There are so many reasons to resist the FDA on this action — really, as many reasons as there are individual 23andme users. Some of us want to seek out distant relatives and clues about national origins, or satisfy curiosity about patterns of disease in our family lines. For adoptive families, home genome testing can be hugely valuable in cases where one knows little about the medical history of an adoptee’s birthfamily. It’s our body, and our right to inform ourselves about it — or so we thought.
Some are blaming the company for rolling out the popular service in the absence of a clear regulatory go-ahead, and, in recent months, ignoring repeated signals of the FDA’s wish that it submit to comprehensive regulation that would greatly drive up the cost of its service. But other commentators have suggested that the firm has some pretty decent legal arguments that its service is not subject to regulation as a diagnostic test or “medical device” (genetic predispositions are not diagnoses). As an information-based service, it might even enjoy protection under the First Amendment. Admittedly, the company waved a red flag in front of regulators when it launched a marketing campaign that stressed the possible health benefits of knowing one’s genetic predispositions. But as Timothy Lee argues at the Washington Post:
Having more information about your health status is never dangerous by itself. It only becomes dangerous if patients use it to make dangerous medical decisions. But most dangerous medical decisions can’t be made unilaterally; they generally require the assistance of licensed medical professionals who will do their own assessment of the situation before performing procedures that could harm patients.
The FDA very likely has decent legal grounds to forbear from a crackdown should it choose to. But the key takeaway sentence from Matthew Herper’s piece in Forbes criticizing the company is: “This is not the way to deal with a powerful government regulator.” Disrespectful, anti-authority attitudes from someone an agency intends to regulate? Ask former Buckyballs CEO Craig Zucker where that gets you.
What can users, potential users, and well-wishers do?
* “First, download your 23andMe raw results now if you have them,” warns Razib Khan at Gene Expression.
* If you like signing Change.org petitions, there’s one here asking the FDA to back off.
* In a separate piece for Slate, Khan suggests where the situation might head before long: services like this can move offshore. All the relevant information consumers want from them can be delivered via the web. In the mean time a highly innovative and valuable enterprise will have been pushed out of the U.S. to some freer part of the globe, but maybe we need to get used to that happening.
And then? It may take a while before our government works up the nerve to ban mailing a saliva sample to a foreign address. Based on existing trends, I’d guess the more likely intervention, circa 2018 or so, would be for the Treasury to direct credit card companies not to process payments from U.S. residents to genome kit providers. Would we have the spirit to resist then? And if then, why not now? More: Alex Tabarrok, Slate Star Codex (by analogy, “banning people from weighing themselves without a prescription is neither clinically nor ethically sound,” although weight awareness sometimes leads patients into unwise health decisions), Nita Farahany, Brad Warbiany, earlier 2011. Alex Tabarrok’s post is especially worth reading, an excerpt:
…Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. …
…the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases….
The FDA also has the relationship between testing and clinical validity ass-backward. The FDA wants to say no to testing until clinical validity is established but we are never going to discover clinical validity until we have mass testing.