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FDA have banned interpretation of health related DNA results
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NDW
Grub
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FDA have banned interpretation of health related DNA results
I have just logged onto 23andme.com and have read that there will be no more interpretation of health results regarding DNA tests pending an FDA decision.
"December 6 2013: Pending an FDA decision, 23andMe no longer offers new customers access to health reports. Customers who received their health information prior to November 22, 2013 will still be able to see their health reports, but those who purchased after that time will only receive their ancestry information as well as access to their uninterpreted raw data. These new customers may receive health reports in the future dependent on FDA marketing authorization"
https://www.23andme.com/health/
Is this an undeniable attempt by the FDA to keep us all sick and ill?
"December 6 2013: Pending an FDA decision, 23andMe no longer offers new customers access to health reports. Customers who received their health information prior to November 22, 2013 will still be able to see their health reports, but those who purchased after that time will only receive their ancestry information as well as access to their uninterpreted raw data. These new customers may receive health reports in the future dependent on FDA marketing authorization"
https://www.23andme.com/health/
Is this an undeniable attempt by the FDA to keep us all sick and ill?
Grub- Posts : 146
Join date : 2012-03-18
Re: FDA have banned interpretation of health related DNA results
Na. 23andme is a rogue company. There is actually a class action lawsuit against them. They have been ignoring the FDA. FDA just doing its job.
NDW- Posts : 216
Join date : 2011-06-18
Re: FDA have banned interpretation of health related DNA results
"Genes" controlling our health is one of the silliest ideas coursing through the veins of medical culture. If anyone is interested, check out Cold War in Biology by Carl C. Lindengren.
droddy- Posts : 297
Join date : 2011-01-10
Re: FDA have banned interpretation of health related DNA results
23andme.com provided good services. Just two possibilities that it told people to look into were hemochromatosis and MTHFR. That they should look into it further if they have just these two common issues.
That they may need frequent blood donations if they have the common hemochromatosis (iron overload) issue which is common in those of European descent. And another is they may need to supplement folate if they have common MTHFR issue.
Personally see no reason to ban the services they gave and in my eyes is the equivalent of modern day book burning or revoking licenses away from doctors who don't follow the standard narrow protocols given to them. People do not need less information given to them. They need more information. If they use the information wrong, then it was that persons fault. Not 23andme.com's.
Here's one quote
That they may need frequent blood donations if they have the common hemochromatosis (iron overload) issue which is common in those of European descent. And another is they may need to supplement folate if they have common MTHFR issue.
Personally see no reason to ban the services they gave and in my eyes is the equivalent of modern day book burning or revoking licenses away from doctors who don't follow the standard narrow protocols given to them. People do not need less information given to them. They need more information. If they use the information wrong, then it was that persons fault. Not 23andme.com's.
Here's one quote
After years of living with fibromyalgia, fatigue, anxiety, panic, demyelination of white brain matter, multiple lesions on the brain, MS like symptoms, internal bleeding, septic shock, pulmonary embolisms, brain aneurysm, dissected carotid artery, hashimoto’s and just overall declining health, I decided it was time to give up or dig deeper and get DNA analysis. I first went to the geneticist who told me there was no need to check any further and that they would not be able to tell me why I was sick and only declining. I mentioned to this doctor that I was going to look into 23andme. He told me that 23andme was useless and too hard to understand. Little does he know that because of 23andme, I’m getting my life back. At one time I was on over 20 prescription medications a day and now I am down to two. In the next year I hope to be off of the other two medications.
http://www.mthfrsupport.com/sharing-mthfr-and-23andme-stories/
Business as Usual: FDA Prevents Citizens from Analyzing Their Own DNA
On November 22, the FDA sent a warning letter to 23andMe.com to stop its inexpensive ($99 per test) “do-it-yourself” genetic testing service for health screening and ancestry purposes, because consumers could be “misled” and harm themselves by “self-treating.” For example, the FDA posits that an individual who learns they have a predilection for cancer would, as a result, undergo unnecessary preventive surgery, chemotherapy, and other “morbidity-inducing actions.”
