I know a bunch about pharma. The folks who are doing this and saying it's cheaper are often completely neglecting costs that are borne by corporations: the initial R&D, but also the immense amount of quality control and regulatory compliance.
I've also talked to the biohackers. S ome of them are smart, careful, and just get stuff done in the lab. Then there are the attention hogs who inject themselves on youtube (typically with no ability to know if they did anything at all), many of whom, after a few years, realize that what they are doing is naive, and that there was actually a reason for the entire establishment around pharma.
Those costs aren't all borne by corporations, just the profits. The cost is the cost of public schooling of the children that invent these things, the invention and development of internet partially funded by DARPA that allows quickly conveying scientific information these companies use, the millinia of scientific research that precedes the invention.
The corporation then benefits from regulatory capture, and insanely high regulatory barriers to lock away less capitalized competitors from introducing their own unique drugs. Those who can afford the insane regulatory costs then can squeeze consumers dry.
Open up a maximally free market for pharmaceuticals and watch these snakes die. If I want to GC/MS some shit I bought out of some guys basement to check purity myself then let me.
Even in academia, where most research originates and matures before being sold to corporations, the vast majority of research is tax-payer funded. I wholeheartedly agree with you stance. It's unsurprising that these regulatory barriers keep all but the wealthiest corporations out of the market considering that big pharma and insurance account for significant share the donor-base of most politicians in the United States.
Tax base funds the work, donor base collects the rewards.
Most of the R&D done to make drugs isn't done at universities. They do some initial discovery work and invent entire new categories of drugs, but their overall role in the process of taking a druggable target to market is limited.
Academia gets to keep rewards; universities patent discoveries and license the technology to industry. This made $$$ for Stanford and UC (billions of dollars).
I am sympathetic to the idea that regular joe of US doesn't get enough benefit for their tax payments but actually I think if you look at all the benefits americans get indirectly from living here, it's hard to say for certain that individuals aren't recompensed properly. And, I suppose, if they wanted, many people can buy stock in pharma and enjoy the profits themselves.
> You think academia know how to optimize structure? Bulk manufacturer? Organize clinical trials across the globe? Check all the regulatory boxes?
Yes? That is literally where the standards for these things are developed, and constantly tested? For example: the techniques for optimizing structure? Developed in academia. Bulk manufacturing? Reliant on tons of science, engineering, and mathematics, that was developed in academia.
QC and regulatory costs are absolutely borne by the corporations that are getting their drugs approved. Those are major expenditures.
I'm not completely arguing with the idea that pharma overprices drugs, but to me, that's a distinct problem from who pays for, and benefits from research and development.
My argument is terrible. That's why yours is found at the bottom, and mine at the top.
Fuck the thieving snakes claiming it is "their" work when an entirely different 3rd party with no prior contract with the pharma snakes uses their own reagents and chemicals and published or reverse engineered synthetic pathway to produce a substance.
"You are free to make your own drugs." I suppose you are, if you're willing to violate the CSA and FDA/DEA regulations, as my comment pertained to being able to buy drugs _someone else_ made in their basement (although I'd also like to include making your own as well).
>Why would making your own medicines violate the CSA or DEA regulations? You just looking to get high?
Maybe you are unaware. Many medicines are controlled substances. Some people are ill and not just looking to get high, although I think getting high is OK too.
>You sounds like a very angry anarchist
Shit, I am an anarchist. I guess you impugned my character and my statements must be irrelevant. Oh wait, that is ad hominem fallacy.
>who doesn't really understand R&D works and what kind of effort is required to put into it.
I am not angry about R&D. R&D I find to be one of the legitimate components of pharma. It takes so many people to bring a drug to market, I don't think you can really understand the complete picture of how R&D works either. But thank you for the arrogant superiority complex. Are you in R&D or something or why do you think I'm attacking researchers? I've continually said (and perhaps this was better reflected on other comments, apologies if not clear enough on my prior) researchers are important to drug development and that they create real value.
It's the regulatory capture, lobbying, insanely high regulatory barriers that enable many pharma businesses to squash new development from competitors that leaves a bad taste in my mouth, corrupt intermingling with FDA and agencies. Amongst other things, but those are some of the larger ones.
Just to frame all this a bit better: in Italy epipens cost… wait for it… ZERO - nil - nada.
You have a diagnose of anaphylactic shock risk? You get epipens. Public healthcare pays for it, therefore everyone pays for it with their taxes.
Without a prescription, you can get one for around 75€, which is already considered criminally expensive.
This is true for thousands other products. So please now tell me again how r&d and other costs justify the US prices for the same drugs that are sold profitably Yet way cheaper in other western markets.
The direct cost to the consumer is $0 (or lira, or EU, or whatever), but that's because public healthcare negotiated with the power of a volume customer to agree on a fixed price, which is paid for by the government, which is paid for by people's taxes. So what you're doing is spreading the cost of the drug across the population. I had a similar situation when I had kaiser- no out of pocket costs.
As to why drugs are expensive in the US: because the market bears it. Demand is just elastic enough (or inelastic, I always get it backwards) in the US that providers slowly edge prices up. Sometimes they get it wrong for example aduhelm didn't sell so it had a huge price drop recently.
Drugs are expensive partly because there is not a free market. Drugs that have been off-patent for decades which have 20 generics in other countries have none or only a few here. Anti-parasitics for example, that cost a few cents in Africa are $20 a pill here, for no reason at all, other than regulatory hurdles designed to ensure profit.
How much does public healthcare pay for them? That's the crucial question here, not whether the cost is borne by the individual using the good or by the taxpayers as a group. I mean, clearly universal access to healthcare is improved by collectivizing the cost, but it's improved even more by eliminating the cost, or most of it.
No. Spreading the costs over millions of taxpayers makes the cost you pay into the system way smaller, plus gives the government a huge contractual power when dealing with pharma companies.
It’s really not that hard to comprehend, but I yet have to find a single American that for some reason doesn’t try to justify or straight up defend the US broken and unequal healthcare system.
Yes, medical cost in the US is out of control. No, the government should not be the provider. That doesn't fix the problem. It just makes new ones. Our government is extremely limited by the Constitution on what they are supposed to do. Unless "providing medical services" is added as a power of government to the Constitution there will continue to be a large, vocal opposition to government healthcare.
Apologies in advance if I’m mistaken, but isn’t your Constitution supposed to protect your right to “life, liberty, and the pursuit of happiness?”
How does one have life and liberty if they have a crushing burden of medical bills?
More simply, how does one have life if the medication needed to save you - is $750 a dose? or $300 an injection (and expiries with no refundable “core charge” whether you use it or not)?
R&D and quality control provides benefits to patients, and it is critically important to figure out how to reduce the cost of R&D and quality control so we can do a lot more of them. That's what Four Thieves Vinegar and other biohackers are doing.
Regulatory compliance doesn't provide benefits to patients; it's a deadweight loss. As you are presumably aware, to a significant extent, the reason that regulatory compliance is so costly is that, being costly protects established drug companies from competition.
Quality control and initial R&D have nothing to do with why Epi Pens, insulin, or Daraprim are absurdly overpriced in the US. That's purely monopoly rent extraction.
Nothing I said above disagrees with the fact that many pharma are indeed doing what you call "monopoly rent extraction". I think all of those drugs are overpriced for non-economic reasons.
Regulatory compliance, for example, with the FDA approval process, isn't a deadweight loss; it's a process that reduces the risk a dangerous drug will be given to the public. It's mostly costly due to incompetence and bureaucracy, not because pharma is evilly plotting to continue to be the only people who can get stuff through the FDA.
If somebody comes up with magical ways to reduce the costs of R&D and QC in pharma, I'm all for it. Just be aware: I've worked around pharma for decades and it will only get more expensive to do any of this. Nobody is going to come in and magically disrupt the business with a new technology pharma didn't think of yet.
Umm, the variance in prices in only very slightly due to quality, like often 5% or 1% or less than 1% of the variance. Please show data accounting for why anti-parasitics that costs 5 cents per dose for a horse or 5 cents per dose in India with 20 high quality generic versions are $50 in the US. Hint. BECAUSE WE DO NOT HAVE A FREE MARKET ON HIGH-QUALITY AND SAFE DRUGS. WE HAVE A PAY TO EXTRACT RENT SYSTEM.
I wish you wouldn't post things like this because, although what you are saying is factually correct, you are saying it in a patronizing and shouting way, which will lead people to associate these insights with acting like an asshole. That makes it harder for them to assimilate them, even when I'm the one explaining them and even if I'm managing not to act like an asshole.
I'm sorry but I used to work in healthcare and we see people suffer because they can't afford the $10 monthly copay on drugs that should cost no more than $10 or $20 for a year supply, like a giant bottle of generic aspirin. The fact that they suffer due to pure exploitation is disturbing.
What reduces the risk that a drug will be dangerous is testing, quality control, replication, and transparency. Regulatory compliance is, at best, a means to those ends, not an end in itself. At worst, and far too often, it's a major obstacle to them.
People don't have to be evilly plotting when their incentives are set up to empower only people who do evil things. Don't forget that, in the US, we're talking about the same regulatory regime that rejected magainin, hasn't brought a new class of antibiotics to market in half a century, has outlawed the flavored vape liquids that help people quit smoking, won't allow you to buy a blood sugar meter until after you have diabetes, prohibited covid testing at the beginning of the pandemic, delayed covid vaccination until five or six months after China was doing mass vaccination, and routinely cuts off opiate addicts cold turkey. It's a Kafkaesque farce, as you know very well, and quite possibly the primary cause of death in the US today.
So, uh, how are we going to ensure that all that testing, QC, and transparency occurs... without some sort of regulatory agency that enforces it? and that agency woudl use compliance (submit this and that form and follow this and that process)... so it would seem that they act as proxies for the value of the things you listed.
In the comment you responded to, I am not taking up the subject of how to achieve testing, replication, QC, and transparency. I am merely pointing out that, to reason clearly about the issue, it is essential to distinguish these goods—genuinely valuable benefits to drug users which should be maximized—from any potential means for achieving them, such as regulatory compliance, which is a deadweight loss to be minimized, even if it is an unavoidable one, as you claim it is.
To do otherwise is similar to measuring the progress of a software project in lines of code, measuring the quality of an airframe design by its weight, or measuring the security provided by the TSA in the number of fingernail trimmers confiscated. It's counting regulatory compliance activities on the wrong side of the ledger.
The people who write the rules take money from the rent extractors and the people who enforce the rules have huge conflicts of interest and go immediately to and from working with the rent extractors. It is a corrupt system of rent extraction that has some quality benefit for the consumer that is extremely inefficient. CRONY-CAPITALISM, MONOPOLIES past patent expiration, and A LACK OF A FREE-MARKET extracts rent from the consumer and destroys a countries' industrial competitiveness as does any form of corruption. Just look up how many generics are available in somewhere like India, or look at drug costs on the Mexican [more] free-market, or just do some research into what is actually happening.
There is a really simple number that tells you what the costs of a company are vs its prices to users. Its called profit. So are the pharama companies profitable?
Yes, most large pharma are very profitable (it's one of the most profitable sectors). As we liked to joke, Roche isn't so much a pharma company as it is a wealthy family that invests in pharma because it's so profitable (until recently there was a very interest structure of family cross-ownership of all the Basel-based pharma firms that was set up for or less for MAD purposes).
I hope we can eventually have self-contained machines that can synthesize many different types of medications. By certifying the machines or testing them thoroughly, you can lessen the worry that people will synthesize the drugs wrong.
I think this is almost possible for a large range of simple, small-molecule drugs.
The point of this exercise is that the regulatory capture effectively prevents life saving treatments from reaching the people who need them.
For example, better quality insulin is far more expensive because there's tremendous capture not only in the insulin market but the bioreactors required to make the insulin from bacteria. The process isn't insanely complicated, chemistry-wise, but the fact that only a few can make it and its MUCH better means they can charge more.
Another example is one-off drugs for rare but potentially curable conditions. They are often so expensive that they're pulled from the market because 1% of 1% of the population needs them and you can't use that to drive revenue.
3D printing took off precisely because of the LACK of regulatory capture. Imagine you had an FDA synthesizer that could make something common and simple like blood pressure medication for fractional cents on the dollar. You wouldn't be able to find the plans for this like you could for a 3D printed gun, for example, because the technology requires actual expertise to use. So you'd likely be left buying it from some biotech firm who will happily charge a price equivalent to a lifetime supply of all the drugs it can produce. You once again reach the affordability problem. Not because the technology is that far out of reach or so esoteric, but to be able to even get the device into the people's homes who need it you would need to find centuries of deeply entrenched and well capitalized special interests. Pharma would rather you die from something preventable than leave a single penny uncollected. Normally this would be considered hyperbole but in this case it's absolutely, verifiably true.
You can be certain if any DIY "3d molecule printer" ever took off there would be heavily armed alphabet soup boys at the DEA ready to kill whoever to keep the interests of big pharma in power.
I remember a few years ago, someone made a suggestion, that, because a lot of these overpriced drugs are paid by insurance companies.
So why don't insurance companies contract an independent lab to make their own medicine instead of paying ridiculously high prices for out-of-patent medicine? Of course, it would be a proper lab, with certifications and quality control, not some guy's basement, so it would be expensive, but on the other hand, the alternative is also way too expensive.
The big insurance companies own, at least in part, the large pharmacies. Manufacturing drugs adds a risk bundle of appeasing regulators and liability for adverse effects from the drugs made.
Insurance companies are happy to be the buyer and seller as that is plenty profitable without the legal risk.
It all sounded nice and good until I read the part about the microlab using spare bicycle tubing, and wanting drug dealers to cut heroin with PrEP meds...what can possibly go wrong with cutting everh dose of heroin with an HIV drug made through bicycle plastic tubing?
Your information may be out of date. Wiki[1] says "In December 2021, the FDA approved Apretude, which is an injectable form of PrEP", and Apretude seems to be a brand name for cabotegravir, which is the chemical named in the OP. (The capital letters in PrEP make me think it's a specific drug, but apparently people use it to mean several different drugs with similar purposes.)
PrEP is a generic term for a medication that you take before the act, yeah. I was mostly refering to Truvada here which is the one that gets most passed around.
Er... Is the anti-HIV stuff human experimentation? Are these guys collecting data? Seems like they're taking a drug that's known to help (incidentally it got FDA-approved in December 2021, based on trials whose results were announced in November 2020; I'm sure the FDA had excellent reasons for that delay) and sticking it where they think it'll help those who take it. This is compared to drug dealers who take a drug known to be harmful (fentanyl) and stick it where they think it'll substitute for more expensive ingredients and will keep the customers coming.
Are you really saying that the former is a crime against humanity and the latter isn't?
Not an Anachist but I wonder how much of the danger here is due to the law. Ideally they would simply be selling the epipencils and doing testing etc but there is no way they would be able to do this. So instead the best they can do is create DIY kits.
I wonder how far they can legally push the DIY kit. Can they ship you supplies with the kit? Can they ship you expresso-like packs for your DIY machine?
This reminds me of vaping in Australia: since vaping liquids containing nicotine are illegal, people make their own liquid by mixing nicotine-free vaping liquids (which are legal) with nicotine extracted from products such as Nicorette (which are also legal) - unfortunately some just go back to cigarettes rather than going through all that trouble.
Luckily, I didn't go back to the stinkies - I never smoked again (I also quit vaping after a while, quitting vaping is not hard because it's not nearly as addictive as ciggies are).
Supplements aren't unregulated. They're treated as food. And I'd bet there's some bit of regulation somewhere that says you can't arbitrarily label a medicine as a supplement.
They're unregulated as a matter of law until there are reports of injury. Unlike food, there's no requirement that the manufacturing adhere to any kind of standard, or that the contents of the supplement match the ingredient list.
Well, if people can even successfully defend against murder charges if they acted in self-defense, to preserve one's own life, why should they not be able to defend against piracy/drug laws if the alternative is death? Some medicines are too expensive, in absence of a proper public health system, and being unable to pay means certain death to some people.
I love this. I have a disorder with no cure, so I will take medication daily for the rest of my life. Worse, it's a controlled substance, so there are all sorts of obstacles thrown in my way arbitrarily. I have to get a new prescription written by my doctor every 3 months, which is a pain in the ass as I have to deal with the bureaucracy. Every time I change jobs, new insurance requires "prior authorization" in addition to a new prescription, so more BS. If I'm traveling abroad, the pharmacy can't ship overseas, and if I get a prescription there, the insurance company won't cover it (and it's more than $1000 / month). Doctors office running a few days behind or not answering faxes (lol) from the pharmacy when I need a new script (happens most of the time I need one)? SOL. Fuck this whole system. I am sick of having to ask permission to get the medicine I need.
> “If you're going to die and you're being denied the medicine that can save you, would you rather break the law and live, or be a good upstanding citizen and a corpse?”
It's obviously better to risk using DIY medicine than to die, and it sounds appealing—mutual aid, neighbors helping neighbors, saving lives with free medicine! But framing it this way significantly misrepresents the issue of for-profit medicine.
People mostly aren't dying because they can't afford life-saving medicine. They are selling their homes, emptying retirement accounts and their kids college funds, going into debt and going bankrupt to pay for life-saving medicine.
These guys have given people a new option. You don't have to go into debt—you could instead choose DIY medicines of dubious quality that could have costly medical consequences for you.
This isn't quite as appealing. It isn't some radical, utopian alternative. It's just how the system works today for poor people in so many areas of life: education, housing, food, medical care, etc. The rich can afford quality, while the poor have to make hard trade-offs and take risks to stretch their dollars.
> People mostly aren't dying because they can't afford life-saving medicine.
No, people are definitely dying because they can't afford medicine. They're not taking things they need, they're cutting pills in half, they're diluting injections. When they finally die from some acute episode, what got them there is never recorded.
The amount of bullshit I have gone through to get albuterol inhalers (which cost $5 in civilized countries, but used to cost $20 in the US until a consortium of pharma lobbyists churned the patent and got the price up to $80.) I've met people in parking lots to buy out of date medicine in a crumpled brown paper bag. I guarantee that more than one person dies from this every single day, and none of them are recorded any differently than any other asthma death. Not being able to obtain this absurdly cheap to produce medicine that has been available for half a century has put me into intensive care for a week, causing years of medical debt when I was young. I wouldn't have been there if I hadn't been trying to manage without an inhaler.
Daraprim and emergency epinephrine seem like the same type of thing. To be honest, though, I prefer to Meet the Criminals Smuggling Their Own Medicine. For Albuterol, ordering inhalers from India was the real answer.
It's also worth mentioning that albuterol and similar inhalers used to be an exception to the prohibitions on CFCs (these inhalers an't used in large enough volume to do significant ozone damage), but due to lobbying from the companies that made them, they no longer are.
Why would a company lobby to outlaw its current product? Well, they had patents on "improved" CFC-free versions, allowing them to exclude new entrants from the market.
Agreed, regulators granting your company a monopoly is definitely the opposite of capitalism in a significant sense, even if the company does use wage-labor to produce products whose ownership rests with the owners of the means of production rather than the laborers.
State regulations which are exploitable due to lobbyism which is capital transferred into law generating power. Neo-Feudalism is the final form of unregulated capitalism and has always been it.
Why not just step forward into the Acceptance-Stage of Ideology-Death, instead of being caught with the intellectual trousers down half a century later by ones googling grandkids on a witch hunt?
Why wouldn't a capitalist corporation choose to lobby the government to bend the rules in their favor if they think that that would give the best ROI? In what version of Capitalism would this not happen? What would remove this incentive structure?
lobbying is just utilizing accumulated capital to create favorable conditions. that capital was accumulated by a capitalist firm. that firm's competitive strategy might be aesthetically unappealing to you, but the firm exists in the first place because it can more efficiently utilize resources than any individual could.
capitalism is a way of organizing production with workers being paid a flat rate and owners keeping all additional value added by the workers in exchange. is that not how pharmaceutical companies are arranged?
”"It's crazy that I live in Canada, but now I'm looking at having to sell my house for coverage of my medication."
Earlier this week, McLaren walked to her local Shopper's Drug Mart and paid nearly $8,000 for a 21-day supply. On Tuesday she swallowed her first pill, worth $262.40 for just one day of treatment.”
I said mostly. Some die without medicine, but I'd argue that the number is small in comparison with people who are affected economically. By focusing on deaths, you're effectively minimizing the problem.
It's similar to issues like homelessness: 0.15% of the population are on the street, but the number of people affected by housing costs is much larger.
Or police shootings of unarmed black men: 100-200 per year, which pales in comparison with millions of incarcerated black men.
We hear so much about these tiny problems is because political activists have chosen media-centric strategies to influence policy makers. The idea is to use outrage to get on the news, and then bring up the bigger issues. But in practice, policy makers just solve the outrageous problem: body cams for police; more shelters. Then the media goes away.
What if the DIY medicines weren't of dubious quality? What if they were higher quality than the ones that cost US$750 a dose? What if everyone had an analysis machine that could analyze the medicines, DIY or not, to find out what was in them, and the DIY stuff turned out to be purer and more precisely dosed? That's what happened with Linux versus, say, Solaris and Microsoft Windows, and it's what's happening now with programmable insulin pumps.
Also, medical consequences have to get pretty costly before they're more costly than selling your home and emptying your retirement account and your kids' college funds.
> What if everyone had an analysis machine that could analyze the medicines, DIY or not, to find out what was in them
I can fairly confidently predict this will not happen like it did for software. Chemical analysis has been around a long time and remains difficult for experts to do accurately without context, let alone for a layman. Gas chromatography, for example, requires large and expensive machinery and some idea of what the substance is composed of in order to determine the concentration of analytes.
Reagent testing is cheap, simple, and straightforward, but it is generally only capable of detecting whether or not some class of substances are present above a particular concentration. You cannot use reagent testing to determine "how pure" a medicine is, let alone whether the impurities (which there will assuredly be) are potentially harmful.
As is currently the case for illicit drugs, I imagine there will be an ecosystem to verify that A) the active ingredient is actually present and B) some limited range of problem impurities are not present, but that is a much less stringent form of quality control than pharmaceutical companies perform.
Clearly making it happen will require a revolution in manufacturing, which may or may not already be underway, but making it happen for software required decades of continuous revolution in semiconductors and telecommunications.
Some kinds of analysis machinery, like GC, ICP, and DSC or DTA, are probably inherently fairly large; other kinds, like FT-IR, other kinds of spectrometry, TLC, HPLC, other kinds of liquid chromatography, XRF, XRD, and NMR, can be miniaturized and mass-produced. There hasn't been much pressure to do this because bio and chem labs don't care if their spectrophotometer costs US$0.12 or US$12000 or whether it weighs 100 mg or 100 kg; they need one to get their work done, they don't need it to be portable, and they aren't going to lose it because it stays in the lab. But that doesn't mean it can't be done. Even Victorian-era-style reagent testing can be made quantitative in some cases!
> Some kinds of analysis machinery, like GC, ICP, and DSC or DTA, are probably inherently fairly large; other kinds, like FT-IR, other kinds of spectrometry, TLC, HPLC, other kinds of liquid chromatography, XRF, XRD, and NMR, can be miniaturized and mass-produced
Many of the types of analysis listed here are elemental analysis only, which are useless for trying to identify pharmaceutical analytes or determine their concentration.
Out of all of these, microfluidic liquid chromatography is the least science fiction. There's plenty of literature about it but nobody really "has it working", and the reality is that it's not likely to ever have the same capability as benchtop HPLC.
> Many of the types of analysis listed here are elemental analysis only, which are useless for trying to identify pharmaceutical analytes or determine their concentration.
That's mostly true, but if a pill has significant amounts of lead, arsenic, and mercury in it, you know something went wrong, and you shouldn't take it. Even XRF might be enough to allow you to safely use lead-based or arsenic-based catalysts in your synthesis.
> Out of all of these, microfluidic liquid chromatography is the least science fiction. There's plenty of literature about it but nobody really "has it working", and the reality is that it's not likely to ever have the same capability as benchtop HPLC.
Thanks! Can you think of any other plausibly miniaturizable general-purpose analysis techniques? Those are just the ones I came up with off the top of my head. I think microfluidic liquid chromatography doesn't actually have to run faster than the bear, just faster than color-changing DanceSafe test kits.
Probably the 'manufacturing revolution' will be modifying yeast, plants, etc. to produce the chemical compound of interest. Everyone needn't have expensive equipment - testing can be outsourced. Such an effort would need a GPL like agreement to keep people honest, but the technology exists.
Conceivably, but I was a lot more enthusiastic about this possibility 35 years ago before the humans had much experience with it. It turns out DNA is a really shitty programming language for humans. Like, worse than Malbolge.
They use rare earth permanent magnets and don't offer the resolution of superconducting magnet NMR, but they are much smaller and cheaper (tens of thousands of dollars, new) than superconducting units or the even older resistive electromagnet NMR units. The first one I saw was from picoSpin, which has since been acquired by Thermo Fisher Scientific. I think that there are multiple vendors now. Here's a current picoSpin unit:
Benchtop NMR spectrometers already exist (for decades now), and some are already cryogen-free, permitting room-temperature measurements, eliminating the dewar and cryogens which account for a lot of the mass and volume of traditional NMR spectrometers. We now have room-temperature superconductors, which might work to eliminate the bulky, heavy permanent magnets in current benchtop devices, though the pressures required may turn out to be impractical. Beyond that I can handwave at improved electronics and SQUIDs, but I don't really know.
Do you think there are some fundamental obstacles to miniaturizing NMR, and if so, what?
I'm not arguing with what you're saying, but GC/MS can be bought for like $100 a sample and it's conceivable a system can be invented where private auditors audit the output of an unregulated pharmaceutical manufacturer in such a way that the QC assurances to the consumer are as good or better as in our current system, with much lower regulatory costs.
In the limit what you are describing is a generic drugmaker.
It's certainly possible to audit drug quality by sending it to labs, and people do that for darknet drugs all the time, but there are still problems:
1) There is no way to use ex-post analysis alone to achieve the kind of QA that pharmaceutical companies do; they have visibility into the entire manufacturing process and process control. Put another way, a sample of a drug cannot be used to verify that the process used to manufacture it is safe.
2) There is no assurance that anything you get in the future is made with the same process.
The only way I see this working, honestly, is for a rogue jurisdiction to offer safe harbor to "generic pirates". The rogue jurisdiction would offer legitimate regulatory oversight in exchange for tax revenue, and the drugs would be smuggled out of the jurisdiction for sale. To some extent this is already the case in grey markets where brand name drugs which are sold for less in other countries get arbitraged/smuggled back to high-cost markets.
Buy n = 1024 doses of your insulin or whatever, D(0, i) for i from 0 to n - 1 = 1023, homogenize each dose, and divide each one in half into half-doses called E(0, i) and F(0, i).
Mix pairs F(0, 2*i) and F(0, 2*i + 1) into 512 new doses D(1, i) for i from 0 to 511. Homogenize these new doses and divide each one in half into half-doses called E(1, i) and F(1, i).
Mix pairs F(1, 2*i) and F(1, 2*i + 1) into 256 new doses D(2, i) for i from 0 to 255.
And so on, until in step k = lg n = 10 step you mix the half-doses F(k - 1 = 9, 0) and F(9, 1) into a single dose D(k = 10, 0). Send this D(k, 0) off to the lab to be analyzed.
If the lab is equipped to detect dangerous impurities in your insulin at one-thousandth the danger level, which is reasonable for many contaminants, and the sample comes back clean, then you know that all 1024 doses were safe, though some of them may have the wrong dose. Mix the remaining 1023 doses well so that they all have the same dose and store them safely.
If not, you need to track down the contamination (or massive dilution), so in the next iteration, you send E(9, 0) and E(9, 1) to the lab for analysis. If one of them comes back safe, you know the 511 doses that were mixed into it were okay, and you can mix them well and store them safely, then repeat the process on the contaminated subtree.
Depending on your cost function (latency, shipping and handling costs, etc.) and your priors for correlation among the samples, it might be worthwhile to recurse more deeply on failure: instead of sending E(9, i) for i from 0 to 1 to the lab, you might instead send them E(6, i) for i from 0 to 15. If one out of 30 doses was randomly contaminated, for example, about 14 out of the 16 groups will be bad on average, while if it's one out of 100, then you'll have about 7 bad groups out of 16. At some point you need to give up on the recursion, too, or you'll end up testing almost all 1024 doses when they're all bad.
This of course doesn't solve the problem of future buys, just reduces it by the factor of n.
I think we are seeing the same thing, a system designed to remove corruption/regulatory capture/lobbying as far as possible from the process. I'm seeing a "rogue" auditor that performs the same service, while you are seeing a rogue government. If the outcome is the same, I am fine with either. Your pointed weakness regarding auditing the manufacturing process could be incorporated into either.
>it's conceivable a system can be invented where private auditors audit the output of an unregulated pharmaceutical manufacturer in such a way that the QC assurances to the consumer are as good or better as in our current system, with much lower regulatory costs.
No, it's not. This is ideological libertarian nonsense. There's a reason pharma came to be regulated in the first place. All this will lead to are more injuries and death of consumers.
Heck, even the FDA can't guarantee all generics are equivalent to the branded version (some anticonvulsants come to mind). Might be a while before this ability comes to the masses.
Most major OSS projects are controlled by a few companies who pay developers to work on them. They're more like industry consortiums than DIY anarchist collectives.
Something can be both an industry consortium and a DIY anarchist collective, like Linux; the Linux Foundation isn't Linux. It turns out that industrial companies don't appreciate being subject to monopoly rents any more than private individuals do! The GPL is undeniably very anarchist, and it serves as a kind of constitution that keeps the companies that participate in GPL projects from controlling them. Consider, for example, Oracle and LibreOffice, MariaDB, and Jenkins, or GitHub (now Microsoft) and Git.
The solution isn't to destroy capitalism or exclude industrial companies from participation. We tried that a century ago. It went badly, because, as it turns out, capitalism is better at limiting the damage done by ambitious psychopaths than the alternative systems are; if Beria had been born in Ohio maybe he would have ended up running a soap company or a division of GE instead of mass-murdering dissidents.
Similarly, the GPL (and, to a lesser extent, non-copyleft open-source licensing) reduces the damage selfish companies can do to software projects and the people and companies that depend on them.
We need to figure out how to do the same thing to drug companies and the FDA, because they are just killing far too many people and causing far too much needless suffering today.
It's misleading to mix up anarchism and marxism-leninism. While both are anti capitalist, ML is the one where you're just replacing one hierarchy (economic power) with another (party membership). Anarchism is fundamentally against coercive hierarchy.
Anarchism is indeed fundamentally against coercive hierarchy, yes, and I apologize for not being clearer about that. That said, Emma Goldman and many other anarchists were delighted to be deported to Soviet Russia until their famous disillusionment; historically speaking, the mainstream of anarchism considered state communism more friend than enemy, until they saw how it worked out in practice. And my own experiences with nominally anti-hierarchical organizations have not given me great faith.
>What if everyone had an analysis machine that could analyze the medicines
Because, as a post below notes, this is a pure fantasy. At this point you're proposing actual magic.
>Linux versus, say, Solaris and Microsoft Windows
Your choice of operating system isn't going to severely harm or kill you. "Move fast and break things" is a problem when the "things" are people.
>medical consequences have to get pretty costly before they're more costly than selling your home and emptying your retirement account and your kids' college funds.
Welcome to the reality of healthcare in the US for the uninsured (and often times for the poorly-insured).
Meh it's the classic black market vs white market debate, where here the white market is a huge oligopoly with insane markups to pay off lobbyists / regulator / advertisers / the rich people who own the pharma companies. Sometimes the black market is even more expensive but in DIY it often isn't.
If it were me I'd just make it all in one go, hopefully enough to be set for life, huge pile of it whatever drug I need to stay alive. Create a homogeneous mixture, GC/MS the mixture for purity and then package it for long term storage.
> People mostly aren't dying because they can't afford life-saving medicine.
I don’t where you live. But in California there are clearly destitute people on the street in need of simple medical interventions like antibiotics.
For whatever reason* they aren’t able to get medical help — and I’m not just meaning people in mental crisis and drug addiction. There are seemingly “regular” people suffering from what should be 19th century style deaths.
* I’ve noticed that EMTs are very cynical about helping poor looking people. I’m sure the classism extends to getting care, even when hospitals are legally required to provide immediate help without taking finances in to account.
Affordability is not the only reason people are being denied medicine. Many people have wanted, e.g. ivermectin, monoclonal antibodies, etc; and even gone to court to fight to get them, not because of the cost but because doctors, pharmacies and/or government bodies refuse to provide.
The -mabs are often denied because they really are expensive to make. Ivermectin is super cheap and quite safe in the usual doses; in the case of covid, denying it to people isn't directly causing any harm, but also very little good, if any.
>The -mabs are often denied because they really are expensive to make.
Source? According to the HHS via Washington Post[1], many doses of monoclonal antibodies have already been made, but only 20% of those distributed have been used, with 80% sitting on a shelf. The article suggests a few reasons for the lack of use, but it does not mention cost to make them.
I can get the medicines I need to "save" me. I can't get the medicines that would help me to die. I wonder what this group's moral posture is on using their equipment to manufacture Nembutal (or other barbiturates).
I would like to have 15g of Nembutal in a safe place, so that I can kill myself painlessly and without leaving a mess, should the circumstances require that. I know that no medical professional would help me do that, because they would immediately be disqualified. Instead they would have to strive officiously to prolong my life.
Nembutal is illegal to possess, at least it is here. That's not like the drugs this group are helping people to make, which are all legal to possess provided you have a prescription, or so the article says. There's no "therapeutic" use for Nembutal that can't be met by a safer drug.
As a result Nembutal is really difficult to source (also because it's part of the traditional cocktail used in US death-by-poisoning executions).
This is pretty interesting, but skimming the article I didn't see any mention of lab testing the purity and quantity of drugs produced. There's a lot of fiery talk but how do we know that the results are usable?
This is a very important step in the production of medications. We need to know that nothing went wrong with the synthesis and we aren't ingesting toxic and potentially fatal byproducts. Dosage can also be wrong if measuring an impure compound.
