Pubdate: April-May 2000
Source: Policy Review (US)
Copyright: 2000 Policy Review
Pages: 51- 61
Contact:  214 Massachusetts Ave. NE, Washington, DC 20002
Fax: (202) 608-6136
Website: http://www.policyreview.com/
Author: James R. McDonough
Note: James R. McDonough is director of the Florida Office of Drug Control.
Also: At least two articles have been published which reference this 
article. They are at:
http://www.mapinc.org/drugnews/v00/n417/a01.html 
http://www.mapinc.org/drugnews/v00/n453/a08.html

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. 
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MAP posted-by: Richard Lake