'DISGUSTING' FEDERAL POT DEFENDED

Court Left No Time For Clinical Trials

THE Flin Flon marijuana that's getting bad reviews from some patients was
not tested by users and could be improved, says the grower.

"The individuals who tried this product are the first humans ever to use
it," Brent Zettl of Saskatoon's Prairie Plant Systems said yesterday. "This
is a very early-stage product... We haven't hit the mark yet on this medicine."

Zettl, whose company grows government marijuana on contract in Flin Flon,
was responding to complaints this week from patients who called the dope
weak, disgusting and not fit for human consumption.

Prairie Plant Systems began shipping the marijuana Aug. 13 to a small group
of Health Canada-approved patients who require the drug to alleviate
symptoms such as nausea.

The 30-gram packages of dried leaves and buds, which sell for $150, were
originally intended to be used in clinical trials. But an Ontario Superior
Court judge ordered the department either to change its marijuana
regulations by July 9 or begin supplying pot itself directly to needy patients.

Health Canada appealed that order but until there's a final ruling, the
department has been forced to distribute its marijuana directly to 10
patients, two of whom are getting seeds only. Another 39 patients have also
applied. "It would have been better to have had this go through the
clinical trials first," said Zettl. "Through the clinical trials, there
would have been patient feedback."

Prairie Plant Systems was required to produce marijuana with 10.2 per cent
THC, the main active ingredient, though some patients complained that it
seems weaker.

A Victoria patients-rights group said this week that it sent samples of
government marijuana to an independent lab that measured the THC at only
three per cent, though the group refused to identify the lab or say how it
got the samples.

Zettl said his company hired three labs, each of whom verified the 10.2 per
cent THC content and declared the product well within Health Canada
guidelines for contaminants such as lead, arsenic and microbes.

"The material has been tested and retested," he said. "We jumped through a
lot of hoops." Patients also complained that the marijuana was too finely
ground, though Zettl said that was to ensure that clinical doses were standard.

"The coarser the material, the higher the probability that the dosing will
wander," he said.

The only other current users of Health Canada marijuana are 32 patients
enrolled in a $235,000 clinical study at Montreal General Hospital. The
project, directed by McGill University's Dr. Mark Ware, will determine how
smoked marijuana can alleviate pain.

Ware declined an interview yesterday, and Zettl said he has received no
feedback from the study about the quality of the product.

A Health Canada official said the department has received one telephone
call from a patient complaining about the quality of the dope, and has been
told to expect a letter from another dissatisfied customer.

But Richard Viau said it's too early to say whether the department will
make changes to the product.

"We'll have to see what the feedback is and then determine if there's any
actions to be taken," said Viau, director of the drug analysis service. He
added he is confident of the Prairie Plant System lab results which were
reviewed by Health Canada.

Prairie Plant Systems is currently using four strains of marijuana, whose
flowering tops or buds range in THC content from 11 per cent to 30 per
cent. The company mixes dried leaves, which have lower THC, with buds to
lower the overall THC to meet Health Canada's specifications. The company's
$5.75-million contract with Health Canada ends in 2005.