Medical Testing Abroad

The social, political and economic conditions for medical testing in the third world are radically different from those in the United States. This coffee talk focused on testing AZT, a drug used for AIDS therapy, in Africa.

· Pharmaceuticals giant Merck & Co. tested AZT on AIDS patients in both the United States and sub-Saharan Africa. There were three groups of patients who underwent the therapy:

1. Long therapy: More expensive, but potentially more effective. This therapy required patients to return to the clinic periofically

2. Short therapy: Less expensive, but not as much potential benefit as the long therapy

3. Placebo: Placebo patients still received regular clinical check-ups, but were only given a placebo. Without these placebo patients, the entire study would not have been scientifically valid.

· Before AZT was tested in Africa, the long therapy was tested on patients in the United States. Written informed consent was gained from all participants in the study. In Africa, however, it was much more difficult to clearly gain informed consent. Many subjects of the study in Africa could not read, and/or did not understand what would be happening to them.

· These studies offered potential health benefits to people who would otherwise receive none, and were approved and condoned by the governments of the African countries in which they occurred.

Some Thoughts/Reactions/Speculations/Questions/Opinions:

· Assuming medical advances in the United States result from foreign studies like this, will we even share these advances with the countries in which we experimented? Are people of the third world serving as guinea pigs for American interests?

· From some philosophical perspective, any potential benefits of this study are irrelevant. People were used as a means to an end. This violates Kant’s categorical imperative.

· On the other hand, a utilitarian perspective would justify such studies, provided they ultimately brought the greatest good for the greatest number of people. In the end, there is evidence that this study helped more people than if nothing had been done. Thus, this issue in bioethics could be reduced to the philosophical debate of Kant vs. Mill.

· Should we even attempt to test a medical treatment without gaining informed consent?

o No! Universal human rights must be upheld, and engaging in any “therapy” without informed consent would violate the principle of universal human rights.

o Yes! As long as people know they’re going to be helped (in the short run or the long run?), it’s okay to study a therapy without full informed consent

· The governments of these African countries approved the studies. In a way, the governments offered surrogate consent. On the other hand, should a government, whose actual representation of the people is often questionable, be allowed to speak for individual consent?

· When the government is corrupt, which is not uncommon, there is a fee (really a bribe) that companies pay to perform research. Engaging in this research is problematic for two reasons:

1. It propagates the system of government corruption

2. It can be guaranteed that the government is not providing any sort of ethically acceptable surrogate consent.

· Americans were tested with the more expensive, long therapy. Africans were tested with the short therapy. Thus, it can be argued that American test subjects received superior treatment to the African test subjects. Does this mean that the Pharmaceutical companies treated Africans inequitably?

· Africa is radically different from the United States. In different parts of Africa, there are different health standards (less water, more anemia, etc). A group of Africans and a group of Americans might respond differently to the same treatment. Since we are dealing with two separate situations, this is not a double standard.

o For example, because of the social situation in Africa, it might be more difficult for test subject to make regular visits to the clinic over a long period of time. Consequently, the short therapy might be the most appropriate therapy for societies such as those tested in Africa.

· From an experimental standpoint, there was already sufficient data on the long therapy after trials in the United States. Additional testing of the long therapy was not nearly as scientifically useful as testing of the short therapy.

o But why wasn’t the short therapy tested in the United States?

o On the other hand, this study was also done in Thailand, and data from it helped other people.

· The placebo does no actual harm to test subjects. In fact, these subjects receive free medical check-ups that they would not otherwise receive. Therefore, it is valid to argue that all participants in the study are receiving at least some health benefits

· Is there some universal ethical standard for all people?

· If so, can we throw out this standard in the name of science?

· Should an international law protect the most basic of human rights?

o How would we enforce it?

· Because societies are different, what might be considered unethical in one society is acceptable in another. For example, coercion is frowned upon in the United States. In other countries, however, it is accepted that people do what doctors tell them to do.

o Are we saying that American standards of human rights are superior? How would we enforce American standards in other countries?

· This debate is generally confined to the United States because the United States is almost entirely responsible for research abroad.

· In the near future, much more medical experimentation will occur in foreign countries. These issues will continue to arise.