Commentary

Counterblaste to the I.O.M.

In mid-March of this year, the report of the U.S. Institute of Medicine
(Joy et al., 1999) on the topic of 'medical marijuana' was finally
published, having been commissioned by the U.S. Drug Czar and his White
House Office of National Drug Control Policy in January 1997. The
widespread and growing use of marijuana for medicinal purposes and the
passage of legislation in several U.S. states recognising patients' rights
to use, and physicians' rights to recommend marijuana had been countered by
the Drug Czar's denunciation of medical marijuana as "a cruel hoax,"
"Cheech and Chong medicine," and a "Trojan horse" for across-the-board
legalisation of drugs. A review of the scientific evidence on marijuana by
an organisation with irreproachable credentials was thus called for,
although at the time - January 1997 - the request to the I.O.M. was widely
seen as merely a stalling tactic by an unremittingly prohibitionist federal
government pressed to divert attention from the recent successes of the
drug policy reform movement.

The I.O.M. document, summarising a purportedly scientific and thorough
review of all available evidence, left no doubt that marijuana - or at
least some of its active ingredients - showed significant promise for
certain conditions: "For [some] patients...cannabinoid drugs might offer
broad spectrum relief not found in any other single medication." Examined
from the point of view of the U.S. federal government's long-standing
prohibitionist policies, however, the report's findings were not considered
significant enough to justify any change of direction: Even for the
terminally ill and severely afflicted who find marijuana of some use or
comfort, harassment, arrest, seizure of assets, and imprisonment are still
deemed appropriate federal action for 'sending the right message' about the
'great danger to society' posed by the weed, medicinal or not. The stark
'message' that the Feds were sending was unmistakably loud and clear: In
1997 there were three-quarters of a million marijuana arrests in the U.S.,
90 percent of them for simple possession. Even larger figures are expected
for 1998 and 1999. The I.O.M. study shunned consideration of the larger
social questions: "Can marijuana relieve health problems? Is it safe for
medical use? Those straightforward questions are embedded in a web of
social concerns, most of which lie outside the scope of this report."

The I.O.M. report went on to recommend further extensive research on the
medical use of cannabis: "Recommendation 1: Research should continue into
the physiological effects of synthetic and plant-derived cannabinoids and
the natural function of cannabinoids found in the body." Publicly, at
least, the U.S. federal government agrees. But marijuana research,
according to some top scientists, has been actively thwarted by the U.S.
government for decades, and there has been little if any loosening of the
stringent requirements for approval of proposed research projects. As an
example of recent stonewalling, Rick Doblin of the Multidisciplinary
Association for Psychedelic Studies writes,

"Obtaining approval for MAPS-sponsored medical marijuana research has
...been difficult. As reported in the last Bulletin, the National
Institutes of Health (NIH) rejected for the second time the grant
application of Dr. Ethan Russo, U. of Montana, for a study of the use of
smoked marijuana in people whose migraines are not successfully treated by
currently available medicines. The NIH letter explaining the rationale for
its decision arrived well after the news of the rejection of the grant. The
NIH reviewers focused in large part on an issue that cannot be resolved and
that has nothing to do with the scientific merit of the protocol design,
the supposed need for preliminary data to supplement extensive historical
and anecdotal reports. It is difficult to imagine that the NIH reviewers
didn't realize that it is impossible to obtain permission to conduct
preliminary studies, or didn't know that the NIH Expert Committee on the
Medical Uses of Marijuana recommended full-scale trials. Despite the
Clinton Administration rhetoric in favor of medical marijuana research, the
reality is continued obstructionism. In a victory for the opponents of
medical marijuana, Dr. Russo has decided that it is futile to reapply to
NIH a third time. The Clinton Administration position that the controversy
over the medical use of marijuana should be resolved through scientific
research rather than at the ballot box will remain dishonest and deceptive
until good-faith efforts to conduct research, such as attempted by Dr.
Russo and supported by MAPS, are permitted to proceed." (Doblin, 1999)

Indeed, while marijuana officially remains a schedule I drug "with high
potential for abuse and no accepted medical use" it is difficult to see how
any U.S. research agenda could attain the necessary freedom from corrupting
political imperatives rooted deep in moralistic and religious convictions.
Under such pressure, what little research as has been allowed over the
years has been largely directed at supporting prohibitionist policy and
prejudice, and there is little sign that the tendency will improve in the
near-term, the I.O.M. recommendation notwithstanding.

