Jacob Redmond
Well-Known Member
A law passed nearly a year ago in Wisconsin to help children with seizure disorders hasn't helped anyone here yet. Families who pushed for it say they feel duped and want to know what happened.
The bill was a bit controversial because it centered around a form of medical marijuana and a component of Cannabis called Cannabidiol or "CBD." Even though doctors say CBD doesn't give you a high like other parts of Cannabis can, there's still a hesitation to prescribe it.
The law is aimed at helping children with severe seizure disorders, like Nic Volker and Ava Gehrung. Nic is a 10-year-old Monona boy who has up to 200 seizures a day, twice as many now as he did when the legislation was first passed. His mom, Amylynne, was one advocate who pushed for the law so Nic could try CBD as a treatment. Ava, 9, and her family met Amylynne and Nic at the hearings on CBD.
Ava's mom, Nancy, says she was relieved when the bill was first passed. "I remember thinking, we just have to wait until the fall to get it." That's when many families thought it would be available, after harvest time. Amylynne says, "My hope for Nic was that he would be seizure free by now."
But both children's conditions have gotten worse, even with traditional treatments like surgery and anti-seizure medication. That's why their parents want to at least try CBD. Even though Wisconsin law says people can legally possess it, they still can't get it.
Doctors have to go through a lengthy process to prescribe it, including obtaining an Investigational New Drug permit from the Food and Drug Administration. The FDA wasn't able to tell 27 News whether any Wisconsin doctors have applied for the permit, but those who keep a close eye on the situation haven't heard of any.
Plus, there's nowhere in Wisconsin that dispenses CBD, even if a doctor was willing to get a permit and prescribe it. If a patient gets it from another state, like Colorado, they would get in trouble with the law for transporting it across state lines because the Drug Enforcement Administration regulates CBD like a Schedule I controlled substance. Amylynne says, "If I knew this bill wasn't going to work, I would have moved to Colorado. It's bothersome to me now that a year has gone by and Nic has lost another year of his life."
The lawmaker who wrote the bill, State Representative Robb Kahl, says it will work, but it's still a work in progress. "We knew it would take awhile. The same thing happened in Colorado. It took awhile, but now it's abundantly used," he tells 27 News.
If a doctor was willing to go through the FDA application process, CBD could be legally shipped to Wisconsin. In the meantime, Rep. Kahl says he's trying to get the transport issue taken care of for families willing to travel on their own. "We've heard some families are going and bringing it back to Wisconsin, but there's a risk with that," he says. Rep. Kahl's office says he's communicated with members of the Congressional delegation asking them to support efforts to remove barriers to interstate transport of CBD Oils. The federal omnibus bill passed a few months ago prohibits the federal government from interfering with state medical marijuana laws, including Wisconsin's. So the question is whether or not the wording of the bill would preclude federal law enforcement agencies from preventing shipment of CBD oils formulated to comply with our law.
Rep. Kahl is also asking the Legislative Council whether tribal governments in Wisconsin may now legally produce CBD oil for distribution. Recently, the federal Department of Justice sent tribal governments nationwide a letter setting conditions to be met for them to grow and process marijuana on their lands.
There's also an effort to get CBD approved by the FDA. One pharmaceutical company is conducting clinical trials right now on a pure form of CBD for children with severe seizure disorders. Stephen Schultz, Vice President of Investor Relations, says their drug, Epidiolex, is showing promise and GW Pharmaceuticals hopes to apply for FDA approval by the end of this year.
Schultz says there's an important difference between Epidiolex and CBD oils formulated in states like Colorado. "CBD oils can differ batch to batch depending on how it's grown and formulated. If you overcook, you could end up with a lot of THC (a psychoactive component of Cannabis). If they have molds or microbes in them, you introduce neurotoxins. There are a fair amount of stories of kids not responding or responding in a negative way (to oils) because of neurotoxins."
Two clinical trials are open to patients across the country with Dravet Syndrome and Lennox-Gastaut Syndrome. The first is an expanded access program designed to get Epidiolex to the most difficult seizure cases. The second and final stage of the clinical trials is a placebo-controlled trial to see if the medicine works or not. Schultz says GW Pharmaceuticals' data so far on the first phase of the trial was "extremely promising." But he adds, "When it comes to a drug, you really need to have those placebo-controlled trials." Data on that has not been released yet.
Another company, Insys Therapeutics, plans on conducting clinical trials for Cannabidiol Oral Solution in children with Dravet Syndrome and Lennox-Gastaut Syndrome and that will likely include Wisconsin patients. Insys says it has had interest from a few Wisconsin-based hospitals and research facilities already, but would not say which.
Ava and Nic's families wonder how long they can hold out for one of those things to come through for them. "Every seizure can cause more brain damage than Ava already has. This isn't a joke. This is about a life and death situation," Nancy says. Amylynne adds, "Yes, it's extremely frustrating. Nic has already been through so much already."
