Professional Frank Snowden:
This morning I want in a way to circle back in time to
cover an issue that’s been lurking in the background but
we’ve never faced directly. You will remember that when we
talked about the Paris School of Medicine,
there was the ethical issue raised of the relationship of
the patients to the physicians who were using them for medical
studies, and we’ve talked about this as
well in a variety of other contexts.
in the breakthrough of the mosquito theory of transmission
of malaria, we’ve seen that there were human experiments
involved in that. But there wasn’t really an
ethical framework of a formal kind until well into the
twentieth century, and it’s that development that
I want to look at this morning– the development of a framework
of bioethical experimentation for human studies–
and to do that, I’d like to look at the
Tuskegee syphilis study from 1932 to 1972,
which was, if we like, the catalyst around which a
framework of biomedical ethics was developed.
Now, the Tuskegee study was a
complex story. It captured the national
imagination, because it seemed to embody everybody’s fears as a
worst-case scenario in medical ethics.
Tuskegee as a study embodied a
number of features that contributed to that.
Clearly it demonstrates,
as I think we’ll see, the corrupting influence of
commercial considerations on medicine and medical research.
It demonstrates the negative
impacts of scientific arrogance. It brings out the dangers of a
military chain of command model of public health,
in which no one questions or resists decisions from higher
authority. It shows the exploitation of
the poor and disadvantaged by powerful interests and the
government, and it also clearly embodies racism.
This is an experiment that
began with an idea that racial groups are a serious biological
category, not just a social one,
but that races are biological entities,
and that the differences from one group to another are so
significant that diseases themselves follow different
paths in the bodies of different racial groups.
Well, the place where this
unfolded was in Macon County, Alabama in the 1930s,
and Tuskegee is here in Alabama.
Let me look a little more
closely. That’s Macon County in the
state of Alabama. There are a number of features
we need to think about when we remember Macon County,
and we need to take off our twenty-first century spectacles
and think back to a different world in the 1930s,
when this experiment got underway.
And at that time,
Macon County was one of the most disadvantaged places in the
whole of the United States. It had a large population of
poor and illiterate African-American sharecroppers,
and this was the time of apartheid in our country.
Studies had revealed in
connection with the social conditions of the sharecroppers
in Macon County an overwhelming burden of disease and suffering.
In a rigidly segregated
environment, the African-American population was
also overwhelmingly illiterate. In fact, the state of Alabama
spent sixty-five dollars a year on each white student in the
county, but less than seven dollars for
every African-American student. Venereal diseases,
and especially syphilis, were also rampant in Macon
County. Well, the story that unfolds is
a pretty awful one, but paradoxically,
it begins with good intentions. The good intentions were those
of a philanthropic program established by an
organization–I guess we would call it an NGO–the Julius
Rosenwald Fund. Rosenwald at the time was the
president of the Sears & Roebuck Company,
and under these auspices, Dr.
Thomas Parran conducted a study
of syphilis in the south in 1929 and ’30, and this study had a
clear moral purpose. The idea was that it was to
begin by demonstrating the burden of syphilis,
and that this would be a first step that would pave the way for
the federal government subsequently to step in and
establish a national syphilis eradication program.
The vision was this:
in year one, there would be a Wasserman test
survey of six states in the south of this country;
that is, establishing the extent, the prevalence,
of syphilis. In the second year,
there would begin a program of treatment and of education.
Let’s look at what was found in
the beginning of the study year one was actually completed,
and it found that the United States had a national rate for
syphilis of 4 for every 1,000 of population.
On the other hand,
for African-Americans, the rate was 7.2 for every
1,000 of population were syphilitic.
But if we come now to Macon
County, Alabama, and that’s the point,
the statistics were absolutely staggering.
Fully 360–and no,
I’m not making a mistake– 360 per 1,000 of population of
the African-American population of Macon County,
Alabama was found to be afflicted with syphilis.
So, Macon County–and this is
the point– was clearly placed on the map
as the very ideal place if you were interested in how syphilis
affected the bodies of African-Americans,
and particular, African-American males.
Well, the year two of the
philanthropic program never got under way.
