Babies as Guinea Pigs: Biotech company turns two Peruvian hospitals into laboratories

by 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