Government Challenges



“We want to make sure that we are not promoting panic but we are promoting vigilance and preparation.”

– U.S. President Barack Obama at the Flu Summit (July 9, 2009, National Institutes of Health, Bethesda, Md.)


What is a public health emergency and when is it declared? How does government weigh its responsibility to prepare the nation for a flu pandemic against other threats to society, such as terrorism attacks or the growing impact of obesity? And did the 2009 H1N1 pandemic uncover a hole in pandemic response plans, showing that there was too little preparation to mitigate a mild outbreak?

In trying to prepare the nation for a flu pandemic, the government inevitably faces a myriad of challenges. Congress has to weigh careful spending of limited resources (financial as well as manpower and equipment) against the risks and uncertainties of the threat. Authorities have to think through how different agencies can work effectively and quickly in an emergency and anticipate legal, economic and social implications of response measures. States have to coordinate between their communities as well as across borders.

And all this happens with one big elephant in the pandemic planning room: public opinion. How people think and feel about pandemic flu preparedness and official response matters a great deal to politicians who want to be reelected. It also matters to federal agencies that cannot run health campaigns such as vaccination programs without public support. And it matters to state and local health officials who can prevent neither panic nor pandemic fatigue without constantly communicating to the public the current decision-making process and the thinking behind it.

This is one of the reasons journalists play such a crucial role in the pandemic flu story.

In this section, we explain major challenges federal and state governments must address when planning for a pandemic, as well as the response structure currently in place.

In Pandemic Reporting, experienced journalists discuss how they handle their roles as sources of practical information as well as watchdogs of government plans and actions during a pandemic.

In Crisis Communication, you can learn more about the complex environment both journalists and health officials operate in during an infectious disease outbreak.

On this page...
  What is a public health emergency? »
  Who is in charge during a pandemic? »
  State planning »
  The most ambitious vaccination plan in U.S. history »
  Antivirals: How many should be in the stockpile? »
  Financial challenges »
  Liability issues »
  Communications: Too many messages, too little time »



What is a public health emergency?

The U.S. Department of Health and Human Services (HHS) declared a nationwide public health emergency on April 26, 2009, in response to 20 confirmed cases of the newly discovered H1N1 virus, then called swine flu, in California, Texas, Kansas, New York, and Ohio, as well as in Mexico and Canada.

HHS renewed the emergency status on July 24 and Oct. 1.

The formal declaration of a Public Health Emergency (PHE) is a tool that facilitates HHS’ preparation and mobilization for disasters and emergencies. Specifically, HHS has cited its power to enable Food and Drug Administration (FDA) authorization of emergency-use drugs, devices, or medical tests under certain circumstances, for example lab tests to detect the pandemic flu strain and the emergency use of antivirals.



Who is in charge during a pandemic?

The National Strategy for Pandemic Influenza, issued by the Department of Homeland Security (DHS), on Nov. 1, 2005, guides U.S. preparedness and response to an influenza pandemic, with the intent of

1. Stopping, slowing or otherwise limiting the spread of a pandemic to the United States;
2. Limiting the domestic spread of a pandemic, and mitigating disease, suffering and death;
3. Sustaining infrastructure and mitigating impact to the economy and the functioning of society.1

The Implementation Plan for the National Strategy, released by DHS on May 3, 2006, includes more than 300 actions for federal departments and agencies and sets expectations for state and local governments and other non-federal entities. It also provides guidance for all federal departments and agencies on the development of their own plans.2

Developed in response to concerns about avian flu, the implementation plan gives the Department of Health and Human Services (HHS) the lead in the federal medical response and DHS the lead in overall domestic incident management and federal coordination, as advised by the administrator of the Federal Emergency Management Agency (FEMA).3

In a February 2009 report and in subsequent reports and testimonies the Government Accountability Office (GAO) found unclear and untested federal leadership roles, responsibilities, and coordination, as well as gaps in planning at all levels of government, among other issues. The GAO also cited the need for performance monitoring and accountability for pandemic preparedness, including setting priorities and providing information on needed funding.

In August 2009, the President’s Council of Advisors on Science and Technology (PCAST) issued a report on U.S. Preparations for 2009-H1N1 Influenza. It generally supports the planning efforts of the last four years but finds that “the large number of tasks and responsible units tends to obscure the primary seat of responsibility.” The report suggests that the president’s homeland security advisor identify the people, agencies and processes for decision making in the next phases of the 2009 H1N1 pandemic.

