Study on infants in Peru sparks ethics inquiry

A doctor administers oral rehydration solution to a Peruvian child Copyright: WHO photolibrary

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A legal inquiry was launched last week to determine whether Peruvian babies were given a medicine made from genetically modified rice without their parents’ informed consent during a clinical trial.

The researchers deny any wrongdoing and are backed by Peruvian doctors and ethicists, but the claim has prompted Peruvian parliamentarian Mercedes Cabanillas to take action.

On 13 July Cabanillas asked the Public Defender’s Office to investigate, and it has since launched an inquiry.

The clinical trial in question was led by Nelly Zavaleta of Peru’s Nutrition Research Institute and began in August 2004. It involved 140 boys aged 5-33 months who had been admitted to one of two Peruvian hospitals.

They were divided into three groups and randomly given one of three oral rehydration solutions for treating infant diarrhoea — a major killer in developing nations.

One solution, made by US company Ventria Bioscience, contained proteins found in breast milk that had been produced from rice with human genes inserted into its DNA.

Zavaleta and colleagues found that this solution significantly cut the severity and duration of acute diarrhoea.

But critics fear that introducing two human genes into plants to produce drugs could threaten people’s safety.

Gynaecologist Herbert Cuba, who heads a small non-profit organisation called the Peruvian Medical Association, has denounced the trial, saying it was unethical to use transgenic products that no country has approved.

Wilfredo Ardito of the Peruvian Association for Human Rights, accepts that the parents signed forms indicating their consent for the children to take part. "But we doubt it was an informed [consent]. We think that parents were not properly informed.”

But Zavaleta insists that the study met all legal requirements — three independent scientific groups validated the study’s safety before it began.

The Peruvian College of Physicians has backed Zavaleta’s research, saying that its scientific societies and ethical committee concluded that the study, "fulfilled all the administrative, ethical, technical and legal requirements needed to carry out this sort of study".

The college says that Cuba’s association does not, in fact, represent any official institutions or medical groups, and his accusation must be considered personal.

The head of the college Amador Vargas added that children in the trial did not receive transgenic rice but just the two human proteins "which are harmless", as they are broken down within 24 hours.

Salomón Zavala Sarrio, a member of an ethics and health committee at the National Major University of San Marcos agrees. He told SciDev.Net that Peru has strong ethical standards and that Zavaleta’s trial had respected all of the regulations.

While Cuba says Peru was chosen for the trial because it is a poor nation with lax law enforcement, Ventria Bioscience says it was chosen because 20 to 25 per cent of the 36,000 children who die there every year are victims of diarrhoea.

Diarrhoea kills about two million children each year, mostly in developing nations.