After participating in and critiquing the NIH training, this article is an interesting one.
After reading, do you think it is morally right or wrong for doctors to bend the rules of clinical studies in order to help their patients? Why or why not?
(Submitted by Caren Steinway)
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It is reassuring to realize the extent to which the obligation of doing what is best for the patient is intact in our medical system with regards to the doctor patient relationship. A doctor's allegiance to fulfilling his/her obligation to the patient by enrolling his/her patient in a clinical study when other criteria would bar them from receiving an experimental treatment that could potentially help, is a testament to the strong commitment doctors feel to act beneficently with regards to their patients. However, this well-intentioned means of doing what is best for a patient, has greater negative implications for society as a whole. Inclusion of patients like Louise who do not meet the criteria to participate in clinical research could very likely compromise the results and conclusions of the research. Although there is the potential for Louise to be helped by the experimental treatment, her inclusion in the study would create a "complication [that would be] potentially so significant it could prevent future use of the drug." Skewing the data and perhaps altering the results of the study in the hopes that one individual would benefit from the experimental treatment does not seem ethically justifiable. From a utilitarian point of view, in which the most morally justifiable action is the one that creates the greatest good for the greatest number of people, it seems clear that the potential good created for Louise as a result of her participation in the trial does not outweigh the potential harm that her participation could produce for the research that could otherwise benefit many other individuals. Therefore, although a doctor may be clearly well-intentioned in trying to do the best for his/her patient by enrolling the patient in a clinical study, the doctor's actions would not ethically defensible. Additionally, it is important to consider that the treatment is in the research phase and is purely experimental. As the article points out, "many experimental treatments are as good as standard therapy, few actually end up superior and some are worse." Therefore, although it may provide some home for certain individuals in dire circumstances to participate in a last-hope trial, the odds that they would significantly benefit from the treatment are slim. With this in mind, it seems even more unjustifiable to allow participants into clinical trials who will likely not reap significant benefits from the experimental treatments, and whose participation has the potential to severely compromise the integrity of the research.
ReplyDeleteAlthough it would seem that the doctor is acting in a way to better the health of the patient and in that sense holding up a doctor's commitment to the patient, by recommending this patient to the clinical trial, the doctor is actually causing much more harm than good. As shell.k and the article said, many of these trials do not neccesarily have better effects than traditional treatments and in fact many can be worse.
ReplyDeleteEven if the doctor is fairly sure that the clinical drugs may be successful, it is still unethical to recommend that patient to the trial from a utilitarian perspective. The patient's participation in the clinical trial will skew the results of the study and may result in the drug being rejected instead of approved. This could potentially undermine the future treatment of thousands of patients with the same disease in the future.
Although it may seem easy to focus on the short term potential positive effects on the patient, doctors must look at the issue as a whole and explore the possible negative consequences of recommending the patient to the study.
Although what Ankit and Shell.K say make a lot of sense, I believe that the rules and guidelines of these studies may be limiting in certain ways. Sometimes, it is important to separate the ethical world of right and wrong from the legal and standard rules. In certain circumstances, allowing the rules and regulations to dominate our thinking may hinder our ability to think about what is the most ethical choice in the situation. I believe that this may be one of those cases.
ReplyDeleteAlthough I do not support the concept of fudging patient data to allow them access to certain treatments/experiments, I believe that certain exceptions can be made to create a better world. Rules and regulations are made to give guidelines for the best results for general situations; however, these rules do not address issues or outliers such as this one. It seems that the allowing the patient to participate in the clinical trial will not harm anyone in the short run or the long run. In fact, it appears that only good could come from the action. Also it is the doctor's "duty" to save as many lives a possible. Thus, from both a Kantian and a utilitarian point of view, recommending the patient is not unethical.
Also, in response to Ankit's comment about skewing the data, I do not believe allowing her to be in the study will give the data bias. In certain experiments that allowing certain patients to create bias, I agree with Ankit. It would be unethical to recommend the patient, however, in cases where the patient would not skew the results, I believe it is perfectly fine to "bend the rules."
I realize that allowing some people to be "special" clearly violates the ethical concept of Justice, but the benevolence caused from such an act outweighs this infraction. Another issue this might raise is that every doctor will fudge results to allow their patients to participate if some do. I believe that these issues should be addressed, but it is not morally wrong for a doctor to bend the rules to help their patients.
After reading the article, I think it is morally wrong for doctors to bend the rules of clinical studies in order to help their patients. Medical research is done for the purpose of making beneficial contributions to society, and it is done solely for the benefit of people. Although a doctor has a duty to improve his/her patient’s condition, it is unethical to bend the rules in such a way that will aversely affect others in the society, like in the case of Louise in this article.
ReplyDeleteAlthough Louise’s doctor had the duty to maximize benefit and minimize pain, her original idea of using experimental drugs involved in a clinical study was ethically wrong. The experimental drugs that the doctor wanted to use were being researched, and the doctor predicted that Louise’s use of these drugs could result in muddy data, which could alter the whole outcome of the trial. This has to be looked at from a utilitarian point of view because the consequences are far too risky. Although the drugs could possibly enable Louise to live long enough to see her grandchild, there was also a possibility, though maybe minimal, of altering the data, which would result in negative consequences for the people that would take that drug in the future.
Because doctor’s have to focus only on improving the condition of the patient before them, I think there has to be a distinguished line between clinical research and actual treatment to patients. Because research is done to benefit the greater number of people, I believe that any drugs or treatments that are being research should always and only be used in cases that will further the research. Doctors should not be given room to make the decision between the life of a patient and the development of a drug or treatment under research.
In the medical profession, one of the major principles that physicians must follow is the principle of beneficence; it calls for the doctor to do anything in their power to increase and improve the well being of their patients. However, while following one principle it may at the same time conflict with another medical principle. In this article, we are presented with a doctor who has an ethical dilemma of giving the patient the study drug to extend her life just a few more months, but this would then affect the results of the clinical trial and could hurt the chances of other patients having access to the drug. In the article it is stated, “but as doctors working within a patient-doctor relationship, they need to focus only on improving the condition of the patient before them.” This statement illustrates the importance of the principle of beneficence within a physician- patient relationship. Although giving this patient the experimental drug so that she can live to see her grandchild, I do not think that it is ethically right for the doctor the bend the rules of the clinical trial. If the doctor bends the rules to help out this one patient, it will be indirectly harming the lives of other patients. This violates the principle of nonmaleficence, where the physician may do no harm to the patient. This patient does not fit the criteria for enrollment into the clinical study of the new drug due to her liver failure, so if the doctor were to bend the rules and enter her into the study it may lead to investigators falsely assuming data, which would prevent future use of the experimental drug. By preventing future use of the drug, fewer lives are able to be saved. I think that solution that the doctor found to supply the patient with the drug to extend her life is morally acceptable. The doctor was able to give the patient the drug without bending the criteria of the clinical trial, and the patient lived long enough to become a grandmother.
ReplyDeleteI agree with Laura. I think it is completely unethical for doctor's to bend the rules of clinical trials. I find it very very irresponsible, and I think it is putting many people's lives in danger as well. If this has been a successful trial up to the point a patient that should not be in the trial is admitted into the trial it puts everything in jeopardy. I think it is also terribly unfair to all of those other people who were rejected from the trial with potentially the same problems as Louise. While I do agree with shell.k that it is admirable and reassuring to see a doctor with such conviction to his/her patient, it is also irresponsible of him as a medical professional to jeopardize the study of a potentially life saving drug. I appreciate the doctor for his compassion and his effort to make every possible action to help his patient. This is a strong following of beneficence which is an attempt by the physician to do everything in or out of his power to extend his patient's life. He is also ethnically wrong s vanessa mentioned in that he cannot bend the rules of research ethics. One thing we do not know is if Louise would have even been accepted. While the doctor says the chances are slim, we are still not told whether they tried to get her into the study. Maybe if the doctor plead his case to the lead researcher he may have allowed Louise to partake. Transparency in this case makes a big difference.
ReplyDeleteAlthough the doctor may be acting in the best interest and it may seem like he is acting in a way to do the most good for his patient he actually is not. Clinical trials are designed with control groups for a reason and not everybody involved is going to get the new drug. Clinical trials must be viewed from a utilitarian perspective, meaning that what is gained from the trials will provide the most good to the greatest number of people. In the moment, the person in the trial that is not receiving the new drug may feel like they are getting short changed, but their role in the trial is crucial. Without control groups there is no way of knowing if it is the drug that is actually working and not some other varibale, or if the drug is even working at all. The control groups provide a basis for comparison, making them absolutely necessary for a new drug to be studied. If all doctors thought the same way as this particular doctor there would be no use in running clinical trials. The trial and its data would be compromised by every doctor trying to get his or her own patient the new drug. Doctors and patients alike must realize when entering a clinical trial that they may not be receiving the new drug, but that they should continue in the trial because of the data and information that will be collected from it. This information has the potential of saving many lives in the future, which is why the doctor should not compromise the clinical trial by trying to get his patient the drug.
ReplyDeleteTorri