Used to use CFC as the propellant. CFCs got banned. So, the FDA lets GSK _re-patent_ the same *medication* but just with a new propellant.
What propellant did they use? R-134a. The same HFA that everyone switched to after CFC was taken out of use for refigeration.
It wasn't even a novel change.
Inhalers went from $5 generics to $90 brand name only overnight. Of course, GSK also secured further patents that prevented things from primatine mist from existing at all. Disappeared from the market and primatine tablets were the only thing left.
Oh.. and R-134a is getting phased out again soon. Just in time for the GSK patents to be renewed, I guess. So, they're going to leave people who need a simple medication for breathing issues without anything on the market, _again_. I wonder if they'll even get the single year of "generic tease" again.
I didn’t really understand this comment so I dig into it a bit more. Here is my current understanding…
In the US to market a generic you need to show that it’s the same as an existing approved product currently on the market.
To avoid genetics being produced companies withdraw products where patent coverage has expired. They then release a new product which is substantially the same and has no or minor benefits, but is covered by patents.
Because the old product is no longer on the market, the FDA will not approve a generic. Even though the exact same product /was/ on the market.
This seems like a weird interaction between patents and the FDA rules which wouldn’t occur in the same way elsewhere (seems like the FDA rules kind of suck to me at first glance).
> In the US to market a generic you need to show that it’s the same as an existing approved product currently on the market.
On a related note, you don't need to show that it's actually the same, just that it's close enough. And that doesn't always work out for the best. An easy example being anticonvulsants. My younger brother died from an epileptic seizure and post-death examination determined the active ingredient of the anticonvulsant he was taking wasn't present in his blood. He had just been switched from brand-name to generic. Come to find out that this is/was a known issue that the FDA hadn't figured out how to solve. The generics aren't made using the same process and the end result isn't identical to the real drug.
This is something nobody knows how to solve. The best health agencies manage to do is prohibiting some manufacturing procedure after it was shown that things built with it are ineffective.
> Because the old product is no longer on the market, the FDA will not approve a generic. Even though the exact same product /was/ on the market.
This isn't the case, it doesn't need to still be on the market.
However if the approved product was produced with chemicals that are now banned (or the approved drug itself was banned) - then you _can't_ make a generic because you would have to use a banned chemical to do it.
---
Similar shenanigans to prevent generics include slightly modifying existing generics like ketamine for example, before getting it approved for depression treatment. You cannot patent ketamine for depression, so you can slightly modify it and patent that instead.
Because the old product is no longer on the market, the FDA will not approve a generic.
That's not a requirement to get a generic approved.
As long as a molecule has been approved before (through a New Drug Application), all follow-on drugs get approved through an ANDA (Abbreviated New Drug Application).
The real reason why inhalers are so hard to make generics for is that it's not just a drug - it's a delivery system, which is way more technologically complex than just producing a bunch of a chemical and putting it in pills.
Generic companies aren't interested in the investment. Having a factory make a ton of drug is cheap for the most part. You can put it in pills can cost a few cents per pill.
Investing in a new inhaler device is a major investment. Kind of similar to how generic injectable drugs is not as attractive - the investment is much higher.
The lawsuit implies that inhalers are a special case, where the normal FDA rules don’t apply. By adding new patents covering inhalers the manufacturer triggers FDA rules preventing the FDA from approving a generic, or so the lawsuit implies:
Because of the complexities of producing drug-device combinations like inhalers, the Food and Drug Administration employs a special set of regulatory requirements when approving generic inhalers.
Specifically, when a brand-name manufacturer lists a patent for a product with the Food and Drug Administration (FDA), the FDA is prohibited from approving the generic version of that product until the patent protection expires or is challenged and overturned.
> As long as a molecule has been approved before (through a New Drug Application), all follow-on drugs get approved through an ANDA (Abbreviated New Drug Application).
But there are shenanigans that can happen there. IIRC, to get a new generic approved, you have to demonstrate it's the same as the existing generics, which requires a supply of that drug. Years ago I read a company (it might have been one of Martin Shkreli's) that played a trick with that:
1. they manufactured a generic drug,
2. put extreme restrictions on its supply chain so no competitor could get ahold of enough of their product to do the equivalency testing, and
The CFC ban really threw the baby out with the bathwater.
We went from "let's put this stuff into every household item, and release it into the atmosphere by the billions of tons" to "nothing must ever contain CFCs ever again, including critical medical products that use only insignificant amounts".
Similar mistakes were made with asbestos and dental amalgam, where the panicked removal often released more contaminants than would have been during the item's entire lifetime otherwise, and the substitute materials were later found to have their own problems.
There's a big lesson in this for future regulatory action regarding environmental issues.
Interestingly this did not happen with lead. The regulations for that have significant exceptions for things like medical technology, aviation, military use, and equipment only used by trained professionals. And of course the one big massive hole: aviation fuel.
Lead is still everywhere: In fishing ballast, in curtains, in camera stands, ...
I used to love removing those little lead pellets from curtain weight ropes. It wouldn't have crossed my mind to so much as wash my hands afterwards. I've seen children chewing on fishing lead, and nobody seemed to even be aware there's a risk involved.
I mean, people used to ADD LEAD TO THEIR WINE(!!!) by the grams to give it that "heavy sweetness". Still, it took centuries for the population at large to notice that this might be a problem.
Nah, that's not how any of it works, you can stop fearmongering. Even if so, it's not lead but a material composed with lead atoms, just like how lead is used now in many alloys without danger. I don't understand the low key fearmongering.
>> And soon, every single piece of electronics will be lead apatite…
> Nah, that's not how any of it works, you can stop fearmongering. Even if so, it's not lead but a material composed with lead atoms, just like how lead is used now in many alloys without danger. I don't understand the low key fearmongering.
Nah, that's not fearmongering. That is plain reasoning within the context of a valid concerned discussion of lead.
Previous uses of lead, historically incorrectly assumed to be (using your words) "without danger", have been phased out for a long time (e.g. lead additives for car gasoline), or are being actively replaced (e.g. lead-based water pipes in homes). https://www.epa.gov/lead/learn-about-lead
LK-99, the possible superconductor implied in adastra22's lead apatite comment, is 74 percent lead by mass.
I up the ante: imagine lead-based superconductor technology becomes a mass market reality, and therefore lead would be used in everyday appliances such as electrical cables, floating toys etc.
Nobody wants bulk masses of lead landing in trash uncontrollably.
If your only concern is the lead landing in trash uncontrollably, you can solve it by just controlling the trash (we mostly do that already).
Lead has been phased out because of direct contamination and environment contamination. A chemically stable superconductor tape won't be a problem for either of those.
The manufacturing process will probably be much more of a problem, but again, it's a matter of solving that problem.
You are using the same logic as anti-vaxxers who point at the ingredients of vaccines and say "there's mercury in there, it MUST be bad for you!". Lead as part of a bigger molecule behaves differently from lead as a standalone metal.
Lead-containing compounds are toxic. In fact, as far as I'm aware, lead-containing compounds are the only toxic kinds of lead. Metallic lead is only hazardous because corrosion forms lead salts on its surface.
No longer with Aviation fuel. FAA allows unleaded AVgas now.
And it isn't a hole, it is needed for anti-knock. Most General Aviation (GA) Planes really do run on very basic carb systems (with magnetos!) and believe me, the Air Fuel (AF) mixture is a big deal when you are at 10,000 feet or so, especially when it is warm.
When it's cold it's easier to fly, and also less lead is needed AFAIK.
Not aviation fuel in general. Jet fuel does not contain lead. Only aviation GASOLINE for piston engines contains lead, and that can finally be phased out now that unleaded replacements are available for the whole fleet.
You write "nothing must ever contain CFCs ever again, including critical medical products that use only insignificant amounts" while Wikipedia at https://en.wikipedia.org/wiki/Montreal_Protocol writes:
> There were a few exceptions for "essential uses" where no acceptable substitutes were initially found (for example, in the past metered dose inhalers commonly used to treat asthma and chronic obstructive pulmonary disease were exempt) or Halon fire suppression systems used in submarines and aircraft (but not in general industry).
You write "and the substitute materials were later found to have their own problems."
Could you be more specific? I mean, there's no wonder material that has no problems. I don't think you mean that trivial observation, so do you mean the substitutes overall were more harmful than asbestos, across the full product cycle from mining to disposal?
And, does "the panicked removal" mean to include the use of unlicensed workers not following legal requirements for removal? As I recall, predatory contractors did take advantage of the situation, but then what's the lesson - that we need more government oversight of all building contract work?
Regarding "its on problems" I think patent commenter was primarily talking about amalgamated filings.
The scare is that amalgamated filings contained mercury. The thing is that they were bonded with silver which made them safe.
