You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation.
There's a societal cost for lots of people injuring themselves, and offloading the responsibility of researching safety to the average consumer will cause fear and superstition, limiting people's willingness to try new products, and I would argue that that reduces innovation. Regulation in this area has been a net societal benefit.
Don't forget that marketing budgets for pharmaceuticals are also huge. The average person has no chance. The constant bombardment already means people go to their doctor asking for Rx by name even without understanding the medical need or if they're right for it. Now remove regulation... the warnings basically just blur into the background. Already we get so many warnings on prescriptions that they just turn into nothing because people become so habituated to them. It's identical to the paradox that is windows/browser security -- the more you warn, the more people just click through and ignore.
Yes, it’s possible to do this. You may be surprised to hear that the USA is one of only two countries on the entire planet which it’s even legal to advertise drugs. All others outlaw it completely.
Indeed, that was surprising to hear, and a quick google search found me many countries in Europe where advertising drugs is legal, within some restrictive framework.
Both of those links say that there's a total ban on advertising prescription drugs to consumers, which is more specific than what the parent said but still very broad.
I’m sorry, yes, I should have specified prescription drugs, as that is what I meant. In context, though, this was what was discussed by the grandparent post: “[…] people go to their doctor asking for Rx by name […]”.
Before 1997 it was impractical to advertise them, though. You couldn't mention both the name of the drug and what it was for in an ad without including the entire warning label text. The deregulation was another Clinton thing, and its main beneficiary was the SSRIs.
I believe that's still the case -- which is why we get all those commercials with happy people having family moments while a voice in the background quickly announces "if you have experience any of the following symptoms head to the ER immediately."
Not too many problems, that's in general exactly how it works today. FDA approvals are generally marketing approvals: what you're allowed to advertise your drug for and to who. Physicians can do more or less whatever they want in terms of prescribing things. (Drugs which aren't approved for marketing for anything yet are a little different, but can still be made available as an "investigational" drug, which is a much lower, primarily safety, bar.)
Don't forget that lobbying budgets for pharmaceuticals are also huge. I'd rather pharmaceuticals spend money to show me ads while I still get to make my own choices than spend money to buy laws that restrict my choices.
And people will also choose to eat potato chips, not exercise, smoke, and drink heavily. You can't protect people from themselves, and even if it was an ethical government job to do so, i.e. take away people's freedoms because the government says it knows better, like with marijuana (I am REALLY humoring you, if you can't tell), there is no practical argument either. How much do you think your high estimate of X% who get sick by their own incompetence (which of course goes down significantly when people realize that they shouldn't blindly trust everything in our markets -- that blind, oft-misguided trust is another side effect of the FDA/USDA) will be DWARFED by the percentage of people saved by life saving drugs that make it to market faster/would otherwise be blocked. Do you know how many people the FDA has sentenced to die directly by rejecting appeals from terminally ill patients to get access to experimental drugs/procedures? Not to mention the indirect damage of delaying medicinal progress...
You can't protect all people from themselves, but you can protect a lot of people from themselves.
If you look at smoking [1] in the US, smoking went from 42.4% in 1965 to 16.8% in 2014. Raising awareness, taxing cigarettes, outlawing advertising, warnings on packaging, these things work.
The same could be done with alcohol if society wanted. One of the reasons why it hasn't happened with alcohol is because alcohol is ingrained into our culture.
> by the percentage of people saved by life saving drugs that make it to market faster/would otherwise be blocked.
Do you have any estimates for this? Do you have estimates about how many people would die by allowing poorly-vetted drugs on the market?
> which of course goes down significantly when people realize that they shouldn't blindly trust everything in our markets
How would you suggest the average person go about evaluating a drug/treatment?
> sentenced to die directly by rejecting appeals from terminally ill patients to get access to experimental drugs/procedures
sentenced to die implies that experimental drugs/procedures would save them. Undoubtedly some could be saved, but I doubt it would be more than a small fraction.
Oddly, the people you're asking to implement this harm reduction plan are often making the same mistakes as those who would "benefit" from the regulations.
