|The following questions were prepared by the online community (see previous post):
RESPONSES TO FLU WIKI QUERIES
William F. Raub, Ph.D.
Science Advisor to the Secretary of Health and Human Services
Q1. Shared responsibility. In a recent Washington Post article, the Federal preparedness plan was taken to task by local officials as being too oriented toward vaccine and antiviral production infrastructure and not enough for surge capacity and local hospital needs. What can the federal government do in concert with state and local agencies to ensure sufficient food and necessities have been stockpiled locally, and a plan worked out for distribution to the poor and working class families that will allow them to SIP if a pandemic rolls through? How does that schematic help vulnerable families? Also what about a federally mandated moratorium on mortgage payments, credit payments and utilities during a pandemic so that these working poor can afford to stay away from work until it passes? How are vulnerable families going to be supported? And what is happening at the Fed level to assure intra-agency agreement and coordination at the state level (e.g., is the Department of Education pushing state cooperation with public health and homeland security state agencies)?
A1. The recent Washington Post article dealt primarily with assertions that the federal government has not done enough to help healthcare institutions prepare for the surge in patients that is likely to accompany an influenza pandemic - especially if mitigation efforts are not highly effective. The article did not address directly the points that this question appropriately raises.
Before responding to the latter, I feel compelled to note that many of the critics of the federal government's role in healthcare emergency preparedness overlook or downplay the fact that the Department of Health and Human Services (HHS), in response to directions from the President and the Congress, has provided approximately $2 billion dollars in financial assistance since 2002 to all 50 States and 4 major urban areas to help hospitals and other healthcare entities within their jurisdictions enhance surge capacity. Whether the federal role should be bigger or smaller is a legitimate subject for debate. What is disappointing to many of us is that some commentators continue to espouse the unrealistic expectation that the federal government has the fiscal and logistical wherewithal to do everything for everyone. It does not. In fact, as Secretary Leavitt has stressed repeatedly in State Summit meetings with Governors and in numerous other fora, preparedness for pandemic influenza must be a shared responsibility among governments at all levels, the private sector, and individuals. To the extent that potential partners refuse to apply their talents and assets unless the federal government foots the bill, they are abdicating their responsibility and thereby placing their communities at higher risk than need be.
Our citizens have every right to expect that the federal government will continue to play a prominent role in pandemic preparedness; and it will. In particular, HHS will continue to give highest priority to those tasks that it is best positioned or uniquely able to undertake. This includes a) stockpiling prepandemic vaccine and antiviral drugs; b) providing financial and technical assistance to States to help them, among other things, create complementary stockpiles of antiviral drugs and develop and test various mitigation strategies, such as school-closing policies and procedures, to slow and limit the spread of infection; c) creating a domestic vaccine production capacity commensurate with the expected requirements of a pandemic; and d) sponsoring advanced development projects toward the next generation of vaccines, therapeutics, and diagnostics.
Turning to the questions above, I begin with the matter of helping poor and working class families gain access to necessities of daily life during an influenza pandemic. HHS has taken important steps in this regard and will continue to build on those initiatives. In particular, HHS agencies (primarily the Centers for Disease Control and Prevention and the Office of the Assistant Secretary for Public Affairs) have developed and promulgated a suite of checklists and other guidances to help individuals and organizations prepare for an influenza pandemic. These can be found on the HHS-operated website titled Pandemicflu.gov.
For example, if those individuals who have the means and will to create a multi-week stockpile of food, water, and other necessities do so, local entities such as municipal governments, private emergency response organizations (notably, the Red Cross), faith-based organizations, and community organizations will be able to target their assets and services toward those who cannot afford to undertake this level of personal preparedness. In a similar vein, if businesses and other organizations develop and implement realistic plans to continue operations in the face of an influenza pandemic, this will do much to ensure that supply chains for critical goods and services do not collapse. Even degraded supply chains, coupled with well-designed and well-executed local emergency response plans, can do much to help needy citizens maintain access to fundamental goods and services.
With regard to the questions about financial policy interventions such as a moratorium on mortgage payments, I cannot provide definitive answers now. Such matters fall outside the authority of HHS and thus are best addressed by the Department of the Treasury and perhaps others such as the Department of Commerce. My colleagues and I will take the liberty to convey these thoughtful queries to our counterparts in the other Departments and subsequently share their response with you.
With regard to coordination at the State level, HHS is deeply involved. First, since 1999, HHS has provided funding to State and local public health departments to enhance their preparedness for naturally occurring, accidental, or terrorist-induced emergencies. This has included strengthening relationships with public safety and emergency management agencies. Second, since 2002, as cited above, HHS has provided States with funding to foster analogous preparation by hospitals and other healthcare entities.