The FDA’s argument is, quite clearly, a straw man: of course patients have to obtain medical advice before making major health decisions—it’s not as if consumers can go under the knife without significant medical consultation! The FDA’s true message is clear: because individuals can’t be trusted to make sound health decisions, they don’t have a right to private information on their own DNA.
It’s also worth noting that FDA action against 23andMe was sparked, in part, by a complaint by UnitedHealth Group, the largest publicly traded health insurer. UnitedHealth isn’t exactly an unbiased observer—they want access to information about your DNA. After all, if individuals were allowed to keep their DNA test data private, they wouldn’t have to share their results with insurers who, for example, could use an inherited health risk to deny insurance or charge exorbitant rates.
The FDA’s stance on DIY genetic testing could very well drive up healthcare costs. Besides premiums being raised on those forced to report DNA results to insurance companies, in-office testing is far more expensive. As tests are priced anywhere from $300 to $3,500, this could significantly add to the overall cost of healthcare.
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This, of course, should be unconstitutional. However, violation of citizen's right has become the norm due to special interest groups.
We do, from time to time, have national heroes who effectively deal with government suppression. The CEO of Uber Taxi shows how to do it. Tesla Motors is using similar strategies to bypass car dealer monopolies that suppress competition.
As Harvard Business Review points out, the healthcare system is in need of total disruption as it suppresses innovation that causing increased deaths in the population. This is one of the reasons that the U.S. healthcare system is number 38 in the world, roughly equivalent to some developing nations. Yet many of our citizens think U.S. healthcare is the best in the world because we spend more money per capita on healthcare than any other nation.
1 France 4 2 Italy 11 3 San Marino 21 4 Andorra 23 5 Malta 37 6 Singapore 38 7 Spain 24 8 Oman 62 9 Austria 6 10 Japan 13 11 Norway 16 12 Portugal 27 13 Monaco 12 14 Greece 30 15 Iceland 14 16 Luxembourg 5 17 Netherlands 9 18 United Kingdom 26 19 Ireland 25 20 Switzerland 2 21 Belgium 15 22 Colombia 49 23 Sweden 7 24 Cyprus 39 25 Germany 3 26 Saudi Arabia 63 27 United Arab Emirates 35 28 Israel 19 29 Morocco 99 30 Canada 10 31 Finland 18 32 Australia 17 33 Chile 44 34 Argentina 15 35 Denmark 8 36 Dominica 70 37 Costa Rica 50 38 United States 1
http://blog.frequencyfoundation.com/2013/12/business-as-usual-fda-prevents-citizens.html
ubraj- Posts : 2245
Join date : 2009-06-19
Re: FDA have banned interpretation of health related DNA results
Notice how the FDA has not banned similar services of similar companies. It was only 23andme. From a consumer's perspective I'm sure they are a great company, but from a regulatory one, they are fools.
NDW- Posts : 216
Join date : 2011-06-18
Re: FDA have banned interpretation of health related DNA results
My guess is that the medical cartel, which includes the FDA wants to keep consumer access and independence limited, so that we will be subject to their inflated prices.
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Re: FDA have banned interpretation of health related DNA results
I've never heard of any other DIY testing. If one does exist please post it here as it would benefit many people that I can send it to.
Thank you.
Thank you.
ubraj- Posts : 2245
Join date : 2009-06-19
Re: FDA have banned interpretation of health related DNA results
Dear 23andMe Customers,
I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.
It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well.
23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.
I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.
I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.
Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.
Anne Wojcicki
Co-founder and CEO, 23andMe
I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.
It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well.
23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.
I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.
I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.
Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.
Anne Wojcicki
Co-founder and CEO, 23andMe
sanderson- Posts : 1198
Join date : 2012-03-13
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