The FDA has officially designated psilocybin as a breakthrough drug. This will make it possible to legally deploy clinical trials of extracts from hallucinogenic mushrooms for the treatment of a serious ailment of our time - chronic depression. The safety of small doses of psilocybin for the human body has already been officially proven earlier.
The term “breakthrough therapy” was introduced in 2012 as a way to bypass bureaucracy and give doctors a chance to validate controversial treatments in a fast-track manner. This method does not guarantee the emergence of a new drug, but it allows testing exotic methods in a clinical setting if they have real benefits in the treatment of a specific disease. In the case of psilocybin and depression, unofficial research has been going on for decades and its effectiveness has long been proven - in words. Now there is a chance to legitimize this practice.
Some experts are frankly surprised by this step by the state, because the recognition of psilocybin as a reliable drug will force the redesign of the restrictive protocol No. 1 (Schedule 1 control). It bans the importation and distribution of addictive substances into the United States, even if they have great medical potential. When marijuana was officially recognized as a drug and recommended to patients, officials made an “exception of exceptions” for the single cannabidiol, Epidiolex, but never changed the protocol.
If psilocybin becomes a cure, major reforms in American medicine are inevitable, and it will surely ricochet around the rest of the world. For example, already now, many physicians and biologists are working on collecting evidence that will redraw the old criteria for assessing drugs and the dangers of drug addiction. Indeed, if in practice people often survive for decades, compensating for health problems by taking illegal drugs, then it is illogical to continue to take the archaic position of total prohibition of all narcotic substances.