Rick Santorum

Mr. SANTORUM

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 President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. SANTORUM

Mr. SANTORUM. Mr. President, I rise today to urge my colleagues and the American people to carefully consider one of the most pressing public health issues which faces America, an issue about which far too few people are aware and which is ever so obliquely tucked into the many pages of the appropriations measure we are about to consider. This issue has to do with the workings of our national organ transplantation and allocation system and by extension the lives of hundreds of Americans whose lives hang in the balance. Ideally, our national organ transplantation and allocation system-- which at its core is about saving lives--would be governed according to standard medical criteria whereby donated organs go to those who need them most. Sadly, though, this is not the case. Our current organ allocation system has evolved into a needlessly contentious debate where fragile life-and-death decisions are being reduced to economic-- and many times geographic--factors. If you are an American citizen who needs a liver transplant to survive, and you reside in Arizona, California, Colorado, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New York or Pennsylvania, you have much less chance of receiving a transplant than someone else with a similar level of illness who lives in another part of the country. That is the conclusion of the latest patient outcome data from the U.S. Department of Health and Human Services (HHS). Despite enhanced capacities to keep organs viable for longer periods of time and to make them available to those who would benefit most, many regional transplant centers are still attempting to keep donated organs in their own geographic area. These ``organ hoarding'' policies and practices contribute to the deaths of thousands of Americans whose lives could otherwise be saved. Consider: While an estimated 62,000 potential recipients are waiting their turn to receive organs, only 20,000 transplants take place in a given year. More than 4,000 Americans die each year--at least 11 per day--while awaiting organ transplants. Of those, it is estimated that 1,000 Americans--more than 3 each day--might have been saved if the system operated more fairly. Last year, HHS issued new regulations designed to reduce these inequities. The 1998 Final Rule contained provisions to make the national organ transplant system more fair. Its goal was to ensure that the allocation of scarce organs is based on medical criteria determined by physicians, and not on geography. But a rider to the 1998 omnibus spending bill delayed implementation of the regulations for a year--and required the Institute of Medicine (IOM) to study the impact of the Final Rule. Whereas I opposed the moratorium that Congress passed just over one year ago because I was convinced that the HHS rule was in the best interest of patients, many of my colleagues ignored previous studies by the Office of the Inspector General and the General Accounting Office, among others, and were swayed by the rhetoric of this very emotional debate when they supported this one-year moratorium. Proponents of the moratorium then argued that we did not have sufficient evidence to conclude that the current system has inequities. So innocent transplant candidates had to wait at least another year for a sensible policy of broader organ sharing. Yet, ironically, some of my colleagues' action of endorsing a moratorium reflected a bit of wisdom. If not for the provision in the Omnibus Appropriations bill of 1998 which called on the IOM to study these issues, we would not have such clear evidence in support of the rule, evidence that is void of partisan or special interest input. By its very nature, the IOM was able to distance itself from the pronouncements of those with vested interests and to undertake an academic, evidence-based review of the issues. To question the integrity of the report is to question the integrity of the Institute of Medicine, of our nation's greatest minds, and of the scientific process itself. As charged by Congress, the IOM released its report on June 20, 1999. And the results were a vindication for patients everywhere and irrefutably argue for pressing forward with the HHS Final Rule with its call for broader organ sharing. The IOM report has five noteworthy highlights. The first is waiting times. The IOM concludes that waiting time for liver transplantation is an issue only for the most critically ill patients. For patients who are less acutely ill, waiting time is not an appropriate criterion in deciding about the allocation of donor organs. The IOM suggests that equitable access to transplantation would be best facilitated by development of a system with objective criteria that reflect medical need. The second is larger Organ Allocation Areas. The HHS Final Rule places priority on sharing organs as broadly as possible, within limits dictated by science and technology. The IOM report concurs with this approach, and specifically recommends establishing Organ Allocation Areas (OAAs) for livers. The IOM suggests that OAAs serving at least nine million people each would significantly promote equity in access to transplantation, and be feasible with current technology. The third is federal oversight. The IOM report recommends that HHS continue to exercise the legitimate oversight responsibilities assigned to it by the National Organ Transplant Act. The report further notes that strong federal oversight is necessary and appropriate to manage the system of organ procurement and transplantation most effectively in the public interest. The report also recommends the establishment of an Independent Scientific Review Board to assist the Secretary in these efforts. The fourth is data collection and dissemination. The IOM report finds that current data are inadequate to monitor some aspects of the organ transplantation program. They suggest that the Organ Procurement and Transplantation Network contractor should improve data collection, and make standardized and useful data available to independent investigators and scientific reviewers in a timely fashion. The fifth is effects on organ donation and small transplantation centers. The IOM was also asked to consider whether the requirements in the Final Rule would decrease organ donation, or cause harm to small organ transplantation centers. It found no evidence to suggest that either of these concerns would be realized. The IOM concurs that changes in the organ transplantation system--along the lines proposed by the Secretary--would improve fair access to lifesaving transplantation services. Mr. President, 20 years ago retaining local allocation of organs was a sensible policy because organ viability--the window of opportunity during which an organ can be successfully transplanted--was not very long. But over the past two decades, the scientific knowledge and techniques for the retrieval, preservation and transplantation of donated organs have improved tremendously and have led to the development of organ transplantation as a means to save lives. These recent advances in science and technology now permit broader sharing of organs, with more focus on medical necessity and less restriction by geography as criteria for organ allocation. And yet, despite these enhanced capacities to keep organs viable for longer periods of time and to make them available to patients in parts of the country far from where those organs