FDA bans preventative medicine to hide the cost of Obamacare?
Post Reply
 
Thread Rating:
  • 0 Votes - 0 Average
  • 1
  • 2
  • 3
  • 4
  • 5
27-11-2013, 08:30 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 07:46 PM)Ohio Sky Wrote:  They want some evidence of the link between the known genetic markers for certain conditions, and the results given by the test.

YES! That's my point. The only possible way to prove the link, the predictive power, is to let the years go by, collecting the medical histories and cross-referencing to the DNA database. And that's what they're doing. And the FDA stopped it. So now we'll never know, since it's impossible to prove this link in advance. Again, this is like banning germ theory when it was introduced because nobody has yet proven the connection to disease. With this ban, progress is halted.

(27-11-2013 07:46 PM)Ohio Sky Wrote:  23andme hasn't shown that they even know jack about these genetic markers, let alone that they have the knowledge to develop a test for said markers.

I have a 23andme test. Every genetic marker comes with a cross reference to a peer-reviewed study.

(27-11-2013 07:46 PM)Ohio Sky Wrote:  That's why the FDA exists. This company has failed to live up to its responsibilities as a dispenser of medical information, plain and simple.

Huh??? They are the dispenser of medical information?! If so, we're doomed, and there will be zero progress. No, there's nothing at all in the FDA's charter that says they are a dispenser of medical information, let alone giving them some exclusive role. The people (naively imo) through Congress gave the FDA the authority to regulate food and drugs, hence the name: The Food & Drug Administration. They are NOT authorized to regulate research. And I think it's wildly dangerous to do so. Scientific advancement comes from those odd-ball researchers who have crazy, unorthodox ideas that the mainstream balks at, but end up being true. Like evolution, germ theory, relativity, etc. If the government regulates research and bans any research that they feel is not part of the current mainstream, then there will be zero progress.
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 08:34 PM (This post was last modified: 27-11-2013 08:38 PM by WeAreTheCosmos.)
RE: FDA bans preventative medicine to hide the cost of Obamacare?
My brother was supposed to buy a few kits for the family xmas gifts, but he procrastinated... and now its too late.

Its not even medicine, or anything you can consume. Its not even a diagnosis. Its information about your genetics and how they relate to the findings of studies. Sure, I'd bet that some of those studies may be reinterpreted, or proven wrong some time in the future, but since the vast majority are likely accurate, GIVE ME THE DAMN INFORMATION and let me draw my own conclusions FUCKIN FDA
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 08:46 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
You could hypothesis that the religious right want it banned because of evolution bias more so than OBAMACARE

Theism is to believe what other people claim, Atheism is to ask "why should I".
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 08:48 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 08:30 PM)frankksj Wrote:  YES! That's my point. The only possible way to prove the link, the predictive power, is to let the years go by, collecting the medical histories and cross-referencing to the DNA database. And that's what they're doing. And the FDA stopped it. So now we'll never know, since it's impossible to prove this link in advance. Again, this is like banning germ theory when it was introduced because nobody has yet proven the connection to disease. With this ban, progress is halted.

You misunderstand me. Let's say this test identifies all redheads as having a higher than average risk for heart disease. Do we get all redheads to take this test and tell them that they need to be worried about heart disease and then wait 20 years to see what happens? No, we find out FIRST if such a predisposition even exists. It does not exist merely because the test says it does. We must identify the specific genetic markers that increase the risk factors for X, and then demonstrate that this test actually indexes those genetic markers and provides corresponding results. They have not done so. The FDA has asked the company for evidence that the criteria for identifying such risk factors is credible, not to prove in advance that the test is accurate for those who have used it.

(27-11-2013 08:30 PM)frankksj Wrote:  
(27-11-2013 07:46 PM)Ohio Sky Wrote:  23andme hasn't shown that they even know jack about these genetic markers, let alone that they have the knowledge to develop a test for said markers.

I have a 23andme test. Every genetic marker comes with a cross reference to a peer-reviewed study.

They have failed to file necessary paperwork with the FDA to provide them with this information. If they have done their research (which it seems they have) it should be a simple matter of filing the necessary forms to get their merchant status reinstated.

(27-11-2013 08:30 PM)frankksj Wrote:  
(27-11-2013 07:46 PM)Ohio Sky Wrote:  That's why the FDA exists. This company has failed to live up to its responsibilities as a dispenser of medical information, plain and simple.

Huh??? They are the dispenser of medical information?! If so, we're doomed, and there will be zero progress. No, there's nothing at all in the FDA's charter that says they are a dispenser of medical information, let alone giving them some exclusive role. The people (naively imo) through Congress gave the FDA the authority to regulate food and drugs, hence the name: The Food & Drug Administration. They are NOT authorized to regulate research. And I think it's wildly dangerous to do so. Scientific advancement comes from those odd-ball researchers who have crazy, unorthodox ideas that the mainstream balks at, but end up being true. Like evolution, germ theory, relativity, etc. If the government regulates research and bans any research that they feel is not part of the current mainstream, then there will be zero progress.

I'm referring to 23andme, and giving people information about diseases and conditions they need to be concerned about is most certainly medical information.

I won't argue that the FDA should be meddling in everything under the sun, and I think they overstep their bounds often. But there must be some regulation of food and drugs, and medical devices have also fallen to the FDA as a fairly recent technology that isn't regulated elsewhere. I don't see how you have made the link between this situation and the ACA.