Government bureaucrats are not special or different from us regular folk. Why should we expect them to be?
All of your points are born of the flawed assumption that it is ethical to take away people's freedoms because you think you know better. Even if you DO know better and could PROVE it (which is never guaranteed in theory OR in practice -- see: FDA, USDA), I would never support coercive measures. It's about as moral and effective as outlawing suicide. The practical arguments are already lost. There were a lot of well-intentioned common folk and bureaucrats who think JUST LIKE YOU and tried something called Prohibition, and it didn't work. Same with the drug war.
True, there are always people who will do that. I try to eat very low-carb and it's helped my heath dramatically, but even I occasionally will have a burger or real pasta.
The issue is education. It's very difficult to tell what is healthy and what isn't. There is a lot of research coming out that shows us sugar and starches are very bad for us. The stress from those carbs can damage our arteries and is what allows cholesterol to build.
The industry has a vested interest in people not knowing/believing in that. Sugar and HF Corn Syrup is a massive industry. Soda companies have been losing money as people finally move away and now we start to see the tides change.
Regardless, we need good education about what is and isn't health. Otherwise people struggle with weight and just get frustrated and resolve themselves to eat unhealthy because nothing seems to help reduce their weight or cravings.
I agree, and the FDA and USDA basically have a monopoly on providing that education in the current system. They aren't doing so well. Scaling back as the original commenter suggested would still offer government-stamped peace of mind for some products, but for those that aren't approved/are still pending, there will be room for private reviewing organizations to step in, probably providing consumers with more diverse opinions.
Over-regulation prevents what we call in the software world "rapid iteration". It may take more time for the dust to settle, but eventually the best solutions naturally rise to the top by this method.
how many lives were lost due to over-regulation of fats instead of sugar? i stand by my belief that experimentation with 1000 different diets will prove the subset that works over time.
Meaning a single FDA approved over-the-counter drug is responsible for over 20 times as much liver failure as all dietary supplements. Some regulation may be beneficial but the current policies are clearly suboptimal.
Acetaminophen is a interesting example - it's a very (centuries) old drug that predates the regulatory framework we have today. Some scholars (see ref. 1 for some history) suggest that it would not be approved by today's FDA.
It's thus a poor selection if one wishes to discredit the FDA's efficacy; indeed, some other widely-used therapeutics (e.g., aspirin) came into use before drug efficacy was required for new drug approval.
At the same time, there are numerous examples of drugs either not approved by the FDA or withdrawn from the US market by the FDA. It's not clear how less regulation would achieve this type of nation-wide safety benefit.
I've been thinking recently about government regulations like this and about where it should end.
Why are we so sure that we can't trust people to make an educated decision about an experimental drug or any of the many other things we regulate, many of which only impact themselves and don't put the general public at risk in any way. Yet one of our most deeply held values is trusting them to make an educated decision about who should run the country. It's certainly not any less complex of a topic when you consider all of the policy areas that there are to evaluate politicians across.
You didn't show any evidence of the FDA being a net benefit. You only showed that the FDA probably could have reduced that specific type of liver injury by regulating those specific supplements. But the government is not magic, and the FDA almost certainly has also caused injuries by overly or erroneously regulating other things. I have no idea what the net effect is, but you certainly haven't shown it to be positive.
Sorry to reply so late. I think we would do well to separate concerns about recreational drugs from the FDA's regulation of pharmaceuticals. I totally agree that our regulation of marijuana (when compared to similar substances like cigarettes) has been problematic.
Are there examples of pharmaceuticals you were considering?
The issue with non-regulated dietary supplements may well be caused by the current state of regulation (this is strictly my own opinion/observation).
In the current state of things, we've grown accustomed to seeing warnings when the government thinks there is a potential danger with a particular FDA regulated drug. So perhaps the lack of warnings with supplements is giving people a false sense of security about the dietary supplements...ie, "if they were dangerous, surely there'd be a warning". If, as the parent comment suggests, the paradigm shifts so that the government's position is one of several factors to consider, perhaps then people would look at supplements with a greater degree of caution and suspicion. In other words, changing the paradigm may change people's behavior in terms of how they approach both drugs and supplements.