first may have been retrieved, many small regional transplant centers incredibly still fight to keep donated organs in their own geographic area. The Final Rule reflects ongoing commitment by the Secretary of Health and Human Services (HHS), which I share with many of my colleagues on both sides of the aisle, to maintain the most equitable and advanced transplantation system and to reform the anachronistic allocation system which is needlessly costing lives. The basic principles that underlie the 1998 Final Rule were supported by the conclusions of the IOM study. In late October of this year, HHS released a revised Final Rule, incorporating information and suggestions from the IOM and from the transplant community. This revised Final Rule is the culmination of the IOM study, four Congressional hearings, public hearings and consultations conducted by HHS, and nearly five years of public comment. Today, proponents of the status-quo system of rank inequities have managed to include in this bill language which calls for yet another moratorium. They now say that any new regulations must be developed only after the National Organ Transplantation Act (NOTA) is reauthorized. This is an interesting change of argumentation now that the facts, as contained in the IOM report and other publications, have been publicized about how the current system in fact does not operate in the public's interest. Whereas I certainly look forward to working with my colleagues to reauthorize NOTA, and most especially to the opportunity to develop a clear mandate and strategies for increasing organ donation, plans for future NOTA reauthorization should not be used as an excuse to perpetuate the current inequitable system which the Final Rule seeks to remedy. Additionally, the current NOTA statute does provide the Secretary with the necessary authority to immediately address the needs of those who are dying every day because of inequities in the system. Currently, NOTA mandates that HHS and the transplant community share responsibility to govern the organ transplantation and allocation system. The he underlying principle on which Congress enacted NOTA back in 1984 to better coordinate the use of donated organs and to address the concern that the sickest patients receive priority for organ transplantation. As a result of this law, the Organ Procurement and Transplantation Network (OPTN) was established. As you know, the OPTN's membership is comprised of organ procurement organizations and hospitals with transplant facilities. The primary function of the OPTN is to maintain both a national computerized list of patients waiting for transplantation and a 24-hour-a-day computerized organ placement center, which matches donors and recipients. Currently, the United Network for Organ Sharing (UNOS), a private entity, holds the federal contract for the OPTN and establishes organ allocation policy. I would like to assure my colleagues that under the revised Final Rule, development of the medical and allocation policies of the OPTN remain the responsibility of transplant professionals, in cooperation with the centers, patients and donor families represented on the OPTN board. Most importantly, in the revised Final Rule, HHS provides for the public accountability that is necessary for a national program on which so many lives depend. The HHS regulations for broader organ sharing have been the subject of rigorous debate in Congress, within the transplant community, and on the pages and airwaves of the local and national media. While constructive discourse is the root of our democracy, what has concerned me over the past couple of years is that deceit and fear have characterized this particular debate. Even for those who are extremely close to these issues, it has become more and more difficult to distinguish the true facts. Indeed, this is the very reason that Congress stipulated the Institute of Medicine study this issue. My greatest concern is for the lives of worthy, innocent transplant candidates which hang in the balance each day, each hour, each minute that we delay moving forward with these regulations. Please make every consideration to expedite the process so that the transplant community can move forward to improve the system so that more lives can be saved. As my colleagues may know, the federal Task Force on Organ Transplantation (formed in 1986), in a critical decision, established that donated organs belong to the community, and it identified that community as a national one. Consistent with this decision, the new HHS regulations identify donated organs as a precious national, not local or regional, resource--thus helping to elicit what James Childress, a medical ethicist who served on the transplant task force, calls ``communal altruism'' or public commitment to organ donation. Childress, an authority on the subject of organ donation, states in a 1989 edition of the Journal of Health Politics, Policy and Law, ``Donations of organs cannot be expected unless there is public confidence in the justice of the system of organ distribution.'' In order to maintain an effective system for the allocation of life- saving organs, we must first ensure that we have an adequate supply of those organs. An adequate supply relies on public generosity and commitment, which, in turn, relies on the public perception that the system for organ allocation is both publicly accountable and fair. The HHS regulations have prompted debate in large part because they would change the allocation system from a local/regional one to one of broader organ sharing. They would allocate organs to the most medically urgent patients first, rather than to those residing in the same geographic area as where the organ was donated. And I emphasize, that while the HHS regulations call for a national system, they do not call for a national allocation system. They leave the specific policy decisions in the hands of the transplant community. I have registered as an organ donor; when I die, I do not care whether or not my organs go to a resident of Pittsburgh; I hope they go to the person who needs them the most. The majority of Americans share my sentiments. According to the results of a Gallup public opinion survey released this past June, most Americans--83 percent--want donated organs to go to the sickest patients first, regardless of where they live. Not only do the HHS guidelines meet standards of effectiveness, in part, by helping to ensure broad public commitment to organ donation, they also meet the related standard of equity. By creating a process designed to lead to a broader geographic sharing of organs, these proposed regulations equalize waiting times among transplant centers, thus also--and effectively--save more lives. CONSAD Research Corporation has already identified a number of alternative policies that would equalize waiting times and save more lives. The HHS regulations further require standardized medical criteria to be used when placing patients on the national waiting list and determining their priority among all patients needing organ transplants throughout the United States. They therefore call for equitable organ allocation throughout the country to ensure that the most medically urgent patients, within reasonable medical parameters, have first access to organs. We know that there currently exists enormous disparity in waiting times for organ transplantation from region to region in the United States. Mr. President, I ask unanimous consent that the chart of recently released HHS data be printed in the Record.

