Vidic 2:00 pm
R06
A CHOICE ABOUT DRUG SAFETY
Xinyu Li (xil155@pitt.edu)
BACKGROUND INFORMATION
Union Medical (U Med) is a testing company designed to
certify, both the safety of the clients’ products and their
process of production. I worked at U Med two years ago and
handled a case related to a Lapatinib manufacturing
company named Deep Lifecare (DL). The company used the
basic idea of precision medicine and manufactured Lapatinib
as their product. We were retained by the client to provide a
confidential report in connection to the release of Lapatinib
into the market.
Precision medicine consists of databases such as the
Precision Medicine Initiative and the 100,000 Genome
Project and shares the information between different
hospitals and researchers in order to manufacture new
treatments and new drugs to help individuals.
The grand challenge for engineering is to develop
effective tools and techniques for rapid data analysis and
rational diagnosis in order to apply proper treatment and
screen a variety of drugs. [3]
Lapatinib (Tykerb) is a precision medicine therapy
targeting a certain protein (HER2-positive) on the surface of
a certain kind of breast cancer (HER2-positive metastatic
breast cancer). The product, Tyrosine-kinase inhibitors,
blocks the tyrosine kinase enzymes, which are important in
certain cancer cell functions. Once the protein is blocked,
chemotherapy or other therapy can more readily damage the
tumor cell. According to Johnson, in 219 of their phase III
participants, patients who used Letrozole alone had a 64%
survival rate after one year. However, patients who used
Lapatinib with Letrozole had a 72% survival rate after one
year. The survival rate after one year rose significantly. [6]
[7] [8]
Due to the effectiveness and huge market of this drug, the
foreseeable profit is high. Moreover, this therapy was neither
invasive nor life-supporting and therefore considered lowrisk. Due to its simplicity, the project was envisioned to take
only six months of development time. As a result, many
companies were working on this profitable drug at the time.
According to the standards of production, the design
reviews of the product needed the approval of both the
Project Manager, the Lead Product Development Engineer,
and the Quality Engineer.
THE SITUATION
After our drug tests on animals, the product had no
serious safety concerns. Yet, while checking the process of
production, I realized that there had been no documentation
that stated the final review had been approved by any of
DL’s representatives. I spoke with the client about the
University of Pittsburgh, Swanson School of Engineering 1
2015-11-03
missing document and suggested the client have a
conversation with the Quality Engineer for his viewpoint.
The Quality Engineer admitted that he was overworked (he
was the resource on two other, higher priority projects), and
that he would not be able to review the paperwork for
another week. Since the project had already been delayed
once to resolve a technical issue, it was six months behind
schedule, and the project team (especially the team leader)
was getting pressure from senior management to release the
product. As a result of that pressure, the team leader signed
for the release of the product, ignoring the final phase
documentation.
I was told by my test team that the risk was rather low
and by the client that the Quality Engineer would review the
paperwork once he had done the work at hand. But I still
believed that the product was not completely safe and should
not be released to the market. Because the Quality Engineer
didn’t review the paperwork, the faulty sealing of the
product during the production process may cause some
chemical reaction that might harm the patients. However
releasing the product has many economic benefits too. So I
looked at codes of ethics and previous cases to consult how
others would act in similar situations.
RELATED CASE STUDY
According to the National Society of Professional
Engineers (NSPE), professional engineers play a critical role
in advising their clients about local code requirements.
Professional engineers have a fundamental obligation to act
consistently in regards to such requirements because of
engineers’ impact on public health, safety, and welfare.
I considered several cases over the years that addressed
similar issues as those raised in this case. Many of them
presented strong points. One good example is BER Case
No.89-7: “Engineer A was retained to investigate the
structural integrity of a 60-year-old occupied apartment
building which his client was planning to sell. Under the
terms of the agreement with the client, the structural report
written by Engineer A was to remain confidential. In
addition, the client made clear to Engineer A that the
building was being sold “as is” and he was not planning to
take any remedial action to repair or renovate any system
within the building prior to its sale. Engineer A preformed
several structural tests on the building and determined that
the building was structurally sound. However, during the
course of providing services, the client confided in Engineer
A that the building contained deficiencies in the electrical
and mechanical systems, which violated applicable codes
and standards. While Engineer A was not an electrical nor
mechanical engineer, he did realize those deficiencies could
cause injury to the occupants of the building and so
Xinyu Li
informed the client. In his report, Engineer A made a brief
mention of his conversation with the client concerning the
deficiencies. However, in view of the terms of the
agreement, Engineer A did not report the safety violations to
any third party” [5].
In determining that it was unethical for Engineer A not to
report the safety violations to the appropriate public
authorities, the Board of Ethical Review realized a conflict
between two of the NSPE ethic codes: “the obligation for
engineers not to disclose, without consent, confidential
information concerning the business affairs to technical
processes of any present or former client or employer, or
public body on which they served” [6] and “the obligation
for engineer to hold paramount the safety, health and welfare
of the public” [7], which made it difficult to determine
which code was the primary obligation. By further
considering the NSPE ethic codes, another rule applied in
this situation: “Engineers shall not reveal facts, data, or
information without the prior consent of the client or
employer except as authorized or required by the law or this
code” [8]. As the third code presented, the obligation asking
engineers to hold paramount the safety, health, and welfare
of the public should be considered prior to the code asking
engineers not to disclose, without consent, confidential
information concerning the business affairs or technical
processes of any present or former client or employer, or
public body on which they serve.
The board concluded that it was unethical for Engineer A
not to report the safety violations to the appropriate public
authorities.
Similarly, the Biomedical Engineering Society Code of
Ethics also requires engineers to use their knowledge, skills,
and abilities to enhance the safety, health, and welfare of the
public. [9]
If I chose not to report on my client and let the drug enter
the market using the U Med’s certification of drug safety,
patients might be jeopardized since that the drug is 100%
safe. As a result, my action would damage the health of
public. Sign on the certification of the drug (Lapatinib) is
violating the BME code of ethic.
Moreover, the BME (Biomedical Engineering) ethic code
stated that engineers shall strive by action, example, and
influence to increase the competence, prestige, and honor of
the biomedical engineering profession.[10] Once the drug
has caused problems, the code enforcement officials may
publish the violation of codes of U Med and DL. U Med and
DL may never have any chance to make any kind of profits.
The prestige and honor of the biomedical engineers may also
be jeopardized. As a result, I need to evaluate the
consequences while consider the code of ethic.
REASONS NOT TO REPORT
Confirming that the product is safe to use with a little
flaw in documentation might provide both DL and U Med
profitable money in order to run the company. Moreover, my
supervisor would appreciate my work since I have reported
several of our clients due to some small problems and I
finally do something right. I may get fired by deteriorating
clients and company without bring any actual profit for the
company if I chose to report on my client.
Moreover, since Lapatinib is neither invasive nor life
supporting, therefore considered low-risk; the drug had also
been tested on small animals; the drug itself might not have
serious problems just the unfinished documentation proving
the drug is absolutely safe.
Furthermore, the original estimated time for this design
was six month. Due to some technical problems, the time
have expanded for another six month. Researchers were
exhausted. If I push the client to wait for another week for
the Quality Engineer to review the final phase
documentation and the Quality Engineer found a problem
throughout the project, the project would have to start all
over again. It may cost more than six month. While if I
simply chose not to report on my client, the resources and
human workforce would not be wasted and they could begin
the design of another useful drug for patients all over the
world.
On the other hand, if I chose to report on my client, and
the authorities were bribed or the authority didn’t consider
this a serious problem, I may be treated as whistle blower
and lose both my job and future possibilities to get a job.
DISCUSSION
Much of that same reasoning applies in this present case.
Under this reasoning, I had the obligation to pursue the
matter further and report to the authorities. A careful
evaluation of my situation was needed. Although I was not
completely sure about the product’s safety, I could choose to
ignore the problem, certify the safety of the DL’s product
(lapatinib) and increase profit for both U Med and DL. On
the other hand, I could follow my obligations and report the
violation to the code enforcement officials. I faced a
dilemma.
REASONS TO REPORT
There is a conflict between two of the NSPE ethic codes:
the obligation for me to protect my client’s confidential
information and the obligation for me as an engineer to
prioritize the safety of the public [6] [7]. After deeper
research on the codes of ethics, I found a code that stated
“engineer shall not reveal facts, data, or information without
the prior consent of the client or employer except as
authorized or required by law or NSPE Code” [8].
Therefore, the second code applied as a more primary
obligation.
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Xinyu Li
the public interest, it was worth doing. I chose to report on
DL for the unfinished product. By report the violation of
codes to appropriate public authorities, I maintained the
safety, health and welfare of public. Patients would not be
harmed and both U Med and DL would endure less
economic damage than the collapse of reputation and all
future business.
OTHER’S OPINIONS
My refusing to ignore the problem with documentation
and turn to appropriate public authorities may be considered
as whistleblowing.
“Our society could not function if individuals routinely
broke their agreements.” Most individuals obey the fidelity
to their employer or client if not violate the code of ethics.
However, in some cases the interests of public may be
different from the interest of individuals’ employer or client.
“For government workers, ones professional duty sometimes
includes a legal and moral duty to report violations of
international law, especially if the violations are being
covered up” [11].
For example, in Prism, Edward Snowden reported the
unethical actions of the US government. (The individual
responsible for one of the most significant leaks in US
political history is Edward Snowden, a 29-year-old former
technical assistant for the CIA and current employee of the
defense contractor Booz Allen Hamilton.) Edward Snowden
arrived in Hong Kong from Hawaii at 2013. He carried four
laptop computers that enabled him to gain access to some of
the US government's most highly classified secrets. He then
unveiled some unethical actions, top secrets, of US
government. I interviewed him about how did he decided to
become a whistleblower and the reasons behind this. “When
you are in a position of a privileged access like a systems'
administrator for the sort of intelligence community
agencies, you are exposed to a lot more information on a
broader scale than the average employee. You should always
carefully evaluated every single document you disclosed to
ensure that each was legitimately in the public interest," he
said. "There are all sorts of documents that would have made
a big impact that you didn't turn over, because harming
people isn't the goal. Transparency is. The problems you see
kind of buildup, and you realized that these things need to be
determined by the public not by somebody who recently
hired by the government "[12].
His action is appreciated by most people since it’s the
justice. In 2007, a survey commissioned by the US
Democracy Corps of 1,014 “likely voters” revealed that 70
percent supported whistleblower protections and 40 percent
stated that they would be much more likely to vote for a
Congress that enacts such legislation [13]. Whistleblowing is
considered as the cause of justice and the right thing to do in
this kind of situation.
REFERENCES
[1] “Engineer Better Medicines” NAE Grand Challenges for
Engineer
(blog
entry)
http://engineeringchallenges.org/9129.aspx
[2] S Johnston, J Pippen Jr, X Pivot, et al. (2009) “Lapatinib
combined with letrozole versus letrozole and placebo as
first-line therapy for postmenopausal hormone receptorpositive metastatic breast cancer”. J Clin Oncol. (published
journal) DOI: 27(33):5538-46, 2009.
[3] KL Blackwell, HJ Burstein, AM Storniolo, et al. (2010)
“Randomized study of lapatinib alone or in combination
with trastuzumab in women with ErbB2-positive,
trastuzumab-refractory metastatic breast cancer. J Clin
Oncol.”(printed article) DOI:28(7):1124-30, 2010.
[4]KL Blackwell, HJ Burstein, AM Storniolo, et al. (2012)
“Overall survival benefit with lapatinib in combination with
trastuzumab for patients with human epidermal growth
factor receptor 2-positive metastatic breast cancer: final
results from the EGF104900 Study”. J Clin Oncol.
(Published Journal) DOI: 30(21):2585-92, 2012.
[5] E. Bechamps, J. Browne, H. Koogle, L. manning, P.
Pritzker, H. Streeter, R. Haefeli.(1989) “Duty To Report
Safety Violations-Case No. 89-7” BER Case No.89-7 (online
case study) http://www.nspe.org/sites/default/files/Ber897.pdf
[6] “Code of Ethics for Engineers” (2007) National society
of Professional Engineers Section III.4. (Online website)
http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/
CodeofEthics/Code-2007-July.pdf
[7] “Code of Ethics for Engineers” (2007) National society
of Professional Engineers Section II.1. (Online website)
http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/
CodeofEthics/Code-2007-July.pdf
[8] “Code of Ethics for Engineers” (2007) National society
of Professional Engineers Section II.1.c (Online website)
http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/
CodeofEthics/Code-2007-July.pdf
[9] “Biomedical Engineering Society Code of Ethics” (2004)
Biomedical Engineering Society Biomedical Engineering
Professional Obligations NO.1
(online
pdf)
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics(2).pdf
[10] “Biomedical Engineering Society Code of Ethics”
(2004) Biomedical Engineering Society Biomedical
Engineering Professional Obligations NO.2 (online pdf)
CONCLUSION
Considered the consequences that the reputations of U
Med and DL might be harmed if the product (Lapatinib)
harm individuals. Moreover, More than three codes of ethic
required me to use my knowledge, skills and abilities to
enhance the safety, health and welfare of public. My action
might be considered as whistle blower. But as long as it was
the action that supported by justice and was legitimately in
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Xinyu Li
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics(2).pdf
[11] “Whistleblower Ethics” (2013) America Vol. 209 Issue
7, p5-5. 1p (published article) DOI:0002-7049
[12] “NSA whistleblower Edward Snowden: 'I don't want to
live in a society that does these sort of things' ” (2013). The
Guardian
(online
blog)
http://www.theguardian.com/world/video/2013/jun/09/nsawhistleblower-edward-snowden-interview-video
[13] US Democracy Corps (2007)
ADDITIONAL SOURCES
C. Beck, J. Branch, D. O’Brien, L. Patterson, R. Andreoli, M.
Usmen, S. Sundler. (2014) “Public Health and Safety-Delay
in Addressing Fire Code Violations” National Society of
Professional Engineers Case Studies No. 13-11 (Online pdf)
http://www.nspe.org/sites/default/files/BER%20Case%20No
%2013-11-FINAL.pdf
J. Monzon, A. Monzon-Wyngaard (2008) “Professional
ethics in Biomedical Engineering Practice and research”
IEEEE EMBS Conference (Published article) DOI: 978-14244-1815-2/08
K.
matthewsm
(2012)
“What’s
Ethical
about
Whistleblowing?” The Corporate Social Responsibility
Newswire
(online
blog)
http://www.csrwire.com/blog/posts/280-what-s-ethicalabout-whistleblowing
“To release or not to release: an engineer's perspective”
(2010) Stanford Biodesign ethic case studies (online pdf)
http://biodesign.stanford.edu/bdn/ethicscases/EthicsCase21.p
df
ACKNOWLEDGEMENTS
Writing Center instructor, helped me to set up my scenario
and fixed some grammar. Mier Chen, University of
Pittsburgh student, help me look through my essay and make
suggestions.
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Xinyu Li
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