Reefer Madness --
The Federal Response to California's
Medical-Marijuana Law
New England Journal of Medicine: Legal Issues in Medicine
August 7, 1997 -- Volume 337, Number 6
by George J. Annas
Introduction
Marijuana is unique among illegal drugs in its political
symbolism, its
safety, and its wide use. More than 65 million Americans have
tried
marijuana, the use of which is not associated with increased
mortality. (1)
Since the federal government first tried to tax it out of
existence in
1937, at least partly in response to the 1936 film Reefer
Madness,
marijuana has remained at the center of controversy. Now
physicians are
becoming more actively involved. Most recently, the federal drug
policy
against any use of marijuana has been challenged by California's
attempt to
legalize its use by certain patients on the recommendation of
their
physicians. The federal government responded by threatening
California
physicians who recommend marijuana to their sick patients with
investigation and the loss of their prescription privileges under
Drug
Enforcement Administration (DEA) regulations. (2)
The editor-in-chief of the Journal suggested that prohibiting
physicians
from helping their suffering patients by suggesting that they use
marijuana
is "misguided, heavy-handed, and inhumane." (3)
He recommended that
marijuana be reclassified as a Schedule II drug and made
available by
prescription without the usual requirement of controlled clinical
trials.
Many states, including Massachusetts, had previously passed laws
that
permitted their citizens to use marijuana for medicinal purposes
under some
circumstances. (4)
California's law seems to have engendered a uniquely
harsh federal response because California is a large,
trend-setting state;
because its new marijuana law is very broad as compared with
others; and
because the law was passed by popular referendum. In this article
I will
discuss the new California law and its implications for
physicians.
The California Proposition
In the fall of 1996, California voters approved the Medical
Marijuana
Initiative (Proposition 215) by a vote of 56 to 44 percent. The
act is
entitled the Compassionate Use Act of 1996, and its purpose is to
give
Californians the right to possess and cultivate marijuana for
medical
purposes "where that medical use is deemed appropriate and has
been
recommended by a physician who has determined that the person's
health
would benefit from the use of marijuana in the treatment of
cancer,
anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis,
migraine, or
any other illness for which marijuana provides relief." (5)
Nothing in the
act permits persons using marijuana for medical purposes to
engage in
conduct that endangers others (such as driving while under its
influence),
condones "the diversion of marijuana for nonmedical purposes," or
permits
the buying or selling of marijuana. (5)
The two operative sections of the
law are as follows: Notwithstanding any other provision of law,
no
physician in this state shall be punished, or denied any right or
privilege, for having recommended marijuana to a patient for
medical
purposes.
[Existing California law] relating to the possession of marijuana
[and the]
cultivation of marijuana, shall not apply to a patient, or to a
patient's
primary caregiver [the person who has consistently assumed
responsibility
for the patient's housing, health, or safety] who possesses or
cultivates
marijuana for the personal medical purposes of the patient upon
the written
or oral recommendation or approval of a physician. (5)
The primary purpose of this law is to provide a specified group
of patients
with an affirmative defense to the charge of possession or
cultivation of
marijuana, the defense of medical necessity. To use this defense,
the
patient must be able to show that his or her physician
recommended or
approved of the use of marijuana, either orally or in writing.
Obviously, a
note from a physician is better evidence than a simple assertion
that "my
doctor said this would be good for me," and most patients will
want a
written statement to help protect them from problems with the
police.
Nothing in this law changes current law against buying or selling
marijuana
or affects federal law; it merely provides that qualified
patients and
their primary care givers can possess and cultivate their own
marijuana for
personal medicinal purposes, without violating state drug laws.
