135th Meeting Minutes

Minutes – May 12, 2020

The National Advisory Council on Drug Abuse convened its 135th meeting at 11:00 a.m. on May 12, 2020. This meeting was conducted virtually. The closed portion of the meeting held on May 12th was for reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open portion, which was open to the public, began at 12:45 p.m. and was also video cast. The Council adjourned on May 12, 2020 at 4:03 p.m. 

Council Members Present
Linda Chang, M.D.
H. Westley Clark, M.D., J.D.
Gail D’Onofio, M.D.
Karl Deisseroth, M.D., Ph.D.
Carlos del Rio M.D.
Lakshmi Devi, Ph.D.
Marie Gallo Dyak
Daniel Goonan
Christian Heidbreder, Ph.D.
Paul Kenny, Ph.D.
Kenneth Mackie, M.D.
Lisa Marsch, Ph.D.
Jessica Hulsey Nickel
Edward Nunes, M.D.
Robert Rancourt, J.D.
Sharon Walsh, Ph.D. 

Council Chair
Nora Volkow, M.D.

Executive Secretary
Susan Weiss, Ph.D.

During the Open Session of Council, 475 participants joined live via the videocast. 

Closed Portion of the Meeting – May 12, 2019

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2). 

   Dr. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. She reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public. 

   Dr. Susan Weiss, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies. 

2. Application Reviews

   Drs. Rita Valentino, Carlos Blanco, Elena Koustova, and Kurt Rasmussen, Directors of NIDA’s Division of Neuroscience and Behavior, Division of Epidemiology, Services and Prevention Research, Office of Translational Initiatives and Program Innovations, and Division of Therapeutics and Medical Consequences presented their Division’s/Office’s assigned and peer reviewed applications for consideration by the Council. For each application, Council provided unanimous en bloc concurrence with the initial scientific review. Nine Special Council Review applications, two MERIT awards, and one Administrative Supplement were presented to Council for review, and Council concurred with program assessments. The initial review of all Trans-NIH Initiatives, including NIH Common Fund, Blueprint, and BRAIN applications as well as foreign applications and applications with a secondary assignment to NIDA also received Council concurrence. 

   Council and staff were recused from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications for which there was a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave the room if an application in conflict with that member was acted upon en bloc.

Open Portion of the Meeting

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed all attendees. She reminded all in attendance that the meeting was open to the public in compliance with the Government in the Sunshine Act, was available via videocast, and indicated that public comments can be submitted via email within 10 days of the meeting. 

   She then called attention to future Council meeting dates: September 10, 2020, February 9, 2021, and May 11, 2021 (NACDA) and May 12, 2021 (CRAN).  

2. Consideration of the Minutes of Council

   The Minutes of the January 2020 NIDA Advisory Council were unanimously approved as written. 

3. NIDA Director’s Report (NIH Videocast @ 0:01:15) — Nora Volkow, M.D., Director, NIDA

   Dr. Volkow first presented an overview of the current and projected NIDA budget including the base funds and additional NIH HEAL InitiativeSM funds. She then discussed priorities for NIH regarding COVID-19 to develop treatments and diagnostics and screening tools through the public-private partnership Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) and Rapid Acceleration of Diagnostics (RADX). Congressional funds have been allocated for projects such as serological testing, point of care, and research on populations at higher risk of infection. Specific to NIDA, Dr. Volkow addressed the intersection of COVID-19 and substance use disorders including pharmacological effects, structural changes such as access to medications for opioid use disorders (OUD) and limited peer-support groups, and social challenges including the effects of housing instability and incarceration on disease transmission. She emphasized that the pandemic is occurring during the ongoing opioid crisis and given the challenges, overdose mortality is expected to rise as people have less access to medication and unobserved overdoses cannot be reversed. Despite these difficult circumstances, Dr. Volkow discussed the opportunities that may arise from the sudden shift in daily living such as increased access to telemedicine, establishment and use of mental health hotlines, virtual support meetings, expansion of take-home medicine, and release of non-violent offenders from justice settings. Moving forward, she anticipates using existing research infrastructure such as HEALing Communities and JCOIN to better understand how the pandemic is affecting the ongoing opioid crisis. Dr. Volkow concluded her presentation by highlighting the upcoming virtual BRAIN Initiative meeting and the success of the virtual National Drug and Alcohol Facts Week. 

   Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 0:47:36). 

4. Communicating NIDA Science and Strategic Planning Update  (NIH Videocast @ 1:27:00) — Jack Stein, Ph.D., 
   Chief of Staff, NIDA, Director, Office of Science Policy and Communication 

   Dr. Jack Stein provided a brief overview of the Office of Science Policy and Communication (OSPC). OSPC serves as the interface between NIDA research and the professional community and ensures NIDA is the trusted source of scientific information on substance use and substance use disorders. The office consists of two major branches: the science policy branch and the communications branch which in recent years have experienced a growing level of interest for congressional briefings and testimonies and for comments to various media outlets. Dr. Stein then detailed two recent OSPC initiatives: refreshing the NIDA webpage and updating the NIDA Strategic Plan. He highlighted the new webpage design for the heavily trafficked website and popular landing pages. Dr. Stein presented an overview of the Strategic Plan and a timeline for expecting feedback and final adoption of the plan. The Strategic Plan serves as a foundational framework to guide NIDA over the next five years and consists of three overlapping goals: understanding drug use behavior and the brain, developing and testing prevention and treatment strategies, and implementing evidence-based strategies in real world settings. Cross cutting issues include big data, technology, comorbid conditions, and health disparities, to name a few. OSPC plans to incorporate feedback from public over the summer and fall and anticipates the publication of the NIDA Strategic Plan in the spring of 2021. 

