The End of Medical Marijuana

The End of Medical Marijuana

 

Be careful what you wish for.  National legalization of marijuana (either generally or for medical use) will mean the end of medical marijuana as it exists or is expected to be will disappear.  No dispensaries. No budtenders.  No shiny display cases of varietal selections.  They will be replaced by brown plastic vials with child-proof lids from a professional licensed pharmacy.  Medical marijuana will be absorbed into scientific, allopathic, single-molecule medicine, overseen by the FDA.

As legalized marijuana comes to the attention of practicing doctors, they will insist that its conforms to the norms of medical practice: known and reliable standardized doses, standard and controlled methods of administration, adequate knowledge of side effects, knowledge of interaction with other drugs, and reliable sources of supply among others.  Patients will have the same expectations and will also expect the convenience of using their normal pharmacies as a source of the drug.  As these expectations are met, the identity of the source – and even the names “marijuana” and “Cannabis” – will disappear.

Almost all effective botanicals have made the same journey from plant to pill, from foxglove and willow bark to digitalis and aspirin.  Even the “herbal remedies” in the health food store are sold as extracts or tinctures. Herbals in general have been replaced by single-molecule vitamins, either individually or in multi-vitamin combinations.  No whole plant appears on the shelves.  Cocaine and opium are examples of the process.

Cocaine first appeared as coca leaves expressed into tonics like Vin Mariani and Coca-Cola.  Then pure cocaine was extracted from the leaves and prepared in topical and injectable forms.  Soon derivative drugs like Novocain, procaine, and all of the other –caines used by doctors and dentists were developed.  Coca, in this country, remains only as a denatured flavoring in Coca-Cola.

Opium is the paradigmatic drug for this story of development.  It was used as a tincture or elixir until after the Civil War[1].  By that time morphine, one of the three alkaloids in opium, had become available both as pills and in injectable forms.  These were followed by heroin, a derivative of morphine.  Codeine, the second alkaloid, soon became the primary cough suppressant in medical use.  Thebaine, the third opium component, became the basis of the derivatives hydrocodone and oxycodone, today’s primary pain relievers sold under names including OxyCotin, Vicodin, and Percoset (in the last two, the opiate is combined with acetomenaphin).  To these were added synthetic opioids like Fentanyl and methadone.  Dosage forms were developed to include orally ingested pills (including time-release versions) and liquids, injectables, and transdermal patches.

Marijuana has started down a similar path.  For a century, from O’Shuaghnessy’s articles in the 1830s until the Marihuana Tax Act of 1937, it was used mainly as a tincture or elixir, much like laudanum or Vin Mariani.  The rebirth of medical marijuana in the 1970s was primarily through dried flowers ingested by smoking, with a few users incorporating it in edibles.  Many users have now switched from smoking to cold vaporizers, using either flowers or refined hash oils.  Two products have moved further in the progression.

Sativex is a whole-plant extract distributed through an inhaler designed for sub-lingual absorption.  It has gained market acceptance by many users and has been approved by many national health agencies; and trials in preparation for approval by the FDA are underway.

Marinol is a synthetic THC in a sesame oil suspension for oral dosing.  It has approved FDA labeling, but it has never lived down its origin as a DEA creation designed to supplant medical marijuana.  Marinol has two medical problems that have prevented wider use.  First, it was based on older, now outdated science.  When it was developed THC was thought to be “the” active ingredient in marijuana; since then CBD and other cannabinoids have been shown to be more responsible for many of the effects attributed to marijuana.  This realization will probably shape much of the new research.  Second, Marinol is an oral dosage primarily for nausea – not the most promising combination.

Sativex took a different approach.  It is a whole-plant extract packaged in a metered inhaler for sublingual absorption.  It maintains quality control and measured doses by being licensed only for a single cultivar grown only in licensed greenhouses.

Marinol and Sativex suggest the routes for future developments.  First is the isolation of single-molecule drugs and their derivatives from the variety of cannabinoids, similar to the way morphine, codeine, and thebaine were developed from opium.  Second will be investigation of various means of administration: orally, by inhalation, sublingually, transdermally, topically, by injection, or even by suppository.

The main stumbling block on the road to modern medical products from marijuana is the requirement of FDA-approved labeling for distribution.  The research, testing, and application for a new drug product can cost up to a half-billion dollars and take over five years.  This massive investment in time and money is the major reason that pharmaceutical companies rarely apply for NDAs on anything other than new Molecules or delivery devices that they can patent, insuring themselves a monopoly market for the life of the patent.  Since the cannabinoid molecules are already known, private concerns are unlikely to pursue their approval.  Two routes might be possible.  Non-profit groups could combine with academic researchers, with the resultant patents and labeling licensed to manufacturers; or the federal government could impose a small tax (as little as a dime on ounce on general marijuana sales would probably be enough) to support research, testing, and FDA procedures, with the patents to be held by a public entity like NIM.

Whatever route is followed, scientific cannabinoids will soon replace medical marijuana.  Within a decade at most, patients will have three choices: buy their marijuana-based drugs through a pharmacy, grow their own, or, at least in the Southwest, find an isolated curendaro or herbario who will sell to them.

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[1] See my earlier postings “Did Everyone Use Opium?” and “Paregoric”.