The thing is that some dentists are often removing them, to replace with other filings. The process exposes patient to mercury and the alternative filings often don't last as long as the amalgamated one.
https://en.wikipedia.org/wiki/Dental_amalgam_controversy makes it seem like much of the controversy came from people "using pseudoscience to scare patients into more lucrative treatment options", not the government. The major new regulations in the US seems to be installing filters at the dentists' to keep mercury waste out of the public sewer system.
I therefore don't see the lesson from regulating CFCs, nor from asbestos, nor from dental amalgam.
The big lesson is that CFC removal has been a massive win for humanity and that kind of categorical and decisive climate action is exactly what we need in the future!
We have sadly not applied the same ideas to asbestos. We definitely need to. And to many other terrible materials that poison us and our environment all the time (like PFAS).
This was not a mistake. It was a humanity saving decision. It's the blueprint to save us from the climate catastrophe.
> The big lesson is that CFC removal has been a massive win for humanity and that kind of categorical and decisive climate action is exactly what we need in the future!
That's one lesson. Another lesson is that when powerful people take such celebrated "decisive" action, less powerful people get trampled underfoot, in this case through potentially crippling medical costs.
> This was not a mistake. It was a humanity saving decision.
The phasing out of CFCs was not a mistake. The way it was implemented, however, contained many mistakes, some of which have negatively impacted many lives, as illustrated by the top-level comment.
The lesson has nothing to do with the CFC removal.
The problem isn't that CFC got removed. The problem is that a new patent got granted for an insignificant change. Why that change happened in the first place doesn't matter.
No, the CFCs in medical inhalers were of insignificant quantity and should not have been changed. The new propellants are equal-to-slightly-inferior, in my experience.
Had we done nothing, CFCs from inhalers would be something like 1/3rd of total emissions right now (simply because of the drop). But it's far worse. The world population is much higher now, and healthcare is much more accessible around the world. India, China, the Philippines, many countries with hundreds of millions of people can now prescribe them; they were never included in any 1991 numbers because their healthcare systems weren't that well developed back then. If you factor all of those people in, the majority of CFCs would be emitted by inhalers.
CFCs and Inhalers are a significant problem. No one deserves to get skin cancer because of CFCs.
You should blame manufacturers and the insane patent system, not the scientists working hard to keep the planet from dying.
The interesting thing is that most of the world kept the CFCs inhalers for many years. Immediately ceasing production so that people are thrown under the bus was a US thing.
I really think we are looking at a case of "corruption harms people" and not one of "unintended side effects should be looked upon".
We have sadly not applied the same ideas to asbestos. We definitely need to.
Removing asbestos causes its own problems and if not done correctly can cause more damage than just leaving it alone. Obviously we should never use asbestos as building material again, and when we run across it while renovating or demolishing a building, it should be dealt with correctly, but proactively going into buildings and ripping out asbestos that isn't being disturbed might not be the best way to go.
Asbestos is still everywhere, but whenever it's found (at least where I live), it's red alert and specialist cleanup crews suit up and come in to dispose of it safely. Most countries banned its use, but I just read that Russia still mines and uses it in construction.
Not my experience. It’s often removed by unlicensed handy men who don’t have any training or much awareness and who will tell you candidly that they think it’s not really dangerous anyway. At least that’s been my experience as a renter here in the bay area.
For some kinds, you really don't have to worry that much, e.g. removing asbestos-containing floor tile by prying up (vs. trying to grind it away) only requires that you double-bag it when you take it to the landfill, and there's a recommendation to wet it down to prevent dust, and to wear a mask.
But yeah also there's totally unlicensed folks ripping lagging off old boilers in a t-shirt. No worries, they usually filter it thru a cigarette.
Your comment creates a false appearance that FDA has anything to do with granting a patent. If you or anyone else has an issue about a patent being granted (assuming the rest of your comment is correct) then you should take it to the United States Patent and Trademark Office (USPTO) https://www.uspto.gov/.
They're like $6 each if you buy them from this pharmacy in India. $600 Advair inhalers are $30-ish. The website I linked doesn't even ask for a prescription.
I buy them by the dozens. I never run out anymore. (It's good to over order, as it takes 6-8 weeks for delivery to the US.)
Separately, note that there is supposedly a temporary worldwide albuterol inhaler production shortage, so maybe don't over order this quarter.
Note that almost none of the drugs offered at these shops are FDA-approved. The Indian ones are mostly produced in accordance with the regulations of the local Indian counterpart to the FDA (generically, the NRA of the country is CDSCO). Some of the Indian drugs are counterfeits though, not produced in accordance with CDSCO rules but falsely labeled as such.
The Chinese chemical distributors are even less stringent -- for those you absolutely should provide your own QA/QC by getting an HPLC/etc test done by an independent lab ($100 or so per compound tested).
I've been using Ventoline (the GSK brand name they use for Albuterol or Salbutamol depending on your location), to control my asthma for years. I used to use the variant with propellant but I switched of it to the one without. The main reason I switched was environmental concerns (https://www.bbc.com/news/health-50215011).
But after switching I find that for me, inhalers without propellant works just as well or better than the ones without.
Since the propellant seems to be the problem in this case. It could be worth checking if the generics or even the GSK non propellant ones, are cheaper than the other one in the USA?
"New drug exclusivity" is an FDA regulation separate from patents. Basically you get a minimum of 5 year exclusivity for new molecular entities, and you can add on another couple years if it's a rare disease.
Being an asthmatic American old enough to remember going to buy an albuterol inhaler sans prescription, thank you for bringing this up. But I think you mischaracterize it, based on my (possibly wrong) understanding: switching propellants made it a different drug. Which means prescription. Prescriptions aren't just used to limit access to dangerous substances, they're also used to grant monopolies on substances. So yes, the price went up nearly an order of magnitude, but the access was cut off. Because when the propellant formulation changed, even though the active ingredient was the same, a prescription was required in the US to acquire it.
Meanwhile, in Australia where I lived for several years, you could still go to a chemist and just buy an inhaler.
The Montreal Accords, a treaty signed by the US, banned CFCs. They had a clear exemption for inhalers, as long as they were necessary.
GSK invented a new delivery method. They patented this method. The existence of method made the Montreal Accords now ban CFC based inhalers.
The FDA approved the new method (makes sense).
It seems like you have an issue with the USPTO or maybe the diplomats who negotiated the Montreal Accords. The FDA wasn't stopping anyone from making generics. Although maybe once a product can no longer be legally sold it is also unapproved. It doesn't really matter which is the case, they weren't the driving force.
I get it for free on the NHS in Scotland. That said, ventolin inhalers are still cheap even after the propellant switch (which was in the mid 90's). Tangent, but I _despise_ the "easi-breathe" inhalers that my pharmacy gives to me (which are 10x the cost of the older ones). The feedback on the inhalation is shitty, the actual dispersion of the inhaler gets blocked, they use like 5x the plastic, and I've had to throw out most of the plastic shells before the actual inhaler is used because the little plastic tabs stop working.
I had a look at demonstration video for easi-breathe, I guess it might be useful for some people. But for me it looked most like a solution in search of a problem, and I would probably be livid if someone forced those one me.
You seem to be somewhat unhappy with the inhalers you are using, so something that you could look into is switching to ones that don't use propellant. I find that for me, they are nicer to use than the propellant ones. I initially switched for environmental concerns, but now I would be unhappy to switch back, even if they made a propellant one that was good for the environment.
Btw. anyone that wants to try without propellant and gets pushback, play the I care about the environment, and I want to try card. Most people will fold in the face of that argument.
Even the old Intal Spininhalers look easier and they made a nice whizzing sound as the impeller span, but they had to be cleaned regularly as the powder stuck to the moving parts.
The other think I note was the nasal inhalers worked well up to the mid 1990s then became painful. If you have a sore nose duue to hay fever the last thing you want to do in inhale water up your nose. The old inhalers I now guesses used CFCs and were nice to use. The suggestion by my grandmother for hayfever was to inhale salted water up the nose, I only tried that once - it hurt.
Those things are absolutely fucking useless. I've taken to just popping the top off to press the button down. Fortunately I don't need to use my inhaler more than once every few months but when I do need it it's incredibly frustrating.
I remember in the early aughts I could get a bottle of Colchicine for four bucks. Thanks to that walleyed expression of human avarice, the 2006 United States Unapproved Drugs Initiative, it became someone's IP and - presto! - went to sixty bucks. So, well, sorry, guess you just gotta grunt your way through a crippling weeklong gout attack. Thanks a bundle. Lord knows, it's good to be made safe from a pharmaceutical invented three thousand years ago from a goddamn flower.
