DEA Moves To Loosen Medical-THC Rules
FILED 11/11/98

Synthetic THC, a prime active ingredient in marijuana, may soon become as available in neighborhood drugstores as Tylenol with Codeine(TM), thanks to the federal Drug Enforcement Administration. The DEA's sudden downscheduling of THC may foretoken a pending change in the legal classification of marijuana itself, currently unprescribable on Schedule I of the federal list of controlled substances.

On Nov. 5, barely hours after voters in six states and Washington, DC approved new medical-marijuana laws, the DEA formally proposed to have THC shifted off Schedule II to a much less restrictive category. The surprise downscheduling was announced with manifest satisfaction by Unimed Pharmaceuticals of Buffalo Grove, IL, which manufactures THC under the generic name "dronabinol," and co-markets it through the Roxane drug company of Columbus, OH as Marinol(TM).

Unimed itself credits the passage of seven medical-marijuana referenda in last week's elections for the DEA's decision to downschedule THC: "This proposed ruling comes on the heels of voter-approved referendums," their P-R directors point out, "in which residents of Arizona, Washington, Colorado, Alaska, Nevada, Oregon and the District of Columbia supported measures that endorse the use of medical marijuana."

The makers and merchandisers of Marinol clearly anticipate a boom in demand for it, from physicians in areas where sick people will now be asking for recommendations to legally use marijuana. Whereas many physicians may remain prudently afraid of recommending whole marijuana to patients, for fear of prosecution under federal law, Marinol has been a legal prescription article for over 10 years. As a Schedule II drug, however, doctors and pharmacists handling Marinol were subject to intense individual scrutiny from the DEA, which also had a firmly-worded proviso discouraging doctors from prescribing it for so-called "off-label" applications.

Officially, Marinol is approved by the Food and Drug Administration solely for use in stimulating appetite and abolishing nausea, medical applications for which THC has long been shown supremely and uniquely efficacious. However, patients using marijuana have also found it equally effective for uncountable other applications, such as reduction of eyeball pressure in glaucoma, forestalling of epileptic seizures, quelling of spastic convulsions, reduction of inflammation, and the alleviation of many different kinds of pain, from migraine to arthritis. After Marinol is moved to Schedule III, as the DEA is recommending, doctors can presumably begin prescribing it for most or all of these other conditions without fear of having the DEA yank their licenses and haul them into federal criminal courts.

As NORML Publications Director Paul Armentano has pointed out in a recent survey, though, synthetic THC may very well turn out not to work very well for many of these other medical applications, and may even be counter-productive for some of them. THC is only one of several pharmacologically active ingredients in whole marijuana. Other "cannabinoids" have been shown to have unique effects of their own, especially CBD, or cannabidiol--which in some respects has been likened to a THC "antagonist," modifying, reducing, or even abolishing some of THC's effects. As Armentano demonstrates in his extensive review of cannabis medical literature, supplemented by patient reports, the presence of CBD in whole marijuana may not only enhance THC's beneficial effects in many conditions--especially with epilepsy and spastic disorders--but may be really the reason why many patients who report that pot helps their conditions also report that Marinol is either ineffective or plain disagreeable for them.

"Marinol's lack of CBD," Armentano concludes, " probably contributes to why patients report unpleasant feelings after consuming oral THC, but few report adverse psychoactive effects from smoking marijuana." Marinol's mode of delivery, as a pill-shaped capsule taken orally, also has a lot to do with it, he points out; after passing through the stomach, much of it is converted to a really hyper-psychotropic "metabolite" before it reaches the brain, causing profound, unalleviated euphoria (or dysphoria, quite often) that lasts over four hours in first-time patients. Thus the smoking of whole marijuana, complete with THC-mollifying CBD, can be superior, says Armentano, since it gives patients the opportunity to control the dose from puff to puff of smoke.

The Unimed company, interestingly, is currently working on aerosol and sublingual (under-the-tongue) preparations of THC which will presumably offer some of the same advantages as marijuana smoke, albeit without the advantages of CBD. This is of particular interest in view of their triumphal press release about re-scheduling, which says that the DEA decided to move Marinol to Schedule III only after learning that "because [oral] Marinol has a gradual onset of action, it has a very low potential for abuse."

This conclusion was contained in a study of Marinol completed last year by the Haight-Ashbury Free Medical Clinics. After over 10 years in medical distribution, the Free Clinic researchers determined, Marinol has never succeeded in becoming an item of interest to recreational dopers, not even to their own chronically "cannabis-dependent" clientele, mainly because its psychoactive effects are uncontrollable and disagreeable: "The onset of action is slow and gradual, it is at most only weakly reinforcing, and the overwhelming majority of reports of users indicate that its effects are dysphoric and unappealing."

Whether aerosol or sublingual THC preparations will be any more agreeable for patients, they ought certainly to work more quickly than pills taken orally. Whether that will also enhance their "addiction liability" by making THC more "reinforcing" is another question, besides the question of whether THC is really the best ingredient in pot for epilepsy, multiple sclerosis, and pain conditions. This may or may not be studied scientifically over the next few years, depending on how liberally the DEA proposes to tolerate "off-label" prescriptions for Marinol, and whether any formal research projects are undertaken to determine its relative usefulness for any of those other applications.

And as long as the DEA keeps pot itself on Schedule I, of course, there will never be any way of measuring its superiority over pure, isolated, synthetic, hyper-potent THC.

Dean Latimer - Special to HT News

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