Rachel Straughn

November 7, 2014
BIOEN 215 AA
Assignment 4: Reflection on Ethics
Learning, research, and experimentation are all integral parts to science. In healthcare
specifically, testing medicines on living organisms and other controversial topics are faced every
day. As unsure as I felt about some ethical issues surrounding medicine, bioengineering, and
experimentation, now is as good a time as any to address these issues and decide what my
opinion regarding them is. For example, animal testing is a topic that I have avoided up until
now, for I never actually had to conduct any experiments on animals in the past. However,
when I seriously imagine myself in that situation, I believe I will be able to carry out the desired
experiment. If there is a way to improve the lives of others, humans have a right to use it, and I
believe animals are included in the resources available to achieve whatever the goal is. More
recently, I began considering the topic of human trials as it was mentioned in class. A quote
from Dr. John Semmlow included in one of the lectures which said If you are ever successful in
biomedical engineeringyou will kill someone initially shocked me, but I have had time to
ponder it and decide what Dr. Semmlow really meant when he said that. If I am going to
seriously pursue biomedical engineering, I need to understand that all products and processes
will always have a chance of failing due to a variety of factors. While I obviously never intend to
kill anybody, I know that I could someday have an integral role in the design of something that
does fail, possibly resulting in the death of a patient. Current regulations require that patients
understand all risks involved. Additionally, this product or process may have already (or will
after learning more in trials) saved countless more lives than it ended. As unpleasant as it may
sound, I believe it is necessary in healthcare and medicine to closely examine the large-scale
impact on people worldwide, and use that as a means of determining whether or not the topic
is worth pursuing.
With all of that being said, there are many regulations to guide the technically and
ethically challenging process of improving healthcare. The Food and Drug Administration has
established strict rules for identifying the risks of a product or innovation, and the consequent
steps that need to be taken to prove its safety and effectiveness. In terms of medicine, the FDA
is generally more difficult than its counterparts in other countries when it comes to getting a
device, process, or drug into the market. In my opinion, I would say things are better safe than
sorry and support the current structure of the FDAs regulations. While biomedical engineers
may have to struggle with finances and time constraints in order to pass these regulations, the
ultimate goal is to advance medicine and healthcare. One current concern regarding the FDA
and its regulations is the quick distribution of the drug ZMapp for the treatment of Ebola in
Americans. Several critical trial steps were skipped as the drug was given to human patients.
The ethics issue in this case is deciding if it is appropriate to disregard federal regulations in an
urgent medical situation. In an environment with sufficient medical resources, the average
Ebola survival rate is about 50 percent. However, it can drop to just 10 percent in areas where
there is little medical resources. In the Americans case, I do not think ZMapp was crucial to
their survival, for they were flown back to American hospitals which had sufficient medical
equipment and staff. If ZMapp were developed in a country in Africa, my opinion would be

different. The fatality rates there are much higher, thus the urgency to produce and release a
drug would be higher as well. This is just one healthcare case where situations can vary so
greatly that it is impossible to develop a standard set of regulations.
In the future, it is important that I understand what my beliefs and limits are before
beginning any work in the area of bioengineering. While many factors may determine the
success of a product (such as money and publicity), the first and foremost goal is to always
improve the health and well-being of as many people as possible. In order to achieve this goal, I
will undoubtedly have to undergo the pressure of meeting FDA standards and overcoming
other obstacles, but the end result of everything will certainly be worth it.