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