Pubdate: Wed, 23 Feb 2011
Source: AlterNet (US Web)
Copyright: 2011 Independent Media Institute
Author: Paul Armentano
Note: Paul Armentano is the deputy director of NORML (the National 
Organization for the Reform of Marijuana Laws), and is the co-author 
of the book Marijuana Is Safer: So Why Are We Driving People to Drink 
(2009, Chelsea Green).


But Your Dime Bag Would Still Send You to Jail

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.

Rescheduling 'Dronabinol'

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."

Who Stands to Gain?

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 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 DEA rejected 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.
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MAP posted-by: Richard Lake