Placebo trials are experimental trials that involve the administration of a substance that does not really have any effect on the individual’s system. This means that it is a neutral trial that will have neither positive nor negative effects on the physiology of the person it is administered on. Whatever positive benefits may be derived out of placebo trials are merely therapeutic and may arise from the potency of the power of suggestion. These trials are most often used in randomized control trials in investigating the effectiveness of a specific treatment.
(Miller and Brody, 3) However, with the rise of the use of such trials, there have been many more questions raised. Are these placebo control trials indeed necessary? What ethical issues are raised with the implementation of placebo trials? The debates regarding the ethicality of placebo trials in investigative research continue to rage across the scientific community. The discussion has become so complex that the sides taken regarding the matter have evolved to more than just “yes” or “no” to the question of placebo ethicality.
There have been numerous aspects of placebo trials that have undergone the scrutiny of those directly involved with fields utilizing these trials. The main aim of this paper is to understand the obligations of medical practitioners who are employing placebo trials in their own scientific investigations of the effectiveness of various treatments. What ethical standards should these individuals, physicians and the like, take into consideration when conducting investigative researches with placebo trials? Glass and Waring
The main problem with a physician’s utilization of placebo trials for investigative purposes is the fact that they are part of the profession that involves the assurance of optimal health for their patients. Some of the researchers and critics exploring the ethical holds on medical practitioners with regards to placebo trials have looked at it from a legal standpoint. Glass and Waring (582) indicate that they have found“no legal precedent allowing physicians to ‘opt out’ of their professional obligations because they are researchers in addition to being physicians”.
It is emphasized that the physician must do all in his power in order to insure that the client receives all possible modes of treatment that would maintain or enhance his or her health. As a researcher, the physician is viewed as a fiduciary, a person delegated with power that will be used for the benefit of another person and who is held legally against the highest standards of conduct. The physician-researcher as a fiduciary, then, has a moral ascendancy over his or her patient-subject.
(Glass and Waring, 578) This means that a placebo trial that would involve having the physician-researcher observe the null effect on the health of a patient-subject and at the same time have knowledge of the betterment of the health status of patient-subjects in the other experimental trials. (Glass and Waring 579) Thus physician’s are now ethically compromised and even legally liable for their utilization and continuation of the placebo trial.
Knowing that there is a treatment that could improve the health of those in the placebo arm of the experiment but not applying that treatment on the participants in that arm indicates their sacrifice of the health of those participants for the scientific progress afforded by research data. The ethical responsibility of the physician-reseracher, therefore, is in the fact that clinical studies of treatment effectivity make use of participants who have been diagnosed with the specific medical condition hoped to be treated by the experiment’s procedure. Hawkins
Hawkins (484) states that the true problem faced by physician-researchers is a moral one. The moral norms and societal dictates placed upon those in the medical profession involve the fact that they need to be able to give a sick person all the possible chances of being treated. However, Hawkins (484) points out that this moral responsibility is limited. She states clearly “researchers do not owe effective treatment to everyone around them. ” (473) The obligations of a physician to his or her patient are enclosed within a given framework, that of the physician-patient relationship.
In order for such a relationship to be established, the physician must come into agreement with the client that he or she will indeed act as one half of that relationship. The same agreement must be made on the part of the client. Although this agreement may not be explicit, it is nevertheless positively acknowledged by both parties. (Hawkins, 476) There is, according to Hawkins, no ethical dilemma in a physician-researcher’s use of placebo trials. Just because these researchers have had medical training and have taken a medical oath does not mean that they are always in the role of a physician.
These are individuals that have many other different roles as fathers, mothers, non-practicing physicians, friends and the like. The role they take as a researcher, therefore, does not mean a continuation of their role as a physician. (Hawkins, 479) The obligations of an individual in the role of a researcher is separate from his or her role as a physician thus their obligation in placebo trials involves simple assurance that the participant will not be harmed by the procedure that will take place. Miller and Brody
Some critics of placebo control trials state a weakness in therapeutic obligation of physician researchers as the main grounds of contestation of the ethical foundations of the said trials. Miller and Brody (8) state that even when based on the principles of clinical equipoise, an ethical basis of assigning participants in different experimental arms which involves disagreement among experts as to the effectiveness of either arm, therapeutic obligation is still a weak attack against the ethics of placebo trials.
The individuals who knowingly participate in experiments with placebo arms are not exploited as long as no harm befalls them. Also, they are aware that they enter the experimental set-up as participants in a research and not as patients of the researchers who happen to also be physicians. (Miller and Brody, 5) Miller and Brody thus state that “placebo trials are not unethical just because they withhold proven effective treatment”. (6) It is thus seen that the responsibility and obligation of the researcher with regards to the ethicality of placebos is not in their therapeutic obligations as physicians.
However, this does not mean that placebo trials are completely ethical. This also does not mean that researchers are devoid of ethical obligations to their participants assigned to placebo arms of the investigative experiments. The ethical obligation of the researcher in placebo trials is the same as that of researcher in any clinical trials. This involves the proper acquisition of informed consent from the participants. Also, researchers must be able to assure the fact that participants will not be exploited or put in harmful situations.
Miller and Brody also insist that researchers must first establish that the investigation has scientific merit and that scientific merit is increased with the implementation of the placebo trial. (8) Analysis and Argument All three articles assessed above have merit and, at the same time, also have faults. Glass and Waring (582) stating that no legal precedents were found that indicated physicians were no longer tied to their professional obligations is faulty.
In much the same way that a lawyer does not have to give counsel to every jaywalker he or she sees, the physician likewise does not have professional obligation over individual’s whose relationship to him is simply that which exists between researchers and participants. I also disagree with Hawkins’ statement that morality is what binds the physician thus the use of placebo trials is not unethical. What is ethics but a concept in the realm of morality? Yes, there are standards and regulations with regards to ethical conduct. However, as a whole, ethics is based on morality thus a moral problem is, in fact, an ethical problem.
The middle ground taken by Miller and Brody also seems to be misled. A placebo trial is not equivalent to other clinical trials. It involves factors that are not present in other trials, such as the exposure of the participants to neutral treatment. In other clinical trials, there is still exposure to some form of treatment thus there is an effort to aid the participant. I believe, however, that physician-researcher’s obligations to the patient-participant, is limited solely to the relationship of researcher and participant. The role taken by the individual is not that of a physician but that of a researcher.
The participants are also aware that they enter into the experiment not as patients but as participants. Although they are not given the chance to undergo possibly effective treatment, it is not the moral obligation of the researcher to insure that they do. Even if, for example, a person persists to smoke, I am not morally or ethically obligated to make sure that he or she stop. Placebo trials are valid research designs and should not be stopped simply because of a feeling that it is unfair to those who, in the first place, willingly submitted themselves to the experiment’s conditions.
Glass, Kathleen G. , and Waring, Duff. “The Physician/Investigator’s Obligation to Patients Participating in Research: The Case of Placebo Controlled Trials. ” The Journal of Law, Medicine & Ethics 33 (2005): 575-585 Hawkins, Jennifer S. “Justice and Placebo Controls. ” Social Theory and Practice 32 (2006): 467- 496. Miller, Franklin G. , and Brody, Howard. “What Makes Placebo-controlled Trials Unethical? ” The American Journal of Bioethics 2(2002): 3-9
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