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"If you want support for decisions, you must get people to understand the underlying rationale, and that's what ethics is," Caplan said in a recent interview. "It's important to have a framework. It's important to have consistency or to explain expectations. It's in the interest of getting compliance."

Exploring vaccine priorities offers an example of how to explain the ethics behind a pandemic planning issue. In its pandemic influenza plan issued in November 2005, the US Department of Health and Human Services (HHS) made recommendations about which age and occupational groups should have priority for vaccination. Vaccine production and distribution workers, as well as frontline healthcare workers, received top priority, as recommended by the National Vaccine Advisory Committee (NVAC) and the Advisory Committee on Immunization Practices (ACIP).

Several other groups followed, including people between 6 months and 64 years old with two or more high-risk conditions or prior hospitalization with pneumonia or influenza, pregnant women, household contacts of severely immunocompromised people, household contacts of children 6 months or younger, public health and emergency response workers, and key government leaders. The recommendations are subject to change depending on the epidemiology of a pandemic virus.

In making those recommendations, ACIP members quickly focused on minimizing hospitalizations and deaths, said Jon Abramson, MD, ACIP chairman and Pediatrics Department chairman at Wake Forest University School of Medicine in Winston-Salem, N.C. Four ethicists outside the Centers for Disease Control and Prevention (CDC) participated closely, Abramson said. At least one proposal that seemed logical to Abramson got "shut down" by the bioethicists, and ACIP followed their advice.

"It's incredibly valuable" to have ethicists' participation, Abramson said. "If you can't make your case to the public on ethical principles, you're in trouble."

Another way to allocate vaccine
The ACIP recommendations were challenged on May 12, when bioethicists writing in Science suggested an alternative. Ezekiel J. Emanuel, head of the Department of Clinical Bioethics at the National Institutes of Health, and Alan Wertheimer, a senior research fellow there, called the NVAC-ACIP guide the "save-the-most-lives" principle.

The authors suggested focusing instead on what they called the "life-cycle principle," based on the idea that each person should have an opportunity to live through all the stages of life. They also suggested refining that principle based on gradations within a life span. This would give priority to people between early adolescence and middle age on the basis of the amount people have "invested" in their lives balanced by the likely time left to live, they wrote in Science. Under that principle, "20-year-olds are valued more than 1-year-olds because the older individuals have more developed interests, hopes, and plans but have not had an opportunity to realize them."

The authors also emphasize public order as a principle that should affect the ranking of flu vaccine recipients. That would emphasize the value of ensuring safety and protecting the availability of life's necessities.

Combining the principles would lead to high priority for vaccinating those involved in bringing vaccines to the public, as well as healthcare workers. It would emphasize vaccinating people aged 13 to 40, who are last in line under the NVAC-ACIP recommendations.

Explaining the rationale for federal guidance helps state planners, according to Kathy Harriman, PhD, MPH, RN, supervisor of the Infection Control and Antimicrobial Resistance Unit of the Minnesota Department of Health.

If states don't understand and buy into federal guidelines, Harriman said, myriad localities could have differing standards of care and priorities.

"I find it troublesome that states and local governments will make different decisions," she said. But she added that room for disagreement is the American way, and different localities have different needs and resources.

"The decision logic should be the same in each place," she said. At this point, however, many aspects of pandemic planning principles remain unclear. "How are decisions being made? Who's making them? Who's deciding who's making them?"

A member of the Healthcare Infection Control Practices Advisory Committee (HICPAC), which advises the CDC, said that bioethics is part of the committee's work, but she described a less-explicit process.

"I think the discussions occur, but they're not named," said Carol O'Boyle, PhD, RN, an assistant professor of nursing at the University of Minnesota. For instance, in discussing distribution of seasonal flu vaccine in the face of a projected shortage last year, "We did look at the greatest good. We did look at protection of the vulnerable."

Bringing ethics out in the open
Caplan said that articulating the ethics underlying federal recommendations could enhance US pandemic planning. He described the two most important roles for ethicists as (1) offering suggestions about the fairest approach when rationing is necessary and (2) explaining what the rules are and why they exist.

For example, he said, it's important to explain to hospital staff members that they have an ethical duty to go to work during a pandemic. In an informal poll, he recently asked medical students whether they would report to work during a pandemic. About 40% said they would not.

"I was completely astounded," Caplan said. "I didn't think it was going to be that high." Those informal findings have led him to plan a formal survey for hospital employees to learn more about their feelings on the issue, he added.

To date, Caplan gives the federal government low marks for talking about its decision-making process. The federal pandemic plan shifts a great deal of authority to states, which he called "a risk transfer" from the federal government.

"It's not even clear who is supposed to be in charge and to enforce the rules," Caplan said. He called for town forums, congressional hearings, and high school and college teaching units to discuss rationing and resources. He suggested enlisting the support of popular media representatives such as Oprah Winfrey and CNN TV's Anderson Cooper to host discussions.

"I want it out there," Caplan said. "It's nice that there are experts, but ultimately ethics should facilitate democratic discussions."

Caplan is doing his part by leading the Ethics of Vaccines project, an 18-month effort begun December 7, 2005, to understand the vaccine field and propose an ethical framework to guide people in the safe, effective, and ethical use of vaccines. It includes a Web log intended to generate more discussion about ethics and vaccines.

CDC tries citizen forums on vaccine issues
A separate effort is under way at the CDC, said Roger Bernier, PhD, MPH, senior advisor for scientific strategy and innovation at the agency. A vaccine expert and epidemiologist, Bernier became convinced a few years ago that some segments of the American public had a "trust problem" on vaccine issues. He developed a public engagement model to elicit public opinion and tested the model for the first time on pandemic influenza. The result was a collaboration among 14 public and private organizations that linked about 300 stakeholders and citizens in four regions and involved citizen forums.

The groups reached consensus, Bernier's report said. Assuring the functioning of society (using a minimum number of vaccine doses) was the first immunization goal, and reducing individual deaths and hospitalizations due to influenza was the very close second. "There was little support for other suggested goals to vaccinate young people first, or to use a lottery system or a first come, first served approach," the report noted.

Different groups bring different perspectives to the analysis of policy issues, or, as Bernier said in an interview, different lenses. Public health experts and advisors have not been explicit in the past about their own perspectives. It is important not to substitute citizens for experts, but when decisions are values-driven, citizens can play an important role in articulating the values.

"This project illustrates that the lenses are not always identical, and shows the usefulness of public engagement," Bernier said.

"We need the public for three reasons," he added. "We need their help, we need their advice, and we need their buy-in. . . . Even if we have the world's greatest plan, if there's not compliance, it can't be implemented."

Putting health threats in context
Steven Miles, MD, a professor in the Center for Bioethics at the University of Minnesota, urged people to take an additional step back and make sure that discussions about pandemic planning are occurring in the appropriate context—by assessing the threat in relation to other and potentially more pressing health threats worldwide.

"It's ethics' role to basically insist on a structural firewall between the politics of fear-mongering and homeland security, and the science of public health risk assessment," Miles said. "Within the context of that firewall, we need threat assessments that address bioterrorism threats compared with other health threats, and a way of dealing with both the certainties and the uncertainties."

The threat of pandemic flu, like the threat of an anthrax attack, has been removed from the context of other public health threats, such as multidrug-resistant tuberculosis (MDR-TB) and polio, and ought to be reintegrated into that context, Miles said. Right now, gauging the likelihood of a pandemic or anthrax attack occurring within a given period, as well as assessing their health and economic effects, amounts to plucking probabilities out of the air, in his view. In contrast, the threat of MDR-TB is much better understood.

"We can get a better sense of where our money has to be allocated," he said. Although fighting the Marburg fever outbreak in Angola last year got a lot of public attention, the expense of sending a medical team to contain an outbreak that affected only a few hundred people should be considered in the context of the impact of MDR-TB in Angola.

"We win the skirmish with Marburg as MDR-TB makes a full scale assault on our health systems," Miles said.

Miles went so far as to assert that bioethics has never been optimally used in settling major healthy policy questions. The field has been used "to issue a benediction on courses of action that have already been decided upon," he said. "In the context of a genuine moral controversy, where the political balance of power is not set, where the uncertainty is high, the ability to bring in bioethicists to set up a framework of arguments has never been done."

Caplan sounded a more optimistic note.

"Ethics is very powerful," he said. "It's the glue to prevent anarchy. I'm not saying it'll work, but it's the best glue we've got."

See also:

Citizen voices on pandemic flu choices
http://www.keystone.org/spp/documents/FINALREPORT_PEPPPI_DEC_2005.pdf

Science article "Who should get influenza vaccine when not all can?"
http://www.sciencemag.org/cgi/content/summary/312/5775/854

HHS pandemic vaccine priority groups
http://www.hhs.gov/pandemicflu/plan/pdf/AppD.pdf

Ethics of Vaccines project: http://www.vaccineethics.org/

University of Toronto Joint Centre for Bioethics' publication "Stand on Guard for Thee: Ethical Considerations in Preparedness Planning for Pandemic Influenza"
http://www.utoronto.ca/jcb/home/documents/pandemic.pdf