[Congressional Record Volume 144, Number 6 (Wednesday, February 4, 1998)]
[Senate]
[Pages S350-S373]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]



                         Privilege Of The Floor

  Mr. President, I ask unanimous consent that two fellows in my office, 
Caroline Lewis and Diane Robertson, be granted floor privileges for the 
consideration of the Satcher nomination.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  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

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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,

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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. HATCH. Will the Senator yield?
  Mr. KENNEDY. I would be glad to yield.
  Mr. HATCH. I was supposed to be here at 2 to give a short speech and 
introduce a bill. Would it be all right with the distinguished Senator 
from Maryland if I do that? I have to chair the Judiciary Committee.
  Ms. MIKULSKI. I can enter my statement into the Record. I am not 
debating the merits, if my colleague will yield--but just to affirm the 
competency.
  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?
  Ms. MIKULSKI. I will speak for less than 5 minutes.
  Mr. HATCH. If I could go immediately following the Senator from 
Maryland.
  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.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Ms. MIKULSKI. Mr. President, I thank my colleagues for this 
arrangement.
  Mr. President, It is a great honor for me to support the nomination 
of Dr. Satcher.
  I enthusiastically support his nomination to be Surgeon General and 
Assistant Secretary of Health.
  This position, which serves as the nation's spokesperson on public 
health issues, has been vacant far too long. When I decide whether to 
support a nominee, I look at the nominee's competence and personal and 
professional integrity. Dr. Satcher is highly competent. Dr. Satcher 
has the greatest personal and professional integrity of any nominee who 
has come before our Committee in recent years. Dr. Satcher has a truly 
remarkable story. He's overcome substantial odds and hardships. He 
graduated from that great institution Morehouse College in Atlanta, 
Georgia, where Dr. Martin Luther King graduated and thousands of 
African-American men.
  At a time when there were few African-American physicians in our 
country, Dr. Satcher attended Case Western University in Cleveland, 
Ohio, where he received his medical degree. Dr. Satcher was the first 
African-American to earn an M.D. and a Ph.D. at Case Western. He was 
later a professor at Charles R. Drew Medical School in Los Angeles, 
California and returned to his alma mater, Morehouse, to become the 
head of the school of Medicine there. He served as president of Meharry 
Medical School in Nashville, Tennessee from 1982 to 1993 before 
becoming the director of the Centers for Disease Control.
  I have worked closely with Dr. Satcher, when he was the head of the 
Centers for Disease Control. He was enormously helpful and responsive 
with my state's psfesteria crisis.
  During his tenure at the Centers for Disease Control Dr. Satcher 
established himself as a very capable leader in the arena of public 
health. He aggressively took on the responsibilities of promoting 
health and preventing disease, injury and premature death. Whether it 
was increasing childhood immunization rates, expanding the breast and 
cervical cancer screening program, researching effective treatments for 
AIDS, or stressing preventive measures in pursuing good health, Dr. 
Satcher has done an excellent job.
  I admire his work on the issues of minority health, especially sickle 
cell anemia, which affects mostly African-Americans. I also admire Dr. 
Satcher's courage to look at the link between guns and the public 
health. Too many young African-American men are being killed by gun 
violence in our cities. I was also pleased with the way Dr. Satcher 
took on the issue of food safety.
  I am very concerned about recent incidents which have forced us to 
take a good look at the safety of our food supply.
  Dr. Satcher was on cue when he laid the groundwork for a new Early 
Warning System to detect and prevent food-borne illnesses. This 
initiative will help respond to outbreaks of food-borne illness 
earlier, and give us the data we need to prevent future outbreaks.
  The work Dr. Satcher has accomplished at CDC, along with his 
experience as a physician and scholar before that, directly prepare him 
for the role of a good surgeon general.
  As Surgeon General, Dr. Satcher will be America's advisor on public 
health issues and the national leader in developing public health 
strategies.
  I know Dr. Satcher will provide this country with a strong voice for 
public health. I wholeheartedly endorse this nominee. I urge my 
colleagues to support Dr. Satcher's nomination.
  The PRESIDING OFFICER. The Senator from Utah is recognized.
  Mr. HATCH. I thank the Chair.
  (The remarks of Mr. Hatch and Mr. Cleland pertaining to the 
submission of S.J. Res. 40 are located in today's Record under 
``Submission of Concurrent and Senate Resolutions.'')
  The PRESIDING OFFICER. The Senator from Massachusetts.
  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

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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.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

        [From the New England Journal of Medicine, Oct. 2, 1997]

  Ethical Complexities of Conducting Research in Developing Countries

          (Harold Varmus, M.D. and David Satcher, M.D., Ph.D)

       One of the great challenges in medical research is to 
     conduct clinical trials in developing countries that will 
     lead to therapies that benefit the citizens of these 
     countries. Features of many developing countries--poverty, 
     endemic diseases, and a low level of investment in health 
     care systems--affect both the ease of performing trials and 
     the selection of trials that can benefit the populations of 
     the countries. Trials that make use of impoverished 
     populations to test drugs for use solely in developed 
     countries violate our most basic understanding of ethical 
     behavior. Trials that apply scientific knowledge to 
     interventions that can be used to benefit such populations 
     are appropriate but present their own ethical challenges. How 
     do we balance the ethical premises on which our work is based 
     with the calls for public health partnerships from our 
     colleagues in developing countries?
       Some commentators have been critical of research performed 
     in developing countries that might not be found ethically 
     acceptable in developed countries. Specifically, questions 
     have been raised about trials of interventions to prevent 
     maternal-infant transmission of the human immunodeficiency 
     virus (HIV) that have been sponsored by the National 
     Institutes of Health (NIH) and the Centers for Disease 
     Control and Prevention (CDC). Although these commentators 
     raise important issues, they have not adequately considered 
     the purpose and complexity of such trials and the needs of 
     the countries involved. They also allude inappropriately to 
     the infamous Tuskegee study, which did not test an 
     intervention. The Tuskegee study ultimately deprived people 
     of a known, effective, affordable intervention. To claim that 
     countries seeking help in stemming the tide of maternal-
     infant HIV transmission by seeking usable interventions have 
     followed that path trivializes the suffering of the men in 
     the Tuskegee study and shows a serious lack of understanding 
     of today's trials.
       After the Tuskegee study was made public, in the 1970s, a 
     national commission was established to develop principles and 
     guidelines for the protection of research subjects. The new 
     system of protection was described in the Belmont report. 
     Although largely compatible with the World Medical 
     Association's Declaration of Helsinki, the Belmont report 
     articulated three principles: respect for persons (the 
     recognition of the right of persons to exercise autonomy), 
     beneficence (the minimization of risk incurred by research 
     subjects and the maximization of benefits to them and to 
     others), and justice (the principle that therapeutic 
     investigations should not unduly involve persons from groups 
     unlikely to benefit from subsequent applications of the 
     research).
       There is an inherent tension among these three principles. 
     Over the years, we have seen the focus of debate shift from 
     concern about the burdens of participation in research 
     (beneficence) to equitable access to clinical trials 
     (justice). Furthermore, the right to exercise autonomy was 
     not always fully available to women, who were excluded from 
     participating in clinical trials perceived as jeopardizing 
     their safety; their exclusion clearly limited their ability 
     to benefit from the research. Similarly, persons in 
     developing countries deserve research that addresses their 
     needs.
       How should these principles be applied to research 
     conducted in developing countries? How can we--and they--
     weigh the benefits and risks? Such research must be developed 
     in concert with the developing countries in which it will be 
     conducted. In the case of the NIH and CDC trials, there has 
     been strong and consistent support and involvement of the 
     scientific and public health communities in the host 
     countries, with local as well as United States-based 
     scientific and ethical reviews and the same requirements for 
     informed consent that would exist if the work were performed 
     in the United States. But there is more to this partnership. 
     Interventions that could be expected to be made available in 
     the United States might be well beyond the financial 
     resources of a developing country or exceed the capacity of 
     its health care infrastructure. Might we support a trial in 
     another country that would not be offered in the United 
     States? Yes, because

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     the burden of disease might make such a study more compelling 
     in that country. Even if there were some risks associated 
     with intervention, such a trial might pass the test of 
     beneficence. Might we elect not to support a trial of an 
     intervention that was beyond the reach of the citizens of the 
     other country? Yes, because that trial would not pass the 
     test of justice.
       Trials supported by the NIH and the CDC, which are designed 
     to reduce the transmission of HIV from mothers to infants in 
     developing countries, have been held up by some observers as 
     examples of trials that do not meet ethical standards. We 
     disagree. The debate does not hinge on informed consent, 
     which all the trials have obtained. It hinges instead on 
     whether it is ethical to test interventions against a placebo 
     control when an effective intervention is in use elsewhere in 
     the world. A background paper set forth our views on this 
     matter more fully. The paper is also available on the World 
     Wide Web (at http://www.nih.gov/news/mathiv/mathiv.htm).
       One such effective intervention--known as AIDS Clinical 
     Trials Group protocol 076--was a major breakthrough in the 
     search for a way to interrupt the transmission of HIV from 
     mother to infant. The regimen tested in the original study, 
     however, was quite intensive for pregnant women and the 
     health care system. Although this regimen has been proved 
     effective, it requires that women undergo HIV testing and 
     receive counseling about their HIV status early in pregnancy, 
     comply with a lengthy oral regimen and with intravenous 
     administration of the relatively expensive antiretroviral 
     drug zidovudine, and refrain from breast-feeding. In 
     addition, the newborn infants must receive six weeks of oral 
     zidovudine, and both mothers and infants must be carefully 
     monitored for adverse effects of the drug. Unfortunately, the 
     burden of maternal-infant transmission of HIV is greatest in 
     countries where women present late for prenatal care, have 
     limited access to HIV testing and counseling, typically 
     deliver their infants in settings not conducive to 
     intravenous drug administration, and depend on breast-feeding 
     to protect their babies from many diseases, only one of which 
     is HIV infection. Furthermore, zidovudine is a powerful drug, 
     and its safety in the populations of developing countries, 
     where the incidences of other diseases, anemia, and 
     malnutrition are higher than in developed countries, is 
     unknown. Therefore, even though the 076 protocol has been 
     shown to be effective in some countries, it is unlikely that 
     it can be successfully exported to many others.
       In addition to these hurdles, the wholesale cost of 
     zidovudine in the 076 protocol is estimated to be in excess 
     of $800 per mother and infant, an amount far greater than 
     most developing countries can afford to pay for standard 
     care. For example, in Malawi, the cost of zidovudine alone 
     for the 076 regimen for one HIV-infected woman and her child 
     is more than 600 times the annual per capita allocation for 
     health care.
       Various representatives of the ministries of health, 
     communities, and scientists in developing countries have 
     joined with other scientists to call for less complex and 
     less expensive interventions to counteract the staggering 
     impact of maternal-infant transmission of HIV in the 
     developing world. The World Health Organization moved 
     promptly after the release of the results of the 076 
     protocol, convening a panel of researchers and public health 
     practitioners from around the world. This panel recommended 
     the use of the 076 regimen throughout the industrialized 
     world, where it is feasible, but also called for studies of 
     alternative regimens that could be used in developing 
     countries, observing that the logistical issues and costs 
     precluded the widespread application of the 076 regimen. To 
     this end, the World Health Organization asked UNAIDS, the 
     Joint United Nations Programme on HIV/AIDS, to coordinate 
     international research efforts to develop simpler, less 
     costly interventions.
       The scientific community is responding by carrying out 
     trials of several promising regimens that developing 
     countries recognize as candidates for widespread delivery. 
     However, these trials are being criticized by some people 
     because of the use of placebo controls. Why not test these 
     new interventions against the 076 regimen? Why not test them 
     against other interventions that might offer some benefit? 
     These questions were carefully considered in the development 
     of these research projects and in their scientific and 
     ethical review.
       An obvious response to the ethical objection to placebo-
     controlled trials in countries where there is no current 
     intervention is that the assignment to a placebo group does 
     not carry a risk beyond that associated with standard 
     practice, but this response is too simple. An additional 
     response is that a placebo-controlled study usually provides 
     a faster answer with fewer subjects, but the same result 
     might be achieved with more sites or more aggressive 
     enrollment. The most compelling reason to use a placebo-
     controlled study is that it provides definitive answers to 
     questions about the safety and value of an intervention in 
     the setting in which the study is performed, and these 
     answers are the point of the research. Without clear and firm 
     answers to whether and, if so, how well an intervention 
     works, it is impossible for a country to make a sound 
     judgment about the appropriateness and financial feasibility 
     of providing the intervention.
       For example, testing two or more interventions of unknown 
     benefit (as some people have suggested) will not necessarily 
     reveal whether either is better than nothing. Even if one 
     surpasses the other, it may be difficult to judge the extent 
     of the benefit conferred since the interventions may differ 
     markedly in other ways--for example, cost or toxicity. A 
     placebo-controlled study would supply that answer. Similarly, 
     comparing an intervention of unknown benefit--especially one 
     that is affordable in a developing country--with the only 
     intervention with a known benefit (the 076 regimen) may 
     provide information that is not useful for patients. If the 
     affordable intervention is less effective than the 076 
     regimen--not an unlikely outcome--this information will be of 
     little use in a country where the more effective regimen is 
     unavailable. Equally important, it will still be unclear 
     whether the affordable intervention is better than nothing 
     and worth the investment of scarce health care dollars. Such 
     studies would fail to meet the goal of determining whether a 
     treatment that could be implemented is worth implementing.
       A placebo-controlled trial is not the only way to study a 
     new intervention, but as compared with other approaches, it 
     offers more definitive answers and a clearer view of side 
     effects. This is not a case of treating research subjects as 
     a means to an end, nor does it reflect ``a callous disregard 
     of their welfare.'' \2\ Instead, a placebo-controlled trial 
     may be the only way to obtain an answer that is ultimately 
     useful to people in similar circumstances. If we enroll 
     subjects in a study that exposes them to unknown risks and is 
     designed in a way that is unlikely to provide results that 
     are useful to the subjects or others in the population, we 
     have failed the test of beneficence.
       Finally, the NIH- and DCD-supported trials have undergone a 
     rigorous process of ethical review, including not only the 
     participation of the public health and scientific communities 
     in the developing countries where the trials are being 
     performed but also the application of the U.S. rules for the 
     protection of human research subjects by relevant 
     institutional review boards in the United States and in the 
     developing countries. Support from local governments has been 
     obtained, and each active study has been and will continue to 
     be reviewed by an independent data and safety monitoring 
     board.
       To restate our main points: these studies address an urgent 
     need in the countries in which they are being conducted and 
     have been developed with extensive in-country participation. 
     The studies are being conducted according to widely accepted 
     principles and guidelines in bioethics. And our decisions to 
     support these trials rest heavily on local support and 
     approval. In a letter to the NIH dated May 8, 1997, Edward 
     K. Mbidde, 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 of 
     issues here which needs to be clarified. It is not NIH 
     conducting the studies in Uganda but Ugandans conducting 
     their study on their people for the good of their people.
       The scientific and ethical issues concerning studies in 
     developing countries are complex. It is a healthy sign that 
     we are debating these issues so that we can continue to 
     advance our knowledge and our practice. However, it is 
     essential that the debate take place with a full 
     understanding of the nature of the science, the interventions 
     in question, and the local factors that impede or support 
     research and its benefits.
                                                                    ____


                [From the New York Times Oct. 15, 1997]

        AIDS Experts Leave Journal After Studies Are Criticized

                        (By Lawrence K. Altman)

       Two internationally recognized AIDS experts are resigning 
     from The New England Journal of Medicine's editorial board 
     over the content and handling of articles criticizing the 
     ethics of Federally financed studies of AIDS treatments in 
     third-world countries.
       The countries seek a drug regimen less costly than those 
     used in the United States to thwart transmission of the AIDS 
     virus from mothers to infants. In trials involving more than 
     12,000 infected pregnant women in Africa, Thailand and the 
     Dominican Republic, some women receive the drug AZT, which 
     has worked in studies in the United States, while others 
     receive dummy pills.
       The journal's attack on the studies, which compares them to 
     the infamous Tuskegee experiment, has led to wide discussion, 
     including harsh criticism of the journal itself, and focuses 
     attention on the role of the 25-member editorial aboard and 
     the two who are resigning in protest, Drs. David Ho and 
     Catherine M. Wilfert. The two objected to not being consulted 
     before publication of an attack on research that could save 
     lives, and Dr. Ho worried that the attack itself could 
     jeopardize future research on experimental AIDS vaccines.
       Dr. Jerome P. Kassirer, the journal's chief editor, said 
     the board's function is to give advice on broad issues and 
     suggestions of authors for editorials and reviews, but that 
     the board was not routinely consulted.
       Dr. Ho, a virologist at the Aaron Diamond AIDS Research 
     Center in Manhattan, and Dr. Wilfert, a pediatrician at Duke 
     University in Durham, N.C., are the journal board's chief 
     advisers on AIDS.
       A third board member, Dr. Richard P. Wenzel, chairman of 
     medicine at the Medical

