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Comment by hacker789 | Hacker News Reader

Not having a test done could kill people, too.

It's a cost benefits analysis. Medicine does this, and is constantly updating their recommendations for screening based on the data that comes back. For example, it used to be recommended that all women perform a breast self exam every month, then data showed us this didn't prevent cancer and actually caused harm because it lead to needless surgeries and biopsies. (Sources here: http://en.wikipedia.org/wiki/Breast_self_exam)

Things like Prostate-specific antigen screening of healthy men is no recommended by the United States Preventive Services Task Force because "the potential benefit does not outweigh the expected harms." (Source in: http://en.wikipedia.org/wiki/Prostate-specific_antigen)

The jury is still out on mammogram screening of healthy women for breast cancer. (See: http://en.wikipedia.org/wiki/Mamogram)

The Cochrane analysis of screening indicates that it is "not clear whether screening does more good than harm". According to their analysis one in 2,000 women will have her life prolonged by 10 years of screening, however, another 10 healthy women will undergo unnecessary breast cancer treatment. Additionally, 200 women will suffer from significant psychological stress due to false posivitive results.[10] Newman points out that screening mammography does not reduce death overall, but causes significant harm by inflicting cancer scare and unnecessary surgical interventions.[11] The Nordic Cochrane Collection notes that advances in diagnosis and treatment of breast cancer actually may make breast cancer screening no longer effective in decreasing deaths in breast cancer, and therefore no longer recommend routine screening for healthy women as the risks might outweigh the benefits

This is why we use science and do studies and always question if we are doing the right thing.

And because of that, perhaps you should be getting that test (or not getting the test), with the help of a physician who is better equipped to help you interpret the results.

Or at maybe for particular results the company should just refer you straight to a doctor for more information.

These are the questions that I think the FDA will be interested in having the company addressing.

If you believe 23AM's technology is so important that its use will save lives, it's hard to understand how you might believe the FDA is out of bounds in regulating it. Unless your argument is that the FDA should be abolished entirely.

It all depends on what is meant by "regulate". If the FDA just wants 23andMe to make it clearer to their customers that:

1. Like any screening, their results could be inaccurate.

2. Before making any changes based on their results—aside from eating more healthfully, exercising more, and sleeping better—they really need to talk to a doctor.

... then few people would have a problem with it. And maybe that's all the FDA is trying to do! I don't really know.

Sadly, when an activity or product could result in a bad outcome, certain types of people are incredibly eager to ban (or heavily regulate) it.

Those people don't realize that by doing so, they themselves are actively harming the people who benefit from that activity or product by preventing or heavily limiting their access to it.

Just like we shouldn't ban health discussion boards (and we shouldn't make it illegal to participate in health-related discussions without government-mandated credentials), we shouldn't limit people's freedom to choose services like these. It's wrong.

We just need to make sure the services aren't lying about what they're offering.

That in fact appears to be what the FDA is interested in; their letter references attempts to clarify 23AM's "labeling". Presumably, the FDA would like 23AM to stop overtly mentioning health conditions in their marketing; they could write copy that refers to the importance of genetic testing in health management while explicitly stating that their consumer service is not intended as a medical diagnostic.

It seems clear that FDA does not in fact want to shut 23AM down, but that they do want 23AM to radically change their marketing. Which seems fair, because 23AM's marketing is disquietingly clinical.

> It seems clear that FDA does not in fact want to shut 23AM down, but that they do want 23AM to radically change their marketing.

I don't think that's accurate either. I think that the FDA views that 23andMe must do one of the following:

1) Provide necessary evidence to support their current marketing claims, or

2) Change the way they are marketing their product, or

3) Cease marketing their product altogether.

I don't see that the FDA necessary has a strong preference as to which manner of complying with the law 23andMe takes.

Sorry, you're right, I was being imprecise. Obviously, I think (2) is the only viable option here; 23AM doesn't appear to be set up for clinical genomics. But that bias was built into my comment implicitly, not stated directly like it should have been.

But often people get certain tests when they have certain symptoms or risk factors. For example, smokers are much more likely to have lung cancer. Screening them for lung cancer is a good idea, even if the screen has some false positives because there's a reason why the the group has above average risk for the disease.

People are screened for the BRCA gene when they have a history of certain cancers in their family. If you get a positive result, there's a small chance its wrong. But, if you took all of American and gave them that test, there'd be thousands of people getting positive results, living in fear, and sometimes taking medical action.

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