Why The FDA Ban On Providing Health Reports Based On Personal Genomes Won't Work
from the because-DNA-is-digital-data dept
When the first human genome was sequenced — that is, when most of the 3 billion base-pairs that go to make up our DNA were elucidated — as part of the Human Genome Project, around $3 billion was spent. Today, the cost of sequencing is falling even faster than Moore’s Law, which means everyone could have their genome sequenced soon, if they wished (and maybe even if they don’t….). By analyzing the DNA, and looking at the gene variants found there, it is possible to spot predispositions to certain diseases or medical conditions, potentially allowing lifestyle changes or treatment that reduce the risk. The well-known personal genomics company 23andMe was offering this kind of service, at least on a small scale. But that stopped at the end of last year, as the company explains:
We no longer offer our health-related genetic reports to new customers to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
At this time, we do not know the timeline as to which health reports might be available in the future or when they might be available.
According to an article in MIT Technology Review, here’s what had happened:
in November 2013, the Food and Drug Administration had cracked down on 23andMe. The direct-to-consumer gene testing company’s popular DNA health reports and slick TV ads were illegal, it said, since they’d never been cleared by the agency.
But as that same article goes on to explain in detail, users of 23andMe are having no difficulty in getting around that ban on obtaining health-related analyses of their genomes, using third-party sites like Promethease:
Promethease was created by a tiny, two-man company run as a side project by Greg Lennon, a geneticist based in Maryland, and Mike Cariaso, a computer programmer. It works by comparing a person’s DNA data with entries in SNPedia, a sprawling public wiki on human genetics that the pair created eight years ago and run with the help of a few dozen volunteer editors. Lennon says Promethease is being used to build as many as 500 gene reports a day.
That kind of analysis is possible because, once sequenced, DNA is essentially just digital data: very easy to upload and compare against biomedical databases storing information as digital files. Even though they are not currently allowed to analyze it, companies like 23andMe still provide customers with access to the raw genomic data, which can then be sent to services like Promethease for a basic report drawing on its DNA database.
This raises an interesting question: given that the information on SNPedia is drawn from public databases, can the FDA stop people using it to circumvent the ban on 23andMe? According to MIT Technology Review, the FDA believes the answers is “yes”, but that just won’t work in practice. Even if the FDA manages to shut down all the services like Promethease, it would be easy to write a program that searches the main public biomedical databases for exactly the same kind of information about particular gene variants found in somebody’s genome. The software could be shared freely as open source, making it impossible to prevent people from obtaining the program and carrying out such searches independently on their own computers.
It’s true that there are good reasons why the FDA might be concerned about members of the public being given medical analyses of their genome in inappropriate ways. For a start, the results are generally probabilistic, rather than definite predictions; that makes them hard for non-experts to interpret. And when it isn’t about probabilities — if it is certain that you will develop a disease, possibly a devastating one — there’s a strong argument that counselling needs to be made available when that information is given to the person affected.
Still, regardless of the extent to which the FDA’s actions are understandable, trying to stop people comparing their DNA with publicly-available information is futile. As the copyright industry has learned the hard way, once data is digital, it is essentially uncontrollable. The best thing to do is to accept that fact and move on. In this case, that means the FDA should encourage companies offering analysis to do a good job, not block them completely.