`
`UNITED STATES DISTRICT COURT
`
`NORTHERN DISTRICT OF CALIFORNIA
`
`THE CITY AND COUNTY OF SAN
`FRANCISCO, CALIFORNIA and THE
`PEOPLE OF THE STATE OF CALIFORNIA,
`Acting by and through San Francisco City
`Attorney DAVID CHIU,
`
`Case No. 3:18-cv-7591-CRB
`
`DECLARATION OF G. CALEB
`ALEXANDER, M.D., M.S.
`
`Plaintiffs,
`
`v.
`
`PURDUE PHARMA L.P., et al.,
`
`Defendants.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 2 of 76
`
`TABLE OF CONTENTS
`
`
`I.
`II.
`III.
`
`Page
`BACKGROUND AND QUALIFICATIONS OF AUTHOR .................................. 1
`DATA SOURCES, METHODOLOGY, AND OPINIONS .................................... 3
`ABATEMENT FRAMEWORK .............................................................................. 9
`Category 1: Prevention – Reducing Opioid Oversupply and Improving Safe
`Opioid Use ................................................................................................... 11
`A.
`Health Professional Education ......................................................... 11
`B.
`Patient and Public Education ........................................................... 13
`C.
`Safe Storage and Drug Disposal ...................................................... 15
`D.
`Surveillance, Program Development and Evaluation, and
`Leadership ........................................................................................ 16
`Category 2: Mitigating Epidemic-Related Harms .................................................. 18
`A.
`Harm Reduction ............................................................................... 18
`B.
`Managing Complications Attributable to the Epidemic .................. 24
`C.
`Distributing Naloxone and Providing Training................................ 28
`Category 3: Treatment and Recovery ..................................................................... 30
`A.
`Connecting Individuals to Services and Care .................................. 30
`B.
`Treatment for Opioid Use Disorder ................................................. 34
`C.
`Management of Non-Medical Opioid Use ....................................... 40
`D.
`Mental Health Counseling and Grief Support .................................. 44
`E.
`Workforce Expansion and Resiliency .............................................. 46
`F.
`Criminal Justice System ................................................................... 49
`G.
`Public Safety .................................................................................... 52
`Category 4: Addressing Needs of Special Populations .......................................... 54
`A.
`Homeless and Housing Insecure ...................................................... 54
`B.
`Black, Indigenous, and People of Color (BIPOC) and LGBTQ
`Populations ....................................................................................... 57
`Pregnant Women, New Mothers, and Infants .................................. 60
`C.
`Adolescents and Young Adults ........................................................ 64
`D.
`IV. MEASURING THE SUCCESS OF ABATEMENT EFFORTS ........................... 66
`V.
`ESTIMATED IMPACT OF PROPOSED ABATEMENT REMEDIES ............... 67
`VI.
`POTENTIAL OBJECTIONS TO PROPOSED ABATEMENT REMEDIES ...... 69
`VII. CONCLUSIONS .................................................................................................... 73
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`- i -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 3 of 76
`
`I.
`
`BACKGROUND AND QUALIFICATIONS OF AUTHOR
`
`My name is G. Caleb Alexander. I am a practicing general internist and
`
`Professor of Epidemiology and Medicine at Johns Hopkins Bloomberg School of Public
`
`Health. I have been retained by Plaintiffs to provide my scientific expertise regarding
`
`ways to abate or reduce the harms caused by opioid epidemic in the City and County of
`
`San Francisco and to estimate the size of specific populations that may require abatement
`
`interventions over a 15-year period, from 2022 to 2036. I have also been asked to provide
`
`recommended cost estimates for certain abatement interventions (generally medical
`
`costs); the remaining costs are provided in the expert report of economist Dr. William
`
`Padula, who calculates the total cost of my recommended abatement plan.
`
`As a physician, I am responsible for the primary care of approximately 250
`
`patients. While I do not specialize in the care of patients with opioid use disorder (OUD),
`
`I have patients in my practice with OUD who I co-manage with addiction specialists. As a
`
`pharmacoepidemiologist, I focus on the study of the uses and effects of drugs in well-
`
`defined populations. Pharmacoepidemiology is a bridge discipline that combines insights
`
`and tools from clinical medicine, pharmacology, and epidemiology to generate
`
`fundamental new knowledge regarding the utilization, safety, and effectiveness of
`
`prescription drugs, as well as the effects of pharmaceutical policy. I received a B.A. cum
`
`laude from the University of Pennsylvania (Philosophy) in 1993, an M.D. from Case
`
`Western Reserve University in 1998, and an M.S. from the University of Chicago in 2003.
`
`During the past decade, I have devoted much of my professional time to
`
`addressing the opioid epidemic. I have served as one of three Co-Editors of monographs
`
`issued by the Johns Hopkins Bloomberg School of Public Health providing
`
`comprehensive, concrete, evidence-based solutions to the epidemic, the most recent of
`
`which was issued in October 2017. I have also testified in front of the U.S. Senate and the
`
`U.S. House of Representatives and briefed groups such as the National Governors
`
`Association, the Food and Drug Administration, Congressional Black Caucus, Centers for
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`- 1 -
`
` DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 4 of 76
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Medicare and Medicaid Services (CMS), and the National Academy of Science,
`
`Engineering and Medicine (NASEM).
`
`
`
`I have published around 325 scientific articles, many in highly respected
`
`journals such as The Lancet, Annals of Internal Medicine, JAMA, and The New England
`
`Journal of Medicine. This includes more than 50 articles related to opioids, including
`
`analyses of prescription opioid use in the U.S. and evaluations of the structure and impact
`
`of regulatory and payment policies on opioid prescribing, dispensing, and utilization. I
`
`have also co-authored policy perspectives; a widely referenced public health review of the
`
`epidemic; analyses of the potential impact of the coronavirus pandemic on the care of
`
`individuals with OUD; and an evaluation of the public health impact of select abatement
`
`remedies in the U.S.
`
`
`
`I have also led or participated in teams examining many other facets of the
`
`crisis, including: availability of naloxone in retail pharmacies; opioid initiation among
`
`members of households with a prescription opioid user; the effect of reformulated
`
`Oxycontin on opioid utilization; physicians’ knowledge and attitudes regarding non-
`
`medical opioid use; use and impact of medications for addiction treatment; costs and
`
`healthcare utilization associated with high-risk opioid use; automated algorithms to
`
`identify non-medical opioid use; the relationship between high-risk patients receiving
`
`prescription opioids and high-volume prescribers; opioid use and safety among
`
`individuals with HIV, chronic kidney disease, or recent surgery; increasing prevalence of
`
`synthetic opioids in the illicit drug supply; potential financial conflicts of interest among
`
`organizations opposed to the CDC’s 2016 Guideline for Prescribing Opioids for Chronic
`
`Pain; the quality of preventive and chronic illness care received by individuals with OUD;
`
`and perceived consequences of prescription drug monitoring programs.
`
`
`
`I have served as an expert witness regarding how best to abate the opioid
`
`epidemic in several cases in both federal and state courts. In the third opioid MDL
`
`bellwether trial case before Judge Dan Polster in the Northern District of Ohio, I testified
`
`at trial in both the liability and remedy phases, and my testimony was the foundation for
`
`
`
`
`
`
`
`- 2 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 5 of 76
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`the abatement remedy Judge Polster ordered for Lake and Trumbull Counties, Ohio. I
`
`performed this work through Monument Analytics, a health care consultancy I cofounded
`
`that is separate and distinct from Johns Hopkins, and I was assisted during this process by
`
`Monument Analytics’ employees and consultants. My rate of compensation for this matter
`
`is $900 per hour. I am also reimbursed for my out-of-pocket expenses. I am not
`
`compensated based on the outcome of this matter nor the substance of my report. A copy
`
`of my CV is attached as Exhibit 1.
`
`II.
