A proposed relaxation in international ethics for human trials in developing countries could lead to patients losing access to drugs that they have helped to test, according to an article in medical journal The Lancet today.
The authors accuse US regulators of trying to limit the rights of trial subjects in developing countries. A number of pharmaceutical firms, such as Novartis and GlaxoSmithKline, are moving significant numbers of trials to India and other low-cost countries. In the UK volunteers for clinical trials are paid around £100 a night, but industry sources suggest the cost can be as little as a tenth of that in the developing world.
The US's Food and Drug Administration has proposed that some of the trials required for a drug's approval in the US will not have to be conducted under the Declaration of Helsinki guidance drawn up in 1964.
The article's authors Peter Lurie, of US consumer group Public Citizen, and Dirceu Greco, of the Minas Gerais federal university in Brazil, said that the US has repeatedly tried to water down the Helsinki rules, after lobbying from drugs firms, but have now proposed to bypass it for certain drug approval applications.
The article says rules to prevent conflicts of interest in trials are at risk, as well as the access of trial subjects to a successful drug once tests are over, which would not be present under the proposals from the FDA. "The Declaration of Helsinki is the standard-bearer for international research ethics. It would be tragic if the US tendency to flout international mores claimed the declaration as another victim," it adds.
There is already controversy over the use of patients in developing countries. Dr Chandra Gulhati, the editor of India's Monthly Index of Medical Specialities, said: "Poor people will be used as guinea pigs for drugs they will never be able to use."
A GSK spokesman said: "We conduct all our clinical trials according to the same high standards, wherever they take place," The FDA said the Helsinki agreement's ethical standards are weaker than the authors suggest. It said the US needed to have more control of its trial standards.
