And Nothing But the Truth

And Nothing but The Truth

By Peter J. Pitts

Copyright © 2024 by Peter J. Pitts

All rights reserved. This book or any portion thereof may not be reproduced or used in any manner whatsoever without the express written permission of the publisher except for the use of brief quotations in a book review or scholarly journal.

First Printing: 2024

ISBN 978-1-304-43613-9

Cognito Press

757 Third Avenue

New York, NY 10017

www.cmpi.org

Graphic design by Mandi Vollmer.

Book Dedication

This book is dedicated to my late father-in-law, Leonard Mogel. (He always said his parents were too poor to afford giving him a middle name.) He taught me many things, the most important being the responsibility and value of speaking truth to power. He preached it. He practiced it. And the world is better off because of his being so robustly a part of it. He made a difference. He was happy and fulfilled. He loved and was loved. That’s a life well lived.

Peter J. Pitts

New York City

May 2024

Introduction

The great physicist Niels Bohr said, The opposite of a correct statement is a false statement. But the opposite of a profound truth may well be another profound truth. In other words, when it comes to things like physics and healthcare policy, it’s complicated.

Why title this book "And Nothing But the Truth? We are living in an age of misinformation (mistaken beliefs) and disinformation (purposeful lies). Mis/Dis" has always been a thorn in the side of public health agencies like the Food and Drug Administration but exploded during the COVID-19 pandemic. And I’ve got the scars to prove it.

When it comes to Mis/Dis, the public health community is in an asymmetric warfare situation. Alas, in the real world, politics, polemics, tweets, and threads trump advanced educational degrees, impressive academic affiliations, and peer review. But, as Gandhi reminds us, Even if you are a minority of one, the truth is the truth.

Healthcare evolution, in technology and policy, is a never-ending parade of complicated and contradictory truths. This book tries to make some sense of them.

Chapter One

Above All Else, Honesty

You can always count on Americans to do the right thing — after they’ve tried everything else.

Winston Churchill

The Pogo-ization of Post-Pandemic Vaccine Policy

By Peter J. Pitts

Originally published in The Patient, April 12, 2023

Introduction: Post-Modern Immunization Platforms

Currently, we have a post-pandemic window of opportunity for the public health community to take the plunge and lead the USA toward embracing immunizations or be bogged down in politics. As FDA Commissioner Dr. Robert Califf has pointed out, the battle over vaccines and other interventions is asymmetrical — between knowledge and ignorance.¹ There are many fronts and many players. The FDA has a bully pulpit, but talk is cheap, resources are scarce, and the unrestrained and well-resourced purveyors of misinformation and disinformation can play fast and loose with the truth, using social media as their mouthpiece. However, for America’s public health community, there must be one goal — to have more people immunized. However, moving the needle can’t just be about COVID-19 vaccinations.

COVID-19 was an opportunity and the tip of the iceberg of an important public health teaching moment. In addition to ensuring any new immunization is safe, effective, and urgent, America’s healthcare leadership has a golden opportunity to update our government systems — simplifying reviewing, approving, scheduling, and reimbursing vaccines and other immunizing agents. These and other updates are critical to inform public health policy, keep pace with evolving viruses, and retool systems to ensure access, and to incentivize healthcare providers.

In addition to keeping pace with evolving viruses and updating our reimbursement and implementation systems to ensure broad access to vulnerable populations, we must also keep pace with rapidly evolving nontraditional preventives that can significantly reduce hospitalizations and serious outcomes. This means we must improve and adapt our scientific communication beyond the boundaries of professional journals and lobbyists — to barbershops, pulpits, pediatricians, and parent-teacher associations across America.

We do not want vaccination rates to return to their pre-pandemic levels — we want to improve upon those numbers. This is not about returning to the status quo — it’s about changing public health behavior to fully, and enthusiastically, embrace the value of immunization. In the words of Edmund Burke, He who wrestles with us strengthens our nerves and sharpens our skill. Our antagonist is our helper.

According to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), We have to do a better job communicating the best possible science supported by the best possible data. Through that basic formula, we can (i) restore high standards of science for all immunizations and (ii) devise and actively communicate 21st-century scientific standards and guidance on innovative technologies (e.g., monoclonal immunizing agents to fight respiratory syncytial virus [RSV] in children). Success doesn’t mean returning to pre-pandemic immunization rates, it means surpassing them. This is especially true when it comes to childhood vaccination rates.

Death by a Thousand Cuts: The Penalty of Process Fouls

During the pandemic, the American public was introduced to many phrases unknown to the vast majority of people, with one of the most important being emergency use authorization (EUA).² The emergency was clear — a deadly pandemic. Less clear was the distinction between an authorization and an approval. This distinction-with-a-difference was especially contentious when it came to the two mRNA vaccines (and, shortly afterward, their boosters). Mixed in with another term from the COVID-19 lexicon, vaccine mandates, rhetorical regulatory precision, rather than clarifying and reassuring, resulted in confusion and suspicion that the FDA was using the general population as lab rats — even though nothing could be further from the truth.

