Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. As I understand, the way it was represented to me, when you were Governor.

Mr. KENNEDY. I will make it available later on this afternoon.

Mr. KENNEDY. It is my understanding, that these papers were approved either by the Governors of the States or their Administrators and that you signed for your state.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I want to join Senator Byrd and others who were speaking today in support of prompt action on an issue of major importance to the country--the ISTEA reauthorization that will set the country's course for the next six years on transportation policy and investments. I noticed the majority leader had indicated that there were some differences about the consideration of that proposal last year. But the fact of the matter remains that when I look over what we are involved in outside of the Dr. Satcher nomination, it seems that we certainly would have the opportunity for the consideration of the ISTEA reauthorization. And looking over the anticipated schedule, I would think that we could deal with this, and deal with it appropriately, certainly before the February recess. I don't know what else has been placed on the schedule prior to that time next week. Certainly we would make time for any kind of consideration or resolution on the issues of Iraq. But barring that, it would seem to me that reauthorization could be dealt with by that particular time. This debate has major ramifications, not only for the Nation's transportation system, but for the economy and the environment. What Congress does with this legislation will, in many ways, define the degree to which communities across the country will be able to take full advantage of the possibilities for economic development and growth in the years ahead. Without a modern, safe and efficient transportation network, America's businesses can't compete as efficiently, America's cities can't be revitalized as effectively, and America's families will lose valuable time in the daily struggle to move from home to work, and carry out all the other responsibilities of daily life. This legislation will also have a major impact on the environment, as we debate what direction the law should take. A major goal is to preserve and strengthen the innovative intermodal approach established under the original ISTEA, including special emphasis on public transit, the Congestion Mitigation and Air Quality Program, bikeways and other initiatives that enhance the quality of life in our communities. I hope we will be able to build on the original ISTEA law, sustaining its innovative programs and laying the foundation for greater economic growth. To do that, we need to make a substantially larger investment that will address the many urgent transportation needs facing the country, and also facing my own State of Massachusetts that has some very special needs. I commend Senator Byrd for his extraordinary leadership on all of these vital infrastructure issues. The amendment he proposed last fall will make a significant difference for all states, enabling us to meet all of the new challenges more effectively. I think he makes a compelling case. Let the Senate make its judgments. Let the Senate decide. It is difficult to justify and say we are not going to let the Senate decide because we might have the votes for a particular position, which is at least partly delaying the opportunity to consider the legislation. We can't afford to have this important debate drag on into the months ahead. The country's transportation needs are urgent and can't wait. We should take up the ISTEA legislation and complete action on it promptly, to avoid paralysis in critical ongoing work involving transportation construction, public transit operations, traffic safety programs, and other issues that demand attention. Mr. President, I may have more to say on this subject. I know that the Senate is anxious to recess in order to hear the full report of the Secretary of State. So I will yield at this time and hope that the Senate will follow the leader's motion for adjournment.

