Bill Frist

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce the Medicare Quality Improvement Act--a bill to help revitalize the Medicare Program by providing for the alignment of payment and other incentives. I want to thank Senators Jeffords, Gregg, and Breaux for their work in helping craft this crucial legislation. To meet the needs of the 21st century health care system, it is critical that payment policies be aligned to encourage and support quality improvement efforts. Even among health professionals motivated to provide the best care possible, the structure of payment and other incentives may not facilitate the actions needed to systematically improve the quality of care, and may even prevent such actions. For example, redesigning care processes to improve follow-up for chronically ill patients through electronic communication may reduce office visits and decrease revenues for a medical group under some payment schemes. Current payment practices are complex and contradictory; and although incremental improvements are possible, more fundamental reform will be needed. In this report, ``Crossing the Quality Chasm,'' the Institute of Medicine encouraged the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality to develop a research agenda to identify, test, and evaluate options for better aligning payment methods with quality improvement goals. The demonstration project authorized by this legislation is part of that larger research agenda--to help us understand the appropriate alight of payment and other incentives and improve the quality of health care in a way that will not increase the overall costs of Medicare. We already have identified appropriate ways to align provider incentives. Research supported by the Robert Wood Johnson Foundation has noted at least 11 different incentive models--models that can be implemented by a wide variety of organizations and applied to a range of medical groups, providers, and health plans. In many circumstances, key components of these models have been implemented in several health care markets, and the research has shown that both financial and nonfinancial incentives, such as technical assistance, are important in motiving appropriate care. However, we do not know how these incentives might apply to Medicare, and that is why this demonstration is so vital. It has been an honor and a pleasure to work closely with my distinguished colleagues on this bill, and I look forward to continuing to work with them and others as we move forward on the debate about how to more appropriately reform Medicare.

Mr. FRIST

Mr. FRIST. Mr. President, I agree with my distinguished colleague that we need to do a much better job in pushing the pharmaceutical industry to make sure that when it comes to testing of drugs or investigating drugs that they are adequate, especially as you look at bioequivalency in a varied population. In fact, in the HELP Committee, as my colleague knows, we have passed legislation and we will continue to work on legislation that says we need to do more in terms of testing to see what the bioequivalent standard is. What is called in my profession of medicine a ``dose response'' relationship is in populations--whether it varies by race, age, or gender--we need to do a lot more. We need to keep pushing there. My concern with bioequivalence--we will agree, whichever population it is or whether clinical trials are being conducted--the way this language is written today allows a significant loophole for a lessening of the bioequivalent standards that we as the American people deserve. That is my concern. As the Senator from New Hampshire addressed in his question to me, we are reaching out. Clearly, we are in the minority. We are not going to have the votes. But I am going to continue to reach out. And I think you will see that our side will continue to reach out in the interest of cost savings. We do not want to push so hard that we lower the standards for the safety of the American people who take these drugs. I do not care if the cost savings is $100, $50, or $5. If that drug is not bioequivalent--if the dose is too strong, then your blood will not clot properly and you can get a stroke from bleeding in the brain, or, if the dose is too weak, then your blood clots too easily and you can get a stroke from having a blood clot go to your brain--you have done a disservice to the American people. As the Senator from New Hampshire just mentioned, I will continue to reach out on this particular issue of bioequivalence. You heard Senator Hatch from Utah stress that we need to slow down a bit to make sure that your intent in having cost savings does not hurt the American people. That is really the issue. I am not the expert. Of course, I have dealt with a lot of these drugs, and I know what it is like being told by a managed-care organization that you have to switch drugs. The fear I have is that the drug has not been tested in a certain population effectively. Again, it could be by race or gender or age. That concerns me. Therefore, I do not want any lowering of those standards by our Government. The Biotechnology Industry Organization sent a letter to Senator Kennedy dated July 15. I ask unanimous consent that it be printed in the Record.

Mr. FRIST. Mr. President, in response to my distinguished colleague, this issue of having a general agreement that we would work out technical language, and then after 48 hours or 72 hours have the bill come to the floor without the opportunity, in a bipartisan way, to be able to access experts in the field, is what concerns me most. You can take an initial bill and improve it a little bit, and then you can leave something out and not reach bioequivalency. In response to the question is a particular instance where during the discussion, the mark-up, we said let's get together and make absolutely sure that we address it in a way so that standards are not being loosened; yet, the bill that comes to the floor does not have that guarantee in it.

Mr. FRIST. Mr. President, let me continue. Let me answer one question, and then return to my comments. I would be happy to yield for a question.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to introduce the Medicare Quality Improvement Act--a bill to help revitalize the Medicare Program by providing for the alignment of payment and other incentives. I want to thank Senators Jeffords, Gregg, and Breaux for their work in helping craft this crucial legislation. To meet the needs of the 21st century health care system, it is critical that payment policies be aligned to encourage and support quality improvement efforts. Even among health professionals motivated to provide the best care possible, the structure of payment and other incentives may not facilitate the actions needed to systematically improve the quality of care, and may even prevent such actions. For example, redesigning care processes to improve follow-up for chronically ill patients through electronic communication may reduce office visits and decrease revenues for a medical group under some payment schemes. Current payment practices are complex and contradictory; and although incremental improvements are possible, more fundamental reform will be needed. In this report, ``Crossing the Quality Chasm,'' the Institute of Medicine encouraged the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality to develop a research agenda to identify, test, and evaluate options for better aligning payment methods with quality improvement goals. The demonstration project authorized by this legislation is part of that larger research agenda--to help us understand the appropriate alight of payment and other incentives and improve the quality of health care in a way that will not increase the overall costs of Medicare. We already have identified appropriate ways to align provider incentives. Research supported by the Robert Wood Johnson Foundation has noted at least 11 different incentive models--models that can be implemented by a wide variety of organizations and applied to a range of medical groups, providers, and health plans. In many circumstances, key components of these models have been implemented in several health care markets, and the research has shown that both financial and nonfinancial incentives, such as technical assistance, are important in motiving appropriate care. However, we do not know how these incentives might apply to Medicare, and that is why this demonstration is so vital. It has been an honor and a pleasure to work closely with my distinguished colleagues on this bill, and I look forward to continuing to work with them and others as we move forward on the debate about how to more appropriately reform Medicare.

Mr. FRIST

Mr. FRIST. Madam President, I yield myself 20 minutes to speak in opposition to the amendment.

Mr. FRIST. Madam President, I rise to address the issue introduced in the last hour and a half; that is, the issue of reimportation of drugs, especially as it affects the safety of the American people. They have been introduced by the proponents of this legislation as myths. By calling them myths, it is as if in some way we should say they are myths. They are not real, therefore, let's proceed down this path. I want to give a little bit of historical perspective to these so- called myths and explain to my colleagues why I believe they are not myths but reality. The potential of such reality can result in direct harm as we look at public health and safety. I look forward to the afternoon because the debate will continue. The debate ultimately will start with cost and buses running back and forth to Canada. Then Senators will say that this idea is appealing and critically important to pass so we can lower the cost of prescription drugs. We are all for lowering prescription drugs costs. Prescription drugs cost too much; they are out of reach today for too many people. The focus is on cost. It is motivating and a driving force because it is something on which we all agree. Prescription drugs costs too much today--the rate of increase is too much. But to focus on cost without focusing on public health and safety is wrong and irresponsible. If we look at the legislative history of the consideration of reimportation of drugs and pharmaceutical agents from other parts of the world outside of the borders of the United States to this country, we have a lot to learn. It is a rich history in terms of lessons learned. I will not focus on the cost issue, but let me just dismiss the cost issue in terms of my comments now by saying there is no evidence that this amendment will guarantee price savings. For seniors, individuals with disabilities, or the American people who are listening today, there is no evidence to indicate this. It is pretty dramatic, holding up two bottles and saying one comes from another country and one from the here. The assumption is that it will reduce the cost of prescription drugs in the United States, however, that evidence is not there. What I want to focus on--and I think it is even worse than not being able to make that assurance to the American people--is my concern with health. From July 1985 to June 1987, nine hearings were held and three investigative reports issued regarding the issue of reimportation of pharmaceuticals. These efforts, over that time, led to the enactment of the Prescription Drug Marketing Act of 1987. That law was specifically designed to protect America's health and safety against the risks of drugs that in some way may have been altered or counterfeit imported medicines. The act, a product of the debate at that time, found among other things, ``a significant volume of pharmaceuticals are being reimported. These goods present a health and safety risk to American consumers because they may become subpotent or adulterated during foreign handling and shipping.'' The overall purpose of the Prescription Drug Marketing Act of 1987 was to ``to decrease the risk of counterfeit, adulterated, misbranded, subpotent or expired prescription drugs reaching the American public.'' In the Committee report which accompanied the Prescription Drug Marketing Act, the Commerce Committee concluded: Reimported pharmaceuticals threaten the American public health in two ways. First, foreign counterfeits, falsely described as reimported U.S.-produced drugs, have entered the distribution system. Second, proper storage and handling of legitimate pharmaceuticals cannot be guaranteed by U.S. law once the drugs have left the boundaries of the United States. I mentioned the history because it is incumbent upon us--as we look at this legislation and change, modify, defeat, pass, improve, strengthen this legislation--that we have to address the issues that were so prominently raised at that time. That was from 1985 to 1987. At that time, we did not have nearly as many cost concerns as we do today. In 2000, as was mentioned on the floor, Congress revisited the issue and passed at that time the Medicine Equity and Drug Safety Act. This act allowed reimportation of prescription drugs if the Secretary of Health and Human Services could guarantee the safety and certify that cost savings would result. Safety and cost savings, again, are two issues that remain current today. We want to bring down the cost of prescription drugs, but we certainly do not want to do it if it is going to hurt the American people. Since that time, two Secretaries of Health and Human Services--of two administrations--have stated that the Food and Drug Administration cannot guarantee the safety of reimported prescription drugs. In fact, then-Secretary Shalala called it ``impossible . . . to demonstrate that [reimportation] is safe and cost effective.'' Let us jump to the next administration. Secretary Thompson also concluded that reimportation would ``pose a greater public health risk than we face today and a loss of confidence by Americans in the safety of our drug supply.'' Those were Secretaries of Health and Human Services and their overall approach in reimportation. Let us now turn to the Commissioners of the FDA. When FDA Deputy Commissioner Lester Crawford was asked to comment on ``whether reimportation (from Canada) now raises greater challenges than it did previously''--meaning prior to September 11--and ``what is your view as it relates to safety as it relates to drugs for the consuming Americans,'' Deputy Commissioner Lester Crawford replied, ``The problem would be if it becomes apparent to the rest of the world, including the world of terrorists that we are not interdicting shipments of drugs that come from Canada. . . . I think this is a signal to a would-be terrorist that this might be a way to enter the United States. . . . It also would be a signal to a community that it is not as dangerous as terrorists obviously, but to the transshippers and these would-be people in various countries that may not have a regulatory system or may not have a regulatory system for exported drugs. . . . I think the important issue is that we are in a new world, compared even to 2 years ago, and that it is incumbent upon us to address this whole idea of having drugs produced or imported or reimported from outside our boundaries at the same time we are trying to strengthen our boundaries in terms of what comes into this country. How careful can we be, how assured can we be that a product is not counterfeit, has not been adulterated, or is not the product of somebody who has ill intent against America. At the same time, we are working to make the borders less porous and tightly overseen, we want to make our borders more porous when it comes to chemical and pharmaceutical agents. Former FDA Commissioner, Dr. Jane Henney, expressed severe reservations regarding the importation of drugs. This is from a different administration than the current one. Dr. Henney said: The trackability of a drug is more than in question. Where did the bulk product come from? How is it manufactured? You're just putting yourself at increased risk when you don't know all of these things. Let us go back to another FDA Commissioner. Remember, the FDA Commissioners are those people who we have, as a nation, given the responsibility of overseeing the public's health and safety of food and drugs. Dr. David Kessler, former head of FDA, stated: In my view, the dangers of allowing reimportation of prescription drugs may be even greater today than they were in 1986. For example, with the rise of Internet pharmacies, the opportunities of illicit distribution of adulterated and counterfeit products have grown well beyond those available in prior years. That is David Kessler, former head of FDA. He continues: Repealing the prohibition on reimportation of drugs would remove one of the principal statutory tools for dealing with this growing issue. Let us look back to an FDA Commissioner from the Carter administration, Dr. Jere Goyan, who said it best. This is FDA Commissioner Goyan: I respect the motivation of the Members of Congress who support this legislation. They are reading, as I am, stories about the high prescription drug prices and people which are unable to pay for the drugs they need. But the solution to this problem lies in better insurance coverage for people who need prescription drugs, not in threatening the quality of medicines for us all. It is important because, again, in our urge to bring down the cost of prescription drugs and restrain that skyrocketing of costs, we do not want to put drugs out of the reach of the American people. We do not want to do that unintentionally. Given the statements of the FDA Commissioners and the Secretaries of Health and Human Services, we do not want to open the door and increase the risk to the public health. Last fall the FDA affirmed its concern about the safety of reimported drugs--even those from Canada, and I understand the underlying amendment is focusing on one country--stating they could not even provide safety assurances for those drugs entering the Nation over our northern border. The FDA further noted that reimported drugs ``pose considerable risks to consumers because they may be counterfeit, expired, superpotent, subpotent, simply tainted, or mislabeled.'' I point this out early in the debate and want to turn to other people and to the other side, who say: Yes, our amendments are written with more safeguards in the pieces of legislation that come forward. I think that needs to be debated. Ultimately, the safety issue is the key issue in addressing this legislation as we shape it and vote for or against it. I fear that, in spite of the proponents' attempts in the underlying amendment to establish a mechanism to assure safety--and it is fairly elaborate--a lack of success, lack of assurance of having these safety mechanisms, at the end of the day, puts at risk the American people. This is all in the interest of bringing down the cost of prescription drugs, which is something that we agree with, but there are better and more direct mechanisms to deal with that issue of cost. We see an elaborate set of safety mechanisms that I think are impossible to implement, which wholesalers and pharmacists are not equipped to handle and, more importantly, mechanisms that only ultimately add--and nobody talks about it--to the cost of prescription drugs. Regardless of whether a pharmaceutical is originally manufactured here in the United States, once a drug leaves this country and crosses borders, I believe it is impossible to ensure that it is properly handled. It is out of our reach and our vision. We can sort of pass the laws and pass regulations, but in truth, we are not going to see it. It is impossible to guarantee how it is handled, stored, at what temperature it is stored, and whether it is safe for eventual use. Most people know--we have talked about this in the Chamber of this body--it is very important how drugs are stored, at what temperature, and their potency. In fact, certain drugs that are used in a routine way, if improperly handled, can become lethal if mishandled in being brought back into this country. Even more hazardous to the health of Americans is counterfeit medicines. I mentioned terrorism, and I do not want to overstate that, but again, we are currently working very hard to fight issues such as bioterrorism. We are working hard to make sure we are able to track and regulate contents of agents that can be used against us. I do not think we should be moving in the direction of opening those borders broadly when I contend it is impossible, or next to impossible, to guarantee their safety. There is one interesting example. Gentamicin sulfate is a prescription medicine to treat people with resistant infections, abdominal infections, and people who are very ill. Several years ago, FDA reported that this drug resulted in 17 deaths and 202 serious reactions. This drug is a very powerful drug, a very good drug, and one of the best antibiotics out there when used in a targeted, specific way. Ultimately, it was no surprise to later find that the medicines causing these 17 deaths were being imported from another country. It was not Canada. It happened to be China. Both the current and former leaders of the FDA have made it ultimately clear, really crystal clear, that they will have a tough time establishing mechanisms that are sufficiently elaborate, complex, and detailed enough to ensure pharmaceuticals coming into this country from foreign manufacturers are safe to use. The underlying amendment purports to address drug safety by only allowing U.S.-approved drugs to be reimported and incorporating a drug testing requirement. Again, it sounds very good, but let me state up- front--and we can debate it as the day goes on--end product testing, after a drug has traveled and handled in certain ways, simply is not adequate. End product testing is not adequate to demonstrate that a drug was manufactured in accordance with U.S.-approved standard and quality requirements. Also, testing at the moment of import, at the time it actually comes into the country, does not ensure the integrity of the drug throughout its shelf life once it arrives here. Drugs are fluid agents. They are agents that can be adulterated. They can be changed, and, as I mentioned, their storage is critically important. I will close mentioning this whole danger of counterfeiting drugs because, again, in this environment post-September 11, it is one we need to look at. We need to address this issue up-front. It is the new environment in which we are working. In that regard, I am hopeful we can address this amendment to make absolutely sure we have safe drugs for the American people. We need to make sure that we have not opened the door at the same time we are putting interest in lowering costs and reducing costs over time, opened the door, opened our borders, or made them more porous in a way that ultimately will hurt the American people. I yield the floor.

Mr. FRIST

Mr. FRIST. Will the Senator yield?

Mr. FRIST. Mr. President, clearly the United States does subsidize the world in terms of research and development. For better or worse, many other countries do have strict price controls. Those price controls ultimately translate pretty uniformly across the world into less investment in terms of research and development and investigation and experimentation for future cures of a broad range of diseases that we globally suffer with today. The hope out there--whether it is Parkinson's disease, emphysema, heart disease, or lung disease--comes in the development of new drugs. My question to the Senator is to verify the data that at least has been made available to me. In the United States our pharmaceutical industry--and I will phrase this as a question--spends about how much? The answer is the United States spends around $30 billion for research and development in the private sector coming from private investment in this country. In Canada, the cost for all research and development in pharmaceutical agents is not $30 billion; it is $1 billion. I mention that because people glorify the Canadian system and how inexpensive it is. We need to be very sensitive to the fact that the United States is doing the world's research and development in the pharmaceutical arena which gives us the hope. Canada does not. The system described does not. Would the Senator agree with that?

Mr. FRIST. Would the Senator yield for another brief question?