[[Page S355]]

     College of Virginia in Richmond, said in an interview that he 
     agreed with much of Dr. Wilfert's criticism but was 
     withholding a decision about resigning until after the issue 
     was discussed at the board's annual meeting in December.
       Drs. Ho and Wilfert said in separate interviews that they 
     had resigned independently largely because the journal had 
     not consulted them before publishing an editorial that 
     likened the new experiments to the Tuskegee experiment, in 
     which poor black men suffering from syphilis were left 
     untreated.
       Dr. Ho, Dr. Wilfert and others have taken issue with the 
     Tuskegee comparison in part because the subjects in the AZT 
     studies were told that some would get dummy pills. In the 
     Tuskegee study the men were not told that penicillin had 
     became available while the study was under way, and so did 
     not know that effective treatment was being withheld.
       A full-time staff of editors produces the weekly journal, 
     but Dr. Ho said that ``the reason you have an editorial board 
     to help with policy is to get some input when you have major 
     issues like this one, and that clearly did not take place.''
       In the editorial process, ``it was clear that my role was 
     not crucial,'' he said.
       Dr. Ho said he was deeply concerned about how the critical 
     editorial would affect the future of studies to evaluate 
     experimental AIDS vaccines in developing countries.
       Dr. Wilfert said she was resigning because the journal 
     published the editorial and another critical article on Sept. 
     18 without presenting the other side.
       ``It was like ignoring half of it on purpose,'' Dr. Wilfert 
     said.
       Because her name was on the masthead, ``It implied that I 
     agreed with it when I didn't,'' she said.
       ``It is an error and bad policy'' and ``a grievous misuse 
     of the journal's power,'' Dr. Wilfert said.
       ``Those are not decisions that a few people in the 
     editorial office ought to feel comfortable with, because no 
     one small group of persons, no matter who they are, can cover 
     the waterfront well enough'' in translating health policy and 
     practice in developed countries to those in developing 
     countries, Dr. Wilfert said.
       Dr. Wilfert said she was resigning effective Dec. 31 in 
     order to ``vent my spleen'' at the annual meeting. She said 
     she feared that if she resigned sooner ``the issue might not 
     be discussed at the meeting.''
       The journal published a rebuttal two weeks after its 
     attack. It was written by Dr. Harold Varmus, the head of the 
     National Institutes of Health, and Dr. David Satcher, the 
     head of the Centers for Disease Control and Prevention, 
     and would not have been printed so quickly had not Dr. 
     Varmus received a leaked copy of the original editorial 
     before publication, those involved in the dispute said.
       Dr. Marcia, Angell, the journal's executive editor, wrote 
     the editorial.
       Dr. Wenzel, the board member from Richmond, said that if 
     the authors of the critical articles ``really knew the facts 
     they would have done a better job.''
       The journal's chief editor, Dr. Kassirer, said he regretted 
     Dr. Ho's said Dr. Wilfert's decisions to resign and was 
     unaware of any similar resignations at the journal, which was 
     founded in 1812.
       The editorial board members, who have no set term, Dr. 
     Kassirer said, are named by the chief editor, who can elect 
     not to renew them as members and has done so.
       Dr. Kassirer said that Dr. Wilfert ``wanted to have prior 
     consultation of the material in the journal, which is just 
     not acceptable to me because prior consultation is not what 
     the editorial board is for.''
       He said the journal intentionally did not strive to present 
     all sides of an issue ``because if you did you would end up 
     with a kind of Talmudic discussion in ``which readers could 
     end up having no particular view one way or the other and it 
     would be rather boring.''
       Dr. Varmus, the National Institutes of Health director, 
     said that ``The New England Journal of Medicine is trying to 
     attract more attention by making political ethical 
     philosophical and economic statements that have traditionally 
     not been in that journal in such an inflammatory way.''
       But he also said that ``before you inflame the public and 
     attract so much attention, you might want to ask experts on 
     the editorial board what they thing.''
       The Massachusetts Medical Society owns The New England 
     Journal of Medicine. Dr. Ronald A. Arky, a Harvard Medical 
     School professor who heads the society's publications 
     committee to which Dr. Kassirer reports, said he learned of 
     the resignations last Friday.
       ``The committee will want to hear from the editor about the 
     resignations'' at their next meeting in early November, Dr. 
     Arky said.
                                                                    ____


                  [From Time Magazine, Sept. 30, 1997]

 It's AIDS, Not Tuskegee--Inflammatory Comparisons Won't Save Lives in 
                                 Africa

                         (By David D. Ho, M.D.)

       In the current issue of the New England Journal of 
     Medicine, Peter Lurie and Dr. Sidney Wolfe of the advocacy 
     group Public Citizen charge that some U.S.-sponsored AIDS-
     research projects in Africa are unethical. The journal's 
     editor, Dr. Marcia Angell, goes even further, comparing these 
     studies to the infamous Tuskegee experiment in which black 
     men in the South were deliberately deceived and denied 
     effective treatment in order to determine the natural course 
     of syphilis infection. This comparison is inflammatory and 
     unfair and could make a desperate situation even worse.
       Doctors in the U.S. have known since 1994 that the drug AZT 
     can substantially reduce the chance of transmission of the 
     AIDS virus from an infected woman to her newborn child. 
     Unfortunately, administering AZT to pregnant women is 
     complicated and quite expensive--about $1,000 per mother. 
     That's far beyond the means of most developing countries, 
     where 1,000 newborns are infected each day.
       Hoping to find an AZT regimen they could afford, African 
     researchers sought sponsorship from U.S. health agencies and 
     launched a number of scientific studies in which some mothers 
     were given short treatments with AZT and some, for the 
     purpose of comparison, received a placebo. It is the 
     inclusion of these placebo groups that the critics find 
     objectionable. Giving a sugar pill to an AIDS patient is 
     considered ethically unacceptable in the U.S. To give one to 
     a pregnant African, Dr. Angell writes, shows a ``callous 
     disregard of [a patient's] welfare for the sake of research 
     goals.''
       These clinical trials, however, 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 and to the constraints of each 
     study site. African scientists have argued that it is not in 
     their best interest to include a complicated and costly AZT 
     regimen for the sake of comparison when such a regimen is not 
     only unaffordable but logistically infeasible. They have, 
     instead, opted for a study design that is achievable in 
     practice and is likely to provide lifesaving answers 
     expeditiously, even though it includes a group of women 
     receiving a placebo. While the inclusion of this placebo 
     group would not be acceptable in the U.S., the sad truth is 
     that giving nothing is the current standard of care in 
     Africa.
       The ethical debate here is obviously a complex one, without 
     a clear distinction between right and wrong. Comparisons to 
     Tuskegee don't help; neither does the imposition of Western 
     views, or what Dr. Edward Mbidde of Uganda calls ``ethical 
     imperialism.'' Calm and careful deliberations are in order. 
     Insisting on the infeasible in the name of ethical purity is 
     counterproductive in the struggle to stop this deadly virus.

  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.
  The PRESIDING OFFICER. The Senator from Minnesota.
  Mr. WELLSTONE. I thank the Senator from Massachusetts. I say to 
Senators who are out here for the debate, I shall not take long.
  I rise to support the nomination of Dr. David Satcher to be the next 
Surgeon General of the United States and Assistant Secretary of Health. 
Dr. Satcher is a man above reproach, whose life path has brought him 
here today to serve as the 17th Surgeon General. We should not delay in 
confirming this nomination.
  What is it that makes Dr. Satcher such a wise appointment for Surgeon 
General of the United States? Look back over this man's life, for the 
fabric of a person is woven over the course of a lifetime. Dr. 
Satcher's fabric is tight knit, vibrant, trustworthy and strong.
  Where does he come from? Is it from his childhood, growing up in 
rural America in a poor family with poor access to medical care, nearly 
dying at the age of 2 from whooping cough? Is that what makes him such 
an outstanding spokesperson for childhood immunization, for childhood 
nutrition, for preventive health? Is that what makes him such a 
powerful role model for children to follow their dreams?
  Or is it from the tragic loss of his first wife, the mother of his 
children, at a very young age from cancer? This man knows the tragedy 
of disease, not just on an academic level, not just on a professional 
level, but also on a very personal level.
  Or is it from his professional, academic and public service careers 
that truly do make him very special? This is a man who has used his 
considerable skills to serve those people in our country who were quite 
often the poorest of poor and, in particular, I have in mind poor 
children all across our Nation.
  After graduating from Case Western Reserve Medical School, his life 
has been spent caring for patients, teaching students and promoting 
public health, and he has done it well. His most recent position has 
been as Director for the Centers for Disease Control and Prevention.
  In his 4 years as Director for the Centers for Disease Control and 
Prevention, Dr. Satcher had--a little bit of

[[Page S356]]

evidence--spearheaded initiatives that have increased childhood 
immunization rates from 55 percent in 1992 to 78 percent in 1996; 
improved the Nation's capability to respond to emerging infectious 
diseases; laid the groundwork for a new early warning system to detect 
and prevent foodborne infections; expanded the CDC's comprehensive 
breast and cervical cancer screening program from 18 States to all 50 
States; and under Dr. Satcher's stewardship, the CDC has directed its 
attention to the causes and consequences and prevention of an epidemic 
which has long been a concern of my wife Sheila and of concern to me, 
and that is the epidemic of domestic violence against women in our 
country.
  Mr. President, I frequently come to the floor to talk about fairness, 
what is the right thing to do, what is the fair thing to do. And today 
I want to talk about fairness; yes, to Dr. Satcher, but even more so to 
fairness to the people in our country who are waiting for leadership 
from this Surgeon General; fairness to the families and children of 
inner cities I have visited all across America who are waiting for a 
spokesperson to tell them how to improve some of the unsafe conditions 
that they live under, how to improve their health care for themselves 
as parents and for their children; fairness to the residents of rural 
America who are medically underserved and are waiting for new ideas to 
make health care accessible; fairness to the youth of America who have 
been waiting for a clear and credible voice to lead them away from 
tobacco addiction before they light their first cigarette; and fairness 
to the victims of domestic violence and cancer and drug and alcohol 
abuse who are waiting for Dr. Satcher to speak from his bully pulpit 
about preventing these terrible tragedies.
  Mr. President, it is not fair for us to delay any longer Dr. David 
Satcher's nomination. We have the responsibility to vote. We have the 
wisdom, or should have the wisdom, to vote for this man who can do so 
much for our country. Elementary justice demands that the United States 
Senate vote for confirmation of Dr. David Satcher as Surgeon General 
and Assistant Secretary of Health. I yield the floor.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, that was an excellent statement by my 
friend and colleague, the Senator from Minnesota.
  Mr. BINGAMAN. Mr. President, I rise in support of Dr. David Satcher 
for confirmation both as the Surgeon General of the United States and 
Assistant Secretary for Health. In so doing, I want to speak both to 
the position of Surgeon General itself and to the qualifications of 
this nominee.
  From 1871 until the present, 16 individuals have had the honor to 
serve as this nation's chief advisor on public health matters. These 
individuals served to protect, improve, and advance the health of all 
people in the United States. While there are those that criticize and 
may disagree with the position, in many ways the Surgeon General serves 
as the health conscience for the country.
  Many Americans may not know the history of this position and can name 
few of the 16 individuals who have served as Surgeon General. However, 
most Americans can point to ground breaking reports or initiatives that 
were conducted by Surgeon Generals. For instance, they are aware of the 
role of the Surgeon General in programs to immunize millions against 
polio. Most can cite the important declaration in 1964, by the Surgeon 
General that: ``smoking can be hazardous to your health.'' Indeed, past 
Surgeon Generals have issued benchmark reports on smoking, nutrition, 
water fluoridation, and HIV and AIDS.
  The public deserves to have this position filled; it has been vacant 
for too long. We have been without a Surgeon General since December of 
1994. We need an identifiable, objective leader as we deal with the 
broad spectrum of health care issues before the country. Dr. David 
Satcher is that leader.
  Dr. Satcher is a distinguished family physician, academician, and 
leader in the arena of public health. Indeed, he has headed the Centers 
for Disease Control and Prevention since 1993. He has written that he 
will utilize the position of the Surgeon General to focus on issues 
that unite Americans. I am particularly interested in his commitment 
to, and expertise on, the issues of health promotion and disease 
prevention. During his confirmation hearing before the Committee on 
Labor and Human Resources, he emphasized his desire to promote healthy 
lifestyles and focus on issues of critical importance such as better 
nutrition and exercise. Dr. Satcher recognized the opportunities for 
lifestyle modification as a way of improving the health of Americans. 
His performance in this arena in the past and his stated agenda for the 
future, place prevention as a focal point.
  Mr. President, the accomplishments of Dr. Satcher at the CDC have had 
a direct impact in my home state of New Mexico. For New Mexico, border 
health issues are of utmost importance. Dr. Satcher has helped develop 
an innovative strategy to combat threats from new and reemerging 
communicable diseases like tuberculosis which cause problems in our 
border region. Greater outreach to the general public and health 
professionals has resulted in four straight years for declining TB 
rates.
  Additionally, he has worked to improve the quality and quantity of 
immunization services. He has promoted better community involvement in 
the immunization programs. Nationwide, childhood immunization rates 
rose to a record 78 percent under his leadership at the CDC.
  Another initiative, the CDC comprehensive breast and cervical cancer 
screening program, has flourished under Dr. Satcher's leadership. This 
program has undeserved and minority women has grown from being offered 
in the initial eighteen states, to including 50 states, the District of 
Columbia, 5 U.S. territories, and thirteen Native American 
organizations. Outreach efforts such as this lead to increased access 
and are key to reaching low income minority and older women. They 
afford the opportunity as well to educate at risk women on early 
detection of cancers.
  In closing, Dr. David Satcher is eminently qualified to speak out for 
the public's health and the nation's health needs. The nation deserves 
to have this position filled now. His commitment to public health will 
be a credit to this country. Please join me in supporting Dr. David 
Satcher for Surgeon General and Assistant Secretary for Health.
  Mr. KENNEDY. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. ASHCROFT. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered. The 
Senator from Missouri is recognized.
  Mr. ASHCROFT. Thank you, Mr. President.
  There have been a number of charges made and some pretty strong 
language suggested, as well as a lot of repetition and volume regarding 
some of the circumstances surrounding the conduct of Dr. Satcher in his 
role as an individual involved both in domestic health situations and 
international health situations.
  Let me begin by going through a number of these issues and referring 
to what notable authorities and investigators have indicated.
  When I raised the issue of the CDC, under the direction and in 
cooperation with Dr. Satcher, being involved with blind HIV testing for 
newborns--and while learning about the level of HIV present in the 
newborns not providing information to parents and sending newborns home 
without that kind of information--there was a pretty vociferous 
response, indicating that there were things in the studies that were 
worth learning. I don't challenge that. There are things that are worth 
learning that can be learned from medical research. As a matter of 
fact, it is sometimes easier to learn a lot of things more quickly if 
you don't really pay much attention to the ethics that are involved. 
You can learn the most, probably, with research that might be damaging 
to individuals.
  So the mere fact that there are items to be learned and that there is 
value in terms of statistical data that can be assembled from the 
study, doesn't justify the existence of a study. As a matter of fact, 
when you are running rats

[[Page S357]]

in a study, you can learn a lot of things very quickly. The reason we 
use animals in a lot of studies is because we accord to human beings a 
kind of standing that says the learning objective is not the end of all 
that we do: we also have to respect the dignity of the individuals 
involved.
  So I just wanted to mention a couple of the kinds of things that were 
said around the country and by authorities regarding these so-called 
blind HIV tests.
  Here is what was said in the New York Daily News on the 27th of June 
in 1995. They put it this way:

       Only politics, radical politics, explains the separate 
     standard for AIDS.

