Hey there, thanks for watching! I created this video in a rather short time so I did not want to go into any of the topics in too much detail (still 15min long, lol). Let me know your thoughts and as always, a particular shoutout to my channel members! www.patreon.com/totalsynthesis | instagram.com/totalsynthesis_official/
I am a vet of VN. Back in the 70s I was given a dose by a friend at UMass. It was the only day I can recall where the fear, my constant companion, disappeared. Please let the FDA know , we are suffering needlessly
I have a friend who is a a veteran, serious PTSD. His cure was a batch of my shrooms, one day him and his GF came over unannounced and apparently he had a really bad episode and it was a matter of desperation. Whole ass crying and therapy session later in my living room and it’s like he cured…. Tripping unlocked that ability to process it all. Makes me wonder how much certain types of PTSD is just unprocessed events. obviously not all types are the same but, like his seemed to be caused by the fact his brain was refusing to process the events. Lot of substances that actually do a lot of good out there that we as a society and the government specially look at so negatively simply and only because they make us feel amazing in some way.
As noted in other comments, the disingenuous concern by the FDA regarding the possible side effects or relative efficacy of some drugs under consideration when measured against other candidates being studied, reveals a significant bias towards those submitted by large pharmaceutical companies. The drug candidates being submitted by novel groups or those that do not qualify for a patent, get a much more rigorous and prejudicial review requiring more hoops and obstacles to overcome. Also, considerations of abuse potential and illegal diversion are driven by political biases rather than real world possibilities. When a physically addictive drug is examined for a risk benefit analysis, the profitability of that drug is also included in the calculation. Thus we had oxycontin approved for use over cannabis in spite of the superior safety profile seen in cannabis. The FDA along with the DEA and most other federal agencies have become so hopelessly corrupted by outside influences that their mandates mean little or nothing when the public health is concerned.
@@josh16More "anti-mass experimentation with an unproven new gene therapy technology". Only the Novavax shot fit the true technical definition of a vaccine.
Thanks! Very informative and on point. It is unexpected for me how that kind of trial could be so unserious and biased. But it is a tough one to organise really.
The government: "There's not enough studies!" Also the government: "Studying psychedelic drugs without permission is illegal and no, you don't have permission" Also the government: "Try this brand new 'safe and effective' anti-psychotic and/or vaccine it's FDA approved so it's like totally safe trust me bro"
This comment is a bit curious considering you are taking a skeptical opinion on vaccines as well as anti-psychotics. Do you have a psychotic disorder, and as a result, have a skeptical opinion of vaccines? Why would you be skeptical of anti-psychotics? I haven't read any mainstream skepticism for them, while I know that anti-vaccine sentiment is in the mainstream.
@@brandoncrooks1681abilify is the reason why you should be skeptical of antipsychotics. liquid lobotomies. also vaccines are supposed to be researched unresearched expedited vaccines is how to give everyone cancer or autoimmune disease in old age and all of their children because of a fluke 101, it isn't a smart activity
@@brandoncrooks1681 The reason I used anti-psychotics and vaccines as examples is because those classes of drugs specifically have lower standards to meet in order to pass FDA guidelines. Despite having higher risk and lower efficacy, they get approved while other naturally occuring drugs do not. MDMA is an amphetamine. They've decided it's too dangerous to be legal because.... reasons. Oh, but your kid acts like a kid? Better give them some FDA approved amphetamines.
Based upon the quote you give from Walter Dunn at the end, it seems they're really concerned about the "S" in GRAS/E. It's unfortunate that the study authors did not appropriate gather the safety data that they were advised to. It's weird when companies do this, they get advised that they need to do something, don't do it, and act surprised when it's inadequate. Hope they figure it out next time.
No molecule should be illegal if it wasnt designed to be a weapon, like poisons. Even more if their effects arent addictive, MDMA addiction is soo weird, its considered non addictive, but its prohibited anyway due to not having a "Real clinical use" and being just recreational
@@mach1shobhan And tobacco... and its legal... and it has several side effects like cancer or dead, lso every time someone smokes near other person its bad for the other person, its a public health problem, but if they make smoking ilegal people would suicide or some shit, idk
I think meditating with MDMA twice a year equally separated helps. Especially going through trauma episodes that I’ve been happening recently and in the past and accepting things and seeing them in different perspectives. Definitely help
@@joeldichter1320 its so insanely thereapeutic, i did it while on some other hallucinogens and just sat in my bed and turned on music i heard in my childhood and reflected over my life and past mistakes and harms and learned to forgive myself and all those who wronged me, learned to let go of the past and finally move on from all that troubled me learned to show extreme empathy and care which ive always been a bit weak on, learned to truly love and be loved, learned what that felt like as it was smth i had once lost long ago i learned to let my negativity flow from me and to connect to the greater energies and powers out there, to go with the flow and live in the moment only a single time and this drug changed everything abt my life and i cant wait till a few months from now when i have a chance to do it again and further what i experienced the first time :) the fact someone could make something this beautiful and profound, something that makes you want nothing more than to love others and grow past your own mistakes, illegal- is utterly tragic
Honesetly you can also do that very effectively with plain ol amphetamine at the right dose spaceing in the right setting. i do it once a week to make sure im processing everything thats happened that week, then use the remainder of the the time to work through past stuff with a pen and paper. works great! lets you be your own therapist where your interested in identifying traumas and figureing out how to resolve them, but have enough of an emotional safety blanket to not recoil away from painful memorys, as a bonus figureing out the traumas and resolveing them gives you a huge mental reward.
