Source: Seattle Times (WA)
Contact:  http://www.seattletimes.com/
Pubdate: Tue, 21 Jul 1998
Author:  Lisa M. Krieger, Knight Ridder Newspapers

DOCTORS PUT POT TO THE MEDICINAL TEST

SAN FRANCISCO - Three times a day, a neatly machine-rolled marijuana
cigarette is delivered from a locked cabinet at San Francisco General
Hospital to Patient No. 9.

He closes the door to his small white room 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 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."

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). Body composition is tested to see if
marijuana affects weight or appetite. A large plastic bubble is pulled over
the patient's head for 30 minutes each morning to monitor carbon-dioxide
levels.

The results of the experiment could influence the debate over the medicinal
use of marijuana, which won public support in California with the 1996
approval of the state's Proposition 215. The courts have since been
shooting down the law.

Not motivated by politics

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, an AIDS expert and professor
of medicine at the University of California at San Francisco.

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.

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, although seven patients continue to receive pot
under this program.

Since then, the federal government has denied there is any legitimate use
for marijuana. It now is formally classified 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 chemotherapy.

New urgency to pot issue

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. It warned that
physicians who recommended medicinal marijuana would be punished under
federal law.

The government cautioned that marijuana had about 400 components, some of
them cancer-causing. And it said modern medicines, such as the THC-based
drug Marinol, are superior to marijuana.

Difficulty getting permission

Technically, marijuana - like any other Schedule I drug - is available for
research. But every proposal had failed to receive federal approval.

Five years ago, Abrams first tried to win permission to study the drug.

He found a supplier of pot in the Netherlands, but the Drug Enforcement
Administration 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 the 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.

Government-grown

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.

The marijuana is grown 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.

Hard work about to begin

Long-awaited results could help break the emotional stalemate over
medicinal marijuana, Abrams said. 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," Abrams said.
"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," he said. "Despite road
blocks, the scientific questions prevailed."

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.

Treatments turned life around

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 picturesque view of the terra-cotta shingles of the
hospital roof below. A fan pulls the thick marijuana 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."

- ---
Checked-by: (Joel W. Johnson)