<DOC> [109th Congress House Hearings] [From the U.S. Government Printing Office via GPO Access] [DOCID: f:25176.wais] VA'S FLU VACCINATION PROGRAM THURSDAY, DECEMBER 15, 2005 U.S. HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON VETERANS' AFFAIRS, Washington, D.C. The Subcommittee met, pursuant to notice, at 10:05 a.m., in room 334 Cannon House Office Building, Hon. Michael Bilirakis [Chairman of the Subcommittee] presiding. Present: Representatives Bilirakis, Boozman, and Strickland. MR. BILIRAKIS. The hearing will come to order. Good morning. Today's hearing will provide the Subcommittee an opportunity to learn more about the Department of Veterans Affairs (VA) influenza vaccination program. Since the National Response Plan, published by the Department of Homeland Security, is a blueprint for the coordinated efforts of Federal agencies during disasters, the Subcommittee had also intended to hear testimony regarding interagency collaboration, and I underline that for emphasis, interagency collaboration or lack thereof, between VA, the Department of Defense (DoD), the Department of Health and Human Services (HHS), and the Department of Homeland Security, with regards to potential outbreak of a pandemic flu. Unfortunately, it is a busy time of the year, and the Department of Homeland Security's key witness regarding a potential flu pandemic is on travel. I learned yesterday morning that DoD was also unable to send a witness to discuss their role in a possible flu pandemic. The Subcommittee had also requested testimony from the Surgeon General. However, according to HHS, the Surgeon General is not involved in the planning and preparation for a flu pandemic, which I find puzzling since the Surgeon General's duties, I believe, would require him to mobilize, deploy and exert leadership and oversight of the Commission Corps in the event of a pandemic. I would also expect that the Surgeon General's office would be the lead in any national public health education campaign. The Subcommittee will continue to explore this issue. I do have, as you might imagine, serious concerns regarding the level of interagency collaboration and coordination between Federal departments in their ability to adequately respond to a flu pandemic. The need for interagency collaboration and coordination on this issue is a matter that I will be recommending the Committee pursue in a second session of this Congress. Full Committee Chairman Buyer and I serve on the Energy and Commerce Committee, which has jurisdiction over public health issues. Given the cross jurisdiction issues, I'm sure that we will be working with our colleagues and the Energy and Commerce Committee on this important matter. As we are all aware, influenza is highly contagious, spreading through direct contact and aerosol exposure. The virus can also persist for several hours on inanimate objects, such as toys or doorknobs. In addition influenza is infectious before symptoms appear in its victims which enhances the virus's ability to spread. While the virus is usually non-lethal in healthy individuals, it can cause severe medical complications in a hospital environment, especially in an in-patient setting. The complications can severely degrade a sick individual's medical condition and in some cases, cause death. Since VA provides care to millions of older veterans who are considered high risk, this certainly is a serious concern. Over the past several years, there has been widespread discussion in preparation for a potential flu pandemic. As numerous health officials have previously stated, an influenza pandemic is likely at some point in time. My Energy and Commerce Health Committee devoted an entire hearing to this subject some time ago -- historical records suggest that influenza pandemics have occurred periodically for at least four centuries. In the 20th Century alone, there have been three influenza pandemics. The 1918 Spanish flu pandemic killed between 20 and 100 million people worldwide and at least 500,000 in the United States. The 1957 Asian flu pandemic killed about 69,800 people in the United States. The 1968 Hong Kong flu killed about 33,800 people in the United States. In 1997, the H5N1 avian flu emerged in Hong Kong and reemerged in 2003, this virus has caused the greatest concern for the potential of a flu pandemic. According to the VA, which as I understand it, has very good story to tell and I am proud to say, influenza prevention is a public health priority for the Department. On an annual basis, the VA Undersecretary for Health issues a VHA directive that provides policy and implementation guidance in the use of influenza vaccine. The VHA flu directive and VA's flu vaccination coincides with the national vaccination campaign. We are anxious to learn more about VA's annual flu immunization program. As I have said earlier, it is my understanding that the department has been extremely proactive in its efforts to educate and administer a highly successful preventative health campaign, and, again, I commend them for that. I would now like to recognize Ranking Member Mr. Strickland from Ohio. Mr. Strickland. MR. STRICKLAND. Thank you, Mr. Chairman, for holding this hearing. We are all interested in knowing how the Department of Veterans Affairs handles what some may think of as routine and reoccurring function by hearing testimony on VA's annual flu vaccination program. We are also interested in testimony regarding the threat of emerging or reoccurring infectious diseases, and the VA's preparedness to meet such threats, especially the avian flu threat. To call VA's annual flu program routine really does not alert one to the seriousness of the potential threat; and, I think we all realize that. For example, as has been mentioned, the 1918 influenza pandemic, also called the Spanish Flu, killed between 20 and 40 million people worldwide in a one- year period of time. This flu was easily transmitted from person-to-person and had a mortality rate of 2.5 percent, much higher than other influenzas of the day and was particularly deadly for the age group, those between 20 and 40 years of age. This age group is a different group from those usually impacted severely by other strains of influenza. In fact this particular strain of the flu is considered so virulent that the U.S. Department of Health and Human Services has published an interim final rule to add some reconstructed replication competent forms of the 1918 pandemic influenza virus to the list of HHS select agents and toxins. The HHS select list contains biological agents or toxins that could pose a severe threat to public health and safety, to animal and plant health, or animal or plant products. It affects their possession use and transportation. A review of the HHS list finds other select agents, mostly viruses, which will kill humans quickly in horrible and effective ways. Variants of the 1918 Spanish influenza have now joined the ranks of Ebola, Lassa Fever, Marburg, Crimean-Congo and South American Hemorrhagic Fever and the Rift Valley Fever virus. Considering the company that at least one strain of the flu now keeps, we certainly can't think of influenza and our efforts to combat it as routine. Now today we will hear how the VA administers its annual influenza vaccination program. We will hear about the program's problems and successes. We will also hear about resources and methodology for assuring that the flu vaccine need is met. We remember the vaccine shortages of last year, something we do not want to repeat nationally or VA-wide for the upcoming flu season. We hope to also hear about the surveillance and control problems for infectious diseases that are used by VA. Finally, I anticipate we may hear testimony regarding the possible avian flu pandemic. The threat is a real threat that we hope we do not have to face unprepared. I'm interested in how the experts today rank the threat of H5N1 strain of the avian flu. Some experts see similarities between this strain of the avian flu and the Spanish Flu of 1918. We know that viruses do mutate, so the question becomes, is the H5N1 strain of avian influenza a significant threat today as compared with other infectious diseases and will future mutations likely make it more or less of a threat to humans? Our panel of witnesses today contains several distinguished VA experts on infectious diseases and we thank you for being here. Unfortunately, other invited guests were unable to be with us from HHS and DoD. I am sure that they would have provided the perspective of their respective agencies on this general problem had they been here. Perhaps there will be a hearing in the future, Mr. Chairman, when we can invite them to testify before us. To reduce the threat of dangerous viruses, we may isolate, we may vaccinate or treat the problem. We have sometimes, as a nation and as a healthcare community, taken special steps to vaccinate against emerging strains of what was considered a viral agent. For example, in 1976, the U.S. implemented a massive program to vaccinate the nation against the swine flu. The decision to begin the swine flu vaccination program is still questioned from many viewpoints, but the target strain of the swine flu never reappeared after the first case that was found at Fort Dix, New Jersey. But this fact alone does not invalidate the 1976 decision to implement that national vaccination program for swine flu. So I anticipate the VA and this nation's healthcare community will keep one eye firmly fixed on the avian flu, and the other eye scanning the horizon for newly emerging strains or other communicable and deadly agents. We must strike a balance of anticipation for what is the known threat and the anticipation of threats that are not known or anticipated. Where national security and the welfare of this nation's citizens are at stake, we must not let our general and broad-based preparedness lapse because we anticipate a single threat vector. Mr. Chairman, I thank you once again for this hearing, and I thank the witnesses for being here, and I look forward to hearing what they have to share with us. MR. BILIRAKIS. Would the gentleman from Arkansas have an opening statement? MR. BOOZMAN. No, I don't. I just appreciate you and the Ranking Member having this hearing at this time. It certainly is a topic that is so important and really look forward to the testimony. I thank you, sir, and I thank you for making the hearing this morning. MR. BILIRAKIS. So at this time, I would like to recognize our first and only panel. Dr. Lawrence Deyton is Chief Consultant, Public Health, Strategic Health Care Group of the U.S. Department of Veterans Affairs. Dr. Deyton will be accompanied by Victoria Davey, Deputy Chief Consultant, Public Strategic Health Care Group, the U.S. Department of Veterans Affairs. Dr. Robert Muder is the staff physician hospital epidemiologist with the Veterans Affairs of Pittsburgh Health Care System, and Dr. Denise Cardo is director of the Division of Health Care Quality Promotion with the Centers for Disease Control and Prevention (CDC), of HHS. Thank you so very much for taking time to come here and extending us the courtesy of meeting our invitation, and I say invitation, we use these terms a little loosely, and it is a very soft term. But I am always concerned that you are all busy people, as are those who could not be here with us today, and I am always concerned that we have given them adequate notice, because plans are made well in advance sometimes. But once we're satisfied that we have given adequate notice, then it is more than just a invitation, and it should be that way. Your written testimony will be made part of the record. I would ask you to limit your testimony to five minutes if you could, or as close to it as you can, and I would now recognize Dr. Deyton, I suppose will be first. Yes. Dr. Deyton, please proceed. STATEMENTS OF DR. LAWRENCE DEYTON, MSPH, M.D., CHIEF CONSULTANT, PUBLIC HEALTH, STRATEGIC HEALTH CARE GROUP, U.S. DEPARTMENT OF VETERANS AFFAIRS AND VICTORIA DAVEY, RN, MPH, DEPUTY CHIEF CONSULTANT, PUBLIC STRATEGY HEALTH CARE GROUP, U.S. DEPARTMENT OF VETERANS AFFAIRS DR. DEYTON. Thank you very much, Mr. Chairman. MR. BILIRAKIS. Is that mike on? It doesn't look like it is. DR. DEYTON. Now it is. MR. BILIRAKIS. Okay. Now it is. DR. DEYTON. Thank you very much, sir. Mr. Chairman, members of the Committee, we do sincerely appreciate the opportunity to be here today to discuss VA activities related to both the seasonal influenza as well as the pandemic influenza, other infectious disease issues confronting the VA and particularly glad that Dr. Cardo is with us. We work very closely with the CDC and other agencies and look forward to discussing that with you. Mr. Chairman, influenza vaccination is one of the VA's highest priorities in public health. We have established an annual program to promote influenza vaccination that, frankly, Mr. Chairman, is unequaled in effectiveness by any other integrated health care system. The annual VA seasonal influenza vaccination campaign is composed of five interrelated system-wide activities that I will very briefly review. First, as you are already said, the Undersecretary for Health issues an influenza vaccination directive to the entire VA health care system that requires our health care facility directors to implement an annual active influenza vaccination program for both patients and staff. Second, each year the VA launches a systemwide influenza vaccine campaign and distributes an influenza vaccine tool kit to each VA facility with resources to help those facilities organize, promote and carry out their local vaccination programs. Third is VA's timely purchase and distribution of influenza vaccine itself. VA solicits bids for our vaccine supply every January and distributes that supply each fall and winter. Over the past eight years, VA has steadily increased the amount of influenza vaccine purchased by slightly less than a million doses back in 1998, and an estimated 2.4 million doses for this influenza season at a cost of approximately $18.5 million. Fourth, VA provides ongoing guidance to front-line health-care staff during each influenza season. Last year the