Research Findings on
Medicinal Properties of
Marijuana
by Kevin B.
Zeese, Esq.
President,
Common Sense for Drug Policy
I. Background to the Medical Marijuana Debate
With the passage of initiatives in California
and Arizona the debate about the medical utility of marijuana is
in the spotlight once again. On December 30, 1996, the federal
government announced that it intends to use their authority to
stop doctors from recommending or prescribing marijuana to their
patients and is planning a public relations campaign to
demonstrate marijuana has no medical value.
The memorandum describing their policy stated
that: a practitioner's action of recommending or prescribing
Schedule I substances is not consistent with the public interest'
(as that phrase is used in the federal Controlled Substances Act)
and will lead to administrative action by the Drug Enforcement
Administration to revoke the practitioner's registration."
Further if a physician does not have a bona fide doctor
patient relationship when recommending or prescribing marijuana
they will face criminal prosecution.
In addition to threatening doctors for giving
medical advice to their patients the Clinton Administration is
undertaking a public-relations offensive" which will include
a campaign to discredit the notion that smoking marijuana has
medicinal benefits." In their December 30 memorandum, the
Administration described a public relations effort with medical
associations and the public reenforcing the
messagethat marijuana has no medical value. On
December 29, 1996 retired General Barry McCaffrey, the nation's
drug czar, claimed in a column syndicated by the Scripps-Howard
News Service that No clinical evidence demonstrates that smoked
marijuana is good medicine." He has consistently described
medical marijuana as Cheech and Chong medicine."
The purpose of this compilation is to provide
policy makers, health professionals and the public with the
published literature and reports filed with the Food and Drug
Administration that demonstrates that doctors have a basis for
recommending marijuana as a medicine to their patients.
II. The Long History of Marijuana as Medicine
Marijuana has long been recognized as having
medical properties. Indeed its medical use predates recorded
history. The earliest written reference is to be found in the
fifteenth century B.C., Chinese Pharmacopeia, the Ry-Ya. Between
1840 and 1900, more than 100 articles on the therapeutic use of
cannabis were published in medical journals. The federal
government in its 1974 report Marihuana and Health states:
The modern phase of therapeutic use of cannabis
began about 140 years ago when O'Shaughnessy reported on its
effectiveness as an analgesic and anticonvulsant. At about the
same time Moreau de Tours described its use in melancholia and
other psychiatric illnesses. Those who saw favorable results
observed that cannabis produced sleep, enhanced appetite and did
not cause physical addiction.
The 1975 report of the federal government began
its discussion of medical marijuana by stating Cannabis is one of
the most ancient healing drugs." The report further noted:
One should not, however, summarily dismiss the possibility of
therapeutic usefulness simply because the plant is the subject of
current sociopolitical controversy."
The list of medical uses of cannabis from historical
references includes:
Anorexia Asthma Nausea
Pain Peptic Ulcer Alcoholism
Glaucoma Epilepsy Depression
Migraine Anxiety Inflammation
Hypertension Insomnia Cancer
Interestingly, relief of many of the symptoms
marijuana was used for in these illnesses are many of the same
symptoms that have been proven in modern research. This should
not be surprising unless we want to assume that all of the
experience of thousands of years did not have some factual basis.
III. Modern Research Findings on Medical Marijuana
As can see from this compilation there has been
a tidal wave of published research demonstrating marijuana's
medical usefulness. Indeed, it is stated in the research studies
conducted by various states under FDA protocol that the research
being conducted was in the final phase of approval by the FDA.
When the federal government stopped research on the medical use
of marijuana in 1992 the drug had nearly completed the
requirements for new drug approval.
Drug Czar Barry McCaffrey's assertion in his
Scripps-Howard News Service column that No clinical evidence
demonstrates that smoked marijuana is good medicine" is
inconsistent with the facts. Whether this is an intentional
deception, as part of the federal government's stated public
relations offensive against medical marijuana, or whether it is
based on ignorance does not matter. The reality is General
McCaffrey's statements are not consistent with the facts.