Well right just because you get psychotherapy and MDMA doesn't mean your wife isn't going to divorce you, you aren't fired from your job or kicked out of college etc. This treatment program perhaps needs to be longer - up to a year with psychotherapy continuing after that.
The research papers/evidence from the og pychotherapist suggest that a single dose of this medication can be life changing for those with ptsd. USA has always treated those with ptsd as money tickets; take the war vets as a prime example, they intend to use up your soul and give you nothing in return...
No "drug" should be illegal. As long as people know the positive and negative side effects, let people and their doctors decide what medication they want to take.
Making it difficult to access drugs reduces the number of consumers and addicts and is therefore good. Drugs make you unhappy and any reduction in their consumption is a positive. Even the prohibition of alcohol in the U.S resulted in a significant reduction of alcohol consumption and liver diseases. It also caused no violent crime increase, you can google that.
@@fluiddynamics3591 you are WILD to believe the Prohibition had positive effects. Organized crime increased as people illegally brewed their own alcohol, but also police forces suffer from loss of funds due to distilleries and breweries, and subsequently alcohol sellers (from clubs, restaurants, convenience stores and more) went out of business and thousands lost their jobs. Because the police couldn’t do nothing, the government deliberately poisoned thousands with methanol to deter consumers from drinking alcohol. Humans have never lived on this earth without using psychoactive or highly addictive drugs. We’ve even found life saving meds from them, and still finding new research in them today. Now, I draw the line at hard, manufactured drugs like crack/meth/cocaine, but psychedelics have little to no negative effects from use with the exception of those who may have bad reactions.
@@fluiddynamics3591 "Drugs make you unhappy" is a very weak argument imo. I get where you're coming from, but that's some VERY broad strokes you're painting with.
The negative side effects of a drug can be hidden from the public. For example, thalidomide caused severe deformations in the children of mothers in pregnancy. While mothers in Germany were heavily impacted, the tragedy didn't extend to the U.S. because of the stubbornness of the FDA.
@@cesardelgadillo4139 those weren’t “hidden” effects, we had no understanding of chirality and spatial arrangements in chemical structures. As I’m a pharmaceutical scientist, thalidomide completely changed the standards of how we approve drugs for public consumption.
This was just a blurb I asked AI to write about the group you are referencing for whoever to read but it summed it up well from what I know about what happened. Psymposia, a media organization known for its critical approach to the psychedelic science community, played a significant role in the recent controversy surrounding the FDA’s evaluation of MDMA for PTSD treatment. They have been particularly vocal about the ethical concerns and potential biases in the clinical trials conducted for MDMA-assisted therapy. Their investigative work, particularly through a podcast series called *Cover Story*, brought to light allegations of inappropriate conduct and methodological flaws within the trials. These revelations, alongside concerns from other critics, contributed to the skepticism surrounding the data presented to the FDA. Psymposia’s involvement and the issues they raised likely added pressure on the FDA advisory committee, which ultimately recommended against approving MDMA for PTSD at this time. The group’s focus on exposing potential risks and ethical breaches in psychedelic research has made them a polarizing figure within the community. Supporters argue they are holding powerful interests accountable, while critics believe they may be hindering progress in psychedelic therapies by amplifying negative narratives. The FDA’s decision reflects a complex balance of these ethical concerns, the safety and efficacy data, and the broader implications for the future of psychedelic medicine. Psymposia’s role in highlighting these issues demonstrates their influence in shaping the discourse around this controversial and evolving field [oai_citation:3,Can MDMA still win FDA approval? Supporters rally as time runs out | Health News Florida](health.wusf.usf.edu/npr-health/2024-08-01/can-mdma-still-win-fda-approval-supporters-rally-as-time-runs-out) [oai_citation:2,As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence | MPR News](www.mprnews.org/story/2024/05/13/npr-ecstasy-mdma-ptsd-fda-approval) [oai_citation:1,FDA Psychopharmacologic Advisory Committee Votes Against Supporting Effectiveness of MDMA for PTSD](www.hcplive.com/view/live-updates-fda-psychopharmacologic-advisory-committee-meeting-mdma-ptsd)
MDMA is not dopaminergic, but its pharmacology is unique in the way it affects both monoamine and hormonal systems. A great deal of MDMA's efficacy as an antidepressant stems from sigma-1 agonism, and increases in hormones like DHEA (which is dependent on the isomer used).
After going over all the problems with this study, its clear why they didnt approve it. This trial is chock full of holes and potential, even if unintentional, bias. I hope further studies give the FDA the data they need.
