While the gist of the article is true - antibiotics development is an area where 'the market' seems to discourage innovation - I always roll my eyes when I see Achaogen name dropped in articles like this. Achaogen would have had a much longer runway had the leadership not began demolishing it as soon as it was clear that the FDA might grant approval for one or more indications. They faced the usual struggles associated with bringing a new antibiotic to market, but in the final stretch before final approval began to behave like a valley startup: setting enormous piles of cash on fire to hire a massive workforce before having anything resembling stable income, and widespread frivolous expenditure on nonessential projects and perks across the company. The leadership also seemed obsessed with emulating nearby Bay Area tech companies, and it was never clear how or why this was supposed to help Achaogen succeed as a pharma enterprise.
Source: was there for the explosion in growth, and the eventual implosion.
Wait, what happens to the formulations after the company goes out of business? Is all the effort really just lost?! Surely it’s just bought by another org?
In Achaogen's case, Cipla purchased global rights to Zemdri (plazomycin) outside China and other IP for practically pennies on the dollar: $16M USD. Everything else went to liquidators for the most part.
It remains to be seen if Cipla is actually going to do anything worthwhile with Zemdri. I personally doubt that they are capable of it.
Were they hiring a big sales force like a typical pharma company or were they less directly relevant jobs? That's interesting how that played out - I guess they were a bit overconfident in their market predictions
A large sales force was hired (probably far too large of one, and definitely larger than institutional investors cared for), but there was also massive growth and spending in departments that were not strongly contributing to go-to-market activities (e.g. massive laboratory expansions oriented towards development of future products, massive growth in many back-of-house business ops teams, and some jaw-droppingly frivolous investments in facilities that I don't feel comfortable disclosing in public).
This is genuinely a pretty big problem in the field. The reward for making a good antibiotic is getting a drug that nobody will use since they want to preserve it for when a bacteria becomes resistant to everything else. We've yet to see really great successes from other approaches like phage therapy, but I do think that long term, the only commercially feasible way to fight bacteria is to use some technology along those lines, where you can keep adapting the therapy to deal with resistance so people will be encouraged to use it and you will have revenues from the product. Still a lot of technical problems to overcome there, but there are interesting approaches (such as using the phage as a CRISPR vector) that go ahead and engineer the phages to get around some of the roadblocks that have stopped them from being useful in general. And we shouldn't underestimate non-antibiotic approaches as well - some good progress in C. diff has been made with stool transplants. Lots of ways to target bad bacteria, unfortunately the one that's worked the best so far is the least commercially sustainable.
The problem is that in America, creating jobs is a significant focus in government spending, including military spending. There's not a lot of jobs in antibiotics the same way that there are lots of well paying jobs to bring to your congressional district if you fund a plane to nowhere. Elsewhere in the world maybe it's different and there's an opportunity there, but spending decisions like those in the US are very jobs driven and antibiotics just don't really fit into that
The US military spends a considerable amount of money on biomedical research, usually on diseases and procedures that no one else prioritizes for funding, including the rest of the government, because it is neither politically fashionable nor lucrative. The boring but important stuff that no politician will ever talk about in front of a camera.
As a well-known example, modern trauma medicine was practically invented by the US Army. They systematically invested in research for the better part of a century to maximize survival rates, minimize recovery times, and restore full body function post-trauma to the extent possible. If you are in a serious car crash, most of the procedures to optimize your outcome were originally developed in a battlefield context by the military.
They also fund a lot of research for relatively common diseases that attract little government funding otherwise due to lack of fashionability e.g. multiple sclerosis. Their incentives are different than either the rest of government or the private sector, and that is probably a good thing.
Yup. BARDA (Biomedical Advanced Research and Development Authority) which is responsible for supporting the development of bioterrorism countermeasures has a number of grants for research that overlaps nicely with antiinfective development.
Because based upon WTO agreements and others, the US cannot force all contractors and suppliers to hire only or mostly within the US.
The one exception is “national security”. So military spending is the most efficient to create jobs in the US because you can prevent hiring in other countries.
An example in the opposite direction is US subsidies for solar energy. These subsidies do create some jobs installing them, but the majority of jobs end up created overseas in other countries like China.
Interesting, one of the areas that the UK government and the EU are apparently arguing over is our apparently quite right wing government wants more freedom to support UK companies through state aid than the 'socialist' EU would like.
If we were to be constrained by WTO rules (an organisation hardcore Leavers seem very fond of) perhaps we can expect an increase in UK arms spending, though this being the UK no doubt this won't mean any improvements for the people at the sharp end of things.
Government procurement is interesting, eh. We've recently spent something like £1Billion on masks - hundreds of millions to companies which seem all to have connections to Tory faithful ... and AFAICT none of which have provided useable masks. (Aside from corruption why would they pay if the product isn't useable??!).
I dare say defence procurement will be similar.
Here's to cutting all that contracting red-tape the EU had us wade through. /s
> ... to pay the Debts and provide for the common defence and general Welfare of the United States
Right after "common defence" comes "general warfare" but for some reason that's something most Americans (or at least their politicians) seem to prefer to ignore.
Most Americans agree that "the welfare of others" ought to be cared for, they just disagree who ought to be primarily responsible for the care. With too broad an understanding of "general welfare" you'd wind up with a 10th amendment that means nothing, because "the general welfare" includes everything, so the Federal government is the only government. I would hate to make Federal lawmakers spend brainpower making laws regarding snow removal that worked equally well in LA and AK.
The 'common defence and welfare' provide the reasons for taxation, and are enumerated in the following items. Note that James Madison — who wrote much of the Constitution — vetoed a federal works bill because he found it unconstitutional. The Wikipedia article at https://en.wikipedia.org/wiki/Taxing_and_Spending_Clause#Gen... is pretty good.
I think it's pretty obvious that the narrow view is the only defensible one.
I'm not an historian or a lawyer so I'm not sure exactly what the founding fathers had in mind or if they even held a consistent view of the question.
However two things seem clear to me.
1) In practice in the US today the "general welfare" clause is interpreted expansively when it suits the purposes of the politicians. This is also supported by the article you link: "To date, the Hamiltonian view of the General Welfare Clause predominates in case law. ".
2) I think that most people throughout the developed world believe that ensuring the general welfare of a country's citizens is an essential function of government. Outside of the US, especially in Europe and democratic Asia this is probably an extremely dominant view. In the US you hear a lot of very vocal people, apparently such as yourself, argue against it, but I think that's a minority view even here.
> I think that most people throughout the developed world believe that ensuring the general welfare of a country's citizens is an essential function of government.
State governments are sovereign, too, and have far fewer constitutional restrictions on what they may do. I may not agree with the social-welfare schemes dreamt up by Texans, Michiganders or Californians, but they do not effect me, so it's not really my business. OTOH a federal social-welfare scheme effects me and is patently unconstitutional.
Definitely fair to call it an over generalization - I grew up in a town with a "private sector" that only existed because of government contracts and have worked on pursuing DoD contracts for life sciences applications, and from what I've seen, it's fair to say that creating employment in the US continues to be a very large part of the driving force behind why funding is allocated by the government. The program managers aren't necessarily keeping it front of mind, but the people signing the legislation to give the program managers their funds to manage basically only care about the jobs part, and that bleeds through in a lot of subtle and non-subtle ways
Sounds interesting. I've heard of some of the stuff on this subject but I'm probably not familiar with all the details or examples. Maybe I will check it out.
