Babies as Guinea Pigs: Biotech company turns two Peruvian hospitals into laboratories
Silvia Ribeiro*
The biotech company Ventria Biosciences sponsored tests, on babies and children hospitalized at two pediatric institutes in Peru, of two new experimental drugs derived from transgenic rice that was genetically engineered with synthetic human genes to produce artificial human milk proteins.
The experiments - results of which were revealed this May in the US - were carried out at the Institute for Child Health and at the Nutrition Research Institute, both in Lima, Peru. The Peruvian public found out about the experiments when they were denounced by the Peruvian Human Rights Association and the Network for a GMO-Free Latin America. Ventria is a biotech company that specializes in so-called “Pharming,” which refers to planting genetically-modified crops that are cultivated to produce pharmaceutical agents or chemicals. Such plant varieties are even more controversial than the GM (genetically-modified) crops designed for agricultural use. This is because the “Pharm” crops could contaminate food crops, via the movement of pollen or accidental mixing of crop residue, with significant health risks, particularly if they enter the human food chain.
So far, no drug produced by transgenic crops has been approved for human use in the US or anywhere else in the world. Ventria began planting GM pharma crops in California, but was forced to move them to Missouri and then to North Carolina in response to resistance by farm groups and by consumer and environmental organizations.
Because of the long and uncertain approval process for new drugs, especially those of this type, the company apparently decided to carry out their experiments on children in the Third World, where regulations are more lax and where it seems easier to find institutions that lack adequate funding (or ethics).
In a recent public relations move to makeover its image, Ventria now calls these products “medical foods,” most likely in order to evade the stricter regulations for drug approvals. The company is carrying out experimental production of two recombinant human proteins, Lactoferrin and Lysozyme, which are present in their natural forms in mothers’ milk, saliva, semen and other human bodily fluids. The recombinant versions are produced in genetically engineered rice, which contains the synthesized human gene sequences responsable for their production. Two of these, extracted from the modified rice, were tested on Peruvian children.
Ventria experimented with 140 children from the age of 5 months to 3 years who were suffering from diarrhea and were hospitalized at the above mentioned pediatric institutes. The tests lasted 48 hours in the hospital, with two follow-up visits during the following two weeks. The children were divided into three groups. One so called “control group” received an oral glucose-based re-hydration solution, a second group received a (non transgenic) rice-based solution, and a third group got the same rice solution with the addition of the recombinant Lactoferrin and Lysozyme.
According to the brief summary of the results that was published by the company, the children who received the recombinant treatment took an average of 3.67 days to recover, while the control group took an average of 5.21 days. Ventria announced the results while ignoring the fact of having used Peruvian children as guinea pigs, when they wouldn’t have been allowed to administer the same tests in their own country. The purpose of the tests is to hasten approval and attempt to gain moral legitimacy for the commercial use of their controversial product, which they now say is mostly for the Third World.
Nevertheless, their preferred market is not that of children in poor countries suffering from diarrhea, but rather the more lucrative market for so-called “nutriceuticals”, including sports drinks and dietary supplements, among others. The Third World children simply offer more public relations value for the company.
According to US pediatrician Jim Diamond, a surprising aspect of the results published by Ventria is that they used a group of children given a glucose solution as a control group, when there is an abundant medical literature showing that rice-based (non-transgenic) solutions work faster and more effectively in treating acute diarrhea.
This means that the company, with the complicity of the Peruvian institutes, may have intentionally used a less effective control for comparison purposes, in order to make the positive effects of their product appear more dramatic. On the one hand, they exposed one group of children to unapproved transgenic drugs, while on the other, another group may have had their recovery delayed, because of an inferior treatment, for the purpose of obtaining better looking results.
There are many scientific articles — readily available on the Internet — that reveal cases of adverse reactions like allergies, formation of anti-bodies, etc. caused by exposure to transgenic human proteins, such as anti-coagulants, growth hormones and insulin. In some cases this has led to the removal of products from the market.
During the process of public consultation motivated by Ventria’s experimental use applications to grow experimental field trials of pharma crops in the US, a number of organizations, including Consumers Union, the Center for Food Safety and Friends of the Earth-USA, provided authorities with comprehensive reports, referencing the scientific literature, in which they described in detail the possible adverse health effects of Ventria’s recombinant Lactoferrin and Lysozyme. (1) They pointed out that the recombinant proteins are not identical to their natural counterparts, which means they could provoke immune system disorders or allergic reactions. The increased levels of Lactoferrin and Lysozyme could also favor the growth of pathogens, like the Helicobacter pyloris bacteria, which can cause gastritis and stomach cancer, the bacteria that cause meningitis, and others that cause illnesses that are difficult to treat because of antibiotic resistance.
Obviously Ventria knew about these reports when they decided to go ahead and place Third World children and infants at risk in experimental drug trials. If the Peruvian institutes also knew about these reports, then their complicity is criminal. If they didn’t carry out due diligence concerning risks, then their negligence is of the same order.
*This article is an English translation from the Spanish, which appeared in La Jornada (Mexico City) on July 1, 2006. Translated by Peter Rosset.
(1) Consumers Union’s Comments on USDA Animal Plant Health Inspection Service (APHIS) Environmental Assessment for Field Test of Permit of Ventria Bioscience rice genetically engineered to express human lactoferrin, USDA/APHIS Docket No. 05-006-1, http://www.consumersunion.org/pub/2005/03/002090print.html Freese, Bill; Hansen, Michael and Gurian-Sherman, Doug. “Pharmaceutical Rice in California”, July 2004, http://www.centerforfoodsafety.org/pubs/CARiceReport7.2004.pdf
Bill Freese at the Center for Food Safety has written an excellent summary on this issue. The briefing paper “An Assessment of Genetically Engineered Pharmaceutical Rice and Its Potential Use in Oral Rehydration Solutions to Treat Severe Diarrhea” will soon be available at www.centerforfoodsafety.org
comment left by: Stephanie Weisenbach with GEAN, www.geaction.org
August 8th, 2006 at 2:46 pm
GMOs: Already affecting the young
The Republic, Friday, 14 July 2006 http://archivo.larepublica.com.pe/index.php?option=comcontent&task=view&id=116503&Itemid=38&fechaedicion=2006-07-14
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 [segĹ“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.”
comment left by: Stephanie Weisenbach with GEAN, www.geaction.org
August 8th, 2006 at 2:47 pm
http://www.scidev.net/news/index.cfm?fuseaction=readnews&itemid=2992&language=1
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.