Direct Action – Kick NIDA out of Canada!

Chris & David update our “shwag-study” expose with the NIDA’s “pharma-jacking” of the Medical Marijuana Access Program legal challenge. Help us kick the NIDA out of Canada! See info box for details.
Contact Health Canada and let them know what you think of the NIDA Schwag Invasion.
[email protected]
or
1-866-337-7705

Health Canada’s Media-rep Andrew Swift answers Pot TV’s Questions about NIDA cannabis. Hi Chris, Sorry for the delay, here are the answers to your questions about the marihuana from NIDA. I was out of the office yesterday, although I understand you have some questions about the gentleman that was commissioned by Health Canada as part of a court challenge. Perhaps we could do the same thing & you could send some questions by email that I could find the answers for? Let me know,
Andrew

1. Considering the reputation BC has for the best cannabis in the world,and also the recent Federal harvest of Cannabis from the Flin Flon mines, why is it that good organic Canadian cannabis is not being used for this Canadian study?

Cannabis used in clinical trials must be fully characterized and standardized. The work to ensure the material being produced by Prairie Plant Systems (PPS) is of research-grade is nearing completion but was not ready in time for the CRIT study. Rather than postpone the CRIT study it was decided to use a supply from NIDA. The NIDA supply is research -grade marijuana. In the future, research in Canada will be conducted using the PPS product.

2. How is NIDA regulating the THC levels in their cannabis? Is it a chemical extraction that is taken to the desired THC level and sprayed back onto the leaf matter as is the case with nicotine in American cigarettes?

Information regarding the NIDA product has been provided to Health Canada for regulatory approval of the trial to be conducted. As with all drug submissions, this information is considered “proprietary” and must be treated as confidential.

3. What are the chemical differences between NIDA cannabis and so called “street marihuana”?

See answer to Question 2.

4. If there are chemical differences, isn’t Health Canada testing a product that is somehow different than the medical marihuana people are currently finding benefit from?

The necessity to have results using fully characterized and standardized material is the reason research-grade material is used for clinical trials. Specific details of the NIDA product are considered “proprietary” and must be considered confidential. One can assume that the marihuana currently grown and used for medical purposes in Canada comes from a variety of strains with a variety of chemical differences.

5. How is the NIDA cannabis grown? Organic? Chemical fertilizers? Hydroponic?

See answer to Question 2.

6. Does NIDA take the plant to flower or just grown to the vegetative state?

See answer to Question 2.

7. Considering that NIDA refused to give Canada seeds for their medical marihuana growing project, how is it that they came to give their standardized cannabis to Canada for this study?

The National Institute on Drug Abuse (NIDA) oversees the cultivation of research-grade marihuana on behalf of the U.S. government. NIDA’s supply of marihuana is subject to a number of constraints associated with the cultivation of a research-grade crop and therefore, the supply may at times be variable. NIDA and the US Drug Enforcement Agency makes decisions about each request for marihuana independently.

8. What do you have to say to calm the fears of the Canadian cannabis community that largely believes the use of NIDA cannabis, (with NIDA and the US Federal government being known for their Draconian stance against medical cannabis), is a deliberate attempt to make this study fail, and justify continued persecution of medical cannabis users?

An appropriate scientific study of a drug substance requires, among other things, that the substance used in the research must have a consistent and predictable potency, must be free of contamination, and must be available in sufficient amounts to support the needs of the study. NIDA allocates resources to cultivate a grade of marihuana that is suitable for research purposes. In the future, the PPS supply will be available for use in research in Canada.

Our response to Andrew Swifts Answers Hello Andrew, I must say that my colleagues and I were quite alarmed in Health Canada’s answers (or rather the lack thereof) to our questions regarding the use of NIDA cannabis for the Canadian Medical Marijuana Study. It seems that the lack of answers regarding NIDA canabis and now Health Canada’s hiring of a NIDA anti-marijuana, pro-synthetic cannabinoid Doctor with Canadian
tax-payers money to testify against Canadian patients, marks a new era of
Ann McLellan’s health Canada backtracking on previous promises and
obligations of that department.

1)In response we ask Health Canada if the Hiring of NIDA researcher
Professor Billy Martin, is being done in an attempt to set a precedent that
there is no medical marijuana, thus reversing the Parker vs Regina decision
that required Health Canada to come up with workable regulations for the
distribution of Medical Marijuana?

2)Considering that so little is known about the quality of NIDA cannabis,
the chemical differences between it and all other strains of cannabis, the
fact we do not even know whether the THC contained in it is from cannabis
flowers or chemically extracted solutions, or even how it is grown,
wouldn’t
it be advisable for Health Canada to wait for the PPS cannabis to be “ready
in time for the CRIT study” before spending the tax-payers money on a
“proprietary” cannabis product – a product that Canadians are not allowed
to
know about?

3) Considering the NIDA cannabis growing and regulating techniques are
secret “properiteteary” information, why is PPS so open with their own
information regarding the medical cannabis they grow, and wouldn’t it be
better to use cannabis with known background information rather than
cannabis of unknown quality? Why is it that in order that it be medicine it
must first be “secret property”?

4) Considering the fact that the Senate report has many references to
“Compassion Club” standards being superior to NIDA standards, how can you
convince Canadians that these tests aren’t being conducted with an inferior
unnatural cannabis product – a product even the Senate is suspicious of –
and thus meant to fail?

How do you feel about the invasion of Canada by these “rope-salesmen” pretending to be herbalists? Please write letters to the Ottawa Citizen, the rest of the press and to your “representatives”!!!

Other NIDA antics and example letters you can use to invision your own statement to send off are provided below.

Even more info regarding the NIDA, the Medical Marijuana Access Program, the Health Canada clinical studies and other related matter is available in the discussion forums at www.cannabisculture.com – specifically the “current news and events” forum.

Monday, October 28, 2002

Marijuana expert’s credibility in question

Health Canada hires scientist developing alternative to drug to outline weed’s dangers

Shannon Kari
The Ottawa Citizen

TORONTO — The federal government has hired a U.S. scientist to outline the dangers of smoking marijuana in a continuing court case, despite his ties to a large pharmaceutical company that manufactures a synthetic alternative to the drug.

Professor Billy Martin has worked with Solvay Pharmaceuticals Inc. for the past year to further development of a metered dose inhaler for THC — the major psychoactive component in marijuana — that was patented by the Virginia-based scientist.

Solvay, a Belgian-based multi-national pharmaceutical company, also markets Marinol, a drug with chemically synthesized THC that can be obtained by prescription in Canada.

“I agree with most scientific experts who assert that the future lies with pure synthetic cannabinoids as medications rather than marijuana,” Martin wrote in an affidavit filed in Ontario Superior Court.

Marinol takes at least two hours to fully enter the bloodstream, which makes it less effective for pain relief, according to advocates of smoking marijuana for medical use.

Martin, who was unavailable for comment, was commissioned by Health Canada as part of its response to a court challenge to the new Marijuana Medical Access Regulations.

Seven chronically ill people and the founder of the Toronto Compassion Centre, which distributed marijuana, argue the regulations are unconstitutional.

A spokeswoman for the Justice Department said its lawyers determined there was “no conflict” in using Martin as an impartial scientific expert. As well, the scientist’s connections to Solvay were disclosed to the applicants.

“He is the leading expert,” said Health Canada spokesman Andrew Swift, who indicated Martin will be paid about $9,000 Cdn for his evidence in the Ontario court case.

Martin is the chairman of the Pharmacology and Toxicology department at Virginia Commonwealth University in Richmond. Since 1988, he has been the director of a special research centre funded by the U.S. National Institute of Drug Abuse.

