Mahmoud ElSohly, PhD -the only marijuana grower licensed by the U.S. Drug Enforcement Administration – testified Dec. 12-13 in opposition to the granting of a DEA license to Lyle Craker, PhD, a professor of Plant and Soil Sciences at UMass Amherst. The scene was a hearing room at DEA headquarters in Arlington, Virginia, presided over by Chief Administrative Law Judge Mary Ellen Bittner, who must decide whether granting Craker a license would be “in the public interest.” Excerpts of ElSohly’s testimony (on direct examination by ALJ Bittner and DEA lawyers) follow.
ElSohly: I am research professor at the National Center for Natural Products Research at the Research Institute of Pharmaceutical Sciences, School of Pharmacy, University of Mississippi. I’m also the resident and laboratory director of my own private laboratory, which is an analytical forensic laboratory in Oxford, Mississippi, ElSohly Labs, Incorporated.
I came to Mississippi right after I finished my doctorate degree from the University of Pittsburgh and started out as a post-doctoral fellow in 1975. In 1976, I became a research associate at the Research Institute of Pharmaceutical Sciences and started working on the marijuana project with my predecessor, Dr. Carlton Turner… I was a teaching assistant at the School of Pharmacy at the University of Pittsburgh before coming to Mississippi, and before that, I was a teaching assistant at the School of Pharmacy, Department of Pharmacognosy at the University of Cairo, and before that, right after graduation with a pharmacy degree from the University of Cairo, I worked with a pharmaceutical company in Egypt… Pharmacognosy is the science of the crude drugs, science of natural products, herbal products.
Q: What areas of research have you accomplished with marijuana? ElSohly: My main focus was actually on the chemistry of the plant. We have done quite a number of publications on the extraction of the plant material, isolation of different components, analysis of the plant material, both with the material that we grow and harvest at the university and also we have confiscated material that we receive. We receive materials from DEA’s regional labs. We receive materials from other State narcotics agents and so on, and we’ve published work along those lines dealing the potency of the materials on the illicit market.
We did work with the pharmacology of some of the cannabis constituents. We did some work with developing procedures for extraction and isolation of tetrahydrocannabinol, normally referred to as THC, which is the main component of the plant and has the psychological properties and most of the pharmacological properties ascribed to the plant. We have developed a process for extraction of the material in an economic way. We also developed other processes for manufacturing or synthesis of other cannabinoids that might have other biological activities.
We have done some product development work that dealt with… a product of THC. We have done quite of number of publications on the analysis of biological effects as a result of ingestion of marijuana and ingestion of the cannabinoids. So we’ve really covered quite a wide range of activities with the plant or with the cannabinoids that are the major components of the plant…
The current folks I have with me: Mr. Zlatko Mehmedic, who is the quality control person. I have Dr. Samir Ross, who was a co-investigator on a project a few years ago. I have Mr. Don Stanford, who is a quality assurance officer for the project. I have a quite of number of young investigators that are working there. Prior to that, I was collaborating with Dr. Carlton Turner who was my predecessor on the project. [Turner left Ol’ Miss to become Drug Czar under Reagan. After a tour of treatment centers he declared that homosexuality “seems to be something that follows along from marijuana use.”]
Q: Can you explain to us what are cannabinoids in terms of marijuana?
ElSohly: Cannabinoids, Your Honor, are the natural components that only exist in the cannabis plant. This is a group of chemical compounds that have not been identified in any other plant. They are defined as a C- compound, meaning they contain carbons. Also, there are derivatives and there are synthetic analogs. Any compounds that were made to mimic those compounds that exist in the plant material are referred to as cannabinoids.
Q: Would the cannabinoids be considered active or inactive ingredients or both?
ElSohly: Some of the cannabinoids -of course, the major cannabinoid that exists in the plant material is the THC, and even THC actually does not exist in the plant material as free THC. It exists as a precursor that has to be heated in order to produce the THC; but nonetheless, it’s the THC that actually exerts most of the pharmacological activities of the plant. There are many, many other cannabinoids that actually do not have the psychological activities that are associated with the drug, but the major cannabinoid is the THC and its precursor.
Q: These other cannabinoids that you mentioned, are they considered active or inactive ingredients, or unknown?
ElSohly: They might have activities, but those activities are not necessarily in the same spectrum of activity as THC. Some just have no known pharmacological activities per se.
Q: How many cannabinoids are there known in marijuana?
ElSohly: At the last count, I believe there is a total of 66 different cannabinoids.
Q: Are there any other active ingredients in the marijuana plant other than cannabinoids?
ElSohly: Again, it depends on what the definitions of “active” are, but as far as I personally know, most, if not all, the pharmacological activities ascribed to the cannabis plant could be accounted for by the activity of THC. So, although some of those other components might contribute to the overall activity of the plant, the net result of the activity of the plant is because of the THC.
Q: You also mentioned the term “extraction…”
ElSohly: Well, extracting the plant material is just like, really, when you make coffee, you’re extracting the coffee grinds. When you make tea, you’re extracting the tea leaves. It just happens for these two examples you use water to do that, or hot water in particular. But with the cannabis plant, because the components in the cannabis that have biological or pharmacological activity are not water soluble or water immersible, then the extraction is usually carried out with an organic solvent. The solvent of preference in most of those extractions is ethanol, simply because if you have some leftover solvent in the extract, then it’s not something that would be, you know, terrible to have. But other organic solvents have been used to extract the plant material, such as petroleum distillates, such as chloroform, such as methyl acetate, acetone, just to name a few.
Q: Dr. ElSohly, in terms of your work with the marijuana plant, are you familiar with the term “fingerprinting”?
ElSohly: Fingerprinting is when you try to define the characteristics of a given group of plants whether based on the country of origin or source or something like that. You’d say, for example, that Mexican samples have a certain fingerprint, a chemical fingerprint. Columbian samples would have possibly a different fingerprint. Jamaican samples would have a third fingerprint. Domestic samples would have a different fingerprint. So when you refer to fingerprinting, you’re chemically defining the components of the plant material that would be characteristic for a given region, and we have done this work back in 1992 or so and, you know, determined that you can actually tell the country of origin or the source of the plant material by doing an exhaustive chemical analysis, which we have done, and we have shown that you can actually tell the difference between Mexican marijuana versus Columbian versus Jamaican versus Thai material versus domestic, is it grown indoors or outdoors… The fingerprint is like an I.D., like a person having a fingerprint that would be characteristic only for that person. We have analyzed over 170 different components in the plant material that make up the fingerprint for the different types of marijuana.
Q: Now, Dr. ElSohly, based on your education and experience, when you talk about potency of marijuana, can you explain to us what potency means in the context of marijuana?
ElSohly: Usually when you talk about the potency of marijuana, you’re talking about it in terms of the concentration of THC in the plant material. So the potency of the plant is directly proportional to the amount of THC in the plant on a weight-by-weight basis. The higher the THC content, the more potent the drug is. The lower the THC content, the less potent the drug is.
Q: Can you tell what “yield” means in this context?
ElSohly: The yield refers to the amount of usable material that one can get or would get from cultivated plants. It depends on whether it’s indoors or outdoors, what the growth cycle is, what part of the country, what kind of plant material, and so on. So when I refer to the yield, I’m referring to the amount of usable plant material that could be obtained, let’s say, per plant or per unit of area… I would have to be given the specifics of the case… If you cut a plant from the base and you just weigh it, a green plant, and I can tell you how much usable material you can get out that plant… Usable material means smokeable material, not seeds, not sticks, not roots, but actual leaves and buds.
Q: Do you provide some of this marijuana to researchers
ElSohly: Actually, all the material we produce under the NIDA contract is used for research.
Q: Is that clinical, nonclinical, or both?
ElSohly: Well, all of the above.
Q: Are you aware of the University of Mississippi’s work with marijuana before you started working there?
ElSohly: Yes, I am.
Q: When was the University of Mississippi’s initial registration with DEA, to your knowledge?
ElSohly: I would say around 1968… You must have a registration with the DEA to be able to do any work with a controlled substance… I believe the first registration was to my predecessor, Dr. Coy Waller, the first investigator that worked at the university back in 1968. After that came Dr. Carlton Turner, who took over in 1971 as director of the project, and so the registration changed to his name, and then it changed to my name in 1980… The registration at the university has always been an analytical laboratory registration that allowed the university to do the cultivation -the production of this material for government use and research activities- and also to do the analytical work, receiving samples from different parts of the country for analysis, and also allowed the distribution under the NIDA program to other investigators. So it’s an analytical laboratory license that really is a broad license that allows you to do research, manufacturing, and distribution.
