Thread by @RegulatoryAtty

ATTN #CBD stakeholders: @US_FDA today holding scientific conf. on CBD/other #cannabinoids. I'll be live tweeting throughout. Not sure we'll get much insight on immediate path forward for consumer products but I'll share noteworthy observations. Agenda: bit.ly/3pHXU8V

I'll be paying particular attention to @DrAbernethyFDA's remarks at 9:05a (head of #FDA's #CBD Policy Working Group) and @DThrockmortonMD's keynote at 9:15a (one of Agency's principals for regulating R&D, manufacture & marketing of #cannabis & cannabis-derived #drug products).

And we're underway! First up is Kaveeta Vasisht, MD, PharmD. Associate Commissioner for Women’s
Health and Director, Office of Women’s Health, FDA. She's noting ubiquity of #CBD products in marketplace, many of which are targeted to #women.

Now speaking is @DrAbernethyFDA. Noting growing pub. interest in #CBD & #cannabis. Many unanswered questions. "Little is known" about safety & efficacy. We apply "rigorous, science-based approach." There are "significant knowledge gaps." Committed to advancing #hemp products.

@drabernethyfda now discussing role of #CBD working group. ID'ing of data gaps, how #research can be quickly performed. We'll continue to update public. Women more likely to use products than men. Use during #pregnancy and lactation raise questions of safety.

Now speaking: @DThrockmortonMD. One of #FDA's principal #cannabis-derived #drug regulators. Noting strong pub. interest in area. Giving flavor of Agency's work in this space. Not just #CBD. Many other #cannabinoids and #terpenes. Uses in #drugs and non-drugs. Also #synthetic.

More from @DThrockmortonMD: 4 products approved by #FDA, most recent #Epidiolex. Not an easy area to regulate. Evolving #legislative landscape. #Farmbill retained FDA's authority. Challenge: state-level #cannabis activity. Referencing #elections2020 and ballot initiatives.

More from @DThrockmortonMD. Scientific uncertainties - what we don’t know about #CBD.

Dr. Throckmorton: We know of intense interest in this area. It’s our responsibility to respond and continue to engage. Discussing FDA’s #CBD work plan.

Throckmorton: Summarized May 2019 #CBD heating and reopening of docket (indefinite).

Throckmorton: Discussion of enforcement action/#warningletters and #testing of products.

Throckmorton: Actions on #botanical #drug development and FDA/CDER botanical review team.

Throckmorton: Summary and conclusions. FDA has well defined role to play for #cannabis and canna products. FDA supports research. Actively exploring pathways. Comitted to promoting #publichealth.

1st panel: Use of CBD & Other Cannabinoids: Perspectives from Patients & Healthcare Professionals. Now speaking - Cinnamon Bidwell, PhD. from @ucboulder Center for Research and Education Addressing Cannabis and Health (REACH). Noting #research challenges bc of Schedule I status.

Dr. Bidwell: Discussing #observational #anxiety study. #Cannabis from #Colorado dispensaries. Mobile lab used. Tested pre- and post-cannabis use. Preliminary results: #CBD more effective in lowering #anxiety than #THC, and more pronounced reduction in #female subjects than #male.

Preliminary results from Bidwell #cannabis and #anxiety study.

Now speaking: Daniel Clauw, MD. Prof. of #Anesthesiology, #Medicine and #Psychiatry, @UMich. Discussing why #men & #women will respond differently to #cannabinoids when used for #pain. Sex differences in pain and #sensory processing.

Very interesting insights from Dr. Clauw re what sort of pain #CBD might be more effective in treating. #nociceptive pain originating from periphery and centralized/#nociplastic pain (originating from #CNS or systemic mechanisms).

Now speaking: @ShariBerman68. Patient Leader. Two-time #cancer survivor, #cannabis patient educator. Very impactful; first-hand experience with cannabis. Disconnect btw #patients & #doctors. People are curious abt. #CBD/other #cannabinoids.

More from @ShariBerman68: scheduling of #marijuana makes #research difficult. Doctors need to be educated because #patients need information (dosing, side effects, drug interactions).

Back at 1045a for panel 2- Sex Differences in Effects of #CBD/Other #Cannabinoids.

We're back - panel 2 moderated by Dr. Inna Belfer, Program Director, Basic and Mechanistic Research Branch, Division of Extramural Research, National Center for Complementary and Integrative Health, NIH. #FDACBDscientificconference

Now speaking: Dr. @IgorKoturbash, Associate Prof. & Chair, Dept of Environ. Health Sciences; Founder & Co-Director, Center for #DietarySupplements Research, Fay W. Boozman College of Public Health, @UniversityofArkansas for Medical Sciences. #fdacbdscientificconference

Conclusions from Dr. Koturbush. Vehicle can affect #hepatotoxicity.