“Marijuana has a long history of use by humanity,” conceded Martin in his evidence. But he stressed “the science base is far from clear.”

There have been very few valid scientific studies about the potential clinical benefits of marijuana, said Martin, in part because of “the financial burden of a clinical evaluation on a product without a commercial sponsor.”

The federal government established new marijuana guidelines after the Ontario Court of Appeal ruled in July 2000 that a blanket prohibition violated the Charter of Rights and Freedoms.

Lawyers challenging the regulations argued in Superior Court last month the new rules are so complex that seriously ill Canadians cannot make use of them.

In defence of the regulations, the Justice Department made a number of references in its written arguments about the health risks of smoking marijuana, contained in a 1999 report issued by the U.S. Institute of Medicine. The report was commissioned by the U.S. government’s Office of National Drug Control Policy.

Martin served on the advisory panel for the report.

Contact: [email protected]

Ottawa Citizen

You can send your letters to all of these papers.

Source: National Post (Canada)
Contact: [email protected]

Source: Globe and Mail (Canada)
Contact: [email protected]

Source: Toronto Star (CN ON)
Contact: [email protected]

Source: Halifax Herald (CN NS)
Contact: [email protected]

Source: Ottawa Citizen (CN ON)
Contact: [email protected]

Source: Winnipeg Free Press (CN MB)
Contact: [email protected]

Source: Edmonton Sun (CN AB)
Contact: [email protected]

Politicians;
Senator Pierre Claude Nolin, President of the Senate Committee on Cannabis.
Room 143 – East Block
Senate of Canada
Ottawa, Ontario
K1A 0A4

The House of Commons Committee on the Non-Medical Use of Drugs
Committee member email addresses:

Chair:
– Paddy Torsney (Liberal) [email protected]

Vice Chairs:
– Carole-Marie Allard (Liberal) [email protected]
– Randy White (Canadian Alliance) [email protected]

Members:
– André Bachand (P.C.) [email protected]
– Bernard Bigras (Bloc Quebecois) [email protected]
– Libby Davies (NDP) [email protected]
– Hedy Fry (Liberal) [email protected]
– Mac Harb (Liberal) [email protected]
– Dominic LeBlanc (Liberal) [email protected]
– Derek Lee (Liberal) [email protected]
– Réal Ménard (Bloc Quebequois) [email protected]
– Jacques Saada (Liberal) [email protected]
– Kevin Sorenson (Canadian Alliance) [email protected]

A past report on the “shwag studies”:

“Participants will be barred from using non-study marijuana during the trial and will be tested to ensure they are honouring that rule. Street marijuana contains compounds not found in study-grade marijuana, Gough explained. “
These tests are meant to fail………

Canada: Subjects Smoking Gov’t Marijuana
URL: http://www.mapinc.org/drugnews/v02/n1893/a10.html
Newshawk: Cannabis Health (http://www.cannabishealth.com/)
Pubdate: Thu, 10 Oct 2002
Source: Edmonton Sun (CN AB)
Copyright: 2002, Canoe Limited Partnership.
Contact: [email protected]
Website: http://www.fyiedmonton.com/htdocs/edmsun.shtml
Details: http://www.mapinc.org/media/135
Bookmark: http://www.mapinc.org/mmjcn.htm (Cannabis – Medicinal – Canada)

SUBJECTS SMOKING GOV’T MARIJUANA

Toronto Research Targets Medicinal Pot

TORONTO ( CP ) — Will marijuana-induced munchies help people with HIV and AIDS combat nausea and avoid the weight-loss that the disease brings on? Researchers in Toronto are hoping to find out.

Canada’s first government-sponsored trial of medicinal marijuana in HIV/AIDS officially started yesterday, led by researchers from St. Michael’s Hospital and the Community Research Initiative of Toronto.

“I think the time is right to look at this,” said principal investigator Dr. Kevin Gough, medical director of HIV services at the hospital.

“Let’s find out what role, if any, that smoked cannabis has in, not only HIV and AIDS, but other medical illnesses as well.”

Advocates of medicinal marijuana believe the drug can be useful for a wide range of conditions. Anecdotal evidence suggests it helps in pain control, curbs nausea brought on by chemotherapy or HIV/AIDS drugs, and stimulates the appetite of people who have lost interest in eating as a result of their conditions or medications.

But anecdotal evidence doesn’t cut it when you are asking a government to allow large numbers of ill people to buy and smoke what is still an illegal substance.

So Health Canada has authorized research to gather clinical evidence that may have implications for Canadian policy, and that will likely be scrutinized by governments outside Canada as well.

The current study is a pilot to gather information that will be used to design a larger, multi-centre clinical trial. The pilot phase, involving 32 participants with HIV/AIDS, is expected to last about a year.

All participants will have smoked marijuana before. Because there is little consensus on any risks associated with marijuana use, researchers can’t ethically ask people to take the drug for the first time for a study.

But only people who haven’t used the drug in the previous 30 days will be eligible to take part. That’s to ensure there are no lingering effects of non-study marijuana in their systems.

Over a two-month period, each participant will be given three supplies of varying strengths of marijuana plus a placebo. They will be asked to use each for a period of one week and will not be informed which is which.

Throughout the study they will keep a diary detailing how much they smoked, how they felt, and how much and what they ate.

After using one strength for a week, they will be asked to go a week without smoking marijuana, to cleanse the drug from their systems.

Participants will be barred from using non-study marijuana during the trial and will be tested to ensure they are honouring that rule. Street marijuana contains compounds not found in study-grade marijuana, Gough explained.

Although Canada is in the process of developing its own supply of study-grade marijuana, the crop – being grown in an underground facility in Manitoba – isn’t ready for use. The marijuana for this study comes from the U.S. National Institute of Drug Abuse, currently the only producer of research-grade marijuana in North America.

Ottawa probes marijuana’s effect on pain
First clinical trial to follow 32 patients over eight weeks

Tom Arnold
National Post

Thursday, October 10, 2002

Jeff Vinnick, National Post
Anne McLellan, the federal Health Minister, said the government would not consider distributing medical marijuana without trials.

ADVERTISEMENT

The federal government is putting up $840,000 for Canada’s first clinical study into whether marijuana use can help ease pain.

The Community Research Initiative of Toronto and St. Michael’s Hospital in Toronto are to begin evaluating the therapeutic effects of smoked cannabis in HIV/AIDS.

In the clinical trial, 32 patients will be closely examined over eight weeks to test the safety of short-term exposure to different strengths of cannabis, and how cannabis interacts with HIV medications. The analysis will also include the effect of smoked marijuana on nausea, pain, mood and neuro-cognitive function.

The results of the study will help determine the design of a larger, multi-centre, clinical trial across the country. It is also important because Anne McLellan, the federal Health Minister, has said she will not proceed with medicinal legalization without clinical trials looking at the plant’s effectiveness.

“There is so little good concrete scientific data about the potential benefits or effects of smoked cannabis in a number of illnesses, including HIV and AIDS,” said Kevin Gough, an infectious diseases specialist who will act as the study’s principal investigator.

“HIV itself, the disease, and the medications we use to treat it, produce a number of side effects, including loss of appetite, nausea, and pain. Other diseases like cancer and multiple sclerosis can also lead to similar symptoms that might benefit from smoked cannabis, but the studies aren’t there.

“This is the first trial in Canada to be looking at cannabis in any medical context,” added Dr. Gough, who is also medical director of HIV services at St. Michael’s Hospital in Toronto.

For those suffering from HIV or AIDS, loss of appetite and weight loss can be life threatening, said Derek Thaczuk, former chairman of the board of directors of the Community Research Initiative of Toronto, an organization dedicated to research on HIV and AIDS.

“There is plenty of anecdotal evidence to suggest that smoking marijuana increases people’s appetite and therefore helps them gain weight,” he said. “What we’re doing with this study is subjecting it to some scientific rigour and trying to get quantitative answers to the question of ‘Can smoked cannabis help with this condition and if so, how much?’ “

The marijuana has been imported from the U.S. government’s National Institutes of Drug Abuse. The organization grows its own marijuana on a farm in Mississippi. The Canadian research team purchased 500 grams for the research project.

Mr. Thaczuk, who chairs the Toronto research initiative’s scientific committee, said work on the study has been carried out for two years with Health Canada, and the scientific and HIV/AIDS communities.

The study is based on a method known as a placebo-controlled crossover design. This means all participants will receive marijuana containing four different strengths of tetrahydrocannabinol (THC) at different times, including a placebo. Each patient will smoke the various forms of the drug for a week, monitoring their usage, pain level and weight. They will remain marijuana-free for the next week, but still self-monitoring.

Although they will be smoking medicinal pot in their own homes whenever they choose, they will undergo a battery of tests as an in-patient at a clinic once a week.

THC is the component of cannabis known to cause the “high” people experience. THC is also believed responsible for the drug’s potential medical benefits, such as appetite stimulation.

The study is expected to be completed within one year.
The federal government has funded another study, one in which researchers at McGill University will research the therapeutic effects of marijuana on neurological pain. The $235,000 project is to get underway this fall.

In August, Ms. McLellan prompted applause when she told doctors at a meeting of the Canadian Medical Association in New Brunswick that she was uncomfortable with people smoking pot to relieve pain and that the government would not look at distributing medicinal marijuana before it does clinical drug trials.

Ms. McLellan’s comments appeared to contradict her predecessor Allan Rock, who had suggested he was looking at easing up on legal access to the drug as medicine. However, she insisted she was not backing away from the government’s plan to distribute marijuana for medicinal purposes.

Like any other drug, she said, the safety, efficacy and long-term effects of marijuana must be studied before approval. Canadian doctors have led a powerful lobby against prescribing pot as medicine, arguing it has not been tested for safety or efficacy.

Example letter:

Dear Editor,

Regarding the SUBJECTS SMOKING GOV’T MARIJUANA story in the Thursday, 10th of October edition of the Edmonton Sun;

I deplore the “shwag tests” that Health Canada will be conducting using low-potency, chemically fertilized NIDA Mississippi bunk-weed. These tests do not respect the strain, quality or mode-of-administration preferences of the study subjects.

The only legitimate tests are those that study those who use cannabis in ways they have chosen to use cannabis, in order to remove the possibility of researcher bias interfering with results.

For just one example of the researcher bias impacting negatively on the results, we are told that “street marijuana contains compounds not found in study-grade marijuana”. Perhaps these compounds are medically effective? Consider the wisdom found in Chevallier’s Encyclopedia of Medicinal Plants; 1996;

“The whole herb is worth more than the sum of it’s parts, and scientific research is increasingly showing that the active constituents of many herbs….interact in complex ways to produce the therapeutic effect.”

Ancedotal evidence (a collection of individual testament) was quite enough to give legitimacy to many of our most effective medicines. For example, asprin, digitalis and curare were not recognized as therapeutic through controlled experiments, but rather through folklore.

Cannabis is NOT Thalidomide, and does not require the “safety and efficacy tests” that became required of synthetic medicines following the Thalidomide disaster. Neither do any of the other herbs used from the beginning of time.

These tests will make sick and dying people suffer needlessly. In these tests, HIV patients must abstain from their pain and nausia and appetite-stimulation medicine for one month to remove the true medicine – the “street cannabis” – from their systems. Others will be given a “placebo” – meaning they will suffer and might die as a result of having NO medicine – just to satisfy the “controlled studies” criteria of anti-cannabis Health Canada. And the NIDA weed is notorious for it’s lack of potency and quality – you might as well consider all NIDA cannabis to be a “placebo”.