The lack of adequate research uncontaminated by ideology, especially with
regard to understanding the illegal 'recreational' use of marijuana, has of
course permitted the long-standing demonisation of cannabis and the
dismissal of claims for its utility and safety as mere 'anecdotal evidence'
of little or no use as 'scientific proof.' Thus the I.O.M. report could
'safely ignore' not only sociological concerns but a vast body of common
knowledge about cannabis that remains 'illegitimate' simply by virtue of
the illegality and demonisation of 'the evil weed,' and use what little
government-approved research as existed to disguise, more than reveal, the
true medical and social potentials of cannabis. The facts that were thus
ignored or discredited by the report, as well as the objections to the
medical use of whole smoked cannabis presented there, reveal that to a
significant extent the essential substance of the I.O.M. report is ideology
dressed up as science. When social and scientific concerns are as
interfused as they are today concerning medical marijuana and the larger
issue of substance prohibition in general - especially in view of the
overwhelming evidence that prohibitions are invariably self-defeating and
in the long run may amount to crimes against humanity - no study which
rejects important evidence as 'anecdotal' and 'outside its scope' will be
truly objective, nor will it resolve, but instead perpetuate the problems
it has been commissioned to clarify. Amid all the calls for exacting
scientific evidence for the efficacy and safety of the medical use of
marijuana, where are the equally stringent requirements for scientific
evidence which proves the merit of current repressive prohibitionist
policy? Much testimony that would lead to wide-ranging changes in
approaches to drug use is dismissed as "anecdotal", yet the evidence that
putting drug users in prison has any benefit to society falls short even of
the anecdotal, indeed, the entire concept and practice of drug prohibition
seems based primarily on misplaced moralism, lies, racism and historical
errors. Why should science require far more stringent evidence for
recommending the reversal of bad drug policy than for supporting its
continuation?

Let us evaluate certain aspects of the I.O.M report, and especially its
stated objections to the use of whole 'crude' smoked marijuana as a
medicinal product, from a position less beholden to U.S. prohibitionist
convictions than mainstream institutions today appear capable of. To its
small credit, the I.O.M. Report did stress the lack of evidence that
marijuana was significantly 'addictive,' or a 'gateway' drug that in itself
enticed users to graduate to 'harder drugs,' ("it is the legal status of
marijuana that makes it a gateway drug"), and also found no convincing
evidence that medical availability of cannabis would stimulate illegal
'recreational' use of the drug. These were not revolutionary admissions
however: considering the wealth of evidence showing such suspicions as
products of 'reefer madness' fanaticism, the I.O.M. would have severely
tarnished its credibility had it stated otherwise. But the superficially
generous admission of the obvious may often be a way to disguise a partisan
evaluation of the controversial.

"Because marijuana is a crude THC delivery system that also delivers
harmful substances, smoked marijuana should generally not be recommended
for medical use. Nonetheless, marijuana is widely used by certain patient
groups, which raises both safety and efficacy issues," states the I.O.M.
Report. "If there is any future for marijuana as a medicine, it lies in its
isolated components, the cannabinoids and their synthetic derivatives."
"Marijuana's future as a medicine does not involve smoking," insisted Dr.
Stanley Watson, a neuroscientist and substance-abuse researcher from the
University of Michigan and co-author of the report.

Despite the authors' insistence that scientific rigor was their rule,
embedded in the above quotes and in the substance of the Report are value
judgements and prejudices, and we can discern the way in which scientific
objectivity has fallen prey to moralistic conviction by way of the
following arguments. The principal stated and implied conclusions of the
report in objection to the use of smoked marijuana - which reflect current
medical and scientific paradigms - need some careful examination and
rebuttal. Among those conclusions and paradigms are:

o Smoking "delivers harmful substances" and is dangerous to health and
unsuitable as a drug delivery method. No other drugs are smoked. o An
efficient medicinal product should ideally consist of a single purified
substance. When herbal remedies or mixtures are found to be of value,
research then isolates the active ingredient and industry produces a
standardised and scientifically-tested pharmacological product. o Whole
('crude') marijuana contains variable and uncertain amounts of active
ingredients, as well as a range of inert and inactive substances. The
'efficiency' of 'crude' marijuana is thus uncertain. o Certain substances
and activities are 'harmful'. "Marijuana is not a completely benign
substance," the report stresses.

