The antibiotic paradox: why companies can’t afford to create life-saving drugs
nature.com
nature.com
Source: was there for the explosion in growth, and the eventual implosion.
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).
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.
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.
The DoD is partnering with (funding) phage therapy research companies.
http://www.theshadowworldbook.com/
Mind you - not a book for the easily angered.
The political contributions of the sheet metal shop in your district that stamps some widget for the F-35 at 50x market price definitely matter.
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.
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.
I dare say defence procurement will be similar.
Here's to cutting all that contracting red-tape the EU had us wade through. /s
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.
I think it's pretty obvious that the narrow view is the only defensible one.
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.
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.
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.
BARDA [1] has a defence mandate, though it reports to HHS, and is a major public funder of antibiotic research (per the article).
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.
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.
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)
[0] If. Big if.
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.
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.
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."
There's a lot of hidden cost wrt bureaucracy and other such issues.
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.
Doesn't the government fund research grants with several billions each year?
> 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.
> 10/10 would abandon business ethics again.
News version: https://www.wsj.com/articles/antibiotic-makers-find-rewards-...
Free podcast: https://www.wsj.com/podcasts/the-journal/the-broken-business...
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 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 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.
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.
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.
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.
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.)
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.
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.
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.
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.
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.
> 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.
Hahaha, beautiful.
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.
If snake oil can kill Steve Jobs, don't think you and your loved ones are immune.
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.
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.
Again, you clearly have no understanding of what the FDA approval process actually entails.
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.
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.
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.
It seems like taxes could fund non-profits to be able to do this sort of research, and then pay for the vetting process and manufacturing.
It would probably save TONS of money, too.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
"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.
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.
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.
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?
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.
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.
Would you not agree with those two points of comparison?
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?
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.
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 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.
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.
But it's the second, and weaker, of the two arguments I made. The argument I develop in my first three paragraphs stands.
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.
I get the impression these companies aren't too concerned with the actual costs involved.
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.
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.
I wrote about it 11 years ago
http://magarshak.com/blog/?p=93
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.
Disclaimer: I am a left-libertarian
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.
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).
https://en.wikipedia.org/wiki/Doctrine_of_equivalents
And moreover, patented drugs are repurposed all the time and always by their original developers. Show me a counterexample!
Instead they change one atom on working drugs and extend patents another 17 years.
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.
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.
But consider all the other cases where open source software hasn't "won":
Photoshop v GIMP
Maya v Blender
Windows v Linux
MS Office v LibreOffice
IDA Pro v Ghidra
There doesn't seem to be a clear trend to me of open source software winning out over closed-source software, or vice versa.
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