HHS Releases Draft Proposal for U.S. Preparedness for Influenza Pandemic

HHS on Wednesday released the "long-awaited" first draft of a proposal for U.S. preparation for and response to an influenza pandemic, the Washington Post reports (Brown, Washington Post, 8/26). The "Pandemic Influenza Preparedness and Response Plan," in development since 1993, will appear in the Federal Register (Altman, New York Times, 8/26). HHS over the next two months will seek comment on the proposal from state and local health departments, the medical community and the public (Washington Post, 8/26).

According to the proposal, "An influenza pandemic has a greater potential to cause rapid increases in death and illness than virtually any other natural health threat" (Howard Price, Washington Times, 8/26). A flu pandemic could force hospitals to divert patients; affect the economy, law enforcement and transportation; and prompt schools and borders between nations to close, according to the proposal (McKenna, Atlanta Journal-Constitution, 8/26).

"Pandemic" flu refers to a new strain of flu that can spread through human populations worldwide. Most new flu strains only have small genetic variations from current strains, and as result, most individuals retain some level of immunity. However, in rare cases, a human flu strain can combine with a strain carried by birds or pigs to create a new hybrid strain that potentially could spread among humans.

Such hybrid flu strains caused three influenza pandemics in the 20th century -- a 1918-1919 outbreak of "Spanish flu," which killed 50 million individuals, and two smaller pandemics in 1957 and 1968. Experts said that that a new flu pandemic is likely and could cause between 89,000 and 207,000 deaths in the United States; flu on average kills between 20,000 and 40,000 U.S. residents annually. Concerns about a potential flu pandemic have increased recently with the spread in East Asia last winter of the H5N1 avian flu strain, which killed millions of birds and could combine with a human flu strain (Washington Post, 8/26).

The draft proposal focuses on five main areas: vaccine development and production; surveillance; medication stockpiles; research; and public health preparedness (Washington Times, 8/26). According to the proposal, "Vaccination with a pandemic strain-specific vaccine is likely to be the most important strategy for preventing morbidity and mortality from pandemic influenza" (New York Times, 8/26). However, because the production of large amounts of flu vaccine takes six months after target strains are identified, manufacturers have begun to seek alternative methods that use cell cultures to improve their ability to expand the amount of vaccine produced, according to Bruce Gellin, director of National Vaccine Program at HHS and lead author of the proposal (Washington Post, 8/26).

The proposal also recommends the development of flu strain libraries that manufacturers could use in vaccine development, as well as the use of new molecular techniques to produce high-growth strains (Washington Times, 8/26). Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, also said that "there is ... a full-court press going on right now to develop" flu vaccines that target many different strains, rather than only one strain (Washington Post, 8/26). In addition, Aventis and Chiron have begun to develop vaccines to protect against the A(H5N1) avian flu strain. The vaccines are expected reach NIAID in October and November, after which time the agency will begin safety studies; results of the studies are expected in spring or later (New York Times, 8/26).

Meanwhile, the draft proposal calls on the federal government to expand the national stockpile of the medication oseltamivir -- marketed by Roche as Tamiflu -- which in many cases can prevent flu infection in individuals exposed to the virus. The government currently has about one million doses of oseltamivir in the national stockpile, but CDC Director Julie Gerberding said that the government "would like to have closer to 100 million" (Washington Post, 8/26). Officials for Roche, the only company that manufactures oseltamivir, said that the company cannot supply that amount. Gerberding also asked "to what extent will taxpayers be willing to invest in stockpiling large supplies of expensive drugs for years in which we don't use them?"

In addition, a study on oseltamivir scheduled for publication on Saturday in The Lancet indicates that resistance to the medication develops "faster and more often than researchers had expected," the New York Times reports. In the study, Japanese researchers analyzed flu strains in 50 children before and during treatment with oseltamivir. The study found that 18% of participants began to produce flu strains resistant to oseltamivir within four days of when treatment began. Previous studies had found only a 4% resistance rate in children and a 0.4% to 1% resistance rate in adults (New York Times, 8/26).

The draft proposal also calls for other efforts to prevent the spread of flu in the event of a pandemic. According to the proposal, health officials may have to screen travelers, close schools and impose quarantines. However, "given the nature of the flu -- which is transmitted much more easily" than viruses such as SARS -- "even that might not slow the pandemic much," according to the Post (Washington Post, 8/26). The proposal also recommends that hospitals free beds for patients infected by flu and that public meetings remain limited (New York Times, 8/26).

According to the Post, many of the recommendations in the proposal currently are "underway" (Washington Post, 8/26). The AP/South Florida Sun-Sentinel reports that federal health officials have encouraged states and hospitals to develop plans to triage and treat flu patients; only 25% of states had specific plans in place last year. In addition, CDC has begun to improve surveillance to identify flu strains when they emerge worldwide, "providing an early warning," according to the AP/Sun-Sentinel (Neergaard, AP/South Florida Sun-Sentinel, 8/26).

According to Bush administration officials, the draft proposal represents a broad outline of recommendations that should serve as a "starting point for public discussion," the New York Times reports. They said that they could not resolve a number of "complex practical and ethical issues that could stand in the way of carrying out" the recommendations in the proposal, according to the New York Times (New York Times, 8/26).

"What we're trying to do from a preparedness perspective is to say this is real, this is serious, and that the time to be complacent about flu is over," Gerberding said (Washington Post, 8/26). She added, "The point of putting this out now is to draw attention to the fact that there are hard decisions we, as a public, have to face up to. One of them is, how are we going to deal with the potential for a very serious outbreak in the context of what in the short term are having only the options of isolation, quarantine and a limited amount of treatment?" Gerberding said, "It's very important that we walk into those decisions knowing what the realities are and what the stakes are. If a serious pandemic evolved today or in a year, and we have not yet expanded vaccine production or treatment capacity, how are we going to ration scarce resources?" (Atlanta Journal-Constitution, 8/25). Gellin added, "This is an opportunity to begin to educate the public about what a pandemic is and what will be necessary to respond to one" (Washington Post, 8/26).

HHS Secretary Tommy Thompson, said, "Our proposed strategy draws upon a wealth of experience and knowledge we have gained in responding to a number of recent public health threats, including SARS and avian flu." He added that the plan is designed to serve as a roadmap for national preparedness efforts (Washington Times, 8/26). Dr. William Schaffner of Vanderbilt University, who advises the government on flu vaccine policy, said that a flu pandemic "may never happen, but each year we have to pay the premiums" (AP/South Florida Sun-Sentinel, 8/26). The draft proposal is available online.