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February 20, 1997
Doctors, Researchers Call For Clinical
Trials On Medical Marijuana
At National Conference; NORML Voices Concern Over Methodology Of Future Studies
February 20, 1997, Bethesda, MD:
Several prominent physicians called for clinical trials to
examine marijuana's therapeutic potential in the treatment of
serious illnesses such as spasticity disorders, AIDS wasting
syndrome, and nausea, during a two-day conference organized by
the National Institutes of Health (NIH). A panel of doctors
assembled by the agency will now debate the issue and recommend a
course of action within four weeks.
Although many speakers acknowledged prior scientific evidence demonstrating marijuana's medical utility, most saw a need for additional controlled studies. Panelists disagreed over the specific nature of future trials, and remained divided over what medical and safety standards should be applied to marijuana.
"Marijuana must be shown to not just be effective [as a medicine], but advantageous" over oral THC and conventional medications, explained Dr. Robert Temple of the Food and Drug Administration. Temple admitted that FDA Cosmetic Act does not require a drug to demonstrate "superiority" over all existing conventional medications before receiving federal approval, but assumed that the political climate surrounding marijuana mandates the drug to meet this higher standard. "I don't think the FDA will be the sole determinant" of marijuana's medical efficacy, he explained.
"Why do we need to [establish] superiority?" asked one panelist. "I thought we just needed to show it worked?"
NORML's Executive Director R. Keith Stroup, Esq. agreed. "While we are encouraged that researchers appear anxious to partake in specific, controlled studies to further examine marijuana's medical potential, we are concerned that marijuana will be held to a higher scientific standard than that applied to other medications or required by law," he said. "Political concerns, not questions regarding medical utility or safety, are preventing marijuana's approval as a legal medicine."
Panelists were also divided on whether peer-reviewed double blind, controlled studies could realistically be conducted on inhaled marijuana. For example, some researchers doubted that patients could be administered a placebo marijuana cigarette. Others questioned whether placebos were even necessary in Phase III human trials for marijuana.
"The NIDA conference raised more questions than answers," remarked NORML's Deputy Director Allen St. Pierre. "Let's hope that these latest calls for research are not used as stalling tactics by the federal government to keep patients suffering needlessly."
NORML, in conjunction with other national drug-reform groups, held a press conference during the event featuring presentations by both doctors and patients who advocate the use of medical marijuana. Advocates stated that enough evidence already exists to: 1) reclassify marijuana as a "Schedule II" prescription drug for specific illnesses, and 2) begin wide-scale, Phase III human trials on marijuana to answer remaining questions about its medical value for certain illnesses.
"It is clear that NIDA has blocked FDA-approved medical marijuana research in the past," said St. Pierre. "With increased national interest on this issue and public scrutiny, we hope that NIDA will finally be compelled to supply the marijuana necessary to complete the clinical trials demanded by the public, seriously ill patients, and the medical community."
For more information, please contact Allen St. Pierre or Paul Armentano of NORML @ (202) 483-5500.
Charges Dismissed Against Key West Cannabis Buyers' Club
February 19, 1997, Key West, FL:
Charges were dismissed against the proprietor and one member of a
Key West club that distributed medical marijuana to seriously ill
patients who possessed a physician's recommendation. The
motions were held at the Monroe County Courthouse and the entire
process took only half an hour.
The Key West club, known locally as the Medical Cannabis Advocates of Key West (MCA), served approximately 90 patients and operated openly in an office directly across from the county courthouse and sheriff's station for 14 months before being raided by Special Operations detectives this past August. Club owner Zvi Baranoff and member Jamie Levario, who is HIV positive, were charged with second-degree felony possession and distribution of marijuana.
NORML Legal Committee member Norman Kent, Esq. of Fort Lauderdale, represented the defendants and applauded the decision. "It's hard to ask for much more," he said. "From a personal standpoint, it's a complete triumph."
"The state is recognizing that marijuana is medicine," explained Baranoff, who was given a six-month pre-trial intervention. "I'm really proud to help people get their medicine."
Kent said Levario will now sue the federal government. "The next step is to make Jaime a plaintiff in a civil suit ... to allow [him] the use of medicinal pot," Kent explained. Kent was victorious in a similar suit in 1988 that affirmed glaucoma patient Elvy Musikka's right to use marijuana as a medicine. Musikka was later accepted into a federal program that currently provides marijuana as a medicine to eight patients.
Joe Hart, current director of the MCA, told the Key West Citizen that the court ruling means the club is back in business. However, he said that the club intends to keep a lower profile than in the past.
For more information, please contact Attorney Norm Kent @ (954) 763-1900
or Zvi Baranoff of the MCA @ (305) 293-7067.
Virginia Votes To Maintain Marijuana Prescription Law
February 17, 1997, Richmond, VA:
Legislation to repeal an 18 year-old state law permitting
physicians to prescribe marijuana for patients suffering from
cancer or glaucoma, was voted down by a Virginia Senate committee
by a 9-6 vote.
The vote signaled a major victory for medical marijuana proponents and was a significant blow to the Clinton administration, who were reportedly backing the bill. "All of the professionals and people in the know told me that this bill was going to pass no matter what," said Virginia activist Lennice Werth, who lobbied against the bill. "What really stopped this bill was the power of the people."
Testimony in favor of keeping Virginia's progressive medical marijuana law was provided by physicians William Regelson of the Medical College of Virginia and NORML Board Member John Morgan of City University of New York (CUNY) Medical School, as well as patients. Regelson, who conducted government-approved research in the 1970s on the benefit of THC in cancer patients, told the Senate Education and Health Committee that his studies demonstrated that marijuana is "superior as a medicine" and better than synthetic THC.
Dr. Billy Martin, a Virginia Commonwealth University pharmacology professor who testified both against and in favor of the bill, advised delaying action on the measure until future scientific studies are conducted.
"The purpose of putting this on the books was to be ready if federal policy changed," agreed Sen. Richard Saslaw (D-Fairfax County), who noted that pending federal studies may encourage the federal government to reschedule marijuana.
Although Virginia's law does not provide for legal access to the drug because it is in "positive conflict" with federal marijuana prohibition, the state's recognition of marijuana's therapeutic value does help patients suffering from serious illnesses a stronger legal defense against marijuana possession charges.
For more information, please call Lennice Werth @ (804) 645-8816 or Allen St. Pierre of NORML @ (202) 483-5500.
MORE THAN 10 MILLION MARIJUANA ARRESTS SINCE 1965 . . . ANOTHER EVERY 54 SECONDS!