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 1:52:40). 

5. DTMC: Strategies, tactics, and accomplishments in facilitating a pipeline of new treatments for Substance Use Disorders (NIH Videocast @ 1:55:40) — Kurt Rasmussen, Ph.D., Director, Division of Therapeutics and Medical Consequences 

   Dr. Rasmussen first introduced the staff and organization of the Division of Therapeutics and Medical Consequences. He then identified DTMC’s prime directive: new treatment options for patients battling addiction. Dr. Rasmussen put this in the context of the Opioid Crisis and mentioned the rise in use of other substances including methamphetamine, cocaine, and synthetic opioids. NIDA serves as the catalyst for developing new treatment options through providing grant opportunities, generating new data through clinical trials. Dr. Rasmussen then detailed the drug development pipeline from the early preclinical stage to compounds in various stages of clinical trials. He concluded by sharing DTMC’s goal of having multiple medications, devices, and psychophysical interventions in an integrated and orchestrated fashion to help individual patients. 

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:21:35). 

6. Points to Consider Updates (NIH Videocast @ 2:29:19) – Susan Weiss, Ph.D., Director, Division of Extramural Research 

   Dr. Weiss provided a brief history of the of the origin of the Points to Consider Document Regarding Tobacco Industry Funding. It was first created in 2011 to highlight the issues NIDA applicants should consider when receiving funding from tobacco industries and serves as a guide to avoid actual and perceived conflicts of interest. In 2016, the document was revisited to reflect e-cigarette companies and the potential harm reduction benefits their products may produce. Shortly after, in 2019, the document was revisited because the electronic nicotine delivery systems (ENDS) industry became a concern as adolescent use of ENDS began to rise. At that time, Council recommended researchers do not accept “in kind” donations. In 2020, in response to learning NIDA grantees served on advisory councils for groups associated with the tobacco industry, Dr. Weiss arranged a workgroup of various experts both external and internal to NIDA who met over the past few months to discuss if conflicts of interest should extend to non-paid positions and if more consideration should be given to the dramatic rise in adolescent use of ENDS. The workgroup recommended the Point to Consider document be updated to include a statement suggesting researchers be cautious about consulting relationships with the tobacco industry to avoid any perceived conflicts of interest. In addition, the document should be updated to reflect the evolving nature of ENDS, including the fact that tobacco companies own some ENDS products and the direct marketing of products to adolescents. Dr. Weiss emphasized that objectivity in research is crucial to building an evidence base for ENDS and there cannot be an actual or perceived influence by industry. She concluded by outlining the next steps for the workgroup which include incorporating the recommendations into the document and bringing to Council for final approval in September. 

   Following the presentation, a discussion with Council occurred (NIH Videocast @ 2:42:20). 

7. Concept Clearances (NIH Videocast @ 2:43:30)

   Division of Epidemiology, Services, and Prevention Research (DESPR) 
   • Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access – Heather Kimmel, Ph.D., Health Scientist Administrator
   • Multi-Site Studies for System-Level Implementation of Substance Use Prevention and Treatment Services – Lori Ducharme, Ph.D., Health Scientist Administrator
   • Development & Testing of Novel Interventions to Improve HIV Prevention, Treatment, and Program Implementation – Richard Jenkins, Ph.D., Health Scientist Administrator
   • AIDS-Science Track Award for Research transition – Richard Jenkins, Ph.D., Health Scientist Administrator
   
   Division of Neuroscience and Behavior (DNB) 
   • Cutting-Edge Basic Research Awards (CEBRA) – Amy C. Lossie, Ph.D., Health Scientist Administrator
   • Advancing Technologies to Improve Delivery of Pharmacological, Gene Editing, and Cargoes for HIV and SUD Mechanistic or Therapeutic Research – Jonathan Pollock, Ph.D., Branch Chief, Genetics, Epigenetics, and Developmental Neuroscience Branch
   • Elucidating the Effects of ART on Neuronal Function in the Context of SUD – Roger Sorensen, Ph.D., Branch Chief, Integrative Neuroscience Branch
   
   Division of Therapeutics and Medical Consequences (DTMC) 
   • Device-Based Treatments for Substance Use Disorders – Will M. Aklin, Ph.D., Health Scientist Administrator

   Office of Research Training, Diversity, and Disparities (ORTDD) 
   • Providing Research Education Experiences to Enhance Diversity in the Next Generation of Substance Abuse and Addiction Scientists – Albert Avila, Ph.D., Deputy Director
   • NIDA Mentored Clinical Scientist Development Program Award – Albert Avila, Ph.D., Deputy Director

8. Public Comments (NIH Videocast @ 3:06:20)
   No public comments were submitted. 
9. Adjourn (NIH Videocast@ 3:12:23) 
   The 135th meeting of the National Advisory Council on Drug Abuse was adjourned at 4:03 p.m.  

Certification

I hereby certify that the foregoing minutes are accurate and complete.

• Nora D. Volkow, M.D.
  Director, NIDA
  Chair
  National Advisory Council on Drug Abuse
• Susan Weiss, Ph.D.
  Executive Secretary
  National Advisory Council on Drug Abuse

Council Roster

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.