The Zidovudine Case, the International Debate and Moving Forward
It is well known that we live in a world of disparities between developed and developing nations. As developed nations continue to hurtle down the path of progress and globalization, it seems like these divides will only deepen unless developing countries find a way to rapidly industrialize. Health has proven to be the cornerstone of societal development; by promoting economic progress and multiplying human resources, advancing healthcare has quickly become the primary objective for development . While technology of developed nations has made strides over the past decade, the state of international health research has reached a second watershed, in particular the state of biomedical research being conducted in developing countries. In order for the frontrunners of scientific discovery to continue pushing forward, still-developing nations must develop a growing dependence on outside aid. One of the major causes of this second watershed is the glaring gap between the standard of healthcare in developing host countries and the standard in the developed sponsoring countries. As breakthroughs continue, developing countries are left to be dependent on outside sources to provide higher standards of health with no plausible alternative. After the polarizing response to the Zidovudine experiments at the turn of the century, both sides of the health standards debate became vocal and are currently locked in an ethical stalemate, raising the question of how to move forward.
Zidovudine is a drug regimen that is administered to mothers and infants when the mother is a positive carrier of HIV. When administered early enough in the pregnancy, applied with strict adherence to the guidelines, and continued after birth, the transmission rate from mother-to-infant can be decreased from 25.5% to 8.3% . This drug regimen has quickly become the standard protocol for treatment of pregnant women with HIV in the developed world, but many third world countries lack the necessary funds and resources to instate Zidovudine nationwide. The treatment requires long term care and must be started early in the pregnancy, costing up to thousands of dollars per patient. Since this treatment is not practical to be instated in developing countries, research has been done to find cheaper alternative treatments that can become the standard protocol in these areas. The finding of these alternative drugs is where the debate escalates. When trying to find alternative treatments for pressing diseases, a control group is necessary for regimen comparison. Under the Declaration of Helsinki and other similar regulatory documents, the control group in a biomedical experiment with human subjects may not be an untreated group if an effective treatment has been identified. The control group must be given the standard treatment to be compared against the developed drug. The main question here is whether or not the standard of treatment in developing countries is the same as the standard of treatment in developed countries.
At first glance, the answer to this question does not seem like the Mobius strip that it is. Of course researchers everywhere are striving to bring better, more optimized medicine to every country, developing or otherwise. In this state of mind, every research subject should be given the highest treatment available by default, free from discrimination of economic resources and nationality. The results of experiments should always come second to the overall well-being of the subjects, and knowingly giving a subject an inferior treatment is unethical . Allowing for research controls based on relative medical standards opens the doors for companies to go into underdeveloped areas and exploit their lack of resources for cheaper results. By using areas with lower standards of health, companies can use this as a way to get off the hook for providing more expensive standard treatments required if they conducted the human trials in their home countries. Opponents of the Zidovudine experiments claim that ethics should not be principles that are relative to one kind of area and change in another. Ethics are laid down to protect people and provide morals to scientific experiments regardless of the nation’s developmental state. By requiring controls of biomedical experiments to be the highest treatment available, medicine has nowhere to move but forward, continuously pushing for better global standards of care and treatment of people. In a perfect world, this should be the case; but the perfect world does not exist.
It is unreasonable to think that every nation on earth is equal economically, politically, and scientifically. Each country has strengths, weaknesses, and teams of talented scientists that are striving to make their world a better place. In the same way it is unreasonable to believe that every nation is the same, it is unreasonable to believe that a blanket application of healthcare standards can be beneficial to each nation . The Zidovudine case exemplifies the complete halt in progress when populations are not given necessary individual attention. To test the new regimens, the control group was designed to be untreated so that researchers could see if the new treatment was effective compared with the current common treatment, which in these areas was no treatment at all. However, with the strict ethical regulations, Zidovudine was required to be administered to the control group. While this seemed ethical, by requiring this modified control all the experiments could do was prove that the new regimen was not as helpful as the best regimen. All the results can say is that the area should instate an impossible treatment and leaves the community with no alternative.
Opponents of the untreated control group state that the sponsoring country should provide Zidovudine, but does this not further dependence on developed countries and completely block individual progress of developing countries? The idea that Western healthcare is the best healthcare and should be required worldwide is an idea of “medical imperialism” that only serves to handicap developing countries and never gives them the chance to identify feasible and affordable treatments that fit the needs of their populations . What works for one area may not work for another and developed countries forcing “better” but inappropriate methods on countries that are deemed technologically inferior does not seem ethical, but seems driven by intellectual bigotry.
The debate on healthcare standards and the regulations that guide the ethics behind biomedical research has, until now, focused directly on the definitions of control groups and the wording and application of internationally approved rules. However, to move forward, the discussion has to shift from superficial regulation to how to reduce the global inequities of health. It is true that researchers around the world need to commit themselves to the highest ethical standard to avoid exploitation of peoples and encourage development and collaboration between nations . Unfortunately, the reality is that research ethics are universal, but medical care standards are not. Instead of holding an impossibly high standard over all nations, each community should be given individual attention on what questions need answering and how medical research can best benefit them. This way, developing nations can take plausible steps towards their own best sustainable healthcare, not toward the healthcare that was chosen for them. By ending medical and ethical imperialism, developing countries are given a second chance to thrive, facilitating their brightest minds to push their nation further and giving their people freedom from dependence on outside nations.
It is hard to picture what the future of international medical research could look like, but some current cases help to shape that vision and give hope for what is to come. In Gadchiroli, India, medical trials were conducted involving the treatment of newborn infants with suspected sepsis. A standard effective treatment for infants with sepsis was already in place in India, but the research subjects were from a community where the national standard of care was not available. After gaining a community concurrence for participation, an untreated control group was used to seek out an effective treatment that would be available to communities of the same demographic across India. This study resulted in proving a method that reduced neonatal mortality due to sepsis by 72% . If the researchers had adamantly adhered to standard of care clauses set forth by international ethics bodies, these experiments would have had to contain a non-sustainable control group and the study could not have taken place due to lack of funding and resources. Landmark trials such as the Gadchiroli trial vindicate the stance of researchers promoting the progressive improvement of health in individual populations and also succeed in exemplifying how individualized research can be both ethical and effective.
While the debate on global health standards has polarized many leading medical researchers and ethicists, it has succeeded in bringing global health inequities to the center of the world stage. The goal of debate should always be to identify means of reducing these inequities, and should never lose focus of the bigger picture to the small details of wording and application. By resolving this debate, the world can continue prosper and countries can collaborate to push each other and facilitate each other’s growth. It is not a perfect world and nations cannot be treated as if it is, but by continuously striving and advancing respective arenas, nations can move upward together toward a progressive global health community.
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