The federal government is looking to contract a small business to grow, test, store and ship thousands of kilograms of marijuana of varying potencies and concentrations.
No, really. The contract notice was published on the site Federal Business Opportunities last week—not long after a similar listing called for applications from prospective federal joint rollers. The new posting seems quite a bit more comprehensive, though.
The National Institute on Drug Abuse (NIDA) is soliciting “capability statements” from businesses with the space and technology to produce, analyze and distribute cannabis and cannabis products “for research purposes.”
That’s probably in the agency’s best interest. After all, the government has been roundly criticized for failing to expand its marijuana production to meet demand. Since 1968, just one farm at the University of Mississippi has been federally authorized to cultivate cannabis for research purposes—a monopoly the government has taken some steps toward breaking, although it has faced resistance from now-former U.S. Attorney General Jeff Sessions.
Experts have also raised questions about the quality of the “research-grade” cannabis produced for federal research, as it seems to be significantly less potent and chemically diverse than the flower consumers are getting in legal states.
The listing makes clear that NIDA wants a decently large cultivation operation, including both indoor and outdoor grows. It also emphasized the need to develop marijuana with varying concentrations of THC, CBD and other cannabinoids. Whatever business receives the contract will also be tasked with developing cannabis extracts like oils, capsules and “vaping fluids.”
Here are the full job responsibilities listed on the notice:
-Grow, harvest, process, analyze, and store marijuana for research purposes or procure marijuana and marijuana products from existing commercial enterprises, including from qualified foreign sources, as required by the Contracting Officer’s Representative (COR) to meet program needs.
-Process marijuana to produce a range of standardized and pure extracts containing varying ratios (high, low and equal ratios) of tetrahydrocannabinol (THC) and cannabidiol (CBD) including pure (>99%) delta-9-THC, CBD, and other cannabinoids.
-Store and maintain quality of products, including periodic analyses required to obtain and maintain Food and Drug Administration (FDA) quality requirements for Investigational New Drug (IND) research.
-Develop new methods for growing marijuana plants containing high THC and low CBD; high CBD and low THC; equal ratios of CBD and THC; and placebos as directed by the COR.
-Manufacture standardized marijuana cigarettes.
-Manufacture Current Good Manufacturing Practice (CGMP) human-use marijuana extracts and dosage forms of marijuana extracts (including but not limited to oral solutions, oils, vaping fluids, capsules/tablets) within a range of varying concentrations of delta-9-THC and CBD, and analyze their strength and stability at various intervals.
-Maintain a secure shipping facility, ship marijuana and marijuana products, and establish billing and accounting procedures to allow the collection of fees from product recipients as authorized by NIDA.
There are some basic requirements that applicants have to meet in order to be selected for the job, though. For example, they must prove that they can obtain the necessary licenses to work with controlled substances and also be able to maintain a facility capable of supporting “production of up to 2000 kg of marijuana” and storing “approximately 5000 kg of marijuana stock.”
That’s a lot of federal ganja…
If this sounds like the kind of project your business is willing and able to handle, the deadline to respond to the notice is December 10.
Photo courtesy of Chris Wallis // Side Pocket Images.
Epilepsy Patients Who Use ‘Artisanal CBD’ Have Higher Quality Of Life, Study Finds
Epilepsy patients who used nonprescription CBD products reported a higher quality of life and better sleep than patients who did not take the cannabinoid, according to the results of a newly published study in the peer-reviewed journal Epilepsy & Behavior.
Patients who used CBD products also better tolerated epilepsy medications, used fewer prescription medications overall and experienced reduced psychiatric symptoms such as anxiety, the study found.
No significant differences in seizure control were observed between patients who used CBD and those who did not, but the study’s authors noted that “both groups included a high number of individuals with no past month seizures.”
“These findings further emphasize the need for controlled research to determine optimal CBD product types, doses, and concomitant use of other medications that maximize possible clinical benefit while minimizing potential risks,” the report says.
The study, “Cross-sectional and longitudinal evaluation of cannabidiol (CBD) product use and health among people with epilepsy,” was published Tuesday. It focuses specifically on what authors call “artisanal CBD”—alternatives to the prescription drug Epidiolex, which the U.S. Food and Drug Administration approved in 2018 to treat certain rare types of epilepsy.
“Pharmaceutical CBD is currently a restricted prescription medication, and insurance coverage is often limited to only those patients with the specific approved indications,” the report says. “As a result, a large number of patients with epilepsy elect to use alternative CBD products sold widely as dietary supplements by commercial vendors.”
The research was funded by Realm of Caring, a nonprofit foundation devoted to cannabinoid therapies that is sponsored by companies that make CBD products. The group conducted the study in collaboration with researchers at the Johns Hopkins University School of Medicine.
