Silicon Valley Is Too Focused On Taking the Easy Path in Health Care (cnbc.com) 135
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.
Brilliant (Score:4, Insightful)
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Some regulations do - the patent system is an example. The system was actually designed to help innovation, however in its current form it harms innovation more.
However, regulations in some actors are needed in order to protect you from greedy profiteers that would sell you about anything to make a quick profit. Healthcare is an example.
Re:Brilliant (Score:4, Insightful)
All regulations do. The fact that we don't document every regulation stifles innovation (And spurs innovation in other areas), we don't know exactly where the wash is.
Every regulation takes from production, and transfers it to compliance.
FYI, this is neither "good" nor "bad", it just is. Some regulations are needed, others just get in the way, duplicate other regulations, run counter to others etc. The fact that we rarely look at the consequences for regulations, and make adjustment, enhancements, and revoke so very few ineffective ones is my actual frustration in the whole process.
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Some regulations actually encourage innovation (carbon credits). Moreover, without truth in advertising / some burden of proof that what you are putting out there in healthcare actually works, it's easy for a large company (l'll choose Merck since they seem to have no problem publishing fake data to this end) to claim they've made a drug that cures a particular disease causing funding in that field to evaporate.
Similarly, since there are no non-profit pharmaceutical manufacturers (due to the
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In this case, I think the FDA would benefit from making it easier to start a clinical trial, i.e. speed up its evaluation process, allow to skip animal testing, etc. But in exchange for that, counseling for informed consent must be much more rigorous, namely telling them that they risk loss of life, limb, eyesight, or other bodily functions, and that they will have limited legal recourse if anything goes wrong.
Terminally ill patients could be encouraged to sign up for phase 1 trials, and so long as nothing
Re:Brilliant (Score:5, Insightful)
Yep....
I think the reply to them is pretty much, "Duh".....
That's the way it is with overly onerous regulations...it ONLY helps the big guys that can afford to fund a full department dedicated to only the regulation and documentation side of the business.
It is understandable in some respects, due to this being medicine...lives can be affected by errors, but the regulations aren't just targeted at direct patient interaction...but many other things.
It does bring up, however, questions as to how some parts are SO over-regulated, yet direct patient contact items, like heart regulators, insulin and other drug pumps are able to be put out there, without even *basic* encryption, so as to protect patients from being literally hacked, and possibly killed.
Re:Brilliant (Score:5, Insightful)
It is understandable in some respects, due to this being medicine...lives can be affected by errors, but the regulations aren't just targeted at direct patient interaction...but many other things.
Just to be clear, interactions with the patient are only a tiny slice of what can kill a patient. Making sure a drug companies' formulation facilities are bacterial-free is pretty far removed from patient interactions.
If you're making a test blood poisoning [wikipedia.org], that's never going to be put into a patient. You want to be sure the raw components are bacterial free though obviously or else the tests are going to be useless and doctors won't know if they're facing blood poisoning or something else. To make sure the raw components are bacterial free you want the facilities to be bacterial free. If you find bacteria, you need to shut down production while you sterilize everything. That's a huge cost.
If you're trying to start selling a cheaper test and you get a report saying you need to shut down production for a week, any sane business is going to say "Hmm... that will kill us... is it REALLY necessary to shut down if we have three bacterial colonies on a single plate? Lets talk to the undergrad who reported the test, ask him if he really wants everyone to lose their jobs? 'Isn't it maybe possible you accidentally sneezed on the plate?'"
Easy to justify: you know your facilities are clean, you spend a shit ton of money cleaning them. And that's just like the doors! That's not even the production vats! No way is the whole thing contaminated. Plus these aren't even going to go into people... You do testing of all the lots of blood tests, you'll know if they're compromised... And besides, any doctor worth his salt is going to be able to identify SEPSIS without a %100.00000000 accurate blood test, it's so common! Fire the kid and ship it.
Regulations are necessary especially when it's not directly interacting with a patient. Yes they are huge barriers to efficiency, granted, but healthcare is simply not a place the free market works at any level. The end result is not sales, it's literally life or death. Society simply does not tolerate that. Investors who get into healthcare and deceive themselves into thinking it is a free market deserve to lose their money. Politicians and pundits who try to reform healthcare towards "free market" are deceiving themselves and or the public, and deserve to be thrown out of their jobs hard. If they try to exempt themselves from such "free market" solutions while subjecting everyone else to it, they deserve literal crucifixion even if they do claim it's just a reconciliation loophole they'll totally close later.
