From my cold dead… Spit!?
In November 2013, the Food and Drug Administration took it upon itself to ban the at-home, personal genome service 23andMe.
This is unimaginably stupid, and if the decision isn’t reversed, it will have a long-lasting impact on healthcare innovation for years to come.
WTF is 23andMe?
23andMe is a rapid gene testing company. That work(ed) like so:
- You pay them $99
- They send you a box with a special plastic tube
- You spit into the tube (a lot), and seal it shut
- Put the tube full of your geney spit into the box
- Mail the box back to 23andMe
- 23andMe does science!
- A few weeks later you get an email telling you that your results are ready to view online
Pretty straightforward, but nifty stuff.
The results (like this site) span the range of practical, interesting and trivial information about your body, and things you can expect from it over time.
- Eye color
- Earwax consistency
- Ability to metabolize alcohol
- Cancer risks
- Risks for tons of other diseases
And it presents all of this information in a beautifully designed, easy-to-read format. The presentation of health information on the site is an incredible feat on its own. It’s even cooler because everything is pertinent to you and your genes.
In my case, I mostly confirmed a ton of things I already knew (more on that in a bit) or suspected from carefully following my family’s medical history… But 23andMe did explain my laughable tolerance for alcohol.
In addition to the medical information, 23andMe gives a massive amount of ancestry information, allowing you to meet distant relatives through their site. It’s neat stuff, and at times it’s a bit strange.
The FDA banned that?
Technically the FDA didn’t ban the testing… They banned the spit tube. The FDA didn’t really have standing to ban the test, so they classified the spit tube as a medical device… Like a pacemaker.
Pretty lame loophole right?
The FDA is concerned that people will make bad medical decisions based on the gene report. It’s not an unfounded concern because there is a margin of error in your results (and you’ll rarely know if something is incorrect), and genes don’t always react as they are expected to.
Nothing is certain when it comes to our genes. We all have little genetic bombs in us that are likely to detonate, but may lay dormant while something completely unexpected kills us.
What Does the Ban Mean?
23andMe can grandfather in early users. Those of us who used it prior to the ban can still access or data.
Anyone who used the service post-ban can only access ancestry information… Which while it’s interesting is a bit like ordering an ice cream sundae and receiving a cup with a few sprinkles instead.
23andMe is appealing the ban. We’ll see what happens.
Plenty of opportunities to make bad decisions
Have you ever gone on WebMD? Almost any symptom on there will present a range of diseases from common cold to cancer.
People also make bad decisions after visiting psychics, palm-readers and other snake-oil pushers.
And then there are the myriad dietary decisions that people make. People self-diagnose themselves all the time and casually make life-changing decisions with little-to-no information on their own health.
Finally, there’s doctor error. No exaggeration, I have nearly died twice because of misdiagnosis or poor judgment by seemingly competent doctors.
What’s at stake?
Banning 23andMe is banning patients from information about their own bodies. There’s really nothing more personal than your own genes. You should be able to learn about them.
As a teen I complained to my doctor about some very scary symptoms and he ignored me. Told me that it was in my head. I took him at his word because I was young and naive. Sophomore year of college, I almost died in my dorm room because of the very symptoms that I complained about. The problem was fully remedied, and I’m healthier today than I ever was as a child.
Years later my 23andMe results included information about the condition that I was born with and nearly died from. Had I been in possession of my own genetics information, my parents, doctors and I would have known what to look for. A very terrifying chapter in my life could have been completely avoided.
Patients need to be empowered with information about their bodies, not sheltered from it.
Banning 23andMe is a warning to any innovator who might seek to empower patients. Let 23andMe be a beacon of what the 21st century has to offer. Active, empowered, educated patients working with their doctors and loved ones towards better health.
You can help by petitioning the FDA to reverse their decision.
(Story via BoingBoing)