study of medical use of marijuana Posted: 01-26-08 17:59pm
Three times a day, a neatly machine-rolled
marijuana joint is delivered from a locked
cabinet at San Francisco General Hospital
to Patient No. 9. He closes the door to
his small white room, stuffs a towel under
the door and lights a match. A nurse
watches through a window.
Following strict research protocol, he
inhales for five seconds, holds for 10,
then releases. He waits 45 seconds. The
exercise is repeated 10 times.
Patient No. 9, a 34-year-old former Navy
man with HIV, is a volunteer in a new $1
million, two year research experiment that
hopes to help resolve a long-running and
emotional debate in federal drug policy:
Does marijuana, the country's most widely
used illegal drug, have medicinal value?
The study -- the first and only
government-sanctioned marijuana-therapy
research project in the United States --
pays volunteers $1,000 to undergo more
than three weeks of isolation and rigorous
medical testing. They smoke pot, ingest a
tablet form of the drug or take a
placebo.
``It is a really intense study,'' said
Patient No. 9, who has experience in pot
smoking and much patience -- both
necessary criteria for the study. ``I knew
that coming in.''
The patient, a muscular 34-year-old man
with tattoos and a gold chain, relaxes by
reading Stephen King and watching
``Jurassic Park'' and Disney videos
including ``The Little Mermaid,'' ``The
Lion King'' and ``Hercules.'' His earnings
from the study will help finance an autumn
trip to Disney's Animal Kingdom in
Florida.
Critical to the research are the blood
tests that measure immune function,
hormones, the AIDS virus and marijuana's
active ingredient,
delta-9-tetrahydrocannabinol (THC). There
are also tests of Patient No. 9's body
composition to see if marijuana has any
effect on weight gain or appetite. A large
plastic bubble is pulled over his head for
30 minutes each morning to monitor his
carbon dioxide levels.
The results of the experiment ultimately
could influence the debate over the
medicinal use of marijuana, which won
public support in the 1996 approval of
California's Proposition 215. The courts
have since been shooting down the law.
The study's lead investigator insists that
the experiment is motivated by medicine,
not politics.
``It was the need to find answers so that
patients could be best advised concerning
marijuana,'' said Dr. Donald Abrams, a
professor of medicine at the University of
California-San Francisco, a renowned
Stanford-educated AIDS expert.
Pot used through ages, But scientific
documentation lacking
Marijuana has been used as a recreational,
ceremonial and therapeutic substance
throughout history. But neither risks nor
benefits have been scientifically
documented.
``The policy cart has tended to pull the
scientific horse with respect to
marijuana,'' said Dr. David Smith, founder
and medical director of the Haight Ashbury
Free Clinics Inc.
Marijuana once was more readily available
through the federal government.
In 1978, it was distributed to a limited
number of patients under an
Investigational New Drug procedure. But
when requests burgeoned in 1991, the
program was suspended, though seven
patients continue to receive pot under
this program.
Since then, the federal government has
denied there is any legitimate use for
marijuana. The agency formally classifies
it as a Schedule I ``controlled
substance,'' the same as heroin and LSD.
That means it has no recognized medicinal
purpose and may not be prescribed.
A band of dissident doctors and
pro-marijuana activists have sought to
reverse the government's stance,
contending the illicit weed already is
being used by tens of thousands of
patients suffering from muscle diseases,
glaucoma and the side effects of cancer
chemotherapy.
The AIDS epidemic brought new urgency to
the issue, as many people turned to
marijuana as a medicinal treatment for
HIV-associated anorexia and weight loss.
An estimated 11,000 Bay Area residents
with HIV obtained marijuana for medicinal
use from local marijuana buyers clubs
before most were shut in a
post-Proposition 215 crackdown.
Without solid research, doctors have been
unable to advise their patients on the
effect of the drug on appetite, lung and
immune function. Nor did they understand
the interaction, if any, between marijuana
and anti-viral protease inhibitors.
Because both drugs are metabolized by the
same liver enzyme system, there is reason
to fear that pot smoking can concentrate
the AIDS drugs, causing toxicity -or
alternatively, reduce levels of AIDS
drugs, rendering them useless.
Sympathy for sick people who could benefit
from marijuana led to the passage of
Proposition 215. It allowed seriously ill
patients and their primary caregivers,
with the oral or written recommendation of
a doctor, to possess and cultivate
marijuana for patients' personal use.
The government's response to Proposition
215 was swift and dramatic. It warned that
physicians who recommended medicinal
marijuana would be punished under federal
law, including criminal prosecution.
The government cautioned that marijuana
had as many as 400 components, some of
them cancer causing. And it said that
modern medicines, such as the THC-based
drug Marinol, are superior to marijuana.
Technically, marijuana -- like any other
Schedule I drug -- is available for
research. But every proposal had failed to
pass muster with the federal government.
Five years ago, Abrams first tried to win
permission to scientifically study the
drug. He found a supplier of pot in the
Netherlands, but the Drug Enforcement
Administration (DEA) refused to let it be
imported. Nor would the DEA donate pot
confiscated in arrests. The National
Institutes of Drug Abuse would give him
government-grown pot only if the National
Institutes of Health approved the study.
But his proposal was turned down by NIH,
which criticized its design and expressed
concerns about the risks of smoking.
Abrams went back to the drawing board,
redesigned the study -- and finally, last
October, got the federal approval and
funding to proceed.
Moderate potency - Only legal pot farm in
United States
As pot goes, the 1,400 joints used in the
study are nothing special: Only moderately
potent, they're a little too dry, although
free of seeds and stems.
Since the cigarettes arrive freeze-dried,
San Francisco General Hospital nurses say
they have to humidify them in a special
chamber.
As a connection, Uncle Sam grows his own.
It takes place on a seven-acre marijuana
farm on the outskirts of the campus of the
University of Mississippi, originally
created to provide pot through the 1978
program. Located in the northeast corner
of a state known for its long growing
season, the Research Institute of
Pharmaceutical Sciences is the only legal
marijuana plantation in the United
States.
Long-awaited results could help break the
emotional stalemate over medicinal
marijuana, said Abrams. If the drug is
found to be dangerous, doctors will know
to warn their patients. But if it works,
the push will increase for the drug to be
approved for medicinal use.
``It is clear that the real hard work is
just about to begin,'' said Abrams. ``We
are delighted with the way the study is
going so far. Answers to important
questions will be answered by the trial.
We are really pleased that after a long
time, the study is launched and going
smoothly.''
``Five years of persistence has clearly
paid off,'' said Abrams. ``Despite
roadblocks, the scientific questions
prevailed.''
Saying thanks - Patient No. 9 wants to aid
science
Not long ago, Patient No. 9 -- the
anonymity is a condition for media access
-- was so sick with AIDS he signed
``do-not-resuscitate papers'' in
preparation for death. His weight dropped
from 240 to 163 pounds. He was fighting
Pneumocystis pneumonia, Kaposi's sarcoma
and internal parasites.
Experimental treatments turned his life
around. The pneumonia and parasites were
cured; his KS receded. AIDS virus levels,
once sky-high, became ``undetectable'' in
tests. He wants to give something back to
science, as a way of saying thanks, he
said.
In preparation of the pot study, he paid
his bills and rent in advance. He got
ahead on his work; mail is being handled
by his roommate.
Not wanting to become the focus of
attention, he's not telling many people
about his role in the experiment. ``I told
them I'm on vacation, visiting my
mother.''
He doesn't mind the confinement: The
12-by-17-foot hospital room is neat and
clean, with a pink blanket and a
picturesque view of the terra-cotta
shingles of the hospital roof below. A fan
pulls the thick sweet smoke out into the
cool San Francisco air.
He selects his meals from a special menu,
rather than the usual hospital fare. A
refrigerator in his room is stocked with
cereal, fresh fruit, yogurt, crackers,
soda, juice, three kinds of ice cream and
five types of cookies.
Although not allowed visitors, he can talk
on the phone and take an occasional stroll
with a nurse chaperon.
The restrictions don't bother him. ``I
volunteered because I am a strong believer
in research,'' he said. ``It has to be
done well, because the feds will
scrutinize this up and down, every facet
of it.''