Neha Anand: Testing Drugs in the Developing World
In the last two decades, many pharmaceutical companies, including Bayer, GlaxoSmithKline, and Pfizer, have outsourced their clinical trials to developing countries, where testing is significantly cheaper and faster. Developing nations have welcomed drug testing as a mechanism to provide otherwise unaffordable healthcare to the public. However, treating patients in the developing world has triggered several ethical debates. Clinical trials in the developing world have failed to receive clear consent from patients, inform them about potential risks, and compensate them for their cooperation. Furthermore, it remains uncertain whether data collected in these trials abroad are applicable at home.
Drug-testing in the developing world appeals to pharmaceutical companies that seek to maximize the cost-effectiveness of drug trials. The New England Journal of Medicine reported in 2009 that conducting a trial at an academic medical center in India, where companies pay their clinical staff far lower salaries, costs less than a tenth of the cost of a trial in the U.S.
Although these foreign trials benefit pharmaceutical companies, they may not be ethical. Acquiring clear consent from patients is one of the most significant ethical challenges of holding trials in the developing world. The incentive of free care draws underprivileged individuals to volunteer for the studies. Due to a lack of education and language barriers, however, it can be difficult to discern whether the patients understand the terms and consequences of their compliance. In a 2012 case in India reported by BBC, several patients of the Dalit caste (the “untouchables”) suffered atrocious side effects and even death after a drug trial. These deaths often even went unreported. In the past several years, seventy-three clinical trials on 3,300 patients, including 1,833 children, took place at the Maharaja Yeshwantrao Hospital in Indore. Many patients and their families could not understand English (spoken by the coordinators of the study), were not given a formal consent form, and were not informed that they were receiving a trial drug.
Even among the patients who do consent to participate in a trial, many are unaware of the risks and terms. The label of “drug” leads them to believe that it must have a favorable effect. Furthermore, the patients may not understand that their involvement in the trial does not guarantee that they will receive treatment; there is equal likelihood that these patients are placed in a control group and receive placebo drugs. The Center for Research on Multinational Corporations highlights a study conducted in Uganda, Zimbabwe, and the Cote d’Ivoire from 2003 to 2006 that split patients into two groups to study anti-retroviral treatment for HIV/AIDS. One group received continuous treatment while the other received interrupted treatment for twelve weeks. Those in the latter group bore far more serious health risks than the former. The inequality of treatment during trials can be fatal for the populations who sign up for clinical trials.
Volunteers who put their lives at stake deserve compensation. While patients will receive monetary or food rewards, oftentimes the family is not compensated when the patient dies. In the trial case with the Dalit caste in India reported by BBC, the families who lost a member in the clinical trials received no compensation.
If the trial drug cures the patient, the patient expects to continue treatment with the drug afterwards. However, the drug may be too costly for participants to afford after commercialization. Pharmaceutical companies argue that providing the drug for free to participants is far too costly. In 2001, the free supply of imatinib, a drug used to treat various types of cancers, was tested on populations in South Korea, Hong Kong, India and other countries, and then suspended. The pricing of the drug became so high that even patients in developed nations could not afford them. The dispute over the price is still ongoing.
Furthermore, the validity of the application of data from clinical trials in third-world countries to developed nations is contended as well. The New England Journal of Medicine found that differences in the quality of care and hospital infrastructure affect the application of results from clinical trials in developing nations to individuals in the United States. Genetic differences also reduce applicability of a study. One study showed that there was a significant difference in pharmacologic response between those of African and European ancestry. In light of these disparities, it may not be ethical for drugs tested solely on a population abroad to be approved and marketed in the United States.
In response to ethical debates, international regulatory bodies have established standards for clinical trials. The Declaration of Helsinki published by the World Medical Association in 1964 exemplifies a revolutionary shift in thinking surrounding conduct with human experiments. The document specifically includes a provision that declares “vulnerable research populations require special protection.”
Even though several regulatory bodies exist to combat ethical violations in clinical trials, local governments in developing nations do not always enforce these regulations. In order to eliminate unethical testing abroad, we must focus on incorporating education programs and overcoming language borders, in addition to supporting larger regulatory institutions. Education of patients plays a critical role in keeping clinical trials ethical. If patients were educated on the type of drug that was being tested, the risks involved, and the compensation afterwards, many of the ethical obstacles of trials would be removed. Likewise, language barriers could be eliminated if consent contracts were in the patients’ native language and if professional translators were present at the trial. On a larger scale, developing nations need to create policy in conjunction with pharmaceutical companies that will increase the transparency of clinical trials and tighten regulation.
It is pivotal to recognize the tendency for exploitation as well as the uncertainty regarding validity of pharmaceutical clinical trials. Growth in understanding of the potential shortcomings of clinical trials in the developing world will hopefully drive the necessary political, legal and social changes to establish transparent and credible clinical trails in the future.
Neha Anand is in Ezra Stiles College. This perspective has been re-uploaded from our 2015 issue.