Guns blazing as they head for the exit, the Bush gang has blasted the hopes of Lyle Craker, a UMass Amherst botany professor who applied in June, 2001 for a DEA license to grow marijuana for FDA-approved medical research. On Jan. 12 Craker got a formal letter of denial from DEA Administrator Michele Leonhartt. Mahmoud ElSohly of the University of Mississippi remains America's only legal grower, as far as the feds are concerned.
Some of the destructive regulations promulgated by Bush in recent months may be reversible, but the DEA's rejection of Craker appears to be final. Lawyers are exploring the appeal options, according to Rick Doblin, who organized legal and political support for Craker. Doblin didn’t sound optimistic on the phone Jan. 13.
Prof. Craker has already won an appeal —but it didn't count, as we shall explain. His application had been rejected by the DEA in December, 2004, following a three-and-a-half year "evaluation process." With pro-bono help from DC lawyers and the ACLU, he appealed. An extensive hearing was conducted by Administrative Law Judge Mary Ellen Bittner at DEA headquarters in Arlington. Team Craker argued that "the current system does not provide an adequate and uninterrupted supply of marijuana for legitimate purposes," and "creating an alternative to the current NIDA-controlled monopoly would promote the advancement of science and research by adding competition without increasing the risk of diversion."
The DEA called ElSohly, who spent December 13 and 14, 2005, defending his monopoly. His testimony was revealing. Much of his work for the government involves testing the potency of thousands of marijuana samples seized by law enforcement agencies throughout the country. On his own time, presumably, he has patented a THC-extract suppository, which a corporation called Insys is trying to market. (Can they think of a better slogan than “Up yours, America?”) El Sohly also has a contract with Mallinckrodt, a giant chemical company that plans to market a THC-extract pill as an alternative to Marinol (which is synthetic THC in prescribable pill form).
ElSohly testified that the marijuana he grows for NIDA meets all the needs of U.S. researchers. His most recent crop, grown in the summer of 2002, averaged about 7% THC. It was stored in drums lined with plastic in refrigerated vaults. Upon getting word from NIDA that a researcher’s request had been granted, ElSohly sends a batch to the Research Triangle Institute in North Carolina to be machine-rolled into cigarettes.
ElSohly testified that marijuana higher than 8% THC would gum up the rolling machines. Moreover, he said, administrators from the University of California's Center for Medicinal Cannabis Research had advised him that patients in clinical trials could not tolerate marijuana with THC content above 8%. That's a dubious claim. In any case, one puff of an 8% THC cigarette provides the same amount as two puffs a of 4%-THC cig. Clinical trial protocols can be adjusted accordingly.
One of the recipients of ElSohly's NIDAwanna is Irvin Rosenfeld, a Ft. Lauderdale stockbroker whose rare bone disorder qualified him for the "Investigational New Drug Program" launched by the feds in the Carter era (and closed to new patients by Poppy Bush when AIDS patients began applying en masse at the start of the '90s). "I had a strong personal interest in ElSohly's testimony," writes Rosenfeld in a forthcoming memoir. "If the quality of government-issued medicine improved, I could smoke less, and the mild side effects would be even milder.
“An aspect of medical marijuana use that the Drug Czar and other Prohibitionists won't acknowledge is: the higher the concentration of THC and other active ingredients, the smaller the amount required by the patient. If the main adverse effect is damage to lung tissue —as Ethan Russo and other researchers have found— then the less a patient has to smoke, the better. Nevertheless, the government regularly issues warnings that 'today's pot is much stronger than pot in the 1970s...' as if that made it more dangerous instead of more efficient!"
One of ElSohly's self-serving contentions was that all marijuana studies should be conducted with material similar in potency to the national average. "What makes sense," he said, "is to look at the national data for potency, for what's out there on the street, and… mimic what's out there and to do research with those kinds of materials."
