The War on Drugs: History, Policy, and Therapeutics

Psilocin and psilocybin, hallucinogenic principles contained in certain mushrooms, notably the two Mexican species Psilocybe mexicana and P. cubensis (formerly Stropharia cubensis). Hallucinogenic mushrooms used in religious ceremonies by the Indians of Mexico were considered sacred and were called “god’s flesh” by the Aztecs. In the 1950s the active principles psilocin and psilocybin were isolated from the Mexican mushrooms. As a result of their subsequent recreational abuse, psilocin and psilocybin and the mushrooms that contain them came under strict regulatory control.

Psilocin and psilocybin are not used in modern medicine, but research suggests that they may have potential applications in the treatment of anxiety and in the improvement of quality of life for terminally ill patients. The substances have also been used in human subjects to better understand the effects of hallucinogens on the brain and to investigate various aspects of psychosis, personality, and consciousness.

Britannica, T. Editors of Encyclopaedia (2018, July 5). psilocin and psilocybin. Encyclopedia Britannica. https://www.britannica.com/science/psilocin

Description of Psilocybin by Dr. Jonathan Iliff

Psilocybin Labeled a Breakthrough Therapy

What is a Breakthrough Therapy?

"Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)."

Office of the Commissioner. (n.d.). Breakthrough therapy. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy.

From "Psychedelic psilocybin therapy for depression granted Breakthrough Therapy status by FDA" -by Rich Haridy

"In an extraordinary step forward for the psychedelic drug research community, the US Food and Drug Administration (FDA) has just given psilocybin therapy for treatment-resistant depression a Breakthrough Therapy designation. This classification suggests the treatment has demonstrated significant potential in early clinical evidence, allowing the FDA to assist and expedite subsequent development and review processes."

...

"One of the interesting looming implications of psilocybin's acceleration towards legitimate medical use is that if it passes phase III clinical trials the FDA will be forced to recommend a change to the drug's restrictive Schedule 1 control. Schedule 1 is the most restrictive category of drug control in the United States, essentially establishing the substance as highly addictive and having no medical benefit. This kind of oppressive classification limits the breadth of research into potential beneficial uses for specific drugs."

Haridy, R. (2018). Psychedelic psilocybin therapy for Depression Granted Breakthrough therapy status by FDA. New Atlas. Retrieved from https://newatlas.com/psilocybin-magic-mushrooms-depression-fda-breakthrough-therapy/56928/?itm_source=newatlas&itm_medium=article-body.