Mr. KENNEDY

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

Mr. KENNEDY

Mr. KENNEDY. Mr. President, first of all, I want to express the appreciation of all of us to the majority leader for scheduling this nomination promptly in this session. I thank the majority leader for scheduling this Satcher nomination, and also for filing the cloture motion. We had an opportunity to make the presentation, and the excellent presentation by Senator Frist yesterday, which I thought was just so compelling. There were those who took some issue with the record of Dr. Satcher. But I do believe that at the end of the day yesterday the membership would be convinced of the quality of this extraordinary nominee and the incredible opportunity that all America has for his service when he is confirmed, which I expect will be on Tuesday next. So we look forward to the opportunity to vote and to hopefully see Dr. Satcher in that important position. In response to questions raised yesterday, I also am including a copy of a letter from Dr. Harold Varmus, Director of the National Institutes of Health, to Senator Ashcroft regarding studies of maternal-to-infant transmission of HIV in developing countries. I ask unanimous consent that these materials be printed in the Record.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, earlier today, a request was made to consider the cloning legislation that had been introduced by my friend and colleague, Senator Bond. Objection was made to the consideration of that legislation by the Senator from California. I want to just indicate to our Members that I think Senator Feinstein was quite right to file that objection. Many of us who are on the Labor Committee believed we would be debating the Satcher nomination this afternoon. It is an enormously important matter that has been delayed too long. We have an outstanding nominee. In fairness, we should be continuing that debate today. The leadership has decided to move on to this cloning legislation. I believe that this legislation that is being proposed is one of the most important scientific and ethical issues of the 21st century. The legislation itself was introduced 2 days ago. It was put on the calendar 1 day ago. It has not received 1 day of committee hearings. It has not received 1 minute of committee markup. This legislation is a matter of enormous significance and importance to the research communities all across this country and they understand that this legislation does not only impact human cloning. As the research community has pointed out, technologies that would be banned under Senator Bond's bill offer the key for reaching resolution of a number of very important diseases: Cancer, diabetes, birth defects, arthritis, organ failure, genetic diseases, severe skin burns, multiple sclerosis, muscular dystrophy, and spinal cord injuries. Stem cells may be the key to reproducing nerve cells, which is not possible today, and other cells that may be used to treat Alzheimer's disease, Parkinson's disease, Lou Gehrig's disease. The major researchers in every one of these areas oppose strenuously the Bond legislation because they believe that it will provide a significant barrier to meaningful progress in a number of promising research areas. I will be delighted to discuss these issues, as Senator Feinstein believes we should, in a timely way so that we can at least have an opportunity to consider these measures in the committee and report those out. Therefore, I join Senator Feinstein in objecting to the consideration of cloning legislation at this time. We have introduced legislation of our own on this subject. We hope that the Senate will consider it in due course, and that we can work out an acceptable compromise on this issue to give it the careful action it deserves. A rush to enact bad legislation on this subject would be far worse than passing no legislation at all. Every scientist in America understands that, and the American people should understand it, too. Several months ago, the world learned of one of the most astounding developments in modern biology--the cloning of a sheep named Dolly. This incredible scientific achievement awakened widespread concern about the possibility of a brave new world, in which human beings would be made to order and where individuals would seek to achieve a kind of immortality by reproducing themselves. There is widespread agreement among scientists, ethicists, and average Americans that production of human beings by cloning should be prohibited. The President reacted rapidly and responsibly to this scientific advance and the unprecedented issues it raised by asking the National Bioethics Advisory Commission to study the issue and make recommendations. The Commission recommended that creation of human beings by cloning should be banned for at least five years, and the Administration has submitted legislation to implement this recommendation. The legislation that Senator Feinstein and I have introduced will assure the American public that reproducing human beings by cloning will be prohibited. It follows the President's legislation and the recommendations of the Commission. It makes it illegal to produce human beings by cloning, and establishes strict penalties for those who try to do so. If the legislation the Majority Leader is seeking to call up achieved this objective, I believe that it would be passed unanimously by the Senate. Unfortunately, it goes much farther. It does not just ban cloning of human beings, it bans vital medical research related to cloning--research which has the potential to find new cures for cancer, diabetes, birth defects and genetic diseases of all kinds, blindness, Parkinson's disease, Alzheimer's disease, paralysis due to spinal cord injury, arthritis, liver disease, life-threatening burns, and many other illnesses and injuries. All of these various kinds of research have broad support in Congress and the country. A blunderbuss ban on cloning research would seriously interfere with this important and life-saving research, or even halt it altogether. Scientists, physicians and other health professionals, biotechnology companies, pharmaceutical companies, and citizens and patients working with organizations such as the Cystic Fibrosis Foundation, the Parkinson's Action Network, the AIDS Action Council, the American Diabetes Association, and the Candlelighter's Childhood Cancer Foundation understand this. The Senate should understand it, too. Let me read from a letter signed by the organizations I have just cited and many others as well and sent to members of Congress on January 26, 1998. The participating organizations said, ``We oppose the cloning of a human being. We see no ethical or medical justification for the cloning of a human being and agree . . . that it is unacceptable at this time for anyone in the public or private sector, whether in a research or clinical setting, to create a human child using somatic cell nuclear transfer technology.'' But they go on to say, ``Poorly crafted legislation to ban the cloning of human beings may put at risk biomedical research.'' They point to a long list of diseases where cloning research could be critical, including cancer, diabetes, allergies, asthma, HIV/AIDS, eye diseases, spinal cord injuries, Guillain-Barre syndrome, Gaucher disease, stroke, cystic fibrosis, kidney cancer, Alzheimer's disease''--the list goes on and on. They conclude: ``We urge the Congress to proceed with extreme caution and adhere to the ethical standard for physicians, `first do no harm.' We believe that there are two distinct issues here, cloning of a human being and the healing that comes from biomedical research. Congress must be sure that any legislation which it considers does no harm to biomedical research which can heal those with deadly and debilitating diseases.'' These are reasonable tests for legislation in this important area. First, do no harm. Proceed with extreme caution. No one can pretend that the legislation the Majority Leader is seeking to call up meets these tests? Proceed with extreme caution! The Majority Leader's legislation was introduced on Tuesday of this week. There has not been a single day of hearings held on it. Not one single day. I doubt that