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HOW TO STEWARD MEDICAL COUNTERMEASURES

AND PUBLIC TRUST IN AN EMERGENCY

A Communication Casebook for FDA and its Public Health Partners 

How the US Food and Drug Administration (FDA) and other US government officials convey information about medical countermeasures (MCMs) will affect uptake, compliance, and ultimately survival in the aftermath of a natural disease emergency or a chemical, biological, radiological, or nuclear (CBRN) attack. Moreover, effective communication regarding MCMs has the potential to strengthen psychological resilience as well as engender public trust in science, government, and public health.

In 2014-2016, the UPMC Center for Health Security undertook an in-depth project to provide evidence-informed advice to the FDA about communication issues inherent in the emergency use of MCMs. During that initiative, the Center engaged in research, analysis, and deliberation with an expert working group that included top scholars in risk and crisis communication and leading figures in the MCM enterprise. A major outcomes of the project was the “best practices” oriented text, How to Steward Medical Countermeasures and Public Trust in an Emergency: A Communication Casebook for FDA and Its Public Health Partners. The full casebook, along with its individual chapters, are available for download.

The purpose of the casebook was to provide FDA and other officials who deliver public health information with real world inspired opportunities for reflective learning on the principles of effective MCM emergency communication. The casebook critically examined communication dilemmas about MCMs in the context of the 2015-215 Ebola outbreak, the 2011 Fukushima nuclear accident, the 2009-10 H1N1 influenza pandemic, and the 2001 anthrax  letter attacks, recommending specific action items for the FDA to help mitigate comparable issues in the future. The Ebola and anthrax cases underscored, for example, the need for sensitivity regarding historical conflicts between public health and minority communities, and the importance of taking steps – both before and during an emergency – to address any public anxiety around discrimination and human experimentation in the context of MCM clinical trials.


 

Chapter One: Introduction

How FDA and other US government officials convey information about medical countermeasures (MCMs) will affect uptake, compliance, and ultimately survival in the aftermath of a natural disease emergency or a chemical, biological, radiological, or nuclear (CBRN) attack. Moreover, effective communication regarding MCMs has the potential to strengthen psychological resilience as well as engender public trust in science, government, and public health. The purpose of this casebook is to provide FDA and other officials who deliver public health information with “real world” inspired opportunities for reflective learning on the principles of effective MCM communication and on the wider contexts that influence the development, delivery, and consumption of accurate, timely, and meaningful MCM information in an emergency. Communication successes will better enable FDA to fulfill its regulatory role and activities and “facilitate the development of and access to safe, effective, and quality MCMs” to counter CBRN and emerging infectious disease threats (for more on FDA’s MCM-related mission, activities, and collaborators, see Appendix A).


 

Chapter Two: West Africa Ebola Epidemic

Abstract

In late 2013, an Ebola outbreak began in Guinea, quickly growing to become the largest Ebola epidemic on record. Widespread transmission occurred in Guinea, Liberia, and Sierra Leone with imported cases and limited transmission occurring in other countries, including the United States. The absence of approved medical countermeasures (MCMs) and a severely limited supply of investigational drugs—in early stages of development and with limited production capacity—compounded delays in the global response to the epidemic. Several of the major communications challenges for the West Africa Ebola epidemic concerned the development, testing, and use of investigational MCMs. Questions arose in the media, public, government, and even the scientific community regarding the status of individual—often highly publicized—MCMs, specifically calling for increased transparency for the testing, approval, and production processes; challenging traditional requirements for testing; and questioning allocation of limited supplies of these products in the context of the growing Ebola epidemic.


 

Chapter Three: Fukushima Nuclear Accident Of 2011

Abstract

The Tohoku earthquake in Japan caused a series of tragic and cascading disasters in Japan, including the release of radiological materials from the Fukushima Daiichi Nuclear Power Plant. The vast majority of the nuclear release affected only Japan, and as a result, no medical countermeasures were recommended in the US. However, despite messages to the public by health authorities not to purchase, stockpile, or administer potassium Iodide (KI), some consumers still sought out the radiation countermeasure. Additionally, when KI was not available, some consumers attempted to acquire potassium from other sources even though these sources were ineffective and/or not approved by the FDA. The adverse effects of such behaviors were the potential occurrence of negative side effects from taking unnecessary or unapproved products. Additionally, in the event of a future emergency requiring KI for a limited proportion of the population, demand for KI by those who would receive no benefit may prevent those who need KI from accessing it.


 

Chapter Four: The H1N1 Influenza Pandemic Of 2009-2010

Abstract

The H1N1 outbreak of 2009-2010 was the result of a novel flu strain. The response to H1N1 was multifaceted and involved multiple governmental organizations. In particular, at the beginning of the outbreak FDA instituted an H1N1 management system to coordinate a response, which included creating seven teams to address specific public health needs related to H1N1. While FDA’s response to H1N1 was thus far-reaching, in relation to communication several components of FDA’s response could have been enhanced: communicating about vaccine production including responding to concerns that the vaccine was risky, rushed through production, or untested; being more transparent about the vaccine manufacturing process generally including reasons why vaccine production might be delayed; strengthening collaboration with other health entities to overcome disparities in MCM uptake; and finally, in conjunction with CDC, clarifying the use of new MCMs/new uses of approved MCMs to both healthcare providers and the public.


 

Chapter Five: 2001 Anthrax Letters

Abstract

The dissemination of Bacillus anthracis via the US Postal Service (USPS) in 2001 represented a new public health threat, the first intentional exposure to anthrax in the United States. The attacks resulted in 22 cases of anthrax—eleven inhalational and eleven cutaneous—five of which were fatal.1 Public health officials faced the challenge of communicating risk during rapidly evolving circumstances in response to terrorist attacks that affected numerous states and Washington, DC. A total of 21 USPS facilities were contaminated in the attacks, and 32,000 potentially exposed persons initiated post-exposure prophylaxis.2 These attacks followed closely after those of September 11th, further complicating the challenge of addressing a new threat in a nation still recovering from a traumatic event.3,4,5 Conflicting public health guidance across different government jurisdictions and changing directives about prophylaxis undermined public confidence in health authorities’ handling of the crisis and in the recommended personal protective actions, particularly among affected minority populations