International Biopharmaceutical Association Publication
THE USE OF PRISONERS IN CLINICAL TRIALS:
A DOOR THAT SHOULD BE LEFT CLOSED.
Adebowale Aderibigbe
A student of KRC – CRA Training.
aaderibi@gmail.com
Abstract
Clinical trials are essential to the drug
development process. Before the Food
and Drug Administration can approve a drug to be sold on the market, it has to
go through three extensive phases of human testing. The pre-clinical
phase of
testing on animals is done prior to phase one of clinical trials. Due to the
untrusting nature of the American public, pharmaceutical companies are finding
it hard to recruit subjects for clinical trials. Before congress banned the use
of prisoners in medical experiments, a lot of pharmaceutical products were
tested on prison inmates. Commercial cosmetics and toiletries, hair
transplants,
implantation of foreign bodies, burns and radiation of the skin, exposure
hallucinogenic, carcinogenic chemicals were all tested on prisoners. In
response
to social and political indifference, the congress banned the use of prisoners
in clinical trials. Last month, the prestigious
recommended that government loosen regulations on the use of prisoners. In my
opinion, the ban should be left in place.
Introduction
A prisoner refers to any
individual involuntarily confined or detained in a
penal institution. The term is intended to encompass individuals sentenced to
such institution under a criminal or civil statute (2).The issue of prisoner
use
in the testing of new drugs and therapies has long been a touchy, controversial
one. From the late 1940s to mid-1970s, inmates at
prison and other correctional facilities across the country were used as human
guinea pigs in gruesome medical experiments. They were made to believe they
were
‘volunteers’ paid a few hundred dollars a month and not notified that they
would
be exposed to chemical warfare agents and radioactive, hallucinogenic and
carcinogenic chemicals. Many prisoners in
month to have their testicles irradiated by government researchers (2). It was
not till 1978 that Congress passed a law that limited testing on inmates to
research involving only the most minimal risk. What brings up this horrendous
topic again, you might ask?
In August 2006, the Institute of Medicine (I.O.M), a
federal panel of medical
advisers, recommended that government permit greater research with prisoners
but
under tough new regulations that would prevent the abuses of the past and limit
experiments to those that have a direct potential benefit to prisoners. In my
opinion, this move is ill-advised and would only serve to open old wounds and
lead to further exploitation of prisoners.
Prisons are coercive.
The key element to any ethical
system of human subject testing is informed,
voluntary consent. Without informed and voluntary consent, an individual cannot
be allowed to take part in any clinical trial. It has long been established
that
prisoners cannot give any meaningful consent because detention facilities are
inherently coercive. “Incarceration is one of society’s coercive powers. Any
further act-official or otherwise- involving prisoners, including research,
must
be carefully scrutinized for its retributive or extra-punitive purpose or
nature. Thus prisoners should not feel compelled to take part in research as a
condition or consequence of their incarceration” (6).This is also the position
the National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research takes as reflected in both of its Belmont report and
Research Involving Prisoners report. It is for this reason (coercion), that all
50 states and the federal government banned sex among prisoners and staff.
Prisoners are
illiterate, mentally ill and substance addicted.
Another reason why prisoners cannot
give consent is that the average American
prisoner is more than likely to be functionally illiterate, mentally ill
and
substance addicted .How can an illiterate prisoner decipher the legal papers
necessary to seek their consent when only lawyers can understand what is
written
in the documents? According to the National Institute for Literacy, low
literacy
is strongly related to crime. Seventy percent of prisoners fall into the lowest
two levels of reading proficiency (9). Also the American Psychiatric
Association
estimates that one in five prisoners are seriously mentally ill with up to five
percent actively psychotic at any given time (10). We all know the role drugs
and substances play in crime and as such most inmates are substance addicted.
None of above named groups can give consent that is legally binding and
perceived as voluntary.
Prisoners are
impoverished.
On the average, American prisoners
tend to be impoverished citizens and as such
dangling money in front of most of them in exchange for being tested upon would
make great financial meaning to them. The fact that they might acquire long
term
hazardous health problems would never cross their minds. All they see is the
dollar bills being thrown at them. For instance, “during the Holmesburg
experiments, inmates could earn up to $1,500 a month by participating. The only
other jobs were at the commissary or in the shoe and shirt factory, where wages
were usually about 15 cents to 25 cents a day” Professor Allen Hornblum said.
Hornblum is a witness to the horrors that happened at the
His account of his encounters in Holmesburg is compiled in his book, Acres of
Skin. The money was so good that some inmates sued the Food and Drug
Administration for banning tests! (4) A prisoner who spoke to government
advisers prior to the ban said that “death is a way of life. The only place in
this prison that people don’t die is in the research unit. Just what do you
think you are protecting us from?”(5)
Prisoners lack basic
healthcare.
The idea of offering expensive
cutting edge research to prisoners who lack
basic health care does not make sense. Why can’t these experiments be carried
out on people who can afford them instead of prisoners who are impoverished,
illiterate, mentally ill and substance addicted? The answer is that whatever
happens within the prisons cannot get to the general public unless people like
Professor Hornblum talk about them. After experiencing the horror of medical
experiments at Holmesburg he said “it just goes to show how prisons are truly
distinct institutions where the walls don’t just serve to keep inmates in, they
also serve to keep public eyes out.”(7)Pharmaceutical companies and government
researchers cannot run the risk of performing on regular citizens. Obviously,
the atrocities being committed would be known to everyone. Also, free citizens
can seek legal actions against them.
Past abuses
There are well documented reports
of prisoners showing adverse reactions to
these experiments. In the famous Nuremburg trials in which many Nazi scientists
were accused of murders, tortures and other atrocities in the name of medical
science, Dr. Gerhard Rose (one of those accused) made a point when he stated
that he had done nothing that the
in which American Dr. Richard P Strong performed a series of experiments in
1906. Dr. Strong had inoculated the cholera virus into inmates of the Bilibid
Prison in
inmates involved. They were inoculated with bubonic plague serum which had been
mistaken for the cholera serum. The deaths of the inmates did not stop the good
doctor from continuing experiments on other Filipino prisoners. Six years later
his beriberi experiment resulted in an even higher number of fatalities. The
surviving prisoners were compensated with cigars and cigarettes (3). During
Professor Hornblum’s study of Holmesburg Prison, he met an inmate, Al Zabala,
who had taken part in the United States Army’s chemical testing. After a
disorienting few hours in a padded cell, Zabala faced a barrage of questions
from psychologists who returned him to his cell wearing a tag: “Please excuse
this inmate’s behavior. He can’t think or act in a coherent manner”. Zabala
later left prison with $1,500 and serious behavioral problems. A few years
after
his release, he locked himself in his sister’s house and refused to eat for
three days.(3) Another event took place at the San Quentin Prison in
Between 1918 and 1922, castrated inmates received transplanted testicles of
executed inmates in a bid to make the castrated men fertile. Hundreds of the
inmates were also injected with animal testicular substance; some received a
piece of ram’s testicle the size of a silver dollar, which was transplanted
into
the scrotum or abdominal wall (3). In New York’s Sing Sing, an inmate named
Louis Boy ‘volunteered’ to become a human blood cleaning agent for a young girl
dying from cancer. For 24 hours, the prisoner and the ill eight year old girl
were laid side by side and their circulatory systems were linked together with
rubber tubing. The objective of the whole experiment was to cleanse the
cancerous blood from the girl’s body through his body. Needless say the risky
experiment failed as the girl later passed away. In reaction to public
admonishment of the experiment, the governor gave Mr. Boy his freedom (3).
These
are just a few of the horrors. Shouldn’t these sordid stories be enough to put
a
stop to all kinds of experiments on prisoners?
Business as usual.
There are now approximately 4,400
biotechnology companies in the world with
total revenues of over $40 billion and R&D expenditures of over $32
billion. In
the
160,000 people, with total revenues of over $22 billion and sales of
biopharmaceuticals amounting to $16 billion (8). Obviously, there is a lot of
money involved in the production of drugs. The part of drug development that
takes up the most time is patient recruitment. It takes up about thirty percent
of clinical trial time-more than any other clinical trial activity (1). These
delays cost drug companies millions of dollars each day. The drug companies
know
that clinical trials are an important aspect of getting their therapies
approved
by the FDA and patients are the core of clinical trials. In the last two years,
several pain medications including Vioxx® and Bextra®, have been pulled of the
market because early testing did not include large enough numbers of patients
to
catch dangerous problems (7).The helmsmen of this industry would not want to
see
their investments go down the drain because there are not enough subjects to
test their novel therapies on. They would go to great extents to ensure they
get
a return on their investments. The easy way out is to prey on the 2.3 million
prison population.(7) As evident from the past incidences, what starts as a
scientific research quickly becomes pure business. No amount of regulations can
prevent abuses from happening when billions of dollars are at stake.
Conclusion
The pharmaceutical industry is
buzzing about the new recommendation by the
inmates across the country. It means that their problem of having to look for
subjects will be a thing of the past. Like a hawk waiting to steal a chick from
a chicken, they await the lift of this ban. Even with the strict regulations
the
IOM proposes, there will be a lot of atrocities committed on inmates who cannot
give any meaningful consent, inmates who are mentally ill, substance addicted
and illiterate, inmates who are poor and lack basic health care. The government
should think carefully about lifting the ban. They should particularly pay
attention to all the past abuses that have taken place. Every citizen of this
great country (either in prison or outside) needs their rights as humans
protected.
REFERENCES
1) Barnes, Kirsty. Prisoners may be used
to fill clinical trial shortage. In-
Pharma
Technologist.com online
magazine. www.in- pharmatechnologist.com/news.
2) Hornblum, Allen. Acres of Skin: Human Experiments at
Holmesburg, Routledge,
First edition, May 1999.
3) Hornblum, Allen. They were cheap and available:
Prisoners as research
subjects in twentieth century
www.bmj.bmjjournals.com.
4) Kinney, David. The
Atrocities Against Its Own Citizens. www.worldfreeinternet.net/news.
5) Shah, Sonia. Testing Drugs on Prisoners: The easy way
out, Boston Globe, Aug
17, 2006.
6) Stone, Howard T. Currents in Contemporary Ethics:
Discerning Minimal Risk in
Research Involving Prisoners as Human Subjects, The Journal of Law, Medicine
and
Ethics, Fall 2004.
7) Urbina, Ian. Panel Suggests Using Inmates in Drug
Trials, New York Times,
August 13, 2006.
8) www.krctraining.com
9) www.nifl.org
10) www.psych.org