I’m sure everyone reading this knows by now that 23andMe has been ordered to stop marketing their DNA test until they comply with previous FDA requirements. I wrote about this earlier. Forbes and several others have weighed in too. The Forbes article is particularly interesting because it is written by Matthew Herper who has covered the FDA for 13 years, so has significant perspective.
Since that time, a firestorm of questions, comments and emotions have been forthcoming, from all directions. As consumers, we feel trapped, caught in the middle of a battle, along with our DNA and results. And sadly, it looks like the battle didn’t have to occur, had 23andMe not ignored the FDA for months after promising results it never delivered. I want to make a couple of comments, then talk about what we, as consumers, can do to prepare for the worst case.
But before I do that, I want to make it very clear that I don’t expect that the worst case scenario will happen. What would that be? 23andMe going out of business. I don’t think that will happen. Even though they, according to the FDA letter, have been negligent in taking care of business and meeting their commitments, they have bright minds and deep pockets….and 15 days to make some sort of conciliatory peace with the FDA. Now I’m not a psychic, but I’m betting that 23andMe headquarters is very busily figuring out all of the things they need to do to put this ugly public chapter behind them. Of course, I could be wrong. This could be the death knell for 23andMe. But I don’t think so, unless they cannot prove the accuracy of their product or they continue to ignore the FDA and fail to meet commitments.
Most of the questions and concerns voiced today by consumers revolve around what will happen to results they already have on the 23andMe website.
There is no reason to think that the results would be removed as long as the website is functional. And their website is their link with the world, so as long as there is 23andMe, there will be a website.
However, the unthinkable has happened before, and 23andMe appears to have been somewhat negligent, so, just in case, what can we do?
1. Print your health results for future reference
On your personal page at 23andMe, select the “Health Overview” option which will then display your elevated risks in each of 4 option categories..
For each of the 4 sections, Health Risks, Inherited Conditions, Traits and Drug Response, there is a blue link at the bottom that says “see all 122 risk reports,” for example. Click on the “see all” link and then simply print the results in each of the 4 categories. If you want to preserve any of the more detailed information in any of the categories, you’ll have to use screen shots.
2. Download your raw data file
Regardless of what you do, or don’t, do with these results, they are yours. After downloading your file, you can simply save the results for later, you can upload them to donation based www.gedmatch.com (when GedMatch is again accepting files, currently estimated to be Dec.1) or you can transfer your file to Family Tree DNA to add your results to their data base and avail yourself of their matches and tools. Right now, the transfer price for either 23andMe or Ancestry files is only $49, which is significantly less than taking a new test at $99 (although the $99 test currently comes with a $100 restaurant.com giftcard.) This gives you the ability to find new matches with people who haven’t tested at 23andMe.
To download your raw data file at 23andMe, sign on to your account, then click on your name in the upper right hand corner of the screen, then on “Browse Raw Data,” then on “Download” in the upper right hand corner of the screen. You’ll then be prompted for your password again and the answer to your secret question. Default will be set to download all data. Leave it that way. You’ll then be asked if you want to open the file or save it. Save it. On a Windows PC, if you don’t direct otherwise, it will be saved in the Downloads directory with a file name where the word “genome_” preceeds the name of the person who tested. Mine is “genome_Roberta_Estes_Full_20131125XXXXXX.
Word of Warning…..
In the past month, 3 of the 5 files I’ve downloaded from 23andMe have been incomplete. I’ve been working with 23andMe for three very frustrating weeks now via e-mail to try to figure out why they are incomplete. So far, I have no answers and I’ve asked if these incomplete files have affected my (and my families) results posted at 23andMe. To date, I’m still getting their standard reply about not being responsible for third party upload sites, which of course is not the question I asked, at all.
A normal 23andMe file will have about 950,000 rows on a spreadsheet, each one representing a single location tested. 23andMe confirmed this number last week. For example, I have 991,000 plus change and my niece has 960,000 plus change. All 3 of the incomplete files have only 574,515 lines each, exactly. And yes, all of them are build 37, and no, they did not test at the same time. I even downloaded them a second, third and fourth time, from different locations using different computers, etc. The files are simply massively incomplete.
These incomplete files cannot be uploaded and utilized by other tools (www.gedmatch.com) or firms, including Family Tree DNA because 40% of the data is missing.
Given this experience, the FDA’s concerns about accuracy have certainly given me pause to reflect….
You can get a good idea as to whether your file is complete or not by the zipped file size when it downloads. The zipped size of the incomplete files is around 5K (4901 to be exact) and the zipped size of the correct files is about 8K (8262 and 8013K to be exact).
Good luck getting help if your file is incomplete. In order to contact the 23andMe customer service department, you have to jump through hoops, stand on your head, pat your stomach and rub your foot at the same time while chewing gum and blowing bubbles. Ok, tiny exaggeration. You really only have to click on “help” then use the “what’s your question” function, and then at the end of that exercize when you don’t receive the answer you need, you can submit a question to them via a form….but not until you go through that process. They’ll get back with you in about a week with a canned reply and then you can begin the back and forth dialogue, with 2-3 day intervals between each e-mail.
3. Contact your matches
If you haven’t contacted all of your matches already, now would be a wonderful time to send invitations. I send a message with each one that includes my e-mail address. Unfortunately, you are forced to utilize the in-house messaging system at 23andMe, so unless you’ve exchanged e-mail addresses with your matches, if the 23andMe system goes away, you have no way to contact anyone ever again.
4. Send your e-mail address to all of the people who have already accepted match requests
Obviously, this is for the same reason. Otherwise, your ability to communicate with your matches will disappear if the website does. Personally I far prefer e-mail rather than the messaging system anyway, so this is not a wasted opportunity.
I want to say, again, that I don’t believe that anything horrible will happen to 23andMe. I don’t want to be an alarmist. They have deep pockets and lots of lawyers. They may get a slap on the hand, but in the long run, I think they’ll be around in one form or another, assuming, of course, that they can prove their results are accurate. I do have to ask myself why 23andMe has been unable to do this in 5 years. Was it just not a priority, corporate arrogance, or is there a real problem lurking? However, as for my data and results, better safe than sorry, and we should probably be taking these steps anyway. I’m glad I downloaded the data files for my family, because it has exposed a problem that I otherwise wouldn’t have known existed. Hopefully, I’ll still have time to get it resolved.