The PCAST report recommends ways to test and refine plans. The report presents a scenario of a more serious infection than the spring 2009 outbreak in which H1N1 infects 30 to 50 percent of the population, sending 15 to 30 percent to the doctor, hospitalizing 0.3 to 0.6 percent, and killing 0.01 to 0.03 percent. However, one analysis argues that worst-case scenarios are not the best way to prepare for the flu.

Questions reporters should ask:

Who has the authority to make decisions in a pandemic?
Who will be at the table when those decisions are made?
What are the competing interests for different situations and decisions (such as reducing illness, reducing death, limiting social disruption, maintaining health care systems, maintaining social infrastructure and limiting economic losses)?
What are alternative approaches?
What are the trigger mechanisms for interventions and actions?
What happens if people disagree, such as public health officials and educators in the case of school closings?


State planning

States and local communities will be on the front lines during a major health crisis. “Each community will experience the pandemic as a local event…the center of gravity for the response will be local,” according to the federal Pandemic Implementation Plan.

You can find state-by-state pandemic plans, a list of antiviral allocations and purchases, contact information for state departments of agriculture and public health and more online at flu.gov

The impact of a mild scenario, including state-by-state cases, hospitalizations and bed capacity is calculated on page 6 of the Challenges Ahead report from the Trust for America’s Health.

The Trust’s latest annual assessment of state-by-state preparedness for pandemic flu and other public health emergencies is also online.

Story ideas:

How does your state fare in the latest report?
Has it already purchased its share of federally-subsidized antivirals to use during a pandemic flu outbreak?
Has it recently cut its public health budget and if so, what effect is that having on flu preparations or other public health initiatives?
Does your community have a pandemic flu plan? How does it compare to flu plans in other towns in your area?
How much do local businesses, schools and faith-based organizations know about your community’s pandemic preparations?
Would they know whom to call in an emergency?

(See also: Challenges for Communities)


The most ambitious vaccination plan in U.S. history

When making the decision to order a large amount of pandemic vaccine, the government takes two risks:

The risk of spending millions of dollars on a vaccine that ends up arriving too late for the next pandemic wave, or that turns out to be ineffective against a changed pandemic strain. (See Prevention Basics: Vaccinations for details on why this is the case.)
The risk of buying millions of doses of a vaccine only to run into public resistance against a voluntary vaccination campaign, eventually watering down the intended preventive success of the vaccine.

Nevertheless, most Western governments decided quickly to order the 2009 H1N1 pandemic vaccine for most or all of their population. There was some early resistance in select governments around the world that was based on the high cost of vaccines that could be ineffective by the time they were ready.4

In the United States, two Republican doctors from Georgia, Reps. Phil Gingrey and Paul Broun, questioned the decision to spend $1.5 billion on an H1N1 vaccine in a case that illustrates that many decisions about pandemic preparedness are politically driven.

Said Paul Broun: “I don’t think we need to spend $1.5 billion on flu vaccine when ... the research shows that it’s not going to be very virulent. ... We are stealing our grandchildren’s future by borrowing and spending. ... This hysteria over the flu is driving the media, and it’s driving the administration, driving the leadership here. We’ve got to stop that.”5

Knowing that the effectiveness of a vaccine depends upon who gets it and when, the CDC and HHS launched the most ambitious vaccination plan in U.S. history in fall 2009: immunize everyone with the 2009 H1N1 vaccine. The campaign was to begin with the most at-risk segments of the population. Communities were asked to identify those people and figure out how to reach them with vaccines.

Only one of the five egg-based flu vaccine manufacturers is based in the United States, making the country heavily dependent on imported vaccines. On May 6, 2009, the FDA approved a second egg-based influenza facility in Pennsylvania for Sanofi Pasteur, which makes Fluzone.6

Information about the number of federal vaccine doses allocated, ordered, shipped, and distributed is updated each Friday at flu.gov.

States provide the CDC with vaccine-ordering information. The CDC has contracted with McKesson Corporation to distribute the vaccine to about 90,000 locations identified by states, along with related equipment such as syringes and sterilization swabs.7

For more information on vaccines, including opposition to the vaccine campaign, see Prevention Basics: Vaccinations



Antivirals: How many should be in the stockpile?

National pandemic planning calls for a stockpile of antivirals large enough to treat 25 percent of the U.S. population, or 75 million people. However, according to the Trust for America’s Health report8, nearly half of the states’ stockpiles covered less than 25 percent of their population. (Find updated state allocations online at Flu.gov.)

There are concerns about depleting the antiviral stockpile through prophylactic use (also see Treatment Basics: Antivirals). The PCAST report9 recommended that the antivirals should be available both for treatment and for prophylaxis for those at greatest risk of serious illness. And a September 2009 CDC recommendation suggests antivirals be reserved for patients with severe case of flu or who are in groups at high risk for developing complications.

