The FDA and its regulation of genetic data purchased by Americans
Link here. The article is a detailed history of the company 23andMe, which offers individuals a way to get their personal genetic data. The company was growing and flourishing, providing data to its customers, until the FDA stepped in.
In 2009, the FDA started asking 23andme for evidence that the company’s products worked as advertised and wouldn’t harm customers. The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives. Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant.
The next years were difficult ones for 23andme. It communicated with the agency on a few occasions and promised in January 2013 that data would be forthcoming. According to the FDA, it then ceased communicating with regulators entirely in May, even as it started a new advertising campaign. Fed up, the agency sent [Anne] Wojcicki [company CEO] a strongly worded warning letter on 22 November 2013 ordering her company to stop marketing its product.
It was a self-inflicted wound for the company. “There was a bit of arrogance,” says Richard Scheller, who was an executive at Genentech at the time. As a result, 23andme was forced to drastically cut its customer offerings, threatening its viability.
Wojcicki was stunned. “It became clear that we had pissed them off,” she says. “I really didn’t know that we had done so many things that angered them.”
Soon after the letter arrived, Wojcicki called Kathy Hibbs, a lawyer then working for Genomic Health, a gene-testing company in nearby Redwood City, California. “Can I get my whole company back in one year?” Wojcicki asked Hibbs.
“You can get it back, but it will take years,” Hibbs replied. And to get there, she counselled, Wojcicki would have to cooperate with regulators.
It was a tough adjustment for Wojcicki; she didn’t think that the FDA should be able to stop customers from learning their own genetic information. But Hibbs and others convinced her that capitulating to the FDA’s demands was the fastest way to rescue her company. [emphasis mine]
The FDA’s high and mighty attitude here really offends me. It appears that before and after their demands, nothing really changed. All that had happened was that a government agency took control of a private company’s operation, coming between it and its customers. Right now it limits the data that the company can release to its customers, the people that pay for the service in order to obtain their own genetic data.
In other words, the FDA doesn’t think ordinary people are smart enough to see their own data. If that doesn’t capture the arrogance of government, I don’t know what does.
Readers!
My annual February birthday fund-raising drive for Behind the Black is now over. Thank you to everyone who donated or subscribed. While not a record-setter, the donations were more than sufficient and slightly above average.
As I have said many times before, I can’t express what it means to me to get such support, especially as no one is required to pay anything to read my work. Thank you all again!
For those readers who like my work here at Behind the Black and haven't contributed so far, please consider donating or subscribing. My analysis of space, politics, and culture, taken from the perspective of an historian, is almost always on the money and ahead of the game. For example, in 2020 I correctly predicted that the COVID panic was unnecessary, that the virus was apparently simply a variation of the flu, that masks were not simply pointless but if worn incorrectly were a health threat, that the lockdowns were a disaster and did nothing to stop the spread of COVID. Every one of those 2020 conclusions has turned out right.
Your help allows me to do this kind of intelligent analysis. I take no advertising or sponsors, so my reporting isn't influenced by donations by established space or drug companies. Instead, I rely entirely on donations and subscriptions from my readers, which gives me the freedom to write what I think, unencumbered by outside influences.
You can support me either by giving a one-time contribution or a regular subscription. There are four ways of doing so:
1. Zelle: This is the only internet method that charges no fees. All you have to do is use the Zelle link at your internet bank and give my name and email address (zimmerman at nasw dot org). What you donate is what I get.
2. Patreon: Go to my website there and pick one of five monthly subscription amounts, or by making a one-time donation.
3. A Paypal Donation or subscription:
4. Donate by check, payable to Robert Zimmerman and mailed to
Behind The Black
c/o Robert Zimmerman
P.O.Box 1262
Cortaro, AZ 85652
You can also support me by buying one of my books, as noted in the boxes interspersed throughout the webpage or shown in the menu above.
Link here. The article is a detailed history of the company 23andMe, which offers individuals a way to get their personal genetic data. The company was growing and flourishing, providing data to its customers, until the FDA stepped in.
In 2009, the FDA started asking 23andme for evidence that the company’s products worked as advertised and wouldn’t harm customers. The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives. Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant.
