FDA identifies the idiot gene: 23andMe users
The latest news of the CNBC Disruptor50 companies upending the status quo in the markets:
A commuter on the subway or television viewer in New York may have recently been caught by this slick advertising enticement: "What will you think about when you don't have to think about money?"
That ad got us pondering this week's Food and Drug Administration crackdown on personal genetics profiler 23andMe. The FDA announced in a letter to the company Monday that after "many interactions," the regulator had no choice but to call for an immediate end to sales of 23andMe home DNA profiling kits.
The agency said that the $99 Personal Genome Service (PGS)—spit into a little cup, send away in the mail and, presto, your DNA is revealed—violates the Cosmetic Act and has no proper marketing clearance.
The FDA is worried about you.
"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses ... because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these," the letter said. "For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist."
23andMe co-founder Anne Wojcicki had been on a public relations charm offensive of sorts in recent weeks, appearing on CNBC, among other places. She was also the subject of profiles in magazines, including Fast Company.
In fact, you might have thought the news 23andMe was trying to get past was already in the past—maybe the recent scandal page reports about Wojcicki's marital relationship with Google co-founder Sergey Brin or headlines about 23andMe taking out a patent for designer babies.
Nope, that was all much, much, less important to the genetics testing company.
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Look, health is no laughing matter, and the FDA is right to have concerns—especially given the predatory history of the medical and drug industry. Yet there's a fine line between a regulator's looking out for your best interest and one being a little overly paternalistic, or just behind the times.
Regulators are often late to the game, too. After all, our financial overseers allowed Americans to sink in the financial crisis before taking any action to reform the system, but in the case of 23andMe, is the FDA too early?
Which brings us back to the ad on the subway and TVs. The advertiser was the New York State Lottery. Oh, and this past week, New Jersey also voted to approve online gambling.
So let's sum it up this way: the U.S. regulatory system has no problem with the risk gene when it comes to the poker table. In fact, combine the risk gene with the idiot gene and you can get a nice fat chunk of change for government coffers as idiots pull the slots and play the tables and foolishly believe the law—the house always wins—isn't as hard science as the number of human chromosomes. That marketing on the subway is certainly misleading—after all, what are the chances that you really won't have to worry about money ever again if you play the lottery—probably worse odds than the most rare genetic conditions.
Yet it's the deck of 46 chromosomal cards that we all have no choice but to play that is stacked against us and likely to mislead if we actually try to play them. But go right ahead and double down on blackjack. There is a time and place for the American idiot gene, and apparently, it isn't when it comes to genetics.
So, better to live and die penniless, but, still thinking you won't have to worry about money one day, than live with heightened hypochondria, or at least armed with information about your genetic profile that in consultation with a trusted medical professional, could lead you to live a healthier life—and in the aggregate could contribute to a mass genetic profile that helps medical researchers.
Look, you probably have the idiot gene. The FDA may be correct in that assessment. But why do so few other regulators covering other walks of life seem to care?
23andMe released a statement on its blog responding to the FDA letter, we assume with a slightly different argument.
And in other news on the CNBC Disruptor50 companies:
The New York Times reports that drones are becoming a journalist's best friend. Yet some of the early backers are putting down the remote. The Los Angeles Times reports that one of the biggest dronemakers saw a big earnings drop in the most recent quarter as spending on drones plummeted.
Spin reports on the continuing war among rock's middle-aged men over streaming music, with the latest battle of the bands featuring Moby taking on Radiohead's Thom Yorke, who is ceaseless in his attacks on Spotify.
—By Eric Rosenbaum, CNBC.com