(from the NORML Foundation, http://www.norml.org)
May 25, 1999, Washington, DC: Department of Health and Human Services officials announced new regulations Friday that may allow researchers access to medical marijuana for non-federally funded research. The policy change, scheduled to take effect on December 1, 1999, adopts recommendations of a 1997 National Institutes of Health (NIH) panel that urged officials to supply medical marijuana for non-NIH funded research.
"This is a step in the right direction," NORML Executive Director R. Keith Stroup, Esq. said. "But it is also further evidence that the wheels of change grind exceedingly slowly for medical marijuana reform." Health officials said that the new policy will facilitate medical marijuana clinical trials. "The goal of this program must be to determine whether cannabinoid components of marijuana administered through an alternative delivery system can meet the standards enumerated under the federal Food, Drug, and Cosmetic Act for commercial marketing of a medical product," the guidelines state.
Present NIH policy allows only those funded by the agency to use marijuana for research purposes. Under the new guidelines, non-NIH funded researchers must still submit their protocol to institutional peer review, secure a DEA registration to conduct marijuana research, reimburse the National Institute on Drug Abuse (NIDA) for the cost of the marijuana, and gain NIH approval for their study. Researchers who wish to conduct human trials must also proceed through the FDA process for filing an Investigational New Drug (IND) application. Stroup cautioned that the new policy offers little hope for individual patients wishing to gain legal access to the government's supply of medical marijuana. "Despite recommendations from the Institute of Medicine to allow single patient medical marijuana trials, the NIH guidelines rebuff any efforts to allow individual patients access to the drug," he said. The regulations stipulate that "single-patient requests for marijuana... would not... be supported under this program."
In March, the IOM advised the government to treat medical marijuana patients with chronic conditions as "n-of-1 clinical trials, in which patients are fully informed of their status as experimental subjects... and in which their condition is closely monitored a documented under medical supervision." "Federal officials are selectively implementing those recommendations from the IOM and NIH that pose little threat to medical marijuana prohibition, while ignoring any findings that challenge current federal policy," Stroup concluded.
|Issue #92, 5/28/99 Thanks, and Another Special Offer Through June 30 | Medical Marijuana Activist Convicted in Federal Court: Jury Not Allowed to Hear Evidence of Medicinal Use | Four Guards Charged in Beating Death of Nassau County Inmate | Senate Juvenile Justice Bill Passes in Wake of Colorado School Shooting, Would Dramatically Increase Surveillance and Drug Testing | New York Assembly Speaker Says No to Rockefeller Drug Law Reform...Or Does He? | Policy Change May Allow for Non-Government Funded Medical Marijuana Research | Conviction of Juror in Nullification Case Overturned | New York: No Rockefeller Reform This Year, Presentations in Westchester Area by Reconsider | Editorial: Growing Pains||
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