Medical Research and Ethics in Developing Countries
Adey Mulugeta Gebru
Biology Senior Seminar
Stan Grove
November 21, 2005
Thesis
Medical Research has been conducted for many years in developed countries and has proved to be useful. The limited sources and current situations in developing countries make medical research even more debatable. How beneficial is the research to the developing countries & what ethical issues are being addressed?
Outline
I Introduction
II. History of Medical Research III. Ethical Issues with Clinical Trials in Developing Countries IV. Conclusion V. Bibliography I. Introduction
Medical Research studies are done to give information about human beings and health issues. Medical research can be done to find out further information about a disease, to test how well a new medication works or just to know how to stay healthy (Women can do 2005, para.1). The main purpose of medical research is to improve medical treatments for future patients. With medical research informed consent is always required. The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant (E-trials, 2005, para1.). If you decide to enter the research, you give your official consent by signing the document.
There are several types of medical research. Some studies are done to find out what causes a disease. Others are done to improve treatmwnt of a disease.
Observational studies look at the same group of people to see how their health changes (Women can do, 2005, para.3). A very good example of this is the Framingham Heart study where a group of people were studied to see how cholesterol and blood pressure are associated with heart disease.
Epidemiological studies are different in that they are done in a larger group of people like a whole country at a time. They come up with more generalized outcomes.
Intervention studies are more concerned with studies that come up with life style changes as a way of having a healthy life (Women can do, 2005, para.4) One example can be quitting cigarette smoking to have a healthier heart.
Prevention studies as the name says it look at ways to prevent people from getting sick instead of finding a remedy for their disease (Women can do, 2005, para.5).
In this paper more concentration will be given to the last type of medical research: clinical trials. Clinical trials are tests that are done most of the time to see the best way to treat a certain condition (Women can do, 2005, para.7). In some cases clinical trials also look at ways to prevent a disease. Clinical trials test new drugs or new medical devices. Clinical trials are done on human subjects, and these volunteers can be used to see the wanted effect or the side effect of a certain drug (Women can do, 2005, para.7). Since this research involves injecting or exposing subjects to something foreign, it involves many ethical issues.
3. How are Clinical Trials Conducted?
Clinical Trials are done on human volunteers, with their consent. In America these studies are done in stages known as phases ( Women can do, 2005, para.9). There are three phases.
The first phase involves 20-100 individuals who are healthy and lasts up to one year (Women can do, 2005, para.10) . The purpose of this phase is to know the best dosage of a drug to use for further testing and to know how quickly the body is breaking down the drug (Women can do, 2005, para.10). They try different dosage on different people and conclude the best dosage to use for future testing.
The second phase involves several hundred people, last s from one to two years and is conducted on individuals who already have the disease are being given medication for (Women can do , 2005, para.11). This phase helps researchers to see if the drug is having the desired effect, to confirm best dosage and if it is time to start testing for safety issues.
The third phase involves a couple hundred to thousands and lasts two to four years (Women can do, 2005, para.12). This phase looks at how well the investigational drug works and to see how much of the drug is required to achieve the wanted result (Women can do, 2005, para12). This phase is usually done in comparison to an already existing treatment or to an inactive treatment known as placebo. A placebo treatment is a treatment with no effect and is similar to a control that is used in laboratory experiments.
The last phase, phase four, is started after the results of the first three have been given to the Food and Drug Administration (FDA) for approval. This phase involves many tests; it includes all the test done in the first three plus test s to see the best way to administer the drug for example tablets or capsules (Women can do, 2005, para.12).
II. History of Medical Research
Medical research in some form of it has been going for hundreds of years. One of the earliest was done by Frederick II a king of Persia, when he tested the effect of exercise on digestion in 1200 B.C. In the late 1800 an investigator known as Bill Roth researched about breast cancer and how much surgery and mastectomy was needed ( Reese). In the 1950’s Wynder and Doll studied the link between lung cancer and smoking.
Although much medical research has had very positive outcome there has been quite numerous cases of unethical medical research performed.
An example that is mentioned many times when thinking of unethical research is the Tuskegee Study of Untreated Syphilis. This study was sponsored by the U.S. Public Health System and lasted from 1932 to 1972 (Angell, 1997, p.848). Four hundred twelve poor African American males with untreated syphilis were studied and compared with 204 men without the disease to see the natural history of syphilis (Angell, 1997, p.848). When the research was started there was no known treatment for syphilis. But even after penicillin was discovered and proved as the best treatment for syphilis these men were deprived of the treatment and the study was continued (Angell, 1997, p.848). The study was finally terminated when a reporter found out about it and it became front page news.
There were numerous ethical violations. Subjects did not provide informed consent and they were denied effective treatment even after it was available. If we ask the question of why this was done their answer might simply be that these people are poor and would not have had the treatment anyway. So all they did was follow what would have happened naturally. They might have looked at this is as an opportunity that could never be repeated.
This is a good example to use because it demonstrates how a group of people can be taken advantage of when there is a point of vulnerability. These African Americans have a lot in common with the developing countries’ society we are going to discuss in the rest of the paper.
III. Ethical Issues with Clinical Trials in Developing Countries
A well known ethical condition for comparing two treatments for a disease is the belief that one treatment is not better than the other (Angell, 1997, p.847). Most of the time investigators hope the new treatment would be better than the older one but they have no evidence that it is. If they did have evidence that this treatment was better than the older one then they would be found guilty of knowingly giving a substandard treatment to some of the participants in the trial (Angell, 1997, p.847).
