HIGHTIMES

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HIGH TIMES Responds To The DEA's Proposal To Reschedule Marinol
FILED 12/08/98

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.

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