These tests, aside from being cruel, were designed to fail. We in the Canadian Cannabis community want cannabis to be tested on how intelligently it can be used, not on how badly research can be conducted. User wisdom and user autonomy must be factors in the present and any future research on cannabis.

Sincerely,

David Malmo-Levine
Cannabis consultant
www.pot-tv.net
www.potshotzine.com
www.cannabisculture.com
[email protected]
(be sure to include a city and telephone number)

Please also, if you have time, send your letter to these politicians, involved in the latest “non-medical” use of cannabis BS research study…..gotta educate and empower everyone!

“Participants will be barred from using non-study marijuana during the trial and will be tested to ensure they are honouring that rule. Street marijuana contains compounds not found in study-grade marijuana, Gough explained. “
These tests are meant to fail………

Canada: Subjects Smoking Gov’t Marijuana
URL: http://www.mapinc.org/drugnews/v02/n1893/a10.html
Newshawk: Cannabis Health (http://www.cannabishealth.com/)
Pubdate: Thu, 10 Oct 2002
Source: Edmonton Sun (CN AB)
Copyright: 2002, Canoe Limited Partnership.
Contact: [email protected]
Website: http://www.fyiedmonton.com/htdocs/edmsun.shtml
Details: http://www.mapinc.org/media/135
Bookmark: http://www.mapinc.org/mmjcn.htm (Cannabis – Medicinal – Canada)

SUBJECTS SMOKING GOV’T MARIJUANA

Toronto Research Targets Medicinal Pot

TORONTO ( CP ) — Will marijuana-induced munchies help people with HIV and AIDS combat nausea and avoid the weight-loss that the disease brings on? Researchers in Toronto are hoping to find out.

Canada’s first government-sponsored trial of medicinal marijuana in HIV/AIDS officially started yesterday, led by researchers from St. Michael’s Hospital and the Community Research Initiative of Toronto.

“I think the time is right to look at this,” said principal investigator Dr. Kevin Gough, medical director of HIV services at the hospital.

“Let’s find out what role, if any, that smoked cannabis has in, not only HIV and AIDS, but other medical illnesses as well.”

Advocates of medicinal marijuana believe the drug can be useful for a wide range of conditions. Anecdotal evidence suggests it helps in pain control, curbs nausea brought on by chemotherapy or HIV/AIDS drugs, and stimulates the appetite of people who have lost interest in eating as a result of their conditions or medications.

But anecdotal evidence doesn’t cut it when you are asking a government to allow large numbers of ill people to buy and smoke what is still an illegal substance.

So Health Canada has authorized research to gather clinical evidence that may have implications for Canadian policy, and that will likely be scrutinized by governments outside Canada as well.

The current study is a pilot to gather information that will be used to design a larger, multi-centre clinical trial. The pilot phase, involving 32 participants with HIV/AIDS, is expected to last about a year.

All participants will have smoked marijuana before. Because there is little consensus on any risks associated with marijuana use, researchers can’t ethically ask people to take the drug for the first time for a study.

But only people who haven’t used the drug in the previous 30 days will be eligible to take part. That’s to ensure there are no lingering effects of non-study marijuana in their systems.

Over a two-month period, each participant will be given three supplies of varying strengths of marijuana plus a placebo. They will be asked to use each for a period of one week and will not be informed which is which.

Throughout the study they will keep a diary detailing how much they smoked, how they felt, and how much and what they ate.

After using one strength for a week, they will be asked to go a week without smoking marijuana, to cleanse the drug from their systems.

Participants will be barred from using non-study marijuana during the trial and will be tested to ensure they are honouring that rule. Street marijuana contains compounds not found in study-grade marijuana, Gough explained.

