The Ethics of Global Clinical Trials in Lower-Income Countries

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NEEDHAM, Massachusetts — Although many samples of a population could undergo testing, large pharmaceutical companies often test new drugs in lower-income countries. The practice is more cost-effective. In many other countries, people take the side effects and ingredients listed on the bottles of medicines for granted; they disregard the risks that the participants of those trials took. In the majority of instances, civilians in lower-income countries have no choice but to take part in dangerous and often incomplete drug-testing trials to help their families keep afloat. Women in lower-income countries adversely demonstrate this effect as well; their families will often force them into taking part in trials without their consent. Misinformation, a lack of supplemental resources and limited income options make the concept of global clinical trials in lower-income countries unethical.

Why are Global Clinical Trials Harmful?

Clinical trials are necessary in order to combat communicable and non-communicable diseases in a safe manner. However, when the trials begin to spread globally, the question of ethics comes into play. For scientists who need test subjects to make new medicine, regions of lower-income communities prove to be cost-effective. These countries also have a large turnout of participants. Unfortunately, many of these participants are at a major disadvantage when they sign up for global clinical trials.

The risks of taking part in any kind of clinical trial are high regardless of location; yet, in these regions, participants do not always know the risks. According to a BBC investigative study, in India, members of the lowest caste were entered into drug trials in 2011 without full knowledge of the trial. Under the image of providing aid to sick civilians, drug testers in the clinical trials administered drugs with very little information given. Although many of the civilians gave individual consent, they were not fully informed on the situation, so that scientists could complete their tests and collect data. Taking advantage of people with trust in healthcare destroys the progress the world has made in uplifting people from poverty. In 2011, these trials caused the deaths of 438 people. Most of the deceased took the chance of treatment without anyone informing them of the risks it posed.

Additionally, administering global clinical trials goes against many ethical standards doctors and scientists establish when considering the benefit of patients. For those living in poverty, being offered a strong support system and trustworthy aid is essential in reducing gaps between classes in society. One problem with conducting these global clinical trials in lower-income countries is that upon the completion of the trials, most participants cannot get the medicine. Even if the drug gains approval and is released into the market, its prices are often too high for individuals in these countries. This elicits the question, is it ethical to put participants through the risks of the trial if they cannot even get the medicine in the end?

Other Ethical Questions

Although there is a push to promote larger access to essential medicines, such as antiretroviral therapy that slows HIV in the body, most drugs are cost-prohibitive. However, with a global clinical trial, the various parts of the trial need accounting for as well, including the control group. For most clinical trials held, doctors create a placebo control group in order to test the effectiveness of a proposed drug among groups of people.

Patients also rarely know whether or not they have received a placebo drug. As a result, they place their trust in the system of the trial even with their health on the line. However, many scientists debate whether it is ethical to administer a placebo drug among participants when a possible treatment is around. Oftentimes, these global clinical trials provide treatments or potential cures for diseases that are quite serious. This situation further blurs the ethicality of administering placebo pills.

The attention to the small details in global clinical trials has also drawn comparisons to clinical trials in countries with larger healthcare services. A lot of global clinical trials have been cited as “careless” and “less meticulous.” This results in problematic side effects and sometimes even death. In a study on HIV in the United States in the 1990s, all of the participants in the clinical trial had access to zidovudine or other antiretroviral drugs. However, 15 out of 16 countries in Africa, Asia and the Caribbean did not have access to any antiretroviral drugs in the control groups. The nonprofit Public Citizen made a call to halt the trials. Yet, before it could go through, dozens of infants in Thailand got unnecessarily infected with HIV. Many patients in lower-income countries are at the mercy of large pharmaceutical companies, that see no choice but to participate in dangerous, misinformed or unethical global trials.

Participants of Global Clinical Trials

Those who participate in global clinical trials in lower-income countries span from a wide spectrum of backgrounds. Many seek potential treatment for an ailment that they cannot cure in their region’s healthcare system. Additionally, many others participate in trials to earn money for themselves and their family. Others get forced into participating for the same reason. For example, families in lower-income countries often force women to take part in clinical trials. Even though they do not give their consent, they still face the risks of such trials. This poses a hazardous ordeal and ethical hurdle.

To overcome this massive invasion of freedom and basic human rights, global clinical trials must confirm that individuals are participating willingly. Consent is the most significant aspect of the global clinical trials that participants are privy to — stripping away that right violates their freedom. According to the World Health Organization (WHO), more than 60,000 people worldwide participated in clinical trials. Out of those people, very few citizens of lower-income countries experienced a safe and inclusive clinical trial.

Solutions

In order to combat the advantage that large companies have on groups of people in lower-income countries, the international community needs to be aware of global clinical trials. Additionally, pharmaceutical companies must also improve the quality of the trials. As Alex John London, Professor of Philosophy and Director of The Center for Ethics and Policy at Carnegie Mellon University, stated in an article published by EMBO Reports, “You want to make sure that you don’t take advantage of deprivation and that you don’t see the world as a convenient population of sick people where you can go and get the data that you need to make more robust health systems in high-income countries.”

The questionable aspect of global clinical trials can improve by allowing participants to gain clarity on their role in the trial in a manner that would not affect test results. In addition, healthcare professionals can conduct the global trials in a safer manner by simply clearing the trials with background checks and a complete understanding of variables. Most importantly, changing the mindset toward globally-directed clinical trials is imperative toward making strides in healthcare. If clinical trials can safely occur in the United States, a stronger effort and better communication can create a safe global clinical trial in lower-income countries.

The WHO and the ICTRP

WHO is an example of an NGO attempting to ease the discrepancies in misinformation that global clinical trials often face. WHO is starting out with a project on clinical trials called the WHO International Clinical Trials Registry Platform (ICTRP). The values of the project include transparency in goals and patient-doctor communication. To achieve this, the ICTRP is trying to promote access to guidelines, registration and regulations. By opening up the channels between the healthcare system and participants, the ICTRP is allowing for those in lower-income countries to experience a safer, more secure trial. Although experts cannot confirm or assure safe results of the trial, the participation and circumstance regarding consent and knowledge will improve through the ICTRP.

– Esha Kelkar
Photo: Unsplash

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