Compassion and the Use of Unapproved Drugs
The federal government has been in the business of regulating
drugs for
almost a century, and few exceptions have ever been made to the
basic rules
of the Food and Drug Administration (FDA), even for patients with
cancer or
AIDS. In 1979, for example, the FDA was successful in convincing
a
unanimous U.S. Supreme Court that Congress intended no exception
for
terminally ill patients who sought to take laetrile, an
unapproved drug,
for cancer. The FDA's primary rationale was that the use of this
unapproved
and useless drug could prevent patients from seeking conventional
treatments for cancer that offered them at least some chance of a
cure. (6)
Under President Ronald Reagan, however, the FDA responded with a
great deal
more flexibility to the AIDS epidemic and permitted the use and
sale of
drugs not yet approved (but in use in ongoing clinical trials)
if, among
other things, "the drug [was] intended to treat a serious or
immediately
life-threatening disease." (7)
More surprisingly, the FDA also permitted
individual patients to import unapproved drugs from other
countries for
their personal, medical use. (8)
These regulations were almost purely
political, had no scientific basis, and tended to conflate
treatment and
research and to undermine the very purpose of clinical trials.
(8) The
theory used to justify these exceptions to federal drug laws was
the very
one rejected by the Supreme Court: terminally ill patients have
"nothing to
lose" and should not be deprived of the hope (even the false
hope) that
they might escape death. (6) (8)
Given this history, it is not surprising that the advocates of
the
medicinal use of marijuana concentrate their reform efforts on
helping
patients with cancer ameliorate the adverse effects of
chemotherapy and
helping patients with AIDS counteract weight loss and fight their
disease.
Virtually no one thinks it is reasonable to initiate criminal
prosecution
of patients with cancer or AIDS who use marijuana on the advice
of their
physicians to help them through conventional medical treatment
for their
disease. Anecdotal evidence of the effectiveness of smoked
marijuana
abounds. (9) Perhaps the
most convincing is the account of Harvard
professor and author Stephen Jay Gould, one of the world's first
survivors
of abdominal mesothelioma. When Gould started intravenous
chemotherapy, he
writes:
Absolutely nothing in the available arsenal of anti-emetics
worked at all.
I was miserable and came to dread the frequent treatments with an
almost
perverse intensity. I had heard that marijuana often worked well
against
nausea. I was reluctant to try it because I have never smoked any
substance
habitually (and didn't even know how to inhale). Moreover, I had
tried
marijuana twice [in the 1960s]... and had hated it.... Marijuana
worked
like a charm.... The sheer bliss of not experiencing nausea --
and not
having to fear it for all the days intervening between treatments
-- was
the greatest boost I received in all my year of treatment, and
surely the
most important effect upon my eventual cure. (10)
Similarly, in patients with AIDS, marijuana has been credited
with
counteracting such side effects of treatment as severe nausea,
vomiting,
loss of appetite, and fatigue, as well as with stimulating the
appetite to
help prevent weight loss.
The White House Press Conference
Had the California proposition been limited to the use of
marijuana for
terminal illnesses such as cancer and AIDS, it would probably
have caused
much less concern. Arizona passed a much broader initiative that
permitted
physicians to prescribe any drug on Schedule I, but in April
1997, the
Arizona legislature amended the law to apply only to drugs
approved by the
FDA, thus effectively repealing it. (11)
The California law applies only to
marijuana but makes it available for a wide range of medical
conditions,
including anorexia, pain, spasticity, glaucoma, arthritis,
migraine, "or
any other illness for which marijuana provides relief." (5)
This very broad
definition of the potential medicinal uses of marijuana seemed an
explicit
endorsement of the drug itself, which the Clinton administration
and others
believed to be sending the wrong message to America's youth.