When antivirals are released from the national stockpile, states and local communities control their use. CDC guidelines influence the use of antivirals, but they may not be strong and clear enough to promote optimal use of the drugs. The PCAST report recommended that state and federal supplies should be monitored.

Tip: The FDA tracks fraudulent 2009 H1N1 influenza products.

There currently is no systematic way to ensure that vaccines, medication and equipment in the national stockpile are replenished and upgraded as needed.



Financial challenges

On June 24, 2009, President Obama signed into law the Supplemental Appropriations Act, 2009 (Public Law 111-32). In that legislation, Congress allocated $7.65 billion to HHS to prepare for the 2009 H1N1 influenza outbreak, including a $5.8 billion contingent appropriation. After spending an initial $1.85 billion on the procurement of vaccines, expansion of surveillance activities and preparation for a possible immunization campaign, the president on July 16 designated an additional $1.825 billion for an emergency fund to support additional measures related to influenza vaccination efforts. That left $3.975 billion in reserve as contingency funds.10

The breakdown of HHS funds as of September 2009 is available in the Trust for America’s Health report (page 3).



Liability issues

Since June 25, 2009, individuals and entities that develop, distribute, dispense, prescribe, administer or use the 2009 H1N1 vaccine have broad liability protections under the federal Public Readiness and Emergency Preparedness Act (PREP Act). The protection does not include willful misconduct or other negligence in medical care unrelated to vaccines. It covers licensed medical professionals and others.11 12 

The PREP Act provides compensation to individuals for serious physical injuries or deaths from pandemic, epidemic or security countermeasures.13



Too many messages, too little time

What makes outbreak communications tough for health officials and governments? Reasons include:

The rapidly evolving nature of the outbreak.
The number and complexity of the messages.
The many channels of information to the public.
The need to address misinformation, disbelief and misconceptions held by the public.

In a pandemic, the CDC is the lead federal agency for communication with state and local health departments, health care providers and the general public.

The PCAST report14 took a good look at how the CDC fared during the first wave of 2009 H1N1 and concluded that the agency needed to coordinate its recommendations with medical organizations and, more importantly, ratchet up planning and the preparation of messages for public communications. The CDC also needed to do better with new media and social networking channels, especially to reach the younger people at risk.

Summarizing the PCAST and Trust for America’s Health reports15 16 , the CDC’s information campaign also needed to:

Refocus public attention on 2009 H1N1 and its relationship to seasonal influenza.
Keep the public updated about the severity of the epidemic
Educate the public about when and where to seek medical attention—and when not to.
Inform the public about personal and community-wide action that may be necessary and steps people can take to prepare.
Reach groups at particularly high risk.VRespond effectively to unexpected events, such as reports of adverse events that occur following, but not necessarily because of, vaccination.

Read a frank account of how the CDC’s director of media relations Glen Nowak sees his job.

Story ideas:

How did the Web site flu.gov start and evolve?
What is its role in flu communications and coordination? And how effective is it? (Note the September 2009 flu.gov blog entry.)
How are widgets and other social media tools being used? Whom are they reaching? And what is their impact?





Sources


  1. Flu.gov, National Strategy for Pandemic Influenza: Implementation Plan,

  2. Homeland Security, Department Response to H1N1 (Swine) Flu, Oct. 5, 2009.

  3. U.S. Government Accountability Office, Influenza Pandemic: Sustaining Focus on the Nation's Planning and Preparedness Efforts, Feb. 26, 2009, p. 10.

  4. GlobalSecurity.org, Russia's chief doctor rules out chance of swine flu pandemic, June 2, 2009.

  5. Politico, Republican doctors question virus vaccine, May 7, 2009.

  6. U.S. Food and Drug Administration, FDA Approves New Influenza Vaccine Production Facility, May 6, 2009

  7. Trust for America's Health, H1N1 Challenges Ahead, October 2009.

  8. Ibid.

  9. GlobalSecurity.org, op. cit.

  10. President’s Council of Advisors on Science and Technology, Report to the President on U.S. Preparations for 2009-H1N1 Influenza, Aug. 7, 2009.

  11. Flu.gov, Coverage Under the Public Readiness and Emergency Preparedness (PREP) Act for H1N1 Vaccination.

  12. Department of Health and Human Services, Pandemic Influenza Vaccines—Amendment, June 25, 2009.

  13. Health Resources and Services Administration, Countermeasures Injury Compensation Program.

  14. GlobalSecurity.org, op. cit. 

  15. Ibid.

  16. Trust for America's Healt, op. cit.




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