Binky
05-25-2005, 07:48 PM
My friends,
I have recently heard the depressing tale of medical users who have signed
up for the MOLSI/COMPASS multi-center investigation into the safety of
medicinal cannabis who have received the PPS cannabis, found it inadequate,
and then decided to suppliment their use with other sources while continuing
on as participants in this study.
I can tell you as a researcher that this is a HUGE problem, which will
undoubtably make any findings stemming from this study very questionable.
Although I certainly understand the allure of free cannabis (even if it is
shwag), I urge anyone taking part in this study that doesn't find the PPS
cannabis adequate in addressing their pain or weak compared to street
cannabis to report this to the researchers, and to drop out of the study
immediately. This is the only independent evaluation of the PPS supply ever
done by HC, and thus may be the only real opportunity that we will ever have
to get PPS/HC to actually put out a better product.
If you know someone who's part of this study but can't stick to the
guidelines that they use only the PPS cannabis for twelve months time, then
please urge them to do the right thing and drop out of this study. To
continue to screw with this protocol and to pretend that this cannabis is
fine is to condemn us ALL to several more years of this poor quality
product.
If we want change, REAL change, then we have to ask for it.
With concern,
Philippe Lucas
Dear friends,
I am pleased to announce that after months (years?) of campaigning by Canadians for Safe Access, pressure from medical users, and personal communication with the OCMA's interim director Dr. Richard Viau (attached), the OCMA has finally started to conduct some of the mycotoxin testing on the PPS cannabis long ago required by Health Canada's own regulations. Earlier this week Dr. Viau informed me that aflatoxin testing has just been performed on all batches of the PPS cannabis shipped out to date, and according to him all tests came in at safe levels (CSA intends to confirm this last statement through ATI request). We look forward to hearing the results of ochratoxin testing, which is also required by Health Canada's "Evidence for Quality of Finished Natural Health Products" prior to making an herbal product available to the public. (see below)
Although happy to report that thus far this product has tested free of one type of mycotoxin, we have to wonder what Health Canada could/would have done had the opposite been true nearly 20 months after they had actually begun to distribute this cannabis to our nation's sick and suffering.
We hope that this will mark the start of a new era of increased transparency, communication and cooperation between Health Canada, medical users, and those individuals and organizations who work so hard to help them; and that this reflects a newfound sense of accountability by the OCMA in regards to the legitimate concerns of our nation's critically and chronically ill. In any case CSA will continue to defend the rights of Canadian medical users to access safe cannabis from a source of their chosing, be that compassion clubs, pharmacies, the federal govt, the black-market, or self-supply; we wish to thank you all for your continued support.
Keep up the good work,
Philippe Lucas
Canadians for Safe Access
Vancouver Island Compassion Society
DrugSense
From the OCMA website titled: Product Information Sheet on Dried Marihuana
(Cannabis spp.)
http://www.hc-sc.gc.ca/hecs-sesc/ocma/publication/information_sheet_dried_marihuana.htm
"The dried marihuana product meets all Canadian requirements applicable to
Natural Health Products (NHP). For more information on these requirements,
consult the Appendix 2: Acceptance Limits for Microbial and Chemical
Contaminants of the publication "Evidence for Quality of Finished Natural
Health Products", which can be found at
http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/evidence_for_quality_nhp_e.html
From the "Evidence for Quality of Finished Natural Health Products" website
cited above:
Para 2.2.2:
"Mycotoxins (aflatoxins): Testing is required for a plant or plant
material, alga, fungus or enzymes derived from these sources. Testing must
be done according to AOAC International methods. Although testing methods
and tolerances for other mycotoxins, such as ochratoxins, have not yet been
established, appropriate measures should be taken at the raw material stage
in order to ensure that the finished products do not contain such toxins."
===
Sent: Tuesday, March 29, 2005 5:44 PM
Subject: the lack of required aflatoxin testing on the PPS cannabis
(cc. Dr. Keith Martin; Libby Davies; Valerie Lasher; Minister Dosanjh;
Lynne Belle-Isle; Robert Gower),
Hello Dr. Viau,
Below is the information which we discussed today in regards to Health
Canada requirements that all herbal plant materials be tested for
aflatoxins and ochratoxins prior to being made available to consumers.