Third, HHS is leading an effort involving 8 Cabinet Departments of the federal government to help States refine their plans for countering pandemic influenza. The primary focus of our planning guidance, technical assistance, and readiness assessments is help all agencies of State government, not just the health departments, understand what they can do to help mitigate and otherwise counter an influenza pandemic. To be sure, this involves looking inward to do what is necessary to continue their respective operations. But it also involves looking outward to establish and test partnerships with other agencies of state government, local governments, and the private sector - including both for-profit and not-for-profit entities. The doctrine of shared responsibility says that we all are in this together. State-based partnerships are one of the most promising ways to prepare for pandemic influenza.
Q2. Vaccine allocation. If health care workers and first responders as well as emergency personnel are 'top of the list', what about funeral directors and other mass casualty personnel? What about their families? When will the priority allocation scheme be announced? Is implementation a state or federal responsibility?
A2. The working group that was tasked to define a priority order for administration of vaccine to counter an influenza pandemic now is weighing the information received from a second round of public consultation and is updating its earlier draft document to accommodate the most persuasive comments and critiques. The intent is to have a plan suitable for public release within the next several months. Implementation necessarily would be the joint responsibility of the federal government, States, and local governments. The challenge will be to achieve as nearly uniform an implementation as practical while accommodating the reality that every State will have particular needs that are special - even unique - to it.
Looking further ahead, please recognize that vaccine prioritization policy must be a work in progress rather than a one-time decision. Any plan completed and promulgated in the near term necessarily will be subject to reconsideration, revision, and reissuance from time to time as we learn more about the pandemic influenza threat or acquire better means to counter it.
With regard to the relative priority of funeral directors and other mass casualty personnel compared to other occupations or groups of individuals, HHS will not be able to provide a definitive answer until the working group completes its task. However, I am aware that various commenters have stressed the importance of these occupations for an effective response to and recovery from an influenza pandemic; and I feel confident that the working group is giving them due consideration.
In a similar vein, a definitive response on the prioritization of family members of individuals in various high-risk or otherwise critical roles also must await the working group's completion of its task. For now, I note that this issue has been on the minds of many of us from the beginning and continues to elicit a considerable diversity of opinions. Many argue that those who will be protecting and serving the rest of their communities deserve not only immunization for themselves but also the peace of mind that comes from knowing that their loved ones are protected too. Others argue that the biggest mitigation benefit for the community overall will come from directing the earliest lots of vaccine strictly to members of high-risk and other critical groups - thereby protecting them as quickly as the flow of vaccine allows and then covering their family members in accord with where they fall within lower priority categories.
Closely related to this conundrum are the poignant comments of several senior citizens during the public consultations. On the basis of experience with seasonal influenza and the three pandemics of the 20th century, medical experts expect that infants, young children, and elderly individuals would be among those facing the highest mortality risk during the next pandemic. This consideration alone would justify placing elderly individuals within the highest priority strata for immunization. Yet, several senior citizens stated that they willingly would give up their place in line if that would ensure that their grandchildren were protected first. Other seniors go further to include the parents of those grandchildren, arguing that to do otherwise is to risk having a generation of pandemic orphans.
Q3. New vaccine technologies. The bulk of US expenditure on panflu prep has gone to vaccine R&D to private industry. How many years away are we from bulk vaccine production with novel technologies (such as DNA vaccines)? Has HHS been assured the vaccine will become internationally available to rich and poor nations and not nationalized in an emergency?
A3. No one can say with certainty when new technologies such as DNA vaccines will take center stage for influenza vaccine manufacturing. But, from the vantage point of what we know today, I think that most experts would say that it is more than 5 years away.
HHS is committed to accelerating the maturation of DNA vaccines and other emerging technologies. The National Institutes of Health, an HHS agency, has funded important research on DNA vaccines against influenza viruses. And the Office of the Assistant Secretary for Preparedness and Response, part of HHS Headquarters, recently solicited and now is reviewing contract proposals for advanced development of a DNA vaccine. The latter initiative is a critical milestone on the path from the laboratory bench to the manufacturing floor.
