An independent research body gets set to offer the first detailed study of marijuana and its effects on Veterans suffering from Post-traumatic stress disorder (PTSD). But, suddenly, the entire project derails. What happened? The government-supplied cannabis shipment was found to be substandard at all levels, and the researchers involved cried public foul.
The government-funded university sponsor retaliated by pulling out of the study. This was contrasted with a University of California, San Diego study that was set to examine the effects of a shaking disorder in the elderly. Researchers there were able to bypass the poor-quality federal marijuana altogether—they decided to receive a shipment of very high-quality Tetrahydrocannabinol (THC) capsules from a large corporation in Canada. The shipment resulted in a 100-percent stock gain for said Canadian company within 24 hours, and makes national headlines.
Something does not add up.
Since the late 1960s, the federal government has required all marijuana used in research to come through the regime, grown at a single facility at the University of Mississippi, and overseen by the National Institute on Drug Abuse (NIDA). The NIDA is under the umbrella of the Department of Health and Human Services (DHHS). The issues associated with the cannabis grown at Ole Miss are legendary in the research world, considering that the chief marijuana developer at the University of Mississippi has called cannabis a “gateway drug” multiple times (on record), and was instrumental in shaping Ronald Reagan’s stiff marijuana penalties in the 1980s.
In other words, the chief overseer of a federally-funded marijuana research program personally believes the product he grows is a societal toxin. Could this be a reason for the poor-quality cannabis produced at UM?
The Mississippi grown marijuana seems to be sub-par in physical appearance, and it might also have a potency conundrum. Supposedly, the marijuana grown for the NIDA has a maximum potency of about 13-percent THC. However, Sue Sisley, M.D., of the Multidisciplinary Association for Psychedelic Studies (MAPS), conducted her own testing and found that the strain labeled at 13-percent that she received for her Veterans PTSD study was actually closer to eight-percent. Compare this to the 19-percent THC content available in commercial marijuana sold in Colorado, according to an independent laboratory that tests commercial marijuana. In fact, some commercial growers are developing strains that push 30-percent. The physical difference in quality between commercial cannabis and the NIDA-supplied research cannabis MAPS received is quite staggering, and you can clearly see for yourself here.
The Center for Medical Cannabis Research at the University of California, San Diego got federal approval to import cannabis from Tilray—a GMP-certified medical cultivation company based in Canada, but active on five continents—for use in clinical trials. The ongoing tests plan to assess relief for elderly patients with essential tremors, which is a nerve disorder that causes shaking comparable to Parkinson’s disease. The UC San Diego researchers said they needed marijuana extracts in capsule form because it’s easier to monitor the precise doses patients receive; research might be more difficult when patients smoke or vaporize the cannabis.
Additionally, there was more concern regarding the quality of marijuana UC San Diego could obtain from NIDA, and how effective it would be for the purposes of the study. Marijuana compounds have been imported for clinical trials before, including by Britain-based GW Pharmaceuticals, which won approval in July 2018 to sell its purified cannabidiol (CBD) capsule, Epidiolex, to treat severe forms of epilepsy. Epidiolex was the first cannabis drug approved by the US Food and Drug Administration (FDA).
On the other hand, the Veterans clinical trial administered by MAPS, the aforementioned California non-profit, was completed in February (publication of results coming) after a long road of work. It is an original examination funded by a $2.156 million grant from the Colorado Department of Public Health and Environment (CDPHE). It explores whether smoking marijuana can help reduce PTSD symptoms; 76 US Veterans with chronic, treatment-resistant PTSD participated. Since its inception in 1986, MAPS has raised over $36 million for psychedelic therapy and medical marijuana research and education. MAPS is working to evaluate the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses regulated by the FDA.
So, here we have two equally-based research institutions that each seeked forms of cannabis for equally meritorious studies.
Johns Hopkins University in Baltimore, Maryland was the primary research site for the MAPS exercise on PTSD, offering its facilities and access to test subjects. But Dr. Sisley—Principal Investigator with MAPS—dared to question NIDA’s shipment of marijuana when it arrived to the laboratory in January 2017. It stands to reason that in order to investigate the real-world effects of marijuana, researchers need a product that looks and feels like marijuana that test subjects would actually consume. But what arrived was something completely different. “While the real stuff is chunky and dark green, the government weed is stringy and light in color,” Dr. Sisley said during a PBS News Hour interview. “It appears to be full of stems, which most consumers don’t smoke. It doesn’t resemble cannabis. It doesn’t smell like cannabis.”
That public challenge to government cannabis had sizeable consequences. Johns Hopkins University, infuriated by the disclosure, pulled its rug out from under the study within 48 hours despite 18 months of participation. Fueling Dr. Sisley’s concerns were lab tests which revealed the government-supplied marijuana MAPS received from NIDA showed very high levels of mold and yeast due to extensive periods of refrigeration. This could have signaled the death of the entire flagship study. Dr. Sisley and her team persisted, and Scottsdale, Arizona eventually provided a new location for the MAPS clinical trial. Mold and yeast issues were addressed, and a grant from the State of Colorado put everything back on track for a 2019 date. But in an ironic twist, the local Veterans Affairs Medical Center in Scottsdale refused to allow MAPS researchers through its doors to find the 76 veterans it needed to conduct the study.
Another obstacle, but MAPS eventually pushed through another wall. Meanwhile, UC San Diego Health—as well as a foreign-based company—can import medicinal cannabis compounds to the United States for clinical studies.
Why was a clinical trial specifically designed to study Veterans and PTSD forced to use lousy, US-lab grown marijuana when two million Veterans continue to die at the rate of 22 per day from PTSD-related issues? And why was the veteran-related study almost destroyed by a government-funded educational institution?
Marijuana is medically legal in 33 US states, but cannabis research is still a torturous process. And in the eye of many Veterans, the “thank you for your service” mantra is still not enough.