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Ethical issues that arise in the average rheumatology practice and in clinical research are often straightforward. The AMA Code of Medical Ethics and the Office Practice and Procedures Manual offer useful information.1 In research, the Protocol and Investigators Agreement spells out who you can enroll and how the trial must be conducted. But still—even when you’re doing everything correctly and listening to the inner voice that separates right from wrong, situations come up that you could never foresee.
We are a clinical practice and research center located in a major U.S. city. Many of us have been here for years. We have seen the amount of administrative tasks required to conduct a clinical trial more than quadruple and the length of a consent form grow from six pages to 30 or more. Paper documents have been replaced by electronic data capture, accompanied by a perplexing number of vendors and clinical research organizations (CROs) that oversee aspects of the trial, each with its own required training, passwords and (unhelpful) help desks. So we have it all covered, right?
Case 2
A patient who has been in a clinical trial before is offered enrollment in another study. There is a long, clearly written consent form, and a copy of it is given to the patient to take home to read.
“This is your working copy. If you like to read with a highlighter or write questions on the form, go ahead. Your doctor will review it with you at the screening examination if you decide to go ahead with it.”
The patient returns two weeks later, having discussed the consent form with her primary physician. She is accompanied by a family member, who is a nurse. The patient reports they have all discussed how the study will work. The patient, her daughter, the PI and study coordinator have a one-hour meeting discussing the study. The patient reports that she understands everything, has no questions and can tell the PI the difference between the blinded treatment arms. The consent is signed, and the screening visit is completed. Two weeks later, all results are in, and the patient returns to be randomized. But just before she is assigned to a treatment group, the patient says, “I do not want to do it if I get the pill, so make sure that I get the shot.”
Wait, you want me to make sure you get what?
Case 3
It started out like any other Tuesday morning. One of our rheumatologists was seeing a 45-year-old woman who was new to the practice. When entering the room, she found this woman crying and sitting in the chair of the examining room on a cushion she had brought from home. She reported having been in a car accident six years prior and had suffered with lower back pain and radiculopathy ever since. She had never had any back, neck or sacroiliac pain prior to that time. She had no history of psoriasis, uveitis or inflammatory bowel disease. There was no morning stiffness, and pain was exacerbated by physical activity and relieved by rest. She got no relief from large doses of non-steroidal anti-inflammatory drugs. Her pain was clearly mechanical in nature. She had been through numerous rounds of physical therapy and epidural injections, and she was currently under the care of a pain management physician who was prescribing her large doses of narcotics for years.
For reasons unknown, her pain management doctor had recently given her a trial of prednisone, 20 mg daily. When she reported to him that her pain was much better while taking prednisone, he informed her that she must have inflammatory back pain, and that she should see a rheumatologist as soon as possible so she could be started on adalimumab.
Wait, you want me to do what?
Case 4
A patient was referred by a local hospital emergency room for follow-up and treatment of “clear-cut systemic lupus erythematosus (SLE).” After examining the patient, our rheumatologist called the referring physician to discuss the situation and was told to “use the steroid of your choice.”
Our rheumatologist explained that the patient did not have SLE. It did not seem to matter, and the choice of steroid was still up to us.
Wait, what?
Case 5
A patient in her 40s who suffers with rheumatoid arthritis and fibromyalgia has been followed by a single rheumatologist in our practice for a number of years. The patient had been working full time, but for the past year or more she has been unable to work as we attempted different treatments to improve her condition. Despite the time and effort we spent completing the Family and Medical Leave Act (FMLA) and short-term disability forms for her, she lost her job.
Patients often request our aid on applications for disability, Supplemental Security Income, FMLA, handicap parking placards and protection from utility shutoffs. Some of these requests seem like patients are trying to “milk the system.”
She now presented with paperwork from the financial aid office of her daughter’s college requesting a letter from the physician treating the parent of the student, stating that the parent will never be able to work in any capacity in the future. We were told that failure to make such a statement would affect her daughter’s ability to obtain an education. Yet her condition is treatable, and her disability potentially quite temporary; she could reasonably expect to return to full function with effective treatment.
On the other hand, her disease has not yet been well controlled, and she’s been unable to work, earn an income or pay for her daughter’s education. It is our responsibility to do what we can to correct that situation.
As rheumatologists, we are often beset with paperwork requests from patients to aid with applications for disability, Supplemental Security Income (SSI), FMLA, handicap parking placards and protection from utility shutoffs. Some of these requests are legitimate, and others seem like patients “milking the system.” Doing the right thing can seem like a difficult balance.
Once you’ve considered the question carefully, don’t hesitate to draw a line in the sand.
Case 6
Other kinds of ethical dilemmas also arise—ones in which everything is done right, but still ends up feeling wrong. For years, we treated a man who had been the director of the camp that his treating physician had attended every summer as a boy. The patient was a hero to his rheumatologist and was a well-respected, well-spoken and intelligent educator. His visits were a highlight of the week. Over the years, his cognitive function declined, and detailed evaluation confirmed the presence of progressive dementia. He asked his rheumatologist to speak to his children about his need to relocate close to them so he could have more help and support. The patient and his family were grateful that his rheumatologist was the one who informed them of the diagnosis, but even now, several years later, it didn’t seem entirely right.
His rheumatologist still remembers thinking, “Wait, what? You want me to do what?”
The Right Choice
In clinical practice, our office is way ahead of the curve: We implemented electronic medical records almost a decade ago. Our clinical systems promote efficiency, quality and safety. We have organized ways of doing things. The physicians have good communication and working relationships with other providers, and everyone is on the same page—at least that’s usually the case.
Although our patients may not request specific medications the way television commercials say they should, they do ask us for things. Sometimes, the things they ask for are hard, or even impossible, because of our medical opinions, our beliefs, our egos and our faith that we, and medicine, will ultimately prevail.
In each of these cases, we were asked to do something we weren’t expecting. To comply was difficult and/or potentially unethical. Each of these situations tested our resolve to do the right thing. These cases create tension between competing priorities, including the basic bioethical tenets of patient autonomy, justice, beneficence and non-maleficence.2
Even when the best choice is clear, we may be tempted to make a different choice, especially given all the unfairness in healthcare delivery. Protocol criteria exclude patients who would benefit from study treatments. Co-pays put biologicals out of reach for many. Other practitioners and our patients may ask the impossible. So sometimes the question is less about what to do and more like, “Wait, what? You want me to do what?”
How should these cases be handled? Good communication, patience and resolve are good starting points. Don’t be afraid to ask a trusted colleague what they would do or look to the published literature for advice.1,3,4 Once you’ve considered the question carefully, don’t hesitate to draw a line in the sand. Often, the answer to difficult requests we face should be “No, I cannot do that—and here’s why.”
Donah Zack Crawford, MA, is the director of clinical trials at the Arthritis Group in Philadelphia, a member of the ARHP Programming Committee and a past ARHP representative to the ACR Committee on Ethics and Conflict of Interest.
Jill Johnson, MD, is a staff physician at the Arthritis Group.
Neal K. Moskowitz, MD, PhD, is a staff physician at the Arthritis Group.
James Udell, MD, is director and principle investigator of the Arthritis Group. He is a member of the ACR Communications and Marketing Committee, and immediate past president of The Philadelphia Rheumatism Society.
References
- The American Medical Association Code of Medical Ethics. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.page.
- Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 7th ed. Oxford University Press, 2012.
- Antommaria AHM, Bramlage KS. Enrolling research participants in private practice: Conflicts of interest, consistency, therapeutic misconception, and informed consent. AMA J Ethics. 2015 Dec;17(12):1122–1126.
- Friedman E. The Right Thing: Ten Years of Ethics Columns from Healthcare Forum Journal. San Francisco: Jossey-Bass, 1996.
Editor’s note: If you have questions, comments or a case you’d like to see in Ethics Forum, email us at [email protected].