Undersecretary for Health issued seven separate advisories to our front-line staff between October and February, mostly to deal with the issues related with the shortage that you have already referred to, Mr. Chairman. Already this year, we have issued three advisories to the field. VA's fifth activity, which is key to the success of our influenza vaccination program is that we hold our health-care managers accountable through a VA-wide performance measure on influenza vaccination. The results of our approach to influenza vaccination are better than any other health care organization for which there are data. By our chart review program, VA-wide influenza vaccination rate for veterans age 50 or older, was 75 percent in 2003 season and 75 percent again last year, despite the shortages last year. By a phone survey that we performed, 88 percent of veterans report that they have been vaccinated for influenza. In contrast the CDC phone survey report of adults over the age of 65, and that is a high risk group, much more likely to be vaccinated than those over the age of 50, the CDC survey showed only 68 percent of average citizens were vaccinated in 2003, and 63 percent in 2004. MR. BILIRAKIS. Is that 88 percent or 85 percent, whatever the figure, is that of all veterans or just those that are qualified for treatment at the VA centers, in other words on the list? DR. DEYTON. The 88 percent is of veterans who are eligible for VA care who are over the age of 64. MR. BILIRAKIS. Okay. DR. DEYTON. So the highest risk group that we know that we want to make sure and get vaccinated, because they are at higher risk of complication. MR. BILIRAKIS. Thank you. DR. DEYTON. A survey of the Medicare population, sir, again, over the age of 65, but Medicare population has the advantage of having influenza vaccine covered under Medicare. That survey showed a rate that was nearly identical to the VA rate for those over the age of 50. CDC has also shown that commercial insurance plan influenza vaccination rates for ages 50 to 64 were also only 52 percent in 2003, and it dropped to 28 percent in 2004. Again, that is year, last year, when we had the shortage. So we are proud of the success that VA has had in the seasonal influenza vaccination program. But we constantly are seeking ways to improve it, such as putting emphasis this year on vaccination health care facility staff to make sure they stay healthy and that they don't transmit influenza to their patients. VA also strongly supports the President's proposal currently being considered to create capacity for annual influenza vaccination for every man, woman, and child in this country. Mr. Chairman, let me now turn to pandemic influenza. We don't know when or where pandemic influenza will strike, but based on its history that you reviewed for us, we believe that it will, and because the VA health care facilities are located in all states and nearly every community in the nation, we liken VA to a fine-meshed sieve when it comes to infectious disease and public health threats to our nation. If it happens anywhere in the nation, veterans will be affected and VA facilities will need to be read to respond. VA's pandemic influenza preparedness program is compromised of eight interrelated activities. First, VA's pandemic influenza preparedness is being built on the foundation of our successful seasonal influenza vaccination program which I just described. Second, VA has established a stockpile of the anti-viral drug oseltamivir, or Tamiflu, which may be the only effective human drug against the current strain of influenza that is causing disease in birds and sporadically in humans in Asia. Last fall, the VA stockpiled 5.5 million capsules of this drug oseltamivir for pandemic emergencies which will be distributed only if and when a pandemic might occur. Third, Mr. Chairman, there is a worldwide shortage of this drug, oseltamivir, and VA researchers have initiated a study that may help us extend the effective supply of that drug by co-administration with a drug called probenicid. That is a drug that can slow the elimination of other drugs from the body. Positive study results could have a significant impact on the VA supply as well as the nation's supply of the drug oseltamivir. Fourth, we developed and distributed a Respiratory Infectious Disease Emergency Plan for VA facilities. Based on our experiences with preparation for other recent infectious disease challenges, including Anthrax in 2001, the smallpox vaccination program several years ago, SARS, the influenza vaccine shortages from last years, and now the specter of pandemic influenza. This plan is a resource for VA front-line providers and administrators for preparations, planning and responses needed to assure continued patient care, communication, staffing and facility operations. Fifth, VA has been a full participant, Mr. Chairman, in U.S. Government-wide pandemic influenza planning efforts led by the White House and led by the Department of Health and Human Services. VA also is helping to develop the national pandemic influenza plan being coordinated by the White House from which Federal-agency-specific plans will flow. The national plan is due January 1st of 2006, and the VA plan which is well along in development is due February 1st. Sixth, because even the best plans need to be tested, we will conduct an operational tabletop exercise on pandemic influenza to test the VA plan, and as we would in a pandemic, also test coordination and communication among VA, state and local health officials, and our other Federal agency partners that will need to respond. Seventh, by smart use of the VA's national electronic medical record system, we hope to provide realtime surveillance in reporting of illness suggestive of influenza if a pandemic looms. The President's budget request on pandemic influenza preparedness, now pending before Congress included resources to allow the VA to do realtime reporting of influenza syndromic activity directly to the centers for disease control, as part of a system already being built to improve VA surveillance of health-care-associated infections. Finally, Mr. Chairman, we have developed and we actively promote a national education campaign called "Infection, Don't Pass It On,'' to engage VA staff, VA patients and visitors to any of our medical centers around the country in preventing transmission of infection because even in the absence of an affective vaccine or supplies of antiviral medicines, there is something each of us can do to limit the impact of a pandemic influenza. Common sense approaches that our mothers and grandmothers all taught us really do work. Wash your hands frequently. Cover your coughs and sneezes. If you are sick, stay at home so you don't infect other people. This campaign, "Infection: Don't Pass It On,'' uses over a hundred educational posters and other materials and is actively promoted across the VA health care system and is used in some local, state and private health care organizations. DoD health care providers use this, and other countries have adopted the VA plan, including