Mr. FRIST. Just a quick followup question. Based on what you have said, the only choice a manufacturer has is to set it at the price that Canada allows or to not sell it. If a manufacturer decided not to sell a medicine at a price the government allowed, then is it correct that the government would authorize a Canadian company to copy and sell the drug, even without the patent holder's permission, which, it would seem to me, throws out the meaning of patents? If we throw out the meaning of patents when it comes to pharmaceuticals and drugs, what are the implications for us in this country or the person listening today who has heart disease or HIV/ AIDS, as they look with hope for that cure?

Mr. FRIST. Mr. President, I will be very brief. The Senator from Pennsylvania addresses a very important point, which forces us to look to the future in terms of future cures, whether it is for HIV/AIDS, emphysema or heart disease. He hit the point very directly, in a way that I have not heard on this floor, in response to one of the main reasons why drug prices are higher in the United States than in Canada. I would like to ask the Senator the following question. Typically, in the United States an individual company will set prices in such a way to cover research. They will look at supply, demand, and the efficacy and efficiency with which the goal of cure or prevention is carried out. In order for the prices of medicine to be sustained over time, you must allow some recoupment of that investment in research. We all know that, on average, only 3 out of 10 medicines that are eventually approved in this country actually generate enough revenue to pay for that investment over time in the United States.

Mr. FRIST. That is correct. That is the United States. The real question goes to the following: In Canada they have a very different system. Everybody looks to Canada's system as if it is similar to or in some ways better than ours. In Canada, not the United States--this is what you essentially said--is it not correct that each company is denied the freedom to set prices for its own innovative medicines?

Mr. FRIST. Mr. President, will the Senator yield for a question?

Mr. FRIST. Mr. President, the Senator made the point which is important and I tried to introduce earlier today. In this environment where we do have a lower threshold for worrying about terrorism and worrying about what comes across our borders, he made the linkage, based on his experience dealing in the field of bioterrorism and the agriterrorism arena and the field of intelligence, that we are moving in one direction of bioterrorism to close our borders to the potential for counterfeit agents, potential bioterror agents coming in. I made the point earlier that we need to look at it in this new environment. My question is, Does he agree with a recent op-ed published on July 16 in the Washington Times by a former FBI agent linking bioterrorism and prescription drugs and reimportation? The agent states: During my 3 decades with the FBI, however, I worked with other Federal agencies whose main goal was preventing illegal narcotics from crossing our borders. When going after prescription drug shipments it usually was large quantities, mostly acting on tips. Neither we nor the 3 Federal agencies we cooperated with on such efforts--the U.S. Food and Drug Administration, the Drug Enforcement Administration, and the Customs Service--had enough personnel to go after prescription drug smuggling at the time. With the massive new threat of terrorism, we have even less resources to devote to such activities. Terrorists easily could use the cover of counterfeit drug smuggling to sneak lethal prescription drugs or worse, biological and nuclear weapons, into our country. Do you agree with the thrust of the FBI's statement?

Mr. FRIST

Mr. FRIST. Mr. President, this morning the members of the Senate Committee on Health, Education, Labor, and Pensions, HELP, voted to support the nomination of Dr. Richard Carmona for the position of U.S. Surgeon General. While the Surgeon General has played a major role on health care matters for more than one hundred years, the unique challenges confronting our Nation at the beginning of the 21st century require an elevated level of leadership. The threat of bioterrorism is real--a fact made clear in the last year as anthrax attacks killed five people, infected 22, and exposed hundreds. These attacks highlighted the inadequacy of our Nation's public health infrastructure to prevent, detect, and respond to an infectious disease outbreak, whether such an outbreak is intentionally or naturally caused. Since that time, much has taken place. We in Congress have passed, and the President has signed into law, the Public Health Security and Bioterrorism Preparedness and Response Act. We have significantly increased the Federal commitment to upgrading capacity in State and local health departments and we are now considering how a new Department of Homeland Security could enhance our efforts to prevent and respond to bioterrorism. Despite these steps, we are still not fully prepared to meet the threat of bioterrorism and much work remains to be done to bolster our public health system. This will be one of the most important tasks facing the country and facing the incoming Surgeon General. Dr. Carmona's experience and expertise prepares him well for this effort. As we strengthen the public health system's capabilities, we are also challenged by a growing epidemic of chronic disease that significantly impacts our Nation's health. Take, for example, obesity. Sixty-one percent of American adults and 13 percent of children and adolescents are overweight or obese, and these rates are increasing among all age groups. In my home State of Tennessee, the rate of obesity has grown from 12 percent to 22 percent over the past decade. An estimated 300,000 deaths each year in the United States are linked to being overweight or obese. Those who are obese have a 50- to 100-percent increased risk of premature death. This problem is now one of the most serious public health challenges facing the country. Next week, Senator Bingaman, Senator Dodd, Senator Stevens, and I will be introducing the Improved Physical Activity and Nutrition Act to help address this problem. I look forward to working with Dr. Carmona to address this issue. Additionally, youth smoking and substance abuse are a significant concern. Twenty-five percent of adults smoke--with even higher rates among young adults. Tobacco use is the leading cause of preventable death in this country, and alcohol misuse contributes to one-third of motor vehicle crash related deaths. Over one-half of 10th graders have smoked tobacco. Sixteen percent of 8th graders have been drunk at least once in the past year. Twenty-five percent of high school seniors have used an illicit drug in the past 30 days. There are a number of approaches we can take to these problems as legislators. Last Congress, we reauthorized the Substance Abuse and Mental Health Services Administration, in which we included a special emphasis on youth drug abuse. But the Surgeon General bears a special responsibility to help educate the Nation about the dangers of such behavior, and I am pleased that this will be a priority for Dr. Carmona as Surgeon General. During the Health, Education, Labor, and Pensions Committee hearing on his nomination, Dr. Carmona emphasized that his priority will be prevention: to prevent unnecessary illness, disability and death. Many of the major health problems facing the country can be improved with a focus on prevention, and Dr. Carmona's focus on these issues will benefit the country as he serves us as Surgeon General. Before the hearing on Dr. Carmona's nomination, there were concerns raised regarding some aspects of his professional background. The committee appropriately inquired about these issues during the hearing. Dr. Carmona's responses were forthright and direct, and I believe he has addressed concerns about his ability to perform the duties of the Surgeon General. His background and experience as a trauma surgeon, as a director of a county health system, and as an expert in emergency medical systems, along with her personal drive and commitment to improving the health of all Americans, will serve the country well. Mr. President, I intend to support Dr. Carmona's nomination. I urge my colleagues to support him as well.

