People's records are already stored, and they flow through the medical system. The value add from the point of view of most patients view comes from making diagnoses and recommendations. Exactly what the FDA is prohibiting 23andme from doing.
The FDA seems to say that 23andMe is supposed to provide some evidence that the diagnosis and recommendations they make are better than rolling a dice. The FDA also gave them years to do that it didn't shut them down immediately to give them some time to actually provide evidence.
As far as the timing goes Google Health got shut down before the FDA got 23andMe to stop giving diagnoses.
They almost certainly wouldn't run trials in the form the FDA requires today. They'd still want to convince people to buy their products. They'd still want to avoid getting sued. People would still want convincing.
There are many ways to convince people to buy products that don't have much to do with running expensive medical trials. You can bring the doctor to a fancy all expensive paid vacation where he get's lectured on all the great benefits.
They'd still want to avoid getting sued.
I rather have a group of experts in a government department examine whether or not a drug does what is claimed than push that task to courts and let juries make the corresponding decisions.
Do you think this case is handled better if someone sues 23andMe in court because they got cancer and 23andMe told them they had a low cancer risk? It's somehow less violence if the whole process goes through a jury than when it's government regulators doing their job?
I don't think the libertarian position of passing all issues to the courts is a wise move. Having regulations where a diagnostic company can tell a jury: "We follow the rules laid out by government agency X" is valuable. Otherwise the jury has to make up rules on the spot.
The FDA seems to say that 23andMe is supposed to provide some evidence...
No, that's not what they say. They're not asking for "some evidence", they're asking 23andme to jump through their hoops. Dance for me, peasant.
23andme provides plenty of evidence in terms of peer reviewed papers as citations to their customers. Evidence isn't lacking, freedom is.
As far as the timing goes Google Health got shut down before the FDA got 23andMe to stop giving diagnoses.
This strikes me as yet another dishonest debating point. Are you unaware that the reg...
This is prompted by Scott's excellent article, Meditations on Moloch.
I might caricature (grossly unfairly) his post like this: