Pubdate: Sat, 21 Jan 2017
Source: Montreal Gazette (CN QU)
Copyright: 2017 Postmedia Network Inc.
Contact:  http://www.montrealgazette.com/
Details: http://www.mapinc.org/media/274
Author: Christopher Curtis
Page: A3

PHYSICIANS SPEARHEAD CANNABIS CLINICAL TRIAL

Clinic involved in one-year study of marijuana in managing chronic pain

Gilles Richard doesn't harbour any illusions about his disease.

It has latched itself to his lungs, his bones and he fears it will
eventually seep its way into his brain. Over time, he says, the sickness
will prevail.

"I like to say I just want five good years," says Richard, a retired
physicist. "But it could be three, it could be two . ... I won't take
anything for granted."

Faced with this grim fate, Richard seems unfazed as he sits in the waiting
room of the Sante Cannabis medical clinic on Amherst St. in Montreal's
Centre-Sud borough. The 60-year-old wears a suit and tie, he smiles at
passersby and offers to chat about topics ranging from molecular biology
to the latest episode of The Walking Dead.

Seven years ago, Richard was diagnosed with multi-system sarcoidosis, a
rare and incurable genetic disease that causes inflammatory cells to form
lumps around vital organs. Richard uses medical cannabis to help manage
the chronic pain that's become a fixture in his life.

Because of provincial restrictions surrounding the drug, however,
Richard's medical insurance won't cover the cost of cannabis. While
marijuana is an increasingly common treatment for chronic pain, epilepsy,
multiple sclerosis and dozens of other conditions, the drug exists in a
sort of regulatory grey area.

Sante Cannabis is at the centre of an effort to change that.

Next week, the clinic will announce its plan to have Health Canada and the
U.S. Food and Drug Administration approve and regulate cannabis-based
therapy.

The clinic has partnered with a pharmaceutical research firm to recruit
more than 500 patients and conduct a one-year study surrounding the safety
and efficacy of marijuana in the treatment of chronic pain. A
representative of the firm, Tetra Bio-Pharma, says the clinical trial
should cost about $2 million and will mostly recruit patients in the
Montreal area.

It will be the first such clinical trial in Canadian history.

"With most (drugs) you move slowly, you wait and plan and you're unsure
what the testing will reveal," said Dr. Guy Chamberland, Tetra Bio's chief
scientific officer. "But I know (cannabis) works, it's just a question of
boxchecking right now."

The trial's goal is to have North American regulators approve the
treatment and issue it a drug identification number - the eight-digit code
that indicates a drug can be sold in pharmacies and covered by insurance
providers.

Chamberland's firm is working with Algorithme Pharma to test the safety of
inhaled-cannabis on 72 human subjects in a study that begins later this
winter. The subjects will be paid to smoke marijuana several times a day
in a lab where doctors can observe the effects of the drug on their
health.

"I don't think we'll have a hard time finding recruits, we'll be paying
people to smoke (cannabis)," Chamberland said.

The real challenge begins in the trial's next phase which, according to
Chamberland, should begin in about six months. To that end, doctors at
Sante Cannabis will recruit and monitor patients as they use cannabis to
treat their chronic pain. In Quebec, the physician's college only allows
doctors to prescribe medicinal cannabis once all other treatment options
have been exhausted. The college maintains that there isn't enough
research on cannabis to justify approving it.

What this means, in practice, is that by the time a patient is prescribed
marijuana, they're often at the end of their rope.

"The people who come to me are desperate, they've run out of options,"
said Dr. Antonio Vigano, a palliative care doctor at the McGill University
Health Centre. "My area of expertise is related to cancer nutrition and
rehabilitation. I deal with a lot of people who suffer severe weight loss,
loss of appetite, chronic pain and we don't have much that can help them
except cannabis."

Vigano, who will oversee the study, works 10 hours a week at Sante
Cannabis. On a typical day at the clinic, the waiting room is packed and
its receptionist fields up to 200 calls from prospective patients.

Some have degenerative diseases like multiple sclerosis, others suffer
from nausea that comes with chemotherapy and others are looking for a
solution to the debilitating seizures brought on by epilepsy.

Erin Prosk, the clinic's director, says many of the people who wind up at
Sante Cannabis are looking for an alternative to opioids - a class of
painkillers that mimic the effects of heroin. Most opioids are highly
addictive and an overdose can be lethal.

Years of opioid use can also lead to significant cognitive delays.

Dr. Michael Dworkind, who also works at the clinic, told the Montreal
Gazette that some of his patients reduced their opioid use by using
cannabis. He says that because cannabis and opioids target different pain
receptors in the brain, there's potential for the drugs to be used in
combination.

"This is groundbreaking; the data we gather here can change the way we
view chronic pain treatment," said Prosk. "It's also critical that we
understand what the risks of cannabis are and monitoring its use for one
year will give us a much better idea of that."

With the legalization of recreational marijuana use looming in Canada,
Prosk worries that Health Canada's medicinal cannabis program could fall
to the wayside.

"There's a medical use for this and one that needs to be recognized by
health care providers and insurance companies," she said. "To us, this is
the first step toward attaining that goal."

Whatever the study's outcome, it's unlikely Richard will benefit from it.

He does a good job hiding his symptoms; he's cheerful, funny and quick to
show off pictures of his two grandsons. But Richard clearly struggles: his
hands shake, he walks with a cane and he'll spend up to 12 hours in bed
each day.

"Some days I have two or three good hours and some days I have none," he
says. "I'm still an information junkie, I always have audio books handy or
some sort of documentary on the go. Sometimes I prey on people in hospital
waiting rooms to see who wants to chat."

"But (the disease) is already affecting my memory and it will probably get
worse. I've developed such an incredible tolerance to pain medication.
When I went to the surgeon to have a (lump) removed from my arm, what they
were shooting me up with had no effect. Whether it's opioids or cannabis,
this is what my body needs until I finish my life."
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