News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Wisconsin's medical marijuana law runs into roadblocks - WXOW News 19 La Crosse, WI ? News, Weather and Sports |
Author: Web Staff
Contact: aedesk@wxow.com
Photo Credit: None Found
Website: Home - WXOW News 19 La Crosse, WI ? News, Weather and Sports |
The bill was a bit controversial because it centered around a form of medical marijuana and a component of Cannabis called Cannabidiol or "CBD." Even though doctors say CBD doesn't give you a high like other parts of Cannabis can, there's still a hesitation to prescribe it.
The law is aimed at helping children with severe seizure disorders, like Nic Volker and Ava Gehrung. Nic is a 10-year-old Monona boy who has up to 200 seizures a day, twice as many now as he did when the legislation was first passed. His mom, Amylynne, was one advocate who pushed for the law so Nic could try CBD as a treatment. Ava, 9, and her family met Amylynne and Nic at the hearings on CBD.
Ava's mom, Nancy, says she was relieved when the bill was first passed. "I remember thinking, we just have to wait until the fall to get it." That's when many families thought it would be available, after harvest time. Amylynne says, "My hope for Nic was that he would be seizure free by now."
But both children's conditions have gotten worse, even with traditional treatments like surgery and anti-seizure medication. That's why their parents want to at least try CBD. Even though Wisconsin law says people can legally possess it, they still can't get it.
Doctors have to go through a lengthy process to prescribe it, including obtaining an Investigational New Drug permit from the Food and Drug Administration. The FDA wasn't able to tell 27 News whether any Wisconsin doctors have applied for the permit, but those who keep a close eye on the situation haven't heard of any.
Plus, there's nowhere in Wisconsin that dispenses CBD, even if a doctor was willing to get a permit and prescribe it. If a patient gets it from another state, like Colorado, they would get in trouble with the law for transporting it across state lines because the Drug Enforcement Administration regulates CBD like a Schedule I controlled substance. Amylynne says, "If I knew this bill wasn't going to work, I would have moved to Colorado. It's bothersome to me now that a year has gone by and Nic has lost another year of his life."
The lawmaker who wrote the bill, State Representative Robb Kahl, says it will work, but it's still a work in progress. "We knew it would take awhile. The same thing happened in Colorado. It took awhile, but now it's abundantly used," he tells 27 News.
If a doctor was willing to go through the FDA application process, CBD could be legally shipped to Wisconsin. In the meantime, Rep. Kahl says he's trying to get the transport issue taken care of for families willing to travel on their own. "We've heard some families are going and bringing it back to Wisconsin, but there's a risk with that," he says. Rep. Kahl's office says he's communicated with members of the Congressional delegation asking them to support efforts to remove barriers to interstate transport of CBD Oils. The federal omnibus bill passed a few months ago prohibits the federal government from interfering with state medical marijuana laws, including Wisconsin's. So the question is whether or not the wording of the bill would preclude federal law enforcement agencies from preventing shipment of CBD oils formulated to comply with our law.
Rep. Kahl is also asking the Legislative Council whether tribal governments in Wisconsin may now legally produce CBD oil for distribution. Recently, the federal Department of Justice sent tribal governments nationwide a letter setting conditions to be met for them to grow and process marijuana on their lands.
There's also an effort to get CBD approved by the FDA. One pharmaceutical company is conducting clinical trials right now on a pure form of CBD for children with severe seizure disorders. Stephen Schultz, Vice President of Investor Relations, says their drug, Epidiolex, is showing promise and GW Pharmaceuticals hopes to apply for FDA approval by the end of this year.
Schultz says there's an important difference between Epidiolex and CBD oils formulated in states like Colorado. "CBD oils can differ batch to batch depending on how it's grown and formulated. If you overcook, you could end up with a lot of THC (a psychoactive component of Cannabis). If they have molds or microbes in them, you introduce neurotoxins. There are a fair amount of stories of kids not responding or responding in a negative way (to oils) because of neurotoxins."
Two clinical trials are open to patients across the country with Dravet Syndrome and Lennox-Gastaut Syndrome. The first is an expanded access program designed to get Epidiolex to the most difficult seizure cases. The second and final stage of the clinical trials is a placebo-controlled trial to see if the medicine works or not. Schultz says GW Pharmaceuticals' data so far on the first phase of the trial was "extremely promising." But he adds, "When it comes to a drug, you really need to have those placebo-controlled trials." Data on that has not been released yet.
Another company, Insys Therapeutics, plans on conducting clinical trials for Cannabidiol Oral Solution in children with Dravet Syndrome and Lennox-Gastaut Syndrome and that will likely include Wisconsin patients. Insys says it has had interest from a few Wisconsin-based hospitals and research facilities already, but would not say which.
Ava and Nic's families wonder how long they can hold out for one of those things to come through for them. "Every seizure can cause more brain damage than Ava already has. This isn't a joke. This is about a life and death situation," Nancy says. Amylynne adds, "Yes, it's extremely frustrating. Nic has already been through so much already."
News Moderator: Jacob Redmond 420 MAGAZINE ®
Full Article: Wisconsin's medical marijuana law runs into roadblocks - WXOW News 19 La Crosse, WI ? News, Weather and Sports |
Author: Web Staff
Contact: aedesk@wxow.com
Photo Credit: None Found
Website: Home - WXOW News 19 La Crosse, WI ? News, Weather and Sports |
