Drug Trial Catastrophe & Safety of Secretly Tested Pharm Crops

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Drug Trial Catastrophe & Safety of Secretly Tested Pharm Crops

press-release

Mon, 10 Apr 2006 14:47:12 +0100

 

 

 

 

The Institute of Science in Society Science Society

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This article can be found on the I-SIS website at

http://www.i-sis.org.uk/DRGSSTFC.php

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ISIS Press Release 10/04/06

 

Drug Trial Catastrophe & Safety of

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Secretly Tested Pharm Crops

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A monoclonal antibody drug tested in a clinical trial made

all six healthy volunteers violently ill, yet transgenic

crop plants with similar drugs are being tested in secret

locations and the unsuspecting public are being exposed

without their knowledge or consent. Prof. Joe Cummins and

Dr. Mae-Wan Ho

 

A fully referenced version of this article is posted on ISIS

members' website

http://www.i-sis.org.uk/full/DRGSSTFCFull.php.

Details here http://www.i-sis.org.uk/membership.php

 

Drug trial reactions attest to the deadly nature of MAB

drugs

 

The London drug trial that left six healthy volunteers

dangerously ill has raised awkward questions on the science

and ethics involved in all stages of drug research and

development ( " Drug trial catastrophe – collapse of science

and ethics " , this series http://www.i-sis.org.uk/LDTC.php).

The drug, code named TGN1412, is a genetically engineered

humanized monoclonal antibody (MAB) aimed at treating

leukaemia and autoimmune diseases such as multiple sclerosis

and rheumatoid arthritis. Hundreds of MAB drugs are under

development, 18 of which have already been approved by the

US FDA, with warnings posted on each and every one of them

( " Warnings over FDA approved monoclonal antibody drugs " ,

this series http://www.i-sis.org.uk/WOFAMAD.php).

 

The violent reactions of all six human volunteers injected

with TGN1412 serves as a graphic demonstration on how deadly

such drugs can be.

 

In the aftershock of the episode, bioethicists and others

have called for tighter regulation of human drug trials and

a more cautious protocol. However, no one has raised the

alarm over the distinct possibility that the general public

might be exposed without informed consent to transgenic

crops producing such drugs.

 

Secret pharm crops with MABs

 

Currently, the MAB drugs approved have mainly been prepared

from cell cultures. The cost to the patients would be at

least $20 000 to $50 000 per year; the colon cancer drug

Erbitux costs $17 000 per month [1]. So, only the wealthy

could benefit from such drugs, if at all. Producing the

drugs in transgenic farm animals or in crop plants,

therefore, promises to greatly reduce the cost of MAB drugs.

And plans are afoot to do just that, with reckless disregard

for the safety of the general public.

 

Laboratory mice have already been modified to produce human

antibodies and there are efforts to create farm animals

producing human antibodies [2]. Human monoclonal antibodies

have been produced at relatively high levels in chicken eggs

[3]. And humanized MABs have been produced using the yeast

Pichia pastoris, `glycoengineered' to express human patterns

of glycosylation (carbohydrate chains on proteins) to avoid

immunological problems arising from non-human glycosylation

[4].

 

Plant-based production of recombinant antibodies has been

discussed extensively. A review published in 2003 [5]

reported that six plant-derived antibodies have been

developed as human therapeutics. The drug, Avicidin,

developed by NeoRx and Monsanto, had some anticancer effect

on colon cancer; but it caused severe diarrhoea and was

withdrawn. A plant-derived antibody CaroRx produced in

tobacco claims to reduce tooth decay by preventing adhesion

of the bacterium Streptococcus mutans. A MAB targeting the

cancer-antigen CEA was produced in tobacco, pea, rice and

wheat. A humanized MAB recognizing herpes simples virus 2

was produced in soybean. Tobacco plants were transformed

with a viral vector to produce antibodies targeting non-

Hodgkin's lymphoma. Finally, a MAB produced in tobacco

targeted human chorionic gonadotropin, and was intended for

use in contraception, pregnancy detection and therapy of

tumours [6]. Plants have been transformed to produce

prophylactic antibodies against rabies and other disease

conditions [7].

 

We have drawn attention to the hazards of producing

genetically modified vaccines and therapeutic antibodies.

The main threat is the genetic pollution of major food crops

resulting in food that is toxic [8]. Humanized MABs

structured to attack herpes virus or regulate the human

immune system were to be produced by transgenic strains of

the green alga Chlamydomonas in large plastic tubes near a

beach in Hawaii Chlamydomonas is a common soil microbe so

the nature and location of the production facility would

risk spreading the transgenic strains and the human genes

also to soil microbes [9].

 

Molecular pharming (producing pharmaceuticals in transgenic

crops) is turning into a new battlefront in the struggle of

the global civil society against transgenic crops. Too many

governments of industrialised countries appear to be

prepared to allow biotech corporations to contaminate our

food supply with un-prescribed and dangerous drugs [10].

 

The precise MABs in pharm crops deemed confidential business

information

 

There have been at least 29 field tests of transgenic crops

known to be producing antibodies, but the actual genes have

been deemed confidential business information (CBI). The

crops modified include maize and soybean; and the companies

testing the transgenic crops are Prodigene, Monsanto and

Agracetus, among others. The field releases were in Hawaii,

Nebraska, Wisconsin, Iowa, Indiana Minnesota, Puerto Rico,

Texas and other states [1]. Other crops and MABs may have

been tested, but designated CBI, as are the actual locations

of such tests, and no effort has been made to notify

bystanders and neighbours that are likely to be directly

exposed to the drugs. People may be exposed to MABs from

transgenic crops by pollen, dust debris from leaves, stems

and flowers, and from polluted surface and groundwater. Once

the MAB genes escape to fertilize neighbouring crops, they

will persist within the contaminated crops, by virtue of

simple Hardy-Weinberg equilibrium in elementary population

genetics!

 

There is no case for using crop plants in the open field to

produce these drugs, as they could easily be produced in

plant cell culture under fully contained conditions.

 

The secretive field trials should never have been allowed,

as they are exposing people, without their knowledge or

consent, to drugs that could become life-threatening, as the

London drug trial so vividly demonstrated.

 

The location and nature of current and previous field trials

should be made public now before any more damage is done,

and all further field trials should be banned.

 

 

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