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perplexing contradiction by cfia



I am sharing the discussion below even though it is perplexing.Hirudin
is a powerful anticoagulant drug but can cause internal bleeding.
My reply to a cfia scientist follows:Thank you for the useful comment.
Can you point me towards the decision  document on those field trials
are are they CBI? The claim that hirudin was being commercially produced
is referenced as follows:
Transgenic plants as factories for biopharmaceuticals

 Glynis Giddings, Gordon Allison, Douglas Brooks, Adrian Carter
SUMMARY: Plants have considerable potential for the production of

biopharmaceutical proteins and peptides because they are easily

transformed and provide a cheap source of protein....
Nature Biotechnology18, 1151 - 1155 (01 Nov 2000) Research


"This method of purification ensures that hirudin in the plants only

becomes active after harvesting, thus limiting environmental exposure.

Oilseed rape transgenic for hirudin is now grown commercially in Canada

by SemBioSys (Calgary, Canada)"20.Boothe, J.G., Parmenter, D.L. &

Saponja J.A. Molecular farming in plants: oilseeds as vehicles for the

production of pharmaceutical proteins. Drug Develop. Res. 42, 172-181

(1997).
Along with these comments farm newspapers reported that Kamloops, BC was
the area chosen for the commercial production.
Any clarification you can give me on these conflicting reports and on
the field trials  would be appreciated.
Sincerely, Prof. Joe Cummins


William Yan wrote:
Dear Prof. Cummins:

Thank your for your message below regarding hirudin in canola.  I am happy
to provide you with the following information:

Canola expressing hirudin has been permitted for small-scale confined
research trials in Canada but has not been approved for unconfined
release/commercialization. The Canadian Food Inspection Agency's Plant
Biosafety Office regulates environmental releases of plants with novel
traits, including plant molecular farming. Health Canada would be
responsible for regulating any product derived from these plants under the
Food and Drugs Act and Regulations (foods, drugs, cosmetics, medical
devices).

For further information, please contact Dr. Stephen Yarrow, Director, Plant
Biosafety Office, Plant Health and Production Division, Canadian Food
Inspection Agency (syarrow@inspection.gc.ca).

best regards,

William Yan, Ph.D.
A/Director, Bureau of Microbial Hazards
Food Directorate
Health Canada





jcummins <jcummins@uwo.ca> on 2003-01-15 10:04:31 AM

To:    William_Yan@hc-sc.gc.ca
cc:

Subject:    hirudin production in canola


Hello Dr. Yan,
Several reports in the scientific literature refer to the commercial
production of the anticoagulant drug , hirudin, in canola oil bodies in
western canada. I have searched the Health Canada web site for the
decision documents on the commercial production of the biopharmaceutical
drug. I would appreciate your help in locating any pertinent documents
on biopharmaceutical production of hirudin. Sincerely, Prof. Joe Cummins

.