An anarchist takes on Big Pharma by teaching patients to make their own meds
statnews.com
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It's not something that we should have to consider. But this is the world we live in, now; legitimate supply lines of life-saving medicine have collapsed for a fair number of people. I understand why people might be troubled by someone actively going out and advocating this as opposed to simply making the information available, but if you're offered medicine with 95% efficacy that you can afford and use vs. a well-regulated 99.99% that only exists theoretically...well, come on.
https://motherboard.vice.com/en_us/article/bjxwma/people-are...
The real issue is probably that there are so many moving parts, especially when you get to the more complex drugs (e.g. antibodies). You would have to go through a million patents to find all the information required to create the actual molecule and also get it in a state to put into your body.
And even with all the information, it is unlikely anyone is sufficiently resourced (whether it's money, tools, or know-how) to actually make something viable.
(as a minor defense of the pharma companies, you're paying them not just to do a bunch of organic synthesis for you, but also to do ongoing QA that the synthesis process is working correctly. and not all processes are equally easy/amenable to industrial-scale duplication.)
What I find most dubious about the article is the lack of attention to synthetic biology. Because QA in that sense can become say, “this modified organism can produce the drug in question under most conditions and all future populations will carry the new genes with X% assurance” - ONCE -and you’re done.
This is quite possibly the real Pharma killer, IMO.
There's so much tooling and expertise that goes into front end, back end, deployment, db, QA, etc ,etc, etc just to get one app going. Why would would drug deployment be any different?
Also the same semi-synthetic organism could be applied in traditional pharmaceutical process settings as well, if for no reason other than cost reduction (and probably workforce reduction as well). So even “big pharma” has some incentive to contribute to this sort of technology.
But this is exactly like saying "Reddit is just a few SQL queries, a reasonable programmer could whip up their own version in a weekend." Just like there is only one reddit/StackOverflow/Facebook even though plenty of people have the same basic idea, even knowing the chemical formula doesn't help that much. The trick is in the execution: generating reliable quantities of reliable strength and without any contaminants.
There is a whole field, process engineers, devoted to this quite difficult problem.
(I’m pretty sure the legal answer would be yes on so many fronts)
Imagine a natural disaster happens, and the strong hoard more water and food and shelter and medicine than they could ever use in a million lifetimes and protect it with guns. Then you tell the poor "in an emergency scenario, here are some options to keep you and your children alive a few more days that aren't totally safe but are better than nothing. Your makeshift roof might fall down in a bad storm, your food won't be perfectly clean, but it's better than doing nothing and waiting to die".
This is what is happening in the US. In this analogy, the natural disaster is free market capitalism, the strong are the ultrawealthy owning class, and the guns they use to protect their property are the police and legal system, who provide the violence that is inherently necessary to keep order in a massively unequal society.
Imagine a true free market healthcare system. Or just one step further than ours: no medicare. Imagine if every middle-aged middle or lower class American had to, as their parents age and require more healthcare than anyone can feasibly afford, choose: bankruptcy and permanent insurmountable debt, or watch your parents die knowing you chose not to stop it. What glorious freedom.
Medicare costs 17% of GDP and it has 44 million people. If you expanded medicare to every single person in america (10x), how much do you think the GDP cost would be then? And what do you think will be the prescription at that point?
Its also a ludicrous proposition to say that because its closer to free market, thats what makes it worse compared to socialized services. Its qualitatively different because it has tremendous regulation and rules. And the proposed solution is to add more regulation.
The problem is actually created by the government in the first place. If you fix the length of the patents or eliminate the patents in the first place the cost of drugs will drop close to the cost to produce them.
Monopolies are well studied in economics and the effects of monopoly pricing due to government granted patents are what we see here, this is a government created problem not a free market one.
Government-protected monopolies (i.e. drug patents) are almost the antithesis of free-market capitalism.
Every property right is a government-protected monopoly; without these government monopolies what you have is an end to private property which may be desirable but is certainly not free-market capitalism, it is communism.
That risk exists no matter what you "actively advocate" for. When you actively advocate for Obamacare, do you face moral responsibility for those who were forced to take a much lower-quality insurance policy because the premiums on their existing unsubsidized policy doubled?
Or, when you actively advocate for the repeal of Obamacare, do you face moral responsibility when a patient who can no longer afford insurance skips a critical doctor visit and dies as a result?
Because humans are not mindless programmable automatons, mere advocates should not be held responsible for other peoples' actions. Otherwise, we'll end up throwing lawyers in jail for successfully representing guilty defendants who go on to commit further crimes.
The medication was discovered in 1969. The application method, which is the shitty excuse for the patents protecting its $2,200/month price tag, was first approved for use by the FDA in 1979. The drug has been for sale in it's current form for over a decade.
This is what government granted monopolies look like.
Long term don't these companies think that charging outrageous prices for drugs will cause a future voter/government backlash of some sort... or maybe they think they should extract profits now because of a chance of drug price regulation coming to the US in the future?
No, because it demonstrably won't. People say they're angry and then do nothing about it. The US has an entire political party angrily decrying any effort to regulate healthcare as socialist slavery.
The drug companies know they'll be just fine. Maybe some token slaps on the wrist and public performance of cosmetic changes to appease people now and then, but nothing will happen to them.
Argubly regulation is the problem we're in this mess. Do you think an epipen would cost $600 if there weren't a Government granted monopoly?
We have two parties who love the current amount of regulations on competition - you need to go to an AMA approved medical school to become a doctor, there aren't H1Bs for health care workers, and the government gets to pick and chose who's allowed to sell medication.
They just disagree on the amount of subsidies for poor people. One party thinks prepaid consumption with cross subsidies is insurance and the other party thinks that insurance shouldn't be so binding if you get sick.
But in terms of overall effect, one can't ignore other nations which pay much lower prices for healthcare with both regulation for drug patents, as well as regulation on drug prices. That combination manages to deliver better care at lower costs than the US (we pay on average double per capita). So I don't think one can generically fault "regulation" for a poorly performing health market in the US.
You're absolutely right, however, I do think the worst parts of our medical system exist as consequences of regulation.
The mandate that emergency rooms treat anyone who enters is onerous and there's no free lunch, paying customers are stuck with the bill.
