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Death Kits: Would You Purchase Your Genetic Fate?

Death Kits: Would You Purchase Your Genetic Fate?

How interested are you in knowing your risk of dying? If the whole truth is what you’re after, it may be closer than you think… as a new kit that tells you your risk of dying gets ready to hit the market.

23andMe Inc., which is backed by Google, has been marketing a $99 genetics test that will assess your risk for more than 240 health conditions. The only snag? They aren’t getting along so well with the Food and Drug Administration.

The FDA wrote in a†letter to 23andMe that after “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, you have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and the FDA has not received any communication from 23andMe since May.” Rut-ro. Over at Mother Jones, Kevin Drum†wrote off 23andMe as another start-up that “apparently believes federal laws apply only to ordinary mortals.” None of this is sounding good.

Luckily, the media attention seems to have sparked something within the company. “We recognize that we have not met the FDAís expectations regarding timeline and communication regarding our submission,” the company said in a statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.” They recently stopped marketing the kit until they can get their affairs in order.

As embarrassing as this whole public ordeal may have been, especially for a new company, it does raise the question of whether or not the rules that are currently in place by the FDA are necessary, not-to-be-messed-with parameters or just outdated laws that are getting in the way of groundbreaking inventions.

“The legal question is pretty simple,” said Daniel Carpenter, author of Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. “The definition of a device under the Federal Food, Drug and Cosmetics Act is anything intended for the use or diagnosis of a disease or other conditions.” These definitions were set up in 1938 and not updated much until 1976. According to the Washington Post, the personal genetic test and the personal medicine behind it didnít exist when the regulations were written.

If 23andMe is able to get off the ground, what it hopes to start is a traditional pay-for-product model where consumers pay $99 for a kit that helps them test and mail in their saliva, later receiving a genetic report on their health. In the long term, the company would like to take the genetic information they receive from their individual clients and study the data to help uncover medical connections, find disease markers and discover treatments. Really cool, so long as you’re okay with your information being used.

Since the FDA can’t really balk at allowing consumers to swab their own spit (not much risk there), they’ve instead focused on the fear of what these kinds of results might do mentally to the people who sign up for them. Sure, you might think you’re ready for anything… but what if you go through the process and find out you’re positive for a cancer gene. There’s the more serious idea that you might be so upset that you harm yourself, but there’s also the chance that you’ll undergo chemoprevention and intensive screening. But what if it was a false positive and another real problem goes undetected? I’d probably say better safe than sorry (though I’m sure the stress associated with the whole ordeal wouldn’t be very welcome). But the FDA isn’t buying it. The question then becomes, are they responsible for policing your reaction to possible bad news?

“This is a new problem, and we need a new regulatory architecture for it,” said Carpenter, who thinks the FDA should be focusing on ensuring that the science beneath these kinds of genetic tests is sound instead of worrying about how people might react to it.

So what do you think? Should kits like these be allowed on the market? What changes would you like to see before they’re made available? And should the FDA be more willing to bend on old rules, if the time and science calls for it?

Source: Washington Post

Photo by ACME/flickr.com

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Lo Lankford

Lo Lankford is a recent Los Angeles transplant after a decade in the Big Apple. In her "spare time" (ha!) she used to run a dog rescue called Badass Brooklyn and helped save over 400 dogs. Otherwise? Nerd'do well, whistle blower, proud hillbilly from the sticks.

144 comments

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2:26PM PST on Mar 2, 2014

Personally, I think this is extremely morbid; although there are plenty of hypochondriacs out there who would just LOVE to make their individual claims of "feeling sick" or feeling bad" all the time more valid (alleged reasons ~vs~ actual problems - lol).

Besides, NO test can successfully predict death OR how one will pass; plus, the will to live is a very strong one, as I'm sure many people (especially those who are cancer survivors) will attest!! As for me, I'm just putting my faith and trust in God and when He "calls me home", that will be my "time" to go!! Meanwhile, all I can do is try to obey and follow Him, loving and helping all those I'm able, as He's taught us to do.

I'm sure some will disagree with me and that's their right...this is only MY feeling on the subject matter in this article! However, it is a bit interesting, in theory.

11:55AM PST on Mar 1, 2014

The body disintegrates into ashes, after the bugs have had their way, so why not donate it science. Hopefully, some useful parts can be given to someone who needs them to improve or save their life.
I have made my wishes clear to my family, so this can be done quickly after death, in order for another useful purpose. What better legacy can you leave this planet? Besides, imagine how happy you could make someone else.

If you believe in god and/or karma, what better method could you use to improve your after life?

7:43AM PST on Mar 1, 2014

Yes, I would like to know when I am about to pass-on to wherever, asap!!

3:52AM PST on Feb 27, 2014

I always no one is promised tomorrow, who knows what will happen? So would I want to know if it was possible to say when I will die, no I don't would rather leave it as it is.

2:41AM PST on Feb 25, 2014

Thanks.

1:33AM PST on Feb 25, 2014

Thank you :)

2:44PM PST on Feb 24, 2014

One things for sure.

If you don't order one.

You'll be 99. ahead, & trust me.

Even with the cheapest cremation, your heirs will have a better place to spend it.

8:30PM PST on Feb 21, 2014

Given a choice, I'm not certain I would want to know exactly when my time comes.

11:25AM PST on Feb 21, 2014

I don't want to know ... I want my life to unfold as God wants and besides ... I know my fate. We will ALL die eventually. Some early and some late.

4:34PM PST on Feb 20, 2014

Thanks

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Disclaimer: The views expressed above are solely those of the author and may not reflect those of
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