Most readers of this blog may already know that 23andMe is an innovative Silicon Valley company backed by Google Ventures that has been providing affordable genetic tests to consumers indicating their genetic risks for certain diseases. It explicitly does not provide diagnoses. The recent controversy around the FDA’s crackdown on 23andMe has been very instructive. There are important public policy issues surrounding FDA’s Warning Letter to 23andMe as outlined by Ezra Klein’s blog. I think this episode can also be seen as a cautionary tale both entrepreneurs and the regulators.
I had been planning to get the 23andMe test before the November 22 Letter came out but because it was expensive enough at $99 I kept putting it off. In the first few days after the FDA letter, 23amdMe was still offering the service, so I ordered one. It came a few days later to my mailbox:
Before submitting the test I had to agree to the terms and conditions, that included these important caveats:
Fair enough- they are saying that this is not medical advice (I knew that already), and an acknowledgement that the genetic information I get will be incomplete and possibly in error. They’re saying that if I can’t handle the information then don’t do it. I accepted the conditions and consented to have my results included in their growing crowd-sourced database that will be used by researchers to accelerate the pace of discoveries and cures.
Next I opened the box and found the test tube. Looks pretty safe, doesn’t it?
I waited 30 minutes after eating or drinking anything and then mustered enough saliva to fill to the indicated line on the tube. I then screwed the top on and mailed it off to 23andMe’s processing center in Los Angeles. I had been looking forward to getting the results until I saw 23andMe CEO Anne Wojcicki’s post December 5th saying that customers who purchased the kits after November 22 (like me) will not have access to the promised health related results. No discount, either, on the $99 unless I want a full refund and agree to cancel the test entirely. I am disappointed both in 23andMe and in the FDA. I understand why 23andMe had to back down, but am still disappointed not to get their interpretation of the data. I will get my unanalyzed DNA dataset and the ancestry information only. My disappointment with the FDA is that they over-reacted to what is still essentially an information service. I am curious about the assertion that this is a dangerous “device” and wonder if they have exceeded their mandate.
Hubris is a part of the human condition that has been documented since the bronze age. It is an overconfident pride. FDA’s letter asserts that “if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery”. Patients do not do their own surgery. Before prophylactic or any other surgery a discussion would take place with the medical team. That is a good thing for consumers, and yes, it is disruptive to a paternalistic medical culture to have an activated patient asking questions about the evidence. The FDA declaration that this Personal Genome Service is considered a Class III medical device- the most restrictive classification- seems to me to be an unreasonable escalation of what should have been the exploration of an open question. As Duke University’s Misha Angrist wrote of the FDA letter, “it reads like the letter of a jilted lover”. Hubris indeed.
As David Dobbs pointed out last week in the New Yorker, “if the F.D.A. indeed insists on making 23andMe prove beyond doubt the validity of every single correlation, no genetic-testing service will be able to economically deliver medically relevant genetic information directly to consumers. It will destroy the industry and leave medical genetics in the hands of a medical establishment that has already failed to give people an easy way to obtain and use the elemental information in their own spit.”
What about other medical decision support services?
I have had similar questions about the “Meaningful Use” of Electronic Health Record systems incentivized by the Center for Medicaid and Medicare Services via the 2009 stimulus package. Even though such systems automate clinical workflows and offer clinical decision support information to providers they are not subjected to FDA requirements for pre-market clearance and adherence to design controls of regulation-inspired “quality management” systems. This was in part because within HHS there was an internal debate balancing the FDA’s mandate with the need for speed in the implementation of the 2009 American Reinvestment and Recovery Act (ARRA). Fortunately for the public, there was enough internal pushback that the FDA regulators were held at bay. Had Electronic Heath Records been held to Class III standards, many of the products then, and now, on the market – especially the market leaders at the time- would likely have received similar letters as did 23andMe last month.
Lessons for Innovators
I see 3 lessons for entrepreneurs from the unfortunate drama of 23andMe vs FDA:
- Take the FDA seriously, even if you think it’s crazy that they think your product is a medical device.
- Find your local or regional biotech trade association and work with them to better understand the regulatory climate and how to be effective within it.
- Explore regulatory climates in countries outside the US. Most of the world’s growth in the next decade will be outside the US. The rapid growth of mobile internet access opens new opportunities for medical information services.
I look forward to the policy discussion about the classification of health information services as medical devices. Hopefully the FDA can find a better balance than what we have seen so far. I hope that they do it soon. I’m really curious about what’s in my 23andMe report that the FDA won’t yet allow me to see.