The work at the University of Mississippi is the result of a contract with the National Institute on Drug Abuse that actually is a competitively-renewed contract, a cost reimbursement contract. The advertisement for the contract was on the Federal Register… giving investigators a chance to submit a response to that request for proposal or RFP… The proposal usually has two components, a technical component and a business component. The technical proposal is reviewed, and the respondents to the RFP would be classified by priorities -this gets so many points, this gets so many points, and so on. They pick the top one or two… and then they look at the business proposal of the price as a secondary qualification, and then they pick the organization that most fits not only in terms of the technical merit, but in price merit. After that, there are some negotiations as far as the price goes with the top organization that they pick. This goes into a three-year cycle. Every three years, the contract is re-advertised, and they get a new request for proposal. It might add new items. It might delete some items, but the basic structure of the contract is the same… The government has options to grow or not to grow. There is a basic clause in the contract for having the contract in place for doing all of the peripheral work that is done besides the production of the plant material. In 1999, for the first time, the government decided to make it a five-year cycle. So the contract that started in November of ’99 was actually a five-year contract.
Q: Now, as of 1980, were you, in essence, the person in charge of the U. Miss.
ElSohly: I was the one who actually submitted the response to the request for proposal.
Q: Were these bids that were submitted for the contracts, were these bids open or secret bids?
ElSohly: These are secret bids. Nobody knows who submitted them. As a matter of fact, to this date, as long as I’ve been working with this contract, I never knew who else applied for the contract. So they are secret bids, and then once you are chosen, whoever it is, it becomes public knowledge, but the whole review process, the whole selection process, and all of that is confidential.
Q: Dr. ElSohly, can you please just generally describe the job functions in relation to being the director of the NIDA project at the University of Mississippi?
ElSohly: Well, I basically oversee all of the different activities that go on with the contract. Of course the registration is in my name. So I am the one responsible for getting the registration in place and following the rules and regulations for dealing with the controlled substance. I direct all of the activities on the contract. I communicate with NIDA and the DEA regarding all of the different aspects, scientific and legal aspects of the project. I supervise all of the activities that go with the contract, the growing, the harvesting, the potency monitoring, the analysis, the extraction of the plant material, the isolation of different components. All of the different aspects of the project, I oversee all of those activities.
Q: Now, Dr. ElSohly, was there a specific written contract that you had with NIDA in 1999?
ElSohly: Yes, there is. Every contract cycle, there is a contract. I might add that even though the contract is a three-year or a five-year contract, it’s actually an incrementally funded contract, which means that you don’t get all the money for all five years or three years at the same time. You get one year at a time, and, you know, I assume the government will have an option to not necessarily do the whole entire three years or five years. So every year, the contract, if everything is going well, they fund another year and another year and another year, but they don’t have to re-advertise between those years, but at the end of the cycle… then there is new advertisement and a new contract will be in place.
Q: Dr. ElSohly, how long did the ’99 contract between you and NIDA exist, for what period of time?
ElSohly: The contract was… supposed to end in November of 2004, but the contract was actually, for some variety of reasons, extended until the new contract was put in place in March of 2005.
Q: Did you as the director of the University of Mississippi bid on the NIDA project contract in 2005?
ElSohly: Yes, I have.
Q: Were you awarded that contract?
Q: And how long would that contract go for?
ElSohly: This one is also for five years.
Q: I’m just going to direct your attention to Government Exhibit 12…
ElSohly: This is the award document for the 1999 contract.
Q: And who are the parties to this contract?
ElSohly: The National Institute on Drug Abuse and the University of Mississippi.
Q: Is there any other party that’s involved in this contract, either as a major contracting party or a subcontracting party?
ElSohly: We usually in this contract would have actually two subcontractors. One major subcontractor, the Research Triangle Institute of North Carolina, that manufactures the cigarettes; and then in the years we grow, we would have a subcontractor for security, but that’s not a technical contributor to the contract. The Research Triangle Institute, RTI, is a technical subcontractor.
Q: Well, let’s call them RTI. How do they operate under this contract?
ElSohly: Their major function is the manufacturer of the cigarettes that are required under the contract. One item in the contract requires that we manufacturer cigarettes, and they carry out all the activities that are related to that manufacturing process, the analysis, the certification, the distribution, and all of the different aspects of getting those materials, those cigarettes, to the researchers. But all the paperwork and everything goes from NIDA to the University of Mississippi as the contractor. We will make sure all the paperwork from our part is completed, and only then we release the material from RTI. We give them the release to ship the materials directly from RTI to the investigator.
Prior to 1999, there was actually two separate contracts. The University of Mississippi had a contract to grow and do the analysis and all the aspects and RTI had a totally separate contract for the manufacture of the cigarettes. So there were two separate contracts. In 1999, the government decided that this should be just one contract that involved the whole activity, and we elected to subcontract that portion of the manufacturing of the cigarettes to RTI since they’ve been doing that for many years and they have the expertise to do that.