The licencing system isn't optimal for cost effective care.
There's a lot to be desired for people who favor supply side solutions to expensive problems.
I don't think that's onerous, I think that is a minimal, and admittedly imperfect, expression of our societal intent that people shouldn't die unnecessarily in emergency rooms - either from lack of being able to pay; nor from a practical standpoint, lack or delay of on-hand proof of ability to pay.
Removing those regulations would cause all sorts of other problems. Someone arrives in an ambulance near-death, if I lack morals then one level of maximized extraction price is to have those patients commit to pay a value that represents the earning potential for that person for the rest of their life. They have to agree before getting admitted. Even more profitable, if I judge that person as having a well connected social network, I can charge even more because I know their friends and colleagues would chip in to save them... I'm not sure how a competitive market with no regulation changes the worst case for this transaction - if someone is near death then moving on to another emergency room is out of the question.
I see universal healthcare with a shared cost-pool as the lowest overhead way to provide for our social moral desires (but then I'm not in fear of the regulation with may be needed to implement that policy).
Insurace with a shared risk pool is a technically workable, but adds even more overhead, and ends up a more expensive way to do the same thing... but again regulations are involved (and fixing very flawed ones at that).
Actual markets don't work that way. If you could actually make that much money then someone would open a competing emergency room right across the street, let everyone know that they charge $1 less and take all the business. Then the first emergency room would charge $2 less to take it back, until they're both charging reasonable prices.
It's the same reason you don't have to sign your life away to buy food even though you would die without it.
The problem in the US is that the regulations on the market for medical services work almost the exact opposite of that. There is no price transparency at all so you have no idea which facilities are more expensive. And if someone wants to open a competing facility, they have to get a Certificate of Need proving that the existing facilities don't have enough capacity. Even though having enough capacity doesn't preclude charging outrageous prices in the absence of competition.
> I see universal healthcare with a shared cost-pool as the lowest overhead way to provide for our social moral desires (but then I'm not in fear of the regulation with may be needed to implement that policy).
The existing US system is pure corruption. It's heavily regulated but the regulations are a result of regulatory capture by insurance companies (who want higher costs because higher costs means more vig), and all the industries the insurance money pays for like pharma.
The result is that medicine in the US is outrageously expensive. But the expense doesn't go away even with universal coverage unless you fix the regulations, and if you did that then people would be able to afford medicine out of pocket without insurance.
Isn't that exactly what's happening in slower motion with the incredible price hikes in many drugs such as insulin? And you assume that the neighborhood can sustain two emergency rooms - a second competitor isn't going to arise if the setup costs are high and the competitor can't undercut and survive the competition phase. This is exactly why there aren't multiple competitors to residential ISPs, because after the risk and costs are factored in setting up overcapacity for a market isn't a good investment.
Further if you look at the drug markets, sufficient cost and time barriers exist and allow even makers of generic drugs (with no patent monopolies) to charge inhuman rates for drugs. And generally investors are not going to back efforts to fund a head-to-head competitive slugfest when the market of users for a given drug is basically of fixed size. Again building overcapacity is generally avoided in these markets because of the high entry barriers.
https://www.nytimes.com/2017/04/14/business/lannett-drug-pri...
Again, the market for medicine suffers from regulatory capture. The regulations make it prohibitively expensive (literally millions of dollars) for new competitors to enter the market, which allows the incumbents to conspire to fix prices.
If we had the same standards for manufacturing medicine as we have for manufacturing food, that wouldn't be happening.
> And you assume that the neighborhood can sustain two emergency rooms - a second competitor isn't going to arise if the setup costs are high and the competitor can't undercut and survive the competition phase.
All you need is for the profits from entering the market to exceed the entry cost, which is exactly the case when the existing provider is charging outrageously high prices.
It is certainly true that adding a competitor will increase total costs. But that means total costs will at most double. That's not good, but it's not anywhere near as bad as having a monopoly that can demand your lifetime earnings in exchange for saving your life.
And everybody knows that to begin with, which is why you get this:
> This is exactly why there aren't multiple competitors to residential ISPs, because after the risk and costs are factored in setting up overcapacity for a market isn't a good investment.
It would be a good investment if the incumbent ISP was charging $500/month for residential internet service. But they know if they did that then it would open the door to a competitor who could charge $400/month and still pay the cost of duplicating the entire infrastructure.
So instead the incumbent charges $50-$100/month, even in areas where they have a monopoly, because they know that price is low enough to deter new competitors from entering.
A credible threat of competition is enough to prevent prices from becoming completely outrageous even in areas where there continues to be a monopoly in practice. Only monopolies under no threat of competition, like the ones enforced through patents or Certificate of Need laws, can charge outrageous prices without that happening.
The competition doesn't pay the cost of duplicating production - not after the competition has lowered the price. At least the chance of that is why no one tries to enter.
To make even the generics at a reasonable quality is a barrier sufficient in an of itself. And a competitor risks the incumbent lowering the prices to cut off the incumbent - no investor is signing up for that expensive fight as evidenced by the article... generics are rising in price to reflecting the effectiveness of the barriers. (well and lack of price regulation by our healthcare system)
But that's the whole point -- what is causing the barriers to be so high? Regulatory capture isn't just patents. Drug companies like the fact that a would-be competitor has to pay millions of dollars in regulatory compliance costs to enter the market. Because it should cost them $1 to make drugs they sell for $1.25, but apply enough red tape and it costs them $100 to make drugs they can sell for $300. They still can't charge $10,000 because that would invite competitors, but the $99 in overhead is what allows them to charge $300 for something that should cost $1.25. The overhead raises the barrier to competition, resulting in less competition.
And the fact that most of the drugs are paid for by insurance companies or the government only exacerbates the situation, because they're deep pocketed bureaucracies under orders to pay whatever price the seller sets. No surprise the sellers take advantage of that.
> (well and lack of price regulation by our healthcare system)
The problem with price regulation is that it only solves a small part of the problem. If you're wasting $99 in overhead, you might shave off some of the profit margins but you're still spending $100 to produce something that should cost $1 and sell for <$2. You have to actually address the regulatory costs -- and if you did that then you would have competition.