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Capital costs exist in any industry. You need to own a mine to get into mining. You need to own land to farm. And you need to prove you're not selling rat poison in the pills. I don't see what the issue is.
I mean, its possible that the regulations are overreaching. But it seems far more likely they are a reaction to something.
Re:Brilliant (Score:5, Interesting)
While I might normally be inclined to agree with you, I have to point out that regulation in the healthcare industry is there for a very important reason. When you're dealing with human bodies and human lives, you need a very carefully regulated system to prevent someone's mistake from turning into a disaster that costs a lot of lives or causes a lot of harm.
For example, those annoying regulations that require extensive clinical trials and testing of new drugs are there for a very good reasons. They're in place to prevent disasters like what happened in West Germany and the UK in the 1950's, when the drug Thalidomide [wikipedia.org] was okayed for sale without adequate testing.
Re:Brilliant (Score:5, Insightful)
Regulations are good and necessary to a free market, but established players tend to get regulations which are not good or necessary for a free market tacked on. Governments get in on the action to try to extract money and craft perks for their special interests. Sometimes the unnecessary regulations are simply the result of well-meaning officials who think they are improving upon what a free market could deliver, but in reality have the effect of freezing the state of the art.
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I don't think the statement that "regulations are good an necessary to a free market" is nearly as "obvious" to others as it is to you. Thanks for really adding to the discussion.
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Re:Brilliant (Score:5, Informative)
It's not so much regulations. Health care needs regulations. It's that US regulators are notoriously bad at it. My friends in the medical device business do most of their work in places like Germany and other Northern European countries because the regulators are strict, but they do their jobs predictably and in a timely manner. They shun the US because the regulators are sloppier and everything takes forever in the US.
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So what happened when Vioxx was found to cause heart attacks? people said the regulators responsible should have been fired
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Why are you complaining about a single drug approval from almost 20 years ago? Unless they reject every drug, they're going to make some errors by approving drugs they shouldn't approve sometimes. You want new drugs, it's never going to be risk free.
And you are responding to a post where I say US regulators are bad at it. And your point is that ... they made a mistake once. Yes.
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It also showed that the drug manufacturers are far more proactive and effective than the FDA at ensuring patient safety.
As it should be... If someone sets your house on fire and the fire-alarm doesn't work, you first blame the guy who lit your house on fire... Rather than blaming the fire-alarm.
On topic of regulations it makes no sense to argue that they are all bad, or they all stifle innovation or competition.. Lots of regulation have positive effects. It's just that Americans have a hard time seeing it as anything other than black/white.
Sorry, the world doesn't reduce to good vs. bad.
In field of medicine US regulat
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Yes, including innovation like snake oil and Thalidomide.
Snake oil actually works... (Score:2)
Just found this today on HN: "Snake oil can be beneficial for arthritis and other conditions (2007)"
https://news.ycombinator.com/i... [ycombinator.com]
The article being discussed is
https://www.scientificamerican... [scientificamerican.com]
> Snake Oil Salesmen Were on to Something
> Snake oil really is a cure for what ails you, if that happens to be arthritis, heart disease or maybe even depression
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Changing Regulations are worse for innovation, than the number of existing ones. The problem is we got ACA, we can deal with this, then the Republicans want to dump it and replace it. So all the systems that have been made, tested and optimized for the old way, will need to be rethought, remade, and retested...
As a Health Care IT Worker, I have a bunch of nice of haves that will actually lower cost and improve care that I have just started, if they are going to take such regulations away or change them.
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You shall not infringe on the sacred subscription model of big pharma lest you be regulated out of existence. Curing people is a sin against the holy drain of capital. A life that goes on without buying the divine treatment is a life lost and crime against the revenue-stream gods.
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The problem with your comment is that you are assuming the two used of "they" refer to the same groups of people (though there *is* overlap).
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Setting aside the fact that "they" are not a monolithic entity, so "they" don't exist, there is another way to read the summary above: where it says that these startups don't pursue mainstream medical business opportunities because "it can take more than a decade to make a return" you could read that as an issue with the r
the problem... INVESTORS.... (Score:5, Insightful)
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Really. This story even isn't about 'health care'. It's about investment risks and opportunities. And as soon as the subject of 'valuations' comes up, you should run for the hills.
