The signed informed consent document, which was usually attached to the chart, required the volunteer’s real name on the signature line. To protect confidentiality, I kept all signed informed consents under lock and key in my home office. All that was necessary for the “real name” chart was the comment: “Consent signed. Held by Principal Investigator.”
Each volunteer then received a code number, such as DMT-3. From that point on, this anonymous identification was the only one they possessed, and I was the only person who knew the key. They each received a new hospital chart labeled only with their DMT number. The first time we used the code number was for the psychiatric examination detailing their history of drug use and emotional problems.
There was one final concern. This related to outside agencies looking at charts in order to assess long-term effects of exposure to experimental drugs. In my melatonin studies, I included a phrase in the informed consent stating that the manufacturer of melatonin and the FDA might review patient files in order to investigate any risks or problems associated with receiving melatonin. When I included this comment in the DMT consent, prospective volunteers objected. Nevertheless, there had to be some mechanism by which legitimate investigation into possible long-term health risks resulting from DMT could occur. However, it must be voluntary.
The compromise we developed was that if the FDA or the DMT manufacturer wanted to interview research volunteers or look at their medical records, they first had to go through me. I would check with the individual volunteers to see who was interested. Research records certainly could be subpoenaed, but without the key to the code numbers they would be of limited use. I would refuse to divulge the key on the grounds of patient-doctor privilege. It would be a mess, but it was worth it.
As it turns out, in five years of studies with over sixty DMT volunteers, not one breach of confidentiality or anonymity ever occurred. Neither have there been, five years since the studies’ completion, any requests by the authorities to review volunteers’ charts.
The Research Center’s Scientific Advisory Committee acknowledged that the science of the DMT protocol was relatively direct and uncomplicated. They realized the primary obstacles were ethical, political, and administrative, areas in which they had less authority and responsibility than the ethics committee.
There were security and liability concerns, however. The Research Center asked me to keep volunteers in the hospital overnight, to make sure they were watched by the nursing staff for a full day after their participation. I replied that this would cut down on the number of prospective volunteers. Previous DMT studies had sent their volunteers home in the afternoon, following morning studies, with good safety results. They accepted this.
The Research Center scientists also wanted to establish the best time of day to give DMT. Was there a daily rhythm in DMT sensitivity? Were responses greater in the morning or evening? I answered that I didn’t know, but that by giving DMT to everyone at the same time of day, in the morning, we would standardize that factor. We could investigate possible changes in sensitivity throughout the day in a different study.
My research colleagues also requested more justification from the animal literature for drawing blood levels of the various hormones I wanted to measure. These references were easy to provide. Finally, they wanted volunteers to submit urine samples for testing for drugs of abuse.
Within a month, on February 19, 1989, the Research Center approved the DMT protocol. They also agreed to fund my request for testing hormone levels and for developing a method of measuring DMT in human blood.
Three days later, the Human Research Ethics Committee also approved the study.
I then began looking for a source of DMT. At the same time, I had to make sure it was legal for me to possess it once I found it. The simpler of these two tasks was possession, and this depended on the DEA providing me a Schedule I permit.
In April 1989 I met with the university hospital pharmacy about the security requirements the DEA would request for storing a Schedule I drug. Since the pharmacists previously had worked on a marijuana study, they believed their safeguards were adequate.
I sent in my DEA Schedule I permit application. It stated that the permit was necessary to possess laboratory-grade DMT so we could begin developing a way to measure DMT in human blood. Later, the permit would need to cover the human-grade DMT volunteers would receive. This human-grade DMT needed to be purer than that required for laboratory work. Giving people DMT would not begin until the FDA approved the study and the purity of the human-grade drug.
One section of the DEA application asked for DMT’s “drug number.” I called the DEA office in Washington, D.C., and a staff person looked up DMT on the list of national drug codes. This number went into the appropriate box.
I called the DEA two weeks later, but they had no record of receiving my application. The person with whom I spoke said, “We’re moving into a new office, and everything’s in boxes.”
Another two weeks passed—still no record of my request. In a few days, though, I received the entire application back. They needed the correct drug number for DMT. This number was on a sheet of paper they enclosed with the returned application. The person with whom I had spoken earlier had given me the wrong number. I entered the correct number and mailed back the “revised” application that day.
The DEA also wanted a New Mexico Board of Pharmacy Schedule I permit; I applied for and received this certificate within a few weeks. “It’s all up to the DEA,” the staff at the New Mexico Board said.
The DEA then told me they would approve the request for laboratory-grade DMT if the hospital pharmacy and staff passed necessary security checks. The paperwork went from Washington to Denver, and from Denver to Albuquerque.