The next years were difficult ones for 23andme. It communicated with the agency on a few occasions and promised in January 2013 that data would be forthcoming. According to the FDA, it then ceased communicating with regulators entirely in May, even as it started a new advertising campaign. Fed up, the agency sent [Anne] Wojcicki [company CEO] a strongly worded warning letter on 22 November 2013 ordering her company to stop marketing its product.
It was a self-inflicted wound for the company. “There was a bit of arrogance,” says Richard Scheller, who was an executive at Genentech at the time. As a result, 23andme was forced to drastically cut its customer offerings, threatening its viability.
Wojcicki was stunned. “It became clear that we had pissed them off,” she says. “I really didn’t know that we had done so many things that angered them.”
Soon after the letter arrived, Wojcicki called Kathy Hibbs, a lawyer then working for Genomic Health, a gene-testing company in nearby Redwood City, California. “Can I get my whole company back in one year?” Wojcicki asked Hibbs.
“You can get it back, but it will take years,” Hibbs replied. And to get there, she counselled, Wojcicki would have to cooperate with regulators.
It was a tough adjustment for Wojcicki; she didn’t think that the FDA should be able to stop customers from learning their own genetic information. But Hibbs and others convinced her that capitulating to the FDA’s demands was the fastest way to rescue her company. [emphasis mine]
The FDA’s high and mighty attitude here really offends me. It appears that before and after their demands, nothing really changed. All that had happened was that a government agency took control of a private company’s operation, coming between it and its customers. Right now it limits the data that the company can release to its customers, the people that pay for the service in order to obtain their own genetic data.
In other words, the FDA doesn’t think ordinary people are smart enough to see their own data. If that doesn’t capture the arrogance of government, I don’t know what does.
Readers!
My annual February birthday fund-raising drive for Behind the Black is now over. Thank you to everyone who donated or subscribed. While not a record-setter, the donations were more than sufficient and slightly above average.
As I have said many times before, I can’t express what it means to me to get such support, especially as no one is required to pay anything to read my work. Thank you all again!
For those readers who like my work here at Behind the Black and haven't contributed so far, please consider donating or subscribing. My analysis of space, politics, and culture, taken from the perspective of an historian, is almost always on the money and ahead of the game. For example, in 2020 I correctly predicted that the COVID panic was unnecessary, that the virus was apparently simply a variation of the flu, that masks were not simply pointless but if worn incorrectly were a health threat, that the lockdowns were a disaster and did nothing to stop the spread of COVID. Every one of those 2020 conclusions has turned out right.
Your help allows me to do this kind of intelligent analysis. I take no advertising or sponsors, so my reporting isn't influenced by donations by established space or drug companies. Instead, I rely entirely on donations and subscriptions from my readers, which gives me the freedom to write what I think, unencumbered by outside influences.
You can support me either by giving a one-time contribution or a regular subscription. There are four ways of doing so:
1. Zelle: This is the only internet method that charges no fees. All you have to do is use the Zelle link at your internet bank and give my name and email address (zimmerman at nasw dot org). What you donate is what I get.
2. Patreon: Go to my website there and pick one of five monthly subscription amounts, or by making a one-time donation.
3. A Paypal Donation or subscription:
4. Donate by check, payable to Robert Zimmerman and mailed to
Behind The Black
c/o Robert Zimmerman
P.O.Box 1262
Cortaro, AZ 85652
You can also support me by buying one of my books, as noted in the boxes interspersed throughout the webpage or shown in the menu above.
a government agency took control of a private company’s operation
Isn’t this the very definition of fascist?
…and then the left accuses the right of being fascist for the left’s deep state tactics.
It’s a tangled web they weave.
ken anthony rhetorically asked: “Isn’t this the very definition of fascist?”
Well, what do you know? It is the very definition of fascism.
http://www.dictionary.com/browse/fascism
“1. a governmental system led by a dictator having complete power, forcibly suppressing opposition and criticism, regimenting all industry, commerce, etc., and emphasizing an aggressive nationalism and often racism.”
http://www.dictionary.com/browse/regiment
“3. to manage or treat in a rigid, uniform manner; subject to strict discipline.“