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These investors pump MILLIONS into these tech ventures, half of it wasted on real estate and furniture. They can not only afford to give them fair wages, they can also afford to wait for results.
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The long game's too risky (Score:3, Interesting)
Most of those jobs would become government jobs (Score:2)
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I would take that bet. I've had the misfortune of supporting a major Silly Valley corp that was trying to 'innovate' an existing industry.There was an attitude that technology is magic and that they would be able to come in and in 18 months be better at that industry than companies which have existed for a century. The individual engineers and project managers are also not interested in anything that isn't 'disruptive', including hard work and studying their competitors. They didn't seem to grok the basic c
Re:Brilliant (Score:4, Insightful)
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I've never met this guy before but I can confirm it cured my cancer and gave me a six pack.
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A six pack of what? Curing cancer is great, but I might still think twice if I'm stuck with a six pack of natty light.
Problem is lack of public beta (Score:2)
One problem with snake oil is that not all snake species produce eicosapentaenoic acid (EPA). This led some snake oil makers to end up producing ineffective products. So long as you can document that it's from a snake species whose oil is rich in EPA, I'll buy.
In areas where the Chinese water snake isn't available, producers switched to imitation snake oils with other ingredients, some of which have since been proven effective. Brands have included Stanley's (capsaicin/camphor), Vicks VapoRub (camphor/menth
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"Public beta" for software generally doesn't kill people.
If your concern is safety, have a private trial for safety and a public trial for efficacy.
Snake oil actually works... (Score:2)
...for arthritis, heart disease or maybe even depression:
https://www.scientificamerican... [scientificamerican.com]
> Snake Oil Salesmen Were on to Something
> Snake oil really is a cure for what ails you, if that happens to be arthritis, heart disease or maybe even depression
F*ck the poor (Score:3)
Why sell to people with no money?
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Because the US is a third world country.
The modern countries on this planet provide health care instead of selling it.
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Why would anyone want to get into medicine, with all the headaches it involves...if they didn't stand to make a buck....in fact, a few of them considering all the insurance/litigation that comes with it, and if a Dr...all the years of study coupled with huge student debt bills to pay off, and shorter working life that most other careers.
You certainly don't go into that career for only altruistic reasons....you don't get the best
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>You certainly don't go into that career for only altruistic reasons....
A lot of people most certainly do. Do you really want a doctor that is concerned about money more than taking care of you?
> you don't get the best people that way.
Doctors Without Borders, USAID, CDC, UNICEF all disagree with you.
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"Modern countries" have their free healthcare paid for by high taxes and government redistribution. That's one way to do it, but not necessarily a better way.
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Nice FUD, sir.
Demonstrably socializing medicine is the better way, evidence is here [nakedcapitalism.com].
Best.
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Because the US is a third world country.
The modern countries on this planet provide health care instead of selling it.
That's some complaining. What do you want to do about it?
And before you say "single payer", understand that single payer will be a lot more expensive than the current system [bloomberg.com] because US health care workers get paid a lot and they probably won't just sit back and accept huge pay cuts. And they have enormous political clout in the US.
Also, why should the US be like other countries when most people in the US want a more US-like system?
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Single payer would be cheaper. Private insurance runs around a 20% admin overhead. Even if you do not believe the 1.5% admin rate quoted for medicare, I am pretty confident it is much less than private. And if single payer could get rid of the 7 figure hospital exec's which are not part of the insurance overhead, even better. So we would get rid of 2 non-participatory costs (insurance execs and hospital admins) who contribute zero to keeping people alive.
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I wish I weren't joking but my father (biomedical repair technician) has had the joy of dealing with several managers like this over the years. One questioned why they had so many different spools of hosing and suggested that they order just what they need. The problem is that they basically
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So still super expensive then. Why should we switch to a system most people don't want to save a couple percent?
... 7 figure hospital exec's ...
And added government worker pension costs will be many times that. Pensions don't provide patient care either.
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Nice try quoting bloomberg, like they are a perfectly neutral observer there. *Just* getting rid of the overhead of having multiple inefficient systems competing with each other in an anti-competitive market would be a bonus. Then there is the matter of the single payer being able to negotiate better medicine practices and prices. This is what nearly every country in this world does. The champion is Japan. Notice they have a lot of centenarians there.
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Based on 2014 figures (the latest I found when I looked), US per capita health care is three thousand dollars more expensive than the next most expensive one (Switzerland). I think saving most of a trillion dollars a year does count as less expensive, and I think most people would want less expensive health care.