The root problem is US taxpayers should be directly paying for these studies to prove and disprove medicines, but apparently, the budget for that is not politically possible, and instead we have politicians giving away monopoly rights so the burden of the study will fall mostly on afflicted people who need the medicine.
It is crazy how there is so much crowing about high medicine prices, when the US already has world class research in the form of higher education facilities, and it could just officially research and develop medicines and put them in the public domain.
In case you're not kidding though, no. A politician who pisses off big business in America loses even the support of their own party.
The media ignores them, smears them, then grinds them into dust to make an example of them. Their social media pages are de-ranked, and an army of bots highlights their weak points while attacking their strong points.
Their opponents in every election get funded just enough to win, however much that is; even elections against others in their own party.
And if they're still somehow successful after all that, there's other, darker things that can happen.
It's even more depressing than that. Those who are on ballots are there because they've gotten Corporate America's stamp of approval. The ones who don't have said approval never make it on the ballots, and in the extremely infrequent case that they do (see Bernie Sanders) , they are there so corporate friendly politicians and media outlets can mock them as a subtle reminder to the rest of the country that the corporations own the country and it's not worth stepping out of line.
The politicians you get to vote for are propelled there by their connections iwth big businesses. The corruption is complete and voters play no role in policy change
The thing is that more often than not, that's not really how it works. While outright bribery does happen ("we may have a job opening after your term that you might be suitable for wink wink, nudge nudge") this is the exception rather than the rule.
Most of the power from these organisations is just from having politicians attention and ears: if you constant hear viewpoint A from people you like and respect and rarely or never hear opposing viewpoints, then, well, don't be surprised if politicians lean towards viewpoint A. This is basically what "lobbying" is. The problem is that talking to democratically elected representatives is a basic right, and not something you can (or, IMHO, should) take away.
What we do need is better representation of the public interest and balance things better, somehow...
> US taxpayers should be directly paying for these studies to prove and disprove medicines
I think you are right people should pay for it? I could pay for it, but who would run the study? Are they going to be efficient? Or is it going to be a waste of money? Could EU pick this up? They are trying to be a bastion of science.
Is it going to be efficient taxpayers pay via increased Medicare and health insurance costs to market/lobby and pay for profits a private company needs to gamble that much on developing a medicine, that may not even be that effective?
Drug companies have the second or third highest profits and profit margins after tech companies. Sounds like a lot of “efficiency” could be gained by taxpayers taking the risk of R&D themselves.
The EU is not close to being a global bastion of science by any measure relative to the US or China afaik. EU doesnt come close in terms of funding nor papers published nor any other measure that I could think of.
> it could just officially research and develop medicines and put them in the public domain
I don't think that's true. At least not for rare diseases. There are thousands of them and they impact very small populations. The current cost to develop a drug and get it through trials is > 1 billion dollars.
An obvious improvement is to just be OK when another serious regulator approved the drug too. If, say Europe or Australia calls it safe and effective, and the market is small, then approve with their study.
> An obvious improvement is to just be OK when another serious regulator approved the drug too. If, say Europe or Australia calls it safe and effective, and the market is small, then approve with their study.
I wish this were true, however history paints a different picture
I know, it is not going to help you a bit, but I want to share how it works in Germany and many other European countries. I happen to sometimes consult on managerial stuff in pharmaceutical circles in Europe, but I'm not a medical professional by any stretch of imagination.
Anyhow, in Germany there is something loosely translated as "traditional remedies", which are basically phyto-pharmaceuticals known for generations. If they match a few criteria, esp. clinical efficacy (ie. empirical proof, this is not homeopathy we are talking about), those are written down in a "book of remedies". Once written down in this book, the remedy can be produced by anyone. Most of them may only be sold in pharmacies and sometimes they are so potent and dangerous that they require prescriptions (Colchicine is easy to overdose, but does not require a prescription). By virtue of being public, your pharmacist could mix them up (most do not do this anymore), or they can be produced as generics -- and they are.
This sometimes creates weird situations. For example, there is a common stomach remedy best known under the trademark name "Iberogast". The traditional remedy is a concoction of nine herbs and written down as such. Now, a few decades ago independent studies showed that three of these nine herbs are basically contra-effective and should be removed. Doing that, however, creates a new remedy, which is not recorded in the book and therefore may not be produced freely.
The main producer of Iberogast, Bayer, went to great length to create a new, improved formula, with clinical trials and all that jazz. Obviously, Bayer has the exclusive rights to this improved formula before it can be written into the book of remedies again. It is selling it under the name of "Iberogast Advanced". You probably should prefer this "advanced" version, but you can still go to your pharmacist and get a "classic" concoction mixed up, or buy one of the generics.
Can you just buy the six herbs and combine them yourself?
Under American law, such a traditional (or innovative) remedy can be produced and sold by anyone. It would be an unregulated supplement instead of a regulated medicine. The effect is that doctors can't prescribe it.
Doctors are still free to tell you that you might be interested in independently obtaining and taking a supplement.
And suddenly the capitalist "free markets!" and "let the market decide"! are gone in favor of protectionism. It's a weird dystopian world where corporations get to roam free on the one side, but get to protect their own interests at the detriment of competition and the average people.
Modern pharmaceutical financials are the equivalent of taking hostages one-by-one and letting them pay for their lives. There is a fantastic book by Marcia Angell that details this.
Yeah I have no desire to defend the FDA here but summarizing this as “I care about the dying while this government agency is only concerned with politics” does a massive disservice to the argument. It is political will that is responsible for the existence of the FDA and we live in a time of massive epistemological crisis specifically in the subset of the population of the US that votes. That and some subset are ideologically bent on dismantling regulatory bodies in general. Ignoring this reality probably jeopardizes any potential benefit of the FDA
> It is political will that is responsible for the existence of the FDA and we live in a time of massive epistemological crisis specifically in the subset of the population of the US that votes. That and some subset are ideologically bent on dismantling regulatory bodies in general. Ignoring this reality probably jeopardizes any potential benefit of the FDA
Can you please say this in english for people who aren't terminally caught up to politics du jour?
FDA is in drastic need of reform, ask anyone who deals with them directly (and is willing to be honest). That's not a political or ideological statement.
> Can you please say this in english for people who aren't terminally caught up to politics du jour?
Not OP but I believe they are referring to the fairly sizeable part of the voting population who believe that we need to deregulate everything and dismantle any agency that is responsible for regulations. That and the increasing distrust by the right of medical professionals and scientists makes for a dangerous combination.
People wouldn’t distrust “The Science” and all manner of government institutions if they weren’t so obviously corrupted. But like everything human, they are fallible:
I personally refuse to blindly accept anything. Science is a work in progress. “Professionals” started just like I started - as a novice. I don’t need to be told what to think.
You maybe not, but a sizable part of your population is literally dumb enough to drink bleach to "cure cancer" or whatever [1], and around half the US can barely read at 6th grade level [2].
The root problem is not that science and journalism have their issues, there is no such thing as a "perfect system". The root problem is that the American population is, at large, too incompetent to keep up with the rapid changes in modern life, and that there are a lot of malicious actors exploiting this.
> The root problem is that the American population is, at large, too incompetent to keep up with the rapid changes in modern life
Too incompetent by what definition? That presupposes that there's some level of competency that's mandated at-large. If you're dumb enough to believe drinking bleach will cure cancer, especially with the internet at your fingertips, you kinda deserve whatever consequences come from that. It's not yours, mine, or the government's job to prevent that.
Taken to its logical conclusion, this kind of thinking builds laws and societies catering to the lowest common denominator which is a preposterous suggestion. You hit the nail on the head in the sentence right before—there is no perfect system. But one that caters to the lowest possible subset of mental cognition is definitely not a step in the right direction.
The people do not need to be told what to believe.
> It's not yours, mine, or the government's job to prevent that.
That's where we disagree. A government's entire raison d' etre is to reasonably protect its citizens from harm, at least that's the conventional European ideal. And that includes keeping them safe from demagogues of all kind - I'm German, believe me if there's one thing we know it is just how much devastation it can bring in the end if left unchecked.
Americans see the world differently, but they haven't had a war on their home turf in like, what, 200 years (and haven't learned much of it either, given how absurdly popular Confederate flags seem to be). Here, we have people still alive who got shipped off to concentration camps in their youth!
> People wouldn’t distrust “The Science” and all manner of government institutions if they weren’t so obviously corrupted. But like everything human, they are fallible:
It's even worse than that "science" has been politicized in the general discourse into a code-word meaning "you must obey and respect our policy" or "my political opinions are objectively correct." I mean, "I believe in Science" is a literal political slogan meaning the latter, FFS.
You also occasionally have scientists who exploit their positions to give their non-scientific views unearned authority.
Though this is all probably a later stage of a progressing disease. Science was one of the last institutions to enjoy widespread respect, so of course short-sighted tacticians can't resist the temptation to draft it into political fights.
