This is a great writeup fairly assessing the state of psychedelic medical studies. There is an uphill battle in that vein, as even regular drugs are having trouble beating the ever-strengthening...
This is a great writeup fairly assessing the state of psychedelic medical studies.
From personal experience of my social circle, it's a crapshoot if any given drug or dosage works for mental health anyway on a personal level. There is often a prolonged trial-and-error phase. Properly tested and labelled marijuana is great in that vein because it becomes easier to figure out what does and doesn't work for you. Especially as an opiate alternative, but also for doing the delicate bipolar management dance. Doing a salvia when I'm depressed helps keep me from bottoming out and doing an indica when I'm hypomanic helps keep me grounded (in part by forcing sleep). The key being actually taking small doses of accurately labelled drugs rather than getting stoned with whatever the dealer had, the way I did in my youth. I'll use between 1 and 3 times a week and it complements my usual regiment well with less side effects compared to adjusting doses. But again, good luck testing this in a blind study.
Plus, my hypothesis is that we don't give enough weight on clearing out environmental causes of mental health problems. Turns out 95% of my severe depression was caused by interacting with my parents. Betting we'd see a drastic reduction in clinical depression if we addressed burnout (and overall job dissatisfaction) as a society.
People do forget that mental health diagnoses are specifically about the amount of distress the symptoms cause and that environment is so key to all of that. It's why medication - of whatever sort...
People do forget that mental health diagnoses are specifically about the amount of distress the symptoms cause and that environment is so key to all of that.
It's why medication - of whatever sort - is a great tool. But so is therapy.
My ADHD would be much more of a disability in a different job, and when it's disabling I get deeply depressed. So in my old, worse, job, I was depressed a lot of the time. ADHD meds address my depression better than antidepressants
Slightly off-topic but as frustrating as this must be to the researchers, are there any positives for this? I've heard of the placebo effect being used to successfully treat some things before, so...
There is an uphill battle in that vein, as even regular drugs are having trouble beating the ever-strengthening placebo effect.
Slightly off-topic but as frustrating as this must be to the researchers, are there any positives for this? I've heard of the placebo effect being used to successfully treat some things before, so is it possible that we may be able to get some silver lining out of this cloud?
I mean at the end of the day, who cares if the drug is a placebo if it works and doesn't have any nasty side effects? Even the most harmless drugs I can think of can have nasty side effects at the...
I mean at the end of the day, who cares if the drug is a placebo if it works and doesn't have any nasty side effects? Even the most harmless drugs I can think of can have nasty side effects at the wrong doses.
I think the key problem is that there needs to be some way of differentiating between a placebo treatment, FDA-certified drugs, and snake oil. The thing that's interesting is that the placebo effect often works even if users know its a placebo. As such, proper labeling is key.
It really must be so incredibly difficult working in medical research. Humans are such complicated creatures and trying to figure out how to fix all the issues we seem to have is a big job.
It really must be so incredibly difficult working in medical research. Humans are such complicated creatures and trying to figure out how to fix all the issues we seem to have is a big job.
To be clear, I agree with you fully. It is extremely important to identify things as such, and for medicines to actually work as you describe. It's still not necessarily a bad starting point in a...
To be clear, I agree with you fully. It is extremely important to identify things as such, and for medicines to actually work as you describe.
It's still not necessarily a bad starting point in a regimen of a non-emergency treatment however. Another tool in the toolbox, as they say. Especially if it's made cost-effective.
One example that comes to mind is sleep aids. Is a placebo a bad starting point for someone having a bit of trouble staying asleep?
This very heavily depends on what side effects the placebo has. This is easy enough when the placebo is a cup of warm milk or a spoonful of honey (both examples from my childhood). But most...
Is a placebo a bad starting point for someone having a bit of trouble staying asleep?