Thanks for the video. I can see both sides of this. While there seems to be definite lapses on the part of MAPS/Lycos, it also points to the difficulty of dealing with both trauma and psychedelics from the traditional science/medicine framework. Science wants everything to be quantifiable and classifiable. And sorry, but that just ain't possible when dealing with psychedelics/entactogens, or with the deep inner parts of humans. This is why we have such terribly ineffective treatments for these issues.
This^ but also, Hamilton Morris Patreon has a decent pod on this topic if anyone wants to go deeper into it. They rejected it because of a lot of different weird small things along with the main reasons that you pointed out, not that I agree with the outcome.
Working as a PhD student in the medicinal chemistry field, seeing the gross inattention within these MDMA trials made me personally reflect greatly on the potential value of the drug within the modern scope of psychiatry. When I first saw the data released by MAPS (and previous investigations going back >40 years ago), it almost seemed ludicrous and irresponsible not to largely implement the drug to help with disorders that affect tens of thousands of people (PTSD, anxiety disorders, suicidal idealization). In Lou of modern MDMA bioisosteres, I believe MDMA is being "held onto" by classical thinking and large public desire rather than prescriptive and medicinal benefit. MDMA holds great value unquestionably, but in the modern era of pharmaceuticals, we should be more focused on developing safer drugs that are equal to or have better pharmacokinetics and tolerability. I see MDMA more as a stepping stone rather than a true marketable or implementable drug. Nonetheless, I don't think it should be held to the strict regulations currently applied to it, nor do I think it doesn't have any medicinal use. The problem, as it usually does, falls on the backs of humans and their biases rather than the molecule itself.
This was an sound review from the FDA and gives me more confidence that the psychedelic renaissance can be adequately regulated. At least from what I have seen, public perception of clinical psychedelia is ignorant to the inevitable outcome of patented drugs with prohibitive monetary and time costs associated with treatment. People have daily lives and the medical system has finite allottable time at its disposal, scheduling a 6+ hour session with a medical doctor on call is in of itself a huge challenge and barrier to treatment. Not only do these drugs need to be better than the status quo, they need to be superior to such a degree that warrants this human cost. Awesome video as always.
You are neglecting the obvious. The medication regulation and the medication industry absolutely FORBIDS the approval and licensing of any medication or supplement that causes any mood elevation or any elation. Feeling good or being happy are not medically approved objectives. Soon after Prozac hit the market, an improved analog was created and became very popular in Europe. Decades later, it remains forbidden in the US. Its major improvement was the sin of being a mood lifter.
@@mduckernz Thanks, This example was published in the mid 1990s and my memory is failing me. This was mentioned in posted personal comments. It was discussed as being available here, perhaps to meet tourist needs, and some doctors were permitted trial use. Perhaps, It has since been approved.
Very interesting report. I'm in Australia where it's been approved, however progress is slow. I'd personally like to get treatment for PTSD, because life isn't enjoyable when you don't want to be alive. It's like you just want everything to stop, just for a sec, so you can catch your breath. I certainly know what mdma's like, and I think it can help me in that professional setting. It's certainly helped me outside of that setting. However I've felt a little concerned with how things have been progressing. It's so messed up, you've got the "evil" elicit drug trade, where you pour out your heart to a stranger and they listen and can truely feel your pain, if not just for that moment. But to make something official in our society is to put this weird rubber stamp on it and say, ok this is "completely" safe. Then let every greedy psychopathic person loose on it, because it's safe. Life doesn't work like that, things can be dangerous or safe based on how it's done. A greedy enough person will happily hurt you for the tiniest bit of perceived benefit to themselves.
In my opinion, the massive episode of depression after a recreational dose makes it too dangerous to treat something like PTSD, a person may over-dose (not overdose) and end up with said depressive episode. While it may possibly be rare for people to exceed their prescribed dose or gain reliance on the medication, the consequences of such are too dangerous
Has anyone ever looked into varicosity, proneness to develop varicose veins and prostate hyperplasia as a side effect from using MDMA or similar drugs? This might become a problem years after using this drugs but I have received reports of acute phlebitis after use of substituted amphetamines.
this was very eyeopening lol. I fear that the money might right out before actual proper trials get done, these trials sound like they would need like100x more work and scrutiny than this company put in so far.
Not collecting pulse and blood pressure in the final phase trials might be the significant reason why approval was denied. Other factors is not having criteria when a subject is safe to be discharged and data integrity. Religious movement labeling can be applied to scenarios where there’s no consensus.
@@plontetris3297 Really depends tbh! The videos on specific total syntheses are like end of undergrad or graduate level, but sometimes it's also much easier. What is most challenging for you or what reactions are you not so familiar with?
@@totalsynthesis hmm, honestly its mostly with organometallic and radical chemistry, feels like they deviate so much from the typical "nucleophile" "electrophile" story that most organic reactions undergo
I'm not surprised. Based on my own experiences (not necessarily just me taking the drug), it can be quite harmful and tends to form cults of worship around it.
I look at things we already have that are harmful shock therapy my cousin lost half his vision permanently from 2 sessions drugs like lithium I won’t even get started on the damage a lot of our drugs we have for mental illness are I don’t see the damage in trying mdma as some people that’s what works for them some psilocybin some ketamine but some people need that forced peace and serenity that pure mdma provides and not to mention we have lots of other similar drugs that already exist with much less neuro toxic profile and have very almost identical effects idk why we don’t try those also
It was alluded to in your other video i think, neurotoxicity as i recall. Going to keep watching but, i suspect that’s probably why. And there can be some heavy side effects for some people.
Ah, nope. Just general health issues, not neurotoxicity. True for the side effects though. I find the study claims to be dubious, however. That could apply to a wide variety of drugs and it is curious it is applied here and not in other places.
@@ILLUMINATED-1 Mdma related neurotoxicity is usually related to heat+mdma, thermic effects, rather than just mdma itself. There are some very rare extreme side effects on some people, but we cant really know for sure those are 100% mdma related, and not something like mdma (serotonin releasing) + SSRI/MAOI, or some other fucked up thing. That's what we have to deal with when 99%+ of the evidence comes from non supervised case reports
Im happy they rejected it , the way they didnt trials were horrific , people were abused and hurt , seriously what were they thinking , they were going to train psychiatrists for crying out loud
You're missing the point. The FDA directors and panels are simultaneously on pharma boards or directly or indirectly employed or will be employed by big pharma. Thus many of these new drug approvals or denials are biased. Especially when some future big paying job is on the line and billions in pharma sales at stake. Its big business. I get that and don't necessarily disagree with that. Now what I will say about FDA testing is that the studies should be paid for globally with random global panelists. Then we don't have as much of the above gross bias. If the unconstitutional Analogs Act was repealed because it makes beneficial drugs such as MDMA illegal before they are invented and properly scientifically researched then we wouldn't be going down any of these dumb roads. This Act was passed not because of reasonable chemical and medicine science, but the hysterics of a DEA judge/group in the 80s with no science or medicine background to render these types of important legal decisions. As such the Analogs Act needs to be repealed.
would have been dissapointing if they approved an overaged rubbish street drug instead of letting scientists develop better, non-neurotoxic and such alternatives. unsupervised broad acessability would also have been a BIG concern to me, with everyone already doing da special K to "cure their depression" nowadays... EDIT: with "broad accessibility" im referring to the ease of illegally sourcing MDMA
Use would be done in a doctors office you are not taking this stuff home and they do have lots and lots of drugs that are a lot less neuro toxic with similar if not even better effects than mdma already exist idk why they don’t try those
Feebleminded; any drug can be considered rubbish when used in the wrong context. The worst lies are the lies we tell ourselves; maybe you should get some first hand experience before parroting someone else's agenda
@@science_and_anonymous I believe sometimes in the next year or so the focus will shift off of mdma and onto less neurotoxic substances with similar effects I think what makes people comfortable with mdma is it’s history of use
Here's the deal MDMA use in psychotherapy has been around for decades, perhaps 50 years or more with good results. This is why psychotherapists in the 80s didn't want it banned. None of this is new.
The publicity blitz might have been why the rejection happened, trying politicized marketing against the government is not a wise move because if the approval happened, there’s a large portion of the next pending substances that would follow the same tactic and it would create a host of advertising issues like tobacco was to children.
Hey there, thanks for watching! I created this video in a rather short time so I did not want to go into any of the topics in too much detail (still 15min long, lol). Let me know your thoughts and as always, a particular shoutout to my channel members!
www.patreon.com/totalsynthesis | instagram.com/totalsynthesis_official/
Dude is on 1nstagram
I am a vet of VN. Back in the 70s I was given a dose by a friend at UMass. It was the only day I can recall where the fear, my constant companion, disappeared. Please let the FDA know , we are suffering needlessly
This breaks my heart. I took mdma in 1985 and it was the only day in my life I felt nothing but pure joy
I have a friend who is a a veteran, serious PTSD. His cure was a batch of my shrooms, one day him and his GF came over unannounced and apparently he had a really bad episode and it was a matter of desperation.
Whole ass crying and therapy session later in my living room and it’s like he cured…. Tripping unlocked that ability to process it all. Makes me wonder how much certain types of PTSD is just unprocessed events. obviously not all types are the same but, like his seemed to be caused by the fact his brain was refusing to process the events.
Lot of substances that actually do a lot of good out there that we as a society and the government specially look at so negatively simply and only because they make us feel amazing in some way.
As noted in other comments, the disingenuous concern by the FDA regarding the possible side effects or relative efficacy of some drugs under consideration when measured against other candidates being studied, reveals a significant bias towards those submitted by large pharmaceutical companies. The drug candidates being submitted by novel groups or those that do not qualify for a patent, get a much more rigorous and prejudicial review requiring more hoops and obstacles to overcome. Also, considerations of abuse potential and illegal diversion are driven by political biases rather than real world possibilities. When a physically addictive drug is examined for a risk benefit analysis, the profitability of that drug is also included in the calculation. Thus we had oxycontin approved for use over cannabis in spite of the superior safety profile seen in cannabis. The FDA along with the DEA and most other federal agencies have become so hopelessly corrupted by outside influences that their mandates mean little or nothing when the public health is concerned.
