Bill Frist

Mr. FRIST

Mr. FRIST. I ask the period of morning business be extended for 3 hours under the earlier parameters.

Mr. FRIST

Mr. FRIST. Mr. President, the time has come--as it does at the conclusion of every Congress--to honor those members who will be departing from this body. This is a task not easily done. The Senate is one of the highest pinnacles in public service to our nation. Those who serve here have often dedicated their lives--and with great success--to changing America for better. Today I wish to honor two Senators who have indeed changed America for the better--Phil Gramm and my fellow Tennessean and partner in the Senate for the last eight years, Fred Thompson. Senator Gramm began his service in Congress as a House Democrat in 1978. Five years later he switched parties. But rather than serve out his term as a Republican, he resigned his seat and let the people of his district choose whether they wanted to be represented by a Republican. Well, they did, and Phil Gramm became not only the first Republican in history to represent the 6th district of Texas, but the only member of Congress in the 20th century to resign and then win re- election as a member of another party. Phil and I share the same commitment to being a citizen legislator . . . to bringing professional expertise to public service. In Phil's case, he's an economist, a college professor, and a public health expert, and his legislative accomplishments reflect that experience. He's been a staunch proponent of tax relief, economic growth, and a balanced budget. And the Gramm-Rudman Act stands as one of the most groundbreaking pieces of budget legislation in the second half of the 20th century. Fred Thompson has been a dear friend for many years and great partner with whom to work on behalf of the people of Tennessee in the United States Senate. Fred was elected in 1994 to fill 2 years of an unexpired term. He was then reelected in 1996. And just as he did in Hollywood, he rapidly rose to become a star in the Senate. In 1997, Fred was elected chairman of the Governmental Affairs Committee, making him one of the most junior Senators in history to serve as chairman of a major Senate committee. As chairman, he held hearings on issues such as improving the federal regulatory process; reforming the IRS; exploring ways to eliminate waste, fraud, and abuse in government; and a number of national security issues, including the proliferation of weapons of mass destruction and missile technologies. Senator Thompson has also been a member of the Finance Committee--one of the most influential committees in the Senate. From that position, he has focused on reducing taxes, reforming the tax code to make it simpler and fairer, and restoring the Social Security and Medicare programs to long-term solvency. Though Fred has served eight years in the Senate, the scale and number of his accomplishments would lead one think he has spent an entire career in this chamber. Phil Gramm and Fred Thompson will be missed by each and every one of their Senate colleagues. For me it has been an honor, a privilege and a pleasure to work with them both. They have brought to the Senate a rare combination of intellect, charisma, political skill and, above all, a steadfast commitment to principle. And for that they will also be missed by the American people.

Mr. FRIST

Mr. FRIST. Madam President, I will quote a couple paragraphs from each. The first is from Dr. Neal Halsey, who is profiled in the article in the New York Times and who is characterized as being concerned about the Thimerosal threat. Dr. Halsey heads up the Johns Hopkins University Institute for Vaccine Safety, and he wrote saying that this story absolutely misrepresents my opinion on this issue. . . .There is no ``threat'' as thimerosal has been removed from vaccines used in children. The headline, the press release issued prior to publication, and the caption are inappropriate. I do not (and never did) believe that any vaccine causes autism. He continues: I stated to the author on at least two occasions that the scientific evidence does not suggest-- Does not suggest-- any causal association between vaccines and autism and he reaffirmed that the article would reflect my opinion. Unfortunately, the title implies the opposite opinion. He concludes: The general public and parents of children with autism have been misled by the title of this article and the news release. . . .I encourage interested readers to review my scientific publications and to read objective reviews of this and other vaccine safety issues conducted by the Institute of Medicine. The second letter is from Dr. Samuel Katz, Professor and Chairman Emeritus at the Department of Pediatrics at the Duke University School of Medicine. Dr. Katz writes: As one of the two authors of the July 7 joint PHS/AAP 1999 statement that you cite in your article . . . it is appropriate that several misconceptions in your article be rectified. . . .we chose to recommend the removal of Thimerosal, not because there was any evidence of its toxicity to vaccine recipients, but to enhance public confidence in vaccines. To the credit of the pharmaceutical industry, within 1 year all vaccines for children were free of Thimerosal. Dr. Katz concludes: Despite the absence of Thimerosal from these products over the past two years, there has been no decrease, in fact an alleged increase, in the incidence of autism among our childhood population--strongly suggesting other factors involved in its ideology. Regrettably, this exemplifies another issue where the best-intentioned actions have served to benefit no one other than the liability lawyers who feed on events of this sort as sharks in bloodied waters. The final statement is from Every Child by Two, the Rosalynn Carter- Betty Bumpers Campaign for Early Childhood Immunizations in a statement released today: Most importantly, we are concerned that the Senate may be inadvertently fueling fears that vaccines cause autism. In fact, well-respected studies concluded that the evidence is inadequate. Much research is available to support these conclusions. Madam President, the third claim--and I will be brief on the third claim--we have heard on the floor from the advocates of the Lieberman amendment, which I encourage my colleagues to oppose, is that the vaccine provisions do not belong in the homeland security bill. I would argue just to the contrary. If we do not have a stable manufacturing base for vaccines, there is absolutely no way we can prepare our communities and our Nation in the event there is a biological warfare attack on our soil. We talk a lot about smallpox, and we all know today we are inadequately protected because today we are inadequately vaccinated against smallpox. We cannot destroy the manufacturing base for our vaccines today. We started with 12 vaccine companies in this country, companies that made vaccines. In large part because of the liability issue, the number of companies making vaccines has decreased to four vaccine manufacturers in the world. Only two vaccine manufacturers are in this country, and at the same time, the National Institutes of Health is embarking upon a new initiatives to develop a vaccine for botulinum toxin, a major initiative on their part. If we vote to strike these provisions, we are putting at risk our manufacturing base which we absolutely must have to be a prepared Nation. Vaccine development cannot be ramped up quickly because manufacturing is a highly complex process. These important provisions further stabilize the vaccine supply system, and thus, are key to our ability to establish appropriate homeland security. Those are the three claims we have heard over the last 2 to 3 days. I encourage my colleagues to look at earlier statements on what the vaccine provisions are specifically. I urge my colleagues to vote against the Lieberman amendment tomorrow and to move forward on this important homeland security bill.

Mr. FRIST. Madam President, I rise to address a homeland security issue that we will be voting on tomorrow morning. Specifically, I would like to discuss the Lieberman amendment. This amendment strips out certain provisions which Senator Lieberman and other proponents of the provision believe are unrelated to the underlying homeland security bill. More specifically, I want to address the issue of vaccines. There are three claims that have been made by the proponents of the Lieberman amendment, as they relate to the vaccine provisions. For my colleagues who were not on the floor Friday, I refer them to some of my underlying comments on the policy of the homeland security bill and the vaccine provisions which I mentioned on the floor Friday. This afternoon, what I would like to do specifically is examine these three claims. First, the proponents of the Lieberman bill say that the underlying vaccine provisions in the bill remove individual rights to sue. Their second claim is that Thimerosal, contained in vaccines, causes autism. The third claim I would like to refute is that these vaccine provisions do not belong in the homeland security bill. Claim No. 1: The proponents of the Lieberman amendment say the vaccine provisions remove individual rights to sue. They are saying these provisions are an example of Republicans fronting for special interests; that they take away individual rights to sue and provide legal immunity from liability for vaccine makers. My response is that these provisions do nothing more than require injuries that are related, or allegedly related, to a vaccine to first proceed through the Vaccine Injury Compensation Program (VIC program). The VIC program was very specifically established in the mid-1980s for all injuries that are allegedly related to a vaccine. Since the mid-1980s, all such injuries alleged to be caused by a vaccine are collected and channeled quickly and appropriately first through this Vaccine Injury Compensation Program. A no-fault, efficient alternative to our tort system; very quickly. That requirement is law today. The provisions that are in the underlying homeland security bill simply restate and clarify what that law is and what that law does. If there is an alleged vaccine-related injury, you first go to the Vaccine Injury Compensation Program. After a period of time, whether or not the program decides in your favor, whether or not there is what you regard as adequate compensation, at the end of that program, you can simply state that you still want to go to court. Whatever that program decides, you are free to go to court. You are free to sue, and there are no caps in terms of liability. The provisions in this bill take away no one's right to sue. The provisions in the underlying homeland security bill provide no immunity from liability. A little perspective: There are currently about 875 cases alleging injury due to the presence of a preservative called Thimerosal that is no longer used in vaccines. Right now, these 875 cases are in front of the Vaccine Injury Compensation Program, consistent with the law since the 1980s. These cases are in no way affected by the provisions in the homeland security bill. I want to repeat that. These 875 cases that are in the Vaccine Injury Compensation Program are being dealt with in an orderly process that was outlined several months ago, and they are in no way affected by the provisions in the underlying bill. If individuals are unsatisfied with what the Vaccine Injury Compensation Program decides, at the end of it, you can say: Forget what you have concluded from me; I am going straight to court. Anyone can do that today, and one can still do that with the provisions of this bill. The only people who are really affected by the language in this underlying homeland security bill are the trial lawyers who are trying to circumvent the very law this body passed in the mid-1980s--a law which has worked very well since that point in time. The trial lawyers basically are trying to create a loophole in the current law. The provisions in the underlying homeland security bill state very simply that you first go to the Vaccine Injury Compensation Program, and for good reason. After which, you can still go to court and sue with no caps or no limits. Claim No. 2--and this one probably bothers me as much as any because it is twisting medical science. I am not sure exactly what the reasons are, but this claim is Thimerosal-containing vaccines cause autism. Additionally, proponents claim that Thimerosal as an additive in a vaccine has a causal relationship to the autism, a disease with increasing incidence. The incidence of autism is increasing. We do not know why, and that is why it is important for us to conduct the appropriate research. There has been a lot of misrepresentation about the various vaccine provisions in the bill, but this one really irks me the most. It is grandstanding which crosses the line because it is not what science says. It is not what the medical community says. It is not what medical science in the broadest sense says. In fact, it is the exact opposite of what the Institute of Medicine has said. Last week on the floor one of my colleagues said these provisions in the underlying homeland security bill--saying why they must be stricken--said specifically: Liability protection for pharmaceutical companies that actually make mercury-based vaccine preservatives that actually have caused autism in children. . . . That is scientifically wrong. Science does not validate it. Let me tell you what science says. I quote the October 2001 Institute of Medicine record. The report is called ``Thimerosal-Containing Vaccines and Neurodevelopmental Disorders.'' That report concluded: The hypothesis that Thimerosal exposure through the recommended childhood immunization schedule has caused neurodevelopmental disorders is not supported by clinical or experimental evidence. The argument that is being used in support of the Lieberman amendment as the reason to support stripping these provisions is based on a false premise, a totally false premise, according to medical science today. What bothers me about it, and the reason this bothers me more than any of the other three claims, is probably because it scares parents. It says vaccines are going to hurt your children, and that demagoguery is going to mean these parents are not going to let their children get these childhood vaccines. These vaccines fight diseases that have caused pandemics and epidemics, diseases that will kill children if we do not make the vaccines available. Epidemics will occur, and death will ensue. I challenge my colleagues to go to the American Academy of Pediatrics and to the Institute of Medicine and ask that question: Does Thimerosal, according to the scientific literature, cause autism? The answer is no. A number of the people on the floor have also held up a New York Times magazine article quoting it as further proof that the preservative Thimerosal causes autism. I do not want to spend a lot of time on it, but I do want to read what the people who are quoted in the article are saying. I ask unanimous consent that two letters be printed in the Record.