This very heavily depends on what side effects the placebo has. This is easy enough when the placebo is a cup of warm milk or a spoonful of honey (both examples from my childhood). But most medications are not side effect free. The ethics of prescribing something like that depend a lot on whether the potential benefits outweigh the risks of side effects. And if you're getting no more than you would from a sugar pill, it's very hard to justify that the risks are worth the reward. Would you take something with the known potential side effects of Ambien for your insomnia if you knew it was no better than placebo?
Would be neat if they just taught that stuff in elementary school, along with a class about yourself, who you are, what it means to be a human without any political agenda.
Would be neat if they just taught that stuff in elementary school, along with a class about yourself, who you are, what it means to be a human without any political agenda.
The interventions you mention take time and actual lifestyle changes before they have any impact; the placebo can “work” right away. By analogy, there’s my morning coffee. The alertness and energy...
The interventions you mention take time and actual lifestyle changes before they have any impact; the placebo can “work” right away.
By analogy, there’s my morning coffee. The alertness and energy I have in the mid-morning are real effects of caffeine; the instant mood lift and banishment of grogginess at the first sip are pure placebo.
I found Salvia divinorum tincture to be kind of a nasty trip, and didn't get any noticeable mood benefit. I did get a numb, burning sensation in my mouth for a couple of days, and lost all muscle...
I found Salvia divinorum tincture to be kind of a nasty trip, and didn't get any noticeable mood benefit. I did get a numb, burning sensation in my mouth for a couple of days, and lost all muscle coordination for 6 - 8 hours. Like literally falling off the couch and being unable to get back on without assistance, which just added to the unpleasantness. Saw colors, really interesting synesthesia from music. I did not need to know that bare skin sticking to a leather chair feels like being slowly digested. It was overall more irritating than enlightening.
It's discouraging to hear that many studies are flawed. But at the same time, there's a bunch of things to unpack here. I would write a longer comment, but I don't have the time, so I'll summarize...
It's discouraging to hear that many studies are flawed. But at the same time, there's a bunch of things to unpack here. I would write a longer comment, but I don't have the time, so I'll summarize my feelings in a few bullet points:
Their general statement about "psychedelics" being a popular term for hallucinogens is concerningly off the mark. Psychs are a subset of hallucinogenic drugs, and most people who use them would agree that they don't even have to be hallucinogenic at all to be psychedelic. The purpose of the trip is to induce the psychedelic headspace. Ketamine is a dissociative; MDMA is a stimulant and entactogen; LSD and psilocybin are psychedelics; and something like Amanita muscaria is a deliriant. All of these are distinct subclasses of drugs that can induce hallucinations.
This point is important because there are different approaches depending on the class of drug and mechanism of action. In ketamine treatments, the "high" is often seen as an unintended side effect; some companies are trying to develop NMDA antagonists that don't produce any kind of high, because the downstream effect on BDNF is seen as the desirable effect. This is a lot more of a "treat issues with chemicals" approach like SSRIs and less of an "enhance therapy with drugs that allow one to alter and re-examine thought patterns" approach like LSD or MDMA.
This field is a huge argument in favor of publicly funded research. The article mentions ketamine nasal spray, which is making a very cheap and commonly available anesthetic very expensive. Pharmaceutical companies have a vested interest in patentable drugs, and these drugs are so old that they can't be patented, but you can patent specific formulations of the drug or isolated isomers of the drug like esketamine. There's no guarantee that these are necessarily better for the patient, but they're definitely better for the drug company's finances.
The article recommends active placebos, but it's hard to find convincing active placebos that aren't, you know, full-blown drugs that might work for the same reasons that the drug under study works. For similar reasons, they recommend using a different therapist in follow-up from the one who was present at the treatment sessions. This is good from a scientific methodology standpoint, but these experiences are, to put it mildly, intimate, and from a patient comfort perspective, I imagine a lot of patients would prefer to stick to one therapist through the active treatment sessions and the non-drug followup sessions.
