Commentary
“The Google of Healthcare”: enabling the privatization of genetic bio/databanking

https://doi.org/10.1016/j.annepidem.2016.05.007Get rights and content

Abstract

Purpose

23andMe is back on the market as the first direct-to-consumer genetic testing company that “includes reports that meet Food and Drug Administration (FDA) standards….” But, whereas its front-end product is selling individual genetic tests online, its back-end business model is amassing one of the largest privately owned genetic databases in the world. What is the effect, however, of the private control of bio/databases on genetic epidemiology and public health research?

Methods

The recent federal government notices of proposed rulemaking for: (1) revisions to regulations governing human subjects research and (2) whether certain direct-to-consumer genetic tests should require premarket FDA review, were reviewed and related to the 23andMe product, business model, and consumer agreements.

Results

FDA regulatory action so far has focused on the return of consumer test reports but it should also consider the broader misuse of data and information not otherwise protected by human subjects research regulations.

Conclusions

As the federal government revises its decades-old human subjects research structure, the Executive Office of the President (EOP) should consider a cohesive approach to regulating private genetic bio/databanks. This strategy should allow the FDA and other agencies to play a role in expanding current regulatory coverage.

Introduction

23andMe is back on the market as the first direct-to-consumer (DTC) genetic testing company that “includes reports that meet Food and Drug Administration (FDA) standards for being clinically and scientifically valid [1].” Its current product includes 36 health-related carrier-status reports and consumers' raw genetic data (in addition to ancestry and other nonmedical “wellness and trait” information) [1]. Forbes has reported that recent investors estimate its value at $1.1 billion [2].

But, that valuation is not on the basis of 23andMe's $199 test kits. Whereas its front-end product is selling individual genetic tests online, its back-end business model is amassing one of the largest genetic bio/databanks in the world [3], [4]. Since 2007, 23andMe has offered an inexpensive product to consumers (personalized genetic analysis) to generate broader consumer data and then leveraged that data to generate profit, becoming—as board member Patrick Chung put it—“the Google of personalized health care [3].” And 23andMe recently surpassed its goal of 1 million consumers [5].

Although the focus of the governmental and academic debate surrounding DTC genetic testing has been on whether FDA regulation is enough to protect consumers receiving sensitive medical information without a clinician intermediary [6], the more important question moving forward will be how to manage increasingly large and valuable private bio/databanks. As the U.S. federal government, and in particular the Department of Health and Human Services (HHS), considers revisions to its regulations governing human subjects research to include de-identified human biospecimens and whether certain DTC genetic tests should require premarket FDA review, this article argues that the Executive Office of the President (EOP) should take into consideration potential enabling of the private genetic bio/databank market when contemplating the individual and public health effects of its administrative rulemaking.

Section snippets

The 23andMe bio/databank

When consumers purchase the 23andMe product, the company analyzes hundreds of thousands of their single nucleotide polymorphisms to produce genetic information [7]. In so doing, consumers contribute both their saliva specimen to 23andMe's biobank and their genetic analysis to its databank. No matter whether 23andMe is returning ancestry, wellness, trait, or carrier-screening information to the consumer, the genetic data it is generating can be much more robust. Consumers are asked if they would

Potential problems with the 23andMe cohort

Although some companies vie for the opportunity to collaborate with and gain access to 23andMe's database, there are others who have voiced caution. A first concern is related to demographic bias. Private data sets are much more likely to be populated with educated, wealthy, white participants (a selection bias problem 23andMe itself has tried to address [15]). Such cohort disparities can skew research agendas in the future as researchers only have access to data from a limited portion of the

Current law

Such potential private bio/databanks issues have caused scientists, scholars, and lawmakers to question how our existing regulatory structure (in large part created before the advent of DTC genetics and such banks) can and should limit private cohorts. Although there are many laws and regulations of relevance to such banks, this article will focus on the two currently under revision—the regulations governing human subjects research and the premarket FDA review of certain DTC genetic tests—and

Proposed law

Two recent federal regulatory notices are particularly relevant at this juncture.

First, in September 2015, the highly anticipated Notice of Proposed Rulemaking (NPRM) of revisions to the Common Rule was released. These revisions focus on attempting to make informed consent more meaningful in the human subjects research context—broadening the scope of regulatory jurisdiction in some cases, and limiting it in others [48]. Of particular importance to this discussion is the NPRM proposal to expand

Discussion

Both these rulemaking notices are important in their own right, but the EOP would be well advised to contemplate the effect of their intersection. If the Common Rule is codified as proposed, hospitals and clinics will have to spend significant resources setting up consent and tracking structures to convert clinical biospecimens to deidentified data for research. The Common Rule NPRM itself anticipates the need for as many as 21 million secondary-use consent forms to be filled out, at 10 minutes

Conclusion

As the federal government revises the decades-old human subjects research structure, it is necessary for the EOP to consider a cohesive approach to regulating private genetic bio/databanks generally. This strategy should allow FDA and other agencies to play a role in expanding current regulatory coverage for private companies molding themselves in the Google business model image: offering an inexpensive low-risk health-related product for the ulterior purpose of private consumer health data

Acknowledgments

This publication was supported in part by NCI and NHGRI grant 4UM1HG006508-04. The author would like to thank Kata Chillag, Edward B. Goldman, Valerie Gutmann Koch, Paul A. Lombardo, J. Scott Roberts, and Patricia J. Zettler for their review and feedback on this article.

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