The fact that we were able to field large placebo-controlled trials for all the COVID-19 vaccines (both mRNA and traditional technologies) should have been a terrific story of the healthcare ecosystem coming together in a time of crisis. But the reverse was the reality. The lack of basic social science and communication skills from (among others) US Health and Human Services Secretary Xavier Becerra, the FDA, CDA, NIH, White House, and state public health authorities, was an inexcusable process foul. Sound science and solid partnerships were negatively impacted by poor communication. The FDA must embrace the necessity of social science and build the agency’s capacity for it — and this cannot wait until the next PDUFA reauthorization in 2032.

In the shark-infested waters of post-pandemic healthcare policy, the FDA needs to build a bigger boat.

Another process foul was the way in which both the FDA’s Vaccines and Related Biological Products Advisory Committee³ (VRBPAC) and the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices⁴ (ACIP) publicly dickered and dithered over the appropriate population designations for both the initial vaccine rollout and then proceeded to repeat the mistake with booster schedules, frustrating vaccine advocates and empowering vaccine antagonists. The result? Low booster rates. A smaller but significant process foul was the way that the Moderna bivalent booster data were presented to both FDA and CDC advisory committees. A self-inflicted wound among vaccine advocates that has been allowed to fester.⁵

Another process botch came after a July 4, 2021, Independence Day super-spreader event in Barnstable County, Massachusetts, where 469 COVID-19 cases were identified among Massachusetts residents who had traveled to the town during July 3–17; 346 cased (74%) occurred in fully vaccinated persons.⁶ The CDC introduced the term breakthrough infection into the COVID-19 vocabulary but buried the lede. The media headline from this story was that existing vaccines were ineffective. But the actual story was the complete opposite. Of the infected revelers, five patients were hospitalized, and no deaths were reported. This was real-world proof that the vaccines work — not by providing total immunity, but by radically mitigating the symptoms.

But that wasn’t the published story. Breakthrough infections became the story. This self-inflicted social science wound was further exacerbated by President Biden who told the American public on July 21, 2021, that, people who get their COVID-19 vaccines are completely protected from infection, sickness, and death from the coronavirus.⁷ While his statement was retracted by the White House and clarified by public health authorities, the story was in the public domain, resulting in a further erosion of trust in vaccine effectiveness, and reinforcing in the minds of many Americans that Uncle Sam’s right hand didn’t know what the left hand was doing.

After his election, President Biden regularly said that science is back. Unfortunately, following the science, didn’t always happen. Before either the FDA’s VRBPAC or the CDC’s ACIP even voted on the Moderna bivalent booster, the White House was publicizing a national rollout strategy. That strategy didn’t work, and the reasons why Americans did not roll up their sleeves are attributable to the above-mentioned process botches. The most common reasons for not receiving the bivalent booster dose were lack of awareness of both the eligibility for vaccination (23.2%) or the availability of the vaccine (19.3%), followed by the perceived lack of immunity against infection (18.9%).⁸ Following the science cannot be the chosen path only when it is politically convenient. According to one VRBPAC member, The train had left the station before we voted.

Populations Versus People

Preventive programs work when they are adopted by populations. A valuable lesson learned from the COVID-19 experience is that America’s health literacy needs to be improved.⁹ Success does not just refer to how many people have been vaccinated, but what that looks like from the perspective of various at-risk populations. Our new national focus on issues such as health equity¹⁰ is an opportunity to address this important public health priority. This is particularly germane when it comes to exciting new advances in treating RSV, the third leg of the current tripledemic.¹¹ We must advance America’s health literacy, for example, in recognizing the distinction-with-a-difference between vaccines and immunization interventions such as the new monoclonal antibody treatments that (just like vaccines) can significantly reduce hospitalizations and serious outcomes for at-risk populations.¹² This played out live at the February 23, 2022, meeting of CDC’s ACIP where advisors and experts valiantly struggled with a myriad of implementation and reimbursement issues of adding a monoclonal for RSV into systems that were developed over 50 years ago; this in turn raised the specter of possible access and first-dollar coverage issues for underserved patients.¹³

Technology and innovation need to be embraced for what they do (not what they are defined as) and implementation systems should be made flexible in order to ensure uptake of any new preventive interventions in our public health toolbox.