Although Canada is in the process of developing its own supply of study-grade marijuana, the crop – being grown in an underground facility in Manitoba – isn’t ready for use. The marijuana for this study comes from the U.S. National Institute of Drug Abuse, currently the only producer of research-grade marijuana in North America.

Ottawa probes marijuana’s effect on pain
First clinical trial to follow 32 patients over eight weeks

Tom Arnold
National Post

Thursday, October 10, 2002

Jeff Vinnick, National Post
Anne McLellan, the federal Health Minister, said the government would not consider distributing medical marijuana without trials.

ADVERTISEMENT

The federal government is putting up $840,000 for Canada’s first clinical study into whether marijuana use can help ease pain.

The Community Research Initiative of Toronto and St. Michael’s Hospital in Toronto are to begin evaluating the therapeutic effects of smoked cannabis in HIV/AIDS.

In the clinical trial, 32 patients will be closely examined over eight weeks to test the safety of short-term exposure to different strengths of cannabis, and how cannabis interacts with HIV medications. The analysis will also include the effect of smoked marijuana on nausea, pain, mood and neuro-cognitive function.

The results of the study will help determine the design of a larger, multi-centre, clinical trial across the country. It is also important because Anne McLellan, the federal Health Minister, has said she will not proceed with medicinal legalization without clinical trials looking at the plant’s effectiveness.

“There is so little good concrete scientific data about the potential benefits or effects of smoked cannabis in a number of illnesses, including HIV and AIDS,” said Kevin Gough, an infectious diseases specialist who will act as the study’s principal investigator.

“HIV itself, the disease, and the medications we use to treat it, produce a number of side effects, including loss of appetite, nausea, and pain. Other diseases like cancer and multiple sclerosis can also lead to similar symptoms that might benefit from smoked cannabis, but the studies aren’t there.

“This is the first trial in Canada to be looking at cannabis in any medical context,” added Dr. Gough, who is also medical director of HIV services at St. Michael’s Hospital in Toronto.

For those suffering from HIV or AIDS, loss of appetite and weight loss can be life threatening, said Derek Thaczuk, former chairman of the board of directors of the Community Research Initiative of Toronto, an organization dedicated to research on HIV and AIDS.

“There is plenty of anecdotal evidence to suggest that smoking marijuana increases people’s appetite and therefore helps them gain weight,” he said. “What we’re doing with this study is subjecting it to some scientific rigour and trying to get quantitative answers to the question of ‘Can smoked cannabis help with this condition and if so, how much?’ “

The marijuana has been imported from the U.S. government’s National Institutes of Drug Abuse. The organization grows its own marijuana on a farm in Mississippi. The Canadian research team purchased 500 grams for the research project.

Mr. Thaczuk, who chairs the Toronto research initiative’s scientific committee, said work on the study has been carried out for two years with Health Canada, and the scientific and HIV/AIDS communities.

The study is based on a method known as a placebo-controlled crossover design. This means all participants will receive marijuana containing four different strengths of tetrahydrocannabinol (THC) at different times, including a placebo. Each patient will smoke the various forms of the drug for a week, monitoring their usage, pain level and weight. They will remain marijuana-free for the next week, but still self-monitoring.

Although they will be smoking medicinal pot in their own homes whenever they choose, they will undergo a battery of tests as an in-patient at a clinic once a week.

THC is the component of cannabis known to cause the “high” people experience. THC is also believed responsible for the drug’s potential medical benefits, such as appetite stimulation.

The study is expected to be completed within one year.
The federal government has funded another study, one in which researchers at McGill University will research the therapeutic effects of marijuana on neurological pain. The $235,000 project is to get underway this fall.

In August, Ms. McLellan prompted applause when she told doctors at a meeting of the Canadian Medical Association in New Brunswick that she was uncomfortable with people smoking pot to relieve pain and that the government would not look at distributing medicinal marijuana before it does clinical drug trials.

