Stopping 23andMe will only delay the revolution medicine needs
Stopping 23andMe will only delay the revolution medicine needs
Stopping 23andMe will only delay the revolution medicine needs
MESO-Rx
Anabolic Steroids
Genome (DNA) Sequencing/Analysis
- Thread starter Michael Scally MD
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The FDA and Thee
Regulators move to control 23andMe's new genetic tests.
Review & Outlook: The FDA and Thee - WSJ.com
The good news is that modern medicine advances at a much faster pace than government, but the bad news is that the regulators eventually catch up. Right on cue, the Food and Drug Administration is now bidding to take over the emerging field of personal genetics.
In a warning letter on Monday, the FDA ordered 23andMe to "immediately discontinue marketing" its genetic tests. Consumers have been mailing in a saliva sample and $99, and the six-year-old Silicon Valley start-up analyzes their genome to reveal information about their predisposition for some 250 diseases, as well as inherited traits and ancestry.
23andMe—named after the number of chromosome pairs in human DNA—does not make diagnoses. The company helps patients and curiosity-seekers to understand their own biology. Patients can also offer their code for research projects—nine of 10 do—to contribute to discoveries about the relationships between genetics and health that could transform traditional medicine. 23andMe has already assembled the world's largest DNA registry for Parkinson's disease.
The FDA can't abide such unsupervised innovation. The agency is declaring 23andMe's service an "adulterated" product under the Federal Food, Drug and Cosmetic Act of 1938, in one more case of 20th-century law undermining medical progress in the 21st.
The FDA lacks any specific statutory authority to regulate genomic sequencing technologies. President Obama knows this, because as a Senator in 2006 and 2007 he introduced bills that would regulate the genomics industry. They never passed. Yet in 2010 the FDA simply decreed by fiat that these tests are considered new medical devices that require premarket testing and approval.
23andMe has been working with the FDA on approval for years, and the agency's letter scolds the company for offering new tests and services before it has received permission for the older versions. Imagine an iPhone app that needed federal approval for every update. But behavior that would be considered visionary in Mountain View is the quickest way to offend the FDA establishment.
The FDA claims that 23andMe merely has to prove that its tests are safe and effective. But what does that even mean given that FDA's main concern seems to be what patients will do with the information the company provides?
The not-so-benevolent paternalists at the FDA write that "serious concerns are raised if test results are not adequately understood by patients," and 23andMe's direct-to-consumer model may inspire people to "self-manage" their care. For example, a false positive for the BRCA1 genetic marker that increases the risk for breast cancer "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions."
Or maybe it would lead a woman to talk to her physician about the options and, er, double check the results before undergoing a life-altering operation.
23andMe told us in a statement that, "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns." That's what companies hostage to the bureaucracy always say, but it might do better to mount a legal counterstrike.
The agency's 2010 regulatory move was extralegal, and the Supreme Court and appellate circuits have begun to rein in the FDA for abridging freedom of speech. The judiciary has held in recent years that regulations on off-label drug use, cigarette labeling and other topics violate the First Amendment, and that people have a right to know basic information about their own bodies and to use it to make decisions about their own lives.
23andMe might also want to start scouting locations for a new overseas headquarters, if only to send a message about how Mr. Obama's regulators are chilling innovation and investment. You can mail a tube of saliva anywhere. The scientists and entrepreneurs helping to lead medicine into the genomic era have little need to operate inside the U.S. if that means begging the government for a hall pass every time they want to do something new and potentially life-saving.
Regulators move to control 23andMe's new genetic tests.
Review & Outlook: The FDA and Thee - WSJ.com
The good news is that modern medicine advances at a much faster pace than government, but the bad news is that the regulators eventually catch up. Right on cue, the Food and Drug Administration is now bidding to take over the emerging field of personal genetics.
In a warning letter on Monday, the FDA ordered 23andMe to "immediately discontinue marketing" its genetic tests. Consumers have been mailing in a saliva sample and $99, and the six-year-old Silicon Valley start-up analyzes their genome to reveal information about their predisposition for some 250 diseases, as well as inherited traits and ancestry.
23andMe—named after the number of chromosome pairs in human DNA—does not make diagnoses. The company helps patients and curiosity-seekers to understand their own biology. Patients can also offer their code for research projects—nine of 10 do—to contribute to discoveries about the relationships between genetics and health that could transform traditional medicine. 23andMe has already assembled the world's largest DNA registry for Parkinson's disease.
The FDA can't abide such unsupervised innovation. The agency is declaring 23andMe's service an "adulterated" product under the Federal Food, Drug and Cosmetic Act of 1938, in one more case of 20th-century law undermining medical progress in the 21st.
The FDA lacks any specific statutory authority to regulate genomic sequencing technologies. President Obama knows this, because as a Senator in 2006 and 2007 he introduced bills that would regulate the genomics industry. They never passed. Yet in 2010 the FDA simply decreed by fiat that these tests are considered new medical devices that require premarket testing and approval.