Wales and Australia. Mr. Chairman, around us are some posters from that campaign as an example of the kinds of materials that we have available. In summary, VA has a successful program for seasonal influenza vaccination and has begun to apply that approach to prepare for a possible pandemic influenza. I assure you, Mr. Chairman, VA will continue to protect our veterans, our employees, and the VA health care system against seasonal influenza and to build strong defense against pandemic influenza as we fully implement the national strategy outlined by the President. VA will be there for veterans who rely on us for their health care. This concludes my statement. We are happy to answer any questions you have, sir, and, again, thank you very much for this opportunity. MR. BILIRAKIS. Thank you, Doctor. [The statement of Dr. Deyton appears on p. 23] MR. BILIRAKIS. Ms. Davey, is there any brief comments you would like to make at this point, brief, of course, but at the same time you have taken time to be here? MS. DAVEY. Thank you, no, nothing. MR. BILIRAKIS. No? All right. Dr. Muder, you are on, sir. STATEMENT OF ROBERT MUDER, M.D., STAFF PHYSICIAN, VETERANS' AFFAIRS PITTSBURGH HEALTH CARE SYSTEM, U.S. DEPARTMENT OF VETERANS AFFAIRS DR. MUDER. Mr. Chairman, members of the Committee, thank you for inviting me here. My invitation came somewhat late, so as your staff know, I did not submit written testimony. At the VA Pittsburgh Health Care Center, I am the hospital epidemiologist which means I am in charge of preventing infection transmission in our hospital. Under the direction and encouragement of VA central office, we have a multi-faceted approach toward combating influenza in our health care system which consists of three separate campuses. We have a very aggressive immunization program, directed at getting the vaccine to our veterans. It consists of reminders both by mail and by telephone. Through the months of October through December, we run a walk-in influenza clinic for our patients. We actively promote receipt of influenza during regular clinic visits, and we have a program to immunize essentially all of our long-term care residents. In addition we have a very good success in getting our employees immunized. Seventy-five percent of our employees have received the flu vaccine so far this year, including 95 percent of our direct care givers in our long-term care facility. We also have a program to identify cases of influenza rapidly, both presenting from the community and occurring in an epidemic fashion or long- term care facility. This involves regular communication with our local health department for documentation of influenza activity in our community, rapid influenza antigen testing, and this year, we are going to be able to back that up through a collaboration with the University of Pittsburgh to get rapid molecular confirmation through PCR testing at the University of Pittsburgh virology lab. We have a plan which we actually have used several times in past years to combat influenza outbreaks in our long-term care facility, which may occur despite near universal immunization, and this involves isolation, exclusion of sick employees, and providing influenza prophylactic drugs to our patients at risk. We have actually done this five times in the 20 years since I have been working at the VA. In addition to our influenza activities, we have a number of innovative approaches to infection control and the spread of other infectious diseases within the hospital which are really one of the most significant risks that a hospital patient undergoes. Four years ago, we entered into a collaborative agreement with the Centers for Disease Control and the Pittsburgh Regional Health Care Initiative, which is a group of hospitals, employers and insurers in Western Pennsylvania, to pilot a control program for Methicillin Resistant Staph or MRSA, which has historically been the number one hospital-acquired pathogen in our facility. This involved bringing industrial engineering processes to bear on solving the problem. It included increasing staph education and awareness of the consequences of MRSA infection, the means of transmission, and the approaches necessary to prevent transmission, and also included removing those barriers to hand hygiene and isolation. This included identifying patients with surveillance cultures from MRSA on admission, immediately isolating patients, developing a computerized system to notify the wards each day of patients who needed to be in isolation, providing appropriate hand sanitizer, isolation equipment for staph and monitoring their usage. We initially started this in Fiscal Year 2001, on a general surgical unit. Within two years, we had experienced a 75 percent decrease in MRSA infection on that unit. We then applied this to our surgical intensive care unit, and within one year, had a similar reduction in the rate of MRSA infection. Starting this past fall, we initiated a comprehensive MRSA control program throughout our facility which included all units in both the acute and long-term care facility. We are doing surveillance cultures on all patients. We are putting those patients in isolation, providing staff with the training and equipment that they need in order to isolate these patients effectively. We continue to have the collaboration and support of the CDC and the Pittsburgh Regional Health Care Initiative. In addition our hospital administration has been very, very supportive in addition to actively promoting this. They have actually enlisted our hospital in a community-wide effort, under the auspices of the CDC and the Allegheny County Health Department to make this a regional initiative. They have also invited the directors of our VISN to Pittsburgh for a meeting in which we presented this program to the directors of our VISN and are continuing to promote this as a potential VISN-wide initiative, and we have had a great increase and a great deal of interest from a number of the hospitals within our VISN, who have contacted us to get additional information in terms of the particulars of the program, the results and the resources necessary to recreate our experience in their hospitals. MR. BILIRAKIS. Thank you very much, Doctor. Dr. Cardo. Is that correct? Did I pronounce that correctly? DR. CARDO. Yes, you did. MR. BILIRAKIS. Okay. STATEMENT OF DENISE CARDO, M.D., DIRECTOR, DIVISION OF HEALTHCARE QUALITY PROMOTION CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES DR. CARDO. Good morning and thank you for the invitation to testify on influenza pandemic planning. CDC and other agencies are working together to prepare the United States for this potential threat to our nation. In order for an influenza virus to cause a pandemic, it must first be a virus to which there is little or no preexisting immunity in the human population. Second, the virus must be able to cause illness in humans, and third, have the ability for sustaining person-to-person transmission. So far the H5N1 virus circulating Asia meets the first and two criteria, but not yet the third. In the current H5N1 outbreaks