Direct Action – Marinol cigs? Why study them?

This episode Chris leaves a telephone message with Health Canada’s Andrew Swift, and our whistle-blower from Vermont – Matt Johnson – tells us more about the “extract product” Marinol cigarettes we’re studying instead of buds.
Contact health Canada media Representative Andrew Swift and tell him you are an independent reporter looking to do a story on Health Canada’s use of the “patented NIDA cannabis extract product” in the CITR study.
Andrew Swift. (613) 957-2988

Dear David and Chris,

I am still waiting to hear from some folks, but I thought I would show you what I have found so far. The NIDA marijuana product is first grown by the University of Mississippi and then given to an organization called the Research Triangle Institute (RTI), a nonprofit organization based in Research Triangle Park, North Carolina, that services government clients among others (http://www.maps.org/mmj/treatyanalysis.pdf ). RTI’s website can be found at http://www.rti.org/index.cfm .

Interestingly, they also synthesize and sell a variety of cannabinoids. On the following webpage you can see that they manufacture and sell synthetic delta-9-THC (8th chemical listed), as well as other cannabinoids.

http://www.rti.org/page.cfm?sec=4&focus=612&cat=618&topic=0&objectid=99617508-915B-4FA5-8E28C9F7BDEBB028

Although not conclusively demonstrating that NIDA marijuana is standardized with synthetic THC, the fact that this organization is also in the business of synthesizing and selling THC is certainly suggestive and consistent with that hypothesis. It is also consistent with the fact that NIDA also supplies “placebo” marijuana with no THC, which is used in virtually every study for experimental control. Perhaps RTI first transforms all the marijuana into the “placebo” by extracting cannabinoids, and then adds a standard amount of synthetic delta-9-THC in order to create the “active drug”.

Some more interesting information is available on NIDA’s website:

http://www.drugabuse.gov/about/organization/nacda/MarijuanaStatement.html

“Cigarettes are produced in three potencies: strength 1 – 3-4 %; strength 2 – 1.8-2.2 %; and strength 3 – placebo, as close to 0% as possible. During the past three years, the following quantities have been shipped: 1994 – 24,000 cigarettes; 1995 – 23, 100 – cigarettes; and 1996 17,700 cigarettes. Virtually all of the cigarettes shipped in the last three years have been for single patient INDs. As of March 1997 there were 278, 100 cigarettes in stock. The cigarettes are maintained in frozen storage and have a useful life of approximately five years…

“These costs from the contracts with the University of Mississippi and RTI that are associated with the growing of cannabis and the production and shipping of cigarettes are approximately $420,000 during a growing year and $300,000 during a nongrowing year. Funding at this level allows for the production of cannabis cigarettes with a uniform potency and purity, consistency of seed stock, the analysis of THC content and adjustments when necessary, and other activities crucial to the production of research grade cannabis cigarettes” (emphasis added).”

The director of the Marijuana Project at the University of Mississippi (where the marijuana is initially produced) is Dr. Mahmoud A. ElSohly. His contact information at the University can be found here http://www.olemiss.edu/fsdir/E.html . He is also the head of a company called ElSohly Laboratories Incorporated, which develops technology for drug testing. http://www.watervalley.net/users/eli/

At the University of Mississippi, ElSohly is funded through Nov. 2004 with NIDA grant 7N01DA007707-001 “Production Analysis & Distribution Cannabis and Marijuana”

(Information on federal grants can be found at http://crisp.cit.nih.gov/ )

“Abstract: The primary function of this contract is to provide materials to support research on marijuana abuse, its effects on psychological and physical development and its potential medicinal use. It was recognized long ago that such studies require a source of cannabis material and its dosage forms such as marijuana cigarettes with consistent and predictable potency, free of contamination and in amounts to support a wide variety of research needs. Such production was established in the late 1960’s by the government and this contract is a continuation of that effort. Preparations of cannabis needed for research are mostly classified under the Controlled Substance Act and therefore not available commercially. The National Institute on Drug Abuse has been providing the scientific community with standardized preparations of cannabis, cannabinoids and other drugs of abuse for basic and clinical research through its drug supply program. This contract consolidates production of cannabis and manufacture and distribution of cigarettes. The production, manufacture of cigarettes, and distribution of plant materials and cigarettes require analyses of both growing and stored materials to determine optimum harvesting time, formulation aspects, potency, content uniformity and stability. The purpose of this contract is to obtain, prepare, test, and provide cannabis preparations of marijuana cigarettes of various strengths, placebos, and bulk marijuana to investigators in drug abuse and related research.”

