Interview

As told to Jeff Ferenc

The release in December 2009 of the seventh annual Trust for America's Health (TFAH) study on the health care industry's ability to protect the public from diseases, disasters and bioterrorism illustrated a number of improvements in this nation's response capabilities. Many of these could be seen during the H1N1 outbreak, including an increase in the country's vaccine production capacity, upgraded laboratories and surveillance systems. As the study points out, however, the H1N1 outbreak also underscored the "existing gaps in public health preparedness." Decades of chronic underfunding of public health meant that many of the core systems that would have been invaluable to have in place during an emergency were not at-the-ready when H1N1 emerged, the study concluded. To get some deeper insights into the nearly 100-page report, we spoke recently with Richard Hamburg, deputy director of TFAH.

How did investments by states and the federal government in pandemic and public health preparedness over the past several years improve U.S. readiness for an influenza outbreak?

What we have seen post 9/11 is a significant investment—somewhere around $8 billion—in all hazards emergency preparedness. In addition, in preparation for a potential H5N1 pandemic (bird flu) outbreak Congress and the prior administration invested over $7 billion in pandemic preparedness, with most of that money appropriated in FY 2006.

Since that time there's been ongoing appropriations of more than $300 million a year at the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), National Institutes of Health (NIH) and Department of Health & Human Services (HHS). An additional, more significant investment was made as part of a 2009 supplemental appropriations bill that included an additional $7.7 billion. So we're looking at approximately $15 billion in pandemic-specific investment. That is significant and has allowed us to increase the nation's capabilities to produce vaccine.

Billions of dollars have been invested in everything from research into cell-based technologies, increases in current egg-based capacity and retrofitting facilities. There are contracts with a whole host of vaccine manufacturers that have been established over the last five years or so. In particular, the state and local capabilities have increased dramatically.

I know when we asked the question just a handful of years ago whether a state had a pandemic influenza plan that, as recently as 2003, only 13 states said they did. By 2004 it was up to 30 states as the threat of the H5N1 virus was becoming clear. We've seen some dramatic improvement in state and local capabilities. There was $600 million appropriated to states and localities as part of that initial $7 billion investment. That's the good news. The bad news is that money ran out. It was expended by August 2008. So between then and this emergency supplemental bill, there's been no additional investment in pandemic preparedness at the state and local level. That was a problem.

We've also seen an increase over the years in funds to expand laboratory capacity. As far back as 2003, we asked state laboratory officials whether states had sufficient lab capacity to test for bio-threats. Only six states answered yes in 2003; that number increased to 44 states in 2007.

There seems to have been some issues with H1N1 vaccine production, or at least the speed at which the vaccine was distributed, and the egg-based production system as not the most expeditious way to do it. What happened?

Unfortunately, we didn't see as much vaccine as we expected earlier on in the process. There seemed to be some issues with production. One of the problems was such an intense demand early in the middle of the second wave of H1N1 and far less vaccine than we expected. That shows some of the deficiencies of relying on the egg-based technology.

I also think there were some expectations that manufacturers would be able to produce sufficient amounts earlier in the process, which unfortunately did not happen. Now we're in a situation toward the tail end of a second H1N1 wave where we need to get the message out more effectively that, in fact, the vaccine is available in greater quantities and not just for the priority populations.

We have to educate the public that these outbreaks do come in waves and there is the possibility of a further wave. And you never know the virulence of the strain farther along in the outbreak.

What tangible results were achieved by this greater investment?

I mentioned vaccine development and that if the federal government hadn't made the multibillion-dollar investment starting in 2005, we'd be in far worse shape right now. Back then there were only two manufacturers licensed to produce influenza vaccine in the United States. Greater availability, albeit slower than we had hoped for, was due to investment that began in 2006 when Congress appropriated $7 billion over three years for advanced development, increased production capacity, purchase of vaccine and antiviral medications, development of diagnostics, and building of state and local capacity.

Also, the investment in state and local preparedness was significant. This allowed states and localities to better coordinate efforts—we're talking about 3,000 local public health departments and that's a lot of plans and coordination that couldn't have been done as well without the investment. There certainly was a good deal of exercising plans over the last year, and in particular over the last couple of months, some substantial development of after-action reports. I'm looking forward to seeing what some of the recommendations are.

The investment in antiviral medications also was important and I think the only downside to the investment in the antivirals was, unlike other aspects of stockpiling, that it was a state and federal partnership. So, as you saw in our report, not all states purchased their portions of subsidized antiviral medications.

Some places had more availability than others, which is not a good thing necessarily. There are a lot of reasons for that; some just might have been prioritization. A couple of states were not as sold on the concept of stockpiling that much anti-viral medication. A lot of it was, in fact, due to budget problems at the state level and lack of resources.

The report found that 20 states scored 6 or less out of the 10 key indicators for public health emergency preparedness. What does this say about their ability to respond to health emergencies or bioterrorism?

These indicators are a snapshot and we try to have some consistency from year to year. It shows that the bar continues to be raised and there are important aspects of emergency preparedness that are not where we'd like to see them. If you look at the scores overall within the categories, we see that for most of these indicators the majority of states—35, 40 and up to 44 states in some cases—met some of the indicators.

But certainly there's still a ways to go as far as laboratory capacity. In particular with some of these issues if you look at the public health labs and staffing capacity in a true emergency as was defined in this particular survey by the Association of Public Health Laboratories, do they have enough staff to work five 12-hour days for a six- to eight-week period?

Almost a dozen states did not have that capacity—not surprising since we saw over 15,000 budget cuts in '08 and the first six months of '09 in local health departments, and some similar cuts at the state level.

Do you think the decades of underfunding impacted the response capabilities in terms of the H1N1 outbreak?

Absolutely. Chronic underfunding means that many core public health systems weren't at the ready, so to speak. When H1N1 emerged, for example, we saw some gaps in real-time disease surveillance and laboratory capacity for laboratory testing. We've seen some limits in hospital surge capacity.

The one thing that's truly visible and measurable is the shrinking public health workforce. The National Association of County and City Health Officials estimated that 15,000 local public health care workers lost their jobs during 2008 and the first half of 2009. We've seen hiring freezes. We've seen furloughs.

As a result, one of the negative impacts is that if you're in a time of budget cuts and layoffs and you have an emergency like the H1N1 outbreak and you have limited staffing then you are able to spend less time on food safety tracking response, for example, or on programmatic activities around injury prevention and chronic disease, mental health and so on. You have a bit of a domino effect.

The other thing is that even though there were significant federal funds available over this period between 2005 and 2009, each year the president's budget sought to cut emergency preparedness funding. In most cases a large percentage of those proposed cuts were restored by Congress and ultimately signed into law. However, we lost a little ground each year. If you factor in the effects of inflation, over the course of those five years federal emergency preparedness funds were cut by about 25 percent. That's the cumulative effect of those cuts.

Let's go back to the number of states that bought the subsidized antiviral drugs for their stockpiles. When we had 13 states that bought less than 50 percent of their share of the subsidized antiviral drugs, was this due to a lack of available funds or were other factors at work?

States had varying reasons for failing to purchase the subsidized levels of antivirals. Certainly I think the major cause was limited resources. Some did report questions about their effectiveness. Some were reluctant to spend resources on purchasing and stockpiling antivirals that have a limited shelf life. There's a shelf-life extension program that covers supplies that are stockpiled in the Strategic National Stockpile.

However, we have this unique case of some antivirals or at least some of the state-subsidized amounts fall outside the scope of the Strategic National Stockpile, thus they aren't covered by the shelf-life extension program. So in essence the same medicine in theory has a shorter shelf life if stockpiled by the states rather than the federal government.

Surge planning and capacity seemed to be an issue for a number of hospitals during the peak of the H1N1 outbreak. What standards or resources are needed to aid hospitals in this area?

There's an existing hospital preparedness program that's administered by HHS. It has been effective to a certain degree in improving preparedness, but we certainly have a long way to go.

One of the problems is the availability of funds. It's another category similar to the public health emergency preparedness grants through the CDC that I mentioned have been decreasing slowly but surely over the last five years. And only now I think it's in the first budget this past year that at least a small increase was recommended.

The same thing for the hospital preparedness program—funds for that program have gone down dramatically. When you divide up the several hundred million dollars available under this program between the thousands of hospitals out there, oftentimes it's less than $100,000 per hospital. We believe that hospital preparedness has several priorities, including interoperable communication systems, bed tracking, personnel management and hospital evacuation planning. Those are things that need to be done more effectively.

The funding has to be more robust and predictable. This up-and-down level of funding for preparedness has been a long-term problem. We also need to ensure that the federal government takes the lead in developing altered standards of care, guidance in providing funding for training of health personnel on the various legalities and ethics of a disaster situation. I think it's a complicated issue that needs more attention and more resources.

As you look back on the seven years of these studies, how do you feel overall about the nation's ability to protect the public from disease and disasters and in particular bioterrorism, which after 9/11 seemed to get a significant amount of attention?

We're certainly better prepared for disaster than we were seven to 10 years ago. There weren't even funding streams specific necessarily to emergency preparedness. If there were, they were woefully underfunded. In one of the examples where we tracked progress made in 2004, only 18 states met the standards for disease surveillance, while today 45 states meet the criteria set by the CDC.

Unfortunately, we have a system that continues to fund by emergency, so to speak. That's almost a bigger issue than levels of funding; it's the reliability of the funds. That's one of the reasons why you can have billions of dollars out there being appropriated and provided to states and local health departments and then you wonder why all these layoffs are taking place. Much of that money is one-time money; they are emergency supplementals.

The public health community has to do a better job of identifying just what that core infrastructure needs to look at and what that core level of funding should be. It's no way to run a business, in this case the business of public health, by simply having to rely on the threat of a public health emergency or the response ex post facto after the public health emergency. That's an area where we need to know what are the minimum standards, what are the dollars that are needed. We need to have a more reliable funding source.

This article first appeared in the March 2010 issue of Materials Management in Health Care.

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