If you have first-hand knowledge of the FDA’s torpor, get in touch
jakeseliger.com
jakeseliger.com
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.
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.
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.
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.
Due to lead's negative environmental and health impacts ( https://echa.europa.eu/hot-topics/lead ) it is regulated e.g. by REACH ( https://en.wikipedia.org/wiki/Registration,_Evaluation,_Auth... ) and the Toxic Substances Control Act of 1976 ( https://en.wikipedia.org/wiki/Toxic_Substances_Control_Act_o... ).
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.
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.
> 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?
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.
Even limiting it to dental amalgam, p-e-w says there is a lesson for future regulatory action. What is that lesson?
I don't recall the government ever said amalgam fillings should be removed, and the FDA now certainly says to leave them in: https://www.fda.gov/medical-devices/dental-devices/dental-am...
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.
https://www.bbc.com/future/article/20220321-what-happened-to...
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.
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 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.
They caused massive damage to the planet. And they continue to do so, the CFCs they emitted will be in the atmosphere for decades.
https://downloads.hindawi.com/journals/crj/1998/137198.pdf In 1991 metered inhalers were responsible for 1% of all CFCs. Since then production has gone down 30-fold https://i0.wp.com/research.csiro.au/acc/wp-content/uploads/s...
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.
I really think we are looking at a case of "corruption harms people" and not one of "unintended side effects should be looked upon".
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.
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.
"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.
Even generic drugs get 6 months exclusivity.
The FDA doesn't control what the patent office approves.
anyway.
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.
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).
There’s more information in the lawsuit here:
https://casefilingsalert.com/wp-content/uploads/2022/08/GSK-...
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.
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
3. jacked up the price to an extreme degree.
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.
If someone wants to make a generic, not only does the drug patent need to expire, but also the device patent.
But nothing stops a company from developing their own device. The issue is that it won't be a generic - it will be a new inhaler.
That's expensive to do.
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.
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.
On the issue of patent vs exclusivity https://www.fda.gov/drugs/development-approval-process-drugs...
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?
https://www.alldaychemist.com/
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).
Every new refrigerant we use now is basically extremely flammable or volatile
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.
Meanwhile, in Australia where I lived for several years, you could still go to a chemist and just buy an inhaler.
Someone please correct me if I'm wrong.
https://www.hhs.gov/sites/default/files/covid-19-unapproved-...
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.
They are not on the ballot because successfully getting attention when running for office requires huge amounts of money.
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...
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.
Correct me if I'm wrong, I might very well be.
https://www.cnn.com/2021/07/10/politics/aduhelm-alzheimers-d...
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.
For the other drugs, we have no clue how much FDA rules are raising the prices by. That’s scary.
It did exactly that, until the Bayh-Dole act in the 1980s.
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.
I wish this were true, however history paints a different picture
Although it is other way round: the world stopped trusting US certification.
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.
Colchicine does require a prescription in DACH.
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.
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.
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.
https://en.m.wikipedia.org/wiki/Replication_crisis
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.
[1] https://en.wikipedia.org/wiki/Miracle_Mineral_Supplement
[2] https://www.snopes.com/news/2022/08/02/us-literacy-rate/
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.
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!
> https://en.m.wikipedia.org/wiki/Replication_crisis
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.
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.
FUD as a policy is very powerful.
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.
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.
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.
Covid _related_ deaths. Big difference.
It was a big deal.
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.
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.
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
Scientific position statements:
ACOG (US): Abortion is an essential component of comprehensive, evidence-based health care. https://www.acog.org/clinical-information/policy-and-positio...
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...
WHO (International): Access to quality abortion care is a critical public health, equality and human rights issue. https://apps.who.int/iris/rest/bitstreams/1476856/retrieve
Recommend the full decriminalization of abortion.
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...
FIGO (International): Access to safe abortion is a human right and a critical component of the sexual and reproductive health and rights (SRHR) of women and girls. https://www.figo.org/resources/figo-statements/addressing-ba...
> 36 whole states
https://en.wikipedia.org/wiki/Abortion_law_in_the_United_Sta...
> and the world.
https://en.wikipedia.org/wiki/Abortion_law
> 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.
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.
> 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.
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.
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.
costs billions of dollars. that's the FDA's fault.
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.
Yeah, because it would cost them too much to get it approved. Which is the FDA's fault.
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.
> 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.
I am now fully convinced that the dentist lobby is keeping the caries vaccine from us.
Many, many dentists do this now, all it takes is the willingness to lie.
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.
Forget cavities though, brushing is great to get rid of film and grime and stench. I’ll keep brushing.
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.”
https://www.marketplace.org/2018/03/16/mouth-full-mint-clean...
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.
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.
0: https://www.thesaurus.com/browse/torpor
1: https://trends.google.com/trends/explore?q=torpor&date=now%2...
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).
(They "torporate"?)
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.
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.
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.
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.
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.
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.
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.
Even Canada allows over-the-counter CPAP/APAP sales.
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.
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.
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.
Thanks for reading. And for everyone, appreciate every day that you get.
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.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-r...
Cheers for proving the point, and I'm glad you didn't struggle getting off it it, like some.
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.
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 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?
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.
https://pubmed.ncbi.nlm.nih.gov/21507989/
https://www.gvsu.edu/cms4/asset/F51281F0-00AF-E25A-5BF632E8D...
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 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.
The puritan trend runs deep, though, eh? People must suffer. They must not have pain relief.
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.
I've interacted with a person from the pharmaceutical world who actually advertised this as their main selling point.
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?
The NIH got $45bn[0] in 2021. It's not exactly poorly funded.
Cancer research funding disbursed by NIH has gone from $5.4bn in 2015 on a yearly upward trend to $7.6bn in 2022. [1]
[0] https://www.nih.gov/ABOUT-NIH/WHAT-WE-DO/BUDGET
[1] https://report.nih.gov/funding/categorical-spending# (type "cancer" in the filter box, hit enter and then click on the Cancer row to get the aggregate)
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.
"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…”"
The FDA's "torpor" is easily overcome when incentives are aligned in that direction.
There's also the movie "Dark Waters" about DuPont and Teflon if you want to trust your government even less.
"ex post completely safe" is your head just completely in the sand about all the myocarditis that has been inflicted?
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.
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.
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.
Was the adolescent paralyzed by the drug or paralyzed while the drug trial was running?
Any illness, injury, or death during a trial, regardless of cause, is reported in the study results.
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.
I think the mistake being made was the FDA and vaccine companies trying to placate lunatics.
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 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.
https://en.m.wikipedia.org/wiki/Pandemrix
"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 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.
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
A KitFox (Kit or Factory built) runs from just $50k to $150k https://kitfoxaircraft.com/
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.
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.