My question is: in light of exceedingly high levels of aspergillus and
penicillium prior to gamma irradiation and of the regulations cited below,
why has neither Health Canada nor PPS ever tested for the presence of
aflatoxins or ochratoxins, or even for the type of aspergillus that might
indicate the presence of aflatoxins (ie. flavus, parasiticus)? As you
surely know, gamma irradiation is effective at destroying molds and
bacteria, but does not destroy these mycotoxins.
By the way, the test results which I refer to are hardly isolated
instances; they range from July of 2003 all the way to November of 2004,
and according to these documents, out of 7 tests conducted over the period
ranging from April 23rd of 2004 and Nov. 2004 (I have omitted the July
28th, 2003 sample since PPS insists that it was merely an experiment) the
average amount of aspergillus in the PPS cannabis prior to gamma
irradiation is over 460cfus, which should be a clear indication that
aflatoxins could be present in the finished cannabis product being shipped
to exemptees. In addition, the average penicillium count for the same
period is 3146cfus, which may be an indicator for the presence of
ochratoxins. And finally, the average overall mold count for this period
is 1724cfus, and the average aerobic bacterial count is a whopping
12,416cfus, both of which I believe are high enough to alert your office of
a potential problem with either the production, processing or storage of
this cannabis product. I would also like to add that I am not being in any
way selective in the use of this data, and have cited and averaged all of
the results I obtained under an ATI request asking for any and all
aspergillus tests perfomed by PPS.
With all due respect, Dr. Viau, considering that this cannabis is destined
for use by critically and chronically ill Canadians whose immune system may
be particularly vulnerable to opportunistic infections, this appears to be
a very serious regulatory oversight by Health Canada and/or PPS.
Additionally, since this cannabis product is most likely to be inhaled
rather than orally ingested, these high levels of impurities are of
particular relevance, since even the minor presence of mycotoxins could
have serious health implications to end-users smoking this cannabis
product. I suggest that in light of this information (available to both
your office and PPS for some months now, and which appear in these tests to
be a systematic and ongoing problem) Health Canada has an ethical
responsibility to temporarily cease the distribution of this product until
these concerns are acknowledged, properly addressed and fully resolved.
I hope that we can work together to address these significant and ongoing
concerns, and I look forward to quick response to this important health
matter from your office.
Sincerely,
Philippe Lucas
mailto:phil@drugsense.org
I have recently heard the depressing tale of medical users who have signed
up for the MOLSI/COMPASS multi-center investigation into the safety of
medicinal cannabis who have received the PPS cannabis, found it inadequate,
and then decided to suppliment their use with other sources while continuing
on as participants in this study.
I can tell you as a researcher that this is a HUGE problem, which will
undoubtably make any findings stemming from this study very questionable.
Although I certainly understand the allure of free cannabis (even if it is
shwag), I urge anyone taking part in this study that doesn't find the PPS
cannabis adequate in addressing their pain or weak compared to street
cannabis to report this to the researchers, and to drop out of the study
immediately. This is the only independent evaluation of the PPS supply ever
done by HC, and thus may be the only real opportunity that we will ever have
to get PPS/HC to actually put out a better product.
If you know someone who's part of this study but can't stick to the
guidelines that they use only the PPS cannabis for twelve months time, then
please urge them to do the right thing and drop out of this study. To
continue to screw with this protocol and to pretend that this cannabis is
fine is to condemn us ALL to several more years of this poor quality
product.
If we want change, REAL change, then we have to ask for it.
With concern,
Philippe Lucas
Dear friends,
I am pleased to announce that after months (years?) of campaigning by Canadians for Safe Access, pressure from medical users, and personal communication with the OCMA's interim director Dr. Richard Viau (attached), the OCMA has finally started to conduct some of the mycotoxin testing on the PPS cannabis long ago required by Health Canada's own regulations. Earlier this week Dr. Viau informed me that aflatoxin testing has just been performed on all batches of the PPS cannabis shipped out to date, and according to him all tests came in at safe levels (CSA intends to confirm this last statement through ATI request). We look forward to hearing the results of ochratoxin testing, which is also required by Health Canada's "Evidence for Quality of Finished Natural Health Products" prior to making an herbal product available to the public. (see below)
Although happy to report that thus far this product has tested free of one type of mycotoxin, we have to wonder what Health Canada could/would have done had the opposite been true nearly 20 months after they had actually begun to distribute this cannabis to our nation's sick and suffering.