It would be interesting to compare the rigor of this study series to the rigor of a certain mRNA vaccine study series.
Lol!
Are you anti vax?
@@josh16More "anti-mass experimentation with an unproven new gene therapy technology". Only the Novavax shot fit the true technical definition of a vaccine.
@@josh16 It sounds like he is pro-science because he is asking for studies to be done.
Thanks! Very informative and on point. It is unexpected for me how that kind of trial could be so unserious and biased. But it is a tough one to organise really.
The government: "There's not enough studies!"
Also the government: "Studying psychedelic drugs without permission is illegal and no, you don't have permission"
Also the government: "Try this brand new 'safe and effective' anti-psychotic and/or vaccine it's FDA approved so it's like totally safe trust me bro"
This comment is a bit curious considering you are taking a skeptical opinion on vaccines as well as anti-psychotics. Do you have a psychotic disorder, and as a result, have a skeptical opinion of vaccines? Why would you be skeptical of anti-psychotics? I haven't read any mainstream skepticism for them, while I know that anti-vaccine sentiment is in the mainstream.
So you think we should use the old ones like thorazine? orr
@@brandoncrooks1681abilify is the reason why you should be skeptical of antipsychotics. liquid lobotomies. also vaccines are supposed to be researched unresearched expedited vaccines is how to give everyone cancer or autoimmune disease in old age and all of their children because of a fluke 101, it isn't a smart activity
@@brandoncrooks1681 The reason I used anti-psychotics and vaccines as examples is because those classes of drugs specifically have lower standards to meet in order to pass FDA guidelines. Despite having higher risk and lower efficacy, they get approved while other naturally occuring drugs do not. MDMA is an amphetamine. They've decided it's too dangerous to be legal because.... reasons. Oh, but your kid acts like a kid? Better give them some FDA approved amphetamines.
great video again! thank you for your deep dive in the real reasons and explaining them in such an easy to digest way
Thanks!!
Based upon the quote you give from Walter Dunn at the end, it seems they're really concerned about the "S" in GRAS/E. It's unfortunate that the study authors did not appropriate gather the safety data that they were advised to. It's weird when companies do this, they get advised that they need to do something, don't do it, and act surprised when it's inadequate.
Hope they figure it out next time.
No molecule should be illegal if it wasnt designed to be a weapon, like poisons.
Even more if their effects arent addictive, MDMA addiction is soo weird, its considered non addictive, but its prohibited anyway due to not having a "Real clinical use" and being just recreational
even alcohol doesnt have real clinical use last time i checked
@@mach1shobhan And tobacco... and its legal... and it has several side effects like cancer or dead, lso every time someone smokes near other person its bad for the other person, its a public health problem, but if they make smoking ilegal people would suicide or some shit, idk
I think meditating with MDMA twice a year equally separated helps.
Especially going through trauma episodes that I’ve been happening recently and in the past and accepting things and seeing them in different perspectives.
Definitely help
@@joeldichter1320 its so insanely thereapeutic, i did it while on some other hallucinogens and just sat in my bed and turned on music i heard in my childhood and reflected over my life and past mistakes and harms and learned to forgive myself and all those who wronged me, learned to let go of the past and finally move on from all that troubled me
learned to show extreme empathy and care which ive always been a bit weak on, learned to truly love and be loved, learned what that felt like as it was smth i had once lost long ago
i learned to let my negativity flow from me and to connect to the greater energies and powers out there, to go with the flow and live in the moment
only a single time and this drug changed everything abt my life and i cant wait till a few months from now when i have a chance to do it again and further what i experienced the first time :)
the fact someone could make something this beautiful and profound, something that makes you want nothing more than to love others and grow past your own mistakes, illegal- is utterly tragic
Honesetly you can also do that very effectively with plain ol amphetamine at the right dose spaceing in the right setting.
i do it once a week to make sure im processing everything thats happened that week, then use the remainder of the the time to work through past stuff with a pen and paper. works great! lets you be your own therapist where your interested in identifying traumas and figureing out how to resolve them, but have enough of an emotional safety blanket to not recoil away from painful memorys, as a bonus figureing out the traumas and resolveing them gives you a huge mental reward.
Well right just because you get psychotherapy and MDMA doesn't mean your wife isn't going to divorce you, you aren't fired from your job or kicked out of college etc. This treatment program perhaps needs to be longer - up to a year with psychotherapy continuing after that.
The research papers/evidence from the og pychotherapist suggest that a single dose of this medication can be life changing for those with ptsd. USA has always treated those with ptsd as money tickets; take the war vets as a prime example, they intend to use up your soul and give you nothing in return...
No "drug" should be illegal. As long as people know the positive and negative side effects, let people and their doctors decide what medication they want to take.
Making it difficult to access drugs reduces the number of consumers and addicts and is therefore good.
Drugs make you unhappy and any reduction in their consumption is a positive.
Even the prohibition of alcohol in the U.S resulted in a significant reduction of alcohol consumption and liver diseases. It also caused no violent crime increase, you can google that.
