Should private companies be allowed to sell you medical interpretations about said genome ad lib? I think that this is where the case for regulation shines.
That's not a problem. There's already a gatekeeper for drugs. You can't get a prescription without an MD signing off on it. If the MD is doing his job, there's no reason for an additional obstacle.
I'm suggesting where I think the regulatory hurdle should be placed.
I stand by my suggestion to disentangle concerns with giving someone their sequence (no concern--it's THEIR sequence!) from the concerns about companies offering quasi-medical services based on that sequence. The latter issue is perhaps analogous to practicing medicine without a license, although that is admittedly a bit of an overstatement since they're generally making predictions, not diagnoses. At any rate, the companies' behaviors are concerning.
That's not disrespectful at all. In fact, it's to be expected that those who are closest to a technique are the most familiar with its pitfalls.
> it is a statistical fact that certain studies have associated certain SNPs with certain conditions
Sort of, but that's not as relevant as you seem to think. The SNP reported in each study is not generally presumed to be the causal SNP; it's just tagging the causal SNP. For any particular person, it is possible that recombination occurred between the tagged and causal SNPs, interrupting the haplotype.
Even if we assume that sort of thing doesn't happen (which, most of the time, it won't), we're still talking about odds ratios of at most (for lipids) 1.3. That type of minimal increase in risk extremely difficult to convey. In fact, in medical practice, it often wouldn't even be worth reporting (depending on, e.g., background prevalence of disease).
So really, I think that issues are more complex and subtle than one might gather from reading your post. Should you have the right to get your genome sequence? Yes. Should you have the right to read the published literature? Yes. Does a company have the right to interpret that literature as a quasi-medical service? Again, this is the place where regulation makes sense.
But what does that have to do with the regulations being proposed, namely requiring a doctor's permission/interpretation to get DNA tests from reputable sites like 23&Me?
2. The FDA is a LOT dumber and slower than you might think. Very few graduates of George Church and David Reich are going into the federal bureaucracy rather than starting companies or becoming profs.
If you have ever worked with them, the FDA is the TSA, third tier guys who do "safety theater". They assuredly do not keep you safe. They keep their budgets and jobs safe. Their general orientation is "restrict everything so we can't be blamed for anything, and then cry that we're underfunded when we've bitten off more than we can chew".
This is a much longer story but if you have an open mind on the topic start by googling "Jeffrey Shuren FDA" or the lawsuit between the FDA and the FTCLDF. Or just talk to some friends at biotechs. Most people won't talk on the record for fear of FDA retaliation, just like everyone goes along with the idiocy for the 10 mins the TSA has power over you. It's not worth losing your company/flight over a stupid rule that a bureaucrat is mindlessly enforcing.