October 7, 1999
FDA Approves Marijuana Study On Migraines, Final Approval Awaits NIDA Review
1999, Missoula, MT: The Food and Drug Administration has granted
approval to Ethan Russo, MD, a Montana neurologist, to study the effects of
smoked marijuana as compared to oral dronabinol (Marinol(R)) and injected
sumatriptan (Imitrex(R)) in the treatment of migraine headaches.
Russo will enroll 40 patients with severe migraines, and employ a double-blind, double-dummy crossover design (neither the patients nor examiners will know whether they are employing real cannabis or THC-free cannabis or true dronabinol or a placebo).
The study still faces a roadblock in the National Institute on Drug Abuse (NIDA). NIDA, the only American supplier of research marijuana, has recently changed its policy and will only provide marijuana to researchers whose studies have gained FDA approval as well as a NIDA Public Health Service review.
"NIDA has added a new hoop through which cannabis researchers must jump," Russo said. "For any other substance, even cocaine or heroin, approval of an Investigative New Drug (IND) application by FDA allows the researcher to proceed directly to clinical trials. NIDA has thrown up a new and unnecessary barrier to this research."
If NIDA demands changes in the protocol, Russo would need to file another IND application with the FDA which would cause further delays. In the meantime, the delay hinders Russo's ability to raise funding from private sources for the projected $250,000 study.
"Ethan's chances of obtaining approval for his marijuana/migraine study from NIDA's Public Health Service review are very good, simply because NIDA needs to show that it isn't blocking research," said Rick Doblin, President of Multidisciplanary Association for Psychedelic Studies (MAPS). "For me the most intriguing question is not whether the protocol will be approved but what will NIDA charge for one pound of its low potency pot, which is all that Ethan needs for his study."
For more information, please contact Ethan Russo, MD at (406) 327-3372 or Rick Doblin, President of MAPS at (617) 484-8711.
Canadian Government Grants 14 More Patients The Right To Cultivate And Use Marijuana For Medical Purposes
1999, Ottawa, Ontario: Health Minister Allan Rock this week announced
that he has granted 14 more Canadians the right to cultivate and smoke marijuana
for medical purposes. In June, Rock allowed two AIDS patients the same
exemption from federal law.
"Fourteen more individuals will be exempted under Section 56 (of the drug law) so they can use marijuana for medical purposes because they're very sick or they're dying," Rock said. "They have satisfied us that they are legitimate cases."
None of the 100 applicants for the federal exemption have been fully rejected and officials say there may be more exemptions coming.
The Canadian government is now looking for an independent firm to cultivate marijuana for the patients who choose not to grow the cannabis on their own.
In August, Health Canada, Canada's health care bureaucracy, offered $7.5 million to the Medical Marijuana Research Project, a joint effort between the Medical Research Council of Canada and the therapeutic products program of Health Canada, over the next five years to evaluate the medical use of marijuana.
"Americans should ask their elected officials to adopt the same compassionate and pragmatic approach as the Canadian government," said Allen St. Pierre, NORML Foundation Executive Director.
For more information, please contact Allen St. Pierre, NORML Foundation Executive Director at (202) 483-8751.
Gov. Ventura Asks For Federal Cooperation For Industrial Hemp Production
1999, St. Paul, MN: Gov. Jesse Ventura (Reform) has asked President
Bill Clinton for federal cooperation in allowing farmers in Minnesota to grow
In July, legislation was approved by the MN legislature mandating state officials to seek federal permission to cultivate hemp. The U.S. Drug Enforcement Agency recently informed Minnesota officials that the state cannot apply for a blanket permit and that farmers themselves must apply to the DEA and the Minnesota Board of Pharmacy to grow experimental plots of industrial hemp.
"Our neighbors in Canada are ahead of us in the effort to establish industrial hemp as an alternative crop for farmers," Ventura wrote to President Clinton. "They have already given their producers the opportunity to grow industrial hemp, and I understand their process is working well. Given the success we have seen in Canada and the continuing economic challenges Minnesota farmers face, I am anxious to move forward on the opportunity to grow experimental and demonstration plots of industrial hemp."
Ventura has called for a seminar in November to instruct farmers on how to apply for the permits.
"Our producers are looking for economic alternatives, and government should not stand in their way," Ventura wrote to Clinton. "I hope that by working together in a fair a rational manner, we can create a viable opportunity for industrial hemp production in Minnesota."
For more information, please contact Tom Dean, NORML Foundation Litigation Director at (202) 483-8751 or John Wodele of Governor Ventura's office at (651) 296-0001.