Ethical Issues in International Medical Research

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Table of Contents

Introduction
Double standards and unequal protection of subjects
Lack of appropriate support to the patients after the trial
Failure to address the health needs of developing countries
Conclusion
Bibliography
Foonotes

Introduction

There is a trend among medical research companies to conduct clinical trials in developing countries such as India, Russia, Argentina, or Brazil¹. This form of outsourcing gives rise to several ethical issues. First of all, one has to speak about the adoption of double standards which means that the subjects from developing countries do not receive the same level of care and protection, appropriate for Western Europe or the United States.

Many of the studies carried out in poor regions of the world can be prohibited in advanced countries due to ethical considerations. Thus, the question is how to eliminate such practices². Secondly, there is an ongoing debate among medical scholars if the research companies have some obligations to the patients at the post-trial stage. In this case, one can speak about the necessity to provide medication to the subjects of clinical trials.

The third issue is the responsibility of clinical research companies to address health needs of local populations, especially in very poor countries. This paper is aimed at analyzing these problems and finding ways of resolving them. It is possible to say that they cannot be properly addressed without full commitment of international organizations, domestic health agencies, and local governments that have establish legal framework for conducting medical trials.

Double standards and unequal protection of subjects

Such problem as double standards have several dimensions. One of them is the absence of legal mechanisms protecting the rights of the subjects³. The thing is that many developing countries have practically no laws specifying the rights and obligations of research companies or trial participants. Moreover, there is practically no governmental supervision over such medical studies.⁴ At least, this supervision cannot be compared to the control exercised by Food and Drug Administration or other health agencies working in advanced countries⁵. This is one of the reasons why many pharmaceutical companies choose these regions⁶. Such clinical trials are rarely audited.

This lack of monitoring enables these organizations to carry out the studies which can be potentially dangerous for the patients. For example, Ruth Macklin points out that many research companies prefer to carry out placebo-controlled studies in order to reduce the duration and cost of the study⁷. Nonetheless, in many cases, placebo-controlled trials are hardly permissible especially when the patient requires immediate treatment⁸ that is available to medical workers. Furthermore, one should not forget in many cases, the patients recruited by the researchers are not able to demand any compensation provided that the drug produces adverse effects on his/her health. Hence, one can argue that the cost of medical trials is often reduced at the expense of the patients.

This issue is of the crucial importance to the organizations engaged in medical trials. On the one hand, they certainly help those people who cannot afford the treatment and medications⁹. For many of these individuals participation in a clinical trial is probably the only way for them to receive adequate healthcare services. Nevertheless, this disregard of ethical standards can endanger the lives of the participants. More importantly, Ruth Macklin argues that such practices only contribute to the violation of human rights in developed countries¹⁰. As a result, they will never be able to sustain growth if the basic rights of an individual are not protected by the state. Thus, the importance of this ethical dilemma cannot be underestimated.

At the present moment, there are very few legislative mechanisms which can be used to address this problem. Admittedly, one can mention the Declaration of Helsinki that is aimed at protecting the rights of people participating in clinical trials¹¹. However, this international treaty contains some loopholes enabling medical corporations to lower the standards of care.

For example, according to this agreement, drugs must “be tasted against the best therapeutic methods”¹². Nonetheless, in many cases, the research companies deliberately misinterpret this requirement by establishing the standards which can be suitable for developing rather than advanced countries. Currently, this issue is the domain of local ethics committees and health agencies that decide whether a particular trial complies with current ethical standards.

It seems that the resolution of this problem requires more active participation of international agencies. For example, the World Health Organization should exercise more control over the ethics committees in developing countries in order to ensure that the basic rights of the subjects are upheld and that there is no overt threat to their life or health.

Additionally, the health agencies in the developed countries, for instance, Food and Drug Administration should reject the results of those trials which were done with overt violations of medical standards. Finally, local governments need to pass legislative acts which can protect the rights of clinical trial subjects. Currently, many of them are lacking. This strategy will eventually force such companies to change their policies. These are some ways of resolving such a problem.