in Asia since January 2004, 138 human cases have been confirmed by the WHO. These cases have resulted in 71 deaths, a fatality rate of around 50 percent. We cannot predict the severity and impact of an influenza pandemic, whether from H5N1 virus currently circulating in Asia, in Europe or the emergency of another influenza virus of pandemic potential. However, modeling studies that a medium-level pandemic could result in 89 to 170,000 death. A more severe pandemic, as happened in 1918, could have a much greater impact. There are several important points to note about pandemic, about influenza. First, pandemics happen. There were three during the past century. Second, the capacity to intervene and control the spread of the virus, once it gains the ability for sustain person-to-person transmission, will be extremely limited. An outbreak anywhere in the world increases the risk everywhere. Third, H5N1 avian influenza strain that is circulating in Asia among birds, is currently considered the leading candidate to cause the next pandemic. However, it is possible that another influenza virus which could originate anywhere in the world, could cause the next pandemic. This uncertainty is one reason we need ongoing laboratory surveillance on influenza viruses that affect humans. And, fourth, because early detection means having more time to respond, it is critical for the United States to collaborate with domestic and global partners to expand any strength the scope of early warning surveillance activities. In the United States, the HHS pandemic influenza plan is a blueprint for pandemic influenza preparedness and response and provides guidance to national, state and local policymakers in health departments with the goal of achieving a national state of readiness and quick response. Among CDC's roles in preparation for a pandemic, we are working to ensure that states have sufficient epidemiologic and laboratory capacity, both to identify new viruses throughout the year and to sustain surveillance during a pandemic. We are improving our reporting systems so that influenza information needed to make public health decision is available quickly, and we are enhancing monitoring of resistance to current antiviral drugs, to guide policy to their use. Another aspect of preparedness and one with which I work directly involves the health care system. Health care facilities, including those in the VA, need to be prepared for the potential rapid pace and changing characteristics of a pandemic. With input from our partners, CDC has developed guidance that provides health care facilities with recommendations for developing plans to respond to an influenza pandemic and guidance on the use of appropriate infection control measures to prevent transmission during patient care. Tabletop exercises have identified gaps and provided recommendations for health care facilities to improve their readiness to respond. In conclusion, although much as been accomplished, more preparation is needed for a possible human influenza pandemic. As the President mentioned during the announcement of his national strategy for pandemic influenza, our first line of defense is early detection. CDC is closely monitoring the international situation in collaboration with WHO, current affected countries, and other partners. We are using our extensive networks of partners to enhance pandemic influenza planning. And, lastly, the national response to the animal domestic influenza seasons provides a core foundation for how the nation will face and address pandemic influenza. Thank you for the opportunity to share this information with you, and I am happy to answer any questions. [The statement of Dr. Denise Cardo appears on p. 33] MR. BILIRAKIS. Thank you, Doctor. I would tell you all at the outset that obviously our time to ask questions of you is limited, but there are many questions that we have of you and many of those will be submitted to you in writing by the staffs. Hopefully you would respond to them in a timely fashion, because we are here, after all, to help you, so to speak, to do the job. Dr. Deyton, you mentioned a VA research study that might help with antiviral treatment for a pandemic influenza. Will you tell us more about that without using, hopefully, all of my five minutes? DR. DEYTON. Yes, sir. I think you refer to our study of the combination of the drug oseltamivir with a drug called probenicid. Probenicid is an old drug that has been around a long time, sir, that is actually a generic drug, that we have observed has a property that it slows down the excretion or metabolism of other drugs that I might take. And so by giving that drug with the drug, oseltamivir, we might effectively stretch the limited supply that we have of that drug. So VA has now initiated that study. It has been approved by the FDA. It has been approved by VA for funding. We expect to start in a few weeks, where we will study the combination of those two drugs to see the blood level of the drug, oseltamivir, and hopefully the results will demonstrate if we can use that drug to effectively extend our nation's supply of oseltamivir which is in a limited worldwide shortage. MR. BILIRAKIS. Now tell me, I have always been curious about research and concerned about overlap, although I realize a lot of overlap just necessarily has to take place. Is your research coordinated, let's say, with CDC, DoD, HHS, et cetera? DR. DEYTON. The research study itself involves probably less than 100 patients. We can do it interior to the VA, pretty quickly and pretty easily. We have got a pretty vigorous research program. Obviously we have communicated with CDC, DoD and other agencies that we are doing this research, and we, fortunately, received lots of encouragement to move ahead rapidly. I get a call about every other week from staff at CDC and HHS and DoD, about the status of that research project, because if there the results are positive, it is going to help all of us. MR. BILIRAKIS. So CDC is sort of depending upon and looking to the VA to sort of continue on with this research so that it can be helpful, well, not only just to the veterans or the VA, but to all Americans, is that right, or everything in the world actually? Is that correct, Doctor? DR. CARDO. Yes, and I think that is the beauty of the collaboration. We work very closely with the VA when we're developing recommendations. A lot of the research that is being done at the VA can help us then to review and revise some national policies. I think MRSA is a very nice example. We started the collaboration with a local VA, and we saw major improvement in the prevention of MRSA. Now it is a CDC recommendation, and we are expanding our collaboration, not just for more VA hospitals, but for the whole region in Pennsylvania. So I think that is the beauty of the collaboration, and we agree with your initial points, Mr. Chairman, that the only way we will be able to fight the pandemic is really working together and learning from each other. MR. BILIRAKIS. Well, is CDC basically, if anybody in effect is in charge, because you have DoD, HHS, and