Study on infants in Peru sparks ethics inquiry

Paula Leighton
18 July 2006
Source: SciDev.Net

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.

Two children have already developed allergies after an experiment with transgenic serum. Fabrizio and Jordano are among 140 children who received a rehydrating substance that contained plant-human genes. Mothers are demanding that the Ministry of Health monitors the state of their children.

The day that Diana Canessa Garay thought that she would lose her only baby, a “helping hand” appeared in the corridors of the Children’s Hospital. It was dressed in white and had a woman’s voice. It was a nurse who claimed to have a “remedy” to end the acute diarrhoea that the mother’s little Fabrizio had suffered [for?] eight months. To this desperate mother of 24 it was enough to hear that “rice serum” would cut the diarrhoea, for her to authorize the provision of that “medicine”. They did not explain that the rehydrating salt was of transgenic origin (with modified genes) and that its sale is prohibited because still it is in experimental phase. Nothing mattered to her but the immediate recovery of her boy, so Canessa signed the document on 15 February 2005. “They wanted to experiment with my baby, but they deceived me,” she lamented now that her son is already suffering [segÅ“n asegura?] the first consequences of the experiment.

With food one does not gamble

Transgenic foods are those that have been manipulated genetically in the laboratory. A specialist in this subject, Luis Gomero Osorio, of the Action Network for Alternative Agriculture (RAAA), explains that to these foods genes of the same species or others are added to them to enhance certain qualities. This way it is possible to obtain blue maize with cheese flavour, blue tomatoes or to increase the production of crops.

Nevertheless, a large sector of the international scientific community and several NGOs have noticed that transgenic foods are risky for the public health. Ivonne Y‡–ez, representative of the Network for a GM-Free Latin America, explains that when proteins modified by the hand of man are introduced in the food chain these can trigger allergies and other types of ills in the people who consume these foods.

Rice with human genes

The union of genes of the same species (generally plant) is commonly practised abroad, specially in the United States. Nevertheless, the union of different species as the vegetable and the human one “is aberrant”, according to Gomero. However, American pharmaceutical company VENTRIA BIOCIENCE did it with the rice. To this food they added two human proteins, soon these were isolated to make up a rehydrating solution. The purpose was to obtain a serum that helped stop acute diarrhoea and dehydration.

The commercialization of the serum has been rejected in the United States. The governmental organisation of that country that guards the safety of medicines (Federal Administration of Drugs and Foods, FDA) has [said] no to VENTRIA 3 times [? Uncertain translation, please check].

In spite of these antecedents the laboratory decided to experiment with 140 children in the third world. And what better place than Peru where legislation does not exist on GM and where our own Ministry of Health gives authorization?

The chosen centers of health were the Children’s Hospital in Lima and the Hospital of Trujillo. According to the person in charge of the study in our country, Nelly Zavaleta, the experiment was successful because the diarrhoeas were cut almost immediately. Nevertheless Zavaleta and our minister of health, Mazzetti Pillar, refuse to use the word “transgenic”. They prefer to say that the serum has “transgenic origin”. And what is the difference? “A transgenic has all its letters because its genes have been altered,”[??] says an expert in the subject.

Examination of the children

The allergies are the first consequences of transgenic food consumption. Fabrizio who now is 2 years old already suffers from them. “After they gave him the serum, my baby became sickly, delicate. Now he is allergic to everything, to chocolates, mandarins. I do not know what will happen to him later, the Ministry of Health must do a followup investigation of his health,” laments Diana. Another young mother, Johana Sanchez Turreate, also fears for the life of her 3-year-old son Jordano, who also developed allergies after receiving the serum.

Executive must observe law

On Wednesday, the Association for Human Rights (Aprodeh), the Plenary Session of the Congress of the Republic approved the controversial Law on Development of Biotechnology. According to the Peruvian Association of Consumers (Aspec) it would normally be overseen[?] by the Executive because it will be a door opened for the indiscriminate entry into our market of transgenic foods that are produced abroad on a large scale, specially in the United States.

The same position was adopted by the Peruvian Medical Association. This union of specialists was the one that denounced the scandal of the experiments on 140 children in the country. The case already is being investigated by the Fifth Penal Office of the public prosecutor of Lima headed by Cesar de los Rios.

ANALYSIS

Flora Luna Gonzales, biologist, university professor and expert in transgenics:

“The long-term consequences can be many. The children who have consumed this serum can suffer diseases like Alzheimer’s, because if the altered protein has a fault it can produce an amieloide [amyloid] substance that is deposited in the neurons and alters its function. Also it can cause pulmonary fibrosis because the protein with a fault can alter [elastasa?] that gives elasticity to the lung.

“The degenerative diseases to which the children expose themselves are many, to say nothing of the allergies. The condition that has taken control of our children does not have a name. In no place in the world have these types of experiments on people and much less on suckling babies, been done. Abroad they have only done them on monkeys.

“The minister of Health lies when she assures us that these experiments with transgenic products will not bring future consequences to these defenceless children. It is necessary that a clinical followup investigation is done by those who did the experiment. At the moment there is a world-wide wave of rejection of consumption of these foods and Peru cannot be an exception.”