Concerns about patient safety from transgressions by therapists are very valid. This is quite shocking and obviously way out of line. These drugs make already vulnerable patients more vulnerable.
Unfortunately, the overblown hysteria about these drugs that got all research shut down around the 1970s has perhaps caused an overreaction in the opposite direction: suppress all negatives, to prevent another complete shutdown of all research. The fact that a lot of pharmaceutical research is funded by private companies is a huge issue. As mentioned, these drugs are generally not patentable. In addition, they're usually intended to be taken infrequently, not daily like traditional psychiatric drugs, again cutting into profit margins. It's not a big conspiracy theory to suggest that companies might want to focus research on avenues that make them more money. This is why this kind of research should be publicly funded.
For the record, I've tried to use psychedelics for therapeutic purposes. Didn't do jack shit for me, but it didn't have any long-term negative consequences either. Unfortunately, this wasn't in a controlled medical setting, because that wasn't available to me at the time. I'd be interested in trying again in a medical setting, but unfortunately it's very expensive and/or plain inaccessible at the moment. I'm on the fence; I've heard too many stories of people successfully using these drugs for long-term mental health gains to dismiss them as useless. But I definitely don't think they're a panacea, a miracle cure for everybody. As I've said, my own experiences were disappointingly ineffective.
A key aspect of effectiveness is surely down to exactly how you spend your trip. Just dosing someone and giving them therapy under the influence is a spin on the roulette wheel of outcomes....
A key aspect of effectiveness is surely down to exactly how you spend your trip. Just dosing someone and giving them therapy under the influence is a spin on the roulette wheel of outcomes. Without proper guidance and planning a study is no different than handing an untrained person a scalpel and telling them to fix the pain in a patient's leg. Surely a scalpel is involved in the proper solution, but the important part is the exact procedure to be followed.
Are there studies where therapists try to explore hundreds of patients minds with them on a trip? Perhaps an MRI or an equivalent tool would be required to guide someone effectively. People can get good results from these drugs - and from the inside you have all of the perspective necessary to explore around. But to get consistent results we'll need a pilot for the trip.
The way I see it, the psychedelic is equivalent to the first step in surgery where you open someone up. All of the important work comes after that.
Nearly all major studies on therapy+hallucinogenic drug in this realm (MDMA, LSD, mushrooms, etc.) have a rather standard protocol. The prospective patients are screened for pre-existing mental...
Nearly all major studies on therapy+hallucinogenic drug in this realm (MDMA, LSD, mushrooms, etc.) have a rather standard protocol. The prospective patients are screened for pre-existing mental health conditions (anything besides the target is often a reason to be excluded, at least during the research phase as a means to best understand outcomes). If they pass the screening they are then set up with a series of appointments (and in some cases they might even have a number of sessions with the therapist to get to know each other before getting to typical drug+therapy structure). The first appointment is essentially an educational- the patient is told what they are to expect, the format of what is going to happen, how the hallucinogen works, etc. and are allowed to ask questions. This usually lasts several hours. The second appointment is where they receive a dose and undergo a session of therapy. There is time to settle in, ask questions, etc. Then they are dosed and the therapist is in the room. The structure of the timing from receiving a dose to the actual therapy, the cool down period, and the decompression are all standardized to the time the drug is active one's system. There is then 1-2 more appointments where a retrospective/unpacking session happens and possibly another normal therapy session.
These things are incredibly curated and structured. I've seen documents put together that even specify how many pillows, blankets, and seating should be present, what kind of lighting to use, and even what kind of exercises to go through to prepare and create a safe/warm/cozy place for the person to be in the best possible headspace for therapy.
