AAMC Reporter: January 2006

Academic Medicine Prepares for Potential Pandemic

As the nation girds for a potential avian flu pandemic, academic medicine finds itself in the thick of the preparations.

Medical schools and teaching hospitals are educating students and public officials, performing research, and collaborating with the larger academic and health care communities. They're purposefully addressing related issues through the curriculum, ratcheting up the testing of vaccines, and helping to shape public policy.

Such efforts, of course, are crucial to the nation's defense against a potential outbreak. Moreover, they come at a time when a key question on many people's minds has been: If the disease should actually strike and spread rapidly, as it may well do, will the United States — and the rest of the world — be ready?

Many basic facts about avian influenza are clear. Known as H5N1, it is a highly contagious disease spread by birds that was first detected in humans in Southeast Asia in the late 1990s. Wild birds carry the virus harmlessly in their digestive tracts, but domesticated birds are highly susceptible to the contagion.

So far, more than half the cases in which the virus has "crossed the species barrier" to infect humans have resulted in death. As of late December, there were 141 confirmed cases of avian flu in humans, with 73 reported deaths, according to the World Health Organization.

A worst-case federal projection warns that if avian flu were to gain a foothold in the United States — through mutation or a combination of avian and human flu — it could kill 2 million people and sicken 90 million more in a matter of months.

"If past is prologue, we are due for another pandemic," Health and Human Services Secretary Michael O. Leavitt said at the 2005 AAMC annual meeting in November. "No nation on Earth can afford to ignore this fact.... Pandemics happened in the past, and they will happen in the future.... We're not as well-prepared as we need to be, and our goal is to change that."

Leavitt is not alone in that view. Many experts and leaders throughout science and health care have been warning that the nation is under-prepared for a pandemic.With that in mind, much is being done to increase readiness.

For its part, the Bush administration proposed a $7.1 billion avian-flu package, including such initiatives as increasing both disease surveillance and the surge capacities of hospitals, long-term boosts in vaccine production, and expanded stockpiles of anti-viral medications, such as Tamiflu.

Meanwhile, vaccine-related research stands out as a principal way in which academic medicine has been contributing to the campaign to defend the nation against a flu pandemic.

Vaccine Trials

James Campbell, M.D., University of Maryland

Three medical schools — the David Geffen School of Medicine at the University of California, Los Angeles; the University of Maryland School of Medicine, and the University of Rochester School of Medicine and Dentistry — have been holding avian flu vaccine trials involving about 450 healthy adults from ages 18 to 65. The research is being financed by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

James Campbell, M.D., a researcher working on the trial at Maryland's Center for Vaccine Development in Baltimore and an assistant professor of pediatrics at Maryland School of Medicine, said that so far the trial seemed to hold considerable promise.

"Preliminary results show that we've had an immune response that we think would be protective of people," Campbell said. "And the safety profile is the same as the regular flu vaccine. It's tough to say definitively, but we haven't seen any side effects of concern."

Another NIAID-commissioned vaccine trial, involving about 260 volunteers who are 65 and older, is under way at four academic medical sites: UCLA, Rochester, University of Cincinnati Children's Hospital Medical Center, and Vanderbilt University Medical Center.

"I think this is one of [academic medicine's] key roles in American health care," said Thomas R. Talbot, M.D., M.P.H., assistant professor of medicine and preventive medicine at Vanderbilt University School of Medicine and associate hospital epidemiologist at Vanderbilt Medical Center.

"We have experience with this. We have the science and the laboratory infrastructure, and the clinical component as well. And we use our infrastructure to rapidly, yet thoroughly, test these new vaccines and provide information for preparedness," said Talbot, an infectious-disease researcher working on the trial at Vanderbilt.

The pharmaceutical company Sanofi Pasteur, based in Swiftwater, Pa., manufactured the trial vaccine, which is made from an inactivated H5N1 virus.

