Silicon Valley’s Ultimate Exit (2013)
genius.com
genius.com
Balaji Srinivasan is being considered to run the FDA. If chosen, he is expected to radically weaken its regulatory power, purportedly in the interests of promoting innovation in the pharma space. He's described it as the big enemy for any biotech innovator to overcome.
When we have an opt-in healthcare system, people who are in perfectly good health will opt into favorable plans only they qualify for. Those born with expensive conditions or who develop a chronic illness won't be able to opt in, and will find themselves in a high risk pool paying hardship-tier premiums.
When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living. Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans.
The problem with an opt-in society is that only some people get the privilege of opting in. It's an almost self-contradicting concept. Societies only hold together if their members don't favor exit. Members collectively recognize they're all on the same side, by way of the social contract they've entered into, and they know the rules need to be the same for everyone. A modicum of loyalty - in Hirschman's sense - is an absolute prerequisite for a group to be called a society.
When it comes to our health, let's show some loyalty to our fellow Americans and use our voices, instead of fleeing the inconveniently poor and sick. The veil of ignorance hasn't come off yet, after all: if you get cancer tomorrow, you might well become one of them.
About the opt-in society, I think it can create rules to prevent the disadvantages you mention; for example by paying a percentage of your salary/profits instead of a fixed amount; or perhaps by taking -free of charge- one sick poor person for every 10 healthy ones that enter the system.
This is a very rough way to put it, but it's a fantastic idea. Policymakers call this universal healthcare.
These people need our votes, though.
Banning patents sounds good; it sounds like freeing technology from greedy capitalists. But in practice, it means freezing (or at least dramatically slowing) the development of new medical technology.
The Epipen does not "still have an enforceable patent" because there is not an Epipen; there is a series of them. The original design is not encumbered by a patent.
The specific problem with patents and drugs or medical devices is the FDA decisions on what products are interchangeable. The reason drug companies get away with these "minor tweak" patents is that the FDA doesn't see the changes as minor, and so will not permit a prescription written for a new patented version to be filled with a generic based on the old unpatented version.
You can make the argument in this case that the problem is not patents per se, but the interaction of patents with prescription drug regulations. These sorts of "tweak patents" are useless outside the world of prescription drugs.
Why the purportedly? Do you have reason to believe he has any ulterior motives?
I didn't know anything about this guy before this so I googled him.
http://online.stanford.edu/instructors/balaji-s-srinivasan
"the co-founder and CTO of Counsyl, a genomics startup"
Ok, so he clearly has some experience as a biotech innovator.
> He's described it as the big enemy for any biotech innovator to overcome.
Seems reasonable.
The current market in biotech and rate of innovation seems underwhelming. Would you agree?
The current level of legislation in biotech seems to favor too-big-to-fail type companies? They sure seem to get away with egregious crimes. Eg: bribery [1] , knowingly selling HIV contaminated blood products , even moving such sales to Asia and Africa after it became public in the US [2] , numerous other ethical issues [3]
[1] https://www.bloomberg.com/news/articles/2016-09-30/glaxo-to-...
[2] https://www.ncbi.nlm.nih.gov/pubmed/24785997
[3] http://ethics.harvard.edu/pharmaceutical-industry-institutio...
Seems to me the current system isn't working properly. Is there reason to believe a guy like Baraji shouldn't be allowed to try to reform it?
You write as if Srinivasan is being considered to run HHS/Obamacare. He's not. The FDA has nothing to do with health insurance.
When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living.
I get the impression you want to remove this option from people, thereby giving them exactly zero ways to make a living. Is that correct?
Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans.
You seem very confused. The FDA does not currently regulate prices. However, FDA regulations do drive prices up and create a lot of monopolies in the pharmaceutical space.
If you want to learn what Srinivasan might actually mean for the FDA, I strongly recommend reading this blog post (written by a Trump hater, FYI): http://slatestarcodex.com/2017/01/18/watch-new-health-picks/
The hypothesis Balaji and others here suggest is that the FDA requires drugmakers to pass useless onerous regulations and expensive studies before it'll approve a drug. In so doing, the drugs become more expensive to market.
Having worked a little in the drug discovery area, I'd advance a different hypothesis: the low hanging fruit are gone.
Balaji in his post explicitly mentions insulin coming to market in 2 years. That's a pretty easy thing to approve: you have a molecule that is identical to one produced by your own body, that has known or easily understood physiology and pharmacokinetics. All you have to show is that your preparation isn't toxic, so of course it's going to take nearly no time to get approved.
Contrast with a cancer drug. There you have a really complicated disease, not very good model systems before you get to test the molecule in a human subject, and when you get there most of your patients die anyway because diseases are hard/they're too sick/it doesn't work well enough.
I think the information/silicon technology side of silicon valley doesn't quite understand how hard biochemistry and biotech actually is. In traditional engineering you know a lot about the inputs to your system (code, silicon, plastic, etc.) and you know a lot about how they work. In Biology/Biochemistry/Physiology none of that is true. Your inputs, underlying system and outputs are hugely complex and in many ways completely non-understood.
