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Bioterrorism program may harm public trust
Plan may complicate vaccination campaigns
Public health officials should carefully evaluate the reasons for low rates of participation of health care workers in Phase 1 of the federal Smallpox Preparedness Plan before expanding the vaccination campaign if they hope to preserve the public’s trust in vaccination campaigns as a viable public health measure, a group of ethicists from the University of Pennsylvania warn.
In a paper published in the Fall 2003 edition of the American Journal of Bioethics, Pamela Sankar, PhD, and colleagues from the University of Pennsylvania Center for Bioethics and the Children’s Hospital of Philadelphia argued that the federal plan is missing some key elements necessary to encourage targeted populations to participate and these issues must be addressed both in order to make the plan successful and to ensure public trust in future public health initiatives.
"Foreign intelligence reports that identified the United States as the potential target of a bioterrorist attack were cited by the government as justification for the unprecedented speed of the development and implementation of the CDC’s [Center for Disease Control and Prevention’s] Smallpox Vaccination Program," the authors wrote. "Passing time has demonstrated that this haste was unnecessary, as there has been no attack on the United States population or elsewhere. Passing time has also shown that we should be grateful the program was unnecessary because people chose not to trust the government’s plan for protecting them."
As of this summer, only roughly 10% of the estimated 440,000 targeted hospital personnel had consented to receive the vaccine during Phase 1 of the program.
Sankar and colleagues cited a number of factors as the likely reasons for the unexpectedly low participation:
• Health risks associated with the vaccine
The smallpox vaccine is a live-virus vaccine that carries a risk of transmission of the virus, vaccinia, to close contacts. There also is a high risk of health complications for people who are immunocompromised or have other health conditions.
Prior to implementing the vaccine program, the CDC developed a comprehensive screening program designed to weed out personnel who were likely to experience an adverse reaction (estimates indicated that the current vaccine would be contraindicated in one in five Americans). The agency also developed guidelines for the covering of the vaccine site in vaccinated health care workers to prevent transmission to patients and close contacts.
However, Sankar and colleagues argued, the screening programs were not extensively tested in small groups prior to the large-scale implementation of the vaccination campaign, and some people who received the vaccine experienced unforeseen health problems.
Although the overall incidence of adverse events was within expected parameters, previously unknown adverse events emerged. In March 2003, public health authorities reported a possible increased incidence of cardiac inflammation and ischemic cardiac disease among recently vaccinated individuals.
• Liability and risk to patients
Throughout the preparation and launch of the smallpox plan, media reports indicated that health care providers were concerned both about the risk of transmission to patients and the liability they might face if they accidentally transmitted vaccinia.
In addition, they questioned whether they would be compensated in the event they experienced and adverse reaction to the vaccine and were unable to work.
These concerns were not rapidly and comprehensively addressed, leading to widespread mistrust of the vaccination campaign, the authors stated.
Federal legislation that released the manufacturers of the vaccine from any liability associated with the vaccine’s side effects was passed while the vaccination campaign planning was in its infancy; yet, by contrast, legislation to protect vaccine recipients was not passed until the program already was under way.
Because of this, some unions requested that their members refrain from participation until liability and safety concerns had been addressed.
Health campaigns need public trust
The federal government’s slow response in addressing these issues hurt participation in the smallpox program because those asked to participate did not trust the campaign’s leadership and direction, the authors argued.
This, in turn, could hurt future federal public health initiatives.
Participation in public health campaigns, particularly vaccination campaigns relies on maintaining public trust and confidence in the process, the authors stated.
The lack of participation in Phase 1 of the smallpox plan also may have a larger impact on other vaccination campaigns — particularly those targeting the public at large — because of the specific population involved in this effort, says Peter H. Meyers, JD, professor of clinical law at the George Washington University School of Law in Washington, DC, and director of the law school’s Vaccine Injury Clinic.
"What is so interesting here is that it is the medical establishment here who is saying, We don’t trust the vaccine. We don’t see the need for it. We don’t want to be involved with it,’" he tells Medical Ethics Advisor. "There is a very big debate in this country, and in many countries, about the dangers and risks and benefits of vaccines. And there is a lot of concern about public mistrust of vaccination. And a lot of doctors and health care professionals always say the mistrust is the result of the public getting misinformation, going to the Internet and getting scare stories and misinformation, and that if the public had all the information about the risks and benefits of vaccination, then they would choose to be vaccinated. But that has not been the case with this program."
Bioterrorism complicates decision making
But preparing for a potential terrorist attack with a weaponized infectious agent is much different than implementing a typical large-scale vaccination program, and such efforts should be judged differently, argues Ronald Blanck, DO, president of the University of North Texas Health Science Center in Fort Worth, former U.S. Army Surgeon General, and head of the Army Medical Command.
Even a nominal threat of a bioterrorist event merits some pre-activity response. And when public health officials were informed that there was information an attack was possible, they had no way of knowing whether the country needed to be prepared for an attack the next day or the next year.
A multisite release of weaponized smallpox has the potential to cause massive mortality and morbidity nationwide, and a plan that involves having a set number of health care workers pre-immunized so that they would be able to quickly and safely care for those affected is a prudent protective measure, says Blanck.
"Given the reasonable assumption that an attack is possible, then I think it would be ethical behavior, particularly as health care workers, to do two things: one to minimize the threat, which you do that by immunizing a certain group. If a certain group is immunized, they can immunize the rest after a release, and, all of a sudden, you have reduced the threat of an severe outbreak to near zero," he says. "And the second obligation public health officials have is to avoid causing as much distress, illness and morbidity as possible. How do you do that? By limiting those who are immunized to health care workers, not immunizing the whole population — particularly since we know that with smallpox, you can be immunized after exposure — but immunizing a select number."
Blanck agrees that some elements of the federal plan could have been handled differently — particularly concerns about liability. But now that liability issues have been resolved, health officials should do more to communicate the essential facts and benefits of the program, he adds.
"I must admit that I don’t think these concerns have been well answered yet," he says. "The CDC and the feds should have really gone to bat and really clearly and articulately laid out the liability protection. However, it is my belief that mostly that has been done and there is no reason for not getting [the vaccine] now."
Blanck also says that new methods for preventing vaccine transmission from vaccinated health care workers have not been well publicized and that federal officials need to make more of an effort to ensure that health care workers nationwide know that they can reliably prevent transmission to patients and to contacts, he adds.
Public health officials need to be more proactive and forthcoming and, perhaps, initiate "traveling road shows" to lay out the true pros and cons of participation in the program, and to provide as much background information as possible about what the threat is and why they think the smallpox plan is necessary, he says.
"At this point, the number of health care workers who have not stepped up and said, Hey this is our responsibility,’ particularly with the things we have seen, is disappointing," Blanck says. "I’m not convinced that it is enough to really do what we want. We haven’t assured a suitable protected group to respond in the event of a release. I would still like to see more participation."
1. Sankar P, Schairer C, Coffin S. Public mistrust: The unrecognized risk of the CDC smallpox vaccination program. Am J Bioethics 2003; 3:W22-W-25.