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.

* the author is a researcher at ETC Group

Translated by Peter Rosset
(the original Spanish version didn't include
footnotes)

(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