Ms. McLellan’s comments appeared to contradict her predecessor Allan Rock, who had suggested he was looking at easing up on legal access to the drug as medicine. However, she insisted she was not backing away from the government’s plan to distribute marijuana for medicinal purposes.

Like any other drug, she said, the safety, efficacy and long-term effects of marijuana must be studied before approval. Canadian doctors have led a powerful lobby against prescribing pot as medicine, arguing it has not been tested for safety or efficacy.

http://www.newswire.ca/releases/October2002/09/c9505.html

Canada’s first marijuana study to begin

Toronto Researchers to Explore Effects of Smoked Cannabis in HIV/AIDS

TORONTO, Oct. 9 /CNW/ – The Community Research Initiative of Toronto
(CRIT) and St. Michael’s Hospital in Toronto announced today the start of the
first Canadian study evaluating the therapeutic effects of smoked cannabis in
HIV/AIDS. The study represents more than two years of development and planning
with Health Canada, the scientific and HIV/AIDS communities.
The goal of this pioneering research project is to create scientific
knowledge about the safety and efficacy of smoked marijuana and its ability to
increase appetite in patients with HIV/AIDS,” says Principal Investigator, Dr.
Kevin Gough, Medical Director, HIV Service, St. Michael’s Hospital in Toronto.
Unlike previous cannabis studies, the Toronto team is conducting the research
on an outpatient basis. The study will also test the safety of short-term
exposure to different strengths of cannabis, and how cannabis interacts with
HIV medications. Secondary areas of analysis will include the role of smoked
marijuana on nausea, pain, mood and neuro-cognitive function. The results of
the pilot study will help determine the design of a larger, multi-centre,
clinical trial across Canada.
“There is anecdotal evidence suggesting that using marijuana
therapeutically may increase appetite, provide pain relief or reduce nausea,”
commented CRIT spokesperson, Derek Thaczuk. “Only when the safety and
effectiveness of medicinal marijuana is demonstrated in rigorous, carefully-
designed scientific studies, can it be accepted by the medical community.
Research of this nature is pivotal in understanding whether marijuana is a
credible therapy in disease management, ” he continued.
The study is a placebo-controlled crossover design, meaning that all
participants will receive cannabis containing different strengths of
tetrahydrocannabinol (THC) at different times including a placebo (no THC).
THC is the component of cannabis known to cause the “high” people experience.
THC is also thought to be responsible for cannabis’ possible medical benefits
(e.g. appetite stimulation).
The study is being conducted by CRIT, a research organization that
focuses on community-initiated research in the area of HIV/AIDS, in
partnership with St. Michael’s Hospital and the Canadian HIV Trials Network
(CTN). St. Michael’s Hospital is a Catholic teaching and research hospital,
affiliated with the University of Toronto, specializing in heart and vascular
disease, inner city health, trauma/neurosurgery, diabetes comprehensive care,
minimal access therapeutics, and mobility disorders. CTN is a national
organization that coordinates clinical trials in HIV/AIDS. The funding for
this initiative has been provided by Health Canada.
Co-investigators for this study include; Sergio Rueda (Community Research
Initiative of Toronto), Dr. Joel Singer (Canadian HIV Trials Network), Dr.Tom
Chin (St. Michael’s Hospital), Dr. Ahmed Bayoumi (St. Michael’s Hospital), Dr.
Don Kilby (University of Ottawa), Pauline Darling (St. Michael’s Hospital),
Shelley Schwartzberg (St. Michael’s Hospital), Scott Walker (Sunnybrook Health
Science Centre) and Dr. Sean Rourke (St. Michael’s Hospital).

-30-

For further information: please contact: Audra Millis/Adah Pettingill,
NATIONAL Public Relations, (416) 848-1432/(416) 848-1386
This press release concerns more than one organization.
To view releases from one of these organizations, please select from below.

COMMUNITY RESEARCH INITIATIVE OF TORONTO
ST. MICHAEL’S HOSPITAL

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