Ethical Considerations³⁴

Public health involves the abilities of the state, under certain circumstances, to sometimes require individuals to act in ways that they might not otherwise act. Public health officials need to think about how to address situations in which individuals choose to do the opposite of what ACIP recommends.

For example, what if ACIP recommends against vaccination and an individual patient insists on being vaccinated, perhaps because of an unconfirmed bioterrorism attack? Or, as another example, what if someone not on the restricted list of personnel claims that due to the essential nature of his or her job, he or she should be vaccinated? In ordinary clinical care, health care providers aim to respect patient autonomy. The patient gets to judge the risks and benefits, in conjunction with the physician, and even if the physician is trying to dissuade a patient from trying a drug that might be risky, ultimately it is the patient's choice. In the public health arena, society is not necessarily always going to respect the same level of patient autonomy.

Fairness, justice, and equity are additional principles to consider in developing any type of plan. Although the anthrax situation brought to the forefront issues concerning race, class, and access to power, it is important to remember that the science of epidemiology is often shaded with and confounded by sociodemographic characteristics. For example, those at highest risk for HIV infection come from segments of populations that are already disadvantaged in many other ways. When there is a negative confluence of morbidity and social factors, there is often a lot of controversy.

These factors have to be considered in making recommendations so that policy makers can anticipate the circumstances in which ACIP makes a recommendation about immunization and an individual refuses to comply. Perhaps they refuse because of existing medical risks (e.g., impaired cell-mediated immunity), religious objections, or fear of side effects. But many might refuse because of mistrust of government, in particular its ability to present fair and considered public health messages. Are some of those reasons more compelling? The classic public health dilemma is always when is state coercion warranted, and how can such intervention be conducted in a way that respects civil liberties?

Ethical analyses in public health differ in some respects from clinical medicine. Informed consent is still important, but it is more difficult in the case of smallpox because the data are uncertain, incomplete, and changing, and there are serious time constraints in trying to get consent before vaccination. The determination of risks and benefits to some extent is going to be made by the government and if the new cell-based vaccine is under an IND, then the vaccine cannot be prescribed in the same way that approved vaccines currently are prescribed, which restricts patient choice and possibly access. Fairness is a particular concern when society requires people to do things they do not want to do, or forbids or discourages them from doing things they want to do. If access to the vaccine is restricted, then there must be a plan for how that access will be determined at the local level to ensure fairness. If people are being treated differently in one city with one outbreak versus another city with a different outbreak, there are going to be concerns about fairness and equity.

This conference has focused primarily on the ACIP recommendations, however, the decision-making process by which the recommendations are made, and the process by which they will be modified as new information becomes available, are equally important. The public must believe that policy makers considered all of the options, weighed all the risks and benefits, thought hard about it, and made the best decision under the circumstances, acknowledging that there was uncertainty. In public health, perceptions may be as important or even more important than reality. No matter how sound the guidelines, unless they are presented to the public in ways that they will understand and find acceptable, they will not work.

Indemnification for Adverse Events³⁵

Vaccines generally are susceptible to litigation and liability for several reasons. Typically they are given to large numbers of healthy people. Thus, if someone experiences an adverse event, it can be relatively easy to persuade a jury that the adverse event was caused by the vaccine. If vaccines are distributed in the interest of public health rather than in the interest of profit, it by no means mitigates or reduces the possibility of liability litigation. This is especially true if it turns out after a vaccine is distributed that the threat does not materialize, which occurred in 1976 with the swine flu vaccine. In addition, although it is typical for vaccines to be accompanied by warnings, such warnings, no matter how carefully constructed, often fail to hold up in the litigation process.

There are several reasons why smallpox vaccine could be far more susceptible to litigation than the typical vaccine. First, FDA review will to some extent be attenuated and could be incomplete at the time the vaccine is actually distributed. Second, the side effects are far more serious and common than those experienced with vaccines that people have become accustomed to over the past few decades. In addition, many of the individuals experiencing side effects will be those who were not actually vaccinated and thus they will be seen by juries as completely innocent, and possibly uninformed, victims.

In general, the public is not aware of the risks of smallpox vaccine. If the vaccine is distributed, there is a good chance it will be distributed quickly. It may not be provided by physicians. All of these factors make the smallpox vaccine especially susceptible to tort liability litigation, which could add up to billions of dollars if the vaccine is used on a mass scale. It is obvious that this kind of liability could threaten bankruptcy for a small vaccine firm, even for a medium-sized vaccine firm. Thus, policies are needed regarding liability exposure for smallpox vaccine. Tightly targeted tort reform could limit punitive damages, a measure unlikely to be acceptable.

Another option is indemnification after liability has occurred, possibly through Executive Order 10789. The problem with this form of indemnification is that it is discretionary—there does not have to be indemnification if liability occurs. If ex post, it would apply after a firm has gone through the litigation process. It covers “reasonable” liability expenses, which makes for a great deal of uncertainty about what kind of indemnification would actually occur. Perhaps most limiting of all, it only applies to vaccines that are given to consumers and patients directly by the federal government.