But these more structured, well thought out studies are not the only studies happening and humans come in many variations. There will likely be plenty of noise to sift through and it won't be effective for everyone, but that's entirely okay (and in fact, arguably desirable). This is simply meant to be another tool in a toolbox - the appropriate tool for a patient should be a discussion between a patient and their doctor. In many cases this particular tool is able to fix people who've gone through every other possible tool in the toolbox and found no solutions. It's really not that important to know whether it works better than placebo so much as it is important to figure out how to structure these in an effective manner and ensure it's 'safe' enough to do to become a medical mainstay for patients for which it seems a useful tool to explore.
I have a family member who is going through this right now. She tells me that it’s done more for her than any treatment she has had for multiple decades. That is more than enough for me to believe...
I have a family member who is going through this right now. She tells me that it’s done more for her than any treatment she has had for multiple decades. That is more than enough for me to believe that these kinds of drug therapies are worth exploring.
Part of the problem with attempting to study psychedelics in a double blind kind of paradigm is that it could be that the wild experience is part of mechanism. In other words, there is no effect...
Part of the problem with attempting to study psychedelics in a double blind kind of paradigm is that it could be that the wild experience is part of mechanism. In other words, there is no effect separate from the subjective experience of taking them. This obviously makes it impossible to do a double blind study, but this is a limitation in the mechanism by which we identify effectiveness and has nothing to do with actual effectiveness.
To my mildly trained scientific mind, longitudinal studies that do a good job accounting for a complex constellation of confounding factors will be the most useful evidence of this kind of intervention.
Side note, there are plenty of other interventions susceptible to this kind of limitation, chief among them being residential care, which might be suffering from the intervention equivalent of inverse-agonism at a neural receptor site. That is to say, it might increasing the opposite of its intended effect, doing my harm than good, at least in some circumstances.
I don't know if "impossible" is the right word. The regulatory guidelines in the article seem to outline a clear enough path. The ones that stick out to me the most are "active placebo" and...
I don't know if "impossible" is the right word. The regulatory guidelines in the article seem to outline a clear enough path. The ones that stick out to me the most are "active placebo" and "dose-response."
Active placebo would be something like if you are studying MDMA, you also have a study arm dosing Adderall as a control. You'd be able to tell that something is happening, but you won't know which study arm you're in because they also suggest enrolling participants who are not experienced with the drug.
Dose-response would require a study using multiple dose levels, and you couldn't be sure which dose you're on unless you're an experienced user of that drug.
Both of these would be examples of possible double-blinded studies that could provide data on efficacy.
I think the risk with active placebos is the potential that it actually has an effect on the same condition. My Vyvanse has done more to help my depression than my old SSRI did - and while this is...
I think the risk with active placebos is the potential that it actually has an effect on the same condition. My Vyvanse has done more to help my depression than my old SSRI did - and while this is because I have ADHD, it's an example of potential risks with this method.
Ideally it would be something we have a ton of data on to serve as a better control. I picked Adderall in the example because it's been dosed to millions, so we should be able to reasonably...
Ideally it would be something we have a ton of data on to serve as a better control. I picked Adderall in the example because it's been dosed to millions, so we should be able to reasonably control for its effects. Even so, it's certainly a noisier measurement than we can get with other drugs without an obvious tell, with many caveats as your personal experience shows. However, it is A LOT better than throwing up our hands and saying that it's too hard a problem, so let's just grant exemptions to the normal rules and allow doctors to prescribe medications we have poor data on. I'm not saying you're saying this, just that the article mentions some drugs that have been approved on seemingly weak evidence.
I took a peek at the study cited for the idea that a quarter of physicians wrongly think that a breakthrough designation means a drug is safer than previous treatments. That study also says that "70% [of physicians] incorrectly believed [FDA] approval required both a statistically significant and clinically important effect." Since doctors and the general public trust the regulatory agencies so much, it's incredibly important that they force industry to do everything reasonable to prove that these medicines work for their intended purpose.
Sorry, I kind of ended on a tangent from what you were talking about. I guess I just have strong feelings about this subject.