Honestly my concern is too little. Say you make a measurement expecting 90% purity but its actually 60%. You're getting way less epi and may continue struggling to breathe after taking the shot. Scary shit.
Due to the pandemic I’ve often thought about what the ideal model for vaccines and other drugs would be. I understand that there’s enormous costs for pharma companies to bring a new drug to the market, and I guess a lot of new drug prospects end up not going anywhere, but it’s hard to swallow that there’s drugs out there that are cheap to manufacture and are life saving (or life changing) for people that need them yet some/many of them can’t afford them.
What’s the best way to fix this? Direct government funding? Indirect one via subsidising the drugs for those who need it? Im
For one thing we can cut down on red tape. The covid vaccines have proven that the typical FDA approval process is way too long. Trials are usually the most expensive part of drug development, so this would cut down on costs to consumers by a lot.
But they claim their site has been under construction for about a year now.
I think it's important to note that this group is more about political activism and getting headlines than they are about actually producing and distributing the medication.
My first thought was how dangerous this is. Then after thinking some more, I was left questioning how a developed country can mess up so badly that some people feel this is their only option.
Also, the article mentions an MIT professor's safety concerns, but, upon reflection, given the conditions some of these drugs are meant to treat, the error rate would have to be very high to make it worse than no treatment.
The market tends to fail when it's strangled by regulations (which pleases the large incumbents, whose necks are much thicker than their competitors). For any apparent market failure, try translating your complaint into a business plan, and see what obstacles you hit. "These drugs are way too expensive. Why can't I make a profit by making the drug and selling it for a lower price?" Answer: the patent system forbids it.
And for medical conditions that don't yet have drugs developed: "Why can't I make a profit by investing some reasonable amount of money to develop a drug?" https://en.wikipedia.org/wiki/Cost_of_drug_development puts the average cost in the billions of dollars. How much of that is due to intrinsic difficulty, and how much is artificially imposed?
I'm not sure if life saving medicine should or even can be understood through economic equilibrium. This is ultimately a question of ethics, politics and sheer survival. This isn't a market in the first place and it doesn't help that we pretend it is.
Everything is a market. Someone has to produce a finite supply for some cost. There is some demand for the medicine. Suppliers can be incentivized to produce by demand through price.
Look up the percentage of all drugs that were invented in the United States. Socialized medicine is subsidized by capitalist innovation overseas. There are so many problems with the US system, but they have more to do with regulatory capture (including difficulty of FDA approval + difficulty of becoming a doctor) and price transparency than anything else.
Sit tight and assess! This is like reading a propaganda pamphlet with the inevitable very long term "it may work, we'll have to wait and see in a decade or two, but until then at least our profits are not affected"-solutions.
> If you send your compounds off for proper testing it shouldn't be that dangerous, but that will increase the cost a few 100% most likely
> Testing usually doesn't come cheap, but you also might be able to drop by a well equipped Chem department at a university for testing as well
I don't think it's that easy. Even if you successfully synthesize the right chemical, you also have to get dosage and delivery right (consistently!).
From the OP:
> In response, Four Thieves published the instructions for a DIY epipen online that can be made for $30 in off-the-shelf parts and reloaded for $3.
If I had to depend on an epipen to save my life, I don't think I'd want a DIY version that may not work when I need it (e.g. mechanism fails, storage stability issues, dosage issues, etc.). Sure I guess it's better than nothing, but it's also proof this clearly isn't the solution to the $600 epipen problem.
> Shkreli drove the price of the lifesaving HIV medicine Daraprim sells up to $750 per pill. So Four Thieves developed an open source portable chemistry lab that allows anyone to manufacture their own Daraprim for just 25 cents apiece.
The article calls Daraprim and "HIV medicine" throughout, but isn't that misleading? I thought it was an anti-parasitic (that may be used by HIV patients to treat secondary infections).
> If I had to depend on an epipen to save my life, I don't think I'd want a DIY version that may not work when I need it. Sure I guess it's better than nothing, but it's also proof this clearly isn't the solution to the $600 epipen problem.
DIY versions are normally more expensive than mass-produced equivalents. So either this DIY version has atrocious quality, or $600 is far too expensive. (Judging by the prices in normal countries, $600 is far too expensive!)
> DIY versions are normally more expensive than mass-produced equivalents. So either this DIY version has atrocious quality, or $600 is far too expensive. (Judging by the prices in normal countries, $600 is far too expensive!)
Yeah, the answer is $600 is far too expensive.
IMHO the answer is some kind of regulation (e.g. limiting the profit margin on generics or even drugs more generally), or some kind of boutique government-owned generic maker tasked with being a manufacturer of last resort and selling generics at its cost (which should be higher than a non-price-gouging private company, so it works to put a price-ceiling on those companies and also acts as insurance against unavailability).
If any company could enter that market with being sued into the ground, you'd get top notch a quality product for a fraction of the price before you could finish spelling epinephrine.
It makes more sense when you realize that much of US population is ok with vulture capitalism: extract as much rent as possible from everything, no matter the consequence to society or harms done, especially if focused on poor people.
See also payday loans, overage bank fees, credit card APRs, etc.
> After a few minutes of gloating about pharma bro Martin Shkreli “rotting at Fort Dix” for raising the price of Daraprim, a lifesaving HIV medicine, from $13 to $750, Laufer grew serious. “It’s been two years, but despite everything that’s happened, the price of Daraprim hasn’t changed,” he said.
Shkreli went to jail for securities fraud- not raising the price of a drug. I think Shkreli was a convenient scapegoat for the pharmaceutical industry though. All the time and energy people spent angry at Shkreli was time spent not directing their anger at the industry that allowed it.
while all that drama on the surface, the industry had coopted government's War on Drugs and pushed opiates (great thing when used as needed) into the opioid epidemics, and now they coopted government's War on Covid and has been pushing billions of doses of the vaccines (great thing when it works) which clearly fail to control the spread (and thus these vaccines have only limited use, i.e. only for the people who really need it (like high risk groups, etc.) - the situation pretty similar to opioids. And if one looks at those 3rd, 4th, ... boosters - sales tactic wise it looks eerily similar to the jacking up the "12hr" opioid dose approach as it simultaneously increases sales and creates addiction). I wonder if several years down the road we'll see vaccine trials/settlements similar to the opioids ones.
