Across the U.S., prospective organ donors are frequently turned away if they test positive for or admit to using marijuana. That’s also true for patients who need new organs but consume cannabis.
For example, Garry Godfrey, an event planner in Maine who suffers from a hereditary disease that causes renal failure, made headlines last year after being denied a kidney transplant and taken off the wait list due to his medical marijuana use.
Yet up until this point, there’s never been research that specifically investigated the effects of marijuana on kidney donations to shed light on whether these bans could be justified.
But now, a new study finds that cannabis consumption by kidney donors or recipients doesn’t have any effect on the outcomes of transplants.
A team of researchers took up the task, reviewing living kidney transplants that were performed at a single academic institution from 2000 to 2016. Both kidney donors and recipients were divided based on whether they’d used cannabis, and their outcomes were compared using a “variety of tests.”
The review involved medical records of 294 living donors, including 31 who used cannabis, and 230 living kidney recipient records, including 27 recipients who used cannabis.
Contrary to concerns that the use of marijuana would have a negative impact on transplant outcomes, there weren’t any noticeable differences between the groups that could be attributed to cannabis. Long-term kidney function was virtually the same and there were no discernible differences in pre- or post-operation characteristics, either.
The study, published Thursday in the Clinical Kidney Journal, concluded that it could help “increase the donor pool” if institutions start to consider allowing kidney transplants from cannabis consuming donors.
“A significant shortage in available potential kidney donors exists,” Duane Baldwin, the study’s lead author, said in a press release. “Our goal with this study was to start a conversation on this topic and to encourage other centers to study this important question.”
“It is our hope that considering marijuana using donors could ultimately save lives,” he said.
Teen Marijuana Treatment Admissions Fell Sharply In States That Legalized, Federal Report Shows
States that have legalized marijuana for recreational use have seen sharp declines in youth treatment admission rates for the drug, according to a new federal report that also shows teen admission rates for cannabis misuse fell nationwide by nearly half during the 2008-2017 period.
Medical cannabis laws, meanwhile, appear to have no connection to teen treatment rates, according to the peer-reviewed research published on Thursday by the U.S. Centers for Disease Control and Prevention.
The data seem to refute warnings by legalization critics who predicted that ending prohibition would lead to ballooning rates of youth substance misuse.
“Consistent with prior research on medical marijuana and adolescent marijuana use, medical legalization status does not appear to correspond to treatment admission trends,” says study, published in the CDC journal GIS Reports. “Notably, however, 7 of 8 states with recreational legalization during the study period fall into the class with the steepest level of admissions decline.”
Author Jeremy Mennis, a professor at Temple University, assembled the report by collecting state-level data on teen treatment admissions where the primary substance used was marijuana. Dividing the annual admissions numbers by the number of adolescents in each state, obtained through U.S. Census data, allowed him to determine each state’s admission rate over time.
Mennis then displayed the state-by-state data on a map, taking into account both the state admissions rates themselves and the direction each was trending over time.
“The map depicts both the slope of the admissions rate (ie, admissions rate gain or loss) and the mean of the admissions rate (ie, admissions rate magnitude) for each state,” the report says.
Nationwide, the average annual admissions rate over the study period “declined over the study period by nearly half, from 60 (admissions per 10,000 adolescents) in 2008 to 31 in 2017,” according to the CDC study.
While some states saw increases in admissions rates over that period, states that had the highest rates of treatment admissions all experienced declines. All three states on the West Coast, for example, had among the highest treatment admissions rates during the period studied—but also showed the steepest declines in admissions over that time. California, Oregon and Washington State have all legalized cannabis for adult-use.
“All 12 states in the high mean admissions rate class sustained admissions declines,” the report says, “with 10 of those states having declines in the steepest category (states colored darkest blue).”
Some states—Wisconsin, Indiana and South Carolina—had too much missing data to include in the report.
What’s behind the trends isn’t immediately clear from the data. Mennis writes that possible causes for the declines, as well for the variation between states, “include changes in attitudes toward marijuana, as well as differences in marijuana use and incidence of CUD [cannabis use disorder], as well as in socioeconomic status, treatment availability, and health insurance.”
“Whatever the causes of the observed patterns,” the report says, “this research suggests that a precipitious national decline in adolescent treatment admissions, particularly in states legalizing recreational marijuana use, is occurring simultaneously within a period of increased permissiveness, decreasing perception of harm, and increasing adult use.”
The findings generally align with past studies looking at teen marijuana use in legal states, which have found that youth consumption has remained steady or fallen even as the perception of harm caused by marijuana has decreased.
In a presentation to lawmakers in North Dakota this summer, the deputy coordinator for the federal High Intensity Drug Trafficking Area (HIDTA) program’s National Marijuana Initiative, Dale Quigley, acknowledged that teen use was falling both nationally and in legal states.
“For some reason, the use rate among this age bracket is going down,” said Quigley, who lives in Colorado. “We’re not 100 percent sure why it’s going down. It’s a good thing that it’s going down, but we don’t understand why.”
Another study, released by Colorado officials in August, showed that youth cannabis consumption in the state “has not significantly changed since legalization” in 2012.
A CDC report published the same month, meanwhile, found that cannabis use by high school students has fallen in recent years after an earlier increase. Youth lifetime marijuana use “increased during 2009–2013 and then decreased during 2013–2019,” the report found.
“We are reassured by the latest results from the 2019 Youth Risk Behavior Survey because they show that youth marijuana use has not increased over the past decade, even as more states across the country have passed progressive marijuana laws,” Sheila Vakharia, deputy director of the department of research and academic engagement for the Drug Policy Alliance, said in a statement at the time.
Earlier studies looking at teen use rates after legalization have found similar declines or a lack of evidence of an increase.
Last year, for example, a study took data from Washington State and determined that declines in youth cannabis consumption could be explained by replacing the illicit market with regulations or the “loss of novelty appeal among youths.”
Another study from last year showed declining youth cannabis consumption in legalized states but didn’t suggest possible explanations.
Photo by Sharon McCutcheon on Unsplash
FDA Is Hosting A Conference On CBD, Sex And Gender This Week
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
New FDA Guidance Will Make It Easier To Approve CBD-Based Medicines
The Food and Drug Administration (FDA) is releasing new draft guidelines that are meant to streamline approvals for generic oral CBD medications.
In a notice published in the Federal Register on Wednesday, the agency said it is soliciting public feedback on its guidance to researchers who are interested in submitting abbreviated new drug applications (ANDAs) for CBD solutions.
To expedite the approval process, FDA said applicants can request a waiver of an in vivo bioequivalence study if they meet certain requirements. This guidance comes two years after the agency approved the brand-name CBD-based epilepsy medication Epidiolex from GW Pharmaceuticals.
Going forward, if a drug company wants to produce generic versions of that 100 mg/mL cannabidiol solution, they could follow specific rules to skip the in vivo bioequivalence study step if the draft guidance is finalized. The drug would have to be derived from Cannabis sativa L, contain no more than 0.1 percent THC and have “no inactive ingredient or other change in formulation from the [reference listed drug] that may significantly affect systemic availability.”
Researchers must use “appropriate analytical methods” such as macroscopic or microscopic analysis or DNA bar-coding methods to determine that the solution is being made from cannabis sativa.
“Due to the many cultivars within this species, identification and authentication of plant species should be conducted at the cultivar(s) level if the potential cultivar(s) will be used as a natural source of the [botanical raw material],” FDA said.
Further, when collecting that raw cannabis, the agency said applicants must follow “established good agricultural and collection practices (GACP) procedures to minimize variations in BRM and eventually ensure the batch-to-batch consistency of the drug substance.”
A public comment period on FDA’s draft guidance will last until November 23. FDA also recently closed a comment period on separate draft guidance on developing cannabis-derived medications. However, three other federal agencies are currently accepting input on a variety of other proposed cannabis- and drug-related regulations.
While this latest document isn’t the separate comprehensive CBD guidance that advocates and industry stakeholders have been waiting for, it’s another example of how the scientific landscape around cannabis is changing, with a federal agency helping to facilitate the production of cannabidiol-based drugs.
Separately, FDA announced on Tuesday that it will be hosting a public meeting in November to discuss gender and sex differences in the effects of CBD and other cannabinoids.
The agency also recently held a meeting to help inform cannabis researchers and cultivators about opportunities to protect their proprietary information and promote studies into the plant.
It also recently submitted draft guidance on CBD enforcement to the White House Office of Management and Budget—a long-anticipated move that comes after hemp legalization.
The agency was mandated under appropriations legislation enacted late last year to provide an update on its regulatory approach to CBD, and it did so in March. The update stated 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.”
FDA has been using enforcement discretion for CBD in the years since hemp became legal.
The agency has continued to issue warnings to cannabis businesses in certain cases—such as instances in which companies claimed CBD could treat or cure coronavirus—and provide public notices about recalls.
In July, FDA also submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has performed on the contents and quality of cannabis-derived products that it has tested over the past six years.
Also that month, a congressional spending bill for FDA was released that includes a provision providing “funding to develop a framework for regulating CBD products.”
The agency is also actively looking to award a contract to help study CBD as the agency develops regulations for products containing the non-intoxicating cannabinoid.
Read FDA’s draft guidance on developing CBD medications below:
Photo by Kimzy Nanney.