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Fears over clinical trials in poor countries

5th July 2011

Science journalists in Qatar have heard that an increasing number of clinical trials are being held in developing countries, which often lack the legal or ethical frameworks to protect people.

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According to a recent presentation to the 7th World Conference of Science Journalists, the number of clinical trials in poor countries tripled in the period 2000-2008 compared with the total number over the previous half-century.

The figure only included trials registered with the United States drug regulator, the Food and Drug Administration.

There was also a growing trend for 'transitional' countries, which have characteristics both of developed and developing economies, to take part.

Brazil, China, India, Mexico and South Africa were cited as examples of transitional countries.

Drug makers were attracted to developing countries by lower costs and a high level of willingness among the population, as well as little exposure to previous trials or drugs.

Such patients were described as "treatment-naive".

The governments of these countries for their part were attracted by the promise of advanced medical science and access to the latest medications.

But many countries have begun taking part in trials without an adequate legal or ethical framework.

Ames Dhai, director of the Steve Biko Centre for Bioethics at the University of Witwatersrand, South Africa, told the meeting that legal and ethnical frameworks were developing faster in some poorer countries than in others, potentially putting patients at risk.

Dhai said a less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation were all factors that made pharmaceutical companies want to operate in developing countries.

And in countries that have set ethical standards, there are often no guarantees that they would be upheld by those carrying out the trials.

Dhai said the problem lay more often with implementing existing rules and guidelines.

He said researchers and sponsors often adopted an "imperialistic attitude" and disregarded local laws and best practices.

In South Africa, vulnerable people living in poverty are frequently recruited to take part in clinical trials, and are more likely to accept authority and not question what is happening.

In India, a recent trial of two vaccines for papilloma viruses exposed ethical shortcomings in the Indian system.

Experts estimate that as many as 80% of trial participants in developing countries have little idea what sort of study they are taking part in.

Dhai said the needs of biomedical research should be better balanced with the full protection of people and communities that participate in research.

Sonia Shah's book, The Body Hunters, reports that trial participants in poorer countries fear negative effects on their future access to healthcare if they stop participating in trials.

 



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