The local Albuquerque DEA field officer, Agent D., came to the university to meet me and look over the pharmacy in early June of 1989. She asked for the names of all those pharmacy staff who might have contact with the DMT, as well as our addresses, phone numbers, and social security numbers. She found several breaches in security and asked us to get a locked freezer. That freezer was to be placed in the locked narcotics vault. She said I could not have a copy of the freezer key—only the hospital pharmacists should. If any of the drug ended up missing, they didn’t want to suspect me of stealing it.
She had the unsettling habit of joking, every so often, “Well, that won’t land you in jail.” And, “Don’t worry—we won’t take you away in handcuffs for that.”
I tried to laugh with her.
When we said good-bye that day, she summed it up: “It’s your ass on the line. If anything goes wrong—theft, loss, bad record keeping—we look to you for explanations.”
As anxious as her visit made me feel, Agent D.’s last words were the most troubling: “By the way, where will you get the DMT you’ll give to your volunteers?”
Later that month, the DEA approved in principle my request for permission to possess laboratory-grade DMT. I promised not to give this lower-grade drug to volunteers and would await FDA approval on human-grade DMT before starting the study. The DEA still held control over whether I could possess human-grade DMT, because this was to be a different batch of drug.
In March 1989, within a week of obtaining university approvals for the DMT study and just after mailing in my forms to the DEA, I called Sigma Laboratories in St. Louis, Missouri. Sigma was the chemical supply house that had provided melatonin for my human pineal project. There was a listing for DMT in their catalog, and I asked if they would sell some to me. I requested laboratory-grade DMT for our efforts to measure DMT in body fluids. I also asked for clinical-grade drug for human use. Sigma told me that there was no problem in purchasing laboratory-grade DMT—the only requirement was a Schedule I permit from the DEA.
Obtaining human-grade DMT was going to be more complicated, as it called for Sigma putting together specific documentation for the FDA, a “drug master file.” Sigma recommended contacting the investigators who administer
ed DMT to humans in previous studies to find out who had supplied them. Sigma then would know how much detail to provide the FDA. If there were problems finding out who used to have those files, they recommended utilizing the U.S. Freedom of Information Act. This law allows citizens to request privileged information as long as it does not threaten American national security interests.
I obtained a list of all the currently active investigational drug permits in the country so that I could contact anyone who possessed one for DMT. Unfortunately, there weren’t any. My request to find out about the existence of old permits, using the Freedom of Information Act, was not successful. There were no records or files at the FDA for previous DMT permits.
My application to give DMT to humans went in to the FDA in late April. I asked for a reactivation of the old DMT permits that the first generation of researchers had used, hoping the FDA itself might be able to find those old hidden files. One of the scientists who had given humans DMT, a co-author of the “decent burial” paper, agreed to let the FDA look at his old records on my behalf. However, in later correspondence, he 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 previously 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 confidence. Nevertheless, they agreed to send the FDA all the information they possessed about their DMT.
I asked Ms. R., “If Sigma’s DMT doesn’t have all the necessary manufacturing 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 requests 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 directors.”
This was true. The rising tide of AIDS and drug abuse brought into focus the delays in the drug approval process at the FDA. A new division formed to provide expedited review of new drugs for these problems. Fortunately, my DMT request went to this new division rather than Dr. L.’s, where my MDMA proposal never made any progress.
Several months passed, and Ms. R. never did receive any information from Sigma. Sigma felt that the FDA had broken confidentiality, and they probably did not want to get any deeper into what they knew would be a long and complicated process. What was in it for them? I gave up hoping to obtain Sigma’s DMT for human use.
A densely worded letter arrived from the FDA in August 1989, spelling out twenty separate requirements the human-grade DMT must meet. There were no questions about general toxicity, which would require complicated and expensive animal testing. Nor were there concerns about the study’s scientific merit. On those counts, in any event, I was encouraged.
I called the chemist colleague who previously had offered his dire prediction about my only publication being one on the failure to obtain permission to run the study. I asked him directly, “Will you make me some DMT?”
He declined. He did not believe his current laboratory would meet the requirements to qualify as a “manufacturer.” It would be too expensive and time-consuming to try.
I also asked David Nichols, Ph.D., a chemist and pharmacologist at Purdue University in Indiana. He recommended Dr. K. at the National Institute of Mental Health, who directed a program that made hard-to-find research drugs. Dr. K. said his contract prohibited use of his compounds in humans, although perhaps in the future he might request to synthesize human-grade drugs. Dr. K. recommended calling Lou G., an old colleague at a chemical supply house in Chicago.