I know you said you're not saying I'm saying this, but I'd just like to explicitly say that I'm saying the opposite of this (which I think is clearer from my other comments than this one). My...
it is A LOT better than throwing up our hands and saying that it's too hard a problem, so let's just grant exemptions to the normal rules and allow doctors to prescribe medications we have poor data on
I know you said you're not saying I'm saying this, but I'd just like to explicitly say that I'm saying the opposite of this (which I think is clearer from my other comments than this one). My mother was (and to a lesser extent still is) a victim of alternative medicine. I don't think the US cracks down on ineffective medications enough.
This is a great writeup fairly assessing the state of psychedelic medical studies.
There is an uphill battle in that vein, as even regular drugs are having trouble beating the ever-strengthening placebo effect.
From personal experience of my social circle, it's a crapshoot if any given drug or dosage works for mental health anyway on a personal level. There is often a prolonged trial-and-error phase. Properly tested and labelled marijuana is great in that vein because it becomes easier to figure out what does and doesn't work for you. Especially as an opiate alternative, but also for doing the delicate bipolar management dance. Doing a salvia when I'm depressed helps keep me from bottoming out and doing an indica when I'm hypomanic helps keep me grounded (in part by forcing sleep). The key being actually taking small doses of accurately labelled drugs rather than getting stoned with whatever the dealer had, the way I did in my youth. I'll use between 1 and 3 times a week and it complements my usual regiment well with less side effects compared to adjusting doses. But again, good luck testing this in a blind study.
Plus, my hypothesis is that we don't give enough weight on clearing out environmental causes of mental health problems. Turns out 95% of my severe depression was caused by interacting with my parents. Betting we'd see a drastic reduction in clinical depression if we addressed burnout (and overall job dissatisfaction) as a society.
People do forget that mental health diagnoses are specifically about the amount of distress the symptoms cause and that environment is so key to all of that.
It's why medication - of whatever sort - is a great tool. But so is therapy.
My ADHD would be much more of a disability in a different job, and when it's disabling I get deeply depressed. So in my old, worse, job, I was depressed a lot of the time. ADHD meds address my depression better than antidepressants
Slightly off-topic but as frustrating as this must be to the researchers, are there any positives for this? I've heard of the placebo effect being used to successfully treat some things before, so is it possible that we may be able to get some silver lining out of this cloud?
I mean at the end of the day, who cares if the drug is a placebo if it works and doesn't have any nasty side effects? Even the most harmless drugs I can think of can have nasty side effects at the wrong doses.
I think the key problem is that there needs to be some way of differentiating between a placebo treatment, FDA-certified drugs, and snake oil. The thing that's interesting is that the placebo effect often works even if users know its a placebo. As such, proper labeling is key.
It really must be so incredibly difficult working in medical research. Humans are such complicated creatures and trying to figure out how to fix all the issues we seem to have is a big job.
To be clear, I agree with you fully. It is extremely important to identify things as such, and for medicines to actually work as you describe.
It's still not necessarily a bad starting point in a regimen of a non-emergency treatment however. Another tool in the toolbox, as they say. Especially if it's made cost-effective.
One example that comes to mind is sleep aids. Is a placebo a bad starting point for someone having a bit of trouble staying asleep?
This very heavily depends on what side effects the placebo has. This is easy enough when the placebo is a cup of warm milk or a spoonful of honey (both examples from my childhood). But most medications are not side effect free. The ethics of prescribing something like that depend a lot on whether the potential benefits outweigh the risks of side effects. And if you're getting no more than you would from a sugar pill, it's very hard to justify that the risks are worth the reward. Would you take something with the known potential side effects of Ambien for your insomnia if you knew it was no better than placebo?
Would be neat if they just taught that stuff in elementary school, along with a class about yourself, who you are, what it means to be a human without any political agenda.
Believing that you can teach someone "what it means to be a human" without engaging with politics is itself a political stance.
I don't think that can be divorced from political agenda.