@@fluiddynamics3591 you are WILD to believe the Prohibition had positive effects. Organized crime increased as people illegally brewed their own alcohol, but also police forces suffer from loss of funds due to distilleries and breweries, and subsequently alcohol sellers (from clubs, restaurants, convenience stores and more) went out of business and thousands lost their jobs. Because the police couldn’t do nothing, the government deliberately poisoned thousands with methanol to deter consumers from drinking alcohol. Humans have never lived on this earth without using psychoactive or highly addictive drugs. We’ve even found life saving meds from them, and still finding new research in them today. Now, I draw the line at hard, manufactured drugs like crack/meth/cocaine, but psychedelics have little to no negative effects from use with the exception of those who may have bad reactions.
@@fluiddynamics3591 "Drugs make you unhappy" is a very weak argument imo. I get where you're coming from, but that's some VERY broad strokes you're painting with.
The negative side effects of a drug can be hidden from the public. For example, thalidomide caused severe deformations in the children of mothers in pregnancy. While mothers in Germany were heavily impacted, the tragedy didn't extend to the U.S. because of the stubbornness of the FDA.
@@cesardelgadillo4139 those weren’t “hidden” effects, we had no understanding of chirality and spatial arrangements in chemical structures. As I’m a pharmaceutical scientist, thalidomide completely changed the standards of how we approve drugs for public consumption.
Fuck it We backyard chemist will make it ourselves!
I wish
Hamilton posted a video on his Twitter that explains how the judges got influenced by some group.
This was just a blurb I asked AI to write about the group you are referencing for whoever to read but it summed it up well from what I know about what happened. Psymposia, a media organization known for its critical approach to the psychedelic science community, played a significant role in the recent controversy surrounding the FDA’s evaluation of MDMA for PTSD treatment. They have been particularly vocal about the ethical concerns and potential biases in the clinical trials conducted for MDMA-assisted therapy.
Their investigative work, particularly through a podcast series called *Cover Story*, brought to light allegations of inappropriate conduct and methodological flaws within the trials. These revelations, alongside concerns from other critics, contributed to the skepticism surrounding the data presented to the FDA. Psymposia’s involvement and the issues they raised likely added pressure on the FDA advisory committee, which ultimately recommended against approving MDMA for PTSD at this time.
The group’s focus on exposing potential risks and ethical breaches in psychedelic research has made them a polarizing figure within the community. Supporters argue they are holding powerful interests accountable, while critics believe they may be hindering progress in psychedelic therapies by amplifying negative narratives.
The FDA’s decision reflects a complex balance of these ethical concerns, the safety and efficacy data, and the broader implications for the future of psychedelic medicine. Psymposia’s role in highlighting these issues demonstrates their influence in shaping the discourse around this controversial and evolving field [oai_citation:3,Can MDMA still win FDA approval? Supporters rally as time runs out | Health News Florida](health.wusf.usf.edu/npr-health/2024-08-01/can-mdma-still-win-fda-approval-supporters-rally-as-time-runs-out) [oai_citation:2,As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence | MPR News](www.mprnews.org/story/2024/05/13/npr-ecstasy-mdma-ptsd-fda-approval) [oai_citation:1,FDA Psychopharmacologic Advisory Committee Votes Against Supporting Effectiveness of MDMA for PTSD](www.hcplive.com/view/live-updates-fda-psychopharmacologic-advisory-committee-meeting-mdma-ptsd)
The FDA does it's job well, which is why it should be abolished.
MDMA practically is fast acting SSRI with additional dopamine boost, the result is same, downfall, when you don't use it, difference is timing
MDMA is not dopaminergic, but its pharmacology is unique in the way it affects both monoamine and hormonal systems. A great deal of MDMA's efficacy as an antidepressant stems from sigma-1 agonism, and increases in hormones like DHEA (which is dependent on the isomer used).
After going over all the problems with this study, its clear why they didnt approve it. This trial is chock full of holes and potential, even if unintentional, bias. I hope further studies give the FDA the data they need.
Thanks for the video. I can see both sides of this. While there seems to be definite lapses on the part of MAPS/Lycos, it also points to the difficulty of dealing with both trauma and psychedelics from the traditional science/medicine framework. Science wants everything to be quantifiable and classifiable. And sorry, but that just ain't possible when dealing with psychedelics/entactogens, or with the deep inner parts of humans. This is why we have such terribly ineffective treatments for these issues.
This^ but also, Hamilton Morris Patreon has a decent pod on this topic if anyone wants to go deeper into it. They rejected it because of a lot of different weird small things along with the main reasons that you pointed out, not that I agree with the outcome.
