Human medical experimentation in modern times: How immigrants, poor people, mino

[Guest guest]

http://www.newstarget.com/019193.html

 

March 7 2006

 

Human medical experimentation in modern times: How immigrants, poor

people, minorities and children are modern-day guinea pigs for Big

Pharma (part one and two)

 

" The concentration camps were used as a huge laboratory for human

experimentation, " says Wolfgang Eckhart, professor of Historical

Medicine at the University of Heidelberg in Germany. During the

Holocaust, Bayer, Hoechst, BASF and other German pharmaceutical and

chemical companies combined into a powerful cartel known as

Interessengemeinschaft Farbenindustrie Aktiengesellschaft (IG Farben).

As well as manufacturing everything from the deadly gas used to kill

Holocaust victims, the gasoline used to move war vehicles and the

explosives used to bomb enemies and conquer Europe, IG Farben was also

trying its best to put a large number of highly profitable new drugs

on the market and used concentration camp prisoners as human guinea

pigs to do so.

 

Now, over 60 years after the Holocaust, we'd all like to think that

society is above such cruelty, but in reality, human experimentation

is still a common practice in modern medicine. Big Pharma operates by

many of the same rules and motives as IG Farben did, and the test

subjects are still the most vulnerable members of society -- the poor,

immigrants, minority groups and children.

 

" Few doctors dispute that testing drugs on people is necessary. No

amount of experimentation on laboratory rats will reliably show how a

chemical will affect people, " David Evans, et al. writes in the

Bloomberg article " Drug Industry Human Testing Masks Death, Injury,

Compliant FDA " . Doctors have recognized the importance of human

experimentation since the days of Hippocrates, though the ancient

Greeks used it to benefit individual patients rather than science

itself or any profit-driven industry. In 1833, William Beaumont, the

army surgeon physician who pioneered gastric medicine with his study

of a patient who'd sustained a gunshot wound that left his digestive

system permanently exposed, established the importance of human

experimentation as long as it is with the subject's consent.

 

However, sometimes it's difficult to find human test subjects,

especially for studies involving pain or high risk. In the 1930s,

research scientists discovered a solution to their difficulty in

finding willing test subjects: Don't ask for their consent. In the

infamous Tuskegee Syphilis Study, the United States Public Health

Service diagnosed 200 black men with syphilis and, rather than

treating or even informing them of their illness, used them as human

guinea pigs to study the symptoms and progression of the disease.

Today, as the University of Virginia Health System writes in its

online documentary " Bad Blood " , " The Tuskegee Syphilis Study has

become a powerful symbol of racism in medicine, ethical misconduct in

human research, and government abuse of the vulnerable. "

 

During the Holocaust, IG Farben trumped the moral depravity of the

Tuskegee Syphilis Study. Why use and abuse only 200 unwilling human

test subjects when you can choose from the multitudes imprisoned in

Nazi concentration camps? IG Farben callously used concentration camp

inmates of all ages for painful, debilitating and often deadly

experiments. Because of this, medical experimentation has become

synonymous with injustice, cruelty, prejudice and total disregard for

human life. Today, few people would try to justify or support IG

Farben's medical experiements, but the sad truth is that modern human

medical experimentation is in many ways similar to the horrors carried

out by IG Farben.

 

Experimental drug testing centers

During the Nuremberg Trial, Dr. Waldemar Hoven, the Nazi doctor who

gave lethal injections to his patients at Buchenwald, gave the

following account of the medical experiments he and other

concentration camp physicians performed: " It should be generally

known, and especially in German scientific circles, that the SS did

not have notable scientists at its disposal. It is clear that the

experiments in the concentration camps with IG preparations only took

place in the interests of the IG, which strived by all means to

determine the effectiveness of these preparations. They let the SS

deal with the -- shall I say -- dirty work in the concentration camps.

It was not the IG's intention to bring any of this out in the open,

but rather to put up a smoke screen around the experiments so that ...

they could keep any profits to themselves. Not the SS but the IG took

the initiative for the concentration camp experiments. "

 

Like IG Farben, Big Pharma doesn't perform its own experiments.

