Wouldn't it be nice if there were more government warnings and less restrictions / regulations?
Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials. Consumers could then take the government's recommendations into consideration when making a decision and drugs could get to market much faster.
The history of medical reversals -- and in this case, nutrition reversal -- shows that the government isn't magic.
A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves.
Imagine the history of the past few decades if the state had outlawed any foods with more than X% cholesterol. Or trans-fats. Or any of the other food fads over that time. It would have been terrible, especially now that the recommendation is reversed. The whole time, consumers were allowed to factor government warnings into their decisions, but food producers weren't breaking the law by selling foods with (X+1)% cholesterol.
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?
The science behind nutrition health is extremely complicated and expecting it to remain constant represent a total misunderstanding of how nutrition research is done and how results are determined.
> The history of medical reversals -- and in this case, nutrition reversal -- shows that the government isn't magic.
What it shows is that nutrition science is hardly 'solved' and you'd be hard pressed to find a researcher in the field suggest otherwise.
> A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves.
The problem with this is that the average consumer is both A) dumb, and B) doesn't know what they need. Alternative medicine skirts very cleanly around FDA regulation by not making any medical claims on it's product. They still market their product as a solution for various diseases and conditions, but they never make a formal claim. It's a $30,000,000,000 industry of people buying stuff that does nothing, or worse yet, can cause potential harm. To suggest their is no value in regulation of the drug markets is to suggest that people's health has no value. The defense of, 'well, people are responsible for their own decisions' doesn't hold any water when we know that the direct consequences of that mentality can be measured in literally tens of billions of dollars.
Federal regulators are not in any way the consumer in this line of discussion, so your comment is a non sequitur. Doctors are not expected to regulate the drug industry, federal regulators are. Please read the comment I was responding to.
Also note that the proposed (and current) alternative is for these consumers to vote for politicians who will make these scientific decisions for them.
The problem with this is that the average consumer is both A) dumb, and B) doesn't know what they need.
Unfortunately, a significant number of bureaucrats and statists would prefer consumers to be dumb (or at least say that they are) in order to maintain power.
Oh and let me guess, you're not one of the dumb ones....it's the other guys right? ;)
For nearly all the products I buy, I'm definitely 'dumb'. I have a narrow expertise that gives me insight into a narrow set of consumer products where I can effectively evaluate product quality and value. For nearly everything else, I'm 'dumb'.
If you show me a rack of food product, I probably can't identify which is the best for a particular person given a set of goals. I probably can't even tell you which ones are 'bad' or 'good', because I don't really know. While food is but one subject, this applies to nearly everything I purchase. Which plastics are the best for a given task? What ingredients in a shampoo would actually give me results I want? What kind of bed or bedding is the best for my comfort? To all these questions: I have no idea. I'm at the mercy of google or a salesman, the latter which has a different motive than me which immediately calls that in to suspicion.
I'd be a fool to say I'm an all-knowing consumer, but so would anyone. Most people don't know what the need. They know what problem they want to solve, but they have no idea what the best product or solution is to solve said problem. Acknowledging this, we can easily see why when it comes to our health, it's probably best to see some regulation lest people do what they do best: make really dumb choices.
Do you just blindly take whatever the doctor prescribes to you without doing your own research? How do you know your doctor is an expert? I'm pretty sure my doctor is not an expert in lots of things pertaining to medicine. He's not studying all the new research. That doesn't mean I can't have a conversation with him, but it's healthy to be skeptical of doctors too...that's why we get second opinions.
I don't have a huge problem with the FDA, but I'd rather have a number of choices of where to get information, and at the end of the day make my own choice on what to consume.
Also if people are so stupid like the OP suggested why not ban a whole plethora of foods like Twinkies, potato chips, soda, etc..?
"Do you blindly take whatever the doctor prescribes to you without doing your own research?"