The interventions you mention take time and actual lifestyle changes before they have any impact; the placebo can “work” right away.
By analogy, there’s my morning coffee. The alertness and energy I have in the mid-morning are real effects of caffeine; the instant mood lift and banishment of grogginess at the first sip are pure placebo.
That's a helluva Freudian slip there.
Ironically never did salvia but I sure as shit jumble it up with satvia every single time.
BRB gonna go do some medicinal bath salts......
I found Salvia divinorum tincture to be kind of a nasty trip, and didn't get any noticeable mood benefit. I did get a numb, burning sensation in my mouth for a couple of days, and lost all muscle coordination for 6 - 8 hours. Like literally falling off the couch and being unable to get back on without assistance, which just added to the unpleasantness. Saw colors, really interesting synesthesia from music. I did not need to know that bare skin sticking to a leather chair feels like being slowly digested. It was overall more irritating than enlightening.
It's discouraging to hear that many studies are flawed. But at the same time, there's a bunch of things to unpack here. I would write a longer comment, but I don't have the time, so I'll summarize my feelings in a few bullet points:
Unfortunately, the overblown hysteria about these drugs that got all research shut down around the 1970s has perhaps caused an overreaction in the opposite direction: suppress all negatives, to prevent another complete shutdown of all research. The fact that a lot of pharmaceutical research is funded by private companies is a huge issue. As mentioned, these drugs are generally not patentable. In addition, they're usually intended to be taken infrequently, not daily like traditional psychiatric drugs, again cutting into profit margins. It's not a big conspiracy theory to suggest that companies might want to focus research on avenues that make them more money. This is why this kind of research should be publicly funded.
For the record, I've tried to use psychedelics for therapeutic purposes. Didn't do jack shit for me, but it didn't have any long-term negative consequences either. Unfortunately, this wasn't in a controlled medical setting, because that wasn't available to me at the time. I'd be interested in trying again in a medical setting, but unfortunately it's very expensive and/or plain inaccessible at the moment. I'm on the fence; I've heard too many stories of people successfully using these drugs for long-term mental health gains to dismiss them as useless. But I definitely don't think they're a panacea, a miracle cure for everybody. As I've said, my own experiences were disappointingly ineffective.
A key aspect of effectiveness is surely down to exactly how you spend your trip. Just dosing someone and giving them therapy under the influence is a spin on the roulette wheel of outcomes. Without proper guidance and planning a study is no different than handing an untrained person a scalpel and telling them to fix the pain in a patient's leg. Surely a scalpel is involved in the proper solution, but the important part is the exact procedure to be followed.
Are there studies where therapists try to explore hundreds of patients minds with them on a trip? Perhaps an MRI or an equivalent tool would be required to guide someone effectively. People can get good results from these drugs - and from the inside you have all of the perspective necessary to explore around. But to get consistent results we'll need a pilot for the trip.
The way I see it, the psychedelic is equivalent to the first step in surgery where you open someone up. All of the important work comes after that.
Nearly all major studies on therapy+hallucinogenic drug in this realm (MDMA, LSD, mushrooms, etc.) have a rather standard protocol. The prospective patients are screened for pre-existing mental health conditions (anything besides the target is often a reason to be excluded, at least during the research phase as a means to best understand outcomes). If they pass the screening they are then set up with a series of appointments (and in some cases they might even have a number of sessions with the therapist to get to know each other before getting to typical drug+therapy structure). The first appointment is essentially an educational- the patient is told what they are to expect, the format of what is going to happen, how the hallucinogen works, etc. and are allowed to ask questions. This usually lasts several hours. The second appointment is where they receive a dose and undergo a session of therapy. There is time to settle in, ask questions, etc. Then they are dosed and the therapist is in the room. The structure of the timing from receiving a dose to the actual therapy, the cool down period, and the decompression are all standardized to the time the drug is active one's system. There is then 1-2 more appointments where a retrospective/unpacking session happens and possibly another normal therapy session.
