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Think Before You Spit

Think Before You Spit

I went in with an open mind, enthusiastic to discover more. However, I have emerged with deep concerns about privacy, the ability to withdraw from medical research, and who really owns one's data — FlourishAnyway

     
Think Before You Spit
image by: The Beauty Boy

Advances in DNA testing are making it very easy for people to learn about their genetic makeup and to find out where their ancestors came from. Since 2007, 23andMe has provided consumers with low-cost genetic testing kits that promise to answer the questions; who and what are we?

All you have to do is spit in a vial and send them your saliva along with a check for $99, of course. Once your check clears, 23andMe will study your DNA and send you a comprehensive report detailing your overall health, your inherited traits, your predispositions, and a little story about where your ancestors came from. Sounds fascinating, right?

But, do you really understand what you’re getting yourself into when you send in your sample? Probably not.

Of all the at-home DNA testing companies 23andMe is the most well known. However, it’s been a very bumpy road for the company. For example, in 2007, the FDA turned a blind eye to the information that 23andMe was providing their customers. After all, what harm was there in telling someone that they’re predisposed to having dry earwax, or male pattern baldness? Not much.

Fast forward a few years and a few hundred thousand customers. 23andMe starts providing customers with very specific information about their overall health, such as whether a person has an increased risk of developing breast cancer, or a metabolic disease, or whether they’re likely to have a bad reaction to certain medications. This made the FDA very unhappy with 23andMe.

Why? Because the health related information that 23andMe was providing its customers required very specific FDA approvals. According to federal law, “any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is a ‘medical device’ that needs to be deemed safe and effective by the FDA.” But 23andMe chose to bypass the FDA approval part. Uh-oh.

In 2009, 23andMe started negotiating with the FDA and in 2012, they officially started the clearance and approval process so that they could legally sell the kits that they had already been selling for five years. However, in early 2013, 23andMe ignored all FDA imposed deadlines, let their applications expire, and ignored all emails and phone calls, essentially cutting ties and putting an end to the clearance process. The FDA did not take this well, and imposed a moratorium on all sales of test kits sold by 23andMe because they “lacked agency authorization.” Uh-oh again.

Why would 23andMe act in such a reckless manner? It makes me think that providing genetic information to consumers wasn’t their intention in the first place. Think about this. Why would a company clearly involved in collecting and analyzing DNA samples and selling medical devices thumb their nose at the governing body of all medical devices? Because the service 23andMe intended to provide had nothing to do with medical devices and the dissemination of health related information. Rather, 23andMe was collecting and stockpiling massive amounts of genetic information. I know this sounds a bit wacky, like Trump wacky, but it’s not.

23andMe’s co-founder, Anne Wojcicki recently said that the company’s goal has always been to “facilitate scientific research about genetics in a brand new way.” Providing people with information about their health and ancestry was simply a way to get people to unwittingly agree to provide their DNA for said research. Still think it’s wacky?

Okay. Let’s do the math: it makes more sense.



23andMe's business plan was never to just sell genetic test kits to the public for $100. Even as the company reached its first goal of 1 million users and made $100 million in revenue because that’s a miniscule amount of money in the biotech world and chump change for Google and Facebook. Oh, did I forget to mention that Google and Facebook are 23andMe’s biggest investors? They are, and $100 million over a 10 year period is nothing to them.

So, what is their plan? 23andMe is building a massive database. A database comprised of people who are sharing not only their DNA, but also their most personal details such as information about their sexual preferences, exposure to pesticides, drug and alcohol use, diet, and mental health via a required questionnaire.

What are they doing with this info?

Phase 1

23andMe has information about you that other companies will pay a lot of money to have access to. For example, 23andMe has already partnered with and sold your information to 12 pharmaceutical companies, such as Genentech and Pfizer. Each company paid an average of $50 million to 23andMe.

Phase 2

23andMe is actively searching out and collecting DNA from millions of people who suffer from diseases such as Parkinson’s, Alzheimer’s, and cancer. They are using this genetic material to identify the cause of these conditions through genetic pattern matching. This could lead to cures for people who have these diseases as well as the means to prevent them from ever happening in the first place. Sounds benign, right?

Phase 3

Medical patents - they already have one for designer babies. Developing and holding a medical patent on the regions in our DNA that are responsible for certain diseases and any potential therapies that arise would make billions of dollars for 23andMe. 23andMe is on its way to becoming an unstoppable powerhouse in the biotech field.

Finally, have you thought about who owns your information once you submit it? You, or 23andMe?

23andMe does. Although, way down, in the teeny, tiny print 23andMe gives you the opportunity to opt-out. Which says that they won’t use your DNA in research or share your information. However, that’s a bit of a lie because there really is no real way to opt-out. Also in the teeny, tiny print it states that even if you opt-out 23andMe has the right to use your “information for internal purposes.” What the hell does that mean?

There are many reasons to be wary of genetic testing, especially in a world of hackers, data breaches, and pre-existing condition disqualifiers. Do you really want information in a database that says you will develop Alzheimer’s Disease or cervical cancer in the next 20 years? Even more frightening, do you want that information in a database that life insurance and health insurance companies use to determine whether or not you're eligible for coverage? I don’t.

Be really careful, once you provide your information to 23andMe it can never be taken back. And, no matter how curious you are, the benefits that 23andMe provides pale in comparison to its risks.

Think before you spit.


Stacy Matson is a health enthusiast from Southern California and regularly blogs on Celebrity Health for A Healthier World, as well as contributing to the Best of Best.

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Last Updated : Wednesday, August 9, 2017