Yes, and the more serious or painful the issue is, the more likely I am to blindly take the stuff. I'm simply not rational: I know this happens to a few other people as well, who all have migraines. Some folks willingly admit that when the migraine gets bad enough, it really doesn't matter if they overdose on pain medication because that would make the pain stop: I was similar with my gall bladder pain. Didn't care what they shot into my veins, so long as I stopped dropping to the floor in pain.
"if people are so stupid like the OP suggested, why not ban a while plethora of foods like twinkies, potato chips, soda, etc?"
We have to an extent: A lot of schools have taken such snacks out, for example, and some have tried to stop folks on welfare from buying any of it. And we tax it. But the real reason we don't do that is because food carries its own risks that aren't nearly as instantly deadly as drugs.
The main exception is new food products, colorants, and flavors. Now, I'm a little fuzzy on the actual regulation, but there are approved and non-approved things to use for food, and I was thinking you had to prove it generally safe for humans. I could be wrong on this bit, however.
> Do you just blindly take whatever the doctor prescribes to you without doing your own research?
Yes. I'm do not have a medical background and at best, I could gain a surface-level understanding of the drug, which is not useful to determine which drug(s) are best for me.
> How do you know your doctor is an expert?
They went to 10 years of school and several years of residency to do doctor things. These things are also regulated by several boards which have the power to revoke medical licenses if doctors suck.
Basically, yeah. As a general rule, the bigger the change you want to make to existing practice, the better your model for that domain needs to be. (I call that the "if it ain't broke" heuristic.)
Changing the composition of an entire nation's schoolchildren's food supply ... should require something like skyscraper-failure-prediction accuracy.
It's no defense that "science learns and revises". If the learning and revising is still that big, you don't have a basis for telling others to do it your way.
(IMHO, this is, at root, the same mentality as "fake it till you make it" / "all self doubt must be Impostor Syndrome and never an accurate assessment".)
Only through people's incorrect interpretation of reality.
>nutrition science is hardly 'solved' and you'd be hard pressed to find a researcher in the field suggest otherwise.
You'd be hard pressed to find a climate scientist not in agreement with the consensus on climate change, at least one that isn't already promoting book deals on Fox.
That's not at all true, and that level of ignorance is actually quite dangerous.
Scientists in no field are punished for disagreement. Even in really fringe science, disagreement is not only well-funded, but encouraged. A great example is String Theory: It has a lot of supporters and a lot of people saying it's untestable bunk, but research for both sides continues.. Consensuses happen when there is sufficient data to collapse to a consensus, not because 'funding'. Disagreements are extremely common in research and suggesting that the overwhelming consensus on the state of climate change is somehow a conspiracy or due to research pressures (that don't seem to exist anywhere else...) is complete garbage.
Are your a scientist? You seem very naive about the scientific world.
If you haven't experienced the cut throat nature of science or the immensely aggressive politics you may need to reassess your rose colored view.
The mantra, is your haven't heard it, is publish or perish.
Disagreement is well funded? What are your talking about? Good data is well funded. Doesn't matter how much you disagree, if the data is missing or bad you get no money.
Nope, that's not how it works. Do you work in the science community? Many fields of science and engineering are gradually being eaten by politics. Going against progressive politics is dangerous for the career of any academic scientist in the US. This isn't a huge issue (yet) for math or hard physics. It's hard to politicize those fields (not for lack of trying; I could go on a very long rant about how non-scientists are trying to make scientific fields conform to their political expectations), but for other fields like environmental science (which, by the way, is only weakly scientific in the sense that it does not follow good practices for having high predictive power, so it's relatively easy to manipulate) political concerns are very powerful.
This is a bit rambly, but the gist of it is that it's naive to pretend that many nominally scientific fields are actually entirely objective and free from politics.
String theory doesn't, as far as I know, have significant government policy implications, so I wouldn't expect heterodoxy to be stigmatized as much as in climate science.
Yes! We could replace those flawed and lobbied against restrictions with advice. The market would be free once again to innovate.
