A four-step policy proposal to pave the path forward for healing, freedom, and recovery. How long can our ailing veterans, victims of trauma, and sufferers of treatment-resistant depression wait?
"Recently, an application for MDMA-assisted psychotherapy for PTSD was rejected by the FDA. While the full reasons for the rejection remain unclear..."
The reasons are very clear.
The Multidisciplinary Association for Psychedelic Studies (MAPS) and its for-profit branch LYKOS had its Phase III trials de-published for covering up a suicide attempt, failing to report data that FDA explicitly asked for, and recruited therapists and participants into a grandiose, exaggerated organizational culture that made blinding of trials impossible. This organization was also held criminally liable for the death of a 20-year old in their care, is alleged to have stolen money from an elderly man, and has covered up sexual and physical abuse multiple times. Moreover, these treatments would have cost $15,000 or more if FDA had given these entities "exclusive authorization" (a monopoly) to sell them for six years. The approval process is flawed, yes. But "evergreening" and exclusivity rules are even worse for innovation over all.
Certainly, the federal government should de-schedule psilocybin mushrooms. But MDMA has a much more acute harm profile than other psychedelics, and the federal government should not do business with organizations that have lied to medical journals and the FDA.
Some but not all of these issues, as well as multiple other issues not mentioned here, were discussed by the public advisory panel, but the FDA has not publicly stated which issues were decisive by the FDA itself in the rejection. In addition, some of this was in phase II, not phase III data under consideration, and some of the issues were still under investigation. The death was associated with a harm reduction program at a festival rather than clinical trial research. Overall, the point we made is true that the specific reasons by the FDA for the rejection have not been elucidated by the FDA.
I have an elderly friend, who for her 80th birthday went to the desert last year, with a small group of people who signed up for the ayahuasca ritual. She had images for a short amount of time of a computer with Japanese figures from a game, then she fell asleep. She was very disappointed. No epiphany or metaphysical answers she was hoping for. When I was young, I spent a lot of time with Dr. Timothy Leary, and his friends, including those studying the therapeutic effects of LSD on human consciousness. I learned a lot. During his time working at Harvard, he and Richard Alpert were involved in the Harvard Psilocybin project. They were fired due to various concerns on methodology. I think it is a shame that therapeutic exploration on mind altering substances were neglected until recently. However, I know recklessness in this domain is lethal, so I support proceeding with great caution. I have seen the dark side of an immature approach on the body, mind and spirit.
As with your friend, it's fairly common for people to try psychedelics and not feel much of anything. While they benefit a lot of people, some do not benefit and some actually see their mental health worsen. Unfortunately, the lack of willingness to follow accept methodology with the Harvard Psilocybin Project continues into the present. With the recent FDA application with MDMA, the company involved failed to report suicidality as well as data FDA explicitly asked for that could speak to dependence risk with this class of amphetamines.
There are a lot of deeply unserious people pushing for the commercialization of psychedelics. That is distracting from simply decriminalizing them at the community level and promoting greater harm reduction education.
Of course, a reckless diet, reckless driving etc....There are parameters we need to abide by, like not driving after drinking, not climbing Everest without training and guides, not driving without a seat belt, not taking experimental gene products etc.....
YES! A thousand times YES. Let’s have a return to common sense. Maybe now we can ditch the ones in the FDA who are captured by Big Pharma and put people in there who are actually concerned with our health and safety instead of their own pocketbooks. (Could that ever actually happen? I really don’t know.) The list of conflicts of interest - the overlap between FDA employees and pharmaceutical company employees - is absolutely mind-blowing; half the FDA moonlights for Pharma. Truly the wolves have been guarding the henhouse. And that is why psychedelics have been stymied. Big Pharma makes a lot less money bc 1, they can’t patent a plant, and 2, these treatments are *actually* safe and effective, so people don’t need as many unsafe, ineffective - even harmful - pharmaceuticals. We moms of kids with epilepsy - especially the intractable seizures - know this very well. CBD was blocked at every turn until a pharmaceutical company came out with *their* version of it. The people of this country deserve better. Throw out the shills and let’s make America mentally healthy again.
