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A solution now being proposed, notably in the IOM Report, is what might be called the "pharmaceuticalization" of _________________: prescription of isolated individual cannabinoids, synthetic cannabinoids, and cannabinoid analogs. The IOM Report states that "if there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids, and their synthetic derivatives." It goes on: "Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug, but such trials could be a first step towards the development of rapid-onset, non-smoked cannabinoid delivery systems”. (Joy et al., 1999: 11).
Some cannabinoids and analogs may have advantages over whole smoked or _________________ marijuana in certain circumstances. For example, cannabidiol may be more effective as an anti-anxiety drug when it is not taken along with delta-9- tetrahydrocannabinol (THC), which sometimes _________________ anxiety.
Other cannabinoids and analogs may occasionally prove more useful than marijuana because they can be administered _________________ly. For example, 15 to 20 percent of patients lose consciousness after suffering from a thrombotic or embolic stroke, and some people who suffer brain syndrome after a severe blow to the head become unconscious. The new analog dexanabinol has been shown to protect brain cells from damage by glutamate excito_________________ in these circumstances, and it can be given _________________ly to an unconscious person (Leker et al. 1999; Shohami et al. 1995).
Presumably other analogs may offer related advantages. Some of these commercial products may also lack the _________________ effects which make marijuana useful to some for non-medical purposes, and therefore will not be defined as "abusable" drugs subject to the constraints of the Comprehensive Drug Abuse and Control Act. Nasal sprays, nebulizers, skin patches, pills, and suppositories can be used to avoid exposure of the lungs to the _________________ matter in marijuana smoke. Will these developments make marijuana itself medically _________________?
Surely many of these substances will be useful and safe enough for commercial development. The question is whether pharmaceutical companies will find them worth the enormous cost of development. Some may; for example, an inverse cannabinoid _________________ that reduces appetite might be highly lucrative, but for most specific symptoms, analogs or combinations of analogs are unlikely to be more useful than natural _________________. Nor are they likely to have a significantly wider spectrum of therapeutic uses, since the natural product contains the compounds (and _________________ combinations of compounds) from which they are derived. THC and cannabidiol, for example, provide the same protection for brain cells that dexanabinol provides after a stroke or traumatic injury. Synthetic tetrahydrocannabinol (Marinol) has been available for years, but patients generally find whole smoked marijuana to be more effective. The cannabinoids in whole mariuana can be separated from the burnt plant products by devices already being perfected that will be inexpensive when manufactured in large numbers. _________________ is a highly effective means of delivery, and faster means will not be available for analogs (except in a few situations such as parenteral injection in an unconscious patient or one with _________________ impairment). Furthermore, any new analog will have to have an acceptable therapeutic ratio. The therapeutic ratio of marijuana is not known because it has never caused an overdose death, but it is estimated on the basis of _________________ from animal data to be 20,000 to 40,000. The therapeutic ratio of a new analog is unlikely to be higher than that; in fact, it may be less safe because it will be physically possible to _________________ more. There is also the matter of an analog's classification under the Comprehensive Drug Abuse and Control Act. It is a rule of thumb that the more _________________ the classification of a drug the less likely are physicians to prescribe it. That is why Unimed successfully sought a reclassification of Marinol from Schedule II to Schedule III.
As with Marinol, the commercial success of new cannabinoid products will depend to a considerable extent on how _________________ the prohibition against marijuana is enforced. While the pharmaceutical companies are less likely to be interested in developing medicines which are _________________ly scheduled or even scheduled at all, one wonders how motivated they would be to develop cannabinoid products if they had to compete with natural marijuana on a level playing field; that is, if marijuana were legally available as a medicine. I have yet to examine a patient who has used both smoked marijuana and Marinol who finds the latter more useful; the most common reason for using Marinol is the illegality of marijuana, and many patients choose to ignore the law when they believe that the difference between the two puts their health, comfort or economic well-being at risk. If patients were legally allowed to use marijuana, relatively few would choose Marinol.
With the present prohibition in place, the economic _________________ of pharmaceutical-industry-generated cannabinoid products and the motivation to develop them will be _________________ to the _________________ with which the marijuana prohibition is enforced. One of the prices of the present level of enforcement is the more than 700,000 marijuana arrests annually; and the _________________ costs are enormous. And still most patients who find _________________ useful medicinally choose illegal marijuana over prescription dronabinol (Marinol) for reasons of efficacy and cost. One has to ask whether there is any level of enforcement which would _________________ enough compliance to _________________ drug companies to commit the many millions of dollars it will take to develop new cannabinoid products. Unimed's developmental costs for dronabinol were relatively small because the United States government underwrote much of it and it involved a substance which already existed. We can safely predict that new products will be more expensive than the _________________ priced Marinol. It appears, then, that in the United States two powerful forces are _________________ over the issue of medicinal _________________. On the one hand, there is a growing interest in and acceptance of the medicinal importance of _________________, and there is every reason to believe that this development will continue to gain momentum. As it does so it increasingly _________________ the _________________ any use of marijuana.
At the same time, there does not appear to be widespread interest in moving from an absolute prohibition against _________________ to a regulatory system which would allow for the responsible use of this drug. The federal government, until recently has denied any medical utility to _________________, and it appears to be _________________ opposed to any relaxation of the prohibition. There is little doubt that pharmaceutical companies will develop some cannabinoid products which will be at least as useful as marijuana, and some will be _________________ so. Also, some may be expected to be free or nearly so of psychoactivity; this will allow them to be placed outside of the constraints of the Comprehensive Drug Abuse Act classification, or at most assignment to Categories IV or V. They will require prescription and they will be expensive, but there will be a market. What is uncertain, and of course critical to a decision to develop new cannabinoid products, is _________________ size of the market.
The "pharmaceuticalization" of marijuana will only succeed if the pharmaceutical products displace marijuana as a medicine. This seems unlikely in view of the latter's limited _________________, easy availability, low cost relative to _________________, ease with which it can be self-titrated, growing access to vaporization devices, and its remarkable medical _________________. And if the legal costs of using marijuana are _________________ not so high that most people choose marijuana over dronabinol, it is difficult to imagine a level of enforcement which would eliminate use of the plant material. It seems inevitable that at least for some period of time there will _________________ two distribution pathways for this medicine: first, the conventional model of modern allopathic medicine through pharmacy-filled prescriptions for FDA-approved medicines; and second, a model closer to the distribution of alternative and herbal medicines, where there is little if any quality or quantity control. Either way, growing numbers of people will become familiar with _________________ and its derivative products. They will learn that its harmfulness has been greatly _________________ and its usefulness underestimated. We can expect that with this growing sophistication about _________________, there is likely to be growing pressure to change the way we as a society deal with people who use this drug for any reason.