Mr. SANTORUM. Mr. President, these disparities were first brought into sharp focus in the 1997 Report of the OPTN: Waiting List Activity and Donor Procurement, and now even more so in this recently released HHS data. Why the median liver transplantation rate during one year for ``listed'' candidates in Chicago would be 23% and 83% in Milwaukee is unconscionable. Equally disturbing is that a patient of blood type ``O'' would have a median waiting time of 721 days in western Pennsylvania and just 46 days in Iowa. As we can see from the facts under the current allocation system, often a critically ill patient in one region can go without a life- saving organ while a healthier patient in another region--one with a larger supply of organs--can be treated as a priority. In meeting this standard of equity, the HHS regulations can help to prevent what has become an alarming and extremely parochial trend--that of states passing ``local first'' laws or resolutions. Kentucky, Louisiana, Oklahoma, South Carolina, Wisconsin, Arizona and Texas have either passed laws or resolutions or have proposed such laws that strive to keep organs in their respective states, while not necessarily allocating these organs to state residents. This is a critical distinction: Patients often travel from other states for the high-quality care offered by large transplant centers, which generate considerable revenue. When states seek to retain organs in this manner, they are serving economic self-interest, not patient interest. And what of the patients who reside in states with no liver or heart transplant program? These patients, including those with Medicaid and Medicare, must travel to other states, where the access to organs and the waiting times can vary significantly. The new HHS guidelines would better meet procedural and substantive standards of justice than does current policy. They would encourage more public participation in the policy making process and, therefore, more accountability, and they would equalize the treatment of medically similar cases. In developing policies for the life-and-death issue of organ allocation, we should rise to broadly accepted standards of justice rather than acquiesce to narrowly defined regional interests. Arthur L. Caplan of the University of Pennsylvania Center for Bioethics and Peter Ubel of the Philadelphia Veterans Affairs Medical Center wrote in The New England Journal of Medicare on Oct. 29, 1998, ``We believe that the United States should end policies that permit geographic inequities and move quickly to determine the best use of data on the efficacy of outcomes to create a more equitable national system of distribution.'' Because I believe that any organ allocation system should be defined by, and accommodate, the moral principles of effectiveness and equity, I strongly support the proposed change to a national allocation system as outlined in the Department of Health and Human Services revised regulation. I firmly believe that the Secretary needs to exercise her authority so that a more equitable system based on uniform medical criteria can immediately move forward. Again, I will repeat for my colleagues that plans for future NOTA reauthorization should not be used as an excuse for delay while innocent Americans are needlessly dying. Further delay prevents more needy transplant candidates from receiving vital, life-saving organs. Now, I realize that this body will likely adopt this conference report, despite its containing this controversial language for another moratorium. But let us bear in mind that the President has vowed to veto this legislation over this issue and other spending priorities contained herein. Thus, it is not too late. When our leaders reconvene to negotiate budget priorities with the administration, I urge my colleagues to oppose another moratorium, and join me in ending a system that unfairly deprives patients of access to life-saving organ transplantation, and allow the regulations to go forward. This is an issue which transcends politics.