VA, et cetera, so if anybody is in charge to determine this collaboration and coordination, is it CDC? DR. CARDO. HHS is responsible for the health piece of the plan. The President is responsible for the whole response, and there are several activities related to public health. They are related to CDC. Some of the research related to pandemic evolve not just from CDC, but NIH and other groups, but there are lots of groups that are looking at that and working together, so not just CDC, but HHS. We are really looking at all the pieces with research. MR. BILIRAKIS. I just hope that they are working together as much as you say that they are. That is why we intended to have the other agency departments here. In terms of sufficient stockpiles, VA has their stockpiles. DoD has their stockpiles, et cetera. Who is responsible? Are they just responsible for their own stockpiles? Someone has to be in charge to determine whether there are adequate stockpiles and where they are located, so that one group can maybe use the other stockpiles if needed? DR. DEYTON. Very good question, sir, particularly as we are planning for the possibility of a pandemic. There are limited supplies of the drug oseltamivir, which may be useful. There is very limited supplies of vaccine for a possible pandemic influenza. So the national plan is being developed specifically to articulate those kinds of issues. Each agency has different stockpiles. There is the strategic national stockpile which CDC operates for the whole nation, mostly to distribute to states and Federal health care systems. VA and DoD also have established some stockpile of the drug oseltamivir, and what the plan will be doing, and again the national plan is due to be released January 1st, will be articulating how the coordination of whatever supply we have will be used when we need it. Dr. Cardo may have another point. DR. CARDO. No, I agree 100 percent with what you said. One example of how we collaborated with the VA during the shortage of influenza vaccine illustrates the collaboration. The VA has its own vaccine supply and it had enough for their population, and donated vaccines to CDC to be used for additional needs. Most of the things we predicted that may happen, may be different. So I think the communication not just at the national level, but also at the local levels have been extremely important to facilitate the collaboration. I just want to highlight again that the stockpiles for both antiviral drugs and vaccines are currently limited in comparison to the potential needs. MR. BILIRAKIS. Thank you. I know my time is long over. Mr. Strickland. MR. STRICKLAND. Thank you, Mr. Chairman. I have been interested in your questions about collaboration and coordination, because it seems to me with the government, being as big as it is, and these agencies, being as complicated as they seem to be to me, that it is really important that there be some way to make sure that all agencies understand what is being done by various other parts of our government and I would just hope that is happening. I have a couple of questions about this oseltamivir. How long does it take to get a larger supply of this? You say it has been around a while and it is kind of a generic, is that correct, and you are finding that it may have this beneficial effect. DR. DEYTON. Yes, sir. The drug oseltamivir is an antiviral drug that may be effective against this avian flu, this pandemic flu, that may be circulating. The drug that we are studying to give in combination with the oseltamivir is called probenicid, and that is the drug, sir, that is a generic drug and it has been around a long time. MR. STRICKLAND. Now do you have an adequate supply of that drug? DR. DEYTON. Good question. First, we don't know if it is really going to be effective in doing what we hope it will. If it is effective, then I think certainly everybody will be interested in making sure we have an adequate supply to give in combination with the drug oseltamivir. It is a drug which is -- I am not a chemist -- but I understand is relatively easy to make, and so I would expect, particularly the manufacturer of the drug, oseltamivir, would be very interested in making sure that there was enough probenicid. Certainly the strategic national stockpile, I am sure, would be very invested in making sure that there was enough oseltamivir to give in combination to make maximal use for the public. And I bet you the Generic Manufacturer's Association would be very interested in ramping up a supply of that drug, and quite frankly, if there is inadequate supply, the various agencies of the Federal Government would roll up our sleeves and make it ourselves probably. We have that capability. MR. STRICKLAND. Now when you talk about a stockpile, do these drugs degrade overtime? When you place a drug in a stockpile, how long is it likely to be effective or does it have to be continuously replaced? DR. DEYTON. We manage stockpiles very aggressively, in fact, to make sure the drugs that are in stockpile are active and they haven't expired. So there is a routine of rotation and replacement of drugs that might be coming close to their expiration date. And that is how we manage all stockpiles, and CDC manages the strategic national stockpile in exactly that fashion, and there are smart people who understand logistics that have tracked expiration dates and make sure they are rotating older drugs out and replacing them with new drugs. Vicky, did you want to add? MS. DAVEY. Fortunately, the shelf life of oseltamivir is quite long. It is at least five years. MR. STRICKLAND. Great. Dr. Deyton, you had described using resources to make sure that staff was vaccinated and appropriate vaccinations took place of your patient population and so on, the hope being that you could prevent illness and perhaps save lives, but also save resources and save money. That just seems to make common sense -- but I am wondering if you have collected any data to support the beneficial effects of what you have tried to do. DR. DEYTON. There is a considerable amount of literature and research studies and data that do demonstrate that the more people get influenza vaccination, the less illness there is both from influenza, other respiratory infections, cardiac disease and other diagnoses. So there are lots of literature on that, some of it actually has been done by VA researcher. Dr. Kristin Nichol is part of our system and she has done a lot of the work here. CDC has sponsored really most of this research. There is very good evidence that that is the direction to go, which is why we take so seriously the influenza vaccination because in the VA system, obviously, we care for a group of veterans who, on average, are older, and have other chronic medical conditions. So the more veterans who use our system that can be vaccinated, the better everybody is, certainly the individual veterans and their families. And as you say, sir, also the whole VA system. That is also why we are taking very seriously making sure our staff do a better job of getting vaccinated. We saw last year with the