Notebook Set-Up:

Take a look at the sample page to get an idea of what your notebook should look like. The questions
and sample answers are also provided for you.

Name of Experiment: Dr. Southam's Cancer Study

1. What was the experiment about?

Ex: This experiment was about a doctor named Chester

Southam who injected cancer cells into healthy patients to
see whether or not their bodies would fight off the cancer.

2. Who were the people who were harmed in the

experiment? How were they harmed?

Ex: The people who were harmed were his patients. Some
of them contracted cancerous lesions that had to be
surgically removed.

3. What are (at least two) of the Nuremberg Codes that

were broken in the experiment? How?

 Principles 1 and 2 of the Nuremberg codes were

broken.

4. What strikes you as the most fascinating and/or

most disturbing part about the experiment?

Ex: The most fascinating part of this experiment is that

some prisoners willingly volunteered to be injected with
cancer in order to repay their debts to society.
 STATION 1: The Tuskegee Syphilis Study

Between 1929-1931, the Rosenwald Fund (an organization that promoted the education and
health care of poor African-American farmers) sponsored a study with the Public Health Service
(PHS) to identify the Southern counties with the highest rate of syphilis (a sexually transmitted
disease. It can lead to a range of painful, chronic and deadly symptoms, such as infection in the
nerve-system, or cardiovascular-complications) among African-American males. Their original
intention was to identify and treat the disease.

Macon County, Alabama had the highest rate, with over 35% of the male population infected
with the disease. The PHS approached the Tuskegee Institute (located in Macon County) about
forming a research group in order to study the effects of untreated syphilis on a black male population
for a duration of six to nine months and then
follow-up with a treatment plan.

The study, during the first year, was led

by Dr. Taliafero Clark. The PHS enrolled six
hundred Macon County men (399 with syphilis
and 201 who weren’t infected) to be part of the
study. None of the men actually knew what the
study was for. They were lured in with the
promise of “free health care,” and treatment of
“bad blood,” a local term that encompassed
several different afflictions, including: anemia, fatigue, and other venereal diseases.

The men were told that they were going to get free medical exams, meals, and burial
insurance. For those who actually had syphilis, they were never informed of their diagnosis nor given
any treatment for it. Additionally, very painful and unnecessary spinal taps were performed on many
in the study.

It was said that the reason for the deception was that it would be the only way the men would
stay in the study and the researchers wanted to closely observe the course of the disease over a
large sample-size to see the effects as the disease progressed, even to death.

The deception seemed to partly result from the lack of respect the doctors had for the men’s
intellectual capabilities. Most of the participants were illiterate, which the researchers thought was
helpful as it would be harder for the subjects to figure out what was going on.
 In a letter to a colleague, according to a Michigan State 2005 medical ethics curriculum, Dr.
Clark wrote that “these negroes are very ignorant and easily influenced by things that would be of
minor significance in a more intelligent group.”

Dr. Raymond Vonderlehr was the on-site director of the study. He was the one who gained
“consent” of the men for the painful spinal taps by framing them as a “special free treatment.” In
letters he sent to the men with the header from the Macon County Health Department, it read:

You will now be given a last chance for a second examination. This examination is a very special one
and after it is finished you will be given a special treatment if it is believed you are in condition to
stand it.

The study, originally only intended to go nine months, went beyond a year and then, due to
breakthroughs, extended for over 40 years.

In 1928, Nobel laureate Alexander Fleming discovered penicillin. By 1945, penicillin was the
accepted treatment for syphilis.

Despite this, the subjects of the Tuskegee Syphilis Experiment were never administered nor
offered penicillin as treatment. The study administrators wanted to watch the progression of the
disease as the men got sick and, in many cases, died for the forty years the study went on even
though for much of it an effective treatment was available. It is estimated that 128 of the men died
either directly from syphilis or complications related to it, 40 infected their wives, and there were 19 of
the men’s children born with syphilis.
 STATION 2: The Milgram Experiment

If an authority figure ordered you to deliver a 400-volt electrical shock to another person, would
you follow orders? Most people would answer this question with a strong "no", but Yale University
psychologist Stanley Milgram conducted a series of obedience experiments during the 1960s that
led to some surprising results.

