COUNTY SEEKS MEDICAL POT STUDY APPPROVAL

Supervisor Nevin hopes clinical trials will help change U.S. law

San Mateo County has submitted a proposal to the National Institute on Drug
Abuse seeking approval for a clinical study of the medical use of marijuana.

The county-sponsored protocol - a formal proposal and set of guidelines -
was submitted to NIDA on March 19.

Approval from NIDA is crucial to conducting the study, as it is the sole
federal agency responsible for legally providing the drug for such surveys.

With NIDA approval, the county will then seek the blessing of the Food and
Diug Administration. Clinical trials in the county could start this summer
at the earliest with approval from both agencies.

The protocol outlines how to monitor the effects of smoking marijuana on
subjects with such medical conditions as chronic nausea, anorexia or
ameliorating weight loss stemming from AIDS treatments and cancer treatments
such as chemo or radiation therapies.

County Supervisor Mike Nevin has helped to spearhead the push for the
clinical trials to be conducted under the auspices of the county government
in county facilities.

"What hat we've done is we have pushed the envelope as San Mateo County is
the first governmental entity that's been willing to put its money up to
conduct clinical trial," said Nevin.

"Our hope is that these clinical trials will ultimately lead the United
States of America to change the law."

The state of California itself has been at the forefront in support of the
legal medical use of marijuana, having passed Proposition 215 in 1996 to
that effect. Proposition 215 came two years in advance of similar measures
passed in Alaska, Arizona, Colorado, Nevada, Oregon and Washington states,

The study will include a group of 60 volunteer subjects being treated for
AIDS or cancer. The subjects will be divided into two groups of 30. One
group will begin taking the drug immediately and continue for six weeks,
stop, and then continue in the trial for another six weeks without taking
the drug.

The second group of 30 will go through the trial in the reverse order.

The marijuana will be obtained from NIDA, the sole legal grower of marijuana
in the country with farms in Mississippi. Under the current proposal, the
test subjects will be able to smoke their prescribed marijuana cigarettes at
home.

"We submitted the protocol so that they do not smoke on-site, they would be
given a supply of 28 cigarettes a week." said Dr. Scott Morrow, the San
Mateo County Health Officer and co-author of the proposal.

"We submitted it like that because if they were required to smoke on-site
that would limit our ability to get as many subjects as possible."

Morrow suggested, however, that the protocol will be subject to modification
due to the constraints that NIDA or the FDA will likely impose.

The study, according to Morrow, is not the first of its kind but is part of
a nationwide effort to investigate the drug's usefulness weighed against its
harmful side effects.

Only days ago the National Academy of Science's Institute of Medicine - the
private, nonprofit organization that provides health policy advice to the
federal government under a congressional charter - released a report
affirming the beneficial uses of marijuana in specific medical cases and
called for continued clinical trials.

The report warned, however, that smoking marijuana is a poor system of
delivery due to harmful side effects, such as an increased risk for cancer
and lung damage.

The Institute of Medicine report also suggested that trials should be
limited to patients likely to benefit from marijuana most and only for
short-term use.

The county has allocated $50,000 for the initial submission of the protocol
and is prepared to allocate up to $500,000 for the clinical trial, should it
be approved. The trial will, according to Morrow, likely be done on an
outpatient basis through county clinics. The County Health Services
Department will hire between two and three research specialists to run the
trial.

A second protocol will be submitted in April that will focus on possible
pain relief benefit I of marijuana.

The push to investigate the possible medicinal benefits of marijuana is not,
according to Nevin, part of an effort to legalize the drug for recreational
use, but rather an opportunity for the medical community to put it to test.

"We haven't given the medical profession chance to breathe or a chance to,
in fact, a conclude that marijuana does work in specific cases," said Nevin.

"It's not my intent to suggest that marijana should be legal, but this
substance has some ingredients that work in specific cases. it makes sense
that it should be an option any other drug."