the remarkable effort that has been expended on creating intuitive interfaces that allow consumers to grasp complex risk predictions far more easily than anything you’ve seen in a general practitioner’s practice. It ignores the remarkable technical accuracy of the companies’ products, which measure hundreds of thousands of genetic markers with an accuracy orders of magnitude higher than many tests used routinely in a clinical setting. It also ignores the benefits to consumers of engaging with their own genome, a powerful education in the complexities and uncertainties of modern genetics.
Many commenters on the personal genomics industry immediately declared the report to be flawed and biased, and a spirited defense was soon posted on the blog of one of the targeted companies, 23andMe. Nonetheless, the GAO has hit its mark. Already its central claims have been echoed by news agencies around the world. With each of those echoes, public confidence in the industry will fall, and regulators will gain support for further attacks.
The costs of regulation
It would be all too easy to use the false claims and unethical behavior depicted in the tapes to justify a whole-sale FDA crackdown on the direct-to-consumer genetic testing industry, and that was certainly the flavor of the Congressional proceedings. However, such a move would be short-sighted, and would ultimately harm consumers more than it protected them.
Regulation comes at a cost. Each additional barrier thrown in the path of companies means increased costs to consumers, reduced competition (as entrepreneurs move into less burdensome fields), increased lag times between new discoveries and finished products, and ultimately weaker innovation. In some cases these costs are justified, which is why we tolerate a massive regulatory burden on pharmaceutical companies despite the resulting higher price of drugs. However, we must insist that each new regulatory obstacle be justified by the protection it provides to consumers.
Reputable DTC companies are already bound by regulation: their testing laboratories must be certified under Clinical Laboratory Improvement Amendments (CLIA) standards, which govern the technical accuracy of results. The false claims and unethical marketing highlighted in the GAO report would also seem to fall under the mandate of the Federal Trade Commission (FTC), who have already made some moves towards educating consumers about DTC genetic tests. It would seem appropriate to consider whether strengthening these existing mechanisms would serve consumers better than introducing FDA regulation.
Excessive regulation would devastate the industry, and that would harm more than just the companies involved. For all its faults, the DTC industry is currently an engine of innovation for technologies that will be crucial to the coming era of genomic medicine, such as intuitive interfaces for exploring large-scale genetic data. Close the industry down and those innovations will also disappear, with much broader negative consequences than the FDA or Congress appears to realize.
A way forward
There are alternatives to the paternalistic approach of locking tests away from consumers unless they’re deemed to exceed some FDA-defined threshold: for instance, empowering consumers to make their own informed decisions about genetic testing products. Coupled with strengthening of the existing CLIA regulations and a boosted FTC mandate to purge the industry of scammers, such an approach would help to protect genetic test customers without destroying the innovative DTC industry.
As Dan Vorhaus and I have previously argued here on Xconomy, the key to this approach will be increasing the transparency of the industry. As a starting point, creating a mandatory database of genetic testing products containing information about the scientific basis of companies’ claims—preferably by building on the NIH’s proposed Genetic Testing Registry—would provide a platform for consumers to make an informed comparison of reputable tests. It would also provide an even playing field for public critiques of the markers and algorithms used by each company, spurring the industry as a whole towards improving their products.
Crucially, this database would need to be accompanied by education of both consumers and clinicians about the value and limitations of existing genetic tests. These are complex issues, and challenging to convey to consumers without a PhD in statistical genetics. But as we move into an era where whole genome sequences move from luxury goods to cheap commodities, they are issues we must learn how to communicate—and soon.