Go try to make and sell some generic drugs and see how far you get. Spoiler: you're very wrong.
I agree with about 95% of this: https://market-ticker.org/akcs-www?post=231949
We just need smarter regulations:
> every medical facility needs to have a price for each billing code
> every healthcare facility has to publish their prices
> heatlh care facilities must honor their published prices for everyone
> if someone needs car and they can't pay, the government will pay for the care but the government holds a debt and can garnish wages / use tax refunds / credit welfare to cover the debt
If people could shop on price for routine care, medical companies would become more efficient and extend those prices to people in an emergency
Go ask the people who get jobs as billers - most hosptials have more billers than beds, they can sort it out.
Before you go to surgery agree on the price of everything and ask for a video so you can verify the work was done as billed and there wasn't any padding. In an emergency situation, you're entitled to the price they advertise. IF you can't afford it, the government picks up the bill and maybe you pay for it, maybe you don't. If you want insurance, you can buy insurance but let the insurers use every actuarially relevant bit of information so the insurance works as insurance
Secondly, what about people who become destitute because of a medical procedure and do what they sometimes do in Holland ? (if you're fucked on bills and the state comes after you and you would become homeless, simply rob places until you get convicted for 10 years, and stay in prison for 10 years. Free tv and internet, and nobody garnishes any wages. Outside you wouldn't be able to pay rent).
Several years ago, I had my gallbladder out in an emergency surgery. I was in intense, intense pain. My friends worried I was having a heart attack. They drove me to the hospital, because I could barely stand, let alone drive. Such intense pain I was barely conscious.
In the ER, I remember they did an ultrasound to determine it was my gallbladder, and then pumped me so full of morphine I was fully incoherent. Still in agonizing pain.
Then, a few hours later, they cut me open and pulled it out. It was starting to go necrotic. They said, had I waited a week, I simply would have died of blood poisoning.
At no point was I in any condition to agree to a price on anything--incoherent from pain, and the morphine. I was in no position to shop around. My friends didn't even know what was wrong with me, they just drove me to the ER because we all thought I was dying.
Even if I had been able to agree to anything--which I couldn't, due to pain--having a video recording of the surgery would have done absolutely nothing for me.
Oh, and while I was in the ER, I did see a couple of gunshot victims--fully unconscious--wheeled through from ambulances. What are they agreeing to??
Man, I don't think you've ever really experienced the health system, and I don't think you've thought about your plan.
(Sadly, I also don't think people's real experiences are going to change your mind, either, but it'd be great if you did think about how nonsensical that fix you're proposing is.)
You get to pay the advertised price which is going to be much lower than the myster price today.
Regarding gun shots - I think people with gang tattoos shouldn't get healthcare for bullet / stab wounds. Let gang bangers quash their own beefs.
And you obviously haven't thought one bit about the very common situation where someone without health problems is suddenly struck by them, and in a way that makes them unable to price-negotiate.
You're ignoring the reality of the health care world, and hey, fine, it's a free country, but it doesn't make you look like a reasonable or thoughtful person. It makes you look like someone with a blind faith in an ideology.
The whole point of negotiation under duress is rendered moot when the person under duress gets to pay prices that are presented to people who aren't under duress.
Let me craft an analogy - once upon a time I was going on a road trip and forgot to get my oil changed until the day of the trip. I called up the dealer and asked if they could sneak me in - they could, and I got to pay the same oil change price as someone who scheduled it two weeks in advance. The dealer didn't jack up the price because I needed an oil change immediately and they couldn't because they list their prices and are legally bound to honor them.
I think healthcare should have the same thing - every medical facility should have to publish their prices and they should be bound to honor them.
And in my system, if you can't pay, you're not going to debtor's prison. You get to go on your way and you might see less social security or tax refunds until you've made good on your debt.
Again, you don't know a single thing about the gunshot victims wheeled through the ER the night I was there.
You keep bringing up gang imagery, or trying to say somehow that those gunshot victims I saw deserved it or don't deserve medical care (they're just gang bangers and you want to call the cops??? no, they're fucking gunshot victims, and you don't know shit about them).
That is stupid, offensive, and wrong.
You don't know a thing about them and you've now twice inserted your completely-made-up-out-of-your-own-head "gang bangers" or "teardrop tattoos" shit.
Where the fuck is this gang banger garbage coming from?
You know what's offensive? I pay more than my fair share healthcare expenses and I don't get better access to care than lazy people.
You know what's stupid? Health insurers can't adjust my policy based on my gender, but auto insurers can.
You know what's wrong? The status quo that makes it better to present to an E.R as a lazy jobless poor person than someone who's working poor.
You know the system is bad, why are you defending it? Why don't you go out and tell those gang bangers to put down their guns? They won't, and you're too scared to talk to them because you know deep down that violent poor people in bad parts of town are dangerous and beyond reason.
You don't know shit about these gunshot victims but in your mind "gunshot victim = gang member".
Do you honestly really think that everyone who has been shot and taken to a hospital ER is a gang member?
Honestly, really? No one who's been shot isn't in a gang?
If your answer is "yes, every gunshot victim is a gang member" then you're a real prize moron, no two ways around it.
Neck tattoos, chains, bad attitude, won't tell the police who shot them = probable gang member
Wearing a suit, eager to talk to the police = probably not a gang member.
DO YOU UNDERSTAND???????
I'm talking about gun shot victims who look like gang members.
You're talking about people you've seen. If those people don't look like gang bangers, that's fine, then they can get help.
That's not 1/1000. Not 1/1000000. Not 1/1000000000. Zero. Entire companies get shut down because of a single mistake. Think about how ridiculous that is. A company owns 5 separate factories, and in one of them a product was produced that may, in a panel of doctor's opinions, have caused the death of a patient (mostly one who would have died without the medicine), and all 5 are immediately shut down until an extensive investigation is not just run, but run in an approved manner by outside experts, and the resulting cause was both found, approved by the panel of doctors and the government.
And of course, a company is supposed to take care of any patient they damaged, for life, full treatment for all ailments (not just the one that had something to do with what they did), ...
We used to let people prepare medicines in corner shops with at least a few ingredients they procured themselves. Needless to say, pretty cheap. Mistakes were ... not common, but certainly more so than today.