more than a few members of this body have even had the opportunity to read the legislation. Many of our offices have been deluged with calls from health organizations, scientific bodies, and individual scientists and physicians who are seriously concerned about the damage this bill may do to fundamental research and to possible discovery of long-sought cures for dread diseases. Within a few days, we will have dozens if not hundreds of distinguished scientific bodies and disease societies expressing their opposition to this bill in its current form. As far as I know, there is not a single major scientific body of any stature that has endorsed this legislation. What is the rush? What is the rush? It is not as if, despite the absurd publicity given to Richard Seed, a baby will be cloned tomorrow. To quote again from the letter I cited earlier, ``The American Society for Reproductive Medicine, the Biotechnology Industry Organization, and the Federation of American Societies of Experimental Biology have all stated that their members will not seek to clone a human being. These three associations include essentially every researcher or practitioner in the United States who has the scientific capability to clone a human being.'' It is also important to recognize that the Food and Drug Administration already has broad jurisdiction over human cloning, and would act vigorously to shut down any clinic that operates without FDA approval. Such approval depends on a finding that human cloning is safe and effective. But given the current state of science, no human cloning procedure could possibly be called safe at this time. The FDA approval process is not a permanent ban on human cloning, but it effectively bans the procedure for the near future. So we have a situation where the procedure is not yet perfected, where the scientists who are competent to clone a human being say that they will not do it, and where the FDA already has the legal tools and responsibility to prevent it. We do not need to act today--and we should not act today--because this bill goes far beyond the simple prohibition of the creation of a human being by cloning. The sponsors of this legislation state that all they want to do is ban cloning of a human being and that they do not want to interrupt important research. But their bill goes far beyond that, and it does not deserve to pass. This bill would clearly interfere with medical research that offers hope for a cure of many deadly diseases. A letter I received two days ago from leaders of the Society for Developmental Biology states: ``As active researchers in developmental biology, we understand the implications of the Dolly cloning results for basic science and human health.'' These techniques are essential for basic research because, as the letter goes on to say, ``Many diseases, including heart disease, diabetes, and neurodegenerative diseases (such as Parkinson's Disease) involve the depletion or destruction of a particular cell type. One of the great hopes in medicine is to learn ways to replace the lost or damaged cells, for example by stimulating the body to regenerate its own missing cells or by growing the cells in culture and providing them to patients. The main obstacle is that most of the needed cell types cannot be grown in culture, nor can their growth be stimulated in any known way. Dolly was grown from the nucleus of an adult cell, proving that the genetic material of an adult body cell can be reprogrammed by the egg to restore the genetic potential for specializing into all possible cell types. Basic research on genetic programming will likely lead to novel transplantation therapies for numerous human diseases. In essence, we all carry in our cells a library of all the information needed to build a healthy human, and Dolly proves that the information can be reactivated and used again. What are the implications? For example, instead of diabetes meaning a lifetime of insulin injections accompanied by serious side effects, perhaps we can learn how to cause the reactivation of pancreas development genes and the regeneration of the missing cell types. Such exciting ideas are no longer far-fetched.'' The key ingredients of this research offer great hope. DNA from an adult cell is placed in an egg cell that has had its own DNA removed. The egg cell then begins to grow and divide under the instructions of the adult cell DNA. The procedure involves what is called ``somatic cell nuclear transfer technology.'' In the case of Dolly, the technology was used to create a sheep embryo from an adult sheep cell. The embryo was implanted in the womb of the female sheep and ultimately resulted in the birth of a baby sheep named Dolly. The legislation that Senator Feinstein and I have introduced makes it illegal to implant a human embryo using this technique in a woman's womb. Without that, no baby, no human being can be created by current cloning technology. This is what Dr. Seed says he is going to do. This is what most ethicists oppose. This is what the American people want banned--and our legislation will do it. But the bill proposed by the Majority Leader will go much farther. It will block this new technology in all other cases as well. It will make it impossible to carry out the research that the overwhelming majority of scientists and researchers say is so important. It will make it impossible to use this new technology to grow cells that can be used to cure diabetes or cancer or Alzheimer's disease or spinal cord injury. The Majority Leader's bill--page 2, line 13, paragraph 301 is entitled, ``Prohibition on cloning.'' It is the heart of the bill. It states, ``It shall be unlawful for any person or entity, public or private, in or affecting interstate commerce, to use human somatic cell nuclear transfer technology.'' That is the end of the statement. It does not just ban the technology for use in human cloning. It bans it for any purpose at all. That means scientists can't use the technology to try to grow cells to aid men and women dying of leukemia. They can't use it to grow new eye tissue to help those going blind from certain types of cell degeneration. They can't use it to grow new pancreas cells to cure diabetes. They can't use it to regenerate brain tissue to help those with Parkinson's disease or Alzheimer's disease. They can't use it to regrow spinal cord tissue to cure those who have been paralyzed in accidents or by war wounds. Congress should ban the production of human beings by cloning. We should not slam on the brakes and have scientific research that has so much potential to bring help and hope to millions of citizens. As J. Benjamin Younger, Executive Director of the American Society for Reproductive Medicine, has said: ``We must work together to ensure that in our effort to make human cloning illegal, we do not sentence millions of people to needless suffering because research and progress into their illness cannot proceed.'' Let us work together. Let us stop this know-nothing and unnecessarily destructive bill. Together, we can develop legislation that will ban the cloning of human beings, without banning needed medical research that can bring the blessings of good health to so many millions of our fellow citizens. I bet you could take the legislation that we are talking about here, and I bet there aren't three Members of this Senate who have read this legislation. They could not. It was just out yesterday. And most of the Members have been involved in the various other measures. And we are being asked to vote on it. No committee, no explanation, absolutely none that is going to affect very, very important research. That is not the way that we are going to try and move on into the next millennium, which is really the millennium of the life sciences. As science, as chemistry and physics have been in our past history, life sciences are going to be the key to the next millennium. And we want to make sure that we are going to meet our responsibilities and our opportunities in a way that is going to bring credit to the kind of research and can help make an enormous difference to families all over this country and really all over the world. Mr. President, I yield the floor. Mr. FRIST addressed the Chair.

