Table.
Examples of medical countermeasure (MCM)a emergency communication dilemmas,b by category
| Category | Examples |
|---|---|
| Certain MCM aspects make the public uneasy. | |
| • Attributes of the MCM | |
| ◦ Induce dread. | • Irradiated or genetically modified component |
| ◦ Suggest that an MCM product is unsafe because it is not fully tested. | • Developed via the animal rule, in clinical trial, under accelerated regulatory approval, and/or in sped-up surge production |
| ◦ Raise fears because the MCM has been adulterated. | • Adjuvanted or compounded |
| • Unfamiliar technical jargon spurs misunderstanding. | • Killed vs live vaccine, egg-based vs cell-based production |
| • Regulatory process seems opaque because: | |
| ◦ Regulatory mechanisms under which an MCM is being made available are unfamiliar. | • Emergency use authorization, investigational new drug |
| ◦ Regulatory terms have ambiguous popular meanings. | • Approved, authorized |
| • Administration of the MCM might contradict everyday norms and personal experiences. | • Use of expired products in the Strategic National Stockpile, unfamiliar use of a familiar drug, or administration by a nontraditional provider |
| MCM supply and demand are out of sync. | |
| • A novel and/or highly lethal threat prompts unwarranted demand among low-risk groups. | • After the shock of the 9/11 attacks, and as cases of anthrax infection emerged in connection with tainted letters, public demand for ciprofloxacin escalated, affecting decisions about the antibiotic’s production and distribution.21 |
| • High-risk individuals and groups are not aware of the threat and/or the appropriate MCM and, as a result, do not seek out the recommended MCM. | • During the 2009 H1N1 influenza pandemic, pregnant women were more likely than women in general to have concerns about the vaccine and to resist vaccination, despite being more vulnerable to complications from H1N1 infections.22 |
| • High-risk groups and infected people facing a highly lethal disease strongly desire access to unproven MCMs that are very early in development. | • During the 2014-2015 West Africa Ebola epidemic, as investigational vaccines and therapeutics began to show efficacy in animal trials and safety in Phase 1 clinical trials, public demand arose for the compassionate use of the potentially life-saving MCM in affected communities, a position argued as the most ethical. Some experts countered that using MCMs without knowing whether the products would help, prove useless, or even harm those who took them would be itself unethical.23 |
| • A system of designated priority groups determines access to scarce MCMs, potentially eliciting public concern about being left out. | • During the 2009 H1N1 influenza pandemic, local public health departments and organizations opted to implement national vaccination guidelines in various ways as a result of the limited supply of vaccine, the availability of various formulations, and on-the-ground exigencies. Various applications of the priority group framework, especially when occurring in close geographic proximity, led some people to wonder why one jurisdiction was vaccinating a certain subset of its population and another was not.24 |
| • Too few MCMs exist to meet genuine needs in an emergency. | • In a pandemic influenza, the supply of vaccine—given current technology—will exceed demand, at least during the initial stages of the crisis. It typically takes approximately 6 months from the outset of any outbreak for the first doses to become available, and logistical challenges will likely slow down distribution and affect early availability.25 |
| • Out of misplaced belief or misinformation, or because they are unable to access MCMs, people turn to unsafe, ineffective, or fraudulent alternatives. | • In the United States, after the 2011 Fukushima nuclear accident, some consumers sought out potassium iodide—in some cases, they unknowingly purchased fake potassium iodide—despite messages by health authorities not to purchase, stockpile, or administer the drug. Moreover, when potassium iodide was not available, some people turned to salt and other dietary supplements as potential remedies for perceived risks from radiation exposure.26 |
| Authorities have discordant views on MCMs. | |
| • Various health officials issue divergent guidance on MCM allocation and administration. | • During the anthrax attacks, health authorities in Maryland and Virginia followed CDC guidelines about prophylaxis, whereas authorities in Washington, DC, had their own policy. Differences among the jurisdictions fostered confusion in affected groups about which advice to follow, whether that from the jurisdiction in which they worked or the jurisdiction in which they lived.27 |
