Q&A: Bioshield Program Successful After “Rocky Start,” HHS Preparedness Chief Says

Health and Human Services Assistant Secretary for Preparedness and Response Nicole Lurie, shown in 2009, said the department's Bioshield program has been a success despite a "rocky start" in spurring production of WMD medical countermeasures (AP Photo/Alex Brandon).
Health and Human Services Assistant Secretary for Preparedness and Response Nicole Lurie, shown in 2009, said the department's Bioshield program has been a success despite a "rocky start" in spurring production of WMD medical countermeasures (AP Photo/Alex Brandon).

WASHINGTON – A multibillion-dollar federal program to spur manufacturing of medical countermeasures against weapons of mass destruction had a “rocky start” but over the last decade has added 11 new products to the nation’s emergency stockpile, a top Health and Human Services Department official said.

There are another 80 pharmaceuticals in various stages of development for treating victims of a biological, chemical, nuclear or radiological incident, noted Nicole Lurie, assistant HHS secretary for preparedness and response.

“Think about the fact that we started with zero. We now have 80, so I would call that in and of itself pretty successful,” she told Global Security Newswire.

Then-President George W. Bush signed Project Bioshield legislation in 2004, setting aside $5.6 billion over 10 years for federal acquisition of drugs that might not otherwise have a viable market.

The initial cornerstone of the program was to be procurement of 75 million doses of a new anthrax vaccine for the Strategic National Stockpile. Instead, the deal collapsed after California-based VaxGen fell years behind in delivery of the product.

Bioshield has faced other complications, including recent questions on Capitol Hill about a single-bid contract for a new smallpox drug. Issue watchers have also questioned whether the funding pot was large enough and argued companies needed financial support before reaching the end of the expensive drug research and development process.

Health and Human Services focuses on the positives, including acquisition of new countermeasures against smallpox, botulism, radiation and other WMD threats. Nearly 30 million doses of the sole licensed anthrax vaccine had been added to the stockpile by 2011.

The department established the Biomedical Advanced Research and Development Authority in 2006 to help companies through the drug development ‘valley of death” – a term used to describe the extended, costly research and development process that is often difficult to surmount. It has been the recipient of $1.9 billion originally designated specifically for Project Bioshield, which as planned will empty its coffers at the end of this budget year. Biodefense legislation now in Congress would authorize another $2.8 billion for the effort over five years.

Lurie took charge of the HHS branch that manages BARDA and Bioshield activities in 2009. She previously served as the department’s principal deputy assistant health secretary, has been a public health specialist for the RAND think tank and served in Minnesota state government and higher education.

In a wide-ranging telephone interview, Lurie discussed her goals for the Obama administration’s second term, the dangers of reduced public health funding, and the ways in which social media can be used to strengthen readiness for disaster.

GSN: A number of top administration officials have used the beginning of President Obama’s second term as a departure point from government. Do you intend to stay and what is influencing your decision?

Lurie: What I would say is that I think that the mission of this organization is critically important. I feel like we’ve achieved a huge amount in the first term but there is still a lot more to do, and I have a long list of priorities that I would like to accomplish before I decide to leave.

GSN: What do you see as your greatest challenges going forward?

Lurie: I think that the greatest challenges are to continue to be sure that the country is as prepared and as resilient as it possibly can be for facing the whole array of disasters that could come or situations that could come our way.

Within that, there still is a lot of development and modernization to do both in terms of the medical countermeasure enterprise … but also for us to be able to innovate in building strong day-to-day health care systems that can optimally work in disasters, and to continue to innovate in ways that will help people become more resilient.

GSN: What are some specifics of those projects you still want to see borne out toward meeting those goals?

Lurie: A first area of priority is in the area that I would call health resilience and health resilience technologies. One of the things that we’ve realized from many disasters is that we have large numbers of people in our society who not only have chronic illness but are pretty technology dependent now to manage that illness or to stay alive.

Many of them are functioning quite independently and quite well at home, but when the power’s out for prolonged periods of time they have trouble. They can’t stay at home, they often have trouble finding a source of adequate power, they may need to pick up all of their equipment and go to a shelter, and it’s just not an optimal situation for them at all.

So one of the things that we’re working quite hard on right now is what we’re calling a health resilience technology program. This is a technology program that is seeking solutions to that problem. We are working now with one of the department’s innovation fellows to develop some pilot technologies and to help stimulate industry and the market, much the way that we’ve used BARDA and Project Bioshield to stimulate the market to do medical countermeasures, to make these kinds of technologies. So they might be a signaling device that you would let an emergency manager know, for example, that your device was soon to be out of battery power. They may be longer-lasting universal batteries, they may be small home generators that don’t give you carbon monoxide poisoning, they may be other things. But we are very focused on getting this set of technologies developed.

A second area of innovation is the way in which we can use and leverage new emerging social media for better preparedness, response, recovery and resilience.

A third area of focus is really better preparing and leveraging the health care system by shifting a little bit away from a focus on solely preparing hospitals to preparing the health care system in a community and all of the various components that make up the health care system.

GSN: Social media is something that a lot of different agencies are trying to get their heads around. How do you see HHS and particularly your branch as being able to put it to use toward readiness?

Lurie: We are using social media in a variety of ways. First, I would say we are working to use social media to build resilience, so to strengthen the connections between people before disasters occur.

In ASPR we’re actually the first to use the federal America Competes Act and sponsored a challenge for a Facebook app that will let people identify who their lifelines were in advance of a disaster, with the idea that people would make commitments to one another in advance of a disaster to get each other out of harm’s way, give people a place to stay after a disaster or whatever. To help them think about preparing and to become more resilient.

A second way in which we’ve been using social media is for better situational awareness. We do a lot of monitoring of current social media channels and are continually experimenting with new ways to get earlier awareness of what is going on on the ground, whether it’s from what people are Tweeting or what pictures they’re taking, or other kinds of ways of knowing.

Along those lines we’re also experimenting with it for other ways of doing surveillance and having an idea about the health issues that are occurring in a given community. We’ve been using it to get a better situational awareness and response and to match the needs of either responders or individuals with the resources that are available.

Finally, we’re doing similar kinds of things in recovery. So really across the whole disaster spectrum.

GSN: How prepared would you say the U.S. is today to deal with the effects of an act of bioterrorism or another unconventional attack?

Lurie: What I would say is we have made a lot of strides since ASPR was established [in 2006]. Some of the strides in particular are that we have a strong recognition that all disasters are local, you know, state and local agencies lead the response.

We have a much better recognition and understanding now of each agency’s role and responsibilities. Everybody’s got plans. We work in a very close relationship with states and communities around planning so that we have a good sense of each other’s capabilities and each other’s gaps.

We now have thousands of personnel through the National Disaster Medical System and others as well as tons of medical equipment that we can have in place within hours of a state’s request to help them out. And we saw this very much in Hurricane Sandy when we were there within 4 ½ hours of [New York] state asking us for help. …

We’ve placed much more emphasis on the behavioral health aspects of preparedness and response and recovery. We have made substantial progress in developing medical countermeasures … and in changing the approach that we use as a country both to develop medical countermeasures and to public-private partnerships in particular.

In all of those areas, the planning, the connectedness, the execution of the plans, the having the medical countermeasures, I think we are far better off than when we got started.

Now having said that, there’s still a good ways to go. Certainly what you saw at the beginning of this century was a substantial investment in public health after 9/11 and after the anthrax attacks. I think public health really started making a lot of progress in getting itself organized.

The budget cutbacks, particularly at the state and local level, have been particularly troubling. I fear that we could really be backsliding and compromising our preparedness and our health security as a result. A chain is only as strong as its weakest link. And if in fact all disasters are local, we need local governments and state governments to be really strong in this regard.

GSN: A couple years back [Health and Human Services Secretary Kathleen] Sebelius described the process for preparing and then deploying medical countermeasures as “full of leaks, choke points and dead ends.” What are the persistent issues there and how has the department sought to overcome those?

Lurie: When the secretary talked about that she also directed us to do a review of the medical countermeasure enterprise, which was a very comprehensive review of how it is that we make medical countermeasures and how it is that we deploy them at the end of the day.

We have now been engaged in a very deliberative process of acting on those recommendations. We have a very strong governance and decision-making process now for the entire medical countermeasure enterprise.

I think we have much more effective ways of engaging our private sector partners in making medical countermeasures. We have better ways of having our federal agencies work together with companies throughout the development process. We’ve streamlined our contracting processes and our contracting times.

So I’d like to think that we are much better partners than we were at the beginning of this. A key player in this obviously has been BARDA and the tremendous work that it’s done on advanced development and procurement of countermeasures. But also the FDA, and the FDA has engaged with us through the [2012 Public Health Emergency Medical Countermeasure Enterprise Strategy and Implementation Plan] really at the front end of the development process rather than way down the line so that we can begin to anticipate what the regulatory needs and the regulatory process are going to look like and be as responsive as possible.