That's not why people distrust "The Science". At least in the US.
The reason some people distrust it, is because some politicians have figured out the best way to stay in power is to create wedge issues out of everything, blame the "rich" "elites" at these agencies for everything that's wrong in their constituents' lives and seed distrust about everything claiming they're the only people who can fix it.
I don't think so. I think the phrase "trust the science" has caused massive damage, and that's not been individual politicians. Repeatedly changing the story, and saying clearly unknown things as absolutes over and over, and collaborating with social media (and traditional media) to wipe out conversation about these things - that later change anyway - is what's done it. People in the US seem already slightly tilted away from authoritarianism. They're sensitive to this stuff.
It's not in a vacuum. In general, deceiving people, and then telling them that you did it to protect other people is not going to increase their trust.
Massive error in going with the "we lied to the public about masks in order to retain supply for healthcare workers" angle.
Looks like the new error is to imply that distrust in the face of this is anti-Science.
I’m sympathetic to the issue in OP, but the reality is that we all deal with their work (indirectly) every day and not being poisoned is going great for hundreds of millions of people.
Meanwhile the audible complaints from people dealing with them “directly” and evincing what you find “appropriately honest” amounts to a very biased sample. The acuity of the need for reform is far from settled, at least if we’re looking for an empirical basis.
Our last president went on live TV and said we should try cleaning people's lungs with bleach. The leading American news channel regularly aired anti-vaccine propaganda. People at protests were calling for the execution of officials at the CDC, FDA, and NIAID. Meanwhile the "deep state" saved lives.
If you aren't aware of those things, you are ignorant of some of the most important events in recent history. Covid-19 killed a million Americans, more than any war. Being clueless doesn't put you above the fray.
I disagree, it is not trivial to delineate the difference between direct death and related death. It's an important distinction. For example, the deaths in World War 2 jumps from ~53 million, up to ~80 million if we include "related" deaths (famine, etc). So, it is definitively not quibbling.
Also, I'm not sure why a million deaths makes this "some of the most important events in recent history".
If we're going by this mindset, then we have to agree that Roe v Wade is perhaps the one of the worst events in all of American history—contributing to more than 64 million American deaths (and still rising). I might highlight that's more than all of the deaths in World War 1 (~40 million), and more than all of the directly-related causes of death in World War 2 (~53 million).
IMO, COVID was _a deal_, but we've much bigger deals afoot and COVID is basically gone now.
For the purposes of discussing the impact of an event we generally refer to the "excess death" metric rather than "direct" or "related deaths" which are very challenging to define and determine, as you stated.
In this context, whether the death was directly due to COVID or a consequence of health strain/policy decisions/phobia delaying care is irrelevant to the overall impact of the virus on the population.
> For example, the deaths in World War 2 jumps from ~53 million, up to ~80 million if we include "related" deaths (famine, etc). So, it is definitively not quibbling.
I don't understand what you think this "definitively" demonstrates? Non-combat fatalities is absolutely relevant and should be included when discussing the impact of WWII on the world population.
The statement that WWII killed ~80 million people is valid and accurate.
> If we're going by this mindset, then we have to agree that Roe v Wade is perhaps the one of the worst events in all of American history—contributing to more than 64 million American deaths (and still rising).
I'm assuming you're referring to 64 million abortions suggesting you believe a fetus is considered a human being. This is not the view of the scientific community, 36/50 US states and the vast majority of the international community so no we don't have to agree on that.
> This is not the view of the scientific community, 36/50 US states and the vast majority of the international community
Unless you've got sources, I'm going to have to respectfully disbelieve that you somehow speak for the scientific community at large, 36 whole states, and the world.
Despite the morally-devoid echo chamber that many choose to live in, we've seen time and time again that social consensus doesn't mean anything when it comes to morality or truth.
I seem to recall at one point, owning human beings as slaves was both lawful and even considered morally necessary by many US states, and even the international community! Yet we can easily look back and realize that was a bitter mistake that has and will continue to affect generations to come. Not because we somehow "came to a consensus" that slavery was wrong, but because we finally acknowledged what was always true—slavery is wrong. Our consensus was just us coming to our senses.
I'll say it again, consensus means nothing when the subject is murder. The entire world agreeing does not, in any way, shape objective moral truth.
I can't tell if you're seriously asking me for sources that the scientific community stance on abortion is that it is a basic right, fetuses are not human beings and abortion is not murder.
I'll give you the benefit of the doubt that you've somehow not heard any scientific opinion on the matter despite how pervasive it is. Given how common knowledge this is I did not feel it necessary to provide sources.
> Unless you've got sources, I'm going to have to respectfully disbelieve that you somehow speak for the scientific community at large
SOGC (Canada): In an era where restrictions limit access to abortion in only a handful of jurisdictions globally, American women now have fewer reproductive health rights than their mothers and grandmothers did. As our neighbours south of our border face a dawning crisis in health care, the Society of Obstetricians and Gynaecologists of Canada (SOGC) stands firmly in support of reproductive choice and equitable access to safe, high-quality abortion care for all people in Canada and around the world.https://www.jogc.com/article/S1701-2163(22)00548-5/fulltext
RANZCOG (AUS + NZ): The College strongly supports the availability of abortion being an essential aspect of safe healthcare delivery, and stands with healthcare professionals across the world in protecting patients’ access to care.https://ranzcog.edu.au/news/ranzcog-statement-on-roe-v-wade-...
Royal College of Obstetric and Gynecologists (UK): Like nearly 90% of the country, we believe in a woman’s right to choose. No woman should be forced to continue a pregnancy against her will.https://www.rcog.org.uk/about-us/campaigning-and-opinions/po...
Decriminalization means removing abortion from all penal/criminal laws, not applying other criminal
offences (e.g. murder, manslaughter) to abortion, and ensuring there are no criminal penalties for having,
assisting with, providing information about, or providing abortion, for all relevant actors.https://apps.who.int/iris/bitstream/handle/10665/349316/9789...
> I'll say it again, consensus means nothing when the subject is murder.
Whether your moral or religious conviction leads you to believe that human life begins at conception and therefore that abortion is murder is your prerogative but this is your opinion and completely unsupported by science, evidence, or even regulation in the majority of locales on the planet.
Abortion as a basic human right endorsed by nearly every professional and scientific authority.
> The entire world agreeing does not, in any way, shape objective moral truth.
Objective moral truth as determined by who, you? I provided my sources, I welcome yours.
> Objective moral truth as determined by who, you? I provided my sources, I welcome yours.
I appreciate the good faith interpretation of my comment. Indeed I was not aware of the (seemingly) universal consensus on this topic within the scientific community. However, as I said earlier consensus does not in any way dictate morality.
Indeed I wish objective morality was determined by me, but that is not the case. By definition, it is self-evident and requiring no proof. I'd submit that the source of moral truth would be whatever has created that which is created. Though we may disagree on that, our opinions and disagreement don't change reality. (Ironically, I think we can both agree on that point).
Whether or not morality is universal does not change simply because one denies it. So again I say, the entire world coming together to congratulate itself on its "forward progress" by murdering the unborn, does not make it a good or moral thing.
I’m not trying to debate or convince you of the right to or morality of abortion. Going back to your original statement of:
> If we're going by this mindset, then we have to agree that Roe v Wade is perhaps the one of the worst events in all of American history
I strongly disagree with your original assertion that by applying the excess death metric to WWII or the pandemic we consequently have to agree on the applicability to abortion which is, as you have agreed, a morality discussion.
The question of whether abortion represents a tragic loss of human life is an entirely different discussion of morality for which I respect our differing views which need not be reconciled to resolve a debate on the most appropriate statistic to quantify the loss of human life during a pandemic or war as you stated in the original comment I replied to.
In fact, your usage of “unborn” obviates the debate. “Excess deaths” are derived from the population statistic and regardless of whether one believes a fetus has achieved moral personhood or whether abortion is murder we do not count an “unborn” person in the population or birth rate statistics prior to delivery (i.e. since inception the US has never counted a pregnant female as 2 people for census purposes) therefore abortion is not relevant to this statistical measure discussion.
Sure, I understand your point about not wanting to support the FDA, but simplifying the argument to "I care about saving lives while the FDA only cares about politics" oversimplifies things. The FDA exists because of political decisions, and we're currently facing a major crisis of knowledge, especially among certain groups of U.S. voters. Some of these groups are determined to break down regulatory agencies. Ignoring this situation could likely put any potential advantages of the FDA at risk.
So many HN commenters lament their employers, both private sector and non-profit universities or similar. Their bosses, the short term thinking, management issues - the complaints are never ending.