The research reprinted in this compilation
includes randomized, double-blind, placebo controlled studies,
research using a variety of objective and subjective measurements
and a range of research protocols. Doctors have a sound basis on
which to recommend marijuana for use by their patients. Indeed,
physicians are well aware of the medical value of marijuana. One
study, a scientific survey of oncologists found that almost one
half (48 percent) of the cancer specialists responding would
prescribe marijuana to some of their patients if it were legal.
In fact, over 44 percent reported having recommended the illegal
use of marijuana for the control of nausea and vomiting.
This publication addresses research that has
been published in three areas: cancer, glaucoma and muscle
spasticity. All of the materials herein were published after
1970. The materials enclosed are either published in peer review
journals, government publications or are reports submitted to the
federal government by state agencies.
A. Published Research Studies
There have been several studies which have been
published which focus on the medical value of smoked marijuana
and cancer therapy. These include:
- Vinciguerra et al., Inhalation Marijuana
as an Antiemetic for Cancer Chemotherapy," The
New York State Journal of Medicine, pgs., 525-527,
October 1988 involved 56 patients who had no improvement
with standard antiemetics. When treated with marijuana 78
percent demonstrated a positive response. No serious
negative side effects were seen. - Chang et al., Delta-9-Tetrahydrocannabinol
as an Antiemetic in Cancer Patients Receiving High Dose
Methotrexate," Annals of Internal Medicine,
Volume 91, Number 6, pg. 819-824, December 1979 is a
randomized, double-blind, placebo controlled trial of THC
and smoked marijuana which found a 72 percent reduction
in nausea and vomiting. The research found that smoked
THC (marijuana) was more reliable than oral THC. - Foltin, R.W., Brady, J.V. and Fischman,
M.W. 1986. Behavioral analysis of marijuana effects on
food intake in humans. Pharmacology, Biochemistry and
Behavior. 25: 577-582 and Foltin, R.W. et al., 1988
Effects of Smoked Marijuana on Food Intake and Body
Weight of Humans Living in a Residential
Laboratory," Appetite 11:1-14; Greenberg, et
al. 1976 Effects of Marijuana use on Body Weight and
Caloric Intake in Humans," Psychopharmacology
49: 79-84. All demonstrate that marijuana increases
appetite and food intake. - Doblin et al., Marijuana as Antiemetic
Medicine: A Survey of Oncologists' Experiences and
Attitudes," Journal of Clinical Oncology,
Vol. 9, No. 7, July 1991. A random survey of clinical
oncologists found that 44 percent of respondents report
recommending the (illegal) use of marijuana for the
control of emesis and 48 percent would prescribe
marijuana to some patients if it were legal. - Sallan, S.E., Zinberg, N.E. and Frei, D.,
Antiemetic Effect of Delta-9-tetrahydrocannabinol in
Patients Receiving Cancer Chemotherapy," New
England Journal of Medicine, 293(16): 795-797 (1975).
The researchers conducting this study of THC noticed that
some patients were dropping out of the research and
choosing to use marijuana from the street instead. They
followed up on these patients. In their conclusion they
reported on the marijuana patients and stated that
natural marijuana was more successful than synthetic THC
for some patients.
The cancer research is relevant to marijuana as
a useful therapy for AIDS patients. The same symptoms are needed
to be controlled among AIDS patients: appetite, nausea and
vomiting. There have been recent reports of AIDS and marijuana in
the literature. A study with THC found relief of nausea and
significant weight gain in 70 percent of patients. However,
one-fifth of the patients did not like the psychoactive effective
of synthetic THC, indicating marijuana is likely to be preferred
by AIDS patients. This is consistent with a survey of people with
AIDS conducted by a researcher in Hawaii in 1996. The survey
found that 98.4 percent of AIDS patients were aware of the
medical value of marijuana and 36.9 percent had used it as a
antiemetic. Of those that had used is 80 percent preferred it
over prescription drugs including synthetic THC. A study being
conducted in Australia of HIV patients found that those who use
marijuana had a better quality of life. In particular, those that
were HIV positive for over ten years found marijuana to be
critical. One patient told the researcher that he considered
marijuana to his savior."