Instead, it doles out the " dirty work " to experimental drug testing

centers, some of which confine test subjects for portions of the

study. In a Bloomberg article entitled " Miami Test Center Lures Poor

Immigrants as Human Guinea Pigs " , Argentinian immigrant Roberto

Alvarez describes the eight days he spent confined to the Miami-based

SFBC testing center: " It can be weird inside. It's like a jail. "

 

In many ways, it is like a jail. In Miami's SFBC, which is the largest

center of its kind in North America, test subjects sleep six to a room

in double-decker beds. They even have uniforms to wear -- purple

drawstring pants and T-shirts, much like the uniforms of concentrate

camp victims. Dr. Hoven's criticism of IG Farben's experiments in Nazi

concentration camps could easily be directed to Big Pharma's human

experiments. In fact, it has. " Some test centers, FDA records show,

have used poorly trained and unlicensed clinicians to give

participants experimental drugs. The centers ... sometimes have

incomplete or illegible records, " David Evans, et al. writes.

 

Informed consent?

Even though the FDA has required informed consent of test subjects

since 1981, many people believe that researchers often don't fully

explain risks and potential side effects, so as not to deter potential

test subjects. " Human subjects are in very short supply, so it's not

surprising that under the growing pressure to find them, there are

sometimes terrible ethical violations, " says Marcia Angell, who was

editor-in-chief of the New England Journal of Medicine from 1999 to

2000. The centers meet the legal requirements of informed consent by

providing an informed consent form, but the form may be written in a

language the potential subjects do not fully understand because they

are immigrants, who make up a large portion of human test subjects.

Even if they are written in the subjects' native language, the forms

may be long and dominated by obscure technical jargon. In " Drug

Industry Human Testing Masks Death, Injury, Compliant FDA " ,

Argentinian immigrant Roberto Alvarez admits, " The thing I pay most

attention to when filling this thing out is this: How much it pays and

how long it takes. I don't read them too carefully, " while skimming

through a 12-page consent form.

 

The Nazi doctors didn't even bother with consent forms. Why waste time

when you can just force-feed concentration camp inmates a pill or

inject them with an experimental substance? " I remember one of the SS

doctors holding my jaw open and forcing pills down my throat, "

Auschwitz survivor Zoe Polanska Palmer told BBC Radio 4 reporter Mark

Handscomb in It's My Story. Granted, giving potential subjects long

consent forms written in language they can't fully understand is

better than shoving pills down someone's throat, but it still seems

unethical and it can still put human life at risk.

 

Even Kenneth Lasseter, the executive medical director of the SFBC

experimental drug testing center, admitted in the Bloomberg article,

" It's clear to me. Perhaps it needs to be explained more. " Lasseter

was speaking of the consent form for an experimental drug that may

treat overactive bladders. " The goal of this study is to determine the

highest daily dose of TD-6301 that will not cause an undesired

increase in heart rate. " Yes, that wording may be clear to Lasseter,

but it may not be clear to the average test subject. " They're saying

it backwards to a population that may not be of the highest education

level. The real purpose of the study is, 'We're going to make you sick

in order to find out at what level you get sick when given this drug.'

Obviously, they don't want to say that, " University of Miami

bioethicist Ken Goodman told David Evans, et al..

 

Preying on immigrants and other poverty-stricken individuals

During the Holocaust, the Nazis confined the marginalized sectors of

society -- Jews (including children), gypsies, homosexuals, the

mentally ill and the mentally retarded -- into camps that became human

guinea pig-filled laboratories for IG Farben's experimental drug

studies. Today, marginalized populations still make up a large portion

of experimental drug test subjects; however, socioeconomic factors,

rather than concentration camp authorities, make them more likely to

sell their bodies to Big Pharma.

 

It's no accident that SFBC, the largest experimental drug testing

center in North America, is located in Miami. According to the St.

Petersburg Times, Miami-Dade County " is the only county in the country

where more than half the residents are foreign-born. " After immigrants

come to Miami from countries like Cuba, Colombia, Haiti, Nicaragua,

Jamaica, Argentina and Mexico, they need money, yet experience the

employment limitations that little or no fluency in English, little

education, unfamiliarity, prejudice and, in some cases, lack of a work

permit brings. With few other options available, these immigrants find

one of the few legal jobs that doesn't require any amount of English

proficiency or education and may even accept forged social security

cards: Professional guinea pig.

 

Many immigrants participate in multiple, simultaneous drug studies.

