There are important lessons from the response to the anthrax vaccine, which may inform communication in the case of a pandemic or bioterrorist event. We recommend several strategies to improve communication in such situations ().
. Recommendations for Communication about INDs and EUA Products during a Pandemic or Bioterrorist Event
The media context at the time of the vaccine offer may have exacerbated the communication challenges. There was significant negative coverage of the lack of a definitive recommendation by CDC and scientific disagreements with the vaccine offer expressed by other health departments, other health professionals, and labor unions.52,56–66
Newspaper coverage referred to the vaccine offer as “experimental” and reported the workers' fear of being “guinea pigs,” as well as pointing to the analogy to the Tuskegee syphilis study.51,57,58,62,63,66–72
Less frequently was there a discussion of who was at risk and proximity to areas of high risk.51,73–75
This certainly suggests the need to work intensively with media to help ensure that public health messages are communicated accurately, as well as monitoring media reports to improve messages.
At the time, the IND was the only way to get an unapproved product, or an approved product for an unapproved use, to people in an emergency.15
For all INDs, the FDA provides general requirements for informed consent stating clearly that the consent form would not release the investigator or sponsor of liability for negligence. However, postal workers' comments suggest that they believed they were releasing the CDC from liability. This was reinforced by the media when on December 20 CNN stated, “Individuals who opt to receive the vaccine would have to sign an informed-consent form, a move that would essentially relieve the manufacture [sic] of any liability.”26
This echoes findings from an earlier study of African Americans, where participants understood the purpose of an informed consent procedure but many believed it to be tantamount to signing away their rights.53
In a future public health emergency, it may be necessary to invoke the EUA, which does not require informed consent. This would likely present challenges similar to the anthrax or smallpox vaccine. The FDA recommends that a fact sheet with information on the EUA product be provided to the public.14
The individual recipient can refuse an unapproved treatment protocol, but there is no written consent. This makes the government's response to an emergency potentially more efficient and swift, but it raises the question of how informed the public will be when receiving the EUA product. Public health professionals will need to be highly vigilant to ensure that the fact sheet provides information in an accessible manner and highlights the potential risks of the EUA product. Additionally, information about the EUA will need to be accessible through multiple channels, in different languages, and at different literacy levels. It will also be critical that CDC communicates with healthcare providers on the rationale and use of the EUA. Moreover, it will be essential to work with the media to make coverage of the EUA, its risks and benefits, and its rationale as clear as possible.
Since we know that difficulties in ensuring adequate informed consent during research are already well documented,53,76
we expect that in the mental noise of an emergency, there will be problems in communicating about an EUA. To some extent, Flory and Emanuel offer guidance from their review of interventions to improve informed consent.57
They found that using standard consent forms in conjunction with 2 meetings with a health professional to discuss consent is the most promising method for increasing understanding. Although this would be difficult in the context of mass vaccination or EUA, public health professionals could use multiple channels, such as written materials appropriate for the populations affected, involving community partners as educators, and holding community forums, to increase understanding of the EUA product. Quinn elsewhere recommends a set of relevant strategies for working specifically with minority communities to prepare for emergencies.77
Additionally, it is critical that the public fully understands their option for refusal of an EUA.
Fears of experimentation are rooted in the legacy of the Tuskegee syphilis study, which remains a cultural symbol in the African American community.53
It is possible that if an IND or EUA is necessary, Tuskegee will be raised as a “red flag” by some. In 2001, public health professionals were uncomfortable talking about the Tuskegee study, as one participant indicated, and unable to effectively address the nuanced concerns underlying its being raised. Clearly, the study is not the only obstacle, yet it cannot be dismissed. Therefore, it is essential that public health professionals know about the Tuskegee study, understand its significance, and demonstrate the skills to address the concerns about experimentation and trust that are at the root of the legacy. We would even assert that public health professionals working with INDs or EUA products in minority communities proactively raise the Tuskegee study themselves and make the distinctions between that study and the IND/EUA product. Although many would see this as risky, we would argue that, in fact, opening that dialogue fosters trust, enables the public to ask questions, and demonstrates cultural competence. It is helpful if a rapid assessment can uncover what Covello refers to as “hidden symbolism” and broader cultural considerations.55
In addition, we must be cognizant that fear of experimentation cuts across racial lines and is likely to be a factor with an EUA.
In crisis situations, it is likely that uncertainty will contribute to different opinions about the use of a vaccine or an IND/EUA product. In 2001, public health professionals were unprepared for the vaccine recommendation, and agencies did not have consensus about its use, which contributed to further distrust and suspicion among postal workers. It is highly likely that, in a future event, uncertainty will create a similar situation in which professionals disagree, potentially leading to an erosion of trust. In a discussion of the question of “speaking with one voice,” Clarke and colleagues offer some useful guidance.78
They argue that, in times of great uncertainty and with highly diverse audiences, having multiple voices may actually be useful. We concur, with the provision that the professionals or agencies in disagreement join together to discuss in public the rationale and processes by which they come to their conclusions. Creating an open forum in which audiences can understand more about the science and decision-making processes can foster trust and enhance the public's ability to make informed decisions about an IND/EUA product.
The rate of anthrax vaccine uptake was very low.79
The percentage of people at risk who receive any vaccine is determined in large part by their perceived risk of getting the disease, as well as their perception regarding the vaccine's safety.16,20,25
Other predictors of vaccine uptake were physicians' recommendations and having an acquaintance who had been vaccinated.20
A physician's advice and support from friends and family influenced adherence among those exposed to anthrax.33
These data reinforce the critical importance of targeted communication with clinical providers in order to strengthen their recommendations for people at risk. Additionally, at the beginning of the anthrax attacks, the “outrage” experienced by people at risk was significant, leading to heightened perceived risk.80
After 5 deaths, there were no further illnesses or fatalities. Over time, postal workers were given more information on the side effects from the antibiotics than to possible risks from exposure to the anthrax spores. At this point, the “hazard” and “outrage” components of risk were low, leading to a very low perception of risk from anthrax among most people. Effective crisis and emergency risk communication at this juncture could have increased the hazard component of perceived risk and contributed to higher rates of adherence to antibiotics and vaccine uptake.
Tensions resulting from perceived unfairness and inequity between the postal workers and Senate staff continued during the vaccine period.52,60,68,75,81
This likely fueled the ongoing distrust and reduced uptake of the vaccine. Addressing issues of equity and fairness is essential to building trust in preparation for future events, particularly in light of existing literature on perceived discrimination in bioterrorist or pandemic events.
It is fundamentally important that CDC and other public health agencies continue efforts to repair the breach in trust created during the anthrax attacks. One potential avenue for repairing trust is to disseminate results from related research through the channels of postal unions and the USPS management. This approach recognizes the importance of responding to audience needs and using appropriate messengers.
There are several important limitations to this study. Although we recruited aggressively for the study, there could be inherent bias in those who chose to participate. While some participants indicated whether they had taken or not taken the vaccine, not all provided that information. Generalizability cannot be understood in a statistical sense, but the themes presented in this article were heard across the 3 sites and different data collection methods.
We can be certain that in the future we will grapple with communicating about the use of novel countermeasures, such as an experimental or off-label vaccine or drug, in the midst of a rapidly evolving emergency. Public health agencies must begin now to build trust and educate diverse publics, before the uncertainty and time pressures of that emergency create major obstacles for communication. Failure to start now to engage and educate can lead to unnecessary risk, disease, and deaths, whether in a pandemic or a bioterrorist attack.