HHS also has a strong interest in vaccine adjuvants. These are chemical substances that, we added to vaccine, increase the magnitude and, sometimes, the scope of the immune response. Thus, addition of an adjuvant can have a dose-sparing effect - meaning that protective immunity is achieved with smaller quantities of vaccine than if the adjuvant were absent. Further, addition of an adjuvant may increase cross-protection - meaning that the vaccine elicits an immune response against more strains of influenza virus than if the vaccine were used alone. HHS is funding a variety of advanced development projects involving adjuvanted influenza vaccines; and several manufacturers are pursuing independent efforts.
But we need not and do not place all our hopes on new vaccine technology. One of HHS' highest priorities, in concert with an array of leading pharmaceutical companies, is to enhance and expand US-based production capacity to the point that it can generate 600 million doses of an pandemic influenza vaccine (two doses for every American) within 6 months of the time that a reference strain of the actual pandemic virus is developed. When this initiative began just over two years ago, the US had only a small fraction of this target capacity. Only two domestic manufacturers of approved influenza vaccine existed; and only one of those had a product that was licensed for use in all appropriate age groups. Today, six companies, with HHS funding, are in various stages of implementing commercial scale production with cell culture methods and/or expanding capacity for conventional manufacturing using chicken eggs. The target date for the achieving the 600-million-doses target is 2011. The work is on schedule.
The driving motivation to build the target production capacity within the United States is to ensure that we can provide pandemic influenza vaccine for every American without having to purchase and import it from foreign manufacturers. A condition of HHS' funding for the participating companies is that their manufacturing facilities be located within the United States. At the same time, we hope and expect that these manufacturers, once they have met the needs of the US market, will have opportunities to sell their life-saving products to others around the world. Our current collaborations with the World Health Organization and other international partners are an important step toward creating the mechanisms that will be needed to combat pandemic influenza in a coordinated manner around the globe.
Q4. Antiviral technologies. A frequent question about antivirals are their availability. Right now, most state health departments advise against individual stockpiling. Why is that? Whatever the new medicines, will there be enough, and who will allocate the scarce resources? Will the US continue to make this a state 'unfunded mandate'?
A4. Public health officials advise against individual stockpiling of antiviral drugs for a variety of reasons. The one that I hear most frequently is the concern that many individuals will not hold onto the drugs until an influenza pandemic is upon us but instead will use them for other purposes, probably without contemporaneous direction from a healthcare professional, and probably incorrectly. For example, individuals could be tempted to break into a household cache of antiviral drugs in response to a cough, sniffles, fever, or other symptoms of influenza-like illness during the winter months. Yet, insofar as seasonal influenza is concerned, only about one third of those who experience influenza-like illness are likely to have influenza. Thus, through inappropriate use of the drugs, the individual would incur the adverse-event risks that are associated with the particular pharmaceutical without experiencing an offsetting benefit. Moreover, widespread misuse of antiviral drugs during the normal influenza season could accelerate the emergence of drug-resistant influenza viruses and thus reduce the effectiveness of drug therapy for the annual epidemics.
Several years ago, public health officials raised essentially identical concerns regarding the prospect of household caches of antibiotic drugs as a modality of personal preparedness for a bioterrorism event - say, an attack involving wide-area outdoor release of the bacterium that causes anthrax. In response, HHS' Centers for Disease Control and Prevention tested the concept through a field trial in St. Louis. The study team enrolled over 4,000 households, each of which received in-person counseling and a MedKit containing an appropriate antibiotic for each member. The study team then revisited the households during the succeeding 2 to 8 months to retrieve the MedKits and interview the householders regarding their experiences with and attitudes about home stockpiling. The results of the study are strongly encouraging. They show that, with proper counseling and appropriate packaging of the drugs, well over 90% of the households maintained the package properly and neither misused nor abused the drugs. Moreover, the vast majority of those interviewed was enthusiastic about this aspect of personal preparedness and expressed inclination to purchase such a MedKit if one were come onto the market.
HHS is following up on this encouraging outcome through two parallel initiatives. One seeks to encourage commercialization of antibiotic MedKits. The other seeks to apply the lessons learned with antibiotics to determining how to design an antiviral MedKit and assess its feasibility. Household stockpiling of pharmaceuticals for use during public health emergencies could be an important modality of personal preparedness if we can develop products and approaches that are affordable; easy to obtain, maintain, and use; and consistent with medical and public health principles.
