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2003, Number 1

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Rev Med Inst Mex Seguro Soc 2003; 41 (1)

Bioethics and Placebo Utilization in Controlled Clinical Trials

Ramírez VI, Cabrera PC

Language: Spanish
References: 27
Page: 65-74
PDF size: 77.55 Kb.


ABSTRACT

At present, discussions on ethics in placebo-controlled clinical trials (PCT) are a quite contro-versial issue. Here, some historical aspects about studies in human beings are overviewed. To discover potential adverse reactions that may be overseen, the scientific need to compare a drug against a placebo is also considered. The issue concerning ethics in carrying out placebo-controlled trials (PCT) when drug safety has already been proved is analyzed. PCT in perinatal HIV prevention, performed in undeveloped countries and carried out despite having effective treatment, are also discussed. The ethics of assaying drugs compared to placebo when such trials are considered unethical in developed countries is also considered. Trials effectuated in developing countries, in which an expensive drug is on trial against a placebo, are questioned, especially if there is no intention of making such a drug available to the studied population. It is concluded that one of the risks of the internationalization of clinical investigation is the potential exploitation of susceptible people in undeveloped countries. It is unacceptable to obtain scientific knowledge at the cost of unnecessary suffering to one part of a population; therefore, performance of interventional trials in developing countries by using different ethical criteria from those observed in developed countries must not be endorsed.


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