FDA, Researchers Still in the Weeds on Cannabis, CBD, and Gender

FDA, Researchers Still in the Weeds on Cannabis, CBD, and Gender

The results of the election still remain murky, but with an additional five states legalizing medicinal or recreational cannabis use last month voters have sent a clear message to the medical, research, and regulatory communities: It’s time to step up.

The US Food and Drug Administration (FDA) is trying to take a step in the right direction, as demonstrated by a day-long virtual symposium held recently by the Office of Women’s Health. The session focused on gender differences in the use of cannabidiol (CBD) and cannabis-based products, potential sex and gender interactions with regard to anxiety, pain, and pregnancy, and other outcomes.

In a keynote delivered to more than 600 healthcare practitioners, policymakers, patients, and other stakeholders, Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, underscored the complexities of cannabinoid therapeutics and the logistical and regulatory challenges the agency faces.

“Not only does the category involve a broad spectrum of cannabinoid compounds well beyond CBD and [tetrahydrocannabinol (THC)], but FDA is charged to regulate all of the products potentially containing these compounds in a setting where federal and state legislation might be at odds,” said Amy Abernethy, MD, PhD, Principal Deputy Commissioner of Food and Drugs at the FDA.

CBD Research Lacking

A number of panelists at the symposium highlighted that while women comprise the majority of patients using CBD or THC to treat conditions such as anxiety, pain, and sleep, they’ve been historically underrepresented in research. “Women are not sharing the risks, nor are they sharing the benefits of research equally,” said Betty Jo Salmeron, MD, staff clinician in the Neuroimaging Research Branch at the National Institute on Drug Abuse.

Not only are these differences exemplified in sex-specific differential rates of/therapeutic response to these conditions, but also in the dearth of data available to guide clinical practice. Researchers know that women are driving use of CBD across the nation, but regulatory obstruction means that available data mostly derive from animal or observational studies.

Take anxiety, for example. Cinnamon Bidwell, PhD, assistant professor and director of the Center for Research and Education Addressing Cannabis and Health at the University of Colorado at Boulder, has been evaluating the effect of THC and CBD use on anxiety in an ongoing cohort study.

“Preliminary data show that relative to THC, CBD users had a significantly greater trend toward reductions in self-reported anxiety,” Bidwell said, noting that the differences were even greater in women. “Women who started at higher levels of anxiety had larger declines after 4 weeks of self-directed use.”

“These sex differences are also observed [with] cannabinoid analgesic effects, but so far, the data (mostly from meta-analyses) are quite a mess,” said Daniel Clauw, MD, professor of anesthesiology, medicine, and psychiatry at the University of Michigan in Ann Arbor.

“When we look at THC and CBD in animal models of pain, it seems that CBD might be more effective for pain states that are nocice

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