As the federal government continues to develop regulations around CBD, the Food and Drug Administration (FDA) will host a public conference on Thursday to highlight how the cannabinoid’s use and effects may differ based on sex and gender.
The daylong meeting, organized by FDA’s Office of Women’s Health, will include presentations on “sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation,” according to an agency description.
“Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference,” it says.
The @FDAWomen will host a free virtual public meeting on Thurs., 11/19 to discuss potential sex & gender differences in use and responses to cannabidiol (CBD) and other cannabinoids. @NCCIH_David & Dr. Inna Belfer, NCCIH program director, will participate. https://t.co/KEbSsT9O56 https://t.co/ERD8SCpqPq
— NIH NCCIH (@NIH_NCCIH) November 12, 2020
(A Federal Register notice from September indicated a registration deadline of Monday, but the system was still accepting new sign-ups as of Tuesday morning.)
In addition to remarks by FDA officials, the event will feature four panels throughout the day:
- 9:30 a.m. — Use of CBD and Other Cannabinoids: Perspectives from Patients and Healthcare Professionals
- 10:45 a.m. — Sex Differences in the Effects of CBD and Other Cannabinoids
- 1 p.m. — Use of CBD and Other Cannabinoids in Pregnancy
- 2:30 p.m. — Government Agency Perspectives on CBD Research and Evaluation
Speakers include an array of academics, researchers and other health professionals, such as professors from research departments at the University of Colorado at Boulder and Johns Hopkins University, among others. On the government side are panelists from FDA and the National Institutes of Health.
Each panel discussion will include a Q&A session to respond to questions from attendees, FDA said in September.
Sex and gender are important factors to consider in CBD regulation not only because the compound could affect people’s bodies differently—such as in the case of pregnancy—FDA says, but also because of what the agency calls “psychosocial,” or gender-based, differences.
“Conditions for which CBD is often marketed, such as chronic pain, anxiety, depression, and sleep disturbances, are more prevalent in women than men,” the event listing says. “Therefore, consideration of issues pertaining to the safety of CBD products may be particularly important to address in women.”
— FDAWomen (@FDAWomen) November 6, 2020
FDA has been especially active among federal agencies since Congress legalized hemp and its derivatives through the 2018 Farm Bill. The agency is developing regulations expected to allow for the lawful marketing of CBD products, and it also recently held meetings to promote studies into the cannabis plant and inform researchers and cultivators about opportunities to protect their proprietary information from competitors.
The agency was required by law to give an update on its regulatory approach to CBD, which it did in March, saying that “FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions.” In July it submitted draft enforcement guidance to the White House.
“FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD,” says the description of Thursday’s sex and gender event. “However, there are many unanswered questions about the science, safety, and quality of products containing CBD… This public meeting will provide further insight into the scientific evidence suggesting the presence or absence of sex and gender differences in use and responses to CBD and other cannabinoids.”
In the years since hemp became legal, FDA has been using enforcement discretion in its approach to CBD products. The agency has issued warnings to cannabis businesses in certain cases—such as when some companies claimed CBD could treat or cure the virus that causes COVID-19—and provided public notices about recalls.
In July, FDA submitted a report to Congress on the state of the CBD marketplace, outlining studies the agency has performed on the contents and quality of cannabis-derived products it has tested. The agency is also looking to award a contract to help study CBD.
A proposal from Senate Appropriations Committee last week would further fund FDA’s work with cannabinoids by earmarking $5 million to support the agency’s regulatory activities around cannabis, including “targeted research for cannabis-derived substances, such as cannabidiol.”
Photo by Kimzy Nanney
Feds Want Help Finding Evidence On Marijuana And Kratom’s Role In Treating Pain
A federal health agency is conducting a review of studies to learn if marijuana and kratom could potentially treat chronic pain with fewer side effects than opioids.
The Agency for Healthcare Research and Quality (AHRQ) is asking the public to help identify research that specifically looks at the risks and benefits of cannabinoids and kratom, a type of plant known for its analgesic effects. The agency said the rise in opioid prescriptions and overdoses necessitates exploring plant-based alternatives.
The public is invited to submit studies on how these substances impact chronic pain until the January 4 deadline.
“Some data suggest that cannabinoids may have analgesic properties, though research in this area is mixed,” AHRQ, which is part of the Department of Health and Human Services, said in a notice, adding that THC “has demonstrated analgesic properties, though its psychoactive effects and abuse potential increase its risk and suitability as an analgesic.”
Other ingredients in marijuana like CBD, CBG and CBC “may also have some analgesic or anti-inflammatory properties and are not thought to be psychoactive or addictive, but these cannabinoids may not be as potent as THC,” the agency said.