Some people say we can't do what every other developed country in the world already does. I think those people are dishonest or spineless defeatists.
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Based on 2014 figures (the latest I found when I looked), US per capita health care is three thousand dollars more expensive than the next most expensive one (Switzerland). I think saving most of a trillion dollars a year does count as less expensive, and I think most people would want less expensive health care.
Some people say we can't do what every other developed country in the world already does. I think those people are dishonest or spineless defeatists.
If you read the article, you will see that countries don't cut health care costs. They only have lower costs because they never got high to begin with. But going back in time isn't really an option.
You can name-call anyone you want, as much as you want. Do you think that will get health care workers to say "yes" to large pay cuts? Do you think it will convince voters and politicians to listen to you instead of doctors and nurses?
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What I am saying is that every other country in the world has much lower health care costs, and that many of them have better health care results. I'm also saying that the US can accomplish pretty much anything any other country can accomplish. I didn't think those things were all that controversial.
That's a Bloomberg editorial, and I haven't been impressed with them in the past. It also says it would be difficult to get lower health care costs, which is reasonable. It ignores many of the costs that
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No country has significantly reduced health care costs.
Yes, if the US could go back in time 100 years, perhaps we could keep health care costs from rising like other countries have succeeded in doing. But going back in time is not an option.
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If we were to streamline the health insurance industry, we'd save money on health care. If we had some sort of negotiation on drug prices like other countries do, we'd save money on health care. Doing these things would significantly reduce health care costs. It wouldn't get us anywhere near second place, but it would be significant savings.
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Some money might be saved. There are probably some studies for how much. Drugs are less than 10% of the total health care cost, and if changes cause fewer therapeutic drugs to be developed you'd see other care costs rise as a result.
Realistically, it would be hard to make the case for big changes based on a one time cost saving of 5% or so. That's about 1 year of health care inflation. Maybe 2 years.
The main point is that there are no easy wins and no big wins. You can tell a story about much lower cos
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Health insurance administration is a big cost also.
I'm not saying that it would be easy, but we could arrive at approximate parity with the second-most-expensive by reducing the increase in health care costs, which can't go up faster than total wealth indefinitely.
I also really hate the idea that the US can't do something every other developed country does as a matter of course, so I'm going to look for ways to accomplish it.
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Because the US is a third world country.
Sorry, the US is still a first-world (NATO-aligned) country (although Trump might have changed that if the threat of the US dropping out hadn't caused the deadbeat members to start paying toward their share of the costs.)
Of course if you're using the evolved meaning of "poor, economically peripheral" or "mass of underpaid or unemployed serfs under the domination of a Fearless Leader and/or an elite", the US is on the track to that, by replacing the lower class workers
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> Of course if you're using the evolved meaning of "poor, economically peripheral" or "mass of underpaid or unemployed serfs under the domination of a Fearless Leader and/or an elite", the US is on the track to that, by replacing the lower class workers with cheap, illegal, immigrant labor and the middle class workers with H1-B effectively indentured servants.
It was just an intentional insult.
> Having it provided to the serfs by the rulers is a legacy of noblesse oblige, where the royalty of Europe (a
Re:tech innovation causes chronic ills? (Score:4, Informative)
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?
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The future is in offshore data processing (Score:2, Insightful)
The current situtation in healthcare is stupid.
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. Doctors are actively fighting this democratization of information. Fuck them.
AI and machine learning have done a better job at diagnosis than humans for decades, but aren't widely used. WHY?
Fuck the system. I will get the images, and the data - or sensors that I own will - and they will be processed outside of the reac
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You've sent you genome to a country in Eastern Europe? That's really dumb. And I am an Eastern European.
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Promethease, by the SNPedia guys. I'm not that worried about my dataset. I'm not that special, neither are you.
Re:The future is in offshore data processing (Score:5, Insightful)
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.
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That's largely because the information 23andme wants to present has not been proven to be true.
Which in turn is because nobody has suggested an efficient way to fund said proof.
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Typically life science startups use, you know, VC money to pay for such proof. 23&me just couldn't be bothered.
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As I understand it, venture capitalists tend to be unwilling to fund clinical trials that don't result in a patent or other exclusive rights that keep free riders from unfairly benefiting from the VC's investment.
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As I understand it, venture capitalists tend to be unwilling to fund clinical trials that don't result in a patent or other exclusive rights that keep free riders from unfairly benefiting from the VC's investment.
