THE IMPACT OF CALIFORNIA
PROPOSITION 215 ON
LESTER GRINSPOON, M.D.
AND JAMES B. BAKALAR
FROM THE DEPARTMENT OF PSYCHIATRY,
HARVARD MEDICAL SCHOOL, AND THE MASSACHUSETTS MENTAL HEALTH CENTER
74 FENWOOD ROAD
BOSTON, MASSACHUSETTS 02115
1996 the people of California approved Proposition 215, an initiative that could, in
effect, make marihuana legally available as a medicine in the United States for the first
time in many years. Under the new law, patients or their primary caregivers who possess or
cultivate marihuana for medical treatment recommended by a physician are exempted from
criminal prosecution. The treatment may be for "cancer, anorexia, AIDS, chronic pain,
spasticity, glaucoma, arthritis, migraine, or any other illness for which marihuana
provides relief." Physicians may not be penalized in any way for making the
recommendation, which may be either written or oral.1
Although this law will provide a defense for patients in criminal cases, it is not
a long-term solution for the problem it addresses, because the federal government will not
allow authority over drugs to revert to the states. Nevertheless, it is likely that
similar laws will be more widely adopted, because the California vote signals a growing
public impatience with the present legal obstacles to medical cannabis.* According
to a 1995 poll conducted by the American Civil Liberties Union, 85% of Americans believe
that marihuana should be available as a medicine.2
The history of cannabis as a medicine goes back at least 5,000 years to
ancient China and extends well into the twentieth century. Nineteenth-century European and
American physicians were familiar with marihuana. Between 1840 and 1900, more than one
hundred papers on the therapeutic use of the drug then known as Indian hemp were published
in medical journals. It was recommended as an appetite stimulant, muscle relaxant,
analgesic, hypnotic, anticonvulsant, and treatment for opium addiction. As late as 1913,
Sir William Osler cited it as the best remedy for migraine.3
In the nineteenth century medical cannabis was administered chiefly in oral form, as an
alcoholic solution. But the potency of these solutions varied, and patients responded
erratically to oral ingestion. Shortly after the turn of the century, synthetic
alternatives became available for insomnia and moderate pain, two of the most common
indications for the use of cannabis. In the United States, what remained of its medical
use was effectively eliminated by the Marihuana Tax Act of 1937, which was ostensibly
designed to prevent non-medical use but made cannabis so difficult to obtain that it was
removed from the pharmacopeia. Since 1970 the federal government has classified it as a
Schedule I drug, with a high potential for abuse, no accepted medical use, and lack of
safety for use under medical supervision.
In 1972 the National Organization for the Reform of Marijuana Laws (NORML) entered
a petition to transfer marihuana to Schedule II so that it could be legally prescribed. As
the proceedings continued, other parties joined NORML, including the Physicians
Association for AIDS Care. In 1986 the Drug Enforcement Administration (DEA) finally
acceded to the demand for public hearings required by law. During the hearings many
patients and physicians testified and thousands of pages of documentation were introduced.
In 1988 the DEA's Administrative Law Judge, Francis L. Young, declared that marihuana in
its natural form had a currently accepted use in treatment in the United States and
therefore fulfilled the legal requirement for transfer to Schedule II. He noted in his
opinion that it was "one of the safest therapeutically active substances known to
man."4 His order was overruled by the DEA.
Since 1976 a few patients have been able to obtain medical marihuana legally
through an Individual Treatment Investigational New Drug program (commonly referred to as
a Compassionate IND) that was discontinued in 1992 after a deluge of applications from
people with AIDS. About three dozen patients eventually received marihuana under the
program, and eight survivors are still receiving it. Beginning in the 1970s, 35 states
also enacted legislation establishing special IND research programs under which patients
with certain disorders could use cannabis. These projects eventually proved unworkable and
are now in abeyance. For all but eight residents of the United States, marihuana remains a
Shortly before the federal government blocked the last legal access, organizations
were founded to distribute medical marihuana in open defiance of the law: the cannabis
buyers' clubs. These clubs purchase cannabis wholesale and provide it to patients on the
written recommendation of a physician. Patients are generally asked to donate enough to
cover costs; those who cannot pay may receive marihuana free. Although some of the buyers'
clubs have been raided and closed, most are still flourishing, and new ones are being
organized. Backers of the California initiative have talked of legitimizing buyers' clubs
through state action.
Marihuana is a strikingly safe, versatile, and potentially inexpensive medicine.
When we reviewed its medical uses in 1993 after examining many patients and case
histories, we were able to list the following: nausea and vomiting in cancer chemotherapy,
the weight loss syndrome of AIDS, glaucoma, epilepsy, muscle spasms and chronic pain in
multiple sclerosis, quadriplegia and other spastic disorders, migraine, severe pruritus,
depression, and other mood disorders.5 Since then we have
identified more than a dozen others, including asthma, insomnia, dystonia, scleroderma,
Crohn's disease, diabetic gastroparesis, and terminal illness. The list is not exhaustive.6
Cannabis could be therapeutically significant even if only a few patient with a
given symptom or disorder benefited. For example, several people told us that cannabis
helped them free themselves of alcohol, opiate, or tobacco addiction. We do not know how
common or how powerful this capacity is, but further exploration would be worthwhile even
if only a few highly motivated substance abusers could benefit. As nineteenth-century
physicians understood, anyone who is sophisticated about drugs would gladly exchange
alcohol, opiates, or tobacco for marihuana.
Cannabis has also been found useful in the treatment of osteoarthritis. Aspirin is
believed to cause more than 1,000 deaths annually in the United States. More than 7,600
annual deaths and 70,000 hospitalizations caused by non-steroidal antiinflammatory drugs
(NSAIDs) are reported. Gastrointestinal complications of NSAIDs are the most commonly
reported serious adverse drug reaction.7 Long-term
acetaminophen use is thought to be one of the most common causes of end-stage renal
disease.8 Cannabis smoked several times a day is often as
effective as NSAIDs or acetaminophen in osteoarthritis, and there have been no reports of
death from cannabis.
It is often objected that the evidence of marihuana's medical usefulness, although
powerful, is merely anecdotal. It is true that there are no studies meeting the standards
of the Food and Drug Administration, chiefly because legal, bureaucratic, and financial
obstacles are constantly put in the way. The situation is ironical, since so much research
has been done on marihuana, often in unsuccessful efforts to show health hazards and
addictive potential, that we know more about it than about most prescription drugs. In any
case, controlled studies can be misleading if the wrong patients are studied or the wrong
doses are used, and idiosyncratic therapeutic responses can be obscured in group
Anecdotal evidence is the source of much of our knowledge of drugs. As Louis
Lasagna has pointed out, controlled experiments were not needed to recognize the
therapeutic potential of chloral hydrate, barbiturates, aspirin, insulin, or penicillin.9 Anecdotal evidence also revealed the usefulness of propranolol
and chlorothiazide for hypertension, diazepam for status epilepticus, and imipramine for
enuresis. All these drugs had originally been approved for other purposes.
In the experimental method known as the single patient randomized trial, active
and placebo treatments are administered randomly in alternation or succession. The method
is often used when large-scale controlled studies are inappropriate because the disorder
is rare, the patient is atypical, or the response to treatment is idiosyncratic.10 Several patients have told us that they assured themselves of
marihuana's effectiveness by carrying out such experiments on themselves, alternating
periods of cannabis use with periods of abstention. We are certain that the medical
reputation of cannabis is derived partly from similar experiments conducted by many other
Some physicians may regard it as irresponsible to support, let alone advocate the
medical use of cannabis on the basis of anecdotal evidence, which seems to count successes
and ignore failures. That would be a serious problem only if cannabis were a dangerous
drug. The years of effort devoted to showing that marihuana is exceedingly dangerous have
proved the opposite. It is safer, with fewer serious side effects, than most prescription
medicines, and far less addictive or subject to abuse than many drugs now used as muscle
relaxants, hypnotics, and analgesics.11
Thus it can be argued that even if only a few patients could get relief from
cannabis, it should be made available because the risks would be so small. For example,
many patients with multiple sclerosis find that cannabis reduces their muscle spasms and
pain. A physician may not be sure that such a patient will get better relief from
marihuana than from the baclofen, dantrolene, and high doses of diazepam that the patient
has been taking, but it is certain that a serious toxic reaction to marihuana is extremely
unlikely, and risk-benefit considerations therefore make it worth trying.
The chief legitimate concern is the effect of smoking on the lungs. Many
physicians find it difficult to endorse a smoked medicine. Although cannabis smoke carries
even more tars and other particulate matter than tobacco smoke, the amount needed by most
patients is extremely limited. Furthermore, when marihuana is an openly recognized
medicine, solutions for this problem may be found, perhaps by the development of a
technique for inhaling of cannabinoid vapors. Even today, the greatest danger of using
marihuana medically is not impurities in the smoke but illegality, which imposes much
unnecessary anxiety and expense on suffering people.
Furthermore, if cannabis were not prohibited, it would be less expensive than most
conventional medications. The cost of medical marihuana would be $20 to $30 an ounce, or
about 30 cents per cigarette. One cigarette usually relieves the nausea and vomiting
produced by cancer chemotherapy. So does the standard dose of ondansetron (Zofran), the
best present legally available treatment, which costs the patient $30 to $40 -- at least
100 times the price of marihuana.
A synthetic version of delta-9-tetrahydrocannabinol, the main active substance in
cannabis, has been available in oral form for limited purposes as a Schedule II drug since
1985. This medicine, dronabinol (Marinol), is sometimes said to obviate the need for
medical marihuana, but patients and physicians who are familiar with both disagree. A
patient who is severely nauseated and constantly vomiting, for example, may find it almost
impossible to keep a pill or capsule down. Oral THC is erratically and slowly absorbed
into the bloodstream; the dose and duration of action of smoked marihuana are easier to
titrate. Furthermore, oral THC occasionally makes many patients anxious and uncomfortable,
possibly because cannabidiol, one of the many substances in marihuana, has an anxiolytic
When medical use of marihuana in the United States was effectively outlawed by the
Marihuana Tax Act, the American Medical Association, to its credit, opposed the ban. Since
then, unfortunately, physicians have become largely ignorant about marihuana. As both
victims and agents, they have too often promoted the spread of misinformation and
frightening myths. But now they are relearning what their nineteenth-century counterparts
knew, and they are coming to this knowledge in an unusual way -- not from articles in
medical journals or from pharmaceutical company advertisements, but from their patients.
In a typical case a person with, say, HIV infection discovers that marihuana slows or even
reverses his weight loss. On his next visit to the doctor he steps on the scale and proves
it. Eventually the doctor's incredulity is overcome, and he may tell other patients.
This remarkable, perhaps unique learning process has now been going on for some
time. In the spring of 1990 investigators randomly selected more than 2,000 members of the
American Society of Clinical Oncology (one third of the membership) and mailed them an
anonymous questionnaire. Almost half of the recipients responded and only 43% of them said
the available legal antiemetic drugs (including oral synthetic THC) provided adequate
relief to all or most of their patients. Forty-four percent had recommended the (illegal)
use of marihuana to at least one patient, and half would prescribe it to some patients if
it were legal. On average they considered smoked marihuana more effective than oral
synthetic THC and roughly as safe.13
Many patients who use marihuana to relieve symptoms ranging from muscle spasms to
severe depression have discussed with us the reactions of their physicians. A few
physicians condemn the marihuana use, and some pretend to ignore it or profess
indifference, but most offer some encouragement or moral support -- what would be termed a
"recommendation" under the California initiative. Yet federal law declares
marihuana to be unsafe for use even under medical supervision. Obviously physicians
confronting the needs of their patients can recognize the foolishness of this law. But
most have been either afraid to do more or unable to provide further help because they
know too little.
Thus many physicians may now be asked to assume responsibilities for which they
are unprepared. More and more patients will approach them with questions about marihuana,
and they will have to provide answers. They must not only listen more carefully to their
patients but educate themselves and one another. They will have to learn which symptoms
and disorders may be treated better with marihuana than with conventional medications, and
they may need to explain how to use marihuana. It is not as simple as taking a pill; some
preparation and instruction may be required, both to attain therapeutic goals and to avoid
unwanted effects. The psychoactive effects must be explained to marihuana-naive patients,
who may otherwise suffer some degree of anxiety. Many patients will also have to be taught
the mechanics of smoking and the correct way to titrate the dose.
Eventually physicians must acknowledge more openly that the present classification
of marihuana as a Schedule I drug is scientifically, legally, and morally wrong. They have
both a right and a duty to be skeptical about therapeutic claims, but only after
dismissing fears and doubts connected with the stigma of illicit non-medical drug use.
Advocates of medical marihuana are often charged with the hidden agenda of encouraging
"recreational" use. This false accusation represents in distorted form a certain
truth: some opponents of medical marihuana are interested only in insuring that the
dangers of non-medical use are exaggerated and prohibition continues.
Pharmaceutical companies will not pursue the clinical research needed to test
marihuana's therapeutic potential, because they have little to gain and much to lose. The
federal government, so far, has only blocked the way. In 1994 Donald Abrams of the
University of California, San Francisco, sought approval for a pilot study comparing
smoked marihuana with oral THC in the treatment of the AIDS wasting syndrome. Although his
project was approved by the FDA and several institutional review boards and advisory
committees, the National Institute on Drug Abuse and the Drug Enforcement Administration
prevented him from receiving the marihuana he needed.14
The protocol was finally accepted, but only after it had been changed from an
efficacy to a safety study. The California vote should persuade federal authorities to
relent. But even if they do, a research program designed to study the many clinical uses
of this versatile drug will take years, and meanwhile other ways must be found to
accommodate the needs of a rapidly growing number of patients.
*Arizona voters have approved a related but
more restrictive initiative which permits physicians, "notwithstanding any law to the
contrary", to prescribe Schedule I controlled substances, including marihuana,
"to treat a disease, or to relieve the pain and suffering of seriously and terminally
ill patients." The physician must document scientific research supporting the
prescription and must obtain written approval from a second physician (Arizona Revised
Statutes, 13-3412.01). Like the California law, this initiative may provide a criminal
defense for patients. However, few physicians are likely to write such a prescription,
since there is no legal way to fill it and they could still be charged with violating
1. California Health and Safety Code Section 11362.5
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legalization of marijuana. Survey conducted for the American Civil Liberties Union, 1995
3. Osler W. The principles and practice of medicine, 8th ed. New York:
Appleton, 1913, p. 1089.
4. Drug Enforcement Administration (hereafter DEA), in the Matter of
Marijuana Rescheduling Petition, Docket 86-22, Opinion, Recommended Ruling, Findings of
Fact, Conclusions of Law, and Decision of Administrative Law Judge, September 6, 1988.
5. Grinspoon L, Bakalar JB. Marihuana, the Forbidden Medicine. New
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Annals of Internal Medicine 1979;91:819-824. Zuardi AW, Shirakawa I, Finkelbarb E, and
Karnio IG. Action of cannabidiol on the anxiety and other effects produced by delta-9-THC
in normal subjects. Psychopharmacology 1976;76:245-50.
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