Until we find a balance between care provided and acceptable risk there will be no reasonably priced healthcare. Until we stop giving health at any cost, and count on "management" mistakes to do cost saving (regulating that people get thrown out of hospital the day after open heart surgery unless there are complications. Well, if you want to survive, you bloody well hope your doctor finds some complication. Needless to say, proposals for making it same day are on the table. Good luck).
And of course, like good capitalists faced with demands like this, companies don't say "are you bloody insane ? This will bankrupt the entire country", they say "How secure do you want it to be ? Perhaps even a bit more ? I mean we can always do better. That'll be $xxx(xxxxxxxxxxxxxxxx)".
Well articulated counterpoint: http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...
Also, we live in a country where most places they don't even allow opening a new hospital without the permission of surrounding hospitals, and all of the recent healthcare regulations have encouraged a seriously problematic consolidation just like the big banks.
As an industry, healthcare is so over-regulated it isn't even funny. The good news is that drug prices are still generally falling outside of big examples like Daraprim and Epipens and there are fairly effective solutions to the spikes we could have if the FDA would get onto more reciprocity with other nations: http://marginalrevolution.com/marginalrevolution/2016/02/the...
Also relevant, the US Cost disease: http://slatestarcodex.com/2017/02/09/considerations-on-cost-...
Also, the comparison there in the drug vs the chair market there is poor too. The key difference between manufacturing drugs and chairs (as in the example), is that anyone could enter the chair making with one guys who has had high school woodshop. Manufacturing a drug has a much much higher bar...
If that's what you got from SSC's cost disease article, you might have some bias in your framework.
Party B: Remove old regulations which disadvantage pharma
All property is government intervention. And property is good. Because property is capitalism, and capitalism is God's will.
/s
Property existed long before third-party regulation.
Rather than ownership being enforced by a third party with monopoly on violence, it was enforced by the threat of escalating violence from the property owners themselves.
Eg. You take one goat from my herd and refuse to give it back, and we are now at war. Result: Nobody takes any goats.
So the property was defined by mutual understanding and mutual enforcement, not regulation.
This is still done in some societies and sub cultures (Eg. Criminals). Even animals do it, with things like territory or sharing food from a kill.
A mutual cultural belief in property strengthens this mechanism and makes it work more smoothly. This cultural belief is part of what ""free-market" types" (sic) would like to spread.
Force protects the object, sometimes the government exerts the force sometimes not.
But if I show up with a better club then all his stuff is now mine. A third party enforcing certain resource allocations with overwhelming force is different to everyone defending their own stuff.
Government is the difference between property rights and might-makes-right.
Bingo. Ownership exists without government - ownership exists to the extent others respect the claim.
Government is the difference between property rights and might-makes-right.
Governments are legitimate because of their might. Why do you think the basic social contract between authorities and the governed is "obedience for protection"?
Even in places like East Germany or prison where overt markets are suppressed, people still exchange things with each other, even developing bootleg currencies such as loose cigarettes. And if there’s a sudden shortage of a specific good inside these black markets, the price will go up; likewise if there’s a sudden surplus, the price will go down; likewise; if there’s a sudden surplus in whatever good is used as a currency (e.g. cigarettes) then there will be inflation, at least until its cost-effective to switch currencies.
No, that's not even arguable. Other countries with even more highly regulated healthcare manage to provide it for much, much less. You're just regurgitating mindless libertarian talking points that have no relation to the real world.
The particular form of regulation in the US may be a problem, but regulation in general is demonstrably not.
IF we regulated single payer health care into existence, we'd have cheaper care. The problem isn't regulation per se, it's our current regulations.
"Ultima ratio regum" is an appalling way to enforce fairness, but it doesn't seem to me that greed in general will stop short of a true class war or an external threat ala a World War.
Also to be clear I am definitely not advocating this route, I'm trying to figure out what anyone can do to prevent it and thus far I am at a loss.
You quietly find another path and make these insanely expensive drugs vastly less relevant. The real challenge is effectively spreading the word. Something truly disruptive in this area seems to be about the most offensive thing a human being can do.
I just don't understand how people can make such a blatantly destructive set of choices when it's really clear that it will come back and bite them in a way even the most psychopathically mercenary people should understand, let alone anyone with a more advanced morality than "I got mine".
I spent ~5.7 years homeless while classist assholes (online and off) shit all over me.
I believe part of this is happenstance. Humans are little monkeys with brains designed to parse a social order for a tribe of 150 members. With 7 billion people on the planet and a global economy by necessity, the paradigms developed to parse our tribe break in the face of a sudden new world order.
It is actively dangerous to give a damn about the welfare of other people. Some of that is also happenstance. Strangers from extremely different backgrounds face substantial obstacles to good communication.
But, we really need to solve this, even if we are all cold hearted sociopaths who don't give a damn about anyone but ourselves. Like you said: If we don't, this will eventually go very bad places.
Given the recent mass shooting in Las Vegas, the record destruction of hurricanes in Texas and Florida, and the ongoing fires in California, I think it is reasonable to assert that our choices are already coming back to bite us. We can do something more sensible or continue to suffer the consequences.
Businesses have no concern over their long term viability. Executives are not incentivized in anyway to care about long term interests. In fact all their bonuses and compensation explicitly reward the short term. Compounding the problem is a simple cost benefit analysis means they've already costed out the future "backlash," and still find themselves to be more profitable.
The "long term" is nothing but a mental exercise with no real world manifestation for businesses. The closest you can probably get to it having meaning is for business school grad students doing case studies.
The best solution is probably to simply drop patent extensions for these things and allow generic drug manufacturers to do what they do best, but if you do that too early you risk damaging funding for new drug development. Too late and you wind up with companies just building up piles of cash like we have today. You need to hit that point of "we need to develop new drugs to make a profit" - what that is, I'm not sure.
Why aren't more American's up in arms about this?
Establish strict price controls, ban drug patents, and make production volume guarantees a hard condition of receiving federal drug discovery money. And the money should be large enough to be worth it. Ideally, 90%+ of a drug company's income should be from federal contracts and not from sales.