We hope that this will mark the start of a new era of increased transparency, communication and cooperation between Health Canada, medical users, and those individuals and organizations who work so hard to help them; and that this reflects a newfound sense of accountability by the OCMA in regards to the legitimate concerns of our nation's critically and chronically ill. In any case CSA will continue to defend the rights of Canadian medical users to access safe cannabis from a source of their chosing, be that compassion clubs, pharmacies, the federal govt, the black-market, or self-supply; we wish to thank you all for your continued support.
Keep up the good work,
Philippe Lucas
Canadians for Safe Access
Vancouver Island Compassion Society
DrugSense
From the OCMA website titled: Product Information Sheet on Dried Marihuana
(Cannabis spp.)
http://www.hc-sc.gc.ca/hecs-sesc/ocma/publication/information_sheet_dried_marihuana.htm
"The dried marihuana product meets all Canadian requirements applicable to
Natural Health Products (NHP). For more information on these requirements,
consult the Appendix 2: Acceptance Limits for Microbial and Chemical
Contaminants of the publication "Evidence for Quality of Finished Natural
Health Products", which can be found at
http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/evidence_for_quality_nhp_e.html
From the "Evidence for Quality of Finished Natural Health Products" website
cited above:
Para 2.2.2:
"Mycotoxins (aflatoxins): Testing is required for a plant or plant
material, alga, fungus or enzymes derived from these sources. Testing must
be done according to AOAC International methods. Although testing methods
and tolerances for other mycotoxins, such as ochratoxins, have not yet been
established, appropriate measures should be taken at the raw material stage
in order to ensure that the finished products do not contain such toxins."
===
Sent: Tuesday, March 29, 2005 5:44 PM
Subject: the lack of required aflatoxin testing on the PPS cannabis
(cc. Dr. Keith Martin; Libby Davies; Valerie Lasher; Minister Dosanjh;
Lynne Belle-Isle; Robert Gower),
Hello Dr. Viau,
Below is the information which we discussed today in regards to Health
Canada requirements that all herbal plant materials be tested for
aflatoxins and ochratoxins prior to being made available to consumers.
My question is: in light of exceedingly high levels of aspergillus and
penicillium prior to gamma irradiation and of the regulations cited below,
why has neither Health Canada nor PPS ever tested for the presence of
aflatoxins or ochratoxins, or even for the type of aspergillus that might
indicate the presence of aflatoxins (ie. flavus, parasiticus)? As you
surely know, gamma irradiation is effective at destroying molds and
bacteria, but does not destroy these mycotoxins.
By the way, the test results which I refer to are hardly isolated
instances; they range from July of 2003 all the way to November of 2004,
and according to these documents, out of 7 tests conducted over the period
ranging from April 23rd of 2004 and Nov. 2004 (I have omitted the July
28th, 2003 sample since PPS insists that it was merely an experiment) the
average amount of aspergillus in the PPS cannabis prior to gamma
irradiation is over 460cfus, which should be a clear indication that
aflatoxins could be present in the finished cannabis product being shipped
to exemptees. In addition, the average penicillium count for the same
period is 3146cfus, which may be an indicator for the presence of
ochratoxins. And finally, the average overall mold count for this period
is 1724cfus, and the average aerobic bacterial count is a whopping
12,416cfus, both of which I believe are high enough to alert your office of
a potential problem with either the production, processing or storage of
this cannabis product. I would also like to add that I am not being in any
way selective in the use of this data, and have cited and averaged all of
the results I obtained under an ATI request asking for any and all
aspergillus tests perfomed by PPS.
With all due respect, Dr. Viau, considering that this cannabis is destined
for use by critically and chronically ill Canadians whose immune system may
be particularly vulnerable to opportunistic infections, this appears to be
a very serious regulatory oversight by Health Canada and/or PPS.
Additionally, since this cannabis product is most likely to be inhaled
rather than orally ingested, these high levels of impurities are of
particular relevance, since even the minor presence of mycotoxins could
have serious health implications to end-users smoking this cannabis
product. I suggest that in light of this information (available to both
your office and PPS for some months now, and which appear in these tests to
be a systematic and ongoing problem) Health Canada has an ethical
responsibility to temporarily cease the distribution of this product until
these concerns are acknowledged, properly addressed and fully resolved.
I hope that we can work together to address these significant and ongoing
concerns, and I look forward to quick response to this important health
matter from your office.
Sincerely,
Philippe Lucas
mailto:phil@drugsense.org