The participants in the Milgram experiment were 40 men recruited using newspaper ads. In
exchange for their participation, each person was paid $4.50. Milgram developed a shock generator,
with shock levels starting at 30 volts and increasing in 15-volt increments all the way up to 450 volts.
The switches were labeled with terms including: "slight shock," "moderate shock" and "danger-
severe shock." The final two switches were labeled simply with "XXX."

Each participant took the role of a "teacher" who would then deliver a shock to the "student"
every time an incorrect answer was given. While the participant believed that he was delivering real
shocks to the student, the “student” was a helper in the experiment who was simply pretending to be
shocked.

As the experiment progressed, the

participant would hear the learner plead to be
let go or even complain about a heart condition.
Once they reached the 300-volt level, the
learner banged on the wall and demanded to be
released. Beyond this point, the learner became
completely silent and refused to answer any
more questions. The experimenter then
instructed the participant to treat this silence as
an incorrect response and deliver a further shock.

Most participants asked the experimenter whether they should continue. The experimenter
issued a series of commands to prod the participant along:

1. "Please continue."
2. "The experiment requires that you continue."
3. "It is absolutely essential that you continue."
4. "You have no other choice; you must go on."
 If the subject asked who was responsible if anything would happen to the learner, the
experimenter answered “I am responsible”. This gave the subject a relief and many continued.

The measure of obedience was the level of shock that the participant was willing to deliver. It
was predicted that no more than 3 out of 100 participants would deliver the maximum shock. In
reality, 65% of the participants in Milgram’s study delivered the maximum shocks.

During the Stanley Milgram Experiment, many subjects showed signs of tension. 3 subjects
had “full-blown, uncontrollable seizures”. Although most subjects were uncomfortable doing it, all 40
subjects obeyed up to 300 volts.

Of the 40 participants in the study, 26 delivered the maximum shocks while 14 stopped before
reaching the highest levels. It is important to note that many of the subjects became extremely
agitated, distraught and angry at the experimenter, but they continued to follow orders all the way to
the end

Pre-Taped Audio: What the "learner" said when the teacher triggered the shock at some levels

 75 volts: “Ugh!!!”
 105 volts: “Ugh!!!” (Louder)
 120 volts: “Ugh!!! Hey, this really hurts.”
 150 volts: “Ugh!!! Experimenter! That's all. Get me out of here. I told you I had heart trouble.
My heart's starting to bother me now. Get me out of here, please. My heart's starting to bother
me. I refuse to go on. Let me out.”
 180 volts: (Shouting) “Ugh!!! I can't stand the pain. Let me out of here!”
 195 volts: “Ugh!!! Let me out of here. Let me out of here. My heart's bothering me. Let me out
of here! You have no right to keep me here! Let me out! Let me out of here! Let me out! Let me
out of here! My heart's bothering me. Let me out! Let me out!”
 210 volts: “Ugh!! Experimenter! Get me out of here. I've had enough. I won't be in the
experiment any more.”
 315 volts: (Intense scream) “I told you I refuse to answer. I'm no longer part of this
experiment.”
 345-435 volts: (Silence)
 450 volts: (Silence)
 450 volts: (Silence)
 STATION 3: Stanford Prison Experiment
Psychologist Philip Zimbardo (1973) was interested in finding out whether the brutality reported
among guards in American prisons was due to the sadistic personalities of the guards or had more to
do with the prison environment. To study the roles people play in prison situations, Zimbardo
converted a basement of the Stanford University psychology building into a mock prison. He
advertised for students to play the roles of prisoners and guards for a fortnight.

