MEDICINAL POT SPARKS ONGOING DEBATE

Drug Companies, Government and Doctors Remain Divided on Plant's Medical Future

A decade after Canada legalized the medical use of marijuana, most
doctors are still refusing to sign the declarations patients need to
get legal access to pot - meaning patients in pain risk being jailed
if they use a drug that helps them function.

It's a predicament that threatens to become worse because of proposed
changes to how Health Canada regulates access to the drug.

At first glance, it appears the government is easing up on strict
rules for obtaining medicinal marijuana. Health Canada has proposed
removing itself as the ultimate arbiter in approving or rejecting
applications to possess.

Instead, doctors alone would sign off on requests.

But the nation's largest doctors' group said the proposals would have
the perverse effect of putting even greater pressure on MDs to
control access to a largely untested and unregulated substance they
know little to nothing about, a drug that hasn't gone through the
normal regulatory review process. Their licensing bodies have told
doctors that they are under no obligation to complete a medical
declaration under the current regulations and that any one who
chooses to do so should "proceed with caution."

Dr. John Haggie, president of the 75,000-member Canadian Medical
Association, said the changes being proposed would essentially
offload all responsibility for using and monitoring marijuana to the
doctors who sign an authorization - "and they'd be kind out of out
there, without any infrastructure around them to assess it, to
monitor it and to know if they were doing the right thing."

"I don't think that's appropriate or fair," Haggie said.

Observers said doctors fear doing harm, exposing themselves to legal
action and becoming the "go-to" source for people seeking pot not to
alter their pain but to alter their consciousness.

Haggie said physicians want fundamental research into some basic
questions - is it safe? Who does it work for? Who should not use it?
Yet the Conservative government abruptly terminated a medicinal
marijuana research program in 2006. According to Health Canada, the
government believes clinical research is "best undertaken by the
private sector, such as pharmaceutical companies."

A world leader in cannabis research said the logic defies him.

"I cannot imagine how a government agency can supervise (a marijuana
access) program knowing that there is very little data out there - on
safety issues in particular - and not try to stimulate research,"
said Dr. Mark Ware, head of the Canadian Consortium for the
Investigation of Cannabinoids, a non-profit network of more than 150
clinicians and researchers investigating the potential role of
cannabinoids in diseases from arthritis to glaucoma.

No drug company wants to evaluate smoked marijuana as a medicine,
Ware said, because there's no money in it for them. Funding agencies
have been less than approachable, he added, because there's little
appetite to support studies involving a product that's often smoked.

In clinical parlance, "They don't see it as a safe, viable drug
delivery system," said Ware, director of clinical research at the
Alan Edwards Pain Management Unit at the McGill University Health Centre.

Ware said he wonders how much the government's disinterest in
research might be tied to its tough-on-crime political agenda - "that
somehow facilitating research on medicinal cannabis is a way of
accepting that it may have some value as a medicine."

In a study published in the Canadian Medical Association Journal last
year that involved 21 patients with neuropathic pain - a common and
dreaded condition that causes electric, stabbing pain - Ware's group
found that smoked cannabis at low doses reduces pain, improves mood
and helps sleep, without making people high.

All had "refractory" pain, meaning pain that had defied all
traditional treatments. No serious or unexpected side effects were reported.

Ware avoids prescribing cannabis to patients with a history of
psychosis or schizophrenia, because it's psychoactive at high doses -
and sometimes even therapeutic doses.

It can also be dangerous to people with unstable heart disease.

Still, there has never been a proven overdose death caused by
marijuana in humans, according to Ontario's highest court. Ware said
that for patients for whom it works, cannabis can achieve about 30
per cent reduction in pain intensity.

But doctors remain wary - their chief concern being: How do I know
when a patient is seeking a licence for a legitimate medical purpose
and not simply to get legal access to an otherwise illicit drug?

Ware's consortium has been working hard to educate and support
doctors around the use of cannabis.

He said data from Health Canada suggest that the average medical user
is consuming two grams per day - about four joints when smoked.

"It's just taking that information and getting it into the hands of
practising physicians. Then at least they know what the ballpark is."

Some patients were getting authorizations for far higher amounts,
because doctors didn't know that 30 or 40 grams a day could be
outside the "normal" range, he said.

The Montreal doctor, who is helping reform medical school curricula
to better educate physicians around pain, received about $2 million
under the now-dead medicinal marijuana research program.

Health Canada said the proposed changes to the program - which would
include removing the rights of patients to grow their own supply of
marijuana or to appoint designated growers, forcing users to get
their pot from a licensed commercial producer instead - would make
the program less complicated for seriously ill Canadians.

Paul Lewin begs to differ. Doctors already are boycotting the program
en masse, the Toronto lawyer said. Lewin said medical regulators and
insurers sent letters to the government, "saying, 'Don't put us in
charge, don't make us a gatekeeper, we don't know anything about pot,
this is a plant product, it's an unapproved drug.'"

Lewin said the court heard stories of how some doctors encouraged
their patients to use pot for their pain.

The patients would return, reporting that the marijuana was helping,
that they were feeling less pain. But when they asked the doctors to
sign their forms, "that's when the mood changes," Lewin said. "That's
when they say, 'Get out. I'm not risking my practice over you.'"

Lewin's client, Matt Mernagh, started growing marijuana when he found
it provided some relief from chronic pain and other symptoms of
scoliosis, fibromyalgia and epilepsy. But he couldn't get a licence
to grow, because he couldn't find a doctor to sign his declaration.

Police found Mernagh's plants in 2008 when they were in his apartment
building on an unrelated call. He was charged with production.

Lewin took the case to the Superior Court in Ontario. The court
declared the federal medical marijuana program unconstitutional.

The case is scheduled to go to the Court of Appeal for Ontario in March.

Lewin said the proposed changes to the marijuana access program are
likely to scare off some of the few doctors willing to
signdeclarations, meaning "more seriously ill, law-abiding Canadians
will be wrongfully treated as criminals" and subjected to humiliating
arrests, medicine seizures and possibly even jailed, he said.

Ware said doctors need education and guidance.

They would need to know whether patients who come seeking a licence
for medical pot have been arrested for trafficking or diversion in the past.

Abuses of the designated production licenses have occurred and Ware
believes they should be phased out. But the consortium of cannabinoid
researchers said that it's not only easier and cheaper for patients
to grow their own supply but the act of growing their own "medicine"
may be therapeutic in itself. "It gives them a sense of control and
ownership of their health and treatments."

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THE PROPOSAL

The following information was provided by Health Canada to Postmedia News:

In 2001: 727 doctors supported an application for an authorization to
possess marijuana.

In 2010: 3,187 doctors signed a declaration. Between Jan. 1 and Oct.
25, 3,803 doctors supported an application for an authorization to possess.

As of Sept. 30: 12,216 people in Canada held authorization to possess
marijuana for medical purposes.

Who has authority to approve or reject submissions in the new system?

Under the proposed changes, patients would continue to consult with
their physician in order to obtain access to marijuana for medical purposes.

Once it has been determined that the use of marijuana for medical
purposes is appropriate, the physician would provide the individual
with a document. Health Canada is consulting the medical community on
the form that this document would take. Individuals would then send
the physician's document directly to a licensed commercial producer
of their choice. The licensed producer would validate the document
from the physician by confirming that the physician is licensed to
practice medicine in Canada.

The licensed producer would register the individual as a customer and
would process the order for a specific amount of dried marijuana.
Health Canada would maintain an upto-date list of licensed producers
on its website, and work with the medical community to disseminate
this information as widely as possible.