If you are facing a terminal illness or life-threatening condition, you might be eligible to legally use psilocybin (mushrooms) under state and federal Right To Try laws. Below we provide more information about psilocybin treatment and Right To Try laws, and a FAQ sheet you can download to review with your family and physician.
If you do meet criteria for use of an investigational substance, such as psilocybin, under Right To Try, we can offer facilitation, support, and integration of your psilocybin sessions, in collaboration with your physician. Review the information below and talk with your physician to explore whether this is a treatment option you would like to pursue.
PSILOCYBIN (MUSHROOMS) FOR END OF LIFE DISTRESS
Major research institutes, including Johns Hopkins University, New York University, Harbor-UCLA School of Medicine, and the Heffter Research Institute, among others, have conducted rigorous studies of classic hallucinogens, like psilocybin and LSD, for end of life depression and anxiety. Psilocybin is a naturally occurring substance found in certain species of mushrooms. These mushrooms have a very long history of ceremonial use among indigenous populations, particularly in Mexico and Central America where they are called “the flesh of the gods.”
In a major study by researchers at New York University, 29 patients with life-threatening cancer were given a single moderate dose of psilocybin with psychotherapy. Patients reported an immediate reduction in anxiety and depression, and 60-80% of patients reported sustained improvement at 6 months. At follow-up, 70% of patients reported the psilocybin session was among the top five most personally meaningful experiences of their lives.
Johns Hopkins School of Medicine conducted a similar study, administering 51 patients a single high dose psilocybin session with therapeutic support. Patients again reported large and sustained increases in depression and anxiety, as well as increased optimism, death acceptance, and life meaning. Researchers linked these therapeutic improvements to the mystical-type experience that psilocybin can produce. In interviews with study participants, they shared experiences of coming to new understandings of death and dying, a sense of interconnectedness or unity with all things, and reconnecting with a sense of aliveness and belonging. The most common adverse effects reported in these studies were headache, nausea, transient anxiety, and elevated blood pressure and heart rate. All adverse effects were described as tolerable and no signs of serious harm or addiction were observed.
THE RIGHT TO TRY LAW
In October 2018, psilocybin was designated a “breakthrough therapy” by the U.S. Food and Drug Administration for treatment-resistant depression. It is currently undergoing clinical testing for eventual legal use for this condition.
This process can take many years. Until then, patients with a terminal illness who are not enrolled in a clinical trial can possibly access investigational substances through the FDA’s compassionate use program.
Another law, called The Right To Try, allows patients to bypass the FDA mechanism and, instead, approach a manufacturer directly for access to an investigational substance. Right To Try limits the liability of prescribers, manufacturers, distributors, and patients for recommending, providing, or possessing an investigational drug. Colorado was the first state to pass a Right To Try law, and in 2018, similar legislation was passed at the federal level.
AM I ELIGIBLE? The table below compares the requirements for the federal and state Right To Try:
RIGHT TO TRY
Patient has a “life-threatening” condition: likelihood of death is high unless course of condition is interrupted; the disease or condition has a fatal outcome.
An “eligible investigational drug” has passed Phase I testing and is currently being investigated in clinical trials.
Patient has exhausted approved treatment options and is unable to participate in a clinical trial.
Treatment is recommended by a doctor, with adequate informed consent.
Right To Try law limits liability of a sponsor, manufacturer, dispenser, or prescriber.
Not much about access to the investigational drug.
RIGHT TO TRY
Patient has a “terminal illness”: a disease that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.
same as federal.
same as federal.
same as federal.
similar to federal.
The State shall not block or attempt to block an eligible patient’s access to an investigational drug.