3 ms·

Genetic tests are useful for many things, some people have used them for ancestry, especially African Americans who have traced history that had been obscured b

Genetic tests are useful for many things, some people have used them for ancestry, especially African Americans who have traced history that had been obscured by slavery. I think "test" is even the wrong terminology. A better one would be "picture" or "snapshot". A photo can be used for many purposes, one of which is to make medical diagnoses. Personally, what I want from 23andme is not a diagnosis, I just want a dump of my DNA hyperlinked with relavent scientific artifacts on suspected function or links to diseases. The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition. IMHO, Personal Genomics is a personal right, in the same way that consensual sex, or recreational drugs are. As I mentioned elsewhere, the FDA should prioritize going after stuff that is actually proven dangerous or fraudulent/malevolent, not preeemptively trying to cut the kneecaps off of a potentially revolutionary new cottage industry. If they want to impose some silly advertising disclosure, fine, but I don't think the FDA should be in the business of banning this. Hopefully eventually someone makes a version which can be built by hackers, so people can shotgun analyze DNA at home and it becomes impossible to control.

timr 13y ago
"Genetic tests are useful for many things" Nobody is arguing that they aren't. The point is, you know nothing about the accuracy or precision of the test in question. Just because it's "genetic" doesn't mean it's a valid test. "The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition." That's just Not Even Wrong. The FDA's mandate isn't to prove that a drug or test isn't useful before regulating (an impossible bar) -- otherwise, we'd be back in the bad old days of patent medicines. The FDA is there to ensure that the risks of drugs and medical tests are balanced by their benefits.
- cromwellian 13y ago
  In order to ensure that the risks are balanced, they need to evaluate the expected value of false negatives vs false positives. If they don't have this information, they are regulating blind. If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing. The FDA can play a role if they want to independently test sequencers and publish data like the highway safety council and crash test ratings, but I see no reason to "regulate" genetic sequencing anymore than someone should regulate mass spectrometers.
  - timr 13y ago
    "If they don't have this information, they are regulating blind." Yes, exactly. That's why they've been asking the company for that information for months, and why they shut down sales of the product until the company complies. Glad we agree that this is the right move by the FDA. "If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing." They aren't sequencing anything -- they're using microarrays. How can you possibly have such a strong opinion on something that you know nothing about?
  - cromwellian 13y ago
    Well, excuse me for being lazy and using less specific terminology than you desire. Yes, I know how 23andme's SNP probing works. I just prefer to imagine a personal genomics market in general that evolves to the state where we can all have our full genome sequenced. And we're not going to get there without having early adopters and baby steps instead. I don't need government protection from this, certainly not over a one time fee of $99 that has ample disclaimers, and at worst, will cause me to waste time asking my doctor over a condition I don't have, and at best, find out the cause of a disorder that doctors haven't been able to diagnose. Yes, and in some very rare cases, some people will be told they don't have the BRCA gene when they really do, as if there's an epidemic of women have been avoiding mammograms because of DNA tests, instead of lacking healthcare, or being given confusing directives over the years over when, and how often they need to have exams.

timr 13y ago

"Genetic tests are useful for many things" Nobody is arguing that they aren't. The point is, you know nothing about the accuracy or precision of the test in question. Just because it's "genetic" doesn't mean it's a valid test. "The FDA can't prove that this information isn't useful, and the fact that the utility of information is unknown is not cause to ban its acquisition." That's just Not Even Wrong. The FDA's mandate isn't to prove that a drug or test isn't useful before regulating (an impossible bar) -- otherwise, we'd be back in the bad old days of patent medicines. The FDA is there to ensure that the risks of drugs and medical tests are balanced by their benefits.

cromwellian 13y ago
In order to ensure that the risks are balanced, they need to evaluate the expected value of false negatives vs false positives. If they don't have this information, they are regulating blind. If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing. The FDA can play a role if they want to independently test sequencers and publish data like the highway safety council and crash test ratings, but I see no reason to "regulate" genetic sequencing anymore than someone should regulate mass spectrometers.
- timr 13y ago
  "If they don't have this information, they are regulating blind." Yes, exactly. That's why they've been asking the company for that information for months, and why they shut down sales of the product until the company complies. Glad we agree that this is the right move by the FDA. "If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing." They aren't sequencing anything -- they're using microarrays. How can you possibly have such a strong opinion on something that you know nothing about?
- cromwellian 13y ago
  Well, excuse me for being lazy and using less specific terminology than you desire. Yes, I know how 23andme's SNP probing works. I just prefer to imagine a personal genomics market in general that evolves to the state where we can all have our full genome sequenced. And we're not going to get there without having early adopters and baby steps instead. I don't need government protection from this, certainly not over a one time fee of $99 that has ample disclaimers, and at worst, will cause me to waste time asking my doctor over a condition I don't have, and at best, find out the cause of a disorder that doctors haven't been able to diagnose. Yes, and in some very rare cases, some people will be told they don't have the BRCA gene when they really do, as if there's an epidemic of women have been avoiding mammograms because of DNA tests, instead of lacking healthcare, or being given confusing directives over the years over when, and how often they need to have exams.