What is the difference between using MDMA and psychedelics that result in therapeutic effects instead of not helping or causing other mental disturbances?
I hope the right people read your suggestions. They seem very practical in my view.
I believe there should be reduced demonisation for naturally occurring substances that humanity has learned to co-exist with in the past and has some natural evolved resistance and detox capacity for.
When totally foreign substances are used in treatment it breaks the natural functions of the body instead of realigning them.
On a bit of tangent, I also hope the prez-elect and his administration will take a hard look at reforming how psychiatry broadly is used — or misused — by a wide variety of federal agencies.
One example is the Federal Aviation Administration (FAA) Civil Aerospace Medical Institute (CAMI). The FAA Federal Air Surgeon, Susan Northrup, should resign, and the Aerospace Medical Certification Division, AAM-300, of CAMI needs to be drastically overhauled or replaced. The operation is an abyss of power drunk bureaucrats masquerading as “medical experts” with recklessly wrong beliefs about “psychiatric” issues, and they are having a ruinous effect on pilots and air traffic controllers.
We (humanity) would benefit greatly if Dr. David Martin would be allowed to present his totally unambiguous findings concerning the Covid/vaccine fiasco on a grand scale. He is ABSOLUTELY the go-to source on this topic.
This is a great post which really underscores the benefits of psychedelics and the absurdity of not allowing them to be used properly. The big Pharma lobby is huge. 3.4 pharmaceutical lobbyists for every US Senator and Congressperson. I did notice at my doctor's office, a ketamine treatment center. Seems like that's a step in the right direction. sabrinalabow.substack.com
I think this letter, to be addressed properly, requires we rethink the entire area of psychological drugs - including those now legal. Every time another school massacre occurs, I question the "legal" drugs the child was taking. All to often such details are conveniently omitted. I question what would have happened to me if when I was a child they gave me ADHD drugs? In short, I am not confident we even know how to handle these powerful drugs, legal or not. Surely teachers and counselors have time and time again proven themselves insufficiently reliable or mature enough at playing a role in potentially dangerous health decisions. Just ask parents scared of having their child being groomed by activist teachers intent on playing God with children. Before we answer the questions posed by the letter, we need to take a hard look at our systems and capabilities. Having said that, the letter correctly points out the hypocrisies in our health system. And for those unable to personally manage drugs of any kind, the results can be deadly. We can all agree this is an area where we need to tread very carefully.
I am all for the use of plant medicine, psychedelics to treat depression, anxiety, deal with trama and addiction. Gabor Mate is a good person to look at regarding this. I did LSD back in the day in my 20s. Now in my 70s I have within the past 20 years, used ayahuasca 3 times under guidance of shaman. I feel that 95% of people should participate in ayahuasca under guidance of wise person. I have also used mushrooms more recently and one catapult experience with DMT. From my experience the plant medicines give you the insight that you need, facilitate healing and alter your view of the world. I met my angels and guardians and felt extraordinary loved under influence of ayahuasaca. Under the influence of psilocybin I fell in love with everyone. Overwhelmed by beauty. I carry these experiences with me and can draw upon them.
What fools you are. How's that shit show of genocide, war with Iran, China, Venezuela, yeah, what a fucking pile of crap you all have fed yourself. WHO the fuck cares about "the path forward for healing, freedom and recovery" for fucking AmeriKKKans and Westerners when daily dozens are bombed and murdered by that fucking caring Wailing Wall White House, which is now MIGA -- make isra-Hell great again.
Dirty dealings.
“All the other stuff, the love, the democracy, the floundering into lust, is a sort of by-play. The essential American soul is hard, isolate, stoic, and a killer. It has never yet melted.” -- Lawrence
Fuck your cocksucking belief in this next trauma creating, safety net cutting, fucked up white boy/men "administration."
Rogan? Vance? YOU HAVE got to be kidding, these two fucking ignorant fucking fan boys.
"Recently, an application for MDMA-assisted psychotherapy for PTSD was rejected by the FDA. While the full reasons for the rejection remain unclear..."
The reasons are very clear.
The Multidisciplinary Association for Psychedelic Studies (MAPS) and its for-profit branch LYKOS had its Phase III trials de-published for covering up a suicide attempt, failing to report data that FDA explicitly asked for, and recruited therapists and participants into a grandiose, exaggerated organizational culture that made blinding of trials impossible. This organization was also held criminally liable for the death of a 20-year old in their care, is alleged to have stolen money from an elderly man, and has covered up sexual and physical abuse multiple times. Moreover, these treatments would have cost $15,000 or more if FDA had given these entities "exclusive authorization" (a monopoly) to sell them for six years. The approval process is flawed, yes. But "evergreening" and exclusivity rules are even worse for innovation over all.
Certainly, the federal government should de-schedule psilocybin mushrooms. But MDMA has a much more acute harm profile than other psychedelics, and the federal government should not do business with organizations that have lied to medical journals and the FDA.
Some but not all of these issues, as well as multiple other issues not mentioned here, were discussed by the public advisory panel, but the FDA has not publicly stated which issues were decisive by the FDA itself in the rejection. In addition, some of this was in phase II, not phase III data under consideration, and some of the issues were still under investigation. The death was associated with a harm reduction program at a festival rather than clinical trial research. Overall, the point we made is true that the specific reasons by the FDA for the rejection have not been elucidated by the FDA.
I have an elderly friend, who for her 80th birthday went to the desert last year, with a small group of people who signed up for the ayahuasca ritual. She had images for a short amount of time of a computer with Japanese figures from a game, then she fell asleep. She was very disappointed. No epiphany or metaphysical answers she was hoping for. When I was young, I spent a lot of time with Dr. Timothy Leary, and his friends, including those studying the therapeutic effects of LSD on human consciousness. I learned a lot. During his time working at Harvard, he and Richard Alpert were involved in the Harvard Psilocybin project. They were fired due to various concerns on methodology. I think it is a shame that therapeutic exploration on mind altering substances were neglected until recently. However, I know recklessness in this domain is lethal, so I support proceeding with great caution. I have seen the dark side of an immature approach on the body, mind and spirit.
Thank you for sharing.
As with your friend, it's fairly common for people to try psychedelics and not feel much of anything. While they benefit a lot of people, some do not benefit and some actually see their mental health worsen. Unfortunately, the lack of willingness to follow accept methodology with the Harvard Psilocybin Project continues into the present. With the recent FDA application with MDMA, the company involved failed to report suicidality as well as data FDA explicitly asked for that could speak to dependence risk with this class of amphetamines.
There are a lot of deeply unserious people pushing for the commercialization of psychedelics. That is distracting from simply decriminalizing them at the community level and promoting greater harm reduction education.
Recklessness is frequently lethal in many other things besides psychoactive substances.
Of course, a reckless diet, reckless driving etc....There are parameters we need to abide by, like not driving after drinking, not climbing Everest without training and guides, not driving without a seat belt, not taking experimental gene products etc.....
The problem is the choice of the people setting the parameters and their bad intent.
YES! A thousand times YES. Let’s have a return to common sense. Maybe now we can ditch the ones in the FDA who are captured by Big Pharma and put people in there who are actually concerned with our health and safety instead of their own pocketbooks. (Could that ever actually happen? I really don’t know.) The list of conflicts of interest - the overlap between FDA employees and pharmaceutical company employees - is absolutely mind-blowing; half the FDA moonlights for Pharma. Truly the wolves have been guarding the henhouse. And that is why psychedelics have been stymied. Big Pharma makes a lot less money bc 1, they can’t patent a plant, and 2, these treatments are *actually* safe and effective, so people don’t need as many unsafe, ineffective - even harmful - pharmaceuticals. We moms of kids with epilepsy - especially the intractable seizures - know this very well. CBD was blocked at every turn until a pharmaceutical company came out with *their* version of it. The people of this country deserve better. Throw out the shills and let’s make America mentally healthy again.
It would be easier to ditch the FDA.
What is the difference between using MDMA and psychedelics that result in therapeutic effects instead of not helping or causing other mental disturbances?
I hope the right people read your suggestions. They seem very practical in my view.
I believe there should be reduced demonisation for naturally occurring substances that humanity has learned to co-exist with in the past and has some natural evolved resistance and detox capacity for.
