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Title: FDA Designates Psilocybin as “Breakthrough Therapy” for Severe Depression
Source: Blacklisted News/Free Thought Project/FDA
URL Source: https://www.blacklistednews.com/art ... hrough-therapy-for-severe.html
Published: Nov 27, 2019
Author: Matt Agorist
Post Date: 2019-11-30 03:30:02 by Deckard
Keywords: None
Views: 622
Comments: 14

For years, those who have been following and even participating in the benefits of psilocybin have understood and read about the ability of magic mushrooms to combat a number of ailments. From helping the terminally ill come to grips with their own mortality to treating PTSD and depression — psilocybin has a wide range of benefits. Up until recently, however, the government has ignored these benefits and prosecuted those for seeking them out. All that is now changing though, and the US Food and Drug Administration (FDA) has just granted Breakthrough Therapy status to psilocybin for its ability to clinically treat depression.

It is estimated that roughly 7% of the entire United States adult population has had at least one major depressive episode. That number represents over 17 million people, according to the most recent figures out of the National Institute of Mental Health. These numbers are concerning as they have been increasing year after year.

Despite the growing number of people prescribed antidepressants, depression rates continue to climb. It is time to try something new; and while the government usually hinders the process of trying new things, because things have gotten so out of hand the FDA seems ready to break that paradigm. The FDA has granted psilocybin therapy a Breakthrough Therapy designation in hopes of curbing the ever-increasing rates of depression.

According to the FDA,

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

A breakthrough therapy designation conveys all of the fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.

This designation is most often requested by pharmaceutical companies seeking to fast track their new drugs to the market. It is rare that natural medicines like psilocybin are considered for such designation. However, this is the second year in a row that the FDA has given this designation to psilocybin.

The 2018 breakthrough status has focused on psilocybin’s potential to treat severe treatment-resistant depression, or depression in patients who have not improved after undergoing two different antidepressant treatments, according to New Atlas.

As New Atlas reports:

Back in late 2018, the FDA granted Breakthrough Therapy status to the ongoing work from COMPASS Pathways investigating psilocybin, the key psychoactive compound in magic mushrooms, as a therapy for treatment-resistant depression. A large, multi-center Phase 2 trial spanning the US, UK and Europe is currently underway testing a variety of dosing strategies.

This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder (MDD).

“What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” Dr. Charles Raison, the director of clinical and translational research at Usona, said in the statement.

These benefits, although they are now being accepted by the state, have been known about for some time. For years, the Free Thought Project has been reporting on the beneficial effects of psilocybin mushrooms ranging from treating PTSD to addiction and depression. In the land of the free, however, in all places except for Oakland and Denver, cops will kidnap and cage you for having them.

The FDA designation illustrates that resistance to this tyranny is growing and at least one dispensary in Canada is defying the law as well and selling medicinal magic mushrooms online for people with depression and other ailments.

It appears that the push for legalizing mushrooms may be happening just as fast as marijuana and this is amazing news — not just for recreational users, but for people who can benefit from psilicybin.

What’s more, it paves the way for people who are now taking dangerous pharmaceuticals to transition into a much safer treatment.

As TFTP reported last year, a study, published in the scientific journal Neuropharmacology, found that clinically depressed people could benefit from psylicibin.

“Psilocybin-assisted therapy might mitigate depression by increasing emotional connection,” neuroscientist and study author Leor Roseman, a Ph.D. student at Imperial College London, explained to PsyPost.

This is almost the exact opposite of how standard anti-depressants operate, as SSRI’s typically work by creating an “emotional blunting.”

“[T]his is unlike SSRI antidepressants which are criticized for creating in many people a general emotional blunting,” noted Roseman.

“I believe that psychedelics hold a potential to cure deep psychological wounds, and I believe that by investigating their neuropsychopharmacological mechanism, we can learn to understand this potential,” explained Roseman.

The government also stands to lose if more people start using psilocybin.

As TFTP previously reported, mushrooms and psychedelics used to be widely accepted as a treatment for many ailments until government moved in to stop the expansion of human consciousness.

