MARIJUANA ON THE BALLOT

While it has long been clear that chemical compound found in the marijuana
plant offer potential for medical use, smoking the raw plant is a method of
delivery supported neither by law nor recent scientific evidence. The Food
and Drug Administration's approval process, which seeks to ensure the
purity of chemical compounds in legitimate drugs, sets the standard for
medical validation of prescription drugs as safe and effective.
Diametrically opposed to this long-standing safeguard of medical science is
the recent spate of state election ballots that have advocated the use of a
smoked plant - the marijuana leaf - for "treating" an unspecified number of
ailments. It is a tribute to the power of political activism that popular
vote has displaced objective science in advancing what would be the only
smoked drug in America under the guise of good medicine.

Two recent studies of the potential medical utility of marijuana advocate
development of a non-smoked, rapid onset delivery system of the cannabis
compounds.

But state ballot initiatives that seek legalization of smoking marijuana as
medicine threaten to circumvent credible research. Advocates for smoking
marijuana appear to want to move ahead at all costs, irrespective of
dangers to the user. They make a well-financed, emotional appeal to the
voting public claiming that what they demand is humane, useful, and safe.
Although they rely largely on anecdote to document their claims, they seize
upon partial statements that purport to validate their assertions. At the
same time, these partisans - described by Chris Wren, the highly respected
journalist for the New York Times, as a small coalition of libertarians,
liberals, humanitarians, and hedonists - reject the main conclusions of
medical science: that there is little future in smoked marijuana as a
medically approved medication.

A Dearth Of Scientific Support

Compounds found in marijuana may have medical potential, but science does
not support smoking the plant in its crude form as an appropriate delivery
system.

An exploration of two comprehensive inquiries into the medical potential of
marijuana indicates the following:

o Science has identified only the potential medical benefit of chemical
compounds, such as THC, found in marijuana. Ambitious research is necessary
to understand fully how these substances affect the human body.

o Experts who have dealt with all available data do not recommend that the
goal of research should be smoked marijuana for medical conditions. Rather,
they support development of a smoke-free, rapid-onset delivery system for
compounds found in the plant.

In 1997, the National Institutes of Health (NIH) met "to review the
scientific data concerning the potential therapeutic uses of marijuana and
the need for and feasibility of additional research." The collection of
experts had experience in relevant studies and clinical research, but held
no preconceived opinions about the medical use of marijuana.

They were asked the following questions: What is the current state of
scientific knowledge; what significant questions remain unanswered; what is
the medical potential; what possible uses deserve further research; and
what issues should be considered if clinical trials are conducted?

Shortly thereafter, the White House Office of National Drug Control Policy
(ONDCP) asked the Institute of Medicine (IOM) to execute a similar task: to
form a panel that would "conduct a review of the scientific evidence to
assess the potential health benefits and risks of marijuana and its
constituent cannabinoids." Selected reviewers were among the most
accomplished in the disciplines of neuroscience, pharmacology, immunology,
drug abuse, drug laws, oncology, infectious diseases, and ophthalmology.
Their analysis focused on the effects of isolated cannabinoids, risks
associated with medical use of marijuana, and the use of smoked marijuana.

Their findings in the IOM study stated:

"Compared to most drugs, the accumulation of medical knowledge about
marijuana has proceeded in reverse. Typically, during the course of drug
development, a compound is first found to have some medical benefit.
Following this, extensive tests are undertaken to determine the safety and
proper dose of the drug for medical use. Marijuana, in contrast, has been
widely used in the United State for decades .... The data on the adverse
effects of marijuana are more extensive than the data on effectiveness.
Clinical studies of marijuana are difficult to conduct."

Nevertheless, the IOM report concluded that cannabinoid drugs do have
potential for therapeutic use. It specifically named pain, nausea and
vomiting, and lack of appetite as symptoms for which cannabinoids may be of
benefit, stating that cannabinoids are "moderately well suited" for AIDS
wasting and nausea resulting from chemotherapy. The report found that
cannabinoids "probably have a natural role in pain modulation, control of
movement, and memory," but that this role "is likely to be multi-faceted
and remains unclear."

In addressing the possible effects of smoked marijuana on pain, the NIH
report explained that no clinical trials involving patients with "naturally
occurring pain" have ever been conducted but that two credible studies of
cancer pain indicated analgesic benefit.

Addressing another possible benefit - the reduction of nausea related to
chemotherapy - the NIH report described a study comparing oral
administration of THC (via a drug called Dronabinol) and smoked marijuana.