When totally foreign substances are used in treatment it breaks the natural functions of the body instead of realigning them.
Naturally occurring substances should be exempt from government regulation.
Replace getting high with getting high. How could THAT go wrong?
This proposal seems sensible.
On a bit of tangent, I also hope the prez-elect and his administration will take a hard look at reforming how psychiatry broadly is used — or misused — by a wide variety of federal agencies.
One example is the Federal Aviation Administration (FAA) Civil Aerospace Medical Institute (CAMI). The FAA Federal Air Surgeon, Susan Northrup, should resign, and the Aerospace Medical Certification Division, AAM-300, of CAMI needs to be drastically overhauled or replaced. The operation is an abyss of power drunk bureaucrats masquerading as “medical experts” with recklessly wrong beliefs about “psychiatric” issues, and they are having a ruinous effect on pilots and air traffic controllers.
If a problem is caused by a federal agency, the obvious solution is its abolition.
That suits me. I'm just not sure the general public is on board with being quite so drastic yet.
Freedom is not drastic, oppression an regulation is.
We (humanity) would benefit greatly if Dr. David Martin would be allowed to present his totally unambiguous findings concerning the Covid/vaccine fiasco on a grand scale. He is ABSOLUTELY the go-to source on this topic.
This is a great post which really underscores the benefits of psychedelics and the absurdity of not allowing them to be used properly. The big Pharma lobby is huge. 3.4 pharmaceutical lobbyists for every US Senator and Congressperson. I did notice at my doctor's office, a ketamine treatment center. Seems like that's a step in the right direction. sabrinalabow.substack.com
I think this letter, to be addressed properly, requires we rethink the entire area of psychological drugs - including those now legal. Every time another school massacre occurs, I question the "legal" drugs the child was taking. All to often such details are conveniently omitted. I question what would have happened to me if when I was a child they gave me ADHD drugs? In short, I am not confident we even know how to handle these powerful drugs, legal or not. Surely teachers and counselors have time and time again proven themselves insufficiently reliable or mature enough at playing a role in potentially dangerous health decisions. Just ask parents scared of having their child being groomed by activist teachers intent on playing God with children. Before we answer the questions posed by the letter, we need to take a hard look at our systems and capabilities. Having said that, the letter correctly points out the hypocrisies in our health system. And for those unable to personally manage drugs of any kind, the results can be deadly. We can all agree this is an area where we need to tread very carefully.
I am all for the use of plant medicine, psychedelics to treat depression, anxiety, deal with trama and addiction. Gabor Mate is a good person to look at regarding this. I did LSD back in the day in my 20s. Now in my 70s I have within the past 20 years, used ayahuasca 3 times under guidance of shaman. I feel that 95% of people should participate in ayahuasca under guidance of wise person. I have also used mushrooms more recently and one catapult experience with DMT. From my experience the plant medicines give you the insight that you need, facilitate healing and alter your view of the world. I met my angels and guardians and felt extraordinary loved under influence of ayahuasaca. Under the influence of psilocybin I fell in love with everyone. Overwhelmed by beauty. I carry these experiences with me and can draw upon them.
The easy way to solve most of our drug problems would be to abolish the DEA and the FDA.
What fools you are. How's that shit show of genocide, war with Iran, China, Venezuela, yeah, what a fucking pile of crap you all have fed yourself. WHO the fuck cares about "the path forward for healing, freedom and recovery" for fucking AmeriKKKans and Westerners when daily dozens are bombed and murdered by that fucking caring Wailing Wall White House, which is now MIGA -- make isra-Hell great again.
Dirty dealings.
“All the other stuff, the love, the democracy, the floundering into lust, is a sort of by-play. The essential American soul is hard, isolate, stoic, and a killer. It has never yet melted.” -- Lawrence
Fuck your cocksucking belief in this next trauma creating, safety net cutting, fucked up white boy/men "administration."
Rogan? Vance? YOU HAVE got to be kidding, these two fucking ignorant fucking fan boys.
https://paulokirk.substack.com/p/what-the-fuck-kind-of-lobotimizing
Vance's conversation on Joe Rogan's Podcast indicate an openess to exploring these treatments.
Maybe he has already been doing so.