| • Health professional guidance competes with advice from other trusted sources (eg, media, political, religious, community). | • Among low-income African Americans in Los Angeles County, California, longstanding distrust in the US government stemming from the Tuskegee experiment led local faith-based leaders to urge congregants not to accept the H1N1 pandemic influenza vaccine, local disc jockeys to advise their African American audiences against vaccination, and community members to forward chain emails and to like Facebook posts with anti-vaccination messages.28 |
| • Information on benefits and risks change as MCMs are used and clinical information is reviewed, which alters their recommended use. | • During the anthrax attacks, CDC switched from recommending costly ciprofloxacin to inexpensive doxycycline as an equally efficacious, prophylactic antibiotic for inhalational anthrax. Some observers perceived the shift as an instance of health care inequity because postal workers received doxycycline, whereas Capitol Hill employees received ciprofloxacin.27 |
| • Opinions differ on using randomized controlled trials to test efficacy of MCMs in an emergency. | • During the 2014-2015 West Africa Ebola epidemic, compassionate-use advocates saw broad distribution of investigational vaccines and therapeutics as the best way to provide the most benefit to the most people in an outbreak with a high case fatality rate. They argued that clinical trials were unnecessary because historical data from Ebola outbreaks could serve as a control group and that giving someone a placebo in the Ebola context would be unethical. In contrast, others asserted that a trial design without a placebo control group would be invalid and unethical, random allocation would more fairly distribute a scarce resource that could also cause more harm than benefit, and a randomized controlled trial was the most robust study design for testing efficacy.20 |
| • Public health authorities overseas promote or prohibit an MCM in contrast to US policy and practice. | • As a result of manufacturing problems, a predicted shortfall occurred in mid-2017 of the yellow fever vaccine currently approved by the FDA (YF-VAX) at a time when the mosquito-borne disease posed an increased threat. In response to the shortage, the FDA allowed the manufacturer to import into the United States another yellow fever vaccine licensed in 70 other countries, as an expanded access investigational new drug.29 |
| Certain groups have unmet or poorly considered needs. | |
| • Previous grievances with biomedicine or public health erode trust in MCM recommendations. | • Some African American postal workers potentially exposed to anthrax during the 2001 letter attacks were hesitant to be vaccinated and expressed fears of being experimented upon given the lack of a public health consensus about the value of the anthrax vaccine against the historic background of the Tuskegee experiment.9 |
| • Individuals do not access critical MCM information because major health institutions remain unschooled in how language, culture, and citizenship status can create barriers. | • During the 2009 H1N1 influenza pandemic, some migrant and seasonal farmworkers—whether documented or undocumented—hesitated to travel to clinics for information, vaccination, and/or treatment, fearing deportation with federal Immigration and Customs Enforcement officials present in local communities.30 |
| • Guidance for pregnant women, children, and other at-risk groups must be issued despite limited data on safety, efficacy, and dosing. | • Constituting 25% of the US population, children have age-specific characteristics (eg, increased skin permeability, faster metabolism, higher respiratory rate, greater surface area-to-mass ratio) that increase their vulnerability to the effects of chemical, biological, radiologic, and nuclear threats.31 Despite children being more often severely affected in disasters, many vaccines and pharmaceuticals approved for use by adults as MCMs do not currently have pediatric formulations (eg, liquid vs pill form), dosing information, or safety information.32 |
Abbreviations: CDC, Centers for Disease Control and Prevention; FDA, US Food and Drug Administration.
a Drugs, biologics (eg, vaccines), and devices (eg, personal protective equipment) used to diagnose, prevent, protect from, or safely treat conditions arising in connection with a natural disease emergency or a chemical, biological, radiological, or nuclear attack.
b Complex circumstances in which effective communication may help counteract the public misunderstanding, misusing, or missing out on a recommended MCM during a public health emergency.