A Pending Step Backwards
If you’ve been reading this blog, you know that I’ve been suggesting to my patients that they get the 23andme personal genome testing. I’ve been working with them to delve deeper into the results than 23andme does to find out more about addiction and the potential treatments open to them. Recently the FDA has sent letters to the three genetics testing companies that offer services to the public asking why these tests should not be considered medical devices and why they should not be regulated by the FDA. This is the first step on the part of the FDA in taking over regulation of this market, and that’s bad.
Currently if you want to go to your doctor and get testing for a particular mutation, for instance the MTHFR mutation I discussed a few articles ago, it can be ordered from a number of different labs. The MTHFR polymorphism test can be done at a national reputable lab for about $125. Compare that to the cost of 600,000 polymorphisms tested for by 23andme for $500. By the way, the national reputable lab is the same one that runs 23andme’s testing for them. It shows us the pricing power inherent in a monopoly.
What 23andme and the other companies are doing is disintermediating the physician ordering and the private retail lab and offering bulk testing with modern equipment to the general public. What’s got most of Pharma, Medicine and others up in arms is that they are breaking the guild. It’s a guild I happen to belong to.
The guild of medicine worked fine for a long time, but it is not ready to comprehend or digest the information from 600 thousand tests for polymorphisms, much less the total genome scan that will be under $1000 within five years. Currently our research is also controlled by a guild that you must be a part of or agree with to get any serious funding for questions. This generally limits the questions asked in research as readers of this blog have seen me point out before.
The greatest benefit of the disintermediation is that thousands of people can get their own results and bring them to their physician as informed, or at least curious, consumers. Also these thousands of people can agree to pool their information along with other factors of their health history and jump start research into areas that the academic centers just can’t or won’t go. One such area is addiction. What would happen if the thousands of people who have bought services from 23andme answered just one question on a survey: “Does opioid pain medicines give you energy or make you sleepy?” We would likely have a quick, cheap study with an N in the thousands that would answer the question of who should and shouldn’t take opioids for pain and we’d have that answer within days. Currently, it’s a question Medicine has struggled with for decades and on which it is currently clueless.
I want to be able to buy a personal genome service without interference from the FDA. I want my patients to be able to do it as well. The future is here, and it’s time we recognize that.
June 13th, 2010 at 10:16 am
thank-you, Doctor, for the guidance…