Devices & Diagnostics

Six smart takes on the 23andMe FDA standoff

Here are a few long reads beyond just where the FDA warning letter told genetic testing startup 23andMe to put it. Check out these smart takes while you’re stuck in line at the grocery for an hour. (How could you forget yams?!) If you think your family dinner arguments are heated, you won’t want to miss […]

By Lindsey Alexander on November 27, 2013

Here are a few long reads beyond just where the FDA warning letter told genetic testing startup 23andMe to put it. Check out these smart takes while you’re stuck in line at the grocery for an hour. (How could you forget yams?!)

If you think your family dinner arguments are heated, you won’t want to miss this drama.

“I’m happy to take on the fight, but I don’t want to disappoint a customer,” Anne Wojcicki told Fast Company at Innovation Uncensored earlier this month. Woah.

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The first three are recommended by Dr. Eric Topol:

1. In this post, Dr. Gholson Lyon, an assistant professor in human genetics at the Cold Spring Harbour Laboratory, takes on the large issue of whether the FDA (or possibly even legislation) can keep up with genetic testing, and its inherent hypocrisy over data decisions:

I dream of a world in which we have phenotype and genotype data on millions of individuals, so that we can really begin to better understand genotype-phenotype relationships.

Instead, we still live in the medical world described in the Pulitzer prize-winning novel Arrowsmith pubished in 1925, where doctors pretend to know far more than they actually do. The sad fact is that there is no way the FDA can evaluate and regulate each and every genetic variant in the billions of letters which make up the human genome that get variably expressed in trillions of cells in every human body.

 


2. This great Slate column about the “old economy vs. new economy” battle that must play out over the next decade. Best quote:

In hindsight I suspect that the FDA targeting 23andMe is going to seem rather like the RIAA shutting down Napster. The data is coming. The institutions designed to protect the public from fraud need to think more about empowerment rather than engaging in fiat paternalism.

3. The title alone says it all: “The FDA and Thee,” an oped at WSJ. (In fact, the ticker on the video reads: “The FDA’s Genetics Power Play.”) This piece goes into then Sen. Barack Obama’s calls for genomics testing regulation, and urges 23andMe to consider doing business overseas:

23andMe might also want to start scouting locations for a new overseas headquarters, if only to send a message about how Mr. Obama’s regulators are chilling innovation and investment. You can mail a tube of saliva anywhere. The scientists and entrepreneurs helping to lead medicine into the genomic era have little need to operate inside the U.S. if that means begging the government for a hall pass every time they want to do something new and potentially life-saving.

4. This patient’s take on a scare from the sometimes perils of digital health glitches:

I clicked the link and a warning appeared: you have to specifically agree if you want to know the result of potentially unnerving, life changing results. I clicked OK and was forwarded to the result. It said:

“Has two mutations linked to limb-girdle muscular dystrophy. A person with two of these mutations typically has limb-girdle muscular dystrophy.”

I let that sink in for a moment. I had never heard of this illness before. . . .

It also appeared to me that I had absolutely no idea what the “technical information” behind the fine printed link on the 23andMe result page meant.

5. Sage Bionetworks CCO John Wilbanks points to 23andMe’s own hypocrisy in “23andMe Gets a Nastygram for the Holidays.” The company who claims it’s all for open data and personal health isn’t being so forthcoming itself:

This fits into a general pattern of espousing open science while not practicing it for the company. So the data are either really bad, and releasing them would forestall the chance to get more people enrolled and wait for Metcalfe’s Law to kick in, or they’re so good that they’re worth picking a public fight with the federal agency least likely to be disrupted by a startup.

His take on the moral of the story? They either have great results and data today, or they don’t.

6. Finally, an opinion piece from Fast Company, which recently did an interesting piece on the ramifications of genetic testing for adoptive parents and a cover story on 23andMe CEO Anne Wojcicki. Its claim: Health insurers are quaking underneath their visors and in front of the screens of their risk prediction models.

While Wilbanks (above) says this argument means the startup doesn’t have enough ammo to go after the FDA, it is an interesting assessment. Eventually, payers will need to figure out how genetic testing fits in to their risk pools, how much patients must disclose and how providers should bill for preventative medicine based on genetics.

Make sure to watch the video of Wojcicki on the company’s tenuous relationship with the FDA.

There’s also a very interesting (and lively) conversation that leans more toward the FDA being in the right in the Medical Devices Group on LinkedIn. Many medical device experts view the 23andMe spit kit clearly as a diagnostic solution. (You must be a member of the group to view.)

For more on 23andMe and the FDA, click here.

To read a petition filed with the White House to “overrule” the FDA warning letter, click here.

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