AHRQ said that a prior review of research into alternative pain treatments including cannabis found “too little evidence to draw meaningful conclusions on either benefits or harms,” but that analysis did not investigate other plant-based compounds (PBC) like kratom.
The federal agency also made a notable admission about the consequences of marijuana prohibition and the potential benefits of state-level legalization.
“Although some PBCs thought to reduce pain are currently classified as Schedule I by the Drug Enforcement Administration, the recent legalization of cannabis by several states may lead to more, and higher quality, research on them,” AHRQ said. “Initiatives to develop and study alternative interventions for chronic pain are expected to contribute to this increase in research on PBCs, specifically for pain.”
There are four main questions that AHRQ is hoping to answer with its living systematic review:
1. In adults with chronic pain, what are the benefits of cannabinoids?
2. In adults with chronic pain, what are the harms of cannabinoids?
3. In adults with chronic pain, what are the benefits of kratom or other plant-based substances for treatment of chronic pain?
4. In adults with chronic pain, what are the harms of kratom or other plant-based substances for treatment of chronic pain?
Earlier this year, AHRQ also announced that it was reviewing studies into the opioid alternatives for treating acute pain and migraines, including marijuana.
The agency has made other cannabis-related requests in the past, soliciting scientific information about the potential use of cannabinoids in the treatment of Alzheimer’s disease, for example.
Separately the Centers for Disease Control and Prevention (CDC) received hundreds of public comments on marijuana and kratom after asking for input on input on “individual stakeholder’s values and preferences related to pain and pain management options.”
Photo courtesy of Chris Wallis // Side Pocket Images.
Federal Health Agency Hosts Conference On Marijuana And Cancer Research
A federal health agency will host a symposium this month on research into marijuana as a therapeutic in the treatment of cancer and other related issues.
“This workshop will highlight the state of the science in cannabis, its chemical constituents (e.g., cannabinoids) and cancer research, including cancer epidemiology, use in cancer patients, cancer biology and prevention, pre-clinical and clinical cancer symptom and treatment side-effect management, as well as the use of cannabis and cannabinoids as cancer therapeutics,” the National Cancer Institute (NCI) said of the virtual event, which is taking place from December 15-18.
The deadline to register to attend is coming up on Friday.
REGISTRATION DEADLINE: Dec. 4 –For the virtual National Cancer Institute Cannabis, Cannabinoids and Cancer Research Symposium, December 15-18, 2020. Details:https://t.co/cw78ubeBp6 pic.twitter.com/Fp31cHJRYx
— NCI Epidemiology (@NCIEpi) November 27, 2020
“The workshop will also address current barriers to research and strategies to navigate these hurdles to ensure feasibility of rigorous studies designed to address gaps in knowledge as well as potential research opportunities in the area of cannabis cancer-related research,” NCI said.
Scheduled sessions include panels on potential clinical implications of marijuana legalization efforts, risks and benefits of cannabis use for cancer patients, the function of the endocannabinoid system as it concerns cancer-related pain and how marijuana affects appetite, nausea, vomiting and neuropathic pain in patients.
Researchers from a wide range of universities and regulators from the National Institutes on Health and Food and Drug Administration (FDA) will participate in the event.
As Congress continues to consider amending federal cannabis policy—with a vote on a bill to legalize marijuana happening this week—agencies have expressed notable interest in the issue.
For example, FDA held a public conference last month that looked at the use and effects of CBD differ based on sex and gender.
The National Center for Complementary and Integrative Health in 2018 sponsored a working that touched on various aspects of marijuana research, particularly under the current federal framework of prohibition.
Photo courtesy of Brian Shamblen.
CBD Doesn’t Impair Driving, Landmark Study Finds, While THC’s Effects Fade In Hours
Small doses of CBD appear to have no significant impact on driving, according to first-of-its-kind research published Tuesday in the Journal of the American Medical Association.
Similar doses of THC, meanwhile, were associated with short-term impairment “modest in magnitude and similar to that seen in drivers with a 0.05%” blood alcohol concentration, the study found. After about four hours, signs of marijuana impairment faded.
The University of Sydney-led experiment is the latest to study the effects of cannabis consumption on drivers, an issue of growing public concern as more jurisdictions around the world remove laws against the plant and its chemical components.
“The results should reassure people using CBD-only products that they are most likely safe to drive, while helping patients using THC-dominant products to understand the duration of impairment,” said Iain McGregor, academic director of the university’s Lambert Initiative for Cannabinoid Therapeutics.
The new research was funded by the Lambert Initiative, which studies the health effects of cannabis, and conducted at Maastricht University, in the Netherlands. Marijuana Moment reviewed a draft of the paper prior to its publication on Tuesday.
To measure the effects of the cannabinoids on drivers, researchers first had participants vaporize one of four cannabis blends: mainly THC, mainly CBD, a combination of the two cannabinoids or a placebo containing less than 0.2 percent total cannabinoids. The target dose for each cannabinoid other than the placebo was 13.75 milligrams.
Subjects then got into cars and took to the road. Accompanied by a licensed driving instructor, each completed a 100-kilometer circuit on a stretch of Dutch highway twice: first 40 minutes after consuming the cannabis blend and again four hours after consumption.
Researchers measured driving impairment by tracking how much drivers’ vehicles drifted in the lanes—a common metric known as standard deviation of lateral position (SDLP)—as well as fluctuations in vehicle speed. Participants were also tested in a laboratory setting for cognitive and psychomotor performance, blood cannabinoid concentrations and cardiovascular indicators such as heart rate and blood pressure.
Consuming CBD alone seemed to have little impact on performance.
“There were no significant differences between CBD-dominant cannabis and placebo,” the study says. “SDLP in the placebo and CBD conditions did not differ, indicating that CBD…did not impair driving.”
“These findings indicate for the first time that CBD, when given without THC, does not affect a subject’s ability to drive,” said Thomas Arkell, the study’s lead author.
Participants who consumed THC or a blend of cannabinoids, meanwhile, showed moderate but statistically significant impairment behind the wheel during their first test drive, posting SDLP numbers similar to drivers with blood alcohol concentrations of 0.05 percent. The study’s authors note the degree of impairment “is thought to indicate the lower limit of clinically relevant driving impairment.”
Unlike many drunk drivers, however, subjects who consumed THC or the THC–CBD blend seemed distinctly aware of their risk behind the wheel. That was true even as observable signs of their impairment faded.
Subjects described themselves as “significantly more impaired” after consuming THC or both cannabinoids, with a top complaint being decreased confidence. After the tests were completed, however, most subjects were able to correctly observe that their quality of driving itself was worse only during the first test.
“Participants considered their driving at 240-300 min to be significantly more impaired in the THC and THC/CBD conditions than in the placebo condition despite there being no difference across conditions in SDLP at that point in time,” the authors write.
The second test began four hours after consumption, which researchers say is about the time it seems to take for THC’s effects on driving to fade.
“Previous on-road and simulator studies have described increased SDLP for up to 3 hours following inhaled cannabis,” the study says. “Consistent with this, the present study failed to detect SDLP at 4-5 hours.”
That doesn’t mean consumers should necessarily assume they’re good to drive after just four hours. Higher inhaled doses or edible products, authors note, could extend the duration of impairment “and so these results should not be considered definitive.”
Similar limitations could apply to the study’s CBD findings. Authors note the 13.75 mg target dose in the study is considerably lower than what’s typically given in certain treatments, such as for pediatric epilepsy. “Driving outcomes may differ with higher CBD and THC doses and different CBD:THC ratios,” they write.
More fundamentally, the researchers acknowledge, the experiment could be failing to detect extremely minimal impairment caused by CBD. Confidence limits used in analyzing data from the 26-person experiment “suggested the possibility of subclinical impairment” too small to be measured in the study.
Nevertheless, the authors said, the findings offer valuable real-world data about how cannabis affects drivers—or, in some cases, apparently doesn’t.
“While some previous studies have looked at the effects of cannabis on driving, most have focused on smoked cannabis containing only THC (not CBD) and have not precisely quantified the duration of impairment,” said McGregor at the University of Sydney’s Lambert Initiative. “This is the first study to illustrate the lack of CBD effects on driving and to also provide a clear indication of the duration of THC impairment.”
Despite widespread concerns that relaxing cannabis laws could lead to more dangerous roadways, data on the subject has been largely inconclusive, allowing speculation to run rampant.
After evaluating available evidence last year, experts tasked by U.S. congressional lawmakers to look into the issue concluded that fundamental questions about THC’s impact on driving remain unanswered.
“Although laboratory studies have shown that marijuana consumption can affect a person’s response times and motor performance,” wrote the Congressional Research Service, “studies of the impact of marijuana consumption on a driver’s risk of being involved in a crash have produced conflicting results, with some studies finding little or no increased risk of a crash from marijuana use.”
The lack of clear evidence has frustrated both legalization opponents, who worry about increased highway dangers, but also medical marijuana patients who are at risk of arrest and conviction for THC-impaired driving even days after their medicine’s effects wear off.
In Pennsylvania, the House of Representatives approved a measure in October that would protect registered medical marijuana patients from being penalized under the state’s DUI laws.
“You can ask any veteran or anybody that’s using medical cannabis right now, if they took the prescription on Monday, [on] Wednesday, they’re not high,” Rep. Ed Gainey (D) said in a floor speech before the vote. “And if they got pulled over, they darned shouldn’t be charged for being intoxicated or under the influence of medical marijuana.”
Photo courtesy of the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney