11th Annual Pegalis Law Group Health Law Colloquium THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19
DATE Opening remarks will be made by Anthony W. Crowell, Thursday Dean and President; Professor of Law, New York Law School. November 19, 2020 CO-MODERATORS Adam Herbst, Adjunct Professor, NYLS; Co-Director, NYLS TIME Health Law and Patient Safety Project; Lecturer at Columbia 6:00 p.m.–7:30 p.m. EST University’s Mailman School of Public Health Steven E. Pegalis, Adjunct Professor, NYLS; Co-Director, COST NYLS Health Law and Patient Safety Project; Member, Free NYLS Board of Trustees
CLE PANELISTS 1.5 credits in Ethics Alison Bateman-House, Assistant Professor, Division of Medical Ethics, Department of Population Health at and Professionalism Grossman School of Medicine, NYU Langone Health (NY transitional and Arthur Caplan, the Drs. William F. and Virginia Connolly nontransitional) Mitty Professor and Founding Head, Division of Medical Ethics at Grossman School of Medicine, NYU Langone New York Law School is Health certified by the New York State Continuing Legal Education Hon. Richard N. Gottfried, New York State Assembly Board as an Accredited Provider (District 75); Chair of the Assembly’s Committee on Health of Continuing Legal Education Alicia Ouellette, President and Dean; Professor of Law, in the State of New York. Albany Law School
RSVP: www.nyls.edu/VaccineCLE Zoom link will be sent with written materials 24 hours in advance of the program.
WE ARE NEW YORK’S LAW SCHOOL
1 Since 1891 AGENDA
6:00-6:05pm – Opening Remarks – Anthony W. Crowell, Dean and President, New York Law School
6:05-6:10pm – Welcome – Professor Steven E. Pegalis
6:10-6:15pm – Introduction of the Panel by Moderator Professor Adam Herbst (please see detailed bios included below)
6:15-7:05pm – Panel Discussion 1 Ethics and Professionalism CLE Credit, NY Transitional and Nontransitional
7:05-7:30pm – Substantive Question & Answer with Audience 0.5 Ethics and Professionalism CLE Credit, NY Transitional and Nontransitional
REMINDERS Attorney Attendance Verification: For any attorneys seeking CLE credit, per our accreditation guidelines, please complete this form by reporting back to us the three codes that were announced during the program. Ideally, you can complete this form by Monday, Nov. 23rd. CLE Certificates will be emailed to the email you provide in this form within 30 days. LINK: https://nyls.wufoo.com/forms/111920-cle- program-attendance-verification/
Feedback on the Program: For all attendees - please let us know what you thought about the program. Please share your feedback here: https://nyls.wufoo.com/forms/cle-evaluation-form-111920/
2 Table of Contents
Starts on Page Presenter Bios Page 1 Ethical Considerations for Protecting the Options of Subjects in Primary Epidemic Vaccine Page 4 Trials Fair Compensation for Rare Vaccine Harms Page 5 “Hell Freezes Over!” The Pharmaceutical Industry Stands in for a Politically Impaired FDA Page 8 Make Pre-Approval Covid-19 Vaccines Available Through Expanded Access, Not an EUA Page 12 New York State Vaccine Program DOWNL VISIT LINK: OAD https://www.governor.ny.gov/sites/governor.ny.gov/files/atoms/files/NYS_COVID_Vac cination_Program_Book_10.16.20_FINAL.pdf
3 11th Annual Pegalis Law Group Health Law Colloquium THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19 SPEAKER BIOS
OPENING REMARKS CO-MODERATORS
ANTHONY W. CROWELL ADAM S. HERBST Dean and President, New York Law School Adjunct Professor, NYLS; Co-Director, NYLS Health Law And Patient Safety Anthony W. Crowell is the 16th Dean and Project; Lecturer at Columbia University’s President of New York Law School (NYLS). He Mailman School of Public Health has served in the role since May 2012 and has taught state and local government law at NYLS A senior hospital administrator, Adam Herbst since 2003. has devoted his career to specializing at the intersection of where health care law meets A first-generation student and a long-time New York City public servant, with communications, technology, and employment issues. He is an Dean Crowell proudly reintroduced NYLS as “New York’s law school.” adjunct professor at NYLS and a frequent speaker on health care access The School’s new motto illustrates NYLS’s commitment to building a at New York Medical College, Columbia University’s Mailman School of legal profession that reflects the diverse populations it serves. It also Public Health. Professor Herbst co-directs the NYLS Heath Law and Patient underscores NYLS’s identity as the only law school in Lower Manhattan, Safety Project and teaches health policy, bioethics, and healthcare access. the epicenter of the world’s economy. Under Dean Crowell’s leadership, NYLS issued the School’s first comprehensive Strategic Plan, annual Professor Herbst has extensive experience in structuring agreements progress reports on that plan, and most recently, the 2020 Strategic while advising on risk mitigation, and in offering solutions on operations, Plan. NYLS also published an Institutional Diversity Plan, built an Office board governance, and regulatory matters. He has worked on issues of Diversity and Inclusion, and adopted a dynamic and successful new related to housing, education, public health, and economic development. curriculum, Think BIG. The School further strengthened academic and bar He also has trial experience in both federal and state courts, and in support programs and dramatically expanded clinical and experiential arbitrations throughout the country. learning programs to leverage New York City as the ultimate classroom.
Prior to his appointment, Dean Crowell served as Counselor to New York City Mayor Bloomberg. For more than a decade in City Hall, he STEVEN E. PEGALIS successfully managed a broad portfolio of legal, regulatory, legislative, Adjunct Professor, NYLS; Co-Director, governance, administrative, and operational matters focused on NYLS Health Law and Patient Safety enhancing New York City’s performance, competitiveness, accountability, Project; Member, NYLS Board of Trustees and public integrity. He coordinated and oversaw the work of city Steven Pegalis is the founder of Pegalis agencies, boards, and commissions; spearheaded government reform Law Group, LLC. He represents plaintiffs in and business process initiatives; and negotiated and implemented catastrophic medical malpractice actions and landmark reforms to the city’s lobbying and campaign finance laws. Dean specializes in perinatal brain injury cases. Crowell earned a Bachelor of Arts from the University of Pennsylvania and a Juris Doctor from American University. He is a member of the Board of Trustees at NYLS, where he also teaches medical malpractice as an adjunct professor. Professor Pegalis moderates the Annual Pegalis Law Group Lectureship on the Intersection of Law and Medicine to promote patient safety at NYLS. He also co-directs the NYLS Health Law and Patient Safety Project. Professor Pegalis has authored, American Law of Medical Malpractice, volumes 1–3. He has written and lectured on the subjects of trial advocacy, technique, and patient safety.
4 THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19
SPEAKER BIOS (continued)
Professor Pegalis is admitted to practice in New York, the U.S. Court group of internationally recognized medical experts, bioethicists, and of Appeals, 2nd Circuit, and the U.S. District Courts for the Eastern patient representatives. CompAC advises Janssen Pharmaceutical and Southern Districts of New York. He holds both a Juris Doctor and Companies of Johnson & Johnson on requests for compassionate use Bachelor of Law from New York Law School. and off-label access to many of its medicines.
Professor Caplan previously served as a member of the WHO Ebola Ethics Committee. He is now a member of the WHO’s Monitored Emergency Use of Unregistered and Experimental Interventions Advisory DISTINGUISHED PANELISTS Committee on COVID-19. He has helped set policy for WIRB-Copernicus Group for reviewing research studies and compassionate use. Professor ALISON BATEMAN -HOUSE Caplan has also been consulted by Moderna and other vaccine Assistant Professor, Division of Medical companies on seeking emergency use authorizations. Ethics, Department of Population Health, New York University School of Medicine Professor Caplan earned a Doctor of Philosophy from Columbia University.
Alison Bateman-House is an assistant professor in the Division of Medical Ethics at New York University (NYU) Grossman School of Medicine. THE HONORABLE RICHARD N. GOTTFRIED She serves as Co-Chair of the Working Group Assembly Member, District 75, New York on Compassionate Use and Preapproval Access (CUPA). CUPA is an State Assembly; Chair, New York State academic group—composed of patient advocates, clinicians, members Assembly Committee on Health of industry, former FDA staffers, lawyers, and academics—that studies The Honorable Richard N. Gottfried is the Chair ethical issues concerning access to investigational medical procedures. of the New York State Assembly Committee on Professor Bateman-House also co-chairs the Pediatric Gene Therapy Health, and has served in this role since 1987. and Medical Ethics working group, which includes academics, patient He is a Democrat representing District 75, advocates, industry representatives, and a wide array of clinical and which is located in a Manhattan and includes Chelsea, Hell’s Kitchen, research professionals. Bateman-House serves as the non-voting, Midtown, and part of the Upper West Side. non-paid Chair of the NYU/Janssen Pharmaceutical Compassionate Use Hon. Gottfried is a leading proponent of patient autonomy and Advisory Committee (CompAC) for Infectious Diseases and Neurology/ reproductive freedom. He works to protect funding for Medicaid, Psychology. CompAC won the Reagan-Udall Foundation for the FDA’s community health centers, school health clinics, HIV/AIDS services, 2019 Innovation Award. and other health concerns, and creating and expanding public health Professor Bateman-House has published and spoken extensively on how insurance programs in New York, including Child Health Plus. He is to best handle requests for non-trial access to investigational drugs sponsoring the New York Health Act to create a universal “improved and on related ethical issues. Similarly, she has written and spoken Medicare for all” single-payer health plan for New York. Previously, he frequently on the history and ethics of using human as research subjects sponsored the law to allow medical use of marijuana in New York and on clinical trial accessibility. the HIV Testing and Confidentiality Law.
Professor Bateman-House earned a Doctor of Philosophy and a Master His legislative work includes promoting primary and preventive care, of Public Heath from Columbia University. managed care reforms, granting patients access to information about a doctor’s background and malpractice record, midwife licensure, and insurance coverage for midwife services. Furthermore, his legislative record includes both the Health Care Proxy Law, which allows people ARTHUR L. CAPLAN to designate an agent to make health care decisions for them if they The Drs. William F. and Virginia Connolly lose decision-making capacity, and the Family Health Care Decisions Mitty Professor and Founding Head of the Act, which enables family members to make health care decisions for Division of Medical Ethics, NYU School of incapacitated patients who have not signed a health care proxy. Medicine Hon. Gottfried is a member of the New York Academy of Medicine, the Arthur L. Caplan is the Drs. William F. and National Academy for State Health Policy, the Public Health Association Virginia Connolly Mitty Professor and Founding of New York City, and the New York Civil Liberties Union. He was first Head of the Division of Medical Ethics of NYU elected to the Assembly in 1970 while he was still in law school. He Grossman School of Medicine. earned a Bachelor of Arts from Cornell University and a Juris Doctor from Columbia Law School. Since 2015, Professor Caplan has served as the Chairperson of the Compassionate Use Advisory Committee (CompAC), an independent
5 THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19
SPEAKER BIOS (continued)
ALICIA OUELLETTE Bioethics and Disability: Toward A Disability Conscious Bioethics, was President and Dean, Albany Law School published in 2011 by Cambridge University Press. She has also authored numerous articles published in academic journals such as the American Alicia Ouellette is the 18th President and Journal of Law and Medicine, American Journal of Bioethics, Nevada Dean of Albany Law School. A leader in legal Law Journal, Hastings Law Journal, Indiana Law Journal, and Oregon education, Dean Ouellette has championed the Law Review. Dean Ouellette has presented to distinguished audiences value of law schools as drivers of change in around the globe, including the Yale School of Medicine and the United communities, society, and the lives of students Nations in Geneva, Switzerland. and graduates. As President and Dean, she has presided over Albany Law School’s execution of a new strategic plan, Dean Ouellette has served in leadership positions for numerous fulfillment of an institutional affiliation with the University at Albany, professional and community organizations, including as Chair of the expansion into online graduate programs, and launch of a record-setting Association of American Law Schools (AALS) Section for Deans, fundraising campaign, We Rise Together: The Campaign for Albany Law secretary and a board member for the Commission on Independent School. Colleges and Universities (CICU), secretary and a board member for the Burdett Birthing Center in Troy, NY, and a board member for Prior to her appointment as President and Dean, she served as the the University at Albany’s Institute for Health and Human Rights. In Associate Dean for Academic Affairs and Intellectual Life and a September 2020, Dean Ouellette was appointed to New York Governor Professor of Law. Before joining the Law School in 2001, Dean Ouellette Andrew Cuomo’s COVID-19 Vaccine Distribution and Implementation served as an Assistant Solicitor General in the New York State Attorney Task Force. General’s Office and a law clerk to the Honorable Howard A. Levine at the New York Court of Appeals. Dean Ouellette earned a Bachelor of Arts from Hamilton College and a Juris Doctorate from Albany Law School, where she served as Editor in As a scholar, Dean Ouellette focuses on health law, disability rights, Chief of the Albany Law Review. family law, children’s rights, and human reproduction. Her book,
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14 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access
Trending: Coronavirus Health First Opinion Biotech 1
Make pre-approval Covid-19 vaccines available through expanded access, not an EUA
By Matthew W. McCarthy, David Oshinsky, and Arthur Caplan on behalf of the Vaccine Working Group on Ethics and Policy
November 9, 2020
Reprints2
BioNTech, based in Mainz, Germany, announced positive results Monday about the Covid-19 vaccine it is developing with Pfizer. YANN SCHREIBER/AFP via Getty Images
15 https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ 1/7 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access On Monday, Pfizer and BioNTech announced that their experimental Covid-19 vaccine candidate prevented more than 90% of infections3 in healthy volunteers. Based on these encouraging data — potentially among the most effective for any infectious disease — the companies plan to apply for emergency use authorization4, which would let the Food and Drug Administration formally authorize an unapproved medical product during a state of emergency. While well-intentioned, this approach is ultimately misguided. The world faces a crisis not an emergency.
An emergency use authorization would potentially open the floodgates to deploy an unapproved and unlicensed vaccine to millions (or tens of millions) of individuals before gathering the proof of safety and efficacy that licensing a new vaccine typically demands.
This was never the intent of emergency use authorization, which was actually designed for counterterrorism measures5 to address chemical, biological, radiological, and nuclear hazards — not necessarily a pandemic. (The first use6 of EUA authority was in 2005 through the Project Bioshield Act7 to authorize military vaccinations against anthrax).
We fear that an emergency use authorization for Covid-19 vaccines at this stage of development would not require careful reporting of adverse events and could potentially undermine ongoing and future clinical trials that are still necessary to determine safety and efficacy.
Trending Now: 8 The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race 9
There is a better way to provide Americans with access to a new vaccine.
If the FDA and its independent review committees decide the early evidence supplied by Pfizer and BioNTech — or other companies down the road — is 16 https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ 2/7 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access sufficiently promising, the agency should grant early access to their Covid-19 vaccines through a process known as expanded access10. Expanded access is the use of an investigational new drug product outside of clinical trials to treat patients with serious or immediately life-threatening diseases of conditions when there is no comparable or satisfactory alternate treatment options.
Expanded access is fundamentally different from emergency use authorization, and the distinction between the two is vitally important. Expanded access will preserve the integrity of ongoing large-scale clinical trials under the banner of experimentation while ensuring that high-risk individuals have a pathway to access experimental vaccines that could mean the difference between life and death. An emergency use authorization would not.
Through the expanded access pathway, the FDA would not determine if an investigational Covid-19 vaccine actually works. Instead, via expanded access, it would facilitate access for those at greatest risk without opening the floodgates to access in the way that an EUA might do (although the targeted population for a Covid-19 vaccine could be as limited as the FDA thinks the data support, but that would be difficult to enforce). It would be up to a doctor and his or her eligible patient to determine on a case-by-case basis the risks and benefits of trying a still-experimental vaccine.
The FDA’s history of expanding access to investigational products dates back to the 1970s, but the process first received national attention when patient dying with HIV/AIDS fought for access to antiviral drugs that were available only through clinical trials. The public battle led to much-needed reforms and popularized the idea of compassionate use: allowing broader access to experimental drugs while still classifying them as unproven and experimental.
Related: 11 It’s time to get serious about the economics of expanded access 11
17 https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ 3/7 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access As expanded access has matured — it is now used for all sorts of diseases beyond HIV — the process has been streamlined. Today, it takes less than an hour to complete an expanded access application and the FDA approves 99% of requests. Expanded access is not a formal approval process, just as the EUA is not a formal approval process.
Certain requirements apply for expanded access:
The patient must have a serious or immediately life-threatening disease or condition and have no comparable or satisfactory alternative therapy. The potential benefit must justify the potential risks. Providing the treatment must not interfere with or compromise the ongoing vaccine approval process.
Invoking expanded access for a Covid-19 vaccine would be unusual, but not unprecedented. Meningococcal vaccines and non-U.S.-licensed yellow fever vaccines have been made available through this process, and with good results. Expanded access remains controversial12, however. It leads some patients and their doctors to pursue products that are neither safe nor effective. Given these competing interests, we believe expanded access is not only appropriate in the midst of a worsening pandemic, but also necessary.
