Who should be allowed access to microbiome technology then? You can disagree with the claims made by these companies, but they are all heavily footnoted with “peer reviewed research” and “PhD scientific advisors”. So who should decide what I can buy? Note that CLIA certification is one way to validate basic quality control. If you start demanding efficacy before a lab test can be sold, doctors will lose a lot of tools.
Really good points! I guess what alarms me is the tests were said to lack basic analytic validity. This is far removed from efficacy. Analytic validity is not asking if guidance given on the basis of the tests is effective -- it's really questioning how well the tests even work. If the same lab can compositionally score the same one poop sample in two different ways (not to mention how other labs score), how can you trust it? Who is even checking?
Test inaccuracy is one thing. What you do with the data is another. It's hard to trust advice if there really are fundamental problems with analytical validity, but are those shortcomings reflected in any marketing claims made by such companies? I'd guess not so much.
This paper's call for more regulation would not be about denying you the right to purchase a service from a company or denying that company the right to sell you that service. It's about requiring companies to accurately disclose everything and to prevent them from "making diagnostic claims that could harm consumers," as the authors of the perspective say. Consumer protection is why the government regulates medicine in the first place.
Note that the same "analytic validity" issue applies to research labs too. Why should I be denied access to the tests university researchers do all the time? Nobody checks *their* lab for validity. Meanwhile, peer reviews are way easier to game than thousands of actual customer reviews.
Also, remember that these DTC tests already include disclaimers "not approved by FDA, not to be used to diagnose a disease etc".
Who should be allowed access to microbiome technology then? You can disagree with the claims made by these companies, but they are all heavily footnoted with “peer reviewed research” and “PhD scientific advisors”. So who should decide what I can buy? Note that CLIA certification is one way to validate basic quality control. If you start demanding efficacy before a lab test can be sold, doctors will lose a lot of tools.
Really good points! I guess what alarms me is the tests were said to lack basic analytic validity. This is far removed from efficacy. Analytic validity is not asking if guidance given on the basis of the tests is effective -- it's really questioning how well the tests even work. If the same lab can compositionally score the same one poop sample in two different ways (not to mention how other labs score), how can you trust it? Who is even checking?
Test inaccuracy is one thing. What you do with the data is another. It's hard to trust advice if there really are fundamental problems with analytical validity, but are those shortcomings reflected in any marketing claims made by such companies? I'd guess not so much.
This paper's call for more regulation would not be about denying you the right to purchase a service from a company or denying that company the right to sell you that service. It's about requiring companies to accurately disclose everything and to prevent them from "making diagnostic claims that could harm consumers," as the authors of the perspective say. Consumer protection is why the government regulates medicine in the first place.
Note that the same "analytic validity" issue applies to research labs too. Why should I be denied access to the tests university researchers do all the time? Nobody checks *their* lab for validity. Meanwhile, peer reviews are way easier to game than thousands of actual customer reviews.
Also, remember that these DTC tests already include disclaimers "not approved by FDA, not to be used to diagnose a disease etc".