GSN: Give me a concrete example of how those improvements have borne out.

Lurie: In really concrete terms what I would say is we now have a bunch of medical countermeasures in the stockpile. I think we’re up to 11, hopefully more soon, that we didn’t have before.

We’ve also now seen the successful licensure of cell-based and recombinant flu vaccine, which is a tremendous accomplishment. We have funded the Centers for Advanced Development and Manufacturing, and those are under way. … In all of those areas I think we have had tremendous success.

GSN: Public health spending, as you noted, has been squeezed in recent years and the fiscal 2013 budget if passed would continue that trend. Is there any hope for reversing that and what happens if sequestration takes effect?

Lurie: It would be foolhardy of me to speculate other than to say that I think we all want to work very hard to avoid it. What I would say otherwise is … I am concerned that we have and could have multiple weakening links [in the chain]. But we’ve really taken this as a challenge to become much more efficient in everything we do.

I take very, very seriously our responsibility to be the best stewards we can be of taxpayer dollars, and I think the changes in the PHEMCE that we’ve made have borne that out. We use all the federal dollars that we can for preparedness and response as efficiently and effectively as we can.

This also speaks to the fact that we can’t accomplish national health security with the federal government alone. We need not only federal government but state and local government, private sector partners, voluntary organizations and others to achieve our goal. We’re all in this together and we’ve got to recognize that everybody’s got to step up to the plate in this and do what we can do.

GSN: How important is it that Congress pass the Pandemic and All Hazards Preparedness Reauthorization Act, which backs new funding for Project Bioshield and some of the other readiness programs?

Lurie: Both of those are up for reauthorization now and, again, we believe that reauthorization is pretty central to what it is that we do.

One of the important things that the reauthorized PAHPA will do is also reauthorize Project Bioshield which you know expires at the end of 2013. We will have spent all of the Bioshield money by that time as was anticipated when the original legislation was passed. That means that we are going to need to find a way to fund the Special Reserve Fund moving forward.

The proposed legislation reauthorizes it at $2.8 billion over the next five years. We have clear needs and clear plans to be able to spend that money for a new set of countermeasures which I think are badly needed for us to be able to respond to a fuller range of threats that we still confront.

GSN: To what degree would you say Project Bioshield has met its intended goal of spurring the private sector to manufacture medical countermeasures it otherwise might not have seen a market for?

Lurie: I think I would be the first to agree that it got off to a kind of rocky start, that there were a lot of assumptions made at the beginning about what was possible by having a procurement pot at the very end of the cycle. I think along the way fortunately we all realized that to be serious about developing and procuring countermeasures we needed a federal investment earlier in the pipeline and that is exactly what happened.

So now we’ve got over 80 CBRN products in the development pipeline. Think about the fact that we started with zero. We now have 80, so I would call that in and of itself pretty successful.

We have 11 products in the stockpile that we didn’t have before. I would also call that pretty successful.

In addition, what we are starting to see more and more of, particularly since acting on the recommendations on the secretary’s medical countermeasure review, is we are starting to see products that have benefits day to day or have multiple uses, and so the investment in Project Bioshield we’re starting to see is going to have this spillover effects to other parts of health security and other parts of society in ways that I don’t think we anticipated at the beginning of this.

While I might have started this a little bit cynical about Bioshield I’m now one of its biggest supporters.

GSN: What are some countermeasures that you hope or are planning to see focused on should Bioshield go ahead with that $2.8 billion?

Lurie: We still have a lot of work to do in the area of rad/nuke, we still have a lot of work to do in the area of thermal burns. Think about the fact that getting good products for both of those … we’ll probably revolutionize burn care in this country as we do it.

We have a lot of work to do in the chem area and we still have more work to do for some biothreats and for improving some of the products that we now have for biothreats so that they have a longer shelf life, so that they’re easier to use, that they don’t need [to be constantly kept in cold storage], those things.

As we solve those problems we solve many other problems for global vaccine programs as well.

So still a lot of work to do but I think we’re on a terrific trajectory now with so many promising products in the pipeline.

March 1, 2013

WASHINGTON – A multibillion-dollar federal program to spur manufacturing of medical countermeasures against weapons of mass destruction had a “rocky start” but over the last decade has added 11 new products to the nation’s emergency stockpile, a top Health and Human Services Department official said.