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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4. Mass. Gen. Laws, Ch. 94D, (section)2 (West 1996).
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6. United States v. Rutherford, 442 U.S. 544 (1979).
7. Treatment Use of an Investigational New Drug, 21 C.F.R. (section)312.34 (1988).
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10. Gould SJ. It worked like a charm. The Times. May 4, 1993.
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12. Conant v. McCaffrey, U.S. D.C. No. Cal., No. C97-0139 FMS (1997).
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15. Golden T. Federal judge supports California doctors on marijuana issue. New York
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18. State v. Gladstone, 474 P2d. 274 (Wash. 1970).
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No. 86-22, Sept. 6, 1988 (Young, J.).
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