shortage, we saw staff that were actually sort of stepping back and saying, "No, I'll hold off and not be vaccinated because let's save this vaccine for our veterans.'' Well, that is penny wise and pound foolish, and so we are working on making sure the penetration of vaccination among our staff gets better and betters. So the kind of results like Dr. Muder told us about is very exciting, that we want to make sure and learn from that and replicate that across the system. MR. STRICKLAND. Mr. Chairman, I just had one more question for Dr. Muder. Dr. Muder, you take care of a lot of my constituents, because I represent the Southern Ohio border, and a lot of my constituents come to your hospital, and I have been there to visit. I have always been incredibly impressed by the Pittsburgh VA facilities, but you described for us what you are doing, and its beneficial effects. But I am wondering if the model that you are using is unique to your facility because of what exists in Pittsburgh and you talked about collaboration with the University and so on. Can the model that you have described be easily implemented in your judgment across the VA system, or is it something that is unique to your particular circumstances? DR. MUDER. I think that much of what we do can actually be implemented throughout the VA. We are very fortunate. We are on the University campus. Our physicians are faculty members. We have lots of resources at our disposal in terms of expertise, but many of the things that we do, I think, are things that don't necessarily require that level of expertise. I think they require the determination of the people in the individual facilities to do it. One example would be our MRSA initiative. We have actually gotten a lot of inquiries from other VAs in our VISN who are seriously considered doing it, and they range in complexity from the Philadelphia VA, which is very similar to ours, the Butler VA which is essentially a rural long-term-care facility. Things like immunizing people, you know, doing surveillance for infectious diseases, providing isolation practices, really don't require a university faculty to do it. I think there are things that perhaps we all should be doing, things that can be done in the community, and I think the thing that what it takes is actually the knowledge and a little bit of resources, but I think the resources necessary are not overwhelming and are well within the capability of most medical centers. And in fact, again, I am speaking for myself and not for the VA as an institution, but I think there is ample evidence that comes both from the CDC, from the VA and the private sector that efforts to decrease infection through immunization or through appropriate infection control, really are very, very cost effective, and they are highly effective at preventing illness and death. So, for example, some estimates of MRSA infection depending on whether it is a soft tissue infection or a bacteremia, range from 10,000 to 30,000 dollars per episode, so that you don't have to prevent a lot of illness to really recoup your investment in terms of personnel or laboratory supplies or immunization supplies. And I think we have been very fortunate and our administration understands this, and I think that they understand that this is an important thing to do from appropriateness of medical care and also from a cost- effectiveness standpoint. MR. STRICKLAND. Thank you. Thank you, Mr. Chairman. MR. BILIRAKIS. Thank you, sir. Mr. Boozman to inquire? MR. BOOZMAN. Thank you, Mr. Chairman. I want to compliment you all. It sounds like you have a great story to tell and are well on the way to being very, very prepared and certainly, you will support you in any way we can in helping you to get further prepared. I just have a couple kind of curious questions. Your role is such that in the VA, you know, certainly we have the function of providing for the VA family. And then also in the role of a disaster, you kind of kick into another gear. If we had a full-blown, 1918-type situation, how do you prioritize? Do the VA, do they give first priority, or at that point is it you declare something else, and is it just kind of first come, first serve, or -- DR. DEYTON. It really depends upon what is going on and what the President has said and whatever the governor has said. So certainly the VA priority always is to deliver high-quality health care to our veterans. Our second priority, congressionally mandated priority, is also to back up the Department of Defense health care system. So that is our second priority. Our third priority is obviously to be there for the nation when any disaster hits. So if the President invokes the Stafford Act, and there is a Presidentially-declared emergency, each VA actually is delegated authority to do what they think is the best thing to do for both the veterans if there is DoD health care, as well as the communities in which they reside. And so since you can't say that what is going to work in the Pittsburgh area is going to be exactly what is going to work in, say, Southern California, you do want each individual VA facility to have the authority to respond in whatever way is necessary for what's going on there. MR. BOOZMAN. And then I guess hopefully, in our modeling exercises, that that is part of what goes on. How about the other things? I know we talked about Tamiflu and this is a respiratory disease. Are we adequately stocked with the other things that you need to fight this kind of situation? You know if you had a 1918 or I guess the important thing with this is, is that is also a great exercise. In getting ready for this, we are also getting ready for a biological attack or a nuclear attack or whatever to some extent. So, again, are we looking at, I hope in our modeling, are we looking at being able to have adequate supplies of the other -- DR. DEYTON. Yes, sir. That certainly is a factor that is being built into the tabletop exercises and the modelings. It is hard to know exactly what to respond to until it starts to happen and what you are really going to need. But we already have learned from the activities that we have done. For example, the plan that we are putting in place in the VA system, that we are building, again, flowing from the national strategy and the national plan for pandemic influenza, we are actually modeling after what we did for smallpox. It is not that different. And so we have all developed a lot of expertise in the kind of systemwide responses that have to be put in place, all the resources that have to be brought to bear. How do you ensure staff are adequate and are protected to come in and do their job, the facilities stay open, the housecleaning continues on, the cafeteria workers continue. They are all serious and very important aspects of preparation. The stockpile issue is one of many. Do we have enough antibiotics, enough IV fluids and things like that? MR. BOOZMAN. Very good. Thank you. MR. BILIRAKIS. Thanks, gentleman. Dr. Deyton, let me ask you very quickly, all veterans are eligible for the flu shot? DR. DEYTON. Veterans who are eligible and