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Study Says Pot Doesn't Interfere with AIDS Drugs, Scientific
First Comes After Years-Long Battle With Government Health
Honchos
The Week Online has moved!
Initial results are in from the first government-approved study
of marijuana's effects on people infected with the AIDS virus.
The research, done by a team headed by Dr. Donald Abrams of the
University of California at San Francisco, found that smoking pot
does not disrupt the workings of antiviral drugs that inhibit the
growth of the AIDS virus -- and the patients involved gained
weight.
Abrams announced the initial results at the 13th Annual AIDS
Conference in Durban, South Africa, last week. Further results
will be released soon, Abrams told reporters at the conference.
In an indication of the politically charged atmosphere in which
research on marijuana in the US currently takes place, Abrams'
research proposals dating back to 1992 could not win government
approval as efficacy studies (research that would demonstrate the
effectiveness of marijuana in improving the appetite, body
weight, and general well-being of AIDS patients and others
suffering from wasting syndrome).
Instead, Abrams' research was designed to see whether the
components of marijuana interfered with the body's ability to
break down the components of protease inhibitors, which are
antiviral drugs used by thousands of HIV-infected people to
maintain their immune systems.
Some 62 subjects participated in the study, and all were confined
in a unit of San Francisco General Hospital for the experiment's
21-day duration. Some were given marijuana from the National
Institutes of Health (NIH), some received marinol, and others
received placebos. The 20 patients who received marijuana smoked
it three times a day in a closed, ventilated room so that second-
hand smoke would not affect other participants in the study.
Each patient had a refrigerator stocked with snacks at bedside.
The fridges were locked at midnight.
In all three groups, the study showed that levels of the AIDS
virus either dropped or remained unchanged. Neither marijuana
nor marinol interfered with the breakdown of protease inhibitors.
Also, although the research was not designed as an efficacy
study, Abrams announced that patients gained weight under the
experimental regime, an average of 7.7 pounds for the marijuana
smokers and 7 pounds for those who took marinol pills.
The findings have been greeted with enthusiasm by both medical
professionals and medical marijuana activists.
"Any good clinician with his eyes and ears open has known for a
long time that cannabis is very useful in the treatment of AIDS
reduction syndrome and does not harm patients," Dr. Lester
Grinspoon told the Associated Press. Grinspoon is a professor of
psychiatry at Harvard and author of "Marijuana: The Forbidden
Medicine."
"When all the dust settles and when marijuana is admitted into
the US pharmacopoeia, it will be seen as one of the least toxic
drugs in the whole compendium."
"I guess this refutes Gen. McCaffrey's statements about 'Cheech
and Chong' medicine," snorted Dale Gieringer, leader of
California NORML. "It confirms common sense. AIDS doctors have
been using pot widely in the Bay area and California in general
for years now," he told DRCNet.
Still, said Gieringer, "medicine has to confirm common sense,"
but the study's greater significance may lie in the fact that "it
got done."
"This is the only study on medical marijuana initiated and
completed since Proposition 215 (legalizing medical marijuana in
California) passed," Gieringer noted. "It shows the outrageous
slowness of the government's response to the mandate of the
voters."
"It's astounding that we could only get one study done, and not
even an efficacy study at that," he added. "In a sense, we are
not one step closer to winning government approval of medical
marijuana because it was not an efficacy study."
Gieringer's complaints about government inaction are understated;
the attitude of the federal government could fairly be described
as obstructionist. The saga of Dr. Abram's research helps
explain why.
Abrams had to overcome a series of politically motivated
bureaucratic obstacles, beginning with the DEA's 1994 refusal to
allow Abrams to import Dutch marijuana for a study of AIDS
wasting syndrome. The study had been designed with help from the
Food and Drug Administration (FDA) and had already won approval
from the university and the California Research Advisory Panel.
None of that mattered to the DEA.
Next, Abrams applied to the National Institute on Drug Abuse
(NIDA), requesting to use some of its marijuana supply for his
study. After nine months, NIDA Director Dr. Alan Leshner turned
him down, saying Abrams' FDA-approved study was unscientific.
"I wrote him back and said, well, gee, it's been approved by a
number of august bodies, and for you to tell me it's not
scientific was a little bizarre," Abrams told the Chronicle of
Higher Education in a June interview.
When Leshner then suggested he might approve a request that had
"favorable peer review," Abrams dutifully applied for a grant
from the National Institutes of Health (NIH). His proposal,
modified to address Leshner's concerns, was rejected.
NIH reviewers expressed concerns about marijuana's toxicity --
which is far lower than that of many approved prescription drugs
-- and about patient risk from high cholesterol levels due to
increased appetite. "That is really not something people with
AIDS wasting have the luxury of worrying about," Abrams told the
Chronicle.
By then, Abrams told the Chronicle, he was willing to concede
that the obstacles in his path were more political than
scientific. Belatedly wising up, Abrams changed his research
proposal to examine marijuana's potential negative effects. This
must have been just what the NIH doctors ordered, as Abram's
revised research project to study whether marijuana interferes
with the body's processing of protease inhibitors was finally
approved, some five years after he presented his original
research proposal.