Working as a PhD student in the medicinal chemistry field, seeing the gross inattention within these MDMA trials made me personally reflect greatly on the potential value of the drug within the modern scope of psychiatry. When I first saw the data released by MAPS (and previous investigations going back >40 years ago), it almost seemed ludicrous and irresponsible not to largely implement the drug to help with disorders that affect tens of thousands of people (PTSD, anxiety disorders, suicidal idealization). In Lou of modern MDMA bioisosteres, I believe MDMA is being "held onto" by classical thinking and large public desire rather than prescriptive and medicinal benefit. MDMA holds great value unquestionably, but in the modern era of pharmaceuticals, we should be more focused on developing safer drugs that are equal to or have better pharmacokinetics and tolerability. I see MDMA more as a stepping stone rather than a true marketable or implementable drug. Nonetheless, I don't think it should be held to the strict regulations currently applied to it, nor do I think it doesn't have any medicinal use. The problem, as it usually does, falls on the backs of humans and their biases rather than the molecule itself.
💯
This was an sound review from the FDA and gives me more confidence that the psychedelic renaissance can be adequately regulated. At least from what I have seen, public perception of clinical psychedelia is ignorant to the inevitable outcome of patented drugs with prohibitive monetary and time costs associated with treatment. People have daily lives and the medical system has finite allottable time at its disposal, scheduling a 6+ hour session with a medical doctor on call is in of itself a huge challenge and barrier to treatment. Not only do these drugs need to be better than the status quo, they need to be superior to such a degree that warrants this human cost.
Awesome video as always.
You are neglecting the obvious. The medication regulation and the medication industry absolutely FORBIDS the approval and licensing of any medication or supplement that causes any mood elevation or any elation. Feeling good or being happy are not medically approved objectives.
Soon after Prozac hit the market, an improved analog was created and became very popular in Europe. Decades later, it remains forbidden in the US. Its major improvement was the sin of being a mood lifter.
What is this analog you refer to?
Adderall?
@@mduckernz Thanks, This example was published in the mid 1990s and my memory is failing me. This was mentioned in posted personal comments. It was discussed as being available here, perhaps to meet tourist needs, and some doctors were permitted trial use. Perhaps, It has since been approved.
Still waiting on which analog he is talking about..
@@raiden72 The reporting was from more than ten years ago. My memory has failed and my feeble searches were no help.
Didn't get FDA aproval because it lacks patent exclusivity so no kickbacs for aproving it.😢
Very interesting report. I'm in Australia where it's been approved, however progress is slow. I'd personally like to get treatment for PTSD, because life isn't enjoyable when you don't want to be alive. It's like you just want everything to stop, just for a sec, so you can catch your breath. I certainly know what mdma's like, and I think it can help me in that professional setting. It's certainly helped me outside of that setting. However I've felt a little concerned with how things have been progressing. It's so messed up, you've got the "evil" elicit drug trade, where you pour out your heart to a stranger and they listen and can truely feel your pain, if not just for that moment. But to make something official in our society is to put this weird rubber stamp on it and say, ok this is "completely" safe. Then let every greedy psychopathic person loose on it, because it's safe. Life doesn't work like that, things can be dangerous or safe based on how it's done. A greedy enough person will happily hurt you for the tiniest bit of perceived benefit to themselves.
In my opinion, the massive episode of depression after a recreational dose makes it too dangerous to treat something like PTSD, a person may over-dose (not overdose) and end up with said depressive episode. While it may possibly be rare for people to exceed their prescribed dose or gain reliance on the medication, the consequences of such are too dangerous
Such detailed and good video
Thanks!
BUT WE NEED IT 😭😭😭
On balance, I’m a proponent of exploring psychedelic medical treatments, but I would not have approved this either given all the issues you summarised
Has anyone ever looked into varicosity, proneness to develop varicose veins and prostate hyperplasia as a side effect from using MDMA or similar drugs? This might become a problem years after using this drugs but I have received reports of acute phlebitis after use of substituted amphetamines.
that would be from profound long term abuse not a single use
@@therideneverends1697 The reports I have received are from single/occasional use.
Gold brother, thank you 👍
dude would you consider making videos on the synthesis of Anabolic Steroids, too? stuff like Trenbolone or 1-Testosterone
Yes I might!
Where is the money in curing a physical or mental illness, as opposed to just treating the symptoms?
Just straight up evil to not approve this.
It must have been successful in treating people then i'm guessing.
Did you watch any part of the video?
@@totalsynthesis Actually I did not.
Should I?
@@More_Row Up to you mate
this was very eyeopening lol. I fear that the money might right out before actual proper trials get done, these trials sound like they would need like100x more work and scrutiny than this company put in so far.
Not collecting pulse and blood pressure in the final phase trials might be the significant reason why approval was denied. Other factors is not having criteria when a subject is safe to be discharged and data integrity. Religious movement labeling can be applied to scenarios where there’s no consensus.
Yes, fascinating video!
This channel has taken the place of TheDrugClasroom which is nice
What level of chemistry are these videos at? just finished Clayden but feels like there is a gap between that and this
Which videos in particular? The one you commented on or my videos in general? (it really depends)
@@totalsynthesis in general haha, I can follow most of the videos but honestly never heard of some of the reactions
@@plontetris3297 Really depends tbh! The videos on specific total syntheses are like end of undergrad or graduate level, but sometimes it's also much easier. What is most challenging for you or what reactions are you not so familiar with?
