Health and Ethical Consequences of Outsourcing Pivotal Clinical Trials to Latin America: A Cross-Sectional, Descriptive Study

The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products...

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Published in:	PloS one 2016-06, Vol.11 (6), p.e0157756-e0157756
Main Authors:	Homedes, Núria, Ugalde, Antonio
Format:	Article
Language:	eng
Subjects:	Accessibility Bioethical Issues Budgeting Budgets Clinical trials Clinical Trials as Topic - economics Clinical Trials as Topic - ethics Commercialization Cross-Sectional Studies Developing Countries Distributors Drug Therapy - economics Drug Therapy - ethics Drugs Ethics FDA approval Health surveillance Humans Income Influence Latin America Litigation Medical ethics Medical research Medicine and Health Sciences Observational studies Observatories Outsourced Services - economics Outsourced Services - ethics Outsourcing Patients People and places Pharmaceutical industry Pharmaceuticals Product development Product safety Public health Regulatory agencies Research and Analysis Methods Safety Side effects Social Sciences
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Summary:	The implications of conducting clinical trials in low and middle income countries on the financial accessibility and safety of the pharmaceutical products available in those markets have not been studied. Regulatory practices and ethical declarations lead to the commercialization of the new products, referred to as New Molecular Entities (NMEs), in the countries where tested as soon as they are approved in high surveillance countries. Patients and patients' associations use the Latin American courts to access new and expensive treatments, regardless of their safety profile and therapeutic value. Cross-sectional, descriptive study. To determine the therapeutic value and safety profile of the NMEs approved by the Food and Drug Administration (FDA) in 2011 and 2012 that had been tested in Latin America, and the implications of their market approval for the pharmaceutical budgets in the countries where tested. Latin America. To assess the therapeutic value and safety of the NMEs commercialized in the different countries we used f independent drug bulletins. The prices of the NMEs for the consumers were obtained from the pharmaceutical price observatories of the countries were the medicines had been tested. If the price was not available in the observatories, it was obtained from pharmaceutical distributors. We used the countries' minimum wage and per capita income to calculate the financial accessibility of a course of treatment with the NMEs. We found that 33 NMEs approved by the FDA in 2011 and 2012 have been tested in Latin America. Of these, 26 had been evaluated by independent drug bulletins and only five were found to add some value to a subset of patients and had significant side-effects. The pharmaceutical prices were very high, varied widely across countries and were unrelated to the countries' income per capita or minimum wage. The implementation of clinical trials in Latin America results in the commercialization of medicines with questionable safety profiles and limited therapeutic value, putting patients at risk and causing budgetary strains in pharmaceutical budgets.
ISSN:	1932-6203 1932-6203