A third alternative would be indemnification through specific legislation, which also raises problems. Again, it would be ex post, after the firm has gone through the litigation process, and would be subject to political considerations.

A fourth alternative is government assumption of risk for the smallpox vaccine, an alternative which was implemented for the swine flu vaccine and which is likely to be the most realistic alternative.

Communication³⁶

Vaccine programs, like most public health efforts, require public cooperation and participation to be effective. Indeed, public health programs have, with carefully developed communication strategies, usually succeeded in garnering public trust, cooperation, and participation. Mostly, Americans cooperate with public health officials and programs, although there have been exceptions to this rule, including the reluctance of soldiers to accept anthrax vaccine.

These are difficult times because the needed public trust is low. The public health community did not perform well in response to the anthrax releases. If there is any doubt, ask the postal workers. Public trust is the key ingredient for success, and constitutes one broad measure of the effectiveness of our communications. Trust depends on the public understanding what and how actions will protect people. In the case of smallpox, the public will need to understand the important distinction between protecting individuals with vaccine versus using vaccine in the population to stop the spread of disease.

Public health actions should not be in conflict with public understanding, or lead to a suspicion that there are unrelated political motives or goals in play. Perhaps most importantly, to be effective, public health officials must not adopt reassurance as an objective. Elected officials often demand that public health officials reassure the public. In truth, the public is comforted only by knowing that public health officials are more concerned about and alert to threats to the public health than are individual citizens. Public health officials are never trusted if they are perceived as offering reassurance rather than vigilance and protection.

As a corollary, secrecy is counterproductive and destroys trust. The public should know what the public health officials know. Many citizens may choose to trust their word, and follow their advice, but others will want more information. Experience teaches that information should not be withheld and simplification carries risks. Clear and understandable explanations are indispensable. It helps to be able to explain complex and difficult ideas, but simplification must not even appear to be a way to withhold information. With every useful simplification, communicators must be able to demonstrate a willingness to expand and explain in greater depth and complexity. A knowledgeable person can master understandable simplification as well as the complexity.

Finally, politics will prevail over science in the international context. If smallpox poses a threat or a serious risk to Americans, it poses similar risks to everyone on earth. If the nation is caught up in war imagery, the other six billion people on this planet may see a focus on protecting Americans in a very different light. A vaccination strategy focused entirely on Americans seems likely to trigger international mistrust about our motives and could promote fears of genocide.

Risk Communication³⁷

What is going to be the best risk communication strategy once the final smallpox vaccination policy is announced? Based on the complex scientific and technical information regarding smallpox vaccine, how are public health officials going to transform this information into a message, and communicate it to the right audiences at the right time with the intended effect? Dr. Ed Baker, CDC, has said, “As we move into the 21st century, risk communication may well become the central science of public health practice.”

Since September 11, the Consortium for Risk and Crisis Communication has been conducting tracking studies on the public's attitude, awareness, and beliefs about post-September 11 events, in particular smallpox, smallpox vaccine, anthrax, and anthrax vaccine. Since September 11, there have been 572 media mentions of the smallpox vaccine (particularly as it relates to national security) in the top 20 national daily newspapers. Of interest, public health is now viewed by the public as a national security issue, which provides a strong communications leverage point for any communications campaign.

Although there has been much good coverage of the issues, the public does not understand the information, suggesting that it has not been put into a publicly understandable form. A large majority of the American public lacks basic and correct information, and physicians are poorly informed, not only about the disease, but also about the adverse effects of the vaccine.

A public information campaign will have to be designed to correct misperceptions, identify missing facts and concepts, fill data and information gaps, reinforce correct beliefs, emphasize peripheral ones, dispel myths and rumors, overcome resistance, and anticipate and minimize controversy. The campaign, which could begin today, requires trust in the source of information and trust in the messenger.

The message should be tested for public opinion and the new policy, once decided, should be positioned within the context of public health and national security. Moreover, a common message that outlines both risks and benefits must be sent across all organizations. A “step risk” communication approach is needed, recognizing that people are at varying stages in their awareness and knowledge.

The individual chosen to communicate this message must have numerous attributes. He or she must: convey calmness and resolve; recognize the enormity of events; identify the nature and source of harm; acknowledge uncertainty; be highly visible; take charge of the situation; explain why and how risk information might change; elaborate concrete steps to minimize harm and risk; keep the public informed about any new developments; expose bad news; express personal and honest emotions; deliver candid and complete answers; present clear, strong, and empathic messages; and anticipate the psychological impact of the communications.

Footnotes

34

This section summarizes the presentation by Bernard Lo, University of California, San Francisco.

35

This section summarizes the presentation by John Calfee, American Enterprise Institute.

36

This section summarizes the presentation by Anthony Robbins, Tufts University.

37

This section summarizes the presentation by Tim Tinker, Widmeyer Communications.