Bayer could once again offer Heroin as an addiction free drug. We could get long missed radium cures and snake oil. They could be free to advertise to their heart's content. They can tell us cigarettes are good for us.
The companies can be trusted to have our health at heart. They can spend adequately on SEO to ensure their messages are dominant. Silly government warnings and or indivduals having problems with side effects or Heroin forum posts can sensibly be lost in the far reaches of search.
</s>
Seriously? I can't think of anything more stupid, even though the system is horribly flawed.
Want to go back to food adulteration, and poisons sold as cures? Endless advertorials pushing pointless product? We have an entire vitamins and supplements industry that's pointless (and problematic) for most people.
Go read the history of those regulations and restrictions. I don't want the pre-drug and food adulteration acts world back, thank you very much. How is this the highest voted post?
> currently allow prescription of extraordinarily strong methamphetamine to children
As someone adult diagnosed ADHD and taking "extrordinarily strong amphetamine" from my 40s I'd like to point out they do not affect ADHD sufferers in the same way as neuro typicals. They're used at tiny dosages compared to using recreationally. I would not wish children with the condition to have my hugely damaged teen years because of horribly misinformed popular rhetoric about amphetamines. Using meth is the last resort option when other forms haven't worked.
That popular rhetoric meant I spent an additional 10 years before gaining effective treatment. I had to read and interpret actual papers to get past the media bullshit and gain an informed opinion.
I doubt you can even imagine how much I wish I had been taking "extraordinarily strong", ie correctly dosed, amphetamines from my earliest years. I will add that I'm not in favour of use for weight - many other tactics can work there.
Do you use the term "extrordinarily strong" when you mean "correct dosage" or speaking of paracetamol? Paracetamol is the cause of many deaths unlike amphetamines. Now add the liver damage.
This assumes correct diagnoses. In your case, the cost was lost years of correctable, sub-optimal brain chemistry. To a kid unnecessarily prescribed amphetamines, the cost is a life with a malformed brain.
The issue at hand is how to balance the outcomes. Based on increased prescription rates (600k diagnosed in 1990 to 3.5 million in 2012 [0]), it seems probable to me that we've passed the breakeven point. I bet that increase in diagnoses corresponds with an increase in marketing spend for these drugs, which is another indicator that gives me pause.
You as an adult were able to decide for yourself. Many diagnosed nowadays are young; they do not have the ability to give informed consent to the medication, nor the ability to roll back the effects. Younger brains are more easily harmed as well.
Further complicating the fact is that it requires an assessment of relative importance: is it better to harm by inaction (your situation) or by over-action?
It's really hard to try and fairly balance these and other issues that I'm sure I'm missing. However, thank you for sharing; although uncomfortable, I thought about the issue from a perspective that quickly embarrassingly had not previously occurred.
It's a big subject and I don't want to to drag too far off topic. So I'll just say prescription rates in 1990 were when the condition was barely recognised and hugely under-diagnosed. Most doctors still believed you grew out of it.
Research seeems to indicate a global prevalence of around 5-10%, settling around 7.8%. So those areas, and there are some, diagnosing >10% are overdoing it. Until we have blood or genetic tests it's too reliant on self-reporting. Even so, many still struggle to get diagnosed or are suspected of just seeking recreational amphetamines.
If it does turn out to be 7%, that's over 22.5m in the US, 4.5m in the UK. It's doubtful all would need or want prescription as not everyone is affected similarly.
I wouldn't have hesitated to push for diganosis if I'd recognised it in my own children (It's strongly determined by heredity).
> Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials.
The way you'd like the FDA to work is literally the way it already works. You're allowed to buy basically any drug you want unless it's scheduled by the DEA. Companies just aren't allowed to market them as being effective for a specific disease without passing clinical trials.
Can doctors legally prescribe them without FDA approval? There are many niche drugs currently unavailable for therapeutic use in the USA because no current manufacturers hold an FDA certification.
Drugs have to be approved by the FDA for some condition to be sold at all in the US. Once available, they can be prescribed on and off label, as long as the manufacturer doesn't encourage any kind of off-label use.
Drug approvals are currently much better than nutrition studies. Your suggestion of allowing not-known-to-work "medicine" to be sold would return us to the era of patent medicines, which killed a lot of people. You can look at the supplements market to see people dying from a similar policy right now.
Like anything else, you have to look at both costs and benefits of the alternatives.
The current extremely tough FDA approval process has the benefit you mention: Fewer people are injured by unsafe drugs.
But it also has a big (but harder to observe) cost: If disease X kills 1000 people/year, then each year a cure is delayed kills 1000 people.
The main argument against the current system is that it weighs the deaths of people in the first category vastly more than those in the second.
How many people the FDA process kills this way is hard to calculate, and you can find wildly different estimates. But most discussion assumes it doesn't even exist...
The problem is that we also don't know how many people might be killed by an unsafe drug. It's impossible to know in advance what could fail with a drug - hence the testing. We have no concept of the upper bound of possible deaths.
If a major drug is released without enough drug trials and widely prescribed we could lose thousands. See Voixx for an example. Almost 40,000 people died [0].
This was with a comprehensive drug trial under the FDA process. We would have many more incidents like this if not for drug trials required by regulatory agencies.
On the other hand national statistics on deaths caused by various diseases have been compiled for decades. We can know with certainty the upper bound of people killed per year (which in your example isn't 1000 but some fraction of that - no drug is 100% effective).
Also, many drugs don't prevent deaths but merely comfort the patient or remove some symptoms.
Many drugs have alternates which could be taken.
Many drugs have an upper bound of deaths prevented of 0. Why should we risk any lives for a drug which cannot save any additional lives?
In general humans prefer taking a known risk with known odds rather than an unknown risk with unknown odds.
If an informed consumer wants to make a different choice than the FDA, nobody is stopping them from traveling to a country where the drug is already available.
The FDA has stricter rules now about drugs because of previous problems where some approved drugs killed people, and others were ineffective, and some were both.
So we already have experience with some alternatives to the current scheme.
You are describing a world in which all decisions made by all humans are informed by perfect logic. The beautiful paradox of such a world is that wouldn't require any government, or any other external system of control. Any external system of control in a perfectly logical and rational world would be unable to demonstrate any value whatsoever, as there would be no conflicts to resolve whatsoever.
Thus, in lieu of 100% of humans being 100% rational, 100% of the time, a nonzero amount of government, creating nonzero amounts of regulation it is an absolute necessity.
> Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials. Consumers could then take the government's recommendations into consideration when making a decision and drugs could get to market much faster.
I'd go one step further. Give the FDA competition. Have private companies (similar to UL for electronics) that can endorse and test drugs.
Do not want. See the role of Moodys and S&P in the 2009 meltdown for what a profit motive does to the ability to "endorse" anything that has the potential to harm.
The SEC failed to enforce some of it's regulations and didn't see the upcoming crisis. Multiple other federal agencies did the same thing. Not a single government official from any country (remember that a similar housing boom unfolded in multiple other countries) foresaw the upcoming trauma.
Note that it it was likely politically infeasible for them to have more rigorously enforced much of their regulation during most of the time period it could have helped. The new securities which caused the crisis were very complex and partially were structured specifically to dodge government oversight.
The ratings agencies actively marked bonds as AA which they knew darn well were in reality B or worse. They committed fraud at the behest of the banks.
There is a massive difference between inaction and fraud. That's why the SEC doesn't get a lot of blame.
Do you support vastly expanding SEC powers and making sure it doesn't get "captured" by the financial industry? Do you support massively higher penalties, and far more control over the industry, than it has now, to bring it in line with the power the FDA has?
Do you also only blame the police for not catching a criminal, and not care about the criminal at all?
Private companies have profit incentives. If a horrible substance comes to market they can be paid off to endorse it.
You can argue that no rational company that cares about its reputation would do such a thing, but history has shown time and time again - yes corporations do waive all consideration for public safety in lieu for money.
The government is the perfect institution to endorse safety of substances/drugs/whatever for use by it's citizens. That doesn't mean they are perfect though, but I would trust them a thousand times more than a corporation.
It's extremely wreckless to apply free market economic theories to things like this. In the real world, consumers and businesses are irrational.
No, because government officials are paid off much less often because it's harder.
Outright bribery in the US is rare, difficult, and if caught, will land you in federal prison for a long time. Remember Blagojevich?
Government officials are under much more scrutiny than a private sector executive. There are independent investigators general that have broad latitude to look for malfeasance. The FOIA exists to bring government records to light; there is no equivalent in the private sector. Heck, we spent ~$80mm investigating Clinton over the Lewinsky affair.
The government isn't perfect, but it's a damn sight more transparent and directly accountable to the public than private companies are.
Thalidomide is the poster child for dangerous drugs approved elsewhere but not by the FDA.
Experts estimate that the drug thalidomide led to the death of approximately 2,000 children and serious birth defects in more than 10,000 children, about 5,000 of them in West Germany.
There are some merits to this idea, but there's a major flaw. It's kind of like tax havens. If you have two countries with different tax rates, all else being equal, a multinational will set up HQ in the lower tax county. Likewise, for pharmaceuticals, the company will pick the country that has the lowest barrier to entry and then sell to both.
While within a country a given barrier may be too high or low, it will probably be somewhat randomly too high or low around some appropriate level of safety. With the multi-country scheme, the bias will be towards too low on nearly every drug.
How is it independent? UL is for-profit and relies on revenue from the companies seeking certidication. That's the same, or similar, conflict that exists with the credit agencies and the finance industry.
There is pressure to be favorable towards the customer (the company being inspected). Something similar happened in finance, where issuers were shopping around the big 3 ratings agencies for the best rating.
> Wouldn't it be nice if there were more government warnings and less restrictions / regulations? ... A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate
No, not without specific examples of how government regulations are a burden on innovation. Whenever people argue this point in industry X it always seems difficult to come up with concrete examples.
> and consumers to take a little more responsibility for themselves.
Secondly, again no. Consumers are not rational machines who make rational decisions based on time spent researching what they are consuming.
I was just reading the new laws enacted for 2017 in California, which included a ban on powdered alcohol, even though it has never been for sale in the state. That's one concrete recent concrete example where a warning would have been a nice alternative.
>A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves.
When I look at how little regard people have for this when taking supplements, I find it hard to believe they'll take more responsibility for themselves.
Not against all supplements myself, but once I learned how poorly controlled they are - how there is virtually no manufacturer I can trust who is actually giving me what the label claims (so many mg of nutrition per capsule, harmful ingredients not on the labeling, etc) - I pretty much stopped taking all of them. The risks outweigh the benefits.
The strip mining of the public good that drug companies would do if all sales were allowed boggles the mind.
Such an open policy would only work if all information (including internal information proprietary to the maker) was available to inform buyers, and while I think a fully informed market w would be great, I don't see any real chance of that happening.
Imagine if the FDA, instead of blocking new drugs for 10 years and $1B, it simply withheld its endorsement until satisfied by the clinical trials. Consumers could then take the government's recommendations into consideration when making a decision and drugs could get to market much faster.
The history of medical reversals -- and in this case, nutrition reversal -- shows that the government isn't magic.
A whole raft of restrictions could be converted to warnings and recommendations, freeing up industry to innovate and consumers to take a little more responsibility for themselves.
Imagine the history of the past few decades if the state had outlawed any foods with more than X% cholesterol. Or trans-fats. Or any of the other food fads over that time. It would have been terrible, especially now that the recommendation is reversed. The whole time, consumers were allowed to factor government warnings into their decisions, but food producers weren't breaking the law by selling foods with (X+1)% cholesterol.