These kind of context-less banding about of figures always serve the point the bander is trying to make, and rarely the truth. It leaves out the fact, for example, that regulated medicine is responsible for the rest. If we exclude approved regulated alcohol, the liver damage caused by unregulated 'medicine' is almost noise.
> You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation.
I know this is an incredibly callous opinion but isn't this natural selection at work?
People even go further and knowingly partake of substances known to be harmful (cigarettes). We don't stop them from that, why should we stop them from consuming medication that hasn't yet been deemed safe?
Educating and providing support for those that need it I agree with but if people freely and knowingly choose to act in a self destructive manner with a sound mind, I'm not convinced it benefits society or themselves to forcibly preserve their life.
We as a society have decided that, generally, profiting from causing harm to others incentives bad things.
I don't want cough medicine that might stop my breathing, but heroin was regularly sold as just that before the FDA.
History has shown that without regulation the quality, efficacy, composition, safety and side-effect profile of drugs might stray from reality because of market incentives. The unfortunate truth is that sometimes it is more profitable if those five things are ignored and people get hurt or die. Hence, regulation.
> People even go further and knowingly partake of substances known to be harmful (cigarettes).
Tobacco products are heavily regulated. One could argue that because of lobbying and the amounts of wealth involved, that tobacco companies have been spared some of the stronger regulations they could have faced.
Murder is bad for society, as people who can benefit society through say their knowledge of medicine or physics aren't adept at self defence.
A similar argument could be made that people who aren't very good at taking care of themselves are valuable to society somehow and should be protected from idiotic self-harm but I believe a person's autonomy trumps society's interest in preserving whatever value they have.
> I don't want cough medicine that might stop my breathing, but heroin was regularly sold as just that before the FDA.
Heroin was sold as cough medicine that might stop your breathing? If it tells you you might die and you choose to ingest it, that's on you. If you choose to play Russian Roulette, nobody's stopping you.
In case it wasn't sold with a warning that it might stop your breathing, you could have chosen to verify that it did what you expected before ingesting it. The modern FDA could also warn of the dangers without forbidding the sale of the substance.
> Tobacco products are heavily regulated.
They may be regulated but any adult can still choose to partake of however much they like regardless of the damage to their health.
I actually agree with you. I believe all drugs, including the illegal ones, should be made accessible if I want them. Now, having said that, everyone else has great arguments, and these things can not go unregulated. I'll want officially sanctioned reviews, warnings, I want labels to be truthful, I want legitimate access to accurate and quality information, I need more then known side effects, I need propbability of each one, I need to know the amount and quality of the studies that have shown efficacy and effect, etc.
I think cigarettes is actually a pretty good example of regulation that's not restrictive. I don't want to deregulate to enable business to sell more crap for higher prices with disinformation and attractive pitches. I want deregulation so that I am free to use any drug I would decide to use for myself. Granted, I would need to be guaranteed access to the correct information. Even today, there's not enough regulation around package labels. A lot of products don't mention important facts about them, or are allowed to lie on certain facts.
> Heroin was sold as cough medicine that might stop your breathing? If it tells you you might die and you choose to ingest it, that's on you. If you choose to play Russian Roulette, nobody's stopping you.
Yes, heroin was sold as children's cough medicine by Bayer [1]. It stops coughing because it slows breathing. Take enough and you stop breathing, then die. This how 30k+ Americans die from (non-)prescription opioid overdoses each year.
No, it did not indicate that it could harm or kill you. Why? Because regulations didn't exist that mandated purchasers were informed of all potential side-effects. Regulations didn't exist that mandated testing to determine those side-effects or the safety profile.
> In case it wasn't sold with a warning that it might stop your breathing, you could have chosen to verify that it did what you expected before ingesting it.
