|Ask Dr. Shulgin Online
ARCHIVE: September 12, 2001
Roadblocks to Entheogen Research
Dear Dr. Shulgin:
Why won't the FDA allow studies of the effects, both good and bad, of MDMA on humans?
I think that you are over-concentrating on the FDA as being the delaying-body for such research, when in truth, there is a bureaucratic mass that effectively disallows research in the area of illegal drugs. The obstacles that will be encountered with any such request are many. Let me present a hypothetical example.
You are a Professor of Chemistry at the Athabasca University in Idaho. As an outgrowth of a discussion at the graduate seminar last Monday afternoon you would like to verify that MDA is indeed the primary metabolite of MDMA, in man. So you go into the lab on Tuesday morning, diddle with simple chemicals for a few hours and come up with a few hundred milligrams of MDMA. You eat 120 milligrams of it at 3:00 p.m., collect your urine at 6:00 p.m., and, making a basified extract of it at 6:10 p.m., get a sample for the GCMS at 6:30 and zap it into the machine. By about 7:00 p.m., you see a big peak for MDMA and another, somewhat smaller, peak that is clearly MDA, and you have the answer to your question. Yup. MDA is certainly a major metabolite of MDMA. All this is ordinary, standard laboratory procedure.
But all of this is secret within your isolated laboratory. What would happen if you wanted to publish this observation and share this finding with the world? Were you to send a paper to Nature with this simple finding, they would reject it since any acknowledgment on their part would make them conspirators to the knowing commission of a felony. You have synthesized an illegal drug without permission. You possess an illegal drug with the intent to sell. You have given an illegal drug to a person (yourself) with the intent to achieve an illegal effect. You have analyzed an illegal drug without permission. You and your Department allies, and your complacent University principals, are all clearly co-conspirators in the commission of a felonious crime. You will be dumped from the University and will be unemployable. Believe me, the FDA is only one obstacle to this noble intent. There are many others. Let me try to indicate some of them.
To perform human studies, a research IND must be obtained from the FDA. This requires that the Human Health Committee of your University review your research proposal and approve it. The proposal must be written out completely, with all the minor details spelled out. What is the legal vulnerability of the University if there is some suit bought by one of the research subjects? What are the Good Laboratory Practices (GLP) that will guarantee quality workmanship? What are the sources of the chemical needed and the assurances that they will be adequate? How will the identity and the purity of the product be assured? What is the source of your reference sample that will confirm identity and purity?
And this is, after all, a Schedule I drug. This is for the DEA. What are the security provisions that will guarantee that it cannot fall into the hands of an unauthorized person. Safety vaults. Registration of all dilution samples. Locks on all refrigerators. Who has the Schedule I license that assumes responsibility for everything being proper? How do you get the sample from the pharmacy vault to the experimental clinic safely?
And what are the criteria for the selection of the human subjects involved? Medical insurance provisions? And more specifically, just what are the questions to be asked? Why do you want to know the ratio of MDA to MDMA? Will this help to explain the recognized toxicity of MDMA in man?
Oh, by the way, where is the money coming from, to pay for this research? Please give details as to the sources and amounts of funds that are dedicated to this study, and the reasons for their interests.
You are looking at a minimum of two years of paper-work. I suggest reading Strassman's DMT book The Spirit Molecule for a painful description of this approval process. It is grotesque. The FDA is only a small component of this mess.
-- Dr. Shulgin