Wednesday, October 31, 2007

"Bird Flu" - A Critique of the President's Plan

Duncan and Associates
www.Duncan-Associates.com

President Bush, in a recent speech at the National Institutes of Health, outlined a program to spend $7.1 billion to protect the U.S. from the threat of avian influenza. "Our country has been given fair warning of this danger to our homeland and time to prepare," Mr. Bush said. "It's my responsibility as the president to take measures now to protect the American people." The proposed measures would include detecting outbreaks around the world and at home, stockpiling vaccines and anti-viral drugs, and being ready to respond at the federal, state and local levels in the event that a pandemic reaches the United States.

The President's plan would include $2.8 billion to speed development of a vaccine and $1.2 billion for the purchase of 20 million doses of vaccine. He also said the United States would spend one-billion dollars to increase stockpiles of antiviral drugs, such as Tamiflu? (oseltamivir), Symmetrel? (amantadine), Flumadine? (rimantadine), and Relenza? (zanamavir) - drugs that can reduce the severity of the illness when taken within 48 hours after becoming ill. A further $583 million is to be spent on domestic preparedness -- including $100 million going to the states -- and $251 million for aid to other countries.

The President's plan is apparently rooted in the CDC's long-awaited pandemic flu plan. This document has been more than a decade in the making. That report concluded that the nation is woefully ill prepared for a flu pandemic. Were one to occur, it says, hospitals would be overwhelmed, riots would engulf vaccination clinics, and even power and food would soon be in short supply. Members of the working group that developed the report have complained that no one at the upper levels of DHHS or at the White House considered the problem important or the report's warnings believable.

While many have been relieved to learn that the Bush administration has finally decided to take the threat of a flu pandemic seriously, the administration plan has found many critics. Even many of the Bush administration's usual supporters have questioned the administration's ability to respond effectively to this potential crisis. Conservative Republican and former House Speaker, Newt Gingrich, for instance, has commented that, " The problem with President Bush's plan is that they can't succeed in the current bureaucratic structure. Were the federal government ever entitled to the benefit of the doubt, it forfeited that presumption in the aftermath of Hurricane Katrina."

Quite aside from doubts about the Bush administration's ability to respond in a timely fashion to any emergency, there are a substantial number of serious concerns about the President's plan. These concerns begin with the obviously vital need for early detection of outbreaks. Whether it is detection of avian flu or of bioterrorism, local health departments must carry on the vital frontline activity in detection. Unfortunately, funding for health departments nationally has been declining and the Bush administration is currently supporting further cuts in federal support for state and local public health. If this element of the President's plan is to be effectively implemented, then funding cuts for public health departments need to be restored.

Stockpiling vaccines sounds like an obvious strategy but their currently is no vaccine available to protect humans against the H5N1 virus that it is feared may go pandemic. Vaccine development efforts are under way that hopefully will provide a vaccine in time for use if needed. Clinical trials of a vaccine to protect humans against H5N1 virus began in April and researchers are working on a vaccine against H9N2, another bird flu virus subtype. Some of the problems and issues involved in developing a strain-specific vaccine to prevent a flu pandemic are discussed by David Fedson in a recent issue of the N.A.P.H.P.'s Journal of Public Health Policy (vol. 26, #4, pp. 2-9). Last years shortfall in vaccine for ordinary seasonal flu and more limited shortages this year despite assurances that there would be no shortfall raise serious concerns about the organizational capacity for adequately producing and distributing a strain specific vaccine once it has been developed.

Since a strain-specific vaccine will most likely not be available in the early stages of a pandemic due to its prolonged development time early control measures will most likely rely upon the third element of the Bush plan - stockpiling antiviral drugs. Four antiviral drugs -- amantadine, rimantadine, oseltamivir, and zanamivir -- are approved by the FDA for the treatment of influenza and three are approved for prophylaxis. All four have activity against influenza A viruses, but analyses of some of the 2004 H5N1 viruses isolated from poultry and humans in Asia have shown that the viruses are resistant to two of the medications (amantadine and rimantadine). Monitoring of avian influenza viruses for resistance to antiviral medications needs to be ongoing.

In addition to therapeutic use antiviral medications will probably be used for short-term postexposure prophylaxis for close contacts of influenza patients - often referred to as ring prophylaxis. This approach attempts to stop the spread of contagion. Such a strategy obviously can require a larger supply of the antiviral drugs than would initially be necessary for therapeutic use alone. Of course, of the strategy is successful there will be far fewer patients in need of flu treatment than if an epidemic continued to spread unabated. There is a serious risk of strategy failure, however, of there is not enough medicine immediately available to administer to all contacts as soon as the first cases are reported and enough must be available to last out the duration of the flu season. Depletion of the available stocks would leave the population vulnerable to additional outbreak waves, potentially caused by influx of new cases. Stockpiles thus need to be both large and readily available to frontline public health workers. . Aside from concerns over whether the Bush administration can be more timely and adequate in supplying antiviral medication than it was in getting aid to victims of Katrina, the Bush plan for antiviral stockpiling has another greater flaw. President Bush expects the states and local governments to pay 75 percent of the cost to buy 31 million of the 81 million courses of antiviral medications that will be part of the national stockpile. This at a time when every state seems to be in a fiscal crisis requiring budget cuts. What is to happen to states that cannot afford to pay this 75% share? Will they be given less medication or none at all? If so, then the entire strategy of ring prophylaxis will fail as the deprived states serve as a reservoir of infection spreading the disease to unprotected persons in neighboring states.

The announced plan calls for readiness at federal, state, and local levels and provides for $100 million to go to the states to develop response plans for a pandemic. But this comes at the same time as a $130 million dollar cut in federal aid for state public health, leaving the states with $30 million less to respond to any threat to the public's health. As Dr. Rex Archer, President of the National Association of County and City Health Officials, has commented, "You can't take away $130 million with the right hand, give us $100 million with the left hand, with strings attached, by the way, and expect that that's going to get us where we need to go." A plan is a fine thing but without the resources to carry it into effect it will be as useless as the plans New Orleans and FEMA both had for coping with a hurricane such as Katrina.

The Bush plan is a start and we should be glad that the President recently read John Barry's The Great Influenza and was moved by the experience to take the threat of a flu pandemic seriously. A great deal more thought needs to be given to the details of this plan and whether we face a flu pandemic this winter or not funding for public health desperately needs to be increased.

N ational Association for Public Health Policy
http://www.naphp.org

Relevant Reading:

Barry, J. M. (2004). The Great Influenza: The Epic Story of the Deadliest Plague In History. New York: Viking Press.

Fedson, D. S. (2005). Preparing for Pandemic Vaccination: An International Policy Agenda for Vaccine Development. Journal of Public Health Policy, 26, 4-29. http://www.palgrave-journals.com/jphp/fedson_flu.html

HHS Pandemic Influenza Plan http://www.hhs.gov/pandemicflu/plan/

National Strategy for Pandemic Influenza http://www.whitehouse.gov/homeland/pandemic-influenza.html

Prof. Duncan is an epidemiologist and psychologist whose lengthy career has included positions in law enforcement, public health, and education. He has been a professor at Brown University, Southern Illinois University, the University of Cologne (in Germany), the State University of New york, and the New York State school of Psychiatry. He is currently President of Duncan and Associates and a director of the Fairview Community Health Cent

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