enrolled for VA care can come to any VA facility -- MR. BILIRAKIS. But only those veterans. Not veterans -- I don't have a purple card, for instance. Forget about being a member of Congress. Am I eligible for it? DR. DEYTON. If you have not enrolled for VA health care, VA can't take care of you until you do. But veterans who have not yet enrolled for eligibility, I would encourage -- MR. BILIRAKIS. Well, but for a veteran that doesn't qualify under our criteria, they have not enrolled for VA health care, therefore that veteran is not going to be eligible to walk into the VA. In other words, these posters, which are great posters, are used where? In the VA facility? DR. DEYTON. Yes, sir. MR. BILIRAKIS. Okay. DR. DEYTON. I am proud to say, sir, that they have been adopted by many other private health care providers, DoD, Australia, Wales, et cetera. But these, what you see here, are taken from VA facilities. MR. BILIRAKIS. So the veterans post, VFW, American Legion, et cetera, et cetera, something like this would not be posted in their facility, because many of those people do not have the purple card and consequently would not be able to get the flu shot? DR. DEYTON. Well, two responses, sir. VA has legal authority to deliver care to eligible veterans. I can't give health care to veterans who aren't eligible and enrolled for VA health care. However, you raised another point. I should probably, as soon as I get back to the office, call the VFW and the American Legion and start distributing these posters to them because in fact I don't care how veterans get the message as long as they get the message. All veterans should be seeking a flu shot, be it from the VA if they are eligible enrolled, from their private provider, from their public health clinic, from their state health department, wherever they can get the flu shot, because we think it is going to be good for all of them. MR. BILIRAKIS. Good. All right, I would suggest that you do that because that is all part of the game here, and they could be as just susceptible to serious illness as anyone else as a result of the flu. DR. DEYTON. Absolutely. For example, we know data. I mean we study this intensively because we are so concerned about it. We know that last year and the year before, 45 percent of veterans who did get a flu shot, got their flu shot outside of the VA. So of those veterans who could come to the VA, 45 percent of them got their shots -- MR. BILIRAKIS. Well, they are not expensive. I know my son is an internist, and they are far from expensive. In fact, a heck a lot of more, but more expense than the reimbursement would be for giving them. DR. DEYTON. Right. MR. BILIRAKIS. Well, I don't know, it would be less than $15, I think, isn't it? Something like that. DR. DEYTON. What is the question? MR. BILIRAKIS. Do you know, Dr. Cardo, the reimbursement to a physician who gives a flu shot? Do you know the Medicare reimbursement, for instance? DR. CARDO. No, I don't have that information. MR. BILIRAKIS. It is such a ridiculous -- does anybody in the audience know? It is such a ridiculously low figure. DR. CARDO. It seems it is about 18. MR. BILIRAKIS. 18? All right. DR. DEYTON. But, Mr. Chairman, you have raised a very, very, I think important and interesting point, and that has to do with the demand for influenza vaccination, which has been, quite frankly, from an infectious disease point of view, from a public point of view, the demand has not been anywhere close to what it should be. All of us at this table, I hope all of you up there, also, will really work hard to promote the importance of influenza vaccination for the public. It is a -- I forgot who asked the question -- but it is a good preventive tool. It works at what it is supposed to do. It decreases respiratory infections. It decreases hospitalizations and we all need to get behind it and let the public know that this is good preventive practice. It is not as valued as it should be, and I think all of us would want to work out ways for VA, for CDC, for the Congress, for the President, all, to get behind a major national campaign of influenza vaccination. DR. DEYTON. I can tell Dr. Cardo wants to say something. MR. BILIRAKIS. Dr. Cardo. DR. CARDO. Thank you. I just wanted to take this opportunity to highlight the importance of vaccination, flu vaccination, and also some of the strategies that they are doing at the VA to promote hand hygiene and respiratory hygiene. While we know that the stockpiles may not contain enough antiviral medications currently, and we don't yet have a vaccine for potential pandemic virus, we know that there are several strategies that we can take right now that can help us, not just with the flu season, but also in preparing for a possible pandemic. I think those are strategies that we see that the VA is doing, such strategies that we really encourage all health care facilities to do, and I think the communication piece that the VA has is something that CDC is using also to help other facilities to promote those strategies. I think it is important. MR. BILIRAKIS. We have newsletters. Of course, we have curtailed those greatly, as a result of people saying we are using taxpayers' dollars to promote ourselves or whatever; but our newsletters, theoretically, goes into every household, and in our congressional districts, it would be a great way to do it. MR. STRICKLAND. Mr. Chairman, I became a believer last year. Because of the shortage, I was over with the physician's office, and they offered me a shot, and I said, you know, there is a shortage. And so I chose not to take it. And I was sicker last year than I have been in maybe the last 20 years. It was an incredible experience. So no one had to convince me this year that this was an appropriate thing to do. MR. BILIRAKIS. I am allergic to eggs, and so I haven't been taking it. I remember I took one many, many years ago, and I got sick. I got the flu. I commended the VA, because my staff have been reading through materials and doing their research and whatnot, they assured me that the VA was doing a good job and I meant that. There are gaps. I know the big problem that I found in 24 years, next year will be my 24th and last year here, is turf. That is part of the problem of not being able to get some of these people here. It is turf fights and things of that nature. I know. Then you have the bureaucracy and the organizational charts. If there are ways that you think that the Congress can be helpful to fill in some of those gaps and to take care of some of the problems that are a result of turf and jurisdictional fights, so please don't hesitate to let us know. In the meantime, we thank you so very much, and I know we have learned a lot. There aren't many of us here, but this is a small Subcommittee. So I think there are only a couple of people missing as a matter of fact. Thanks. Thanks so much and, again, we will be submitting a number of questions to you. Thank you very much for coming. DR. DEYTON. Thank you, Mr. Chairman. MR. BILIRAKIS. Hearing is adjourned. [Whereupon, at 11:17 a.m., the hearing was adjourned.]