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There is a petition going to get the government to over rule the FDA. I'm going to sign it. The FDA assertions that people will get chemo or double mastectomies based on the 23andMe test is beyond ridiculous. Where do they think they are going to get the chemo from? Just stroll in to their local hospital, flash their test results and order some up? What about double mastectomies? Will they be flooding the surgeons offices with their 23andMe results in hand and signing up with no review or consultation from the surgeons? Will there be street corner operating theaters? The whole thing is being orchestrated by competitors that probably don't like 23andMe undercutting their thousands of dollars of expected testing revenue by a $99 spit kit.
There is a petition going to get the government to over rule the FDA. I'm going to sign it. The FDA assertions that people will get chemo or double mastectomies based on the 23andMe test is beyond ridiculous. Where do they think they are going to get the chemo from? Just stroll in to their local hospital, flash their test results and order some up? What about double mastectomies? Will they be flooding the surgeons offices with their 23andMe results in hand and signing up with no review or consultation from the surgeons? Will there be street corner operating theaters? The whole thing is being orchestrated by competitors that probably don't like 23andMe undercutting their thousands of dollars of expected testing revenue by a $99 spit kit.
There is a petition going to get the government to over rule the FDA. I'm going to sign it. The FDA assertions that people will get chemo or double mastectomies based on the 23andMe test is beyond ridiculous.
My understanding is that the FDA has asked 23andMe to provide data supporting the criteria they use to determine and inform people of their risks and by default their non-risks re particular health conditions.
That could lead people to decline screening and other preventative measures that might be beneficial, if not life-saving. True, an informed intelligent person wouldn't take the results that seriously but from what I've read on many online forums, many people do indeed take them seriously.
23andMe has in the past agreed to provide the empirical, statistical data supporting their criteria but have not yet done so despite repeated requests from the FDA. Until 23andMe provides the data, 23andMe users would do well to consider their results as akin to astrology.
There is a petition going to get the government to over rule the FDA. I'm going to sign it.
First of all, the FDA IS the government agency tasked with policing Food and Drug regulations designed to keep the public safe... not just from direct dangers like poisons, but from indirect dangers like medicines that don't work and tests that are ineffective.
So here they are, doing their job, going after a company which has failed to meet federal regulations for 5 years, and who stopped communicating with the agency 6 months ago, and now you want to petition because the FDA is actually doing the job they are supposed to be doing?
If 23andMe is on the up and up, it will be easy for them to comply. They simply have to submit the documentation which proves their test is effective for people seeking medical information. On the other hand, the fact that they have been blowing smoke instead of directly solving this issue is very, very suspicious. Where there is this much smoke-blowing going on, at this level, there's pretty much always some fire somewhere.
First of all, the FDA IS the government agency tasked with policing Food and Drug regulations designed to keep the public safe... not just from direct dangers like poisons, but from indirect dangers like medicines that don't work and tests that are ineffective.
So here they are, doing their job, going after a company which has failed to meet federal regulations for 5 years, and who stopped communicating with the agency 6 months ago, and now you want to petition because the FDA is actually doing the job they are supposed to be doing?
You obviously know nothing about it. 23andMe does not test to see if you have a disease. They test to see if you have the genetic markers that predispose you to potentially developing it. It is not a medical test it is a genealogy test. They also publish the information that you can look at from the studies that show where they get their information from so everyone who looks at their results can decide for themselves whether or not the test is relevant information for them based on the test group, size and items looked at. When there is more than one study for a particular item you get your results based on all the different studies. Sometimes this is four or five outcomes for the same item and they show the relevant study that indicates your results. They weight everything (1 to 4 stars) to show when they have good confidence and when the results are extremely preliminary. There is a ton of information available for a very small cost. If you were going to go and get medical tests for every thing they test on I bet you would easily spend over $20K.
Many people have found that the results assist them in determining what they should be looking for when they have an undiagnosed health problem. Many others find that they have something that they were genetically predisposed to getting. You should try it with an open mind. The field is an emerging science, just like most things.
You probably have no problem taking a drug that the FDA passes. Many people who do this find out in a few years that the drugs prescribed by Drs damage their health and then there are class action law suits. Paying your $99 to 23andMe is guaranteed to not damage your health. There is absolutely no physical harm that can come from being educated about the emerging studies linking DNA information to what goes on with our health. It is just information.
First of all, the FDA IS the government agency tasked with policing Food and Drug regulations designed to keep the public safe... not just from direct dangers like poisons, but from indirect dangers like medicines that don't work and tests that are ineffective.