`
`DATA SOURCES, METHODOLOGY, AND OPINIONS
`
`
`In preparing this report, I reviewed materials from a number of sources,
`
`including: Bates-stamped documents and deposition testimony in this case provided to me
`
`by counsel; published reports regarding the epidemic; information derived from other
`
`local and national sources; and peer-reviewed literature, whitepapers, reports from public
`
`health authorities, non-profit organizations, and other publicly available sources. I, along
`
`with some of my team members, also spoke with local stakeholders including:
`
` Phillip Coffin, MD, MIA, Director of Substance Use Research in the Center for
`
`Public Health Research, San Francisco Department of Public Health (“SFDPH”)
`
` Hali Hammer, MD, Medical Director, San Francisco General Hospital Family Health
`
`Center; Director of Quality Improvement, San Francisco General Hospital,
`
`Department of Family and Community Medicine; Clinical Professor, University of
`
`California San Francisco, Family Community Medicine
`
` Judy Martin, MD, Deputy Medical Director at Community Behavioral Health
`
`Services, SFDPH
`
` Tracey Packer, MPH, Director of Community Health Equity and Promotion, SFDPH
`
` Eileen Loughran, BA, Health Program Coordinator and Program Manager, SFDPH
`
` Niels Tangherlini, BA, Paramedic Captain, San Francisco Fire Department; Director
`
`of the Homeless Outreach and Medical Emergency Team
`
` Barry Zevin, MD, Medical Director of Street Medicine and Shelter Health and
`
`Medical Director of Transgender Health Services, SFDPH
`
`
`
`
`
`
`
`- 3 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 6 of 76
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
` Katie Burk, MPH, Viral Hepatitis Coordinator, SFDPH
`
` Hillary Kunins, MD, MPH, Director of Behavioral Health Services and Mental
`
`Health, SFDPH
`
`Many of my findings are based on prior investigations that my team and I have either
`
`performed or synthesized, and expert work that I have done in other jurisdictions.
`
`
`
`Several prior reports focused on San Francisco have informed my opinions,
`
`such as the Substance Use Trends in San Francisco through 2019,1 the Mental Health
`
`Reform Updated Report from October 2020,2 San Francisco Safe Injection Services Task
`
`Force 2017 Final Report,3 HIV Epidemiology Annual Report 2019,4 End Hep C SF
`
`Strategic Plan 2020-2022,5 and San Francisco Community Health Needs Assessment
`
`2019.6 Additional sources I consulted in forming my opinions are cited in my expert
`
`report, including in Appendix D.
`
` My estimates of the size of specific populations in need of abatement
`
`interventions over time appear in “Redress Models” submitted with this testimony as
`
`Exhibit 2 (P-04705). The population estimates are derived from data from state and local
`
`government (e.g., SFDPH, California Opioid Overdose Surveillance Dashboard7), federal
`
`
`1 P-22446: Coffin PO et al. Substance Use Trends in San Francisco through 2019. Center
`on Substance Use and Health. SFDPH. 2020. https://e6deb072-6234-4cd5-8b50-
`9f3f91b97c99.filesusr.com/ugd/91710f_ee467743b09140d981b6ade58068c351.pdf.
`2 P-28742: SFDPH. Mental Health Report Updated Report. 2020. https://www.sfdph.org/
`dph/files/MHR/Mental_Health_Reform_Update_Report_FINAL.pdf.
`3 P-28752: SFDPH. San Francisco Safe Injection Services Task Force, 2017 Final Report.
`2017.
`https://www.sfdph.org/dph/hc/HCAgen/HCAgen2018/February%206/SIS%20Task%20Fo
`rce%20Final%20Report%202017.pdf?TB_iframe=true&width=370.8&height=658.8.
`4 P-28743: SFDPH. HIV Epidemiology Annual Report 2019. 2020. https://
`www.sfdph.org/dph/files/reports/RptsHIVAIDS/AnnualReport2019_Indigo_20200929_W
`eb_fixed.pdf.
`5 P-28744: End Hep C San Francisco. Strategic Plan 2020-2022. https://4z4.c77.
`myftpupload.com/wp-content/uploads/2020/06/EndHepC_2020StrategicPlan_FINAL.pdf.
