RED TAPE CHOKING POT STUDY

Lack Of Approvals Has Delayed Montreal General Clinical Trials

The medical-marijuana clinical trials required by federal Health Minister
Anne McLellan could take more than five years to complete, according to the
McGill University researcher whose groundbreaking study into pot and pain
is entangled in red tape.

In July 2001, McGill announced Dr. Mark Ware had received federal approval
for Canada's first clinical study on marijuana and pain. The year-long
study was to have begun at Montreal General Hospital in January.

"We haven't actually started yet," Ware said yesterday. A "series of
requirements," including an import license to bring marijuana from the
United States, have to be acquired, he said.

Ware's peer-reviewed clinical trial - funded by a $235,000 grant from the
Canadian Institutes of Health Research, a branch of Health Canada - seeks
scientific evidence of anecdotal claims about cannabis as a pain reliever.
It would involve 32 patients suffering from acute, chronic pain.

Although medical marijuana is a controversial matter, Ware insisted the
delay isn't due to the nature of his study, but to his underestimation of
the time required to get various approvals.

"This is a kind of bureaucratic necessity to protect the patients of Canada
against any drug that's not high quality," he said.

While the delay might dismay sick Canadians awaiting the legal right to
smoke pot, more disconcerting is Ware's assessment that it could take five
to 10 years to complete the pivotal clinical trials McLellan has required
before the government will consider sanctioning marijuana as a medicine.

Even multimillion-dollar drug empires spend years getting a drug approved
for use, Ware noted.

Before pot can be approved, various phases of testing are required,
including large clinical trials with very specific pre-determined criteria
and a large numbers of patients, he said.

"Our study, important as it may be, is being perceived (by the public as
well as public officials) as giving definitive answers, but this is a pilot
study" involving a small number of people using small amounts of the drug
for a short period, he said.

Alex Swann, a spokesman for McLellan, agreed yesterday that Ware's pilot
project, along with another clinical trial involving HIV patients in
Toronto, were but first steps in a process requiring broad-based clinical
trials.

Those trials "haven't been designed yet ...so I can't speak to the time
line those trials would take," he said.

McLellan's predecessor, Allan Rock, unveiled a policy to provide
chronic-pain sufferers and terminally ill patients with the right to smoke
marijuana legally. During Rock's tenure, an abandoned mine in Flin Flon,
Man., was converted into a marijuana farm to supply medicinal pot. McLellan
rejected the crop, saying there were too many variations in the harvest to
do clinical trials.