With regard to availability and allocation of antiviral drugs, the strategy that is being played out is as follows. In November 2005, the federal government determined that prepandemic stockpiling of antiviral drugs is essential and proposed a national target of 75 million treatment courses - assuming that, during an influenza pandemic, about 25% of the US population would present for treatment. Further, viewing such stockpiling as appropriate for shared responsibility, the federal government proposed to acquire and stockpile about 60% of the national requirement directly and to look to the States to acquire and stockpile the other 40%. HHS went on to assist the States both administratively and financially - a) by negotiating master contracts with the two pertinent manufacturers to enable States to purchase the drugs efficiently and at a prices well below those that they could negotiate on their own and b) by providing a 25% subsidy for States' purchases through the HHS contracts. Most States have availed themselves of this opportunity, with many of them purchasing the fully subsided amount or more. HHS is hopeful that States will make additional purchases through this mechanism this year.
Each State is responsible for allocating its respective share of the HHS stockpile and its own stockpile, if any. Therefore, as part of their preparedness planning, States need to identify the hospital entities and other healthcare-associated loci where to drugs are to be prepositioned when an influenza pandemic is judged to be imminent. States are not responsible for allocation of antiviral drugs that are held outside the national and State stockpiles - e.g., drugs acquired by businesses or not-for-profit entities for their employees and, possibly, the employees' families. In these instances, allocation is the responsibility of the purchaser. HHS will continue to encourage States, local governments, and private sector entities to share the responsibility for stockpiling antiviral drugs.
Whether this strategy is tantamount to an "unfunded mandate" upon the States is in the eye of the beholder. HHS has committed to providing 60% of each States' estimated treatment requirement; and, for those States taking full advantage of the subsidized purchases, HHS is covering an additional 10% (25% of 40%) - yielding a 70% share. States therefore can provide antiviral drugs for their citizens for 30 cents on the dollar. Some see the offer as being 30% empty. I see it as 70% full.
Q5. Community mitigation. A frequent question that comes up is whether the federal government has doe enough to inform and warn the public about a potential pandemic (H5N1 or other strain). PSAs (public service announcements) have been prepared but rarely shown. How can community mitigation plans locally be supported and implemented without a clear message from the government about the need and the importance of such measures as school student dismissal? What further plans are there for information about pandemics to be given to the public? In this article you suggest low tech plans for home care are good. How will that be supported by HHS and the Federal government (including informing the public of the need)?
A5. Strong, sustained communication about the threat of pandemic influenza and recommended countermeasures is central to preparedness. The challenge is more difficult now than 2 years ago because, for many laypersons, the novelty of the topic seems to have worn off and anxiety seems to have diminished. Nevertheless, the threat remains; and the nation must not let down its guard. H5N1 avian influenza may not become the trigger for the next human influenza pandemic. All of us should hope it isn't. But, if not, history says that, sooner or later, a pandemic influenza virus will spring from some other root.
HHS is committed to continuing its strong role in public communications about seasonal and pandemic influenza. The website Pandemicflu.gov will remain the lynchpin of our messaging machinery. But we recognize that we need multiple modalities to promulgate and reinforce preparedness messages; and we constantly are alert to opportunities to try new approaches and strengthen existing ones. In that regard, we value the new formats and pathways that the Flu Wiki community provides; and we are grateful for the thoughtful recommendations and critiques that have come our way as a result.
I am pleased to see the emphasis on school closing in the question above. Well-timed and well-executed dismissal of students promises to be one of the most effective means for mitigating an influenza pandemic as it reaches each community. Yet the action is much easier to describe than to perform and demands thoroughgoing community-wide planning and testing.
HHS has focused special attention on school closing policies and procedures. Last year, HHS' Center for Disease Control and Prevention provided funding and technical assistance to the States to help them conduct community-level tabletop exercises on this topic. The objective was to bring together representatives of all the pertinent agencies and organizations, as well as members of the general public, to think through how this instrument of mitigation might be shaped and wielded. For many communities, the exercise produced more questions than answers; but they are the right questions in that they make clear why planning is important, what needs to be done to get it right, and who needs to do it. HHS will be alert to future opportunities along this line.
Q6. International cooperation. New WHO databases for viral sharing have been set up by international agreement, and the idea of open source viral sharing has been endorsed by research scientists and international experts. Does the US (CDC, NIH, NAMRU, etc) make all of their viral sequences open source and freely available? If not, why not?
A6. The science agencies of the HHS and other federal government departments are strongly committed to unrestricted sharing of virus isolates and related biological materials. The US is an active partner with the World Health Organization and other member nations in promoting this concept and in seeking remedies for those countries who do not believe their interests are served by this practice. The only instances known to me in which US agencies have not shared samples or sequence information have involved materials restricted by a non-US donor. For example, from time to time, the HHS Centers for Disease Control and Prevention receives material from outside the US with explicit restrictions that limit or preclude further sharing.