Cannabis Chronicles

One of the points of debate brought to the table by the folks who prefer to continue the senseless war on drugs, is that a synthetic marijuana product is already available by prescription. With the following posting we hope to present a farily balanced look at the question: Is Dronabinol (Marinol) really an effective and viable substitute for smoking or eating herbal cannabis?

To get the discussion started, we’ll begin by quoting Wikipedia:

Dronabinol
From Wikipedia, the free encyclopedia

Marinol, a registered trademark of Unimed Pharmaceuticals, Inc. is the commercial name for a product containing dronabinol, an analog of ?9-tetrahydrocannabinol (THC). THC is a naturally occurring component in cannabis.

Marinol is an FDA-approved cannabinoid and is prescribed as an appetite stimulant, primarily for AIDS, chemotherapy and gastric bypass patients. Compare Sativex, a mouth spray for neuropathic pain of multiple sclerosis sufferers approved for use in Canada and in the US as of 2006. While Marinol can serve as an anti-emitic and appetite booster, its immunomodulative effect should be taken into account in the treatment of any compromised immune condition.

Comparisons to medicinal cannabis
Marinol is known to produce side-effects similar to cannabis intoxication. Some have posited that Marinol lacks beneficial properties of cannabis, which contains more than 60 cannabinoids, including cannabidiol (CBD), thought to be the major anti-convulsant that helps multiple sclerosis patients, and cannabichromene (CBC), an anti-inflammatory which may contribute to the pain-killing effect of cannabis. Others have countered that the effects of all of cannabis’s cannabinoids have not been completely studied and are not fully understood to be beneficial.

It takes over one hour for Marinol to reach full effect, compared to minutes for smoked or vaporized cannabis. Some patients accustomed to inhaling just enough cannabis smoke to manage symptoms have complained of too-intense intoxication via Marinol’s predetermined dosages. This powerful psychoactive effect, however, has led to recreational use of Marinol. Many have said that Marinol produces a more acute psychedelic effect than cannabis and it has been speculated that this disparity can be explained by the moderating effect of the many non-THC cannibinoids present in cannabis. Mark Kleiman, director of the Drug Policy Analysis Program at UCLA’s School of Public Affairs had this to say about Marinol– “It wasn’t any fun and made the user feel bad,” Kleiman says, “so it could be approved without any fear that it would penetrate the recreational market, and then used as a club with which to beat back the advocates of whole cannabis as a medicine.” United States federal law currently registers Dronabinol as a Schedule III drug, but all other Cannabis remains Schedule I, except Nabilone. Some taking Marinol to manage nausea have stated that often the Marinol capsule is expelled before it can take effect.

Although Marinol is available for free to those who can demonstrate financial need to Roxane and Unimed Pharmaceuticals, some users have complained that it effectively costs more than cannabis.

Regulatory history

Since at least 1986, the trend has been for THC in general, and especially the Marinol preparation, to be downgraded to less and less stringently-controlled schedules of controlled substances, in the U.S. and internationally.

On July 13, 1986, the Drug Enforcement Administration (DEA) issued a Final Rule and Statement of Policy authorizing the “Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II”(DEA 51 FR 17476-78). This permitted medical use of Marinol, albeit with the severe restrictions associated with Schedule II status. For instance, refills of Marinol prescriptions were not permitted. At its 1045th meeting, on April 29, 1991, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, decided that delta-9-tetrahydrocannabinol (also referred to as delta-9-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. This released Marinol from the restrictions imposed by Article 7 of the Convention.

An abstract published in the April-June 1998 issue of the Journal of Psychoactive Drugs found that “Healthcare professionals have detected no indication of scrip-chasing or doctor-shopping among the patients for whom they have prescribed dronabinol”. The authors suggested that Marinol had a low potential for abuse.

In 1999, Marinol was rescheduled from Schedule II to III of the Controlled Substances Act, reflecting a finding that THC had a potential for abuse less than that of LSD, cocaine, and heroin. This rescheduling comprised part of the argument for a 2002 petition for cannabis rescheduling in the United States, in which petitioner Jon Gettman noted, “Cannabis is a natural source of dronabinol (THC), the ingredient of Marinolâ„¢, a Schedule III drug. There are no grounds to schedule cannabis in a more restrictive schedule than Marinolâ„¢”.

At its 33rd meeting, the World Health Organization Expert Committee on Drug Dependence recommended transferring tetrahydrocannabinol to Schedule IV of the Convention, citing its medical uses and low abuse potential. This would put THC in the Convention’s least stringently-controlled Schedule.

