The FDA and my personal genome
23andMe has become one of the leading players in the fast-growing personal genomics industry, thanks in part to having dropped the price of its so-called spit kits—based on preserved saliva samples—from around $1,000 in 2008 to $100.
In return, the company analyzes 960,000 specific single-nucleotide polymorphisms (SNPs, usually called “snips”), or genetic markers—not a complete sequence—which is added to the information about yourself that you supply the company with through a series of questionnaires, and that identifies your hereditary traits, your likelihood of suffering from certain genetically transmitted diseases, traces your genealogy to certain parts of the world, identifies people with the same or similar genetic roots, calculates the amount of Neanderthal in you, etc. I have previously written about the company on many occasions (albeit in Spanish).
One of the cofounders of the company is Anne Wojcicki, the former wife of Sergey Brin, who is said to have played an important role in the initial inspiration for setting up the company due to his preoccupation about the existence of familial antecedents of Parkinson’s disease. Google invested almost $4 million in the company in 2007, on top of a total of $161 million that it has been able to raise. A very well-documented article in Fast Company last month puts the number of customers at 400,000, with an initial goal of reaching 1 million clients, and a longer term aim to garner 25 million, a figure that when statistically scrutinized will make further discoveries possible.
So why would the FDA disrupt the progress of the company by requiring it to subject its methods to testing as though it were offering medical diagnosis? I tried 23andMe some time ago, and never had the impression that I was undertaking any kind of definitive medical test, and at no time required the kind of accuracy that I would expect from an analysis carried out by a doctor, and nor did the kit give the impression that it was operating at that kind of level, even though the methodology might well do. All the results were awash with warnings against taking them literally and recommended the user to consult a doctor before making a decision on the results. It never occurred to me that the results could be of any use to a doctor, although I did comment on the tests with a few friends who are in medicine.
What is the reason for raising this alarm, supposedly to “protect” consumers, and putting the company in the absurd situation of being seen to be selling something potentially dangerous, or as though it were claiming it had some sort of “miracle product”?
At present, I can think of several devices or applications that I use to manage a number of variables related to my health and that influence my daily routine much more than the results of 23andMe, for example, Fitbit and Endomondo, but there are any number of other products in the quantified self arena. Is the FDA now going to ask the manufacturers of these other devices to show that their measurements and diagnoses are 100 percent correct, so as to avoid users from making erroneous decisions based on them? Good luck with that. The ban on sales of 23andMe is an attempt to stop people from knowing their own genome. It is a decision that by any standards is absurd, particularly so when there are so many other ways to do so.
Can an individual take decisions that would endanger his or her health as a result of having requested to know their genome via 23andMe? Is it really necessary for the FDA “to protect consumers from themselves”? Removing an organ because of a high probability of cancer or submitting to certain medications are not decisions that a person can take unilaterally: a doctor’s opinion is required.
Banning 23andMe from selling its test would be the equivalent of banning people from reading medical textbooks or searching their symptoms on the internet, in other words, absurd. We have the right to request information about our genome. The market will decide on who best offers the possibility to acquire that information, unless 23andMe decides that it wants to start selling its service to hospitals, which would require it to undergo FDA tests. Governments would do better to dedicate themselves to more productive issues, of which there are currently any number that need answering.
With the Government illegally peeking into all my communications, data and metadata, the least thing I want is some sort of ban on my ability to look into my own genome. Sorry, G-men, but such a decision should belong strictly to me!
In other words, less protection please…