In the 1940s, Western medicine began realizing the potential for psychedelics to treat addiction and psychiatric disorders. Tens of thousands of people were treated effectively, and psychedelic drugs were on the fast track to becoming mainstream medicine. But the beast of oppression reared its ugly head.

In 1967 and 1970, the UK and US governments cast all psychedelic substances into the pit of prohibition. People were waking up to the fact that governments intended to keep the world in a state of war, and that governments were working to keep the populace sedated under a cloak of consumerism. The collective mind expansion of that era came to a screeching halt under the boot and truncheon.

As John Vibes pointed out last January, a study actually confirmed the fear of authoritarians and showed they have every reason to oppose legal mushrooms. According to the study from the Psychedelic Research Group at Imperial College London, published in the journal Psychopharmacologypsychedelic mushrooms tend to make people more resistant to authority. They also found the psychedelic experience induced by these mushrooms also cause people to be more connected with nature.

“Our findings tentatively raise the possibility that given in this way, psilocybin may produce sustained changes in outlook and political perspective, here in the direction of increased nature relatedness and decreased authoritarianism,” researchers Taylor Lyons and Robin L. Carhart-Harris write in the study.

Now, as people share information globally, instantaneously, on a scale unstoppable by the state, we are resuming the advancement of medical research on psychedelic substances like psilocybin. Scientists are challenging the irrational classification of psychedelics as “class A” (UK) or “schedule 1” (US) substances, characterized as having no medical use and high potential for addiction. And, the recent pushes in Colorado, Oakland, and Canada are evidence of this.

After 40 years, it appears that another brick in the wall of prohibition is beginning to crumble in the face of science and logic.

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#1. To: Deckard (#0) (Edited)

FDA Designates Psilocybin as “Breakthrough Therapy” for Severe Depression

Taking a page right from the "marijuana is medicine" handbook in order to legalize "medical" use followed closely by recreational use.

I've said it many times on this forum -- legalize marijuana and all the other "soft" drugs will follow.

misterwhite  posted on  2019-11-30   11:10:26 ET  Reply   Trace   Private Reply  


#2. To: Deckard (#0)

Psilocybin occurs naturally in this world. That means God put it here. Researchers should absolutely experiment with this compound to see what benefits can be derived from it. Even though God placed a curse on this world, He did not leave us without balm (think cocaine derivatives and that last root canal you had)

Having worked in a mental health facility while in grad school, I saw clinical depression first hand. Its not like you're feeling blue and having a down day. Its like the patient is flat, expressionless, unable to eat or drink.

The worst case I saw was that of a mother experiencing severe postpartum depression. Otherwise a high functioning loving mother of older children her most recent birth plunged her into an almost deathlike state. We knew that her baby was at home being denied its mother's care.

They report that psilocybin research is being fast tracked. Good! Why? Treatment for clinical depression is greatly lacking. The doctors didn't have a clue as to how to treat the depressed mother. They eventually got permission to use electroshock therapy which, as I recall, helped ease her out of her depressed condition.

If something good can come out of psilocybin, I'm all for it. Because electroshock therapy isn't pretty.

As to recreational use, a Christian would simply ask "why"? Why does anyone need to use drugs recreationally...when one can experience the presence of God in one's spirit.

watchman  posted on  2019-11-30   15:48:06 ET  Reply   Trace   Private Reply  


#3. To: Deckard (#0)

What's scary is this is the nature of the government we all rely on to make timely decisions about issues like when and who to go to war with.

It ain't exactly like mushrooms were some deep,dark secret. Various Indian tribes were using them for things like this hundreds of years before the white man ever came here. Maybe even thousands of years.

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-11-30   22:02:53 ET  Reply   Trace   Private Reply  


#4. To: misterwhite (#1)

I've said it many times on this forum -- legalize marijuana and all the other "soft" drugs will follow.

Misterwhite,with all due respect,eat shit and die.

You are just terrified that somebody,somewhere is going to have a good time,ain't you?

Probably as you sit at your computer desk with a glass full of liquid depressants (alcohol).

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-11-30   22:04:44 ET  Reply   Trace   Private Reply  


#5. To: sneakypete (#4)

You are just terrified that somebody,somewhere is going to have a good time,ain't you?

Hey dummy. The conversation is for medicine. Not for tripping.

Misterwhite is right and you are wrong. Idiotically wrong.

You also made the point it isn't about medicine but about tripping.

You are afraid someone out there might be doing good instead of fucking their mind up. You are so often on the Dark side. The road to hell.

A K A Stone  posted on  2019-12-01   8:33:21 ET  Reply   Trace   Private Reply  


#6. To: A K A Stone (#5)

You are afraid someone out there might be doing good instead of fucking their mind up.

Exactly. Everyone who engages in an activity out of the norm wants everyone else to change -- either their behavior, the law, or their mindset. Because they're not going to.

Alcoholics, drug users, pedophiles, homosexuals, illegals, prostitutes, jaywalkers, sneakypete, etc. all want everyone else to change so they can feel good about themselves.

Sorry, but I feel no obligation to do so. They're lucky we tolerate them.

misterwhite  posted on  2019-12-01   11:21:39 ET  Reply   Trace   Private Reply  


#7. To: A K A Stone (#5)

Hey dummy. The conversation is for medicine. Not for tripping.

Since you wrote the above,it seems like you would understand what you wrote.

BTW,"tripping" is what makes the mushrooms work for people with emotional and mental problems. Without the "tripping" eating the mushrooms would be a waste of time.

Like I wrote earlier,you are just afraid that somebody somewhere is having a good time.

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-12-02   22:36:05 ET  Reply   Trace   Private Reply  


#8. To: misterwhite (#6) (Edited)

Sorry, but I feel no obligation to do so.

Well,I honestly can't say that I blame you. If I were you I wouldn't be happy about it,either.

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-12-02   22:37:18 ET  Reply   Trace   Private Reply  


#9. To: A K A Stone (#5)

You are just terrified that somebody,somewhere is going to have a good time,ain't you?

Hey dummy. The conversation is for medicine. Not for tripping.

Hey,dummy,sometimes tripping IS healing. It can sometimes allow you to see your own thoughts and actions the same as others see them,and this allows you to gain an understanding that you might be responsible for your own problems. The ability to see and understand yourself is the beginning of being able to change for the better.

I specifically remember being in a bar one night and watching with disgust as some drunken asshole started causing grief with innocent people. As I watched with disgust,I had an instant "mind picture" of me doing the exact same sort of thing a few nights earlier. That was the beginning of my healing and the loss of my 24/7 anger.

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-12-06   19:51:13 ET  Reply   Trace   Private Reply  


#10. To: misterwhite (#6)

Alcoholics, drug users, pedophiles, homosexuals, illegals, prostitutes, jaywalkers, sneakypete, etc. all want everyone else to change so they can feel good about themselves.

You give yourself too much credit.I wouldn't piss on you if you were on fire.

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-12-06   19:52:22 ET  Reply   Trace   Private Reply  


#11. To: sneakypete (#9)

my 24/7 anger

That's a lot of anger.

What got you so angry, if I may ask.

watchman  posted on  2019-12-06   21:20:10 ET  Reply   Trace   Private Reply  


#12. To: watchman (#11)

What got you so angry, if I may ask.

Because I refuse to respond to his posts.

misterwhite  posted on  2019-12-07   9:57:02 ET  Reply   Trace   Private Reply  


#13. To: watchman (#11)

my 24/7 anger

That's a lot of anger.

What got you so angry, if I may ask.

Life in general. I don't choose to get any further into it.

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-12-07   14:50:06 ET  Reply   Trace   Private Reply  


#14. To: misterwhite (#12)

What got you so angry, if I may ask.

Because I refuse to respond to his posts.

ROFLMAO! THAT'S funny!

In the entire history of the world,the only nations that had to build walls to keep their own citizens from leaving were those with leftist governments.

sneakypete  posted on  2019-12-07   14:50:48 ET  Reply   Trace   Private Reply  


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