> The current drug regulation regime strikes me as backwards--it seems that the more appropriate assumption should be to not regulate a substance, until it can be shown to be harmful
The problem with this approach is that it would lead to a proliferation of snake-oil salesmen.
If the effort to create a new 'drug' is trivial, but the study on efficacy/harm is long and expensive, then there would be a huge number of snake-oil offerings.
Take colored water, slap a 'it cures cancer' sticker on it, and start selling it the public. In a couple of years, once there are studies showing that it's just colored water, and does nothing, just shut down the product and make a new one. The regulatory/safety efforts would never be able to keep up.
1. In general I don't see the government's role being to police snake oil salespersons. Fraud in the form of inaccurate ingredient lists, etc. but not the snake oil itself (people should be able to sell snake oil, but it should actually be snake oil). I mean, when you have people drinking bleach for various conditions, can you really say the current regime is working? What about physicians overprescribing opioids or other drugs? It's pretty clear it doesn't work, IMHO. People need to be educated, not policed.
2. However, I can see regulating claims at the point of sale without regulating substances. For all the criticisms and controversy over vitamins, I think that's the regulatory regime that should be applied to all substances. Prevent use claims on product, regulate accuracy of ingredient lists but not sale of product per se.
3. We currently have a process for determining ability to consent due to neurodegenerative disease, genetic disorders, psychiatric disorders, etc. This could easily be applied to substance use. It seems to me the better way to approach substances is to assume people know what they're doing, and if their use gets problematic enough, approach it as a loss-of-ability-to-consent issue just like if someone had severe Alzheimer's. Get them assessed by psychiatrists or psychologists, and require it to go through a legal proceeding. That's imperfect, but better to me than just assuming everyone is a criminal.
4. I wish all the money that was going into drug enforcement and FDA regulations would go into research, education, prevention, and treatment. I think we'd have far fewer problems if the FDA were focused on drug use as a public health problem rather than a criminal/regulation problem. Educate, prevent, treat.
Snake oil already seems to be a problem, with CBD oil.
A nurse I know told me about a woman who had been treating her breast cancer with CBD oil, convinced that CBD cures cancer. She finally went to the hospital when her entire breast became necrotic, and died not long after that.
Issues today include snakeoil salesmen, but something else too. Maybe you would call it fad folk medicine. Snakeoil without the salesmen. People writing and sharing elaborate health advice not for profit (maybe for clicks) having little or no connection to science.
The tragedy of this situation is that physiologists have actually figured out a lot about the hormones since premarin was released. But horse urine is still a big business for the drug industry, even after the Women's Health Initiative was shut down early...
10 minutes appointments (edit: and symptomatic prescriptions) aren't long enough to drill down to the root of a patient's symptoms.
This is exactly the kind of snakeoil folk medicine I am talking about.
You are trying to argue that hormone therapy has no therapeutic value because one particular drug is derived from a biological source? Urine is gross so obviously the drug is a fraud? Mixed in with "big business" conspiracy. That is the kind of argument that should only work on a small child.
(Just noticed your reply. It's been 5 days - this reply is strictly "for the record" & I don't expect you to notice).
> You are trying to argue that hormone therapy has no therapeutic value [...]
Estrogen therapy has always been a scam without therapeutic value. DES actually gave women's daughters vaginal cancer. Prescription horse piss actually gave women breast cancer. Etc etc etc.
Various other therapies are appropriate to help restore balance to people's (both male and female) hormone systems.
> Urine is gross so obviously the drug is a fraud?
How many women would take Premarin if their doctor said, "I'm going to give you some concentrated horse urine to help with these symptoms you're having." Exactly none. Synthetic Premarin-equivalents give women breast cancer just the same as genuine horse estrogen.
> Mixed in with "big business" conspiracy.
Pharmaceutical companies create "evidence" to justify their product, then the product gets pulled a few years later when it's realized the side effects aren't worth the negligible benefits. The fines are a fraction of their profits. Call it a conspiracy if you want - I prefer "fraud".
The problem with this approach is that it would lead to a proliferation of snake-oil salesmen.
If the effort to create a new 'drug' is trivial, but the study on efficacy/harm is long and expensive, then there would be a huge number of snake-oil offerings.
Take colored water, slap a 'it cures cancer' sticker on it, and start selling it the public. In a couple of years, once there are studies showing that it's just colored water, and does nothing, just shut down the product and make a new one. The regulatory/safety efforts would never be able to keep up.