Roughly 40% of reported Covid-19 deaths in the United States have occurred in long-term care facilities such as skilled nursing facilities, assisted living centers, veterans’ homes, and the like, and the virus continues to surge across the United States. While it is important to allow ongoing vaccine trials to finish, we simply cannot wait to inoculate the most vulnerable citizens. Vaccination of high-risk individuals and clinical trials should proceed in concert, with doctors and eligible high-risk patients deciding when benefits of inoculation outweigh risks.
Related: 13 A national Covid-19 vaccine confidence project: job No. 1 for President-elect Biden 13
18 https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ 4/7 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access Why does this matter? A recent poll14 indicates that just over half of all Americans (58%) would get inoculated as soon as a vaccine was available, down from 69% who said the same thing in August. The FDA has used emergency use authorizations to facilitate the use of ineffective treatments such as hydroxychloroquine and fraudulent diagnostics such as point-of-care serology tests that have shaken public trust. The agency should not further jeopardize its credibility by authorizing a Covid-19 vaccine for emergency use before Phase 3 clinical trials have been completed. Without public support of a vaccine, it will be difficult to protect everyone from the virus, and the pandemic will persist. A vaccine that few will take is of little value.
The FDA cannot require Pfizer or any other manufacturer to provide a vaccine through expanded access. Given the robust support of the unfortunately titled Operation Warp Speed, however, expanded access will not impair ongoing clinical trials or sap a limited supply chain. But expanded access can work only if drug companies agree to provide Covid-19 vaccines through the expanded access pathway and the FDA agrees to their doing that.
Americans will soon have access to Covid-19 vaccines, but the manner in which these potentially lifesaving inoculations are authorized and distributed must be carefully thought through in order to ensure public trust in the rollout. Key stakeholders must make the commitment to expanded access.
Matthew W. McCarthy is an associate professor of medicine at Weill Cornell Medicine in New York City. David Oshinsky is director of the Division of Medical Humanities at NYU Langone Health and professor of history at NYU. Arthur Caplan is the founding director of the Division of Medical Ethics at NYU Langone Health School of Medicine. They write on behalf of the Vaccine Working Group on Ethics and Policy15.
About the Authors Reprints2
Matthew W. McCarthy
19 https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ 5/7 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access @DrMattMcCarthy 16
David Oshinsky
@DavidOshinsky 17
Arthur Caplan on behalf of the Vaccine Working Group on Ethics and Policy
@ArthurCaplan 18 Links
1. https://www.statnews.com/category/first-opinion/ 2. https://www.parsintl.com/publication/stat/ 3. https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly- effective-early-data-from-large-trial-indicate/ 4. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy- framework/emergency-use-authorization 5. https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging- threats 6. https://wwwnc.cdc.gov/eid/article/13/7/06-1188_article 7. https://fas.org/sgp/crs/terror/R43607.pdf 8. https://www.statnews.com/most-popular/ 9. https://www.statnews.com/2020/11/10/the-story-of-mrna-how-a-once-dismissed-idea-became-a- leading-technology-in-the-covid-vaccine-race/ 10. https://www.fda.gov/news-events/public-health-focus/expanded-access 11. https://www.statnews.com/2019/01/30/get-serious-economics-expanded-access/ 12. https://www.healio.com/news/hematology-oncology/20200303/right-to-try-a-wellintentioned- but-misguided-law 13. https://www.statnews.com/2020/11/08/national-covid-19-vaccine-confidence-project-top-job- president-elect-biden/ 14. https://www.statnews.com/pharmalot/2020/10/19/covid19-coronavirus-pandemic-vaccine- racial-disparities/ 15. http://vaccineworkinggroupethics.org/ 16. https://twitter.com/DrMattMcCarthy 17. https://twitter.com/DavidOshinsky 18. https://twitter.com/ArthurCaplan 19. https://www.statnews.com/topic/coronavirus/ 20. https://www.statnews.com/topic/vaccines/
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Coronavirus Health First Opinion Biotech 20 https://www.statnews.com/2020/11/09/expanded-access-not-eua-for-distributing-preapproval-covid-19-vaccines/ 6/7 11/13/2020 Make pre-approval Covid-19 vaccines available via expanded access The Readout LOUD Politics
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