Budny 10:00
L21
ETHICS IN BIOMEDICAL RESEARCH AND NEUROSTIMULATION
Michael Lynch (mkl20@pitt.edu)
EXCITING NEW
TECHNOLOGIES ARE EMERGING
Everyone who will read this has experienced, to varying
degrees, a headache. Whether it be a migraine or the nagging
throb that comes with the common cold, the sensation can be
debilitating and leave you bedridden for hours. However,
few people are aware of a terrible chronic affliction known
as a cluster headache. Those who suffer from chronic
headaches can suffer from multiple episodes a day that leave
them completely incapacitated. Nicknamed “suicide
headaches” because of their intensity, patients are typically
unable to function properly. It is said that over 600,000
people across Europe suffer from this condition that
drastically reduces quality of life [1]. As a future
bioengineer, I am very interested in the medical aspect of
engineering and I cannot think of a more noble line of work
than researching and working to lessen, or even eradicate,
some of the hardships people must suffer through every day.
My immediate and extended family suffers from migraines
and I have seen everyone from my aunt to my 9 year-old
cousin vomiting and lying in bed for hours because of their
ailment. I cannot fathom the pain that must accompany a
cluster headache. A process developed by Autonomic
Technologies, Inc. known as neurostimulation is at the
cutting edge of discovering a way to alleviate this pain [1].
A fairly routine oral surgery is performed that leaves no
visible scars in which a miniaturized device is implanted and
when a patient feels an attack approaching, they hold up a
small electronic remote to their cheek that begins the process
of neurostimulation [1]. Innovations like this excite me
greatly about the future I could have in this field.
BACKGROUND INFORMATION ON
CLUSTER HEADACHES
The cluster headache is technically classified as a
migraine. Migraines are the most common disabling
headache and are said to affect 11% of the population in the
United States and Western Europe. The World Health
Organization classifies cluster headaches, or severe
migraines, at the highest level of disability (Class VII). That
classification is higher than that of Congestive Heart Failure
as well as Parkinson’s and Alzheimer diseases [2].
Symptoms include a sharp burning on one side of the head
from the neck to temple, swelling around the eye, and
excessive tearing. Scientists are not completely sure what
causes them but they believe there is some correlation to the
brain’s sudden release of serotonin [3]. Cluster headaches
are said to affect 1 in every 1000 people, primarily men [4].
University of Pittsburgh, Swanson School of Engineering 1
2013-10-29
Considering that chronic migraines and headaches are
prevalent in my gene pool, and given that I am a man, I am
at a greater risk for this condition than most. I fully support
the research that is being conducted at ATI and think that
more funding and attention need to be paid to cluster
headaches and migraines on a whole [1]. I feel that
conditions like this are overlooked because they are not fatal
but that does not mean they should be taken lightly. They are
affecting millions of people throughout the world. I am
currently studying to become a bioengineer and I know if I
was to begin suffering from cluster headaches, which is very
conceivable as they are most common among males in
adolescence and middle age, I would not be able to continue
with my studies [3]. Attacks are cyclical and can occur
frequently for days, weeks, or even months and are followed
by a period of remission. Attacks occur more frequently
during the fall and spring, and alcohol and variations of
temperature can trigger and episode during a cluster period
[4]. I am an adolescent male, headaches run in my family, I
study at the University of Pittsburgh (a city notorious for
unpredictable weather) for fall and spring semesters, and I
am on a college campus where alcohol is consumed in
heinous amounts. Not to appear selfish, but I am a zealous
supporter of this research because of how quickly I could be
directly affected by these headaches. Cluster headaches
often disrupt patient’s sleep as well, adding another to
dimension to how devastating an attack can be. The pain on
the side of your head and around your eye is so intense that,
during a period of attacks, waking up multiple times a night
is common. However, there is hope for sufferers of cluster
headaches in the form of a new, highly innovative combative
treatment for patients, known as neurostimulation.
BIOENGINEERING AND CODES OF
ETHICS
Biomedical engineering is arguably the field of
engineering most entrenched with ethical dilemmas. Due to
its heavy involvement and entwinement with the medical
field, biomedical engineers are faced with tough decisions
while conducting research and working in the industry.
According to the National Society of Professional Engineers,
engineers must first and foremost hold the safety and health
of the public above all else. Whether it be a civil engineer
designing a bridge that must adequately support the weight
of rush hour traffic, or a biomedical engineer safely
researching the effectiveness and safety of a new prosthetic
limb, the goal paramount to all else is the welfare of the
Michael Lynch
public [5]. Engineers must also act in a way that generally
upholds the nobility and usefulness of a profession as a
whole [5]. Biomedical Engineers follow a more specific
code as well that delves deeper into the world of medicine.
The patient’s rights and wishes become extremely important
as they are the primary concern and everything is done to
benefit them [6]. No matter what tenet of engineering being
practiced, it should never be about personal gain or
notoriety. The client, or patient, is whom we aim to serve.
Another important aspect of the engineer’s code of ethics is
the responsibility to avoid deception at all costs [5].
Dishonesty is unacceptable in professions on a whole, but
dishonesty in engineering can lead to the death of many,
which ties into to the first point of the code, to keep the
safety of the public above all. If one were to sign off on a
project without disclosing certain risks or weaknesses people
could be seriously harmed. Engineering is not an easy job.
Neither is the path one must endure to earn such a degree.
But the satisfaction of helping people day in and day out and
solving the problems of the modern world, a job that can
only be done by following a strict code of ethical and moral
principles, is worth every minute of hard work that must be
put into such a noble profession.
engineer to conduct morally sound and effective testing on
animals as long as he follows the guidelines. The easiest
was to stay within the code is too hide nothing that is being
done in your lab. Anytime information is withheld your
reputation could be blackened, even if it was not intention to
attempt to deceive anyone. Neurostimulation is not tested on
animals as much as pharmaceuticals, but the risk of
appearing inhumane and immoral still looms. Research is
quite commonly simply a process of trial and error, and error
implies the notion of something going wrong in the test
subjects. When a new finding is released it is usually due to
decades of prior research and the question on the minds of
those opposed to the testing of animals is what is it that
happened to the test subjects where things did not go
according to plan. Another aspect of neurotechnology that is
heavily scrutinized is whether or not the new technology will
alter your state of mind when put into effect. James Cavuoto
touches on the concept of a transformed mental state in his
article and outlines whether or not the altering of patients
minds is indeed ethical [8]. Stimulating the brain in order to
release certain chemicals to feel relief, as in
neurostimulation, is technically altering one’s conscious
state of mind and chemical makeup in general. The
implanting of a device in your brain that essentially changes
who you are is a terrifying prospect, and if not handled with
extreme caution could be viewed as extremely unethical.
NEUROSTIMULATION AND
ANIMAL TESTING
STATISTICS ON ANIMAL TESTING
The neurostimulation that is being developed by
Autonomic Technologies, Inc. appears to be almost
completely free of downsides or ethical dilemmas, but
research involving the brain is usually accompanied by a
certain degree of controversy. As Ben Pless, the President
and Chief Executive of ATI stated, “We hope that our work
may one day offer relief to tens of thousands of severe
headache sufferers” [4]. Public Statements issued by
corporations and research institutes like ATI commonly
exude certain characteristics. They are extremely positive
and uplifting, but can also be very vague which is a
dangerous concept. As engineers, we are instructed never to
deceive, which includes omission of certain unfavorable
details [5]. One of the major criticism of research in the
biomedical field is the use of animal test subjects. Dr.
Rachel Hajar wrote a piece on the prescence of animal
research in the biomedical field and outlined some of the
beliefs held by those opposed to animal research. She stated,
“Those against, contend that the benefit to humans does not
justify the harm to animals. Many people also believe that
animals are inferior to humans and very different from them,
hence results from animals cannot be applied to humans”
[7]. The ethical question of animal research is very derisive,
especially in recent years with the emergence and growing
power of animal rights groups. The testing of animals
behind closed doors is a slightly disturbing concept but,
when done right, does wonders for the advancement of
biomedical technologies. It is quite feasible for a biomedical
Some staggering statistics have been compiled on the
subject of animal testing. According to the Animal Welfare
Association 19.5 million animals are killed each year in
research [9]. Granted, one must take this number with a
grain of salt as the source is undeniably biased, but even if
half of that number is true it is still an astounding statistic.
Not only that but 43% of adults are opposed to the idea of
animal testing. These are numbers that must be considered
when using animals in research. Such high percentages
cannot be ignored; the opinion of the public must be upheld.
Altogether medical research relies heavily on the testing of
animals and although it is met with some resistance I don’t
think anything will change in the foreseeable future.
SOURCES OF GUIDANCE
When I have finally become an engineer and I am faced
with a moral conundrum I know there is somebody that I
will consult even before the formal code of ethics. My sister
has been an engineer for several years now and I know that
her opinion would greatly influence my thoughts and
opinions on what I see as ethical or unethical. It is very
important to consult the advice of a more seasoned veteran
when faced with tough decisions as a young worker. They
have been in your shoes and the experience of another
engineer is often significantly more influential and useful in
2
Budny 10:00
L21
helping one to determine the right thing to do. The
community of engineers is its own best resource and should
be utilized whenever possible. Another source of guidance
that I will use, especially in the field of bioengineering, is
doctors and other researchers. Because of how the fields so
frequently overlap, a doctor’s advice would be invaluable
they are also held to a very high standard of honesty. Similar
to engineers, doctors are a servant to the public and put
others first and foremost.
Proceed With Caution
When the majority of people think of engineering as a
profession, their mind does not imagine engineers in the
medical field facilitating breakthroughs that help hundreds
of thousands of people. They absolutely do not think of a
profession that is so charged with difficult ethical scenarios.
We are approaching the dawn of a new era that will bring
rise to technologies that we would not have dreamed of just
decades ago. But with all this exciting new technology at
our fingertips we must remember to proceed with caution.
Ambition and drive without caution can lead to bad
decisions regardless of motives. Heads can become clouded
when such a promising future awaits us with many
opportunities to help the people around us. Still, the code of
ethics must be always at the forefront of a working engineers
mind. We must “conduct ourselves honorably, responsibly,
ethically, and lawfully so as to enhance the honor,
reputation, and usefulness of the profession” [5]. With
biomedical research we must not only adhere to these rules
but also the code of ethics for medical research. Engineering
is an extremely important profession and without the
problem solvers of this world, our quality of life would be
incomparably lower. The field of bioengineering is one of
servitude to the people, and with their interests fueling us,
we can work together to create a brighter future.
REFERENCES
[1] K. Perry. (2013). “ATI Neurostimulation System Shown
to be Highly Effective in Treating Cluster Headache –
Results of a Multi-Centre European Study.” Business Wire.
(Online Article).
http://www.businesswire.com/news/home/20130
204006697/en/ATI-Neurostimulation-System™-ShownHighly-Effective-Treating
[2] M. Bellack. (2012). “Autonomic Technologies Initiates
European Study of Novel Neurostimulator for the Treatment
of Sever Migraine.” Reuters. (Online Article).
http://www.reuters.com/article/2012/02/27/idUS75595+27Feb-2012+BW20120227
[3] L. Jasmin. (2012). “Cluster Headache.” Medline Plus.
(Online Article).
University of Pittsburgh, Swanson School of Engineering 1
2013-10-29
http://www.nlm.nih.gov/medlineplus/ency/article/000786.ht
m
[4] C. Nordqvist. (2009). “What Are Cluster Headaches?
What Causes Cluster Headaches?” Medical News Today.
(Online Article).
http://www.medicalnewstoday.com/articles/172387.php
[5] (2007). “NSPE Code of Ethics for Engineers.” NSPE.
(Online Article).
http://www.nspe.org/Ethics/CodeofEthics/index.html
[6] (2011). “Biomedical Engineering Society Code of
Ethics.” BME Code of Ethics. (Online Article).
http://ethics.iit.edu/ecodes/node/3243
[7] R. Hajar. (2011). “Animal Testing and Medicine.” NCBI.
(Online Article).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3123518/
[8] J. Cavuoto. (2012). “Medical Mindset, Social
Conscience.” Neurotech Business Report. (Online Article).
http://www.neurotechreports.com/pages/publishersletterMay
09.html
[9] (2012). “Animal Testing Statistics.” Animal Welfare
Association. (Online Article).
http://www.statisticbrain.com/animal-testing-statistics/
ACKNOWLEDGEMENTS
I would like to thank the Librarians at Bevier for always
being available and willing to help. I would also like to
thank Dr. Budny for assigning yet another wonderful paper.