Prohibitionists and government spokesmen seized upon the objection to
smoking as a route for the administration of a therapeutic drug despite the
report's recommendation that smoking might be an interim solution for
certain patients and through research a "step towards the possible
development of nonsmoked, rapid-onset cannabinoid delivery systems."
Ideologues routinely confuse themselves with their own convictions, even
when the facts are imposing, so we might excuse them from parroting the
anti-smoking conclusions of the I.O.M. Report. But scientists should be
ashamed for jumping on the anti-smoke bandwagon without a moment of
reflection. True, in the modern pharmacopoeia, there are no medicinal
substances delivered by smoking, and in the absence of evidence to the
contrary such a route of administration might be avoided. But the argument
that smoking is an inappropriate drug delivery method because no other
drugs are administered that way is logically weak, at least insofar as
uniqueness of method is concerned. Before the hypodermic syringe was
invented no drugs were administered by injection, but with the advent of
the method there was no great movement by government and medical
authorities denouncing injection merely on the basis of novelty, since the
delivery method was found to be effective. (And presumably, drug injection
in those days, with the primitive equipment and minimal understanding of
infections prevalent, involved significant risk of complications.)

With marijuana, however, the nature and effects of the drug make its
smoking far more effective and acceptable for patients than oral
preparations, for problems of solubility make absorption by the oral route
far too dependent on the presence of fats. Indeed, for the minority of
medical users who are averse to smoking, marijuana may be prepared into
'brownies' or other fatty pastries, and as a starting point in the recipe,
the cannabis is usually heated in butter or other oil to dissolve and
disperse the active cannabinoids. Absorption in the gut is then far more
reliable and predictable, if still unduly delayed.

In addition, all medical marijuana users stress the importance of
self-titration of the drug, and insist that smoking is by far the best
existing route for implementing this technique, oral ingestion resulting in
little ability to control the onset of effect or the size of dose.
Presumably, similar and additional concerns would make an injected cannabis
preparation both impractical and unacceptable to the great majority of
patients. Obviously, the primary consideration of a drug/delivery-method
combination is that it should work, and if no other delivery method can be
found superior, it would be absurd to reject the 'novel' or unusual solely
on the basis of its curiosity. And it must be added that in the case of
marijuana, the unusual chemical, biological, and medicinal qualities of the
drug make it unlike any other in the pharmacopoeia, thus the 'novel' route
of administration must be given much leeway until extensive clinical trials
have definitively shown that a safer and equally patient-acceptable route
is in every way equivalent or superior to smoking. Thus, at least for the
present, the peculiarities of marijuana and its use for various medical
applications leave smoking as the superior route of administration, despite
any drawbacks.

"Although marijuana smoke delivers THC and other cannabinoids to the body,
it also delivers harmful substances, including most of those found in
tobacco smoke." The fallacy of believing that 'harm' and 'risk' (and even
'safety') are not entirely relative to one's premises has been
philosophically explored since time immemorium. Likewise, labelling a
substance as "not completely benign" tells us nothing. And calling a mere
substance 'harmful' without reference to how it is used nor concerns of
relativity or value judgement should be an intellectual trap scrupulously
avoided by scientists, at the least. The contention that marijuana smoke
delivers "most of the harmful [sic] substances...found in tobacco smoke" is
a howler, however, and produces the suspicion that lapses of scientific
rigor by the I.O.M. were intentional, allowing the report to legitimate the
continuing and very unscientific status quo of marijuana prohibition.
Paradoxically, even tobacco smoke itself does not necessarily deliver all
the harmful substances "found in tobacco smoke," as we can ascertain from
recent research indicating that bacteria in tobacco leaf that produce
nitrosamines - the chemicals thought to be the biggest cancer hazard in
tobacco smoke - can easily be killed to produce a potentially far safer
tobacco. (Day, 1999) Does marijuana contain such bacteria-produced
nitrosamines? The I.O.M. Report does not say, nor do the references cited.
Certainly marijuana does not contain nicotine, nor does it contain
tobacco-specific bio-accumulated radionuclides such as Polonium210, an
alpha-emitter also suspected of being highly carcinogenic to lung tissue.
And what about other key tobacco toxins such as 4-aminobiphenyl? Are they
to be found in marijuana?

True, burning one leaf or another is likely to produce hundreds of
practically identical combustion products, so that a list of chemicals
found in tobacco smoke vs. marijuana smoke might seem superficially
equivalent. But if even one or two of the principal disease-producing
substances in tobacco smoke are absent, or even significantly reduced in
marijuana smoke, the contention that the two smokes deliver equivalent
'harmful substances' is merely capitalising on current anti-tobacco
hysteria in the attempt to denounce marijuana smoking when the
preponderance of evidence indicates that smoked marijuana may not be a
carcinogen at all. In fact, a United Press International article from
January 30, 1997 reports that,

"The U.S. federal government has failed to make public its own 1994 study
that undercuts its position that marijuana is carcinogenic - a $2 million
study by the National Toxicology Program. The program's deputy director,
John Bucher says the study found absolutely no evidence of cancer. In fact,
animals that received THC had fewer cancers."

Certainly I do not propose that smoking is 'harmless' when indulged in to
excess, and tobacco smoking is renowned for excess. The effect of nicotine
is so short-lived that most tobacco habituE9s require a new dose every
half-hour. And surely, marijuana when burned produces carbon monoxide and a
few more or less carcinogenic combustion products as do cigarettes,
fireplace logs, power stations, and barbecue fuel. But it would not be
stretching credulity to argue that mankind has developed a fairly robust
resistance to breathing smoke for at least part of the day, having lived
for 99% of his time on earth in dwellings with open hearths. In these
dwellings even the pregnant and the new-born would breathe all sorts of
combustion products. Natural selection must certainly have acted to produce
some immunity to smoke inhalation, or it would now be impossible to live in
many of our major cities. The comparison of the daily use of a few puffs of
medical marijuana and living in London or Los Angeles must surely reveal
the latter the more dangerous for the respiratory passages. This must
certainly be the case when the quantity and frequency of marijuana use
required for a given application such as anti-nausea is low and the variety
of cannabis employed one of the potent high-quality strains favoured by
users, so that the smoke intake is very modest compared with the
round-the-clock breathing of polluted air. There are thousands of deaths
yearly in many major cities directly caused by air polluted with a wide
range of carcinogens and irritants, (in the U.K., microparticulates from
diesel exhaust alone are thought to kill 10,000 people a year), yet no one
has identified a single death or cancer caused by marijuana smoking. Why
should living in polluted air seem an acceptable, even disregarded risk
while light to moderate medical marijuana smoking be denounced as
unconscionable?

Extending the argument into sacred pharmacological territory, it cannot be
ignored that all medical preparations have side-effects. Even an aspirin
has potentially dangerous and common, occasionally fatal side-effects, and
in the case of aspirin as for smoked marijuana and many other drugs, it is
the route of administration which leads to the potentially threatening side
effects! The oral method of aspirin use leads to possibly severe and not
uncommon gastro-intestinal consequences having nothing to do with the
purpose of the drug nor its targeted site in the body. The smoked method of
using medical marijuana may lead to some as yet unproved harm to the
respiratory passages. There is simply no practical, logical, or medical
argument which can justify risking stomach lesions taking aspirin for its
neurological effects while denouncing as prohibitive the risk of possible
lung damage smoking medical marijuana for effective therapeutic purposes.
Is lung tissue more sacred than the stomach lining? We use warning labels
on the product's package to alert the physician and user of side-effects,
not logical fallacy disguised as medical truth, as is now being done for
marijuana.

To proceed yet further with standard pharmacological tenets, no medicine,
even a totally purified single chemical entity, affects all persons the
same or to an equal degree, nor will it work equally at all times for the
same person. Sometimes an aspirin works fine, sometimes even several doses
fail to deliver any analgesia whatsoever. The idea that a single purified
substance is the summum bonum in pharmacology, which the IOM report
supports by implication, is rendered uncertain both by this non-specificity
argument and the fact that custom mixtures of drugs sometimes prove the
best for not a few individual cases. In the case of a simple disease or
condition such as an infection, a single purified substance is often
desirable, such as a condition-specific antibiotic. It is no doubt through
the successes of the treatment of such well-defined conditions that the
'single purified substance paradigm' has attained its current prominence,
but there are many conditions which are complex, involving several aspects
of health and multiple bodily systems including psychological
manifestations. The relief of pain and other conditions for which marijuana
has been found useful fall into the category of being multiple-causation,
complex physical and psychological syndromes, and positing that a single
pharmaceutical product MUST be the best remedy is an invalid extension of
the 'simple-disease/simple cure' paradigm. It is obvious to medical
marijuana users and to a growing number of physicians and scientists that
strict reductionism in medical treatment is severely limiting, and that the
synergistic effects of a drug like marijuana on several bodily systems as
well as positive psychological effects combine to produce a wide-spectrum
medicinal potential that we should in principle not expect of a single
purified substance.

