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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 manufacturingor 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 NorthCarolina. 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 forthe 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 gramsor 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.”

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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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 orderto 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 hopingto 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 thestudy’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 expensiveand 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 NationalInstitute of Mental Health, who directed a program that made hard-tofind 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.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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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 rememberwho 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 theFDA 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 carryon 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.

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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 toyour 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 wasto 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 onlyrequirement 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 administered 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 notthreaten 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.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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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 anew 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 numberand 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’sall up to the DEA,” the staff at the New Mexico Board said.

The DEA then told me they would approve the request for laboratory gradeDMT if the hospital pharmacy and staff passed necessary security checks. The paperwork went from Washington to Denver, and from Denverto 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’twant 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 inhandcuffs 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.”

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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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 healthrisks 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 patientdoctorprivilege. 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 theethics 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.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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Within a week of submitting the DMT study, the ethics committee asked me to include the phrase “no currently accepted medical use” in the informed consent’s introductory paragraph. I replied by suggesting this phrase would unnecessarily frighten off prospective volunteers. In addition, if I ever did get permission to run the study, the phrase would no longer, strictly speaking, be true. It then would have currently accepted medical use; in this case, as a clinical research tool. They accepted this answer.

Confidentiality and anonymity were important issues I had to work out with the ethics committee, the Research Center, and the university hospital administration. Nearly all the DMT volunteers had jobs and families, neither of which they cared to endanger by admitting to the use of illegal drugs. Confession to having broken the law was a prerequisite for enrolling in the study, since only experienced psychedelic drug users could participate. I met with staff from the hospital’s medical records department and admitting offices, the head nurse and administrator of the Research Center, and the hospital’s attorney. Together we worked out acomplicated but effective arrangement.

Records of the medical screening performed in the outpatient clinic of the Research Center would hold important medical information. This might be extraordinarily helpful if the volunteer at some future date developed health problems for which the treating physician needed baseline values, for example, regarding heart function. Therefore, we placed the volunteer’s real name on the chart containing results of the physical examination and screening laboratory tests. In this chart was no mention ofdrug use, nor a linking of the volunteer to my drug studies.

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 thecomment: “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.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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The informed consent document would be a major hurdle, and I was direct with the ethics committee about the expected effects of DMT. I did not want to lull volunteers into thinking it would be an easy day, but I also did not want to scare them away by emphasizing potential negative effects. On page two of the consent, this is what the volunteer read:

I understand that the primary effects of this drug are psychological. Visual and/or auditory hallucinations or other perceptual distortions may occur. My sense of time may be altered (short lengths of time passing slowly or vice versa). I may experience very powerful emotions, pleasurable or unpleasant. Opposite feelings or thoughts may be experienced at the same time. I may be extremely sensitive and aware of the environment; on the other hand, I may not notice anything at all in the environment. It may feel like my body and mind have separated. Feelings of impending or actual death or confusion may occur. Euphoria is very common. The onset of the experience is rapid, the experience being very intense with the higher doses within 30 seconds. It peaks within 2 to 5 minutes and is usually felt as only a mild intoxication within 20 to 30 minutes. I will quitelikely feel like my normal self within an hour after the injection.

Regarding risks, the consent form was brief, but honest:
The main effects of DMT are psychological and have been described above. These usually last less than 1 hour. Rarely, emotional reactions to these effects may last longer (i.e., 24 to 48 hours). I can stay at the Research Center as long as necessary to regain my equilibrium, including overnight if desired. . . . DMT is physically safe. Mild to moderate brief increases in blood pressure and heart rate occur.

It would have been premature and inappropriate to suggest in the informed consent that participation in the DMT study offered any potential benefits. While I knew volunteers probably would enjoy their DMT experiences, this was different from suggesting that I was providing treatment for a diagnosable condition. Thus, the consent went on to say:

There are no benefits to me personally as a result of participating in this research. However, the potential benefits are a greater understanding of the mechanism of action of hallucinogenic agents.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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It was incredibly fortunate that the chairman of the crucial ethics committee was a firm believer in libertarianism; that is, that the individual takes precedence over the state. He believed that educated people could make up their own minds. His motto, as head of one of the first and most important review panels, was great encouragement: “We’re not hereto play God.”

The informed consent document is a crucial element of human research. In it, the researcher describes the objectives of the protocol, and why he or she is performing it. The consent states exactly, and in mind-numbing detail, what to expect from participating. It lists the potential risks and benefits associated with volunteering, details how the research team will manage risks, and notes that volunteers will receive all necessary treatment for adverse effects free of charge. The consent reminds the potential research
subject that participation is totally voluntary and ongoing. He or she may withdraw at any time, for any reason, with no penalty or withholding of necessary care. In case a volunteer feels unfairly treated, the informed consent document provides names and phone numbers of people he or she can contact in order to complain.

While negotiating with the university committees, I also began working with the two United States federal agencies that formed the final, and more formidable, regulatory barriers. They held in their hands the ultimatedecisions.

The first was the U.S. Drug Enforcement Administration (DEA). They had a local Albuquerque office, but their headquarters were in Washington, D.C. The DEA would decide if I would be allowed to possess DMT. Ifgranted, this permission would take the form of a Schedule I permit.

The other federal regulatory agency was the U.S. Food and Drug Administration (FDA), which also is based in Washington, D.C. The FDA would decide if it was safe and worthwhile to give DMT to human research volunteers in my study. If granted, the FDA’s permission would take the form of an Investigational New Drug (IND) permit.

When submitting the protocol to the university committees, I told them the study would not begin until the FDA and DEA both gave their permission to administer DMT. However, these federal agencies first required local approval.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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Clinical research scientists in the 1950s and 1960s recognized and usually took into account the unique dangers of LSD and other psychedelics. By doing so, they could successfully prevent or quickly deal with any adverse psychological reactions to these drugs. However, uncontrolled public use, and media-intensive breaches in research protocols by Leary and his colleagues at Harvard, brought the expected responses. These drugs were causing highly publicized problems, and the door had to be shut for damage control.

In order to turn this tide of abuse, Congress emphasized psychedelics’ negative properties at the expense of their positive or neutral ones. What one day was “safety under medical supervision” became “lack of safety under medical supervision” the next. “Medical utility” as research and training tools and aids to psychotherapy quickly changed into “no currentlyacceptable medical use.”

It was into this black hole I peered as I prepared to shepherd the DMT protocol through the regulatory system. them up in 1990, immediately after getting permission to begin the study. I referred to this article as the “what if I’m run over by a bus?” paper. It was important that other people knew how to wind their way through this maze. It was possible, and there was a route through it. If nothing elsecame of the DMT project, I wanted to leave behind this map for success.1

The initial guardians of the regulatory realms were two University of New Mexico School of Medicine committees: the Research Center’s ScientificAdvisory Committee and the Human Research Ethics Committee.

The General Clinical Research Center Scientific Advisory Committee dealt with the science behind my proposal. Fellow researchers on the panel looked at the scientific merit of the study and offered remedial suggestions. They also decided whether to allow its performance at the Research Center, and whether to pay for the many blood tests I requested. Because I had spent the last two years running the human melatonin projectat the Research Center, I was a member of this committee at the time.

The Human Research Ethics Committee dealt with the safety of my proposed study. Its duties were to make sure the project had an acceptable safety profile, and that the informed consent document clearly spelled out the nature of the study and its risks.

Taken from : DMT The Spirit Molecule - Rick Strassman MD.

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