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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.
References
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Quesenberry CP Jr, Friedman GD. Marijuana use and
mortality. Am J Public Health 1997;87:585-90.
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briefing news conference, December 30, 1996.
3. Kassirer JP.
Federal
foolishness and marijuana. N Engl J Med
1997;336:366-7.
4. Mass. Gen. Laws, Ch. 94D,
(section)2 (West 1996).
5. Cal. Code Sec. 11362.5
(1996).
6. United States v. Rutherford, 442
U.S. 544 (1979).
7. Treatment Use of an
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(1988).
8. Annas GJ. Faith (healing), hope
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Marihuana: the forbidden medicine.
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charm. The Times. May 4, 1993.
11. Golden T. Medical use of
marijuana to stay illegal in Arizona. New York Times. April
17, 1997:A14.
12.
Conant v. McCaffrey, U.S. D.C. No.
Cal., No. C97-0139 FMS (1997).
13. Rust v. Sullivan, 500 U.S. 173
(1991).
14. Annas GJ. Restricting
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Engl J Med 1991;325:362-4.
15. Golden T. Federal judge
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News. March 17, 1997:1, 33.
17. Morei v. U.S., 127 F2d. 827 (6
Cir. 1942).
18. State v. Gladstone, 474 P2d.
274 (Wash. 1970).
19. In the
Matter of Marijuana Rescheduling
Petition, U.S. Dept. of Justice, DEA, Docket No. 86-22,
Sept. 6, 1988 (Young, J.).
20. Doblin RE, Kleiman MA.
Marijuana as antiemetic medicine: a survey of oncologists'
experiences and attitudes. Clin Oncol 1991;9:1314-9.
21. Leary WE. U.S.
panel
urges study of medical marijuana. New York Times.
February 21, 1997:A27.
22. Goodman E. Clear thinking in
the medical marijuana debate. Boston Globe. February 2,
1997:C7.
23. Wren CS. Phantom numbers haunt
the war on drugs. New York Times. April 20, 1997:4E.
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