The reason was simple:
it was the Great Depression, and funding for the program
vanished. The phase that had been
intended of education, of treatment,
and hopefully of eradication, never materialized.
What remained was only the
initial study. At this point in the wake of
the activity of the Rosenwald Fund,
United States Public Health Service intervened,
and it had, as we’ll see, two very different objectives.
The first was associated with
this man, and the idea of the syphilis study was his
brainchild. This is Tagliaferro Clark,
and his idea was to have a scientific and racial curiosity.
There had been at the turn of
the century a Scandinavian study on the course of untreated
syphilis in the human body. That was conducted in
Scandinavia, and Dr. Clark thought that since the early
study had involved a Nordic people,
it would be really intriguing, really neat,
to do a companion study to show the natural history of syphilis
untreated in the body of the African-American male.
And if you wanted to do that
kind of study in this country, what place could possibly be
better than Macon County, which offered unlimited
material for just such observations.
Clark started with a profoundly
racist hypothesis that he wished to demonstrate,
and that is the simple one that the African-American male was
racially distinct from the white male,
and was so in ways that could be demonstrated by studying the
natural history of syphilis in their bodies.
It was thought,
or at least he thought, that African-American men had
such a high incidence of syphilis because of their
irresistible furor sexualis,
and their deficient cranial capacity that didn’t really
leave enough room for gray matter to control it.
Secondly, once established in
the body of the African-American man, syphilis,
Dr. Clark believed,
ran a different course than it would in the body of the white
man, and he had an idea of what he expected that difference to
be. In the body of white males,
the damage was overwhelmingly to their more highly
evolved–and therefore more vulnerable–neurologic systems.
He expected that the result in
African-American males would be very different,
being less neurologically sophisticated,
their bodies would experience damage instead primarily to
their cardiovascular systems, and proof was to be gained by
studying the natural course of the disease in a group of
males– African-American males–who
were systematically untreated. So, let’s keep this in mind:
it’s to be in the bodies of African males that are
systematically not treated.
Let’s remember that this is a
study that was based not on any therapeutic objective.
On the contrary,
the main interest of the syphilis study conducted at
Tuskegee was to examine syphilitic black male bodies
postmortem. For this reason,
as the biomedical ethicist, Susan Lederer,
explains, the real purpose of the study was not to treat the
African-American men involved as subjects,
or even as bodies, but rather as cadavers that had
not yet died. Let me quote the words of one
of the physicians involved in the study,
who wrote the following: “The most important phase
of the study was to follow as many patients as possible to
postmortem examination in order to determine the prevalence and
severity of the syphilitic disease process.”
One physician of the
U.S. Public Health Service expressed the thought very
succinctly and with chilling candor.
He said, “Once the study
was established, the subjects had no more
interest for us until they were dead.”
Well, what’s the second
objective of the study? The second aim of the study is
often not remembered so clearly. It was more commercially driven
and less well known. Remember–cast your mind back
to the 1930s– and worldwide at that time,
there was a vast and stable demand for a reliable diagnostic
test for syphilis. The demand was created,
first of all, by law–laws that required,
for example, testing for syphilis before
marriage, testing for syphilis before
induction into the army. And still at this time,
at the start of the 1930s, there was no absolutely
reliable diagnostic test for the disease.
developing such a test was scientifically challenging
because of a feature of Treponema pallidum,
the spirochete that, as you know,
that’s the pathogen responsible for syphilis.
The Treponema pallidum,
as one of its features, has extreme fragility.
It could not really be
cultivated in the laboratory at this time.
So, there was an alternative,
the experimenters thought, and that was a simple one:
to keep a ready supply of serum available through regular blood
samples from untreated syphilitic subjects.
I started to say patients,
but the point is they aren’t patients.
They weren’t to be treated,
they were subjects. And indeed, in the course of
the Tuskegee study itself, two new reliable tests were
developed using Tuskegee blood, and they were successfully
marketed. These two tests were the
venereal disease research laboratory test–
was one–and the other was called “the fluorescent
treponemal antibody absorption test.”
And needless to say,
the subjects of this experiment were never paid for this
particular service that they rendered to science.
Well, a problem faced
Tagliaferro Clark and his experimenters.
The problem was to recruit
volunteers, volunteers to take part in a study that had no
therapeutic purpose. Why would you volunteer,
you might ask, to take part in a study that
has no benefit for you, but whose purpose,
in fact, was to use your living body as a natural history
exhibit, to observe pathology while the
subjects received no treatment, and while their blood serum was
used as a culture medium? Well, they thought of a
solution, and that was to make use of the ample availability of
African-American males in Macon County who were vulnerable to
manipulation because they were desperately poor,
because they were illiterate, because they had almost no
access to medical care and the medical profession,
and because, at this very moment,
they had a substantial and as yet unfulfilled expectation–
the expectation created unknowingly by the Rosenwald
study– that there would soon be a
therapeutic intervention of the United States government.
What the United States Public
Health Service did was to send out mass postings to black
churches in Macon County, and these letters and placards
let it be known that the government was embarking on the
long-awaited treatment program. Let me be clear again about
that: the announcement by the Public Health Service was that
the second phase was underway, and that what was coming was a
program of treatment– treatment for anyone who
thought that he or she– well, in this case,
he–had what was called “bad blood.”
Now, “bad blood”
in Macon County, Alabama, was not a scientific
term, but a really elastic term,
local term, borrowed from popular culture
that had a number of inconsistent meanings.
Bad blood might mean anemia.
It might mean simple
indigestion. It might mean venereal disease.
So, if you had bad blood,
whatever that was, treatment is on the way.
And in addition to treatment,
volunteers, if you volunteered,
were promised that in due course,
they would be provided will all funeral expertise courtesy of
the U.S. government, provided they
allowed their bodies to be subjected to autopsy–
the famous postmortem examination that Tagliaferro
Clark was so enthusiastic about. They would also be provided
with free meals occasionally, and free transport to the
treatment center. So, what was on offer might not
seem enormously expansive, and I think it’s a reflection
of the dramatic conditions, social conditions,
of people at the time that large numbers of people came
forward. And approximately 600 were
selected, and they were regarded by those who were rejected as
the fortunate ones. They were lucky.
They’d been taken into a
treatment program of the U.S. government.
And after selection,
the 600 were divided into two groups: 399 were found to have
syphilis, and they formed the study
group, 200 without syphilis served as controls.
Now, this raises an ethical
issue immediately. Were these volunteers?
I would argue that these 600
African-American males can only by some stretch of the
imagination be called volunteers for a really simple reason:
you can’t be a volunteer if you’re lied to about that for
which you’re volunteering. In other words,
they volunteered for one thing, and what was put in place was
something radically different. They were promised treatment,
but treatment was precisely what they were to be denied
systematically for the remainder of their lives.
Let me quote Tagliaferro Clark,
who presided over the first year of the study,
and directly approved the use of this deception.
He wrote this to a colleague:
“These negroes are very, very ignorant,
and easily influenced by things that would be of minor
significance to a more intelligent group.”
Now, what was the site of the
study? This is a picture of one of the
buildings of Tuskegee Institute, now known as Tuskegee
University. It had a very honorable history.
It was founded by Booker
T.***Washington for the education of freed men after the
civil war, and it was induced to cooperate
by the idea that such cooperation with the study would
enhance its prestige and would gain access for it to government
funding. And there was an
African-American nurse– we see here her with a
doctor–a Eunice Rivers, who was the local
African-American nurse who served as the intermediary
between the physicians of the Public Health Service and the
subjects of the experiment. A lot’s been written about
Nurse Rivers and her role in the experiment.
I think that we ought to
remember the context of the time and the training in which nurses
were trained not to question, but to do as they were told.
Now, at the outset,
something also paradoxical happened,
and I would argue that it in fact, even if you wanted to have
an entirely cold-blooded look at scientific validity for such a
study, this particular study was made
scientifically invalid from the outset.
At the beginning,
the experimenters ruined any possibility that the study could
ever produce valid scientific results because the government
doctors began the study by administering a small dose of
the accepted therapy of the day. In other words,
the experiment is to begin to have a study of untreated
syphilis, and they begin by administering
a small dose of the established therapeutic medication of the
day, which is a combination of
arsenic and mercury compounds plus bismuth.
So, this ruined the premise of
observing purely untreated syphilitics.
Then further weakening the
scientific– if we call it that–validity of
this study was the fact that some members of the control
group contracted venereal disease,
and they were simply transferred to the test group.
They shuffled the deck between
the study group and a control group.
Well, thereafter nonetheless,
this particular study continued for forty years,
down until 1972, and the volunteers thereafter
received no further treatment. They were subject to regular
annual physical examination and blood tests,
and to spinal taps, and they were given something
that they thought was medicine. It was called “pink
medicine,” and they took it regularly,
and actually what it was is aspirin.
Let me give you a primary
source. This is the Macon County Health
Department, and this is the notice that was given to those
who were experimenting. It says, “Dear Sir,
some time ago, you were given a thorough
examination, and since that time we hope
you’ve gotten a great deal of treatment for bad blood.
You will now be given your last
chance to get a second examination.
This examination is a very
special one, and after it is finished,
you will be given a special treatment (I underline that
word) if it is believed you are in a condition to stand
it.” And let me just look at the
very bottom, in case you missed anything along the way.
At the bottom you could read,
“Remember this is your last chance for special free
treatment. Be sure to meet the nurse.”
So, the deception in this study
was systematic and extended. In fact, there was a time when
there was a great threat to this Tuskegee study,
and that was when America entered the Second World War,
because at that time there was the danger that the members of
the study group risked being drafted into the Army,
and that would entail blood tests.
Their syphilis would be
discovered, and the Army would provide treatment,
ending the experiment. So, the assistant surgeon
general of the United States intervened on behalf of the
study and provided the Selective Service Board of Macon County
with the list of all those men included in the study,
and they were exempted from the military draft.
Now, at the outset of this
experiment, what was the therapy for syphilis?
What is the treatment that
these men were being deprived of?
And we have to say that by
contemporary standards, the treatment at the time was
not highly effective, and the most that we can say is
that the members of the study at the outset were being denied the
best available care of the standards of the time.
This was the metal therapy,
as it was called, that I mentioned before.
But what about later on?
This study continues from ’32
to ’72. By later in the 1940s,
penicillin, a highly efficacious remedy for syphilis,
was developed, and it was determined that the
members of the study would be systematically denied the
antibiotic as well. Local doctors in Macon County
were all provided with the names of the members of the study,
and they were instructed by the Public Health Service that those
men were not to be given penicillin.
So, the study continued for
twenty-five more years, when a therapy actually
existed. Well, by 1972,
at the conclusion, twenty-eight of the men in the
study died directly from syphilis.
A hundred others died of
complications related to syphilis.
Forty wives of members of the
study were infected with syphilis,
and nineteen children fathered by members of the study were
more with congenital syphilis. There was, however,
no intention in the Public Health Service to terminate the
study, and this was not, strictly speaking,
a secret study. There were published reports on
a regular basis. This is really one of the more
disconcerting parts of this study.
What does it say about our
society at the time? The first report–in other
words, this is a study and a kind of study that was
published, that was written about publicly
in scholarly articles, and people thought this was
okay. The first published report was
in 1936, and papers were later written every four to six years
or so, until 1970. And strikingly,
there was never a protest within the medical community
about reports on this type of study that appeared in medical
journals for forty years. In 1969, a committee of the
Centers for Disease Control determined that the study should
continue, and this conclusion was backed
by local chapters of the American Medical Association.
The end came only in 1972,
when a former employee of the Public Health Service,
named Peter Buxton, reported this story to the
Associated Press. An article appeared in the
Washington Star in July 1972,
and this caused a national scandal,
with charges against the government of having carried out
the immoral equivalent of Nazi medicine,
of abuse of state power, of racism and many other
things. A famous book appeared by James
Jones called Bad Blood. Bad blood–you now know what
that means. There was a play,
Miss Rivers’ Boys, by David Feldshuh.
There was a movie,
Miss Evers’ Boys, in 1997.
The attorney Fred Gray
initiated a lawsuit on behalf of the patients,
and there was an out of court settlement that gave surviving
patients medical treatment– at last, at last–and 40,000
dollars in compensation. So, let’s think about the
ethics of this experiment, what was learned,
and what ethical framework was established to prevent a
recurrence of something of the kind.
We need to remember,
in judging the ethics of those who initiated and continued the
study, that at the time it started,
there were no clearly spelled out guidelines for biomedical
research on human beings, and it would be unfair and
anachronistic to hold researchers retrospectively
accountable for the standards of 2010.
But I think we need to look at
the concerns that were raised by medical ethicists in a variety
of forums with regard to this experiment–
remembering of course some of the considerations were
retrospective– but I’m going to argue that
many ethical bases made this unethical even by the standards
of 1932. Well, places where this was
raised: there was a congressional investigation led
by Senator Edward Kennedy, that took place in 1973.
The National Medical
Association produced a report in the same year.
There was a National Research
Act in 1974 that created what was called the National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research, which came to be known
popularly as the Belmont Report. There was the class action suit
on behalf of the survivors and their relatives that I
mentioned, and in 1997,
there was an official presidential apology by
President Bill Clinton, of which more in just a minute.
The standard that the medical
ethicists applied was Immanuel Kant’s notion of a categorical
imperative. And that is that ethical
problems– and here I’m oversimplifying
Kant definitely– but the general idea,
which is what is important to us,
and the context of the conclusions of the Belmont
Report, was that ethical problems arise
whenever a human being is not used as an end for his or her
own benefit, but is used only as the means
to some further ulterior objective.
And to give teeth and specific
content to that idea, a number of corollaries were
said to flow, to make that meaningful.
The first was–and we live with
this, and you will know the phrase–the doctrine of informed
consent. Now, remember the letter to the
volunteers that I showed you, saying, “Remember,
this is your last chance for free treatment.
Be sure to meet the nurse.”
That was hardly informed
consent. We know about the hoax of the
pink medicine; the ethically obtuse use of
that term “bad blood,” which wasn’t a medically valid
concept; the fact that the volunteers
were never informed of the availability and utility of
penicillin; and you can’t really have
informed consent if you don’t know what you’re consenting to.
The subjects were never
specifically told that they had syphilis, about the course of
the disease. They were never consulted about
what possible treatment options were available.
And spinal taps were presented
to them as what were called “spinal shots”–
once again, a slightly and deceptive play on words which
suggested that the spinal taps had some therapeutic purpose.
Isn’t that what you understand
when you go to the doctors and you get a shot?
The second thing that was
thought to be an ethical response that’s necessary in
biomedical research is the idea, the principle of beneficence.
That is, the subjects of a
scientific and medical experiment should be entitled to
the expectation that some benefit will ensue for their
suffering and their participation.
And the point about this study
in Tuskegee was that it was entirely designed to be
non-therapeutic. There would never be a benefit
to those who took part. A third major principle
outlined is that biomedical research should be governed by
what was called justice, and by that was meant the
principle that the most vulnerable members of a society
should not be chosen as experimental subjects to the
maximum extent possible. In other words,
biomedical research should refrain from doing its
experiments on prisoners, on the mentally deficient,
on children, the poor, and members of
disadvantaged minorities– people who can be easily
misled, coerced or intimidated– and the point about this
experiment was that the subjects at Tuskegee were targeted
precisely because they were maximally vulnerable.
A fourth notion that should
govern biomedical research is that of a well-designed
experiment. Now, you ask:
how come that becomes an ethical category,
that an experiment should be well-designed;
the protocols should be so drafted that the anticipated
results have a reasonable chance of resulting from the procedures
adopted. In other words,
if you take part in a biomedical experiment,
there should be the expectation that the experiment is so
designed that any risk that you take,
such as it is, should not be entirely in vain.
So, an ethical principle,
it was said, was violated when the Tuskegee
experiment began with a dose of therapy,
and then began by mixing the test and control groups,
so whatever suffering was undergone by the subjects of the
experiment would never have any scientific standing.
In other words,
their suffering would be entirely without benefit to
anyone. A fifth thing is that an
ethical experiment should not violate the law and the existing
ethical guidelines of the government,
professional, and international authorities.
Well, this study in Alabama
violated the law of 1927, which mandated treatment for
syphilis. There was also,
during the course of the experiment–
there was also the idea in 1946–there was an American
Medical Association judiciary counsel that issued a report
establishing the principle of voluntary consent.
In other words,
ethical standards emerged during the course of the
experiment that weren’t there at the outset,
but the experiment continued to violate ethical standards that
were established after it began. And in 1964,
the World Health Organization issues a Helsinki Declaration
that said that informed consent should lie at the basis of
biomedical research. Two other things were mentioned
as ethically very important. One was that in future,
the assessment of the ethics of medical research should not be
by a closed medical caste. In other words,
doctors shouldn’t establish themselves that what they’re
doing is ethical. There should be independent
review boards to establish that. And then this experiment was
said to violate also the civil rights enshrined in the American
constitution: the Thirteenth Amendment
against involuntary servitude, and the Fourteenth Amendment
against trespass. Now, the question is:
what can we say about those who embarked in 1932?
They didn’t have the framework
of the Belmont Report, the Helsinki Declaration,
the judicial counsel report of the American Medical
Association, but I would argue that a
judgment on this isn’t all retrospective.
I’d remind you that already at
the start of the experiment in 1932 it was unethical for
physicians to lie to their patients and research subjects,
and that it was unethical for a research program to violate the
law of Alabama of 1927 that mandated treatment for anyone
known to have syphilis. What’s the legacy of the
Tuskegee experiment? Well, there are positives and
negatives. On the positive side,
this established a legally binding ethical framework for
biomedical research. The universe of conducting
biomedical research is now entirely different from that in
1932, and that’s entirely a positive gain.
This study then did produce
something really positive, which is an ethical framework.
There’s also the fact–and this
is positive too– there was a wide debate of all
of these issues through the press,
through plays, congressional debates,
scholarly literature, television broadcasts,
President Clinton’s public apology and the coverage it
received, and all of you well know that
phrase about informed consent. On the negative side,
there were the sufferings of the study members,
their wives, their children born with
congenital syphilis. There was harm done to a great
university–Tuskegee University–and its reputation.
There was harm in terms of a
breakdown in trust between African-Americans on the one
hand and the medical profession and the government on the other,
and one can see the legacy of this is the HIV/AIDS pandemic
that we’re coming to. In 1990, when asked if HIV/AIDS
as an epidemic was a genocidal plot,
an opinion poll of African-Americans revealed that
ten percent responded yes, and twenty percent that they
were not sure. So, at that time in the 1990s,
thirty percent of African-Americans thought that
perhaps HIV/AIDS was not a disease but a genocidal plot.
And this had
consequences–consequences in terms of the failure of people
to seek medical and public health education and treatment.
If your level of distrust is
pitched that high, you can understand that,
and one of the reasons was the Tuskegee experiment.
So, then I’d like to close by
remembering Clinton’s apology in the White House on May 16,1997.
There were at that time eight
experiment survivors, including this man,
Howard Shaw, plus representatives of three
others. And I can’t compete with Bill
Clinton in eloquence, so I’d rather simply end by
quoting him. What he said was,
“The United States government did something that
was wrong, deeply, profoundly, morally wrong.
It was an outrage to our
commitment to integrity and equality for all our citizens.
To the survivors,
to the wives and family members, the children and
grandchildren, I say what you know.
No power on earth can give you
back the lives lost, the pain suffered,
the years of internal torment and anguish.
What was done cannot be undone.
But we can end the silence.
We can stop turning our heads
away. We can look you in the eye and
finally say, on behalf of the American people,
what the United States government did was shameful,
and I am sorry. The people who ran the study at
Tuskegee diminished the stature of man by abandoning the most
basic ethical precepts. They forgot their pledge to
heal and repair. They had the power to heal the
survivors and all the others, but they did not.
Today, all we can do is
apologize. But you have the power,
for only you (that is, Mr. Shaw) and the others who
are here, the family members who are with
us in Tuskegee, only you have the power to
forgive. Your presence shows that you’ve
chosen a better path than our government did so long ago.
You have not withheld the power
to forgive. I hope that today and tomorrow
that every American will remember this lesson and live by