It was not until mid-September that after a long and occasionally bitter fight permission to continue our research was finally granted by the FDA. The matter was referred to the Neuropharmacology Department and reviewed by Dr. Jonas Cole, a psychiatrist in charge of reviewing pyschotropic drugs. On September 6, 1978, Dr. Cole called Howard. He was very cordial and during a twenty-minute conversation Howard was able to alleviate the FDA's concern over patient care and safety. At the end of the discussion Dr. Cole said that he would write up the conversation and submit it to Dr. Phillip G. Walters, acting director of the Division of Surgical-Dental Drug Products at the FDA. Dr. Cole said that he would recommend that research permission be granted to carry out our investigation of ketamine therapy. He promised written verification in the near future.
As this book goes to press we are awaiting written confirmation from the FDA with regard to our application for an individual investigator's permit. Since one of the conditions of this application is that "the sponsor assures that clinical studies in humans will not be initiated prior to thirty days after the receipt of the notice by the Food and Drug Administration," we have temporarily suspended our research.
Although we do not know just where and under what conditions, we will be able to resume our samadhi therapy we feel hopeful that the work will proceed with minimal delays. If you, our readers, who are interested in undergoing this high adventure, will write to us in care of Para Research, Whistlestop Mall, Rockport, MA 01966, your applications will be directed to the persons or groups who are currently in a position to see that your requests are honored.
As a final word, we would like to affirm our belief that samadhi therapy will soon be a demonstrable power on this planet. We intend to continue to investigate ketamine's remarkable properties and to give guidance where needed. We pray that people everywhere will use it wisely and well.
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