Mr. FRIST

Mr. FRIST. Mr. President, I rise to speak on the underlying bill and on the background for Medicare, Medicare modernization, and strengthening Medicare. First, I am delighted the discussion of health care security for our seniors has reached this stage of debate, active discussion, and active deliberation in this body. The House of Representatives admirably took this issue head on, worked very diligently through a committee process, and produced a bill, after debate, after discussion, and it passed. The House bill received a majority of votes and represents a very deliberate and very solid effort to address the cost of prescription drugs. More importantly, it addresses the issue of health care security--including prescription drugs as a part of the armamentarium physicians or nurses can use in looking seniors in the eyes and saying their health care security can be complete by passage of this bill. I think this is the crux of the issue. Now is the time for us to act to include prescription drugs--that powerful tool, that powerful element of health care as we know it today--as part of the overall health care security package for our seniors. Including a prescription drug benefit within Medicare is long overdue. Prior to coming to the Senate, I was blessed to spend 20 years providing care to thousands of Medicare patients in the field of chest, heart, lungs, pulmonary status, emphysema, lung cancer, heart disease, and stroke. Thirty years ago, medicines, including prescription drugs, were used in these fields. However, 20 years ago prescription drugs were used a lot more, 10 years ago even more, and today they are an absolutely essential part of health care delivery. As a surgeon, I do not want to say prescription drugs are more important than surgery, but it is getting to the point that medicines people take every day are equally important in acute and chronic care and in disease management. Now is the time for us to address the financing of health care delivery in this country, both in terms of the organization of health care delivery and insurance coverage. Everybody knows the Medicare Program is absolutely critical to health care security. I think my colleagues in the Senate will agree that Medicare, health care security for our seniors and for our individuals with disabilities, is critically important and vital. It is imperative that we do not forget that the Medicare debate applies to both seniors and those with disabilities. I believe now is the time to strengthen it. Others might say to modernize it. Yet even others will say to reform it. Whatever word is used, now is the time to take a 1965 program which has been modified over the years in the way that we incrementally do things--and strengthen the program. We need to modernize the program to truly deliver what our seniors and disabled individuals expect us to do--to give them health care security. So whether one uses the word ``save,'' ``strengthen,'' ``modernize,'' or ``reform,'' now is the time to have a discussion on the floor about the process itself. As some people listen to the debate about Medicare and prescription drugs, many will question why we need to address the process. The process is important to help move such complex bills along in order to produce a good bill that can be married with the House bill. We can accomplish what most people want to achieve affordable access to prescription drugs for our seniors. This is a complicated issue because the overall cost of prescription drugs will continue to escalate unless we fix it. Furthermore, health care delivery will continue to change in terms of the overall relative importance of inpatient hospital care, outpatient care, acute care, chronic management, and disease management. The process is designed to take this complex bill which could potentially be the single largest expansion of an entitlement program and modernize it, including the coverage of prescription drugs. It is important to enact a bill in a responsible way. The demand for prescription drugs is going to be high because people will be counting on drugs for cures and to improve quality of life. With that sort of potential growth superimposed on a Medicare Program which is not designed for such growth, the impact will literally bring the overall program down. For some time, the President and I have argued that as we look for prescription drug coverage inclusion, we need to do it in a way that is responsible to the American people--to seniors, to individuals with disabilities, to the taxpayer, to the current generation. This is also important to the next generation coming through the system who, if we do not appropriately fix Medicare, simply will not have the Medicare Program that they expect and deserve for their parents or for them a generation from now. Therefore, Medicare must be strengthened. Medicare must be improved. I argue we should address prescription drugs through a process that includes the committee structure, where appropriate debate can be carried out. It is not clear if people have followed the debate over the course of today, including which bills are going to be considered, if there are going to be large bills to modernize all of Medicare, if there are going to be very specific bills that look at the prescription drug package to be placed in Medicare, or whether there are going to be catastrophic plans. I am hopeful, if we are going to bypass the committee process and come directly to the floor, that we debate all of those bills so the American people and our colleagues will have the opportunity to see the range of alternatives. If we consider just one bill, especially if it is a very partisan bill and has not been taken through a committee process, the long-term risk to the American people is huge. This will not just affect Medicare beneficiaries but will impact generations who will be Medicare beneficiaries in the future and the people who are paying for Medicare today. Pharmaceuticals are a critical component of health care delivery. Now is the time to act, so let's do it. Let's not talk about a plan that will take effect 3 years, 4 years, 5 years from now. Let's go ahead and start today and let's do it in a responsible way. Other Medicare issues my be addressed if health security is our goal. These issues include preventive services and other benefits that are covered by private health care plans today that are not covered in Medicare. When we strengthen, reform and modernize Medicare, we need to do so in a more comprehensive fashion. We need to look at the Federal Employees Health Benefits Plan, the FEHBP--the health insurance coverage my colleagues and I have. You do not hear us complaining very much about our health care insurance. It is the same plan through which about 10 or 11 million Federal employees get their health care today. We ought to look at that model as we look to include prescription drugs. There are a number of principles that do need to be stressed as we look forward because we do not know exactly what amendments are going to be coming to the floor today or over the next several days as we consider prescription drug coverage. I would like to stress four principles as we consider prescription drug benefit plans. First, a prescription drug benefit should be permanent, affordable, and immediate. By ``permanent,'' I mean that we should not look at bills that will fix the program in another 4 to 5 years, rather, we need a bill to fix the program sooner. We need to act now. We need to have a bill that will help seniors and individuals with disabilities as soon as possible. So, I argue we should not start a bill or legislation and have its effect, say, 3 years from now. When I say a prescription drug benefit should be permanent, I think it is dishonest for us to tell seniors that this is the fix when it only applies for 4 years to 6 years. It should be incumbent upon us to develop a plan, a proposal. We need to be smart enough to do it in a bipartisan fashion and include time for adequate discussion, so that we pass a bill that can be sustained over time--whether in times of deficit, or surplus. Additionally, a prescription drug benefit needs to take into consideration breakthroughs in medicine that find cures, treat or prevent such diseases as heart disease, Parkinson's disease, emphysema, and other lung diseases. Therefore, such a benefit must be sustainable to the best of our ability over time. That means when we look at a plan, we don't say it starts at 2005 or 2006 or 2 years from now, and then sunsets 5 years later. I think we need to be honest with seniors and the current generation who is paying for Medicare today by ensuring that this plan is something that can be sustained to the best of our ability, and that it can be sustained over time. So, principle number 1 provides for a permanent, affordable, and immediate prescription drug benefit. A second principle is that a prescription drug benefit should, in some way restrain what cannot be sustained long-term--the skyrocketing cost of prescription drugs that we see today. Seniors and individuals with disabilities cannot afford the high costs of drugs. Likewise, people in the private sector cannot afford it. Thus, a prescription drug benefit must lower the cost of prescription drugs. I would argue the only known way of doing that long term is through an element of competition, an element where you have informed consumers. It is an obligation of us in government to inform consumers. Consumers are those on the front line--seniors listening, to patients, to doctors, to nurses. Really, it boils down to what is happening at the doctor/ patient relationship, to involve an element of educated consumers making smart, and commonsense decisions, long term. The Congressional Budget Office has found that bills similar to Senator Daschle's bill, which will likely be coming to the floor later this week, would not decrease overall drug costs, but would increase drug costs. According to the Congressional Budget Office, bills that rely on public/private sector partnerships and an element of competition will help maintain the costs of drugs. For example, the House of Representatives bill that passed by a majority vote illustrates this point. Additionally, the Breaux-Frist bill, introduced in the 106th and 107th Congress, is based on the Federal Employees Health Benefits Plan model which relies on the private/public partnership. Overall, these bills include an element of competition, capturing the very best of the public and the private sector working together and reducing drug costs for seniors. The third principle--following the first principle of permanent, affordable, and immediate prescription drug benefit and the second principle of competition to lower the cost of prescription drugs--is that a prescription drug benefit should be fiscally responsible. We need to do it. We need to act in this Congress. We need to act now so it will take effect now, and we need to do it responsibly. This is where dollar figures are important, so we know what these relative alternatives are all about. Experts estimate proposals offered by Senator Daschle and some Senate Democrats would cost at least $600 billion over the next 8 to 10 years. In a time of deficit spending and in a time where the economy is tough, this would ultimately require cuts in other fields like education, national defense and Social Security. Furthermore, it would place a heavy financial burden on the current generation receiving benefits, the generation that is paying for those benefits, and the following generations. The fourth principle I would like to stress is that a prescription drug benefit should be bipartisan. That means we need to come together. This is a big challenge. This is a big, new entitlement that at the end of the day is likely to be adopted--and I would argue should be adopted--if it is done in a responsible way. I would argue in this climate, especially in this climate where the Senate is about 50-50, where the American people are about 50-50 in terms of partisanship, that the only way for us to succeed is through a bipartisan bill. We need to have people from both sides of the aisle working together in a commonsense, rational way. Yes, we will concede to tradeoffs on either side to come to common ground. But we need to do it in a bipartisan manner. The good news is that if we can pull it off with the right leadership, if we can pull it off with people who recognize the importance of pulling people together, we can do it and it can be done now. This will result in seniors benefitting very soon. It can be done in a way that is sustainable. I am absolutely convinced there are enough people who will work together in a bipartisan way on both sides of the aisle--majority of Republicans and majority of Democrats--so we can pass such a bill. That is a challenge. It is a challenge because we have about 112 days left until the elections commence. The real risk is in trying to pass such a major piece of legislation in a partisan way--partisan could bring it down to where we do not pass a bill. Amidst all the talk at the end of the day, there are not going to be sufficient votes because the bills are not bipartisan. A lot of the discussion today has been basically the other side of the aisle reaching out and saying we are ready to move forward, we want to take action. But much of the backdrop, is that the Senate Democrats today actually canceled or postponed a markup because of a fear that the tri-partisan bill that normally--normally the bill would come through the Finance Committee to be debated and amendments could be debated and passed or failed. There could be good debate among 20 people in that Finance Committee. The committee of jurisdiction was bypassed today with these bills being brought directly to the floor. If you agree and if the American people agree that a prescription drug benefit is big, now is the time to act. The only way in an environment today that tends to be partisan because of these elections is to demand bipartisanship. The only way to pass a prescription drug benefit is to openly consider the bipartisan and the tripartisan bills. And we do that, I again argue, first in the Finance Committee; however that does not look like that is going to happen. I want to make absolutely sure that the Republicans are not overstating the importance of taking a bill this big through the Finance Committee before coming to the floor of the Senate. The tripartisan bill--the bill that has the majority of votes in the Finance Committee--has not been debated and has not been voted on or marked up in the Finance Committee. Additionally, the bill that Senator Daschle likely will bring to the floor sometime in the next several days is a strictly partisan bill which has not been considered in the Finance Committee either. The American people need to understand that Senator Daschle is playing straight up politics. I asked the Congressional Research Service to look up the top 10 or so major Medicare bills which passed the Congress over the past two decades and to find out: (1) Where were they first considered? (2) Did they bypass committee and brought directly to the floor of the Senate? They responded. It is very interesting. It looks as if there are about 12 to 15 major bills that have been considered over the past two decades. With the exception of one, all of these bills were considered and reported by the Senate Finance Committee before they were enacted into law. Those bills, again for reference--were TEFRA in 1982, DEFRA in 1984, COBRA in 1986, OBRA in 1978, the Medicare Catastrophic Coverage Act of 1998, the repeal of the Medicare Catastrophic Coverage Act in 1989, OFRA in 1989, OFRA in 1993, BBA in 1995, BBA in 1996, BBRA in 1999 were considered through the Finance Committee. The only legislation out of the 13 which bypassed committee was BIPA in 2000. BIPA is the only piece of legislation out of the 13 bills that did not have Finance Committee consideration before congressional passage. However, I should note that even that particular bill--BIPA--was overwhelmingly bipartisan and passed overwhelmingly as part of the HHS appropriations in the year 2000. I mention this because it is important for the American people to understand the importance of the process which is now being bypassed in order to consider bills, which if they remain partisan will simply not pass this body. Let me comment briefly on what I think and what I expect will happen over the next several days. I expect tomorrow we will continue to debate the underlying reforms in Hatch-Waxman. I look forward to hearing from Senator Hatch and others about that particular bill. There will be several existing bipartisan proposals that are currently being filed and currently being submitted that will be introduced. I think we will have a good debate on a range of issues. It will be an educational process as we go through each of the amendments in the bills that come forward. I hope as we consider these bills that we have as a goal to make them not political issues but to make sure that they are substantive policy issues that come forward. It is simply too important to be playing politics with our seniors' health care security. I think there will be a lot of opportunity over the next few days to talk about these specific Medicare proposals. Let me close and simply comment on the patent reform bill and the modifications in Hatch-Waxman that we will in a more systematic way begin to address tomorrow. I think access to prescription drugs clearly needs to be the focus as we go forward, but the overall cost is important too because if you have prescription drugs and other drugs escalating with skyrocketing costs, there is, I think, no system that we can contain that long term over time. The Hatch-Waxman law, which was passed in 1984, has been tremendous, but it has an impact on cost. The cost issues that we see in the private sector today are increasing 11, 12, and 13 percent. I don't think health insurance can simply be sustained in the long term. One major component of the increase in coverage is prescription drug costs which continue to skyrocket. But I need to caution my colleagues who did not have the opportunity to sit through the Hatch-Waxman hearings in the Health Committee, it is pretty technical. It is important that we go back and do it right, that we fix Hatch-Waxman, or that we update it and modernize it because it really hasn't had a major look since 1984. But we must do it in a way that maintains the very careful balance that legislators very smartly put together in 1984. The balance boils down to the fact that you have prescription drugs in the pharmaceutical industry that values patents and certain protections. Because they have those protections for a period of time, they are willing to invest, they are willing to innovate, they are willing to discover, and they are willing to put capital at risk. It is imperative that we all know how important that is. The only answer to finding a cure for coronary sclerosis, for pulmonary emphysema, for acute types of leukemia, or for something as big as HIV/AIDS is going to be research. Furthermore, I would argue that most of the world's research is being conducted in the United States of America. Nevertheless, the protection and the incentives that we give to make these great discoveries must be balanced. This is the balance that was achieved by Hatch-Waxman with access to drugs. That, in large part, is determined by a strong, a productive, a broad, a growing generic drug industry where we know that important drugs are available at a reasonable cost. When Hatch-Waxman started, generics were only about 20 percent of all drugs. Now it is much greater--greater than 50 percent. But it is time to focus on some of those deficiencies in Hatch-Waxman. It is that balance that needs to be reviewed because both generic prescription drug companies and brand name companies have abused or found loopholes in Hatch-Waxman. Now is the time to fix the loopholes. We need to do that in a correct manner. That is what much of the debate will be about as we go forward. Another topic, we had the opportunity last week on a couple of days to talk about is bioequivalence. It too is a little bit technical. But it is very important because, if we get it wrong, it is not just a cost issue. If we get it wrong, it can affect safety issues in terms of drugs and generic drugs. The Hatch-Waxman law allows generic companies to market off-patent drugs if they are demonstrated to be bioequivalent. There are definitions of bioequivalence that are applied today. If you have drug A, and you have another drug, and you are saying, well, this drug is the same as drug A, you want to make sure when you actually take that drug that it has the equivalent impact in fighting disease, the impact that it is billed to have, that the active ingredient is absorbed at the same rate, and that the side effects are the same. The bill, which is the underlying bill on the floor today, could significantly weaken this important patient protection by giving the Food and Drug Administration, the FDA, broad authority to relax the statutory Hatch-Waxman bioequivalency standard. Senator Hatch will be on the floor in the next several days, I am sure. I look forward to joining him in talking about a range of issues that are of concern to him--and he has been around a long time in terms of watching this bill and watching the effectiveness of this bill--and myself and many others. Again, there are many other Members on the floor who wish to talk, so I will bring things to a close. But I wanted to bring forward the principles that I think should underline the debate as we move forward. I wanted to point out, in the bill that is currently actively on the floor, this modification of Hatch-Waxman. There are a range of issues, such as bioequivalence, that I look forward to debating and talking with others about. At the end of the day, in order for us to really be able to look seniors in the eyes and say, health care security is what this bill is all about, it means we are going to have to work together, we are going to have to do it in a way that is bipartisan, that clearly does not have strict partisanship. We cannot play politics with an issue that is this important. I look forward to working with my colleagues as these bills more formally come to the floor. Thank you, Mr. President.

Mr. FRIST. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. FRIST

Mr. FRIST. Mr. President, the Great Smoky Mountains National Park is truly the crown jewel of our national park system. With towering mountains, clear streams, and a diversity of wildlife, Tennessee is fortunate to have such a tremendous treasure in our own backyard. During the Senate's July break, I returned to the Smokies, to once again hike Mt. LeConte, this year with my oldest son, Harrison. Our hike up the Alum Cave trail was exhilirating, and we spent the night at LeConte Lodge, watching the sunset, and enjoying the hearty meals and good fellowship of fellow hikers. My trip to the Smokies this month had another purpose, too. This year, I invited EPA Administrator Christie Whitman to join me in order for her to see first-hand the air quality problem that plagues our beautiful park. Over the coming months, Congress and President Bush's Administration will analyze and pursue policies to improve our nation's air quality. As this process moves forward, I wanted to make sure that the President's top official responsible for protecting our environment heard directly from park officials and saw for herself the unique challenge facing the Smokies. As the first EPA Administrator to ever visit the park, Administrator Whitman demonstrated her personal commitment to address the pollution problem. We hiked to the park's highest point, Clingman's Dome, where Administrator Whitman looked out on a vista where natural visibility should be about 77 miles, but on the hot July day we visited, was reduced to only 15 miles. Air entering the southern Appalachians is trapped by geography and weather patterns, capturing pollution and harmful emissions in the park, and no where is that point made more clear than at Clingman's Dome. Any plan to clean up the air in the Great Smoky Mountains National Park must contain two essential elements. First, we must reduce harmful emissions of sulfur dioxide and nitrogen oxides. President Bush has proposed a plan, the Clear Skies Initiative, that contains the most dramatic reductions in these harmful emissions ever proposed by an administration. The plan would reduce power plant emissions by 70 percent by the year 2018. I will continue to closely study the Clear Skies Initiative and its potential impact on our mountains and across our state. Second, we must reduce emissions in the most efficient and effective manner possible. Our quality of life and future economic development depends on how we pursue these reductions. Tennessee's families, businesses and communities depend on affordable and reliable energy. A thoughtful and responsible approach to address the park's air quality issue requires us to closely examine any proposal and to ensure it is based on sound science. Tennesseans and all Americans deserve no less from their elected officials. It is also important to remember that air quality is a comprehensive problem that requires a comprehensive response. Roughly, one-half of the problems in the Smokies are caused by power plants, one third by cars and trucks, and the rest from various other sources. As we review solutions, we must address every source of emissions. For example, I want to commend local officials for Pigeon Forge's recent Clean Air Week which promoted reducing emissions through the use of low emissions public transportation. Park officials are looking at alternatives to transportation problems in the park, which will not only clean up the air, but enhance the overall visitor's experience. Continued discussion by all, local, State and federal officials along with concerned citizens, will ensure the most innovative, common-sense solutions and ensure we do what's right for the Smokies. Tennesseans are blessed with an abundance of natural resources, and the Great Smoky Mountains National Park is world-renowned. However, we must be mindful that if we are to continue to enjoy the Smokies, all of us have a responsibility to be good stewards of the park. I am committed to fight for what is best for the Smokies, and I am encouraged by Administrator Whitman's recent visit. The Smokies are a unique American experience that must be preserved for generations to come, so that fathers and sons, just like Harrison and I, can know the joys of spending time together on a hike in the woods.

Mr. FRIST

Mr. FRIST. Mr. President, I thank the distinguished chairman and ranking member of the Senate Armed Services Committee for their assistance and support in authorizing funding for a military construction project of critical importance to the State of Tennessee and the United States. I also thank the skilled staff members on the Senate Armed Services Committee who assisted this action: George Lauffer and Michael McCord. The amendment in question was advanced by Fred Thompson and I to authorize $8.4 million in funding for the construction of a Composite Aircraft Maintenance Complex at Berry Field Guard Base in Nashville, TN. This important project is vital to the combat readiness for the 118th Air Wing of the Tennessee Air National Guard. Currently, the 118th is housed in a variety of substandard buildings, some of which are more than 40 years old. This collection of buildings encroaches upon the aircraft clear zone making it difficult for personnel to work and drill, impeding combat readiness and jeopardizing aircraft safety. Aircraft cannot be moved into hangars properly or left on jacks due to wind conditions. All of these problems combine to create significant safety problems and increase the amount of time it takes to repair damaged aircraft. In addition, the 118th needs nine airfield waivers to operate and continue its mission. By constructing this new complex, several of those waivers will be eliminated and the base will be a safer and more efficient place to accomplish its vital mission. I would like my colleagues to know that the 118th played a vital role in the immediate response to the 9-11 tragedy and continues to contribute importantly to the ongoing national security needs of the country. One item of human interest occurred within an hour after the World Trade Center was attacked by terrorists and all of the Nation's aircraft were grounded by the President. The 118th was called and given approval to fly a donated liver from Nashville to a little girl in Houston, TX. At that time, only three non-fighter aircraft were in the air over the United States--Air Force One, its supporting tanker, and a lone C-130 from the 118th. In the shadow of thousands of people killed in New York City that day, the 118th had the privilege of helping to save a life. In the weeks after September 11, the 118th was given numerous alert missions requiring Tennessee Air Guardsmen to be on call 24 hours a day, 7 days a week. The aircraft and maintenance personnel were sleeping in an old converted aircraft hangar at night and prepared to fly anywhere at any time. Early in the month of October 2001, the 118th was again called for an extremely vital mission of National Security and Homeland Security Support. The 118th was one of only five C-130 units deployed for Operation Noble Eagle-QRF (Quick Reaction Force). Their mission was to deploy as soon as possible to a forward base, and be ready for 24/7 operations with a 1-hour alert call out. The 118th proudly performed this mission faster and better than any other Air National Guard, Air Force Reserve, or Active Duty unit. Within 22 hours of notification, the 118th had aircraft in the air moving forward, and was the sole C- 130 unit operationally ready at the 48-hour mark. Over the next 4 months--between October 2001 and February 2002--the 118th became the standard to which other units trained in relation to the QRF. The 118th maintained operational readiness with one-third of the unit deployed, and still preserved exceptionally high training standards at home station. To date, the 118th has activated more than 340 individuals to support the worldwide mission. The unit is currently supporting Air Mobility Command with 33 percent of its aircraft on a daily basis flying active duty missions. Back at home station, Command and Control has been operating 24/7 ever since September 11. The 118th Command Post and Crisis Action Team have played a critical role in the direction and guidance of the unit's response to every assignment and emergency that has arisen. The base medical department, normally two full-time people, has increased to 13 in order to support the increasing number of wing personnel now on active duty. In conclusion, on behalf of the men and women of the 118th Airlift Wing, Senator Thompson and myself, I would like to thank the chairman, ranking member, and our Senate colleagues for authorizing this important funding.

Mr. FRIST

Mr. FRIST. Mr. President, today I rise to introduce, with Senator Feingold and Senator Lugar, a bill that could have a far-reaching impact in preserving some of the most pristine tropical forest in the world. We seek to amend the Tropical Forest Conservation Act, TFCA, a law passed in 1998. The TFCA has led to the preservation of thousands of acres of tropical forest, particularly in the Americas, by allowing low and middle income countries to engage in debt-for-nature ``swaps.'' The TFCA allows eligible governments to divert resources currently needed for debt service toward the conservation and management of disappearing rain forests. Our amendment to TFCA would expand the use of this successful program. Our change would allow more tropical forests to be preserved. Under TFCA, countries are limited to using concessional debt for making swaps. Concessional debt is special low-interest loans reserved for the poorest countries to exchange non-concessional debt, e.g. Export-Import bank loans, etc. for preserved forest land. This change will not only increase the potential for swaps in countries with concessional debt, but also make some countries newly eligible for the program. One example of a country that is not currently eligible for TFCA, but that has great potential for using the expanded program, is the African nation of Gabon. Gabon has some extraordinary, pristine forest land that deserves to be preserved. In the fall of 2000, the National Geographic Society sponsored a 2000-mile, 15-month expedition through Central Africa by Dr. Mike Fay, a well known conservationist. Dr. Fay traveled through some of the last unexplored regions on earth, including the Langoue forest in Gabon. His expedition encountered a remarkable variety of species and habitat that are in danger of disappearing unless we help Gabon's government preserve it. Dr. Fay's observations of the Langoue Forest are compelling. Here are some excerpts from his report: ``[T]here's a river in almost the dead center of Gabon called the Ivindo which has an amazing set of waterfalls. It's a big river, probably a hundred or so meters wide, of slow, black water, and it drains almost all of northeastern Gabon. These chutes, these waterfalls--two in particular called Mingouli and Kongou--make this place an attraction. An Italian named Giuseppe Vassallo, who died about a year and a half ago . . . promoted this place as a national park because he said it was the best forest in Gabon. He talked about it and lobbied for it and cajoled people, but it just never quite happened. We walked across this block that he'd always talked about, and I actually flew over it with him in '98 . . . And we discovered the highest concentration of giant elephants that we'd seen on the entire walk. It's probably the only place left in the central African forest with elephants that are abundant and with a large percentage of very large males, tusks that no one has seen in a very long time, one hundred pounds on a side. Giant elephants, it's something you just don't see because they've been pouched out of the population. [And] naive gorillas, something that we hadn't seen on the entire trip. You can tell they're naive because when they see you they don't run away, they don't look alarmed, they don't act alarmed, they don't vocalize. The males don't charge at all and they get very curious. They come to see you and they approach well within the danger zone. They sit there for hours and they just stare as if it's something they've never seen before, and it's pretty obvious that they haven't. You travel a little bit farther along and there's this mountain that we'd been navigating toward for a few weeks, and it's again full of elephants, and it's got all kinds of beautiful topography and rocky cliffs. It's a real sort hidden forest, and it really gives you a feeling of great isolation being up on this mountain plateau. So we started walking south of the mountain and pretty soon we came upon an elephant trail that lead us a little bit astray. It lead us to the east of where we wanted to go but we kept on following it and it just got bigger and bigger and bigger. I looked a the map and it was obvious that it was navigating us right toward a clearing. Long before you get to an elephant clearing you can tell where you're going, because the elephant trail opens up to like two meters wide, it's covered with dung, and there's a huge amount that are on these ``highways.'' It's a lot like how major highway arteries in the States get bigger as they go into the city, that's basically what it is for elephants, it's an ``elephant city.'' So, we get there, and there it is, this clearing that no one has ever seen before, no conservationist even could have imagined existed in Gabon. This place is just abounding with wildlife and you think ``This place really is what old Giuseppe said it was.'' Even though he had never walked in it, it was as if he just knew this place was the best. The place is called Langoue and it still exists. There are about 1.2 million acres in the Langoue Forest that are completely untouched. Experts familiar with the region estimate that more than 700,000 acres at the heart of the forest could be preserved for about $3.5 million. This part of the forest includes the naive gorillas, the giant elephants, and the waterfalls. At the very modest cost, our amendment will give nations like Gabon a new tool for preserving their remaining tropical forest, for the benefit of the people of Gabon, and for the benefit of mankind. I ask unanimous consent that the full text of the interview with Dr. Fay and the text of a letter from Conservation International appear at this point in the Record.

Mr. FRIST

Mr. FRIST. Mr. President, today I rise to introduce, with Senator Feingold and Senator Lugar, a bill that could have a far-reaching impact in preserving some of the most pristine tropical forest in the world. We seek to amend the Tropical Forest Conservation Act, TFCA, a law passed in 1998. The TFCA has led to the preservation of thousands of acres of tropical forest, particularly in the Americas, by allowing low and middle income countries to engage in debt-for-nature ``swaps.'' The TFCA allows eligible governments to divert resources currently needed for debt service toward the conservation and management of disappearing rain forests. Our amendment to TFCA would expand the use of this successful program. Our change would allow more tropical forests to be preserved. Under TFCA, countries are limited to using concessional debt for making swaps. Concessional debt is special low-interest loans reserved for the poorest countries to exchange non-concessional debt, e.g. Export-Import bank loans, etc. for preserved forest land. This change will not only increase the potential for swaps in countries with concessional debt, but also make some countries newly eligible for the program. One example of a country that is not currently eligible for TFCA, but that has great potential for using the expanded program, is the African nation of Gabon. Gabon has some extraordinary, pristine forest land that deserves to be preserved. In the fall of 2000, the National Geographic Society sponsored a 2000-mile, 15-month expedition through Central Africa by Dr. Mike Fay, a well known conservationist. Dr. Fay traveled through some of the last unexplored regions on earth, including the Langoue forest in Gabon. His expedition encountered a remarkable variety of species and habitat that are in danger of disappearing unless we help Gabon's government preserve it. Dr. Fay's observations of the Langoue Forest are compelling. Here are some excerpts from his report: ``[T]here's a river in almost the dead center of Gabon called the Ivindo which has an amazing set of waterfalls. It's a big river, probably a hundred or so meters wide, of slow, black water, and it drains almost all of northeastern Gabon. These chutes, these waterfalls--two in particular called Mingouli and Kongou--make this place an attraction. An Italian named Giuseppe Vassallo, who died about a year and a half ago . . . promoted this place as a national park because he said it was the best forest in Gabon. He talked about it and lobbied for it and cajoled people, but it just never quite happened. We walked across this block that he'd always talked about, and I actually flew over it with him in '98 . . . And we discovered the highest concentration of giant elephants that we'd seen on the entire walk. It's probably the only place left in the central African forest with elephants that are abundant and with a large percentage of very large males, tusks that no one has seen in a very long time, one hundred pounds on a side. Giant elephants, it's something you just don't see because they've been pouched out of the population. [And] naive gorillas, something that we hadn't seen on the entire trip. You can tell they're naive because when they see you they don't run away, they don't look alarmed, they don't act alarmed, they don't vocalize. The males don't charge at all and they get very curious. They come to see you and they approach well within the danger zone. They sit there for hours and they just stare as if it's something they've never seen before, and it's pretty obvious that they haven't. You travel a little bit farther along and there's this mountain that we'd been navigating toward for a few weeks, and it's again full of elephants, and it's got all kinds of beautiful topography and rocky cliffs. It's a real sort hidden forest, and it really gives you a feeling of great isolation being up on this mountain plateau. So we started walking south of the mountain and pretty soon we came upon an elephant trail that lead us a little bit astray. It lead us to the east of where we wanted to go but we kept on following it and it just got bigger and bigger and bigger. I looked a the map and it was obvious that it was navigating us right toward a clearing. Long before you get to an elephant clearing you can tell where you're going, because the elephant trail opens up to like two meters wide, it's covered with dung, and there's a huge amount that are on these ``highways.'' It's a lot like how major highway arteries in the States get bigger as they go into the city, that's basically what it is for elephants, it's an ``elephant city.'' So, we get there, and there it is, this clearing that no one has ever seen before, no conservationist even could have imagined existed in Gabon. This place is just abounding with wildlife and you think ``This place really is what old Giuseppe said it was.'' Even though he had never walked in it, it was as if he just knew this place was the best. The place is called Langoue and it still exists. There are about 1.2 million acres in the Langoue Forest that are completely untouched. Experts familiar with the region estimate that more than 700,000 acres at the heart of the forest could be preserved for about $3.5 million. This part of the forest includes the naive gorillas, the giant elephants, and the waterfalls. At the very modest cost, our amendment will give nations like Gabon a new tool for preserving their remaining tropical forest, for the benefit of the people of Gabon, and for the benefit of mankind. I ask unanimous consent that the full text of the interview with Dr. Fay and the text of a letter from Conservation International appear at this point in the Record.

Mr. FRIST

Mr. FRIST. Madam President, as a Member of the U.S. Senate and as a physician, I would like to take the opportunity to alert my colleagues to the Defeat the Heat campaign for America's children. Defeat the Heat is a new public safety campaign created by the National SAFE KIDS Campaign, the National Athletic Trainers' Association (NATA) and Gatorade. The campaign's purpose is to educate parents and kids about the dangers and the prevention of dehydration and heat illness. The goal is to teach parents to think of fluids as essential equipment for playing sports, just as they would regard a helmet or shin guards to be protective gear. A survey commissioned by the National SAFE KIDS Campaign reveals that more than three in four parents of active 8-14 year olds do not know how much fluid their kids need to replace what is lost through perspiration, and many do not know how to prevent dehydration. A child can lose up to a quart of sweat during a 2-hour sports game. There are several physiological factors that make children more vulnerable to heat-related illness than adults. Children absorb more heat from the environment because they have a greater surface-area to body-mass ration than adults--the smaller the child, the faster the heat is absorbed. Also, children are not able to dissipate as much heat as adults through perspiration. They produce more metabolic heat during physical activity and do not have the same physiological urge to drink enough fluids to replenish sweat losses during prolonged exercise. How can we help America's children defeat the heat? Drinking enough of the right fluids is the best defense against heat illness because dehydration is one of the first steps to more serious heat-related conditions like heat stroke and heat exhaustion. Children should be sure to drink before, during, and after activity and never wait until they feel thirsty to drink. If children feel thirsty, their body is already dehydrated. It is with great pleasure that I join my fellow Tennessean, Coach Pat Summitt, six-time national champion NCAA Women's Basketball coach at the University of Tennessee, the National SAFE KIDS Campaign, the National Athletic Trainers' Association (NATA), Gatorade, and others in this admirable and worthwhile cause to educate parents about these health risks. As a physician, it is my hope that parents become active in this program to help their children defeat the heat.

Mr. FRIST

Mr. FRIST. Madam President, I rise for a few minutes to discuss in morning business an issue that involves essentially every American today, and that is an issue regarding the shortage of vaccines. Every day, thousands and thousands of parents take their children to physicians' offices all across this great country, not because their children are sick or in response to an acute illness, but because they understand the importance of preventing a potential illness. They want, and they rightfully expect, their children will be able to receive vaccines needed to prevent illnesses that range from tuberculosis to measles to mumps to rubella to chicken pox. Yet--and I tell this to my colleagues and to people listening across the country-- the fact is that many of these parents are being turned away with their children still vulnerable to some of these very destructive and often deadly diseases. Five vaccines that prevent eight childhood diseases have been in short supply in the United States since last summer. Thankfully, there have been no major outbreaks among American children. We thankfully have been vigilant about vaccinations in this country in recent years, and our population on the whole has built up a strong immunity. But we have a short supply of vaccines today. The longer these vaccine shortages continue, the more vulnerable our children become. If we do not take prudent steps today in Congress to address these current and recurring vaccine shortages, it is almost certain--from a public health standpoint, from what we know today--that American children will experience an outbreak of diseases that we have the tools, we have the ability, we have the medicines to prevent. Is it possible to have these destructive diseases appear in this day and time? The answer is yes, and these vaccines that are in short supply today in our country are necessary to prevent such outbreaks that have occurred in other industrialized nations. If we look at Japan, for example, vaccination rates for whooping cough dropped from the 80-percent rate in 1974, to 10 percent in 1976-- from 80 percent to 10 percent over a 2-year period. This caused a dramatic rise in the incidence of the disease from 400 cases and no deaths, to 13,000 cases and 41 deaths within 5 years. The vaccine for pertussis, which is whooping cough, diphtheria and tetanus is one of the five vaccines in short supply. The others are for tetanus, measles, mumps, rubella, chicken pox and pneumococcal disease, which can lead to pneumonia, bacteremia--that is bacteria floating in your blood that can give you fever and make you ill--and meningitis, which is inflammation of the structures that surround the brain. These vaccines for our children are in short supply. The Centers for Disease Control and Prevention, the CDC, reports that new supplies of these vaccines will be available soon. That is good news. Two of the vaccines that are now in short supply will be available later this summer, two more by the end of the year, and the last one in the fall, we believe--maybe a little bit later. That is welcome news. But the underlying, fundamental problems that have caused the current shortage--and past shortages--if not addressed, will cause another shortage in the future. Vaccine shortages will occur year after year, time after time, if we do not act. Now is the time to address the fundamental problems underlying these shortages. Today, there are only four manufacturers producing vaccines for America's children. Of those four, only two are American companies. New companies that may want to produce vaccines are confronted with this dual risk of increasing liability and at the same time questionable return on investment. When you put those two together, there are fewer and fewer manufacturers, and that is contributing to this shortage. The remaining vaccine manufacturers are upgrading and expanding production facilities. Again, that is good news. Even if we have a flood in the supply of vaccines to take care of current shortages, it will be only a matter of time when we have another drought for these lifesaving vaccines. We must address the underlying, fundamental reasons for these recurring vaccines shortages. We have to do that in a thoughtful and comprehensive way based on what we know are the realities in terms of production and usage. It is the job of the Senate to set this framework in place. In March, I introduced the Improved Vaccine Affordability and Availability Act. This act does a number of things. In essence, it requires the Federal Government to build and maintain a 6-month supply of prioritized vaccines that we and our public health and our medical communities agree are necessary to prevent these preventable diseases. This would stabilize the supplies over time and help us to be better prepared in those years in which vaccine production cannot meet the demand at that point in time. It would also expand the funding available for State and local efforts to boost immunization rates. You can have the vaccine and know that the vaccine prevents disease, but unless you actually apply that vaccine to our children it is not going to do much good. This increased vaccination effort will focus on adults and children who are underserved or who are at high risk of contracting vaccine-preventable diseases. Perhaps the most important provisions in this bill are modifications to help restore balance to a program called the Vaccine Injury Compensation Program. This program was created about 20 years ago, in the mid-1980s, to rapidly compensate those who suffer serious side effects from vaccines that we recommend, from a public health perspective, our children receive. It has been very successful. This program also reduces the burden of litigation for doctors and nurses who administer the vaccines, as well as for manufacturers. Until a few years ago, the program seemed to work very well. But now factors threaten it from working so well and will cause an impediment to the supply of vaccines over time. Let me briefly explain. We have had a rush of new law suits, which are threatening our vaccine supplies. The Vaccine Injury Compensation Program is literally being overwhelmed today with new cases. Many of those are broadly without merit. As a result of the program's 240-day decision deadline, State and Federal courts are increasingly becoming the forum for expensive litigation. And many of the meritorious claims and justified claims are not being decided in a timely way. One pending lawsuit is for $30 billion in damages--$30 billion. If you look at the whole value today of the global vaccine market, the total value is only $5 billion. This one lawsuit is six times the global market for vaccines. This climate of legal uncertainty has contributed to an exodus of manufacturers from being in the business at all and also from being in the business here in the U.S. We have seen a subsequent rise in the price of vaccines. Since the 1980s, the number of vaccine manufacturers has dwindled from 12 down to 4. In some cases, only a single manufacturer is producing some of our most critical vaccines. The Improved Vaccine Affordability and Availability Act--S. 2053--restores balance to the Vaccine Injury Compensation Program. It would help compensate those with serious health side affects from vaccines while at the same time ensuring that unwarranted litigation does not further destabilize our vaccine supply. The development and widespread use of vaccines indeed has been one of the most successful public health initiatives in our history. We have reduced the incidence of diseases, such as measles, mumps, and polio, and we have even eradicated smallpox--which over a period of time has killed somewhere between 300 million to 500 million people in the 20th century alone. Smallpox as a disease does not exist. The decision before us is whether or not to build on the successes that we have achieved in vaccines in the 21st century. I speak not only of vaccines that already exist--the vaccines for our children that are in short supply--but also as we look at the role of future vaccines needed to address bioterrorism--when we know we don't have the vaccine for the Ebola virus today. We have inadequate vaccines for three of the seven agents that are classified by our intelligence agencies as critical and for which we are at risk. Some day we will have a vaccine, I believe, that will hopefully cure Alzheimer's disease. What we are looking for is a platform--a comprehensive approach for all vaccine development. The Improved Vaccine Affordability and Availability Act will help us to expand the vaccine market. It will stabilize our vaccine supply, and it will improve access to vaccines. When parents take their children to the doctor, they will not be turned away because of a shortage of supply of these vaccines. Earlier this month the Improved Vaccine Affordability and Availability Act gained additional momentum when the Advisory Commission for Childhood Vaccines--the group that advises the Secretary of Health and Human Services on improving the Vaccine Injury Compensation Program--voted on June 6 in favor of most of the provisions in our bill, S. 2053. I thank the members of the Advisory Commission for Childhood Vaccines, or ACCV, for acting so quickly on a matter of such importance, and also for lending their expertise to this debate. Further, I thank them and express my appreciation for their suggestions in how we can modify some of the provisions in the bill. I urge my colleagues to look at this particular bill and I look forward to working with my colleagues as we move forward in considering the ACCV recommendations. The need to act is urgent. We simply cannot afford to wait until tragedy strikes, or to surrender the gains we have made over the last 50 years in reducing and preventing childhood diseases through vaccination. I urge my colleagues to join Senator Hutchison and Senator Bunning in cosponsoring S. 2053, and to work with us to pass this critical legislation this year.

Mr. FRIST

Mr. FRIST. Mr. President, I am pleased to join Senator Kennedy today to introduce the International AIDS Treatment and Prevention Act. This legislation is another important bipartisan step in our global battle against AIDS and other infectious diseases. The international crisis of HIV/AIDS, tuberculosis, and malaria threatens the entire world. We have done much here at home through Ryan White and other programs. We must show we can lead the world against these scourges as well. This morning, President Bush again underscored this administration's commitment, and his personal commitment, to reducing the spread of HIV/AIDS and demonstrating consistent, compassionate U.S. leadership in this global struggle. When I first came to the Senate eight years ago, HIV/AIDS was a little understood or recognized problem. In that time I have traveled far from the Senate floor. I have been on seven different medical mission trips to Africa, most recently, in January, to Uganda, Kenya and Tanzania. The trips have helped reveal to me the impact that one single virus-- HIV--is having on the destruction of a continent. Not a family. Not a community. Not a State. Not a country. An entire continent. The statistics of this plague are shocking. Each year, three million people die of AIDS, one every ten seconds. Twice that many, 5.5 million--or two every ten seconds--become infected. That is 15,000 people a day. Even more tragically, 6,000 of those infected each day are between the ages of 15 and 24. Ninety percent of those infected do not know they have the disease. There is no cure. There is no vaccine. And the number of people infected is growing dramatically. The disease toll is incalculable. Thirteen million children have been orphaned by AIDS. Over the next ten years, the orphan population may well grow to 40 million equivalent to the number of American children living east of the Mississippi River. I had the privilege of visiting with Tabu, a 28-year-old prostitute, who was leaving Arusha to return to her village to die. She stayed an extra day to meet with us. I will never forget her cheerful demeanor and mischievous smile as we met in her small stick-framed mud hut, no more than 12 feet by 12 feet. Her two sisters are also infected; a third sister has already died. Tabu will leave behind an eleven-year-old daughter, Adija. Not only do HIV/AIDS, tuberculosis, and malaria produce over 50 percent of the deaths due to infectious diseases each year, they have complex disease patterns that result in facilitating each other's spread. By weakening the immune system, infection with HIV increases susceptibility to both tuberculosis and malaria. Furthermore, the increasing number of multi-resistant tuberculosis cases is largely attributed to resistance developed in HIV-infected patients. Finally, in treating severe anemia that commonly accompanies illness due to malaria, untested blood transfusions create a method of HIV/AIDS spread. At home in Tennessee, or even here in Washington, DC, Uganda and Tanzania feel very far away. But the plague of HIV/AIDS and the chaos, despair and civil disorder it perpetrates only undermines the chance for democracy to flourish. Without civil institutions, there is disorder. Last year in South Africa, one of every 200 teachers died of AIDS. In a recent study in Kenya, 75 percent of deaths on the police force were AIDS-related. HIV-related deaths among hospital workers in Zambia have increased 13 fold in the last decade. These losses devastate local economies. Botswana's economy will shrink by 30 percent in ten years; Kenya's by 15 percent. Family incomes in the Ivory Coast have declined by 50 percent, while health care expenditures have risen by 4000 percent. Africa has lost an entire generation. In Nairobi, Kenya, I visited the Kibera slum. With a population of over 750,000, one out of five of those who live in Kibera are HIV/AIDS positive. As I walked the crowded pathways sandwiched between hundreds of thousands of aluminum shanties, I was amazed that there were only children or elderly individuals. The disease had wiped out the parents the most productive segment of the population teachers, military personnel, hospital workers, and law enforcement officers. African orphans therefore lack teachers, role models and leaders. This leaves them vulnerable to criminal organizations, revolutionary militias, and terrorists. Terrorism and crime could become a way of life for a young generation. Africa is not alone. India, with over 4 million cases of HIV/AIDS, is on the edge of explosive growth. China is estimated to have as many as 10 million infected persons. The Caribbean suffers from one of the highest rates of infection of any region in the world. Eastern Europe and Russia report the fastest growth of AIDS cases. These nations are the next generation in the AIDS crisis they present an opportunity for intervention and success if we act quickly and decisively. Due to the social, economic and political destructive effects of this disease, I'm devoting much of my time to this issue, and in particular, to the impact of HIV/AIDS in Africa. Just as our great nation is the leader in the war on terrorism, we must continue to lead the fight against AIDS in order to build a better, safer world. There is perhaps no greater global issue than the spread of deadly infectious disease. As President Bush said today, the United States must lead the fight in this international crises. We must now provide the leadership to confront the global HIV/AIDS, malaria, and tuberculosis epidemics. History will record how we respond to the call. We fight this battle in two ways: by improving primary prevention and expanding access to treatment. Until science produces a vaccine, prevention through behavioral change and awareness is the key. And once again, cultural stigmas must be overcome. Through a combination of comprehensive national plans, donor support and community-based organizations, we can make progress. We know that prevention and treatment go hand and hand, and that the necessary infrastructure must be present in order to delivery care. I have already introduced legislation with Senator Kerry--the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2002. This act would direct the President to work with foreign governments, the United Nations (UN), the World Bank, and the private sector to establish the Global AIDS and Health Fund to fight HIV/AIDS, malaria, and tuberculosis. This fund would provide grants to governments and non-governmental organizations for implementation of effective and affordable HIV/AIDS, malaria, and tuberculosis programs. Additionally, this legislation requires a comprehensive American strategy for combating these infectious diseases, enhances programs targeted toward empowering women, links debt relief to implementation of health programs, extends military to military prevention activities and establishes an incentive program for American clinicians to provide their expertise abroad. The legislation I am introducing today with Senator Kennedy and others is a companion to the Foreign Relations bill. This bill codifies and expands current authorities of the Department of Health and Human Services, HHS, to participate in appropriate HIV/AIDS prevention, treatment, care, and support activities in resource poor nations that are experiencing an HIV/AIDS crisis. Coupled with S. 2525, the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2002, this legislation would provide a better coordinated, enhanced U.S. response to the global pandemic of HIV/AIDS. Under The International AIDS Treatment and Prevention Act of 2002, the Secretary of Health and Human Services is authorized to implement HIV, tuberculosis, and malaria prevention, treatment, care and support services principally through the Centers for Disease Control and Prevention and, where appropriate, with the assistance and technical expertise of the Health Resources and Services Administration, (HRSA) the Food and Drug Administration, and the National Institutes of Health (NIH). The Secretary is also granted the authority to alter or renovate facilities in foreign countries as is necessary to conduct programs for international health activities and to establish family survival partnership grants for the provision of medical care and support to HIV positive parents and their children. This legislation, coupled with the S. 2525, represents an important step forward in our response to HIV/AIDS, tuberculosis, and malaria. History will judge how we as a nation--how we as a global community-- address and respond to this most devastating and destructive public health crisis we have seen since the bubonic plague ravaged Europe over 600 years ago. The task looms large, but by uniting with leadership and dedication from all--we will succeed in counteracting the devastation of HIV/AIDS and stop its advance.