What is dronabinol?
A pharmaceutical formulation of (−)-trans-Δ9-tetrahydrocannabinol, known by its INN dronabinol, is available by prescription in the U.S. and Canada under the brand name Marinol.
Dronabinol is used to treat nausea and vomiting caused by chemotherapy in people who have already taken other medications to treat this type of nausea and vomiting without good results. Dronabinol is also used to treat loss of appetite and weight loss in people who have acquired immunodeficiency syndrome (AIDS).
“Dronabinol is in a class of medications called cannabinoids. It works by affecting the area of the brain that controls nausea, vomiting, and appetite.” (NIH)
The Distinction Between Marinol, Dronabinol, and Delta-9-Tetrahydrocannabinol (THC) by Jon Gettman, Ph.D.
The Drug Enforcement Administration (DEA) provided the following explanation of the similarities and differences between Marinol, Dronabinol, and Delta-9-Tetrahydrocannabinol (THC) in 1999 and 2002 in correspondence related to the 1995 cannabis rescheduling petition.
In a letter to petitioners on June 28, 1999 the DEA provided the following clarification:
A prefatory note is warranted to clarify the distinction between “Marinol” and “dronabinol.” Although these terms are sometimes mistakenly used interchangeably, they have distinct meanings. Dronabinol is the United States Adopted Name for the substance (-)-[Delta-9]-(trans)-tetrahydrocannabinol (hereafter “(-)-Δ-9-(trans)-THC”, which is thought to be the primary psychoactive ingredient in marijuana. See 21 C.F.R. § 1308.12(f)(1). Marinol is the brand name of a product approved by the Food and Drug Administration (FDA) that contains synthetically manufactured dronabinol in sesame oil and encapsulated in a soft gelatin capsule. Id. Dronabinol is the active ingredient in Marinol. Dronabinol, in its pure form, is a Schedule I controlled substance since it is one of the tetrahydrocannabinols and it has no currently accepted medical use in treatment in the United States. See 21 U.S.C. § 812(b)(1); 21 C.F.R. §1308.11(d)(27). Marinol, in contrast, has an accepted medical use and is a Schedule II substance [editors note: Marinol has since been rescheduled to schedule III]. See 21 C.F.R. 1308.12(f)(1); 51 Fed. Reg. 17,476 (1986) (DEA final rule transferring Marinol from schedule I to schedule II following FDA approval of the drug for marketing). It was approved for marketing by the FDA in 1985 for the treatment of nausea and vomiting asociated with cancer chemotherapy. Id. In 1992, FDA expanded Marinol’s approved indications to include treatment of anorexia associated with weight loss in patients with AIDS. (1)
In additional correspondence on September 26, 2002 the DEA repeated this clarification and noted Marinol’s recent rescheduling as a schedule III drug::
In a letter dated June 28, 1999, the Administrtor of DEA clarified . . . the point that “dronabinol” os the United States Adopted Name for the substance (-)-Δ-9-(trans)-tetrahydrocannabinol (also designated (-)-[Delta-9]-(trans)-THC), which is generally accepted as the primary psychoactive ingredient in marijuana. See 21 C.F.R. § 1308.12(f)(1). Marinol is the brand name of a specific pharmaceutical product approved by the Food and Drug Administration (FDA) that contains synthetically manufactured dronabinol in sesame oil and encapsulated in a soft gelatin capsule. Id. Dronabinol is the active ingredient in Marinol. The specific product formulation along, Marinol (dronabinol in sesame oil and encapsulated in a soft gelatin capsule), remains in schedule III. See 64 FR, 35928, 21 C.F.R. § 1308.13 (g)(1). Dronabinol, in its pure form, is a Schedule I controlled substance since it is one of the tetrahydrocannabinols and it has no currently accepted medical use in the United States. See 21 U.S.C. § 812(b)(1); 21 C.F.R. §1308.11(d)(27). (2)
In plain English, the DEA explains that for regulatory purposes THC has been renamed dronabinol, and that it only has an accepted medical use when it is mixed with sesame oil and placed in a capsule. This semantic exercise allows the DEA to deny that THC has an accepted medical use in the United States. THC, according to DEA, is the same chemical as dronabinol, which has an accepted medical use when it is placed in a gelatin capsule and referred to as Marinol. Despite the fact that THC, dronabinol, and Marinol all refer to the same active ingredient, DEA insists that the name of THC be changed twice-over before it can be referred to as a drug with accepted medical use. While this is precisely correct in legal and regulatory contexts, DEA’s semantic exercise begs reference Shakespeare’s famous observation: “That which we call a rose, By any other name would smell as sweet.”
(1) Donnie Marshall, Deputy Administrator DEA, Letter to Simore Monesebian, July 28, 1999.
(2) John B. Brown, Deputy Administrator DEA Letter to Jon Gettman, September 26, 2002.
