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GRU could get marijuana oil trials

State's children could get access to cannabidiol oil in GRU studies

Thursday, April 10, 2014 3:55 PM
Last updated Friday, April 11, 2014 1:13 AM
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Children in Georgia with difficult to treat seizures could get access to a marijuana-derived oil through clinical trials at Georgia Regents University, Gov. Nathan Deal announced Thursday. But even if the state gets selected, it could be three to six months to work out the details, said a lead researcher at GRU who would likely lead the clinical trials.

After the Georgia Legislature failed to pass a bill in March that would legalize cannabidiol oil for treatment of children with seizure disorders, Deal announced he would try to find a way to do it administratively. He said he talked with the Food and Drug Administration and was told of two avenues for getting the oil to the state. One is “pairing” GRU and a company that makes a cannabidiol oil that is being tested in clinical trials elsewhere.

The news release doesn’t name the company but GW Pharmaceuticals is testing a drug called Epidiolex that is a purified cannabidiol oil. GRU has already submitted information about its patient population and its center to the company and is waiting to hear back from them, said Dr. Yong Park, who heads the pediatric epilepsy program.

“Hopefully they will select our center to participate in this study,” he said. “That’s the first step.”

The first study would be limited to children with Dravet syndrome who suffer from difficult to control seizures. Even if GRU gets the nod, it could take a while, Park said.

“Hopefully they go fast track but you have to have a contract with the pharmaceutical company” and the university, he said. “Contract issues, usually in my experience, take about three to four months, sometimes six months to get the contract.”

The other route Deal mentioned would be to get the oil from the National Institute on Drug Abuse’s marijuana farm at the University of Mississippi, which would probably take longer because it would mean going through that agency and the FDA for approval, Deal said in a news release.

It could actually do both trials at GRU in partnership with other institutions across the state, he said.

“We do not see these options as mutually exclusive, and we’re looking to move forward on both options at this time,” Deal said.

The sponsor of Georgia’s cannabidiol oil bill, Rep. Allen Peake, R-Macon, said he was told the NIDA will soon announce it is creating a strain high in cannabidiol, which is not the chemical in marijuana that creates a high.

“We want to be on the very cutting edge in an initiative seeking to obtain that from them so we can do research at our research facility at GRU,” he said.

It is impressive that the announcement included not only the governor but Chancellor Hank Huckaby of the University System of Georgia, Peake said.

“I think it is a great idea,” he said. “It still doesn’t help families immediately but it sure gives them some hope that down the road, and possibly with all of that political muscle in a shorter term, that they’ll have access to some cannabidiol oil.”

While there is little solid clinical research yet showing the oil helps children with seizures, there are numerous anecdotal stories showing remarkable progress.

The announcement was “pretty awesome,” said Valerie Weaver, whose 6-year-old son Preston has Lennox-Gastaut syndrome and suffers seizures daily despite taking a half-dozen medications.

“So hopefully maybe we can get this thing going.”

The company might cover Preston’s syndrome, which affects more patients, in a future study soon, Park said.

Having access to the oil through the federal government would be “a great thing,” he said, “then we need to find the mechanism for how we can use those rather than depend on GW Pharmaceuticals.” But that brings up one big problem, Park said.

“Who is going to sponsor it?” he said. “I don’t know whether the state has a sponsor to study it. I doubt it. We’ll see how it goes.”

After the measure ran into a snag on the last day and failed to pass despite overwhelming support, Peake said he planned to be ready to go when the next legislature convenes to help families, some of whom moved to Colorado so they could legally obtain the oil.

“I fully anticipate we’ll push forward very early in the session a protection from prosecution for possession of cannabidiol oil, similar to what we were trying to do the last day,” he said. “Maybe within a couple of weeks after next year’s session starts we’ll have a law passed so those families can come home.”

Comments (18) Add comment
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Little Lamb
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Little Lamb 04/10/14 - 04:06 pm
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Clinical Trials

Just remember, if they pick a hundred children to receive the cannabis oil for testing, they have to pick another hundred children to receive a placebo. How would you like to be a parent of one of the children taking the placebo?

Then also think about the thousand or so children who are left out of the trial altogether.

GiantsAllDay
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GiantsAllDay 04/10/14 - 05:29 pm
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Sean delete my comment if you

Sean delete my comment if you would like. I am passionate about this one.

GiantsAllDay
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GiantsAllDay 04/10/14 - 05:35 pm
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Great comment, little lamb!

Great comment, little lamb!

Tom Corwin
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Tom Corwin 04/10/14 - 06:26 pm
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Little Lamb

The first clinical trial would only be for children with Dravet Syndrome, which is fortunately fairly rare, so that would exclude a large number of children, anyway. The first trial would only take 30 children and the second one would be 60 children. They wouldn't pick 30 or 60 other children as controls but would likely randomize patients to receive the drug or placebo. Even though the first part of the study would be double-blinded, the second part would be "open label" so the children would be allowed to get the drug even if they got placebo in the first part. As you may know, FDA prefers randomized control double-blind studies when it is assessing whether to approve a new drug. The second part of the study assures the children have access. If the Georgia Legislature approves the bill next year, parents could legally possess the oil without fear of prosecution.

fedex227
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fedex227 04/10/14 - 09:07 pm
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0
.
Unpublished

.

fedex227
11187
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fedex227 04/10/14 - 09:10 pm
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"How would you like to be a parent of one ...
Unpublished

taking the placebo?" So your answer is what? Do away with medical clinical trials altogether?

GiantsAllDay
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GiantsAllDay 04/10/14 - 09:29 pm
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I had to say what I had to

I had to say what I had to say. Even though my speech was shut down by the newspaper, perhaps a few people were able to read it. I've looked over my comments a few times and there is nothing I would change. So my comments are shut down.

GiantsAllDay
9845
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GiantsAllDay 04/10/14 - 09:32 pm
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So why do people in Georgia

So why do people in Georgia have to get permission from old white men fools to get help for their children?

fedex227
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fedex227 04/10/14 - 10:11 pm
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1
???
Unpublished

Why did your comments need to be removed?

GiantsAllDay
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GiantsAllDay 04/10/14 - 10:40 pm
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I didn't cuss or use

I didn't cuss or use profanity in any way. I expressed my outrage with this lousy governor and the legislature in Atlanta. They are cruel men and women who should be helping children. This issue is so much a no brainier. Well, anyway it seems like freedom of the press only goes one way. Our founding fathers said things that rocked the boat and I'm glad they did. I'm pretty sure they believed the people could express their opinion. The AC take on this: if you want to be heard, go out and start a newspaper. Ummm, OK.

fedex227
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fedex227 04/10/14 - 11:08 pm
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Roger that GAD ...
Unpublished

I only asked because as a parent who had to seek help outside the state and enroll in clinical trials for my child through the NIH ... even it if was only to gain another six months time, I thought I knew what you may have written.

Bizkit
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Bizkit 04/10/14 - 11:23 pm
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I get being angry at the

I get being angry at the legislature but why Deal-he is stating he is trying to get it done administratively-much like Obama with executive orders. Seems Deal is supporting this and State legislature not-likely because of fears of their constituents who aren't educated on what this is. This compound isn't psychoactive-in fact just the opposite it is antagonist and considered neuroprotective to the deleterious effects of THC in pot. Further although for 130 years Georgia did only elect old white male Dems now the legislature is over 20% black and there are woman.

fedex227
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fedex227 04/10/14 - 11:25 pm
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Dr. Bizkit, normally I don't respond to individual posts ...
Unpublished

And forgive me if I assume you don't have a child who could benefit from these clinical trials? How exactly does this hurt you?

Bizkit
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Bizkit 04/11/14 - 12:08 am
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What do you mean. I am not

What do you mean. I am not arguing against it-where do you get that. I was responding to GAD's rant against Deal. I think they should allow it. I'm not too fond of Deal but seems like he realizes this is a good idea too.

fedex227
11187
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fedex227 04/11/14 - 01:02 am
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Apologies Bizkit ...
Unpublished

I misinterperted your post.

GiantsAllDay
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GiantsAllDay 04/11/14 - 01:05 am
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Shouldn't these parents be

Shouldn't these parents be allowed to get medicine to their children right now, this minute? Without fear of some Georgia cop slamming their head on the hood of a police car and taking them to jail? Remember people, there are no infractions in Georgia. A misdemeanor is the lowest crime here. So backwards.

corgimom
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corgimom 04/11/14 - 08:02 am
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What's a safe dose? What's a

What's a safe dose? What's a harmful dose? What should be done if it's accidentally injested?

That's why it's not legal, none of that has been determined.

Nobody even knows if it really works.

Children are not medical guinea pigs, what is safe for adults can be toxic for children. Parents are not allowed to use their children as guinea pigs to take unproven medication.

There isn't even scientific evidence that it works.

Anything that's powerful enough to affect a child's brain should be used with great caution, because their brains are still growing and developing.

Bizkit
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Bizkit 04/11/14 - 08:17 am
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Corgimom is right-there is

Corgimom is right-there is only anecdotal evidence this works against this disease treating seizures-so this will find if it really does.

wmarkw
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wmarkw 04/11/14 - 10:27 am
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And wonder why there isnt any

And wonder why there isnt any evidence?? Sheesh broken record with some of you.

If my child had this debilitating condition I would be all over natural medicine even if there isnt any FDA evidence, cause it does work and there are a lot of success stories.

I'm a broken record cause I keep posting this video. I'm sure all you against havent take the time to watch it yet. But it deals with this article to a T. The medicine this little child has to take in the video below is poison.

https://www.youtube.com/watch?v=tAFu-Ihwyzg

WalterBradfordCannon
1481
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WalterBradfordCannon 04/11/14 - 12:42 pm
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@corgimom, that's how and why

@corgimom, that's how and why research is done. But you are wrong that things like efficacy and dosage and side effects are completely unknown. I am including below links to preliminary data. You have to understand, this is being proposed in treatment resistant children with severe epilepsy. A high degree of compassion is called for. Blocking potential new avenues for treatment because of your own illogical bias is absolutely INHUMANE.

http://www.ncbi.nlm.nih.gov/pubmed/24237632
http://www.ncbi.nlm.nih.gov/pubmed/17112679

WalterBradfordCannon
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WalterBradfordCannon 04/11/14 - 12:44 pm
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@TomCorwin, irrespective of

@TomCorwin, irrespective of anything the Georgia legislature does, any parent is still at risk of federal prosecution. It is not happening under this administration, but administrations change. What this will do is stop parents from moving to Colorado or some other state with sane medical marijuana laws to improve the quality of life for their children.

corgimom
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corgimom 04/11/14 - 02:56 pm
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WalterBradfordCannon, nobody

WalterBradfordCannon, nobody knows exactly what it'll do to children. And it's better to have a live child with seizures than a dead child without. That's my level of compassion.

I don't know how old you are, but I come from a generation that had drugs that were supposed to be great but were later on found to cause dangerous side effects that some people died from.

I was given one of those drugs, that was supposedly "safe", so my "bias" isn't illogical at all.

A whole lot of people think that marijuana is harmless, and it's not, especially for children. Any drug that can alter your thoughts and perception and that stays in your body for up to 30 days isn't harmless, especially for children whose brains are still developing. There ISN"T any research as to what that does to any child, long-term.

And Walter, I know many, many women who are DES daughters. You know, where the mothers were given "safe" DES, to prevent miscarriages, and then their daughters were born with lifelong deformities and with a high risk of uterine cancer.

corgimom
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corgimom 04/11/14 - 03:00 pm
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Oh, and Walter, did you

Oh, and Walter, did you happen to read all the way down on the first link, where it said that SAFETY HAD NOT BEEN ESTABLISHED?

You know, where the NIH emphatically stated that it hasn't been? Which is what I said, so I guess the NIH has an "illogical bias" too.

user1234
11
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user1234 04/11/14 - 04:52 pm
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0
so exciting

my child has Dravet's and this would be welcome news to my family as well as the numerous other children who are affected by these devastating neurological conditions.

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