The study included 24 male college students (chosen from 75 volunteers) who were paid $15
per day to take part in the experiment. Participants were randomly assigned to either the role of
prisoner or guard in a simulated prison environment. There was a solitary confinement cell for
prisoners who 'misbehaved'. The prison simulation was kept as “real life” as possible.

Prisoners were treated like every other criminal, being arrested at their own homes, without
warning, and taken to the local police station. They were fingerprinted, photographed and ‘booked’.
Then they were blindfolded and driven to Stanford University, where Zimbardo had had the basement
set out as a prison, with barred doors and windows, bare walls and small cells.

When the prisoners arrived at the prison they were stripped naked, sprayed down, had all their
personal possessions removed and locked away, and were given prison clothes and bedding. They
were issued a uniform, and referred to by their number only. The use of ID numbers was a way to
make prisoners feel anonymous. Each prisoner had to be called only by his ID number and could only
refer to himself and the other prisoners by number. Their clothes comprised a smock with their
number written on it, but no underclothes. They also had a tight nylon cap to cover their hair, and a
locked chain around one ankle.

All guards were dressed in identical uniforms of

khaki, and they carried a whistle around their
neck and a billy club borrowed from the police.
Guards also wore special sunglasses, to make
eye contact with prisoners impossible. Guards
were instructed to do whatever they thought was
necessary to maintain law and order in the prison
and to command the respect of the prisoners. No
physical violence was permitted. Zimbardo
observed the behavior of the prisoners and guards (as a researcher), and also acted as a prison
warden.
Within hours of beginning the experiment some guards began to harass prisoners. They behaved in a
brutal and sadistic manner. Other guards joined in, and other prisoners were also tormented. The
prisoners were taunted with insults and petty orders, they were given pointless and boring tasks to
accomplish, and they were generally dehumanized. Push-ups were a common form of physical
punishment imposed by the guards.

The prisoners soon adopted prisoner-like behavior too. They talked about prison issues a great deal
of the time. They started taking the prison rules very seriously, as though they were there for the
prisoners’ benefit and infringement would spell disaster for all of them. Some even began siding with
the guards against prisoners who did not obey the rules.

Over the next few days the relationships between the guards and the prisoners changed, with
a change in one leading to a change in the other. As the prisoners became more submissive, the
guards became more aggressive and assertive. They demanded ever greater obedience from the
prisoners.

During the second day of the experiment the prisoners removed their stocking caps, ripped off
their numbers, and barricaded themselves inside the cells by putting their beds against the door. The
guards retaliated by using a fire extinguisher which shot a stream of freezing carbon dioxide, and they
forced the prisoners away from the doors. Next, the guards broke into each cell, stripped the
prisoners naked and took the beds out. The ringleaders of the prisoner rebellion were placed into
solitary confinement.

Prisoner #8612 had to be released after 36 hours because of uncontrollable bursts of

screaming, crying and anger. His thinking became disorganized and he appeared to be entering the
early stages of a deep depression. Within the next few days three others also had to leave after
showing signs of emotional disorder that could have had lasting consequences (These were people
who had been pronounced stable and normal a short while before).

Zimbardo had intended that the experiment should run for two weeks, but on the sixth day it
was terminated. Christina Maslach, a recent Stanford Ph.D. brought in to conduct interviews with the
guards and prisoners, strongly objected when she saw the prisoners being abused by the guards.
Filled with outrage, she said, "It's terrible what you are doing to these boys!"
 STATION 4: Baltimore Lead Paint Study
A class action lawsuit accuses Baltimore's Kennedy Krieger Institute of exposing poor black children
to "dangerous lead hazards" during a 1990s housing study.

At the time, lead-based paint coated the walls of an estimated 95 percent of homes in Baltimore's
low-income neighborhoods.

The goal of the study was to find cost-effective processes that would reduce blood lead levels in
children. More than 100 families participated, moving into East and West Baltimore homes that had
undergone different treatments to reduce lead paint and dust exposure. The treatments ranged from
paint removal to new windows and floors. For two years the researchers collected blood, dust and
water samples to gauge each treatment's effectiveness.