“Despite the widespread availability and variety of these alternative cannabinoid products—here referred to as artisanal CBD in contrast to pharmaceutical CBD—controlled studies evaluating their safety or efficacy are rare,” the authors write, “making conclusions about the clinical utility of these products uncertain.”
To arrive at their conclusions, researchers analyzed the results of surveys returned by 280 epilepsy patients who said they used so-called artisanal CBD products and 138 patients who used no cannabis products. The participants were selected using Realm of Caring patient registries and social media posts, and follow-up surveys were collected from a subset of 190 participants.
Most patients (74 percent) were white, and roughly half (55 percent) were female. The average age was 21 years old, and most (90 percent) reported no history of non-medical or recreational cannabis use. A majority (93 percent) reported epilepsy as their primary condition, while the other 7 percent developed epilepsy related to cancer, autoimmune or neuropsychiatric conditions, sleep disorders or other conditions.
Although those who took CBD products reported fewer seizures than those who did not, the difference was not statistically significant and may be due to random chance.
Other measures of well being, however, were higher in patients who took CBD. Participants filled out standardized questionnaires on quality of life, pain, anxiety and depression and sleep.
While some indicators, such as pain, did not meaningfully differ between the groups, artisanal CBD users reported greater health satisfaction. Sleep was significantly better among CBD users, and patients who used CBD were also less likely to meet the clinical threshold for anxiety.
Those who used CBD also had lower odds of having gone to the emergency room or calling in sick to work or school during the past month.
“Generally, higher quality of life, lower psychiatric symptom scores and improved sleep were observed among people using an artisanal CBD product based on both cross-sectional and longitudinal comparisons,” the study says. “Artisanal CBD Users reported significantly better epilepsy medication tolerability, a lower odds of prescription medication use and traditional anticonvulsant use, and reduced healthcare utilization compared with Controls.”
“These findings are consistent with research indicating that practitioners recommending CBD in clinical care for epilepsy report integrating the use of CBD both as a means to improve patient quality of life and as well as for seizure reduction,” the researchers noted.
Other patients—about 1 in 5 of the survey participants—reported adverse effects from CBD. These included drowsiness (11 percent), apparent worsening of epilepsy symptoms (4 percent), high or prohibitive cost of CBD products (4 percent), worries over legality (3 percent) and either concerns about or experienced interactions with other drugs.
CBD dosing didn’t seem to significantly impact the outcomes, although higher doses of CBD were associated with higher quality of life scores and lower odds of a past-month outpatient visit. In general, participants reported using a median dose of 1.4 milligrams of CBD per kilogram of body weight, which authors note “is well below the dose commonly associated with pharmaceutical products (e.g., 10 mg/kg/day is the current recommended maintenance dose for pharmaceutical CBD).”
Authors acknowledge there are a number of limitations to the study, for instance the fact that it’s drawn from self-reported data. “These limitations mean that we are not able to directly verify epilepsy characteristics and did not have control over factors like CBD dose or frequency of administration,” they wrote. Moreover, participants were drawn from Realm of Caring’s patient registry, “which may not generalize to the broader population of patients with epilepsy. Of note, the nature of the sample means that there is a possible referral bias and related increases in expectation for clinical benefit.”
Some of the authors also have links to the commercial cannabis industry, according to a study disclaimer. Of the study’s eight named co-authors, one, Ryan Vandrey, has received compensation as a consultant or advisory board member from Canopy Growth, MyMD Pharmaceuticals, WebMD and Syqe Medical. Another, Marcel O. Bonn-Miller, is an employee of Canopy Growth and a past director at AusCann Group Holdings.
Overall, the study says, the findings “highlight real-world evidence for the possible utility of artisanal CBD products in a diverse and heterogenous population of patients with epilepsy. Although the lack of a placebo control group precludes determination of efficacy, the consistent observation of clinically meaningful differences between groups at baseline and with Controls who initiated artisanal CBD product use over time suggests that use of these products can improve health and quality of life for patients with epilepsy.”
Photo by Kimzy Nanney
Surgeon General Says Stop Locking People Up For Marijuana
The nation’s top doctor said on Sunday that it’s time to stop incarcerating people for marijuana use.
“When it comes to decriminalization, I don’t think that there is value to individuals or to society to lock people up for marijuana use,” Surgeon General Vivek Murthy said in a CNN appearance. “I don’t think that serves anybody well.”
Murthy was answering a question about a new draft federal marijuana legalization bill that was circulated last week by Senate Majority Leader Chuck Schumer (D-NY) and other top senators.
While the surgeon general stopped short of endorsing full-scale commercial cannabis legalization, his comments do indicate support for an approach that would at least decriminalize low-level possession.
President Joe Biden, who opposes broad legalization, campaigned on a platform of incremental decriminalization and expunging past records, but has taken no steps to follow through on those promises since taking office.
“When it comes to marijuana, I think we have to let science guide us,” Murthy said in the CNN interview. “And we know that the science tells us that there are some benefits to marijuana from a medical perspective but there are also some harms that we have to consider—and we have to put those together as we think about the right policy.”
US Surgeon General Dr. Vivek Murthy says he doesn't think "that there is value to individuals or to society to lock people up for marijuana use" but emphasizes the need to "let science guide our process and policymaking" #CNNSOTU pic.twitter.com/g3gNEDEcQ8
— CNN Politics (@CNNPolitics) July 18, 2021
Murthy, who previously served as surgeon general under the Obama administration, said he is concerned about the effort to change cannabis laws getting ahead of the science.
“In terms of our approach to marijuana, I worry when we don’t let science guide our process and policymaking,” he said in the latest comments. “And as surgeon general that’s my role, is to work with policymakers who work with members in the community and the general public to help people understand what science tells us and where you gaps, to help fill those gaps with research and with honest inquiry.”
Previously, in 2015, Murthy said there is “preliminary data showing that for certain medical conditions and symptoms, that marijuana can be helpful.”
But in 2018, the doctor said he is “concerned about how rapidly states have been legalizing marijuana” because there are a “lot of unknowns” about its effects.
Testing People For Marijuana Impairment Based On THC Levels Is ‘Not Reliable,’ Federally Funded Study Finds
The amount of THC in a person’s system after consuming marijuana is not an accurate predictor of impairment, a federally funded study has determined.
The research, backed by a grant from the National Institute of Justice (NIJ), involved 20 people who either ate or vaporized cannabis with varying levels of THC. They were then tested with basic field sobriety and cognitive tests.
While the groups that received doses higher than 5mg of THC were all “negatively impacted” and experienced observable psychomotor impairment, the RTI International researchers found that “THC levels in biofluids were not reliable indicators of marijuana intoxication for their study participants.”
Researchers investigated how marijuana affects skills required for safe driving and found that biofluid levels of THC did not correlate with field sobriety test performance or marijuana intoxication, regardless of how the cannabis was ingested. Read more: https://t.co/Aqkfvplv9P pic.twitter.com/1mWehGKCHQ
— Natl Inst of Justice (@OJPNIJ) June 3, 2021
“Researchers investigated how marijuana affects skills required for safe driving and found that biofluid levels of THC did not correlate with field sobriety test performance or marijuana intoxication, regardless of how the cannabis was ingested.”
That raises questions about “per se” laws that are in place in several states, barring people from driving if they have more than a certain amount of THC in their blood.
“These important findings come as no surprise,” NORML Deputy Director Paul Armentano said. “Despite a handful of states imposing per se THC thresholds as part of their traffic safety laws, there exists no science demonstrating that these arbitrary limits are reliable predictors of either recent cannabis exposure or impairment.”
The study, which was published last year and promoted by NIJ in a tweet on Thursday, also found that various tests, including standing on one leg, balancing and walking and turning, “were not sensitive to cannabis intoxication for any of the study participants.”
Throughout the tests, participants’ blood, urine and oral fluid were collected and then sent to forensic laboratories.
“Results from the toxicology tests showed that the levels of all three targeted cannabis components (THC, cannabidiol, and cannabinol) in blood, urine, and oral fluid did not correlate with cognitive or psychomotor impairment measures for oral or vaporized cannabis administration,” NIJ said.
“Many of their study participants had significantly decreased cognitive and psychomotor functioning even when their blood, urine, and oral fluid contained low levels of THC,” the federal agency continued. “The researchers also observed that standardized field sobriety tests commonly used to detect driving under the influence of drugs or alcohol were not effective in detecting marijuana intoxication.”
In other words, THC does lead to impairment—but the concentration of that compound in bodily fluids does not accurately correlate with the extent to which a person is impaired. And in low doses, it seems some people are not negatively impacted, at least with respect to the standard tests that the researchers utilized.
Late last year, a different study published in the Journal of the American Medical Association found that low levels of CBD do not appear to have a significant impact on driving, and low-level THC consumption has an impact that is “modest in magnitude and similar to that seen in drivers with a 0.05%” blood alcohol concentration.
A a congressional research body also released a report in 2019 that found that evidence about cannabis’s ability to impair driving is currently inconclusive.
Researchers have found on several occasions that traffic fatalities do not increase after a state legalizes marijuana.
Of course, that doesn’t change the fact that both opponents and supporters of legalization generally caution against driving under the influence.