Of 20 patients, nine expressed no preference between the two, seven
preferred the oral THC, and only four preferred smoked marijuana. In
summary, the report states, "No scientific questions have been definitively
answered about the efficacy of smoked marijuana in chemotherapy-related
nausea and vomiting."

In the area of glaucoma, the effect of marijuana on intraocular pressure
(the cause of optic nerve damage that typifies glaucoma) was explored, and
smoked marijuana was found to reduce this pressure.

However, the NIH report failed to find evidence that marijuana can safely
and effectively lower intraocular pressure enough to prevent optic nerve
damage." The report concluded that the "mechanism of action" of smoked
marijuana or THC in pill form on intraocular pressure is not known and
calls for more research.

In addressing appetite stimulation and wasting related to AIDS, the NIH
report recognized the potential benefit of marijuana. However, the report
also noted the lack of pertinent data. The researchers pointed out that the
evidence known to date, although plentiful, is anecdotal, and "no objective
data relative to body composition alterations, HIV replication, or
immunologic function in HIV patients are available."

Smoking marijuana as medicine was recommended by neither report.

The IOM report called smoked marijuana a "crude THC delivery system" that
is not recommended because it delivers harmful substances, pointing out
that botanical products are susceptible to problems with consistency,
contaminations, uncertain potencies, and instabilities. The NIH report
reached the same conclusion and explained that eliminating the smoked
aspect of marijuana would "remove an important obstacle" from research into
the potential medical benefits of the plant.

These studies present a consistent theme.- Cannabinoids in marijuana do
show potential for symptom management of several conditions, but research
is inadequate to explain definitively how cannabinoids operate to deliver
these potential benefits.

Nor did the studies attribute any curative effects to marijuana; at best,
only the symptoms of particular medical conditions are affected.

The finding most important to the debate is that the studies did not
advocate smoked marijuana as medicine.

To the contrary, the NIH report called for a non-smoked alternative as a
focus of further research.

The IOM report recommended smoking marijuana as medicine only in the most
extreme circumstances when all other medication has failed and then only
when administration of marijuana is under strict medical supervision.

These conclusions from two studies, based not on rhetorical conjecture but
on credible scientific research, do not support the legalization of smoked
marijuana as medicine.

The Scientific Community's Views

The conclusions of the NIH and IOM reports are supported by commentary
published in the nation's medical journals.

Much of this literature focuses on the problematic aspect of smoke as a
delivery system when using cannabinoids for medical purposes.

One physician- authored article describes smoking "crude plant material" as
"troublesome" to many doctors and "unpleasant" to many patients.

Dr. Eric Voth, chairman of the International Drug Strategy Institute,
stated in a 1997 article published in the Journal of the American Medical
Association (JAMA): "To support research on smoked pot does not make sense.

We're currently in a huge anti-tobacco thrust in this country, which is
appropriate. So why should we waste money on drug delivery that is based on
smoking?" Voth recommends non-smoked analogs to THC.

In September, 1998, the editor in chief of the New England Journal of
Medicine, Dr. Jerome P. Kassirer, in a coauthored piece with Dr. Marcia
Angell, wrote:

"Until the 20th century, most remedies were botanical, a few of which were
found through trial and error to be helpful. All of that began to change in
the 20th century as a result of rapid advances in medical science.

In particular, the evolution of the randomized, controlled clinical trial
enabled researchers to study with precision the safety, efficacy, and dose
effects of proposed treatments and the indications for them. No longer do
we have to rely on trial and error and anecdotes.

We have learned to ask and expect statistically reliable evidence before
accepting conclusions about remedies."

Dr. Robert DuPont of the Georgetown University Department of Psychiatry
points out that those who aggressively advocate smoking marijuana as
medicine "undermine" the potentially beneficial roles of the NIH and IOM
studies.

As does Dr. Voth, DuPont discusses the possibility of nonsmoked delivery
methods.

He asserts that if the scientific community were to accept smoked marijuana
as medicine, the public would likely perceive the as influenced by politics
rather than science.

Dupont concludes that if research is primarily concerned with the needs of
the sick, it is unlikely that science will approve of smoked marijuana as
medicine.

Even those who advocate smoking marijuana for medicine are occasionally
driven to caution.

Dr. Lester Grinspoon, a Harvard University professor and advocate of
smoking marijuana, warned in a 1994 JAMA article: "The one area we have to
be concerned about is pulmonary function. The lungs were not made to inhale
anything but fresh air." Other experts have only disdain for the loose
medical claims for smoked marijuana.

Dr. Janet Lapey, executive director of Concerned Citizens for Drug
Prevention, likened research on smoked marijuana to using opium pipes to
test morphine.

She advocates research on isolated active compounds rather than smoked
marijuana.

The findings of the NIH and iom reports, and other commentary by members of
the scientific and medical communities, contradict the idea that plant
smoking is an appropriate vehicle for delivering whatever compounds
research may find to be of benefit.

Enter The FDA

The mission of the Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research is "to assure that safe and effective drugs are
available to the American people." Circumvention of the FDA approval
process would remove this essential safety mechanism intended to safeguard
public health.

The FDA approval process is not designed to keep drugs out of the hands of
the sick but to offer a system to ensure that drugs prevent, cure, or treat
a medical condition.

FDA approval can involve testing of hundreds of compounds, which allows
scientists to alter them for improved performance. The IOM report addresses
this situation explicitly: "Medicines today are expected to be of known
composition and quantity.

Even in cases where marijuana can provide relief from symptoms, the crude
plant mixture does not meet this modern expectation."

For a proposed drug to gain approval by the FDA, a potential manufacturer
must produce a new drug application. The application must provide enough
information for FDA reviewers to determine (among other criteria) "whether
the drug is safe and effective for its proposed use(s), whether the
benefits of the drug outweigh its risks [and] whether the methods used in
manufacturing the drug and the controls used to maintain the drug's quality
are adequate to preserve the drug's integrity, strength, quality, and purity."

On the "benefits" side, the Institute of Medicine found that the
therapeutic effects of cannabinoids are "generally modest" and that for the
majority of symptoms there are approved drugs that are more effective.

For example, superior glaucoma and antinausea medications have already been
developed.

In addition, the new drug Zofran may provide more relief than THC for
chemotherapy patients. Dronabinol, the synthetic THC, offers
immunocompromised HIV patients a safe alternative to inhaling marijuana
smoke, which contains carcinogens.

On the "risks" side, there is strong evidence that smoking marijuana has
detrimental health effects.

Unrefined marijuana contains approximately 400 chemicals that become
combustible when smoked, producing in turn over 2,000 impure chemicals.

These substances, many of which remain unidentified, include. carcinogens.
The IOM report states that, when used chronically, "marijuana smoking is
associated with abnormalities of cells lining the human respiratory tract.

Marijuana smoke, like tobacco smoke, is associated with increased risk of
cancer, lung damage, and poor pregnancy outcomes." A subsequent study by
Dr. Zuo-Feng Zhary of the Jonsson Cancer Center at UCLA determined that the
carcinogens in marijuana are much stronger than those in tobacco.

Chronic bronchitis and increased incidence of pulmonary disease are
associated with frequent use of smoked marijuana, as are reduced sperm
motility and testosterone levels in males.

Decreased immune system response, which is Rely to increase vulnerability
to infection and tumors, is also associated with frequent use. Even a
slight decrease in immune response can have major public health
ramifications. Because marijuana by-products remain in body fat for several
weeks, interference with normal body functioning may continue beyond the
time of use. Among the known effects of smoking marijuana is impaired lung
function similar to the type caused by cigarette smoking.

In addressing the efficacy of cannabinoid drugs, the IOM report - after
recognizing "potential therapeutic value" - added that smoked marijuana is
"a crude THC delivery system that also delivers harmful substances."
Purified cannabinoid compounds are preferable to plants in crude form,
which contain inconsistent chemical composition. The "therapeutic window"
between the desirable and adverse effects of marijuana and THC is narrow at
best and may not exist at all, in many cases.

The scientific evidence that marijuana's potential therapeutic benefits are
modest, that other approved drugs are generally more effective, and that
smoking marijuana is unhealthy, indicates that smoked marijuana is not a
viable candidate for FDA approval.

Without such approval, smoked marijuana cannot achieve legitimate status as
an approved drug that patients can readily use. This reality renders the
advocacy of smoking marijuana as medicine both misguided and impractical.

Medicine By Ballot Initiave ?

While ballot initiatives are an indispensable part of our democracy, they
are imprudent in the context of advancing smoked marijuana as medicine
because they confound our system of laws, create conflict between state and
federal law, and fail to offer a proper substitute for science.

Ballot initiatives to legalize smoking marijuana as medicine have had a
tumultuous history.

In 1998 alone, initiatives were passed in five states, any substantive
benefits in the aftermath were lacking.

For example, a Colorado proposal was ruled invalid before the election.

An Ohio bill was passed but subsequently repealed.

In the District of Colombia, Congress disallowed the counting of ballot
results. Six other states permit patients to smoke marijuana as medicine
but only by prescription, and doctors, dubious about the validity of a
smoked medicine, wary of liability suits, and concerned about legal and
professional risks are reluctant to prescribe it for their patients.
Although voters passed Arizona's initiative, the state legislature
originally blocked the measure.

The version that eventually became Arizona law is problematic because it
conflicts with federal statute.

Indeed, legalization at the state level creates a direct conflict between
state and federal law in every case, placing patients, doctors, police,
prosecutors, and public officials in a difficult position.

The fundamental legal problem with prescription of marijuana is that
federal law prohibits such use, rendering state law functionally ineffective.

To appreciate fully the legal ramifications of ballot initiatives, consider
one specific example.

California's is perhaps the most publicized, and illustrates the chaos that
can result from such initiatives. Enacted in 1996, the California
Compassionate Use Act (also known as Proposition 215) was a ballot
initiative intended to afford legal protection to seriously ill patients
who use marijuana therapeutically. The act explicitly states that marijuana
used by patients must first be recommended by a physician, and refers to
such use as a "right" of the people of California. According to the act,
physicians and patients are not subject to prosecution if they are
compliant with the terms of the legislation. The act names cancer,
anorexia, AIDS, chronic pain, spasticity, glaucoma, arthritis, and migraine
as conditions that may be appropriately treated by marijuana, but it also
includes the proviso: "or any other illness for which marijuana provides
relief."

Writing in December 1999, a California doctor, Ryan Thompson, summed up the
medical problems with Proposition 215:

As it stands, it creates vague, ill-defined guidelines that are obviously
subject to abuse.

The most glaring areas are as follows:

o A patient does not necessarily need to be seen, evaluated or diagnosed as
having any specific medical condition to qualify for the use of marijuana.

o There is no requirement for a written prescription or even a written
recommendation for its medical use.

o Once "recommended," the patient never needs to be seen again to assess
the effectiveness of the treatment and potentially could use that
"recommendation" for the rest of his or her life.

o There is no limitation to the conditions for which it can be used, it can
be recommended for virtually any condition, even if it is not believed to
be effective.

The doctor concludes by stating: "Certainly as a physician I have witnessed
the detrimental effects of marijuana use on patients and their families. It
is not a harmless substance."

Passage of Proposition 215 resulted in conflict between California and the
federal government. In February 1997, the Executive Office of the President
issued its response to the California Compassionate Use Act (as well as
Arizona's Proposition 200). The notice stated:

"[The] Department of Justice's (D. O. J.) position is that a practitioner's
practice of recommending or prescribing Schedule I controlled substances is
not consistent with the public interest (as that phrase is used in the
federal Controlled Substances Act) and will lead to administrative action
by the Drug Enforcement Administration (DEA) to revoke the practitioner's
registration."

The notice indicated that U.S. attorneys in California and Arizona would
consider cases for prosecution using certain criteria.

These included lack of a bona fide doctor-patient relationship, a "high
volume" of prescriptions (or recommendations) for Schedule I drugs,
"significant" profits derived from such prescriptions, prescriptions to
minors, and "special circumstances" like impaired driving accidents
involving serious injury.

The federal government's reasons for taking such a stance are solid.

Dr. Donald Vereen of the Office of National Drug Control Policy explains
that "research-based evidence" must be the focus when evaluating the risks
and benefits of any drug, the only approach that provides a rational basis
for making such a determination. He also explains that since testing by the
Food and Drug Administration and other government agencies is designed to
protect public health, circumvention of the process is unwise.

While the federal government supports FDA approved cannabinoid-based drugs,
it maintains that ballot initiatives should not be allowed to remove
marijuana evaluation from the realm of science and the drug approval
process - a position based on a concern for public health.

The Department of Health and Human Services has revised its regulations by
making research-grade marijuana more available and intends to facilitate
more research of cannabinoids. The department does not, however, intend to
lower its standards of scientific proof.

Problems resulting from the California initiative are not isolated to
conflict between the state and federal government. California courts
themselves limited the distribution of medical marijuana.

A 1997 California appellate decision held that the state's Compassionate
Use Act only allowed purchase of medical marijuana from a patient's
"primary caregiver," not from "drug dealers on street corners" or "sales
centers such as the Cannabis Buyers' Club." This decision allowed courts to
enjoin marijuana clubs.

The course of California's initiative and those of other states illustrate
that such ballot-driven movements are not a legally effective or reliable
way to supply the sick with whatever medical benefit the marijuana plant
might hold. If the focus were shifted away from smoking the plant and
toward a non-smoked alternative based on scientific research, much of this
conflict could be avoided.

Filling "Prescriptions"

It is one thing to pass a ballot initiative defining a burning plant as
medicine.

It is yet another to make available such "medicine" if the plant itself
remains - as it should - illegal. Recreational use, after all, cannot be
equated with medicinal use, and none of the ballots passed were constructed
to do so.

Nonetheless, cannabis buyers' clubs were quick to present the fiction that,
for medical benefit, they were now in business to provided relief for the
sick. In California, 13 such clubs rapidly went into operation, selling
marijuana openly under the guise that doing so had been legitimized at the
polls.

The problem was that these organizations were selling to people under the
flimsiest of facades.

One club went so far as to proclaim: "All use of marijuana is medical. It
makes you smarter. It touches the right brain and allows you to slow down,
to smell the flowers."

Depending on the wording of the specific ballots, legal interpretation of
what was allowed became problematic. The buyers' clubs became notorious for
liberal interpretations of "prescription," "doctor's recommendation," and
"medical." In California, Lucy Mae Tuck obtained a prescription for
marijuana to treat hot flashes. Another citizen arrested for possession
claimed he was medically entitled to his stash to treat a condition
exacerbated by an ingrown toenail.

Undercover police in several buyers clubs reported blatant sales to minors
and adults with little attention to claims of medical need or a doctor's
direction.

Eventually, 10 of the 13 clubs in California were closed.

Further exacerbating the confusion over smoked marijuana as medicine are
doctors' concerns over medical liability.

Without the Food and Drug Administration's approval, marijuana cannot
become a pharmaceutical drug to be purchased at local drug stores. Nor can
there be any degree of confidence that proper doses can be measured out and
chemical impurities eliminated in the marijuana that is obtained.

After all, we are talking about a leaf, and a burning one at that. In the
meantime, the harmful effects of marijuana have been documented in greater
scientific detail than any findings about the medical benefits of smoking
the plant.

Given the serious illnesses (for example, cancer and AIDS) of some of those
who are purported to be in need of smoked marijuana for medical relief and
their vulnerability to impurities and other toxic substances present in the
plant, doctors are loath to risk their patients' health and their own
financial well-being by prescribing it. As Dr. Peter Byeff, an oncologist
at a Connecticut cancer center, points out: "If there's no mechanism for
dispensing it, that doesn't help many of my patients. They're not going to
go out and grow it in their backyards." Recognizing the availability of
effective prescription medications to control nausea and vomiting, Byeff
adds: "There's no reason to prescribe or dispense marijuana."

Medical professionals recognize what marijuana-as-medicine advocates seek
to obscure.

The chemical makeup of any two marijuana plants can differ significantly
due to minor variations in cultivation. For example, should one plant
receive relative to another as little as four more hours of collective
sunlight before cultivation, the two could turn out to be significantly
different in chemical composition. Potency also varies according to climate
and geographical origin; it can also be affected by the way in which the
plant is harvested and stored.

Differences can be so profound that under current medical standards, two
marijuana plants could be considered completely different drugs.
Prescribing unproven, unmeasured, impure burnt leaves to relieve symptoms
of a wide range of ailments does not seem to be the high point of American
medical practice.

Illegal Because Harmful

Cannabinoids found in the marijuana plant offer the potential for medical
use. However, lighting the leaves of the plant on fire and smoking them
amount to an impractical delivery system that involves health risks and
deleterious legal consequences. There is a profound difference between an
approval process that seeks to purify isolated compounds for safe and
effective delivery, and legalization of smoking the raw plant material as
medicine. To advocate the latter is to bypass the safety and efficacy built
into America's medical system.

Ballot initiatives for smoked marijuana comprise a dangerous, impractical
shortcut that circumvents the drug-approval process. The resulting
decriminalization of a dangerous and harmful drug turns out to be
counterproductive - legally, politically, and scientifically.

Advocacy for smoked marijuana has been cast in terms of relief from suffering.

The Hippocratic oath that doctors take specifies that they must "first, do
no harm." Clearly some people supporting medical marijuana are genuinely
concerned about the sick. But violating established medical procedure does
do harm, and it confounds the political, medical, and legal processes that
best serve American society.

In the single-minded pursuit of an extreme position that harkens back to an
era of home medicine and herbal remedies, advocates for smoked marijuana as
medicinal therapy not only retard legitimate scientific progress but become
easy prey for less noble-minded zealots who seek to promote the acceptance
and use of marijuana, an essentially harmful - and, therefore, illegal - drug.