Pubdate: Tue, 29 Jul 2014
Source: Ottawa Citizen (CN ON)
Copyright: 2014 Postmedia Network Inc.
Contact: http://www.canada.com/ottawacitizen/letters.html
Website: http://www.ottawacitizen.com/
Details: http://www.mapinc.org/media/326
Author: Marie-Danielle Smith
Page: A6
Bookmark: http://www.mapinc.org/find?323 (GW Pharmaceuticals)

CANADA TRAILS OTHERS ON USE OF MARIJUANA-BASED EDIBLES

Clinical Trials of Pot Products Needed Before Health Canada Will Allow Use

Roll it. Light it. Smoke it. Vaporize it. But don't cook with it.

Despite Canada's strides to regulate medical marijuana, in some ways, 
this country trails other jurisdictions.

Parts of the United States and Israel have gone further in making 
cannabis products, such as oils and foods, legally available as medication.

Under the Marihuana for Medical Purposes Regulations, the new 
regulatory framework implemented April 1, only dried marijuana that 
is smoked or vaporized has been approved for therapeutic use in 
Canada. However, some contend that for children and adults with 
asthma or lung problems who can't smoke or inhale vapour, derivative 
products are a better option.

The obstacle? Clinical trials. Health Canada says the alternative 
cannabis products haven't gone through adequate testing.

"Clinical trials represent the best mechanism through which patients 
can have access to drugs which have not yet been approved for general 
marketing in Canada," the department said in a statement. "Clinical 
trials ensure that the best interests of patients are protected and 
that the drug is administered in accordance with national and 
international ethical, medical, and scientific standards."

Advocates put forward a number of arguments in favour of the alternatives.

Ingesting marijuana-based products creates longer-lasting effects, 
because chemicals enter the bloodstream through the stomach rather 
than the lungs. People with chronic pain could eat food containing 
marijuana butter or oil throughout the day instead of smoking a joint 
every hour.

Another factor is that chemical contents of derivative products such 
as tinctures or oils can be more accurately measured, making intake 
and dosage easier to control.

For example, cannabis-based treatment for children with epilepsy 
requires a specific amount of CBD, a non-psychoactive component of 
cannabis, per kilogram of weight. Oils can be analyzed in a lab to 
ensure the correct dose is being administered.

Marlene Freelan's 4 1/2-year-old granddaughter, Taylor, suffers from 
intractable epilepsy.

The Toronto woman said if CBD rich oil was available it could be an 
option for the girl, whose epilepsy causes "drop" seizures up to five 
times an hour.

The seizures cause Taylor to fall to the ground uncontrollably. She 
wears a helmet, and someone is with her at all times. She has a 
prescription for medical marijuana that her family would use to 
acquire the oil if it was legal, said Freelan, who is in contact with 
her local Conservative MP's office about the issue.

Liberal health critic, MP Hedy Fry, said "the evidence is clear" that 
oil high in CBD can make a big difference for these kids.

"There is absolutely no reason that the minister cannot allow this, 
if she understood or if she followed any kind of evidence-based 
health policy," said Fry. "This blows my mind."

Skirting Health Canada regulations, as some users have taken to doing 
to make their own oil, is costly, she said. Many people can't afford 
to do this, let alone to purchase marijuana from commercial suppliers 
rather than being able to grow it in their backyards, she added.

NDP health critic, MP Libby Davies, also contends the new regulations 
are too restrictive.

"I just spoke with a woman the other day who is suffering from 
chronic pain and doesn't want to smoke. She's looking for help to 
find the right product to use," said Davies, adding her office 
receives calls about issues like these every week. "It causes great 
frustration."

Davies cited Colorado, where oils high in CBD are legally used to 
treat epilepsy.

There, and in California, an organization called the Realm of Caring 
distributes oil made from the "Charlotte's Web" strain of marijuana 
to parents of 437 epileptic children. More than 8,800 people are on a 
wait list for the service, including some Canadian families.

Thirteen more U.S. states have either legalized possession of the oil 
or approved studies that could result in its legal prescription. The 
oil is also being used legally under Israel's medical marijuana laws.

"We've fallen behind," said Davies.

Toronto's Hospital for Sick Children receives regular inquiries from 
parents who want to use the cannabis oil treatment. But a lack of 
Health Canada-approved clinical trials vetting the products is a 
roadblock for the hospital.

"There is insufficient scientific evidence to show that this 
treatment is effective," a spokeswoman for the hospital said.

However, she added, SickKids is working toward developing a clinical 
trial in the future.

A drug with properties similar to CBD-rich cannabis oil has received 
the U.S. Food and Drug Administration's "orphan drug" designation, 
allowing it to be used in clinical trials there.

The drug, called Epidiolex and manufactured by Britain's GW 
Pharmaceuticals, derives CBD from marijuana plants and is free of 
THC, the other major chemical in marijuana that is typically 
associated with pain relief and produces a "high."

The company announced results from early trials in June. It found 
that of 27 children with severe epilepsy treated with the drug over 
12 weeks, a high proportion showed a greater-than-50 per cent 
reduction in seizure frequency. Some children were reported 
seizure-free at the end of the trial.

A petition created last year by Pediatric Cannabis Canada got 11,703 
signatures in favour of making CBD oil legally available. But 
political movement on the issue has been minimal.

Ottawa's Mandy McKnight, who illegally treats her six-year-old, Liam, 
with cannabis oil to help control his Dravet syndrome seizures, said 
recently she is frustrated that her attempts to contact Health Canada 
and local and federal politicians have gone without reply.

"It is very disappointing, very disappointing," she said. "It just 
seems to be that no one wanted to take an effort, to take it on. I 
don't get it."

Health Canada said a drug manufacturer or other sponsor, such as 
SickKids or a physician, could propose a clinical trial for cannabis 
extracts by submitting a clinical trial application to Health Canada 
"at any time."

But Adam Greenblatt, executive director of Montreal-based Medical 
Cannabis Access Society, said Health Canada is not taking a logical 
approach by treating marijuana the same way it does pharmaceutical 
drugs. "They're trying to cram a square piece into a round hole," he said.

Greenblatt said his organization approached Health Canada with the 
idea of making a standardized cookie that would contain approximate 
amounts of THC and CBD, providing longer-lasting effects and making 
patients' intake easier to control.

They told him, "You want to sell a cookie? Well, you've got to put 
your cookie through trials," he said. "I don't think they're opposed 
to these products but they want a product like that to be approved 
like a narcotic."

Health Minister Rona Ambrose was not available for an interview with 
the Citizen.
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MAP posted-by: Jay Bergstrom