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STUDY TARGETS STALEMATE OVER MEDICINAL USE OF MARIJUANA
San Jose Mercury News (CA), Sunday, July 19, 1998
by Lisa M. Krieger
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.''