throbber
Case 3:18-cv-07591-CRB Document 1618 Filed 11/03/22 Page 1 of 76
`
`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

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket