23andMe bows to FDA, drops all medical information from new tests
After a partial attempt to get the Food and Drug Administration to ease up on its complaints, the personal genetics company 23andMe took a rather substantial step yesterday: it pulled all medically relevant information from its site, replacing its normal home page with a disclaimer. This move doesn’t meet the FDA’s original demand—that the company stop selling testing kits entirely—but it does suggest that 23andMe is now taking the issue seriously.
In late November, the FDA sent an open letter to 23andMe, noting that the company is offering a service that fits the legal definition of a medical device and is therefore subject to regulatory oversight. In fact, the company and agency had been negotiating for years regarding how best to bring the genetic tests into compliance.
You guys. This is unbelievable. 23andme.com is one company which should be celebrated. It is an example of a revolution in health. They are a shining example of a site which does things right, which goes above and beyond in providing detailed and comprehensive information about genetic testing and propensity for diseases and disorders to people.
For the cost of a $99 test I found out that my risk for getting a type of glaucoma called exfoliation glaucoma is three times higher than normal. This information is priceless. Because of it I am now vigilant about my eyesight and will make sure to have more frequent checks for early symptoms of glaucoma.
Glaucoma is a disease for which there is no cure, but catching it very early on – before symptoms occur which would incite one to see an eye doctor – is the difference between being able to significantly delay its onset and saving eyesight for many years, or being on an early track to blindness.
How in the hell can my federal government say that there is anything wrong with a company providing that information to me?!? What the hell is going on here? Beyond that, its my fucking DNA and if I want to give it to someone to examine it more closely and report back to me about it, that is my and only my business.
Its not just the case with exfoliation glaucoma – there are results for things like the BCAA genetic variations which incur a significantly increased risk of breast cancer. It was because of this same knowledge that actress Angelina Jolie had a preventative mastectomy and was celebrated as a hero for what she did.
Now our federal government is trying to say that we do not have a right to this information? Are you fucking kidding me?
And not just breast cancer and glaucoma – a host of other conditions: Alzheimer’s, Parkinson’s, bipolar disorder, etc. The list goes on.
The results of 23andme.com can be kind of scary at first, but ultimately they are empowering and invaluable to anyone who wants to make informed choices about their lifestyle and health, to have a better life. How the fuck can our federal government have gotten this so wrong and now has blocked 23andme.com from providing these results to people?
There are completely false claims that 23andme.com is somehow careless, capricious, or haphazard in its providing of results. Nothing can be further than the truth. 23andme.com sets the model for providing comprehensive, highly detailed information. Before a person is even allowed to access certain pages for results regarding risk factors for certain serious conditions, they are forced to click through interstitial pages which warn and provide detailed information about what the results do and don’t mean and about the importance of obtaining genetic counseling.
23andme.com sets a high bar for a completely new type of health service, based on cutting-edge scientific research that is continually being updated, and for this they have been unfairly shot down and almost demonized. Something is seriously amiss.
Its time to write President Obama and write our congressional representatives and explain that there’s a serious problem with the FDA’s decision. Whoever is responsible for the decision should be fired because it is totally inexcusable.
Go to votesmart.org and enter your ZIP code. Find your Congressional representatives there and contact them via their webmail pages.
By the way, filling out the webmail forms is one very useful function provided by Lastpass, which I’ve written about many times before. Lastpass has the ability to create a “fill form profile” – essentially your name and address which it can then automatically fill out forms like the congressional webmail submission forms.
People who care about our government, our democracy, and our society are people who will take the time to learn these types of tools and do these things now and then.
Bay Area Company’s $99 DNA Test Sparks Healthcare Revolution
MOUNTAIN VIEW (KPIX 5) — For $99, and a little bit of spit, a Bay Area company is providing a health care revolution. The revolution comes in the form of a test that arrives at your home in a little box.
KPIX 5 spoke to Lynn Dee and Craig Bolleson when they opened the box and took the test, a DNA test from a Mountain View-based biotechnology and genomics company called 23andMe.
“I think it’s exciting,” said Lynn Dee.
“I love the idea of being able to do something we never could have done 10-15 years ago,” exclaimed her husband Craig, “and, now it’s really become affordable.”
The Bolleson’s have been married for 17 years and have three children. They want to stay healthy for as long as possible, especially for their kids.
When they cracked open the box, the pair discovered the test is pretty simple. Individuals who take the test enter a code that will connect the test to their identities, spit into a tube, and mail it back to 23andMe.
In just a few weeks, test takers log back on to the website and get results. The test and the analysis costs just $99.
The couple wants to find out if they have an increased risk for certain health conditions, such as Alzheimer’s, heart disease or cancer. The results may offer a roadmap on what they can do to stay healthy.
“If I can get a handle on something in advance, I’ll do whatever it takes,” Craig said.
“I’ll definitely take action,” said Lynn Dee, adding that she would bring her results to her health care professional for advice.
… [continue reading]
One last thing: I did mention in one of my first posts about 23andme.com the serious issue about giving consent to 23andme to use your DNA. I wrote:
By the way, when I was going through the kit registration it earlier asked if I consent to allow 23andme to do research with my DNA. The answer to this should be an overwhelming NO. Why? Because they can use the information from DNA to create patents for things like cures for diseases, then charge sick people outrageous amounts of money for treatments or even just for tests. I absolutely don’t want to support this.
I will only ever consent to allow my DNA to be used for research if it is for non-profit purposes for the benefit of all humanity.
I still believe that. 23andme has a unique angle on being able to obtain this information and hence to potentially be able to patent before it would be able to become public domain. I believe that genetic data is not something that any companies should patent.
I do support the government making sure that users of services like 23andme are fully aware about the consent choices they are offered and to require companies to make it clear to users that they do not need to ever give consent.
By the way, this whole sordid affair makes me think how a situation like this could even have arisen. The sad truth is, I’m willing to bet, that a significant majority of elected representatives would flunk the Pisa math test for 15-year-olds.
So many of these fuckers are good at standing at a podium and spewing out hot air, or sending out a small forest’s-worth of mailings at campaign time filled with complete bullshit and negative attack ads against opponents, but lack the mental competence to conduct the basic functions of government, much less be responsible for things like education, health and safety, the economy, civil rights, defense, etc. Its the same bullshit.
This is why we have failures like this, why we have draconian measures imposed by government bodies which are supposed to oversee and protect consumers but ultimately which benefit large corporations and help fuck over consumers, because the politicians responsible for oversight are too fucking incompetent to even know what the fuck is going on.
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