Yep, that's how it works. And diagnostic companies manage to get funded and deal with this.
There's a lot of art in the med field about how to structure things in a way that are protectable.
Theranos will save us! (Score:2)
That's largely because the information 23andme wants to present has not been proven to be true.
Details, details!
We need more startups like Theranos to save our healthcare system.
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OK, so, given that there are billions of possible genetic variants that could potentially affect a person's health, are you proposing that there need to be billions of these "well-controlled studies"?
Nope.
What 23andme wants to claim is if you have genetic variant X, you are more likely to end up with disease Y. That only requires testing variant X. Not all other variants.
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They state right on their home page that nothing they provide should be used to treat any disease.
So...they're admitting to fraud?
If their tests are useless as claimed in their EULA, what exactly are they selling?
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Anyway, the information that 23andMe was providing was current scientific consensus "proof"
Some of the information is. Some isn't. The FDA is requiring 23andMe to only provide the information with proof.
Most startups seem focused on weeding out the weak (Score:5, Insightful)
no, really (Score:4, Insightful)
I totally believe you, pal.
realistic expectations (Score:2)
Not sure why this is news.... (Score:2)
Business wants easy way to make money. News at 11.
They just need to admit to themselves that it's about the money. Once they nail their "low hanging fruit," they're going to diversify... by finding more low-hanging fruit.
we need to take the profit out of Health Care and (Score:1)
we need to take the profit out of Health Care and maybe cut doctors school time down by 2-4 years do they really need 4 years per med?? and we don't need the 500K loans.
Retail, social media and gigging. (Score:2)
They aren't brain surgery. They aren't even primary care. All that model disruption business is about sweeping away old, inefficient systems that support simple and relatively discrete transactions: systems that sell me a book; give me a ride from A to B; or provide someone to mow my lawn for me. The entrepreneur in these scenarios focuses on achieving speed, scale and convenience rather than managing complex, ongoing and labor-intensive processes.
Healthcare services may be inefficient and mind-numbingly
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Note: I kind of hope such startup doesn't happen... But some of the Silicon Valley st
Privatized medicine is immoral and broken, duh (Score:1)
Established medical research firms and patent owners are the only ones able to navigate arduous regulation
People's lives are in the balance
Result: The only way for-profit medical research and treatment can happen is to charge unreasonable and predatory amounts of money for already approved medications, in order to fuel future research AND pacify the insane greed of wall street.
Our system is not set up for innovation or disruption, it is set up for
What a nonsense article (Score:2)
I have appeared before the FDA, discussing a testing protocol for a drug we were designing...when I was the CEO of a Silicon Valley VC-backed pharma company. The article even quotes a partner from NEA which is a life science investor in addition to being a tech investor.
Sure, some people try for easy wins...why not? Some people don't do their homework too -- and not just in the life sciences. And some people (looking at you, 23 & me), get the benefit of the FDA bending over backwards to try to allow
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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
Hype, appy apps, and perpetual beta (Score:3)
...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.
FDA fights medical break throughs (Score:1)
Which YOU pay for out of your pocket.
IF it succeeds you get to use it for (on average) 5 years before it goes to your competitors. They get access FOR FREE.
So WHY would anyone ever come up with a new break through?
People are dying because the federal government via the FDA PUNISHES success and helping people.
I hear the FDA is corrupt, but even if it isn't, disbanding it would
Just do Single Payer (Score:1)
Single Payer Healthcare works.
It's cheaper.
It's Medicare For All.
The vast majority of democracies with good GDP do it.
We should too.
And it's way way way cheaper.
Did I mention the cheaper part?
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Oh, yeah, absolutely. It's the government I think of when I want something inexpensive and high quality.
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Unlike you, I've worked in both sides. Private is more expensive.
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[Off topic] When I see the name Silicon Valley, I can't help but think the area does anything but manufacture Silicon Hardware. Now its the land of software and venture capitalists and start-ups. More of a vultures den.
Seems like the majority of "silicon" or hardware vendors moved to Texas.
They can rename Silicon valley when they finally clean up all the toxic dumping sites they left behind [wikipedia.org]...
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Most of them moved to Japan or Taiwan or South Korea. Texas got the residue. (But I hear that many of the early movers moved on to China, and a few of those have started looking at Indonesia.)
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When that happens, it's the end of medical innovation full stop. Who else is going to do it? Europe? Africa? The Middle East? Russia or China?