[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
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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
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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.
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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.
____________________