Objecting to the proven efficacy of marijuana use on the basis that the
drug contains a complex and varying mixture of substances might be a valid
complaint if the pharmaceutical houses had already produced
condition-specific cannabinoid preparations therapeutically equal to whole
smoked cannabis. The only pharmaceutical preparation that science has
brought us so far is Marinol, consisting of only one active ingredient
(synthetic THC) dissolved in sesame oil to be taken orally, a preparation
which few patients or physicians find as useful or effective as smoked
marijuana. It is possible that the chemistry and pharmacology of cannabis
is so complex that it will require decades of research to produce medicines
tailor-made for conditions which are suitable for treatment right now with
various strains of whole cannabis, and we can imagine that the price tag of
those future researched-for-decades preparations will result in easily- and
cheaply-grown whole cannabis still being the intelligent choice for many.
With respect to cannabis at least, much of the pharmacological argument
against 'herbal medicine' is a symptom of the dollar-signs-in-the-eyes
syndrome.

There is a further possible factor complicating the argument against smoked
cannabis: burning the substance in a certain way may actually produce
altered cannabinoids which are therapeutically useful. It is known, for
example, that cannabinoids in fresh green cannabis are to some degree
carboxylated and largely inactive, and that curing and drying, smoking, (or
heating in butter as mentioned above) de-carboxylates and thus activates
the drug. The hypothesis that smoking itself makes cannabis more
therapeutically active cannot be ruled out but must be thoroughly tested.
Thus medicinal cannabis preparations taken with yet-to-be-developed
inhalers mentioned in the I.O.M. document may still not completely
reproduce the effect of smoked whole cannabis. Let research on vaporisers
and inhalers begin in earnest (and here the I.O.M. report notes that such
delivery methods might not be perfected for many years). But for the time
being, and as has been noted by many, asking patients in need to wait years
for a substitute for what they already have that works, or go to prison and
forfeit their homes for insisting, is a bit extreme!

The argument that whole cannabis supplies unknown and uncertain doses of
active products is flawed in another respect, and here it is the smoked
delivery method itself which supplies the rebuttal. As noted above, medical
marijuana users insist on the importance of self-titration for
administering the drug, so as to obtain the desired level of relief of
symptoms while avoiding taking a dose which produces excess psychological
effects or renders them temporarily overwhelmed, a frequent complaint with
the oral preparation Marinol. The onset of action of the drug when smoked
is particularly rapid, so that no matter what the strength of the whole
cannabis, or its particular blend of active and inert ingredients, a smoker
may arrive at his required dose within a few minutes solely on the basis of
perceived desired effect. Thus may he also select among varieties of whole
cannabis for the best perceived remedy for his particular condition.

And if there are inert and ineffective substances in the collection of "400
chemicals in marijuana," so what? Read the label of any medical preparation
and see: 'active ingredients,' and then 'inert ingredients.' No one would
insist that the food we eat be completely analysed and consist only of
ingredients 'recognised by science' to have benefit to the body. Indeed,
many foodstuffs contain toxins, carcinogens, and irrelevant substances. And
a recommendation to eat only purified vitamins, nutrients, minerals and
sterile bulking agents would be considered absurd by all except the
companies which intended to market such products. The pharmaceutical and
medical paradigms which will not allow medicines to be at all analogous to
foods in their application and benefit is certainly too narrow, and should
be relaxed. And in the case of medical marijuana and other herbal
preparations whose effectiveness depends on their wide-spectrum influence
on both body and mind, current pharmaceutical paradigms become an
absurdity. Let research show which ingredients in natural herbs are
effective, just as research has shown which nutrients in food are required
for various aspects of health. But let us not get sucked into approving the
blinkered profit motives of pharmaceutical companies by supporting the
dictum that 'acceptable medicine' may not be a natural plant or combination
of plants, especially when the desired effect is relief of pain and
psychological distress or other objectives for which the subjective
evaluation of efficacy by the patient must reign supreme.

The onus is on science, industry and government to improve therapy, even
(need I say it?) at the sacrifice of profits and prestige, and not to
attempt to remove currently effective if imperfect therapy from the scene
(and what therapy has been proved perfect?). Current arguments against
cannabis are morality dressed up as science, and (to quote the Drug Czar)
"a cruel hoax."

References

Day, Michael. The Lesser Of Two Evils: If people can't stop smoking, the
next best thing is to make tobacco less harmful. New Scientist, May 8, 1999.

Doblin, Rick. Letter from Rick Doblin, MAPS President. Multidisciplinary
Association for Psychedelic Studies, Bulletin 1999, Vol IX, No. 1, p.3.

Joy, J.E., et al. Marijuana and Medicine: Assessing the Science Base. Janet
E. Joy, Stanley J. Watson, Jr., and John A. Benson, Jr., Editors, Division
of Neuroscience and Behavioral Health, Institute Of Medicine, National
Academy Press, Washington, D.C. 1999.