Lack of appropriate support to the patients after the trial

The second issue, which is also highly relevant to global medical research, is the responsibilities of the companies to the patients, especially when the clinical trial ends. The thing is that many people, who participate in such studies, do it because they have no other access to appropriate medication¹³. After the completion of the research, these people may still need these drugs¹⁴.

It is particularly important when we speak about chronic diseases. Thus, the question is whether research companies are obliged to provide them with medication. The problem is that thousands of low-income people take part in such studies, and they are often left to their own devices when there is no need for them. This ethical becomes even more important if we consider that many local governments have no resources to support these people.

Currently, this issue is not properly addressed by international or governmental agencies. The thing is that the research companies may offer their drugs to the patients or hospitals; however, they are not obliged to do so¹⁵. As a rule, the contracts signed between these organizations and local governments do not contain any provisions for continued treatment of these patients. Moreover, one should take into account that the trial participants often have to struggle with local bureaucracies that are very inefficient, and very often they have to wait for a long time until they do get the medication. Thus, one can say that the present situation is not acceptable, because now impoverished people of developing countries are almost helpless.

Overall, this problem requires close cooperation of governmental and international agencies. First of all, local governments should adopt a set of regulations which specify the obligations of a research company at a post-trial stage. For instance, the new laws may require them to sell tested drugs a reduced price to the hospitals and the patients requiring it. Secondly, secondly local governments and international agencies such as World Health Organization should provide some financial incentives to these corporations. This policy will ensure that the participants of medical trials have access to the drugs at the post-trial stage.

Failure to address the health needs of developing countries

While discussing the responsibilities of international corporations, one should also determine if these organizations should focus on the health needs of less advanced countries. The thing is that the majority of pharmaceutical focus on chronic and common diseases such as asthma, hypertension, depression, cancer, arthritis, cardiovascular diseases, and so forth¹⁶. It has to be acknowledged that this is the most effective marketing strategy for them.

Yet, such scholar as Ruth Macklin believes that these companies must try to address the health problems which are very palpable in a certain region or country¹⁷. For instance, the medical research companies can pay more attention to such diseases as malaria or HIV¹⁸ that are very widespread in African countries. Each year, millions of people die of these diseases, and they have practically no resources.

This issue is not addressed by local or international legislation. This situation illustrates a conflict of interests in which the goals of a particular medical research company are opposed to the needs of local populations. Admittedly, there are some exceptions to this rule. One can mention the Czech Republic that became a center of colon cancer studies because this disease is very common in this country¹⁹. However, medical companies adopt such approach it enables them to minimize costs but not due to ethical considerations²⁰. Very few international companies are willing to focus on the specific health needs of people living in the developing countries because this approach will not increase their profitability.

Again, in order to resolve such a problem, the governments of developing countries should encourage international companies to conduct the clinical trials in their states. They can do it by sharing some of the expenses which these corporations incur. In return, local governments can ask these companies to supply the medication at a reduced price. It seems that form of partnership will be most beneficial for people suffering from many diseases like malaria or HIV.

Conclusion

The ethical issues that have been discussed indicate that people living in developing countries are often in an underprivileged position. They are deprived of legal protection, and international companies are not always willing to promote their interests. Secondly, these people have very limited financial resources and proper medication may be unaffordable to them. Although, the ethical issues related to global medical research may vary; however, none of them can be resolved without active participation of local governments and international organizations. They must adopt a set of regulations which will force international companies to comply with ethical standards. Moreover, the local governments should form alliances with international companies in order to reduce the cost of R&D and subsequently provide effective medication to the population.

Bibliography

Macklin, Ruth. Double Standards in Medical Research in Developing Countries. Cambridge, UK: Cambridge University Press, 2004.

Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects. Princeton and Oxford: Princeton University Press, 2009.

Foonotes

Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009) 13.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), i.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004) 7.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009), 33.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009), 3.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 8.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 17.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 18.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009) 25.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 23.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 19.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 21.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 13.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009) 170.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009) 171.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009) 2.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 24.
Macklin, Ruth. Double Standards in Medical Research in Developing Countries, (Cambridge, UK: Cambridge University Press, 2004), 26.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009), 22.
Petryna, Adriana. When Experiments Travel. Clinical Trials and the Global Search for Human Subjects, (Princeton and Oxford: Princeton University Press, 2009), 23.

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