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Marinol

Marinol, a registered trademark of Unimed Pharmaceuticals, Inc. is the commercial name for a product containing dronabinol, which is synthetic Δ⁹-tetrahydrocannabinol. more...

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Δ⁹-THC is a naturally occurring component of marijuana.

Marinol is the only FDA-approved cannabinoid and is prescribed as an appetite stimulant, primarily for AIDS and chemotherapy patients. Compare Sativex, a mouth spray for neuropathic pain of multiple sclerosis sufferers approved for use in Canada.

Many users complain that not only is the cost of Marinol greater than the cost of the amount of marijuana needed to produce the same effect, but it is also lacking in many of the properties of the whole plant, which contains hundreds of different cannabinoids. However, Marinol is available for free to those who can demonstrate their financial need to Roxane and Unimed Pharmaceuticals. In addition, it takes over an hour for Marinol to reach full effect, but its duration is longer and it is available in controlled dosages, avoiding the uncontrolled strengths that occur when smoking marijuana. It is difficult to maintain an exact level of effect (which is important to most medical users), as well as making its use difficult for people suffering from nausea and vomiting, since they often expel the medication before it takes effect.

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 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 Marinol™, a Schedule III drug. There are no grounds to schedule cannabis in a more restrictive schedule than Marinol™".

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A case for mercy
From National Review, 7/4/05

MANY patients suffering from terrible diseases find that smoking marijuana provides them relief from their symptoms or from the side-effects of their treatment. The chief response to their plea for compassion, on the part of the drug warriors, has been to insist that the Food and Drug Administration has not determined that marijuana is a safe medicine, and that other palliatives are available. It is a despicable response coming from people who have never allowed researchers the freedom to conduct the detailed clinical trials that the FDA would need to verify safety. A cancer patient seeking a break from overwhelming nausea will hardly be consoled by the knowledge that the government is protecting him from the remote risks that pain relief might bring. Whatever the drug czar thinks, some of these patients say that marijuana substitutes do not work as well as marijuana in relieving their pain. Swallowing Marinol takes longer to work, is more expensive, and has more adverse side effects than smoking marijuana. Should we be happy that with marinol there is less risk that cancer patients will experience some illicit pleasure?

Several states have rejected this perverse logic in referenda. The Supreme Court has just ruled, however, that the federal government may continue to prohibit the medicinal use of marijuana. Whether marijuana-using patients in California will face the threat of jail time thus depends not on their state's laws but on the discretion of federal prosecutors.

Justice Scalia makes the best argument for the constitutionality of a federal ban. The federal government, he writes, has the authority under the commerce clause to prohibit interstate commerce in marijuana. It therefore has the authority under the necessary-and-proper clause to take whatever steps are required to make that prohibition effective. The personal use of marijuana may not be commerce. But if Congress has concluded that the personal use must be banned for a ban on interstate commerce to be effective, Scalia reasons, the Constitution allows it to act on that conclusion.

Even as a legal argument, Scalia's opinion is not entirely persuasive. If he is right, then the Prohibitionists were wrong to think they needed to enact the Eighteenth Amendment. They could have passed a statute banning alcohol possession and consumption, on the theory that it was necessary to ban the interstate commerce in alcohol.

But even if Scalia is ultimately correct to think that the courts should not second-guess Congress here, his legal argument sheds light on the folly of the federal policy. Allowing sick people to use marijuana probably would marginally reduce the effectiveness of federal anti-drug laws. But it's not as though those laws would be enforced perfectly in the absence of exemptions for medical marijuana. Other factors undermine the law's effectiveness far more: human nature; the economics of prohibition; the exemption from the law we give, in practice, to most casual drug users. Can it really be maintained that the drug laws are working so well for the nation that we cannot risk reducing their efficacy by giving cancer patients a break? And if not, shouldn't Congress amend the law?

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