It does exactly what it says: stops coughing. You might be able to take 10 bottles over time, but the next time you dose from the 11th bottle, you don't wake up. It could be a multitude of reasons: lack of quality assurance means different batches have different concentrations of the active ingredient, your tolerance for heroin lowered after disuse and you take the same dose you're used to taking and die, what's in the bottle isn't the product you thought it was or you happened to have a drink of alcohol before taking it and overdose from a normal dose. These are the same problems heroin users face in the unregulated black market for drugs. How does "verifying that it did what you expected" help in any of those cases? Why offload the responsibility to ensure a product's safety, side-effect profile and drug interactions on the user when it could just as easily be done at the source by knowledged professionals and save laymen lives from being needlessly ruined?
How does one verify the medicine they bought does what they expected and not give them cancer in a couple of years?
Also, this is a children's medicine. They aren't consenting adults. How can you suggest in good faith that a child verifies the medicine they're given by a doctor, parent, nanny, babysitter, teacher or friend does exactly what it should? What if they're old enough to buy it themselves, but still a minor with underdeveloped decision making processes? What if the child finds the medication? Child proof packaging and bottling exist because of regulation.
But here's the thing:
> History has shown that without regulation the quality, efficacy, composition, safety and side-effect profile of drugs might stray from reality because of market incentives. The unfortunate truth is that sometimes it is more profitable if those five things are ignored and people get hurt or die. Hence, regulation.
With or without regulation, you will have a market of desperate people who need treatment so that they don't end up in pain, injured or dead. Snake oil salesmen took advantage of this. The world doesn't need a Pfizer that, instead of making the investment to develop drugs that treat diseases, pushes a variety of unproven harmful cures because it is immediately profitable to do so. Before you say the market will ensure that drugs are safe, effective, etc: this wasn't the case at all until the FDA. The market didn't incentivize these things and we all suffered for it.
Later we got dextromethorphan: technically an opioid and morphine derivative, like heroin, that suppresses a cough but doesn't completely stop breathing at any dose.
Heroin is cheaper to produce. The market would decide that a certain number of dead children are acceptable because people will buy the cheaper, deadlier medication. Unknowingly, because they lack the necessary information to make an informed decision due to the lack of regulation. The type of information needed for a market to function.
They might not even have the option of purchasing DXM, as it was developed by the government as an non-addictive alternative to codeine. Years later it was brought to market as an antitussive because the market was lacking cough suppressants. The market was lacking because the FDA banned morphine and heroin as OTC cough suppressants.
>They may be regulated but any adult can still choose to partake of however much they like regardless of the damage to their health.
Anyone that purchases cigarettes in America is not purchasing the cigarettes Philip Morris et al want to be selling in their ideal world. Cigarette composition, manufacturing, marketing and price are all heavily regulated by decades of legislation in response to more toxic, addictive cigarettes being introduced and the advertising campaigns behind them.
Without regulation, cigarettes would be more toxic and deadly; and they would cause more damage to someone's health.
RESULTS: DILI was caused by a single prescription
medication in 73% of the cases, by dietary supplements
in 9%, and by multiple agents in 18%. More than 100
different agents were associated with DILI;
antimicrobials (45.5%) and central nervous system
agents (15%) were the most common.
CONCLUSIONS: DILI is caused by a wide array of medications,
herbal supplements, and dietary supplements. Antibiotics are
the single largest class of agents that cause DILI.
So FDA approved drugs cause 73% of these liver injuries, while unregulated supplements cause 9%. I don't understand how that is an argument for FDA regulation?
https://www.ncbi.nlm.nih.gov/pubmed/18955056
You have a theory that the average person will wisely assume the responsibility to vet the health effects of what they consume, but empirical reality disagrees with your theory. Right now people are injuring themselves with products at the margin of regulation.
There's a societal cost for lots of people injuring themselves, and offloading the responsibility of researching safety to the average consumer will cause fear and superstition, limiting people's willingness to try new products, and I would argue that that reduces innovation. Regulation in this area has been a net societal benefit.