The regulatory bodies are an extreme - their employees can basically never be fired, they have arbitrary and capricious control, and their existence has no market test. Most regulatory institutions were created many decades ago. It’s not absurd to think they are ossified, bureaucratic, and purposefully ineffective - “damaging to society”.
If a startup company can be a mess, and a large established company a mess, why not a regulatory agency? Pointing the finger at them and saying they are bad should not be a partisan issue. We should all be highly suspicious of their power, their unelected authority, and the innate desire of humans towards power and vanity who are attracted to such institutions.
Since the 1970s Caries vaccine (https://en.wikipedia.org/wiki/Caries_vaccine) has been under development. Streptococcus mutans was modified in the 2000s to not produce acid (BCS3-L1) with the hope to end cavities, gingivitis, etc., but has seemingly disappeared maybe to reappear in 2033 when the patent expires. Hope to be able to stop brushing teeth before I die or at least still have some left to chew food.
I got pretty deep into bioglass a few weeks ago. It's a calcium sodium phosphosilicate that attaches to your teeth and eventually regrows into basically real bone. The mechanism of action is very interesting.
Recently I was eating some dried mulberries and I chewed a stone (it was hidden inside a cluster), rendering two of my teeth sensitive and probably damaged my enamel.
Using this for 2.5 months now, and my teeth are neither sensitive, nor I feel that damage anymore. I'll continue a couple of more tubes of this, and It'll be probably completely repaired.
From my read, it sounds more like a problem with GSK. They bought the company that produced it, limited the products it was in to just their Sensodyne line, and have not gone through the process to get it approved.
GSK is keeping you from getting the product you want.
That’s the estimated cost of developing a new drug and bringing it to market.
And GSK had ~$16 billion in _profit_ last year. It has been profitable for the past 15 years, usually in the $4b range.
They are choosing to not bring this product to market. They are also choosing to not allow another company bring it to market.
That is clearly the best business choice for them according to their accounting, but they aren’t limited in trying to do it.
"Safety costs too much. The fda should make the decisions based on what would be best for the billion dollar corporations!"
Or maybe they should have the US distribution rights seized and testing paid for and then the product profited on by tax payers instead of a private corporation? Win win for everyone but the billion $ corporation.
don't really see "fuck it, make us less safe so corporations can make more money" as rational policy.
And if you don't think drastically reducing the barriers to entry for products in to the us would make us less safe I'm certainly open to hearing how.
The current model works very well for the billion dollar corporations, largely because they're the only ones who can afford to follow the FDA requirements.
> And if you don't think drastically reducing the barriers to entry for products in to the us would make us less safe I'm certainly open to hearing how.
Most of the barriers to entry are more bureaucracy than safety, and the net effect is fewer medicines are available and those that are are more expensive. The greatest success story of the FDA is thalidomide, which killed or seriously injured around 100,000 worldwide over 50 years ago; meanwhile about 45,000 americans die every year from not being able to afford medical treatment, and that only accounts for medicines that made it through the approval process, not those where it wasn't economical to try.
Regulations suffocating progress is a real problem. It's why, aside from ASML and Spotify, the EU's tech industry has stagnated for 20 years.
The FDA should subsidize safety studies for drugs like this. This would actually make it more likely to get useful, functional drugs in the hands of Americans more quickly, ie the whole point of this article.
Its not the safety studies. I'm sure the safety studies were done in other countries so they can submit it in the US. But if the company claims some beneficial properties to your body then its considered a drug and they need to show efficacy. But if they didn't advertise Novamin as an active ingredient they could sell it in the US but then they can't claim the benefits of that ingredient. I'm not sure how in the EU they can claim benefits without trials.
Freon memory the issue they faced was the FDA not really having a path/category for them to be licensed under. It was a live bacteria “vaccine” with a mechanism of action that basically amounts to “out compete the bad bacteria and stick around forever in the human mouth because the other bacteria would have anyway” … which was a brilliant idea!
Between being early on the applied genetic manipulation tech wave, having a product that reproduces itself and sticks around forever (cue the FDAs concern meter rising) and at least in the eyes of the FDA not really fitting into any existing licensable food/drug categories they have established procedures for… the company stalled … and pivoted to selling some kind of water product I think.
Similar to excessive antibiotic use, the clean feeling may be harmful by disrupting the balance of one’s oral microbiome. The feeling of disgust for natural body odors and biofilms is a product of socialization, in the case of toothpaste the history of marketing is told by Charles Duhig below:
But Duhigg argues the brand might not have succeeded if it weren’t for Pepsodent’s unique ingredient list. The inventor “had decided to add a little bit of mint extract. Mint extract, as well as a couple of other ingredients that he added, are irritants. They cause our tongues and our gum to tingle.”
And the effect of that tingling? It told people that “the toothpaste was working,” said Duhigg, “even though it had nothing to do with how the toothpaste actually worked. And people began to equate that tingling feeling with good dental hygiene. And as a result they began to crave it.”
Maybe it’s my personal mouth biome but if I don’t brush once a day I wake up with a disgusting thick film along the back of my throat and tongue. I’m not ocd about oral health. I have great teeth. I don’t floss and brush once a day. I don’t wear fragrances etc.
I work in healthcare and I’ve smelled a lot of really not nice things, bad breathe can really really stink. It’s not a cultural thing it’s more like a “good lord, shut your mouth you smell like you have a pile of MRSA infected shit festival in your mouth”
I used to smoke and other things, I have terrible sense of smell except when it comes to festering wounds and/or shit, especially infected shit. I pick those up like a hound dog and I know when someone isn’t brushing pretty quickly.
I do believe that mint thing though, I’ve been experimenting with different flavors ginger and orange cream and etc (non minty) and I miss the minty feed back.
I once had an argument with a guy who thought that fluoride didn't work, because if it did dentists would tell you not to use it. After all, why would they undercut their own business? My counter-argument that dentists just want to help people was met with bemused skepticism, as was my speculation that they probably make more money from routine cleanings than from drilling cavities.
I am now fully convinced that the dentist lobby is keeping the caries vaccine from us.
This study seems to be saying that the risk of heart infection is what's limiting success in human trials. That seems a much more reasonable explanation.
Setting aside the pros or cons of fluoride from a dental perspective, it sure is incredibly convenient that a highly toxic industrial byproduct that was expensive to dispose of can now just be diluted down and dumped into municipal water systems and mouthwash.
People also claim that tax law is so complicated because accountants want more work. Actual accountants would prefer another hole in their head to more complex tax law. Same people claim the AMA is suppressing cures for cancer cause reasons.
This is somewhat true isn’t it? Doesn’t TurboTax lobby against automatic filing of taxes like we have in the UK? Most people in the UK do not submit tax returns at all, the appropriate amount of tax is simply withheld from their pay.
Dishonest dentists who want to make more money don't need actual cavities or disease to lie to you and convince you to spend thousands on procedures you don't need.
Many, many dentists do this now, all it takes is the willingness to lie.
the inventor of cotton candy was a dentist. The altruist/optimist in me hopes that he didn't do so just to create a revolving-door effect within the industry and that he legitimately wanted to create a treat, but the pessimist in me can't help but wonder..
Man I’d still brush my teeth even if the threat of cavities was removed in much the same way I shower even though I’d be fine if I didn’t. But I’d still take the vaccine too.
Tangentially, it is the first time hearing the world "torpor", I would understand even "lethargy" [0] which I don't think is that used in common speech (but more than "torpor" for sure).
The use of this word for this particle blog post is to say the least interesting [1] (I would at least use one of the many more popular synonyms). TBH I thought it was the name of a drug or some chemical substance :-p.
The FDA isn't merely a lazy, indifferent regulatory body suffering some sleepy malaise. The FDA is actively beholden to "special" interests and the decisions made by the FDA are a function of both these interests and its own mandate. Threading those needles is complex so processes at the FDA move slowly; it takes a lot coordination to safely and profitably answer to all the masters involved. "Safely," here, has nothing at all to do with medicine.
The correct word is "corruption," but using the correct word would immediately alienate the entire professional class to which Seliger hopes to appeal. Seliger understands this and has employed a friendlier word, implying nothing more terrifying than innocent dysfunction. Such is the lot of one that seeks to discuss the consequences of corruption with those that cannot tolerate the impuning of anything Government, with the possible exception of the DOD.
They are different concepts. Torpor essentially just means "slow and lazy", scientifically it refers to a down regulation of body temperature and/or metabolism, but doesn't reflect on the REASON for it.
Lethargy is slowness specifically caused by how you feel - fatigue, nausea, dizziness, sleepiness, that sort of thing.
Languid is a closer synonym to torpor, although it can actually refer to either meaning, essentially (slow OR tired).
