Protecting consumers from their own genetic data will come at a cost

(This is an edited excerpt from an op-ed piece I just wrote for Xconomy, posted here as I think it provides some nuance on my views on regulation of genetic testing that was lacking from my post last week.

Some context for new readers: a Congressional investigation into the direct-to-consumer (DTC) genetic testing industry last week left a sour taste in the mouths of many observers of the embryonic industry; it was a vicious, one-sided affair, starring a biased report on a "sting" operation performed by the US Government Accountability Office. Along with other recent moves by the FDA, it potentially sets the scene for draconian regulation to be laid down on the industry. Here I argue that other, more careful approaches are the best way forward.

For more discussion from multiple viewpoints on the regulatory battle ahead, check out the posts by my co-authors on Genomes Unzipped and the ensuing comments threads: Caroline Wright argues that genetic data provides educational opportunities that should not be legislated away, and Jeff Barrett and Kate Morley argue that different standards should be applied to medical and non-medical tests.)

The costs of regulation
It would be all too easy to use the false claims and unethical behaviour depicted in the GAO report to justify a whole-sale FDA crackdown on the direct-to-consumer genetic testing industry, and that was certainly the flavour of the Congress 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 realise.

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, 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.


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I mentioned last week on Genetic Future that a reporter with the Washington Post, Rob Stein, had emailed the National Society of Genetic Counsellors to search specifically for people with negative experiences of personal genomics for an upcoming article on the industry. At the time I called for…
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The brief Golden Age of direct-to-consumer genetic testing - in which people could freely gain access to their own genetic information without a doctor's permission - may be about to draw to a close. In a dramatic week, announcements of investigations into direct-to-consumer genetic testing…

Shipping spit tubes to China or India is pretty easy and getting the data back is even easier. The only effect I see of all this possible regulation is the killing of American jobs and companies and sending the work off-shore. Add to that, you can get just as good information from a detailed family history, and I think any concern for the need of ANY government regulation looks pretty stupid.

What a bunch of scammers. When Venter says that it's decades or more before "genomics medicine" is anything but a scam, you know what's going on here.

Cry me a river over "over-regulation". That's the whine you always here from folks who are running a grift.

Mind you, Venter uses pretty strong language in his Spiegel interview...

Some extracts:

Venter: I have a slightly increased risk for Alzheimer's disease. But it impresses me little because I could have dozens of other genes that counteract it. Because we do not know that, this information is meaningless.


Venter: And what else have I learned from my genome? Very little. We couldn't even be certain from my genome what my eye color was. Isn't that sad? Everyone was looking for miracle 'yes/no' answers in the genome. "Yes, you'll have cancer." Or "No, you won't have cancer." But that's just not the way it is.

SPIEGEL: So the Human Genome Project has had very little medical benefits so far?

Venter: Close to zero to put it precisely.... we have, in truth, learned nothing from the genome other than probabilities. How does a 1 or 3 percent increased risk for something translate into the clinic? It is useless information.

Daniel -- you suggested here and previously that "(CLIA) standards . . . govern the technical accuracy of results." As far as I can tell, that's not true. CLIA governs what goes into the lab, and how the lab is run, but it doesn't evaluate the accuracy of the resulting SNP calls.

By Lee M. Silver (not verified) on 30 Jul 2010 #permalink

Hi Lee,

CLIA certification requires that a lab fulfil requirements relating to quality control, personnel qualifications, records maintenance, and proficiency testing; basically, to demonstrate that it has systems in place to ensure consistent, high-quality data. Would it help if I'd said "analytic validity" rather than "technical accuracy"?

Ventner says whatever is popular. Hates it when he's out of the spotlight. Talked idly with Anne and Sergey about googling their genes in the Google Story book but Anne ended up working with Linda. So Ventner gets his revenge by funding Pauline Ng to rip Anne a new one in Nature.

When the genome came out he also promulgated some stuff about no race or ancestry in the genome. Then a few years later his institute is putting out exquisitely color coded pca plots like every other scientist.