E-DRUG: Article of interest - Clinical Trials in Latin America
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http://www.who.int/bulletin/volumes/93/10/14-151290.pdf
Abstract below:
Availability and affordability of new medicines in Latin American countries
where pivotal clinical trials were conducted
Núria Homedes & Antonio Ugalde
[Núria Homedes is with the School of Public Health, University of Texas, Houston, at the El Paso regional campus. Antonio Ugalde is with the Department of Sociology, University of Texas, Austin.]
Objective
To assess whether new pharmaceutical products approved by the United States
Food and Drug Administration (FDA) in 2011 and 2012 were registered,
commercialized and sold at affordable prices in the Latin American
countries where they were tested.
Methods
We obtained a list of new molecular entities (new pharmaceutical products)
approved by the FDA in 2011 and 2012. FDA medical reviews indicated the
countries where pivotal clinical trials had been conducted. The
registration status of the products was obtained from pharmaceutical
registers; pharmaceutical companies confirmed their availability in
national markets and local pricing observatories provided the price of
medicines in retail pharmacies. Affordability was assessed as the cost of a
course of treatment as a proportion of monthly income. Information on
safety and efficacy was gathered from independent drug bulletins.
Findings
Of an expected 114 registrations, if the 33 products had been registered in
all the countries where tested, only 68 (60%) were completed. Eight
products were registered and commercialized in all countries but 10 had not
been registered in any of the countries. With one exception, products for
which we obtained pricing information (*n* = 18) cost more than the monthly
minimum wage in all countries and 12 products cost at least five times the
monthly minimum wage.
Conclusion
Many pharmaceutical products tested in Latin America are unavailable and/or
unaffordable to most of the population. Ethical review committees should
consider the local affordability and therapeutic relevance of new products
as additional criteria for the approval of clinical trials. Finally,
clinical trials have opportunity costs that need to be assessed.
Nuria Homedes <nhomedes@gmail.com>