News (Media Awareness Project) - US CA: Pot Study In Spotlight San Mateo County's Clinical Trial |
Title: | US CA: Pot Study In Spotlight San Mateo County's Clinical Trial |
Published On: | 2001-07-25 |
Source: | San Francisco Chronicle (CA) |
Fetched On: | 2008-09-01 00:12:33 |
POT STUDY IN SPOTLIGHT SAN MATEO COUNTY'S CLINICAL TRIAL IS A FIRST IN U.S.
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."
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."
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