There are essentially 2 kinds people, the ones that want to decide what to do with their lives/bodies. And the other kind are the ones that want the govt/authorities to 'protect' them from their own stupidity. The latter also wants the same rule enforced for all people. The vast majority of people are of the latter kind.
I think this is overly simplistic. There are a lot of gradations in between.
For example, many people would like to have more control but would also like the government to let them know what is safe, based on careful studies and analysis, rather than having to adopt medicine as a hobby.
Even if I'm in the first group, I still need to know things like correct dosage, drug interactions, purity, etc in order to safely self-administer. I'm not quite sure where you would draw the line between "being educated" and "being protected from own stupidity"... Because to correctly self-administer you definitely need to be educated.
That argument is just turtles all the way down. How did those people get educated? How was correct dosage and drug interactions determined in the first place? How was purity enforced? At some point, you're either trusting unverified word of mouth, or you're verifying with the same type of data that the FDA is responsible for collecting and verifying.
There's groups that advocate feeding bleach solutions to cure autism. [0] Should I ask those people? How about the ones that believe vaccines cause autism? We already know we get an opioid crises and overdoses when people self-administer those...
[0] Seriously, I wish I was joking. Search for "autism mms".
jdmichal, what you are mentioning is a fundamental problem of deciding as to who is correct? Am I getting that right?
Well there is no clear answer as to who has the right answer. Most people tend to rely on the first licensed MD that will give them advise. Someone like me will may go in for a second and third opinion, and sometimes based solely on my existing knowledge and opinion of an MD at all. As with with all hard decisions, the answer is: 'it depends'
>At some point, you're either trusting unverified word of mouth,
Mostly, yes. But there are nuances.
>or you're verifying with the same type of data that the FDA is responsible for collecting and verifying.
What makes you think that FDA is the only source of truth? It could be my blood letting friendly barber for me. Well, I'm exaggerating, but you do get the point?
I think the fundamental problem is that, when you say "my blood-letting barber", you're exaggerating. Others could say the exact same thing, and be deadly serious. My argument is exactly this variance. When scientific method starts being replaced by web of trust, people get hurt. And it's not because they're being stupid, like your original assertion. It's because they trusted the wrong person with the wrong information. This happens now, as my last comment made pretty clear. But at least in the FDA we have a relatively good source of information which was gathered using scientific methods to educate ourselves with.
Just to be clear: Other than this point surrounding education, I generally agree that prescription law is too restrictive in the US. I wish we had a layout closer to doctors diagnose and pharmacists prescribe, instead of doctors doing both. Pharmacists are supposed to be the expert in the drugs, but other than drug interaction screening and equivalent / generic replacement, that job has been stripped from them.
>And it's not because they're being stupid, like your original assertion
We are on to something, You think all people have essentially the same fundamental capacity to reason? And all that differs from person to person is information, experience and knowledge?
>But at least in the FDA we have a relatively good source of information which was gathered using scientific methods to educate ourselves with.
Wrong, _you_ think it's a good source of information. I don't.
Anyway we probably are essentially talking one and the same thing.
> You think all people have essentially the same fundamental capacity to reason? And all that differs from person to person is information, experience and knowledge?
I think that decision making is a skill. And like all skills, having those things will improve it. It's also a very difficult skill to judge, because value systems range so broadly. Just because it doesn't look like a "reasonable" choice to you -- which is pretty much defined by "the set of things I would have picked" -- doesn't mean that it wasn't for that person. For instance, I would not care to inject myself with unknown-to-myself drugs, because I'm naturally risk adverse and don't have a need compelling enough to take the risks I associate with such an action. But I also acknowledge that others have different aversions and needs than myself.
> Wrong, _you_ think it's a good source of information. I don't.
OK. Is it because you don't trust their methods? Or their implementation? Regardless, I agree that this seems to be the end of the conversation. If it's the former, than that's a irreparable disconnect in our ideologies. If it's the latter, then I'm undereducated and won't attempt to discuss.
Do keep in mind that I'm separating the FDA's evaluations from things that hinge on that evaluation. The FDA could still be doing its thing, even if drugs could be sold without their approval. (Though they would certainly not get the level of cooperation that they currently enjoy.)
>I think that decision making is a skill. And like all skills, having those things will improve it.
We have a very fundamental difference of opinion, and we will have to leave the discussion at that. And the difference is this: my opinion is that people will significantly vary in their decision making skill, everything else being equal (training, knowledge, experince etc.)
>Is it because you don't trust their methods? Or their implementation?
Both. It's because the vast majority of people in my (subjective) analysis are worse decision makers than me. The FDA is no exception. The FDA is also prone to being corruptible, as is any human enterprise. It's a fundamental difference of opinion I have with you. Look through my profile, and you will see a cynic. Josiah Zayner, the guy who's article is posted would be a guy of similar disposition.
We don't have a difference. Of course talent plays into skills also. And, if it wasn't clear before, I think it's impossible for two people to run the same decision process. Values, needs, experience are all so infinitely varied that there is no such thing.
> Look through my profile, and you will see a cynic. Josiah Zayner, the guy who's article is posted would be a guy of similar disposition.