And if that turns out to not be feasible, just nationalize them. The federal government can hire drug-discovery chemists and manufacture the drugs themselves.
You'll have a hard time selling a plan like that to anyone even slightly right leaning - think about it politically for a second. The government decides what drug development gets priority? Remember the death panels talk from a few years ago?
It's viable, but involves a lot of trust in government, so much that even as a fairly left-leaning person myself I'd have to think twice about it.
This might become necessary if we're to avoid an antibiotic crisis. Bacteria are becoming resistant to antibiotics at a greater rate than antibiotics are being developed. The problem isn't that we've tapped out what antibiotics can do, but rather that drug companies have little to no interest in developing antibiotics because there's very little money in it. Antibiotics are un-sexy drugs that don't make for good marketing campaigns.
Ultimately, if we want to continue to have effective antibiotics, a large entity with no profit motive, nigh infinite money, and a monopoly on force (i.e. the government) will have to get involved.
They should be non-profits.
Due to the risk, investors are looking for high returns from successful drugs.
Now imagine if we had a regulation that both forbade universities from issuing patents and limited the price of any drug that is initially based on public funded research.
[1] There isn't really any such thing, at least as a way to resurrect patents that would otherwise expire.
Unfortunately, no other class of drug class has worked, and the traditional delivery methods (ie - pill form) caused measurable hearing damage, just from the trial periods.
Good luck!
Edit: Sorry, read below that you need the trans-dermal version.
If I knew a thing about pharma manufacturing I'd be spending my time trying to do this.
There are a lot of companies that do that.
The 'market is speaking'.
If it were in way lucrative, someone would be doing it.
I suggest that it's just a very expensive thing to develop and make, and there isn't a huge demand - otherwise, someone probably would.
Now, $600 seems just crazy to me, and like you, my instinct might be 'there's room for someone' - but in reality, it's never that easy.
My father worked in Pharma, and once sold a small empty building on behalf of a company for huge $$$ to a Chinese firm - only because it was 'approved' by the Canadian government for making drugs of a certain quality, and that this approval would have been very expensive to obtain. This is just at the top of the list of how many regulatory issues there are in making drugs - and why they are so expensive.
I mean it does seem a little crazy that there are $600 EpiPen's but no others - when anyone can make them, but that's where we are.
Indian pharma industry is mostly doing these. We export a lot of generics to other continents as well.
http://www.econtalk.org/archives/2017/06/robin_feldman_o.htm...
If no competitor is available, why doesn't anyone set it up? It looks like a great startup opportunity.
As soon as it went out of patent, they patented the drug + transdermal patch. So, in order to keep their profits up, everyone went without the patch system until their original patent was about to expire. So now they can charge $2,200 for something they developed in the 1990s, but intentionally kept off the market to monopolize.
This happens as a matter of course, with every new drug.
Without the transdermal system, I can't take the drug. I have to take too much of the active ingredient, and it causes pain and permanent hearing damage.
Thanks for suggesting grey market alternatives - I hadn't given it a thought. However, they would definitely be grey/black market, since it's not off-patent, which means there will be higher risks, and it will harder to obtain.
Same question with epipen.
It's the usual practice to keep novel delivery system/drug combinations off the market until the original drug patent expires, thereby extending the profitability of the patent, at the cost of users suffering medicine that is consequently decades out of date.
Transdermal delivery unfortunately seems to be underexplored and very expensive in general. Transdermal estradiol is another one that is much more expensive than the pill form but is better in terms of safety. Generic patches available outside the US are less expensive (than patches in the US, still quite a lot more expensive than pill form). I'm not sure if generic patches are completely unavailable in the US or if they are just also quite expensive.
Melatonin is another case where transdermal delivery can be helpful, but it is difficult to find and fairly expensive (not quite as bad, though).
Beyond delivery mechanisms, drug companies also create modified forms of a drug (prodrug or metabolite or slightly different but similar substance) that have small advantages over the previous version. Again, these can't be substituted and doctors need to know to write the prescription for the form available as a generic. Best for the drug companies is when the origional form is pulled from the market by the FDA right after the patent expires, as happened with the antihistamine Seldane/terfenadine (replaced by Allegra/fexofenadine, a metabolite).
In other cases where out of patent drugs are not available as generics it is because the market is small and the current manufacturer can instantly drop their price to match if a generic appears, making it likely that anyone who attempts to make a generic will loose money.
And, since this isn't a generic, or even a pill that can be copied, they aren't stocking it. :(
But it's not clear at all this is the case here. The article itself notes that it's unknown whether anyone has ever used any of these DIY medicines/medical devices, let alone how well they actually work. For all we know he could be pushing complete nonsense that kills people.
If you are (more or less) coping just fine with a health problem, (most often) you shouldn't really take any medicine whatsoever, regardless of whether or not it is approved.
Only if you are distressed and desperate can you (a priori) expect medicine to do more good than harm. And if you are in that category, and the medicines that exist officially did not help, then you must make other attempts to rectify the problem in order to avoid danger.
Admittedly it's not much of a source of relief, but the good thing about the nature of hobbyist tinkering networks is that information about dangers spreads fast, as well as information about discovered panaceas (both when the results are replicated in their favor, and when they falsify the panacea).
This is not super-awesome. Humans have made incredible progress by specializing and optimizing, and this process improves productivity, efficiently, and (most importantly when it comes to medicine) safety.
The idea that we will have people taking the risk of getting sick or dying because they are not able to manufacture drugs with the same purity and potency as pharmaceutical companies shows there is a huge problem with the status quo.
Or were supply lines selectively destroyed by market-cornering adversaries, knowingly, according to the degree of “demand” which might be extracted?
I agree with the conclusion, but for a different reason. "Theft" is the wrong way to think about IP. The economic function of IP is not to protect producers from consumers, but to protect producers from free-riding by other producers.[1] Thus, for example, stealing pills does not offend a drug creator's IP monopoly. Teaching people to make their own pills, who couldn't afford pills anyway, does not really do so either. It doesn't implicate the real purpose of the patent monopoly, which is to keep some other company from profiting by free-riding on the R&D of the original drug creator.
[1] To use a copyright analogy, copyright does not exist to protect content creators from downloaders, but to protect them from companies like Youtube, which make their profits by selling other peoples' content.
I've always wondered about this line of reasoning. Drug is made that could save a life, but is put behind an access and paywall that would prevent person from living. So one steals this drug or makes it in violation of patent rights. Now, logically theft is illegal and stealing it is theft.
However we also have another area of law called "Justification" - it "because committing the crime advanced some social interest or vindicated a right of such importance that it outweighs the wrongfulness of the crime." (source: https://en.wikipedia.org/wiki/Justification_(jurisprudence) ) . This topic came up with the recent ex-marine who "stole" a truck to drive the shooting victims to the hospital, at the Vegas Massacre. On the face, he stole a vehicle. However it was to save lives, which is justification.
So yes, it is theft or violation of patent. However this is in the face of living or dying. Whomever would state this defense would have to admit complete guilt to the court, and rely on this as the defense.
But if this won, it would say that everyone has the right to life-saving drugs, but those that can afford it have to pay.
1) Preserving a reliable institution of private property is also a "public goods problem", and thieves (of physical goods) are free-riding in a very analogous sense (disrupting the very system that enables the production of things-worth-stealing). That free-riding is exactly what makes piracy intuitively feel like theft.
2) Enabling the down-low production of a drug does disrupt the monopoly that drug researchers depend on to justify doing that research. It is therefore likewise free-riding off of their work in discovering exactly which compounds (by which methods) produce useful drugs. Where a producer or a consumer obviates the monopoly isn't relevant.
Now, I agree that it's a matter of scale: a few hobbyists won't make a difference, but if one day someone magically made it possible to reliably produce Viagra in your basement, then Pfizer would definitely care about that and revise downward their estimates of future drug returns upon learning of the possibility.
Perhaps such lawbreaking is simply the symptom of the disease as Dr. Prasad says, which is (patent laws that allow current) drug pricing.
But yes, I strongly believe that it's a very bad economic model that insists that drugs -- or any physical good for that matter -- should (in any sense of "should") be sold at marginal production cost.
The patent system is broken. IP laws are far too powerful and some things should really be sold at marginal production cost + a small markup for distribution.
The function of IP, from a government point of view, is to promote the useful arts and science and to ultimately make them available to the public after a limited amount of protection to the creator. Otherwise, there's no purpose in the government being involved in enforcing monopolies.
The economic definition is also far more useful. Who knows what specific policies will result in "promoting the useful arts and sciences." Preventing free-riding is a more concrete issue that can be addressed with specific policies.
And here's the important part: Such rapid price reductions, it's said, would discourage future investment in R&D, because innovators and their investors would think "why bother; I'm not going to donate my time and/or my capital for no return, just for the sake of being a benefactor to humankind."
A simple analogy: Why bother spending the time and money to plant and raise a crop if your neighbors can come in and harvest the crop without paying you — among other problems, you'll be far less inclined to pay for the seeds and fertilizer it would take for you to raise the next crop.
So goes the theory; the extent to which that theory adequately models reality is something on which I'm not competent to opine.
If you want to look at templates for your own immunotherapy, CRISPR, optogenetic tools etc.: https://serotiny.bio/notes/proteins/
Which, once built can be then be ordered as DNA, shapeways-style using: https://serotiny.bio/notes/pinecone/
The cure for certain kinds of blindness, just approved by the FDA yesterday is, in total, a well-delivered sequence of ~10,000 base pairs of DNA (mfg cost @ 7¢/bp = $700): http://www.businessinsider.com/spark-therapeutics-hereditary...
The sequence may cost 700$ to synthesise. But it's delivery vector is a virus. Synthesizing the DNA, encapsulating the DNA in the virus.. not trivial stuff.
While I agree that drug prices in the US are absurd beyond comprehension or justification, and I've had a ring side view of life sci research, drug development as well as the drug pricing; to posit that, hah, a path breaking gene therapy product just costs a few hundreds or a couple of thousands to produce is misrepresenting the complexity as well as the significance of the achievement.
The amount of research (largely public funded but for the clinical trials, which may also have been public funded: no idea) to get to this point is staggering. the company also likely invested large amounts to Shepard a lab possibility into a viable treatment. FDA approval is a big deal because they are, justifiably, exceedingly strict. It is an arduous process.
There has to be a better solution, which would start with allowing the US CMS / Medicare & Medicaid to negotiate drug prices with the manufacturers. The problem is policy.
I'd argue that the significance of the achievement of these modern gene therapies is in just how simple the technology is relative to other medical procedures. In this case 'simple' is very much a result of an astounding amount of knowledge and work. It's so powerful precisely because it is simple.
And to be clear - I don't actually think anyone should be trying to cure their own cancers with garage-built immunotherapies today. Home-grown insulin-kombucha, maybe... But the technologies of today realistically enable that possibility in the nearish future precisely because they are so elegantly built. Recouping the cost of that R&D to produce something so simple & powerful is always a challenge - and that challenge is far more social in nature than scientific.
Notwithstanding what I've said, I genuinely find it appalling that these drugs are priced at five figures. That's just criminal. In the range of thousands (or even 10s of thousands, if it's a single shot treatment), I'd think the pricing is justified. Maybe if it's a rare disorder, charge a little more.
But the travesty in the US system is that the govt., Via Medicare & Medicaid, is just not allowed to negotiate on costs. That's what the UK NICE does. The American system is insane!
BTW, big fan of what you and serotiny are trying to do. I've just moved back to my home country.. am dabbling in other stuff at the moment, but the dream is to join with friends and start an automated high throughput industrial biotech company. PhD work used a lot of robotics and high throughput screening & mutagenesis and what have you.. and services like serotiny give me the comfort that my pie in the sky idea has a chance..
Since most of the cost of any new medication today is research, we should decouple that cost from production.
The main reason this doesn't happen is that conservatives preach personal responsibility, so want people with hepatitis C to pay for their own treatment at $80,000 a pop. But even if the cost to develop that cure was a billion dollars, that's a tiny amount for the government to absorb. We should be having a space race to cure the worst diseases and then give those cures to the world for free (or nearly free), much like penicillin or the polio vaccine.