Q: Under both of these contracts, are there requirements for growing marijuana?
ElSohly: Yes, sir.
Q: And can you then give a little bit of specifics on the growing of marijuana requirements?
ElSohly: The government actually has several options depending on the demand for materials. They have an option for us to grow only one, one-and-a half acres or six acres or twelve acres, basically the whole garden. We have a 12-acre plot that is secure and so on for production, and the government has three different types of options depending on how much they want us to grow.
So the first thing that has to happen is the government will exercise that option, which means they’re going to have to put more money into the contract just to do that activity. Once we get the request to start the process, then we start the production. We start the production from seed into seedling. It goes to the field for growing them, nourishing them, fertilizing them and so on, cultivating them, until such time as the plants mature, and then we start the harvesting process. And there are some different types of ways that you can cultivate the plant material to get the different potencies as you are harvesting since the contract really requires that you have the plant material with different potencies. So we have to be able to do that. In the 1999 and the current contract, there’s the requirement for having high-potency material, and when I say high potency, it means more than three or four percent, and we have done that in the contract. We have been able to harvest and have the stock and supply of materials as high as 14 percent in bulk, not just by selecting the harvesting of buds and sensimilla and so on, but just in the general production, we have materials ranging all the way from one-and-a-half percent to maybe 14 percent. So this is the production process.
Q: Dr. ElSohly, I want to shift kind of into the contractual-slash-registration process in terms of the requirements for distributing marijuana. So when the University of Mississippi wants to supply marijuana for researchers through NIDA, how does that work?
ElSohly: The correct procedure is for the investigator to send the application to NIDA which then determines, yes, this investigator should get the material. They sign the back of the form and send it to us for processing, and with approval, then we take it from there. If it’s for bulk material, then the material is shipped from our inventory. If it’s for cigarettes, then they’re shipped from the inventory at RTI.
Q: Then what does RTI do?
ElSohly: There are certain forms that have to be filled out by the investigator. We have to receive those forms, and when we have all the proper documentation, then we release the shipment from RTI, which is shipped directly to the investigators, and they have a certain procedure that they follow to do that, including giving the investigator some directions on how to handle the material once they receive it and where to store it and how to humidify it and all of the procedures.
Q: Now, who actually makes the cigarettes to supply to the researchers?
ElSohly: RTI makes the cigarettes. We ship bulk material in multiple kilos to RTI. RTI takes that material, processes it… all the way to making the cigarettes, analyzes the cigarettes, certifies the content of the cigarettes for the THC content and moisture content and all of these aspects, and they are stored at RTI in a freezer, and once they get the order to ship, then they ship that material.
Q: Dr. ElSohly, does the University of Mississippi under your NIDA contract have occasion to sometimes make its own cigarettes?
ElSohly: We’ve only made really one batch of cigarettes… We made that Batch because there was a request from CMCR, the Center for Medical Cannabis Research in in San Diego. They had a request for eight-percent cigarettes and really needed it fast. We got the approval from NIDA… So we made a small batch in Mississippi and then shipped them to RTI where they could be distributed from there.
The reason that RTI did not make those in a timely manner and we had to do this was that the higher the potency is, the more difficult it is for that plant material to go through the cigarette manufacturing machine that RTI has. The cannabis plant, as you might or might not know, is a very resinous plant, and the higher potency means you have more THC, more terpenes. The plant material is very sticky, and it gums the machine the higher the THC content. It makes the plant material actually gum the machine and stop it. So it’s very difficult to do it with this manufacturing. So it has to be hand done, and that’s what we did at the time we made the eight-percent batch.
Q: Thank you, Dr. ElSohly. Now I’d like to ask you what type or kind of researchers obtain marijuana through the University of Mississippi…
ElSohly: Well, that marijuana that we ship to investigators is used for a variety of reasons. It’s used for either animal work, preclinical toxicology in doing animal research. It’s used for clinical work like all the materials that are shipped to CMCR and other investigators around the country. It’s used in chemical research. We use quite a bit at the University of Mississippi and other people around the country that want to investigate the chemistry or any aspects of the plant material. We do that. We ship materials to them. Also, we use it in some of the canine training facilities around the country. They request materials from NIDA, and so we ship materials to them for that purpose… Any research that deals with marijuana comes from our project.
Dr. ElSohly’s informative testimony will be continued.