The EU has more people than the US, now granted there are some poor people in that count, but it is still more than enough to make whatever difference you blame America for not making all alone.
The steel man defense for nuclear weapons is just that: nobody wants to use them.
Since the development of nuclear weapons, there's been no outright wars between the major powers for nearly a century. We've lived through the most peaceful period in all of human history. It's debatable how much nuclear armarment contributed to that. But prima facie, it certainly seems like a major reason that the US, Russia, or China haven't gone to war with each other.
Given the carnage of the previous two world wars, it seems to me that every dollar spent on nuclear weapons was worth it ten times over.
In this particular case I wasn't, for once, arguing against nuclear weapons but rather that spending comparable amounts on antibiotics might actually bring benefits.
That's silly. Of course society will want to use it. It's just that if they're wise[0], they'll use it as needed not spray it about (sometimes literally)
I think they mean "has a sales profile restrained by public health considerations" - sell sugar pills and your market is comparatively limitless in this respect.
> unfortunately the one that's worked the best so far is the least commercially sustainable.
So sustain it non-commercially. Governments have purchased medications in the past, often for exactly this kind of reason. We stockpile vaccines right now, even though the "market" doesn't want to.
Really the most notable thing about this article isn't the science, it's the framing of the problem as "difficult" when... it isn't.
It's politically difficult yeah. If there was like a $500 million or $1 billion dollar reward for bringing a new antibiotic to market (maybe with price regulations on the other end, but i don't think those would matter with antibiotics), this problem would be a long way to solved. Or a GAVI equivalent. But sometimes, scientific problems are easier to solve than political ones. I'd bet on a new breakthrough creating an alternative to antibiotics happening before the (US) government overcomes the political friction required to do what will be framed as bailing out big pharma. Hating big pharma is like the one thing both parties agree on here.
This is what I really wish the WHO would solve. Have a global fund that every country contributes to based on GDP and/or population. The WHO buys an new drugs from the drug companies and then sets up manufacturing and stockpiles. Then we can get rid of all this drug advertising and reduce the cost of health care. We can stop have the same drug be cheaper in Canada than it is in the US. The drug companies can coordinate with the WHO to develop drugs for the most needed conditions. We don't need a 12th ED drug but a shelf stable anti-venom might be needed globally.
If there are vaccines/shots we need globally, we can keep a certain percentage of flu or whatever around and ship to where they are needed. Instead each country has to keep their own stockpile with duplication of effort. In the US, we pay egg farms billions to produce eggs to be used for making flu vaccines for when actually need them but we pay for the farms year round so we have reserved supply. This is silly and there are easier ways to share the costs.
Even better, let WHO shoulder the cost of trialing promising candidate drugs. The current system means every successful drug needs to also shoulder the cost of developing and (especially) trialing nine other drugs that didn't make it. Basically pharma companies currently work like hedge funds who expect most of their startups to fail but expect to make the money back on a single unicorn from each batch. IMO it would be a much healthier ecosystem if smaller labs could just do the development part.
Government funding on products never produces cheap products. The problem with drug prices is the cost of dealing with FDA regulations, not the free market. Insulin has no reason to be that expensive if it wasn't for the clusterfuck of IP protection laws that interact with each other and lock basic products out.
Incentives in medical research are screwed. This article just scratches the surface.
In general, doing research towards direction that might lead to molecule that can't be patented is not possible in commercial medical research. Research is actively directed away from cheap treatments or drugs.
There is a lot of nonsense tossed around about who actually discovers the majority of drugs and how the public sector can be more involved, but you've identified one case where government and academia could make a huge difference, e.g. by running clinical trials on off-patent drugs applied to new conditions. Low risk, low cost, and very little incentive for big pharma, but a big win for taxpayers if the trials identify cheap new cures.
There is this joke about a guy who goes to patent office and says "I invented dynamite!". Patent clerk says: "But dynamite has already been invented." Guy: "I invented more of it."
Drug development is like that. Huge sums of money is spent for creating slightly different molecules to create competitor for already existing drug.
When someone discovers way to treat disease with drug. Competitors learn
how the drug works and develop another molecule with similar function that circumvents patents.
That money should be used to original drug research that is more risky and uncertain but it generates less profits.
Why? Not that I don't believe you, but I can't get a back-of-the-envelope estimate to go that high (certainly from lack of knowledge on my part).
But I'm picturing the kind of study you see in posters on mass transit: "Are you X, Y, and Z and suffering from W? You might be eligible for experimental treatment. Call this number."
Research is super expensive, and the low hanging fruits have been picked. There's no such thing as a cheap drug, unless that cost is subsidized.
Also consider that the lifetime for drugs against viruses or other pathogens can be fairly short. Viruses that are a problem now, like SARS-Cov-2, might be a non-issue 3 years from now, or the vaccines we develop now might be ineffective against future strains.
Unless the government or non-profit organizations can promise grant money, in exchange for R&D, then patents are reasonable.
And note that 20 years is a very long time in IT, but not in Pharma. Many drugs developed 20+ years ago are just as good today.
Only the low hanging fruits that can be patented have been picket. Cheap paths are blocked by incentives.
Between the size of typical government funding and patentable drug there is huge gap of few hundred millions.
> There's no such thing as a cheap drug
Existing molecular entities where the patent has expired are cheap. Besides, the it does not have to be new drug. Effective treatment can be something else.
There's a Steam review for the game Big Pharma that illustrates this paradox to a lesser extent:
> Came within 5% of the top-most goal for a level, and failed for lack of time. Went back several saves and looked at everything. Was my choice of drug wrong? Were my production lines a square or two inefficient, preventing me from utilizing another delivery portal? Was I spending too much on Bolivian Tree Frog Saliva? Did I not get the researchers working on new machines fast enough?
> And then it hit me: my best-selling drug, for erectile dysfunction, beautifully crafted to avoid side effects and have an A cure rating... was devastating the market... for itself. I simply couldn't pull enough profit out of the economy if I cured people.
> Tried again. Made sure to give the sufferers a side-effect free drug which worked... some of the time... enough to get their hopes up... but not enough to stop buying next month's installment.
I believe a workable solution for this would involve:
1. Pharmas separate drug R&D from manufacturing and sales.
2. R&D companies submit proposals to the FDA for new drugs they want to develop. The FDA can also send out RFPs for drugs they'd like to prioritize.
3. The FDA chooses drugs based on likely public benefit, rather than the profitability-driven selection we have today.
4. The FDA _funds the R&D_ for the drugs it chooses. This allows the R&D company to operate with positive cash flow, separately from the eventual (possible) future income from manufacturing and sales. This is also the incentive for developing drugs that aren't patentable, or which will be required only in small quantities.
5. When a drug is approved for release, the FDA will license one or more manufacturers to produce it, based on their quality, cost, and scale. This is why the Pharmas break into separate companies. Some may focus only on R&D, some may focus only on manufacturing. Some manufacturers can focus on large-scale high volume production, while others can focus on small-scale production. This prevents the excuse for charging huge prices for rarely-needed drugs "because the equipment needed would otherwise be producing much higher volume drugs at lower cost".