Mr. FRIST. Less than 15 minutes.

Mr. FRIST. Madam President, I ask unanimous consent to speak in morning business, if that is necessary.

Mr. FRIST

Mr. FRIST. Mr. President, I would be happy to yield, although I felt I was--

Mr. FRIST. Mr. President, I sought recognition first.

Mr. FRIST. Mr. President, I will yield 10 minutes to the Senator from New York. Is that enough time?

Mr. FRIST. I will read from a statement by Dr. Timothy Doran, testifying on behalf of AAP, to the Health, Education, Labor and Pensions Committee earlier this year on behalf of the American Academy of Pediatrics, relating to these provisions. He testified it was crucial: to preserve and strengthen the liability protections for consumers, manufacturers and physicians through the Vaccine Injury Compensation Program. The VICP has been an integral part of maintaining the vaccine market. Enacted in the last 1980's with the support and guidance of the American Academy of Pediatrics the VICP has helped to stabilize what was then and appears again to be a fragile vaccine market. We reiterate our strong support that all claims for vaccine- related injury or death must be filed first with the VICP. We appreciate the intent of the legislative proposal put forth by Sen. Frist and others to craft appropriate modifications as necessary to ensure that the VICP is working to its full potential. Those are the provisions in the underlying bill. That is exactly what is in the homeland security legislation that would be stripped out by the Lieberman amendment. The effect of these provisions in this bill is important because of the new era of bioterrorism, not knowing the direction the world is moving, recognizing we are unprotected today from smallpox. We now have a tremendous initiative by the administration, the private sector, and the public sector. We have better coordination and better public health infrastructure, better communication, better coordination. But at the end of the day, if smallpox is in your community and you know it, you know where to go, that is good, but unless you have a health care provider to put it on your arm, you are not protected. We do not know when it will hit again. The fact the Advisory Commission on Childhood Vaccines endorses these provisions is important. The fact that the American Academy of Pediatrics endorses these provisions is also important. This shows they are not just pulled out or from a single company or they have not been thought through by both trial lawyers and patients and families and providers. We have heard the claims that these are not relevant to the underlying bill. But at the end of the day, in this world where we are at risk from bioterrorism, germs, viruses, I guarantee, based on everything I know and everything I have read, it is critical we increase our protection for these agents. That is what the underlying bill does. The liability protections are important for health care providers. I argue, also, for the facilities where they are administered and the manufacturers. If we allow out-of-control lawsuits to drive people out of the business of making these vaccines, no matter how good our research is, we will not be able to make vaccines which are critically important. We started with 12 companies and we are now down to 4 companies in the United States who make the vaccines. We have no guarantee they will stay in the business. They are unlikely to stay in the business if the huge lawsuits hit them in a way that simply is not favorably judged. The provisions in the underlying bill only restate the original intent of Congress. They restate current law that individuals claiming injury for covered vaccines must first file for compensation under the vaccine injury compensation program, the VICP. These sections state what really should be obvious. A vaccine itself is the sum total of all of its parts as determined by our Food and Drug Administration, and that the manufacturers of vaccines include those who contribute to each of these various components. We have the vaccine, the components, the manufacturers who make the vaccine, and also the people who make the components. Nothing in this language takes away one's right to sue. These provisions simply clarify and restate current law which requires all claims of injury related to a vaccine covered by the compensation program must first go through the compensation program before a lawsuit can be filed. There is much more that needs to be done, I believe in a more comprehensive way, but these provisions take the first step in a timely way, when time certainly matters. In the long run, it is critical to expand the vaccine market for a whole range of microorganisms we are not protected from. We need to provide greater access to their vaccines. We need to be able to look the parents in the eye and say, when you take your child to the doctor or the public health center, those children, as well as all Americans, are not going to be in some way turned away by a barrier that we failed to address in the Senate. That is why a vaccine provision is necessary, is necessary now, is necessary in this homeland security bill. I yield the floor.

Mr. FRIST. In part it says: These claims have been filed against vaccine companies and, in some instances, against health care providers. Thimerosal, as you know, is approved for use by the Food and Drug Administration and is part of the vaccine formulation when licensed; hence clarification is needed to direct these claims to the VICP before tort remedies can be pursued. That is what the underlying bill does. That is what the Lieberman amendment strips out. The American Academy of Pediatrics also wrote in support of this. I'll quote a final sentence from this letter of June 19, 2002: The AAP has reviewed S. 2053 and has the following comments beginning first and foremost with our strong support that all claims for vaccine-related injury or death first must be filed with the VICP. In addition, we concur with the ACCV's most recent recommendations in support of sections 204, 215, 216, 217 and 220. I ask unanimous consent to print the letter in the Record.

Mr. FRIST. Mr. President, I rise to speak in opposition to the Lieberman amendment and will spend a little bit of time over the next probably 30 minutes going to the substance of what this amendment does, talking policy, but also talking to the impact that passing the Lieberman amendment would have on our homeland security. The bottom line is that I believe striking the provisions, which is what the Lieberman amendment does--it pulls out certain provisions from the underlying bill--will put the people of our Nation at greater risk, when we are talking about homeland security and safety and protection of individuals, of families, of children. That is a broad statement. It is a bold statement for me to make. But over the next several minutes I want to give you the substance of it. A lot of people have said these provisions having to do with vaccines and smallpox are one-company provisions. The second argument is that in some way these provisions cut off the rights of individuals to go to court. We have heard statements by the proponents that one agent, one preservative, causes autism and thus in some way the underlying bill will hurt families with children with autism. As a scientist, as a physician, as someone who is very familiar with the provisions that were placed in the homeland security bill, I have a certain obligation to walk my colleagues and the American people who are listening through what the Lieberman provision would do by stripping out the smallpox provisions, by stripping out the vaccine provisions. Let me begin by saying we are a nation at risk. We are at risk from nuclear weapons and from chemical weapons; we know. But when it really comes to what could potentially happen to our homeland--remember this is homeland defense that we are talking about--I would argue that the greatest risk for a weapon of mass destruction to be microorganisms, to be anthrax, which terrorized the Nation, when we don't even think, we don't know, we don't think it was used by a State, or the introduction of smallpox, which we know is a weapon of mass destruction, if introduced into a population that is unprepared, that has not been vaccinated. Vaccine is the front line for people at risk from anthrax. It is the front line for people at risk from smallpox. That means your children. That means your spouse. That means your grandparents. That means your family. So we must not do anything and the Lieberman amendment would do this--to increase the barrier for you to be protected. Iraq has been mentioned. Most of my colleagues know that Iraq had one of the most robust biological weapons programs in the history of the world. It loaded anthrax, it loaded botulism toxin on missiles during the gulf war, inserted it into the warheads of these missiles. We don't know about smallpox. We didn't know that refrigerators had been found in Iraq that said ``smallpox'' across them, but we do know this robust biological weapons program is the foundation for a program of weapons of mass destruction. The interesting thing about these microorganisms, these viruses, these bacteria, is that you don't have to have a big ship out there to send in a missile. We know that once you put smallpox in a society, it will travel through our schools, it will travel through our businesses and through our homes, and the only defense we have--the only defense, in terms of a medical treatment, is that vaccine. That is why, when we talk vaccines and when we talk smallpox, it is incumbent upon us to have those provisions in this bill. I will begin with smallpox because it is the one that, a week from now, can be a problem. What about right now, or tomorrow morning, if we hear of three or four smallpox cases in the country? What actually happens at that standpoint? Smallpox is a disease that is one of the most deadly infectious diseases. There is a 30-percent chance, to anybody who gets it, that they are going to die. If three people are here, one of those three will die if they get smallpox. What is the treatment? The only treatment--real treatment--is to get that vaccine on your arm within 3 days. Some people say 4 days. I personally think it is 3. Some say 5 to 10, but if your child has smallpox, not from when the manifestations start appearing but from the time of actual contact, and that entails having a vaccine out there-- say 300 million doses, because we know smallpox in an unprotected population, which we are, knows no barriers. Right now, if I had smallpox lesions within my mouth, people around these four or five desks probably would already be infected. The only protection is the vaccine itself. The only treatment for smallpox--and this isn't true with all biological agents, but the only treatment is the vaccine within 3 days. The administration has a policy, that I agree with, that basically is, if there is an outbreak, or a case, you can inoculate people in that area. That is a great policy. We don't need to mass-vaccinate everybody. What about right now? People listening, saying we are a nation at risk--Iraq has had biological weapons programs. We know Saddam Hussein is a mass killer, a serial killer, who kills his own people and other people. He hates the United States. We know the most powerful weapon of mass destruction is smallpox, and we know there is a refrigerator sitting there that has ``smallpox'' written on it. What if I wanted to get the vaccine now, just in case? Right now, you cannot get it. I argue that you should be able to get it. But that is not yet the policy of the United States. I think with informed consent, knowing the side effects and knowing what the advantages could be-- lifesaving--weighing the relative risk--what about if a case breaks out in the Northwest, say Oregon, tomorrow? If you wanted to get the vaccine and you live in Nashville, TN, you could not get it. We ought to change that. That is not what we are talking about today, but you see that vaccines are a front line for homeland security. I don't know what is going to happen in Iraq; none of us knows. If we come back and deal with this 6 months from now, or a year from now, or 2 years from now, we are inadequately protecting the American people. I don't want to overstate it, but that is my belief. If smallpox hits here, right now, we are inadequately protected. The Lieberman legislation would strip out a provision, within 2 days or 3 days or 4 days, that would make us more adequately protected as a nation. The threat of liability--this is where the other vaccine provisions are important--should not become a barrier to the protection of the American people. I will repeat that. The threat of liability should not become a barrier to the protection of the American people. Then you go back to the question, What is this threat of liability? I will boil it down and use smallpox as an example. Smallpox can hit here tomorrow or in 30 days or in 60 days from now or in 90 days or maybe never. We all pray it never hits. We have 300 million doses of vaccine. It is not all licensed yet, but it is good vaccine and I have utmost confidence in it. It is a risky vaccine. The childhood vaccines we use, which we are inoculated with--even the anthrax vaccine that potentially has certain side effects--if you look at these, I put smallpox among the most risky because we know the side effects are that about 1 in a million people would die. If you vaccinated 300 million people, about 300 would die. Ten times that number would have serious side effects-- maybe encephalitis or many others that are life threatening. As a matter of fact, probably 30, 40 times that many would have a bad rash, many of which would cause hospitalization. So it is a vaccine, in medical terms, with more potential side effects than others. What would you say if there were an outbreak tomorrow? You would call in nurses and public health officials, and pediatricians and other doctors, and you would say, as part of the American response to bioterrorism and the use of bioterrorist agents or microorganisms as weapons of mass destruction, you need to get this vaccine to as many people as you can within 3 days. It could be maybe 100 or maybe 1,000, or 10,000; and in a city such as New York, it could be a million easily within 3 days. Okay, you have the vaccine. You have willing health care providers. I think of myself as a physician. Everybody could be mobilized to do that. You are basically saying, as American policy: You need to give that vaccine. It has side effects, but we are not going to protect you in the event there is a side effect--death or encephalitis. We are not going to protect you in any shape or form, although you are fulfilling the mandate and the policy, the emergency response of the American people. Why would they not do that? Because of the lack of protection from skyrocketing lawsuits. I have a great fear--and I don't want to say I know for sure, but I have a fear in talking to health care providers and to the nurses who recognize, given that vaccine is important to life saving, but at the same time is subjected to these unlimited lawsuits with punitive damages--they just might say: I cannot subject myself to giving a thousand of those doses, even looking at the statistics. That is the problem, that is why the smallpox provision has to be in there. We have had so many people make all these statements, but nobody has been to the substance. The bill extends the Federal Tort Claims Act-- the FTCA--protection to any person, such as a doctor, or a pediatrician, or a nurse, or somebody who is qualified to be giving that inoculation, lifesaving inoculation, in your arm. It provides them a protection of the Federal Tort Claims Act. What is important there--people say if that is the case, you cannot sue. Well, that is simply not true. It basically says that the Federal Government is going to be on your side and will defend you in any lawsuit and the Federal Government will pay the damages. It does not deny adequate, just, fair compensation if there is a side effect, but what it does do is you are going to have somebody behind you; namely, the Federal Government, to pay you damages. It does say you go to Federal court. People say Federal courts cannot do this. In truth, we all know Federal courts can do that. It is important to point out that in Federal court, the rules that are actually used are going to be applicable to that State or according to State law. Thus, you can still sue, but the Federal Government pays. A lot of people say you should be able to punish anybody--punish that nurse who put that vaccine in your arm--so let's have punitive damages on top of compensation. The underlying bill says you get adequate, just, fair compensation. You are defended by the Federal Government and they will pay you, but there is no punitive damages component, which makes sense because, remember, that nurse is putting that inoculation on your arm to save your life under a plan put forward by our Government, probably in response to an emergency. Over time, I think we need much more balance in terms of the overall provisions. It was not my idea, although I support these provisions strongly, to take these specific provisions out and to put them into the bill. So over time, we need to develop a more comprehensive policy to make sure we have both a full range of vaccines developed, that we have appropriate countermeasures, and if somebody is harmed by a vaccine, there is fair compensation. We need to come back and visit this in a more comprehensive way as we go forward. I will add, though, there is some sense of urgency to this given the threats today. The issue of what is front line is important because the use of germs, microorganisms, and bacteria is new to the American people as weapons of mass destruction. It is causing us to say we understand nuclear weapons, gas, but what about these organisms that can wind their way through a society? What is the front line? That is why vaccines are absolutely important because they become the front line, and that is why we address vaccines in the homeland security bill, especially since we are at risk today. One cannot turn on a television or read a newspaper without learning of this enhanced risk, this higher risk. Let me back out of this broader issue of vaccine. Smallpox is one case. It happens to be a virus. What about the plague which wiped out a third of Europe? What about anthrax? We have an old vaccine. The vaccine has to be administered over and over, so we need newer vaccine developed for anthrax. What about Ebola? About 3 months ago, the National Institutes of Health said in their response to bioterrorism that one of its major priorities is going to be the development of a vaccine for the Ebola virus. That makes sense because we know that other states in their offensive biological weapons programs--and there are 12 offensive biological weapons programs outside the United States; people need to know that--there has been a linkage of smallpox with the Ebola virus. We know Ebola has a 90-percent mortality rate; smallpox has a 30- percent mortality rate. We should at least be thinking of a front line there which means a new vaccine. NIH said 4 months ago--and most people do not even know it--has as one of their major initiatives development of an Ebola vaccine. Why? Because intelligence tell us people have attempted to link viruses. Thus, we need to have an effective response system in terms of the development of vaccine. Research is good. NIH is doing research. But unless we have manufacturers in the field