By Jeremy Gruber

from GeneWatch 28-1 | Jan-May 2015

Nowhere has the confluence of public health, basic research in genomics, and the market economy been on clearer display than in the rise, fall, and subsequent reemergence of the direct to consumer (DTC) genomics industry. 

The industry emerged roughly ten years ago, riding the parallel waves of the growing social interest over personal information and the early euphoria over the seemingly limitless potential of genomic research and development for improving public health. Criticisms that these companies were marketing limited health information with no proven clinical application were regularly given short shrift, replaced by glowing promises of the future. Endless media reports offering little more than public relations talking points became the norm and many scientists themselves trumpeted the industry. This even after a high-profile investigation by the U.S. General Accounting Office in 2010 produced a damning report titled "Direct-to-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices" which led to a congressional hearing that lambasted the industry.

Regulators started to notice, and several years of hearings and letters to the industry from a concerned FDA followed. As the FDA's investigations grew more intense and the industry continued to show little to no profitability, most of the legitimate companies changed course - except for one. Sustained with significant amounts of venture capital, particularly from Google, the DTC company 23andMe soldiered on, seemingly impervious to the industry changes and outside forces marshalling against it. 

But that hubris had consequences and last year the FDA, frustrated at 23andMe's lack of interest in working with them, sent 23andMe a cease-and-desist letter ordering it to stop marketing its health related services. A firestorm of bad press ensued. That action reduced 23andMe, at least in the U.S., to little more than an ancestry testing service. Ramped up marketing overseas and a new engagement with the FDA weren't enough to assure investors in light of continued unprofitability.

So the company that not so long ago rode the slogan "Your genetic information should be controlled by you" recently announced collaborative partnerships with over a dozen biotech and pharmaceutical research groups, from Genentech to Pfizer, hungry to get at its massive database of over 800,000 consumer samples.

Years of the company's and its sycophant's claims to ensure consumer privacy now seem like a distant memory, as the same era of Big Data that transformed tech companies like Google and Facebook into commercial powerhouses where "you" were the product now seems to have firmly taken hold of the industry. Indeed, the leading genetic ancestry company, which not so long ago was similarly claiming no interest in data selling, announced its own intentions to sell data to biotech and pharmaceutical companies not long after.

Several commentators have argued over the years that this was always the industry's intent, that a money-losing fee-for-service business plan was simply cover for an industry that had always intended to sell consumer data once their database became large enough. Perhaps they were right all along. What is clear is that 23andMe's "new" business plan is part of a gold rush occurring at the nexus of Big Data and Big Pharma, one that's even encouraging tech powerhouses such as Facebook, IBM and Apple to get into the business of collecting personal health information in questionable ways in the name of advancing medical research. And there's no end in sight.

Jeremy Gruber, JD, is President and Executive Director of the Council for Responsible Genetics.


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