Lead poisoning can damage nearly every

system in the body, including the brain. For
most children in the study, blood lead levels
stayed the same or dropped. And in 1996,
the State of Maryland made the institute's
lead abatement (reduction) protocol law -- a
policy change that led to a 93 percent drop
in lead poisoning in Baltimore.

The scientists had formed a partnership with a local contractor, who identified slum landlords and
urged them to rent to families with children aged six months to four years, just when they start
crawling around the house and when lead exposure is most dangerous to the developing brain. If the
parents agreed, their home would receive one of three different types of lead removal and their
children—all of whom were healthy and normal and had low blood lead when they joined the study—
would be given regular blood tests to see if their lead levels rose or fell.

The lawsuit, filed in Baltimore City Circuit Court, claims the institute "selected children and their
parents who were predominantly from a lower economic strata and minorities," and, "used these
children as known guinea pigs in these contaminated houses to complete this study."
One child, Max, was a part of the experiments. He moved into a home where some measures were
taken to reduce lead paint and lead dust, but certain lead "hot spots" were not repaired fully. No one
pointed out these "hot spots" to his mother. When Max was tested six months later, his blood lead
had nearly quadrupled, to a level known to cause permanent brain damage.

In 1990, Leslie Hanes, another young black single woman, moved into an apartment that was
supposed to have been fully stripped of lead paint years earlier. In 1992, she gave birth to a daughter,
Denisa, and in the spring of the following year, she too joined the lead study. The day before Hanes
signed the consent form, the contractor found that her apartment was not in fact lead-free. The
remaining lead paint was removed, but by the following September Denisa’s blood lead level had
more than tripled and was now six times higher than that currently considered safe by the Centers for
Disease Control.

Denisa’s mother was not informed of the blood test result for another three months, by which time it
was nearly Christmas. The research assistant who told her about it wished her happy holidays and
advised her to wash her front steps more carefully and to keep eighteen-month-old Denisa from
putting her hands in her mouth. When Denisa eventually entered school, she had trouble keeping up
and had to repeat second grade. This came as a surprise to her mother, a former high school honors
student. As Hanes told The Washington Post’s Manuel Roig-Franzia in 2001, sometimes Denisa
came home crying because she thought she was stupid. “No, baby, you’re not stupid,” Leslie told her.
“We just have to work harder.”

"Children were enticed into living in lead-tainted housing and subjected to a research program which
intentionally exposed them to lead poisoning in order for the extent of the contamination of these
children's blood to be used by scientific researchers to assess the success of lead paint or lead dust
reduction measures," the lawsuit states. "These children's health was put at risk in order to develop
low-cost abatement measures that would help all children, the landlords, and the general public as
well."
 STATION 5: Holmesburg Prison Experiment

It was 1951 when the father of Retin-A first came to Holmesburg Prison.

The 1,200 inmates of Philadelphia's gloomiest jail were plagued by an outbreak of athlete's
foot, and the prison pharmacist had asked Dr. Albert M. Kligman, a University of Pennsylvania
dermatologist, to take a look.

"All I saw before me were acres of skin," Kligman told a newspaper reporter in 1966. "It was
like a farmer seeing a field for the first time."

Kligman became a wealthy man and a famous name in dermatology. He invented Retin-A, the
acne cream and wrinkle-remover widely hailed as "youth in a tube". He developed the drug by
experimenting and researching on the prisoners. Kligman has
denied doing anything wrong: "My use of paid prisoners as
research subjects in the 1950s and 1960s was in keeping with
this nation's standard protocol for conducting
scientific investigations at that time."

"To the best of my knowledge," Kligman added, "the result

of those experiments advanced our knowledge of the
[development] of skin disease, and no long-term harm was done
to any person who voluntarily participated in the research
program."