After thinking
about the issue for approximately two months, the Clinton
administration
announced that it would vigorously oppose the implementation of
the
California proposition and the Arizona law. (2)
Barry McCaffrey, director of the Office of National Drug Control
Policy,
announced at a White House news conference on December 30, 1996,
that
"nothing has changed. Federal law is unaffected by these
propositions." (2)
McCaffrey expressed concern about marijuana as a "gateway drug"
and about
the potential impact of the law on children. As for the potential
medicinal
uses of marijuana, he said:
This is not a medical proposition. This is the legalization of
drugs that
we're concerned about. Here's what the medical advisor in the
state of
California saw as the potential uses of marijuana. [Here
McCaffrey showed a
slide.]... It includes recalling forgotten memories, cough
suppressants,
Parkinson's disease, writer's cramp. This is not medicine. This
is a Cheech
and Chong show. And now what we are committed to doing is to look
in a
scientific way at any proposition that would bring a new medicine
to the
assistance of the American medical establishment. (2)
Secretary of Health and Human Services Donna Shalala said that
the
initiatives reinforced the growing belief among Americans that
marijuana is
not harmful, whereas the administration remained "opposed to the
legalization of marijuana [because] all available research has
concluded
that marijuana is dangerous to our health." (2) Nonetheless, she did say
that the National Institutes of Health (NIH) would continue to
support and
review "peer-reviewed" and "scientifically valid" research on
"the possible
usefulness of smoked marijuana in the limited circumstances where
available
medications have failed to provide relief for individual
patients." (2)
Finally, Attorney General Janet Reno announced that physicians
who followed
the terms of the California law would be the new targets of
federal law
enforcement (instead of drug dealers) and threatened physicians
with loss
of their registrations with the DEA and with exclusion from
participation
in Medicare and Medicaid. She stated:
Federal law still applies.... U.S. attorneys in both states will
continue
to review cases for prosecution and DEA officials will review
cases as they
have to determine whether to revoke the registration of any
physician who
recommends or prescribes so-called Schedule I controlled
substances. We
will not turn a blind eye toward our responsibility to enforce
federal law
and to preserve the integrity of medical and scientific process
to
determine if drugs have medical value before allowing them to be
used. (2)
Doctor-Patient Conversations
Two basic issues are raised by the administration's position. One
involves
government regulation of doctor-patient conversations, and the
other the
quality of evidence necessary to make marijuana available by
prescription.
A group of California physicians filed suit against McCaffrey,
Reno, and
Shalala, arguing that the threats of prosecution against
physicians for
talking to their patients violate their First Amendment rights
and
interfere with their ability as physicians to use "their best
medical
judgment in the context of a bona fide physician-patient
relationship." (12)
In the only comparable case to reach the U.S. Supreme Court, the
Court
narrowly upheld a gag rule related to discussing abortion in a
federally
funded Title X family-planning clinic. (13) The Court upheld the gag rule
because Congress could reasonably limit the types of medical
services
available at a federally funded facility. (14) The Court was able to
sidestep the First Amendment issue because patients (at least in
theory)
had access to other doctors who had an obligation to furnish them
with full
information, and the doctor-patient relationship in a Title X
clinic was
characterized as not "all-encompassing" but, rather, as limited
only to
preconception counseling:
The Title X program regulations do not significantly impinge upon
the
doctor-patient relationship. Nothing in them requires a doctor to
represent
as [his or her] own any opinion that [he or she] does not in fact
hold. Nor
is the doctor-patient relationship established by expectation on
the part
of the patient of comprehensive medical advice. The program does
not
provide post-conception medical care, and therefore a doctor's
silence with
regard to abortion cannot reasonably be thought to mislead a
client into
thinking that the doctor does not consider abortion an
appropriate option
for her. (13)
Even if one accepts this unconvincing rationale, it is impossible
to apply
it to California physicians who believe that marijuana would be
beneficial
for their patients and who are providing their overall health
care.
Patients receiving care for cancer or AIDS rightfully and
reasonably expect
and are entitled to full disclosure and discussion of available
treatment
options. The California physicians are on strong legal ground
with their
lawsuit, and they should prevail. In early April, U.S. District
Court judge
Fern M. Smith granted a preliminary injunction prohibiting the
DEA from
carrying out its threats against California physicians and
encouraged the
litigants to try to work out a settlement of the dispute. (15)
In response to the lawsuit and the growing opposition to its
threats to
physicians, the administration issued a clarifying letter,
essentially
stating that physicians may discuss marijuana with their patients
so long
as they do not recommend its use. (16) This provides no guidance at all. Of
course doctors can talk to patients; the question is what they
can tell
them. The real subject of dispute remains whether physicians can
"recommend" marijuana (and thereby grant their patients immunity
from state
prosecution), as the California proposition provides. Would, for
example,
telling a patient with cancer that other physicians have reported
that
marijuana has given their patients relief from nausea constitute
a
"recommendation"?