As it turned out, Lou, who stayed on after another firm bought his company, had provided much of the DMT for American human studies. However, his Chicago firm did not give those researchers any manufacturing or animal toxicity data.
Lou laughed on the phone as he said, “We just told them it was pure—‘95 percent, more or less.’ Things were a lot looser then.”
I wrote to the National Institute on Drug Abuse (NIDA), asking if they had some human-grade DMT. When a month elapsed, I wrote again. Mr. W. replied and said NIDA drugs usually came from a laboratory in North Carolina. Dr. C. directed this group.
I called Dr. C., who told me they could not make human-grade drugs. When reminded of a recently published study in which his laboratory did so for another research project, he said he’d look into it. Even if he did agree to make the drug, he wouldn’t put the drug master file together for the FDA.
He said, “I don’t want the liability. I don’t have insurance for human use. It’s not in my contract.”
Dr. C. recommended getting some DMT from NIDA and purifying it to the required 99.5 percent purity. He thought they might have 5 grams or so “on the shelf.”
When asked about this, Mr. W. answered, “Our DMT is too old. And we don’t have any manufacturing data.”
He continued, “We’ve got a contract with Dr. C. They make what we ask them. There’s another laboratory that prepares their drugs for human use. I think the bigger issue is that there’s not a lot of movement on DMT these days. It wouldn’t be very cost-effective for us to use much money from our contract for such an obscure drug. Let me see what I can find out.”
A few weeks later Mr. W. called back, saying Dr. C. could make DMT, but I would have to pay for it. Dr. C. agreed to calculate an estimate, but repeated that he would not put together the required drug file for FDA. “It’s too much work.”
This seemed minimally promising. When I asked Ms. R. at the FDA about putting together my own drug file on Dr. C.’s DMT, she said she’d get back to me.
“If Dr. C. made the DMT, could I really use it?”
“I’ll check with the drug abuse staff here,” she answered.
“Why wouldn’t I be able to?”
She answered, “I don’t know. Maybe our director, Dr. H., will call you.”
Dr. C.’s estimate of the cost was over $50,000.
“Well,” I said, “thanks for looking into it.”
Another door closed.
I called Ms. R.: “I’m not having much luck. What do you suggest?”
“I’ll go to the Federal Archives Building and see if I can find the previous DMT researchers’ files.”
In July 1989 Ms. R. found the files for these old studies. “The data in them are terrible,” she said. “There’s nothing—no animal data, no chemistry data. We closed it. They never responded to our requests for progress reports. It won’t help you.”
“How did you ever approve that study?”
“I don’t know. I didn’t work here then.” She tried sounding hopeful. “I’ll send the information you need to set up your own dru
g file.”
The information she sent was designed for a large drug company such as Lilly, Merck, or Pfizer. It had nothing to do with an individual investigator.
I called Ms. R. “I need help. Why aren’t you helping me?”
“Our director’s name is Dr. H. Here’s his phone number. Insist on speaking with him.”
I called Dr. H.’s office. Dr. H.’s secretary said, “You’ll need to speak to Dr. W.”
Before I could protest, he transferred the call to Dr. W.
“This is Dr. W.!,” boomed the friendly but commanding voice on the other end of the line. “I’m the only physician on the drug abuse staff in this new division. I know what you’ve been going through. We’re here to help. Don’t despair.”
“How can I get human-grade DMT?” I asked.
“Find someone to make it for you.”
“How about Dave Nichols at Purdue?”
He replied, “That’s possible.”
“Could you and Dave talk with each other?”
“Have Dr. Nichols write to the director, Dr. H. Here’s his address. The name of the staff working on your request is Ms. M. Call her in two weeks.”
I felt something shift with that phone conversation.
I called Dave Nichols. He quoted me a price of $300—just the cost of supplies.
While all these calls were taking place, I knew that funding from outside the University was crucial for the project to gain all the legitimacy it needed. Additional financial support also would free up my time to find human-grade DMT and help the Research Center pay for some of the work I requested. This, in turn, would increase the Research Center’s backing of the protocol.
In looking over some of the old DMT and schizophrenia research, it appeared that the Scottish Rite Foundation, a branch of the Freemasons, had funded some of it through their Schizophrenia Research program. I asked this program to send an application for funding. My DMT proposal already discussed the importance of understanding DMT’s effects in its possible role as an endogenous schizotoxin. Therefore, it took little work to modify the grant to emphasize these issues more clearly.
DMT: The Spirit Molecule: A Doctor's Revolutionary Research into the Biology of Near-Death and Mystical Experiences Page 12