Believe nothing, no matter where you read it, or who has said it- not even if I have said it- unless it agrees with your own reason and your own common sense. - Buddha
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 08:53 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
SO Shouldn't the FDA Ban , Psychics and faith healers ? on this principal

Theism is to believe what other people claim, Atheism is to ask "why should I".
Find all posts by this user
Like Post Quote this message in a reply
[+] 2 users Like sporehux's post
27-11-2013, 08:54 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 08:53 PM)sporehux Wrote:  SO Shouldn't the FDA Ban , Psychics and faith healers ? on this principal

I'd be okay with that. Dodgy

Believe nothing, no matter where you read it, or who has said it- not even if I have said it- unless it agrees with your own reason and your own common sense. - Buddha
Find all posts by this user
Like Post Quote this message in a reply
[+] 1 user Likes Ohio Sky's post
27-11-2013, 09:00 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
Just ordered a kit for a friends XMAS pres, it still allows internation orders, postage was more than the test.

Theism is to believe what other people claim, Atheism is to ask "why should I".
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 09:01 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 08:48 PM)Ohio Sky Wrote:  You misunderstand me. Let's say this test identifies all redheads as having a higher than average risk for heart disease. Do we get all redheads to take this test and tell them that they need to be worried about heart disease and then wait 20 years to see what happens? No, we find out FIRST if such a predisposition even exists. It does not exist merely because the test says it does. We must identify the specific genetic markers that increase the risk factors for X, and then demonstrate that this test actually indexes those genetic markers and provides corresponding results. They have not done so.

I think the misunderstanding is that you haven't used 23andme. You have to understand what they do. THEY do not start out by saying that they believe redheads have a high risk of heart disease. Rather, over time, as people post their medical conditions and the data shows a correlation between the redhead gene and heart disease, it presents this, starting with a 'low confidence' level. But as years pass, and the correlation becomes stronger, the confidence level gets higher.

23andme is a system to DISCOVER the links between genes and conditions. If you prevent their work until the link is proven, you have given them an impossible task, a catch 22, and discovery comes to a halt.

Sure, when there are peer-reviewed studies suggesting correlation to genes, they DO provide links to the studies with full disclosure and confidence levels. But, over time, the confidence level grows as the gene's successfully predict the outcome.

23andme is purely a scientific research tool that gives out information. They never say "you're a redhead, you'll get cancer". They provide a valuable research tool, like the genome project, that grows scientific knowledge of how genes influence disease.

It is an internet-based research tool, just like Wikipedia. Calling it a "medical device", or a food & drug, is absurd. It's a web site, and the only physical medium you get from them is a plastic tube to spit in. Obviously a plastic tube is not a "medical device". So presumably they're saying the internet and web browser are regulated "medical devices". But this means they can shut down wikipedia and other web sites if they present non-FDA approved information.
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 09:03 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
Maybe we should Ban Earthquake detection devices for the false positives that cause inconvenience, possibly death if someone drives away too fast and hits a tree .

Theism is to believe what other people claim, Atheism is to ask "why should I".
Find all posts by this user
Like Post Quote this message in a reply
27-11-2013, 09:10 PM
RE: FDA bans preventative medicine to hide the cost of Obamacare?
(27-11-2013 09:01 PM)frankksj Wrote:  
(27-11-2013 08:48 PM)Ohio Sky Wrote:  You misunderstand me. Let's say this test identifies all redheads as having a higher than average risk for heart disease. Do we get all redheads to take this test and tell them that they need to be worried about heart disease and then wait 20 years to see what happens? No, we find out FIRST if such a predisposition even exists. It does not exist merely because the test says it does. We must identify the specific genetic markers that increase the risk factors for X, and then demonstrate that this test actually indexes those genetic markers and provides corresponding results. They have not done so.

I think the misunderstanding is that you haven't used 23andme. You have to understand what they do. THEY do not start out by saying that they believe redheads have a high risk of heart disease. Rather, over time, as people post their medical conditions and the data shows a correlation between the redhead gene and heart disease, it presents this, starting with a 'low confidence' level. But as years pass, and the correlation becomes stronger, the confidence level gets higher.

23andme is a system to DISCOVER the links between genes and conditions. If you prevent their work until the link is proven, you have given them an impossible task, a catch 22, and discovery comes to a halt.

Sure, when there are peer-reviewed studies suggesting correlation to genes, they DO provide links to the studies with full disclosure and confidence levels. But, over time, the confidence level grows as the gene's successfully predict the outcome.

23andme is purely a scientific research tool that gives out information. They never say "you're a redhead, you'll get cancer". They provide a valuable research tool, like the genome project, that grows scientific knowledge of how genes influence disease.

It is an internet-based research tool, just like Wikipedia. Calling it a "medical device", or a food & drug, is absurd. It's a web site, and the only physical medium you get from them is a plastic tube to spit in. Obviously a plastic tube is not a "medical device". So presumably they're saying the internet and web browser are regulated "medical devices". But this means they can shut down wikipedia and other web sites if they present non-FDA approved information.

Ah, see that's more information I got from the several websites I looked at after my initial response to the thread. Thanks for the explanation.

I think the issue lies in the existing research they are using, not in the research they are conducting themselves for future use. The FDAs letter to the company didn't reference the data collection by 23andme as being an issue at all. Perhaps a more appropriate response to the problem would be to temporarily limit the distribution of information by 23andme, without interfering with the data collected by them.

Believe nothing, no matter where you read it, or who has said it- not even if I have said it- unless it agrees with your own reason and your own common sense. - Buddha
Find all posts by this user
Like Post Quote this message in a reply
Post Reply
Forum Jump: