DMT The Spirit Molecule - Rick Strassman-pages

Page 122 of 369

Page 122 of 369
DMT The Spirit Molecule - Rick Strassman-pages

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109 directors." LABYRINTH * discovered he had no information about the drug and couldn't remember who had been his supplier. He wished me good luck. In early May the FDA sent their first letter, signed by Ms. P., advising that if they didn't get in touch within a month, the study could proceed. Of course, I had no DMT. However, they now had the application, and my request received a file number. Sigma now agreed to discuss with the FDA putting together a drug master file for me. In June, Ms. P. at the FDA said Sigma was not providing them enough information about how their DMT was made. Sigma replied that their European DMT supplier refused to release any such information—it was a trade secret. Sigma also was concerned that the FDA was asking for more information about DMT than they did for other drugs Sigma previ- ously had provided for human studies. Sigma gave me the name of the FDA chemist assigned to my application: Ms. R. She and I were to carry on dozens of conversations over the next year and a half. I asked Ms. R. why the FDA was requiring more information about DMT than they did about melatonin for my previous research. She replied, "It's case by case." Sigma complained that the FDA was being unreasonable. The FDA wouldn't move forward until they had more information. When I asked Ms. R. if she knew who was Sigma's supplier, saying that I wished to contact them directly myself, she offered their name. When I asked Sigma to confirm this, they were upset by what they felt was a breach of confi- dence. Nevertheless, they agreed to send the FDA all the information they possessed about their DMT. Lasked Ms. R., "If Sigma's DMT doesn't have all the necessary manu- facturing data, could I purify it so it meets your requirements?" She doubted it. The director of the division within the FDA where she worked before was the fellow who told me, at the brain science meeting some years back, "the dying have rights, too." He had blocked all re- quests by previous researchers to purify laboratory-grade drugs in order to give them to humans. "Maybe it's different now," she said. "This is a new division, with new