`6 P-28746: San Francisco Health Improvement Partnership. San Francisco Community
`Health Needs Assessment. 2019. https://www.sfdph.org/dph/hc/HCAgen/2019/May%207/
`CHNA_2019_Report_041819_Stage%204.pdf.
`7 California Department of Public Health. California Opioid Overdose Surveillance
`Dashboard. https://skylab.cdph.ca.gov/ODdash.
`
`
`
`
`
`
`
`- 4 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 7 of 76
`
`
`
`agencies (e.g., CDC, Substance Abuse and Mental Health Services Administration
`
`[SAMHSA]), community-based organizations, peer-reviewed publications, and both my
`
`and others’ expert opinion. The selection of each estimate was driven by the strength of
`
`evidence and appropriateness of the data for the specific context at hand.
`
` Overall, I took a conservative approach to derive the population estimates in
`
`my Redress Models, including my treatment of the impact of the COVID-19 pandemic on
`
`the opioid epidemic. Thus, where available, I reviewed information regarding 2020
`
`service provision and morbidity and mortality and included data that did not raise
`
`significant concerns about potentially disproportionate or effects of COVID-19.
`
`
`
`The layout of my Redress Models mirrors the layout of this declaration. For
`
`each abatement intervention in the Redress Models, I list the estimated size of the target
`
`population, how it was derived, and the sources that informed each step. For each
`
`intervention, I first estimate the size of each relevant population and then project how
`
`these populations are likely to change over a fifteen-year period from 2022 through 2036.
`
`
`
`Several peer-reviewed models,8 including the national APOLLO model I co-
`
`authored,9 project a 10% to 40% reduction in opioid overdose deaths and the active OUD
`
`population as a result of certain key interventions over a period of five to 10 years. The
`
`interventions examined in APOLLO include: (1) reducing prescription opioid oversupply;
`
`(2) increasing the uptake of medications for addiction treatment (“MAT”); (3) increasing
`
`detoxification success; (4) reducing the MAT discontinuation rate; and (5) increasing
`
`naloxone distribution. In addition to estimating the total number of people with OUD,
`
`APOLLO can also be used to estimate the average amount of treatment, or “treatment
`
`months”, per individual and across a population. For example, if APOLLO estimates that
`
`2,000 people are in treatment in any given month in a year, the total duration of treatment
`
`for the year is 24,000 treatment months. If there are a total of 8,000 people with OUD,
`
`
`8 See footnotes 296–300.
`9 See footnotes 294–295.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`
`
`
`
`
`
`- 5 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 8 of 76
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`then the average duration of treatment per individual with OUD is three months (24,000 /
`
`8,000). In San Francisco, I conservatively estimate that total treatment volume will
`
`correspond with an average of 2.5 months10 per individual with active OUD during the
`
`first year of abatement. This treatment volume is increased to an average of five months
`
`by year five, followed by a gradual increase to an average of six months in the fifteenth
`
`year. This increase reflects expected improvements in treatment engagement and retention
`
`due to the programs I propose.
`
`
`
`In all cases, my review of the scientific evidence base was based on a
`
`stepwise process building on the foundation of literature regarding the opioid epidemic
`
`that I was already aware of. To supplement this, I reviewed the content of additional
`
`academic and federal, state, and local governmental studies and reports, including both
`
`their reference lists as well as subsequent reports that have cited them. Finally, in some
`
`instances, additional candidate articles were identified based on keyword searches of
`
`major bibliographic databases such as PubMed. In evaluating studies, I used a number of
`
`qualitative criteria that are often useful in evaluating the strength of scientific evidence
`
`supporting a given scientific finding or claim. These include factors such as the publishing
`
`journal, authorship team, affiliated institutions, funding source(s), data source(s),
`
`methodologic approach, and interpretation. The “Hill Criteria” (strength of association,
`
`consistency, specificity, temporality, biological gradient, plausibility, coherence,
`
`experiment, and analogy) are also an important means of evaluating the strength of causal
`
`inference possible from a given scientific study, and I have applied these criteria as well.11
`
`
`
`For some remedies, such as OUD treatment or naloxone distribution and
`
`training, the evidence base is vast, with thousands of peer-reviewed manuscripts
`
`examining this matter. In these settings, formal evidence syntheses were often available,
`
`typically systematic reviews that represent a pre-specified, transparent, reproducible,
`
`
`10 As this represents a population average, some individuals will be in treatment for less
`than 2.5 months and others may be in treatment for the entire year.
