ENGR0011/0711 Section

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MY ETHICAL DILEMMA INVOLVING CLINICAL TRIALS FOR THE ARGUS II RETINAL PROSTHESIS SYSTEM

Kate Lundy ()

1

Kate Lundy

INTRODUCTION

Engineers have the power to shape our future. Their innovations determine how we as a society live our lives. The whole community depends on and has to put their trust into the engineers’ ability to create functioning methods, technology, and structures which our lives revolve around. In order for engineers’ designs to operate smoothly, engineers must be logical, careful, and thorough. Although it is important for them to work methodically, it is crucial that they also work ethically. Engineers have a great amount of power, for their decisions can affect many people’s lives; with great power comes great responsibility. Therefore, it is important that all engineers work in the best interests of society.

As a biomedical engineer, I feel as though it is my duty to keep the public healthy and safe. In order to do this, I must have standards that guide my decisions. Although I am generally confident in knowing what is right or wrong, there are times when I am faced with ethical dilemmas. In these situations I have to view my options and weigh out the pros and cons of each one in order to come up with an action plan that I feel comfortable with.

MY SCENARIO

Recently I have been faced with an ethical dilemma in my engineering field. For the past few months, my company,BioTech, has been trying to recruit patients for a clinical trial in order to test out the effectiveness and symptoms of the Argus II Retinal Prosthesis system. This new device is the first implanted technology to help adults with severe retinitis pigmentosa, which is an inherited disease that causes blindness due to the degradation of photoreceptors in the retinas [1][2].

Before my company began to search for patients to enter our study, my boss, Dr. X, has taught me and my fellow colleagues the specific procedure we need to follow in order to decide whether or not a patient is acceptable for the clinical trial.More specifically, we need to make sure each patient fits a list of requirements.These included being at least 25 years of age, diagnosed with retinitis pigmentosa, have had some type of vision, having little to no light perception, no electroretinographic response, and functional ganglion cells or optic nerve [2][3]. Patients were not recruited if they had any disease that “affected retinal or optic nerve function, ocular structures, or conditions that could prevent successful implantation, and any inability to tolerate the implant surgery or medical/study follow-up” [2].My boss made it very clear about the importance of following the protocols, for straying from them could affect the validity of the trial and risk the patients’ health. After going through the training process, I felt comfortable and confident in finding qualified candidates for our study.

As our enrolling process began, Dr. X informed us not to expect many contenders for our trial. He explained that retinitis pigmentosa is a rare disease only affecting about 1 in 4000 people [4]. Furthermore, not everyone who qualifies may want to be a part of the study.

However, the recruiting process was even slower than my boss expected. As months went by and fewer people qualified or were willing to participate in the trial, Dr. X was getting more and more anxious. A couple of times I overheard him talking to other coworkers about our slow situation and I could hear the frustration in his voice. One time I even heard him mumbling to himself about thinking of other possible ways to get more people into the trial. At the time, I didn’t think much of it because of course all my colleagues and I were thinking and wishing we could start the trial soon, but that didn’t mean we were going to bend the rules in order to do so.

My ethical dilemma came about when my boss recruited three patients in a week, which was a huge jump from our one or maybe two recruits in a month. Two of the patients he took in were two that I interviewed and didn’t think fit the strict requirements for the clinical trials. When I told Dr. X I already looked at the patients, and thought they weren’t eligible, he told me he double checked all the patients and assured me that when he looked over their credentials, they fit the requirements. I began to doubt myself and I immediately thought I must have read something wrong or missed an important detail in the patients’ data. I have known my boss for quite a while and have always looked up to him as a professional, intelligent, and ethical engineer. Although I had great confidence that my boss would not just accept patients who weren’t qualified into his clinical trial, something didn’t feel right. In my head, I went over my interviews with the patients and tried to remember going through their papers that I believed showed their incompatibility with our trial. The more I thought about it, the more I felt uneasy and questioned my boss’s actions, for I was sure I didn’t misjudge any of the data. I then decided to look at the facts instead of relying on my memory.I gathered the data I collected for the two patients and reviewed them. I couldn’t find any mistake my boss claimed I’ve made.

I was then faced with a new challenge: what do I do now? Do I let it go and ignore the fact that my data doesn’t match my boss’s conclusion? Do I show Dr. X my data and confront him? Do I tell the patients they should withdraw from the study? Millions of questions, plans, and outcomes were rolling through my head. I needed to find some guidance as to what I should do.

SEARCHING FOR A SOLUTION

Over the following few days, I did some research on ethics to help me figure out how to handle my situation. I looked at factual sources that listed the codes of ethics in engineering and magazines that talked about the importance of ethics. But first, I turned to the T.V. series Grey’s Anatomy for direction.

Grey’s Anatomy Relates to My Situation

Although it is important to follow rules, ethical decisions cannot just be determined by them. Ethics are not just black and white where a set of rules can point out what is right and wrong in every situation. A few Grey’s Anatomy episodes that demonstrated a similar situation to mine reminded me of this. In these episodes, Derek asks Meredith “How is it that you don’t know the difference between right and wrong?” [5]. Without hesitation, Meredith responds “I don’t think thigs are simply right or wrong. Things are more complicated than that!” [5]. This discrepancy of legal ethics versus moral ethics is why I decided to first take a look at Grey’s Anatomy before reading the codes of ethics.

While I re-watched the episodes of Grey’s Anatomy that pertained to my case, I kept in mind that it is fiction. However, even though it is a fictional show, it has some realistic elements and it also proposes some great ethical scenarios.

In the episodes I watched, the Seattle Grace Hospital conducts a clinical trial for a new treatment to help Alzheimer’s disease [5]. In order for the clinical trial to be valid, patients are randomly assigned to either the experimental drug or a placebo [5]. Adele, who is the wife of Dr. Richard Webber, is a patient in the clinical trial and was randomly assigned to get the placebo [5]. Knowing this, Dr. Meredith Grey switches Adele’s envelope, which contains the instructions to give Adele the placebo, for one that instructs the surgeons to give her the experimental drug [5]. The question then becomes whether Dr. Grey’s unethical decision by law was in fact right or wrong.

I wasn’t quite sure if I agreed with Dr. Grey’s decision until Alex, who witnessed Meredith’s unethical act, confronted her and talked to her about the possible consequences that she may face and how her action will affect other people [5]. On one hand, she was helping a friend’s loved one, but on the other, she invalidated the trial and as Alex said, her actions changed “the life of the guy who was supposed to get the drug and now won’t” [5]. Moreover, Alex made the point that by illegally switching data in the trial, Meredith risked all the doctors in the hospital being blacklisted by the FDA [5]. These facts made it clear to me that I didn’t agree with Dr. Grey’s decision

Grey’s situation isn’t exactly like mine. For one thing, Grey tampered with the trial in order benefit a specific person, where as in my case, my boss tampered with the data in order to potentially benefit a group of people in the long run [5]. Furthermore, all the patients in the Alzheimerclinical trial were eligible to be in the trial and the questionable ethical misconduct was later in the process of the trial [5]. Contrastingly, my company hasn’t begun the clinical trial andthe unethical action affects the set-up of the study, which invalidates a bigger portion of the trial. Even though there are some differences, in both casesdata was changed unethically. In addition,the unethical decision in both scenarioscould affect not only the person who did it, but also their colleagues, the organization they work for, the patients, and future patients who may use the drug or device.

Grey faced several consequences as a result of her actions. She was frowned upon by her colleagues, she was suspended from her job, and her husband left her out of disappointment [5]. Although these consequences may not be one hundred percent realistic, the episode made it clear that things could have turned out a lot worse and that some sort of consequence will follow unethical behavior. Being able to watch how an unethical situation unfolds, even if it isn’t completely accurate, made me contemplate all the possible outcomes of my boss’s action and the consequences along with it. I imagined the FDA finding out about Dr. X’s action and shutting down our trial, and possibly the company, leaving me and my colleagues unemployed. I worried that even if we weren’t caught by the FDA, all of the people who put their trust into our invalid study would be affected and many medical problems could arise. All of these concerns were followed by the thought that I can’t let this happen.

The Ethical Laws Stated by the NSPE and BMES

After watching Grey’s Anatomy, Ilooked at more professional sources to see if my feelings about Dr. X’s behavior matched the rules of ethics in engineering. I read over theNational Society of Professional Engineers (NSPE)’s and the Biomedical Engineering Society (BMES)’s codes of ethics to familiarize myself with the laws of engineering ethics and gain confidence in my beliefs.Within these sources I found rules that applied to my situation and confirmed that what Dr. X did was unethical. The first rule that stood out to me was written in both the NSPE and BMES codes of ethics. It stated that engineers must work in the best interest of the public’s safety, health, and welfare [6][7]. As I read this, I immediately asked myself if what my boss did was for the “safety, health, and welfare of the public” [6][7].Sure his actions may have allowed the product to be available for public use more quickly and potentially help many patients, but his actions more likely would hinder the public because the trial would be illegitimate. All the data would be skewed and not accurately represent the Argus II Retinal Prosthesis system’s effects on the patients who would actually be using it out in the real world. To further emphasize the wrong doing of my boss, the NSPE code of ethics clearly states that engineers “shall not distort or alter the facts” [6]. If I don’t take action, our clinical trial would be misleading andthe NSPEalso notes, “Engineers shall avoid all conduct or practice that deceives the public” [6]. After going through the codes of ethics, I knew I must talk to Dr. X about his unethical action and prevent unqualified patients from enlisting into the trial, but I still didn’t know how to come about it.

The O Magazine Gives Me Confidence

I began looking through articles and magazines on ethics to help me figure out how I should approach my situation. One of the magazines I picked up was an old Oprah Magazine. To my surprise,as I was flipping through the magazine, I came across an article on ethics. This article not only stressed the importance of ethics, but it also proposed how to train yourself to do the right thing in ethical dilemmas [8]. The method used is known as Social Fitness Training which involves “role-playing morally challenging situations” [8].According to this article, the most important part of the process is to “identify the thoughts that might prevent [you] from speaking up” [8]. I knew that I had many doubts about confronting my boss, and was worried about what may happen if I did. So, as suggested by this article, I jotted down all the negative thoughts I was having.

I continued to read the article for more guidance, and at the very end of the article,a five step process was given to help people like me become more confident in having a tough conversation with someone [8]. The steps were as follows: One,describe your situation in a couple sentences and imagine the discussion you must have with the person involved in your dilemma [8]. Two, write down your thoughts and doubts when thinking about having the conversation with the other person [8]. Three, question each thought’s likeliness of actually being true and list the possible outcomes that are most probable [8]. Four, come up with positive things to say to yourself as you start the conversation [8]. Five, visualize and practice having the conversation in your head [8]. I followed these steps, visualizing how I would approach Dr. X and what I would say. I imagined as many possible outcomes I could, good and bad, and I even rehearsed my speech in the mirror until I felt confident.

MY DECISION AND THE OUTCOME

After much research and internal debate, I finally felt prepared to approach my boss. I decided to respectfully present my data to Dr. X and show my confusion as to why the patients were enrolled into the trial. Once again, he rejected my data and told me to trust his judgement. However, I kept persisting and I expressed my concern for the trial. I proposed testing the patients a third time to confirm their results. I also explained that if we are not careful in choosing patients, and the patients are indeed not fit for the study, several consequence could follow. The FDA could find out and shut down our trial and possibly our company, leaving us without jobs. Furthermore we would be putting not only the trial patient’s health at risk, but also the Argus II’s future patients. I ended my argument with the fact that speeding up the process of enrollment now is not going to help the public, but instead only harm the public. Dr. X responded by saying he would look into the patients data again.

My speech must have reached Dr. X’s conscience because the following day, he told me that he misread part of his data and I was right that the patients were incompatible with the trial’s strict requirements. He informed me that he withdrew the patients from the study and thanked me for approaching him with the concern.

ADVICE TO OTHERS

When faced with an ethical dilemma, it is hard to make a decision that you feel confident in and comfortable doing. Many engineers have faced pressing situations and had to make the choice of acting or not acting. If you are faced with a situation that makes you question what is going on, I recommend first weighing out the pros and cons of doing something about it versus just letting the situation go. Furthermore, think about who is affected by the situation directly or indirectly. If you choose to act and are having difficulties coming up with something to say or are not sure how to approach the other person in your situation, I would suggest talking to a friend or family member about your dilemma. Even talking in the mirror can inspire ideas of how to start the conversation. Going through the steps proposed in the Social Fitness Training program can also be beneficial.

Since engineers play such an important role in society, they have a great responsibility to work in the best interest of the public.People put their lives and trust into engineers’ hands, and engineers must work ethically to maintain their trust.

REFERENCES

[1] FDA. (2015). “Argus II Retinal Prothesis System – H110002.” U.S. Food and Drug Administration. (online article).

[2] A. Ho., et al. (2015). “Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.” Ophthalmology. (online article).

[3]S. Rizzo., et al. (2014). “12-Month Outcomes from a Single-Study Center.” American Journal of Ophthalmology. (online article).

[4]M. Jumper. (2013). “FDA Approves World’s First Artificial Retina.” American Society of Retina Specialists. (online news report).