23 & Me & The FDA

Friday, December 06, 2013


In October, Brooke and OTM producer PJ Vogt analyzed their genetic information using a service called 23 & Me. This week, the company said it would stop providing interpretations of the genetic data it received after a scathing letter from the FDA. Brooke talks to The Verge's Russell Brandom about the company's troubles.

Los Lobos - Las Amarillas


Russell Brandom

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Brooke Gladstone

Comments [8]

raymond carr from alasaka

its been a year no nothibg yet enscan please tell me why? I have sent note after note.i want to my profile . what is taking loog?

Mar. 25 2014 01:18 AM
Paul from Hanover, NH

I'm surprised that OTM did not make the connection between the controversial fiasco of PSA testing for prostate cancer and the prudence exhibited by the FDA wrt 23andMe http://en.wikipedia.org/wiki/Prostate_cancer_screening

The OTM story on 23andMe beat one drum: "Government Bad, Entrepreneurs Good". The PSA fiasco demonstrates on a large scale how people will hurt themselves grievously based on the scary results of one unreliable test.

Dec. 11 2013 12:48 PM

Hi All,

For completeness, here is a link to the letter (all warning letters are published):

When I read this letter, it is so different from the regular warning letters, that I start to think letting them test my genetic data would be like letting the neighbor boy play doctor with me.

Please don't scoff at the FDA. They go a long way towards keeping us from harms we have no hope of identifying for ourselves. Just today, I took two doses of aspirin, and had no worry that there was anything in it that would hurt me, well more than aspirin, which is a bit hard on the stomach.

The FDA has an overwhelming, highly complex, workload. Other countries' medical controls similarly stringent to the FDA, with variations, but similar. FDA was the first, is still the gold standard, and I appreciate their diligence.

Dec. 09 2013 04:50 AM
James from USA

I have a query that I would be interested for OTM to followup on.

If genetic testing like 23&me does not fall under FDA guidelines, what regulations are there to keep the data private and from being used against you by 3rd parties (employers, health insurance companies, etc...)?

For example, does EEO have any clause that protects against discrimination based on genes? Or does HIPPA offer protection?

Dec. 08 2013 07:02 PM
JasonW from Washington, DC

It doesn't matter whether the FDA shuts down 23andMe. The genie is out of the bottle, and literally anyone can get on the Internet and analyze their genome in exactly the same way the FDA has enjoined 23andMe not to.

Just google Promethease and SNPedia, both free open-source resources on the Internet that will allow you to analyze your genome based on the available published research.

Dec. 08 2013 03:44 PM
mercedes from cortlandt manor ny

Please, guys... I've listened twice to this piece about 23&me. I am an RN and am going to "report" to you the way RNs do->shooting for "objective data" that contributes to the whole e.g blood pressure, pulse, color etc.Here goes:
1. Most human beings are really fearful about their own genetic predispositions. So doubting some information is often a part of that fear->"It can't be true. The test MUST be flawed."
2. The part about the disclosed possible or not possible significance of the reported data is also included in many things that the FDA has approved: drugs, devices etc.
3. The FDA is often romanced (lobbied) by companies that are competitors and do not want a specific product okayed by the FDA->It's marketing and competition, not necessarily good medicine. They spend a lot of effort and money doing that.
4. Genetics IS going to play a very big part of our health in the future. There will be al sorts of products out there that are being sold to the public. What I want is a change in perpective by the consumer, which is tha knwoing a lot of this information empowers us to do things differently ergo, particpate in our own health and not expect that a pill (approved by the FDA) is going to take care of everything.
5. IF the technology is good and provides correct info (which is changing as we speak because people are on the research bandwagon), it just may free us up to figure out what we can do and actually individualize medicine rather than having a "recipe" for each malady.
6. I'm not sure about 23&me. I don't know the process. I HAVE actually considered doing it just as went organic about 40 years ago and just as I attempt not to take prescribed medications unless nothing ese works (alternative therapies, diet etc), because I'd like o know how I may be able to contribute to my well being. Knowing somethings just may give us options.

Dec. 08 2013 11:18 AM

The actual genome decoding done by 23andme is likely quite rigorous. When I first joined, I posted inquiries about the test-testest validity, etc, and received responses that reduced my concern about potential false positive reports.

The interpretation, however, is of concern. Even though the list findings in order of validity, etc., as they become a mass consumer service, they need to package the information as an average consumer will understand it. That is to scan down for something to worry about and then reach out for confirmation of their concern.

My first reaction to the FDA action was, "Come on, who is going to schedule an amputation based on these test and what licensed doctor would do it?", but reading how people react and how others reinforce their panic, I now share the FDA concern. In one case, there is preliminary research that finds there may be some correlation between a section of DNA and the eventual contraction of a mutation that eventually leads to a class of chronic cancers that are treatable and when treated, don't appreciably lower your life span. Oh, and the base probability of the cancer-causing mutation is 1/200,000 and typically shows up after age 60. The preliminary correlation is of no use to a consumer, but is a curiosity to researchers. Nevertheless, they report to consumers that they have a "heightened" or "4X risk" of getting the cancer causing mutation. People read that, panic, and post questions as though they are about to be driven to a hospice. Others respond not with assurance and arithmetic, but suggestions as to what research hospitals they should drive to in order to get the best specialist oncology care.

The service shouldn't have provided information as "heightened risk" at all and should be cognizant that in the general population, the word 'cancer' will trigger panic responses that shut out any assurance or reasoning. The alarmed people will surely waste time and resource, and probably acquire some blood pressure rise in the process. Unnecessary tests and procedures, not to mention driving doctors to break normal diagnostic protocols, is something to consider. 23andme has an increasing responsibility to be aware of reactions and consequences and use better judgment and protocol in disseminating interpretation of genomic information. The format of the information, moderation of discussions, and every element of the information service needs to be thoughtfully re-considered.

In the informational wild west, a lot of innocent bystanders might get caught in the cross fire.

Dec. 08 2013 12:52 AM

I think the concerns of the FDA were not adequately expressed, and the FDA's concerns are not overblown. Because the results have no validity, they mean nothing... meaning they're essentially made up. If the results are skewed, and people change their behaviors as a result it may have real world consequences. Who is to say 23andme's process isn't flawed? I'm sure there are plenty of parties interested in being able to control the market to their liking. Obviously this is an exaggeration, but 23andme's actions are quite severe and should not be tolerated. To criticize the FDA in this case is wrong.

Dec. 08 2013 12:20 AM

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