23andMe has been working with the FDA on approval for years, and the agency's letter scolds the company for offering new tests and services before it has received permission for the older versions. Imagine an iPhone app that needed federal approval for every update. But behavior that would be considered visionary in Mountain View is the quickest way to offend the FDA establishment.
The FDA claims that 23andMe merely has to prove that its tests are safe and effective. But what does that even mean given that FDA's main concern seems to be what patients will do with the information the company provides?
The not-so-benevolent paternalists at the FDA write that "serious concerns are raised if test results are not adequately understood by patients," and 23andMe's direct-to-consumer model may inspire people to "self-manage" their care. For example, a false positive for the BRCA1 genetic marker that increases the risk for breast cancer "could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions."
Or maybe it would lead a woman to talk to her physician about the options and, er, double check the results before undergoing a life-altering operation.
23andMe told us in a statement that, "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns." That's what companies hostage to the bureaucracy always say, but it might do better to mount a legal counterstrike.
The agency's 2010 regulatory move was extralegal, and the Supreme Court and appellate circuits have begun to rein in the FDA for abridging freedom of speech. The judiciary has held in recent years that regulations on off-label drug use, cigarette labeling and other topics violate the First Amendment, and that people have a right to know basic information about their own bodies and to use it to make decisions about their own lives.
23andMe might also want to start scouting locations for a new overseas headquarters, if only to send a message about how Mr. Obama's regulators are chilling innovation and investment. You can mail a tube of saliva anywhere. The scientists and entrepreneurs helping to lead medicine into the genomic era have little need to operate inside the U.S. if that means begging the government for a hall pass every time they want to do something new and potentially life-saving.
23andMe: State of the Debate
23andMe: State of the Debate - Bio-IT World
23andMe: State of the Debate - Bio-IT World
Direct to Consumer Genetic Testing: Science & Regulatory Oversight
Genomics|Update|Current
Genomics|Update|Current
23andMe – Why Our Big Government is Right
http://33charts.com/2013/11/23andme-government-is-right.html
http://33charts.com/2013/11/23andme-government-is-right.html
A red letter day for consumer genomics
A red letter day for consumer genomics | Gene Values
A red letter day for consumer genomics | Gene Values
Science, Regulation, and the Epistemology of Big Data
AmericanScience: A Team Blog: Science, Regulation, and the Epistemology of Big Data
What’s better than a holiday card? “Possibly the worst FDA letter of all time.”
AmericanScience: A Team Blog: What’s better than a holiday card? “Possibly the worst FDA letter of all time.”
AmericanScience: A Team Blog: Science, Regulation, and the Epistemology of Big Data
What’s better than a holiday card? “Possibly the worst FDA letter of all time.”
AmericanScience: A Team Blog: What’s better than a holiday card? “Possibly the worst FDA letter of all time.”
FDA’s Culture Is Mendelian Dominant Over 23andme’s Business Model
http://del-fi.org/post/68560843111/fdas-culture-is-mendelian-dominant-over-23andmes
http://del-fi.org/post/68560843111/fdas-culture-is-mendelian-dominant-over-23andmes
HuGE Navigator - An integrated, searchable knowledge base of genetic associations and human genome epidemiology. http://www.hugenavigator.net/HuGENavigator/home.do
HuGE Navigator provides access to a continuously updated knowledge base in human genome epidemiology, including information on population prevalence of genetic variants, gene-disease associations, gene-gene and gene- environment interactions, and evaluation of genetic tests.
The Human Genome Epidemiology Network (HuGENet™) is a voluntary, international collaboration focused on assessing the role of human genome variation in health and disease at the population level.
Since 2001, HuGENet™ has maintained a database of published, population-based epidemiologic studies of human genes extracted and curated from PubMed. The HuGE Navigator replaces earlier search tools for use with this database and provides additional applications for use by researchers and the public.
HuGE Navigator provides access to a continuously updated knowledge base in human genome epidemiology, including information on population prevalence of genetic variants, gene-disease associations, gene-gene and gene- environment interactions, and evaluation of genetic tests.
The Human Genome Epidemiology Network (HuGENet™) is a voluntary, international collaboration focused on assessing the role of human genome variation in health and disease at the population level.
Since 2001, HuGENet™ has maintained a database of published, population-based epidemiologic studies of human genes extracted and curated from PubMed. The HuGE Navigator replaces earlier search tools for use with this database and provides additional applications for use by researchers and the public.
23andMe Is Terrifying, But Not for the Reasons the FDA Thinks
The genetic-testing company’s real goal is to hoard your personal data
23andMe Is Terrifying, But Not for the Reasons the FDA Thinks: Scientific American
But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.
Sound paranoid?
Consider the case of Google. (One of the founders of 23andMe, Anne Wojcicki, is presently married to Sergei Brin, the founder of Google.)
When it first launched, Google billed itself as a faithful servant of the consumer, a company devoted only to building the best tool to help us satisfy our cravings for information on the web.
And Google’s search engine did just that.
But as we now know, the fundamental purpose of the company wasn’t to help us search, but to hoard information. Every search query entered into its computers is stored indefinitely.
Joined with information gleaned from cookies that Google plants in our browsers, along with personally identifiable data that dribbles from our computer hardware and from our networks, and with the amazing volumes of information that we always seem willing to share with perfect strangers—even corporate ones—that data store has become Google’s real asset.
By parceling out that information to help advertisers target you, with or without your consent, Google makes more than $10 billion every quarter.
What the search engine is to Google, the Personal Genome Service is to 23andMe.
The genetic-testing company’s real goal is to hoard your personal data
23andMe Is Terrifying, But Not for the Reasons the FDA Thinks: Scientific American
But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.
Sound paranoid?
Consider the case of Google. (One of the founders of 23andMe, Anne Wojcicki, is presently married to Sergei Brin, the founder of Google.)
When it first launched, Google billed itself as a faithful servant of the consumer, a company devoted only to building the best tool to help us satisfy our cravings for information on the web.
And Google’s search engine did just that.
But as we now know, the fundamental purpose of the company wasn’t to help us search, but to hoard information. Every search query entered into its computers is stored indefinitely.
Joined with information gleaned from cookies that Google plants in our browsers, along with personally identifiable data that dribbles from our computer hardware and from our networks, and with the amazing volumes of information that we always seem willing to share with perfect strangers—even corporate ones—that data store has become Google’s real asset.
By parceling out that information to help advertisers target you, with or without your consent, Google makes more than $10 billion every quarter.
What the search engine is to Google, the Personal Genome Service is to 23andMe.
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The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe.
The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe.
The Sky is Falling for Personal Genomics! Oh, nevermind. It’s just a cease & desist letter from the FDA to 23andMe.
CLASS ACTION FILED AGAINST 23ANDME FOR FRAUD AND DECEPTIVE PRACTICES
http://www.markankcorn.com/blog/2013/12/2/class-action-filed-against-23andme-for-fraud-and-deceptive-practices
http://www.markankcorn.com/blog/2013/12/2/class-action-filed-against-23andme-for-fraud-and-deceptive-practices
23andMe: Now Come the Trial Lawyer Sharks and the Tort Lottery Players
23andMe: Now Come the Trial Lawyer Sharks and the Tort Lottery Players - Hit & Run : Reason.com
23andMe: Now Come the Trial Lawyer Sharks and the Tort Lottery Players - Hit & Run : Reason.com
A government ban on 23andMe's genetic testing services ignores reality
The FDA is regulating 21st century technology with 20th century policy. There is a role for consumer-driven medical research
A government ban on 23andMe's genetic testing services is ill advised | Rahul Rekhi | Comment is free | theguardian.com
The FDA is regulating 21st century technology with 20th century policy. There is a role for consumer-driven medical research
A government ban on 23andMe's genetic testing services is ill advised | Rahul Rekhi | Comment is free | theguardian.com
23andMe grows up. Works to obtain 510k
Gene Sherpas: Personalized Medicine and You: 23andMe grows up. Works to obtain 510k
Gene Sherpas: Personalized Medicine and You: 23andMe grows up. Works to obtain 510k
23andMe Puts Health Reports on Hold
Personal genetics company 23andMe will only sell ancestry reports and raw data as controversy with regulators continues.
http://www.technologyreview.com/view/522341/23andme-puts-health-reports-on-hold/
Personal genetics company 23andMe will only sell ancestry reports and raw data as controversy with regulators continues.
http://www.technologyreview.com/view/522341/23andme-puts-health-reports-on-hold/
Welcome to 23andMe.
https://www.23andme.com/ancestry-only-notice/?redirect=7yioymjefPWs4p2PsIvfqXHmM414M5RgO9-KCVyYj0o=
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.
If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
Upon entering the site, please confirm you understand the new changes in our services.
https://www.23andme.com/ancestry-only-notice/?redirect=7yioymjefPWs4p2PsIvfqXHmM414M5RgO9-KCVyYj0o=
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.
If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
Upon entering the site, please confirm you understand the new changes in our services.
23andMe Stops Offering Genetic Tests Related To Health
23andMe Stops Offering Genetic Tests Related To Health - Forbes
23andMe Stops Offering Genetic Tests Related To Health - Forbes
FDA Supports Development of Innovative Genetic Tests
Just recently the FDA cleared four diagnostic devices for gene sequencing.
FDA Supports Development of Innovative Genetic Tests — Letters to the Editor - WSJ.com
Just recently the FDA cleared four diagnostic devices for gene sequencing.
FDA Supports Development of Innovative Genetic Tests — Letters to the Editor - WSJ.com
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