manufacturing vaccines, we can have the greatest research in the world and know how to do it, but unless we can produce it and produce it quickly, the know-how does not do us any good because we are not going to be able to develop the vaccine to put on your arm and protect you from the Ebola virus. There are provisions in this bill that provide smallpox as a microcosm, but in the macro sense, there are other vaccines. Every year--and the distinguished Presiding Officer knows this--we hear about these shortages of vaccines about every 6 months. People ask: Why are there these shortages? It is multifactorial, and we have to address that. One of the issues we know is this unlimited liability. Think back to the smallpox vaccine. It is put on your arm, and you have a bad side effect. Somebody is going to sue for that side effect. There are no protections today. In the same sense, the manufacturers, the pharmaceutical companies, which is very popular for people to beat upon aggressively these days, the manufacturing companies, the pharmaceutical companies are the only ones that can make the smallpox vaccine, the front line for that weapon of mass destruction, for the Ebola virus. We can, through NIH, promote the research, but only a manufacturing firm, a pharmaceutical firm can make the Ebola vaccine. There used to be in the eighties 12 pharmaceutical companies making vaccines. Then it dwindled to 10, then to 8, then to 7, then to 6, then to 5, and there are now only 4 vaccine manufacturers licensed to sell vaccines in the United States, and only two of these are American companies. Why is that the case? Why would they stand out totally exposed for making a medicine that is lifesaving, yes, but one that with one lawsuit can wipe out their whole development process, their whole manufacturing process today? That is an issue that has to be developed, and the urgency of it is the fact we are a nation at risk from biological agents, and there are 12 states that have offensive biological weapons programs, and we are today unprotected. On the liability issue, people have said one preservative causes autism. They mentioned this on the floor. That is just wrong. The Institute of Medicine has made it very clear that there is no established causal relationship between that preservative and autism. I will and others need to go back and look at the data, but the Institute of Medicine has basically said that to date. We need more research. I was one of the primary authors of the autism research bill. We need to look at it again. I want to assure families in the country that those statements made on the floor of the Senate are wrong. There is nothing in the underlying bill that slows down research for autism or just compensation, if there is an association between autism and a certain preservative. It is interesting, with these vaccines being sort of inherently risky, with the risk of liability costs driven up so high because it is easy--it is not easy, but we can have lawyers coming in and starting these lawsuits. In the 1980s, this body started the Vaccine Injury Compensation Program. They did this through the National Children's Vaccine Injury Act. It was passed in 1986, I believe. The whole purpose of this program is to provide injured patients compensation while attempting to control litigation, based on the recognition that vaccines will always be an easy target because they have inherent side effects and everybody gets vaccines--everybody in this body has been vaccinated. Everybody listening hopefully has been vaccinated. We all depend on those vaccines. That at the end of the day, since everybody gets it and there are certain side effects, that if you want to make a lot of money you can go out and start getting these people and start creating these lawsuits. That is why in the mid-1980s we said we have to put all of this together and look at it in a reasoned way, a way that is efficient, a way that is fair to people broadly. The vaccine injury compensation program is essentially a no-fault alternative to the traditional tort system in this whole area of vaccines. It has been a key component of stabilizing the vaccine market, of not driving even those last four companies--or the last two in this country--out of making vaccines. It has a streamlined process. It puts down a less adversarial alternative so not everybody is going to court and spending weeks, months, and in some cases years trying to have their cases actually looked at. It encourages research and development of new and safer vaccines, and it provides the appropriate liability protection to that nurse who is putting that inoculation, that vaccine, in your arm, as well as the health care providers, the facilities, and the manufacturers. What is in the underlying bill is a narrow set of provisions that were actually taken from a bill that I have studied for the last 3 years and that I introduced this Congress, that should eventually be passed in this comprehensive form, but the provisions have been taken out and included in the underlying bill I feel strongly about and I will continue to talk to my colleagues about them individually as they understand why those provisions were included. I will say that the provisions that are in the bill are far narrower than what I think we actually need to do to have this balance in our liability system so we can continue to develop vaccines to protect our children, the current generation. In the event there is a bioterror attack a week from now, a month from now, a year from now, we will be adequately prepared. The Lieberman proposal would strike these sections that are in the underlying bill. And all of them merely restate to some extent what was intended by Congress. This is a clarification, a restatement. In 1986, when it passed the bill, the underlying bill called the National Children's Vaccine Injury Act, what that act did was to create an administrative mechanism by which those children who have a serious side effect from a vaccine can receive compensation without ever having to prove in court a vaccine caused their particular injury. So you do not have to go to court. You can go to this new administrative body. There are a handful of people who do not believe in vaccines. They just say all vaccines are bad. Most know that they are invaluable and have spared our children from many of the diseases that haunt us. Thus, when you have that which we all really fully understand today, that they are a protection for our children, plus this new threat of bioterror, that is why you link it to homeland security and that is why it is important in this bill. We know we must preserve that manufacturing base so with the research that is done, yes, by the pharmaceutical companies, but also maybe even more importantly by the NIH, we can actually manufacture those vaccines. Section 171 clarifies that the components and ingredients of a vaccine listed in the vaccine's product license application and label are not contaminants or adulterants. Importantly, the advisory committee, from which all of this essentially was taken, is an advisory committee called the Advisory Commission on Childhood Vaccines. They unanimously concur with this particular provision. The next section, section 1716, adds a definition of ``vaccine'' to the Public Health Service Act since that term was not defined at all in the initial legislation back in 1986. This section states the obvious--that the term ``vaccine'' includes all components and ingredients listed in the vaccine's product license application and product label. Again, the Advisory Commission on Childhood Vaccines recommended the appropriate modification which is a part of the underlying homeland security bill, again, which the Lieberman amendment would strip out. Sections 1715 and 1716 restate the original intent of the law that a vaccine is all the ingredients and components in the product which are approved by the FDA. This is an important one because there have been some allegations that all this was stuck in for a single company. The fact is that there are presently more than 150 of these lawsuits against the four vaccine manufacturers, as well as pediatricians, children's hospitals, state health departments and other healthcare providers. From my comments, one can see that it is not a single company. We are talking about a huge issue that reflects back to the protection of our families and our Nation. Section 1714 clarifies that the term ``manufacturer,'' under the VICP, includes any corporation, organization, or institution that manufactures, imports, processes or distributes any vaccine on the vaccine injury table, including any component or ingredient of such vaccine. The Advisory Commission on Childhood Vaccines, again, an independent body making specific recommendations--it is composed, by the way, of trial lawyers, medical providers, and injured parties-- unanimously supported this provision. This provision restates Congressional intent to ensure that any lawsuit alleging vaccine- related injury or death follow the same process and groundrules regardless of whether it is against the final manufacturer, a physician or hospital, or a component or ingredient manufacturer and addresses those lawsuits seeking to circumvent the Vaccine Injury Compensation Program. I also want to point out that these provisions are supported by the American Academy of Pediatrics, and I will talk more about that in a minute. I want to run through a couple of other specific ones, again because nobody has really talked to the substance underlying what this amendment would mean. The congressional intent very much was to encompass the manufacturers of component materials of vaccines in the definition of ``vaccine manufacturer,'' and these provisions--what they do is clarify this intent. They restate the congressional intent as part of the Vaccine Injury Compensation Act. The courts are presently correctly ruling that these amendments--what they are doing is part of that congressional intent. The courts have correctly rejected the contention that a component or ingredient of an FDA-approved vaccine can also be considered substitute an adulterant or contaminant. Among these decisions, the court charged with adjudicating the vaccine injury compensation program recently concluded that the language and legislative history of the National Children's Vaccine Injury Act demonstrated that claims relating to components of covered vaccines are plainly subject to the act. As to the misconceptions that have been presented on the floor, No. 1, these provisions do not prevent patients from suing in court. The statement has been made that it takes away rights. It does not. It does not prevent patients from suing in court. Instead it merely requires, as is required under current law, claimants must first go through the compensation program designed in the 1980s which has worked effectively but does need to be modified, as is being carried out in these provisions. They maintain their right to pursue a court case. One can go through that program itself, the administrative program, in a timely way. If someone does not agree with the compensation that they put forward, they can go to court. I will say that without this clarification, litigation outside the program--and that is what is happening today--will continue and the supply of vaccines could well be jeopardized as we have these huge lawsuits. One lawsuit today is $30 billion. That is what they are looking for in one lawsuit, $30 billion. The whole vaccine industry is only $5 billion. There are about 150 of these lawsuits out there today. Those who desire to bring litigation outside the compensation program will continue to sue the manufacturers of components of vaccines and ultimately that is going to result in the manufacturers of the products themselves simply walking away and not making vaccines and getting out of the vaccine business. Then who is going to make the vaccine for the Ebola virus, which our Federal Government, through intelligence, has identified as one of the six agents of which we are at risk, one of the six agents against which other nations have had offensive biological weapons programs. If litigation continues against component manufacturers outside of the vaccine injury compensation program, those companies that make the components simply are going to be unnecessary to provide the vaccine or those people who make FDA-approved components and give them to the vaccine manufacturers will stop making those components. We saw that in the mid-1990s when raw material suppliers refused to sell the necessary components to the medical device manufacturers. People just stopped making materials there because of this fear of litigation. Ultimately there it took an act of Congress to protect those component manufacturers, the people making the pieces that go, for example, into a pacemaker or, in this case, it would be a component of the vaccine. It took an act of Congress to prevent a shortage back then of pacemakers and of other vital medical devices. These provisions that are in the underlying bill have been unanimously supported by the Advisory Commission on Childhood Vaccines. As I mentioned, that includes injured patients, trial lawyers, and an expert group of patients as well. They have been endorsed by the American Academy of Pediatrics. I ask unanimous consent to have a portion of letters from the Advisory Commission on Childhood Vaccines and the American Academy of Pediatrics printed in the Record.

Mr. FRIST. Normal procedure would be to turn to me?

Mr. FRIST

Mr. FRIST. Madam President, the Senate has been a unique institution since its inception. We take great pride in our deliberative nature. Debate may take time, but it is time well spent. It is always better to pursue the right--rather than the rushed--course of action. This style of governance has served the American people well for more than two centuries. This does not mean the Senate is not a dynamic body. It is full of the same vibrancy that marks this great experiment called American democracy. For within this Chamber have echoed some of the most lively and spirited debates in our Nation's history. And outside this Chamber as well--in committee rooms and caucus meetings and other public forums. On Friday the Senate lost one of its most animated Members in Paul Wellstone. He was a proverbial ``true believer.'' Conviction was not something about which he simply spoke at opportune moments; he showed it time and again with his unabated enthusiasm for being a United States Senator. Paul Wellstone's beliefs rose from a deep and impenetrable well of principle. Indeed, Paul was a proud and unabashed voice for liberalism. His votes often landed him not only on the other side of Republicans, but on the other side of his fellow Democrats, as well. He was a man who simply did not blink in the face of political pressure. He stared it down without regard to price. Even if you did not agree with him, you admired him and the courage he so frequently displayed. I saw this first hand on the Health, Education, Labor and Pensions Committee. There Paul and I served together on the Subcommittee on Public Health and the Subcommittee on Children and Families. We shared a common concern for the health of women and children and the mentally ill. He spoke out often on their behalf. He fought hard for them. And his passion for their well-being will be missed. Paul Wellstone was one of a kind. We were blessed to have him, his wife, Sheila, and his daughter, Marcia, as members of the Senate family. And the people of Minnesota and the United States were blessed to have him in their service. May we keep Paul and Sheila's sons and grandchildren and the families of all those who lost loved ones in our thoughts and prayers in the coming weeks.

Mr. FRIST

Mr. FRIST. Mr. President, I am pleased to speak today on behalf of the Health Care Safety Net Amendments Act, which passed the House of Representatives by a wide margin earlier this week. I urge my colleagues to support this critical bill. This legislation represents an important next step towards improving the quality and availability of health care services for our nation's uninsured and medically underserved. This critical legislation strengthens our Nation's health care safety net and is vital to helping millions of uninsured Americans get the health care they need. Far too many Americans lack health insurance today. We must tackle this problem head on to reduce the number of people who are not receiving care. This bill takes important steps to expand access to care and responds to the challenges providers, particularly our community health centers, face. The Health Care Safety Net Amendments Act reauthorizes the Consolidated Health Center program, the National Health Service Corps and the rural health outreach and telehealth grant programs, and establishes the Healthy Communities Access Program. Together, these programs represent our first line of defense in providing health care to the nation's uninsured and underserved. The bill increases funding for these programs, expands access to health centers, improves existing health infrastructures and takes steps to improve the recruitment and retention of health professionals in underserved areas. A key component of the bill is an increase in funding for the Consolidated Health Centers program, providing more than $1.3 billion for this program. This increase further demonstrates the commitment to this program, which today serves more than 9 million people each year. This is critical to achieving President Bush's goal of doubling the number of community health centers across America. In 1996, the Health Centers Consolidation Act reauthorized the community health centers, the migrant health centers, health centers for the homeless, and health centers for residents of public housing until 2001. Today, our nation's health centers face difficult environmental and operational challenges. Not only do they serve a significant number of uninsured and increasing numbers of immigrants, but health centers are also affected by aging facilities and difficulties in recruitment, retention, and retraining of health center leadership. Today's legislation responds to those difficulties in order to reinforce the important work being done by our Nation's health centers. The bill also expands and strengthens the National Health Service Corps, a program that has placed over 20,000 health care providers in health professional shortage areas in the last 30 years. Presently, over 4 million people currently receive care from National Health Service Corps clinicians. However, to help communities meet their basic health care needs, more clinicians are needed in these areas. The legislation improves recruitment and retention of health care professionals through expanded use of scholarship and loan repayment programs and added flexibility for local communities. Finally, data indicates that uninsured individuals receive most of their care from private health care providers and that private hospitals bear over 60 percent of the costs of uncompensated care; and private, office-based physicians provide more than 75 percent of the ambulatory care for uninsured patients with Medicaid coverage. Given this, today's bill takes into account safety net providers other than those supported by Consolidated Health Centers and the National Health Service Corp, such as local hospitals and emergency room departments, public health departments, home health agencies, and many other health care organizations, through the establishment of the Healthy Communities Access Program that seeks to integrate all of the safety net providers within a community. I appreciate the hard work and dedication to this issue among my colleagues, including Senators Kennedy, Gregg and Bond and Representatives Tauzin, Dingell, Bilirakis and Brown. I also appreciate the hard work of my staff, Shana Christrup, Craig Burton and Dean Rosen, on this important bill.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce the ``West Nile Virus and Arboviral Disease Act''--a bill to help strengthen our public health system and improved research so that we can better respond to West Nile virus and other arboviruses. I want to thank Senators Dodd, Santorum, Bayh, Cochran, and DeWine for their work in helping craft this important legislation. This year, nearly 3000 Americans have been diagnosed with West Nile Virus, WNV. At least 146 have died. While this virus is transmitted to humans primarily through migratory birds and mosquitoes, recent evidence strongly suggests that WNV can be transmitted through blood transfusions, organ donations, and possibly even breast milk. Further, the latest studies indicate that some patients may experience polio- like symptoms as a result of WNV infection. WNV first appeared in North America in 1999 with reports of encephalitis in birds, humans and horses. Prior to this summer, there had been only 149 cases and 18 deaths from this virus. Now, WNV has spread as far south as Florida and as far west as California, encompassing areas with warmer climates that will allow a year-round transmission cycle. In three years, we have lost the opportunity to contain the disease to the northeastern region of the United States, where mosquitos do not breed year-round. As a result, many more people will die and become ill. Clearly, the increasing spread of the disease and these new findings require an enhanced response at the Federal level. We must do more to support State and local public health efforts to combat the spread of West Nile. And we must also intensify research at the federal level to better understand the etiology of the virus, develop improved abatement tools, and prevent the spread of the illness. The Centers for Disease Control and Prevention, CDC, has published national guidelines for surveillance, prevention and control of WNV. CDC also developed a national electronic surveillance system, ArboNET, to track West Nile in humans, birds, mosquitoes, horses, and other animals. However, the data available to the ArboNET system likely underestimates actual geographic distribution of WNV transmission in the United States because the data are provided by up to 54 ArboNet by local health unit surveillance efforts which vary according to capacity and ability. We need to do more to strengthen the capacity of those surveillance efforts. One only needs to examine the map of the spread of WNV to determine that there may be gaps in our surveillance when some States, like Kansas and West Virginia, are surrounded by other states with similar arbovirus patterns but still not indicating the presence of human disease. One of the peculiarities of great surveillance systems is the increased incidence of disease, simply because better information is being collected. Although strengthening our surveillance and response capabilities will help, we must also do more to increase the number of appropriately trained entomologists. There is clearly a need for more individuals who can understand the disease vectors, identify their breeding areas, and take action to eliminate the mosquito population before WNV season. In response to these obvious deficiencies, this legislation establishes a temporary program for the containment of WNV and related arboviral diseases. Through this grant program, which is authorized for two years, but can be extended by the Secretary of Health and Human Services for an additional year, the CDC is authorized to make grants to states. States can use the funds to develop, implement, and evaluate comprehensive, community-based mosquito control plans. Additionally, states can work with local communities to develop and implement programs to support longer term prevention and control efforts, including training to develop a competent public health workforce. Finally, States are encouraged to work with local health entities to develop prevention and control programs. As part of the requirement under the grant program, the CDC is charged with developing, in consultation with public and private health and mosquito control organizations, guidelines for State and local communities for a sustainable, locally managed, integrated mosquito control programs, as well as otherwise increasing CDC's capacity to provide technical assistance. We also need to learn more about this virus and how it is spread. To combat WNV, we must develop: 1. improved insecticides; 2. rapid tests for the presence of WNV in human blood products; 3. pathogen inactivation technologies; and 4. additional methodologies to contain the spread of WNV or other related arboviruses, including the development of an appropriate WNV vaccine for humans and other mammals and better antiviral treatments. In 1972, the FDA banned the general use of the pesticide DDT, ending nearly three decades of application. During which time, the once- popular chemical was used to control insect pests on crop and forest lands, around homes and gardens, and for industrial and commercial purposes. DDT was developed as the first of the modern insecticides early in World War II. It was initially used with great effect to combat malaria, typhus, and the other insect-borne human diseases among both military and civilian populations. A persistent, broad-spectrum compound often termed the ``miracle'' pesticide, DDT came into wide agricultural and commercial usage in this country in the late 1940s, but was banned by the FDA when the Director at that time determined that the continued massive use of DDT posed unacceptable risks of the environment and potential harm to human health. Since that time, we have not developed a replacement for DDT. We have become complacent, assuming that there would be no need to continue to reducing the insect population. We can no longer be complacent. We have not yet developed a rapid diagnostic WNV test for blood products. There are two types of tests available, a serologic test or a polymerase chain reaction, PCR, test, but only the PCR test would be feasible for screening purposes. Experts have suggested that a new PCR test could be available within 18 months if the appropriate market incentives were in place. We need to determine the best way to expedite the development of this test. Pathogen inactivation techniques could be used to purify blood samples by removing all DNA and RNA particles from the blood. However, we have not yet performed a larger assessment to determine the overall health benefit of this technique. Because the process relies on adding additional chemicals to the blood product, those chemicals, or derivatives thereof, may have a particular health effect. Therefore, given that there will be other emerging infectious diseases in our future, we need to develop a proactive, not reactive, mode to dealing with those infections. Currently, scientists have developed an equine vaccine for WNV, but there is no human vaccine. Given the limited vaccine options, many veterinarians are even using the equine vaccine for avians and other mammals. Therefore, we need to focus efforts on developing vaccines for a host of susceptible mammals. In conducting that research, given the nature of all arboviruses and the fact that WNV also infects a host of mammals, we need to build more bridges between veterinary health and public health. Already, avian experts are asked to assist our public health experts to help identify how bird migration would affect the spread of WNV. Additionally, any new vaccine or diagnostic test for WNV may have broader applicability to the host of other mammals affected by the virus. Given the multitude of federal agencies that should be involved with relevant research, the legislation charges the President with expanding, intensifying, and enhancing research related to the identification or the development of insecticides, the development of a screening tools for WNV in both blood and organs, the development of pathogen inactivation technologies, technologies that safety and cost- effectively remove RNA and DNA from blood, and the development of additional methodologies for containing the spread of West Nile Virus and other related arboviruses. This research program is authorized for five years. More should be done to continuously support the development of a capable public health infrastructure and increased response coordination at all levels. At the Federal level, we have significantly increased our resources for these purpose by providing nearly $1 billion for bioterrorism-related activities, activities which should focus on ``dual use'' capabilities to strengthen our ability to respond to all infectious diseases. However, we need to ensure a continued investment if we are to stabilize our public health infrastructure and continue to focus on means by which to increase coordination. Again, I want to commend Senators Dodd, Santorum, Bayh, Cochran, and DeWine for their contributions to the development of this legislation. It has been an honor and a pleasure to work with my distinguished colleagues on this bill, and I look forward to continuing to working with them and others to find better solutions to combating WNV.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce the ``West Nile Virus and Arboviral Disease Act''--a bill to help strengthen our public health system and improved research so that we can better respond to West Nile virus and other arboviruses. I want to thank Senators Dodd, Santorum, Bayh, Cochran, and DeWine for their work in helping craft this important legislation. This year, nearly 3000 Americans have been diagnosed with West Nile Virus, WNV. At least 146 have died. While this virus is transmitted to humans primarily through migratory birds and mosquitoes, recent evidence strongly suggests that WNV can be transmitted through blood transfusions, organ donations, and possibly even breast milk. Further, the latest studies indicate that some patients may experience polio- like symptoms as a result of WNV infection. WNV first appeared in North America in 1999 with reports of encephalitis in birds, humans and horses. Prior to this summer, there had been only 149 cases and 18 deaths from this virus. Now, WNV has spread as far south as Florida and as far west as California, encompassing areas with warmer climates that will allow a year-round transmission cycle. In three years, we have lost the opportunity to contain the disease to the northeastern region of the United States, where mosquitos do not breed year-round. As a result, many more people will die and become ill. Clearly, the increasing spread of the disease and these new findings require an enhanced response at the Federal level. We must do more to support State and local public health efforts to combat the spread of West Nile. And we must also intensify research at the federal level to better understand the etiology of the virus, develop improved abatement tools, and prevent the spread of the illness. The Centers for Disease Control and Prevention, CDC, has published national guidelines for surveillance, prevention and control of WNV. CDC also developed a national electronic surveillance system, ArboNET, to track West Nile in humans, birds, mosquitoes, horses, and other animals. However, the data available to the ArboNET system likely underestimates actual geographic distribution of WNV transmission in the United States because the data are provided by up to 54 ArboNet by local health unit surveillance efforts which vary according to capacity and ability. We need to do more to strengthen the capacity of those surveillance efforts. One only needs to examine the map of the spread of WNV to determine that there may be gaps in our surveillance when some States, like Kansas and West Virginia, are surrounded by other states with similar arbovirus patterns but still not indicating the presence of human disease. One of the peculiarities of great surveillance systems is the increased incidence of disease, simply because better information is being collected. Although strengthening our surveillance and response capabilities will help, we must also do more to increase the number of appropriately trained entomologists. There is clearly a need for more individuals who can understand the disease vectors, identify their breeding areas, and take action to eliminate the mosquito population before WNV season. In response to these obvious deficiencies, this legislation establishes a temporary program for the containment of WNV and related arboviral diseases. Through this grant program, which is authorized for two years, but can be extended by the Secretary of Health and Human Services for an additional year, the CDC is authorized to make grants to states. States can use the funds to develop, implement, and evaluate comprehensive, community-based mosquito control plans. Additionally, states can work with local communities to develop and implement programs to support longer term prevention and control efforts, including training to develop a competent public health workforce. Finally, States are encouraged to work with local health entities to develop prevention and control programs. As part of the requirement under the grant program, the CDC is charged with developing, in consultation with public and private health and mosquito control organizations, guidelines for State and local communities for a sustainable, locally managed, integrated mosquito control programs, as well as otherwise increasing CDC's capacity to provide technical assistance. We also need to learn more about this virus and how it is spread. To combat WNV, we must develop: 1. improved insecticides; 2. rapid tests for the presence of WNV in human blood products; 3. pathogen inactivation technologies; and 4. additional methodologies to contain the spread of WNV or other related arboviruses, including the development of an appropriate WNV vaccine for humans and other mammals and better antiviral treatments. In 1972, the FDA banned the general use of the pesticide DDT, ending nearly three decades of application. During which time, the once- popular chemical was used to control insect pests on crop and forest lands, around homes and gardens, and for industrial and commercial purposes. DDT was developed as the first of the modern insecticides early in World War II. It was initially used with great effect to combat malaria, typhus, and the other insect-borne human diseases among both military and civilian populations. A persistent, broad-spectrum compound often termed the ``miracle'' pesticide, DDT came into wide agricultural and commercial usage in this country in the late 1940s, but was banned by the FDA when the Director at that time determined that the continued massive use of DDT posed unacceptable risks of the environment and potential harm to human health. Since that time, we have not developed a replacement for DDT. We have become complacent, assuming that there would be no need to continue to reducing the insect population. We can no longer be complacent. We have not yet developed a rapid diagnostic WNV test for blood products. There are two types of tests available, a serologic test or a polymerase chain reaction, PCR, test, but only the PCR test would be feasible for screening purposes. Experts have suggested that a new PCR test could be available within 18 months if the appropriate market incentives were in place. We need to determine the best way to expedite the development of this test. Pathogen inactivation techniques could be used to purify blood samples by removing all DNA and RNA particles from the blood. However, we have not yet performed a larger assessment to determine the overall health benefit of this technique. Because the process relies on adding additional chemicals to the blood product, those chemicals, or derivatives thereof, may have a particular health effect. Therefore, given that there will be other emerging infectious diseases in our future, we need to develop a proactive, not reactive, mode to dealing with those infections. Currently, scientists have developed an equine vaccine for WNV, but there is no human vaccine. Given the limited vaccine options, many veterinarians are even using the equine vaccine for avians and other mammals. Therefore, we need to focus efforts on developing vaccines for a host of susceptible mammals. In conducting that research, given the nature of all arboviruses and the fact that WNV also infects a host of mammals, we need to build more bridges between veterinary health and public health. Already, avian experts are asked to assist our public health experts to help identify how bird migration would affect the spread of WNV. Additionally, any new vaccine or diagnostic test for WNV may have broader applicability to the host of other mammals affected by the virus. Given the multitude of federal agencies that should be involved with relevant research, the legislation charges the President with expanding, intensifying, and enhancing research related to the identification or the development of insecticides, the development of a screening tools for WNV in both blood and organs, the development of pathogen inactivation technologies, technologies that safety and cost- effectively remove RNA and DNA from blood, and the development of additional methodologies for containing the spread of West Nile Virus and other related arboviruses. This research program is authorized for five years. More should be done to continuously support the development of a capable public health infrastructure and increased response coordination at all levels. At the Federal level, we have significantly increased our resources for these purpose by providing nearly $1 billion for bioterrorism-related activities, activities which should focus on ``dual use'' capabilities to strengthen our ability to respond to all infectious diseases. However, we need to ensure a continued investment if we are to stabilize our public health infrastructure and continue to focus on means by which to increase coordination. Again, I want to commend Senators Dodd, Santorum, Bayh, Cochran, and DeWine for their contributions to the development of this legislation. It has been an honor and a pleasure to work with my distinguished colleagues on this bill, and I look forward to continuing to working with them and others to find better solutions to combating WNV.

Mr. FRIST

Mr. FRIST. Mr. President, the Members of this body will soon vote on authorizing the President to use the military might of this Nation against Saddam Hussein. This decision has weighed heavily on me, as it has on us all. No one takes lightly the prospect of young Americans risking their lives on the battlefield of war, but we and they swear an oath to defend our rights and freedoms against all enemies. And so our duty we must now do. Saddam Hussein is a direct and deadly threat to the American people and to the people of the world. He holds the power to murder not just hundreds or thousands or tens of thousands, but millions. He defies all international efforts to restrain that power and keep world peace, and he disdains the value of human life, even the lives of his own people. This is an evil, lawless, and murderous man. The resolution before the Senate is carefully constructed to encourage the widest possible international support for unified action against Saddam Hussein. The nations of the world need to show him they will no longer tolerate his arrogant contempt for United Nations resolutions, requiring him to give up his weapons of mass destruction and cease the gross human rights violations he has committed on his own people. I support the President's intensive efforts to build such a coalition, and I pray for his success. No one wants to avoid a war more than I do. I am a physician. I have devoted my life to a profession that is centered on saving lives. Only when we have exhausted all reasonable efforts at keeping peace should we consider waging war. The President shares a firm commitment to this principle. I consider this resolution a strong statement of support for peace and, if the Nation must, for war as well. For if the safety of our people, the security of our Nation, and the stability of the world remain so threatened, we must risk war for peace. To do anything less would leave a grave and growing danger looming over the lives of millions. This evening I will talk about Saddam Hussein's past, his present, and what I consider his greatest danger, a robust biological weapons program. More than chemical and nuclear weapons, Saddam's biological weapons pose a unique and immediate threat. Unlike other conventional weapons, they are easily made. They can be readily concealed and are beyond the reach of inspectors and can readily be delivered across borders and, yes, even across oceans. In the hands of a madman, biological weapons literally threaten us all. I refer to the words on this chart concerning Iraq's weapons of mass destruction, excerpts from an October 2002 unclassified CIA report, which reads: Iraq has some lethal and incapacitating BW-- Biological weapon-- agents and is capable of quickly producing and weaponizing a variety of such agents, including anthrax, for delivery by bombs, missiles, aerial sprayers and covert operatives, including potentially against the U.S. homeland. Indeed, these biological weapons literally threaten us all-- ``potentially against the U.S. homeland.'' Saddam Hussein has pursued the most deadly weapons known to man, with brutal determination. His arsenal has included tens of thousands of tons of chemical agents and biological agents. He has come within months of acquiring nuclear weapons, and he has developed many means, both in number and type, to deliver his desired destruction. History shows that dictators do not amass such weapons without the intent to use them. Indeed, Saddam Hussein has accumulated chemical weapons and used them to attack his neighbors and even murder his own people. During the Iran-Iraq war, which lasted from 1980 to 1988, Saddam Hussein inflicted 20,000 casualties by striking with chemicals-- mustard gas, sarin, and tabun. He also used mustard and nerve agents to murder as many as 5,000 Iraqi Kurds and inflict the misery of chemical warfare on another 10,000. I show this chart briefly to demonstrate the impact of these chemicals. Saddam Hussein used the chemicals on his own people. We can see the effects of this tragedy among the victims, who are women and children in this picture. Saddam Hussein was fully prepared to use biological weapons during the gulf war. In 1995, Iraq admitted it had produced 19,000 liters of botulinum toxin, 8,500 liters of anthrax, and 2,200 liters of aflatoxin. That is enough botulinum toxin--remember, that is the most potent poison known to man--to kill every man, woman and child on Earth. Iraq also admitted it had loaded thousands of liters of agents into bombs, into munitions, into dozens of warheads and aircraft spray tanks, just as American and allied forces prepared to liberate Kuwait. Before the gulf war, intelligence experts believed Saddam Hussein was at least 8 to 10 years from having a nuclear weapon. That estimate was way off. Iraq had already assembled many of the pieces needed to build a nuclear weapon. What it lacked was fissile material that makes up the explosive core of a nuclear device. If Saddam Hussein had been able to obtain that material, either by making it or buying it, he would likely have had a nuclear bomb by no later than 1993. Indeed, Iraq has gone to great lengths to acquire weapons of mass destruction. Its efforts to hide the weapons have been equally ambitious. Saddam Hussein has defied the international community almost from the moment he came to power in 1979. His rule has been a constant threat to peace among the Iraqi people, in the Middle East, and throughout the world. Saddam Hussein has twice invaded sovereign nations. In 1980, he launched the Iran-Iraq war solely for territorial gain. Eight years, one million casualties and hundreds of billions of dollars later, the war ended with Iraq gaining nothing. In 1990, Saddam Hussein started the gulf war by invading Kuwait. His objective? Seize control of his neighbor's oil fields. We expelled him. As we did, he fired dozens of Scud missiles into Israel and into Saudi Arabia and the waters off Qatar. Iraq has shown as much contempt for the international community as it has shown aggression toward its neighbors. Since 1990, Iraq has violated 16 United Nations Security Council resolutions. Inspectors charged with enforcing those resolutions have been deceived, they have been obstructed, they have been intimidated by Saddam Hussein and his henchmen. Saddam Hussein has funneled as much as $9 billion from the United Nations Oil-for-Food program into his weapons of mass destruction program and other illegal activities, starving his people and strangling the economy. To Saddam Hussein international treaties are worth less than the paper on which they are written. Iraq is the only nation publicly cited for violating the Geneva Convention ban on using chemical weapons. Its biological weapons program has directly violated the Biological and Toxin Weapons Convention. And Iraq has utterly ignored the Nuclear Non- Proliferation Treaty, which has been signed by 187 countries since its inception in 1968. Saddam Hussein said in a recent speech, ``The present of any nation or people cannot be isolated from its past . . .'' Indeed. What Saddam has done in the past is reckless, lawless and appalling. But what he is doing now should frighten us all and compel the world to action. Not only does he continue to develop and produce weapons of mass destruction, but he's more likely to use them than ever before. I am particularly concerned about the unique and immediate threat Saddam's biological weapons program presents. Iraq has lethal and incapacitating biological weapons agents potentially to use against the United States homeland. Iraq likely produced two to four times more biological agents than it publicly admitted in 1995. United Nations inspection teams could not account for biological culture growth media that would have easily tripled Saddam's stocks of anthrax--a bacteria that can be rapidly and easily produced as a weapon of mass destruction. Mr. President, 30,000 munitions designed solely for chemical and biological agents were also unaccounted for. Missing biological agents, missing biological munitions and Iraq's pattern of deception lead to only one conclusion: Saddam Hussein today retains a large arsenal of deadly living microorganisms available as weapons of mass destruction. That arsenal likely contains stocks of live viruses and bacteria produced not only before the Gulf War, but also after, especially since weapons inspectors left Iraq in 1998. Saddam has expanded so-called ``dual-use'' facilities--laboratories, research centers and manufacturing plants that have civilian or commercial uses, but are likely used to build his arsenal of microbiological terror, as well. Iraq has rebuilt known biological weapons facilities that were destroyed during the Gulf War, by our military, or after, by weapons inspectors. Also, Saddam retains the equipment and, even more crucial, the human expertise to continue building his biological weapons capability. Unlike nuclear weapons, which take years and massive resources to make, biological weapons are inexpensive, can be made easily, within weeks, in a small room, with minimal equipment and manpower. That is what makes biological weapons so unique and capable of causing such death and destruction. To that end, our intelligence community believes Iraq has built mobile germ warfare production laboratories. Iraq has learned a lot about weapons inspections since the Gulf War. Saddam hid his biological weapons program from inspectors for 4 years. Mobile biological labs are the ideal weapon of deception. They can be quickly moved in inconspicuous trailers and hidden in very small spaces, including, for example, in a single room in one of Saddam Hussein's presidential palaces. Such laboratories would be almost invisible to the outside world. There is also evidence that Iraq may be developing and producing a new generation of more virulent biological agents. Defectors allege that Iraq is developing an agent called ``Blue Nile''--which may be a code name for the ebola virus. Ebola is a deadly virus for which there is no treatment and there is no vaccine. And many experts believe Saddam Hussein may have stocks of the smallpox virus. One of the last naturally occurring smallpox outbreaks occurred on Iraqi soil in the early 1970s, which is precisely when Iraq launched its weapons of mass destruction program. Though U.S. defenses against smallpox are now much stronger, a 2001 study by Johns Hopkins University found that a smallpox attack launched at three locations in the United States could kill in a worst case scenario one million and infect another two million Americans within two months. Saddam has invested not only in developing and producing new viruses and bacteria, but also new means to deliver those agents. Iraq has experimented with a variety of unmanned aerial vehicles as part of its longstanding weapons of mass destruction program. But intelligence experts believe Iraq has vastly improved its designs and now has a drone aircraft that can carry and spray up to 80 gallons of anthrax. Such an airplane would be the most effective way to deliver biological weapons over a vast area and would represent a dire threat to the Iraqi people, its neighbors and the international community. The danger of germ weapons is not merely that Saddam Hussein has them, but that he would use them . . . even against the United States. Biological agents are ideal terrorist weapons. Unlikely other weapons of mass destruction, one cannot hear them or taste them or smell them. They can be invisible to the human eye. They can be transported long distances without detection in, for example, a terrorist's pocket. They can take hours and even days to take effect, allowing a terrorist to be long gone--to escape. Thus, Saddam's robust biological weapons program, combined with the support of terrorism, is a deadly force capable of exceeding the death and destruction of even a nuclear bomb. Saddam does support terrorism. Iraq harbors several terrorist groups that have targeted and murdered American citizens. The Iraqi regime has been in contact with al-Qaida for at least a decade and, as recently as this year, allowed a senior leader to receive medical treatment in Baghdad. I am hopeful that inspectors will return to Iraq with totally unfettered access to all suspected biological weapons sites. But, remember, such a site can be an 8-by-12-foot room deep in the basement of a huge Presidential palace. I am hopeful that Saddam Hussein will disarm and destroy his ability to develop and produce such weapons in the future. But I am not optimistic. Saddam Hussein knows his chemical and biological stocks are the source of his power at home and in his region and can be a tool of blackmail. Weapons of mass destruction are as much a part of Saddam Hussein as freedom and democracy are of America. The test of our resolve in the war on terror was Afghanistan. There we fought the terrorist group and its supporting regimes that murdered more than 3,000 of our own citizens. We were attacked, and, as any capable nation would do, we responded. Now we face a second test. Saddam Hussein has not yet struck, and we hope he doesn't. We hope he disarms his weapons of mass destruction and chooses peace over war. It is his choice. But should he force us to war, we will fight for a noble and a just cause--to prevent a future and far worse attack than that of September 11, 2001. America will be victorious in this next phase of the war on terror, for the worst of a dictator cannot defeat the will of a free people. Saddam Hussein will fight to preserve his grip on power and protect weapons that murder millions. But if we must fight, we will do so for love of country, for respect of humanity, and for the rights and freedoms that all people deserve to enjoy, including the Iraqi people.

Mr. FRIST. I will be happy to yield.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce legislation to authorize an Institute of Medicine study to examine the field of health services research. The health services research is the primary source of information for policy makers, payers, managers, providers and the public concerning the organization, financing and performance of the American health care system. the Agency for Healthcare Research and Quality, AHRQ, is the lead Federal agency in this effort. However, many other federal partners, most institutes at the National Institutes of Health, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs and the Department of Defense, fund and use health services research extensively to advance their mission. The American health care system is facing significant problems with rapidly rising costs, a staggering number of uninsured, racial and ethic disparities, and a compelling need for safer, higher quality care. In the post-September 11 environment, we add the need to assure adequate public health systems and emergency response capacity in hospitals. In this challenging environment, I am increasingly concerned that the information needed from research to address current and future problems in the American health care system may not be available when needed. Therefore, I am introducing legislation today that requests AHRQ to contract with the Institute of Medicine for a report on the adequacy of the organization and financing of the field of health services research for meeting the nation's future information needs. The report should focus on the Federal role in supporting health services research, and in particular, the role of AHRQ in leading the federal effort and coordinating the complementary roles of other Federal agencies, as well as the private foundations and corporations, that conduct and fund health services research.

Mr. FRIST. Mr. President, I rise today to introduce legislation with Senator Kennedy to extend the authorization time for an advisory council for graduate medical education. The Council on Graduate Medical Education, COGME, was created by Congress in 1986 to provide an ongoing assessment of physician workforce trends, training issues and financing policies, and to recommend appropriate Federal and private sector efforts to address identified needs. The legislation calls for COGME to advise and make recommendations to the Secretary of the U.S. Department of Health and Human Services, the Senate Committee on Health, Education, Labor and Pensions, and the House of Representatives Committee on Commerce. In 1998, when we re-autohrized Title 7 programs, we re-authorized the Council through September 30, 2002. Unfortunately, we have not been able to fully review all of the programs outlined in Title 7, including COGME. To give our Committee the additional time to review this council, I am introducing legislation today with Senator Kennedy to extend the time period for its authorization until the end of fiscal year 2003.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce legislation to authorize an Institute of Medicine study to examine the field of health services research. The health services research is the primary source of information for policy makers, payers, managers, providers and the public concerning the organization, financing and performance of the American health care system. the Agency for Healthcare Research and Quality, AHRQ, is the lead Federal agency in this effort. However, many other federal partners, most institutes at the National Institutes of Health, the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs and the Department of Defense, fund and use health services research extensively to advance their mission. The American health care system is facing significant problems with rapidly rising costs, a staggering number of uninsured, racial and ethic disparities, and a compelling need for safer, higher quality care. In the post-September 11 environment, we add the need to assure adequate public health systems and emergency response capacity in hospitals. In this challenging environment, I am increasingly concerned that the information needed from research to address current and future problems in the American health care system may not be available when needed. Therefore, I am introducing legislation today that requests AHRQ to contract with the Institute of Medicine for a report on the adequacy of the organization and financing of the field of health services research for meeting the nation's future information needs. The report should focus on the Federal role in supporting health services research, and in particular, the role of AHRQ in leading the federal effort and coordinating the complementary roles of other Federal agencies, as well as the private foundations and corporations, that conduct and fund health services research.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce legislation with Senator Kennedy to extend the authorization time for an advisory council for graduate medical education. The Council on Graduate Medical Education, COGME, was created by Congress in 1986 to provide an ongoing assessment of physician workforce trends, training issues and financing policies, and to recommend appropriate Federal and private sector efforts to address identified needs. The legislation calls for COGME to advise and make recommendations to the Secretary of the U.S. Department of Health and Human Services, the Senate Committee on Health, Education, Labor and Pensions, and the House of Representatives Committee on Commerce. In 1998, when we re-autohrized Title 7 programs, we re-authorized the Council through September 30, 2002. Unfortunately, we have not been able to fully review all of the programs outlined in Title 7, including COGME. To give our Committee the additional time to review this council, I am introducing legislation today with Senator Kennedy to extend the time period for its authorization until the end of fiscal year 2003.

Mr. FRIST

Mr. FRIST. Mr. President, just a few moments ago, I joined my colleagues on the Health, Education, Labor, and Pensions Committee in unanimously approving the nomination of Mark McClellan to be Commissioner of the Food and Drug Administration. I rise now to strongly urge the Senate to immediately act on the nomination. Dr. McClellan is not a stranger to the Senate. During his service on the Council of Economic Advisors, many of us have benefitted from his expertise, clear-headed analysis, and sound advice concerning health policy matters. Dr. McClellan has served the President well and I know that he will continue to serve the Nation well as the next Commissioner of the Food and Drug Administration. Mark McClellan is an excellent choice to lead the FDA. He is a talented academician and economist who has helped challenge conventional thinking about important health policy matters through groundbreaking research. He is a gifted health policy analyst who has worked to improve the Nation's health care system for all Americans. Perhaps most importantly, he is also a physician who has cared for patients and knows first hand that there are few greater callings than helping to heal one's fellow man. Mark McClellan is uniquely qualified to lead this important agency at this critical time. The challenges confronting the next Commissioner of the FDA are great, perhaps greater than at any other time in our Nation's recent history. Of course, the FDA has an important, ongoing role to play in ensuring the safety and efficacy of drugs, biologics, food, cosmetics, blood products, and devices, goods and products accounting for nearly one- quarter of all consumer spending in the United States. But the FDA Commissioner must be more than simply the head of a large, regulatory Government agency. He must also provide strong leadership on a broad range of critical health policy issues that directly affect the lives and well-being of every American. I would like to highlight some of the issues on which it is critical that the FDA Commissioner provide leadership at this time. The most significant issue we have faced over the past year is terrorism. On September 11 we endured the most horrendous attack on American soil since Pearl Harbor. This week, we mark the 1-year anniversary of the worst attack of biological terrorism in this country. We cannot know when, where, or in what form the next attack will happen, but we must be prepared. This includes speeding the review and approval of rapid assays, vaccines, and other necessary bioterrorism countermeasures. Numerous scientists and research facilities are working to meet the call of the President and Congress to protect our homeland from outside threats. The FDA must help fashion an environment in which these discussions are encouraged and translated to medical practice. At the same time, we cannot ignore naturally emerging threats to the safety and sustainability of our blood, tissue and organ supply. Last week, it was reported that 40 people were exposed to hepatitis C from a single organ and tissue donor and salmonella was transmitted through blood transfusions. This is in addition to the growing body of knowledge we are amassing on West Nile virus. Considered together with the existing shortage of blood, tissue and organ donors, the need to speed the development of new screening and purification products is clearly illustrated. Finally, I would like to highlight the importance of promoting a regulatory environment that values innovations to improve patient care and consumer safety, while at the same time safeguarding the public health. But this must be done without contributing unnecessarily to overall rising health care costs or allowing basic medical treatments to be forgotten. We presently face just this situation with our Nation's vaccine supply. Currently, only four manufacturers produce vaccines and they face the multiple challenges of a growing litigation crisis and changes in the FDA's regulatory oversight. While most of the recent childhood vaccine shortages have been alleviated, our system remains vulnerable to future shortages if we fail to act. Mark has my full support, the full support of the HELP Committee, and I believe the full support of the Senate. It is in not only in our best interest to see that his nomination is acted on quickly, but it is in the best interest of the entire Nation for the Senate to confirm him as the next Commissioner of the Food and Drug Administration. We cannot wait or allow the nomination to be delayed.

Mr. FRIST

Mr. FRIST. Mr. President, each year, nearly 1 out of 4 Americans sustain an injury requiring medical attention. In 1995, injuries were responsible for 148,000 deaths, 2.6 million hospitalizations, and over 36 million emergency room visits. The direct and indirect cost of injury is estimated to be about $260 billion a year, and the death rate from unintentional injury is more than 50 percent higher in rural areas than in urban areas. It is essential that every American have access to a trauma system that provides definitive care as quickly as possible. In recent years, Congress has worked to address this issue through the Trauma Care Systems Planning and Development Act, which authorizes Federal grants to States for the purpose of planning, implementing, and developing statewide trauma care systems. However, this important program expires this year. Therefore, I am introducing bipartisan legislation today, along with Senators Kennedy and Enzi to reauthorize this important program. Among Americans younger than age 44, trauma is the killer. While injury prevention programs have greatly reduced death and disability, severe injuries will continue to occur. Given the events of September 11, 2001 and our Nation's renewed focus on enhancing disaster preparedness, it is critical that the Federal Government increase its commitment to strengthening programs governing trauma care system planning and development. Despite our past investments, one-half of the States in the country are still without a statewide trauma care system. Clearly we can do better. We must respond to the goals put forth by the Institute of Medicine in 1999, that Congress ``support a greater national commitment to, and support of, trauma care systems at the Federal, State, and local levels.'' Today's bill, the ``Trauma Care Systems Planning and Development Act of 2002'' reauthorizes this program and includes several key improvements: first, it improves the collection and analysis of trauma patient data; second, the bill responds to State budget difficulties by decreasing the requirement for State matching funds to the Federal grants; third, the legislation provides a self-evaluation mechanism to assist States in assessing and improving their trauma care systems; fourth, it authorizes an Institute of Medicine study on the state of trauma care and trauma research; and finally, it doubles the funding available for this program to allow additional States to participate. I appreciate the assistance of Senators Kennedy and Enzi on this important legislation, and look forward to working to see this bill passed this year.