As can usually be expected from Wikipedia, that’s a fairly balanced look at Dronabinol aka Marinol. There’s at least one more internet source for information on the debate about Marinol, it’s a side by side “pro & con” discussion about the issue. The side in favor of Marinol being stated by Doctor Robert L. DuPont and others, while the now familar Doctor Lester Grinspoon and friends argue in favor of herbal cannabis rather than synthetic Dronabinol.

Here’s an excerpt for our readers of the arguments in favor of herbal cannabis:

The International Journal of Drug Policy stated in a 2001 article by Lester Grinspoon, M.D., (Vol. 12, 5-6, pp. 377-383):

“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.”
(2001) International Journal of Drug Policy

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The Journal of Cannabis Therapeutic stated in an article by researchers from GW Pharmaceuticals in the U.K. (Vol. 1, No. 3/4, 2001, pp. 183-205):

“In practice it has been found that extracts of cannabis provide greater relief of pain than the equivalent amount of cannabinoid given as a single chemical entity [such as Marinol]…

The oral route of administration for cannabinoids [Marinol] leads to slow and irregular absorption.”
(2001) Journal of Cannabis Therapeutics

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The 1999 U.S. government-sponsored Institute of Medicine report “Marijuana and Medicine: Assessing the Science Base” stated on Pages 205-206:

“It is well recognized that Marinol’s oral route of administration hampers its effectiveness because of slow absorption and patients’ desire for more control over dosing.”
(March 1999) Institute of Medicine

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Andrew Weil, M.D., stated in a 6/6/02 article published in the San Francisco Chronicle :

“Unfortunately, the only legal substitute [to marijuana] available now — a prescription pill containing synthetic THC, marijuana’s main psychoactive component — is not EFFECTIVE enough for many patients. I hear regularly from patients that the pill does not work as well as the natural herb, and causes much greater intoxication.”
(6/6/02) Andrew Weil

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Professor Donald Abrams, M.D., who has conducted U.S. Government approved research at U.C. San Francisco into the effects of smoked marijuana and AIDS patients, noted in a lecture on May 17, 1999:

“When we look at the pharmaecopia, when taken by mouth, delta-9 THC [Marinol] has a very low 6 to 20 percent absorption, and it’s very variable from one person to another….

Smoking THC, the THC is rapidly absorbed into the blood stream and redistributed with a considerable amount of it destroyed by combustion. Peak plasma levels are achieved at the very end of smoking and decline rapidly over 30 minutes, as if it were given intravenously, whereas, if taken by mouth, it’s a slow and doesn’t reach very high peaks and takes a long time to disappear.

The amount of THC one is exposed to might be the same, but certainly the effects are much different. In patients who say, ‘I can control the onset and the duration much easier if I smoke than if I swallow it’ are telling us just what we know from the pharmaecopia.”
(5/17/99) Donald Abrams

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Robert Gorter, M.D., Ph.D., stated in an October 1998 interview with AIDS Treatment News:

“My patients who had experience with both cannabis and Marinol almost always preferred cannabis, because Marinol had more side effects, including headaches and a hung-over feeling.”
(10/98) Robert Gorter

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Congressional Representative Nancy Pelosi, said in her official “Statement in Support of Hinchey Amendment to Allow the Use of Marijuana for Medicinal Purposes” to the U.S. House of Representatives on July 18, 2001:

“Mr. Chairman, opponents of medical marijuana argue there are other ways to ingest the active ingredient in marijuana, including the use of synthetic THC [Marinol]. However, we know that the drug containing THC does not work for all people.”
[Click here for full statement.]
(7/18/01) Nancy Pelosi

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Jerome Kassirer, M.D., former Managing Editor of the New England Journal of Medicine wrote about the usefulness of marijuana relative to Marinol in the journal’s January 1997 editorial:

“Paradoxically, dronabinol [Marinol], a drug that contains one of the active ingredients in marijuana (tetra-hydrocannabinol), has been available by prescription for more than a decade. But it is difficult to titrate the therapeutic dose of this drug, and it is not widely prescribed.

By contrast, smoking marijuana produces a rapid increase in the blood level of the active ingredients and is thus more likely to be therapeutic. Needless to say, new drugs such as those that inhibit the nausea associated with chemotherapy may well be more beneficial than smoking marijuana, but their comparative efficacy has never been studied.”
(1/30/97) Jerome Kassirer