SO LET’S LOOK AT THE TIMELINE OF WHO (the responsible party for the scheduling of Dronabinol and THC)
Dronabinol included in Schedule I of the 1971 Convention on Psychotropic Substances
U.S. government requests UN Secretary General to transfer it from Schedule I to II
WHO 26th Expert Committee recommends transferring dronabinol to Schedule II
CND rejects in March the recommendation, fearing increase of abuse
WHO 27th Expert Committee again recommends in September de-scheduling to Schedule II, adding evidence of therapeutic usefulness and low risk of abuse
CND adopts recommendation and dronabinol is transferred to Schedule II
WHO 33rd Expert Committee meeting undertakes new critical review and recommends transfer to most lenient Schedule IV, requiring hardly any control measures
WHO recommendation is deliberately kept away from the CND through political interference in the procedure by UNODC under US pressure
WHO 34th Expert Committee meeting “updates” its previous review and now recommends transfer to Schedule III
CND decides not to vote on the new recommendation, instead requesting WHO to update the review when additional information becomes available
Lack of funding obstructs its functioning and only after six years the 35th WHO Expert Committee meets and decides there is not sufficient new evidence to merit another review
WHO communicates to the CND that in absence of relevant new evidence its recommendation to transfer dronabinol to Schedule III still stands
CND keeps it off the agenda and no vote takes place; minority discontent leads to the decision to put the issue of CND handling of WHO recommendations on the 2014 agenda
CND to be meeting for 2 additional days to review progress made in the implementation of Member States in The Political Declaration and Plan of Action on International Cooperation Towards an Integrated and Balanced Strategy to Counter the World Drug Problem
After the CND adoption in 1991 of the WHO recommendation to deschedule dronabinol from Schedule I to the less stringent Schedule II of the 1971 Convention, scientific research continued and in 2002, the WHO Expert Committee undertook another critical review, eventually concluding that: “The abuse liability of dronabinol is expected to remain very low so long as cannabis continues to be readily available. The Committee considered that the abuse liability of dronabinol does not constitute a substantial riskto public health and society. In accordance with the established scheduling criteria, the Committee considered that dronabinol should be rescheduled to Schedule IV of the 1971 Convention on Psychotropic Substances.”
But in its subsequent report the Committee reported “no further procedural steps were taken”, explaining that “the procedure was not finished and the Committee’s advice was not sent to the CND at that time”.
Preparations for a special 2003 CND session had started to raise some political tension related to the midterm review of the targets set at the 1998 UN General Assembly Special Session (UNGASS) on drugs towards “eliminating or significantly reducing the illicit cultivation of the coca bush, the cannabis plant and the opium poppy by the year 2008”.
Halfway through the decade, it was clear that the international community was not on track to achieve these lofty goals. The proposal to move dronabinol to the lightest existing control scheme under the UN conventions, added tensions to an already difficult political environment. Some states, notably the U.S., feared that tabling a WHO proposal saying that the main active ingredient of cannabis has valuable medical properties and consequently does not need to be strictly controlled might send “a wrong signal” at a moment when the effectiveness of the UN drug control strategy in general was being reviewed, and even challenged by others. If the WHO believed the main psychoactive ingredient of cannabis did not require strict UN control, why should cannabis or its resin require such control? What is more, if the treaty system was challenged in relation to the inclusion of cannabis, the substance representing the bulk of the illicit drugs market, would that not undermine the credibility of the UN drug control system as a whole?
Political pressure thus kept the issue off the CND agenda in 2003, but it reappeared a few years later when the WHO presented to the CND an “updated” recommendation to transfer it to Schedule III. The WHO stated: “Dronabinol has a low abuse risk because there is no cheap synthesis or isolation possible, so the substance is not an easy object for large profits in the world of illicit trade. It is mainly available in oily capsules, which make them less attractive for drug abusers. And we should also not forget that there is an alternative that is abundantly available almost everywhere and that is called cannabis.” Having reviewed all relevant information provided, the WHO concluded that it did not make sense to postpone the decision or to undertake yet another assessment, stressing its “recommendations are based on the principle that there should be evidence for scheduling”.
However, relaxing treaty controls on the main active compound of cannabis was still too politically controversial. As such, the WHO recommendation was not put to a vote, as procedurally required. Instead the CND decided to do precisely what the WHO had said would not make sense: to postpone a decision and ask for yet another assessment. The CND’s inability to deal with evidence-based recommendations conflicting with the drug control ideology of some of its dominant member states was again evident. These political tensions impeded the WHO’s access to necessary financial resources to exercise its treaty mandate, and the Expert Committee was unable to meet for six years following the 2006 meeting; another example of the WHO being sidelined within the internal UN debates.
When in 2012, the Expert Committee managed to organise its next meeting, it discussed whether it should revisit its recommendation on dronabinol. As the Committee was unaware of any new evidence likely to alter the scheduling recommendation made at its previous meeting, it affirmed “the decision to move dronabinol and its stereoisomers from Schedule II to Schedule III of the 1971 Convention should s t a n d ”.
At the following CND session in March 2013, however, procedural arguments were used to avoid any discussion of the issue. Calling for yet another assessment
would have made a mockery of the whole scheduling procedure as well as demonstrating once again the incapacity of the CND to deal with the underlying conflict between ideology and evidence. Discontent among some countries about this stalemate resulted in the decision to make the issue of scheduling procedures a special agenda item for the CND session in 2014.