FDA shuts down 23andme

[White Haven]

There is absolutely not a real difference from the perspective of outcomes. Look, if the FDA is saying 'we have a problem with a product or service providing an end user with information that they can then subsequently misuse to self-treat' and acting accordingly? Fine. If the FDA's position is 'an uninformed patient who thinks they know more than they actually do is totally not our problem,' then that's fine too. The problem I have is that they're saying both things at oncejust because 23andme has a product and WebMD has a service.

I grasp that there is a difference between a product and a service. I do not, however, care about that difference when the consequence of misusing or misunderstanding both things are exactly the same.

[Mr. Coffee]

Here's the difference, one is an online reference site that goes out of its way to inform the reader that it is not a substitute for getting a diagnosis from an actual doctor and the other is a service offering to make that diagnosis sans doctor. Here's an example.

Let's say your mother is worried about breast cancer.

Now, she goes to WebMD and reads up on breast cancer. Maybe she learns to do the self-feel test looking for lumps and doesn't find any, but she also read that she should consult a doctor and have a mammogram done. She gets the mammogram done and things proceed from there. At no time is WebMD trying to pose as a replacement for seeking professional medical advice.

Or, she orders one of these kits from 23andme. She gets the results back and finds out she doesn't have either brca1 or brca2 (those are the genetic markers associated with an increased ris of breast cancer). She isn't told to get a professional medical opinion, she never gets a mammogram done, and she gets cancer and dies. Who's fault is that? Is it your mom's fault for relying on the test or is it 23andme's fault for trying to make a diagnosis that they are not qualified to give?

[Borgholio]

Did you even read the full unedited text of the FDA letter? I did.

http://www.fda.gov/ICECI/EnforcementAct ... 376296.htm

Here is the most pertinent section:

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at http://www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.

I have bolded some important parts. These are why the FDA is coming down on them. The company is advertising this product as a MEDICAL TEST to determine if you are susceptible or at risk of certain diseases. More importantly, THE TEST CAN BE WRONG. This is marketed as an accurate way to test your genome to see what illnesses you are likely to have to deal with later in your life.

The second paragraph DOES bear a resemblance to things that can happen if you read WebMD. The big difference is that WebMD doesn't give you the information based on the context of a test that NEEDS TO BE PROFESSIONALLY INTERPRETED. WebMD just gives the encyclopedic explanation of various diseases and symptoms. It doesn't claim to allow you to self-diagnose.

[Simon_Jester]

Yes, it's a device. Whoo. Yay. Now, what is the consequence of misusing the device? It's exactly the same as the consequence of misusing WebMD, or just rolling dice and consulting the Critical Illness table, or whatever. The fact that It Is A Device doesn't somehow make it better or worse.

WebMD doesn't tell you anything that you can't learn from a public encyclopedia- if you were going to do something ignorant because of your aching shoulder, you could do it just as well without WebMD.

Genome testing does give you unique, theoretically actionable information about your health. That's the whole point! And therefore, they can reasonably be held responsible for the consequences of that. This is especially true if their tests ever give false positives, or if they accidentally switch test results occasionally, both of which could be real problems for such an organization.

So the FDA has a role in monitoring this service they provide. Because you're hiring them to test your DNA, that's definitely a medical service, and the FDA has standing to ensure that medical services are performed competently and accurately.

[Alyrium Denryle]

There is absolutely not a real difference from the perspective of outcomes. Look, if the FDA is saying 'we have a problem with a product or service providing an end user with information that they can then subsequently misuse to self-treat' and acting accordingly? Fine. If the FDA's position is 'an uninformed patient who thinks they know more than they actually do is totally not our problem,' then that's fine too. The problem I have is that they're saying both things at oncejust because 23andme has a product and WebMD has a service.

I grasp that there is a difference between a product and a service. I do not, however, care about that difference when the consequence of misusing or misunderstanding both things are exactly the same.

No. WebMD is a reference. It is used to say "hey, I have these symptoms. What are the possibilities?" or "what are the risk factors for this disease so I can avoid them?" with a big sign that says *!SEE YOUR DOCTOR!*

23andme is... different. It is an actual diagnostic test of your genome. Imagine it gets a false negative for VKORC1(A), which means if you go into your doctor in need of Warfarin, test results in hand, they might end up giving you too high a dose and you end up bleeding out of your various orifices. This is why the FDA needs to regulate it, and why the accuracy needs to be certified, with false positive and false negative rates quantified and known to health care professionals.

[PainRack]

Perhaps I can step in with another example here in Singapore.

BRCA testing here in Singapore is still relatively ad hoc(although I understand KKH has protocols in place) but we do have a formal screening process with regards to FAP, a condition that is implicated as a risk factor for colon cancer. One of the first step in the process is actually genetic counselling, which includes
1. Medical information about the condition and the risks involved.
2. Financial implications.
3. Pyschoscoial support.

This is done before the screening itself because of the impact a diagnosis has on the patient. If you're told of all the issues beforehand, you just don't have the "I might have cancer! I might have cancer!" mantra pounding away at the back of your mind, distorting the information you receive.

its...... quite startling to see how messages can be wildly interpreted during the initial stages of diagnosis. I have seen people going full hog on Alkaline diets/water, because simple explainations of why they're on certain drugs/sodium bicarbonate to alkalize urine gets distorted into Alkalization is good for my health . I seen people refuse to eat chocolates because of an misinterpretation of a neutropenic diet.


Regulation of medical devices shouldn't be a biggie anyway. Its a device sold as a diagnostic tool, meaning you need stringent QC to prevent harm or inaccuracy. Just what is wrong with that?