Source:   The New England Journal of Medicine
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Mail: The New England Journal of Medicine, 10 Shattuck Street, Boston, MA
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Pubdate:  7 Aug 1997
URL: http://www.nejm.org:80/public/1997/0337/0006/0435/1.htm

The New England Journal of Medicine  August 7, 1997  Volume 337, Number 6 

Reefer Madness  The Federal Response to California's MedicalMarijuana Law

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 editorinchief of the Journal suggested that prohibiting physicians
from helping their suffering patients by suggesting that they use marijuana
is "misguided, heavyhanded, 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, trendsetting 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
lifethreatening 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 antiemetics 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 "peerreviewed" 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 socalled 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) 

DoctorPatient Conversations

Two basic issues are raised by the administration's position. One involves
government regulation of doctorpatient 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 physicianpatient 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 familyplanning 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 doctorpatient relationship in a Title X clinic was
characterized as not "allencompassing" but, rather, as limited only to
preconception counseling: 

The Title X program regulations do not significantly impinge upon the
doctorpatient 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 doctorpatient relationship established by expectation on the part
of the patient of comprehensive medical advice. The program does not
provide postconception 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
physicianpatient 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 administrativelaw 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 LD50 [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 antimarijuana 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 twoday 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 McCaffreyReno 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 physicianassisted 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 lifesaving 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
lifethreatening 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

1. Sidney S, Beck JE, Tekawa IS, Quesenberry CP Jr, Friedman GD. Marijuana
use and mortality. Am J Public Health 1997;87:58590. 

2. Federal News Service. White House briefing news conference, December 30,
1996. 

3. Kassirer JP. Federal foolishness and marijuana. N Engl J Med
1997;336:3667. 

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 Investigational New Drug, 21 C.F.R. (section)312.34
(1988). 

8. Annas GJ. Faith (healing), hope and charity at the FDA: the politics of
AIDS drugs trials. Villanova Law Rev 1989;34:77197. 

9. Grinspoon L, Bakalar JB. Marihuana: the forbidden medicine. New Haven,
Conn.: Yale University Press, 1995. 

10. Gould SJ. It worked like a 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. C970139 FMS (1997).

13. Rust v. Sullivan, 500 U.S. 173 (1991). 

14. Annas GJ. Restricting doctorpatient conversation in federally funded
clinics. N Engl J Med 1991;325:3624. 

15. Golden T. Federal judge supports California doctors on marijuana issue.
New York Times. April 12, 1997:7. 

16. Stapleton S. Medical pot: Feds say talk is OK, just don't recommend it.
American Medical 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. 8622, Sept. 6, 1988 (Young, J.). 

20. Doblin RE, Kleiman MA. Marijuana as antiemetic medicine: a survey of
oncologists' experiences and attitudes. Clin Oncol 1991;9:13149. 

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. 

Copyright  1997 by the Massachusetts Medical Society