So here they are, doing their job, going after a company which has failed to meet federal regulations for 5 years, and who stopped communicating with the agency 6 months ago, and now you want to petition because the FDA is actually doing the job they are supposed to be doing?
If 23andMe is on the up and up, it will be easy for them to comply. They simply have to submit the documentation which proves their test is effective for people seeking medical information. On the other hand, the fact that they have been blowing smoke instead of directly solving this issue is very, very suspicious. Where there is this much smoke-blowing going on, at this level, there's pretty much always some fire somewhere.
I'm sure they know that some of their customers are doing the test just for the health results. It's not unreasonable that their results be reviewed medically. If you have some deadly disease in your family and you get a suggestion that you might be more prone to it it will have results and you should be able to depend on that result being dependable. Yes, its a percentage, but ten percent and say fifty are a lot different.
If they are marketing a cousin match, connecting you to your ancestral roots, it might make you dissapointed or happy, but its not going to make you wonder about the rest of your life. The health results could. If the FDA wants to evaluate their process to see how accurate it is then why would they not sent the information to be evaluated? If you are telling people you're giving them health information you owe them the best you can give. No, nobody is going to rush for surgery without further testing, but what if they are wrong and that shows it and all that worry and stress were for naught?
I intend to use Ancestry since I don't want health results and I'd like to see howmany hints I get about cousins and those that should be cousins. My dad had a kind of dementia and I don't want to know if there is some dna marker for it that I have to wait for and if I did would really want it to be right.
Exactly. Those are two different things. Anyone who's submitted and received results from any of the various vendors offering genealogy dna testing has already learned one thing: the results are highly variable, subject to change, depending upon the sample pool.
In other words, not even the genealogy portion is reliable.
I'm content with the genealogy results I received from ancestry.com in that they've correctly matched me up with relatives. Beyond that, I've no confidence in and ancestry's made no substantial claims. Ancestry has twice radically changed, based upon their sample pools, my ethnicity origins. I've no doubt they'll continue to radically change it as they adjust their samples. At least they've not attempted to evaluate my health risks.
There are more than 3 billion genetic markers. 23andMe claims to have a lock on how to isolate and interpret those which point to health risks. They should provide this information to the FDA and their users.
I'm sure they know that some of their customers are doing the test just for the health results.
Actually, the majority of the customers at 23andme appear to take the test only for the health results. I base that estimate on comments I've read by customers who report low response rates (e.g. 10%) to requests they send to hundreds of DNA matches to share genomes for genealogy purposes.
Starting a comment with a personal insult is never a good idea. And starting a comment with a personal insult that is dead wrong, and then following it with a bunch of completely irrelevant information and opinion that has nothing at all to do with the matter at hand is even worse.
To review...
23AndMe has been marketing a test which claims to give medical information to customers. That makes them subject to regulation as a medical test.
23AndMe has known for five years they would need to document the claims they have been making about their medical test. They even acknowledged to the FDA that they needed to supply this documentation, and claimed they were in the process of preparing it, but then didn't file anything.
Despite all of the above, they have not only not filed any of what they are required to do, and have agreed to do, but six months ago they stopped communicating at all with the FDA.
THAT is what this action is all about.
At this point the FDA has taken no position on whether or not this test is good or bad, accurate or misleading. What they have said is: 23AndMe is not following the prescribed federal regulations, and they need to stop marketing the test until they are in compliance.
It's pretty simple, when you strip away the rhetoric and just concentrate on the relevant facts.
Quote:
Originally Posted by nightbird47
I'm sure they know that some of their customers are doing the test just for the health results. It's not unreasonable that their results be reviewed medically.
Exactly, and the bulk of their revenue, according to business analysts, comes from the medical side. That is why this constitutes a business emergency for them, that they need to resolve quickly.
Quote:
Originally Posted by biscuitmom
There are more than 3 billion genetic markers. 23andMe claims to have a lock on how to isolate and interpret those which point to health risks. They should provide this information to the FDA and their users.
Yes, and they've known about this requirement for years but just haven't complied. Stonewalling the FDA this way certainly LOOKS very suspicious.
Quote:
Originally Posted by cdnirene
Actually, the majority of the customers at 23andme appear to take the test only for the health results. I base that estimate on comments I've read by customers who report low response rates (e.g. 10%) to requests they send to hundreds of DNA matches to share genomes for genealogy purposes.
Given the heavy reliance of their business model on the revenue from medical risk testing, it's hard to believe they would allow matters to get to this point, because this puts the entire business at risk.
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