The FDA and its regulation of genetic data purchased by Americans


Genesis cover

On Christmas Eve 1968 three Americans became the first humans to visit another world. What they did to celebrate was unexpected and profound, and will be remembered throughout all human history. Genesis: the Story of Apollo 8, Robert Zimmerman's classic history of humanity's first journey to another world, tells that story, and it is now available as both an ebook and an audiobook, both with a foreword by Valerie Anders and a new introduction by Robert Zimmerman.

 
The ebook is available everywhere for $5.99 (before discount) at amazon, or direct from my ebook publisher, ebookit.

 
The audiobook is also available at all these vendors, and is also free with a 30-day trial membership to Audible.
 

"Not simply about one mission, [Genesis] is also the history of America's quest for the moon... Zimmerman has done a masterful job of tying disparate events together into a solid account of one of America's greatest human triumphs." --San Antonio Express-News

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.

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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.

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