Not arguing that 23andme should have handled their “bidnez”.
What I take issue with, is the assumption that people are too stupid to be handed their own test results. I’m not exactly sure why YOU feel I need a doctor to interpret, or sanity check for me. Quite the other way around, I have found. I have had to take over diagnosing my own family, as the doctors in my (quite wealthy) county have repeatedly demonstrated that they’d be hard pressed to diagnose a dog with fleas.
I had to save my own son’s life two years ago, after 5 years of them being unable to figure it out, and mine 4 months ago, after 2 years of the same. Two different medical issues. (The doctor I mentioned previously is an anomaly).
So, yes, I need all the help I can get, such as 23andme.
Hope they get their act together soon FDA wise.
What can I say; your experience doesn’t tally with any reality I’ve lived in.
Guess you should be profoundly grateful that what happened to us doesn’t correspond to any realities you’ve lived. Unfortunately, malpractice does happen.
An informed patient is more likely to stay alive, vs a patient who believes doctors are Gods.
Peace out, and Happy Thanksgiving.
I’ve been a customer of 23andMe for more than 5 years and an enemy of the brutal FDA for most of my life.
I’ve posted my personal response to the FDA letter of November 22 on my web site at:
http://www.futurescience.com/fda.html
Genetic testing from 23andMe and DeCodeMe, along with information from SNPedia, saved me from an early and agonizing death. I have nothing but the utmost contempt for the FDA.
Jerry Emanuelson
Generally speaking, posters on BB are more tech savvy than average. If you spent any time reading the threads at 23andMe, you would quickly despair for the human race. A significant number of the new customers brought in by the new advertising (promising medical diagnoses) DO in fact think they’ve been diagnosed. They get even the most basic genetic concepts entirely wrong, and do not seem capable of doing basic research to help themselves understand. The worst of the internet? Imagine them all getting DNA tests at 23andMe and then imagine what the cacaphony would sound like…does sound like.
technogeekagain, you, and I are not the norm. 500,000 customers, almost all of whom have significantly lower IQ and formal education than we three. That’s the crux of the situation. The kit isn’t being marketed to us anymore…it’s being marketed to people who think they’re being sold the Blue Sky. (Historical reference that fits quite well here.)
So does this mean that I should quietly crawl off to the nursing home and die, rather than making use of 23andMe data in ways that offend the FDA, just because many others do not understand their DNA? Does this mean that I should not have used treatments that have kept me very healthy, but were not FDA approved, just because others do not understand how to use PubMed and other sources to research their own best medical treatments?
Jerry Emanuelson
More importantly, why does GOVERNMENT think that it should control what you know about yourself and your body… …
Unless I’m misreading that due to misformatting during copying (a good reason for simply providing the URI and letting folks look it up themselves rather than crossposting), this is a 6:4 vote for “no”. Approaching 2:1 supermajority status.
It’s funny how different comments sections look when you understand the underlying area. I have to assume that all comments threads have thing like these:
The FDA has clearly lost its way. Is a drugstore pregnancy, cholesterol, HIV or other test a ‘medical device’? No.
Actually, it’s more “yes”. They’re all medical devices, but some are “waived”. There’s a list published in 1992 of “waived” tests, and it’s very short. Even if you have a test simple enough to meet the definition, if you want to add something to the list, you have to apply. There’s an HIV test on there now (Orasure), but it’s still a medical device, just a waived one. Here’s Orasure HIV ab card in the FDA index.
As long as 23andme is licensed and accredited by an organization such as the College of American Pathologists, they should be able to offer their product/service.
Well, here you’ve hit on a serious issue that may be what lets FDA get away with this. 23andMe’s laboratory is licensed and accredited - I have been told it’s LabCorp, one of the biggest outfits out there with multiple labs in multiple locations. But 23andMe is not a laboratory, it’s a separate company that sends tests to the laboratory. The FDA is not currently requiring a laboratory to submit for FDA approval (labs come under CMS, often with CAP accreditation) but FDA define a laboratory developed test (LDT) as something developed by the doctors in a single laboratory. Since LabCorp (I believe) do the raw data and 23andMe do the analysis, it doesn’t count as an LDT, and FDA gets an in. This is a gigantic black hole of a grey area, if I may coin a phrase, and FDA is taking full advantage of it.
The reason I had to go through all that: New York State does not allow its citizens to participate in genetic testing by private labs. Only physicians can do so. Why?
Because NYS DOH is the only state that really spends time an money on health care provision and a laboratory finds obtaining NYS DOH approval is almost as hard as a device manufacturer obtaining FDA approval. (Because NYS apply it to laboratories, the FDA’s distinction above does not apply.)
If there are quality issues, the Consumer Protection Agency should intervene.
You can’t have the government you have in your head, you have to have the one that exists in real life. In real life, reports of adverse events from medical devices go to FDA, not CPA. I’m sure we can all vote to change that but right now…
Edit to add: IANAL, and this isn’t legal advice.
This topic was automatically closed after 5 days. New replies are no longer allowed.