Judge Smith made it clear that the First Amendment protects
physician-patient communications and that the government has no
authority
to determine the content of physicians' speech. (15) She also concluded
that the federal statements regarding threatened prosecution were
vague and
thus could lead to physicians' censuring their own speech to
avoid possible
federal prosecution. On the other hand, she noted (correctly)
that the
First Amendment does not protect "speech that is itself criminal
because
[the speech is] too intertwined with illegal activity." (15) Under federal
drug laws, which cannot be affected by legislation in California,
it
remains a crime for physicians to aid, abet, or conspire -- by
speech or
action -- to violate federal criminal statutes. Thus, it is not a
violation
of the First Amendment for the federal government to prosecute or
threaten
to prosecute physicians who specifically intend to aid, abet, or
conspire
with their patients to violate federal drug laws.
Judge Smith could have added that to prevail in such a case the
government
will have to prove more than simply that the physician
recommended
marijuana as worth trying for a medical condition. The "more"
will include
evidence that the physician "associated himself with the venture"
of
illegally purchasing marijuana "as something he wished to bring
about and
sought by his actions to make succeed." (17) This should require at least
that the physician identify a source of the marijuana, and some
connection
between that source and the physician. (18) It is only speech short of this
that the injunction covers. Of course, this formulation still
leaves it
uncertain exactly how far physicians may go in recommending
marijuana use
before the federal government is justified in prosecuting them
for criminal
behavior. Judge Smith concluded with an understatement: "This
injunction
does not provide physicians with the level of certainty for which
they had
hoped." (15)
Marijuana as Medicine
Attempts to have marijuana reassigned from Schedule I to Schedule
II began
almost immediately after Congress passed the Uniform Controlled
Substances
Act of 1970, which established the current system of drug
classification.
The following findings must be made to place a drug on Schedule
I:
"(A) The drug... has a high potential for abuse;
(B) The drug... has no currently accepted medical use in
treatment in the
United States;
and (C) there is a lack of accepted safety for use of the drug
under
medical supervision."
Part A for Schedule II drugs is identical; the other requirements
are "(B)
The drug... has a currently accepted medical use in treatment in
the United
States... and (C) Abuse of the drug... may lead to severe
psychological or
physical dependence."
In 1988, after two years of hearings, DEA administrative-law
judge Francis
Young recommended shifting marijuana to Schedule II on the
grounds that it
was safe and had a "currently accepted medical use in treatment."
(19)
Specifically, Judge Young found that "marijuana, in its natural
form, is
one of the safest therapeutically active substances known to
man.... At
present it is estimated that marijuana's LD-50 [median lethal
dose] is
around 1:20,000 or 1:40,000. In layman's terms... a smoker would
theoretically have to consume 20,000 to 40,000 times as much
marijuana as
is contained in one marijuana cigarette... nearly 1500 pounds of
marijuana
within about fifteen minutes to induce a lethal response." As for
medical
use, the judge concluded, among other things, that marijuana "has
a
currently accepted medical use in treatment in the United States
for nausea
and vomiting resulting from chemotherapy treatments." (19) The
administrator of the DEA rejected Young's recommendation, on the
basis that
there was no scientific evidence showing that marijuana was
better than
other approved drugs for any specific medical condition. Further
attempts
to get the courts to reclassify marijuana have been unsuccessful.
