Robert Celt
New Member
The federal government said recently that it is reviewing marijuana's status as a Schedule 1 drug under the Controlled Substances Act, a move that could loosen tight restrictions on cannabis research.
In a memo to U.S. lawmakers, the U.S. Drug Enforcement Agency said it is reviewing marijuana's current status and hopes to have a decision about potential rescheduling "in the first half of 2016."
Research into marijuana is complicated by the drug's longtime classification as a Schedule 1 drug. That category of drugs, which includes heroin, is defined as substances that have a "high potential for abuse" and "no currently accepted medical use."
The government allows research on cannabis, but the approval process is especially complicated and involves marijuana produced under a contract with the National Institute on Drug Abuse. The product is cultivated at a government-run facility based at the University of Mississippi.
Federal research proposals involving Schedule 1 drugs must undergo review by the National Institute on Drug Abuse, an agency focused on preventing drug abuse and addiction.
The Oregonian/OregonLive last week spoke with Dr. Colin Roberts, a pediatric neurologist and director of the Doernbecher Childhood Epilepsy Program at OHSU, about marijuana's potential change in status and what it would mean for researchers. Roberts' program is participating in several active clinical trials on pharmaceutical-grade cannabidiol produced by Insys, a pharmaceutical company.
Earlier this year, G.W. Pharma announced that an experimental drug made with pure cannabidiol, or CBD, was effective in reducing seizures related to Dravet syndrome, a debilitating form of epilepsy.
Roberts said the search is on for a new drug that could "help us crack the code" for epilepsy patients who don't respond to other treatments, which make up about one-third of people with the disease.
"Honestly I do not know if cannabis is that product, but we have to know first off: Is it safe? And then we have to know, really, does it work? And the reality is we don't have that data yet."
This interview has been edited for length and clarity.
What is involved if, say, an OHSU researcher wants to conduct research on cannabis currently?
Right now, for somebody like myself who is wanting to do clinical research using cannabinoids, the options are to go through with the complicated approval process and get cannabis from NIDA or I can partner with industry. And there are a very few pharmaceutical companies that are producing cannabis.
What I would prefer to do is not have to partner with pharmaceutical companies but to obtain cannabis products in another way to try to answer a whole bunch of questions.
We have a huge number of people in Oregon who are producing cannabis and cannabis products. I can't use those for lots of reasons. There is just no reliable way that I have at an official level to prove that what I am getting is what I think it is or what they say it is.
Same with dispensaries and the products you get at dispensaries. There is no real way of verifying what it is, and that is a problem.
If we are going to do research with something, we have to be able to verify what we are giving them to make sense of the results we get.
What would it mean for researchers if the government moved marijuana from its Schedule 1 status?
If it was not a Schedule 1 substance, I could enlist a lab at the university that could verify for me what these products are and measure them. Currently because it's a Schedule I substance, I can't do that.
What we really need in the medical community is really good data, because if we don't have that we will never understand the impact of these products good and bad. We need to know that and we are not going to be able to generate data at the level that it's recognized nationally and internationally with these kinds of restrictions in place.
How often do your patients parents raise the possibility of using cannabis to treat their child?
Almost every parent has at some point asked me about this. This is so much in the forefront, whether you drive by a billboard or a dispensary or you hear it on the news or a neighbor or family member say, "Hey, haven't you heard about this?" It's a huge question.
What do you say?
I am very honest. I say we don't have the data right now and I ask them what motivates them to want to consider it. It's important that we acknowledge we are all trying to find the right treatment, and I think there are many people motivated to reach out for these (treatments) regardless of any risks.
It's been a big dilemma in the medical community, especially among pediatricians, because our first obligation is to the safety of our patients. One of the concerns is if we simply say, "No, we don't know enough about this," then would those people simply go and do this anyway without our guidance? Are we being better pediatricians for these children by at least following them while they do that?
Would you like to see marijuana's Schedule I status changed?
I think it is something we should be doing. I think it can benefit our knowledge. At this point, I have concerns like everyone else does about the steps we are taking as a state, about how we are rethinking our relationship with cannabis products, which have risks as well as benefits. I am not interested in rescheduling it to improve public access to cannabis.
My interest is to gain knowledge and if that knowledge helps us to better understand the medical and health issues of this product.