Combining these experimental drugs is a recipe for disaster " because

researchers don't know how the different chemicals interact or what

side effects the mix may have on a person, " according to the Bloomberg

article " Miami Test Center Lures Poor Immigrants as Human Guinea

Pigs " . However, given the fact that some studies only pay $25 per day,

what else are the truly marginalized subjects supposed to do? " It's

not the job I would choose, but financial circumstances require you to

do it sometimes,'' Venezuelan immigrant Oscar Cabanerio told Bloomberg.

 

Human medical experimentation on children: The exploitation of poor

children by Big Pharma (part two)

The crimes committed against children define some of the Holocaust's

most morally despicable horrors. In It's My Story, Palmer told

Handscomb of the abuses she received as a 13-year-old at Auschwitz. As

a result of the damage done to her body by the contraceptive drug

experiments forced upon her at Auschwitz, she had to undergo several

painful surgeries immediately following the war and, even after the

surgeries, Palmer remained unable to bear children for the rest of her

life. Today, in her 70s, Palmer has cancer.

 

Now, no one can say for certain whether or not Palmer's cancer is

linked to the medical experiments she underwent roughly 60 years

earlier, but it is a likely possibility. Exposure to drugs and other

chemicals produces extremely negative effects on children, especially

those who are even younger than Palmer was during the experiments.

 

In the April 2004 Pediatrics article " Trends in Environmentally

Related Childhood Diseases, " Tracey Woodruff, et al. writes, " Children

may be particularly susceptible to exposures in utero or during early

life because the fetus' or young child's physiology is undergoing

rapid development, such as rapid cell division, changing metabolic

activity, and evolving hormonal systems. "

 

With this in mind, running experimental drug studies on children seems

especially dangerous and thus horrendous, yet it is still a common

occurrence even in modern society. In her Nov. 30, 2004 BBC News

article " Guinea Pig Kids " and her subsequent documentary of the same

name, Jamie Doran reveals New York City's Administration for

Children's Services' (ACS) little-known practice of using HIV-positive

children kept in the city's orphanages and foster care homes as human

guinea pigs for experimental AIDS drugs. For his documentary and

article, Doran interviewed Jacklyn Hoerger, a pediatric nurse who

worked at the Catholic Church-run Incarnation Children's Home in

Harlem. Hoerger maintains that social work authorities never told her

that the drugs she and the other Incarnation employees were

administering the orphans and foster care children were experimental.

" We were told that if they were vomiting, if they lost their ability

to walk, if they were having diarrhea, if they were dying, then all of

this was because of their HIV infection, " she said to BBC.

 

In reality, these symptoms were due to the experimental drugs that the

workers were giving them. When BBC asked him his opinion on the

experimental drug studies done on New York City's orphans and foster

children, University of Berkeley visiting scholar Dr. David Rasnick

explained, " We're talking about serious, serious side effects. These

children are going to be absolutely miserable. They're going to have

cramps, diarrhea and their joints are going to swell up. They're going

to roll around the ground and you can't touch them. " According to BBC

reporter Doran, Dr. Rasnick went on to call the experimental AIDS

drugs that were given to the children " lethal. " If children refused to

take them by mouth, workers at Incarnation force-fed them the drugs

through feeding tubes inserted into their stomachs.

 

It's no doubt that these HIV-positive and AIDS symptomatic children

needed medication. The question is why were they given experimental

drugs, rather than the same medications that a child living in an

expensive brownstone on the Upper East Side would have received? In

the words of Alliance for Human Research Protection spokesperson Vera

Sherav: " They tested these highly experimental drugs. Why didn't they

provide the children with the current best treatment? That's the

question we have. Why did they expose them to risk and pain, when they

were helpless? Would they have done those experiments with their own

children? I doubt it. " Furthermore -- when you consider the fact that,

according to the BBC article, 99 percent of the children in New York

City children's homes are either African American or Hispanic --

issues of race and prejudice also come into play.

 

Hoerger told BBC that she didn't realize what was going on until she

later took two children from Incarnation home as foster children. As a

trained pediatric nurse, she decided to take the two children she was

caring for in her home off the medications given to them while at

Incarnation. This resulted in " an immediate boost to their health and

happiness, " according to BBC. However, soon after her decision, ACS

came to her home and took the children out of her care. She was then

labeled a child abuser in court and, after that, she never saw the

children again.

 

Performing medical experiments on children is a serious accusation.

Realizing this, while working on his documentary and article, Doran

went to Incarnation for its side of the story, but it only referred

him to its public relations firm. The expensive Manhattan firm told

him that it didn't give comments about what goes on inside the home.

In light of these accusations, former ACS Commissioner John B.

Mattingly ordered a comprehensive review of all ACS records. By early

April, based on the records they had examined, ACS staff members

revealed just how common the experimentation Hoerger described at

Incarnation was throughout the city:

 

* Between 1988 and 2001, 465 foster care children and orphans were

used in experimental AIDS drug trials.

* Most of these children participated before 1996.

* The majority of HIV-positive children living in New York City

were diagnosed from the mid-1980s through the mid-1990s.

* The highest number of AIDS-related deaths among New York City

children happened from 1990 to 1995.

* The 465 children used in the studies were in approximately two

dozen different independent agencies operating under contract to ACS.

 

Then, on Apr. 22, 2005, ACS sent out a press release stating that it

had " contracted with the Vera Institute of Justice to conduct an

independent review of ACS policy and practice regarding the enrollment

of HIV-positive children in foster care in clinical drug trials during

the late 1980s and 1990s. " It also asserted: " The last child to enter

an HIV-related clinical trial while in foster care did so in 2001.

There are no ongoing HIV-related clinical trials involving children in

foster care in New York City. " This directly contradicts the

conclusion Doran writes in his 2004 article: " The experiments continue

to be carried out on the poor children of New York City. "

 

ACS maintains that it ordered the studies with the best interest of

HIV-positive children in mind. " The purpose of the drug trials was to

develop effective treatments for pediatric AIDS, at a time when there

were no known, FDA-approved medications available to treat children

with the disease, and many children were dying, " reads the press

release. As proof of the gravity of the AIDS crisis ACS faced when

conducting the trials, the press release cites the following figures

from the New York City Department of Health and Mental Hygiene:

 

* Out of the 13,927 HIV-positive children under age 13 nationwide

prior to 2003 (according to CDC estimates), the percentage of

HIV-positive children in New York City was " the highest by far of any

jurisdiction in the country. "

* From 1979 through 2003, 3,634 children living in New York City

and under the age of 13 were HIV positive.

 

Even though ACS believes that its decision to give the experimental

AIDS drugs to the 465 foster children and orphans was not wrong, it is

nevertheless ordering the Vera Institute to conduct the independent

study, so as to assure the public and the media. As Commissioner

Mattingly explained, " We are taking this step because, while we

believe that the policies in place at the time reflected good

practice, we acknowledge the need for transparency in all of our

dealings with the public. In order for us to be effective in our

mission to protect New York City's children, we must have a sense of

mutual trust with those families we seek to serve. " According to the

press release, the Vera Institute " will research ACS policies and

procedures to ensure that HIV-positive children and children with AIDS

who were in the care of ACS were appropriately enrolled in the correct

clinical drug trials. " This includes finding out whether:

 

* ACS obtained consent from the children's parents or other

guardians before enrolling them in the experimental drug studies.

* The children enrolled in the trials met the medical criteria to

do so.

* ACS adequately and properly monitored the children who were

enrolled.

* Enrollment was " appropriate based on sound medical knowledge at

the time. "

 

As of an Oct. 5, 2005 update to its web site regarding the analysis,

the Vera Institute still had not completed its investigation. It

writes that it is " assembling an advisory board of medical, child

welfare, legal, and community experts to review our findings and

assure the public of the independence of our research. " Meanwhile, in

its description of the project, the Vera Institute acknowledges both

sides of the controversy:

 

" Opponents of involving foster children in clinical trials -- where

the risks and benefits are often unknown -- worry that this highly

vulnerable population may be too-easily neglected or even exploited.

When it comes to children of color, in particular, they point to

historic examples where the health care system has acted in

discriminatory and prejudicial ways.

 

" On the other hand, those who favor including foster children in

clinical trials argue that enrollment can provide high quality care

and cutting-edge medicine to children who otherwise would receive only

routine medical services. In this view, excluding foster children

unfairly bars them from the best the medical profession has to offer. "

 

It will be very interesting to see the Vera Institute's findings --

which are, according to the Institute itself -- " part of Vera's

mission to improve government systems. " " We hope that the information

we provide will contribute to the public debate that will help shape

future policies regarding clinical trials and children in government

custody, " the site reads. On a national level, between 12,000 and

13,000 children under the age of 13 have participated in National

Institutes of Health-sponsored AIDS drug trials from 1986 to 2005.

 

Even though the Vera Institute's findings are not yet complete, the

Environmental Protection Agency's (EPA) Apr. 8, 2005 cancellation of

its Children's Health Environmental Exposure Research Study (CHEERS)

shows what a combination of intense opposition from environmental and

public health groups (as well as a little help from Congress) can do

to end experimentation on poverty-stricken children.

 

Child medical experiments at the EPA

In October 2005, the American Chemistry Council gave the EPA $2.1

million to study how children ranging from infancy to three years old

ingest, inhale or absorb chemicals. Like IG Farben was for the German

pharmaceutical companies of Nazi Germany, the American Chemistry

Council acts much like a front group for chemical industry bigwigs

like Bayer (which was incidentally also a member of IG Farben), BP,

Chevron, Dow, DuPont, Exxon, Honeywell, 3M, Monsanto and Procter &

Gamble. Studies have already proven that the chemicals made by these

companies have long-term effects on children and adults. A short,

two-year study like CHEERS would of course fail to reveal these

long-term effects and the American Chemistry Council could then

publicize these findings as " proof " that its chemicals were safe.

 

This represents an ethical problem in itself, but the demographic of

the proposed child test subjects worsen the issue, especially in light

of the use of foster children (the majority of which were

African-American and Hispanic) by both the New York City ACS and the

Tuskegee Syphilis Study. According to the EPA's original study

proposal, portions of which were reprinted by the Organic Consumers

Association, test subjects would be chosen from six health clinics in

Duvall County, Fla. Given the characteristics of these health centers,

page 23 of the study proposal itself highlights that minority children

from low-income families would be the likely test subjects: " Although

all Duval County citizens are eligible to use the [health care]

centers, they primarily serve individuals with lower incomes. In the

year 2000, seventy five percent of the users of the clinics for

pregnancy issues were at or below the poverty level ... The percentage

of births to individuals classified as black in the U.S. Census is

higher at these three hospitals than for the County as a whole. "

 

In fact, the health care centers report that 51 percent of their

births are to non-Caucasian mothers, and that 62 percent of mothers

received only elementary school or secondary school educations. If the

EPA were to have proceeded with CHEERS, children born to these health

care centers would have been used as human guinea pigs simply because

they belong to minority groups and poverty-stricken families. In

return for allowing their children to be exposed to toxic chemicals,

the families were to have received $970, a free video camera, a

T-shirt and a framed certificate of appreciation.

 

Fortunately, the EPA decided not to go through with CHEERS, once U.S.

Senators Bill Nelson (D-Fla.) and Barbara Boxer (D-Calif.) decided to

put their feet down and block President Bush's nomination of Stephen

Johnson for head of the EPA. In his Apr. 8 statement, Johnson reversed

the EPA's earlier decision to await a report from an independent

science advisory panel before making a decision about CHEERS. He

explained his decision as being a result of public and media

" misrepresentations " of the study:

 

" Last fall, in light of questions about the study design, I directed

that all work on the study stop immediately and requested an

independent review. Since that time, many misrepresentations about the

study have been made. EPA senior scientists have briefed me on the

impact these misrepresentations have had on the ability to proceed

with the study.

 

" I have concluded that the study cannot go forward, regardless of the

outcome of the independent review. EPA must conduct quality, credible

research in an atmosphere absent of gross misrepresentation and

controversy. "

 

Boxer, who says that she will continue to oppose testing toxins on

humans, called CHEERS an " immoral program to test pesticides on

children " and " a reprehensible idea that never should have made it out

of the boardroom " in her statement to the Associated Press following

Johnson's decision. Luckily, unlike Tuskegee, the study was stopped

before anyone got hurt.

 

This story continues in part three.

 

Or see the Human Medical Experimentation Timeline

 

Or see the comparison chart: Human medical experiments, Nazi Germany /

modern medicine