ENGR0011/0711 Section
Group #
A CHOICE ABOUT DRUG SAFETY
Xinyu Li ()
1
Xinyu Li
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 workedat U Med two years ago and handleda 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, blocksthe 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 foreseeableprofit is high. Moreover, this therapy was neither invasive nor life-supporting and therefore considered low-risk. 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 neededthe approvalofboth 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 missing documentandsuggested 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 haddone 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 lookedat 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 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 appliedin 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.
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.Acareful 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’sproduct (lapatinib)and increase profit for both U Med and DL.On the other hand, I couldfollow my obligationsand 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.
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 hascaused 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 wereexhausted. 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.
OTHER’SOPINIONS
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.
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 thatsupported by justice and was legitimately in 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 andDL would endure less economic damage than the collapse of reputation and all future business.
REFERENCES
[1] “Engineer Better Medicines” NAE Grand Challenges for Engineer (blog entry)
[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 receptor-positive metastatic breast cancer”. J ClinOncol. (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 ClinOncol.”(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 ClinOncol. (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)
[6] “Code of Ethics for Engineers” (2007) National society of Professional Engineers Section III.4. (Online website)
[7] “Code of Ethics for Engineers” (2007) National society of Professional Engineers Section II.1. (Online website)
[8] “Code of Ethics for Engineers” (2007) National society of Professional Engineers Section II.1.c (Online website)
[9] “Biomedical Engineering Society Code of Ethics” (2004) Biomedical Engineering SocietyBiomedical Engineering Professional Obligations NO.1
(online pdf)
[10] “Biomedical Engineering Society Code of Ethics” (2004) Biomedical Engineering Society Biomedical Engineering Professional Obligations NO.2 (online 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)
[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)
J. Monzon, A. Monzon-Wyngaard (2008) “Professional ethics in Biomedical Engineering Practice and research” IEEEEEMBS Conference (Published article) DOI: 978-1-4244-1815-2/08
K. matthewsm (2012) “What’s Ethical about Whistleblowing?” The Corporate Social Responsibility Newswire (online blog)
“To release or not to release: an engineer's perspective” (2010) Stanford Biodesign ethic case studies (online pdf)
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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