Reacting to a DEA suggestion that only a "fringe group" of
oncologists
accepted marijuana as an antiemetic agent, a survey of a random
sample of
the members of the American Society of Clinical Oncology was
undertaken in
1990. (20) More than
1000 oncologists responded to the survey, and 44
percent of them reported that they had recommended marijuana to
at least
one patient. (20)
Marijuana was believed to be more effective than oral
dronabinol (Marinol) by the respondents: of those who believed
they had
sufficient information to compare the two drugs directly, 44
percent
believed marijuana was more effective, and only 13 percent
believed
dronabinol was more effective. (20) Of course, nothing in the FDA
regulations requires a drug to be more effective than an existing
one for
it to be approved. Nonetheless, in the current anti-marijuana
climate, the
NIH has consistently refused to fund research on marijuana. In
the wake of
the California proposition, this position is no longer tenable.
An NIH
panel, after a two-day workshop in February, recommended research
on
marijuana in the areas of wasting associated with AIDS, nausea
due to
cancer chemotherapy, glaucoma, and neuropathic pain. (21) This list seems
reasonable, especially since objective criteria such as weight
gain,
intraocular pressure, and the frequency of vomiting can be used
to
determine the drug's effectiveness.
Such research may be difficult to do, but it is possible to
compare orally
administered dronabinol with smoked marijuana. Some argue that
because the
symptoms of nausea are so subjective and "extremely difficult to
quantify
in controlled experiments," marijuana should be available as a
prescription
drug on a compassionate basis. (3) In fact, current FDA regulations provide
the authority for making marijuana available on a compassionate
basis while
such studies are proceeding. Other support for its compassionate
use would
appear to come from the Clinton administration's solicitor
general, Walter
Dellinger, who argued before the Supreme Court less than two
weeks after
the McCaffrey-Reno press conference that the administration
believed that
Americans had a weak constitutional right "not to suffer."
Although
Dellinger said he did not believe this right was broad enough to
prohibit
the states from making physician-assisted suicide for terminally
ill
patients a crime, it should certainly be broad enough to prohibit
the
federal government from denying patients with cancer and AIDS
access to
drugs that could help them withstand potentially life-saving
treatments.
What About the Children?
The final argument that the administration makes against any
medical use of
marijuana is that this would send the "wrong message" to
children, who
would then use this "gateway drug" and get hooked on much more
harmful
substances, such as cocaine and heroin. There are two responses
to this
argument. The first is provided by Boston Globe columnist Ellen
Goodman,
who asks, "What is the infamous signal being sent to
[children]?... If you
hurry up and get cancer, you, too, can get high?" (22)
The second response relates to the "gateway" issue itself. A 1994
survey
found that 17 percent of current marijuana users said they had
tried
cocaine and only 0.2 percent of those who had not used marijuana
had tried
cocaine. (23) One way
to interpret these data is that children who smoke
marijuana are 85 times as likely as others to try cocaine;
another is that
83 percent of pot smokers, or five out of six, never try cocaine.
(23)
Honesty is likely to make a greater and more lasting impression
on our
children than political posturing and hysteria. Many people want
to make
marijuana legal for everyone. But opposition to the legalization
of
marijuana generally is not a good reason to keep it from patients
who are
suffering. Making marijuana a Schedule II drug does not make it
widely
acceptable or available any more than classifying medicinal
cocaine as a
Schedule II drug made it acceptable or available.
Conclusions
Doctors are not the enemy in the "war" on drugs; ignorance and
hypocrisy
are. Research should go on, and while it does, marijuana should
be
available to all patients who need it to help them undergo
treatment for
life-threatening illnesses. There is certainly sufficient
evidence to
reclassify marijuana as a Schedule II drug. Unlike quack remedies
such as
laetrile, marijuana is not claimed to be a treatment in itself;
instead, it
is used to help patients withstand the effect of accepted
treatment that
can lead to a cure or amelioration of their condition. As long as
a therapy
is safe and has not been proved ineffective, seriously ill
patients (and
their physicians) should have access to whatever they need to
fight for
their lives.
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Copyright 1997, Massachusetts Medical Society.
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