I have posted a number of previous notes about 23andMe, a company that offers consumer-oriented genomic testing on the web (see, for example: 23andMe Database Sheds Light on Genetic Aspects of Racial Mixing; 23andMe Requests FDA Clearance for DNA Saliva Testing; Pfizer and 23andMe Collaborate to Study Inflammatory Bowel Disease). There has been substantial criticism of the company revolving around questions about the quality of the testing, whether the company was acting inappropriately by providing medical advice to customers, and whether it was acting unethically by selling the genetic information obtained from its customers specimens. A recent Forbes article summarized these questions about 23andMe and posed the salient question of whether its customers were suckers or empowered consumers (see: Are 23andMe Customers Suckers Or Empowered Consumers?). Below is an excerpt from the article:
The mock shock we’re seeing is based on the assumption that 23andMe customers have been hoodwinked into contributing their data to these partnerships....But is that really the case? I’m a 23andMe customer and have received regular communications from the company detailing how to opt into or out of research. There’s another way to look at this: that customers know what they’re doing and see this as a way to make a difference. Most of us know that drug company pipelines are weak, and that it costs far too much to develop new therapeutics. It’s in everyone’s interest to find faster, cheaper ways to develop more effective drugs. If access to data at 23andMe helps accomplish that, we all win. Sure, there are different models to consider. For example, I’d like to see an approach that financially rewards people who contribute their data to research that leads to a viable new drug. The fact that Pfizer signed on for a second deal could be a validation of the idea that mining massive amounts of aggregated data can lead to better drug candidates. One of the most expensive elements in developing a new medication is the clinical trial process. It costs a fortune to locate the right people, convince them to participate, account for all those who stop partway through, and of course monitor drug reactions throughout. There’s also the physical toll for all the participants who discover first-hand the side effects of a new drug. 23andMe can’t solve the clinical trial problem, but its data may help drug companies better target their trials toward patients whose genetics make them more likely to do well on a drug, or less likely to suffer adverse reactions. That kind of targeting could save money, put fewer people at risk, get drugs to market faster, and ensure new medications are given to people most likely to benefit from them.
I agree with the author of this article. In my opinion, the company has been transparent about what it was doing with the genomic data derived from submitted cell samples. I personally have obtained important genetic information about myself from the test that I probably would not have otherwise been aware of. I am sure that other companies will copy the 23andMe business model and sell genetic information to drug companies to facilitate drug research and clinical trials. The biggest mistake that the company has made thus far, in my opinion, is underestimating the the power of the FDA. I do suspect that some of the criticism of 23andMe comes from physicians and scientists who are not comfortable with the idea of consumers ordering lab tests, particularly genetic testing for themselves. I don't agree with this viewpoint.
There is a growing movement among consumers of taking more ownership of their own health and healthcare. An important facet of this movement will be to enable them to order lab tests by and for themselves, including molecular and genomic testing. In short and with reference to the headline of the Forbes article, I think that such testing opportunities will lead to more empowered healthcare consumers. The article also broadly endorses the sale of genome data to foster research as long as the consumers submitting their personal specimens are made aware of the sale of such anonymized data.