We should be very wary about the DEA allowing regulation and marketing of pharmaceutical products containing plant-derived THC.
“[M]arijuana has no scientifically proven medical value.” So stated the United States Drug Enforcement Administration (DEA) on page six of a July 2010 agency white paper, titled “DEA Position on Marijuana.”
Yet only four months after the agency committed its “no medical pot” stance to print, it announced its intent to allow for the regulation and marketing of pharmaceutical products containing plant-derived THC — the primary psychoactive ingredient in cannabis.
But don’t for a second believe the DEA has experienced a sudden change of heart regarding patients’ use of the marijuana plant — use that is now legal under state law in 15 states and the District of Columbia (although recently approved laws in Arizona, New Jersey, and Washington, DC still await implementation). Despite growing public support for medical marijuana legalization, America’s top anti-drug agency remains resolute that these hundreds of thousands of medi-pot patients are no more than common criminals, and their herbal remedy of choice is nothing more than the “Devil’s weed.”
It’s not public pressure that’s motivating the agency to consider rescheduling an organic cannabinoid for the first time since the creation of the U.S. Controlled Substances Act of 1970. (Under this act, all prescription drugs are classified as schedule II, III, IV, or IV controlled substances, while all illicit substances are categorized as schedule I drugs.) And it’s not the recent publication of a series of FDA-approved “gold standard” clinical trials affirming the plant’s safety and efficacy that’s prompting the agency into action. (The DEA has so far refused to acknowledge these studies even exist.) Rather, the agency’s sudden call for regulatory change is inspired by far more politically influential forces: The DEA is responding to the demands of Big Pharma.
The DEA initially made public its desire to recognize the use of marijuana plant-derived pharmaceuticals in a “notice of proposed rulemaking,” which appeared in the November 1, 2010 edition of the Federal Register.
The agency posted, “This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to modify the listing of the Marinol formulation in schedule III so that certain generic drug products are also included in that listing.” (Marinol is the brand name for dronabinol, a prescription pill approved by the FDA in the mid-’80s that consists of synthetic THC in sesame oil and is encapsulated in a soft gelatin capsule.)
Specifically, the DEA’s intent is to expand the federal government’s schedule III listing to include pharmaceutical products containing naturally derived formations of THC while simultaneously maintain existing criminal prohibitions on the plant itself. “The DEA has received four petitions from companies that have products that are currently the subject of ANDAs (abbreviated new drug applications) under review by the FDA,” its post reads. “While the petitioners cite that their generic products are bioequivalent to Marinol, their products do not meet schedule III current definition provided above. Therefore, these firms have requested that 21 CFR 1308.13(g)(1) be expanded to include naturally derived or synthetically produced dronabinol.”
By contrast, any use of the plant or plant-derived cannabinoids by the public will remain criminally prohibited. “THC, natural or synthetic, [will] remain a schedule I controlled substance,” DEA spokesman Rusty Payne affirmed to the Washington, DC publication, The Daily Caller, in February. “Under the proposed rule, in those instances in the future where FDA might approve a generic version of Marinol, that version of the drug will be in the same schedule as the brand name version of the drug, regardless of whether the THC used in the generic version was synthesized by man or derived from the cannabis plant.”
Of the four petitioners cited in the DEA’s notice of intent, two are companies seeking to market synthesized THC pharmaceuticals similar to Marinol. According to a March 17, 2010 letter to the DEA from Howard Koh, assistant secretary for health at the U.S. Department of Health and Human Services, representatives from Barr Laboratories (now Teva Pharmaceuticals, the largest generic drug manufacturer in the world) and Insys Therapeutics (a biotech specializing in anti-emetic drugs) both have synthetic-THC products in their pipeline. “In both of these petitions, the Petitioners assert that their generic drug products have a similar chemical properties, composition, and therapeutic value as those of Marinol,” the letter states. (In 2008, Par Pharmaceuticals of New Jersey became the first company to receive FDA approval for a generic version of Marinol.)
A third petitioner — the Canadian-based Cobalt Pharmaceutical — is seeking to bring an organic THC based drug to market. “Cobalt is developing a generic drug product that references Marinol [and is] requesting that the product be placed into schedule III,” states a June 1, 2010 letter from Koh. “This drug product contains naturally-derived dronabinol dissolved in sesame seed oil and encapsulated in a gelatin capsule at three dosage strengths (2.5 mg, 5mg, and 10mg per dosage unit.)” If successful, Cobalt would become the first company since the passage of the federal Marihuana Tax Act in 1937 to legally market a prescription drug in the United States containing natural marijuana plant compounds.
Though not named as a specific petitioner, another major pharmaceutical company that would stand to benefit financially from the legalization of plant-derived THC is the former Mallincrodkt Baker (now Avantor), a worldwide producer of biotherapeutic agents. Testifying under oath in the 2005 administrative legal challenge Craker v. DEA, federally authorized pot farmer Mahmoud ElSohly revealed that he possessed a contract with the Big Pharma firm to provide it with organic THC extracts. Mallincrodkt desired the extracts, Elsohly explained, because they — like Cobalt — wished to bring a Marinol-like pill comprising of actual THC to the U.S. market.
Another member of Big Pharma that stands to benefit from the DEA’s pending change is Bionorica Worldwide, a German-based company founded in 1933 that specializes in manufacturing plant-derived pharmaceutical products. In 2009, a company representative affirmed in a story on AlterNet.org that Bionorica was seeking U.S. FDA approval for both a plant-derived version of Marinol as well as a sublingual THC spray.
The United Kingdom’s GW Pharmaceuticals would also no doubt welcome the DEA’s call for rescheduling. GW Pharma is the manufacturer of Sativex — a oral spray containing plant-derived extracts of the cannabinoids THC and CBD (cannabidiol). The spray is presently available in Canada and the United Kingdom, but could not be legally marketed in the U.S., even with FDA approval, until its natural cannabinoid compounds are reclassified under federal law.
Ironically, the federal government itself also stands to benefit financially from rescheduling. After all, under the U.S. government’s existing monopoly on marijuana production — a monopoly that was upheld in 2009 when the DEArejected its own administrative law judge’s decision in Craker — no domestic-based pharmaceutical company wishing to develop products derived from organic THC could legally acquire the necessary extracts without first contracting to purchase those compounds from the federal government’s sole pot farm, located at the University of Mississippi at Oxford and headed by ElSohly.
Who Stands To Lose? You Do
While the DEA’s forthcoming regulatory change promises to stimulate the advent of legally available, natural THC therapeutic products — and will also likely encourage the development of less expensive yet similarly synthetic alternatives to Marinol — the change will offer no legal relief for those hundreds of thousands of Americans who believe that therapeutic relief is best obtained by use of the whole plant itself. Rather the DEA appears content to try to walk a political and semantic tightrope that alleges: “pot is bad,” but “pot-derived pharmaceuticals are good.”
It’s a position that would appear to be scientifically untenable, and one that will do little to bridge the existing gap between the public’s demand for a rational medical marijuana policy and the federal government’s desire to maintain a criminal prohibition that lacks any rational basis whatsoever.