These things are incredibly curated and structured. I've seen documents put together that even specify how many pillows, blankets, and seating should be present, what kind of lighting to use, and even what kind of exercises to go through to prepare and create a safe/warm/cozy place for the person to be in the best possible headspace for therapy.
But these more structured, well thought out studies are not the only studies happening and humans come in many variations. There will likely be plenty of noise to sift through and it won't be effective for everyone, but that's entirely okay (and in fact, arguably desirable). This is simply meant to be another tool in a toolbox - the appropriate tool for a patient should be a discussion between a patient and their doctor. In many cases this particular tool is able to fix people who've gone through every other possible tool in the toolbox and found no solutions. It's really not that important to know whether it works better than placebo so much as it is important to figure out how to structure these in an effective manner and ensure it's 'safe' enough to do to become a medical mainstay for patients for which it seems a useful tool to explore.
I have a family member who is going through this right now. She tells me that it’s done more for her than any treatment she has had for multiple decades. That is more than enough for me to believe that these kinds of drug therapies are worth exploring.
Part of the problem with attempting to study psychedelics in a double blind kind of paradigm is that it could be that the wild experience is part of mechanism. In other words, there is no effect separate from the subjective experience of taking them. This obviously makes it impossible to do a double blind study, but this is a limitation in the mechanism by which we identify effectiveness and has nothing to do with actual effectiveness.
To my mildly trained scientific mind, longitudinal studies that do a good job accounting for a complex constellation of confounding factors will be the most useful evidence of this kind of intervention.
Side note, there are plenty of other interventions susceptible to this kind of limitation, chief among them being residential care, which might be suffering from the intervention equivalent of inverse-agonism at a neural receptor site. That is to say, it might increasing the opposite of its intended effect, doing my harm than good, at least in some circumstances.
I don't know if "impossible" is the right word. The regulatory guidelines in the article seem to outline a clear enough path. The ones that stick out to me the most are "active placebo" and "dose-response."
Active placebo would be something like if you are studying MDMA, you also have a study arm dosing Adderall as a control. You'd be able to tell that something is happening, but you won't know which study arm you're in because they also suggest enrolling participants who are not experienced with the drug.
Dose-response would require a study using multiple dose levels, and you couldn't be sure which dose you're on unless you're an experienced user of that drug.
Both of these would be examples of possible double-blinded studies that could provide data on efficacy.
I think the risk with active placebos is the potential that it actually has an effect on the same condition. My Vyvanse has done more to help my depression than my old SSRI did - and while this is because I have ADHD, it's an example of potential risks with this method.
Ideally it would be something we have a ton of data on to serve as a better control. I picked Adderall in the example because it's been dosed to millions, so we should be able to reasonably control for its effects. Even so, it's certainly a noisier measurement than we can get with other drugs without an obvious tell, with many caveats as your personal experience shows. However, it is A LOT better than throwing up our hands and saying that it's too hard a problem, so let's just grant exemptions to the normal rules and allow doctors to prescribe medications we have poor data on. I'm not saying you're saying this, just that the article mentions some drugs that have been approved on seemingly weak evidence.
I took a peek at the study cited for the idea that a quarter of physicians wrongly think that a breakthrough designation means a drug is safer than previous treatments. That study also says that "70% [of physicians] incorrectly believed [FDA] approval required both a statistically significant and clinically important effect." Since doctors and the general public trust the regulatory agencies so much, it's incredibly important that they force industry to do everything reasonable to prove that these medicines work for their intended purpose.
Sorry, I kind of ended on a tangent from what you were talking about. I guess I just have strong feelings about this subject.
I know you said you're not saying I'm saying this, but I'd just like to explicitly say that I'm saying the opposite of this (which I think is clearer from my other comments than this one). My mother was (and to a lesser extent still is) a victim of alternative medicine. I don't think the US cracks down on ineffective medications enough.