[HN Gopher] Meet the Anarchists Making Their Own Medicine (2018) ___________________________________________________________________ Meet the Anarchists Making Their Own Medicine (2018) Author : mvanaltvorst Score : 81 points Date : 2022-01-05 10:44 UTC (12 hours ago) (HTM) web link (www.vice.com) (TXT) w3m dump (www.vice.com) | nynx wrote: | 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. | aijeq wrote: | 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. | tehjoker wrote: | 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? | netizen-936824 wrote: | 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. | Xenoamorphous wrote: | 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 | 2OEH8eoCRo0 wrote: | > 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. | trhway wrote: | 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. | jjoonathan wrote: | Pro-opiate _and_ anti-vax? Niiiice! | kragen wrote: | I'd like to be able to discuss ideas on their merits | instead of being confronted with factional applause lights | like "anti-vax". | jjoonathan wrote: | 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. | hhpindia wrote: | snakeboy wrote: | Seems like they're pretty different cases, given how life- | destroying opioid addiction is. | | Pushing vaccines is mostly just profiting by adding another | layer of bureaucracy and annoyance into daily life. | | I'm not really more angry at pfizer than I am Booz Allen for | wasting however many billions of my tax dollars. | trhway wrote: | >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 | | https://www.standard.co.uk/news/health/post-pandemic- | stress-... | | with more expected to come: | | "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? | GuB-42 wrote: | 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. | mrxd wrote: | > "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. | pessimizer wrote: | > 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. | kragen wrote: | 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. | chillingeffect wrote: | That's what I call Metacapitalism. | kragen wrote: | 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. | mrxd wrote: | 92% of contributors to the Linux kernel are paid by | companies: https://www.suse.com/suse- | defines/definition/linux-contribut... | | 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. | kragen wrote: | 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. | nwiswell wrote: | > 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. | kragen wrote: | 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! | nwiswell wrote: | > 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. | dekhn wrote: | Miniaturized NMR? can you explain how that would work? | kragen wrote: | 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? | fabian2k wrote: | Benchtops are at 60-90 MHz field strengths. That is | barely enough to look at more complex molecules, the | bigger routine NMR spectrometers are at 400-600 MHz (and | there are even larger ones, but those are not used for | small molecules that much). And even then those benchtops | cost something close to 100k USD, that's quite far from | affordable. | | The "room temperature" superconductors are not used at | room temperature in these cases, they're still cooled | down. And so far the only spectrometer I know of where | they are used is the still extremely new 1.2 GHz Bruker. | And that one is almost certainly somewhere between 10 and | 20 million USD. The new superconductors are low | temperature superconductors, not room temperature. And | even then they still work better at lower temperatures. | At best you can remove the liquid helium from the system | and use liquid nitrogen only, which is an advantage but | still really far from room temperature. | dekhn wrote: | benchtop NMR doesn't solve this problem, it's not | powerful enough. | | If you had improvements to NMR they would actually go | first to other things than doing chemical analysis of | anarchist drug batches. IE there are other industries | that will buy all your machines if they existed. | | The real question is why would you EVER use NMR for just | about anything? It's really high cost and the total value | of the data is lower than just about any other technique. | It really only makes sense in research situations. | philipkglass wrote: | 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 magnet 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: | | https://www.thermofisher.com/order/catalog/product/912A09 | 13 | dekhn wrote: | An 80MHz desktop NMR in 2022 is hilarious. This owuld be | great to put in a research lab or to teach students, but | it's not something that could be used in a high volume, | high quality pharma testing situation. | | (my phd in nmr is from 20 years ago... even then it was | hard to justify the expense of nmr machines in structural | biology...) | notch656a wrote: | 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. | nwiswell wrote: | 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. | notch656a wrote: | 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. | nwiswell wrote: | > I think we are seeing the same thing, a system designed | to remove corruption/regulatory capture/lobbying as far | as possible from the process | | Not really. It's more like a system to selectively remove | intellectual property rights without destroying the | financial incentive to develop drugs. | notch656a wrote: | Oh. So you don't want a system that removes corruption, | regulatory capture, and lobbying as far as possible? I | don't want to destroy the financial incentive either, I | think it's great people that bring wanted goods to market | profit from it. | | IP is an interesting point, although I'm not convinced | that generating the IP is more than a small fraction of | the cost of a drug. An aggregate I saw from 2011-2018 | puts Research at only 17% of revenue, and only some | proportion of that is geared towards generating IP. That | is to say, with all else removed you could generate an IP | only company for 17% the cost of drug sales. | LiquidSky wrote: | >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. | [deleted] | notch656a wrote: | >No, it's not. This is ideological libertarian nonsense. | | If I could flag your post, I would. This is purely | political nonsense and a god-like attempt to disprove | something through fiat. | rootusrootus wrote: | 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. | LiquidSky wrote: | >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). | notch656a wrote: | 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. | LiquidSky wrote: | >Meh it's the classic black market vs white market | debate, | | No, it's classic libertarian fantasy bullshit. Medicines | aren't toys, and we know exactly what happens when | they're unregulated. | notch656a wrote: | I wasn't aware that analytical instruments could measure | your economic or political ideology. | hammock wrote: | 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. | elchief wrote: | this will be useful in 20 years when society has collapsed, but | you want to survive | petermcneeley wrote: | 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? | mastazi wrote: | 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). | trutannus wrote: | 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. | hirundo wrote: | > I was left questioning how a developed country can mess up so | badly that some people feel this is their only option. | | Regulatory capture. | trutannus wrote: | That and market failure. | dgb23 wrote: | 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. | netizen-936824 wrote: | 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 | tablespoon wrote: | > 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). | wizzwizz4 wrote: | > _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!) | tablespoon wrote: | > 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). | ur-whale wrote: | > IMHO the answer is some kind of regulation | | IMHO, the solution is actually _less_ regulation. | | 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. | tablespoon wrote: | > IMHO, the solution is actually less regulation. | | > 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. | | I doubt it. IIRC, EpiPens are off-patent, and the only | thing holding back competition is the need to demonstrate | the competing product is safe, reliable, and equivalent. | I even believe a competitor product was withdrawn from | the market because it was delivering an unreliable | dosage. | | So if you remove the regulations, you'll probably get a | flood of corner-cutting crap that's dangerous. That's | likely especially true for an "emergency use" item like | an EpiPen, which literally sits on a shelf unused unless | there's an emergency (leaving a big opportunity to sell | defective items undetected by consumers). | wizzwizz4 wrote: | The computer market is not particularly regulated, yet we | still have international big tech monopolies stifling | competition. I think the US simultaneously needs: | | * less regulation, to reduce barriers-to-entry | | * more regulation, to allow competition | | Normally, I'd be concerned about reduced regulations | having safety implications, but the existing situation is | _already_ unsafe. | waterhouse wrote: | Patents are a big part of how the stifling is done. | Getting rid of them, or at least cutting their term by a | factor of 3-4, would help a great deal. | waterhouse wrote: | 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. | dekhn wrote: | 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. | kragen wrote: | 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. | dekhn wrote: | 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. | kragen wrote: | 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. | dekhn wrote: | 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. | petermcneeley wrote: | 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? | dekhn wrote: | 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). | notch656a wrote: | 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. | mayapugai wrote: | 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. | dekhn wrote: | 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. | dekhn wrote: | 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. | camillomiller wrote: | 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 75EUR, 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. | tastyfreeze wrote: | I'm confused. Isn't this like saying I bought you lunch with | money I took from you last year so your lunch was free? ___________________________________________________________________ (page generated 2022-01-05 23:00 UTC)