In response to concerns about the pandemic potential of the H5N1 virus, states have been working with the federal government and with each other over the past several years to develop and refine plans and strategies for use in a pandemic or other public health emergency. The plans developed by the states are now guiding and coordinating the activities of state public health and emergency management officials. They have helped define roles and responsibilities; address the stockpiling and distribution of anti-viral drugs, personal protective equipment and other medical supplies; and include protocols for containment and isolation of infected or at-risk individuals. States also have implemented command structures and conducted exercises to test these preparations and further strengthen their preparedness and response capabilities.

Recognizing the need to share information with the public quickly and accurately to avoid unnecessary panic and economic distress, many governors are activating their state emergency operations centers, providing regular press briefings and launching Web sites and hotlines to disseminate health information. Several states are working with local officials to close schools based on recommendations from the Centers for Disease Control and Prevention, and many are launching new public health education efforts.

While state capabilities to address a public health threat have come a long way, there are still challenges to states’ efforts to combat H1N1. Most notably, the nation’s public health system lacks the surge capacity to meet demands for care in the event the rate of infection dramatically increases. Under normal circumstances, many emergency rooms across the country, especially those in urban areas, are full and wait times can be lengthy. In addition, states continue to face budget deficits and lack much flexibility to divert funds for emergency health needs. While all states have plans to address public health threats, they may not have funds held in reserve for their activation or use.

To learn more about the work the National Governors Association Center for Best Practices has been doing to assist governors with their pandemic plan development, please visit www.nga.org.

As part of the preparation for the swine flu crisis, Rx Response -- an unprecedented partnership created to help ensure the continued flow of medicines in public health emergencies -- has been placed on "Alert Status." Rx Response members are closely monitoring the influenza cases in the United States and working with local, state and federal officials to make sure the nation's pharmaceutical supply chain continues to operate efficiently.

Besides PhRMA, Rx Response members include the American Hospital Association, American Red Cross, National Association of Chain Drug Stores, National Community Pharmacists Association, Healthcare Distribution Management Association, Biotechnology Industry Organization and the Generic Pharmaceutical Association.

Rx Response, a single point of contact for the entire pharmaceutical supply system, has been in touch with federal and state crisis managers over the past several days to share information about the system's flu response capabilities.

There has been a concerted, united effort to improve the public health infrastructure’s preparedness for pandemic influenza with promising results, but there is more work to do.

Improvement efforts to date include pandemic planning exercises and community awareness efforts that identified and addressed gaps in the pandemic plan at both the state and federal levels. Many states have also ramped up their state and city pandemic plans, and have conducted planning drills and exercises. Good information and communication from authoritative sources helps quell panic and direct appropriate actions by the populace in a public health emergency.

While seasonal flu preparedness is separate from pandemic preparedness efforts, the two efforts do correlate. Our continuing improvements in seasonal influenza vaccination rates reflect well on our ability to be successful in our influenza efforts during a pandemic. The National Influenza Vaccine Summit, co-founded and co-sponsored by the CDC and the American Medical Association has played an important role in improving seasonal influenza immunization. Summit participants recognize the impact increasing seasonal immunization has on pandemic preparedness. The summit helps improve communication among the diverse stakeholders in influenza prevention and includes representation from stakeholders in medicine, public health, business and industry.

These are important advances, but more work remains to prepare for a pandemic. For example, challenges still exist in regard to the distribution of countermeasures (antivirals and vaccines) at the local level. Point of care distribution sites have been tested during seasonal flu, but not at a demand equivalency level to a pandemic. And a highly virulent pandemic will cause a significant surge in demand in hospitals, requiring alternate care sites.

To ensure that we don't lose ground on what we have gained in our preparedness efforts, appropriate funding for state and local health departments must continue so that key personnel are available to coordinate efforts. A review of the public health workforce, including clinicians, will need to be addressed to meet future demand in the case of a true pandemic.

The biggest problem with vaccine production is the government stranglehold on pricing, limiting profits to the vaccine manufacturers. The government buys more than half of childhood vaccines and a substantial portion of flu vaccines – at prices that are very low. This is arguably why vaccine makers were slow to invest in the costly new technology and excess capacity needed to respond quickly to immerging threats like the H1N1.

This is part of the reason why the U.S. is not prepared for a pandemic of the type that has panicked the public in the past week. It takes 24 weeks and one to two eggs to create one dose of flu vaccine. Our ability to respond quickly to a pandemic is currently limited by how fast millions of chickens can lay hundreds of millions of eggs.

We would be even further behind had the Bush Administration not began the process several years ago of investing in better technology to produce vaccines using a cell-based process. Instead of growing virus strains in eggs, they are grown in animal cells in large vats. Adopting this would cut the time required to produce a vaccine in half – from 24 weeks down to 10 to 12 weeks.

Also, according to former FDA deputy commissioner Scott Gottlieb, a vaccine adjuvant approved in Europe, but not yet approved in the U.S., could extend vaccine doses to inoculate as many as four times more patients with the current vaccine supply.

In recent years, the FDA has streamlined the process of applying for and receiving approval for vaccines. But more needs to be done.

The outbreak of the H1N1 influenza has been well handled by the government, so far. The response is a testament to our preparedness, but also to the professionalism of the career Federal employees and to the wisdom of our system of government.

HHS, unlike many other cabinet departments, has relatively few political appointees. For instance, the Centers for Disease Control and Prevention will typically have one or two appointees—the Director and perhaps an assistant. The same is true of the National Institutes of Health.

Secretary Sebelius took the oath only a week ago with few appointees named and virtually none in place. The various career employees, especially Dr. Besser at CDC and Dr. Fauci at NIH, have led the HHS response in a calm, clear manner. This would not be the case if political appointments went deep into the agencies and a change of administration became a decapitating event.

So does political leadership matter? The answer is “yes.” It was my honor to serve under the two former HHS Secretaries who have commented on this blog. Donna Shalala, along with Dr. Margaret Hamburg—now nominated to head the FDA, fought hard to create the HHS bio-terrorism plan and to fund it. As the Clinton Administration closed, funding for the plan was less than Secretary Shalala and Dr. Hamburg hoped, but there was a plan and some foundations, such as the (then) National Pharmaceutical Stockpile, had been laid. Without the plan and its foundations, the country would have been much less prepared for the October 2001 anthrax attacks. Michael Leavitt had the foresight and the political tenacity to build the infrastructure we now have for responding to a flu outbreak. As Secretary, Leavitt not only worked with the professionals in HHS to devise the response capability and doctrine, he also visited some 40 States to personally discuss their own responsibilities in a pandemic.

We may have gotten lucky in that the current outbreak may be characterized by mostly sub-acute infections, only time and science will tell. If so, we will have had the opportunity to have tested our preparedness and to draw lessons from the response. As we do, we should also reflect on the proper roles of career and political employees and how, in this instance, we have been well served by both.

Whether through the rapid detection and response to a health threat like H1N1, or through disease prevention and health promotion, the nation’s health depends upon well-funded and effective public health systems. The nation’s medical schools and teaching hospitals, as part of this broad infrastructure, contribute scientific discoveries, clinical care, and health professions training. However, the impact of these efforts is diminished in the context of an underfunded public health infrastructure.

Through a cooperative agreement established with the Centers for Disease Control and Prevention nine years ago, the Association of American Medical Colleges has encouraged medical schools and residency programs to work with public health agencies to improve public health content in medical education; facilitated public health research within our schools and hospitals; and developed resources and opportunities for our members to address current public health challenges. More efforts should be pursued to optimize collaborations between the academic medicine and public health communities.

The recent H1N1 outbreak—coupled with a recession that has led to cutbacks at state and local health departments—poses further challenges to an infrastructure the Institute of Medicine said 30 years ago had fallen into “disarray.” As the H1N1 outbreak and other possible threats clearly show, strengthening that infrastructure is imperative, and should challenge all of us in the medical and health professions to develop innovative approaches and partnerships to support our public health colleagues. While we are now better prepared for an influenza pandemic than in the past, all of us must continue to refine response plans for pandemics as well as a broad range of public health threats as institutional capabilities and societal threats evolve over time.

In 2005 the re-emergence of the H5N1 avian influenza was a reminder that the world was overdue for a pandemic and underprepared. As Secretary of Health and Human Services, I was given responsibility to formulate and implement a national pandemic plan. The plan is the product of wide collaboration and the best available scientific advice. Four years later, we are substantially better prepared but there is still work to be done.

The current administration has done a creditable job thus far in dealing with the rapid spread of the H1N1 virus (so called swine flu). President Obama is backed up by a group of career scientists and preparedness professionals who know what to do. They have practiced each step in regular exercises.

The Secretary of Health and Human Services is the key figure in a pandemic. Our new Secretary of HHS, Kathleen Sebelius, was confirmed, just this week. She is able and qualified and brings solid experience to the office of Secretary. The statement below is offered not as critic of current efforts, but with the hope Secretary Sebelius and other officials will find it useful:

Shortly after I became Secretary of Health and Human Services H5N1 Avian Influenza began to manifest around the world. It was quickly evident this needed to be one of the most urgent priorities. The world is overdue for a pandemic and we were underprepared.

We began feverishly working on pandemic readiness. President Bush requested that Congress appropriate $7.1 billion to prepare the nation and to do our part in the world. Though the H5N1 avian influenza virus has not sparked a pandemic, we used the ensuing three years to build stockpiles of anti-viral medication and supplies, rebuild vaccine capacity, and build alliances with other nations. We also helped state and local governments develop plans, holding pandemic summits in all 50 states and all U.S. territories. We brought together leaders from governments, schools, businesses, churches and health care delivery.

If the new human H1N1 virus achieves pandemic status newly confirmed Secretary of Health Kathleen Sebelius will become the central figure in managing the federal response. She will be hit by an avalanche of tasks and priorities. I would like to suggest seven priorities.

1. Energize state and local governments. There will be a tendency, especially at the White House, to give the impression that the federal government is in charge and that the President has the situation well in hand. The reality is that any state or community that failed to prepare because they think the federal government will come to their rescue will be disappointed -- not because the federal government lacks will, or wallet, but because there is no way the federal government or state government can be everywhere at once. State and local governments need to be activating their plans.

2. Jumpstart a vaccine. It will take 8 to 20 weeks to get a suitable and safe vaccine in place. The Centers for Disease Control, National Institute of Health, Food and Drug Administration, and the vaccine industry need to be brought together into a well organized collaboration. Things can get bogged down easily. If the swine flu becomes a pandemic, President Obama will face a very difficult set of decisions related to vaccine and their dissemination. In the next 30 days, I would recommend Secretary Sebelius read a book written by Harvey Fineberg and Richard E. Neustadt called “The Swine Flu Affair: Decision-making on a Slippery Disease.” It is an excellent post-action review of the swine flu scare during the Ford Administration and mistakes that were made. Secretary Napolitano and others in the White House ought to read this book also. Harvey Fineberg is currently President of the Institute of Medicine. Decisions to vaccinate a nation cannot be taken lightly.

3. De-emphasize the border issues. This is a health issue, not an immigration debate. In similar times, the question of closing the borders has been looked at in depth through a broad process involving every part of the federal government. Bottom line, it just isn’t an effective way to deal with a pandemic. First, the damage done to the economy is massive, which distracts from and debilitates further response. Second, many complicated social issues are presented. And third, it won’t work. There will be people who want to re-litigate this decision. Congress will likely respond to public discussion about this. It will tie up valuable time and officials will be distracted. The White House should refrain from going down that road.

4. Get well-acquainted with the scientists. HHS is a scientific organization filled with some of the best brain power in the known universe; people like Rich Besser who is doing an excellent job. Between CDC, NIH and FDA the United States has the single strongest suite of public health brands in the world. The world wants to hear from these folks. As Secretary, I found the scientists were my best teachers. Not surprisingly, I found competing views, even among the best scientists. It is important to use their advice to establish the best available facts. Then it is equally important to remember that scientific modeling informs our judgment but it is not a substitute for it.

5. Educate and communicate. This is a critical priority. HHS spent millions of dollars preparing materials for this moment. HHS has extremely good tools that are ready to be deployed. They were created in a way that reporters and citizens can go to the HHS website and find the best experts in the world answering questions. This is a time for the Secretary of HHS to be informing but not inflaming. Public health officials must find a balance that inspires planning but not panic. The materials can help do that.

6. The United States must be a major player with the World Health Organization. A pandemic, by definition, is a global event, and will quickly become more than a health discussion. There will be many multi-lateral issues involving vaccines, border closures, even scientific interpretation. The United States is by far the largest contributor of financial and intellectual firepower. WHO is headed by an experienced and able leader, Margret Chan. She led Hong Kong through SARS and a scare with H5N1 avian influenza. However, WHO is a complicated and unwieldy place at times. It needs to be known that the U.S. expects to play its part and have influence on decisions.

7. Study the pandemic plan. The U.S. government has a well-developed playbook in place. It is the product of several years of scientific advice and public input. It has been tested and exercised at many levels. There is a legion of capable career professionals throughout the government who will help frame the decisions the Secretary of Health and President must make. The plan contains the collective thinking of thousands; but improvise as circumstances demand.

Secretary Sebelius has an important job at this moment in history. Her actions will affect every American, every day, in highly personal ways. We must all be committed to help her succeed.

The country’s ability to respond to a pandemic flu outbreak or other health emergencies is light years ahead of where we were just a few short years ago.

So far, the response to the H1N1 outbreak has been swift, visible, and appears to be highly effective. The Administration has displayed strong, coordinated leadership, with the U.S. Centers for Disease Control, the U.S. Department of Health and Human Services, the U.S. Department of Homeland Security, and the White House conveying guidance and strategies based on the best expert advice for how to respond. Public health officials have been actively tracking the cases, working around the clock to analyze lab specimens and offering treatment to those with confirmed cases, dispensing antiviral medications from the Strategic National Stockpile, and letting the public know how to protect themselves and when to seek treatment. This response is possible due to the investments that were made to improve surveillance, coordination, communications, treatment capacity, vaccine manufacturing, and state and local response capabilities.

Some key improvements at the Federal level include:

• HHS has reached its goal of stockpiling enough pandemic influenza antivirals to cover 44 million people. HHS has completed the purchase of 50 million courses of antiviral drugs for the federal portion of the antiviral stockpile goal. As of February 8, 2008, the Strategic National Stockpile contained 39.4 million regimens of Oseltamivir capsules, with 409,000 on order; and 9.9 million regimens of Zanamivir with zero regimens on order.
• HHS has purchased medical supplies for the Strategic National Stockpile, including 104 million N95 respirators, 51.6 million surgical masks, 20 million syringes for pre-pandemic vaccine, and 4,000 ventilators.
• By 2011, U.S.-based vaccine production capacity is expected to be at a point at which it can generate enough pandemic influenza vaccine for every American within six months of the time that the pandemic virus is identified.

At the state level, some key improvements include:

• All 50 states and D.C. have a pandemic flu preparedness plan.
• As of September 2008, states have purchased 22 million courses of antivirals. (The goal is for states to purchase 31 million courses).
• All 50 states and D.C. have adequate plans to receive and distribute emergency vaccines, antidotes, pharmaceuticals, and medical supplies from the SNS, based on a review by CDC.
• All 50 states and D.C. have increased or maintained rates for vaccinating adults ages 65 and older for seasonal flu, which is a key indicator for showing how well states could vaccinate individuals in an emergency.