`11 Hill AB. The Environment and Disease: Association or Causation? J Royal Society of
`Medicine. 1965;58:295-300.
`
`
`
`
`
`- 6 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 9 of 76
`
`
`
`highly structured approach to curating and critically appraising the totality of information
`
`required to address a carefully specified question. Because of their comprehensiveness
`
`and rigor, such evidence syntheses are often regarded as at the top of the “evidence
`
`pyramid.”12 For some abatement interventions, I also used information available from
`
`authoritative sources such as the CDC, National Institute on Drug Abuse (NIDA), or
`
`SAMHSA.
`
`
`
`There is widespread
`
`consensus in both clinical and public
`
`health communities that the abatement
`
`measures identified in this report are
`
`effective in reversing opioid-related
`
`morbidity and mortality. This consensus
`
`is reflected in the high concordance
`
`between the measures discussed herein
`
`and proposals or recommendations put
`
`forward by the SFDPH13 and numerous
`
`consensus panels, task forces, professional society organizations and others,14,15,16
`
`including a report I Co-Edited that was released by the Johns Hopkins Bloomberg School
`
`of Public Health.17 The Johns Hopkins report stemmed from three principles (Figure 1)
`
`12 Murad MH et al. New Evidence Pyramid. BMJ Evidence-Based Medicine.
`2016;21:125-7.
`13 Coffin supra n.1.
`14 P-11731: Christie C et al. The President’s Commission on Combating Drug Addiction
`and the Opioid Crisis. 2017. https://www.whitehouse.gov/sites/whitehouse.gov/files/
`images/Final_Report_Draft_11-1-2017.pdf.
`15 P-41917: National Governors Association. Governors' Recommendations for Federal
`Action to End the Nation's Opioid Crisis. 2018. https://classic.nga.org/cms/governors-
`recommendations-opioid-crisis.
`16 Department of Veterans Affairs. VA/DoD Clinical Practice Guideline for Opioid
`Therapy for Chronic Pain Version 3.0. https://www.healthquality.va.gov/guidelines/Pain/
`cot/VADoDOTCPG022717.pdf.
`17 P-04701: Alexander GC et al. The Opioid Epidemic: From Evidence to Impact. 2017.
`https://www.jhsph.edu/events/2017/americas-opioid-epidemic/report/2017-JohnsHopkins-
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`
`
`
`
`
`
`- 7 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 10 of 76
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`that provide a valuable basis for current efforts. Disagreement about these solutions, when
`
`present, has tended to focus more on the priority of the interventions given limited
`
`funding (e.g., how much should be spent on law enforcement vs. treatment),18 as well as,
`
`in some cases, the potential unintended effects of some interventions. Fortunately, there is
`
`a large evidence base to guide the selection of interventions that should be undertaken in
`
`the San Francisco, and also a recognition of the critical point, as expressed by former
`
`Congressman John Delaney, “that the cost of doing nothing is not nothing”.19
`
` As we20 and others21,22 have argued, the COVID-19 pandemic injects new
`
`urgency into efforts to address the opioid epidemic, given the potential for disruption of
`
`care for many with opioid use disorder, that many individuals with OUD have chronic
`
`comorbid conditions, as well as tobacco use, which place them at higher risk from critical
`
`illness or death should they become infected with COVID-19, and the profound risks for
`
`people with addiction posed by social distancing and other responses to the pandemic,
`
`given that addiction is “a disease of isolation.”
`
`
`
`It is my opinion, based on overwhelming evidence, that an opioid epidemic
`
`currently exists within San Francisco and continues to result in high levels of opioid-
`
`related morbidity and mortality. I further conclude, based on my experience in
`
`epidemiology, clinical medicine, and public health, my extensive application of these
`
`fields to the opioid epidemic, and my analysis in this case, that I am able to determine
`
`what additional evidence-based and evidence-informed measures and approaches should
`
`Opioid-digital.pdf.
`18 Katz J. How a Police Chief, a Governor and a Sociologist Would Spend $100 Billion to
`Solve the Opioid Crisis. New York Times. 2018. https://www.nytimes.com/interactive/
`2018/02/14/upshot/opioid-crisis-solutions.html.
`19 Delaney JK. The Right Answer: How We Can Unify Our Divided Nation. Henry Holt
`and Company. New York: Macmillan Publishing Group, 2018.
`20 Alexander GC et al. An Epidemic in the Midst of a Pandemic: Opioid Use Disorder and
`COVID-19. Ann Intern Med. 2020;173:57-8.
`21 Volkow ND. Collision of the COVID-19 and Addiction Epidemics. Ann Intern Med.
`2020;173:61-2.
`22 Nguyen T, Buxton JA. Pathways between COVID-19 Public Health Responses and
`Increasing Overdose Risks: A Rapid Review and Conceptual Framework. International J
`Drug Policy. 2021;93:103236.
`
`
`
`
`
`
`
`- 8 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 11 of 76
`
`
`be used to reduce opioid-related harms. These measures and approaches are described
`
`below. While I suggest remedies that should be included as part of a comprehensive
`
`abatement plan, and while I consider programs that are already underway, the specific
`
`utilization and combination of measures should be subject to the opinions of stakeholders,
`
`policy-makers, and subject matter experts in San Francisco.
`
`III. ABATEMENT FRAMEWORK
`
`
`There are four major categories of remedies that must be undertaken to
`
`address the opioid epidemic in San Francisco. First, we must improve the opioid
`
`prescription practices and the treatment of pain to prevent new cases of OUD, since opioid
`
`oversupply has been a key driver of the epidemic, and there are many gaps to the optimal
`
`identification and management of individuals with OUD (Category 1: Prevention,
`
`below).23,24 Opioid-related harms arise from many points in the continuum of care,
`
`ranging from how clinicians treat pain to the diversion of opioids throughout the supply
`
`chain. Second, we must improve implementation of strategies that reduce the negative
`
`consequences associated with ongoing opioid use (Category 2: Mitigating Epidemic-
`
`Related Harms). Third, we must identify and treat individuals with OUD and support their
`
`recovery (Category 3: Treatment and Recovery). This is important because even if
`
`prescription opioids were to be responsibly marketed, promoted, and used beginning
`
`tomorrow, there are still thousands of individuals with OUD in San Francisco and many
`
`more with non-medical opioid use who do not yet fulfill formal criteria for OUD. A fourth
`
`part of the abatement framework is focused on the needs of certain subpopulations in San
`
`Francisco that require special consideration (Category 4: Addressing Needs of Special
`
`Populations).
`
`
`23 P-41918: CDC. Contextual Evidence Review for the CDC Guideline for Prescribing
`Opioids for Chronic Pain – United States, 2016. 2016. https://stacks.cdc.gov/view/
`cdc/38027.
`24 Chou R et al. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic
`Pain. Evidence Report/Technology Assessment. 2014;218:1-219.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`
`
`
`
`
`
`- 9 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 12 of 76
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
` No single abatement remedy that is proposed can fully address the
`
`oversupply of opioids and associated morbidity and mortality in San Francisco,
`
`underscoring the importance of intervening comprehensively. Some of the remedies may
`
`interact with one another in synergistic fashion, and successful implementation of some
`
`strategies may be dependent upon the simultaneous intervention of other strategies. For
`
`example, initiatives to decrease stigma and educate law enforcement and other community
`
`members about addiction may increase the demand for treatment, while expansions in
`
`treatment capacity to meet such demand may decrease rates of active OUD, which in turn
`
`may decrease overdose deaths and the need for naloxone. The dynamic nature of the
`
`epidemic, as well as the potential for these sorts of interactions, speaks to the vital need
`
`for surveillance and leadership to maximize the ability of communities to respond
`
`effectively to near real-time intelligence regarding key parameters of the epidemic and
`
`thus to use, and redirect, resources to maximize their public health value.
`
`
`
`Some abatement approaches may be framed in the context of looking
`
`forward ten or fifteen years.25 However, the legacy of the opioid epidemic will endure in
`
`San Francisco far beyond that. This is because while OUD can be treated and may remit,
`
`it is not curable, and some individuals with OUD will require treatment indefinitely.26,27
`
`Others have acquired HIV and/or hepatitis C as a result of an addiction that began with
`
`prescription opioids,28 and they may require indefinite care for these comorbid conditions.
`
`However, over fifteen years, we can put in place abatement strategies that will have a
`
`
`25 This medium-term view is long enough to support infrastructure development and several
`cycles of planning and evaluation while avoiding some of the uncertainty entailed in trying
`to anticipate the magnitude of sequelae from the epidemic that may last decades or even
`generations.
`26 NIDA. Principles of Drug Addiction Treatment: A Research-Based Guide (Third
`Edition). 2018. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/675-principles-of-
`drug-addiction-treatment-a-research-based-guide-third-edition.pdf.
`27 Zhang Z et al. Does Retention Matter?. Treatment Duration and Improvement in Drug
`Use. Addiction. 2003;98:673-84.
`28 Suryaprasad AG et al. Emerging Epidemic of Hepatitis C Virus Infections Among
`Young Nonurban Persons who Inject Drugs in the United States, 2006-2012. Clinical
`Infectious Diseases. 2014;59:1411-9.
`
`
`
`
`
`
`
`- 10 -
`
`DECL. OF G. CALEB ALEXANDER
`CASE NO. 3:18-CV-07591-CRB
`
`
`
`
`
`Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 13 of 76
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`substantial impact on reducing new cases of OUD, more effectively treating those with
`
`OUD, and reducing mortality and related diseases among those who use opioids, as well
`
`as addressing the impacts their opioid use has on families, first responders, and the
`
`criminal justice system. The specific interventions I recommend are described below. The
`
`size of the target population and quantity of resources needed to achieve the expected
`
`reduction in harms is detailed for each intervention in the Redress Models.29
`
`Category 1: Prevention – Reducing Opioid Oversupply and Improving
`
`Safe Opioid Use
`
`A. Health Professional Education
`
`
`
`The goal of this remedy is foremost to train health care providers regarding
`
`the appropriate use of opioids in clinical practice. Historically, many providers have
`
`overestimated the effectiveness of opioids and/or underestimated their risks, contributing
`
`to the oversupply of opioids, not only with respect to whether they are used at all, but also
`
`with respect to the dose and duration of use.30
`
`
`
`The top prescribers (physicians, dentists, nurse practitioners, and physician
`
`assistants) in San Francisco, as defined by prescribed opioid volume, should be the focus
`
`of a comprehensive academic detailing program with the goal of providing training on the
`
`appropriate use of opioids in clinical practice. Each given year, prescribers who meet the
`
`inclusion criteria for being a top prescriber should be visited multiple times, preferably, by
`
`the same academic detailer. Academic detailing is a method of evidence-based, interactive
`
`outreach to prescribers that uses trained personnel to make face-to-face visits with
`
`clinicians to promote optimal prescribing and improve the quality of patient care. It is one
`
`of the most systematic and well-studied approaches to direct training of prescribers and
`
`there are dozens of studies that provide evidence of its value,31 including to reduce opioid
`
`29 See Section V, Estimated Impact of Proposed Abatement Remedies.
`30 Another misconception is the belief that if a patient has “organic” pain, one need not
`worry about the addictive potential of opioids. In fact, there is no evidence that organic
`pain prevents opioid addiction, and the notion that opioids are typically safe for chronic,
`non-cancer pain has cont