It's clear that the vaccines don't confer total immunity. They do change the course of the infection if you contract it, though. As you'd expect: they induce your immune system to create antibodies.
Spend even a few minutes browsing stories from ICU nurses and you'll conclude that pretty much all their admissions are unvaccinated.
Vaccinated => get sick
Unvaccinated => get very sick, maybe die
That seems like a great utility to me.
Sure, that's anecdata, but data doesn't convince people who call others "sheep"
that has no meaningful bearing on the situation of many people who has very low risk of serious decease to start with. Yet the industry got its way, and the vaccines are forced down the everybody's throat.
>Seems like they're pretty different cases, given how life-destroying opioid addiction is.
Pfizer/Booz Allen waste of billions of tax dollars do come with resulting indirect damage to people health and lives who could have been helped otherwise. And for direct damage - I think jury is still out on that one. For example, in UK according to the link they already count 0.3M of heart issues which they officially pinned on pandemic stress
"Mark Rayner, a former senior NHS psychological therapist and founder of EASE Wellbeing CIC, said that as many as three million people in Britain are already suffering from PPSD, thanks to stress and anxiety caused by the effects of Covid-19.
He fears this could result in a dramatic rise in physical health issues, such as coronary heart failure, if cases are not detected or treated early."
Pinning on pandemic stress means they couldn't pin it on covid - either it is non-infected people or timing isn't correlated enough. Now, simple politically correct choice - stress or mRNA vaccines known for causing heart issues?
> Now, simple politically correct choice - stress or mRNA vaccines known for causing heart issues?
Huh? You assume the vaccines cause heart issues, and use as evidence for concluding that vaccines cause heart issues...? Did I misunderstand?
I don't really have an opinion here since I haven't looked at any of the data you're referencing.
Moreover, this is straying from my initial point, which was that opioid addiction is life-destroying on an scale far beyond what we have yet seen from vaccines, and it doesn't even require any careful study to see that since the effect size is so huge, with explicit societal harm in the form of drug trafficking, crime, and overdose deaths.
Arguments like "clearly fail to control the spread" are low effort Gish Gallops that need to be treated as such.
Publicly slugging it out in the weeds grants an optical stalemate to an argument that deserves to lose. Do this a million times in a row and you can launch an entire contrarian movement off vapors -- which is exactly what we have seen.
I don't see any arguments beside cheap meta and labels from your side (which seems to be pretty characteristic of the people pushing the current vaccine campaign).
>Arguments like "clearly fail to control the spread" are low effort Gish Gallops that need to be treated as such.
The failure to control the spread has been obvious for at least half-a-year for anybody doing simple arithmetic on public numbers (and like others i have commented on that as far back then). Now beside being obvious, it is also confirmed by a proper scientific publication
" A person who was fully vaccinated and then had a ‘breakthrough’ Delta infection was almost twice as likely to pass on the virus as someone who was infected with Alpha."
"Unfortunately, the vaccine’s beneficial effect on Delta transmission waned to almost negligible levels over time. In people infected 2 weeks after receiving the vaccine developed by the University of Oxford and AstraZeneca, both in the UK, the chance that an unvaccinated close contact would test positive was 57%, but 3 months later, that chance rose to 67%. The latter figure is on par with the likelihood that an unvaccinated person will spread the virus."
At first I expected the advent of mass vaccination to end the pandemic, because it only had to drop R by a factor of two or so to drop below the critical percolation threshold, so even a vaccine providing 50% sterilizing immunity would be good enough, and the mRNA vaccines turned out to be even more effective than expected. I turned out to be spectacularly wrong about that; as you may or may not be aware, the pandemic did not end a year ago. It turned out that, unlike vaccines like the smallpox vaccine, the covid vaccines did not provide much sterilizing immunity.
Moreover, the virus has become endemic in a number of zoonotic reservoirs, including deer, feral cats, and some mustelids, and vaccinating or exterminating those populations is not realistic in the next few decades. This is not currently a significant source of human outbreaks as far as I can tell, but after the humans reach herd immunity, it will be the only one.
Consequently, the cost-benefit tradeoff for covid vaccinations with the currently available vaccines needs to be evaluated with respect to the benefit to the person being vaccinated. I'm glad I'm vaccinated: as an obese 45-year-old man, my risk of death from covid might approach 1%, which is enormously higher than any plausible risks from any of the vaccines I'm familiar with. But that tradeoff is not the same for everyone, and there are populations where the rate of death or permanent harm from a vaccine, though still extremely low, is likely higher than the rate of death or permanent harm from covid itself.
The situation would be different if, for example, vaccinating schoolchildren prevented them from infecting and inadvertently killing their grandparents. But it doesn't. So the fact that the existing vaccinations clearly fail to control the spread is extremely relevant to the cost-benefit tradeoff, in particular because it means that there's no valid public-interest argument for requiring people to get vaccinated. Since both the cost and the benefit flow to them individually, they should be able to make the decision individually, except in cases such as small children and comatose patients.
This is an argument that deserves rational consideration, not dismissal with mindkiller phrases like "vapors" and "anti-vax". That's the sort of argument, or rather non-argument, that "deserves to lose".
I've also talked to the biohackers. S ome of them are smart, careful, and just get stuff done in the lab. Then there are the attention hogs who inject themselves on youtube (typically with no ability to know if they did anything at all), many of whom, after a few years, realize that what they are doing is naive, and that there was actually a reason for the entire establishment around pharma.