================
First Comes After Years-Long Battle With Government Health
Honchos
The Week Online has moved!
Initial results are in from the first government-approved study
of marijuana's effects on people infected with the AIDS virus.
The research, done by a team headed by Dr. Donald Abrams of the
University of California at San Francisco, found that smoking pot
does not disrupt the workings of antiviral drugs that inhibit the
growth of the AIDS virus -- and the patients involved gained
weight.
Abrams announced the initial results at the 13th Annual AIDS
Conference in Durban, South Africa, last week. Further results
will be released soon, Abrams told reporters at the conference.
In an indication of the politically charged atmosphere in which
research on marijuana in the US currently takes place, Abrams'
research proposals dating back to 1992 could not win government
approval as efficacy studies (research that would demonstrate the
effectiveness of marijuana in improving the appetite, body
weight, and general well-being of AIDS patients and others
suffering from wasting syndrome).
Instead, Abrams' research was designed to see whether the
components of marijuana interfered with the body's ability to
break down the components of protease inhibitors, which are
antiviral drugs used by thousands of HIV-infected people to
maintain their immune systems.
Some 62 subjects participated in the study, and all were confined
in a unit of San Francisco General Hospital for the experiment's
21-day duration. Some were given marijuana from the National
Institutes of Health (NIH), some received marinol, and others
received placebos. The 20 patients who received marijuana smoked
it three times a day in a closed, ventilated room so that second-
hand smoke would not affect other participants in the study.
Each patient had a refrigerator stocked with snacks at bedside.
The fridges were locked at midnight.
In all three groups, the study showed that levels of the AIDS
virus either dropped or remained unchanged. Neither marijuana
nor marinol interfered with the breakdown of protease inhibitors.
Also, although the research was not designed as an efficacy
study, Abrams announced that patients gained weight under the
experimental regime, an average of 7.7 pounds for the marijuana
smokers and 7 pounds for those who took marinol pills.
The findings have been greeted with enthusiasm by both medical
professionals and medical marijuana activists.
"Any good clinician with his eyes and ears open has known for a
long time that cannabis is very useful in the treatment of AIDS
reduction syndrome and does not harm patients," Dr. Lester
Grinspoon told the Associated Press. Grinspoon is a professor of
psychiatry at Harvard and author of "Marijuana: The Forbidden
Medicine."
"When all the dust settles and when marijuana is admitted into
the US pharmacopoeia, it will be seen as one of the least toxic
drugs in the whole compendium."
"I guess this refutes Gen. McCaffrey's statements about 'Cheech
and Chong' medicine," snorted Dale Gieringer, leader of
California NORML. "It confirms common sense. AIDS doctors have
been using pot widely in the Bay area and California in general
for years now," he told DRCNet.
Still, said Gieringer, "medicine has to confirm common sense,"
but the study's greater significance may lie in the fact that "it
got done."
"This is the only study on medical marijuana initiated and
completed since Proposition 215 (legalizing medical marijuana in
California) passed," Gieringer noted. "It shows the outrageous
slowness of the government's response to the mandate of the
voters."
"It's astounding that we could only get one study done, and not
even an efficacy study at that," he added. "In a sense, we are
not one step closer to winning government approval of medical
marijuana because it was not an efficacy study."
Gieringer's complaints about government inaction are understated;
the attitude of the federal government could fairly be described
as obstructionist. The saga of Dr. Abram's research helps
explain why.
Abrams had to overcome a series of politically motivated
bureaucratic obstacles, beginning with the DEA's 1994 refusal to
allow Abrams to import Dutch marijuana for a study of AIDS
wasting syndrome. The study had been designed with help from the
Food and Drug Administration (FDA) and had already won approval
from the university and the California Research Advisory Panel.
None of that mattered to the DEA.
Next, Abrams applied to the National Institute on Drug Abuse
(NIDA), requesting to use some of its marijuana supply for his
study. After nine months, NIDA Director Dr. Alan Leshner turned
him down, saying Abrams' FDA-approved study was unscientific.
"I wrote him back and said, well, gee, it's been approved by a
number of august bodies, and for you to tell me it's not
scientific was a little bizarre," Abrams told the Chronicle of
Higher Education in a June interview.
When Leshner then suggested he might approve a request that had
"favorable peer review," Abrams dutifully applied for a grant
from the National Institutes of Health (NIH). His proposal,
modified to address Leshner's concerns, was rejected.
NIH reviewers expressed concerns about marijuana's toxicity --
which is far lower than that of many approved prescription drugs
-- and about patient risk from high cholesterol levels due to
increased appetite. "That is really not something people with
AIDS wasting have the luxury of worrying about," Abrams told the
Chronicle.
By then, Abrams told the Chronicle, he was willing to concede
that the obstacles in his path were more political than
scientific. Belatedly wising up, Abrams changed his research
proposal to examine marijuana's potential negative effects. This
must have been just what the NIH doctors ordered, as Abram's
revised research project to study whether marijuana interferes
with the body's processing of protease inhibitors was finally
approved, some five years after he presented his original
research proposal.
================
