cannabisnews.com: San Mateo County's Clinical Trial is a First in US





San Mateo County's Clinical Trial is a First in US
Posted by FoM on July 25, 2001 at 08:03:22 PT
By Bill Workman, Chronicle Staff Writer
Source: San Francisco Chronicle
Philip Alden thinks it's ironic that after smoking pot for four years to relieve the stabbing pains and appetite loss brought on by AIDS that he's now abstaining from it for six weeks in the name of science. The 37-year-old Redwood Shores writer and AIDS activist is the first volunteer to be chosen to take part in the nation's first clinical trials by a local government of medical marijuana. In the coming weeks, 59 other HIV and AIDS patients will be accepted into the study to examine the feasibility and safety of the use of pot by seriously ill patients. 
The $500,000 study, paid for by San Mateo County, is expected to take a year and a half to complete and includes the exclusive use of government-grown pot from a federally harvested field in Mississippi. The study comes on the heels of the U.S. Supreme Court's decision in May that a federal anti-drug law makes no exception for the use of pot by seriously ill patients in California -- despite the passage of Proposition 215 in 1996, making it the first state to legalize medicinal marijuana. But some people in the medical marijuana movement hope the research will play a role in eventually persuading Congress to legalize pot as a prescription drug. Like each of the subjects who will be joining him in the trials, Alden is spending six weeks on a marijuana-free schedule, followed by six more weeks of smoking the "government rolled" pot cigarettes that are being used exclusively in the trials for control purposes. Under the study, led by Dr. Dennis Israelski, chief of infectious diseases and AIDS medicine at San Mateo County Hospitals and Clinics, the drug will be given to selected HIV and AIDS patients suffering from neurological problems of pain and numbness in their feet and hands. "I'm well aware that a lot of eyes are on us," said Alden, who suffers from a form of AIDS that prevents nutrient absorption in his body. It threatens to wither his muscles unless he maintains a schedule of often nausea-inducing medications, regular exercise with weights and heavy doses of anabolic steroids. "I really hope the researchers can get some real hard data out of the study," Alden added. "If medical marijuana does nothing else but calm nausea and increase appetite, it's still worth it." That's also the wish of San Mateo County Supervisor Mike Nevin, who fought for three years with the federal government to get the study up and going. "We have finally won the trust of the U.S. government to do these clinical trials, which we hope will lead to proving once and for all if in fact, the substance in marijuana relieves pain and suffering for the very sick," said Nevin. A former San Francisco police officer who does not support the legalization of illicit drugs, Nevin nonetheless believes that if studies eventually establish the medical benefits of pot "then let's make it a pharmaceutical available in every pharmacy in the country." However, Israelski cautions that he is "no advocate of medical marijuana" -- and that the study's primary goal is to explore the feasibility of conducting more extensive studies later into the potential of marijuana for medicinal needs. "I'm a scientist and I need to study it first," he said. "So far," he added, "there is only anecdotal evidence" of its painkilling and other potential benefits. Nonetheless, he said, the San Mateo study includes measures for gathering data on what the volunteers report on the effects of the drug during the trials. A basic question to be answered, he said, is whether pot can be used safely for research in a "real life setting," away from the scrutiny of researchers, and not wind up "in the hands of friends, or children or even pets." Reflecting his concerns for the integrity of the study, potential subjects are being put through three weeks of intensive physical, psychological and other tests, not only to prevent enrolling drug abusers, but also to ensure that entering the trials will not undermine a patient's current medical treatment. "When I was first told of the study, I thought, 'Hey, this'll be easy. I'll just be smoking pot,' " recalled Alden. "But it turned out to be a lot of work. ' The subjects are supplied with a locked kit that contains three pill bottle- size containers, the first of which is filled with 10 cigarettes. The other bottles are used to store cigarettes as they dwindle down to butt ends. Each of the volunteers is required to keep a daily log not only of their marijuana use, but also alcohol and other recreational drugs, and to turn in the pot cigarette ends on their weekly visits to doctors. County health officials also make visits to the homes of the study volunteers to check out conditions. "If we see a lot of people coming and going or someone reading weird poetry on the floor, we might begin to wonder," said Israelski. Israelski conceded that ensuring that the study is not tainted by candidates "who might just want to use us to get free marijuana" is difficult. In the long run, he said, ''we have to put some faith and trust in our patients." Complete Title: Pot Study in Spotlight: San Mateo County's Clinical Trial is a First in U.S. E-mail: Bill Workman at: wworkman sfchronicle.comSource: San Francisco Chronicle (CA)Author: Bill Workman, Chronicle Staff WriterPublished: Wednesday, July 25, 2001 Copyright: 2001 San Francisco Chronicle  Page A - 13 Contact: letters sfchronicle.comWebsite: http://www.sfgate.com/chronicle/Related Articles & Web Site:Medical Marijuana Information Linkshttp://freedomtoexhale.com/medical.htmSan Mateo Set for Legal Marijuana Trials http://cannabisnews.com/news/thread10070.shtmlMedical Marijuana Experiment Begins In San Mateo http://cannabisnews.com/news/thread9291.shtml
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