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Ethics of Argentina cancer drug trials questioned

By Matmas A. Loewy

Last Updated: 2003-05-23 16:47:34 -0400 (Reuters Health)

BUENOS AIRES (Reuters Health) - An official report has found that the Argentine government does not effectively control clinical studies of cancer drugs, the local daily Clarmn reported Thursday.

Clinical trials in Argentina have surged over the last few years, driven by the alleged quality of medical professionals and more recently the deep devaluation of the peso against the dollar, which made recruitment of researchers and volunteers far cheaper in Argentina than in the U.S. or Europe.

The official number of Argentine patients taking part in clinical trials funded mainly by international pharmaceutical companies has increased from 12,400 in 2000 to 19,500 in 2002, and the figures are expected to keep on rising this year.

Eduardo Mondino, the head of the National Ombudsman office, was quoted as saying that his office had found 17 cases between 1998 and 2002 in which doctors tested cancer drugs without authorization of the official regulatory agency ANMAT.

The report does not specify which drugs and doctors were involved, but researchers are said to have failed to notify the ANMAT in cases in which they were legally obliged to do so. Such cases include experimental trials designed to investigate new indications or dosages of approved drugs, indications of non-approved drugs and tolerance and toxicity of new indications or combinations of drugs.

Other irregularities, according to the report, were the failure to get informed consent from patients and the use of social welfare funds to pay for experimental treatments.

An Argentine oncologist who declined to be named tried to offer some explanations.

"If you test cancer drugs according to the official rules, you should give your patients proper and adequate information about their disease and the real prospects of the experimental treatment. But informed consent does not get on well with our culture, in which most families prevent their loved ones from being told that they suffer from cancer," he told Reuters Health.

Manuel Limeres, head of the ANMAT, told reporters that he had ordered an internal audit to evaluate the responsibility of the agency. Meanwhile, Ginis Gonzalez Garcma at the Ministry of Health said yesterday that he had adopted a similar measure.

According to Mondino, from the National Ombudsman office, "lack of official control makes our country attractive to do experimental research without observing the human rights of patients."

Copyright 2002 Reuters