-Matt Johnson
University of Vermont

November 6, 2002

Dear Minister Anne McLellan,

The British Columbia Compassion Club Society (BCCCS) has been distributing
medicinal quality cannabis to over 2000 Canadians in medical need for nearly
six years. Some of our members have been referred to us by your staff
responding to inquiries in regards to accessing medicinal cannabis. A number
of our members also hold licenses issued by Health Canada’s Medical
Marijuana Access Regulations (MMAR) program. Since there is no legal supply
of cannabis, many Canadians prefer the varieties of clean and safe cannabis
supplied by us, rather than going without or buying on the streets.

Although Health Canada has not invited us to be on their MMAR advisory
committee, we believe it is our responsibility, given our experience and
expertise in these matters, to continue to give your ministry feedback and
information pertaining to its endeavors.

The BCCCS is shocked by the recent actions of Health Canada. Specifically,
we object to the decisions to use low-quality National Institute of Drug
Abuse (NIDA) produced cannabis for a Canadian-funded study, and to pay an
American pharmaceutical scientist to testify against Canadians who are
having difficulties with the new MMAR. These decisions are
counterproductive, show a tremendous lack of respect and compassion for
suffering Canadians, and are a waste of precious tax dollars.

The United States government has views on cannabis that do not reflect the
views of its citizens, and absolutely do not reflect the views of most
Canadians. The United States federal government is waging a brutal and
costly “war on drugs” and will not recognize marijuana as the medicine it
is. Canadians, on the other hand, support marijuana as medicine and our
federal government also recognizes it as such. This was demonstrated in July
2000 when the Canadian government chose not to appeal the Ontario Supreme
Court ruling which determined that it is unconstitutional to deny people
legal access to this medicine, and instead created the MMAR and contracted
Prairie Plant Systems (PPS) to grow medicinal cannabis. The fact that the US
government has threatened to retaliate should Canada choose to create more
rational drug laws clearly indicates their position on these matters.

In light of the US position, it appears to be in bad faith that Health
Canada hired Billy Martin, the director of research at the US NIDA, a US
government funded agency which appears to have a mandate to disprove the
medicinal benefits of marijuana. Martin also works for a multi-national
pharmaceutical company, Solvay Pharmaceuticals Inc., that manufactures a
synthetic “alternative” to whole plant medicine, Marinol. One of the
strongest opponents to medical marijuana is the pharmaceutical industry,
which for obvious reasons would prefer that the plant be deemed illegal,
while they patent pharmaceutical drugs that are far more toxic and less
effective than the whole plant medicine.

Health Canada has attempted to justify the use of Martin by stating he is a
leading expert. We reject this statement, as Martin is most definitely not
an expert on herbal medicine. There are many unbiased experts available who
could be more appropriate to call upon in such matters. The Senate’s
Special Committee on Illegal Drugs very recently released a report that
compiled two years of research, available at www.parl.gc.ca
illegal-drugs.asp. Such unbiased and thorough research is a more appropriate
source of information.

Health Canada’s choice to use cannabis from NIDA is waste of tax payers
money and an affront to Canadian sensibilities. Throughout the cannabis
community, comprised of scientists as well as medicinal cannabis growers,
distributors, and users, NIDA cannabis is known for its poor quality. The
THC levels of 0, 4, 6 and 8 percent found in NIDA produced cannabis, are
much lower than those typically found in medicinal quality cannabis. Any
cannabis used for research into its medicinal efficacy must be medicinal
grade, and NIDA cannabis falls well short of that requirement. Even cannabis
found in the black market is likely to be higher quality than the cannabis
from NIDA. The BCCCS believes it is unethical to give poor quality cannabis
to those in need, particularly if they have previously been successfully
relieving their symptoms with higher quality medicine.

This research will thus have little if any merit. If Health Canada insists
on using cannabis from NIDA, Canadians will know that your ministry is
conducting research with predetermined negative results. Health Canada must
establish its own transparent standards for research grade cannabis, and not
rely on the undisclosable ones of NIDA.

We would like to see Health Canada respect the difference between the views
of its own citizens and those of the US government, and to be transparent
and ethical in any research it undertakes. The BCCCS continues to extend its
offer of assistance in these matters. To this end we will send you the
community-accepted standards for medicinal grade cannabis in the near
future.

We look forward to re-establishing the working relationship we had with the
previous minister, and to continue working to meet the needs of Canadians.

Sincerely,

Hilary Black

Founder/Co-Director

BC Compassion Club Society

Rielle Capler

Research and Planning

BC Compassion Club Society

CC: Libby Davies, MP

Pierre Claude Nolin, Senator

Brent Zettl, President Prairie Plant Systems

Canadian Cannabis Coalition

Canadian Cannabis Coalition

http://cannabiscoalition.ca/

Hi Chris and Dave,
As a practicing research psychologist and pharmacologist, I thought I’d
drop you a note about the NIDA pot. Actually, not just about the pot, but
about what it’s use is likely to mean about the Health Canada study.
As you two seem to be intuitively aware of, for a study to really be
scientific, it must meet certain requirements. The two really big ones are
that the study actually be designed to give insight into the research
question, and more importantly, that it be designed so that other,
independent scientists can repeat it, in order to verify the conclusions.
You’ve correctly identified a major problem with the first point in the
Health Canada study. I’ll point out something you’ve missed there that
could be important in a little bit. But first, let’s consider the second
point.
The Health Canada study, by using NIDA, proprietary pot, will not be
repeatable by the Canadian medical community at large. This means that any
conclusions it develops will not be subject to the open scrutiny of the
scientific community, and its relevance is therefore seriously undermined.
Indeed, science is a game of chance, and we know the odds in advance. The
chances that a study will show no effects of a treatment when there are
actually effects is exactly 1 in 20, or 5%. This is the standard level of
chance accepted by the scientific community. In practice, this means that
one study is never enough to determine the effects of its treatments.
Never EVER enough. The preference in the scientific community is to see
the same effect from more than one lab, and hopefully several different
labs, before considering it a fact. This helps weed out crafty cheaters
and bumbling fools who find effects that aren’t there, or find no effect
even when it is clearly there. No such safeguards in the Health Canada
study, are there?
Okay, so much for repeatability, what about the NIDA pot? As I stated
above, standard scientific practice considers a study only able to assess
the treatments it actually uses. In other words, as you’ve rightly
demonstrated, the Health Canada study really will only tell us about the
NIDA cigarettes, not about marijuana in general. Because marijuana comes
in so many chemotypically distinct varieties, it really would make more
sense to come up with a design intended to study some representative types,
rather than one kind of marijuana cigarette alone. But your assumption
seems to be that Health Canada does not realize this basic scientific
principle, and will make conclusions about marijuana in general from the
NIDA cigarettes. I think, instead, that they know exactly what they’re
doing.
Using the NIDA cigarettes, their concern is obviously not what will
happen if it doesn’t work, but if it does. Clearly, if the NIDA cigarettes
work, then they will have strong reason to argue that that’s what should be
provided to all of the medical necessity users of cannabis! Then the US
government would be happy, because they’ll gain the licensing fees on the
procedure used to develop the cigarettes and will be confident in the idea
that most patients will refuse the bunk-weed option. Worse, they might
even end up providing all of the cannabis used medically in Canada. The
Canadian government would then be happy because they could plausibly argue
that medical clubs were no longer necessary, and could maintain their
present stance that ALL distribution of cannabis should remain illegal,
while offering token decriminalization measures designed primarily to sap
energy from the movement for legal marijuana. I think this is so
attractive that they will be sure to design a study that will work.
Even though the NIDA pot recipe is apparently secret, have you worked to
uncover the study methods that Health Canada intends to employ? If you
should acquire such documents, I’d be able to tell you with much greater
certainty whether or not it’s designed to fail. Indeed, you must acquire
them anyway, because although the NIDA pot patent provides them with an
excuse to deny you information, they cannot plausibly deny you information
about the study methods. Indeed, you should be able to get that study
design, and implement it yourselves without much effort at a compassion
club, in order to show them that real pot really does work.
Finally, just thought I’d provide some background on the origins of
standardized pot in research. Standardized pot is an effort at obtaining a
standardized dose. Before the medical revolution of the past 40 or so
years, there was no good way to determine how much drug an individual had
consumed aside from strictly controlling the amount of drug they consumed.
NIDA cigarettes are designed to fulfill this role, which is why they’re 1,
2, or 3% THC. The idea is that you know exactly how much THC is in the
cigarette, you train the subject on how to inhale (really, inhalation must
also be standardized), then you force them to smoke the ENTIRE cigarette.
This way, you know that everyone in your study gets exactly the same amount
of THC into their system (with some error, of course, but hopefully only a
small amount). The ridiculously low potency is a result of the fact that
if it were much higher, you would not be able to force everyone to smoke
the entire amount. There’s no reason at all, indeed, why you couldn’t have
them each take exactly one hit of 25% THC hash. It accomplishes exactly
the same effect.
The problem is, as I’m sure you’re fully aware, the main medical benefit
of cannabis is that people can effectively titrate to exactly the dose they
need, and that much of the effectiveness of the drug may indeed hinge upon
this ability to precisely dose oneself. This isn’t a problem these days,
because you can get nearly real time measurements of the exact blood
concentrations of drugs. So you don’t have to force a standard dose, you
can allow people to find the dose that works (if any), and check their
blood to figure out what that dose was. Any study that doesn’t allow
people to dose themselves to exactly the desired degree is probably
intended to fail. That’s why it would be nice to see the Health Canada
protocol. We could tell exactly what they intend the study to find, just
by knowing what they plan to do.

Some things to think about anyway.

Cheers,
Geoffry

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