Clinical Research

Clinical Research

Introduction:

Clinical trials are ever increasing by the day. In these modern times, given the fact that disease-causing agents are mutating by the day clinical research and trials are necessary. In health or Medicare clinical trials refers to comparison tests of medicines, medications or any medical treatment like medical devices against placebos, other devices or medications, or the official standard medical treatment required for a patients condition.

In medical terms, a placebo is a medical preparation that is pharmacologically inert. Placebos are believed to have therapeutical effects that are solely based on the power of suggestion. A placebo is medically administered in any mode that is legally and medically approved for administering pharmaceutical products. This can be done using psychic surgery or it can also be done through faith healing.

In some cases, there arises the issue of non-specific or subject-expectancy effects concerning placebos. This is commonly referred to as the placebo effect. The placebo effect usually occurs when the symptoms inherent on the patient are altered by an otherwise inert treatment. Some physicians consider this an aspect of the human physiology while others believe or consider it an illusion that usually arises depending on the way that the medical experiments are conducted.

In analyzing this paper, I will seek to find out whether indeed it is unethical to use placebos while the original or the standard medication is available. In addition, I will try to look at some of the different opinions held by individuals and or organizations and how these opinions help or affect the process of clinical trials.

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ANALYSIS:

Clinical research or trials vary greatly. This variation is usually dependent on available budget, involved parties, as well as the researchers doing the research. As thus, clinical trials may be locally based on one clinic or hospital, a government research institute, or it may be international in nature to a level that it is financed by a multi-national pharmaceutical company, with hundreds of participating centers or hospitals spanning the entire globe.

In any clinical research or trial, the sponsor or the company providing the medicine or the medical devices identifies the specific medications it wants tested. After the medication is identified then the sponsor goes ahead and decides on what the medication will be compared to i.e. available treatments or placebos.

After this has been done, the researcher goes ahead and decides the kind of patients that will benefit from the medical device or medicine. In some cases, the sponsor may fail to get an acceptable population or sample for the analysis in their locality. If this is the case then the sponsor looks for researchers who will assemble an acceptable population of patients with the symptoms of the specified condition or disease. after this has been done the researcher s are recruited as agents of the sponsor and they are supposed to administer the treatment for an agreed period of time while at the same time collecting data concerning the progress of the patients’ health.

EXAMPLES OF WHAT CLINICAL TRIALS ARE DESIGNED TO DO:

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Clinical trials are designed to assess the effectiveness and safety of new medications or devices on specific kinds of patients.

Clinical trials are designed to assess safety and effectiveness of different doses of medication than are commonly used.

Clinical trials are designed to assess safety as well as the effectiveness of already marketed medications, devices or any other device on new kind of patients.

Clinical trials are designed to assess whether new medications and or devices are more effective for the treatment of study conditions than those that are currently being used.

Prior to the Helsinki declaration of 1996 on the use of placebos, many scholars, researchers, and or organizations have always questioned the moral and ethical reasons for using placebos. The Helsinki declaration (to be discussed lightly later), is one of the worlds major international code of ethics for research on biomedicines involving humans as subjects. Within this debate many issues were raised that made it possible to argue that indeed the use of placebos especially when standard of medication care is available was indeed unethical. Among the issues that came across included the following that are discussed below.

Firstly, the use of placebos in treatment of illnesses, while at the same time there exist legally and medically acceptable forms of treatment for the condition, symptoms or disease under study was and is still considered unethical. This is considered unethical since using the placebos puts the lives of the patients at risk yet here exist treatments for the conditions. This use of placebos, while treatments for the illnesses exist is considered a means of increasing the profits of the sponsors at the expense of innocent lives of patients. This reality makes the use of placebos under such circumstances unethical.

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Due to this issue article II, section 3 of the 1996 Helsinki declaration gave the provision that “every patient who is enrolled in a medical study of any kind be assured of the fact that they will receive the best proven therapeutic and diagnostic methods”

Compliance with the Helsinki declaration is not mandatory within the United States legal system. Regardless of this fact, the declaration has been influential with many institutions review boards while they consider protocols, which propose placing patient-subjects in placebo control groups.

The latest controversies concerning the unethical nature of placebos were mainly centered on the use of placebos in psychiatric research especially on the study of schizophrenia.

In addition, it has been argued that it is highly unethical to test substances or in this case drugs, that have potential adverse effects on human beings.

In addition to this since testing of substances on animals, is usually done in controlled and well coordinated laboratories it would be very unethical to practice the same on human beings.

It is also unethical for the use of placebos on human beings, given the fact that there are no substitutes for human tissues and humans, yet the same can be done using primates that have almost similar tissues to those of human beings. It is unethical for Christians to alter or change through genetically engineering the natural creation.

At the current level of medical advancement, there is no substitute for psychiatric studies

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especially on schizophrenia. Thus, it would be quite unethical to use placebos on humans knowing the fact that they could end up destroying the patient’s mental level of understanding.

On top of these issues there is always the problem that using placebos on humans without adequate animal testing could end up causing serious injuries and or death to many human beings.

WHY THE USE OF PLACEBOS IS SOMETIMES CONSIDERED ETHICAL:

Many physicians believe that the Helsinki declarations of1996 and the 2000 conclusions were misguided. Although the conclusions have not been adopted legally into United States law, they had the effect of concluding that placebos can and should never be used in place of acceptable standard therapies in any major condition.

What many people, researchers, and or organizations have failed to realize is that the work or the ethics of research work, are and will never be identical to those of clinical care.

This is why researchers cum physicians do not owe their loyalty only to their patients, but also to the nature of their work and that is generating scientific knowledge, unlike general physicians who owe their loyalty only to their patients. In this perspective, we can consider it ethical for researchers to use placebos, as well as their intentions and their research is intended for the betterment of our health as a society.

In addition to this fact, there is also a rational decision that we have to make. This decision can only be made if we think realistically. Whether we like it or, not every new drug or medical device has to be put to test. Even if the drug has a hundred percent success level in animal, testing there is always the first person whom the drug will be tested. In order to avoid serious side effects and or possible deaths, there is need to use placebos for the purposes of

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preventing possible loss of lives within the general population.

Conclusion:

Clinical trials and or clinical research are a very necessary field in the medical world. It is through these trials that new medicines and or state of the art medical equipments are designed. Just like in any other field, there never fail to be the vicissitudes, strengths and weaknesses, opportunities and threats.

The use and or non-use of placebos should be left, to be decided by the specific situations. Since every new day, we need new drugs and better equipments. For this to be achieved we need to make sure that the field of clinical research is guided by the right policies not only from the organizations sponsoring the research but also the involved or participating hospitals as well as government departments.

References:

Manual of ethics, 5th ed. Ethics of Practice: The Physician and Society. Annals of Internal

Medicine , 142 (2005), 570-574.

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Hall, A. Robert, B. Ethical Practice in Managed Care: A Dose of Realism. Annals of Internal

Medicine , 128:5 (1 March 1998), 395-402

Rothman, J. & Michels, B. 1994. The continuing unethical use of placebo controls. New England Journal of Medicine.

Levine J. 2002. Placebo controls in clinical trials of new therapies for which there are known effective treatments, in The Science of the Placebo: Toward an Interdisciplinary Research Agenda. London, British Medical Journal Books.