As you may have read recently, the DEA recently
proposed rescheduling Marinol ®, a brand-name preparation of THC. Since this could
affect the petition
filed by HIGH TIMES magazine and Virginia public-policy consultant Jon Gettman to
reschedule marijuana, the natural source of THC, HIGH TIMES has asked the government to
make this process more public.
We have also provided the formal request to the DEA to hold the public hearings.
Hearings Requested on Marinol ® Rescheduling
For Immediate Release:
December 8, 1998
HIGH TIMES magazine and Jon Gettman have asked the Drug Enforcement Administration
(DEA) to delay the proposed rescheduling of Marinol ®--a pharmaceutical product
containing THC, an active ingredient of marijuana--until after public hearings on the
drug's relationship with marijuana and industrial hemp.
Marinol, aka "dronabinol," is a proprietary product of Unimed Pharmaceuticals
Inc. of Buffalo Grove, IL. Unimed currently markets it as an appetite stimulant for people
living with HIV and as an anti-emetic for people with cancer. The company has also been
granted a patent by the US Patent Office based on recent evidence that Marinol's novel
synthetic-THC composition may be effective in reducing agitated behavior and negative mood
in people suffering from dementia. Unimed recently reported a 73 percent increase in
revenue for the first nine months of 1998--rising from $6.7 million to $11.5 million over
the same period in 1997--in part due to increasing demand for Marinol.
HIGH TIMES and Gettman are co-petitioners in another action
to reschedule marijuana, THC, and Marinol. A hearing has been requested now to determine
if the DEA's proposal to reschedule Marinol satisfies legal requirements for such a move,
and whether it is prejudicial to the Gettman/HIGH TIMES petition.
Marinol is presently a Schedule II drug. The DEA has proposed downscheduling it into
Schedule III. Schedule III drugs must have a lower potential for abuse than drugs in
Schedules I and II, such as marijuana and THC. However, "dronabinol"--the
chemical name for Marinol's active ingredient--is THC. The manufacturer has only changed
the chemical's name.
According to Gettman: "Changing the name of a chemical does not alter its effect
on public health. Would DDT by any other name be any more sweet? While sympathetic to the
need to make cannabinoid drugs more accessible to the public, I believe the remedy is to
downschedule all cannabinoids rather than play word games that set potentially dangerous
legal precedents."
Public hearings have been requested by HIGH TIMES and Gettman in order to present
testimony and cross-examine government witnesses on several issues raised in the comments
filed with the DEA on December 7, 1998. These issues include patient testimony on the
abuse potential and effects of Marinol compared with marijuana, scientific information on
their pharmacological profiles, and DEA policy statements. HIGH TIMES and Gettman are
represented by the law offices of Michael Kennedy in New York City.
HIGH TIMES and Gettman have argued that the rescheduling of Marinol is inconsistent
with DEA policy statements that trace amounts of THC in industrial hemp are such a danger
to public health as to justify a ban on hemp cultivation in the United States. The
proposed rescheduling of Marinol could eventually result in cultivation of cannabis as a
natural source for its active ingredient; cultivation research on this pharmaceutical
by-product would be subject to less strict regulation than cultivation research on
industrial by-products such as fiber, fuel, woody hurds, and hempseed derivatives without
any drug content.
Before they referred the Marinol petition to the Department of Health and Human
Services (HHS) for review, the DEA made a determination that placing Marinol in Schedule
III would not violate international treaties. However, HIGH TIMES and Gettman note the US
Court of Appeals has ruled that the DEA may not make such advance determinations on treaty
obligations; indeed, the findings of an HHS review may require the US to seek the
amendment of international treaties.
According to Gettman, "The DEA is entitled to make interpretive rulings; we just
believe they should be consistent with the controlling legal authority of the US Court of
Appeals. This particular ruling may be very important when it comes to considering the
rescheduling of marijuana. We want an opportunity to subject this ruling to judicial
review now, lest it have an unnecessarily adverse effect on our broader petition."
The Code of Federal Regulations requires the DEA to provide a hearing if requested by
any interested party, defined as one being adversely affected by the rescheduling
proposal. If a hearing is granted, a notice will be published in the Federal Register to
provide an opportunity for public participation.
Special to HT News