I'm fine with cynicism. I just don't buy into the "burn the world" version of it. And it's not even a decision based on facts, but rather that operating that way is just untenable for me. If I strip away all the layers of trust, there's simply nothing left. Yes, we live in a world and society that is terribly broken in many ways. But, regardless, we still have to live in it. And so I choose to accept some baseline axioms, simply to survive.
Having a regulatory framework for the pharmaceutical industry is essential to public safety. But the framework we currently have, as it has evolved, isn't fit for purpose any more.
Regulating drug development is a complex problem, and the people best qualified to supervise the approvals/licensing process are typically folks who've worked in the industry. But this opens the system up to Regulatory Capture:
TLDR is, you get a revolving door between the regulated industry and the regulators, and the regulators are co-opted into maintaining barriers to entry that keep insurgents out (thereby providing a profitable oligopoly to their former -- and usually future -- employers).
There is also a toxic interaction with the WTO-endorsed patent system, which is w-a-y too complex to get into in this comment but which ensures that new antibiotics (which we desperately need) are unprofitable but the price of drugs that are decades out of their original patent coverage (such as insulin) can be made to spiral profitably by tweaking the intellectual property playing field.
I'm sorry, but I don't have a simple/easy answer for this: it's a really gnarly problem that will require not only legislation but international treaty negotiations to mitigate, and simplistic attempts to cut the red tape are likely to lead to snake oil scandals and, quite possibly, a considerable death toll, not just new breakthrough treatments.
I appreciate your comment exposing the nuances, and complexity of something like this rather than the run of the mill <government/business> should just do <x,y,z> to solve this problem. I think the first step in solving any problem is establishing the complexity of the issue and agreeing that all parties want mostly the same things. It seems to often it falls into a limbic system driven response that goes all the way to one extreme or another.
Can you also count regulated scandals too, and not just cherry pick anything that confirms biases. Think thalidomide babies, diclophen environmental problems, etc.
"Most any drug can be made by a company in Asia. Just make a post on Alibaba and you will get a quote in less than a week. If you want premade, prepackaged drugs there are many websites that sell from the same manufacturers that are used by US pharmaceutical companies, same packaging and all. You can find these sites pretty easily after searching Reddit for a few minutes. I hate telling people that the biggest thing between them and a self-administered treatment option is just their own lack of knowledge. That the government makes it so that those like me with knowledge can’t help them order and amdinister drugs they want to try."
I agree with the spirit of the article but this paragraph and their conclusions has me concerned....
I'm not going to anywhere near the same extreme as this guy but regulation is indeed awful and suffocating in every industry. This is why tech is the last bastion of innovation, although with the latest push for regulation the only innovators will be giant corporations with armies of lawyers who can fight through all the red tape and avoid the tidal wave of lawsuits related to data, encryption, anonymous users who post obscene material, and so on.
On the medical side, my prescriber made me visit every 3 months for a 30 minute checkup to get the same drugs for several years. The checkup lasted all of 5 minutes and billed insurance. She literally just made me visit so she could insert the same order on the computer. Such a scam. Finally found a doctor who would prescribe me whatever I wanted during a yearly checkup with few questions. Such a dumb and wasteful system.
Most of the examples that Josiah gives of his friends are of genetic disorders. I too would rather not get sick in the first place, but when you are sick, you are sick.
Maybe? Josiah's post really isn't really about that barrier to better care though. It is more about "corporate greed", perverse incentives, and barriers due to regulation.
"Regulations" exist to prevent unreasonable, dangerous externalities from being socialized onto the people, like the 1976 swine flu vaccine that killed a number of people because clinical trials were skipped.
What do you think of those real but inaccessibly expensive remedies of the day that are mentioned?
Also, what do you have any thoughts about regulation that stops experimental treatment decisions from being made by those who are destined to die anyways?
Personally, I'm for it. You're already doomed. It seems cruel to remove hope from the damned.
Should we use the terminally ill like Guinea pigs, no. But there should be a path to waive liability and consent to experimental drug treatment in cases of terminal illness.
That goes for "off label" uses of scheduled substances too. If I have cancer and am on my deathbed, dose me with LSD please.
A concern I'd have for the experimental treatments is: what is the bar? Can I charge someone a ton of money, and pump them full of water? Who has visibility into the experimental procedures, and whether or not they are just gouging a dying person to transfer their wealth to a company instead of their family or friends.
That is an important point. I would like to think that people would be careful enough in their search for treatment that this would never happen, but it will and does happen to some degree.
A lot of the gouging we currently see happens through FDA-approved treatments that are given monopolies due to regulatory capture.
And that comment sounds like you have empathy surgically removed.
Any measure has positive and negative side. And some are positive for society but bad for individuals.
Education, not regulation, should be tried. Introduce medicine, nutrition and friends in the primary school, inspire people to take care on their bodies and do not promote health outsorcing.
Because what the USA needs is even more deregulation? The only thing Drumpf is doing is deregulating the USA into a hellish nightmare that will kill thousands of people.
This person will not even check their spelling let alone their drug formulas. I would steer clear of any advice to impersonate a PhD and make your own.
I'm sure that we can find spelling or grammar mistakes in your past comments or that you have made spelling mistakes before. This is Dr. Zayner's blog post and not some treatment protocol.