That's why it takes so long to "innovate" or develop new drugs. Bureaucracy may not help, but it's not the main cause either.
An essential blog to read if interested in drug discovery:
http://blogs.sciencemag.org/pipeline/
topic relevant post:
http://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-...
Full disclosure: I once met with Balaji for an informal job interview/get to know the company at Counsyl
However, that doesn't mean bad FDA rules are not also an issue. From the blog post I linked to:
Any pharma company that wants their medication approved in both the US and Europe has to spend a billion or so dollars getting it approved by the FDA, and then another billion or so dollars getting it approved by the Europeans. A lot of pharma companies don’t want to bother, with the end result that Europe has many good medications that America doesn’t, and vice versa. Just in my own field, amisulpride, one of the antipsychotics with the best safety/efficacy balance, has been used successfully in Europe for twenty years and is totally unavailable here despite a real need for better antipsychotic drugs.
For genuine public health emergencies (anyone remember AIDS?) there's fast-track approval, the first antiretrovirals were at market remarkably quickly.
Let me play devil's advocate here and suggest that entrenched market participants love high-barrier-to-entry regulatory regimes. The FDA is "people in the drug discovery business'" moat.
Still, I'd be willing to say EU approval should drop the cost in some way by reusing studies or other things.
Note that "exit" here is not synonymous with "secession", but instead refers to Albert Hirschman's contrast of "exit" and "voice" as two complementary approaches that individuals can use to influence the society around them: http://peterlevine.ws/?p=11887.
In this context, the option of "voice" includes the approach of reforming institutions from within, while "exit" leaves them broken and bypasses them with new alternatives. Given Srinivasan's embrace of "exit", this makes him an intriguing candidate for overhauling a massive federal bureaucracy.
Interestingly, the kind of "exit" he's talking about sounds an awful lot like Timothy Leary's "Turn on, tune in, drop out": https://en.wikipedia.org/wiki/Turn_on,_tune_in,_drop_out
There's no easy solution to this problem. We're out of unclaimed land (seasteading and Mars colonization wouldn't really resolve it, even if they were more plausible.) I don't think Srinivasan has a great concept of why nations work; the problem with a Silicon Valley exit is less that Silicon Valley doesn't have aircraft carriers, and more that it doesn't have, you know, farmland, and I don't think the opt-in society would be allowed: Silicon Valley is rich and prosperous because of the large pool of mainly American consumers it sells to, and it is protected by the auspices of the US government. If they really wanted to leave, they wouldn't be able to take the money-making with them, as the US has no incentive to protect the businesses of a foreign power. I actually think that instead of getting more and more small countries as time goes on, we'll get increasing large blocs caring for things like defense and very general welfare, and increasingly small, atomized communities, either geographically or online, caring for other needs. If we have a large United States government that takes care of the nuclear weapons stockpile, coordinates response to natural disasters, and makes sure people don't die for arbitrary reasons, smaller communities can tax, spend, negotiate as they will. And I expect these communities will increasingly go online; online, Locke's dream can be realized, as there really is infinite space to colonize (if you don't like your current forum, go found a new one.) As long as people have a basic level of security, they'll be free to self-organize and explore new models of society in a virtual world. I can't tell if this vision of the future is utopian or dystopian.
Locke was an early and important writer in social contract theory, but not the original source in which all social contract theory is grounded.
And the government will be there to kindly remind us that: "Democracy is asset insurance for the rich"[0] and we may not skimp on the payments.
[0] Austerity: The History of a Dangerous Idea by Mark Blyth
[1] http://centredelangues.ens-lyon.fr/anglais/espace-etudiants/...
Boy, was he wrong.
Then would some current or future president be the Ballmer of the US?
I mean, yes, Microsoft CEOs serve longer, on average, than US Presidents do, but it's not nearly as stark as you make it sound.
I just don't see it, after spending time in third world countries I believe this is a false statement. It's not free to use a cell phone in the third world, the poorest of the poor can't afford "credit" nor phones, nor have anywhere to charge them. If anything I've seen cell phones usually being used by shady characters using them for nefarious purposes, they're often the only "poor" who can afford cell phones in third world.
Let's also not forget who actually produced the cheap cell phones that made them affordable.
God bless this article.
git clone ....
Create new repo in github. git push ....I was trying to find the course in the archive.org's backup of coursera [3] but it doesn't appear to be searchable.
[1] https://news.ycombinator.com/item?id=5089487
There's probably still a lot of good stuff you can do though: low cost housing and transportation, just for starters.
This is some of the most myopic, ego-stroking bullshit I think I've ever read on this site.
Also the sooner ridiculous "code=law" analogy goes away the better. It's clear this person has very little understanding how affairs of state actually work.
If you think their vision of the future is nightmarish, you don't have to do anything. Just stay where you are.
And I absolutely agree. Its obvious that noone is going to happy with their Mega Govt all the time. We should work on mechanism that allows creating new, smaller Govts out of a Mega Govt as easy as possible. Let the market innovation/compitition advance Governence too.