Later, a group of nearly 300 former prisoners at

Holmesburg Prison in Philadelphia filed a civil suit against the
University and Dr. Albert M. Kligman for carrying out experiments on them between 1961 and 1974.
The suit accuses Kligman and Penn of “negligence, carelessness, and recklessness” in “allowing
infectious diseases, radioactive isotopes, dioxin, and psychotropic drugs” to be tested on the former
prisoners “without their knowledge.”

In one of the studies, for which Dow Chemical paid Kligman $10,000, Kligman
injected dioxin — a highly toxic, carcinogenic compound found in Agent Orange — into 70 prisoners
(most of them black). The prisoners developed severe lesions which went untreated for seven
months. Some of the experiments led to the development of the anti-wrinkle cream Retin-A, from
which Kligman has benefited financially. Although the prisoners were paid to participate in the
experiments—some of which may have caused lasting physical and/or psychological injuries—the
suit argues that they were both “grossly” underpaid and under-informed about the potential dangers.
It also states that the experiments were poorly supervised and controlled, and that both Penn and
Kligman failed to exercise “responsible care, caution, diligence, and prudence” in allowing the
prisoners to be “tested with toxic chemicals and medications in doses beyond scientifically acceptable
standards.”

“We think these individuals are entitled to an apology by the parties, including the University,
the city and Kligman, who made a lot of money literally from the backs of these individuals,” said
Thomas M. Nocella, an attorney representing the former prisoners. “We’re also looking for some
compensation, and a guarantee of future medical treatment for these men and women.” He said the
experiments showed a “repeated pattern of human-rights violations.”

“Their institution has a legacy, and this legacy carries on even into today,” responded Nocella, “and
they’re morally obligated to answer to wrongs that institutions did even a long time ago. They can’t
use the excuse of the passage of time. It was wrong then and it’s wrong now. The Nuremberg Code
was in existence for 20 years before they started doing this. The moral and ethical ideas were out
there. It’s a matter of basic human rights and humanity towards other human beings.”

Nocella also noted that “a lot of testing was done without prior testing on lab animals, so in effect,
these people were guinea pigs.”
 STATION 6: Eugene Saenger's Radiation Experiments

Dr. Eugene L. Saenger, who set off a dispute over medical ethics by leading a cold-war
research study that exposed patients in Cincinnati to intense doses of radiation, died there on Sept.
30, 2007. He was 90. His death was announced by the University of
Cincinnati, where he taught for more than three decades.

Dr. Saenger was a radiologist and an expert in nuclear

medicine whose research contributed to the establishment of radiation
safety standards for patients and medical personnel. But it was a
Pentagon-sponsored radiation study that brought him unwanted
national attention.

The study was intended to answer a question for battlefield

commanders: In the event of a nuclear explosion, how much radiation
could a soldier withstand before becoming disabled or disoriented? One goal was to develop a test
that would quickly indicate a person’s radiation exposure level. The Pentagon turned to the University
of Cincinnati for answers. There, from 1960 to 1971, an eminent radiologist, Dr. Eugene L. Saenger,
and his colleagues conducted experiments on 88 cancer patients, ages 9 to 84, exposing them to
intense doses of radiation and recording their physical and mental responses. All but one of the
patients were terminally ill. Most were poor; 60 percent were black. Twenty-one died within a month
or so, and some suffered severe nausea or mental disorientation.

The Cincinnati study exposed patients to the highest levels of whole-body radiation and, some
experts say, probably caused the most deaths of all the known Government-sponsored radiation
experiments since World War II. There is disagreement about how many died of radiation poisoning
rather than cancer. But whole-body radiation has been discounted by doctors as an accepted cancer
treatment in all but a handful of cancers.

Dr. Saenger later defended the research, saying one purpose had been to improve treatments
and survival rates or to relieve symptoms. But critics like Dr. David Egilman, a clinical associate
professor of community health at Brown University, have argued that it was known that total body
radiation was not effective for the types of tumors the patients had.

