23andMe's Troubles: The Spat over Spit

On November 22, the Food and Drug Administration (FDA) ordered 23andMe to "immediately discontinue marketing" its direct-to-consumer genetic tests unless and until the agency grants it regulatory approval. This is the culmination of more than four years of discussion, in which it seems that the Google-backed company has become increasingly unresponsive.

The Center for Genetics and Society issued a press release welcoming the FDA's action. Executive Director Marcy Darnovsky said:

Our society regulates medical products to protect public health. Without strong public oversight, we're back to the era of snake oil.

Karuna Jaggar, the executive director of Breast Cancer Action (one of the plaintiffs in the successful Supreme Court challenge to the permissibility of patenting human genes), wrote in an article at Huffington Post:

[G]enetic testing is fraught with moral and medical complexity … [and] must adhere to medical rather than business ethics … the FDA has taken a welcome stand to protect public health by insisting that what is clearly a medical service be regulated as such.

Not everyone agreed. GenomeWeb has a roundup of initial reactions: two of the more forceful were "outrageous" (libertarian Ron Bailey of Reason) and "borderline absurd" (Misha Angrist, who used to blog as Genomeboy). Genomics Law Report has useful, and much less dramatic, summaries of the issues (1, 2). Bio-IT World offers a somewhat more speculative collection of opinion, which notes that 23andMe CEO Anne Wojcicki admitted in a blog post that "the regulatory process with the FDA [is] important" and asks pointedly:

If it's so important, why isn't 23andMe participating?

Stanford law professor Hank Greely wondered about that too, highlighting this sentence from the FDA letter:

You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May.

Greely commented:

This sounds as though 23andMe started down the FDA path but, six months ago, not only stopped communicating with the agency but started new and bigger marketing efforts. That sounds as though 23andMe did not just ignore the FDA, but, while walking briskly past it, quickly turned and spat in its face.

Similarly, Forbes' Matthew Herper supports direct-to-consumer genetic testing but headlined his piece:

23andStupid: Is 23andMe Self-Destructing?

That is possible. Less than a week after the FDA letter, a class action lawsuit was filed against the company, citing the letter, and accusing 23andMe of "falsely and misleadingly" advertising their service as providing health services it cannot justify. In the assessment of John Conley, of Genomics Law Report, this is "certainly a case with significant potential." His colleague Jennifer Wagner followed up with more analysis.

The attorney who filed the suit commented to the Associated Press about the 23andMe business plan:

"It seems to me to be a very thinly disguised way of getting people to pay them to build a DNA database."

CGS has suggested this repeatedly since 2007 (kudos to former staffer Jesse Reynolds). And Charles Seife, writing in Scientific American, sounded a similar note in an article titled "23andMe Is Terrifying, But Not for the Reasons the FDA Thinks":

The Personal Genome Service isn't primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.

Greely, who supports the FDA's move, suspects that the company is transitioning to whole-exome and whole-genome sequencing. That might be a reason that they were — and perhaps still are — stalling the FDA. But it could be a high-risk strategy. John Wilbanks put it succinctly:

I'm a deep believer that genetics generally, and personal sequencing in particular, will drive a marked and permanent change in health. But 23andMe are either there today or they aren't. They dealt the play last summer when they started this process, and advertised it. They've upped it by framing themselves as a daring company. But they're going after the FDA with this strategy. And if you come at the king, you best not miss.

This game is far from over, and the stakes are bigger and broader than the fate of a company that Silicon Valley techno-enthusiasts adore. The clamorous debate about 23andMe's troubles is surfacing questions about genetic hype and the geneticization of health; about the role of public policy in protecting public health; and about whether a glamorous and well-funded company will be permitted to make dubious marketing claims about its product, mislead its customers about its business model, and thumb its nose at the public agency that's mandated to regulate what it's selling.

Previously on Biopolitical Times:

• 23andMe Says It's Not (Now) in the Designer Baby Business
• DTC Monopoly and Me
  
• Whither Personal Genomics?
  
• Genomes of the Rich and Famous