> If the risk of a device failure is roughly constant over time,
This is the critical assumption that sometimes does not hold with drugs. Lets take for example tobacco. If in group A we have 1000 people who smoke 1 pack a day for 1 year, and in group B we have 50 people who smoke 1 pack a day for 20 years, well, these two groups have the same 1000 person-years of exposure. But we aren't going to see the same number of adverse health outcomes in the two groups. We are going to see more adverse health outcomes in group B, because the harmful effects of tobacco build up over time. I think we should at least take seriously the risk that something similar happens with any new drug.
I believe this for short-term pharmaceuticals, but I'm not sure about long-term use. Would this method catch increased lung cancer rates from smoking for example? My impression is that only appears with use over the course of a decade or more, which wouldn't show up in trial data (?). I worry specifically that this could be an issue for semaglutide, though it seems like there are similar drugs like exenetide that have been on the market for over a decade so that does limit the risks over that timeframe.
I'm not sure I understand how you mean "unprecedented", here. Even if we focus purely on exposure to drugs or chemicals, surely DES, asbestos, lead, and arsenic all have effects (cancers, mostly) that can pop up decades after exposure, even without noticeable issues when exposed. DES, in particular, was given to women for decades before it was realized it caused cancer in adulthood to women exposed to it when their *mother* was taking it during pregnancy! That's a pretty nonlinear effect, and a famous precedent, right?
DES is not an example. The first DES daughters were so young that many of them weren't adults. And no, cancer doesn't just pop up out of nowhere. It never emerges as full-blown cancer even if that's when people tend to become aware of many types.
With DES, it's not clear to me why you don't think it's an example. In particular, "so young that many of them weren't adults" is a very mild disagreement, or even a mild agreement, given the claim I was making!
While these examples don't necessarily invalidate your larger points, which I'll paraphrase as "people are too afraid of long-term harms, and believe that most drug-takers will pay some price, because they misunderstand risk", I think they go some way to explaining why that is. These examples loom large in the minds of the public, since a single "chemicals bad for you, but you might not know for 10-20 years" story usually has lots of journalistic interest.
And the sun may explode tomorrow. That's also a non-linear risk. I know of no one who has a theory why that should happen, but we clearly don't know everything about the physics of stars yet.
The elephant in the room is currently our Covid vexine based upon mRNA technology. You have overlooked this in your commentary. Near as I can tell, there seems to be a parade of horribles being revealed wrt to its creation and use. Response?
Not in my interest to argue such points. I wastes my time. But thank you for the heads up. I no longer need to read your commentary wrt anything else. Unsubscribing is the most economical response to you. Time will prove you wrong.
You make a good point that fear of new medications is generally overstated - Thalidomide and DES not withstanding. But there certainly are drugs with cumulative ill effects that come from long term use - lithium which harms the kidneys and antipsychotics (especially first gen) that produce Tardive Dyskinesia, come to mind. Probably the most important issue is drug regulation is the approval of drugs (against placebo) that have little benefit over the placebo and certainly no benefit versus other cheaper drugs that are already available. Add to these sham "long acting" reformulations to extend patent rights and you have a drug industry that does not do itself proud most days.
Examples like lithium are beside the point. We can see that lithium has harms right away, making it unlike the risk profile that I've described in the article, where a drug just seemingly randomly flips from good to bad, where the safety signals crop up right away in many users, without warning.
As an aside, lithium is kept on the market in spite of its safety signals for much the same reason chemotherapy is–it works! And we don't have a comprehensive replacement yet.
"The same thing holds with people. If you expose billions of people to, say, a vaccine, then you can start gathering billions of person-years of data right away. If there’s a major risk from the vaccine, then you’ll probably know it very quickly because people vary in how they respond to it and you have so much data to work with."
Once a vaccine is given, there is no going back. If it is found that the vaccine kills people, the damage is done...there is no recourse. If a fan fails, you have a broken fan; if a vaccine kills, you have dead people.
> But somehow people believe otherwise. They have an undeservedly negative view of pharmaceuticals
The type of person consuming and spreading conspiracy hypothesis and mass hysteria about <popular pharma panic> is not likely the type to be swayed by anything so science-coded as a risk/benefit analysis and research.
Science is a weapon of The Establishment and all Establishment Organizations like the FDA consist entirely of card-carrying villains who's primary goal is to find ways to poison the general public and make health care prices as high as possible (/s bc Poe's law)
If corruption and greed were actually the primary reasons for high prices in American healthcare it would be much easier to fix than the real reasons. (Not saying corruption and greed don't exist, just that they aren't the primary problems)
The primary cause of inflated drug prices from my pov (as someone who works in the industry) is that many of the common practices are absurdly inefficient and companies are far too risk averse to innovate in impactful ways, even when better options already exist and are obviously beneficial.
I wrote a brief summary of anecdotal observations in the first post I published and I am working on compiling more in-depth industry-wide data for upcoming posts.
> If the risk of a device failure is roughly constant over time,
This is the critical assumption that sometimes does not hold with drugs. Lets take for example tobacco. If in group A we have 1000 people who smoke 1 pack a day for 1 year, and in group B we have 50 people who smoke 1 pack a day for 20 years, well, these two groups have the same 1000 person-years of exposure. But we aren't going to see the same number of adverse health outcomes in the two groups. We are going to see more adverse health outcomes in group B, because the harmful effects of tobacco build up over time. I think we should at least take seriously the risk that something similar happens with any new drug.
I believe this for short-term pharmaceuticals, but I'm not sure about long-term use. Would this method catch increased lung cancer rates from smoking for example? My impression is that only appears with use over the course of a decade or more, which wouldn't show up in trial data (?). I worry specifically that this could be an issue for semaglutide, though it seems like there are similar drugs like exenetide that have been on the market for over a decade so that does limit the risks over that timeframe.
The author ignores the fact that the risk over time of any given drug may be nonlinear
Whether you support the covid vax or not (thats why this article was written,) leaving this fact out is lying by omission
Nope! It's noted in the article as something to watch out for, but which is unprecedented.
And you've failed to pick out the motivating example for the article. Try to assume less and ask more.
I'm not sure I understand how you mean "unprecedented", here. Even if we focus purely on exposure to drugs or chemicals, surely DES, asbestos, lead, and arsenic all have effects (cancers, mostly) that can pop up decades after exposure, even without noticeable issues when exposed. DES, in particular, was given to women for decades before it was realized it caused cancer in adulthood to women exposed to it when their *mother* was taking it during pregnancy! That's a pretty nonlinear effect, and a famous precedent, right?
DES is not an example. The first DES daughters were so young that many of them weren't adults. And no, cancer doesn't just pop up out of nowhere. It never emerges as full-blown cancer even if that's when people tend to become aware of many types.
With DES, it's not clear to me why you don't think it's an example. In particular, "so young that many of them weren't adults" is a very mild disagreement, or even a mild agreement, given the claim I was making!
While these examples don't necessarily invalidate your larger points, which I'll paraphrase as "people are too afraid of long-term harms, and believe that most drug-takers will pay some price, because they misunderstand risk", I think they go some way to explaining why that is. These examples loom large in the minds of the public, since a single "chemicals bad for you, but you might not know for 10-20 years" story usually has lots of journalistic interest.
To clarify by being explicit: DES does not have known nonlinear risk, which is why I don't consider it an example.
And the sun may explode tomorrow. That's also a non-linear risk. I know of no one who has a theory why that should happen, but we clearly don't know everything about the physics of stars yet.
"And the sun may explode tomorrow. That's also a non-linear risk."
That is true, but there is no choice involved here. With a vaccine, one has a choice to accept or deny.
No insults in my comments section.
The elephant in the room is currently our Covid vexine based upon mRNA technology. You have overlooked this in your commentary. Near as I can tell, there seems to be a parade of horribles being revealed wrt to its creation and use. Response?
There's no "parade of horribles" to speak of. The COVID vaccines worked great.
Nonsense. Unless you are joking. In any event, your credibility is now in question.
Try to provide evidence for your claim.
Not in my interest to argue such points. I wastes my time. But thank you for the heads up. I no longer need to read your commentary wrt anything else. Unsubscribing is the most economical response to you. Time will prove you wrong.
Cool. I am reasonably certain you *cannot* argue your point here, but you are welcome to try.
If you're correct, I will of course update in your direction.
Many people who took the vaccine still got Covid.
You make a good point that fear of new medications is generally overstated - Thalidomide and DES not withstanding. But there certainly are drugs with cumulative ill effects that come from long term use - lithium which harms the kidneys and antipsychotics (especially first gen) that produce Tardive Dyskinesia, come to mind. Probably the most important issue is drug regulation is the approval of drugs (against placebo) that have little benefit over the placebo and certainly no benefit versus other cheaper drugs that are already available. Add to these sham "long acting" reformulations to extend patent rights and you have a drug industry that does not do itself proud most days.
Examples like lithium are beside the point. We can see that lithium has harms right away, making it unlike the risk profile that I've described in the article, where a drug just seemingly randomly flips from good to bad, where the safety signals crop up right away in many users, without warning.
As an aside, lithium is kept on the market in spite of its safety signals for much the same reason chemotherapy is–it works! And we don't have a comprehensive replacement yet.
"The same thing holds with people. If you expose billions of people to, say, a vaccine, then you can start gathering billions of person-years of data right away. If there’s a major risk from the vaccine, then you’ll probably know it very quickly because people vary in how they respond to it and you have so much data to work with."
Once a vaccine is given, there is no going back. If it is found that the vaccine kills people, the damage is done...there is no recourse. If a fan fails, you have a broken fan; if a vaccine kills, you have dead people.
> But somehow people believe otherwise. They have an undeservedly negative view of pharmaceuticals
The type of person consuming and spreading conspiracy hypothesis and mass hysteria about <popular pharma panic> is not likely the type to be swayed by anything so science-coded as a risk/benefit analysis and research.
Science is a weapon of The Establishment and all Establishment Organizations like the FDA consist entirely of card-carrying villains who's primary goal is to find ways to poison the general public and make health care prices as high as possible (/s bc Poe's law)
If corruption and greed were actually the primary reasons for high prices in American healthcare it would be much easier to fix than the real reasons. (Not saying corruption and greed don't exist, just that they aren't the primary problems)
The primary cause of inflated drug prices from my pov (as someone who works in the industry) is that many of the common practices are absurdly inefficient and companies are far too risk averse to innovate in impactful ways, even when better options already exist and are obviously beneficial.
I wrote a brief summary of anecdotal observations in the first post I published and I am working on compiling more in-depth industry-wide data for upcoming posts.
I see where you're going with this.