Please keep in mind that I'm not politicizing this - it's already been politicized. I'm just explaining what happened.
Also, current pharma will be biased against any cost effective solutions as this will cut their margins. There's got to be some alternative path to research and bring in these treatments to the public.
For instance, i think we would have found a vaccine for HIV by now if antiretrovirals weren’t so damn profitable over the lifespan of a patient.
Source: https://www.aaas.org/sites/default/files/NIHMech_1.jpg
http://www.npr.org/sections/health-shots/2017/03/16/52039014...
Also $30 billion is only 0.75% of the projected $4 trillion federal budget for next year. Just percentage-wise this seems like something that should be low on the list for cuts.
http://annals.org/aim/article/2362306/restrictions-medicaid-...
Billions of dollars a year since 2014.
This is pure crazy. If these drug were generic (versus patented), the problem of getting them to El Salvador is not a price problem, it's a supply chain/infrastructure/corruption and theft/political (in the case of birth control in a very Catholic country) problem. Some of these drugs are highly complex and building, supplying, and feedstocking chemicals for a lab to make them is even harder than finding the money for a $5/pop or less prescription
I would say a better solution would be to start a not for profit manufacturer, but when India produces dirt cheap genetics, there does not seem much point.
Only took 2 years and ~$22k, but of course, replicating his synthesis would be a little bit easier... for another PhD Chemist.
https://www.youtube.com/watch?v=ddCuWX4vtOA&list=PLU79801KtV...
I think he said in the last video that it would have been cheaper and faster if he had bought some of the precursor chemicals directly instead of having to make them first.
So cheaper by easily an order of magnitude, possibly ~$100 a batch or less. Of course, if you want FDA grade instead of technical grade your prices for everything skyrocket and your workup has to improve a bunch.
> Q: What about quality control? A: It’s important to know that making small quantities of a chemical is vastly different than making it on an industrial scale. The chemistry isn’t even the same. This is a big reason why chemical engineering is an entire field of study. With smaller reactions, while you do have to be more precise in your measurements sometimes. There are fewer things to go wrong.
Why would making small quantities be vastly different than making it on an industrial scale?
I've heard the same thing about cooking and baking. Supposedly, if a recipe calls for 1 tablespoon of baking powder, then you scale it up 50 fold, you can't simply use 50 tablespoons of baking powder. The claim was that you had to use way more baking powder or much less (I forget which). It sounded like nonsense, but now I'm wondering.
It's a ridiculous answer to the question of quality control, though. It doesn't really have anything to do with that.
The same surface area/volume issue in bulk also plays into reactions that happen at the margins of materials rather than the bulk--metal-catalyzed reactions are a common example.
I'm not a chemist but several times I've seen comments along the lines of "you can do this at home by doing (simple procedure), however in the industry, it is done like that (complex procedure)".
Chemical reactions usually don't have a single product, other side reactions are possible. And they also don't use up 100% of the educt, so you have to get rid of that as well. Purifying your products and making sure they're actually what you want is essential.
Getting the dose right is also hard if you don't know how pure your product is, and if you don't have analytical scales (or work at a very large scale that a kitchen scale is enough).
I've only watched NurdRage videos, but it seems like sending samples to commercial NMR labs is pretty feasible as he does that regularly. So that might not be as big of an issue.
http://www.alternet.org/civil-liberties/noam-chomsky-kind-an...
Sure! Those are the collaborationists, and are the first against the wall when the revolution comes.
I'm only half-joking, see what happened to the Mensheviks in 1917-1921.
Your phrasing implies that Chomsky supports acting "suddenly or without care", which is not the case at all.
Favorite quote: "Anarchists are simply people who believe human beings are capable of behaving in a reasonable fashion without having to be forced to."
Other favorite quote: "human nature is such that they cannot be trusted to do so when given power over others. Give someone such power, they will almost invariably abuse it in some way or another."
I think I derived this definition from David Graeber's work.
Also some people choose a definition that emphasizes the process rather than the features. Those kinds of definitions are like 'removing unjust hierarchy or domination' or something to that nature.
A common misinterpretation of the term is believing that anarcho-capitalists and anarchists are the same, they're not. They're more often opposites.
They could have used the term "libertarian" or "protester" or "political objector" but they go all the way to use "anarchist" as if people making medicine to save their own lives or maintain their own autonomy somehow equates to anarchy.
This to me illustrates in a profound way many problems with health care, and to some extent, politics today: people are told by a privileged, protected elite that they are to take responsibility for their own welfare, but then if you actually take that seriously, you're branded an extremist.
The powers that be--drug companies, the FDA, the federal enforcement agencies, the pharmaceutical companies, physicians--are unwilling to open up competition to reduce their monopolies and regulatory capture. They are squeezing the last drop of blood out of people to line their own pockets, and using safety as a mantra to do so.
To me, this dynamic is so obvious and it's unclear to me why this doesn't get more discussion. People don't have any control over their healthcare, no ability to take responsibility for their own health, because they're legally unable to do so, because it's not in the financial interests of powers that be.
People lash out against homeopathy and antivacciners, but the obvious is staring us in the face: when you have no autonomy in the realm of traditional, scientifically-grounded healthcare paradigm, your only option is to reject it in favor of something else.
Same here: if people have no options to go to, they need to do it themselves, or go without medicine. People do this not because they want to, but because their back is against the wall.
The current regulatory regime, all the way from the FDA to current licensing regulations to drug enforcement, is completely and utterly broken. Not at risk of breaking, but a complete failure.
What?
>Swaggering, charismatic, and complex,
Gag me.
>Michael Laufer has become a fixture in the growing biohacker movement ever since he published plans last year for a do-it-yourself EpiPencil — a $35 alternative to the pricey EpiPen.
That couldn't possibly go wrong, eh?
>It’s not clear whether anyone has actually ever used a homemade EpiPencil to prevent anaphylactic shock.
So nobody's quite crazy enough to try?
>But that seems almost an afterthought to Laufer’s bigger goal — trying to build a DIY movement to attack high pharma pricing and empower patients.
Or, judging by the tone of this article, his attempt to build his own ego.
This is ridiculous and crazy. It's incredibly dangerous to claim to have produced something life saving but not have any actual testing to back it up.