This arm of the FDA would be funded partly by the public, and partly by licensing fees. The math for insurance costs and premiums would change because retails prices for most drugs would drop. That would make insurance cheaper, and some of those savings would probably need to go towards a tax for the FDA's R&D funding. But longer term, the licensing fees might be adequate on their own since the FDA would operate as a non-profit.
Point 1 effectively happens today, with larger and successful pharma firms basically waiting on startups to do the heavy lifting/absorb risk of product development, then swooping in at a late phase to acquire the startup.
Point 2 is outside the FDA's mandate. Other HHS agencies like the CDC and BARDA are a better fit and more or less already do this.
Point 3: again, outside the FDA mandate, and the FDA doesn't 'choose' anything in this sense. It evaluates safety and efficacy. Public health benefit is a secondary factor, and one that doesn't necessarily get heavy weight (e.g. Achaogen getting plazomicin 'Fast Tracked' by the FDA didn't seem to do much in Achaogen's favor in the end, with the drug only getting approved for a less-profitable indication).
Point 4: Again, agencies other than the FDA already do this and are a better fit.
Point 5: This is practically already how the industry works, though the FDA isn't the one calling shots.
If it wasn't obvious, I'm talking about changing the FDA's mandate to nationalize drug R&D, while contracting the work out to private entites. I would actually require those entities to operate as non-profits too, in order to receive FDA contracts.
If other agencies are a better fit for various parts of this plan, I'd do some reorganizing to bring them into a single organization. Maybe that's called FDA, maybe not. It would definitely be doing the FDA's current role in drug approval.
Corrupt behavior of government employees is already illegal, so if your concern is that they'd approve R&D funding for a drug and development company they have a financial stake in, that wouldn't be allowed and would be dealt with, unless they can prove that the drug really should be developed and the company getting the contract and funding really is the best choice.
Same goes for the manufacturing side, once the drug is approved.
And for the approval process, what perverse incentives would be created that don't already exist, and are already being dealt with? Today, anyone at the FDA who approves a drug that they've got some way to benefit from is already breaking the law.
>what perverse incentives would be created that don't already exist
If the FDA is both in the business of facilitating R&D, and regulatory QA for the products resulting from said R&D, you're creating an internal feedback loop that results in a couple predictable courses of action for the organization to appear successful:
1. The R&D program 'picks winners' and puts low-hanging fruit in the product pipeline that's highly certain to pass QA. FDA looks good due to high % of approvals for products it pushes to develop, but doesn't really reward innovation or high-risk + high-payoff projects. While this yields benefits, it doesn't address the issue of trying to get 'moonshot' type projects that result in significant leaps ahead funded.
2.) The R&D program (predictably) suffers from the same sort of high failure rate and safety issues that plague pharma in general; it's not a fault of the FDA per se, but because our collective knowledge regarding mechanisms of action is still rather basic. FDA proceeds to be attacked by Congress, the public, the media, etc. for 'wasting taxpayer dollars' on a low-yield program. FDA officials are thus incentivized to let their standards of quality and efficacy slide in order to protect the agency's image on the R&D side of the house.
The organization will "appear successful" if it brings useful drugs to market at a reasonable cost to patients. There would obviously need to be unbiased criteria for deciding what's useful and what isn't, and the decisions around both selecting criteria and applying them should be made by medical professionals, not bureaucrats or MBAs.
Your second argument could be applied to every government program, which are attacked all the time, with the intent to get rid of them and eventually have no government programs at all. That's a separate problem that needs to be solved.
> R&D companies submit proposals to the FDA for new drugs they want to develop. The FDA can also send out RFPs for drugs they'd like to prioritize.
So I'm Pfizer, and I think I've identified a compound to treat hypertension. I get all the way to phase 1 (which isn't cheap), only to find out that it doesn't actually work better than alternatives. What I do find out is that it's great at stimulating erections. A la peanut butter sandwiches, now we have Viagra.
> The math for insurance costs and premiums would change because retails prices for most drugs would drop. That would make insurance cheaper, and some of those savings would probably need to go towards a tax for the FDA's R&D funding.
Total US spend for pharmaceuticals is on the order of 10% of all spending. Since you can't actually zero that out, you're probably not looking at as much money as you think.
For the viagra example, what's your point? R&D has research right in the name, and research can turn up unanticipated results. If the FDA is funding research into a compound that might be good for hypertension, and it turns out to be good at stimulating erections instead, that's fine. There's a valid medical need for that sort of drug, and there would be no problem finding manufacturers who want to pay for a license to produce it.
The total US spend for pharmaceuticals include tens, hundreds, or thousands of dollar-per-dose retail cost that patients are paying either out-of-pocket or through their insurance. Those high prices are justified by two things: the cost of R&D (both for the specific drug and to cover losses from drugs that don't make it to market) and advertising/marketing. My proposal nationalizes the R&D cost so it's spread out over both the full spectrum of drugs being developed instead of just one company's drugs, and over the full taxpaying population of the US rather than just over the patients purchasing the drug.
As for the advertising and marketing cost, there'd be much less incentive to push drugs as hard as they're pushed today, because there'd be no need for the manufacturing company to try to recoup the R&D cost. So long as their earnings are greater than the actual manufacturing cost and the FDA licensing fee, they're making a profit. And they'd have the whole FDA catalog to choose from when they're deciding which drugs they can manufacture and sell at a profit. I also think it would be reasonable for the FDA licensing terms to include a reasonable limit on margins and profits, so that costs for the patients are reasonable.
So, nothing has to be zeroed out. So long as this setup reduces the retail cost, it'll reduce costs for the insurance companies, and so premiums can drop. That puts more money into everyone's pockets, which will make any additional taxes needed for this scheme less painful (so long as the tax is less than the premium reduction.)
Some minor/major issues with your line of thought: The US isn’t the world. Having the FDA essentially own and also pick winners and losers on the R&D market enormously misses their role, and messes up incentives, your essentially asking for all the money in The pharma industry to be funneled through the gatekeeper who’s traditional role has been to say “no way in hell we’ll let you put this hugely profitable drug on the market because it’s highly addictive, causes liver failure and you haven’t evne finished clinical trials on it...” imagine if the public will trust the guys who’s not only saying “yes this drug is definitely safe” but in the same breath is also ensuring 3 new lambos for his personal fleet.
As for the idea of splitting research and productions, that is an absolutely incredible idea, so great in fact that it’s already standard practice to see biotechs spin up only doing R&D with a plan to get bought up once they go to production.
But honestly, it feels like a scary totalitarian government like reality if we move to a state where the FDA starts getting heavily involved in the financials and starts picking winners and losers. Next thing you know Trump will be declaring through executive orders that hydrochloroquine is safe and effective and that production must go ahead With a company he happens to be invested in, but unlike current reality there won’t be any actual scientific checks of those bogus claims.
The FDA wouldn't be picking winners and losers. It would be picking scientifically valid lines of research, based on proposals from private companies. These are government employees; they're not buying lambos. Do you see CDC scientists getting rich?
Today's drug startup company, which thinks it has a product that could be successfully developed, would write up a proposal to apply for FDA funding. If the FDA scientists decide the proposal has merit, they get funding. If the FDA thinks the company is nuts, the company can still self-fund and do the R&D on their own. Either way the normal testing phases are needed for final approval.
After that, if the FDA funded the R&D, it gets ownership and licenses out the manufacturing. The startup company can move on to work on something else, or having already been paid by the FDA to do the R&D, they can close up shop. If they self-funded the R&D, then they keep ownership and get to license the manufacturing, just like they do today. (Getting bought-out is just a transfer of manufacturing rights from the startup to the pharma, so that can still happen if the startup retains the rights.)
I'm imagining lots of startup companies developing nutritional-based vitamins and herbal products, getting paid to take them through the testing process, and then after approval the startup just moves on to another compound and/or disease. They could run as profitable little businesses for a long time doing this, and we'll get lots of non-patentable but fully tested products on the market that are cheap as dirt for the consumers. We can't get these products today because no one will pay for the testing process, so instead we have unregulated snake-oil products with little to no quality control and vague unverifiable claims about what they're good for.
I've heard the economics of developing new antibiotics making it difficult being mentioned a number of times but this is the first time I've seen an article explaining the economic difficulties so clearly. I do like the sound of some of the proposals, like rewarding new products so they don't have to be at the mercy of a slow introduction to the market.
Its interesting that one of the drugs mentioned isnt viable as a business model because it must be given intravenously. Its almost like the value stream / value chain in medicine expects the drugs to do the work as a replacement for people. If the cost of an in-person visit was free, it would still cost more but might it be viable?
It's not just that there's friction associated with injection-only antibiotics. It's also that most cutting edge antibiotics that must be delivered via injection or infusion tend to be finicky about dose titration (requiring regular blood tests and hence effectively have secondary product dependencies to support use of the antibiotic), and have an unfortunate tendency to cause a number of relatively severe side effects that need to be monitored for over an extended duration.
I do agree that incentives are a problem. However, I also see this as a sign that small-molecule antibiotics may not be the most efficient approach for antibiotics in the future. Designing small-molecule pharmacological agents in general is extremely inefficient in terms of time and money, and lacks robust design methods. I was shocked at how much "throwing everything against the wall to see what sticks" (high-throughput screening) was being depended upon to optimize drug leads. Sure, machine learning can help this process a bit, but it's building upon a shaky foundation.
We should be investing in bacteriophage research and other methods more robust to evolving resistance. This will ultimately be more beneficial for the public good. Of course, incentives probably still need to change in order for this research to gain momentum.
Designing small-molecules is "extremely inefficient" compared to what? We might as well say fishing is inefficient because of all the time spent not reeling in a fish. We should definitely research all plausible alternatives, but nothing in medicine is as convenient as a small-molecule drug that works. So people are going to try to find them.
The FDA should be able to certify drugs as safe, effective, etc. They shouldn't be able to ban drugs for not being that. Helmets in America don't have to be CPSC certified and that's fine. You can choose to buy an uncertified helmet if you want.
Certification is good. But uncertified drugs have their place.
The average US citizen cannot be expected to have a nuanced enough understanding of pharmacology to make informed decisions about the safety and efficacy of drugs. Even trained and licensed physicians often have difficulties making such decisions in non-mundane situations, and rely heavily upon their pharmacy colleagues (either by way of consulting practice-specific literature, or actually consulting with a qualified pharmacist) to assist with making determinations about what would be safe and effective to administer.
They don't have to. They can stick to the pharmacists and all that. If you want me to take a test to demonstrate that I am of sound mind and should be released of my restrictions, that's fine. If you want me to post money so you can afford to bury my body, that's also fine.
But release me from the bonds that bind "the average US citizen".
Again, your position is absurd. Individual pharmacists of the type that serve the average person most often (retail pharmacists) are not equipped or trained to be the gatekeepers deciding which products are safe and effective. Putting that sort of risk and power into the hands of pharmacists will necessarily result in a need for cooperation on de facto standards that will only result in strengthening cartels like the American Pharmacists Association, which are already anti-consumer enough as it is.
>release me from the bonds that bind "the average US citizen".
Well...that definitely vibes with the incoherent disestablishmentarianist approach you seem to be promoting, I guess.
> > me: The FDA should be able to certify drugs as safe, effective, etc.
> you: Individual pharmacists of the type that serve the average person most often (retail pharmacists) are not equipped or trained to be the gatekeepers deciding which products are safe and effective.
I find your response stupefying since it seems to be responding to things I'm not saying...
> > Well...that definitely vibes with the incoherent disestablishmentarianist approach you seem to be promoting, I guess.
I'm directly responding to your (insane) line of argumentation: You're arguing that medications that have not passed regulatory requirements for safety or efficacy should be sold to consumers, and that they can simply rely on retail pharmacists or the like as a stand in for the FDA's approval process.
Interesting. Perhaps my English isn't that good. Please re-write "The FDA should be able to certify drugs as safe, effective, etc." in the way you understand it.
In this universe, you can just get an FDA-certified thing. No stand-in required.
> You're arguing that medications that have not passed regulatory requirements for safety or efficacy should be sold to consumers, and that they can simply rely on retail pharmacists or the like as a stand in for the FDA's approval process.
No. No gatekeepers. The standard is you buy FDA drugs from pharmacists. If you don't want to, you don't, you buy it from who will sell it and you're on your own. It's the escape hatch. Just like you can buy non-Snell-certified helmets.
Do they? The distinction may be lost on consumers, and if an uncertified drug harms people or fails to work and they die before further methods can be tried, it may harm people's trust in the medical system as a whole, causing them to turn to snake oil treatments with even less of a scientific foundation / vetting for harmfulness.
If snake oil can kill Steve Jobs, don't think you and your loved ones are immune.
I don't think I'm immune. I don't think the ones I love are immune. But for myself (and them) I'm willing to take the risk. If you want me to take a test, so be it. If you want me to post a $100k bond so be it. It's not like there's universal healthcare anyway so my costs to you are upper bound.
> But for myself (and them) I'm willing to take the risk
I truly don't think you have the education, training, or exposure to the field to actually make an informed judgment about what such risks would be.
This isn't an insult to you, it's simply a fact of life: We can't all be subject matter experts in all things. This is precisely why regulatory apparatuses, licensure for the practice of certain disciplines, and product safety standards exist.
Ah, but there lies the rub. The regulators don't have the education, training, or exposure either. And crucially, they don't have access to my risk tolerance.
This is most obvious in anti-mask rhetoric from the top public health service in America but also is common in that regulators are safetyists. They will let a million die so that not one will die by their hands. That's okay for them, but not so much for me.
Haha, I'm pretty sure I know more than you do. Just reading Wikipedia doesn't make you an expert, mate. But please, regale us with your expert knowledge.
I think anti-vaxxers and anti-maskers hostile to attempts to protect the population are obvious examples of how you losing trust in the medical system could directly endanger me and my health.
Imagine a covid vaccine is rushed to be released without being certified as safe. It is later discovered to harm many people in some horrifying way, as thalidomide did. Now not enough people are willing to try the next vaccine, and it becomes impossible to eradicate covid even once a safe and effective vaccine is developed.
Now imagine that, except for every single public health threat. The public has an interest in the medical system being trustworthy, and uncertified treatments undermine that trust in a dangerous fashion.
EDIT: If it isn't clear, I don't think you could post enough money to cover even one death as a result of your actions, let alone e.g. being responsible for a superspreader event that leads to many deaths. Even if the drug in question is not for an infectious disease, memes are infectious and if you spread distrust in the medical system that leads people to e.g. drink bleach you are still responsible for that death, even if it is indirect / hard to prove and you cannot be legally held accountable.
I'd rather use regulations to prevent the harm in the first place rather than trying to chase down and sue people after the harm has already been done. This attitude is one reason the USA has a reputation for being litigious/sue-happy.
The anti-maskers were the medical system. I don't think I'm eager to forget that.
Centralization of medical certification leads to this sort of situation where loss of trust in a single organization leads to loss of trust in the methodology. However, in a decentralized system with multiple certification authorities, loss of trust in one just loses trust in that one.
An example of this is helmets: DOT has a helmet rating, but Snell does too. Everyone aims to get helmets that are certified to meet Snell standards, which are superior to DOT standards.
Public health is too important to give it to those who are not capable of making the correct decisions. The CDC killed two hundred thousand Americans. There are certainly many among those who would be alive if there had been alternative health authorities capable of speaking scientific truth.
Besides, there's the obvious answer: price in the externalities. Reduce the costs of filing suits against people who (while sick) visited places where people fell sick immediately after their visit. If my child transmits measles to yours, I should be paying your costs (real and opportunity).
EDIT: Just read your edit.
> ...if you spread distrust in the medical system that leads people to e.g. drink bleach you are still responsible for that death, even if it is indirect / hard to prove and you cannot be legally held accountable.
I think I see the difference in our world-views and I don't think I'm willing to expend the effort to reconcile them. I believe in human agency to a greater deal than you do. For instance, if I were scammed, I would prioritize self-modification to improve scam resistance. You would prioritize society-modification to reduce scam incidence. Okay.
There are 2 reasons that's a bad idea. The first is the obvious; people will harm themselves. How many people would have taken hydroxychloroquine when that was the Covid rage, despite the limited effectiveness and severe complications?
The second is that we still allow advertising on medications. How many people would get duped by ads for things that they don't need? How many hundreds of uncertified "Covid cures" would be making the rounds on Facebook and TV ads? I'm sure they'll all have wonderful test results, based on fundamentally flawed studies that are largely illegible to your average person.
I agree with more funding of scientific research, but why not use X-prizes instead of direct grants to non-profits?
When we have a clear objective in mind (i.e. develop a new antibiotic with no pre-existing resistance in the wild), X-prizes tend to produce much better ROIs. For-profit organizations tend to be much more efficient at hitting concrete targets. An X-prize also doesn't require the government to directly pick winners and losers, or evaluate intermediate progress. That sidesteps a lot of the risk of political corruption that inevitably creeps in with big government budgets.
I think that makes total sense in terms of coming up with a solution to a specific objective.
However, since antibiotic resistance, and treatment of diseases in general (COVID, for example) is a moving target - it would be nice to have machinery in place for solving these problems as they come.
Regarding political funding, that's a whole different problem in itself.
> I don't understand why we don't (as a society) fund more scientific research, in general.
Humans are much better at handling short-term projects than long-term projects. There are many reasons for this including, but not limited to, human psychology, harder to assess risks and payoffs, and limited human lifespans/workspans (e.g. leadership changes every 4-8 years and therefore so will the direction of the project). These issues are very prevalent when, for instance, the development of a new antibiotic can take up to 20 years.
In addition, plenty of science results in duds. We see and hear about the successes, but we don't really see the hypotheses that are failed to be proven and discarded, which I imagine are the vast majority. Most people are not scientists, and this kind of process is foreign to them.
Because I don't really care as much as you do for scientific research chosen by committee. I much prefer that chosen by the market. So when my representatives go up against your representatives in government we get a sort of average position of yours and mine.
I don't know that the details about the drug market are particularly important here. This is just another tragedy of the commons effect. Drug resistant infections are a "problem" (a very severe one to those suffering), but they're an economically insignificant problem. So no one is willing to pay enough for new/unresisted drugs to make it worth their development.
There are plenty of straightforward ways to get these drugs to patients. They just aren't ever acceptable to the people regulating research funding and the drug market.
"Antibiotics present an enduring economic puzzle. These drugs changed the world. Yet despite their unique power, the free market doesn’t value them."
No. The free market -- people -- values these drugs. If there wasn't demand, this article wouldn't have been written. The problem is that drugs are too expensive to bring to market for their developers to profit, and that the single greatest cost is often FDA approval.
The article implies that the solution is to funnel more BARDA grants to companies in order to make drug development profitable. This amounts to using taxpayer money to help private companies pay government fees, with lots of bureaucratic overhead (employees, forms, computer systems, buildings) at each end of the transaction. This is dramatically suboptimal.
Instead of this, the FDA process should be cheaper, or the FDA itself should be privatized, and operate as an entity like Consumer Reports or any other review organization. Government need only be involved with prosecuting fake producers. The consumer requires only access to information, and assurances that a substance they bought is the same they have researched.
Paying government expenses with taxes is an unsustainable Ponzi scheme, and takes us further away from a real solution.
The FDA approval process ensures both that drugs perform an intended function, and that drugs don't harm people. Part of the expense of this process is making sure that both of these aspects are performed to sufficient standards.
It sounds like your suggestion would lower the bar for both these aspects, and only catch issues after the fact - something which could have fatal consequences.
I'm curious how you would see this playing out in a positive light, particularly given the money involved and the incentives to game the system.
Pharmaceutical companies have every incentive to make their drugs safe, because if their drugs hurt people, the drugs will not sell.
Many drugs have passed FDA approval but later killed people. If the FDA were a private company, it might have gone out of business. But as a government monopoly, it's very hard to stop paying for. Between pharma companies, the government, and individual patients, the FDA has the least stake in the health of a particular patient.
UL is an example of a non-government organization that offers product safety certification. You see the UL seal on most consumer electric appliances. Imagine an FDA seal.
Drugs are not magical or special. They are a product like any other, and it is the consumer's right to choose a doctor, and for that doctor to choose proper medication. We regularly choose the best mechanics, plumbers, and other specialists we can find, and their reputation is partly a function of the type and quality of the parts and tools they use.
If you want to see where this kind of free-wheeling approach to cGMP certification and product quality gets you - just take a look at the developing world, where big-name generics manufacturers knowingly dump subpar-quality (or even outright dangerous or ineffective) drugs on the market with impunity. This leads to all sorts of unsavory outcomes, and puts healthcare providers in the position of resorting to incredibly unscientific approaches to dosage management (it's not uncommon for physicians in such cases to recommend dosages many times in excess of what's recommended due to extremely poor active ingredient potency, based mainly on strictly qualitative feedback from patients). It effectively reduces the pharmaceutical market to a guessing game. The quality issues seen in the developing world are also directly linked to antibiotics usage practices that directly contribute to development of resistant strains of bacteria.
It is my understanding that malnutrition, clean water, and access to education/information are foremost among the problems of the developing world, and it's not at all clear to me that regulating medication in those countries would improve anyone's situation measurably.
For my part, here in the "developed" world, I have a family member with a rare autoimmune condition, and access to comparatively few medications. Those that are available are very expensive and not covered by any insurance. There is little competition between their manufacturers.
Because it costs at least 1.4B to bring a drug to market, and because of the rarity of her illness, it's unlikely any company will pursue new research. Thanks to the FDA's inordinately expensive approval process, no company is incentivized to bring a drug to market with an upside of <= 1.4B, regardless of how many people it could help.
UL is not a government organization, but it's not completely disconnected from government regulation.
Most states or localities in the US have building codes which are required to be met to be allowed to build anything in their jurisdiction. These building codes typically require devices to be tested by a recognized lab, of which UL is one.
So there is a choice between UL or some other very similar organization, but you don't have the choice to forgo testing completely or to rely only on some completely different type of testing.
Now of course the public would be better served if the UL could focus on their business without being subjected to the whims of politicians. But the fact that private companies other than the UL can at least compete for the job ensures that costs are reasonable. If the UL charges too much consumers can choose one of their competitors. Even if they have no competition right now another company will arise to compete, if it isn't illegal for another private company to start providing this service.
I see no reason why an individual should not be allowed to build their house with whatever inspection regimen they desire (even none at all). A poorly built house, a house without the endorsement of a respected engineering body, will surely have this reflected in the sale price. I don't see a problem here that needs to be solved.
> It sounds like your suggestion would lower the bar for both these aspects, and only catch issues after the fact - something which could have fatal consequences.
The other side of this is:
1) Since the FDA is a monopoly, it's entirely possible (and probably demonstrable) that they've set the wrong bars, which could have fatal consequences.
2) It's arguable that the costs imposed by the FDA may have fatal consequences themselves, in the form we're seeing today, where life-saving drugs (antibiotics, in this case) can't be developed because of them.
I'm interested in hearing your response to the above two points. I'd also be interested to hear what you'd think of a "de-fanged" FDA wherein they are able to approve or disapprove medications, but are not able to enforce those decisions. People would be allowed to do with their own bodies as they please, but they'd be able to reference the FDA to make those decisions.
Drugs are not somehow different from any other type of product. All products have some level of risk to the consumer, and may or may not do what they're advertised to do.
The Car & Truck Administration (CTA) approval process
ensures both that cars and trucks perform an intended
function, and that cars and trucks don't harm people.
Part of the expense of this process is making sure that
both of these aspects are performed to sufficient
standards.
And yet, we don't seem to need an FDA of cars and trucks costing auto manufacturers $1.4B to develop a new car, and our cars don't explode and kill us. The reason? A car maker who makes unsafe cars goes out of business. Consider Ralph Nader's "Unsafe At Any Speed" did to the Corvair corporation.
Uh, what? In the US, the NHTSA and DOT enforce rather rigorous safety standards, and this requires automakers to front relatively expensive R&D and certification costs. It's a huge (and given the history of motor vehicle safety, necessary) barrier to market entry.
Like the FDA, and as monopolies, NHTSA and DOT have much less stake in the safety of a consumer than do either car producers and drivers.
Personally, I trust myself not to buy a car that I've heard explodes. You may not, and I respect that. But I see no reason to pay for a service that assures you when I myself require no such assurance.
If NHTSA and DOT operated like UL, products that were less safe probably wouldn't have NHTSA or DOT seals, and those products would be much cheaper. People willing to trade safety for cost would be able to own a car. People willing to pay for safety would pay more. Because of the lower barrier to production, there would be probably much greater choice in car buying, and cars would be universally cheaper. In either case, the choice would rest with individual consumers, who know best their situation and risk tolerance.
You're completely ignoring the fact that consumer choices about automobile safety have externalities beyond the buyer. Sure, maybe you and I care enough about auto safety standards to buy a vehicle that isn't dangerous, but I don't trust other consumers to necessarily do the same thing. I don't want to be sharing the road with some corner-cutting jalopy that's likely to throw a tire through my windshield while we're passing each other on the highway, and I definitely don't want a market that permits such low-quality products to be operated in public spaces.
I can think of a few systems in place that mitigate cases like the one you mention.
First, I can think of very few things that could happen to someone's car that would disadvantage you without disadvantaging them. In the case you mention, the missing tire would render the jalopy inoperable, and so the buyer suffers for their poor choice of vehicle. Any buyer thus factors reliability and safety into their decision, whether or not they are particularly concerned about the safety of others. Plus, now they have to walk, and you probably won't be giving them a ride. A counter-argument to this would be effect on climate, an externality that's maybe best left out for now :-)
Second, individuals may sue other individuals for personal or property damage. So, at least one factor preventing everyone from terrorizing you with their jalopies is that they are liable for damage their jalopy causes to others. The decision to purchase a jalopy includes this risk, disincentivizing the purchase of dangerous (to others) vehicles.
Third, it's already a requirement in most jurisdictions that drivers are insured because of the above liability, and insurance companies could easily deny coverage to unsafe vehicles, as determined by any (private) mutually agreed 3rd NHTSA/DOT-like party.
Finally, because there is no competition in the area of safety certification, it seems highly unlikely that the government's assessments of risk correspond to the risk assessed by the average consumer. The fact that most people choose to drive used vehicles that don't meet the government's latest safety standards feels like implicit proof of this.
None of your defenses work outside of a thought experiment where every actor is rational. Real human beings are anything but, and there's a long history of precedents for why all of your positions here are bad ideas (and why regulatory bodies like NHTSA, DOT, and other regulators became necessary).
And your arguments rest on the assumption that politicians and voters are rational, surely?
My bet is on individuals to act in their own best interest. Likewise, politicians have every incentive to act in ways that benefit themselves and their friends at the expense of everyone else. In both cases I acknowledge the capabilities of these humans to use their own brains to think, but only politicians have an incentive become corrupt.
The FDA provides an essential role in verifying the safety of medications and their standards are high because people lives matter.
The reality is that drug development is hard and failure percentage is high. Don't blame the FDA for that. Getting the government out of the picture will either increase the danger to the public with relaxing regulations or have negligible impact on drug development because most drugs fail anyways.
I think it's totally fair to blame the FDA, as it's a monopoly. No entrepreneur is allowed to compete with them and they have no obligation to the consumer -- their only obligations are to politicians. So naturally the costs are sky high and their services don't align with what the consumer wants.
"Peoples lives matter" is meaningless nonsense, and even taken at face value does not imply standards should be high. Remember that high costs and overly restrictive rules introduce delays and prevent drugs from reaching the consumer, and people are harmed and die because of this.
How do we know when the FDA procedures are too restrictive? Well, we can't! Only the consumer can make those tradeoffs for him/herself and communicate their needs and desires via their preferences when selecting products where there are alternatives. With the FDA being a government monopoly there is no such feedback loop, so we just don't know how well their procedures actually align with what the people need.
It's depressing to see how many Americans believe that if something "matters" the only option is to have the government micromanage it. If you're not American then I understand, of course.
How could there not be a monopoly on public safety? The state and the government should have the final word on all things public safety related. Trusting private corporations or companies with public safety is insane.
It's sad and hilarious that Americans truly believe that the government, who is accountable to the electorate, should be somehow disabused of those role simply because it doesn't work as well as they'd like.
You know, instead of reforming it or fixing the problems we have.
The Libertarian "let the free market work" is just complete garbage and history has shown time and time again this doesn't work and will never work.
> How could there not be a monopoly on public safety?
Easily. Simply allow the private sector to provide the services currently under the exclusive domain of the FDA, for example.
> Trusting private corporations or companies with public safety is insane.
I agree 100%. However, companies are not in a position to provide public safety anyway. It's consumers who make up the public, through their choices, who provide for the public safety. They are perfectly capable of being safe without needing the government to interfere in their affairs.
> You know, instead of reforming it or fixing the problems we have.
What's really sad here is the belief that if only we had smarter experts in Washington D.C. they could make the perfect set of rules to regulate everyone's lives, and we would not have any problems. This is utterly naive, and is quite impossible in practice. No matter how smart an expert is, they simply can't know enough to make the optimal balance for you or me. They don't know anything about my life, so how could they evaluate all the trade-offs to make optimal choices for me? There are just too many variables and life is too dynamic.
This is exactly why free markets are great, they provide the distributed feedback that democracy can't. Individuals are free to choose the services and goods that provide the most value, and collectively these preference signals propagate through the market to guide producers, who are in turn free to innovate and create new services they think I will prefer. This "invisible hand" guides the interactions of millions of people across the globe, but it requires freedom.
Wherever there is a free market we see innovation and prosperity. The evidence is all around you.
You start going in the right direction by talking about the cost of the FDA process, but then veer off into the weeds with a solution from extreme Libertarianism. History has shown over and over and over again that this type of hands-off approach and “let the consumer decide” mumbo jumbo absolutely does not work. It’s just as debunked as the trickle down economics theories. They have been tried so many times and failed every time.
If I’m in the ER am I supposed to stop and check every single drug they give me before having emergency surgery? Is the hospital? Would we give the right for every citizen in the country to inspect the premises of every drug manufacturer? So now anyone must be allowed to walk into any factory whenever they want to see what’s going on? How should any layperson be expected to have the knowledge and expertise to even perform an evaluation?
I can imagine some kind of review site where people post 1-star reviews like “took drugs, died anyway”. How many bad reviews/people dead would you say should be enough for a company to be removed?
If you have any choice in how you are treated, you will make your best judgement based on information available to you, such as by the recommendation of a friend, or a Yelp review. This is the same process you use to make any important purchase.
Before you have work done on your car, do you fly to China to inspect the part factory? You don't, because the relatively low risk you perceive that these parts will fail doesn't justify the expense of travel.
Do you perceive low risk because a government agency put a stamp of approval on the part? Probably not. Most likely, your risk assessment is based on information you've gathered about the final product, the auto shop -- that it is well-reviewed, and that your mechanic seems knowledgeable.
Furthermore, only you really know your exact needs. An expensive high-performance car part might provide you some marginal benefit, but not so much benefit that you're willing to buy that part at the expense of something else that's important to you, like your electric bill. A race car or Uber driver might make a different decision and choose a different part to suit their needs.
Medicine is like car parts. Bad ones can kill. But through the free market, a system of feedback is established that tends toward a wider variety, and higher quality, of parts overall.
When politicians prioritize some drugs over others, they interfere with this system, and money is spent on drugs and research that people don't necessarily want or need. You can imagine race car drivers getting together and lobbying politicians to subsidize high performance parts. Because these subsidies are funded by taxes, money is effectively taken from individuals who might prefer a different part. Now, those individuals who are not race car drivers have less purchasing power, and fewer choices overall.
You're correct that this is more or less the libertarian perspective, but I find it in no way extreme. I find it principled, direct, and humane. In our society, where nearly everyone has a smart phone and may conduct research at any time, I can't imagine a more effective system. I'm sure it was much easier to criticize the free market in a time when people couldn't read, or didn't have a global information database accessible on their person at every waking moment.
Man, if only there were some way we could run an experiment where we could see how the industry would react if drugs were not required to be vouched for by a regulatory agency.
Wait, there is: the health supplement industry. You know, the people who can't be bothered to even put in their claimed active ingredients because it's all placebo anyways?
The FDA was set up literally because of these snake oil situations, and modern evidence suggests that snake oil still thrives wherever the FDA is banned from setting foot.
What upsets you about other people using their own money to buy placebos, other than the fact that you can't understand why? At this very moment, millions of people across the globe are buying things for themselves you would never buy for yourself.
Has it occurred to you that the health supplement buyer is in a much better position to decide how to allocate their money than you are? You have limited, aggregate information; they have a total view of their own finances and life situation, and are willing to devote their own time to research their personal decision to buy. For example, they might discover through research that a supplement generally regarded as a placebo has a benefit under circumstances known only to the them.
When you limit the choices of others, based only on general information or your personal perspective, you limit the set of choices others may take. If you do this long enough, you might find yourself some day prohibited from buying something you desperately need, because your situation is an exception to some general rule that nobody ever considered.
The FDA might have made sense at a time when most people were illiterate and information was hard to come by. Now that most (at least in the US) are literate, and own smartphones, taking away choices for the benefit of some hypothetical illiterate serves only to worsen the life of the average person.
> The FDA might have made sense at a time when most people were illiterate and information was hard to come by.
The FDA was established at a time when virtually the entire population of the US was literate [1]. While I don't have the heart to look up statistics, I suspect that the US at the time had the highest (or at least among the highest) newspaper penetration of any country, and that newspaper penetration would have been quite higher than today. Public libraries and schools would have been in full flourish too, by that time. My grandparents grew up on farms on the edges of the High Plains--where you would expect to find the most bumpkin of country bumpkins--and illiterate and ignorant they were not.
For someone whose argument is that the federal agency is necessary only because of public ignorance, you sure seem to be modelling that ignorance you think no longer exists. The problem with your argument is that you neglect to reason that both information and misinformation are incredibly easy to come by, and most people are unwilling or unable to differentiate between them.
[1] It is worth pointing out that, if you measure literacy by the ability to read in your native language, Western Europe has been majority literate for over a millennium.
You're right, that last paragraph is a flawed argument. I retract it, and your findings compel me to assert that I think there was probably never a good reason for the FDA.
But it's the second, and weaker, of the two arguments I made. The argument I develop in my first three paragraphs stands.
Nobody is arguing that the population of the US was illiterate when the FDA was established. The argument is that it might have made sense at a time when the US population was illiterate, but now that everyone has access to a world of knowledge in the palm of their hand 24x7x365 the FDA does not make sense.
The argument was that the FDA never made sense, not even when it was first established in America, and for precisely that reason -- Americans were not illiterate.
Creating medicines is nothing like creating car parts. At all. There's not a single aspect of drug discovery, manufacturing, or distribution logistics that in any way resembles something as crude as producing unregulated widgets for automobiles.
You're simply highlighting how poorly you understand the pharmaceutical industry with this line of argumentation.
I think it's an inane and inept comparison. The manner in which defects arise in each type of product, and the manner in which failure modes manifest are so different as to be incomparable.
I don't see how you can contest that they're both products and that they can both kill people if they're defective. To me these two similarities are plainly true, and it is only these two similarities that are material to my argument.
I might misunderstand, but the direction your argument seems to be heading is that the free market is somehow incompatible with products that have complex failure modes or that can be defective in subtle ways, and that the FDA is thus necessary. Is that right?
When I read the title I thought the point was that companies can't afford to create life-saving drugs, as it is in their interest people to stay ill and keep buying less effective drugs.