Now up - Dr. Ryan Vandrey, Professor, Behavioral #Pharmacology Research Unit, @JohnsHopkins School of Medicine. #FDACBDscientificconference

Dr. Vandrey discussing acute #CBD study. #fdacbdscientificconference

Dr. Vandrey summary. #Females have differential responses to #CBD and other #cannabinoids on some but not effects. #fdacbdscientificconference

Now up - Dr. @zivacooper, Director, @UCLACannabis, Jane and Terry Semel Institute for #Neuroscience and #HumanBehavior; Associate Professor, Department of #Psychiatry and #Biobehavioral Sciences. #FDACBDscientifichearing

Dr. Cooper study summary. #Cannabis decreases #pain response in males, no effect in females. Females exhibit greater #abuse liability outcomes. #fdacbdscientifichearing

Now up - Dr. Yasmin Hurd, Ward Chair of #Translational #Neuroscience and Professor of Psychiatry and Neuroscience, @IcahnMountSinai; Director of the Addiction Institute, Mount Sinai Behavioral Health System. #FDACBDscientifichearing

Per Dr. Hurd - research suggests that #CBD reduces cue-induced craving and #anxiety in individuals with #heroin use disorders. #FDACBDscientificconference

Dr. Hurd concluding thoughts: 1) most studies still predominantly about males; 2) sex effects evident for #THC but not enough data; 3) some evidence to suggest #CBD reduces #cannabis, #opioid, and #alcohol use but evidence is still weak. #FDACBDscientifichearing

Dr. Vandrey - two interesting points: 1) use of #NIDA #cannabis supply can be preferable because it’s #homogenous. 2) we should be looking broader than just #CBD and #THC.

Lunch break. Back at 1p ET with panel 3, use of #CBD and other #cannabinoids in #pregnancy. #FDACBDscientificconference

We're back w/panel 3. Moderated by Dr. Leyla Sahin, Senior Medical Officer, Division of #Pediatric and #Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, @US_FDA.

Now speaking: Dr. Scott Parnell, Assistant Professor, #CellBiology and #Physiology, @unc. Per Parnell, delta-9 #THC potency has increased significantly since 1970s. Research focused on whether #cannabis use causes #birthdefects. #FDACBDscientificconference

Now up - Mark Zakowski, MD, FASA. Professor of Anesthesiology, @CedarsSinai. Discussion of provider attitudes towards #cannabis and #cannabinoid use during #pregnancy. #FDACBDscientificconference

Concluding thoughts from Dr. Zakowski. More research is needed (THEME OF THE DAY). Doctors need to adopt #pleaseaskpleasetell policy re #cannabis use. #fdacbdscientificconference

Now speaking - Nathaniel DeNicola, MD, MSHP, FACOG. Environmental Health Expert, American College #Obstetricians and #Gynecologists. Discussion of meta-analysis of 31 studies of #marijuana use during #pregnancy and impact on stillbirth, low birth weight, and preterm birth.

More from Dr. DeNicola. #fdacbdscientifichearing

Final panel speaker - Katrina Mark, MD, FACOG. Assoc. Prof., Department of Obstetrics, Gynecology & #Reproductive Sciences, @UMmedschool. #Cannabis exposure in utero can affect development of baby's brain. Discussed frustrating state of #research and how it's communicated.

Last panel of the day - Government Agency Perspectives on #CBD #Research and Evaluation. Moderated by Dr. Cassandra Taylor, Chemist, Office of Pharmaceutical Quality, Office of New Drug Products, Botanical Review Team, Center for Drug Evaluation and Research, @US_FDA.

Discussion of #FDA’s internal working groups, #marijuana and #CBD.

Discussing by #FDA of challenges, including shifting legal frameworks, evolving market, and #data gaps. #FDACBDscientificconference

Next speaker - David Shurtleff, PhD. Deputy Director, National Center for Complementary and Integrative Health, @NIH. Remarked that NCCIH has 11 ongoing studies in this space. #FDACBDscientificconference

Dr. Shurtleff discussed NIH Institute’s #womenshealth and #sex/#gender research with #cannabinoids/#cannabis.

A good summary of what #NIH is doing in the #cannabis space, and information on #NCI’s #cannabinoid and #cancer research symposium next month. #FDACBDscientificconference

Next speaker: Betty Jo Salmeron, MD, MA. Staff Clinician, Intramural Research Program, Neuroimaging Research Branch, National Institute on Drug Abuse, @NIH. Fascinating and informative discussion about under-representation of #women in #clinicalresearch.

Up now - Andrew Shen, PhD. Neuroscientist, Nat'l Center for Toxicological Research, @US_FDA. Discussion of #cannabidiol #clinicalresearch, #nonclinical data gaps that exist. Effects on developing fetus, adolescent brain. In utero/lactation exposure.
#FDACBDscientificconference

Last speaker on the panel - David Carbone, PhD. Toxicologist, Division of Neurology Products, Center for Drug Evaluation and Research, @US_FDA. Will discuss #nonclinical research and their role in regulatory process. Rodent developmental and toxicology (DART) studies.

We're on to panel 4 Q&A. Dr. Shurtleff is discussing myriad requirements to sourcing research #cannabis and then actually researching it (#FDA, #DEA, and possibly state requirements). It's "not impossible" he noted (but suggested it can be challenging - which it absolutely is).

Agreement among panelists that research is needed re #cannabinoids other than #CBD and #THC (so called “minor” cannabinoids) and #terpenes. #FDACBDscientificconference

Dr. Vasisht from @US_FDA is closing things out. Noted that over 600 attendees logged in during the last panel (likely higher numbers earlier in day). She’s encouraging researchers to consider sex and gender when conducting #cannabis studies. Agency will issue conference report.

That concludes the conference. Thanks for following along today. I hope these tweets were helpful, especially for those of you that couldn't tune in for the whole program. I'll be unrolling the thread in case it's helpful to see it all in one place. #FDACBDscientificconference

@threadreaderapp unroll please

Here is the entire 55-tweet thread in once place: threadreaderapp.com/thread/1329413…
#FDACBDscientificconference #cannabis #clinicalresearch #womenshealth #marijuana #hemp #CBD #cannabinoids #sex #gender