[2Gkashmiri]

i find this funny. what do you mean "patient's own risk?"

that has always been the case. you go for a minor surgery, you sign a waiver. you go to a doctor, they are supposed to give reasonable care. No one can guarantee success. the same with lawyers or drivers or mechanics or technicians. basically anytime you go to someone for assistance, they can't guarantee anything. the person is themselves always responsible for everything.

[dahart]

Of course there’s always some risk with any drug or medical procedure. But - obviously - not all risk is equal. Unapproved treatments are riskier because they haven’t been proven effective, and they haven’t been well tested for side effects. There is an uncountably large list of cases throughout history of people willing to sell ineffective and/or actively harmful treatments, which is the whole reason the FDA exists. Look up people who died taking ivermectin for Covid [1], or just pick any ailment and do some research on fake treatments, perhaps cancer for example [2]. The UN says half a million people in Africa alone are being killed every year by fake medicine today, currently [3].

[1] https://www.unmc.edu/healthsecurity/transmission/2023/03/14/...

[2] https://en.wikipedia.org/wiki/List_of_unproven_and_disproven...

[3] https://www.un.org/africarenewal/magazine/february-2023/fake...

[2Gkashmiri]

you are not answering my question. i understand "risk". but what does it mean when someone says "on your own risk"? in this context lets say?

if you sign up for dental extraction and you die, didn't you do that on your own risk? or is the doctor responsible in this case? that he/she didn't do their job properly and now they must pay but if the doctor says "on your own risk", that suddenly they are redeemed?

[dahart]

Your question is conflating multiple kinds of risk. Drugs and procedures that are known to work still do have risks of complications or side effects, but statistically speaking, they are known to work and have known levels of risk.

Fake and/or investigational drugs carry an additional and independent risk of unknown efficacy and unknown potential harms. That additional risk layers on top of the first kind of risk of known complications. Drugs with no proven efficacy can carry additional financial risks too.

This is all why we have drug regulations - to hopefully understand the risks, minimize chances of severe harm and/or death, give consumers informed choice and allow them to assess the risk and weigh the risks against the known benefits. Unregulated drugs carry unknown benefits, and unknown & potentially very high levels of risk that patients have no hope of knowing or evaluating rationally, and that is what the comment you replied to is referring to.

Risk isn’t binary like your first comment implied. We don’t just have risk or no risk, we have risks that are known and risks that are unknown, and we have risks with different levels of harm vs benefit, and we have risks with varying levels of likelihood. In medicine it’s important for the risks to be known, for the harm levels to be low, and for the likelihood to be low. That doesn’t always happen, but if harm is likely or high then it’s important for the benefits to be high (to outweight the risks) and its important for anyone accepting the risk to have informed consent.

[adastra22]

History is also full of examples of treatments that do work under unknown (at the time) circumstances and were standardized into common practice through trial and error. This includes most over the counter medication and procedures today.

Most of that advancement stopped with the introduction of the FDA and its equivalents in other countries.

The story of efficacy trials falls apart when you consider the complex reality of the human body and pharmaceutical action. There are many medical procedures and drugs which we know work on certain patients some of the time, but we are prevented from giving to new patients because the high standards of Phase III efficacy haven’t been met.

[dahart]

So what? The U.S. food and drug laws aren’t protecting against things that accidentally work, they are protecting against things that don’t work. These laws are hard won and represent many people lost to both ignorance and greed.

If something has efficacy, then trials will eventually prove it, it’s just a matter of time. You just made a case that the process works. If efficacy can’t be shown, then it’s very risky for people to try the treatment, riskier than using something with known outcomes, and potentially riskier than doing nothing at all.

Either way this is all irrelevant to your bogus claim at the top that the FDA has anything to do with the perception that treatments aren’t improving. The top comment’s hypothesis is incorrect, which adds to the multiple reasons your proposed explanation is wrong.

[adastra22]

Where did I make the case of process works? It doesn’t. there are hundreds of examples of promising medication that will never be approved because there is no money or will to do phase 3 trials. Often because those drugs fell out of patent protection during some normal, typical snag in the testing process.

[dahart]

This may reach nobody, but FWIW I meant to use this link in the sibling comment: https://www.reliasmedia.com/articles/147475-evolving-ethics-...

“The Right to Try Act was ‘unnecessary in the first place’, according to Kearns. Terminally or seriously ill patients have had the ability to access investigational drugs via the FDA Expanded Access (EA) pathway for decades.”

“most people overestimate the odds researchers will determine an experimental drug is safe and effective”

“if an adverse event occurs in a patient who took the drug outside a clinical trial, it could lead to negative repercussions for eventual drug availability. […] Right to try also could divert patients away from participating in clinical trials.“

And to answer your question, your first sentence made the case. All currently approved drugs represent previously unapproved treatments. The FDA is approving 100-200 drugs per year, and processing around 2000 investigational drugs per year. No idea what you mean when you claim progress has stopped, that comment doesn’t reflect reality. https://www.fda.gov/about-fda/histories-fda-regulated-produc...

[dahart]

It doesn’t work? So no new medications are being approved? I suspect that’s not quite correct. ;) Is it possible the examples you’re thinking of simply don’t have enough backing because they’re either not effective, or they have serious side effects? What drugs specifically do you believe are being overlooked?

It is true that regulating drugs and having an approval process causes new drugs to take time, causes some to be rejected, and that people who could use them don’t get them until approved. It is true that some people could die waiting for drugs to be approved that will be shown effective. I lost a friend this year to a cancer that had an experimental treatment that he wasn’t eligible for, and it’s incredibly frustrating. Yet this has been thoroughly debated for hundreds of years, and what we have is a system that is fairly effective at minimizing harm and maximizing effectiveness given the science we have at hand.

Your argument so far has completely ignored:

- The FDA’s Investigational Drug program.

- The Right To Try Act, and all the preceding debate and legislation.

- The fact that most new drugs developed are not effective and some have very serious consequences.

- The fact that unscrupulous actors exist, and there are widespread and serious problem with fake medicines. You have nothing to say about the data I linked to on the distribution of fake drugs currently killing children by the hundreds of thousands???

If you can’t even acknowledge the basis on which the FDA was founded (regulating drugs was made a requirement by Congress) or the fact that they are balancing competing public health benefits, then your argument will get nowhere and is not being made in good faith. If you want to demonstrate why drugs should be unregulated and why we should suffer the harm that would cause, or make the case for relaxing the regulations more than the New Investgational Drug program allows and spell out how it would lead to more benefit than harm, I’m all ears!

You might not be considering the possibility that relaxing drug testing and regulations could backfire and make it harder for effective drugs to reach the market. Maybe it’s worth researching the history of this debate a bit more?

https://jnm.snmjournals.org/content/59/10/1492

[adastra22]

With the FDA rules they are not legally allowed to offer such services, however.

[dahart]

Not sure what you’re talking about. In general the FDA does not regulate medical “services” or procedures.