Coble 1

Bioethics: Ethnography oI Human Testing





Christopher Coble





Mr. Tom Burkhardt
Philosophy 105
November 27, 2011



Coble 2

Medicine is constantly changing to Iit the mold that we set. It bends, stretches, and
branches out as new research is conducted and new cures are Iound. There is no way we can
know where it will end up next, but, there is one thing that can be made certain, medicine is
always moving Iorward. At the twilight years oI the 20
th
century people could be expected to live
till about the age oI seventy years oI age. That`s a long time, but not nearly as long as it is
expected to be in our day oI age, which would be a whopping seventy-seven years. That`s a
seven year increase in only a decade. Why such a large leap you ask? As our world becomes
globalized and skyscrapers loom above our very heads, our medicine increases at a much Iaster
rate than the years beIore. Health care is a multi-billion dollar niche in the business world and the
longer people live, the more money these businesses get. So, it would make sense that these
corporations such as Roche and Johnson & Johnson would want to test their products beIore
putting them on the market, and what easier way to test them than with whom they were
designed Ior, humans. But the point behind all oI this is really to try and understand the ethical
ramiIications oI such testing, is it right? Is risking another human`s liIe worth saving thousands
oI other lives? Is it ok to exploit the bodies oI people to help sell a product? In this essay we will
delve into these questions as well as others. We will examine why people participate, how the
testing is done, and what it means to our modern-day society as a whole.
The Merriam Webster dictionary deIines a clinical study as a scientiIically controlled
study oI the saIety and eIIectiveness oI a therapeutic agent (as a drug or vaccine) using
consenting human subjects. The FDA states that a clinical trial is the most essential stage in the
liIe oI a new therapy; thereIore, the FDA also requires that all new drugs, practices, and
technologies be used on human test subjects beIore being placed on the market. This, oI course,
brings along with it certain unknown risks that must be taken in order Ior the drug to be a
Coble 3

success. So, beIore it is tested on humans it must Iirst be tested on animals to minimize the
potentially dangerous outcomes. (Rados)
Once it has been deemed saIe Ior human testing, subjects can then apply Ior the position.
Almost anyone can apply to be a test subject as long as they have the condition that is being
treated. There really is only one reason why people would want to participate in such a
dangerous process, they have tried everything else and hope a new approach would be more
beneIicial. They may also even want to advance medical knowledge by participating. In a Harris
Poll oI clinical trials Ior cancer, seventy-six percent oI those surveyed said they participated
because they believed that the care they would be receiving would be greater than with other
therapies. (Rados)
Although the above may hold true Ior cancer therapies, a vast amount oI other clinical
trial patients participate Ior monetary compensation. This is obviously a very dangerous way to
make money, but yet, people still participate Ior this reason. David Banks, an FDA pharmacist,
says that people should never under any circumstance participate in a clinical trial because oI
promises oI money. It should only be done Ior reasons that are more beneIicial to the individual
as well as Ior our society. But, rather than it being the Iault oI the participant, could it be the Iault
oI pharmaceutical companies? (Rados)
As I mentioned above, globalization has aIIected the medical industry immensely. With
this movement comes the mass exodus oI test subject positions to third world countries. Many
pharmaceutical companies take advantage oI the economic conditions oI other countries in order
to Iind test subjects Ior their projects, this is the main ethical concern when it comes to human
testing. People in third world countries need the money so they sign up Ior these testing positions
Coble 4

and brave the potentially disastrous consequences. Are these companies exploiting the poor and
using their bodies Ior their own gain or are they providing them with money so they can live a
IulIilled liIe? (Petryna)
Adriana Petryna writes about this very issue in her article Ethical Jariability. Drug
development and globali:ing clinical trials that was published in American Ethnologist, a
scientiIic journal. She comes to the conclusion that as these companies move their testing
grounds away Irom the prying eyes oI the American government they will begin to disregard the
ethical practice oI medical testing and harm the individuals being tested. She also states that
although it may be cost eIIective, it may not be right to exploit a poor society Ior gain. So, this is
the bad side oI why people participate in clinical trials, but that doesn`t mean there are no good
reasons Ior joining a clinical trial. (Petryna)
For every person that may die during a clinical trial there may be thousands more that
survive because oI the beneIits it provides. Medical knowledge isn`t easy to come upon and any
way that someone could help out would help immensely. As a matter oI Iact, this is one reason
that a select Iew people join clinical trials, they think it helps advance medical knowledge. This
reason can also go hand in hand with gaining an inexpensive as well as possibly eIIective
alternative to known cures. (Rados)
Once a cure is made public and is known to be saIe, its price increases tenIold. This
makes becoming a test subject a great alternative Ior those who don`t want to go ahead with
expensive treatments. So there really are three beneIits to becoming a test subject. The cost is
low, it provides the medical community with valuable knowledge, and it provides a newer
Coble 3

alternative and better care to those in need. There are ethical reasons Ior being a test subject and
these are to just list a Iew.
Why people become test subjects is one thing, but how they are treated is an entirely
other ethical aspect oI human testing. Clinical trials may be dangerous, but that doesn`t mean
that a pharmaceutical company shouldn`t try to minimalize the risk associated with a trial. To do
this, most companies take a drug through a rigorous process to approve them Ior human testing.
As I mentioned above this usually takes place during countless animal testing trials. Now, animal
testing would bring us into a whole other ethical realm, so I won`t go there today, but I will say
that without animal testing there would be no testing at all. But anyways, animal testing is a way
to protect those who opt Ior human trials. Pharmaceutical companies are also required to not only
gain written consent Irom the individual but also to inIorm them oI all risks associated with such
a trial. This way the subject can make an inIormed decision on whether or not they want to
participate. They know all oI the risks. (Rados)
Some oI these risks are obvious. An experimental therapy may not be suitable Ior humans
and result in serious side eIIects or even death. OI course, this depends on the type oI therapy
being tested. Testing the latest Old Spice body wash is nowhere near as dangerous as testing a
controversial new brain surgery, but still, they all come with their own special set oI risks. OIten
times most oI these side eIIects are temporary, but there have been instances in which long term
eIIects have been witnessed. And as a risk pops up into question, the next round oI testers must
be inIormed oI it. Once the subject knows the risk they can begin the screening process.
Choosing the subject is a very critical role during the testing process. Every potential
candidate is screened to make sure they are good Ior the testing. They want to make sure that the
Coble 6

patient is entirely suited Ior the test ahead. They go through everything Irom the person`s
medical history to the current medical state including all the medications the person is on. AIter
this they are ready to begin testing. (Rados)
During the trials they are monitored constantly so as no drastic changes take place. The
care that test subjects receive during these trials is phenomenal. Most companies want to make
sure that their patients are healthy. They have to monitor their health Ior testing purposes so this
helps the patient be a little saIer during the process. II the corporation can limit the risks
associated with the testing then they are acting as ethical as possible. (Rados)
Subjects are also Iederally protected by organizations such as the OIIice Ior Human
Research Protections (OHRP) and the Department oI Health and Human Services (HHS). In her
article titled nside Clinical Trials. Testing Medical Products in People, Carol Rados quotes the
director oI OHRP Dr. Bernard A. Schwetz. 'It`s important that we have the rapport with the
public that allows them to trust with this program,¨ says Schwetz, 'Without people willing to
participate, there won`t be any clinical trials.¨ So, in order to look good in the public eye these
companies need to treat their patients ethically, which they do with the things I have listed. All oI
these procedures I have listed are the most ethical way that a large pharmaceutical company can
carry out its testing. Although, I did not say that all these companies practice this. Some
companies completely disregard the rules. (Rados)
The main example oI pharmaceutical companies not testing ethically comes Irom the
writing done by Adriana Petryna. From her article Ethical Jariability. Drug Development and
globali:ing she stated that certain companies have begun to take there testing overseas. This
example was listed above as a potential way to cut costs, but it also allows the companies to do
Coble 7

another thing, cut saIety procedures. Those organizations such as the OHRP and the HSS are not
Iound in most third world countries. As a result, many drug companies take their business over
there so that they won`t have to spend the money on keeping their subjects saIe. Sure it is cost
eIIective, but is it ethical? (Petryna)
Another example comes Irom the writings oI Hazel Muir in her article Dicing with
Death, published in the New Scientist magazine in 2006. In her article she brings light to the
unethical distribution oI drugs that were unknowingly and unwillingly being used as tests. The
companies would send the drugs out without doing testing and the people who were prescribed
these medications would be under watch to see iI they are saIe. Obviously this is a major
malpractice on the part oI these companies. These drugs are not approved by the FDA, but yet
they are still being prescribed. Why you ask? Well this is because these companies want a cheap
way to test their merchandise. (Muir)
Both oI these examples provide a solid critique oI human testing. Companies can beat the
system and use human testing unethically. These companies are what give human testing a bad
name. II done right, clinical studies are the most powerIul thing that we can use to help advance
medical research.
When you look at the bigger picture all oI this seems irrelevant. When you get right down
to it human testing saves millions oI lives every year. In one chapter oI their book called Ethics
Theory and Practice, Jacques P. Thiroux and Keith W. Krasemann delve into something called
cost beneIit analysis. This basically states that iI and end result is great enough, it can outweigh
the potential risks associated with it. In other words, the ends justiIy the means. We can apply
this directly to our issue at hand. Risking another person`s liIe, who may even be dying anyway,
Coble 8

is enough to justiIy saving countless others. This makes human testing overall an ethical process.
But, keep in mind that this does not mean that the way it takes place is ethical; it just means that
the overall process is ethical.



Coble 9

Works Cited
Muir, Hazel. "Dicing with Death." New Scientist 191.2562 (2006): 38-41. MasterFE Premier. Web.
Petryna, Adriana. 'Ethical Variability: Drug Development and globalizing. Clinical Trials. 'American
Ethnologist 32.2 (2005): 183. MasterFile Premier. Web. 27 Nov. 2011.
Rados, Carol. "Inside Clinical Trials: Testing Medical Products in People." FDA Consumer 1 Sept.
2003.MasterFE Premier. Web.
Thiroux, Jacques P., and Keith W. Krasemann. Ethics: Theory and Practice. Upper Saddle River, NJ:
Prentice Hall, 2009. Print

7/9 !4845  4.89347.3%0893      78945074-0      7 %42:7.02-07      .          409.541:2.

.

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

.

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

.

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

.

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

.

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

.

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

.

990.4:3908849078 %82.574.998/40834920.99.      .07.    8034:94:8918.0809..39.085..088  :9 005323/9..08:2.574.9 904.3908934.088809.9:8920.3.309..389...07.

.

8%047.8  207. /7.8907!70207 0-  !0973.0452039.3/!7.9 0$.802.%7.3  934489     .  9.0.983!0450 438:207$059    ..3 3.%7.6:08! .3/09 7.9.33 9.3.    #.    47890/ :7 .0 &5507$.07  !7039.//0#.-97:0.74 38/03...03989      ....3/4-.'.7.390.   !739  .!74/:.0 .89070!70207 0- 4./48 ..8%08930/.8907!70207 0-  %74: .