That approach would be reasonable if the focus of research was harm, not medical benefit; and indeed, almost all the marijuana research NIDA has sponsored over the years has been aimed at finding adverse effects. For those studies, using marijuana comparable to what most Americans are smoking might make sense. But for research aimed at finding beneficial effects, scientists should be provided with the highest-grade strains, not the national average.
Judge Bittner was not impressed by ElSohly's arguments. On Feb.12, 2007, she issued her opinion, which concluded that competition among producers would be in the public interest. DEA lawyers had argued that the existing arrangement involved competition because Craker (and others) could submit a bid against ElSohly every five years when the NIDA contract came up for renewal. Bittner observed, "The NIDA contract requires the contractor to analyze samples of marijuana supplied by law enforcement agencies, a separate activity from cultivating marijuana for research purposes, and a requirement a qualified cultivator may not be able to fulfill."
So Craker won his appeal… but when the name of the game is Administrative Law, nobody wins except the government agency. The judge doesn't decide how the agency must act, her opinion is merely a recommendation that the agency chief can accept, reject, or modify. DEA Administrator Leonhartt and her predecessor, Karen Tandy, sat on ALJ Bittner's opinion for 23 months, and then shot it down, along with the hopes of many drug policy reformers. The record contained letters of support for Craker from Massachusetts Senators John Kerry and Ted Kennedy and 45 members of Congress. "As each day got closer to January 20," Doblin said ruefully, "I couldn't help thinking they might punt it over to the Obama Administration."
Granting a license to a second grower of marijuana for federally approved research seems like the kind of small step away from prohibition that the Obama Administration might be willing to make.
As this goes off to CounterPunch Jan. 15 —the day the DEA decision re Craker was published in the Federal Register— Rick Doblin reports that the lawyers see a ray of hope: “DEA makes a big deal in their final ruling that rejection of the FDA-approved protocols of Donald Abrams and Ethan Russo took place before the current HHS Guidelines were issued. DEA claims that since no rejections have taken place after the guidelines were in force, there is no evidence that it is difficult or impossible for an FDA-approved researcher to obtain marijuana from NIDA. The HHS 1999 Guidelines were issued May 21, 1999. Russo’s protocol was approved by FDA in September 1999 and rejected by NIDA/HHS in December 1999, with the written rejection received in February 2000. We may submit this as new evidence."
A Note on the Coverage
A brief story about the DEA turning down Craker ran in the Boston Globe Jan. 13. It made no reference to the political significance of the timing. Reporter Bina Venkataraman portrayed the whole process and outcome as quite rational: "The DEA decision called the current supply of marijuana for research 'adequate and uninterrupted' and said a second laboratory would not be in the public interest. Since 1968, a federally approved laboratory at the University of Mississippi's School of Pharmacy has grown nearly a hundred varieties of marijuana plants... The plants have been used for clinical studies across the country."
Venkataraman made Rick Doblin out to be a bit of a spinmeister: "Doblin... calls the Mississippi lab a monopoly." When one company controls all the business, it is a monopoly. She falsely summarized and minimized criticisms of ElSohly's operation: "Some researchers complain that access to the laboratory's supply is thwarted by a contract it holds with the National Institute on Drug Abuse, which must approve permits issued by the Food and Drug Administration or the DEA in a process that can take months to complete." Months? The right word would have been "years" or "a lifetime.” And would-be researchers have many complaints in addition to the length of the approval process.
By some strange coincidence —or was it the Ol’ Miss p.r. machine, or NIDA's?— the New York Times ran a flattering interview with ElSohly on Dec. 23, shortly before the DEA announced it was upholding his monopoly. No mention was made of Craker’s application or ElSohly’s opposition to it. I emailed the interviewer, Claudia Dreifus, to ask at whose initiative the piece was written, but didn't hear back. I met Claudia in New York in 1970. She had just published an article about A.J. Weberman, who used to go through Bob Dylan's garbage cans on MacDougal Street. One time Dylan, who had a family and his own privacy to protect, caught Weberman and dealt with him appropriately. Weberman shared his happy recollection of the encounter with Claudia: "All I could think of was 'Bob Dylan is beating the shit out of me.'"
Here she is, all these years later, a professor at Columbia University and a regular in the New York Times Science section, lobbing softballs to Mahmoud ElSohly. Comments in italics are by your correspondent.
Dreifus: What exactly does the Marijuana Project do?
ElSohly: At this laboratory, which began in 1968, we often investigate marijuana's chemistry. We also have a farm where we grow cannabis for federally approved researchers. Our material is employed in clinical studies around the country, to see if the active ingredient in this plant is useful for pain, nausea, glaucoma, for AIDS patients and so on.
The image is of a panoply of clinical trials being conducted in the U.S. —a key point The DEA Administrator made in rejecting Craker’s application.
Dreifus: One of the basic principles of agronomy is to start with good seeds. Where do your seeds come from?
ElSohly. That's a very good question.
Patronizing. He realizes she's not a science whiz.
Most of the illicit material in the 1960s came from Mexico. So, in collaboration with the D.E.A. and the Mexican government, we acquired those seeds. Later, we acquired others from Colombia, Thailand, Jamaica, India, Pakistan and places in the Middle East. That permitted us to study chemical and botanical differences. By 1976, we were growing about 96 different varieties.
Interestingly, that led us to see that there was only one species of cannabis. It had always been thought that there were many. But you could see that the chemistry of this plant is the same qualitatively no matter where it comes from.
He’s claiming undue credit. The one-species theory dates back to Linnaeus The modern paper usually cited in this regard is: Small, Beckstead and Chan. 1975. The evolution of cannabinoid phenotypes in Cannabis. Economic Botany 29:219-232. All three authors were based in Canada, grew their own plants and ran their own analytic lab tests.
What makes each different is the relative proportion of the different chemicals in there, which doesn't make a different species. It's really the same species, but different varieties of it. The different types of varieties hybridize very easily.
Dreifus: Does this mean that one could make genetically modified cannabis?
ElSohly: Yes. Absolutely. That actually has been the trend over the years in the cultivation in the illicit market, and also in the legal market, where we are doing genetic selection, where we select specific materials that have the genes that produce higher levels of THC or some of the other ingredients.
Apparently she means to invoke Monsanto-style Frankenfood genetic modification and he's talking about Mendelian genetics and selective breeding.
Dreifus: So out there in rural Northern California, have they been improving their crops with modern genetics?
ElSohly: They have been doing genetic selection for years. You can see the potency keeps going up. In the 1970s, the seized marijuana had probably 1 percent or less of the active ingredient. Now, it's about 8 percent, on the average.
Some enlightened California dispensary operators have begun using an analytic test lab to determine cannabinoid levels and to check for the presence of mold. According to Steve DeAngelo of Oakland's Harborside Dispensary, "The cannabis that an experienced user would consider ordinary, we're finding, is in the 10%-THC range. Cannabis considered strong would be 20%-THC or higher."
Dreifus: How did you come to your unusual specialty?
ElSohly: The honest truth is
Don't you always tell it like it is, Dr. ElSohly?
that it began out of necessity. In 1975, while I was in my last year of graduate school in natural products chemistry at the University of Pittsburgh, the Lord provided me with twin daughters...
Didn't Mrs. E. have anything to do with it?
Sorry to sound catty. I’ve met ElSohly’s family, his offspring seemed well-adjusted and gorgeous. But his defense of his monopoly has been unseemly, to put it mildly, and the role of the corporate media in upholding marijuana prohibition is reprehensible. Their basic trick is to cover the subject sporadically, assigning reporters who have to make a fast, superficial study of the subject and can barely understand, let alone convey, the connections between legal, political, and scientific developments... Note how assertions made by ElSohly to Claudia D. wound up in the reporting of Bina V... The Times owns the Globe. Maybe they’re applying economies of scale, saving money on facts.
Fred Gardner can be reached at plebesite.com
Date: 16-18 January 2009
Author: Fred Gardner
Source: Counter Punch News