  Meaning there is a separate approach:

       The Centers for Disease Control and Prevention carried this 
     illogic to an absurd end by requiring testing of newborns, 
     then keeping the results secret. That let officials track the 
     epidemic but denied treatment. Fearful of the push to use the 
     results for actual care, the CDC turned churlish and quit 
     testing.

  It is kind of interesting to me that the New York Daily News, which 
doesn't have an ax to grind here, indicates that there was a set of 
circumstances that resulted in the CDC pursuing a logic to an absurd 
end, including testing newborns and keeping the results secret. And 
then when it was suggested that the CDC provide information to parents, 
instead of approaching the problem this way, the CDC just decided to 
quit the program altogether rather than provide information to parents.
  My view is that our objective in health, in confirming one who would 
be a health voice for all the people, should not be that one promotes 
controversial health measures by just keeping people from knowing about 
the situation. We should be informative and have a culture of 
information for people. If people have trouble accepting the 
information, we should work with them to help them get into a position 
where they digest the information appropriately and take steps to 
curtail the risks.
  The Washington Post made a pretty clear statement about this at the 
same time. I think it is important for us to understand that the 
Washington Post isn't some sort of organization that would be unfair in 
its assessment of this kind of situation:

       For the last 10 years, the Federal Government's Centers for 
     Disease Control has urged doctors and hospitals to advise 
     pregnant women at risk for AIDS to be tested for the disease. 
     Now the CDC has recommended extending this effort to all 
     pregnant women.

  The Washington Post goes on to say:

       This expansion is due primarily to completion of a study 
     showing that administering the drug AZT to an infected mother 
     during pregnancy and delivery and to her baby for a period 
     after birth reduces incidence of transmission of the disease 
     from 25 to 8 percent. If only those pregnant women known to 
     be at risk are tested, others with the affliction will 
     inevitably be missed and their babies won't receive the drug 
     therapy that has proven to be so effective. Congress is now 
     considering legislation that will make the AIDS testing of 
     newborns mandatory. The congressional effort to include AIDS 
     in this category deserves support.

  I think that's important:

       A positive test of a child is a sure indication that the 
     mother has the disease. With this information, breastfeeding, 
     which transmits this disease, could be avoided.

  I think it is very important to note that if you had provided 
information about the existence of the HIV virus to the parent, then 
they would know to avoid breastfeeding in certain situations. And 
because some of the babies, as Senator Kennedy has noted, first test 
positive for HIV and then later remit that indicator spontaneously, 
those babies shouldn't be breast fed by mothers with risk of additional 
contamination.
  The article makes another interesting point:

       And finally it is particularly important that the status of 
     children who are placed in foster care be known. The CDC 
     enumerates all these reasons supporting voluntary testing for 
     all pregnant women. In fact, they are of sufficient weight to 
     require the routine testing of all newborns for AIDS.

  The point is this, that testing newborns for AIDS should be attended 
by being able to take advantage of the appropriate therapies and the 
appropriate remedial action.
  Arthur J. Ammann, who is the professor of pediatrics at the 
University of California Medical Center in San Francisco and who was 
the man who discovered both pediatric AIDS and blood transfusion AIDS, 
really was distressed about a program of this kind testing blood 
samples from unidentified children and collecting the epidemiological 
data but not telling parents whether or not kids have AIDS.
  Dr. Ammann is a noted authority who, incidentally, was invited by the 
Labor committee to give a briefing just this week. And he put it this 
way. He indicated that the policies were a violation of the 
international Nuremberg code. ``The failure to inform the guardians of 
known HIV-infected infants, when treatment is available, violates both 
international and national codes of ethics.'' The quote comes from an 
August 3, 1995, Wall Street Journal article.
  I think it is important for us to note that there are very serious 
questions about the kind of testing and the information resulting from 
the tests and the ethics involved therein. And there may be ways in 
hindsight to come back and say, ``Well, there was value to what was 
learned and, therefore, it was appropriate for us to do what was 
done.'' But I do not think this adequately answers the questions. It 
does not really adequately address the question why, when we could have 
moved toward identification and notification, we simply acceded to the 
politics of the situation.
  The New York Daily News said that only radical politics explains the 
separate standard here, in referencing the fact that there are so many 
other diseases which, if you had that kind of information, would have 
been made available immediately.
  Another item which I raised earlier about Dr. Satcher was the idea of 
needle exchanges. The U.S. Congress has expressed itself on needle 
exchanges. And the American people are, I think, loathe to be 
participants in a program which would promote needle exchanges.
  A Member of this body came to the floor to say that Dr. Satcher had 
never supported the expenditure of any resources to provide clean 
needles at Government expense. I think that is technically true. Dr. 
Satcher and the CDC have, I think, not had a program. They have had 
studies in which clean needles were provided, and those have been 
funded.
  The Berkeley study in California was a study funded by the CDC which 
provided so-called ``clean needles'' to drug addicts. As a matter of 
fact, the group known as the Harm Reduction Group, which means trying 
to reduce the harm of IV drug use through needle exchanges, put on a 
conference called the Atlanta Harm Reduction Working Group Conference. 
It was a 2-day meeting designed to advance harm reduction in the 
Southeastern United States by providing government-sponsored or other 
privately sponsored needle exchange programs.
  The CDC was a sponsor or provided funding for this. So it is 
technically true, almost in a sort of lawyerspeak sense, that the CDC 
did not engage in a program of needle exchange. It has just had studies 
where the needle exchanges are used. And they have not exactly advanced 
the policy in some respect of needle exchanges, they have just 
undertaken to do it by sponsoring conferences for private groups, whose 
prime objective is to sponsor these so-called clean needle programs.
  We will have more to say about clean needle programs in the future 
because one of the things that is very difficult about clean needle 
programs is that they frequently provide clean needles to so-called 
drug addicts, and then the needles are not appropriately disposed of. 
And in a variety of settings those needles then are available in the 
culture because they are left laying around. It is dangerous to have 
those needles available.
  Let me move to the ethics of some of the studies that have been 
conducted. It is important to know that challenges have been made to 
the suggestion that the studies in Africa involved breaches of ethics. 
The study in Africa is said to involve a serious breach of ethics, as 
stated by the New England Journal of Medicine, a very important medical 
journal.
  The point was raised by supporters of the studies that two members of 
the board of directors resigned from the New England Journal of 
Medicine when the criticism of the studies was made.
  Let us look at what that means. According to one article, there are 
25

[[Page S358]]

members of the board of directors. There were two who agreed 
sufficiently with the nature of the studies to resign and 23 who 
thought that their resignations were inappropriate and apparently did 
not think they should resign.

  If we are to infer that the two who did resign supported the ethics 
of the way the study was conducted, we might infer that the 23 that did 
not resign opposed the ethics of the study.
  It is pretty clear that in our culture there are separate standards, 
in a lot of ways, for AIDS as a disease and for the HIV virus as a 
disease.
  I think some of that took place as a result of the early acquaintance 
of the culture with the HIV virus. Then people who had the disease 
could not get treatment and individuals would not get close to them, 
and there were elevated desires to have privacy. So HIV was treated in 
a different way than other viruses or deadly viruses would be treated.
  But the only individuals who resigned were individuals who were 
accustomed to the special ethical standing, if it is appropriate to say 
that, or the special rules for HIV. They were AIDS individuals. The 
people in the conventional medical community did not resign.
  Dr. Jerome Kassirer, the editor in chief of the New England Journal 
of Medicine--which is published by the Massachusetts Medical Society--
was asked about his response. He said he was surprised and dismayed at 
the resignations, but he said it was never policy to have editorial 
board members review editorials or other opinions before they were 
published.
  And these individuals who were interested in, I suppose, having the 
opportunity to screen what would be said about these kinds of studies 
simply had not been accorded that opportunity because the medical 
journal itself did not want to accord any special status or 
differential treatment here.
  A lot has been said about the ethics of the studies. Others indicated 
that maybe we should not have followed the ethical requirements because 
not much money is spent on individuals in Africa for health care on an 
annual basis.
  I think there was a statement made about $5.50 being spent per year 
in some of the countries. It varies in different countries in Africa. I 
believe the study that is most sharply in focus would have occurred in 
the Ivory Coast. The key is, some experts said we could not have used 
as a part of the study the 076 AZT regime which has been proven to be 
effective in reducing the number of HIV and AIDS cases among newborn 
children of HIV infected mothers.
  They said we could not use 076 because that treatment is a 
substantial regime and has substantial costs. They were trying to find 
a way for a lower-cost regime. And they were going to compare low doses 
of AZT to a placebo to find out whether low doses could be effective. 
However, that can be accomplished by comparing low doses to the 
standard, proven regime.
  As a matter of fact, the latter comparison is what ethics requires. 
According to the New England Journal of Medicine, published by the 
Massachusetts Medical Society, ``Only when there is no known effective 
treatment is it ethical to compare a potential new treatment with a 
placebo.'' Again, the use of a placebo is ethical ``Only when there is 
no known effective treatment.''
  We have had effective treatments substantiated and approved in the 
United States and internationally with the 076 AZT regime. Now, it 
would be possible to compare a lower level of AZT with this effective 
known treatment to find out whether the low levels were as efficacious 
as the 076 regime. But we chose instead--and I use the word advisedly, 
saying we ``chose'' instead--to use the unknown, low dosage with a 
placebo, with a sugar pill, which has a known consequence.
  We are not comparing two unknowns here. We are comparing a known 
consequence of no treatment, that is the placebo, with the unknown 
consequence of a treatment. But this is not the proven treatment. And 
the real approach we have to understand here is that the ethics of 
modern medicine in America, in a country that cares about individual 
patients as well as about scientific data can be generated, would not 
allow such research. Even though one can generate a lot of data in 
studies that are very dangerous to the people, our standards of ethics 
would not allow it. When there is a known treatment, we compare new 
treatments to the known treatment rather than comparing new potential 
treatments to something that we know will have no beneficial effect.

  And here is the way the editorial in the New England Journal of 
Medicine went forward. It said:

       Those requirements are made clear in the Declaration of 
     Helsinki, of the World Health Organization, WHO, which is 
     widely regarded as providing the fundamental guidelines of 
     research involving human subjects. It states in research 
     ``The interests of science and society should never take 
     precedence over considerations relating to the well-being of 
     the subject.'' And in any medical study every patient, 
     including those of a control group, if any, should be assured 
     of the best proven diagnostic and therapeutic method.

  Now, there was a proven diagnostic and therapeutic method. It was the 
076 regiment which has been proven in the United States and 
internationally. Instead of comparing low dosages of AZT to the best 
proven therapy and diagnosis, they chose to compare low doses of AZT to 
a known placebo. And to say to individuals, ``Well, those of you that 
get the placebo are destined to have no therapy''--and we know what 
that means when it comes to the HIV virus.
  The New England Journal of Medicine noted, ``Further, the Declaration 
of Helsinki requires control groups to receive the best treatment, not 
the local one.'' Individuals have raised in the study the idea that 
``Well, people wouldn't be getting good treatment over here anyhow, so 
we are eligible to disregard the treatment standards for them.'' They 
observe that these are poor people. These are African individuals. We 
can adopt a different standard there. We certainly could not do this in 
the United States, but we can do this over there because things are not 
what they ought to be over there.
  And here is what the New England Journal says: ``Acceptance of this 
ethical relativism''--this is important--``Acceptance of this ethical 
relativism could result in widespread exploitation of vulnerable Third 
World populations for research programs that could not be carried out 
in the sponsoring country.''
  Now, additionally, it has been suggested that the reason researchers 
could not use the 076 regime, which is an expensive regime as in 
comparison to the low dose of AZT, is that there is not enough money in 
these African countries ever to give people the high-dose program. 
Therefore, we cannot experiment with any high-dose programs and find 
out, using them, whether or not the low-dose program would also work.
  The truth of the matter is, you can learn a great deal by comparing 
the low-dose program to the high-dose program. I submit that you have 
the opportunity to learn about as much, if not more, than you have by 
comparing the low-dose program to the placebo. But more importantly is 
that this is consistent with the ethical standards.
  It was suggested that the reason you could use the no-treatment 
program as part of the study--the placebo--is because there was a low, 
low amount of money to be spent per capita on health care in these 
countries. And it said you could not use an $800 program in the test 
because the people could not afford it. They only spend $5 a year on 
medicine. Why is it, then, that you could use the low-dose program, 
which is a $50 program? If one can't afford but $5, one is ineligible 
for $50 just like he would be for an $800 regime. I do understand that 
we are not talking about a regime for trying to give everybody the $800 
program. Theirs was an effort to try and prove that a $50 program might 
work. So all they needed to do was to be able to compare the $50 
program to subjects who were getting the full program. If the less 
expensive program it worked just as well, they would at least have the 
cost down to the $50 level.

  But the point being made by the proponents of the research as it was 
conducted was that it is ethical, because of the costs involved. My own 
view is that if you only have $5, you can't really buy a $50 treatment 
any more than an $800 treatment. To say $50 is close enough and $800 
isn't misses the point. If you are trying to develop the availability 
of the $50 treatment, the tests themselves could be measured against a 
therapy which is more costly.

[[Page S359]]

  The last point I make is that if none of the treatments would be used 
in the countries where the tests are being made, it is unethical to 
conduct tests there. It's clear from international standards, whether 
one is talking about the Nuremberg Code or other standards, you only 
conduct tests in countries where there is a chance that the therapy 
would be used. If the testimony of those who argue against the New 
England Journal of Medicine and these individuals is that you might 
have used the low dose, that is fine, we can conduct them there. 
However, you don't make laboratory rats out of people in the conduct of 
those tests merely because there is not a sufficient level of medical 
resources there to justify the more expensive program being used in the 
United States.
  The New England Journal of Medicine directly indicates that ``The 
test directly contradicted Department of Health and Human Services' own 
regulations governing U.S.-sponsored research in foreign countries, as 
well as joint guidelines for research in the Third World issued by the 
WHO and the Council for International Organizations of Medical Science, 
which require that human subjects receive protection at least 
equivalent to that in the sponsoring country.''
  Now, here you have another standard. It is not that this fell short 
of the ethics of one part or another part, or one little fraction, or 
another little fraction. In the first instance, you never use a placebo 
when an effective treatment is known. Secondly, control groups are 
required to receive the best current treatment, not the local one. 
Thirdly, you don't do, in a Third World country, what you could not do 
in your own country.
  Now, it is pretty clear that there are a number of settings in which 
that idea of using other countries might be productive. But one might 
have trouble getting agreement to this, especially in the light of some 
of the controversy that has existed in the United States. Dr. Satcher 
testified at one time, ``What may not be readily apparent to all is how 
the CDC and the U.S. learned and benefited from international public 
health activities, including those related to HIV protection. It is 
clear that, in some instances, research relevant to both developing 
countries and the U.S. can be conducted more efficiently and 
expeditiously in developing countries because of the magnitude of the 
problem in those settings and, therefore, we have utilized that 
approach.'' Yes, it's more efficient and expeditious, if it is only 
because there is a bigger population. I think that justifies the 
potential if we follow the ethical guidelines. But if we say that we 
can do it more efficiently and effectively there because we don't have 
to provide real medicine, we say to the people of those countries that 
we don't care as much about your lives as we care about lives in our 
own country. If we say these things, we have then also embarked on a 
course of action that has very serious ethical complications.
  I would like to quote from Dr. Arthur Kaplan, the Director of the 
Center for Bioethics at the University of Pennsylvania:

       If you tried to do this study in the U.S., you would have 
     to do it through a throng of demonstrators and a sea of 
     reporters,'' he states. ``I would not do this study without a 
     design that would let me run it without a placebo. I think 
     you owe that to your subjects, even if they are not educated 
     enough or savvy enough to demand it from you.
  Now, that is strong language. I have no doubt that Dr. Satcher is an 
individual of tremendous achievement and great scientific capacity. I 
have not sought to question that, and I certainly don't want to 
question his achievement, his capacity, his intellect, or the fact that 
he does represent the American dream. But I will question the ethics of 
the studies in which individuals were given placebos when it's clear 
that placebos are only ethical in comparisons when there is no known 
effective treatment. I will question the ethics of the studies when we 
owe treatment to our subjects and we fail to give it to them because 
they are in a culture where it's not normally expected. I think Dr. 
Arthur Kaplan is right. I wouldn't do this study without a design that 
would let me run it without a placebo. I think you owe that to the 
subjects. ``Subjects'' is a kind of interesting term there; it is 
really talking about the people who are in the medical study. ``. . 
.Even if they are not educated enough, savvy enough to demand it from 
you.''
  Here is another article titled ``An Apology is Not Enough.'' This was 
printed in the Boston Globe on the 18th day of May, 1997:

       No research in developing countries is ethically justified, 
     unless the treatment developed or proven effective will 
     actually be made available to the population.

  We have had testimony here that the treatments could not be 
available, they would be too expensive. The low dosage treatment 
researchers were seeking to develop was estimated to cost $50. It might 
be possible to create a less costly regimen. But the components of the 
study should be performed ethically, regardless of what the ultimate 
objective is. Even though the objective was a $50 treatment, that 
doesn't mean that there could be no components greater than $50 in the 
study. Because ethics requires it you should be measuring the $50 
treatment that is being experimented with and comparing it to the best 
known treatment. You don't compare it to a placebo.
  A lot of comment has been made about informed consent. I would just 
like to take a few minutes to talk about informed consent, because I 
think it is important for us to try dealing with this problem in the 
cold light of what the international ethical requirements are. All 
guidelines stress the importance of obtaining informed consent from 
individuals asked to participate in the studies. Informed consent isn't 
just signing a paper. I would indicate in a setting where you are 
giving individuals sugar pills and it is known that the individuals who 
get sugar pills are going to have no treatment, that the level of 
information in the consent should be more than a ``sign here,'' or a 
rush to consent. It should be an informed, considered, deliberate 
consent.
  Let's see what the international standards are on informed consent. 
The Declaration of Helsinki, which the New England Journal of Medicine 
cited, makes informed consent a sort of touchstone of ethics 
requirements. The Declaration says:

       In any research on human beings, the potential subject must 
     be adequately informed of the aims, the methods, anticipated 
     benefits, and potential hazards of the study and the 
     discomfort it may entail.
       Guideline 10: When obtaining informed consent for the 
     research project, the physician should be particularly 
     cautious if the subject is in a dependent relationship to him 
     or her or may consent under duress.

  Certainly, in the African studies where these individuals are in a 
situation where the health care availability is not substantial, these 
people are in a dependent relationship to the physicians. In that case, 
the informed consent should be obtained by a physician who is not 
engaged in the investigation or is completely independent of this 
official relationship.

  Another guideline is from the Council of International Organizations 
of Medical Sciences--international ethical guidelines for biomedical 
research involving human subjects. We are not talking about running 
rats through a maze, or animal trials, taking the heart out of a pig 
and seeing if it will work in a variety of circumstances, but rather 
the international ethical guidelines for biomedical research involving 
human subjects. The Council of International Organizations of Medical 
Sciences, CIOMS, in collaboration with the World Health Organization 
make these statements regarding informed consent.

       Guideline 1: For all biomedical research involving human 
     subjects, the investigator must obtain the informed consent 
     of the prospective subject.
       Guideline 2: Before requesting an individual's consent to 
     participate in research, the investigator must provide the 
     individual with the following information, in language that 
     he or she is capable of understanding: Each individual is 
     invited to participate as a subject in research and the aims 
     and methods of the research.

  So they have to be told that they are invited to participate as a 
subject and what the aims and methods are.

       The benefits reasonably to be expected to result to the 
     subject, or to others, as outcome of the research, and any 
     foreseeable risks for discomfort to the subject associated 
     with participation in the research; any alternative 
     procedures or courses of treatment that might be as 
     advantageous to the subject as the procedure or treatment 
     being tested.
       Guideline 3: Obligations of investigators regarding 
     informed consent. The investigator has a duty to communicate 
     to the prospective subject all the information necessary for 
     adequately informed consent.


[[Page S360]]


  All the information necessary. This is a technical area. All the 
information in a technical area like this might include being informed 
that there is a known therapy and that it is unethical to conduct a 
trial without providing the known therapy, according to the Helsinki 
Declaration and a variety of other ethics guidelines.

       Guideline 4: Subjects may be paid for inconvenience and 
     time spent and should be reimbursed for expenses incurred in 
     connection with their participation in the study, and may 
     also receive free medical services. However, the payment 
     should not be so large on the medical services, so extensive 
     as to induce prospective subjects to consent to participate 
     in the research against their better judgment.

  The idea here is, if you are going to offer a bunch of medical care 
free to a person, they might make a judgment about getting involved in 
your program and might look aside and not be aware of, or be sensitive 
to, the risks that would otherwise inure to them as an individual 
participant.
  There is a specific science guideline, No. 8, for research involving 
subjects in underdeveloped countries.

       Before undertaking research involving subjects in 
     underdeveloping communities, whether in developed or 
     developing countries, the investigator must be sure that 
     every effort is made to ensure that the ethical imperative of 
     consent of the individual subjects be followed.

  The first guideline of the Nuremberg code relates to informed 
consent.
  Here we are with another code. We have been through the Helsinki, 
through the CIOMS, which was the Council of International Organization 
of Medical Sciences, and now we go to the Nuremberg code.

       The voluntary consent of human subjects is absolutely 
     essential.

  This means that the person involved should have the legal capacity to 
give consent.

       . . . should be so situated as to be able to exercise free 
     power of choice without the intervention of any element of 
     fraud, force, deceit, duress, overreaching, or other ulterior 
     force, constraint, or coercion, and should have knowledge and 
     comprehension of the elements of the subject matter involved 
     to enable him to make understanding and enlightened 
     decisions.

  I could go further.
  The truth of the matter is that Dr. Satcher claims that there was 
informed consent here. And there has been a lot of statements on the 
floor about the nature of informed consent. The facts of the matter, as 
I have come to understand them--it could be that I need to be 
corrected--is that the informed consent has not been as thorough as 
those who have joined in this debate would want to lead people to 
believe.
  Dr. Satcher, in an article that he wrote with Dr. Varmus states that 
there was informed consent in their studies.

       In the case of the NIH and CDC trial, there has been the 
     same requirements for informed consent that would exist if 
     the work were performed in the United States.

  Well, was there informed consent?
  It is kind of interesting. The New York Times sent a reporter to the 
area, and decided that there wasn't the level of informed consent that 
should exist in these cases. The New York Times article says:

       According to the CDC, before deciding about entering the 
     studies, women who were potential study participants were 
     provided information about HIV and AIDS and about the 
     intended study, and the possible risks and benefits for their 
     children. It was clearly intended that women involved, their 
     children, and others receive a placebo, a capsule without 
     active medication. There would be no way for them to tell 
     which group they were in. Women must give informed consent 
     before participation commences.

  That is what the CDC says. That is in a CDC study, to prevent HIV 
transmission in developing countries, and their report of April 30, 
1997.
  So the CDC, in the case of everybody being given all of the 
information, and that there is an informed consent.
  Here is what happened when the New York Times sent a reporter, and 
the New York Times article brings into question whether many of these 
women truly gave ``informed consent.''
  I indicate to you that I have blotted out the names of the actual 
individuals involved here respecting their privacy. Here is an excerpt 
of the article, along with the accompanying photograph of one of the 
women who participated in the study. According to the article--we will 
call this woman ``AB,''--a 23-year-old, illiterate, HIV-infected mother 
and patient in the study ``still does not grasp, even after repeated 
questioning, exactly what a placebo is, or why she might have been 
given that instead of real medicine.''
  They gave me a bunch of pills to take and told me how to take them. 
Some were for malaria, some were for fever, and some were supposed to 
be for the virus. I knew there were different kinds. But I figured if 
one didn't work against AIDS then one of other ones would.

  This is a picture of AB.
  The reason to enroll in the study last year was clear. It offered her 
and her infant free health care and a hope to shield her baby from 
deadly infection. Unmarried and unemployed, this new mother, like many 
others, said the prospect of health as she brought her baby into the 
world made taking part in the experiment all but irresistible. Still 
the question of whether she and other pregnant women knew of the 
implications of consenting to a placebo test hangs over the subject.
  Let me give you what the New York Times said about this individual's 
circumstance, AB. This is CD? I have the initials on the individuals--

       Minutes after she was informed for the first time that she 
     carried the virus, one pregnant woman--

  This is her picture, CD.

     still visibly shaken by the news, was quickly walked through 
     the details of the test, as well as general advice about 
     maintaining her health and protecting others from acquiring 
     the disease, in less than 5 minutes.

  This is the eyewitness testimony of how this so-called ``informed 
consent'' was obtained ``in less than 5 minutes in which the previously 
unknown concept of a placebo was briefly mentioned.''

       The session was over and DC.--

  Unemployed, and illiterate--

     had agreed to take part in the test. One of the most highly 
     educated of the women who spoke to a reporter, a 31-year old 
     single mother with a degree in law who gave her name only as 
     X, said she had never been made to understand that the 
     medicine being tested, ATZ, was already known to stop the 
     transmission of the virus DURING pregnancy.

  So what we have here is a feint toward ``informed consent.'' We have 
people with formal training with a law degree not knowing about 
effective therapies, not knowing what the real options are, not knowing 
what the real facts are, and we have a situation where we are using a 
placebo knowing that the utilization of placebo in that setting is 
going to result in the absence of any treatment for a disease which is, 
understandably and acknowledged, to be fatal in virtually every 
situation.
  I think this New York Times article suggests to us that some of the 
so-called highly touted ``informed consent'' wasn't as informed as it 
should have been, and by just reading what the international 
conventions and the international declarations require you know that it 
is virtually impossible for a person even of great and substantial 
medical awareness to understand about ``informed consent'' in a 5-
minute interval.
  This is obviously a difficult situation.
  I said when I started that America deserves better. I think Africa 
deserves better than this kind of treatment. I think people in Africa 
deserve to be treated with the same kind of dignity that the people 
America ought to be treated. I don't think we should say local 
conditions over there are different and that changes our ethics. I 
don't think our character is determined by the people we are dealing 
with. It is not OK to do things that are not ethical because you are 
dealing with people who are less well endowed than you are. I don't 
think it is OK to do things that are unethical or wouldn't meet the 
ethical standards here at home because the people are poorer than you 
are, or because they don't have the education. I think as Americans we 
understand that character is not a condition of circumstance. 
Circumstances may reveal character. But character is something on the 
inside that is determined by character itself--not by the circumstances 
outside.
  I really think these are very serious questions about the conduct of 
medical experimentation. No question in my mind that there is a lot to 
be gained from these studies. But the truth of the matter is time and 
time again people, because they have had a a lot to gain from studies 
who haven't been as sensitive to ethics as we have been, have

[[Page S361]]

done things that are inappropriate or ashamed of. There was something 
to be gained from the study. I am not saying this was Tuskegee. There 
was something to be gained by it. And the people who excused it said, 
``Well, these are just poor individuals, and they are not very 
intelligent individuals. So we can treat them differently than we treat 
other individuals.'' And I think the Nation has a real tug in its 
heart. We realized we were wrong. It was inappropriate, and it was 
appropriate that there be an apology. And an apology obviously doesn't 
solve that situation.

  I think we have to ask ourselves whether or not we can excuse away 
the absence of the right ethical standards based on local conditions, 
based on local education, based on the individual's intelligence, based 
on any circumstances. I believe that we have a responsibility to adhere 
to the guidelines. And in the absence of our commitment to those 
guidelines there is a serious deficiency. I believe if we do not have a 
strong commitment to ethics in the office of Surgeon General that we 
will not have a strong commitment to serving the people of this country 
in the way that they should be served.
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER (Ms. Collins). The Senator from Massachusetts 
is recognized.
  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

[[Page S362]]

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.
  The PRESIDING OFFICER (Mr. Faircloth). The Senator from Idaho is 
recognized.
  Mr. CRAIG. Mr. President, sometimes my colleague from Massachusetts 
and I disagree openly, sometimes loudly, on different issues, but he 
and I will not disagree today on the integrity or the excellence of the 
individual before us, David Satcher. But we will disagree. Nobody 
deserves a break on the truth or the facts as it relates to the 
performance of an individual.
  So let the Senator from Massachusetts and I agree that David Satcher 
is an outstanding individual of high quality. We agree. But because of 
differences in philosophy that sometimes produce politics we will 
disagree. I think my colleague from Missouri was doing that today. And 
so no breaks are given to anyone, nor should they be given. We are 
talking about building a record that is tremendously important as we 
reach out to decide whether this gentleman should become America's 
family doctor as the Surgeon General of the United States and therefore 
the record and the facts as they relate to this individual's 
performance and what he has done in the past are relevant and very 
important.
  There is no question that David Satcher will probably be confirmed as 
the Surgeon General, and as he is confirmed and as the American public 
gets to know him it is important that they know a little bit about his 
background so they can be ready and aware of what he might do along 
with what he will be required to do as our Surgeon General.
  I would like to talk about two areas that I think are very important 
to our country as a whole. As I have said, his philosophy is generally 
very different from my own, and that means that I will and do 
fundamentally disagree with the views of many of his efforts and my 
view, my politics, my philosophy is different from our President's. And 
so it is not unusual that he might nominate somebody that I would not 
agree with nor would I want to vote to confirm. But I also recognize 
the reality and the importance of our President being able to nominate 
those whom he feels would serve best under his Presidency based on his 
philosophy and his vision of how the country ought to be. So, while I 
believe the President's choice deserves some deference, I do not 
believe the Senate should automatically rubberstamp any decision that 
our President makes. This is one that he has made. It deserves 
reasonable debate on the floor. I believe I can offer some of that this 
afternoon.

  David Satcher comes to us with a background that includes service as 
a Federal officer. In his capacity as Director of the Centers for 
Disease Control, he was made aware of serious concerns that I and other 
Members of both the House and the Senate had talked about and had 
visited with him about. I was privileged to have that conversation in 
my office some time ago with Dr. Satcher. I was pleased that he would 
come, sit down and engage in a thoughtful and earnest way about 
something that was of concern to me and a very large constituency in 
this country; that I felt he and the tax dollars engaged at the 
National Centers for Disease Control were being misused.

[[Page S363]]

  The House and the Senate had concerns about a crusade mounted by the 
National Center for Injury Prevention and Control about certain kinds 
of things, and our director, the Director of the Centers for Disease 
Control, Dr. Satcher, went in a different direction. He launched a 
study against private firearms ownership in this country.
  Now, you have to scratch your head a bit and say, ``What? Firearms? 
Guns? Centers for Disease Control?'' I did. I scratched my head and 
said, ``Dr. Satcher, where are you coming from?'' Well, he was quoted 
to say this, that his efforts and the studies he was putting forth were 
``to convince Americans that guns are first and foremost a public 
health menace'' and to that end they had ignored years of study by 
criminologists, people much more directed in the area of guns and crime 
than the Centers for Disease Control. But Dr. Satcher being politically 
correct for his President moved on. And therefore went on to say that 
they had labeled violence as an ``epidemic,'' and concluded that gun 
control was the way to cure it.
  What they failed to recognize, and they should have recognized if 
they are good clinicians, is that the state and the condition in which 
the individual is raised produces a violent person, and that a violent 
person will reach out in his or her act of violence and use any tool 
available to them. But, no, because it was politically correct, they 
chose firearms.
  Dr. Satcher, firearms are not an epidemic in this country, they are a 
constitutional right and you ought to understand that. And, while you 
were being politically correct for this President and your philosophy, 
you were being unconstitutional. You were directing the energies and 
the taxpayers' dollars of this country against something that in my 
opinion was, frankly, none of your business. But you chose to move 
ahead, for all the reasons I think I have just stated.
  In short, the so-called research done by that agency was, in my 
opinion, both politically motivated and from a scientific point of 
view--and we have heard about his tremendous scientific credentials 
this afternoon--seriously flawed. Although Dr. Satcher did not 
personally conduct the research, he used his position to defend it. 
Even worse, his leadership at CDC caused it to continue even after it 
came under criticism. So you have to question. My job is to question. I 
think my argument today is legitimate. Dr. Satcher, you were acting 
beyond your professional credentials and, therefore, your science in my 
opinion was flawed. Now he wants to be America's family doctor.
  Mr. President, law abiding gun owners are not a public health menace. 
Violent people are, and have demonstrated by their actions that they 
can become a menace to people's health. It is outrageous that the head 
of any Federal agency would endorse using taxpayers' dollars in a 
political campaign against a constitutionally protected right of the 
taxpayer who paid for the campaign. But the gentleman this Senate is 
about to vote on did just that. He very openly talked to me about it in 
my office and I respect him for coming to visit about it. His only 
argument was he just thought it was important to do.
  I noted that he was very much in sync with the President, and 
therefore he was obviously doing the right thing politically. But I 
think it is time we question him on that issue.
  This is not the only area where Dr. Satcher's extreme views, I think, 
generate some concern. He also supports the legality of partial birth 
abortions. His position on this controversial procedure is at odds with 
what most polling data suggest today is 80 percent of the American 
people, and with the professional and ethical judgment of the American 
Medical Association. In taking this position, Dr. Satcher clearly 
chooses the President's political agenda over the views of his medical 
colleagues. So I think it is important, when there are some who get a 
bit exercised here that somehow we are questioning this gentleman's 
sincerity, or most important his professional integrity, that this man 
is quite often very willing to politicize beyond science something that 
happens to fit the agenda of the President that he serves.
  His views on this particular procedure are so far in the minority, 
and I think it is important that we recognize that. Many Members of 
Congress who advocate abortion voted in favor of banning partial birth 
abortion. Dr. Satcher and President Clinton say the decision to have an 
abortion should be between a woman, her conscience, and her doctor; and 
that abortion should be safe and legal. The partial-birth abortion 
procedure is indefensible on any of those grounds. The procedure we are 
talking about is one of causing and then stopping delivery of a child. 
I could go into the details of that. That isn't necessary to do. It has 
been talked about for a long time on the floor of the U.S. Senate. I 
think Senators, in a large majority now, fit the understanding of the 
American people on this issue.
  So, let me conclude by saying that my intent this afternoon is not to 
impugn the talent or the integrity of Dr. Satcher. It is, though, to 
clearly demonstrate that he is a political nominee who can operate in 
political ways and has chosen to do so to stay in step with the 
President who nominated him and to be out of step, not only with the 
Constitution of this country, but in many instances the vast majority 
of the American people.
  I am not going to attempt to predict the outcome of the vote on the 
floor but my guess is that when the vote settles, Dr. David Satcher 
will be the next Surgeon General of the United States. I and others 
will watch him very closely, hoping he will serve with integrity and 
responsibility, and that he will not choose to use his bully pulpit as 
a leverage against fundamental constitutional rights in our country, or 
what a vast majority of the American people think would be a wrong 
procedure, a wrong process, or an unnecessary law.
  I yield the floor.
  Mr. WARNER addressed the Chair.
  The PRESIDING OFFICER. The Chair recognizes the distinguished Senator 
from Virginia.
  Mr. WARNER. Mr. President, I rise in support of the nomination. If my 
colleagues will permit me to tell a short personal story, my father was 
a medical doctor and he practiced the last half of his career in the 
greater metropolitan area of the Nation's Capital, largely in Virginia. 
He was a marvelous man. His whole life was his family and medicine. He 
was sort of in that vintage of the old timers who, when you called, he 
got in his car or he walked or whatever the case may be, and he went to 
the homes and the hospitals and tended to the sick and the needy.
  I can remember in the Depression days, people would come to our front 
door and he never hesitated to give his God-given brains and expertise 
to the assistance of others. I have to tell you, Mr. President, I have 
said this before, if I had half the brains of my father I would have 
gone to medical school but I came up short and had to sort of accept 
the lot that was cast me.
  The nominee came to visit me, as I am sure he did with many others, 
and I talked to him at great length. He impressed me as a man of 
considerable skills in the medical profession, not in one narrow area 
but a very broad area. His education, his demeanor--I was very 
impressed with him. And I then sought, as all of us do, the 
consultation of our constituents, people who might have known him or 
had a judgment. I found in the State of Virginia he is highly regarded 
professionally. As a matter of fact, one of the most eminent physicians 
in Richmond VA, Frank S. Royal, Sr., whom I have known now for more 
than 30 years personally as a friend, and who has been a friend and a 
counsel to a number of Governors--indeed, Republican Governors. He was 
the late Governor Dalton's physician and closest friend. Anyway, he 
knew the nominee very well, all the way beginning back in his 
education. And he wrote me this letter which I ask unanimous consent to 
have printed in the Record following my remarks, giving an unequivocal 
endorsement of the nominee.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)
  Mr. WARNER. That letter, together with the endorsement of other 
recognized medical organizations and physicians in my State, 
corroborated my own findings. For that reason I am privileged and 
pleased to cast my vote for the nominee.

[[Page S364]]

  I regret, however, that he does not hold all the views that I hold. 
Particularly, I am opposed to partial-birth abortion and have 
consistently and will consistently vote to try to end that tragic 
practice. But we cannot expect this nominee or the nominee for 
Secretary of State or Defense to hold views which are consistent in 
their entirety with the views of individual Senators. I have been here, 
this is my 19th year now. I have cast many votes for nominees, and 
often you do so based on the totality of the credentials.
  Mr. President, I will ask unanimous consent to have printed in the 
Record other documentation which I feel is important to this nomination 
and those reviewing it, and indicate in my own personal judgment we are 
fortunate to have a man of this depth of experience and dedication, who 
could obviously earn many times over a Government salary in private 
practice, to step forward and volunteer to help the ever-increasing 
problems associated with America's health system.
  Mr. President, I yield the floor.

                               Exhibit 1


                                      East End Medical Center,

                                 Richmond, VA, September 30, 1997.
     The Hon. John W. Warner,
     The U.S. Senate,
     Washington, DC.
       Dear Senator Warner: I am very pleased to lend my support 
     to the nomination of Dr. David Satcher to the position of 
     Assistant Secretary for Health & Human Services and Surgeon 
     General. I am confident that all will benefit from his 
     continued advocacy in his new role.
       I am very familiar with Dr. Satcher's creative and 
     innovative approaches to increasing access to health care 
     services for all people through public-private partnerships. 
     His unique proposal to consolidate the acute hospital 
     services offered by Nashville's Metropolitan General Hospital 
     and Meharry Hubbard Hospital into one modern facility on the 
     Meharry campus is scheduled to come to fruition in January 
     1998.
       Dr. Satcher is uniquely qualified for this position because 
     of his dedication to two causes-improving the diversity and 
     quality of the educational experience of health professionals 
     and enhancing the capacity of our public health 
     infrastructure to address the needs of the nation's 
     communities.
       I pledge my support for this nomination and request that 
     Dr. Satcher be confirmed for this position.
           Sincerely,
                                         Frank S. Royal, Sr., M.D.

  Mr. JEFFORDS. Mr. President, I thank the Senator for his very 
excellent words about the nominee, Dr. Satcher, as we work in order to, 
hopefully, bring about his confirmation.
  I would like to make a few comments while we wait and see if someone 
else is ready to talk.
  I think it is important to briefly go through, and I am going to do 
it again another time with perhaps a little visual presentation of what 
we are talking about when we talk about the AZT trials and the 
responsibility of Dr. Satcher and Dr. Varmus, who is the head of NIH.
  We are talking about trials which were designed in Africa, by 
Africans, for Africans, after the review of many boards and groups that 
were working toward a solution to this problem. We are not talking 
about trials in the United States. Those of you who have visited Africa 
know the incredible AIDS epidemic that is going on in those nations. We 
think we have a problem here. The problems in the African nations where 
there is some evidence that the AIDS epidemic started--there are 
millions of pregnant women who are in danger of transmitting HIV to 
their children--are unimaginable.
  The question was, how do you handle that situation? It was decided by 
doctors and health officials in the host countries that they had to 
design some sort of a treatment protocol where they would know what 
would happen when they administered certain doses of drugs. So what 
they did--out of the huge pool of HIV infected pregnant women--was 
invite a group of them to participate in this trial.
  They invited these women--who were not going to receive any treatment 
for their HIV infection--and they said to them that, ``We would like 
you, if you are willing, to participate in our trial; some of you will 
get medicine which might help your baby, some of you will receive a 
sugar pill. You may stop participating in this trial anytime you want. 
The only way we can determine whether the medicine is safe for you and 
your baby, however, is to do it in this way.''
  So it is not a question of whether these HIV infected pregnant women 
had an alternative to go out and get help someplace else. They did not. 
Participation in this trial was the best hope for getting any treatment 
that might prevent them from giving HIV to their babies. Not only that, 
most of these women were not in a situation, for instance, where they 
could have used the 076 regimen even if it had been made available as 
part of the drug trial. They could not buy infant formula; thus, they 
ended up having to nurse anyway. The 076 regimen requires that women 
give up nursing.
  There are a lot of differences--differences in culture and 
differences in circumstances--between here and in Africa. The host 
countries and the international organizations involved discussed all of 
these issues and finally agreed on this regimen for testing. They did 
so because they believed it provided the greatest hope for their own 
people.
  Now they get criticized because these pregnant women who would never 
have gotten any help were invited to participate in a trial where they 
might get some help. They are criticized for doing this, because the 
participants didn't know whether they would receive the medicine or the 
sugar pill. It is a difficult situation, but it can be misleading if 
you don't understand the dynamics of the situation which the various 
countries were facing.
  I hope as we go forward to make an additional point to my 
colleagues--and I am going to try to explain this a little more 
articulately and specifically later. The heads of CDC and NIH were 
separated a long, long ways from what was going on, and they had all 
sorts of review boards and organizations approving this regimen. It is 
not like Dr. Satcher and Dr. Varmus were over there in Africa 
conducting these trials. It was something that Dr. Satcher and Dr. 
Varmus have responsibility for as leaders of CDC and NIH, but certainly 
the design was something which came about by virtue of the many U.S. 
and international organizations trying to figure out how to take care 
of this terrible epidemic and how to, hopefully, save as many of the 
young babies as they can from being infected.

  Mr. President, I yield the floor and suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. KENNEDY. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  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.

[[Page S365]]

     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.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:

                                 Morehouse School of Medicine,

                                    Atlanta, GA, January 30, 1998.
     The Hon. John Ashcroft,
     U.S. Senator, U.S. Senate, Washington, DC.
       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 transmission 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 
     (DHHS) 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 of Dr. Satcher. I share the view of the World 
     Health Organization (WHO), UNAIDS, the National Institutes of 
     Health (NIH) and the Centers for Disease Control and 
     Prevention (CDC) 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.
       In 1994 scientists in the United States found a regimen 
     using the drug AZT that dramatically reduces the transmission 
     of the HIV virus from mothers to newborns. As a result of 
     this breakthrough, perinatal AIDS transmission in the United 
     States has dropped by almost half since 1992. Naturally, such 
     an advance raises hopes of making dramatic reductions not 
     only in the developed world, but in developing nations, where 
     1,000 babies are born each day infected with HIV.
       Unfortunately, it is generally agreed that the regimen that 
     has worked so well in the United States is not suitable for 
     these developing nations. Part of the problem is that the 
     cost of the drugs involved is beyond the resources of 
     developing nations. In Malawi, for example, the regimen for 
     one woman and her child is more than 600 times the annual per 
     capita allocation for health care.
       Just as important, developing nations lack the medical 
     infrastructure or facilities required to administer the 
     regimen, which requires (1) that women undergo HIV testing 
     and counseling early in their pregnancy, (2) that they comply 
     with a lengthy therapeutic oral regimen, and (3) that the 
     anti-HIV drugs be administered intravenously at the time of 
     birth. In addition, mothers must refrain from breast feeding; 
     the newborns must receive six weeks of oral drugs; and both 
     mothers and newborns must be closely monitored for adverse 
     effects of drugs.
       Given the general recognition that this therapy could not 
     be widely carried out in developing nations, the WHO in 1994 
     convened top scientists and health professionals from around 
     the world to explore a shorter, less costly, and less 
     complicated drug regimen that could be used in developing 
     countries. The meeting concluded that the best way to 
     determine efficacy and safety would be to conduct research 
     studies that compare a shorter drug regimen with a placebo--
     that is, no medicine at all.
       After the New England Journal of Medicine (NEJM) published 
     its editorial criticizing the AZT trials in developing 
     countries, two of the three AIDS experts on this editorial 
     board resigned in protest because they disagreed. Many other 
     outstanding biomedical scientists and ethicists have since 
     taken issue with the NEJM editorial.
       As one who feels strongly about what happened in Tuskegee, 
     let me say that it is utterly inappropriate to compare these 
     trials with Tuskegee where established treatment was withheld 
     so that the course of the disease could be observed while 
     these men died. The AZT trials being carried out in 
     developing countries are for the purpose of developing 
     treatment that is appropriate, effective and safe to prevent 
     the spread of HIV from mother to child. Unlike Tuskegee, 
     these programs have a very strong informed consent component.
       Likewise, I do not believe that your criticism of the 
     blinded-surveys of childbearing women is inappropriate. These 
     surveys, which started in 1988, five years before Dr. Satcher 
     came to government, were supported by public health leaders 
     at every level. They were considered to be the best way to 
     monitor the evolving epidemic during that very difficult 
     period when we knew so little of the nature of the problem 
     and virtually no treatment was available. These surveys use 
     discarded blood from which all indentifying information had 
     been removed, to measure the extent of the HIV problem in 
     various communities and groups. The information was 
     invaluable to state and local communities in planning 
     education and screening programs. Using these surveys we were 
     able to document that the percentage of women infected with 
     HIV grew from 7% in 1985, to almost 20% in 1995. At no time 
     was any baby, known to be positive for HIV, sent home without 
     the parent being informed.
       Again, I acknowledge your right to criticize Dr. Satcher, 
     the nominee for Surgeon General. But, I believe that Dr. 
     Satcher's long and distinguished career speaks for itself 
     relative to his commitment to ethical behavior, service to 
     the disadvantaged, to excellence in health care and research 
     and to human dignity.
       Should you wish, I would be happy to review any of the 
     areas where there is any remaining confusion or questions.
       With best wishes and regards, I am
           Sincerely,
                                           Louis W. Sullivan, M.D.
                                                        President.

  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.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. THURMOND. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DURBIN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Illinois.
  Mr. DURBIN. Mr. President, I rise today to speak in favor of the 
nomination of Dr. David Satcher to the position of Surgeon General. As 
many colleagues have noted, he is exceptionally

[[Page S366]]

well qualified for this position. He has been involved, throughout his 
professional career, in a very broad range of health issues and has 
championed improvements in all the areas that he has been involved 
with.
  I find it somewhat unusual that this appointment to an important 
position, though not a Cabinet-level position, seems to always attract 
such debate and such controversy. Certainly, we want someone with real 
leadership skill to serve as the Surgeon General; but why, time after 
time, do we find ourselves embroiled in a debate over who that person 
might be? Some critics will say it is the fault of President Clinton 
for bringing names before the Senate that are so controversial. Yet, I 
think if history serves me correctly, I believe Dr. Koop, an appointee 
of President Reagan's, was a controversial nominee. Dr. Koop caused a 
lot of people some concern. He had some rather strongly held personal 
views on a controversial issue, the issue of abortion. The Democratic-
controlled Congress wrestled with his nomination and came to the 
conclusion that Dr. Koop's medical credentials and in the area of 
public health were so compelling that he should be given a chance to 
serve, even though a majority of the Democrats might disagree with his 
position on the issue of choice or abortion. It is a good thing we did 
because, despite our differences with Dr. Koop on that issue, he proved 
to be an exceptional leader on public health issues for America. In 
fact, some of the initiatives that Dr. Koop really spearheaded, I 
think, were so timely and so important that history will treat him very 
kindly. For example, alerting America at that moment in time to the 
dangers of HIV/AIDS was a controversial thing to do. Yet, he did it 
with the approval of the Reagan administration, at a time when it was 
appropriate. I think lives were saved as a result of that. So I have 
always drawn from the experience of Dr. Koop, who has become a friend 
of mine on the tobacco issues, that you should not judge a person on 
one life experience or one issue, but you should look at the totality 
of the circumstances, look at their values and principles and try to 
determine whether or not that person, man or woman, can do the job.
  That is why it is easy today to rise in support of Dr. David Satcher 
to fill the spot as our Surgeon General of the United States. Some of 
the areas he has worked in have been extraordinary. From increasing 
childhood immunization rates, to improving breast and cervical cancer 
screening, Dr. Satcher has been a leader.
  I want to focus on one aspect of his work at the CDC, in improving 
the Nation's food safety programs. Make no mistake--and I want to 
underline this, if I can--America is blessed with the safest and most 
abundant food supply in the world. You need only travel to any other 
country and take a look at the alternative to appreciate what I have 
just said. But we can do better.
  The General Accounting Office estimates that as many as 33 million 
Americans will suffer food poisoning this year, and more than 9,000 
will die from it, primarily infants and elderly people. The annual cost 
of foodborne illnesses in this country may rise to as high as $22 
billion a year.
  Since 1993, the CDC, under Dr. Satcher's direction, has played a 
critical role in modernizing our food safety programs and responding to 
challenges created by the large amount and variety of food now 
available in the United States.
  As part of this effort, the CDC has led rapid response to outbreaks 
of foodborne illnesses, conducted research into the cause and 
transmission of foodborne illness, and expanded outreach to health 
officials and the public on treatment and prevention of foodborne 
illness.
  The Department of Health and Human Services predicts that foodborne 
illnesses and deaths are likely to increase 10 to 15 percent over the 
next decade. Such estimates make increased vigilance even more 
important. Both early detection and rapid response are critical to 
minimizing health hazards from unsafe food.
  Building on these efforts, President Clinton announced in January 
1997 that the CDC will join forces with the Federal, State, and local 
agencies on new efforts to improve the safety of our Nation's food 
supply.
  CDC and Dr. Satcher have played a key role in the new early warning 
system to help try to catch and respond to outbreaks of foodborne 
illness earlier and to give us the data we need to prevent future 
outbreaks.
  In 1995, the CDC, with the FDA, Department of Agriculture, and State 
health departments, established this network of ``sentinel'' 
surveillance sites in five States that conducted in-depth surveillance 
for foodborne illness and related epidemiological studies.
  Since becoming operational in 1996, the network already has 
identified an outbreak of salmonella caused by contaminated alfalfa 
sprouts and an outbreak of E. coli from lettuce.
  I hope we can do more. We need a Surgeon General in place who is 
sensitive to that need. I think that we can start to consolidate under 
one Federal agency the many disparate Federal agencies that now try to 
keep our food supply safe. Isn't it a curious thing that when you take 
something as common as an egg, and if that egg is broken and served as 
a product, it is the jurisdiction of the Food and Drug Administration. 
If that egg remains in the shell and is sold as a product, it is the 
jurisdiction of the Department of Agriculture. Consumers have to shake 
their heads in wonderment that we would make such arbitrary 
distinctions between products which families view as the same thing, as 
far as they are concerned. It calls for leadership not only in the 
Department of Agriculture, the FDA, the Environmental Protection 
Agency, the Department of Commerce, and many other agencies, but it 
calls for the leadership of a Surgeon General, and that vacancy should 
be filled by Dr. Satcher, sooner rather than later.
  Dr. Satcher, as head of the Centers for Disease Control and 
Prevention, has dramatically expanded the CDC's landmark ``National 
Breast and Cervical Cancer Early Detection Program,'' which offers 
comprehensive breast and cervical cancer screening services to 
medically underserved women nationwide.
  Prior to Dr. Satcher's tenure and leadership at CDC, 18 States had 
the program. Today, all 50 States do, as well as 5 U.S. territories, 
and 13 American Indian/Alaskan Native organizations have programs. This 
expansion was based on strong scientific evidence showing that breast 
and cervical cancer screening can save women's lives.
  As of 1996, more than 1.2 million cancer screening tests were 
provided by the program. There are some critics of Dr. Satcher who 
might dwell or focus on one or two controversial things. I hope they 
will judge the man in his totality, and that they will judge his 
contribution fairly, because if you look at his work in public health, 
it is truly extraordinary.
  There is one area I would like to speak to that has been brought up 
on the floor, and I would like to close with this. Some have been 
critical of the efforts by the Centers for Disease Control to address 
the whole issue of firearm injuries in the United States. Many believe 
that this is entirely too political for an agency that is supposed to 
be dedicated to public health. I disagree. Over 38,500 Americans are 
killed each year with firearms in America; 17,800 homicides; 18,700 
suicides; 1,300 unintentional deaths; 5,800 children and teenagers die 
in America each year from firearm injuries; they are the leading cause 
of death among African American teenagers and the second leading cause 
of death among white teenagers.
  In the city of Chicago, IL, there is a hospital that we all admire so 
much, Mount Sinai. Next to it is a facility known as the Schwab Rehab 
Institute. Mount Sinai Hospital is in a tough neighborhood. In fact, a 
visit there on any weekend evening would be a sobering experience for 
all of us, because the people who come in there, the victims of 
dramatic injury and gunshot wounds, unfortunately, are in great number. 
Those physicians, nurses, and medical personnel scramble to do their 
best to try to keep these people alive. They manage, in many cases, to 
do that, and it takes the miracle of medicine to do it. Those folks 
might find themselves, a few weeks or months later, across the street 
at the rehab institute, Schwab Rehab, where I visited a few times to 
speak to victims of gunshots, and to talk to men in wheelchairs, 
paraplegics and quadriplegics, who will never have a chance to enjoy

[[Page S367]]

full physical mobility, because they were so victimized. It is not a 
surprise to me that many of the Nation's largest medical organizations 
and physician groups are now starting to focus on firearm injuries as a 
national epidemic --not only because of their number, but because of 
the severity of injury that is suffered. What day goes by in a major 
city in America where we don't hear or read about some innocent victim, 
many times a child waiting for a school bus, or a child who is out 
front playing on a bicycle, who is sprayed by random bullets and 
becomes a victim and is perhaps even killed? In that situation, we 
should step back and say, what can we do not just to treat the injury, 
but to reduce the likelihood that that injury will occur.

  I think the CDC, which really tries to improve public health across 
America, should include firearm injuries on the agenda. I am happy that 
Dr. Satcher feels the same way, and I hope CDC does not relax its 
efforts in this area in any way whatsoever.
  Finally, let me say, over the years, I have worked with the CDC on 
the issue of tobacco and tobacco-related diseases. They have really 
been leaders. They have brought out sound, credible evidence of the 
devastation caused by tobacco in America. They have talked about what 
we need to do to reduce what is the No. 1 preventable cause of death in 
America from occurring. I think the CDC has that responsibility.
  Our Surgeon General, in the past, has exhibited the same kind of 
leadership. We have seen those men and women come forward to the post 
and try to identify those issues that are important to Americans. Some 
friends of mine are managers of television stations. Since most of us 
spend a lot of our waking moments watching television, I sometimes say 
to them, ``When you are scheduling your programming for television, 
what do you look for? What are people interested in? What are American 
families anxious to watch and hear about?'' An interesting thing has 
occurred over the last 10, 12 years. You will notice it if you watch 
the news tonight, or any other night for that matter, or any morning. 
Americans are interested in public health issues. They are primarily 
interested in breakthroughs in medical discoveries. You see it every 
day. Since talking with this one station manager in Decatur, IL, 10 
years ago, I have been focusing on it. Most news programs include a 
story about medicine. America's families want to hear what we know and 
what we can share with them that might improve the quality of their 
lives. I think that is a indication of why this debate over the 
appointment of the Surgeon General is so important, and why we should 
not delay it or in any way sidetrack this debate over some tangential 
political issue. What is important is that we put a person of quality 
in this position, who can address the important public health 
challenges facing America. I think that is our responsibility here.
  Let me tell you, after reviewing his background, I think there is 
nobody better qualified for that position than Dr. David Satcher. I am 
happy to support his nomination.
  I yield the floor.
  The PRESIDING OFFICER (Mr. Abraham). The Senator from Arkansas.
  Mr. BUMPERS. Mr. President, I rise this afternoon not just in support 
of but in strong support of the nomination of Dr. David Satcher to be 
Surgeon General of the United States.
  I also want to state that I have a personal prejudice because I have 
worked closely with Dr. Satcher over the last 5 years since he became 
head of the Centers for Disease Control.
  There is a current cute saying making the rounds in Washington, and 
unhappily it is true. This is the only nation on Earth where a person 
is presumed innocent until they receive a Presidential nomination.
  We have had a lot of contentious debate on this floor about various 
nominations. I have not participated in many of those debates. But I am 
participating and I will continue to participate in the nomination of 
Dr. Satcher because I think he is one of the finest medical people in 
the United States. I also happen to think that he is one of the finest 
men, one of the finest people in the United States. I believe that the 
President could not have chosen better for this position.
  Mr. President, it is a real travesty to me that people who want to 
serve their Government in a position such as this are subjected to such 
a contentious process. Admittedly, the position of surgeon general 
doesn't have a lot of clout, but it does have a lot of public relations 
value. There are a lot of public appearances made by the Surgeon 
General. They take a lot of different positions on medical techniques 
and medical practices in this country. In some respects, I can 
sympathize with the Senator from Missouri who is opposed to this 
nomination, apparently based on Dr. Satcher's presumed feelings about 
the issue of partial-birth abortion. I happen to agree with Dr. Satcher 
on partial-birth abortions, but I recognize it is a very, very 
difficult moral question for everyone. I also have to confess to the 
Senate that I voted against Dr. Koop's confirmation to be Surgeon 
General because of his position on that issue, and have lived until 
this day to regret my vote because he turned out to be one of the 
greatest surgeon generals this country has ever had. I didn't know Dr. 
Koop. If I had known him maybe I would have voted differently.
  I do know Dr. Satcher in a very personal, intimate way because I have 
worked closely with him for 4 years. But aside from that, I ask my 
colleagues to look at his credentials. Look at the life of this African 
American who has risen from a poor rural community to become prominent, 
to become a role model. He went to Morehouse College, the same school 
Dr. Martin Luther King graduated from. Do you know what he did there? 
He was Phi Beta Kappa, which means that intellectually he was superior; 
a good student. From there he went on to get his MD and Ph.D. from Case 
Western Reserve in Cleveland. He did that in 1970, and then went into a 
career of academic and public health medicine.
  So far that is pretty impressive, is it not? A man who has spent his 
entire life since 1970 in public health and was a Phi Beta Kappa with 
the highest degrees you can get in medicine. After he graduated he 
served on the faculty at the UCLA Medical School, and as Dean of Family 
Medicine at King-Drew Medical Center in Los Angeles. He was then 
appointed president of Meharry Medical College in 1982. He was 
President of Meharry Medical College until 1993 until President Clinton 
chose him to head up the Centers for Disease Control, an agency to 
which we turn time and time again every year. Whether there is an EColi 
breakout, or a virus breakout in Africa, or whether it is mad cow 
disease in England, or whether it is an avian flu virus in the chickens 
of Hong Kong, it is the Centers for Disease Control who the world calls 
on, and they respond. They respond always in a very professional and 
effective way.
  I don't know what else may be involved in this, other than partial-
birth abortions. I have heard that some people take exception to the 
role of the Centers for Disease Control in conducting research in 
developing countries aimed at reducing transmission of HIV from 
pregnant mothers to newborns through AZT therapy. Let me say, first of 
all, that tests to measure the effectiveness of long-term AZT therapy 
on pregnant women were started long before Dr. Satcher came to the 
Centers for Disease Control. Let me also say those tests were expanded 
upon to measure the effectiveness of short-term drug therapy, because 
the public health infrastructure in Africa could not support the 
longer-term regimen. Getting AZT to pregnant African women during their 
entire pregnancy was almost impossible because of logistics. It was 
just not practical. The short-term regimen provides massive doses to 
pregnant women just before they deliver. And it is this short-term 
approach that holds out hope for the thousands of HIV-infected children 
who are born in Africa each week. In every experiment, the health 
ministers of each African country in which the trials were conducted 
approved the study design.

  But whether you like that or whether you do not like that, or whether 
you don't think the tests should have been conducted, or if they were 
not conducted correctly, the entire process started long before Dr. 
Satcher came to CDC. And the process was a joint effort of NIH, CDC and 
the World Health Organization. And what difference should

[[Page S368]]

it make when we consider the nomination of this outstanding candidate 
for the post of surgeon general?
  Mr. President, there is also controversy on the question of 
preventing AIDS transmission through needle exchange and on the issue 
of making condoms available in public schools. Regarding the former, 
Dr. Satcher has said that science rather than politics should determine 
our policy. On the issue of condoms, Dr. Satcher has stated that such 
decisions should be made in local communities by parents, teachers and 
community leaders. Who here can disagree with those positions?
  Mr. President, on the issue of partial-birth abortion, the American 
Medical Association came out and said they are opposed to it but here 
is what they say about Dr. Satcher.

       The American Medical Association continues to 
     enthusiastically support Dr. David Satcher . . .'' [The 
     surgon general's office] ``has been vacant far too long,'' 
     [and] ``the American public needs a credible voice they can 
     turn to in times of a public health crisis. . . . We urge 
     Congress to look at the totality of Dr. Satcher's expertise 
     and experience. He is a physician, administrator, educator, 
     and outstanding public health leader.

  Why is it we turn to the agencies like the AMA when we agree with 
them and want to ignore them when we don't agree with them?
  Mr. President, I want to go back to say that Betty Bumpers, my wife, 
and I have devoted a large part of our public life, which now spans 27 
years, to improving the immunization of children. It was Betty's idea. 
It was not mine. And until this day she is extremely active. She and 
Roslyn Carter have their own program, and have had it for 7 years, 
called ``Every Child by Two.'' They go around the country and work with 
governors and community groups to educate parents and providers on the 
importance of immunizing our young children by age two. I have paid 
close attention to CDC's immunization program ever since I came to the 
Senate, and over the past five years under Dr. Satcher's leadership, 
our nation has achieved the highest immunization levels and the lowest 
rates of childhood disease in our country's recorded history. What 
parent in the United States wouldn't take great pride in that 
achievement? What Senator would not applaud Dr. Satcher for the role he 
has played in eradicating polio from the Western Hemisphere? Who would 
not applaud Dr. Satcher's efforts to eliminate polio in Africa? The 
elimination of polio in the United States alone saves the taxpayers of 
this country $250 million a year. He had whooping cough when he was a 
child. It made an indelible impression on him, and it was the reason he 
went into medicine.
  So when I think of the many conversations and meetings I have had 
with Dr. Satcher in my office, he is always at the highest professional 
level. I have never heard him utter a statement that didn't reflect 
credit on him personally and didn't reflect credit on his total 
commitment to the health of the people of the United States. What in 
the name of God else do you want--would we reject a man who came up 
from nothing to become one of the preeminent medical people in this 
country simply because we disagree with him on one or two things?
  I notice people who do not want Washington telling them what to do 
often want Washington to tell the rest of the country what to do. If an 
atheist invented a cure for cancer, would you refuse to take it because 
he was an atheist? Of course you wouldn't.
  That is the kind of logic we are confronted with here because you may 
disagree on a policy that really is not a policy. You want to deprive 
this man of the post that the President nominated him for. And what did 
he say in answer to a letter from Senator Frist from Tennessee? What 
did he say to Senator Frist about the issue of partial-birth abortion? 
I see Senator Frist on the floor. He knows exactly what he said and it 
is this:

       Let me say unequivocally that I have no intention of using 
     the position of Assistant Secretary for Health and Surgeon 
     General to promote issues related to abortion. I share no 
     one's political agenda, and I want to use the power of these 
     positions to focus on issues that unite Americans--not divide 
     them. If confirmed by the Senate, I will strongly promote a 
     message of abstinence and responsibility to our youth, which 
     I believe can help reduce the number of abortions in our 
     country.

  Where can you find a more noble or professional statement than that?
  I say to my colleagues: Let us not divide ourselves over an 
appointment of this importance and destroy a man who has devoted his 
entire life to the well-being of the children of this country as well 
as its adults.
  I yield the floor, Mr. President.
  Mr. ALLARD addressed the Chair.
  The PRESIDING OFFICER. The Senator from Colorado.
  Mr. LEAHY. Mr. President, there are many reasons to support the 
nomination of Dr. David Satcher for Surgeon General. An experienced 
physician, Dr. Satcher has distinguished himself as the Chairman of the 
Morehouse School of Medicine, the President of the Meharry Medical 
College, and most recently as the Director of the Centers for Disease 
Control and Prevention (CDC). In recognition of his achievements, Dr. 
Satcher recently received the Surgeon General's Medallion for 
significant and noteworthy contributions to the health of the nation.
  Heading an agency with eleven major branches and responsibility for 
promoting health and preventing disease, injury and premature death is 
no easy task. Since 1993, Dr. Satcher has met the challenge with 
initiative, poise and professionalism. Under his direction, the CDC has 
been instrumental in increasing childhood immunization rates, reducing 
vaccine-preventable childhood diseases, and improving national and 
international defenses against food-borne illnesses and infectious 
diseases.
  Under Dr. Satcher's leadership, the CDC has done its best to respond 
to the threat that infectious diseases like tuberculosis, influenza, 
AIDS and malaria pose to Americans and people everywhere. In 1994, the 
CDC introduced a strategy to improve early disease detection, 
surveillance and outbreak containment worldwide. The CDC is also 
developing and implementing new diagnostic tests and prevention 
guidelines, and providing training, equipment, and supplies for public 
health personnel and national and international institutions.
  The U.S. has a central role to play in the international fight 
against infectious diseases. By providing $50 million to strengthen 
global surveillance and control of infectious diseases in the FY98 
Foreign Operations Appropriations Bill, Congress clearly indicated the 
urgent need for U.S. leadership in this area. As Surgeon General, Dr. 
Satcher would be able to bring together U.S. agencies such as the CDC, 
the Agency for International Development, the Department of Defense and 
the National Institutes of Health in a united effort against emerging, 
re-emerging and endemic diseases. He would also provide an important 
link to the World Health Organization and the health ministries of 
foreign governments.
  Mr. President, I am confident that Dr. Satcher would bring the same 
degree of dedication, commitment, and vision to the position of Surgeon 
General that he has to the CDC. If Dr. Satcher is confirmed, and I hope 
he is, I look forward to working with him in the fight against 
infectious diseases.
  Mr. ALLARD. Mr. President, I ask unanimous consent to go into morning 
business for a period of 45 minutes, that my comments be placed at the 
appropriate place in the Record, and that Senator Enzi's comments 
follow my comments.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The Senator from Colorado is recognized.
  Mr. ALLARD. I thank the Chair.
  (The remarks of Mr. Allard and Mr. Enzi pertaining to the 
introduction of S. 1608 are located in today's Record under 
``Statements on Introduced Bills and Joint Resolutions.'')
  Mr. DODD. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. DODD. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. DODD. Mr. President, I rise today in strong support of the 
nomination of Dr. David Satcher to the positions of Surgeon General and 
Assistant Secretary for Health.
  I commend the president for selecting him to serve as a voice for the 
Nation's public health needs and goals.

[[Page S369]]

Dr. Satcher is a renowned physician, scholar and public health leader. 
During his tenure at the Centers for Disease Control and Prevention, 
the nation saw a dramatic increase in childhood immunization rates as 
well as an increased capacity to respond to and detect emerging 
infectious diseases. In addition, while under Dr. Satcher's leadership, 
the CDC placed a significant emphasis on prevention programs, including 
efforts to screen low-income women for breast and cervical cancer. I 
also applaud his quest to protect the health of our nation's children 
by supporting research into prevention of deaths and injuries from gun 
injuries.
  Dr. Satcher, as has been noted on numerous occasions, is a remarkable 
individual of distinguished accomplishment. This Nation will be richer 
and better off were he to fill the job of Surgeon General and Assistant 
Secretary of Health.
  I am distressed that there are some who want to make another issue of 
Dr. Satcher's nomination. There are those who would argue that there is 
no need for a position of Surgeon General. That has been raised in the 
past. I think that is a legitimate debate, although I happen to believe 
that having an Office of Surgeon General has been tremendously valuable 
to this country, having someone who can speak on behalf of the Nation 
in a clear voice about issues of national concern. No one better 
epitomized that role than Dr. C. Everett Koop, who led the Nation on 
numerous health care issues over the years, speaking very clearly. To 
this day he plays a very important role as a former Surgeon General of 
the United States.
  The position of Surgeon General has been vacant since December of 
1994. We are now going to the fourth year not having filled this 
position. That is inexcusable. This Nation deserves to have a Surgeon 
General.
  As I said a while ago, if there are those who want to eliminate the 
position altogether, then offer legislation that will do that. But we 
have a position that needs to be filled, a position that can play an 
important role, as shown by various Surgeons General over the years, 
leading this Nation in the debate on health care issues. So I hope 
within the coming days here we can complete this nomination process and 
send it to the President and allow Dr. Satcher to assume the job of 
Surgeon General and Assistant Secretary for health.
  Mr. President, parliamentary inquiry. I have a bill I want to 
introduce. I inquire as to whether or not it would be permissible for 
me to do so in this debate?
  The PRESIDING OFFICER. The Senator will be permitted to do so should 
the Senate, by unanimous consent, consent to that act.
  Mr. DODD. Mr. President, I ask unanimous consent to speak as in 
morning business.
  The PRESIDING OFFICER (Ms. Collins). Without objection, it is so 
ordered.
  The Senator from Connecticut is recognized.
  Mr. DODD. I thank the Chair.
  (The remarks of Mr. Dodd, Mr. Kerrey, and Mr. Bingaman pertaining to 
the introduction of S. 1610 are located in today's Record under 
``Statements on Introduced Bills and Joint Resolutions.'')
  Mr. ASHCROFT addressed the Chair.
  The PRESIDING OFFICER. The Senator from Missouri is recognized.
  Mr. ASHCROFT. Madam President, may I inquire as to the state of the 
proceedings? What is the position of the Chamber?
  The PRESIDING OFFICER. The Senate is in executive session and is 
considering the nomination of David Satcher to be Surgeon General and 
Assistant Secretary of Health and Human Services.
  Mr. ASHCROFT. Thank you, Madam President.
  I rise to continue my debate with respect to the nomination of Dr. 
David Satcher, a nomination for two positions, that of U.S. Surgeon 
General and Assistant Secretary for Health.
  The PRESIDING OFFICER. The Senator is recognized.
  Mr. ASHCROFT. Thank you, very much.
  Madam President, there has been some considerable discussion today 
surrounding the ethics of the Centers for Disease Control and the 
studies that they have conducted regarding the transmission of AIDS 
from mothers to newborns--those studies having been conducted not here 
in the United States, but having been conducted in the underdeveloped 
countries of the world.
  These studies were conducted and have continued to be undertaken 
under the auspices of the Centers for Disease Control, under their 
authority and during the time which Dr. Satcher has had responsibility 
for the Centers for Disease Control.
  It is troublesome to me that a number of these studies have not 
really provided the same kind of guarantee in terms of the care which 
would be accorded to individuals if those individuals participating in 
the study were in the United States. Basically what I am saying is that 
the studies were conducted in such a way that they would probably be 
unacceptable in the United States of America.

  A disregard for individuals who participate in clinical trials or 
medical studies is, unfortunately, something that we have had problems 
with before. Not long ago, the United States apologized to a number of 
individuals who are part of what was called the Tuskegee experiment 
because the participants in the study had simply been left without 
treatment as doctors watched the progression of the disease.
  I think the Nation's conscience was shocked as a result of the fact 
those conducting the experiment were interested in scientific data that 
could be developed by watching people suffer and die. It was 
troublesome that we would somehow decide we could allow people to have 
been involved in that kind of experiment. When we discovered the nature 
of the Tuskegee experiment, the country was shocked and saddened by 
what had occurred.
  What was even perhaps more shocking is that after we had been through 
all the problems in assessing the difficulties of Tuskegee, there were 
revelations about these studies in Africa. The Boston Globe, on the 
18th day of May of 1997, published an article entitled ``An apology is 
not enough.'' The article stated that ``Even as the President laments 
the Tuskegee experiment, the United States is conducting questionable 
research in Africa.'' This particular article--while it does not 
purport to say that the African research is similar in every respect to 
the Tuskegee situation, did point out that there are some real problems 
with what is being done in Africa. One of the problems is that in 
Africa individuals who are a part of the study are not given the best 
known medical help. They are not being accorded medical treatment which 
would be required by ethical standards. They were given, however, sugar 
pills or placebos in the face of a virtually always fatal virus. They 
were given capsules which had no real medicinal value.
  This was so shocking to the medical community and individuals who 
cared about medical ethics that it found its way into the editorial 
pages of the Massachusetts Medical Society's journal, the New England 
Journal of Medicine. The New England Journal of Medicine is the most 
widely respected medical journal in the world. Virtually no major 
announcements of medical import are made in the United States without 
appearing in the New England Journal of Medicine. The New England 
Journal of Medicine is prudent with regard to what it publishes. The 
Journal does not publish medical findings just because they have 
scientific value. It is alert to the dangers of science which would 
cause people to set aside ethics.
  For instance, in an editorial of the Journal's, the publication 
states clearly that reports of unethical research will not be 
published, regardless of their scientific merit. You could have reports 
that would be very valuable scientifically, but they could be 
unethical. You could probably learn some things by watching people die 
without treatment, and that data would be valuable scientifically. As a 
matter of fact, that is what happened in the Tuskegee setting. But it 
was clear that kind of experiment was wrong and improper. This medical 
journal takes a stand against that. It says it refuses to publish 
reports, even if they are scientifically meritorious, if those reports 
are the result of unethical research.
  Now, the research which was conducted in Africa was controversial for 
a couple of reasons. The first point of contention was the use of the 
placebo, or the sugar pill that doesn't have medicine, as part of the 
study. The New

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England Journal of Medicine indicates clearly, ``Only when there is no 
known effective treatment is it ethical to compare a potential new 
treatment with a placebo.'' In other words, if you know that you can do 
absolutely nothing, there is no known way to cure something, no known 
way to impair or stop the progress of a disease, then you are allowed 
to try something and measure it against nothing--which is basically the 
placebo. But when you know, in fact, that there is something that 
works, it is unethical, according to the New England Journal of 
Medicine, to use a placebo against some other proposed remedy.

  I think that is the reason the New England Journal of Medicine took 
exception with the CDC studies, particularly as it related to the Ivory 
Coast. Prior to the time of these studies it was pretty clear that a 
regimen had been developed which had been effective in substantial 
measure in curtailing the transmission of the HIV virus from women to 
their children. As a matter of fact, the AZT treatment is called the 
AZT 076 regimen. That regimen has had pretty good results. Normally in 
newborns, 25 percent of those that are born to mothers with HIV carry 
the HIV virus themselves. But the studies indicated that if you 
followed the AZT regimen, the AZT 076 regimen, instead of having 25 
percent, or 1 out of every 4 children emerge with the HIV virus, that 
you could cut it down to 8 percent. So from one-quarter of all the 
babies, 1 out of every 4 babies, to 1 out of every 12 babies. Now that 
is a substantial improvement. It is a clear demonstration, accepted by 
medical authorities, that it is a regimen of treatment that has 
promise, it is effective, and it is worth doing.
  So when you go to Africa to conduct a study, to do it ethically, 
according to the New England Journal of Medicine, it would require that 
individuals in the study compare proposed new treatments not with a 
placebo, but since there is a known effective treatment, new treatments 
would have to be compared against the known effective treatment.
  I quote from the New England Journal of Medicine: ``Only when there 
is no known effective treatment is it ethical to compare a potential 
new treatment with a placebo.'' Now, what we have in the studies in 
Africa is the comparison of a known effective treatment with a placebo. 
This is not appropriate. Only when there is no known effective 
treatment is it ethical to compare a potential new treatment with a 
placebo.
  In reaching this conclusion--this isn't just the opinion of the 
editorialists at the New England Journal of Medicine. They cite the 
Declaration of Helsinki of the World Health Organization as providing 
what is widely regarded as the fundamental guiding principles of 
research involving human subjects. In research on man, they say, ``The 
interests of science and society should never take precedence over 
considerations related to the well-being of the subject,'' and ``In any 
medical study, every patient, including those of the control group, if 
any, should be assured of the best proven diagnostic and therapeutic 
method.''
  It is pretty clear that the best, proven diagnostic and therapeutic 
method is not the placebo, not the sugar pill. The best, proven 
therapeutic and diagnostic method is the 076 regimen, which cut the 
transmission rates from 1 out of every 4 to 1 out of every 12 infants 
infected with HIV. That is a substantial cut. I think it is always 
important for us to understand that we are talking about a nearly 
always fatal virus. We are not talking about a situation where maybe a 
few more people are threatened. The HIV virus, as it ultimately 
develops into a condition known as AIDS, is a final and fatal 
condition. So I don't think it behooves us to take it lightly. As a 
matter of fact, medical authorities have not taken it lightly.
  I will just point out that even those individuals who were involved 
in the very discovery of AIDS and the transmission of AIDS in the birth 
process do not take it lightly. As a matter of fact, studies of 
intensive treatment of AZT ended in 1994, just as soon as it was shown 
that the drug sharply reduced HIV transmission to infants. Four years 
ago, we made it clear that the use of the placebo was over. You would 
not be doing placebo-based tests any longer, because it had been 
demonstrated that the drug sharply reduced transmission of the virus 
from mothers to their babies. That is from the New York Times article, 
``AIDS Research in Africa; Juggling Risks and Hopes.''
  The Third World studies, however, were in progress in 1995. They 
continue to be in progress. Apparently, they were ongoing as of late 
January. Now, the CDC provided funding for the studies on the Ivory 
Coast. The study was simply designed to determine whether a new course 
of AZT--a short course, as opposed to the 076 regimen--whether that new 
short course would have an impact of curtailing the virus in the 
children born to HIV-infected mothers. As we indicated before, the 076 
course cuts transmission of HIV from 25 percent of all infants down to 
8 percent of all infants, or approximately a two-thirds reduction. The 
studies were designed to determine if a smaller dose of AZT would have 
any impact.
  CDC decided to use a technique known as the placebo controlled study, 
and it was their methodology of choice. Now it seems to me that we have 
a clear problem here, and that is that we have an ethical standard for 
a medical test and trial that says you don't use placebos when there 
are effective known treatments. You have had a clearly established 
treatment since 1994, recognized in the United States as a treatment 
that is effective in reducing the incidence of HIV in new-born infants 
by two-thirds.
  One of the reasons that the CDC chose to move forward with the 
placebo-based trials is that the trials are well understood to be very 
informative scientifically. Those who have come to the floor of the 
Senate on repeated occasions during the day have talked about how 
wonderful this was to get this information. I really don't want to get 
into a big argument about whether or not you can get good scientific 
data in trials where you let people die because you give them sugar 
water or sugar pills instead of real medicine. I think it is very 
likely that you can get good scientific data. I think it is very likely 
that the outcomes of your tests will be scientifically valid. You can 
prove that certain kinds of therapies are better than sugar and water. 
But we are not here just to find out what could be scientifically 
advantageous. I think it is important that we remind ourselves of that.
  There were scientists who thought they learned a lot from the 
Tuskegee studies. The mere existence of advantageous or helpful data at 
the end of a test or the mere facility with which scientific data can 
be collected doesn't really determine what the standard should be for 
us. The standard should be that we have our tests conducted in a way 
that is consistent with the ethical standards and with the requirements 
that have not only been developed for the United States, but are 
recognized in the international community.
  Among the guidelines in the international community for tests that 
are clinical and designed to inform our health care procedures is a 
guideline that says you should never test in a culture what the culture 
is totally unlikely to be able to implement. In other words, one 
culture is not allowed to go to another culture that isn't ever going 
to be able to use the therapy and say, ``We are going to use you as 
guinea pigs, we don't want to endure this on our own.''

  There is another standard that is relevant, whether we are talking 
about Helsinki or a number of the other codes. We have the Helsinki 
Declaration; the Nuremberg Protocols; the WHO Guidelines developed in 
Geneva--a variety of guidelines. Another one of these ethical standards 
is that you should not test for a therapy in a country that can 
probably never use it. And you should not test where the cost of using 
a therapy will make it virtually inaccessible.
  That is one of the reasons that I think individuals want to support 
what was done by the Centers for Disease Control in this situation. 
They want to say, well, the 076 regimen is very expensive, therefore, 
it could not be part of a test to discover a less expensive regimen. 
It's important to understand that it is the expense of the outcome, the 
therapy that you are seeking to develop that should define whether or 
not a country or a society would be able to use it. It's not the 
expense of conducting the test that is the key issue, but

[[Page S371]]

the expense of using the therapy after the test is over. Unless the 
proponents of these tests want to argue that they were really hoping 
that sugar pills, which are very cheap, would be the ultimate therapy, 
they have to say that the ultimate therapy they were proposing is 
approximately the $50 therapy that CDC was experimenting with, which 
was the short course, or more confined schedule of administering AZT. 
That is a $50 dose. The 076 regimen, already proven effective, is an 
$800 dose. There is a big difference.
  The point I make is that what you are seeking to test in the country 
is not the $800 dose. That has already been established. That was 
established in the United States, and it was established in France. 
What you are seeking to test is not the placebo. We all know that is 
useless and worthless. You don't even have to be a medical 
practitioner. That is understood. What you are testing is the $50 dose. 
And so you have to ask yourself the question, is the $50 dose something 
that might someday be available and utilized there? If it is, that is 
the test. It doesn't change the need to treat people humanely in 
seeking to provide a basis for using that $50 test.
  So what we really have here is a question of whether or not the 
United States Centers for Disease Control treated individuals in Africa 
with the same kind of respect that they would have treated individuals 
in the United States. The real question is whether or not they followed 
the guidelines which require us to treat individuals as distinct and 
different from the way we would treat, say, laboratory animals where we 
might disregard their health and safety.

  Of course, the New England Journal of Medicine says when effective 
treatment exists a placebo may not be used, and it cites the 
Declaration of Helsinki saying that any medical study of patients, 
including those of a control group, should be assured of the best 
proven diagnostic and therapeutic method.
  I don't think there is any other way of saying it. No matter how thin 
you slice this, it is still baloney. It is clear that the placebo is 
not the best therapeutic method. It simply cannot be categorized as the 
best therapeutic method, which is the method, according to the New 
England Journal of Medicine, that participants in the study are 
required to have.
  This afternoon I took the time to go through the assurance of 
protection document entered into by the Ivory Coast and the CDC that 
lays out the guidelines, principles, and procedures that the parties 
agree to follow in the research. I believe that in the assurance of 
protection document mention was made of the Declaration of Helsinki.
  In biomedical research, involving human subjects and international 
ethical guidelines for them, the protection document states that 
research must be conducted in accordance with established international 
standards for protection of human subjects--for example, the 
Declaration of Helsinki, or CIOMS. Those are examples. But it says we 
must live in accordance with those established international standards.
  The signature page for the relevant officials says that the research 
will be conducted in accordance with the established international 
standards for the protection of human subjects.
  It is kind of interesting that the assurance of protection was not 
obtained until July of 1997, according to Dr. Satcher's written 
responses to questions from the Senate Labor and Human Resources 
Committee. We were dealing with these individuals in the Ivory Coast in 
a way which did not even provide them with a guarantee of the 
protections included in the Declaration of Helsinki and other relevant 
international guidelines. We did not see the guarantees until we had 
articles appearing in major newspapers in the United States that 
criticized the African studies--articles which compared them to the 
Tuskegee experiment.
  Dr. Satcher has claimed that the studies complied with all the rules. 
In the New England Journal of Medicine article with Dr. Harold Varmus 
of the National Institutes of Health, Dr. Satcher asserts that the NIH 
and CDC support trials have undergone a rigorous process of ethical 
review, including not only the participation of the public health and 
scientific communities in developing countries where the trials are 
being performed but also the application of the U.S. rules for the 
protection of human research subjects by relevant institutional review 
boards.
  Dr. Satcher also relies on World Health Organization guidelines 
developed in Geneva in 1994 as authority for the studies. He said that 
the CDC chose to use a placebo controlled study because such an 
approach has been recommended by a WHO conference of international 
experts, including those from many developing countries.
  This World Health Organization conference to which Dr. Satcher refers 
took place in Geneva in June of 1994. Marcia Angell and Michael Grodin 
of Boston University criticized the conference recommendation, saying 
that the CDC and the researchers involved developed the recommendations 
simply to justify their desire to conduct the AZT trials in Third World 
countries.
  I would like to review some of the international guidelines. It is 
pretty clear that people around the country and around the world 
understand that you shouldn't use placebos when there is an effective 
treatment, particularly if you are conducting a trial that includes 
victims of deadly viruses.
  Again, I mentioned that Dr. Marcia Angell said in the New England 
Journal of Medicine that only when there is no known effect or 
treatment is it applicable to compare a potential new treatment with a 
placebo.
  The director of Harvard's Human Subjects Committee has stated that 
use of placebos would be unethical in such cases. The New England 
Journal of Medicine reports that in 1994 a researcher at the Harvard 
School of Public Health applied for NIH funding for an equivalency 
study in Thailand in which three shorter AZT regimens were to be 
compared with the regimen similar to the 076 regimen. The journal 
indicates that the NIH study section pressured the researcher and his 
institution to conduct a placebo trial, which prompted the director of 
Harvard's Human Subjects Committee to reply in a letter. The conduct of 
a placebo controlled trial for AZT in pregnant women in Thailand would 
be unethical and unacceptable since an active controlled trial is 
feasible.
  So here we have medical authorities resisting efforts by our 
Government to accept and conduct a trial which is ethically 
substandard. You have them saying it is unethical; it is unacceptable 
because there are actively controlled trials that are feasible. 
Basically this is a reflection for which we can be grateful in the 
medical community. We don't use sugar pills when we have known capacity 
for treatment.
  I could go through the guidelines as I did this afternoon. I do not 
want to do this. The point is the simple ethics of the matter come down 
to this: If there is a known treatment which is a therapeutic treatment 
it can make a difference. It is unethical instead of giving patients 
that treatment to provide them with sugar pills, or with placebos. The 
known treatment is well established. It is well documented in the 
medical literature. Its availability makes impossible the use of 
placebo studies in the United States in this kind of setting, and to 
echo the statements of many experts, I think it should make it 
impossible in Africa as well.
  Some of those who have commended the unethical studies overseen by 
Dr. Satcher in the Centers for Disease Control have indicated that 
these are poor people and they will never be able to afford the 076 
high-dosage, long-schedule regimen of AZT.
  The truth of the matter is this was a study to experiment with lower 
doses, shorter schedules, and could have been conducted in a manner 
consistent with medical ethics by using as a control group the 076 
regimen. There are medical authorities that will provide testimony to 
that extent.
  The truth of the matter is that we would not do in the United States 
what we did in Africa. And I think that is an important point.
  Dr. George Annas, a bioethicist and professor of health law at Boston 
University, and health law professor Michael Grodin have criticized the 
AIDS work in Africa not only on the basis of the placebo but they said 
that these studies with lower ethical standards were imposed on a 
population that will never receive the fruits of the research.

[[Page S372]]

  It seems to me that there are so many ethical questions surrounding 
this particular AZT trial that demand answers that we should look 
carefully at this study.
  One of the answers of individuals who have commended these tests is 
that ``The individuals knew what was happening''--that participants had 
given their informed consent.
  I will concede that there is virtually always an ironclad, high 
standard of informed consent that is required for medical trials and 
experimentation to take place, and virtually every one of the 
protocols--whether it is the Helsinki Declaration, the Council of 
International Organizations of Medical Sciences, the Nuremberg Code, or 
any number of other CDC or Federal regulatory items--they almost all 
require that participants give their informed consent. Those who would 
defend these AZT trials seem to want to emphasize that since there was 
informed consent, we can overlook breaches in the ethics that might 
have taken place in the design of the studies and in the implementation 
of the trials.
  First of all, the presence of informed consent does not authorize 
unethical activity. The mere fact that people would agree to engage in 
unethical activities and unethical trials with our Government or with 
agencies of our Government does not mean that our Government can or 
should do that. We have standards that require a certain respect for 
human beings and that do not allow our health organizations to treat 
them as experimental subjects. Whether or not there is consent does not 
obviate or does not alleviate or does not mitigate the demand of our 
ethical codes for treating people like human beings and not 
experimental subjects.
  But there still is a real question about the level of the so-called 
consent that was given. This afternoon I had the opportunity to refer 
to an article in the New York Times which talked about a woman who, 5 
minutes after she was informed for the first time that she carried the 
HIV virus, still shaken by the news, was walked through the details of 
the so-called trials and tests, as well as given general advice about 
what she should do to help herself and her baby. In less than 5 minutes 
she was given a quick explanation of what a placebo was. The session 
was over and this unemployed, illiterate individual had agreed to take 
the test. Asked what had persuaded her to do so, she said, ``The 
medical care they're promising me.''
  Here is a situation where this is a mockery of informed consent. 
People who don't even know what a placebo is agreeing to participate in 
a medical study where they have a 50-50 chance of getting the placebo, 
a sugar pill.
  The New York Times article talked about another individual. One of 
the most highly educated women in the test spoke to a reporter. She was 
a 31-year-old single mother with a degree in law who gave her name only 
as ``X.'' She said she had never been made to understand that the 
medicine being tested, AZT, was already known to stop transmission of 
the virus during pregnancies. One of the fundamentals of informed 
consent is helping people understand what kind of therapeutic, known 
cures or known treatments exist, and she wasn't even told about that. 
``I am not sure that I understand all this so well,'' she said, ``but 
there were some medicines that they said might protect the child, and 
they wanted to follow the evolution of my pregnancy and the 
effectiveness of the treatment.''
  People have talked about the situation of following the evolution of 
the pregnancy and the effectiveness of treatment. We have seen 
situations where we have followed the evolution of disease and the 
effectiveness of nontreatment and for half the people in this study we 
are talking about the effectiveness of nontreatment. There is no 
evidence in terms of this woman's testimony that she would have gotten 
real treatment rather than a sugar pill.
  ``Pressed further, X, like other mothers, said that she had not been 
told the results of the tests on her 1-year-old. Asked how she would 
feel if she learned tomorrow she received a placebo when proven 
treatment existed, X's tone changed abruptly,'' according to the New 
York times. ``I would say quite simply that that was an injustice,'' 
she said.
  Well, it appears to me she has a good understanding of ethics if she 
does not have a good understanding of medicine. She understands that to 
provide individuals with a placebo, with a fake pill, and not to tell 
them that there is a real treatment that is available, would be an 
injustice. I could not agree more.
  One of the important concepts about medical ethics is that you should 
only use treatments that host countries could reasonably be expected to 
use. As I mentioned earlier, those who support the studies say that we 
could not use the 076 regimen because it was too expensive. We could 
use the $50 treatments. However, that doesn't comport with their 
statistics which also state that the average expenditure for health 
care is $5. If the per capita spending in these countries is often less 
than $10 per person, as the CDC says, how can these countries afford 
even the $50 treatment.
  Dr. George Annas, whom I mentioned, from Boston University, was 
publicly critical of the AIDS studies on the grounds that ``they were 
being carried out with lower standards in a population who will never 
receive the fruits of the research.''
  These same authors talk about the research being largely unrelated to 
the potential for treatment in these countries. ``No research in 
developing countries''--and I am quoting again from these same two 
authors, Dr. George Annas and Michael Grodin of Boston University--``No 
research in developing countries is ethically justified unless the 
treatment developed or proven effective will actually be made available 
to the population. And the best CDC can say about its new AZT regimens, 
if they work, is that they would be a far more feasible option for the 
developing world.''
  More feasible, yes, but would they be attainable? No evidence of the 
fact they would be attainable. I resume quoting. ``This is a far cry 
from assuring that they will actually be made available.'' And then 
they say, ``In the absence of such assurance, the African women and 
their children are being used purely as guinea pigs. They will be 
subjected to the intrusions and risks of research without any hope, 
much less any expectation, that they or their communities can ever 
benefit from the studies.''
  The problem of treating individuals as experimental subjects is a 
serious problem. It is an ethical problem. And it is one which was so 
problematic that it caused the New England Journal of Medicine and a 
variety of other scholars to say that this is unacceptable.
  As we are debating whether or not we have a nomination for a Surgeon 
General that should be the doctor for America's families, the leader in 
terms of what America should be and can be, I think the ethics of the 
research conducted at his specific direction and under his control are 
important and legitimate concerns.
  I am saddened that Dr. Satcher chose to get involved in 
experimentation in Africa which would have been unacceptable here, 
which medical ethicists have indicated could not have been done here, 
which would have occasioned an outcry from the public and from 
authorities here, but which he thought could be done in Africa because 
these individuals have a different standard of living and that local 
conditions are different than ours. The situation of ethics is not 
something that relates to the economic standing of people, and it 
should not be related to a capacity on the part of a nation to transfer 
experimentation which it would not allow in its own country to be 
undertaken in another country.
  I believe America deserves the highest and best when it comes to 
ethics. I believe we deserve a Surgeon General who would criticize 
rather than implement this kind of anemia in the ethical world. I 
believe we deserve a Surgeon General who understands that human beings, 
regardless of their wealth, social station, national origin or 
citizenship, deserve to be treated as human beings and not as 
laboratory experiments. I regret that too often in Washington we have 
come to the place of thinking that if we can get a big value, or if 
there is a lot of scientific knowledge to be gained, we can disregard 
ethics--that if the payoff is big enough, and particularly if the price 
to be paid is not in our own families, that we can look away from the 
ethics.
  I really don't think that ethics and integrity are divisible. Just 
like we

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should be one Nation, indivisible, I think we should have one ethical 
standard that is indivisible, and I think it should be a high one. I 
think America deserves better than a Surgeon General who is willing to 
adjust on a relative scale of values the ethics that relate to those in 
another setting as compared to individuals who would be here in the 
United States. It is time for us to demand a Surgeon General who will 
appeal to the better angels of our nature, not bow to our basest 
desires.
  As I conclude my remarks, I would indicate the African AZT trials and 
the ethical problems surrounding them are just one aspect of the 
serious difficulties I have with this nomination, difficulties that 
lead me to oppose this nomination. This nominee endorses the practice 
of partial-birth abortion. This nominee has indicated a willingness to 
fund studies for the distribution of clean needles to drug addicts. He 
has indicated a willingness to fund conferences to promote the 
distribution of clean needles to drug addicts, to put the Government in 
the business of facilitating the administration of illegal drugs.
  He has reserved, in a technical statement, that he had never provided 
funding for a Government program to provide clean needles to addicts. 
But he has provided funding for Government studies and he has provided 
funding for other programs to promote the distribution of such needles. 
He has indicated that if he could get the right result from the studies 
he would be willing to have a program that distributed clean needles. 
It may be true that clean needles might help some people avoid illness, 
but frankly I don't know that we should be in the business of assisting 
individuals in the administration of IV drugs merely because there 
would be some ``health benefit'' in a discrete situation where the 
Government provided a sterile instrument for the administration of 
illicit substances.
  Individuals have come to this floor also indicating that they don't 
believe firearms are a disease. As you know, and I think as Senator 
Craig of Idaho indicated pretty clearly, the Centers for Disease 
Control has sought to limit or otherwise conduct studies which might be 
used in seeking to limit the availability or eligibility of people to 
own firearms in this country because they say that firearms are 
dangerous to a person's health. Frankly, the provision that guarantees 
the right of individuals to bear arms in America is the second 
amendment to the Constitution of the United States and I don't believe 
that the Bill of Rights is a disease. I think if we have resources that 
need to be devoted in our culture to the abatement and mitigation of 
diseases, we ought to deploy those resources to fight diseases and not 
to try and build a case for depriving Americans of a right guaranteed 
them by the Bill of Rights.
  In all of these settings the cumulative effect of this candidate, 
this nominee of the President, shows us that we are not being offered 
the kind of Surgeon General to lead the American people in ways that I 
think are appropriate and consistent with the ambitions and aspirations 
of Americans. For these reasons--in addition to my focus today on the 
ethical deficiencies of the African AIDS studies--I think this nominee 
should be defeated.
  Madam President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Vermont is recognized.
  Mr. JEFFORDS. Madam President, I make a point of order a quorum is 
not present.
  The PRESIDING OFFICER (Mr. Gorton). The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. GORTON. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER (Mr. Brownback). Without objection, it is so 
ordered.
  Mr. GORTON. Mr. President, I ask unanimous consent to speak as in 
morning business.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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