“What happened here is one of the worst things this government has ever done to its citizens
in secret,” Dr. Egilman said.
 At one time, Dr. Saenger said the deaths of eight patients had been caused by radiation, but
later he said that none had been caused by it. The university released documents showing that
members of faculty committees that reviewed clinical research had argued privately for years about
the safety and morality of the study, but it had been allowed to continue. The papers also show that
the National Institutes of Health expressed doubts in 1967, rejecting, for ethical reasons, Dr.
Saenger’s proposal to expand his experiment.

Eugene Lange Saenger was born in Cincinnati on March 5, 1917. He received a bachelor’s
degree from Harvard in 1938 and a medical degree from the University of Cincinnati in 1942, then
completed his residency at General Hospital.

He joined the medical faculty at the university in 1949, became a full professor in 1962 and
was director of the medical college’s radioisotope laboratory from 1962 until his retirement in 1987.
He was awarded the Gold Medal by the Radiological Society of North America, its highest honor.

One critical issue in the dispute over the radiation study was whether the patients were ever
fully informed about what was being done. In the first five years, the researchers said, they obtained
oral consent, and later various written consent forms.

But Professor Stephens recounted that “none of them ever said: ‘You may die of this radiation.
Do you wish to participate?’”

“If they had,” she said, “there would have been no experiment.”
 STATION 7: Willowbrook

In the 1950s, researchers used mentally disabled children as test subjects for hepatitis (inflammation
of the liver) research.

Background:

Little was known about hepatitis in the 1950s, so when a

school for disabled children in New York had a hepatitis
epidemic, the New York School of Medicine led by Dr.
Saul Krugman, decided to conduct studies involving the
children. Much of what was done would be considered
unethical today, but did the means justify the ends? Let's
take a closer look at the experiments that were
conducted, as well as the ethical issues.

Hepatitis is a term used to describe inflammation of the liver. There are different causes, many of
which are viral. The Willowbrook experiments resulted in the discovery of two of the viral strains:
hepatitis A and B.

Hepatitis A is caused from ingesting food contaminated by feces or from close contact with an
infected person. Hepatitis B transmission is primarily through sexual contact or exposure to infected
blood, such as from the sharing of needles.

Willowbrook School, located in Staten Island, housed children with mental disabilities. Hepatitis was a
huge problem for students (and staff) at Willowbrook with 30-50%, of student becoming infected.
Because of the high rates of infection, Dr. Krugman decided to involve the children at Willowbrook in
his studies.

Before the studies, it was thought that there were two types of viral hepatitis. There were some ideas
on how each was transmitted; however, doctors were very limited on how to diagnose the disease.

The Studies and Results:

The studies began in the 1950s and lasted for 15 years. Children aged 3 to 10 being housed at
Willowbrook were the subjects of the study. Dr. Krugman noticed that students who were infected
with hepatitis recovered, and then appeared to be immune to future outbreaks of the disease. He
decided to take antibodies (from the blood of infected children) and use them to try to create
immunity, or protection, from hepatitis.
Antibodies are produced by the body in response to an infection, and they are part of the immune
system's response to rid the body of diseases, like hepatitis. Dr. Krugman deducted that injecting
uninfected students with the antibodies would jumpstart their immune system, resulting in a milder
case of hepatitis once they were exposed. In addition, the antibodies would protect the children from
future outbreaks.

Dr. Krugman's research involved 700 students that were divided into two groups:

 Group 1: Involved students that were already housed at Willowbrook. Some of this group was
given the protective antibodies and some were not.

 Group 2: Involved students that were new to Willowbrook. All of these students were given the
protective antibodies. Some students in this group were intentionally infected with hepatitis
(obtained from sick students) and some were not.