However, to date, this has been a fairly mild outbreak. The real test will come if this flu expands exponentially, as bugs often do, sometimes in a “second wave” during the next flu season. With luck, this outbreak of the H1N1 virus will remain mild and die out over the summer. That will give us a chance to reassess our response and capacities – in case it comes back in the fall in a possibly stronger version or if another novel virus appears. A real-time experience with a novel virus outbreak tests all our plans – from communications to policies around school closure and ramping up laboratory and care capacities. We should re-evaluate during this interim period to see what areas need improvement and possibly increased investment.

This H1N1 flu crisis has not tested the limits of the public health system, and we do not know how effective our response would be if the outbreak becomes more severe and the public health needs grow.

Will our public health departments be overwhelmed if large numbers of new cases emerge, particularly if there are large numbers of cases that need to be investigated and confirmed? Will we be ready if public health officials recommend closing large numbers of schools or suspending large public events? Can our health system care for millions of citizens seeking medical care simultaneously? Have we invested in training volunteers to take the place of some health care workers who may be ill or at home looking after family members who are sick?


With news about the influenza outbreak and its severity changing almost daily, this is the best time to make immediate efforts to shore up the U.S. public health system. As Rep. Kay Granger (R-TX) raised, the Administration should continue to spend the resources it has available to continue to develop and manufacture antiviral and vaccine capabilities. Developing pharmaceutical vaccines and treatments is a difficult and complicated endeavor and requires time and resources. For instance, the vaccine in development for the H5N1 “bird flu” will not be effective against the new H1N1 flu strain.

In addition, the President proposed $1.5 billion in emergency supplemental funding to bolster the H1N1 response. This is an important down payment to cover immediate H1N1 preparedness needs and will go a long way to better protect the health of Americans, but will not address all of the gaps in our preparedness needs, which include:

• Ongoing research and development capacity for vaccines and medications.
• Replenishing and expanding the supply of antivirals, vaccines and other equipment needed for the Strategic National Stockpile.
• Strengthening the state and local health department workforce which has been diminished in recent years by budget cuts and layoffs.
• Maintaining real-time disease detection and surveillance capabilities;
• Ensuring the ability to swiftly and safely distribute and administer vaccine and appropriate medical treatment.
• Rapid swine flu vaccine development and production, if the scientific community determines that an H1N1 (swine flu)-specific vaccine is needed, it will require rapid vaccine production capacity to be able to provide a vaccine for all Americans. We need to take advantage of the likely lull in flu during the summer months to develop such a vaccine, which will take major investment of resources. Some experts estimate that it will take $3.5-$5 billion to produce such a vaccine by the fall. That is not part of the President’s supplemental request; Congress should make sure those funds are made available as well in case a decision is made that we need an H1N1 vaccine.


The H1N1 influenza outbreak is a very real reminder of why we need a strong and stable public health system in the United States. This requires an ongoing and sustained investment in our federal, state, and local health departments. Unfortunately, in the past, we have not provided sufficient resources to this system. As we look to reform the health system in coming months, we also have the opportunity to build a reliable funding stream for public health as part of that system. Until we do, we are leaving Americans unnecessarily vulnerable to this and the next health threat, and our hospitals health care providers and public health workers at risk for emergency situations they do not have the capacity to handle.

The US has not dropped the ball. We have always underfunded the public health infrastructure. It always takes a crisis to refund it. I spent years begging for money for our state and local colleagues. It doesn’t get sexy until there is an outbreak. We need to sustain these investments. There are great strategies in the departments (originally designed by Dr. Peggy Hamburg, President Obama’s nominee for FDA). We also need to get the senior Public Health officials in place immediately including Dr. Hamburg, the new CDC director, the new NIH director, etc. The new coordination coming out of the Department of Homeland Security has made solid progress. However, we need our permanent scientific leadership in place.