There's a compelling state interest in preventing unintentional drug overdoses. There's less of a compelling state interest in preventing people from losing tens of dollars buying (at best) marginally useful cold medicine.
So why is the first ⅔ of this article so focused on the weaker case for regulation? It makes me doubt the author's commitment to liberal value of individual freedom! Instead, I fear he just dislikes drug makers and is shoehorning his ideas into an article for a liberal magazine.
The flippant "A pickier FDA doesn’t have to be a slower FDA. We can have abundance for clinical trials..." is really the kicker. I've seen clinical trials abundance ideas that try *not to relax* the current rules (just make them more objectively applied), but I've never seen a serious argument that claims we can make the already-famously-cautious FDA both "pickier" and faster/cheaper.
Great article—it’s wild how much people will pay for guaifenisin and phenylephrine when it is pretty clear they are ineffective.
Clinically I think disease burden is much higher with OTC sleeping medicine like Benadryl, ZZZquil, etc which are usually first gen antihistamines. These cause confusion, somnolence, and even delirium in the elderly. Many of my patients take them regularly.
And don’t get me started on caffeine pills, kratom, or MJ. Even if we don’t require prescriptions I think clear dose limits and warning labels could be helpful.
In addition to the fact that many of these brands used to contain pseudoephedrine, others contained drugs such phenylpropanolamine and dexbrompheniramine. When the FDA made phenylpropanolamine illegal, I suspect many people just kept buying the brand name drugs that used to work. Given that so many Americans still don't understand generics, I'm sure they don't read ingredients on these combo drugs, either.
The phenylephrine saga is indeed ridiculous, but this article omits an important detail: it is actually an effective *topical* decongestant, i.e. it works just fine in a nasal spray. Using it orally was never really indicated by any science-based reasoning.
There's got to be a keyhole solution here that removes the incentive to soft-defraud the normies while allowing biohackers, desperate sufferers (not necessarily terminal), etc a much broader Right To Try. Perhaps some combination of tougher disclosure requirements (if you haven't passed a strict effectiveness test you have to say so in big letters on the box) and an "accredited patient" status one could attain by demonstrating that one is better educated about medical tradeoffs than your average person and therefore should be allowed to take more risks, similar to how "accredited investors" can invest in weirder and riskier things than the general population.
This was great. A confounding variable is also the extent to which a brand, over the course of a person’s lifetime, can denote a widely differing array of active ingredients. Consumers, I think rightly, conceptualize e.g. “Sudafed” and “NyQuil” as discrete distinct things, and ought not to be expected to fine-parse the ratios that go into them over different points in time. I know I don’t!
(Methamphetamine should be legal – sell it in '(otherwise) banned goods' stores – and then let us buy pseudoephedrine NOT under surveillance.)
It's particularly pernicious to want to take a placebo of all things "off the market" – if it's really a placebo, then its users experience it working AND it's not actually harming them.
Sudafed is welcome to put phenylephrine on the homeopathy shelf with the other placebos. But the FDA should not be endorsing a manufacturer's false claims about what a drug can do
It seems like we agree that some 'drugs' are placebos and, e.g. I think the balance of evidence is that vitamin supplementation is unnecessary for almost everyone too – ALL the shelves are full of placebos.
The FDA should absolutely not endorse anyone's false claims, or likely/probably/maybe false claims, but that seems like it should (possibly) be distinct from 'taking something off the market'.
Dextromethorphan isn’t just a neutral “placebo” - you can trip on it if you want. (“Robo-tripping”, I think the kids used to call it, because it was in robitussin.)
Most of the other ingredients in robitussin would count as neutral placebos by this standard! No one is tripping on grape flavoring or purple food coloring, just DXM!
"In fact, this is explicitly how the FDA used to operate before Congress changed the standard in 1962."
The way we access information has changed a bit since 1962. Given those changes, don't you think that the way the FDA functioned in 1962 would actually be more appropriate in modern times than it was back then?
If you're so smart and such a careful reader, why aren't you carefully reading the label and then putting it back on the shelf and not buying Dayquil, since it's a scam product whose active ingredient can be received through other, cheaper means?
I don't know that seems like the most normal thing in the world to do when you're taking potentially lethal chemicals in your body. If i'm not doing it it's because i've been using the same formulation forever like say Dayquil that i could tell you exactly what's the same or different in generics.
Maybe this is one of those things I do that's actually totally weird it wouldn't shock me.
Honestly, dextromethorphan is one of my favorite placebos.
I always feel a little better.
There's a compelling state interest in preventing unintentional drug overdoses. There's less of a compelling state interest in preventing people from losing tens of dollars buying (at best) marginally useful cold medicine.
So why is the first ⅔ of this article so focused on the weaker case for regulation? It makes me doubt the author's commitment to liberal value of individual freedom! Instead, I fear he just dislikes drug makers and is shoehorning his ideas into an article for a liberal magazine.
