FDA Muzzles 23andMe After Talks Break Down

Note: If you’re here for the annotated links to other perspectives on the 23andMe/FDA dust-up, you should go instead to I Got Your 23andMe – FDA Food Fight Links Right Here, to which I’ve moved my ongoing curation on the subject. Below, however, you’ll still find first take on this dust-up, written Nov 25. My longer piece at The New Yorker, published late on Nov 27, is a more considered look.

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[Nov 26, 2013] According to reports at Bloomberg, the FDA has ordered the genetic testing company 23andme to halt sales of its DNA kit because said kit is a “medical device.”

Perhaps more information will make this look sensible (Matthew Herper’s perspective, for instance, calls into question 23andme’s end of things here), but my first take is that this is a bone-headed move hostile to public health. (My second take, an hour in: Some in my Twitter feed have argued that the FDA is pushing for a needed check on 23andme’s methodology that 23andme has resisted. If this move is just a push to get 23andme to account for or strengthen its methodology, I’m for it, and will eat some of my words below. If it’s a move — one that many have feared — to lock up evidence-based direct-to-consumer genetic testing, then my objections stand).

It’s insanity to take steps that reduce the public’s knowledge and interest in medicine. This is like forbidding people how to take their pulse and blood pressure. Stethoscopes and blood-pressure cuffs are medical devices too, but I think everyone agrees it’s a good idea to let people have free access to the information they provide. A high-blood pressure might alarm someone; but if there’s no cause for alarm, a medical workup should make that clear. Direct-to-consumer genetic information can play a similar role.

I’m with Razib Khan: History will look back on this as folly:

Unfortunately this is not surprising, as this was foreshadowed years ago. And, 23andMe has been moving aggressively to emphasize its medical, as opposed to genealogical, services over the past year. But this isn’t the story of one firm. This is the story of government response to very important structural shifts occurring in the medical delivery system of the United States. The government could potentially bankrupt 23andMe, but taking a step back that would still be like the RIAA managing to take down Napster. The information is coming, and if there’s one thing that can overpower state planning it is consumer demand. Unless the US government wants to ban their citizens from receiving their own genetic data they’re just putting off the inevitable outsourcing of various interpretation services. Engagement would probably be the better long term bet, but I don’t see that happening.

The FDA says it’s “concerned about the public health consequences of inaccurate results.” I’ve not heard of any harm come to 23andme customers from such inaccuracies — and even if such cases exist. Inaccurate results will inevitably occur (here’s a story of what seems to be one particularly unfortunate such case), and findings of medical relevance should be confirmed before people act on them. But do those apparently rare errors inflict more harm than the sorts of errors our medical system makes every day? Do they inflict more harm than a lack of information about important risk genes inflict? Does any harm done outweigh the great good that people gain from having inexpensive access to lots of information about medical risk?

A person learning the status of hundreds of genes of medical interest (along with information about their ancestry) with a simple spit-test may learn much actionable information — not to mention an education about genetics —  that would otherwise depend on …  what? Expensive access to doubtless heavily marked-up genetic tests prescribed by physicians and executed by companies happy to charges hundreds of dollars per gene? We need more such information; not less. I pray this will soon be reversed.

Hat tip to Razib Khan, at The FDA and 23andMe – Gene Expression

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Now the links to other perspectives:

 

• For lots of coverage and discussion, track this Twitter search for 23andme

Links added Nov 27:

• My own Nov 27 piece at The New Yorker, How 23andMe Broke the Rules: The F.D.A. Versus Personal Genetic Testing
• FDA vs. 23andMe: How do we want genetic testing to be regulated?. UC Berkeley geneticist and open-science advocate Michael Eisen lays out a concise, bullet-point case for ) why we need direct-to-consumer genetic testing and b) how it might be regulated. A key point that lies at the heart of the dust-up: “Genetic tests are simply not — at least not yet — medical devices in any meaningful sense of the word…. The FDA and companies like 23andme need to come up with standards for accurately and honestly describing the current state of knowledge for genotype-phenotype linkages and their application to individual genotypes.” Those two sentences hit the root of this thing spot on. 
• Why 23andMe is Not for Me — Yet   Writer Ricki Lewis expresses well both some important caveats about genetic testing in general and her own reasons for not getting into it … yet.
• 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks   Charles Seife writes that while 23andMe is indeed using its growing database of genes and health conditions for useful medical research, the company also “reserves the right to use your personal information—including your genome—to inform you about events and to try to sell you products and services.” Seife worries that, while the company so far promises it won’t sell your genetic data to anyone else, there’s good reason to worry that could change.
• Nick Comfort adds some long-cycle perspective, including the  history of hyping anything genetic: 23andMe, FDA, and the history of hype | Genotopia
• 23andme CEO Anne Wojcicki elaborates a wee bit with An Update On FDA’s Letter to 23andMe | The 23andMe Blog. Her message is a bit hard to square with the FDA letter saying the company had not communicated with the agency for 6 months. But perhaps the FDA has the company’s attention. “This is new territory for both for 23andMe and the FDA,” Wojcicki writes. “This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.” 
• Going meta: Here’s a nice wrap-up of by Lindsey Alexander, of MedCity News, of 6 other posts on the FDA-23andMe dustup: Six smart takes on the 23andMe FDA standoff.  Some of those are already listed above. Non-overlapping items include John WIlbanks, with 23andme Gets A Nastygram For The Holidays, and Why 23andMe Terrifies Health Insurance Companies, which may be a bit overwrought … or mnot, since, historically, I’ve found it easy to underestimate the greed or power of the health insurance industry.

Links added Nov 28:

• 23andMe revealed a condition it took my doctors six years to diagnose – Quartz  This piece by Shaheen Pasha shows well the value of a test like 23andMe not as a solid diagnosis — which it isn’t — but as information about risk, to help direct diagnostic efforts. 
• When 23andMe gives results that no one knows how to manage | Dr. Jen Gunter  A smart and nuanced look at the  dilemma a doctor faces when a patient gets a 23andMe result that suggests risk … that you don’t quite know what to do with. Gunter reacts not by suggesting we ban such testing; rather, she accepts it as inevitable, and says “somehow we are going to have to figure out what to do with this kind of raw data.”
• A red letter day for consumer genomics | Gene Values Illiminating post by Dr. Stuart Hogarth, who was in on some of the early FDA-industry meetings on regulating personal genomics kits, on what the FDA letter seems to mean, what in it mystifies him too, what may have gone amiss between 23andMe and the FDA.
• Why The FDA Can’t Be Flexible With 23andMe, By Law. Very helpful explainer/contextualizer by @DavidKroll
• Do Genetic Tests Need Doctors? FDA Defends Its Challenge to 23andMe – Businessweek  Features bits from an interview with Alberto Gutierrez (the FDA official who wrote the warning letter to 23andMe), in which Gutierrez elaborates on why the FDA feels it needs to call the company to heel. His arguments seem mainly aimed at how scared patients can push their doctors to do unnecessary and sometimes harmful procedures. This reveals an interesting tension here: He’s right about fear driving procedures, but that fear comes from many places and is based on many kinds of information, some far, far less solid than even the shakiest of the findings that 23andMe reports. In a world where companies can more readily help people gather information about themselves, where does the FDA draw a line on what constitutes a ‘medical device” that delivers medically relevant information? A woman could very well use Ancestry.com and some newspapers searches to find that many of her female relatives died of breast cancer, and then take that info to a doc and convince the doc to do a double mastectomy. Does that make Ancestry.com a medical device that the FDA should regulate?

Posted Nov 29:

• In Taking Aim at 23andMe, Regulators Missed the Mark | Entrepreneur.com The editorial director of Entrepreneur.com is not impressed with the FDA’s move.
• Cruwys news: 23andMe and the FDA  A useful round-up . It includes what the author says is the 23andMe national TV ad that may have helped provoke the FDA’s move. It does make medical claims about genetic risk findings, and it’s easy to see why this ad might alarm the FDA — and why it might anger them if they’re feeling ignored by the company.