First, this is incredibly sad and I feel for Jake. However, I suspect his plea and guarantee of anonymity will go unanswered. I don’t know Jake from a hole in the wall, and I suspect that’s the case for anyone in his target audience. So, there’s nothing to back a reasonable expectation that he would hold up his end of the bargain. In fact, if he’s about to die there’s little incentive for him to keep his guarantee.
I’m not saying he would break his promise, but it’s a risk. I think he would be much more likely to get someone to speak up if he worked with a reputable, professional journalist that has a history of protecting their sources.
I grieve for this man and his family and loved ones, and I don’t know that I’d have the fortitude to fight for anything in the circumstances he’s facing. But I’m not sure what the goal is here.
If there are experimental drugs that may be helpful, then I think any patient in his situation should have the ability to receive them if they want. But I don’t think that FDA should move faster on approving treatments for velocity’s sake alone.
In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world.
There is a system by which to do so called the Right to Try act, you need to have tried all approved alternatives first and be deemed ineligible to participate in the clinical trial for the investigational treatment.
From the first post of this story it was stated chemotherapy had not been tried yet or been rejected by the clinical trials at that time.
When no comparable or satisfactory approved alternative exists, patients may receive access to investigational treatments under the Expanded Access/compassionate use program.
Determination of whether chemotherapy is a satisfactory alternative is beyond my medical scope so I won’t comment, this is sub-subspecialist expert level knowledge. To my understanding though the Moderna trials are still in phase I (I.e. no data) whereas there is data on chemo and while is not great is something, so I suspect it might be but I have no experience in making this determination.
It’s unfortunate he’s in this position. It is important to keep in mind no system is perfect and some patients will always slip through the cracks (not making a professional judgement on this case) but significantly loosening regulations with investigational therapies may also harm more patients than are slipping through.
> In a perfect world with unlimited resources, I’m sure it would be possibly to quickly assess the efficacy and safety of every new compound. Obviously, as indicated by the continued existence of cancer, this is not that world
Even when you have hundred of millions of $ patient recruitment is the rate limiting step.
Just asking: If you had some chimerical target molecule in mind that you thought was worth trying to treat yourself with, how much would it cost to have it synthesized somewhere?
I am possibly not following your comment - I have no idea how much it would cost to have it synthesized. I would guess a pretty binary distribution between “surprisingly cheap” and “staggeringly expensive.”
Are you saying the point of the post is that he is soliciting evidence of unapproved compounds that the FDA is sitting on that might be useful to treat his condition, and if he can find out about them, he’ll have them synthesized? That’s pretty brilliant if so. If that was the message though, it completely eluded me.
I mean, I'm not saying he's doing that. But that's certainly what I would do. I made some inquiries at one point when I was living in eastern europe, through an American acquaintance who worked for a US drug company that sourced materials from labs there, about what exactly would be involved in taking a patent paper and having one of their subcontractors turn it into a drug. I got some interesting information that made it seem plausibly within reach for someone with a high 7-figure net worth (my plan was to get a price and crowd-source the cost from a network of people suffering from the same thing), but I didn't end up pursuing it. The molecule in question was fairly large and difficult to synthesize and purify, though.
Yeah, that’s a pretty genius idea. I’d be totally supportive of anyone who wanted to pursue something like that. I just don’t think that seeking treatment like that overlaps very much with the FDA’s role and mandate.
Not to say FDA doesn’t need to be reformed; it probably does. But I don’t think mindless sclerosis is what’s taking time to evaluate new drugs.
Okay, this is me thinking with my "I'm going to die, therefore money and propriety are no object" cap: Who gives a fuck what one agency chooses to bless or not bless, if you're going to die? Go where you can get treatment, even if you have to go into debt to do it. This is just one country, one agency. The information itself is available. If you're staying in American and railing against the FDA, while dying, you're not making the best use of your time.
We should proceed from the basic assumption that - with enough money - you can get any drug you want synthesized and professionally administered. Then, maybe, we should question why the FDA is slow to release them. It's a big world, and nothing is stopping anyone from experimenting on themselves, if they have the wherewithal to print what they want to inject.
I'm not saying this guy has the wherewithal. But it's not the FDA that's the problem as much as the 101 fake miracle cures cooked up by seductive pseudo-scientists that the FDA is constantly doing yeoman's service to dispel. Rather than rail against regulation, go somewhere unregulated. That's the beauty of living in a big, messed up world.
CPAP and APAP. Why the hell do I need a prescription for literally any of it at this point? Automatic-adjusting PAPs have been on the market for decades with no patient harm, and I shouldn't need to have to keep getting scripts for new masks.
Even Canada allows over-the-counter CPAP/APAP sales.
There is the example of the required lipids in parental nutrition not being approved causing baby deaths that could easily have been prevented. Eliezer Yudkowski writes about it extensively in Inadequate Equilibria, but some of it is also in https://www.lesswrong.com/posts/x5ASTMPKPowLKpLpZ/moloch-s-t.... It offers an explanation for why some issues that are easy to fix don't get fixed anyway.
Was listening to this podcast about netstates and FDA and just general regulations. The guest is clearly align against regulation at large but does raise several strong points about structural risks and abuses by the FDA. It's really long but lex is a great host
I don’t know anyone who’s informed disagrees that the FDA needs significant reform now. In fact the only good thing I can think of coming from the Trump era it would have been operation warp speed, which could have been the seed that started this reformation. But alas. Nope.
I am very interested in improving approval times, approval costs, and accelerating as much as possible and improving the current situation.
But having done one filing and read tons of filings and talking to others, I don't have many complaints with the current setup.
The closest I have to a complaint is the attitude of a single person who served on an approval committee who wrote advice to those making applications, and that person seemed to have little acceptance of their own role in the process, specifically the high cost of saying "no" unnecessarily.
As with any approval body, their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no". But the FDA, of all the approval bodies I have dealt with, such as IRBs, has managed the best in my experience.
My experience may not be representative though.
Edit: thinking again, I do have one request, pandemic related. I think the FDA should rely more heavily on artificial standards for evaluating diagnostic tests for infectious agents. A key bottleneck in Covid19 diagnostics was obtaining clinical samples to validate new tests, and allowing more validation is synthetic samples would have greatly expanded testing capacity more quickly.
> their decisions have huge penalty for incorrectly saying "yes" but zero penalty for incorrectly saying "no".
The FDA acting out this incentive scheme _is_ the problem.
The issue is the opportunity cost: "I default to no, because while that may cost millions of lives, I don't incur responsibility for their deaths."
The incentives should change to "I am responsible to take informed risks to maximize the wellbeing of the population." There is a literal death toll from their inaction, and it doesn't get counted in the equation. It's possible to design a system that takes that into account; that's what's being argued for.
I would agree that these sorts of agencies should take a proper risk/benefit analysis. And I would argue that the FDA is by far the best at taking this approach, despite lawmakers not yet officially making it their mandate. They have been responding to criticism over the past few decades.
It's not just the FDA. The EU's new MDR requires far more scrutiny on the part of the notified body, to the extent that the bodies are mostly deciding not to bother and ducking out of the medical device game.
There is an enormous backlog of things that are almost exclusively approvals of paperwork to demonstrate the process you followed was the process you wrote down.
The European Commission is likely going to keep extending out their MDR transition timeline indefinitely. That or allow thousands of devices to get taken off the market.
Really grateful to know you’re still with us. I really appreciated your last post on here, and it also made me want to cry. I lost both my parents to cancers and every person we lose is a tragedy that we should be willing to do much more to forestall.
Thanks for reading. And for everyone, appreciate every day that you get.
How about the other side, where the FDA allows things like Singulair/Montelukast to remain in the market despite plenty of evidence of widespread harm?
It's a destructive drug, and anyone given it without a medical background (and some with one!) would never guess the degree of side-effects it offers, because of the innocuous feelings toward the class of drug that it is.
It was initially marketed for anxiety, sleeplessness, and morning sickness over in Europe. This led to a massive amount of birth defects and newborn fatalities. Luckily the FDA did not approve it.
The FDA reviewer was early in her career and was essentially given thalidomide to look over as an "easy start", but luckily she had an interest in fetal development and refused to approve it until fetal interactions were shown to be safe. It resulted in a huge battle with the manufacturer which was only resolved by it being linked to birth defects in the rest of the world - after which they withdrew their application.
I actually just stopped my daily montelukast pill a few months ago. No side effects, I just hated having to take a daily. I was told - years ago - that it was practically benign. What am I missing?
As someone who has actually interacted with the FDA on numerous occasions, I've actually found them to be quite fair, scientifically driven and pretty proactive when it comes to enforcing their mandates of regulating the drug industry.
Sure there have been high profile instances of political interference, but that's the folks at the top, not your average FDA employee.
It’s an incredibly hard place to be, if they approve a drug that eventually is proceed to cause more harm than good, they’ll hang, if they don’t approve, there’s little consequence.
It’s the same problem of being lenient to criminals, if they do nothing and become good citizens that do not commit crime anymore, you gain nothing as a politician, if they commit a crime your career is over.
Given society itself doesn’t value the risks as they should be, why are we expecting the agents of society itself to behave in a manner that will harm them?
While you’re right technically that we don’t see direct repercussions on particular regulators, I think the sentiment itself is close enough to true, because what would probably happen if they ever did rush something to market that caused a bunch of problems is that everyone would suddenly scream for essentially, and return to the extreme conservatism that we are used to seeing from them today.
To put it another way, public outcry, which seems to only stem from bad approvals and not bad denials/delays, will probably always push hard on any version of the FDA causing them to reach an equilibrium point which ends up surprisingly far on the conservative side of the scale. This sucks and I don’t know what to do about it besides the stupid solution I wish for of just having a smart, benevolent, powerful, and incorruptible monarch in charge of everything.
>> It’s an incredibly hard place to be, if they approve a drug that eventually is proceed to cause more harm than good, they’ll hang,
Not really. Fentanyl should be a schedule 1 drug but instead we have people getting addicted and dying at crisis levels. And don't forget Vioxx which killed half a million people over 5 years.
So yes, it's a hard place to be but they will not hang when they get it wrong.
> Fentanyl should be a schedule 1 drug but instead we have people getting addicted and dying at crisis levels.
Fentanyl is already a Schedule 2 drug, and as someone who has had Fentanyl administered during (medical) operations, I think that's where it should remain.
Fentanyl should definitely be Schedule 2, like it is right now. It has a wide variety of accepted medical uses and can be used safely with medical supervision.
Look at the response to thalidomide in Europe. It caused a massive scandal and directly resulted into significant law changes in a significant number of countries.
I'm sympathetic, but it's far too easy to say "the FDA should move faster". The FDA moves at the speed of all of the other Western regulators.
What happens when you're seriously hurt by a treatment because the FDA moved too fast? Aren't you going to sue everyone involved? Aren't people going to be outraged and demand that everyone at the FDA gets fired. Do the people at the FDA want to be dragged in front of Congress?
How is your doctor going to feel when your experimental treatment kills you?
When someone dies while taking one of the drugs, even if it's unrelated to the drug, how far behind will development of that drug be? If the drug is suspected of causing serious harm they might never get to run trials, all because they gave it to people without any controls and any ability to tell if the drug is harmful or not. This can seriously set help for everyone behind.
One of the cornerstones of modern scientific ethics is that you cannot take advantage of people in a power imbalance. If a company can put something out there, and try to convince people who are desperate to take it, now you're just experimenting on people in a massive power imbalance. And of course the companies that will convince people to do this are those with the most amount of money, not with the most helpful product.
This isn't about risk tolerance. This is about building a long-term system that advances treatment for everyone.
Almost certainly nothing that we have would help the person in these desperate conditions. The FDA moving faster won't help.
If you really want to help, advocate for funding NSF and NIH. We barely spend anything on cancer research. That's what will make the difference.
What if a company wants to prey on desperate people who want to do everything to avoid dying, including paying boatloads of money for "experimental" drugs which are just plain old quackery?
> What if a company wants to prey on desperate people who want to do everything to avoid dying, including paying boatloads of money for "experimental" drugs
I've interacted with a person from the pharmaceutical world who actually advertised this as their main selling point.
Death isn't the only aspect to the FDA's consideration. Safety along with efficacy are key.
You don't want to give a patient, dying or otherwise, a drug which is going to cause harm. Remember, doctors provide comfort care at planned end of life which includes morphine pumps, etc. Even during the process of death, we want our loved ones to feel comfortable and safe.
Death isn't a single event. It is a process that takes days. Can you imagine giving your family member an untested medication only for them to die in complete agony?
One thing I'm seeing recently is the issue of peptides such as tirzepatide (brand name: "Mounajro". FDA approves it as a Type-2 Diabetes medication only, yet doctors were prescribing it for its dramatic effects on weight loss due to its appetite suppressant properties. I know doctors that are now refusing to prescribe it due to not wanting to get in trouble with either the FDA or DEA. The street price for this medication is $1,000 USD per month at most pharmacies in the United States today, which consists of four injections (once per week at 5mg per injection. The prohibitive cost of such a peptide naturally makes one look at labs overseas, which typically charge $1,000 USD per gram, equal to about four years of the peptide injections at 5mg per week dosage. It is sad that we have been forced to become our own pharmacists at home in order to get the drugs we need at reasonable pricing. This goes with all compounds, not just this example.
The FDA aren't mustache-twirling villains here. I'm pretty sure they're responding to public pressure; nobody cares about an invisible graveyard the same way as a visible one. Heck, we have people outraged about the emergency approval of a vaccine which saved millions of lives.
So maybe this effort will be successful by using the FDA as a foil, but ultimately we need to convince the public at large to change their/our attitudes.
I think that some people have a revealed preference that new treatments not make it to market because it would enrich the already wealthy, even if that means progress is slower.
The below is from Eliezer Yudkowski's book "Inadequate Equlibria."
"Some babies have digestion problems that require direct intravenous feeding. Long ago, somebody created a hospital formula for this intravenous feeding that matched the distribution of “fat,” “protein,” and “carbohydrate” in breast milk.
"Just like “protein” comes in different amino acids, some of which the body can’t make on its own and some of which it can, what early doctors used to think of as “fat” actually breaks down into metabolically distinct elements like short-chain triglycerides, medium-chain triglycerides, saturated fat, and omega-6, omega-9, and the famous “omega-3.” “Omega-3” is actually several different lipids in its own right; vegetable oils with “omega-3” usually just contain alpha-linolenic acids, which can only be inefficiently converted to ecosapentaenoic acids, which are then even more inefficiently converted to docosahexaenoic acids, which are the actual key structural components in the body. This conversion pathway is rate-limited by a process that also converts omega-6, so too much omega-6 can prevent you from processing ALA into DHA even if you’re getting ALA.
"So what happens if your infant nutrition was initially designed based on the concept of “fat” as a natural category, and all the “fat” in the mix comes from soybean oil?
"From a popular book by Jaminet and Jaminet:
> ""Some babies are born with “short bowel syndrome” and need to be given parenteral nutrition, or nutrition delivered intravenously directly to the blood, until their digestive tracts grow and heal. Since 1961, parenteral nutrition has used soybean oil as its source of fat. And for decades, babies on parenteral nutrition have suffered devastating liver and brain damage. The death rate on soybean oil is 30 percent by age four. In a clinical trial, of forty-two babies given fish oil [after they had already developed liver damage on soybean oil], three died and one required a liver transplant; of forty-nine given soybean oil, twelve died and six required a liver transplant. The death-or liver-transplant rate was reduced from 37 percent with soybean oil to 9 percent with fish oil."
"When Jaminet and Jaminet wrote the above, in 2012, there was a single hospital in the United States that could provide correctly formulated parenteral nutrition, namely the Boston Children’s Hospital; nowhere else. This formulation was illegal to sell across state lines.
"A few years after the Boston Children’s Hospital developed their formula—keeping in mind the heap of dead babies continuing to pile up in the meanwhile—there developed a shortage of “certified lipids” (FDA approved “fat” for adding to parenteral nutrition). For a year or two, the parenteral nutrition contained no fat at all which is worse and can kill adults. You see, although there’s nothing special about the soybean oil in parenteral nutrition, there was only one US manufacturer approved to add it, and that manufacturer left the market, so…
"As of 2015, the state of affairs was as follows: The FDA eventually solved the problem with the shortage of US-certified lipids, by… allowing US hospitals to import parenteral nutrition bags from Europe. And it only took them two years’ worth of dead patients to figure that out!
"As of 2016, if your baby has short bowel syndrome, and has already ended up with liver damage, and either you or your doctor is lucky enough to know what’s wrong and how to fix it, your doctor can apply for a special permit to use a non-FDA-approved substance for your child on an emergency basis. After this, you can buy Omegaven and hope that it cures your baby and that there isn’t too much permanent damage and that it’s not already too late.
"This is an improvement over the prior situation, where the non-poisonous formulation was illegal to sell across state lines under any circumstances, but it’s still not good by any stretch of the imagination. Now imagine trying to explain to a visitor from a relatively well-functioning world just why it is that your civilization has killed a bunch of babies and subjected other babies to pointless brain damage."
"“It’s not that we’re evil,” you say helplessly, “it’s that… well, you see, it’s not that anyone wanted to kill those babies, it’s just the way the System ended up, somehow…”"
"Torpor" can also take the form of failing to promptly disclose, or force the disclosure of detrimental effects. Ask the people whose hearing has been ruined by COVID vaccines.
