FDA Orders 23andMe Off The Market; Apparently Concerned That People Are Too Stupid To Understand Their Own DNA
from the regulatory-overreach? dept
Soon after 23andme launched, there had been regulatory questions about whether it can market its simple DNA test without first getting regulatory approval. There hadn’t been much news on that for a few years, so I had been under the assumption that the company had worked through all the regulatory hurdles. However, according to the FDA, the company has actually failed to meet the regulatory hurdles to make the product legal, and they’re demanding that the company stop offering its product immediately, and fix problems within 15 working days, or face “regulatory action.”
The FDA seems mainly worried that 23andMe’s offering may overstate what it can do, and fail to inform people properly of the possibilities of false positives, which could create significant problems:
Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. 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. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.
The FDA further notes that it’s been talking to the company for quite some time about this, including: “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications” during which it claims to have given the company very specific information and suggestions for how to meet the necessary regulatory hurdles. I certainly recognize the value of the FDA making sure that companies aren’t out there promoting quack medicine, which could create very real harms. But there is also something in all of this that suggests a compliance-by-the-numbers approach of trying to fit a square peg into a round hole by the FDA in trying to classify 23andMe as something that it’s not. Most people I’ve known who use 23andMe don’t use it as the final word on something, but rather as a simple and cheap way of figuring out where they might want to investigate for a more thorough analysis.
It will be interesting to see how the company responds to the FDA, as this has all the hallmarks of a company doing something unique, new and valuable, where the regulatory systems are simply unable to process. It’s entirely possible that there is, in fact, problems with how 23andMe markets its products, but we’ll reserve judgment until more details are available. From a basic informational standpoint, however, we have trouble believing that providing individuals with more information about their own genes should be heavily regulated. A more informed populace is a good thing and should be supported. The idea that people are too stupid to understand what information 23andMe provides seems insulting to the public, and it further perpetuates the myth that the public can’t be responsible for understanding health and medical issues. Keeping the public less informed and more reliant on traditional (read: insanely expensive) healthcare options seems like the wrong choice. The FDA, if anything, should be encouraging more efforts to better educate the public.
Update: A petition has already been set up, by TechFreedom, asking the FDA not to ban home genomics kits and to reconsider:
We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.
We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.