It would seem like testing on 100-1000 people spending $10-100k per person would work, which gives $1-100m, but apparently they cost billions for some reason.
Doctors, Nurses, clinical trail coordinators, paying a lab to process specimens, the list goes on. I work in a medical lab that charges a low flat rate for literally holding onto the specimens for a couple hours, and a high flat rate for any amount of processing, i.e. centrifuging specimens, pipetting into little labelled vials, adding certain preservatives, etc. This processing isn't really automation friendly and regulations require a CAP accredited lab to do the processing so it can't really be outsourced to a lower bidder.
I get the impression these companies aren't too concerned with the actual costs involved.
Start to make patentleft to start competing alongside, and allowing this to be developed.
Just like in open source software, all other science departments run on a gift economy just fine, everyone contributing small parts to a snowball. Newton stood on the shoulders of giants, he says. He didn’t have a swat team shut him down for it.
The engine of Capitalism is about taking risks and investing capital into a project, to recoup it if it turns into products people want to buy with viable unit economics. That works well, but also has major downsides. Countries like USA which do it wind up paying 10x more for the same drugs as others, and you can see other problems in the OP post about not even developing the drugs. May as well try another system (alongside) like patentleft.
Open source and science is a gift economy where everyone contributes what they can afford, and a growing snowball of ideas. It is built on COLLABORATION rather than competition, and requires NONE of the intrusive government interventions to grant monopolies on ideas and “doctrine of equivalents”. Libertarians and progressives alike should welcome it.
Private property is just a man made system, just like any other. We can look around and see what systems work better. Which is far more popular today:
Wikipedia vs Britannica
WebKit / Blink vs IE
Linux / BSD vs SunOS
The Web vs AOL
Linux/Android vs Nokia
Apache / NGinX vs IIS
Programming languages are almost all open source
Wordpress vs Blogger.com
I could go on... but you get the idea. The tortoise beats the hare eventually.
>Open source and science is a gift economy where everyone contributes what they can afford, and a growing snowball of ideas
This doesn't work with pharma. It sort of works for early compound discovery/development, but not for the seriously expensive work: the process chemistry, the animal studies, the human trials, and if all goes well, the costs associated with facing off against adversarial regulatory agencies.
How does that help? That just reduces the commercial incentive to pay for clinical trials and stuff even more. Phasing out patents doesn't work without an idea for an entirely, fundamentally new system of developing, testing, approving, manufacturing, and distributing drugs. I'm not saying that it's not possible to come up with a radically different system that is better than what we have now, but I am saying that kneecapping the system that we have now without any plan for a replacement definitely isn't going to help.
Looks like you edited your comment with a lot of alternate systems, but all the examples you gave are ones that aren't expensive to develop. You have to prove drugs work and take a significant amount of risk that you don't take with software projects like those.
And you've added this idea of a prize based system. Who gets the prize in a system without ownership of IP?
Again, having a clear alternative before tearing down a system that produces things you want (e.g. new drugs to cure diseases) is kind of important. Just eliminating the system because there will be "opportunities" to figure out better ways of doing things later basically just means eliminating the system completely. Drug development is not a net negative to society. Having a new gene therapy to cure a deadly rare disease that costs way too much and isn't accessible is better than just not having that therapy at all.
Costs under a capitalist system of private property and monopolies enforced by government are one thing. Under a system with no profit motive or restrictions on innovation, they are another. We already witness the cost to the US taxpayer. This a lot of money raised by walkathons and public universities and so on. The NIH develops many things and pharma licenses those patents and they don’t pay the public any direct royalties for them. And it devolves into handouts for the large corporations, whether it’s this or banks too big to fail or now with the Fed exceeding its mandate and just making sirect investments into the top corporations to prop up the stock market to restore people’s “confidence” in this system. You talk about cost? The societal cost of the current system is huge, AND the health outcomes and preparedness are far behind what they would be under a system with LESS enforcement private property on such levels.
The starting point to realize about drug development is that 90% of our drug candidates fail. And that's only considering candidates that make it to an initial drug filing, which is itself a tiny fraction of compounds considered internally.
But these candidates are all competing! It’s like if Netscape was never open sourced, we would have closed source browser wars, all our explosion of wealth was BECAUSE of that happy accident. Once anyone is free to build on them, we could have a lot more drugs. Many drugs were repurposed, as well. Viagra was not designed for its current use case. Methamphetamines are strikingly similar to cocaine. Imagine how much innovation could be done if people were ALLOWED to do it!
When you patent a drug, you patent a compound for the purpose it is being used for. If you use it for a different purpose, then you won't violate the patent.
So why don't we see more repurposing of drugs? Because it's expensive to actually go through all of the clinical trials, especially the final Phase III trial (where 50% of drugs fail due to being ineffective).
technically you patent the molecular structure too, and then take out a cloud of dozens of patents around it, while getting as broad language as possible (used for any disease where the pathology is influenced by this molecule, or whatever uspto will let you get away with) But generics companies are heavily incentivized to try and overturn those patents by law, and drugs are repurposed all the time through off label use without a phase III for the indication.
you think the reason that a drug fails a clinical trial is because of ... competition? Like, Bayer's aspirin is just going to stop curing headaches because it's angry that J&J is developing Tylenol? A drug that doesn't work isn't going to start working if it becomes open source, that's not really how chemistry works
Actually, if someone else could build on all the results of all the failed clinical trials, realize it works offlabel for something else or change one atom and make it work as a generic drug... that could help tons of people.
Instead they change one atom on working drugs and extend patents another 17 years.
Changing an atom is a big deal, thats a whole other drug. Evergreens, where they extend patents through small modifications, has nothing to do with the active ingredient since changing that requires another few hundred million dollars in clinical trials. And generics companies are already incentivized by law to sue and overturn patents. I would suggest spending time to learn about what these problems like evergreening actually are, and how drug development actually works from a scientific perspective, before trying to come up with societal structures to do it better. I would also recommend then reading up on the current societal structures so you can get a sense of what off label use actually means, what that entails, how generics companies work, what their incentives are, and so on. But start with the science behind how drugs and drug development works, the statistics of why clinical trials are needed, etc, since you really can't do anything without that basis.
It seems all your examples are on consumer desktop computers. I would even say that iOS and mobile phones promote closed source software and are closed themselves, tightly controlled. And there are many arguments about this, too.
Again, I am not saying there aren’t pockets where closed source will hold out for a long time. I am saying why not have an open alternative also? Patentleft movement in pharma
Further, winning today doesn't mean winning tomorrow. Open Source can start to lag behind neighboring technologies (hardware, other packages) and quickly be beat by somebody investing money into support and upgrades. Something open source is very poor at - timely updates.
The problem with pharma development is not the lack of ideas.
The majority of those are solely popular because they're free, or heavily subsidized. That's not a viable economic model for doing lots of intense, focused development, and a lot of those above projects lack people doing "boring work", or are subsidized by companies relying on closed-source and patented work to fund the boring stuff.
There's also minimal ethical/moral hazard associated with the projects cited. Pharma trials mean that some nonzero proportion of the study populations will subjected to side effects, some of which may be permanent and debilitating. Some study participants may even die as the result of an adverse event. This is a major disincentive to development that the opensource projects cited never have to face.
Source: was there for the explosion in growth, and the eventual implosion.