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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.

Conscious Choice cover

Now available in hardback and paperback as well as ebook!

 

From the press release: In this ground-breaking new history of early America, historian Robert Zimmerman not only exposes the lie behind The New York Times 1619 Project that falsely claims slavery is central to the history of the United States, he also provides profound lessons about the nature of human societies, lessons important for Americans today as well as for all future settlers on Mars and elsewhere in space.

 
Conscious Choice: The origins of slavery in America and why it matters today and for our future in outer space, is a riveting page-turning story that documents how slavery slowly became pervasive in the southern British colonies of North America, colonies founded by a people and culture that not only did not allow slavery but in every way were hostile to the practice.  
Conscious Choice does more however. In telling the tragic history of the Virginia colony and the rise of slavery there, Zimmerman lays out the proper path for creating healthy societies in places like the Moon and Mars.

 

“Zimmerman’s ground-breaking history provides every future generation the basic framework for establishing new societies on other worlds. We would be wise to heed what he says.” —Robert Zubrin, founder of founder of the Mars Society.

 

All editions are available at Amazon, Barnes & Noble, and all book vendors, with the ebook priced at $5.99 before discount. The ebook can also be purchased direct from my ebook publisher, ebookit, in which case you don't support the big tech companies and I get a bigger cut much sooner.

 

Autographed printed copies are also available at discount directly from me (hardback $24.95; paperback $14.95; Shipping cost for either: $5.00). Just email me at zimmerman @ nasw dot org.

2 comments

  • ken anthony

    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.

  • Edward

    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.

Readers: the rules for commenting!

 

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