Mr. KENNEDY

Mr. KENNEDY. Will the Senator yield for a unanimous consent request?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I ask unanimous consent that two fellows in my office, Ellen Gadbois and Diane Robertson, be granted the privilege of the floor during Senate consideration of the cloning legislation.

Mr. KENNEDY

Mr. KENNEDY. I see my friend and colleague, Senator Wellstone. I had some other remarks, but I will either make them later in the afternoon or include them in the Record. I yield the floor.

Mr. KENNEDY. Mr. President, that was an excellent statement by my friend and colleague, the Senator from Minnesota.

Mr. KENNEDY. Madam President, I know that there are others that choose to speak. So I will not take long. Just in a brief response, we have on the one hand the life of Dr. Satcher when we talk about ethics. And if there is any real kind of a question about his judgment and his failing a duty in terms of ethics, I think we ought to take a look at what the facts are and also take a look at what kind of life he has led in terms of the service of the underserved in his professional life, and the work that he has done. And you will see, this extraordinary light that shines brightly in terms of working for the disadvantaged and those that are left out and left behind, those that do not have good health and medical services, and those that are the sickest and neediest in our society. To try to take a situation here about informed consent when we have those that have been involved in the programs themselves who describe the various ways that they went about informing potential subjects to be involved in these trials--particularly with the statements of the in-country personnel and to try to use anecdotal information based upon the conversations with one or two of those people that are involved in the trials--as being somehow a reflection of the failure of Dr. Satcher to reach a high ethical standard is a pretty far stretch. Madam President, I listened with great interest to my friend from Missouri talk about the Helsinki accords, and about the importance of making available the known, effective treatment, that we shouldn't have various kinds of research being conducted if we are denying known effective treatment to these individuals. Well, understand the regimen are talking about when we are talking about known effective treatment because it was the judgment of the medical professions that if we took the known effective treatment that is used here in the United States that there was serious doubt as to whether it would be effective. That is why the lower dose regimen is being tested in developing countries. What do I mean? By using the known effective treatment that is used here in the United States that is referred to by the Senator from Missouri, you have to stop breast feeding. You can't use that regimen and continue to breast feed. It was the judgment of the Centers for Disease Control that if you used the 076 regimen you might also be exposing these subjects to other health risks, such as high levels of drug toxicity due to their entirely different diet. It must be recognized that the 076 regimen is not known to be an effective regimen for populations in developing countries. It was known at the Centers for Disease Control if you are going to use the 076 treatment the standard in the United States, you have to have 100 milligrams of AZT five times. You have to have treatment for 12 weeks of pregnancy and you need to receive intravenous AZT during labor and pregnancy. In order to do this, you have to have a sufficient health infrastructure, one which is going to bring these various infected individuals and bring them back to the center frequently. This infrastructure just is not available. Senator, get real; the regimen that is effective in the United States, the majority of the scientists at the Centers for Disease Control do not believe it could be effective over there. So when you say, they have no effective treatment, we have this treatment here in the United States of America and we are denying those people that effective treatment and it is violating all those ethical considerations, I have to disagree. Understand what is happening in these situations. Understand the these regimens. These developing countries just do not have the infrastructure. You cannot get them to stop breast feeding so they have to follow a different regime, one that permits them to breast feed, one that doesn't require them to come to a clinic on a frequent basis, one that says they do not have to have the elaborate infrastructure that is necessary under the 076 regimen. The idea to put out on the floor that Dr. Satcher is not qualified, not qualified to be Surgeon General because of this kind of a situation is the most extraordinary stretch in terms of misrepresentation and failure to understand what these trials are really about. I am just amazed as we get further and further into it how weak that case is. The Senators who are opposed to Dr. Satcher better do a lot better tonight and tomorrow in their opposition than they have done today. I have listened to these arguments, and I can't believe any one of our colleagues who has been following them can believe that there is very much to it. Take this man whose total life has been committed to his fellow human beings, and try and do the acrobatics and gymnastics and trapeze work in terms of misinterpreting these kinds of studies to show that he is basically flawed in terms of his ethical standards, my goodness, Madam President, give us a break. Give us a break. So, Madam President, I will have more to say on some of these other questions, on the other misrepresentations. There were a series of others. I will just mention in addition one further area that has been raised during the consideration here earlier in the afternoon. Critics have also charged that Dr. Satcher at CDC supported HIV studies on newborns that allowed them to be sent home without telling their parents of their HIV status. This survey was part of an effort to obtain a better idea of how HIV was spreading in different populations. It was implemented by State and local health departments across the country with support from CDC. The survey began at a time when little was known about the impact of HIV on women and their children. The studies were designed to check for the presence of antibodies to HIV infection in newborns. The presence of such antibodies would indicate that the mother is infected with HIV and that her child has been exposed to the virus. Approximately 25 percent of children exposed to HIV develop HIV infection, too. That is the point I made in the debate earlier in the afternoon. That is why this whole area of study is so important and so exciting, and the consequences so important, because this is an area in medical research that offers some really important potential breakthroughs for babies whose mothers are infected. The studies were carried out using blood samples that were left over from other routine purposes and that otherwise would have been discarded. The samples were not identified as coming from specific individuals. At the time, AIDS was not well understood. CDC was surveying newborns as a group to learn more about the incidence of the disease in particular communities. No treatment was available for newborns at that time--none. This was in 1988. This study was part of a responsible scientific effort to learn more about the prevalence of HIV, so that resources could be targeted quickly and effectively. The survey followed strict ethical principles and was approved by the Office for Protection from Research Risks at NIH. A task force of ethicists, lawyers, civil liberties advocates, gay rights proponents, and public health officials met at the Hastings Center, a bioethics think tank, to consider the issue. No objection was raised to these studies. The Hastings Center is one of the important resources in this country in terms of bioethical issues. They have a number of very thoughtful teachers and scholars who have testified before our committees over the years. And they have been included in this review of this particular project. A 1988 review of the issue by a Canadian work group also gave its approval to the studies. So did the World Health Organization's Global Program on AIDS. The Institute of Medicine of the National Academy of Sciences reviewed the survey and approved it as a well- established approach to public health surveys. Here you have it. You have the NIH Office for Protection from Research, you have the Hastings Center, which is one of the leading bioethic think tanks in this country, approving it. No objection was raised. The Canadian group also reviewed the work and so did the World Health Organization's Global Program on AIDS. The Institute of Medicine of the National Academy of Sciences reviewed the survey and approved it as a well-established approach to public health surveys. All of these bodies have approved these surveys. The information in the surveys was used by communities for education, screening, and treatment. The surveys ended in 1995, when new treatments for infants exposed to HIV and other ways to monitor HIV population trends in women of childbearing age became available. In September of 1997, Dr. Satcher recommended the study be formally terminated, and HHS agreed. So Dr. Satcher terminated it. It was going on when he became the head of the Centers for Disease Control, but he terminated the survey. CDC continues to work with States to identify ways to monitor trends of HIV in women of childbearing age. Now, Madam President, I was in the Senate during this period of time. It was in 1988 that we had the first initiatives on pediatric AIDS. My good friend from Ohio, Senator Howard Metzenbaum, on the Health and Human Resources Committee--and I will include the exact references tomorrow in the Record--was the one who offered the first amendment. It was $10 million to try to help and assist in the area of pediatric AIDS. It was a brand-new challenge in public health. And these studies have been referred to as something we would not subscribe to today, but at a time when we were attempting to find out the nature of the threat in terms of mothers and the extent of the challenge for communities and States in our Nation, these surveys were considered and reviewed and approved. To try to use today's standard for an earlier period of time when we virtually knew nothing about how to deal with pediatric AIDS--and there was enormous resistance in this body to doing anything about it then, enormous resistance to get into it at all. People forget all of that. Why get involved in this kind of disease research? We went through all of that. We eventually had the work with the Ryan White bill and several other breakthroughs that were important that moved us into a direction which respected the science rather than the ideology of the time. But during this period of time, and I remember very clearly, it was extremely difficult. We were trying to find out more as a nation and as a people about the prevalence of this disease within the population, and so this kind of survey took place. It is easy to flyspeck it now in terms of how surprising it is that any such study could possibly take place today. And it is always useful and valuable to be a Monday morning quarterback. The studies that were done then had been reviewed in terms of their ethical considerations. Maybe some agree, some differ. We could all certainly find criticisms of it knowing what we know today, but that isn't the question. The fact is this issue was actually started under a Republican administration and ended by Dr. Satcher. Now, it is nice to come out here and say, well, he should have ended it earlier and therefore he is not qualified. If that is your argument, so be it. But it is not, nor should it be, an argument that is elevated to a serious reason for having any second thoughts about this outstanding nominee. Finally, I just say, Madam President, as I started out today, we have an extraordinary doctor who has been willing to take on the responsibilities of Surgeon General and tend to our nation's public health concerns. These are tough issues. They deal with the most difficult kinds of problems that we can possibly imagine. We understand that. And Dr. Satcher deserves great credit for being willing to stand up and say I want to continue to serve, as he has his whole life. We are very fortunate to have such a person willing to stand up, and we are fortunate to have the President nominate him. I am going to be proud to vote in support of him, and I am confident we will have an overwhelming majority of the Senate to do so. As I said, I have been proud to respond to the questions that have come up today and look forward to further debate and discussion on this outstanding nominee. Hopefully, we will get the opportunity of having a chance to approve him. I yield the floor. Mr. CRAIG addressed the Chair.

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

Mr. KENNEDY. Mr. President, some of my colleagues have questioned Dr. Satcher's support for clinical trials of the drug AZT in foreign countries as part of the all-out international public effort to halt the mushrooming epidemic of mother-to-infant transmission of the AIDS virus. Every day more than 1,000 babies in developing countries are born infected with HIV. Clinical trials in the United States in 1994 showed that it is possible to reduce the mother-to-infant transmission of HIV by administering AZT during pregnancy, labor and delivery. However, it is recognized that such treatment would not be feasible in developing countries. Senator Frist talked about this briefly in his presentation. It is too expensive, and it requires ongoing therapy which is not possible in remote areas. It also prohibits breast feeding. For these reasons a group of international experts convened by the World Health Organization in June 1994 recommended that research be carried out to develop a simpler, less costly treatment. The idea was to make it affordable in terms of the limited resources for African countries and also that would be culturally suitable in terms of the breast feeding and in terms of the amount of times that individuals would have to come back for treatment. The idea was to tailor the regime to the existing cultural, economic and social regimes which exist in areas of the world where we have high concentrations of HIV but recognizing that one of the very encouraging areas with regard to HIV is trying to intercept the passage of the HIV into newborn children. Recognizing the possibilities for trying to reduce the communication of HIV to these infants, the challenge was, can we develop an alternative regime that would prevent the babies of those infected with HIV from contracting this disease, and do it in a way which is affordable, culturally acceptable, and effective? So, responding to this urgent need, the Centers for Disease Control and Prevention, the National Institutes of Health, the World Health Organization and other international experts worked closely with scientists from developing countries to develop a treatment that is usable in these countries and can reduce the devastating toll of HIV on their children. Dr. Satcher has acted entirely ethically and responsibly on this issue. The World Health Organization and the developing countries urgently requested the CDC and NIH to provide assistance in designing and conducting these trials, in cooperation with the research communities in the host countries. In a letter to NIH dated May 8, 1997, Edward K. Mbidded, chairman of the AIDS research committee of the Uganda Cancer Institute wrote: These are Ugandan studies conducted by Ugandan investigators on Ugandans. Due to lack of resources, we have been sponsored by organizations like yours. We are grateful that you have been able to do so. There is a mix-up on issues here, which needs to be clarified. It is not NIH conducting the studies in Uganda, but Uganda's doing the study on their people for the good of their people. Dr. David Ho, the director of the Aaron Diamond AIDS Research Center in New York City and Time's 1996 Man of the Year, has stated: These clinical trials were created for Africans by Africans with the good of their people in mind and with their informed consent. The studies were designed to be responsive to local needs through the constraints of each study site. African scientists have argued that it is not in their best interests to include a complicated and costly AZT regime for the sake of comparison, for such a regime is not only unaffordable but logistically indefensible. Before patients were enrolled in the clinical trials, they were specifically informed of their AIDS status and counseled about the risks and benefits of participation, including the fact they might be in a study group that received a placebo instead of an AZT anti-virus drug. This is the critical issue or one of the very major issues that obviously distinguish it from the Tuskegee study where there was no informed consent. At the time when the study started with the African Americans, blacks in this country, in the South, primarily in Alabama, those who participated in the venereal disease studies were never told that there was a cure. They were never informed that there was medical information that could make these individuals healthy. They were maintained, effectively, by the U.S. Public Health Service, in their stage of sickness. And some of them even died. This whole issue of informed consent was a matter of very considerable debate and discussion here in the U.S. Senate in the early 1970's. I had the opportunity of chairing the hearings during that period of time. After those series of incidents, we required informed consent. Every Member of this body and everyone who is listening to this knows that every time they go into a doctor's office and they sign that little sheet, ``informed consent''--they never did that before 1975. That was as a result of Senate hearings. Any tie-in with Tuskegee is a distortion and misrepresentation and a disservice and inaccurate. In Tuskegee there was no ethical review. In these studies there was an ethical review. There was no oversight of those kinds of studies. In this study there is an oversight. There was no counseling about the transmissibility. In this study there was. No informed consent. In this case--yes. It is entirely different. Now, as a practical matter, the only AZT treatment--to come back to the proposal again that was approved for the African countries--as a practical matter the only AZT treatment available to any women in these developing countries is the treatment provided to participants in the study. There was no other kind of treatment. The HIV-infected women in these countries do not have access to AZT because, as has been pointed out, it costs too much. Ethics Committees in both the United States and the developing countries conducted continuous, rigorous ethical reviews of the trials. The committees were made up of medical scientists, ethicists, social scientists, members of the clergy, and people with HIV. The role of these committees guaranteed that the trials would conform to strict ethical guidelines for biomedical research, including the Declaration of Helsinki and the International Guidelines for Biomedical Research Involving Human Subjects. The AMA president-elect, Dr. Nancy Dickey, has stated that these studies are ``scientifically well founded'' and ``in the long run will provide serious answers and are not the kind of superficial, unethical research that the critics are trying to make them out to be.'' Dr. Neil Halsey, the Professor and Director of the Division of Disease Control of the Department of International Health at Johns Hopkins University; Dr. Andrea Ruff, Associate Professor at Johns Hopkins, wrote to Secretary Shalala on October 24, 1997 stating: ``. . . we strongly believe that these trials are ethical and essential for identifying effective, practical regimes that could be implemented in most developing countries.'' Even those within the scientific community who have raised concerns about these trials, such as Dr. Sidney Wolfe, the director of the Public Citizen Health Research Group, have expressed their support for Dr. Satcher. So, I ask unanimous consent to have printed in the Record a series of articles that indicate the broad ethical support for the conduct of these trials.

Mr. KENNEDY. Mr. President, I will just take a few moments to wind up today's comments on truly an extraordinary nominee of the President and an incredibly gifted and talented medical professional doctor, Dr. Satcher. I want to just mention at this time and I will read part of an excellent letter that was made available to us. It was written to our friend and colleague, Senator Ashcroft, from the Morehouse School of Medicine. It is from Dr. Louis Sullivan, who was the Secretary of HHS under President Bush and had a very distinguished career there and has had over the course of his lifetime a very distinguished career. I will read this part, and I will submit the letter in its entirety for the Record: Dear Senator Ashcroft: I understand that in a dear colleague letter you recently questioned the ethics and leadership of Dr. Satcher because of his support of AZT trials to reduce perinatal HIV transmissions in developing countries. You also questioned his role in the HIV-blinded ``Surveys of Childbearing Women'' which started in 1988 and was suspended in 1995. As a biomedical scientist, former Secretary of the Department of Health and Human Services under President Bush, and one who has known and worked with Dr. Satcher for twenty-five years, I write to respectfully take exception to your assessment of the studies and especially Dr. Satcher. I share the view of the World Health Organization, UNAIDS, the National Institutes of Health and the Centers for Disease Control and Prevention that these studies were ethical, appropriate and critical for the health of babies in developing countries. I also agree with public health leaders at every level of government that the HIV- blinded survey which was started five years before Dr. Satcher entered government were ethical, appropriate and critical during the early phase of the AIDS epidemic. More importantly, I agree with those such as Dr. Sidney Wolfe, of Public Citizen, who, while questioning the AZT trials in Africa, strongly attest to the ethics and leadership of Dr. Satcher and strongly support his nomination for Surgeon General. Then it goes on in a very, very important way in this letter. I ask unanimous consent that the letter be printed in the Record. It gives both the history and the background on these AZT tests and responds to all the various issues that I think have been raised on that particular program.

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

Mr. KENNEDY. Mr. President, I want to join in commending my friend and colleague, the Senator from Tennessee, Senator Frist, for an excellent presentation. During the consideration of the nominee, he was careful with his questions, probing with his questions, and obviously prepared prior to the time of the nominee's presentation and during the course of the hearings. I think today we see the result of some very hard and disciplined and informed judgment based upon his evaluation of this extraordinary nominee for the position of Surgeon General and the Assistant Secretary. I listened with great interest to his very detailed description of the great opportunities for this Nation when we gain the service of Dr. Satcher in that position as Surgeon General and Assistant Secretary for Health. I heard with great interest, again, his response to a number of the allegations, quite frankly, misrepresentations that have been made about Dr. Satcher's record. I must say that I find myself in agreement with his understanding of Dr. Satcher's position, and as to his representation to the committee during the course of the nominee's presentation, and in response to various questions. I also want to commend the chairman of our committee, Senator Jeffords, for the work that he has done in both scheduling Dr. Satcher for the hearings, for the way that the hearings were conducted, the balance and the fairness which is so much a part of everything that he is associated with, and for his compelling statement as well. I am very hopeful that the Senate will have the opportunity to vote on this truly outstanding nominee in the not too distant future. This position has been vacant for a very considerable period of time. We have an outstanding recommendation by the President, a truly outstanding nominee, an outstanding candidate, an outstanding individual on the issues of public health. The position of Surgeon General needs to be addressed if we are going to be responsive to the concerns of our families in this country. We have had, quite frankly, enough delay on this outstanding nominee. It is time to act. Mr. President, I commend the leadership for bringing to the floor the nomination of David Satcher to be Surgeon General and Assistant Secretary for Health. Dr. Satcher is extremely well qualified for this position. In fact, his life story is a tribute to the strength and vitality of the American dream. Dr. Satcher was raised on a farm in rural Alabama. He was one of 10 children. His mother was a homemaker and his father was a foundry worker. Neither of his parents finished elementary school, and between them, they never earned more than $10,000 a year. The defining moment of Dr. Satcher's extraordinary life may well have occurred when he was a toddler. It was then, at the age of two, that he survived a near fatal attack with whooping cough. Although whooping cough had been a leading cause of death among young children in the United States, it would become much rarer by the time he was born. But the vaccine was not available to Dr. Satcher's family. They were poor African Americans living in the rural South. They had limited access to medical care, and none of the white doctors who practiced in the area would treat black patients. Fortunately, Dr. Satcher's father was able to talk a black physician in the area into making a house call and, against all odds, Dr. Satcher survived this dire illness. Largely as a result of this experience, he decided he wanted to become a doctor. He stated that he wanted to ``make the greatest difference for the people who I thought have the greatest need.'' Mr. President, he repeated that during the course of these hearings. Anyone who was in that room at that time and had an opportunity to listen to Dr. Satcher make that statement and make that commitment would not be on the floor of the Senate now urging rejection of this nominee. His commitment was to make ``the greatest difference for the people who I thought had the greatest need.'' That was a statement made with extraordinary humility. By someone else, it might have a different ring. But when you were there listening to Dr. Satcher make that statement, you could not help but know that he has been committed to that cause over the course of his extraordinary life, and it has been an extraordinary life. Dr. Satcher's parents wanted their children to get the best education they could as black children attending segregated schools in rural Alabama. Dr. Satcher was valedictorian of his high school class. He was one of only three students, out of a class of seventy, who went on to college. He attended Morehouse College in Atlanta, which awarded him a full scholarship. He graduated magna cum laude and was elected Phi Beta Kappa. I have heard comments on the floor that ``the United States is entitled to the best.'' Three out of seventy graduated from his high school and he goes on to college with a scholarship and graduates magna cum laude. We have the best, Mr. President. We have the best in this nominee. He went on to medical school at Case Western Reserve University, a first-rate, tough medical school. I have had the opportunity to visit that excellent school, and it is one of our best, and it's tough academically, it's vigorous. He was one of only two African American students. He became the first black student to receive a Ph.D. degree and M.D. degree simultaneously. He was also elected to Alpha Omega Alpha Honor Society. After finishing his residency at the University of Rochester, Dr. Satcher went to Los Angeles to join the hypertension clinic at the Martin Luther King, Jr. General Hospital in Watts. I have had the chance to go to that hospital, and it is right on the firing line, in terms of trying to meet human need. He went on to direct research on Sickle Cell Anemia at the King-Drew Sickle Cell Center there, and he founded and chaired the King-Drew Department of Family Medicine. He opened a free clinic in Watts, in the basement of a Baptist church that he had joined, and he served as its medical director until 1979. Mr. President, just keep following along this extraordinary life of commitment to others, and of excellence, in terms of the practice of compassion and reaching out to those who are the hardest pressed. From 1974 to 1979, he taught epidemiology at UCLA, one of the top medical schools. Dr. Satcher then returned to Morehouse College to chair the Department of Community Medicine and Family Practice. In 1982, he became president of Meharry Medical College in Nashville and served in that capacity for 10 years, where he is credited for helping to deal effectively with the college's financial problems. Whether you are talking about going out into the most difficult areas and opening a free clinic in the bottom of a church and trying to help and assist people, whether you are talking about being in the classrooms at UCLA as an instructor to the brightest minds in our country, whether you are talking about being a college president, he has done it all. He has done it all, Mr. President. But his heart is out there with the underserved people. You can't look at his record, and you can't read about it and listen to him and not understand it. Since 1992, Dr. Satcher has ably led the Centers for Disease Control and Prevention in Atlanta, the agency responsible for protecting the Nation's health and preventing disease, injury and premature death. In this capacity he has played a leading role in safeguarding and improving the health of all Americans. In 1992, under Dr. Satcher's leadership, CDC developed and implemented a very successful childhood immunization initiative. Before the initiative, only a little more than half of the Nation's children-- 55 percent--were immunized. Today, the figure is 78 percent, and vaccine-preventable childhood diseases are now at a record low. Dr. Satcher would be the first to say: I don't deserve all the credit for this. He would say: I don't even deserve a great deal of the credit, or even a little of the credit. But he would tell you that he was out there fighting every step of the way with those who do deserve the credit. He was there, and he deserves great credit for this because he made it a priority. It was in terms of not only the availability and accessibility of vaccines, but it was working to try and overcome the kinds of resistance that exists in so many communities locally across this country that he was able to devise strategies to work this through. I find that in my own State of Massachusetts, in a number of different communities, there is a great hesitancy or resistance to move ahead with immunizations for children, for many different reasons--those individuals that have difficulty with the English language and those that have cultural kinds of problems in moving forward, in terms of vigorous vaccination regimes, the repetitiveness in making sure children are going to keep up to speed in terms of the number of times that we have to go back and get these vaccinations. There is a lot of complexity in terms of making sure that children are going to receive those vaccines. But we have gone from 55 percent to 78 percent on his watch. He deserves credit. Dr. Satcher has also led CDC efforts to deal more effectively with the infectious diseases and foodborne illnesses. Our Nation relies on CDC to provide the rapid response needed to combat outbreaks of disease and protect public safety. Under Dr. Satcher, CDC is implementing a strategy against new and re-emerging infectious diseases, like TB, with better surveillance and detection. Many of us thought we had moved past TB, the time of tuberculosis. Yet, we find pockets of it that still exist in many different communities in this country. It is associated so much with the problems of poor housing, poor sanitary conditions, and generally the problems associated with poverty. We have it in many of our communities. We still have it and we can't forget it, and we should not forget it. We need a doctor that understands the response to recent food poisoning incidents. He has been a leader in developing a new early warning system to deal with such illnesses. He has earned many distinguished tributes during his extraordinary career. In 1996, he received the prestigious Nathan B. Davis Award from the American Medical Association for outstanding service in advancing the public health. In 1986, he was elected to the Institute of Medicine of the National Academy of Sciences in recognition of his outstanding leadership. Dr. Satcher is a respected family doctor. Ask those families out there in the Watts area. Ask the families down in the southern parts of our country in rural communities. I think for any of us that took the time to sit through those hearings and listen to him can understand that he has--I suppose the best description is the ``bedside manner.'' There are other words that are more eloquent to describe it. But he has it, and anybody that has ever met him and known him, or talked to him, or, I am sure, have been treated by him would understand and respect him. He is a respected scholar that has been elevated to the most prestigious positions in our country, voted on by those of his peers who understand his scholarship, and he is a respected public leader recognized for his service in public health. His career has emphasized work in patient care, health policy development and planning, education, research, health professions education, and family medicine. His range of skills and experience, and strong commitment to improving public health make him well qualified to be the country's principal official on health care and health policy issues--America's doctor. America is a healthier nation today, and it is healthier in large part because of Dr. Satcher's leadership. He is an excellent choice to be Surgeon General and Assistant Secretary for Health. The Nation faces significant public health challenges. We need a Surgeon General who can speak with candor, and advise the nation on smoking, AIDS, teenage pregnancy, the link between diet and disease, and other major health concerns. In the 1940s, Surgeon General Thomas Parran used blunt talk to warn the public about venereal disease. In 1964, Surgeon General Luther Terry first alerted the public to the dangers of smoking and the link between smoking and lung cancer. Surgeon General C. Everett Koop used his position to raise awareness about AIDS and other major health issues. People listen when the Surgeon General speaks. Dr. Satcher is well-qualified to follow in this distinguished tradition. Dr. Satcher's nomination has broad bipartisan support. He's been endorsed by a large number of health groups, including the American Medical Association, the American Nurses Association, and a wide range of academic health centers and public health organizations. I look forward to working closely with him in the future, and I urge the Senate to give him the overwhelming vote of support he deserves. Mr. President, I have about 10 or 15 more minutes. But I see my friend and colleague from Maryland. I would like to be able to conclude my remarks after the Senator from Maryland.

Mr. KENNEDY. Mr. President, in another letter from Dr. Sullivan to Senator Lott that was made available to all the membership, he said: I enthusiastically support the nomination of David Satcher, M.D., for the positions of Surgeon General and Assistant Secretary for Health of the Department of Health and Human Services. In light of the recent debate about issues regarding his nomination, I wish to communicate with you my experience with, and opinion of, David Satcher. I have known David for over twenty-five years, and I can state unequivocally that he is a physician. . .of [extraordinary] integrity, conviction, and commitment. As Surgeon General and Assistant Secretary of Health, I know that David has no intention of using those positions to promote issues related to abortion or any other political agenda. He has worked throughout his career to focus on health issues that unite Americans--not divide them. And the letter goes on. Both of these letters are from a very, very distinguished leader of the Department under President Bush and someone who has made, in his own way, an extraordinary contribution to public health and to health policy generally. Someone who has known Dr. Satcher for a long period of time should have a very important influence, I would think, and weight with our colleagues. I just mention, finally, Mr. President--and I am sorry my friend from Missouri is not here, Senator Ashcroft. He talked about the State surveys that were taken, and he was highly critical of the State surveys. It has been brought to my attention that the surveys went into effect in 1988, and then were concluded in 1995. Dr. Satcher came to the Centers for Disease Control--started under a Republican administration. But it is interesting that Senator Ashcroft was Governor of Missouri during this period of time, and he signed on for these various State surveys, and supported them. It just has to have somewhat of a ring here today as we are considering these surveys and as the point is being raised about how effective or how wise these surveys will be, that the person who is raising this and the most critical is someone who was a Governor of a State that actually endorsed and signed the applications. I do not think it is necessary, but we will have those available for the Record tomorrow. I think this is just, again, interesting. If these are the best cases that can be made against someone who has such a distinguished record, such a powerful life record in terms of the public interest and service, then we should be about the business of moving ahead and supporting this nomination. We look forward to the further debate. I am puzzled about where those are that have the serious reservations. We have been out here ready to debate this record. We look forward to debating it. I suggest the absence of a quorum.

Mr. KENNEDY. Mr. President, I ask unanimous consent that we recognize the Senator from Maryland for whatever time she expects, and following that the Senator from Utah, and then if I could ask that I be recognized.

Mr. KENNEDY. I would be glad to yield.

Mr. KENNEDY. I would rather hear from the Senator. If I can't, and if what I have outlined is not satisfactory, I would rather let the Senator speak, and I will take my chances. Could we have the Senator speak for 10 minutes?

Mr. KENNEDY

Mr. KENNEDY. Thank you.

Mr. KENNEDY. I thank the Senator. Are we under a time agreement?

Mr. KENNEDY

Mr. KENNEDY. Mr. President, I support this legislation. I disagreed with President Reagan on many issues, but I believe this proposal is an appropriate honor for a distinguished former President. I also support it because of the many personal kindnesses that President Reagan and his family have shown to the Kennedy family over the years. In particular, I remember two extraordinary occasions. On a wonderful morning in the Rose Garden in June of 1981, President Reagan presented a Gold Medal authorized by Congress and honoring Robert Kennedy to our family, and he spoke about my brother. Four years later, on a magnificant evening in June of 1985, President came to my home in McLean, Virginia and spoke about President Kennedy. These are two of the finest tributes that anyone has ever given to my brothers. I believe our colleagues will find these tributes of interest, and I ask unanimous consent that they be printed in the Record.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, several months ago, the world learned of one of the most astounding developments in modern biology: the cloning of a sheep named Dolly. This extraordinary scientific achievement awakened widespread concern about the possibility of a brave new world, where human beings would be cloned and where individuals would seek to achieve a kind of immortality by reproducing themselves. There is widespread agreement among scientists, ethicists, and ordinary Americans that production of human beings by cloning should be prohibited, at least until the possibilities and pitfalls of this scientific procedure are better understood. The President reacted rapidly to this scientific advance and the unprecedented issues it raised by asking the National Bioethics Advisory Commission to study the issue and make recommendations. The Commission recommended that creation of human beings by cloning should be banned for several years, and the Administration has submitted legislation to implement this recommendation. The legislation that Senator Feinstein and I are introducing today will assure the American public that reproducing human beings by cloning will be prohibited. It largely follows the President's legislation and the Recommendations of the Commission. It makes it illegal to produce human beings by cloning and establishes strict penalties for those who try to do so. In addition, it prohibits anyone from beginning the cloning process in this country and carrying out the implantation step in another country. But just as important as what the bill does is what it does not do. It does not seek to use public concern about cloning to establish a back door ban on research into human development. A prohibition that goes too far could outlaw needed research on the prevention, treatment, and cure of cancer. It could outlaw needed research on fertility, to help birth defects, and hereditary diseases. It could outlaw needed research on the cure of spinal cord injuries. All of these various kinds of research have broad support in Congress and the country. Yet a blunderbuss ban on human development research could easily interfere with this important and life-saving research, or even halt it altogether. In addition, the FDA has jurisdiction over human cloning and will act vigorously to shut down any clinic that operates without FDA approval. The FDA must find that human cloning is safe and effective. Given the current state of the science, the DFA would almost certainly decide that a human cloning procedure is not safe at the current time. The FDA approval process is not a permanent ban on human cloning, but it effectively bans the procedures for the near future. The American Medical Association and over forty national medical organizations and research groups have voiced support for the kind of research that is urgently needed to continue the progress we are making against a wide range of diseases. Benjamin Younger, the Executive Director of the American Society for Reproductive Medicine, has said, ``We must work together to ensure that in our effort to make human cloning illegal we do not sentence millions of people to needless suffering because research and progress into their illness cannot proceed.'' The legislation we are introducing today will do what the American people want--ban the production of human beings by cloning. It strikes the proper balance between assuring that human beings will not be reproduced through cloning and allowing needed research to continue. I hope that Congress will act promptly to enact this legislation.