cannabisnews.com: FDA-Approved Marijuana Study At Last Hurdle





FDA-Approved Marijuana Study At Last Hurdle
Posted by FoM on October 06, 1999 at 17:29:08 PT
Source: Reuters Health
The Food and Drug Administration (FDA) has recently granted approval to Dr. Ethan Russo, of Missoula, Montana, to begin a study of the medicinal effects of marijuana in patients with migraine. However, the study has one last hurdle -- it must also be approved by the National Institute on Drug Abuse (NIDA), which will supply the marijuana for the study.
The internal Public Health Service review required by the NIDA "applies to cannabis and no other substances," Russo told Reuters Health.Prior to instituting this review process last May, the NIDA required researchers to get approval and funding from the National Institutes of Health before initiating any study of medicinal marijuana.As approved by the FDA, Russo's study will enroll 40 patients with severe migraine and compare the effects of smoked marijuana and oral dronabinol (a synthetic version of THC, the principle psychoactive component of marijuana), with injections of sumatriptan, an approved drug for migraines.Patients will be randomly assigned to one of two groups for 3 months then crossed-over to the other part of the study, Russo said in an interview. Patients in one group will receive either sumatriptan or marijuana plus oral ("dummy") placebo at the onset of headache and patients in the other group will receive either sumatriptan or THC-devoid marijuana plus dronabinol.Russo hopes to start the study this year. If he does not receive approval to use NIDA-supplied marijuana for the study, Russo may attempt to obtain the drug from a foreign source, British-based GW Pharmaceuticals. However, this would require "another whole process" to gain permission to import marijuana, he said.But even if the study does gain the approval of NIDA, there are other issues to consider, Russo told Reuters Health. The marijuana supplied by NIDA is generally three to four times less potent than "true medical grade marijuana," which can have important implications for both efficacy and safety."Like with any drug, if the potency isn't there, the clinical response may be suboptimal or may not be there at all," Russo said. Moreover, the lower the potency of the marijuana, the more times patients will need to inhale before they feel an effect, increasing the risk of respiratory side effects.And still another issue stands in the way of the trial -- funding. According to regulations, the $250,000 study will need to be funded entirely through private grants. Although Russo and colleagues cannot begin to raise these funds until the approval process is complete, they have "identified a number of people who we hope will be interested in funding the research," Russo told Reuters Health.Reuters HealthUpdated 7:06 PM ET October 6, 1999Copyright © 1995-1999 Excite Inc.Related Links:MAPShttp://www.maps.org/National Institute on Drug Abusehttp://www.nida.nih.gov/DrugAbuse.html Marijuana & The Migraine - Research - 10/02/99http://www.cannabisnews.com/news/thread3117.shtmlMedical Marijuana Research http://www.maps.org/mmj/index.html 
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Comment #4 posted by Thomas on October 07, 1999 at 08:39:54 PT
Sorry But I don't Know
Sorry FoM, but I don't know how you can get the transcript as I have never done this either. I just assumed it may be available like so many other news talk shows. Perhaps they will repeat it.
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Comment #3 posted by STAN DUP on October 06, 1999 at 20:02:25 PT:
STUDY #3001
All this hassle and money over some grass. It boggles even the simple mind. I realize we have to go thru all of this,but!!! The FDA has to aprove the doctor, who must be approved by NIDA, and NIDA says they have to be approved by the NIH. For 40 people to compare natural(GEE,i wonder which one the human body prefer's,duh...) vs. synthetic(which you have to hit up,ha..). And if they can't get any grass from NIDA, they have to get it from london (should be a real nitemare getting that through customs). And if NIDA has only the usual bunk weed they have to try to score "true medical grade" which is probably good common street grass that they will end up having to buy around the corner. And on top of all this it's going to cost {{{{$250,000.00}}}}. Hell, you can buy 5,000 bags of good skunk with that much money! And why do they have to get private money? They can use part of what the govt. is already wasting, you know, the 18 billion we pay for the WAR on marijuana.  All of this to find out what we already know!                           STAN DUP
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Comment #2 posted by FoM on October 06, 1999 at 19:58:20 PT:
I Looked!
Thomas, I check on transcripts at Fox for Hannity and Colmes and you must order them. I never did that before. Do they post transcripts anywhere? Thanks! CNN & ABC do!Peace, FoM!
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Comment #1 posted by Thomas on October 06, 1999 at 19:40:40 PT
Off The Subject
I don't have the link, but if you can get The transcript from the Hannity and Colmes news show on Fox News Cable from October 6, you will surely enjoy it. A woman from the Libertarian party just hammered on this republican congressman (I forget his name) who completely stumbled through the prohibitionist line. It is a joy to see some debating on the tube.
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