;   Medical Translation Insight: Developing world turns less friendly to drug trials - ForeignExchange Translations

Developing world turns less friendly to drug trialsLatin America's importance in clinical research has been growing steadily. We mentioned in the past how medical device and pharmaceutical companies have made Latin America on of the "big three" emerging research markets. Now, though, the region is looking somewhat less hospitable.

The Buenos Aires Herald reports that GSK was fined 400,000 pesos (roughly US$ 93,000) following a report issued by Argentina's National Administration of Medicine, Food and Technology for the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.

The finding comes after much controversy around the trial erupted in 2008. GSK maintains that the deaths are not related to the vaccine trials.

Appeals will undoubtedly drag this issue out for a while longer. But that hasn't stopped the resurfacing of protests against global clinical research in general, antidepressant medication more specifically, and GSK very specifically.

GlaxoSmithKline Fined £60,000 for Killing 14 Babies in Sinister Argentinian Drug Trial is the title of one blog post.

Another blog asks "What price a human life?" and then provides the sobering answer: "By my reckoning that's just over £4,000 per child."

Whatever the final outcome in this tragic situation, clinical research is destined to stay controversial: It is likely that proponents will continue to entice moms to earn extra money by participating in clinical trials and opponents will continue to burn down houses of those they view as killers.

[Thanks to Pharmalot for the tip]

P.S. Somewhat related, there is still more trouble for clinical research: Discussing issues with missing clinical trial data, a BMJ editorial derides the "Alice in Wonderland" feel of clinical research efforts.

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2 Comments:

  1. cgtradmed said...
    US$ 93,000 for 14 infants ! Incredible! Is the fine calculated by weight? This is scandalous. Where is this world going, this is the basic issue to be considered when you realize the price set for one human life.
    Emma Goldsmith said...
    This appears to be outrageous, but the fine actually concerns the informed consent procedure, not drug safety issues. In fact, Synflorix (the study drug) has since been authorised in Europe. I think we need to be very careful of "drug kills 14 babies"-type headlines.

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