ISIS Report 10/04/06
Drug Trial Catastrophe & Safety of Secretly Tested Pharm Crops
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. Details here
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). 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).
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 . 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.
have already been modified to produce human antibodies and there are efforts
to create farm animals producing human antibodies . Human monoclonal antibodies
have been produced at relatively high levels in chicken eggs . 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 .
production of recombinant antibodies has been discussed extensively. A review
published in 2003  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 . Plants have been transformed to produce prophylactic antibodies
against rabies and other disease conditions .
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 . 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
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 .
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 .
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
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.
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.
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