The flippant "A pickier FDA doesn’t have to be a slower FDA. We can have abundance for clinical trials..." is really the kicker. I've seen clinical trials abundance ideas that try *not to relax* the current rules (just make them more objectively applied), but I've never seen a serious argument that claims we can make the already-famously-cautious FDA both "pickier" and faster/cheaper.
Great article—it’s wild how much people will pay for guaifenisin and phenylephrine when it is pretty clear they are ineffective.
Clinically I think disease burden is much higher with OTC sleeping medicine like Benadryl, ZZZquil, etc which are usually first gen antihistamines. These cause confusion, somnolence, and even delirium in the elderly. Many of my patients take them regularly.
And don’t get me started on caffeine pills, kratom, or MJ. Even if we don’t require prescriptions I think clear dose limits and warning labels could be helpful.
In addition to the fact that many of these brands used to contain pseudoephedrine, others contained drugs such phenylpropanolamine and dexbrompheniramine. When the FDA made phenylpropanolamine illegal, I suspect many people just kept buying the brand name drugs that used to work. Given that so many Americans still don't understand generics, I'm sure they don't read ingredients on these combo drugs, either.
The phenylephrine saga is indeed ridiculous, but this article omits an important detail: it is actually an effective *topical* decongestant, i.e. it works just fine in a nasal spray. Using it orally was never really indicated by any science-based reasoning.
There's got to be a keyhole solution here that removes the incentive to soft-defraud the normies while allowing biohackers, desperate sufferers (not necessarily terminal), etc a much broader Right To Try. Perhaps some combination of tougher disclosure requirements (if you haven't passed a strict effectiveness test you have to say so in big letters on the box) and an "accredited patient" status one could attain by demonstrating that one is better educated about medical tradeoffs than your average person and therefore should be allowed to take more risks, similar to how "accredited investors" can invest in weirder and riskier things than the general population.
This was great. A confounding variable is also the extent to which a brand, over the course of a person’s lifetime, can denote a widely differing array of active ingredients. Consumers, I think rightly, conceptualize e.g. “Sudafed” and “NyQuil” as discrete distinct things, and ought not to be expected to fine-parse the ratios that go into them over different points in time. I know I don’t!
Placebos should be legal!
(Methamphetamine should be legal – sell it in '(otherwise) banned goods' stores – and then let us buy pseudoephedrine NOT under surveillance.)
It's particularly pernicious to want to take a placebo of all things "off the market" – if it's really a placebo, then its users experience it working AND it's not actually harming them.
Sudafed is welcome to put phenylephrine on the homeopathy shelf with the other placebos. But the FDA should not be endorsing a manufacturer's false claims about what a drug can do
It seems like we agree that some 'drugs' are placebos and, e.g. I think the balance of evidence is that vitamin supplementation is unnecessary for almost everyone too – ALL the shelves are full of placebos.
The FDA should absolutely not endorse anyone's false claims, or likely/probably/maybe false claims, but that seems like it should (possibly) be distinct from 'taking something off the market'.
Dextromethorphan isn’t just a neutral “placebo” - you can trip on it if you want. (“Robo-tripping”, I think the kids used to call it, because it was in robitussin.)
Sure – but by that standard, nothing is a neutral placebo. Someone could kill themselves taking too much of a homeopathic solution in water.
Most of the other ingredients in robitussin would count as neutral placebos by this standard! No one is tripping on grape flavoring or purple food coloring, just DXM!
"In fact, this is explicitly how the FDA used to operate before Congress changed the standard in 1962."
The way we access information has changed a bit since 1962. Given those changes, don't you think that the way the FDA functioned in 1962 would actually be more appropriate in modern times than it was back then?
Expecting people to read the labels of drugs for tbe active ingredient is too much work really?
I don’t want to say anything mean but
It feels very nanny state. When I take my DayQuil I carefully check everything else for acetaminophen in particular. It’s not that big of an ask.
If you're so smart and such a careful reader, why aren't you carefully reading the label and then putting it back on the shelf and not buying Dayquil, since it's a scam product whose active ingredient can be received through other, cheaper means?
Because liquid DayQuil is magic when I have to work sick and you can just take my money and taste disgusting.
What percentage of people who have bought OTC medication in the US in the last year do you think do this? I would guess ~5%.
I don't know that seems like the most normal thing in the world to do when you're taking potentially lethal chemicals in your body. If i'm not doing it it's because i've been using the same formulation forever like say Dayquil that i could tell you exactly what's the same or different in generics.
Maybe this is one of those things I do that's actually totally weird it wouldn't shock me.
The potential is obvious, but is there any evidence that the combo drugs are more often causin overdoses than straight Tylenol?