@@totalsynthesis hmm, honestly its mostly with organometallic and radical chemistry, feels like they deviate so much from the typical "nucleophile" "electrophile" story that most organic reactions undergo
It needs to please big pharma and the medical industrial complex daddy first.
I'm not surprised. Based on my own experiences (not necessarily just me taking the drug), it can be quite harmful and tends to form cults of worship around it.
I got this notification!
Based subscriber insta-clicking my notifications
@@totalsynthesis perfect timing because I was on break too
I look at things we already have that are harmful shock therapy my cousin lost half his vision permanently from 2 sessions drugs like lithium I won’t even get started on the damage a lot of our drugs we have for mental illness are I don’t see the damage in trying mdma as some people that’s what works for them some psilocybin some ketamine but some people need that forced peace and serenity that pure mdma provides and not to mention we have lots of other similar drugs that already exist with much less neuro toxic profile and have very almost identical effects idk why we don’t try those also
Most farmaceuticals have far worse side effects!
It was alluded to in your other video i think, neurotoxicity as i recall. Going to keep watching but, i suspect that’s probably why. And there can be some heavy side effects for some people.
Ah, nope. Just general health issues, not neurotoxicity. True for the side effects though. I find the study claims to be dubious, however. That could apply to a wide variety of drugs and it is curious it is applied here and not in other places.
@@ILLUMINATED-1 Mdma related neurotoxicity is usually related to heat+mdma, thermic effects, rather than just mdma itself.
There are some very rare extreme side effects on some people, but we cant really know for sure those are 100% mdma related, and not something like mdma (serotonin releasing) + SSRI/MAOI, or some other fucked up thing.
That's what we have to deal with when 99%+ of the evidence comes from non supervised case reports
i cant wait seing ptsd patient raving Pike theres no tomorrow
Off-label prescriptions is the real threat to corporate revenue.
Its almost like an open market reduces monopolistic abuse
Healthy and sober people are the real threat to black market revenue.
Im happy they rejected it , the way they didnt trials were horrific , people were abused and hurt , seriously what were they thinking , they were going to train psychiatrists for crying out loud
I think you should critically look into what actually happened during the trials, hearing, and how things like this affect the future.
Lykos has to show better safeguards within their therapy protocol, the FDA didn’t deny based upon the any aspects of the drug itself.
No need. Ketamine is the one to rule them all.
They will NEVER approve it!
They WILL approve it! But in like 200 years or so, eventually.
@@AlistairKarim They don't even approve some perfectly safe plants and herbs
@@bob-g3e3x Well, that's true. But my point is that current system isn't sustainable, it is not forever.
You're missing the point. The FDA directors and panels are simultaneously on pharma boards or directly or indirectly employed or will be employed by big pharma. Thus many of these new drug approvals or denials are biased. Especially when some future big paying job is on the line and billions in pharma sales at stake. Its big business. I get that and don't necessarily disagree with that. Now what I will say about FDA testing is that the studies should be paid for globally with random global panelists. Then we don't have as much of the above gross bias. If the unconstitutional Analogs Act was repealed because it makes beneficial drugs such as MDMA illegal before they are invented and properly scientifically researched then we wouldn't be going down any of these dumb roads. This Act was passed not because of reasonable chemical and medicine science, but the hysterics of a DEA judge/group in the 80s with no science or medicine background to render these types of important legal decisions. As such the Analogs Act needs to be repealed.
Because its better than all painkilers ,bettrr ,and smoking shards isnt that bad ,and wsaaay more exciting thn mdma ,but you shuld always balance
would have been dissapointing if they approved an overaged rubbish street drug instead of letting scientists develop better, non-neurotoxic and such alternatives.
unsupervised broad acessability would also have been a BIG concern to me, with everyone already doing da special K to "cure their depression" nowadays...
EDIT: with "broad accessibility" im referring to the ease of illegally sourcing MDMA
Use would be done in a doctors office you are not taking this stuff home and they do have lots and lots of drugs that are a lot less neuro toxic with similar if not even better effects than mdma already exist idk why they don’t try those
Feebleminded; any drug can be considered rubbish when used in the wrong context.
The worst lies are the lies we tell ourselves; maybe you should get some first hand experience before parroting someone else's agenda
@@zevkurtzman8108 broad accessibility refers to drug dealers not prescription dude
The indane class developed by the Nichols group holds incredible utility, without neurotoxicity.
@@science_and_anonymous I believe sometimes in the next year or so the focus will shift off of mdma and onto less neurotoxic substances with similar effects I think what makes people comfortable with mdma is it’s history of use
MDMA is gay
Because it works.
Those therapist should not be doing that conduct
Here's the deal MDMA use in psychotherapy has been around for decades, perhaps 50 years or more with good results. This is why psychotherapists in the 80s didn't want it banned. None of this is new.
Easy because they can’t compete with clandestine market
The publicity blitz might have been why the rejection happened, trying politicized marketing against the government is not a wise move because if the approval happened, there’s a large portion of the next pending substances that would follow the same tactic and it would create a host of advertising issues like tobacco was to children.