This condition also applies to using placebo treatments. Only when there is no existing treatment is the using of placebo treatment ethical. Comparing a placebo to a new treatment when there is a known effective treatment is completely unethical. Researchers are responsible for everybody that is involved in their trials. The research’s outcome is secondary to the well being of the individuals. These requirements are made clear in the Declaration of Helsinki of the World Health Organization (WHO), which is regarded as the basic guideline when it comes to ethical code of conduct involving human subjects. It states “In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject,” and “In any medical study, every patient including those of a control group, if any should be assured the best proved diagnostic and therapeutic method (Angell, 1997, p.847).”
The main reason ethical code can be broken is the temptation of the outcome. A researcher might think, if only I took this experiment just a little bit further then that might be the greatest breakthrough ever achieved in medical science. Therefore negligence of the human subjects is going to happen. The conditions developing countries are in make them very vulnerable to these kinds of unethical actions.
Many developing countries have common conditions like poverty and low investments on health care. Due to these conditions ethical policies that are considered normal in the rest of the world are almost forgotten in these countries. Many researchers comment that research that is impossible to do in developed countries is done in developing countries (Angell, 1997, p.849). Low standard of care is provided to individuals involved in research in these countries.
The handling of control groups is especially bad. Some scientists who are involved in these kinds of researches justify their actions by saying they are giving better treatment than the local treatment anyway therefore these people are not losing anything (Angell, 1997, p.849). But the Helsinki agreement says that individuals are to receive the best treatment not something that’s better than the local one.
Developing countries are faced not only with placebo treatment being used when there is an existing treatment but also with clinical trials being performed that are of no use to that country (Angell, 1997, p.849).
Because major funding comes from developed countries, the donors will have a majority of the vote when it comes to deciding what kind of research is going to be performed. The money involved brings a power imbalance and thus leads to the exploitation of the vulnerable parties. Unethical methods are used to get consent because such a huge amount of money is involved. There are many examples of unethical clinical trials that happened in the third world.
The very famous example that shed some light into the unethical ways that research was being performed in developing countries was the US –funded research that looked at the prevention of the mother to child transmission of HIV in Thailand (Science and Development, 2002, para.3). The main funders were the National Institutes of Health (NIH) and the Centers for Disease Control (CDC) (Varmus & Satcher, 1997, p 1004). The main issue was the mothers found in the control group were given a placebo rather than the known effective antiviral treatment. The antiviral treatment had been proved effective in developed countries but was not available locally (Varmus & Satcher, 1997, p 1004). This was brought to international attention in 1997 when it was published in The New England Journal of Medicine (Science and Development, 2002, para.3).
This was an obvious violation of the Helsinki agreement. While there was a known effective treatment the people in the control group were denied this. This is similar to the Tuskegee research mentioned above.
The researchers tried to argue their case by saying that there was no antiviral treatment locally so they had just followed nature take its course. They also said that it was too expensive to always provide the treatment and having a universal standard of care will inhibit the advancement in future medical research (Science and Development, 2002, para.4).
The antiviral treatment that was being used at that time is known as zidovudine (Varmus & Satcher, 1997, p 1004). This drug was approved after an intervention trial known as AIDS Clinical Trials Group Protocol 076 (Varmus & Satcher, 1997, p 1004). This regimen although known to be effective had a couple of complications that came with it. First of it was too expensive for use in developing countries. It required early testing to see if the mother was HIV positive to start the regimen. After the baby was born it had to be given zidovudine for six months and both mother and baby had to be monitored for side effects of the drug (Varmus & Satcher, 1997, p 1005). On top of that the drug and its effects were not known in special conditions such as malnutrition and anemia which have higher incidences in developing countries.
All these complications made researchers think of developing a new regimen that is more practical in developing countries. There are several regimens under going testing, but again the ethical issue comes into question because there is the use of placebo treatments being used instead of the protocol 076 as the control (Varmus & Satcher, 1997, p 1005).
But this time around the donors and researchers have taken into account ethical issues like the use 076 regimen instead of placebo treatment. They have further explained why they would be using placebo treatment. It was not because of negligence but as a matter of fact better answers would be found that way. It is found that placebo treatments as a control give more definitive results are faster and use fewer subjects (Varmus & Satcher, 1997, p 1005). In using the already known treatment it might be difficult to judge the advantage of the new treatment because the two regimens might differ in many different ways. But if placebo was used it will be easy to answer these questions. But again this will mean harming the newborns knowingly when they could have survived and had a normal life had they been given the treatment.
Due to many cases like this the international society has become aware of ethical issues and many changes have come about. The NIH and CDC supported trials have undergone extensive ethical reviews (Varmus & Satcher, 1997, p 1005). The results from these reviews are: the participation of the public health and scientific communities in the developing countries where the trials are being preformed and the application of the U.S. rules for the protection of human research subjects by institutional review boards both in the United States and in the countries involved with the research (Varmus & Satcher, 1997, p 1005). On top of this continuous review will be done by an independent party to monitor if all the rules are being followed.
IV. Conclusion
Medical research, especially clinical trials has benefited the world in great ways. Because clinical trials use human subjects it makes it a very sensitive issue.
The study of medical research being done in developing countries is complex. The situations these countries are in make them especially vulnerable to exploitation. From my research in this field I have seen evidence for this. The countries lack of money has made them a target for unethical medical research. Definitely all the issues could not be handled in this small paper but it gives a general overview of what is happening on the less privileged side of the world.
But on the upside of things I have seen a lot of progress in the area as well. Many of the donor companies are following good ethical rules and regulations. Many researchers here in the states are actively debating these issues indicating there will be more progress in the future. The fact that rules have been revised for the benefit of other countries is a great promise to us.
Medical research is the hope of medicine, because without medical research no advances could be made. Even though it is the hope for medicine great precautions should be taken when performing these researches because we are dealing with human life, and after all the human life is the most precious thing on this earth.
V. Bibliography