This is MAJOR news.
Quotes:
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.
(Dr. Jim Diamond is a current member, and former chair, of the national
Sierra Club Genetic Engineering Committee.)
Subj: GMW: Babies as Guinea Pigs: Biotech company turns two Peruvian
hospitals into laboratories
Date: 7/13/2006 5:17:44 PM Central Daylight Time
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GM WATCH daily
http://www.gmwatch.org
---
This is an English translation from the Spanish of an article in the Mexican
publication, La Jornada
EXCERPTS: Because of the long and uncertain approval process for new drugs,
especially those of this type, the [biotech] 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).
...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.
---
Babies as Guinea Pigs: Biotech company turns two Peruvian hospitals into
laboratories
Silvia Ribeiro*
http://etcblog.org/2006/07/13/babies-as-guinea-pigs-biotech-company-turns-two-
peruvian-hospitals-into-laboratories/
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
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