Welcome to the discussion! Thanks for the link to that thread.
Cheers,
There is no question that 23andMe is not following the typical rules for FDA approval. To this end, it is what I would consider civic disobedience.
On hacker news and elsewhere we can see arguments for and against whether or not a false-positive may lead to harm. The debates are somewhat shallow so let's go up one level of abstraction, away from nitty gritty details of speculating whether or not doctors would recommend dangerous procedures based on one cheap data point and toward the real issue here:
Who is responsible for your health and your safety? If not you, then to what extent can others be held responsible for the lack of efficacious health care options at your disposal, let alone access to your own DNA sequence (with conveniently indexed genetically linked health information)? It seems unfair to lay this entirely in the FDA's court of jurisdiction or even on the feet of your health care provider.
There are clearly times when an individual cannot represent his or her own best interests, particularly within the healthcare scenarios in which one may be unconscious, so we have some universal rules to protect the individual. Medical care can also be confusing and complex, so there is regulation to make sure things are safe and effective.
But even so, what 23andMe sells is information. Not all information is created equal. When your doctor tells you to have a prophylactic mastectomy but the standard for care pathway recommends a mammogram first, do you get a second opinion (this actually happened)? The fact that "second opinion" as a phrase exists within our healthcare system gets at the very idea we are talking about here: you are ultimately responsible for your own health. If you choose to spend your time and resources to sequence your DNA at a consumer rate and accuracy, then you deserve to have that information, regardless of the outcome.
If, as I suspect, 23andMe is not playing ball because FDA regulations currently present an undue burden for the small service that is provided then I support them in this effort to find middle ground with the FDA. I hope that the FDA can adapt to the information age before it becomes completely outmoded. The future is admittedly a brighter one when there is an optimized and effective regulator who actively represents your personal healthcare interests than when there is not, so here is to that.
Cheers,
Joe Gorse
On Mon, Dec 2, 2013 at 7:16 PM, TeMPOraL <temporal.pl@gmail.com> wrote:
There's an interesting discussion thread about this issue on HackerNews:One part of the discussion particularly stood out for me:
https://news.ycombinator.com/item?id=6794122
"If you look at the FDA's website, it's littered with dozens of communications begging 23andme to submit some documentation about their product so that the FDA can evaluate the medical claims they're making.
See, e.g., this one from June 10, 2010:
http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf
All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy:
(...)The FDA then establishes its ability to regulate this (remember, it's legally required to do this):
(...)
They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:
(...)
There's even a helpful mailing address and fax number:
(...)
Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway."
I know that in US of A there's this vision of entrepreneurship as "distrupting" the rules that are perceived to be obsolete (see AirBnB or Uber), but sometimes people just push too far. There's a reason why FDA exists, and it's not only about making money to big pharma.
I hope that 23&Me folks get this issue cleaned up fast; they seem like a good people and company.
(also hi, first post here :))
Jacek Złydach,
http://temporal.pr0.pl/devblog | http://esejepg.pl | http://hackerspace-krk.plTRC - Bringing you tomorrow's solutions yesterday.On 2 December 2013 22:10, Katie Kearns <katie.kearns@gmail.com> wrote:On Fri, Nov 29, 2013 at 12:46 AM, Srihari Yamanoor <yamanoor@gmail.com> wrote:This is the delicate issue - the balance of patient rights vs. commercial profit making, both of which are needed. This is not the first time the FDA has had to deal with this emotionally titillating issue. Cancer patients and their loved ones have never been able to reconcile with the stance of experimental drug administration on patients with no other available treatments (and the ethical/business issues there can be the subject of tons of PhDs).I never used 23andme as I believe genes before data is sort of a cart before horse thing, but can you expand on the "patent me" point. I am interested, even if it needs an offshoot thread.I find the FDA is far too conservative, especially when it comes to people with no other options. But 23andme was clearly way overstepping what the data actually supported in order to make it "easy" for people.
-Katie--To view this discussion on the web visit https://groups.google.com/d/msgid/diybio/CALY99PWXL6ZuUrDPdHzwmvOviORtmENGGyCrHizCGadHKoekoA%40mail.gmail.com.
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