Several other medical schools are performing avian flu research beyond the realm of vaccine testing per se. In one collaborative project, Indiana University School of Medicine in Indianapolis and Purdue University's College of Agriculture and School of Veterinary Medicine are investigating the use of a harmless form of adenovirus as a transmitting agent for the avian flu vaccine. Researchers hope the method will allow the vaccine to be more flexible in fighting different strains of avian flu.

At Virginia Commonwealth University Center for Drug Studies, doctors are developing an auto-injector that makes delivering the flu vaccine easier. And at Mount Sinai School of Medicine of New York University, researchers have reconstructed Spanish flu — which, in one of the world's last great pandemics, killed at least 20 million people in 1918. The aim is to learn more about Spanish flu as a means of predicting future pandemics and treatments.

Peter Palese, M.D., professor and chair of Mount Sinai's department of microbiology, said: "We were quite struck by two things: One, the fact that this research showed that this 1918 flu was inhibitable by FDA approved drugs [Tamiflu]. And two, that the vaccines worked. We were able to protect mice against the virus [by] using the vaccine. That suggests that humans could be protected as well. It is very important in terms of consequences."

In addition to performing research, leaders in academic medicine say they have a role to play in educating the public and informing policy deliberations at all levels of government.

Although people in academic medicine generally agree that the nation must do more to prepare for a possible pandemic, many also have described the administration's avian flu package as a good first step. They particularly support proposals for building and maintaining medicine stockpiles, and for bolstering hospital surge capacity.

Some, however, have called for more federal financial support and more channeling of funds to the local level.

Thomas R. Talbot, M.D., M.P.H., Vanderbilt University

"I think there are increasing steps and efforts being made," said Talbot.

"We shouldn't play Chicken Little and tell everyone the sky is falling," Talbot said. "But by the same token, we should prepare and use our resources to beef up our ability to respond. We've got to have the infrastructure to detect a pandemic locally. And that means making resources available at state and local levels."

Many members of the academic medicine community have appeared in various media reports since the threat of an avian flu pandemic entered the national consciousness last year. But the community is reaching out to the public in other ways. Some medical schools are working with experts in other fields to help shape policy.

The Center for Bioethics at the University of Pennsylvania School of Medicine in Philadelphia has announced an 18-month project on vaccine ethics. It will examine vaccine use and development, and propose guidelines on ethical procedures for researchers, pharmaceutical companies, public-health agencies, health care providers, and the general public.

Faculty members at the University of California, Davis, School of Medicine are collaborating with colleagues in agriculture and veterinary medicine to help California prepare for a possible pandemic by informing the public about the disease and preparation measures, and educating state lawmakers.

'Policy Foundation'

Campbell and the Maryland School of Medicine are making a similar effort, teaming with other schools and departments in the University of Maryland system — including the schools of pharmacy, law, and veterinary medicine — to host a symposium in Baltimore this month as a way to establish a citywide "policy foundation" for responding to an avian flu outbreak.

"We're doing this to get the issues out on the table that need attention locally and to help formulate preparation plans that fit in with the federal plan," Campbell said. "Many academic institutions have an input into policy issues. We have the ability to combine resources in the university and work together with other health care facilities. In situations like this, public health officials tend to come to academia to ask how they should move forward."

Medical schools and teaching hospitals are also educating tomorrow's doctors as part of the campaign to increase preparedness.

"We really get into this stuff with medical students," said Daniel Havlichek, M.D., chief of the Michigan State University College of Human Medicine's Department of Medicine Infectious Disease Section and associate professor of medicine. "They learn how pathogens are transmitted, how to respond to a bioterrorism attack, and other things. Isolation of patients is discussed. We take this very seriously, and it's very important for students to learn this information."

"For medical students and residents, they can be aware of the issues," said Talbot, adding that student research fellows were assisting with Vanderbilt's avian flu vaccine studies. "They should not panic, but they should keep the symptoms on their radar when they look at a patient," he said. "They should keep it in their mindset — be aware that it's an issue — and stay tuned."

Academic medicine is certain to "stay tuned," along with the rest of the nation. As Havlichek put it: "The birds are always going to fly overhead, and nothing will change that."

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