Pharmaceutical
Trials
In the last 30
years clinical trials of the pharmaceutical and biotech industries have
paralleled the ever globalizing world. The continual emphasis that is placed on
globalization is translated into the medical field in the form of
internationally shared clinical data. Although the practice of medicine lies
within the field of science, it encompasses more than the celebration of raw
data being pooled at a global level; yet the outsourcing of pharmaceutical trials
remains at large. This exponential growth of outsourcing in the pharmaceutical
industry provides an opportunity to evaluate the relationship between data
oriented corporate protocols and human beings that the trials are conducted on.
In this review I will follow Petryna’s style
of objectively assessing clinical trials by discussing the benefits and
limitations within this segment of the pharmaceutical industry. I will also attempt
to clarify that raw data is not king when discovered through unethical, and
immoral circumstances. By analyzing clinical trials in a medical anthropology
framework, new conclusions can be drawn to bring needed change to the ‘magic
bullet’ philosophy of the pharmaceutical industry. Using medical anthropology to describe the
global health problem of clinical trials offers the ability to see the
multi-faceted nature of this problem along with the possible contextualized
solutions.
Paradigms of Expected Failure
In the article Paradigms of Expected Failure by Adriana
Petryna, attention is drawn to the problems of outsourcing pharmaceutical
trials while acknowledging the limited benefits. Through critical study with a medical anthropology
framework Petryna brings to light how biopowers known as the “big pharma”
(which are the four major pharmaceutical companies) are setting up clinical
trials in places such as Eastern Europe and Latin America to gather data which
can then be used to gain patents from the United States Food and Drug Administration
or the European Medicines Agency. The practice of outsourcing harnesses the
power of testing populations with minimal to no pharmaceutical drug history
therefore making the citizens the perfect clinical subjects. At the same time
that these companies are maximizing their personal gain, they are providing a
local social good. This dialectic nature of clinical trials remains one the biggest
obstacle when attempting change in the pharmaceutical industry. By highlighting
ethical dilemmas present in the field of clinical trials Petryna discusses how
these unethical operational protocols are affecting the social network of
communities and nations, and how they unfairly direct problems of the clinical
trials away from the big pharma and onto the individual; the beginning of the
paradigm of expected failure. The paradigms of expected failure, or the
inability to predict safety outcomes of clinical trials, is outsourced along
with pharmaceutical testing and are a calculated way for the big pharma to
refuse a majority of complications that participants incur after clinical trials
are over. Of the many questions that surround clinical trials Petryna focuses
on the problems within operational models and the systems that are in place for
human protection. With these two main themes in mind, the essay concludes with
Petryna’s vision of future changes that could be implemented which would tie in
the goals of the pharmaceutical companies in a way that improves the rights for
humans who agree to participate in clinical trials.
Medical Anthropology and Outsourced Clinical Trials
Along with the article Paradigms of Expected Failure I reviewed
what the Global Health Watch publication had to say about the outsourcing of pharmaceutical
clinical trials as a global health problem. While many of the claims were the
same between these two articles there were some notable differences. In Petryna’s
article her main focus was on the treatment of the community and clinical subjects
that participated in trial medicine and how changes in policy could create a
better environment for them. In the World Health Watch article the main theme
was how the power of the four major pharmaceutical companies influences
policies and people to make detrimental choices. Because of differing main
themes the structure of the articles are different. In the World Health Watch
article the beginning discusses how consumerism and advertising lead people to the
“more choice façade”, which is the idea that by advertising prescription drugs
as a consumer you feel like they are giving you information for you to make a
more educated decision but in actuality it’s another method of propaganda. Then
the article continues with how the genuine scientific inquiry has been removed
from clinical trials leading to inaccurate data. Editors of the British Medical
Journal have supported this by stating that they “turn down 90% of articles
submitted because of poor research quality”(World Health Watch 281). After establishing the core problems in the
operational portion of clinical trials the World Health Watch concludes with
how these problems affect communities and individuals that participate in clinical
trials. Although the structure of both the World Health Watch and Paradigms of
Expected Failure were different and resulted in different possible solutions,
both can be viewed as beneficial analyses of a global health problem in need of
a multi-layered revolution.
Redefining Clinical Trials through Medical Anthropology
Medical
Anthropology studies problems in an organized manner that sorts observations
into categories of concepts such as perspective and power. The ethnographic
research that was produced by Global Health Watch and Petryna have discussed
these concepts through identifying individual and scientific perspectives and
the biopower relationship between the big pharma and international governments.
When researching the different perspectives of a problem there are two broad
categories that are evident; the individual perspective and the power
perspective, in this case the scientific perspective. Often in the case of
clinical trials individuals have the opinion that this clinical health care
that they are receiving is a “local social good” (Petryna). Despite the fact
that these clinical trials are present for a limited time, it is possible that
this trial medicine is the only form of health treatment that they have ever received
in their lives. This opinion spreads
throughout the community and when there is good intended dispute put forward by
a doctor about the approaches that pharmaceutical companies are taking, it is
the doctor that is shunned and not the company. The persuasive power of a local
doctor is little compared to the propaganda and advertisement put forward by
the billion dollar company facilitating the clinical trial. The scientific
perspective is held by the biopowers, i.e. the big pharma. This perspective
focuses on clinical trials as strictly a business; humans as test subjects, raw
data as the sole focus, both of which abide by a robotic corporate conduct with
limited ethical boundaries. By definition the pharmaceutical industry is a
biopower, they are playing in two markets, the field of medicine and the field
of consumerism. By intertwining these two fields there become times were profitability
and supply and demand become more important that the medical need for prescription
medications. Unfortunately this is the point that has been reached and we are
seeing the problems in the clinical trials that are outsourced.
Practical Alterations of the
Clinical Trial Industry
After studying the
outsourcing of pharmaceutical trials with a medical anthropological framework
there are a few potential changes that would benefit the humans participating in
trial medicine with little effect on the pharmaceutical industry therefore
making these changes useful as well as necessary. In Paradigms of Expected Failure, Petryna has
three recommendations which she discusses as the most important changes needing
to be implemented now. First, returning the “science of drug development”(Petryna)
back to the clinical trial industry. By returning the core principles of scientific
discovery to clinical research there will be less room for researchers to skew
data, or be faced with unethical choices. Second, Petryna encourages that less
emphasis should be placed on the discursive nature of the pharmaceutical
industry and rather an emphasis on the “behind the scene” type flaws. These
rifts that are present in places where “invisibility and visibility confront each
other”(Petryna), describe the moments where data is collected and in return a prescription
drug is created. Third, there must be comparative analysis that is done in
different nations with different “systems of accountability and law”(Petryna). Through
thorough comparative analyses that transcend the USA or EU conclusions can be
drawn on the status of clinical trials worldwide and how to better approach change
within this pharmaceutical stronghold. The world Health Watch has four alterations
that would improve the clinical trial industry. First, rewarding pharmaceutical
companies based on the health outcomes of new drugs rather than mere
projections formed from the company. Providing incentives based on the outcome of
a drug is the most reasonable change in my opinion. There should only be a
reward based on proof that a new drug is beneficial and needed. Second, policy reform
that makes it easier for generic drugs to be made and distributed to nations
that cannot afford to pay more than the cost of a generic drug. In
underdeveloped countries that cannot afford non generic medications, the
pharmaceutical industry is denying individuals to the right of health care and
a quality of life that they themselves enjoy based on an economic form elitism.
Third, to stimulate a market in which prescription
drugs are being discovered for the greatest medical needs. When only “1 percent
of the medications being produced are for neglected medical disease”(Global
Health Watch) there is an obvious disconnect between medical need and medical
extortion based on profitable afflictions, i.e. musculoskeletal aches and
pains. Fourth, to disassociate the
relationship between drug research and development (R&D) and the cost of
said medications on the market. Patients should not have to pay more for
medications because of the cost to develop said medications; because of this
principle many individuals are withheld medical treatment because of financial
limitations. I think that if these seven achievable goals were implemented in
the operational systems of the clinical trial industry it would be possible to
reform the clinical trials and re-present them in an ethical light to the
international medical community.
Reshaping Personal Opinion of Medical Anthropology
As I continue to
study global health problems it becomes clearer to me that medical anthropology
is a dynamic field that is continually shaped by the problems that it analyzes
and discusses. Specifically after studying the outsourcing of clinical trials,
I have learned that how data is gathered is equally as important as the data
itself. Prior to taking this class,
being a science major, my thoughts were under the influence that getting
accurate data is unequivocally the most important pursuit of a scientist. I can now acknowledge that in an idealized
laboratory setting this may be possible but when the social context of medicine
becomes involved there are more unknown variables than known variables
accounted for. This problem presents an opportunity for medical anthropology to
study the problem in an objective framework to come to conclusions that facilitate
cooperation between those with opposing views. It is clear to me that this form
of mediation is beneficial to any global problem where biopowers, policy
makers, and lay people are involved.
After studying this global
health problem I have concluded that the outsourcing of clinical trials at this
moment is a market in which unethical treatment of humans is occurring. I will
concede to the point that clinical data is necessary to the production of any
prescription drug, but I will not accept the inefficient systems that are
currently in place to protect human test subjects. I stand by what the Adriana Petryna and the
Global Health watch have outlined as ways to improve the outsourcing of pharmaceutical
trials, and if these changes are implemented I have no doubt that the
pharmaceutical clinical trial industry can become a useful international asset
within the medical field.
Bibliography
Petryna, Adriana
2009. Paradigms
of Failure. Springer Science+Business Media B.V. Retrieved December, 2012, from
Shukla, Abhay, et. al.
2011. Global Health Watch 3: An Alternative World Health Report. London: Zed
Books Ltd.
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