Since some of the symptoms varied, Dr. Krugman learned that there were two forms of hepatitis (A
and B). The students who had the protective antibodies and were purposely infected with hepatitis
had mild symptoms compared to students who acquired hepatitis naturally (and did not have the
protective antibodies). This understanding paved the way for vaccinations for hepatitis A and B (that
are used today).
 STATION 8: Thalidomide Tragedy

In a post-war era when sleeplessness was prevalent, thalidomide was marketed to a world
hooked on tranquilizers and sleeping pills. At the time, one out of seven Americans took them
regularly. The demand for sedatives was even higher in some European markets, and the presumed
safety of thalidomide, gave the drug massive appeal. Sadly, tragedy followed its release, catalyzing
the beginnings of the rigorous drug approval and monitoring systems in place at the United States
Food and Drug Administration (FDA) today.

Thalidomide first entered the German market in 1957 as an over-the-counter remedy, based
on the maker’s safety claims. They advertised their product as “completely safe” for everyone,
including mother and child, “even during pregnancy,” as its developers “could not find a dose high
enough to kill a rat.” By 1960, thalidomide was marketed in 46 countries, with sales nearly matching
those of aspirin.

Around this time, Australian obstetrician Dr. William McBride discovered that the drug also
alleviated morning sickness. He started recommending this off-label use of the drug to his pregnant
patients, setting a worldwide trend. Prescribing drugs for off-label purposes, or purposes other than
those for which the drug was approved, is still a common practice in many countries today, including
the U.S. In many cases, these off-label prescriptions are very effective, such as prescribing
depression medication to treat chronic pain.

However, this practice can also lead to a

more prevalent occurrence of unanticipated,
and often serious, adverse drug reactions. In
1961, McBride began to associate this so-
called harmless compound with severe birth
defects in the babies he delivered. The drug
interfered with the babies' normal
development, causing many of them to be born with phocomelia, resulting in shortened, absent, or
flipper-like limbs. A German newspaper soon reported 161 babies were adversely affected by
thalidomide, leading the makers of the drug—who had ignored reports of the birth defects associated
with the it—to finally stop distribution within Germany. Other countries followed suit and, by March of
1962, the drug was banned in most countries where it was previously sold.
 In July of 1962, president John F. Kennedy and the American press began praising their
heroine, FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States
despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application
for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her
concerns was the lack of data indicating whether the drug could cross the placenta, which provides
nourishment to a developing fetus.

She was also concerned that there were not yet any results available from U.S. clinical trials of
the drug. Even if these data where available, however, they may not have been entirely reliable. At
the time, clinical trials did not require FDA approval, nor were they subject to oversight. The “clinical
trials” of thalidomide involved distributing more than two and a half million tablets of thalidomide to
approximately 20,000 patients across the nation—approximately 3,760 women of childbearing age, at
least 207 of whom were pregnant. More than one thousand physicians participated in these trials, but
few tracked their patients after dispensing the drug.

The tragedy surrounding thalidomide and Kelsey’s wise refusal to approve the drug helped
motivate profound changes in the FDA. By passing the Kefauver-Harris Drug Amendments Act in
1962, legislators tightened restrictions surrounding the surveillance and approval process for drugs to
be sold in the U.S., requiring that manufacturers prove they are both safe and effective before they
are marketed. Now, drug approval can take between eight and twelve years, involving animal testing
and tightly regulated human clinical trials.
Name of Experiment: Dr. Southam's Cancer Study

1. What was the experiment about?

Ex: This experiment was about a doctor named Chester Southam who injected cancer cells into
healthy patients to see whether or not their bodies would fight off the cancer.

2. Who were the people who were harmed in the experiment? How were they harmed?

Ex: The people who were harmed were his patients. Some of them contracted cancerous lesions that
had to be surgically removed.

3. What are (at least two) of the Nuremberg Codes that were broken in the experiment? How?

 Principle 1 of the Nuremberg codes were broken because the patients did not give their full
consent in all cases.
 Principle 2 was also broken as the experiment did not yield any positive results and it was not
necessary to conduct the experiments on a human being first.

4. What strikes you as the most fascinating and/or most disturbing part about the experiment?

Ex: The most fascinating part of this experiment is that some prisoners willingly volunteered to be
injected with cancer in order to repay their debts to society.