Regarding glaucoma, there have been published
studies which consistently show that marijuana is effective in
lowering intraocular eye pressure. Heightened intraocular eye
pressure is the cause of glaucoma. Thus published evidence
indicates marijuana preserves the vision of people with glaucoma.
Finally, regarding the control of muscle spasm
there is published literature demonstrating marijuana to be
effective in controlling convulsions. The control of muscle spasm
is important to patients with multiple sclerosis, epilepsy,
spinal cord injury, paraplegia and quadriplegia.
B. State Health Department Studies
In addition to the published research there
have been a series of six studies conducted by state health
departments under research protocols approved by the U.S. Food
and Drug Administration.The focus of these studies, conducted by
six state health agencies was the use of marijuana as an
anti-emetic for cancer patients. The studies, conducted in
California, Georgia, New Mexico, New York, Michigan and
Tennessee, compared marijuana to antiemetics available by
prescription, including the synthetic THC pill, Marinol.
Marijuana was found to be an effective and safe antiemetic in
each of the studies and more effective than other drugs for many
patients.
New Mexico: This study involved 250
patients.The study compared marijuana to THC capsules. The
research protocol was approved by the FDA in 1978. In order to
participate in the research the patient had to be referred by a
physician and had to have failed on at least three other
antiemetics. Patients were permitted to choose marijuana or the
THC pill. Both objective (e.g., frequency of vomiting,
amount of vomiting, muscle biofeedback, blood samples and patient
observation) and subjective measures were made to determine the
effectiveness of the drug.
The study concluded that marijuana was not only
an effective antiemetic but also far superior to the best
available conventional drug, Compazine, and clearly superior to
synthetic THC pill." The study found that [m]ore than ninety
percent of the patients who received marijuana . . . reported
significant or total relief from nausea and vomiting." The
study found no major adverse side effects. Only three patients
reported adverse reactions, none of these reactions involved
marijuana alone. The 1984 report concluded . . . the data
accumulated over all five years of the program's operation do
show that marijuana smoked resulted in a higher percentage of
success than does THC ingested."
Michigan: The Michigan research compared
marijuana to Torecan. It involved 165 patients. Upon admission to
the program patients were randomized into control groups with
some randomized on the conventional antiemetic Torecan and the
remainder randomized to marijuana. When failure on the initial
randomized drug occurred, patients could elect to crossover to
the alternate therapy. This procedure allowed the Michigan
Department of Health to evaluate how well patients responded to
both drugs and allowed patients to register their preference.
The Michigan study reported 71.1 percent of the
patients who received marijuana reported no emesis to moderate
nausea. Ninety percent of the patients receiving marijuana
elected to remain on marijuana. Only 8 of 83 patients randomized
to marijuana chose to alter their mode of antiemetic therapy.
This was almost the inverse of patients randomized to Torecan,
there more than 90 percent - 22 out of 23 patients - elected to
discontinue use of Torecan and switched to marijuana.
Very few serious side effects were found
related to marijuana use. The most common side effect was
increased appetite - reported by 32.3 percent of patients - this
was a positive effect. The most common negative effects were
sleepiness, reported by 21 patients and sore throat, reported by
13 patients.
Tennessee: This study involved an
evaluation of 27 patients. The patients had all failed on other
forms of antiemetic therapy including oral THC. The study found
an overall success rate of 90.4 percent for marijuana inhalation
therapy. In comparison it found a 66.7 percent success rate for
THC capsules. In the under 40 age group, the study found a 100
percent success rate for marijuana inhalation therapy.
The report concludes:
We found both marijuana smoking and THC
capsules to be effective anti-emetics. We found an approximate 23
percent higher success rate among those patients administered THC
capsules. We found no significant differences in success rates by
age group. We found that the major reason for smoking failure was
smoking intolerance; while the major reason for THC capsule
failure was nausea and vomiting so severe that patient could not
retain the capsule.
New York: In describing the purpose of
the marijuana research program the New York Department of Health
stated: [t]he program is a large-scale (Phase III) cooperative
clinical trial . . . ." The central question addressed is
[h]ow effective is inhalation marijuana in preventing nausea and
vomiting due to chemotherapy in patients . . . who have failed to
respond to previous antiemetic therapy?"
By 1985, the New York program had extended
marijuana therapy to 208 patients through 55 practitioners. Of
that, 199 patients were evaluated. These patients had received a
total of 6,044 NIDA-supplied marijuana cigarettes which were
provided to patients during 514 treatment episodes.
In percentage terms the results were stunning:
- North Shore Hospital reported marijuana
was effective at reducing emesis 92.9 percent of the
time; - Columbia Memorial Hospital reported
efficacy of 89.7 percent; - Upstate Medical Center, St. Joseph's
Hospital and Jamestown General Hospital reported 100
percent of the patients smoking marijuana gained
significant benefit.
The report concludes: Patient evaluations have
indicated that approximately ninety-three (93) percent of
marijuana inhalation treatment episodes are reported to be
effective' or highly effective' when compared to other
antiemetics." The New York study reports no serious adverse
side effects. No patient receiving marijuana required
hospitalization or any other form of medical intervention. See,
Evaluation of the Antiemetic Properties of Inhalation Marijuana
in Cancer Patients Receiving Chemotherapy Treatment," New
York Department of Health, Office of Public Health (Annual
Reports).
Georgia: The Georgia program evaluated
119 patients. It compared THC to standardized smoking of
marijuana and with patient-controlled smoking. To enter the
program a patient had to have failed on other antiemetics.
Patients were randomized to either patient-controlled smoking of
marijuana, standardized smoking of marijuana or THC pills.
The report found that both THC and marijuana
were effective in providing antiemetic relief for patients who
were previously unresponsive to antiemetics. The rate of success
was 73.1 percent. Patient controlled smoking of marijuana was
successful in 72.2 percent, standardized smoking was successful
in 65.4 percent and THC was effective in 76 percent of the cases.
In comparing the reasons for failure between marijuana and THC
the report found:
The primary reasons for failure of THC capsules
were due to either adverse reaction (6 out of 18) or failure to
improve nausea and vomiting (9 out of 18). The primary reason for
failure of smoking marijuana were due to smoking intolerance (6
out of 14) or failure to improve the nausea and vomiting (3 out
of 14).
California: California conducted a
series of studies from 1981 through 1989. Annual reports were
submitted to the FDA, state legislature and Governor. Each year
approximately 90 to 100 patients received marijuana. The
California research was described as a Phase III trial."
The study protocol preferred THC pills by
making it much easier for patients to enter that portion of the
study. Patients who received marijuana had to be over 15 years of
age (the THC pill patients had to be over 5 years of age); had to
be marijuana experienced, use the drug on an in-patient basis
(patients could only use marijuana in the hospital and not take
the medicine home) and had to be receiving rarely used and severe
forms of chemotherapy. Thus, the design of the study did not
favor marijuana.
Even with this built in bias against marijuana,
the study consistently found marijuana to be an effective
antiemetic. In 1981 the California Research Advisory Panel
reported: Over 74 percent of the cancer patients treated in the
program have reported that marijuana is more effective in
relieving their nausea and vomiting than any other drug they have
tried." In 1982, a 78.9 percent effectiveness rate was found
for smoked marijuana. By 1983 the report was conclusory in its
findings stating:
The California Program also has met its
research objectives. Marijuana has been shown to be effective for
many cancer chemotherapy patients, safe dosage levels have been
established and a dosage regimen which minimizes undesirable side
effects has been devised and tested.
The California Research Advisory Panel
continued to review data on marijuana until 1989 with similar
results.
C. Studies of Marijuana Constituents
In addition to research on smoked marijuana
there has been a host of research on constituents of marijuana.
This research is relevant in measuring the effectiveness of
marijuana.
The drug for which there has been the most
research is the THC pill. This pill contains pure
delta-9-tetrahydrocannabinol in sesame seed oil. This substance
is now scheduled in Schedule II of the Controlled Substances Act.
When the drug was rescheduled the Food and Drug Administration
acknowledged: The effects of pure THC are essentially similar to
those of cannabis containing THC in equivalent amounts."
Thus, the federal government has acknowledged that THC, which is
available as a medicine, adequately emulates the effectiveness to
marijuana. In fact, the research described above shows that
marijuana is in fact a more effective medicine than the THC pill.
The research which compares marijuana to the
THC pill found that patients preferred marijuana to THC and that
marijuana was more effective at treating symptoms. State studies
in Michigan and New Mexico found that most patients who tried THC
chose to use marijuana instead. The most common reasons for this
choice was because THC was more psychoactive, erratic and
unpredictable. Patients found they had more control and a quicker
response with smoked marijuana than with oral THC. Patients found
it difficult to swallow the pill when they were nauseous.
Patients were also able to limit their use of marijuana to only
the amount needed when it was smoked. For many cancer and AIDS
patients this can involve smoking a very small quantity of the
drug. With the THC pill the patient must ingest the whole pill
and therefore cannot control the dose.
The Chang study published in The Annals of
Internal Medicine found that marijuana was more consistent
than the oral THC pill. As they note this was consistent with the
observations of Sallan and his colleagues in their study
published in The New England Journal of Medicine, Alfred
Chang et al. stated:
Sallan and his co-workers considered inadequate
drug absorption as a possible contributing factor to the lack of
antiemetic response seen in some patients. We concur, since THC
plasma concentrations appeared to be causally related to an
antiemetic response in our study. To avoid this problem, we
switched patients to the inhalation route of drug administration
when vomiting occurred. Inhaled marijuana results in the same
psychological effects as orally administered THC. In our patient
populations, smoked THC was more reliable than oral THC in
achieving therapeutic blood concentrations.
A final reason why marijuana cigarettes are
superior to the THC pill is because it is not only delta-9-THC
which provides positive medical effects. The bibliography
includes research involving other components of marijuana,
including various cannabinoids and delta-8-THC. This research
indicates that it is not only delta-9-THC which has beneficial
medical effects but other components of marijuana. Smoking
marijuana provides the patient with the benefits of the
combination of marijuana's active ingredients as opposed to the
effects of only THC.
IV. State Laws Provide an Avenue to Resolve The Medical
Marijuana Problem
There is strong scientific evidence that
marijuana is a safe and effective medicine. The voters in
California and Arizona have recognized this at the ballot box. It
is time for the federal government to help resolve this problem
rather than threaten doctors with sanctions for providing medical
advice to their patients and denying seriously ill patients
access to a much needed medicine.
The California and Arizona initiatives, as well
as state laws in two dozen states, provide an opportunity to
resolve the medical marijuana problem. Research on the safety and
effectiveness of marijuana is in its final phase. All that is
needed is late-Phase III research. These are broad-based research
studies which result in large numbers of patients receiving
marijuana.
The federal government, in its policy
announcement of December 30, stated that it wanted to ensure the
integrity of the drug approval process. Part of their plan to do
so includes reviewing the research and seeking to fill gaps in
research with new research.
Combining the Food and Drug Administration's
need for late-Phase III research before they approve marijuana as
a medicine, with the decision of voters in California and Arizona
to make marijuana medically available, will satisfy two needs. It
can make marijuana available to large numbers of people under a
research umbrella. (In the early 1980s nearly 1,000 patients a
year were using marijuana medically under federally approved
research programs. In fact, one year California requested one
million medical marijuana cigarettes from the FDA.) In addition,
it could finally resolve the medical marijuana problem and make
marijuana available as a medicine by prescription.
The Food and Drug Administration should contact
the health departments of Arizona, California and other states
which have expressed interest in medical marijuana and ask them
to participate in the final Phase III studies needed to complete
the new drug application process. Getting results from this
research should take less than one year. If they are consistent
with previous research it should result in marijuana becoming a
prescription drug under Schedule II of the Controlled Substances
Act. Such a process will restore the integrity of the medical
scientific process of drug approval which has been undermined by
the use of medical marijuana as a political tool by those
favoring expanded drug war policies.
By taking a constructive approach, rather than
a confrontational one, the federal government avoids conflict
with state law, does not intrude on the doctor-patient
relationship and ensures that, in the end, marijuana is only made
available as a prescription medicine to the seriously ill.
Arizona and California have presented an opportunity to resolve
an issue that is long overdue for resolution.
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