancet Oncol. 2016; 17: 401
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2. US Food and Drug Administration. FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM435003. ((accessed June 7, 2016).)
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3. Ostergren, JE, Gornick, MC, Carere, DA et al. How well do customers of direct-to-consumer personal genomic testing services comprehend genetic test results? Findings from the impact of personal genomics study. Public Health Genomics. 2015; 18: 216–224
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4. Evaluation of automatic class III designation for the 23andMe personal genome service carrier screening test for bloom syndrome. Decision summary. http://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140044.pdf; February, 2015. ((accessed June 7, 2016).)
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