Two Days After The Medical
Marijuana Initiatives
The DEA Proposes Making Marinol A Schedule III Drug!! "Like Codeine With
Tylenol."
More Like Cynicism With Desperation
(Marijuananews note: Whew! I have long
maintained that Marinol is a political -- not a pharmaceutical -- product. This press
release proves it. Unimed itself makes the connection between the elections and the change
in scheduling. When this goes through, THC will be on Schedule III, while the herb on
which it is based will be on Schedule I. This is a bit much even for prohibitionist logic,
or Double Think. Do these people understand what they are doing? This is an absolute
capitulation of the last arguments for opposing medical marijuana. Perhaps this move is
the only way that they can think of to stall. Let them eat Marinol!) See
Synthetic THC Fails
To Provide Relief For Some Patients, New NORML Report Finds
and several important links
November 5, 1998
Company Press Release
Drug Enforcement Administration Proposes Reclassifying Unimeds
Synthetic THC Compound, Marinol, Two Days after Marijuana Referendums Pass
Ruling Would Provide Increased Patient Access to Marinol
BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Nov. 5 1998-- The Drug Enforcement
Administration (DEA) today issued a "Notice of Proposed Rulemaking" in which the
DEA is proposing to reclassify Marinol® (dronabinol) from Schedule II to Schedule III, a
ruling that would provide increased patient access to this FDA-approved synthetic THC
compound. THC is an active ingredient in marijuana. This proposed ruling comes on the
heels of voter-approved referendums in which residents of Arizona, Washington, Colorado,
Alaska, Nevada, Oregon and the District of Columbia supported measures that endorse the
use of medical marijuana.
(Marijuananews note: Unimed even uses the D.C. exit poll results
paid for by the medical marijuana movement!!!)
Marinol, manufactured by Unimed Pharmaceuticals (NASDAQ: UMED), is an oral medication
that the Food and Drug Administration (FDA) has approved for patients requiring appetite
stimulation and for patients undergoing chemotherapy that causes them to become nauseated.
Marinol also is being tested to assess its positive
effects on behavior in people diagnosed with Alzheimers disease and other dementias.
Schedule II drugs are those that are recognized to have medical indications, but have a
high potential for abuse (examples include morphine, cocaine, methadone and
methamphetamine).
Schedule III drugs have accepted medical uses and a
lesser potential for abuse (examples of drugs in this class include codeine with aspirin
or codeine with Tylenol®).
See
Lethal
Dose Of Cynicism From Makers Of Tylenol Poll On Aspirin Dangers Context Of Medical
Marijuana Debate
and important links
The DEA consulted extensively with the FDA before making this recommendation. A
study presented earlier this year at the College of Problems of Drug Dependencys
Annual Meeting showed that because Marinol has a gradual onset of action, it has a very
low potential for abuse.
The study also found that based on information gathered from law
enforcement officials in major cities across the U.S., there is no street market for
Marinol, and no evidence of any diversion of Marinol for sales as a street drug.
See
No Evidence That
THC Is Addictive Says Maker of Marinol After 9 Month Study Including Law Enforcement
"Adoption of the DEA proposal would represent a real pharmacoeconomic benefit to
both patients and to the healthcare system as a whole by reducing the number of costly
office visits by patients for whom Marinol is a medical necessity," said Ronald
Goode, Ph.D., president and CEO, Unimed Pharmaceuticals. "Furthermore,
because the proposed change would allow prescriptions for Marinol to be refilled up to
three times per prescription, patient convenience would be greatly enhanced."
The public has until December 7, 1998 to file comments, objections and requests for
a hearing on the proposed reclassification. The DEA will then rule on the proposed
reclassification.
Unimed is an emerging, Chicago-area pharmaceutical company that develops and markets
life-enhancing pharmaceutical products to address unmet medical needs in patients with
chronic conditions. The company focuses on drugs that have multiple indications and fall
within the areas of endocrinology, urology, HIV and other infectious diseases, hematology
and oncology. Unimed currently markets Marinol® as an appetite stimulant for people
living with HIV disease and as an antiemetic for people with cancer, Anadrol®-50
(oxymetholone) for the treatment of various anemias, and Maxaquin® (lomefloxacin HCl) for
both complicated and uncomplicated urinary tract infections.