Mr. SANTORUM

Mr. SANTORUM. Mr. President, today, I am introducing legislation in response to the lack of progress in negotiations between the United States and the United Kingdom to open up competition through an open- skies treaty for air travel between our countries. International aviation travel is central to the continued growth of commerce and tourism, and every effort must be made to increase these opportunities. This bill mandates that the United States and the United Kingdom come to an agreement that would grant all applications U.S. carriers currently have filed with the U.S. Department of Transportation for route access to the United Kingdom. The bill also mandates more access to London's Heathrow International Airport for U.S. carriers that do not currently have access to this airport. Congressman Bud Shuster, Chairman of the House Committee on Transportation and Infrastructure, has already introduced an identical bill, H.R. 3072, with the Ranking Minority Member, Congressman James Oberstar, in the House of Representatives. Under the current 22 year old bilateral agreement, known as Bermuda II, only two U.S. airlines, American and United, and two from Great Britain, British Airways and Virgin Atlantic, can fly between Heathrow and the United States. Under the current agreement, the British hold dominant rights to air travel between our countries in one of the most restrictive existing bilateral agreements for air travel. For example, British Airways is allowed to fly more routes to the U.S. than all U.S. carriers can fly to the United Kingdom combined. This present policy is unfair and is not in the best interests of American or British consumers. This situation is illustrated by the recent announcement by British Airways that it would be ending its nonstop flights between Pittsburgh and London as of October 31, 1999. This means that a city which has had nonstop for over a decade will no longer have it. Under the current restrictive agreement, only the British can fly to and from Pittsburgh; American carriers willing to pick up this route are unable to do so. The United States has open-skies agreements with over 36 countries which have been completed or are being phased in. Open-skies agreements allow a free market in air service in which airlines can fly where they want. It is inappropriate for the United States to lack a similar agreement with an historic ally and major trading partner such as the United Kingdom. If an agreement is not reached within six months of the bill's passage, the Secretary of Transportation is required to revoke all current slots and slot exemptions held by British air carriers at Chicago O'Hare and New York Kennedy airports. In addition, if the United States and the United Kingdom do not reach an open-skies agreement by the end of 2000, the bill mandates renunciation of the current bilateral agreement. My goal is to provide a strong incentive for our two countries to negotiate a fair, long overdue agreement by increasing competition and choices for consumers and all interested carriers in both countries. Mr. President, I ask unanimous consent that the bill be printed in the Record.

Mr. SANTORUM

Mr. SANTORUM. Mr. President, today, I am introducing legislation in response to the lack of progress in negotiations between the United States and the United Kingdom to open up competition through an open- skies treaty for air travel between our countries. International aviation travel is central to the continued growth of commerce and tourism, and every effort must be made to increase these opportunities. This bill mandates that the United States and the United Kingdom come to an agreement that would grant all applications U.S. carriers currently have filed with the U.S. Department of Transportation for route access to the United Kingdom. The bill also mandates more access to London's Heathrow International Airport for U.S. carriers that do not currently have access to this airport. Congressman Bud Shuster, Chairman of the House Committee on Transportation and Infrastructure, has already introduced an identical bill, H.R. 3072, with the Ranking Minority Member, Congressman James Oberstar, in the House of Representatives. Under the current 22 year old bilateral agreement, known as Bermuda II, only two U.S. airlines, American and United, and two from Great Britain, British Airways and Virgin Atlantic, can fly between Heathrow and the United States. Under the current agreement, the British hold dominant rights to air travel between our countries in one of the most restrictive existing bilateral agreements for air travel. For example, British Airways is allowed to fly more routes to the U.S. than all U.S. carriers can fly to the United Kingdom combined. This present policy is unfair and is not in the best interests of American or British consumers. This situation is illustrated by the recent announcement by British Airways that it would be ending its nonstop flights between Pittsburgh and London as of October 31, 1999. This means that a city which has had nonstop for over a decade will no longer have it. Under the current restrictive agreement, only the British can fly to and from Pittsburgh; American carriers willing to pick up this route are unable to do so. The United States has open-skies agreements with over 36 countries which have been completed or are being phased in. Open-skies agreements allow a free market in air service in which airlines can fly where they want. It is inappropriate for the United States to lack a similar agreement with an historic ally and major trading partner such as the United Kingdom. If an agreement is not reached within six months of the bill's passage, the Secretary of Transportation is required to revoke all current slots and slot exemptions held by British air carriers at Chicago O'Hare and New York Kennedy airports. In addition, if the United States and the United Kingdom do not reach an open-skies agreement by the end of 2000, the bill mandates renunciation of the current bilateral agreement. My goal is to provide a strong incentive for our two countries to negotiate a fair, long overdue agreement by increasing competition and choices for consumers and all interested carriers in both countries. Mr. President, I ask unanimous consent that the bill be printed in the Record.

Mr. SANTORUM

Mr. SANTORUM. Mr. President, The Committee on the Judiciary Subcommittee on Immigration requests unanimous consent to conduct a hearing on Thursday, October 21, 1999 beginning at 2:00 p.m. in Dirksen Room 226.

Mr. SANTORUM. Mr. President, I ask unanimous consent that the Committee on Finance, Subcommittee on International Trade be permitted to meet on Thursday, October 21, 1999 at 2:00 p.m. to hear testimony on the WTO Ministerial Meeting.

Mr. SANTORUM. Mr. President, I ask unanimous consent that the Special Committee on the Year 2000 Technology Problem be permitted to meet on October 21, 1999 at 9:30 a.m. for the purpose of conducting a hearing.

Mr. SANTORUM

Mr. SANTORUM. I have.

Mr. SANTORUM. Two comments. First of all, the definition of ``partial-birth abortion'' is very clear. It requires an intent to do an abortion. So if you were going in, and you were having a delivery, and the delivery is breech, for example, that would not be covered under this. It is very clear. There is no court in the land, that has reviewed this, that has suggested that anyone who is in the process of delivering a child for the purpose of a live birth is covered under this definition because you have to have the intent to have an abortion. If there is no such intent, then you are not covered under the act.

Mr. SANTORUM. She was in the process of delivery, and they had to do something?

Mr. SANTORUM. For another 10 minutes, and then I am going to be gone.

Mr. SANTORUM. Mr. President, what I want to do is give an opportunity for other Senators who have amendments to come to the floor and offer their amendments during this time so we can move forward on the bill, with the expectation we can finish the bill sometime today. Also, if any Senator has a statement on either side of the issue, this is a good opportunity to come down and make their statement about the bill or about any amendment that has been offered to date. I hope we will use this time fruitfully and not delay the Senate any further in acting upon this very important measure. I yield the floor.

Mr. SANTORUM. Mr. President, I ask unanimous consent that the pending amendment be set aside. Obviously, we have a vote locked in at 2 o'clock. I ask unanimous consent that it be set aside.

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

Mr. SANTORUM. Mr. President, first off, I thank the Senator very much for his interest in an honest and open debate. I agree, this is one of the critical issues we have to address, and the courts have confronted this question of undue burden. Underlying that are two issues; one is the center point: Is this medically necessary. Second, are there alternatives to this procedure so as not to have an undue burden. That gets into a couple issues. Let me address the medical necessity issue. I will present the evidence as best I can that supports, we believe, the fact that this is not medically necessary. We have, of course, the AMA which said it is not medically necessary. That is the American Medical Association. They have said in a letter and stand by it that this procedure is not medically necessary. We have C. Everett Koop, obviously someone who has a tremendous amount of respect in this country, who has written directly this is not medically necessary. We have an organization of 600--actually more than 600--obstetricians and gynecologists, many of them members of the American College of Obstetrics and Gynecology, many of them fellows, who have written without any hesitation this procedure is not medically necessary and is, in fact, dangerous to the health of the mother. They go one step further: It is never medically preferable, not only medically necessary. On the other side of the issue--and I am trying to present it, and I know the Senator from California will present her side--what is used is the American College of Obstetrics and Gynecology policy statement on the issue. Several years ago, they put together a select panel, and the select panel reviewed the procedure to determine whether there were cases in which it was medically necessary to perform this procedure. They came forward with a statement. This is what their statement said: [We] could identify no circumstances under which this procedure . . . would be the only option to save the life or preserve the health of the woman . . . They went on to say--and this is where the Senator from California will come in and say, see, that is not the whole story, so I will go on. It says: An intact D&X-- Partial-birth abortion-- however, may-- May-- be the best or most appropriate procedure in a particular circumstance to save the life or preserve the health of a woman, and only the doctor, in consultation with the patient, based upon the woman's particular circumstances can make this decision. We have asked the American College of Obstetrics and Gynecology to provide us an example of where this procedure may be the best procedure because what they say is it ``may.'' For 3 years we have asked them to provide us a factual situation where, in fact, this ``may'' would come into play, and they have not done so. In fact, we have letters, and I would be happy to share them with you; there are dozens--in fact, there is a whole stack--from obstetricians and gynecologists throughout America who take issue with this statement, saying there are no circumstances where this would be the most appropriate procedure. Dr. Frist addressed that issue last night. He went through the medical literature and talked about it. I have asked him to come over, if he can, because I think, as a physician, as a surgeon, he may be better to answer this question than me.

Mr. SANTORUM. Yes, I would be happy to. In fact, I shared with the Senator from Nebraska yesterday an amendment to the bill that I think directly is on point with what the Eighth Circuit decision had concern with, which is the vagueness of the definition, that it could cover more than one abortion. I think this refinement of the definition makes it crystal clear that we are only talking about this one procedure. As I said to the Senator from California, Mrs. Feinstein, when she was going through the Eighth Circuit decision earlier, the Eighth Circuit said our problem with this is it includes too much. Obviously, if you take the logic of that, they would probably not have a problem if it did not include too much.

Mr. SANTORUM

Mr. SANTORUM. Mr. President, I ask unanimous consent there be a vote on the Harkin amendment at 2 o'clock.

Mr. SANTORUM. Mr. President, I suggest the absence of a quorum.

Mr. SANTORUM. Mr. President, I move to table amendment No. 2321 and ask for the yeas and nays.

Mr. SANTORUM. Mr. President, I ask for the yeas and nays on the amendment.

Mr. SANTORUM. Mr. President, I yield back the remainder of my time.

Mr. SANTORUM. I yield 8 minutes to the Senator from Missouri.

Mr. SANTORUM. I yield 8 minutes to the Senator from Oklahoma.

Mr. SANTORUM. Mr. President, how much time do I have remaining?