Pandemic influenza: The rules aren't the same as for typical flu season
Vaccine rationing shifts from protecting vulnerable to protecting masses
The Bush administration's projections of the potential impact of an avian flu pandemic expose the enormity of the ethical issues that come with any plan for rationing and distributing vaccine.
Basing a worst-case scenario on what the United States and the world learned during the three flu pandemics that struck in the 20th century — most notably the Spanish influenza pandemic of 1918 that felled as many as 50 million people worldwide — the federal government's pandemic response strategy, released May 3, cautions that a flu pandemic would cause massive disruptions lasting for months. Though the crisis would be nationwide, President Bush said, cities and states would have to deal with the local effects themselves, without guarantee of a federal rescue.
With current vaccine production capabilities using egg-based media for developing new vaccines, six months after a flu strain was identified, at full global production, perhaps 1 billion doses of vaccine would be available worldwide, experts predict. So the question is not whether vaccine would have to be rationed, but how.
"We have a responsibility to take this planning stage very seriously," says Kathy Kinlaw, MDiv, director of the Atlanta-based Emory University Center for Ethics. Kinlaw is a member of a panel of experts assembled to serve as an external advisory board to the Centers for Disease Control and Prevention (CDC) on the ethical issues related to rationing and prioritizing flu vaccine in a "normal" epidemic and in the event of a pandemic.
"The more we can do now to describe the scope of possibility and enhance our resources and readiness, the less we'll have to rely on allocation," Kinlaw says.
Most Americans have become familiar with flu vaccine rationing in the past three years, but rationing during normal flu seasons has as its primary objective protecting the most vulnerable — the sick, the elderly, and anyone in fragile health — and health care and emergency services workers who have direct patient contact or contact with many people.
"A pandemic is different from a shortfall in a regular flu season, because the basis for prioritization for a vaccine shortfall in a typical season is based squarely on minimizing serious complications," she says. "If you move into pandemic flu concerns, you want to keep those criteria for vaccination for those at risk, but other factors come into play. The nature of a pandemic means large volumes of people are affected in a short period of time, in a short geographical area, and that brings another layer of complexity to the allocation question."
While protection of the most frail is still a priority during a pandemic, distribution of limited vaccine and antivirals where they will do the most good for the greatest number of people becomes the goal.
Good of the many vs. good of the few?
Confronted by the looming threat of a pandemic, America's traditional commitment to the "equal moral worth" of each person would shift, according to John D. Arras, PhD, Porterfield professor of biomedical ethics and professor of philosophy at the University of Virginia in Charlottesville. "[That view] would predictably and justifiably yield to a social value perspective narrowly focused on survival and the minimization of social disruption."
Arras, also a member of the CDC advisory committee focusing on the ethical issues related to a pandemic, writes on the ethics of allocating influenza vaccines in an article in progress for the Yale Journal of Biology and Medicine.
A pandemic on the scale of the 1918 disaster would cripple key social institutions, including schools, courts, prisons, and government. Commerce and domestic travel would be severely curtailed. In that situation, the traditional plan of protecting the most vulnerable — the old, the very young, and the very sick — would be weighed against plans that would protect and preserve life for millions more people.
Arras says that a pandemic would force the consideration of plans that give preference to public health and safety and crisis response workers; protect transportation, food production, utilities, and other key social functions — including companies that produce and transport vaccine; and even rationing by age, dropping elderly people down on the priority scale in favor of those who have yet to live long lives.
Notable is the fact that many of the goals to consider are incompatible with each other.
"When you look at quality of life vs. quality of the benefit, or protecting the most vulnerable vs. getting the greatest good for the greatest number of people affected, you have competing values," says Kinlaw.
An example of how criteria shift is the reason health care workers would be considered high priority in a regular flu season or in a pandemic. During a regular shortfall, health care workers are considered at risk because of their patient contact. During a pandemic, they would be considered priority for vaccine allocation, because in a widespread infection the need for strong health care providers would be critical.
"The ethical reasoning shifts a bit in a pandemic," Kinlaw says. "It's not just a risk of complications, but an issue of keeping strength in our medical system."
Discussion of allocation also has to address what or who constitutes an essential service; public safety, vaccine manufacturers, food processing, and primary government all bear important responsibility in times of crisis.
"What it takes to keep a society running is a whole host of people," says Kinlaw. "You need food, need waste removal — there are lots of potential people we would have to look at on this essential services list."
Regardless of what allocation plan might be adopted in anticipation of a pandemic, its ability to work will be doubtful if there is not widespread ownership of it, Kinlaw stresses.
"When we're talking about allocation, we need to talk about building public goodwill and trust, because when we get to the point of allocation, we need to have people with us and for them to understand how we go there," she says.
Kinlaw says there is a natural tendency for individuals to ignore the looming threat of a pandemic, or to lapse into denial that they will be affected.
"It is easy for the public to not keep this issue in front of them, and somewhere we have to move beyond that, being careful not to be alarmist and simply building fear," she explains. "Somewhere in the middle is where we as citizens and organizations can be persuaded to learn about influenza and take reasonable precautions and see ourselves as partners with local, state, and federal agencies."
Preparations can limit, contain damage
The federal pandemic response plan puts terrific emphasis on and support behind development of speedier, cell-based vaccine development. In addition to improving and streamlining the stockpiling and new production of vaccines and antivirals, the plan takes a cue from the handling of Hurricane Katrina to urge states, local governments, and businesses to do everything they can to prepare to continue functioning despite widespread infections and without guarantee of being rescued by the federal government.
Because 85% of systems that American society depends on are privately owned and operated, including medical services, financial institutions, and food and drug producers, the federal plan pushes businesses to prepare plans for keeping operations going.
Kinlaw says efforts to shorten the time it now takes between recognition of a new viral strain and intervention with a new vaccine "can change the picture" of a pandemic, possibly avoiding some of the ethical dilemmas posed by harsher allocation plans.
"If we can shorten that time, we would be shifting the allocation need, because one of the problems [contributing to a shortage] is that it takes so long to manufacture a vaccine after the virus strain is identified," she says.
Regardless, she admits, "we can come up with some wonderful plans, but if we don't have a system where people can partner with and trust the system, the system will break down."
This is particularly important when considering groups who already are marginalized in society, who already may have misgivings about the equity of the health care system.
Global prevention eyed
The federal pandemic response plan outlines international efforts to monitor and contain influenza outbreaks, but Arras says he wonders if individual nations can act globally enough.
"Ordinarily, when people speak about the moral necessity of global justice, they usually, but not always, assume that giving sufficient aid and support to the distant needy will only put a small dent in our national budgets," he says. "We can thus do good and do pretty darn well simultaneously. This is because the cause of global justice is largely a matter of money rather than scarce commodities."
A pandemic, he says, would pose a greater obstacle because the necessary commodities would be scarce. As for giving equal priority to frail elderly in a third-world country and frail elderly in the United States, Arras says, "it's hard for me to imagine the 'America first' ideology being compromised on a matter of life and death."
"No matter how blissful the state of international relations at the time, my hunch is that the strong wind of nationalism will just blow away any countervailing claims of global justice," he suggests.
Says Kinlaw, "From an ethical standpoint, we need to think globally not only because we need to see the trajectory [of the spread], but also we need to look out and say, 'Where can we be helpful?'"
- John D. Arras, PhD, Porterfield professor of biomedical ethics, professor of philosophy, University of Virginia, P.O. Box 400780, 512 Cabell Hall, Charlottesville, VA 22904.
- Kathy Kinlaw, MDiv, director, Emory University Center for Ethics. Phone: (404) 727-4954. E-mail: email@example.com.
- Implementation Plan for the National Strategy for Pandemic Influenza, Homeland Security Council, Washington, DC. Available on-line at http://www.whitehouse.gov/homeland/nspi_implementation.pdf.