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[SANET-MG] production and marketing of hazardous biopharmaceuticals

May 14, 2004

Prof. Joe Cummins

“ Production and marketing of hazardous biopharmaceuticals without
evident final regulation approval”

Genetic Engineering News (May 1,2004 page34) has a full page
advertisement for animal free recombinant proteins from Sigma-Aldrich
chemicals. The proteins include trypsin (TrypZean) and Aprotinin. A
number of other recombinant proteins produced in rice or maize have been
marketed by Sigma-Aldrich. The advantage of recombinant proteins
produced in plants includes the belief that hose proteins will be free
of prions that spread BSE. A search of FDA and USDA public records did
not turn up any evidence that the modified crops or the protein product
had been finally approved for commercial production. However, the United
States allows marketing of transgenic products produced in field test
releases. The extent and nature of the field test releases are
considered confidential business information (CBI). Exposure of the
public to the toxic products is virtually impossible to trace back to
the secret field tests. It appears as though the government regulators
have a collusive arrangements with corporations to protect the
corporations from liability to persons injured by the recombinant
products in the field or contaminated food.

Trypsin is an enzyme produced in the pancreas and it breaks down
proteins in digestion. The enzyme is used in a number of laboratory
applications, it is used in wound treatment and to treat diabetes. The
enzyme is used in food processing and often put into infant formulations
to aid in digestion. The plant produced product is desirable because it
is free of prions and animal viruses.. The method for modifying crop
plants and preparation of the gene for trypsin is described in US patent
6,087,558 . The gene for trypsin is isolated from bovine pancreas, the
gene is actually to produce trypsinigen which has six additional amino
acids at the start of the enzyme (these amino acids are cleaved to make
active trypsin).The DNA inserted into the corn plans comprises the
ubiquitin promoter, including the first exon and intron; the barley
alpha amylase export signal sequence; a trypsinogen encoding sequence;
pinII terminator(potato protease inhibitor II terminator); 35S promoter
and terminator with the moPAT (maize optimized PAT) selectable marker.
The PAT gene is for glufosinate resistance the maize is herbicide
tolerant but the gene is mainly for selecting transformed cells.

According to material data safety sheets provided by trypsin
manufacturers the product is capable of causing allergy is a skin, eye
and respiratory irritant and may be a mutagen . Known allergens should
not be produced in food crops.

Aprotinin is a protease inhibitor normally prepared from bovine pancreas
and lung. Recombinant aprotinin produced in plants is currently marketed
as indicated above. Aprotinin is listed as a reproductive hazard . There
is serious danger to those exposed to aprotinin after having had a
previous exposure. Fore example a two year old child suffered severe
anaphylactic shock after a test dose of aprotinin . Fatal anaphylaxis
followed aprotinin exposure in a local application of fibrin glue or a
similar application led to an immediate skin reaction following
re-exposure to fibrin sealent . Secret field testing of plant based
recombinant aprotinin could result in severe or fatal anaphylaxis either
in a brief exposure in the maize field of one previously treated during
surgery or exposure of one exposed to the maize field then treated
during surgery.

Recombinant aprotinin derived from the bovine gene was produced in maize
. The genetic construction was similar to those described above for
maize based biopharmaceuticals. The ubiquitin promoter along with the
ubiquitin intron was linked to a signal sequence from barley amylase,
the aprotinin sequence was followed by the transcription terminator for
potato protease II. A selectable marker, bar (glufosinate tolerance) was
added along with the double CaMV promoter , tobacco mosaic virus omega
leader and intron from maize alcohol dehydrogensase along with the
potato protease II terminator . The recombinant aprotinin does not
appear to have been extensively tested using animals even though its
glycosylation pattern may differ from the animal product and effect its
allergenicity and stability.

Field test releases of hazardous, life threatening , biopharmaceuticals
are being conducted secretively with collusive consent of government
regulators. The products of such field test releases may be marketed,
indeed, the loophole that allows marketing of the products of field
tests seems to allow corporations to undertake production and sale
without expensive safety evaluation and testing. The secrecy and
extensive use of CBI designation in field test releases of recombinant
biopharmaceuticals is frequently justified by a perceived threat of
vandalism. Government bureaucrats provide CBI designation and secrecy
even though the corporations undertaking field test releases should be
providing adequate security for their field test releases. Bureaucrats
do not appear to be acting in the interest of the public by providing
secrecy in cases where the public interest is best served by full
disclosure. Efforts should be made to require full disclosure of field
test releases to those potentially injured or killed by the products of
the field test releases.


Cummins,J .“Genetically modified biopharmaceutical products are being
produced and marketed in the United States of America” April 12,2004

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