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 at (202) 483-5500.