Hope_and_the_Limits_of_Research

The case "Hope and Limits of Research" portraits a very common scenario in current fast-evolving medical field and a possible ethical dilemma : an almost foreseeable future for the end-stage tumor patients and the hope (may actually be an hype) for cutting edge research. Both Susanne and Margaret are end-stage breast cancer patients. Dr.Tetler, their oncologist, treated Susanne and Margaret with current established medical procedures but no favorable outcome. As the principal investigator for a phase II trial for a new chemotherapy agent, Dr.Tetler is responsible for the patients recruitment and evaluation of the effects of the new drug. Two potential candidates for new drug trial possess an ethical challenge due to their social-economical background. Margaret is a fully insured co-worker of Dr.Tetler. Susanne is facing insurance and family problems and may not be able to show up for the new drug evaluation during the trial if she was enrolled. What should be the criteria of patients enrollment for Dr.Tetler' Does an end-stage patient have the overriding right to participate in a research that could potentially offer an cure for the disease' Needless to say, sciences including medicine always advance themselves through a trial-error-trial process. However, medical science is more complicated due to the involvement of human being. Medical ethical regulations play an indispensible role in medical science i.e. human subjects are not only considered to provide scientific data for a research but also need be treated in a humane and ethical way. In current case, as the principal investigator of a new chemotherapy drug study, Dr.Tetler is obligated to report the research results to pharmaceutical company. He, meanwhile, is also a physician who needs to treat his patients with the most advanced medical procedures that he can deliver. I believe under current circumstance Dr.Tetler should not put patient's social-economical situation into consideration for his subject enrollments. From this point, Susanne is more vulnerable than Margaret. Even including Susanne in the trial might result in no research data obtained from her due to missed appointment etc, As one of Dr.Tetler's patient (as opposed of merely being study subject), Susanne deserves the latest treatment from Dr.Tetler due to a potential cure of the new drug (even the chance is slim). While the trial organizer (pharmaceutical company) might loss certain portion of their investment in the trial due to Susanne's missed appointment, as a human being, I believe, Susanne should be enrolled in the study. Dr.Tetler should only consider the eligibility based on scientific criteria rather than social-economical considerations of research subjects. Since the trial led by Dr.Tetler is almost the last straw of potential cure for end-stage breast cancers, both Susanne and Margaret are equally vulnerable due to the end-stage nature of their cancers. Even this trial could offer a hope for their disease, Dr.Tetler should make sure a fully understanding of the consent in the study i.e. possible adverse outcomes of this study. This study is only a Phase II trial, as commented by Christopher K.Daugherty, in which the drug's side effects were not previously documented at all. It is very possible that the drug will shorten patient's life due to severe side effects. In this case, Margaret probably is more vulnerable than Susanne. As a colleague of Dr.Tetler, she might personally wish a successful clinical trial AND Dr.Tetler's career. She could potentially overlook minor discomforts such as headache, weakness etc. From this point, I think, a third party observer rather than Dr.Tetler should be involved for a independent observation. Clinical trial is the corner stone of advancement of medical science. Clinical trial data obtained from human subjects will eventually benefit population at-large. However, ethical considerations before, during and after clinical trial as well as a fully informed consent are equally important as the scientific portion of a clinical trial.