Case Study on Patients Included in Experiment Drug Treatments
Lee Christensen, Alex Aden, Josh Billerbeck, Theresa Grote, Austin Studer
Learning Outcomes:

List the possible ethics theories in the case study.

List the different agents who are affected in this scenario.

Analyze the rights held by the stakeholders.

Discuss the consequences in administering the experimental drug to Louise.

Discuss the consequences if the experimental drug is not administered to Louise.

Select the action set for the stakeholders involved in the scenario.
Sandra is a well respected physician at one of the leading medical institutions in the
nation. This case study revolves around a very personal case for her and many other
physicians around the nation.
Louise, a scientist and avid runner in her 50s, first noticed the strange pangs under her
right ribcage a few weeks before we met. Her CAT scan revealed a liver so riddled with
islands of tumor that the radiologist called them “too numerous to count.” None of the
standard surgical, radiologic or chemotherapy treatments would help, and her doctor told
her that she had two, maybe three, months to live.
Louise sought out a second opinion at our hospital. I swallowed hard before going into
her exam room to summarize my findings. It was, and still is, not easy for me to tell
patients they are dying.
But her reaction surprised me. Instead of a grim silence or even tears, she simply smiled.
“I want to become a grandmother,” she said, looking over at her pregnant daughter-inlaw, who was just beginning to show. Louise knew she was going to die from the cancer;
she wanted only to live long enough to see her grandchild born.
For the rest of the afternoon, Louise’s plea played over and over in my mind. I wanted to
offer something — anything — that might increase her chance of survival by a few
months. No standard therapy would work, so I wondered if a clinical trial, a study of a
new drug or treatment, might hold some promise.
I also knew that every research trial maintained strict criteria for enrollment and that
Louise was hardly the ideal candidate and might not qualify. While there were trials that
accepted patients with diminished liver function, her organ was on the precipice of all-out
failure. If she took part in a trial and her liver failed, she could muddy the data, perhaps
even alter the trial’s outcome. The investigators would assume that liver failure was a
side effect of the experimental drug, a complication potentially so significant it could
prevent future use of the drug. But the reality was that her liver failure would have
probably had nothing or very little to do with the drug; it would have been the result of
not having had enough normal liver to begin with.
Nonetheless, an experimental drug seemed to me to be my patient’s only hope. I called
up a medical oncology colleague and was ready to consider violating the entry rules of a
clinical trial. “She just wants to see that child born,” I said to my colleague. “I wonder if
we could finagle things so she could be in a trial?”
It turns out that I am not the only doctor who has considered bending the admissions
criteria of a clinical trial for a patient.
There is an essential conflict for doctors involved in clinical research. As collaborators in
research, they want to obtain information that is valid and able to be generalized for all
future patients; but as doctors working within a patient-doctor relationship, they need to
focus only on improving the condition of the patient before them.
Question for Analysis:

Which theory of ethics is demonstrated in this case study?

Does the patient have the right to ask her doctor for a medical miracle?

Consider the consequences if the drug is administered to Louise.
o Who are the stakeholders?
o What are the benefits?
o What are the costs?
o Who pays for the consequences?

Consider the consequences if the drug is not administered to Louise.
o Who are the stakeholders?
o What are the benefits?
o What are the costs?
o Who pays for the consequences?

Would your answers change if you were Louise knowing you will be damaging
test results for a possible drug to benefit future liver damaged patients?