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Rescheduling Marijuana: What The Move Would Mean For Researchers (Q&A)
Author: Noelle Crombie
Contact: OregonLive
Photo Credit: Beth Nakamura
Website: OregonLive
In a memo to U.S. lawmakers, the U.S. Drug Enforcement Agency said it is reviewing marijuana's current status and hopes to have a decision about potential rescheduling "in the first half of 2016."
Research into marijuana is complicated by the drug's longtime classification as a Schedule 1 drug. That category of drugs, which includes heroin, is defined as substances that have a "high potential for abuse" and "no currently accepted medical use."
The government allows research on cannabis, but the approval process is especially complicated and involves marijuana produced under a contract with the National Institute on Drug Abuse. The product is cultivated at a government-run facility based at the University of Mississippi.
Federal research proposals involving Schedule 1 drugs must undergo review by the National Institute on Drug Abuse, an agency focused on preventing drug abuse and addiction.
The Oregonian/OregonLive last week spoke with Dr. Colin Roberts, a pediatric neurologist and director of the Doernbecher Childhood Epilepsy Program at OHSU, about marijuana's potential change in status and what it would mean for researchers. Roberts' program is participating in several active clinical trials on pharmaceutical-grade cannabidiol produced by Insys, a pharmaceutical company.
Earlier this year, G.W. Pharma announced that an experimental drug made with pure cannabidiol, or CBD, was effective in reducing seizures related to Dravet syndrome, a debilitating form of epilepsy.
Roberts said the search is on for a new drug that could "help us crack the code" for epilepsy patients who don't respond to other treatments, which make up about one-third of people with the disease.
"Honestly I do not know if cannabis is that product, but we have to know first off: Is it safe? And then we have to know, really, does it work? And the reality is we don't have that data yet."
This interview has been edited for length and clarity.
What is involved if, say, an OHSU researcher wants to conduct research on cannabis currently?
Right now, for somebody like myself who is wanting to do clinical research using cannabinoids, the options are to go through with the complicated approval process and get cannabis from NIDA or I can partner with industry. And there are a very few pharmaceutical companies that are producing cannabis.
What I would prefer to do is not have to partner with pharmaceutical companies but to obtain cannabis products in another way to try to answer a whole bunch of questions.
We have a huge number of people in Oregon who are producing cannabis and cannabis products. I can't use those for lots of reasons. There is just no reliable way that I have at an official level to prove that what I am getting is what I think it is or what they say it is.
Same with dispensaries and the products you get at dispensaries. There is no real way of verifying what it is, and that is a problem.
If we are going to do research with something, we have to be able to verify what we are giving them to make sense of the results we get.
What would it mean for researchers if the government moved marijuana from its Schedule 1 status?
If it was not a Schedule 1 substance, I could enlist a lab at the university that could verify for me what these products are and measure them. Currently because it's a Schedule I substance, I can't do that.
What we really need in the medical community is really good data, because if we don't have that we will never understand the impact of these products good and bad. We need to know that and we are not going to be able to generate data at the level that it's recognized nationally and internationally with these kinds of restrictions in place.
How often do your patients parents raise the possibility of using cannabis to treat their child?
Almost every parent has at some point asked me about this. This is so much in the forefront, whether you drive by a billboard or a dispensary or you hear it on the news or a neighbor or family member say, "Hey, haven't you heard about this?" It's a huge question.
What do you say?
I am very honest. I say we don't have the data right now and I ask them what motivates them to want to consider it. It's important that we acknowledge we are all trying to find the right treatment, and I think there are many people motivated to reach out for these (treatments) regardless of any risks.
It's been a big dilemma in the medical community, especially among pediatricians, because our first obligation is to the safety of our patients. One of the concerns is if we simply say, "No, we don't know enough about this," then would those people simply go and do this anyway without our guidance? Are we being better pediatricians for these children by at least following them while they do that?
Would you like to see marijuana's Schedule I status changed?
I think it is something we should be doing. I think it can benefit our knowledge. At this point, I have concerns like everyone else does about the steps we are taking as a state, about how we are rethinking our relationship with cannabis products, which have risks as well as benefits. I am not interested in rescheduling it to improve public access to cannabis.
My interest is to gain knowledge and if that knowledge helps us to better understand the medical and health issues of this product.
News Moderator: Robert Celt 420 MAGAZINE ®
Full Article: Rescheduling Marijuana: What The Move Would Mean For Researchers (Q&A)
Author: Noelle Crombie
Contact: OregonLive
Photo Credit: Beth Nakamura
Website: OregonLive