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Silicon Valley Is Too Focused On Taking the Easy Path in Health Care (cnbc.com)
Silicon Valley investors are increasingly looking at health space, but they are mostly eyeing for opportunities on the fringes of the traditional health care system to avoid long and complicated regulatory cycles, an analysis on CNBC shows. As a result of this, these start-ups will not help low-income and chronically ill patients who need innovation most. From the article: Founders often talk about about how challenging it can be to break into the multi-trillion dollar medical sector. Health care startups face regulatory hurdles, long sales cycles and a high burden of proof -- and that means it can take more than a decade to make a return. As a result, many venture-backed entrepreneurs are looking instead at opportunities on the fringes of the health care system, such as cash-only health services that don't require insurance or tests and apps that aren't regulated by the U.S. Food and Drug Administration. For tech investors, these opportunities hold the chance of an outsized return in five years or less. That often valuations on par with consumer Internet start-ups. [...] Many entrepreneurs acknowledge this, but justify their approach by promising to focus on more at-risk groups once they've nailed the product.
They've figured out that the regulations they're always pushing for make it near-impossible to compete with established companies and hurt innovation.
"No man's life, liberty, or property are safe while the legislature is in session." -- Judge Gideon J. Tucker
I bet you three fiddy that Silicon Valley wants to tackle these problems, but its the INVESTORS that control the pocketbooks of Silicon Valley that don't want to take the risk on. The long game, pfffft, what's that? Humanity? Pffft!
Why sell to people with no money?
Most of the "health" startups seem focused on weeding out the weak, as in "let X voluntarily track your activities and single you out for unaffordable health premiums if you aren't young/healthy/kid-free enough to meet our wearable device targets." So yes, if it seems that the chronically ill are being pushed off the map, well it's by design.
" promising to focus on more at-risk groups once they've nailed the product"
I totally believe you, pal.
If Slashdot were chemistry it would look like this:Cadaverine
I sent my genome to a server in eastern europe to get a detailed health report because the FDA won't let 23andme present all of the information.
That's largely because the information 23andme wants to present has not been proven to be true.
So....fuck the system for trying to prevent 23andme from lying to you, so that you don't go on a medical vacation to treat a disease you don't actually have.
Makes perfect sense.
There's an excellent chance we're going to move to single payer in the next 20 years. The big money isn't in care, it's in being a middle man that skims 10% off the top. A shift to single payer gets rid of most if not all of those middle men...
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I'm not sure where you get that idea from. Infant mortality rate was through the roof in primitive societies and as soon as humans moved from nomadic tribes and started building cities, the chronic diseases of civilization became widespread. Up until recently, diseases such as cholera, polio, small pox, measles, etc. were extremely common and were only made rare or eradicated through innovation. Sure back in primitive societies, if you didn't die early in your life you could certainly live to be 80 and I'll grant that people were on the whole healthier because almost all work involved physical labor and even if you had the equivalent of an office job, you still needed to walk to work. However, the chances of any person actually living to 80 was far, far lower. If the various diseases and lack of treatment didn't kill you, invading neighbors would probably do it quite well. So unless you're proposing we abandon civilization and go back to hunter-gatherer groups, your assertion is just wrong.
Tech innovation has done more for the poor having healthcare than anything else. Even safety nets can't provide services to everyone that haven't been invented or are incredibly costly. Just look at the positive outcomes of Golden Rice in ensuring that some of the world's poorest don't suffer from conditions due to vitamin A deficiency.
If you don't think its fast enough, you are free to start your own company to rectify the situation. Or is everything just someone else's problem?
...doesn't cut it in the realm of health care.
Silicon Valley may be noodling around the margins, but it's probably less because of the "onerous regulation" than the empty product they peddle not being able to live up to the regulations and cope with the existing complexity.
They're not showing up to a business sector that has been moribund and antiquated for decades, they're showing up to a business sector that has been highly computerized for decades, so in some sense they're competing against their Silicon Valley neighbors, too.
And too much of Silicon Valley "innovation" is just empty bullshit, an appy app, perpetually in beta, and lots of hype. Regulation means following rules, audits to make sure you're doing that and actually delivering something of substance.
Genetic variants are different from drugs. For one things, there are billions of genetic variants.
Currently the FDA is trying to apply drug validation studies to genetic variants. That's like requiring cars to have proper horse shoes.
So, umm, this is not the case. Do you have any idea how the non-ag side of the FDA actually operates?
When you go for approval you define the criteria. "All" you have to show is that you will show statically valid evidence that your claims are plausible. Sometimes the Agency wants some specific proof (e.g. they may ask that you use a specific animal to verify a specific procedure or organ consequence) or may want an additional test because they know some classes of can compounds have characteristic issues. But in general they don't dictate anything. Oh yeah, for a treatment there are outcome criteria, but you are mostly the origin of those as well.
Diagnostics are simpler to approve than devices, which tend to be simpler to approve than drugs, which to some degree are simpler than biologics. Each division has its own specialists. And the so-called "billions" of genetic cases are a red herring -- just consider the complex consequences of introducing organic compounds into the body.
Disclaimer: I am not a geneticist, and have not gone for any diagnostic approval, though I am an advisor to a couple of companies that have. But apart from my own experience in the small molecule domain, I do know most of 23&me's regulatory team socially, and we do talk about work. So I know generally what issues they face.