The Next Normal of Immunizations

When it comes to vaccine development and public immunization strategies, the American healthcare ecosystem should not be chasing the new normal, but rather the next normal because, when it comes to healthcare in general and immunizations in particular, there will never be a revised static new normal. What will always be just around the corner is the next normal. Stasis isn’t always good, especially if you believe in the power of innovation. If we have learned nothing else from COVID-19 we should remember and embrace the warning of management guru W. Edwards Deming, who said, it is not necessary to change. Survival is not mandatory.

Our Public Health Goal

For a host of childhood diseases from COVID-19 to annual influenza and RSV, immunization remains the foundation of our public health. We cannot define victory as returning to the pre-pandemic normal. Immunization rates for childhood diseases are abysmally low.¹⁴ Many people inside the public health community believe that aggressively pursuing a more robust immunization education initiative is too risky because of the political environment.¹⁵ Further, the public health potential of future interventions is also threatened as experts struggle with the integration of newer technologies (e.g., immunizing monoclonals) into outdated systems. A shift in our thinking from the effects of a preventive action versus its definition (i.e., immunizing monoclonals) is sorely needed if we are to keep pace with new viral threats.

Politics and outdated implementation systems aren’t the real problems — pertussis, measles, mumps, and rubella are the problems and, frighteningly, polio is the problem. We don’t have a moment to lose. In the words of Abraham Lincoln, You cannot escape the responsibility of tomorrow by evading it today. Or, in the famous words of Pogo, We have met the enemy and he is us.

References

Food and Drug Administration. Overcoming Vaccine Hesitancy & Misinformation, 31 October 2022.

Food and Drug Administration. Emergency Use Authorization. 2024. Available from: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee. Available from: https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee.

Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Advisory Committee on Immunization Practices. Available from: https://www.cdc.gov/vaccines/acip/index.html.

Bivalent Covid-19 Vaccines — A Cautionary Tale. Available from: https://www.nejm.org/doi/full/10.1056/NEJMp2215780.

Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings. Available from: https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm.

Associated Press. Biden Goes Too Far in Assurances on Vaccines. 2021. Available from: https://apnews.com/article/joe-biden-business-health-government-and-politics-coronavirus-pandemic-46a270ce0f681caa7e4143e2ae9a0211.

Sinclair AH, Taylor MK, Weitz JS, Beckett SJ, Samanez-Larkin GR. Reasons for Receiving or Not Receiving Bivalent COVID-19 Booster Vaccinations Among Adults. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9869746/.

Pitts PJ, Freeman E. Health Literacy: The Common Denominator of Healthcare Progress. Available from: https://link.springer.com/article/10.1007/s40271-021-00537-9.

Centers for Disease Control and Prevention. What Is Health Equity? Available from: https://www.cdc.gov/healthequity/whatis/index.html.

MacMillan C. Tripledemic: What Happens When Flu, RSV, and COVID-19 Cases Collide? Available from: https://www.yalemedicine.org/news/tripledemic-flu-rsv-and-covid-19.

Alansari K, et al. Monoclonal Antibody Treatment of RSV Bronchiolitis in Young Infants: A Randomized Trial. Available from: https://www.yalemedicine.org/news/tripledemic-flu-rsv-and-covid-19.

Centers for Disease Control and Prevention. Meeting of the Advisory Committee on Immunization Practices. Available from: https://www.youtube.com/watch?v=H3KYJ9iF7XA&list=PLvrp9iOILTQb6D9e1YZWpbUvzfptNMKx2&index=10.

Seither R, Calhoun K, Yusuf OB, et al. Vaccination Coverage With Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2021–22 School Year. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9869733/.

Confidential interviews with current United States senior public health officials conducted from January–March 2023.

Trust and Science: Public Health’s Home Field Advantage in Addressing Vaccine Hesitancy and Improving Immunization Rates

By Peter J. Pitts and Gregory A. Poland

Originally published in Vaccine, August 31, 2023

Whether it’s harsh truths about atomic power or the merits of vaccines against Covid-19, influenza, and childhood illnesses, it’s science — regularly, honestly, and clearly explained — that is sanity’s ultimate home-field advantage.¹

Introduction

Trust in US federal, state, and local public health agencies (and particularly vaccines) has been badly shaken during the pandemic.² A major cause of that decline is a loss of confidence in our major public health institutions³ due in large part to low public health literacy levels and avoidable governmental communications miscues, and a vaccine review process that was often misunderstood and misconstrued by the general public. As a result, immunization rates — particularly among at-risk populations — are dangerously low.⁴ In this post-pandemic era, flu and other vaccination rates have not returned to pre-pandemic levels across all demographic groups, despite an ample supply of vaccines.

The Role of Trust and Vaccine Hesitancy

To restore faith in our public health agencies, and therefore trust in science and vaccines, we must rebuild confidence in vaccines and promote the advances we have made (through the processes and data