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[SANET-MG] Babies as Guinea Pigs
From GM Watch
Babies as Guinea Pigs: Biotech company turns two Peruvian hospitals into
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
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
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
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,
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
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