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[SANET-MG] feedback on pharm crop products in US market



May 27, 2004

Prof. Joe Cummins

“Feedback on Pharm Crop Products In US Market”

My recent article “Pharm Crop Products In US Market” May 26,2004

http://www.i-sis.org.uk/ has provoked some interesting feedback from
within the community of environmental advocates. The article was about
the production and marketing of genetically modified (GM)
pharmaceuticals produced on field test release plots in the United
States. The pharmaceutical products produced on such test plots are
being sold by Sigma-Aldrich Chemical company and by Prodigene company.
The products marketed include a number of pharmaceutical proteins such
as trypsin, aprotinin , human lysozyme along with a number of others.
Such proteins, as indicated in the original report, have useful
applications but present significant risk to humans and animals.
Aprotinin, in particular is used very extensively in surgical
application as surgical glue to control bleeding., however, a single
exposure is recommended because a second exposure may trigger fatal
anaphylaxis. The product creates a risk to people exposed to the maize
crop then exposed in surgery, or to those exposed in surgery then
experiencing exposure to the maize or debris from the maize.

The criticism from representatives of an environment group was that the
products of the “test” plots were being marketed but were only marketed
to researchers in molecular biology. I believe that kind of comment is
being circulated among people enquiring about the original report. In
reply to the criticism, my reply is that the products are marketed to
researchers but advertised as being free of prions implying that the
products will be used with animals or humans. Furthermore, the hazardous
product aprotinin was reported to be in pre-clinical human trials last
year: “ProdiGene, Inc., a leader in the development and manufacturing of
recombinant proteins from transgenic- plant systems, announced today
that it has begun commercial scale-up of aprotinin, a protease inhibitor
used in cardiac surgery, wound healing, and as a component in
pharmaceutical manufacturing. Aprotinin, traditionally extracted from
bovine lungs, is currently used therapeutically to reduce the need for
blood transfusions in patients undergoing cardiac bypass surgery.
ProdiGene holds the patent for exclusive commercial production of
aprotinin in all plants. Aprotinin produced in maize provides an
alternative to animal-derived material. ProdiGene's recombinant
aprotinin is equivalent to bovine aprotinin but is not limited by the
supply of bovine lungs. This is in keeping with one of ProdiGene's
fundamental strategies to offer non-animal sourced proteins to the
pharmaceutical industry. Pre-clinical trials will begin this fall as a
human therapeutic product. ProdiGene will also market aprotinin for use
in cell culture, research and other non-clinically regulated markets
(http://www.biospace.com/news_story.cfm?StoryID=9388520&ful
<http://www.biospace.com/news_story.cfm?StoryID=9388520&ful>).

Clearly aprotinin manufacture has gone well beyond laboratory tinkering.

Another criticism from the environment group was that we had not cleared
our article with the US Food and Drug Agency(FDA). In reply, I find
questioning FDA bureaucrats to be a waste of time because the
bureaucrats seem unable to respond to a direct questions frankly, I find
them rather goofy.

Another criticism was that I did not clear the discussion with
.proprietary environment groups. That criticism is strong medicine
indeed, however, even though I find environment group researchers less
goofy than FDA bureaucrats it would take a great deal of time to
circulate my findings among the environment groups and not provide much
addition information. The reports of other groups were read and
referenced in the report. Frankly, I think that it is unwise to ape
academic peer review in the real world.

The final criticism was that I was foreign and did not understand the
nuances of the US system. Gosh, that was meant as even stronger
medicine, however, I am not an extraterrestrial nor am I foreign. I was
born in Whitefish Montana, I have university degrees from Washington
State University, University of Wisconsin and I held academic
appointments at Rutgers and University of Washington. Living in Canada
may have changed me in ways that I have not recognized (I was born near
the Flathead Indian Reservation and that may have caused the confusion).

My main reason for writing this essay was to insure that the problem of
commercial pharming under the guise of test plot releases was not
minimized. For example, there are very large test plots approved in
Washington State for barley modified with human genes destined for
pharmaceutical application. That production appears to be going
unnoticed by press and public even though the production is capable of
injuring many members of the public. Secret field production of
dangerous materials may be considered a form of bioterrorism.
Unfortunately, little has been done to make the public aware of such
production.

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