Here ’tis:

Some followers of this mess have noted that the FDA letter ordered the company from “marketing” the test. What does that mean? Does that mean just “to expose for sale,” as in advertise? Or does that usage include selling? Some have wondered if the FDA’s foremost complaint is not the sale, but the marketing; if that’s the case, this might be a simpler mess than it appears. It’s clear from the FDA letter that much of the language there draws on the context of 4 years of conversations we’re not privy to. Much remains obscured here.

• In a comment below my New Yorker story about the 23andMe – FDA standoff, Cold Spring Harbor geneticist Gholson Lyon explains why, in the anecdote described at the end of that article, he was not able to share with the patient’s family his identification of a gene that caused the death of an infant. (A couple of other commenters had said they found that situation implausible.) It has to do with whether a genetic test is done in a lab certified by a federal program known as the Clinical Laboratory Improvement Amendments, or CLIA. As Lyon explains, “[C]urrent law stipulates that genetic test results in America returned to participants must be obtained in CLIA-certified labs, and that much of the research enterprise is NOT performed under such settings. Furthermore, still, the vast majority of exome and whole genome sequencing is NOT performed under CLIA standards, including lack of very rigorous sample tracking and not being performed in any CLIA-certified labs. ” 

Since the lab doing the assay for that patient, however rigorous and accurate it is, was not CLIA-certified, Lyon was forbidden from sharing its results with the family. Many other medical labs are likewise constrained, at least officially.

This pertains to the support that Lyon and others have for 23andMe, for 23andMe says it uses labs that are CLIA certified — which is part of why Lyon and many doctors feel confident using some of the 23andME results as useful information about risk.

And here are two particularly sharp posts from American Science, a group blog about the history of American Science:

AmericanScience: A Team Blog: Science, Regulation, and the Epistemology of Big Data:

What’s at root in the disagreement here might be more than meets the eye.  Although I cannot say so with certainty, I have a strong suspicion that what the FDA is really objecting to here is the use of big data techniques in biomedicine. Traditionally, if a company wants to bring a certain pharmaceutical or medical device to market, it is expected to conduct extensive clinical trials. In so doing, there might not be an expectation that every aspect of the drug or device’s mechanism of action is fully known. However, there would at least be clinical or experimental data to support its safety and efficacy.

But these are precisely the kinds of data that big data will not produce.

AmericanScience: A Team Blog: What’s better than a holiday card? “Possibly the worst FDA letter of all time.”:

Does the agency’s most recently expressed concern over the analytic and clinical validity of PGS mark a departure from previous concerns? Not really. As FDA has made clear in the past through their correspondence with DTC firms, the worry with a medical device is that it be accurate and reliable. That is FDA’s rationale for post-premarket review. But back in 2010 Guitierrez, the head of FDA’s Office of In Vitro Diagnostics, did not want the agency to be viewed as paternalistic and said, “We really don’t have any issues with denying people information. We just want to make sure that the information they are given is correct.”1 So, now we are back to worrying about analytic validity (the reliability of the actual genetic test, meaning laboratory performance) and clinical validity (whether the genetic variant actually corresponds to the condition or trait).

And at Forbes, 23andMe: A Fumbling Gene In Its Corporate DNA?

The author is disappointed in his 23andMe results because they don’t seem to match up with reality — that is, with his health and family history. I find this interesting because it’s a great example of the dissonance between, on one hand, the probabilistic results of genetic effects  and the limited powers of any one gene, and on the other, the expectation that genes produce traits in a straightforward fashion, so that if I carry a gene raising my risk for baldness (I do) then I’ll be bald (I’m not). The writer of this post seemed to carry those expectations — which is just the sort of expectations the FDA worries will lead people to get mastectomies they don’t need. In the comments section, some people are trying to enlighten him. It’s what we might call 23andMe’s FDA problem (one of them, anyway) playing out before us.

 Loosely related posts at Neuron Culture:

• Genetics, Roundly Humbled and Wildly Ambitious
• The Most Dangerous Words in Genetics
• The Genetics of Stoopid
• Genes Aren’t Just Architects; They’re Actors

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