The part I love is that since calls for violence are censored across most of the commercialized web, or heavily euphemized as - - - - € 'get the pitchforks' , when an arab spring-esque explosion finally happens a lotta people are going to be very surprised.
Something along the lines of "the people harmed by this government agency are being surprisingly civil"?
Nobody seems to be doing FDA offices like some people did police stations a couple summers ago. Which makes sense for any number of reasons, but I could see people thinking it doesn't.
Any parent who waited months and months and months after getting their own vaccine before they could vaccinate their own kids against COVID-19 has first-hand experience with this. If ever there was a time to be more slightly more innovative about the approval regime, a widespread active pandemic was it. The FDA failed completely on that dimension and millions of kids paid for it in various ways, especially for a vaccine which is ex post completely safe and even at the time was obviously safe.
Nothing is completely ‘safe’. Even too much water can cause hyponatremia.
The correct question is does the potential benefit outweigh the potential harm? For adults over the age of 40, the vaccine was a no-brainer. For very young children — where the risk was always very low — the question was more complicated.
The European Medicines Agency was even more cautious than the FDA in approving the Pfizer vaccine for 5-11 year olds. I haven’t been following the story recently so I don’t which European countries, if any, have approved the vaccines for children under the age of 5.
Actually, an adolescent subject was paralyzed by the Pfizer vaccine during the trials, and children were never at any serious risk from COVID (which it was clear at that point the vaccines did not prevent anyway), so the FDA's decision to authorize it in those age groups was reckless indeed. Fortunately a solid majority of parents made the correct choice at any rate.
"ex post completely safe" is your head just completely in the sand about all the myocarditis that has been inflicted?
Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to?
Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. If you’ve ever met kids, you know school is basically a series of viral infections constantly.
Not to mention the stress it caused to the schools and childcare and thus to the families because exposure notices were so constant, forcing kids home constantly.
> Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted.
Vaccinated kids did this too. "The pandemic," to the extent one ever really existed, was ended by Omicron being so infectious that even the "careful" ones were forced to face Covid and see that it wasn't really that bad, and that all their assiduous efforts to avoid infection were largely for nought anyway.
I got my first infection from my kids attending school during the Delta wave. We were fine (although I didn't just sit at home and do nothing which was what the treatment advice amounted to at the time). Much like school shooting drills, the stress that was caused by exposure notices, testing, and the like was all a problem of the overreaction in response to the underlying phenomenon, and not the phenomenon itself. Certainly none of it could have been reduced by a higher rate of vaccination, since the vaccines were thoroughly ineffective against transmission at that point.
> Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to?
I do dispute this, yes, given that a huge Israeli population study found no increased risk of myocarditis in Covid-recovered subjects in 2020 pre vaccines. I also dispute that the comparison would matter at all even if it were true, because the risks of myocarditis from the shots and from the virus are cumulative, not mutually exclusive, since the shots do not prevent Covid.
There is not some tidy choice to be made between mutually exclusive outcomes of "myo risk from the shots" and "myo risk from the virus." In every case where someone has developed heart issues after both vaccination and infection (including in a friend of mine who had 3 shots of Moderna), their doctors will invariably attribute it to the virus, and usually won't even report it as a potential side effect of the vaccine, so they seem to have zero confidence at all in vaccination's ability to reduce myocarditis risk from COVID infections.
> Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to?
I would dispute that in the context of young adolescents and children, as I do not think that is known at all. Global covid 19 myocarditis risk in the year after taking the vaccine is 0.02% and vaccine myocarditis risk for adolescents is 0.01%. If myocarditis risk is at all similar to other severe covid symptoms, then it is likely from these stats that there is higher myocarditis risk from the vaccine for young people than from the possibility of being infected with covid and getting myocarditis.
That said, not all myocarditis is created equal and my understanding is vaccine associated myocarditis is generally milder.
I don't have kids but watching my friends go through that was obnoxious. I remember a comment from someone in the vaccine industry. He said the number of vaccines that don't cause problems for adults but causes problems when given to children is zero. Worse the initial trials for children underdosed the vaccine.
I think the mistake being made was the FDA and vaccine companies trying to placate lunatics.
"At the end of March 2011, an MPA press release stated: 'Results from a Swedish registry based cohort study indicate a 4-fold increased risk of narcolepsy in children and adolescents below the age of 20 vaccinated with Pandemrix, compared to children of the same age that were not vaccinated.' The same study found no increased risk in adults who were vaccinated with Pandemrix"
The same does not apply to drugs in general. There are plenty of medications which are fine for grown adults but a big no-no for developing children.
The Covid vaccine was not just another generic influenza vaccine, it was the first-ever approved mRNA vaccine. It works in a completely novel way and although side effects in children were unlikely, there was simply not enough data to rule it out completely.
Sure, but given that there are adverse effects from pretty much all vaccines and covid is generally (ie. in the data not anecdotes) not really risky for children - you are potentially causing more risk from side effects than you are preventing.
This neglects the second order effects of who the children might infect, which imo is the real justification for covid vaccination of children who are not immune compromised.
The CDC itself had language on their website to the effect that Covid posed less risk than influenza to young children. Pre 2020 freakout, would we ever have approved an influenza vaccine using a novel delivery method on the basis of less than two years of testing in humans, and less than one year in the young cohort?
The FDA's "torpor" is easily overcome when incentives are aligned in that direction.
The FDA played a big role in the opioid crisis by permitting manufacturers to claim for years that the narcotics being prescribed were not habit forming. "Preventing deaths" is not necessarily the incentive they're responding to.
The government, through JCAHO, also helped create the opioid crisis, with their push for the healthcare system to treat pain as the "fifth vital sign". Note that while JCAHO is supposedly a non-profit, JCAHO accreditation is a requirement for receiving medicare and medicaid funding from the government, which makes it a pretty big stick to beat the healthcare system with. Of course, now that large amounts of patient harm are recognized as a result, the regulators and bureaucrats are extremely quick to dodge any responsibility, summarized well here with quotes from various JCAHO publications in the past:
The FAA, similarly, has effectively killed air transport save for the wealthy or the airlines. I look out my window everyday and it pains me greatly to see the skies empty. It’s hardly a hobby even these days to fly unless it’s in furtherance of a ticket to fill a job.
I live in a somewhat rural and generally peaceful area. In one direction, I am over twenty miles from one tiny airport that has only private pilots (mostly single engines). In a different direction I am about thirty miles from a bigger airport that has commercial flights as well as a very robust private flight club.
On most days that are at least semi-nice, the sky is filled with a near constant hum of these planes.
I’m all for more GA (and am on the path to my own pilot’s license), but I’m not sure I agree that empty skies are a bad thing.
I think he’s talking about general aviation which is … not in great shape, though the rumors of its demise are still overstated a bit.
The main thing that made general aviation a far less accessible proposition were the lawsuits against the manufacturers in the 70s and 80s, the crushing verdicts and the over engineered basic planes based on suits that had been lost. That’s why a new Cessna 172 is three-quarters of a million dollars.
If I have a particular complaint with the FAA, I don’t think the requirements for a third-class medical are terribly compatible with the modern view of good mental health and treatment. But I understand the box they’re in on this, and don’t have any bright ideas.
>The main thing that made general aviation a far less accessible proposition
Meh, where I live, what made general aviation inaccessible is the fact that boomers and geriatrics have filled basically every airfield parking lot with planes they are keeping indefinitely in storage.
The only ones using the planes are the guys able to pay for the private corp owned hangers
>That’s why a new Cessna 172 is three-quarters of a million dollars.
There are people bypassing this for "recreational" level flying by simply using the experimental labeling on planes
"“I am dying of squamous cell carcinoma, and the treatments that might save me are just out of reach:"
Sometimes I think its better to die, when you get off the treadmill, you may well see that life isnt good after all.
Thats why I'm all for euthanasia, I'd even propose a sort of turn up unannounced to the local incinerating crematorium, optionally leave a few beyond the grave messages, lethal injection and job done.
There's too many people selling hope in a variety of disguises.
Used to use CFC as the propellant. CFCs got banned. So, the FDA lets GSK _re-patent_ the same *medication* but just with a new propellant.
What propellant did they use? R-134a. The same HFA that everyone switched to after CFC was taken out of use for refigeration.
It wasn't even a novel change.
Inhalers went from $5 generics to $90 brand name only overnight. Of course, GSK also secured further patents that prevented things from primatine mist from existing at all. Disappeared from the market and primatine tablets were the only thing left.
Oh.. and R-134a is getting phased out again soon. Just in time for the GSK patents to be renewed, I guess. So, they're going to leave people who need a simple medication for breathing issues without anything on the market, _again_. I wonder if they'll even get the single year of "generic tease" again.