Now we have come to the end of our book and, as you our readers can see, our ketamine research has only just begun. Hopefully, however, the practice of samadhi therapy has been launched; A door has opened. Let us, therefore, proceed together to explore the shining empire that lies on the other side. It is our heartfelt prayer that the benefits of which we have spoken, and others of which we may yet be ignorant, will be conferred upon humanity, and that our species will thereby be better equipped to regenerate our beautiful and beloved planet Earth.
11: The Days Ahead
From the inception of this project we have made strenous efforts to comply with the letter of the law. Since Howard is a physician, licensed to administer anesthetic and narcotic agents, we were able to obtain our supply of ketamine from a reputable pharmaceutical company.
It also should be pointed out that Howard is a member of the International Anesthesia Research Society, a non-profit scientific and educational corporation founded in 1922 to "foster progress and research in anesthesia." We both attended their annual congress and were impressed with our obligation to carry on the private research which this prestigious organization specifically encourages.
An extremely important point which we wish to emphasize is that ketamine is not on the "Schedule of Controlled Substances" issued by the federal government. This "Schedule" includes such psychedelics as DET, DMT, LSD, marijuana, mescaline, peyote and so forth.
Even with regard to these "controlled" psychedelic agents, there has been a considerable softening of opposition to experimentation and research within the last year. Since we keep up with half a dozen different medical journals we could not help being cognizant of this changing attitude. A significant step was taken when the Department of Health, Education and Welfare decided to sponsor a project designed to explore the further reaches of human capability. This project, called "The Limits of Educability" was approved in December 1977. Its stated purpose is to inquire into such topics as altered states of consciousness, values, cultural "visions," emotional blocks to learning, new scientific paradigms, creativity, synergy, "myths of transformation," psychic phenomena, paradox, non-linear processing capabilities, extraordinary human capabilities, "superhealth," and the politics of personal growth. The project will culminate in articles, a book and a conference.
When we started our "pilot study" it was our understanding that because ketamine is not listed in the "Schedule of Controlled Substances" we did not need to apply for a medical "Researcher Registration." On conferring with the local Seattle office of the United States Department of Justice Drug Enforcement Administration we were assured that in our case no such registration was needed. Nevertheless we were extremely concerned about our legal status. The politics of the nervous system are still so murky that we frequently felt ourselves to be stumbling about in the hinterlands of respectability. Consequently, we both wrote to and called Parke-Davis, the company which developed and markets ketamine, and were told that it was necessary for us to submit to the United States Food and Drug Administration (FDA) a "Notice of Claimed Investigational Exemption for a New Drug." In addition, on May 11, Marcia Moore flew to Ann Arbor, Michigan, and conferred for two and a half hours with Dr. Robert Smith, Assistant Director of the Pharmaceutical Division of Parke-Davis.
Acquiring permission to pursue our samadhi therapy turned out to be an exceedingly complex affair during which we found ourselves enmeshed in a wierd bureaucratic limbo. After extensive, expensive and exhausting efforts on our part to make our position clear to Parke-Davis and to the FDA, our application to investigate the psychotherapeutic uses of ketamine was finally accepted by the FDA. We were duly informed that we could begin our research on June 19.
Accordingly, early in June Howard resigned his appointment at the United States Public Health Services Hospital in Seattle. We booked patients, organized facilities and prepared to move full steam ahead. Suddenly, the FDA instructed us to halt all proceedings until new information could be gathered. We conscientiously complied with all their requests but remained unable to obtain the least help or cooperation, or even to communicate with the people in charge of our case. It seems ironic that ketamine in the dosages we are using is routinely given to burn patients and pregnant women on the point of delivery, yet we were strongly discouraged from making any effort to explore its psychological effects.