Even lesser drugs that are just designed to lessen symptoms or relieve pain could go horribly wrong if they aren't prepared properly. We have such strict medical requirements because of that.
In fact from the article it's not clear at all what exactly this guy is offering or how it helps anyone beyond his self-aggrandizing bluster.
> He said this over lunch at an upscale French bistro in the Silicon Valley, where he orders Champagne and sauteed scallops. “If you really take the time to smell the scallops,” Laufer said, inhaling luxuriantly, “you can feel the ocean.”
I really disagree with the commentators that feels that this is an article aimed at lifting Laufer.
It's hard to mess up sodium oxybate, but it's way easier to mess up methamphetamine, for instance.
i personally wouldn't be ready to place my trust in his drug recipes.
Imagine you decide you are a modern day Robinhood, and you go around the U.S. breaking into medical facilities and stealing Epipens to distribute them for free to the general populace. You do this until you and your band get caught, and which point you go to prison.
At the end of your run every person who received a free Epipen got the same quality device as the people who paid exorbitant price for an Epipen. To the degree that you inspire others to do this, they are bound by the same risk of prison time. Finally, since the price you charged was $0 there is no financial incentive for copycats to distribute fake Epipens (or at least if somebody does they must be a bad actor with ill intentions, or they must charge a fee in which case potential buyers will rightly be skeptical of the product).
What the DIY chemist apparently wants to do is persuade non-experts that they can produce Artisanal Epipens that are ostensibly as safe as the real thing (or at least safe enough that the risk is overridden by the alternative). But that is only an argument for a doctor to use an artisanal epipen if it is the only thing that happens to be lying around-- it's not an argument for persuading the general public to practice and spread the idea of DIY non-expert chemistry.
DIY chemistry doesn't come with public policy expertise. It doesn't come with trained (and funded!) epidemiology. And if their DIY ethos goes horribly wrong-- as the "roll-up-our-sleeves-and-research-our-own-vaccines-schedules" movement has-- they won't have the competence in statistics to know just how dangerous their movement has become in terms of public health. Worse, where science tends toward rigor, verifiability, and a narrowly defined scope of research, these DIY chemists will likely be skeptical of the published canon and "wing it" by trying to do their own epidemiology (because after, ignorance and lack of training didn't stop them from being a chemist...)
Worst of all, unlike my Robinhood example there is no natural filter to keep otherwise good faith actors from making decisions that will have terrible consequences for themselves and others. To steal Epipens you've got to break in to a physical place and potentially physically harm or threaten a security guard. This filter keeps tens of millions of people who are no doubt convinced of the deep unfairness of pharmaceutical prices from becoming an angry and dangerous mob whose violence quickly outweighs the single benefit of redistributing epipens to the poor.
Based on that, DIY artisanal epipens are more risky and can scale into a public hazard more easily than just robbing a pharmaceutical warehouse. So I claim that casually encouraging people to make DIY epipens without a systematic, well-tested, and well-funded research regimen is more dangerous and irresponsible than just stealing extant epipens.
So if you're the type of person who rejects robbery out of hand, you probably shouldn't entertain the idea of Artisanal Epipens, either.
If you happen to be unable to afford so much coffee, just rent a car and smash into a tree at 100 miles per hour. So driving cars is also immensely dangerous!
I really hate that nany state we are living in where an average 16 year old is lawfully allowed to drive 5,000 pounds metal machine and kill people at even limited speeds of 50 mph, but yet when it comes to DIY pharmaceuticals we immediately see a vision of most population dying at home because they mixed something wrong.
https://gizmodo.com/how-many-x-would-you-need-to-eat-to-die-...
Here's a novel with a similar premise (but more SF setting) that isn't even out yet: https://www.tor.com/2017/09/18/excerpts-annalee-newitz-auton...
Depending on the drug, the best option is either an equivalent from a compounding pharmacy, or one from a low-price country, such as India, Mexico, etc.
Making your own is only worth the hassle and risk if neither of those options is workable. The EpiPen is an unrepresentative example, because it's mostly about mechanics. With most drugs, you need to bulk out the active ingredient(s) to get a reasonably sized capsule or tablet. For capsules, with mannitol or whatever. For tablets, that plus binding agent(s).
The challenge is that thorough mixing is nontrivial.
Imagine this situation: you Google for a recipe for a drug, and find two different recipes. Recipe A is the real one, while Recipe B will kill you instantly. The troll who posted Recipe B went around the internet claiming that Recipe B is real and Recipe A will kill you. There's no authoritative source to consult, because the actual recipe is patented. How do you know which is real?
That said, ideally we could fix the medicine-specific patent law craziness (and the regulatory inefficiency which necessitates it). Obviously, the specifics are much more complicated than anyone with a side to pick is willing to admit.
Any chemists here? Is it really plausible to synthesize C22H29FN3O9P at home?
- in the East, that's a victim of Communism. - in the West, that's a poor lazy bum.
In both cases, the person is gone and the society failed him.
So, this guy rebels. Let's not paint him in political colors.
Also, I found ASX-05 (Phase III) uses a DM metabolite that is retained much more by the addition of brupropion. DM is the stuff in some cough syrups.
[1] http://www.arkat-usa.org/get-file/22868/ [2] http://www.sigmaaldrich.com/catalog/product/aldrich/648434?l...
Isn't this kind of like the day 3D printers become affordable, mass manufacturing is done?
Infallible and easy to use. But you still need to buy the raw materials, unless we're talking Star Trek energy-matter conversion, which isn't on the horizon.
Otherwise, why would an average consumer think that buying the raw material and feeding it to their 3D printer is that much more convenient than just stopping by Walmart or ordering off Amazon? And would it even be cheaper, since the consumer loses the economy of scale in their individualized production?
Why not start with spider-silk dresses: https://boltthreads.com/
Michael you are a legend and hero for our new dystopian pharma world.
I'm not familiar with the case, but I feel like probably NurdRages "cake mix" comment probably applies: https://www.youtube.com/watch?v=Rd7hXFnSHZc
The question always is that when you are making something, what are your dependencies, where are you starting from. Afterall, to make an apple pie from scratch you need to invent the universe.