Clinical Trials and Placebo in Psychopharmacology

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Table of Contents

Introduction
Analysis
Examples of What Clinical Trials Are Designed to Do
Why the Use of Placebos Is Sometimes Considered Ethical
Conclusion
References

Introduction

Clinical trials are ever increasing by the day. In these modern times, given that disease-causing agents are mutating by the day, clinical research and practices are necessary. In health or Medicare, clinical trials refer 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 patient’s 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 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.

Analysis

Clinical research or trials vary greatly. This variation is usually dependent on the 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 multinational 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 to be 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 researchers 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 patient’s health.

Examples of What Clinical Trials Are Designed to Do

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 the safety and effectiveness of different doses of medication that 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 kinds 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 world’s major international codes 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 the standard of medication care is available, was indeed unethical. Among the issues that came across included the following that is discussed below.

Firstly, the use of placebos in the 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 there 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.

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 best-proven 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.

It would be unethical to test substances or drugs with potentially undesirable side effects on human beings. Further, more it is unethical to mix genes from different organisms. It is known that this happens in biotechnology, whereby xenotransplantation is carried out. This is because people who consume these animals or their breeds take in a mixture of genes. This can be very hazardous in human bodies or can result in hypersensitivity. Besides that, controlled experiments involve introducing only one variable at a time, which is why animals are experimented on while restricted inside a laboratory.

This is not possible, or it can be very dangerous if it was to be done on humans. Probably confining human beings happened during slave trades whereby Africans were used as the experimentation control. However, currently, human trafficking and kidnapping might be used secretly and illegally in scientific testing. This can happen in countries where naughty scientists abuse human rights.

Since animals can be used for scientific testing, it is unethical to use humans for clinical trials. In addition to this, some insects, e.g., Drosophila melanogaster, have a shorter life and reproductive cycle than humans, implicating that quite a few generations can be studied in a comparatively shorter time. Animals can be bred specially for animal-testing purposes; this is done by bringing them to the laboratory when they are free from infection. Besides that, drugs and vaccines produced through animal experimentation are fundamental to modern medicine and treatment. Another benefit of animal experimentation is that in the process of discovering vaccines and drugs, animals receive more medical care because of animal tests that lead to development in the veterinary field.

There have been quite a lot of laboratory examples of substances causing fatality or damage to human beings because of insufficient animal testing. Other alternatives to certain kinds of animal testing are not yet discovered. This leaves animals as the only reliable source of experimentation. However, proper rules and regulations are implemented to safeguard the right of animals. Besides that, man uses more animals for other purposes such as agriculture, hunting, pest control besides animal testing. Rats are used in biological pest control.

The use of animals is involved indefinite research and education for advancing comprehension of cures and treatment for infections and injuries, which affect both humans and animals. For example, felines are experimented upon to come up with immunodeficiency virus vaccines. This is due to their natural tendency to FIV infection. Animal experiments, for some reason, exist for the advancement of these methods of testing. However, procedures that help meet the public apprehension for laboratory animal care and treatment are essential in maintaining that research will carry on.

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 natural creation.

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

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 in the patient are altered by an otherwise inert treatment. Some physicians consider this an aspect of human physiology, while others believe or consider it an illusion that usually arises depending on the way that the medical experiments are conducted.

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 the 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 a need to use placebos for the purposes of 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 equipment are designed. Just like in any other field, there never fail to be the vicissitudes, strengths and weaknesses, opportunities and threats.

Although guidelines on the use of placebos have been set up, it is still not acceptable for them to be used on humans. In addition, as I have pointed out above, animals provide a perfect substitute to humans for purposes of scientific research. Regardless of this fact, we need to realize that even using animals will have its drawbacks. These might include the following mentioned below.

Animal testing is regarded as a terrible science because many animal diseases are induced, and there is no comparison to human infection. For example, genetic and toxin-mediated animal models are now extensively used to model Parkinson’s disease, the anti-vivisection group dispute that these models only seemingly resemble the disease symptoms without cellular pathology.

Another problem with experimentation on animals is that some drugs have hazardous side effects that are not foreseen by animal models. For example, thalidomide disease. Besides that, some drugs have diverse effects on humans and other species. Another disadvantage is that the conditions in which the tests are done may give misleading results. This is because of the stress the environment reflects on the animals.

It is suggested that the laboratory environment and the experiments are proficient in affecting every organ and biochemical function in the body. This is through gradual biomagnifications or through other means. However, clamor, separation, pain, psychological distress, overcrowding, regrouping, separation from mothers, sleeplessness, hypersexuality, surgery, and anesthesia can all increase mortality.

Animal testing requires stiff rules and regulations in order to protect the rights of both animals and human beings. The regulation requires scientific institutions to have a license before testing on vertebrates may be carried out. The institution must submit details of their facilities and the motif for the use of animals they control. Otherwise, it is unethical to test substances or drugs with potentially adverse side effects on both human beings and animals.

References

Cooper, S. (1999).Use of Laboratory Animals in Biomedical and Behavioral Research, the National Academies Press.

Hall, A; Robert, B. (1998). Ethical Practice in Managed Care: A Dose of Realism. Annals of Internal Medicine, 128:5, 395-402.

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.

Manual of ethics. (2005). 5th ed. Ethics of Practice: The Physician and Society. Annals of Internal Medicine, 142 (2005), 570-574.

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

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