Ebola and the ethics of international drug testing

Ebola has been around for nearly 40 years now, and until recently the public was unaware of any available treatments or treatments in development for the disease. In fact, there is no market incentive for pharmaceutical companies to develop treatments as most of its victims are too poor to buy medicines. If and when Ebola spreads to more affluent parts of the world, of course, pharmaceutical companies will adjust their research and development strategies.

As market incentives for development of treatments do not exist, it falls to governments to fund research into possible treatments and vaccines. As Marie-Paule Kieny, assistant director-general of the World Health Organization (WHO), pointed out, “If it hadn’t been for the investment of a few governments in the development of these drugs, we would be nowhere.” Much of the funding for research has come from the United States, not from humanitarian concerns for Africans, but for domestic concerns. According to a Globe and Mail article by Geoffrey York, “most of the research on Ebola treatments has been financed by the U.S. government, often because of fears that the Ebola virus could be used aesculab-stabas a form of bioterrorism.” Be that as it may, it is a relief to know that someone is working on treatment and prevention.

As the disease has occurred in Africa, you might expect that research on it should also occur in Africa with robust drug trials being conducted in an ongoing basis, Bioethicist Arthur Caplan  says it is unreasonable to expect the research to happen in Africa. He wrote, “Privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists.” ZMapp is the drug given to the Americans who contracted Ebola in Africa before being flown back to the US for treatment.

It might be possible for pharmaceutical companies to build such infrastructure, but Caplan encapsulates the real reason research does not happen in Africa nicely: “Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free.” Enthusiastically give away? No, they won’t even develop the drug in the first place.

Now that an experimental treatment (ZMapp) does exist, should it be tested on Africans? Bioethicist George Annas says, “If the drugs we are currently working on have been shown to be reasonably safe, and if there is realistic and robust African review and individual informed, voluntary consent, use of American-developed drugs in Africa could be justified.” Annas is here emphasizing the protection of possible African research participants rather than explaining why only the privileged should receive the drug, and he has good reason.

It isn’t as though the lack of infrastructure in Africa has prevented drug trials from taking place there in the past as you might imagine from the debate over Ebola drugs. In fact, testing has raised serious issues of exploitation in the past as drugs were tested on vulnerable populations with no intention of ever providing those same populations with any treatments that might be developed. In 1994, the HIV drug, AZT (zidovudine) was found (in a study known as AIDS Clinical Trials Group 076)  to prevent transmission from HIV-positive mothers to their infants. The study was considered important in the development of drugs to treat AIDS, but there were no plans to provide AZT to the communities where it was tested once the clinical trials concluded. Research subjects in Africa bore the risks associated with taking experimental medications but would not see the benefits of the medications developed.

As there is no market incentive for pharmaceutical companies to develop treatments while protecting research subjects in vulnerable populations, it is up to governments to help promote treatments for unprofitable diseases. This has obviously happened to an extent., but we could, and should, do more. Philosopher Thomas Pogge has initiated a plan to help improve the situation. He has proposed a Health Impact Fund  that would provide a sort of artificial market incentive for companies to develop otherwise unprofitable treatments. Under the plan, governments would contribute to a fund that would then be distributed to pharmaceutical companies based on their ability to develop drugs that would have the greatest health impact. In order to receive payments from the HIF, companies would agree to provide treatments at cost anywhere in the world. I don’t know whether the Health Impact Fund will provide a solution to treating diseases that primarily affect the poor, but it certainly represents the kind of thinking required to address these serious issues.

If we are not motivated by the suffering of others in the world, and it appears many in affluent countries are not, we may do well to recognize that diseases do spread beyond all borders. Diseases that do not affect us today may well affect us tomorrow. The so-called “free” market is obviously not the solution, so we will do well to consider other options.

About ethicsbeyondcompliance

I hold a PhD in medical humanities with an major emphasis in ethics. I began teaching college-level ethics in 2000.
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