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THE CAPITAL, TALLAHASSEE, May 27, 2015…… Patients could have access to long-awaited, non-euphoric pot products by the end of the year, after a judge on Wednesday rejected a challenge to a proposed rule setting up the medical marijuana industry in Florida.

Department of Health officials could begin processing applications for the low-THC cannabis within 41 days of Wednesday's decision by Administrative Law Judge W. David Watkins, according to an agency spokeswoman.

Watkins pointedly began his 68-page ruling with an excerpt from "Charlotte's Web," by E.B. White.

"Life is always a rich and steady time when you are waiting for something to happen or hatch," Watkins quoted from the children's book.

The name "Charlotte's Web," a type of cannabis cultivated in Colorado, has become nearly synonymous with marijuana that is low in euphoria-inducing tetrahydrocannabinol, or THC, and high in cannabadiol, or CBD.

Parents of children with a severe form of epilepsy pushed the Legislature last year to approve the low-THC cannabis, believing it can end or dramatically reduce life-threatening seizures.

But their joy over the passage the law, and Gov. Rick Scott's support of it, ceded to frustration as delays --- including Watkins' November invalidation of health officials' initial attempt at a rule --- kept pot operators from getting started. Regulations for the industry were supposed to go into effect on Jan. 1.

"We don't know whether to laugh, cry, dance, or do back flips," said Ryan Wiggins, spokeswoman for Payton and Holley Moseley, who advocated for the law on behalf of their daughter RayAnn. "There were times over the past year we truly didn't believe this day would ever come. We are grateful to DOH and their attorneys for all of the work they have put in to getting this right. Today is an outstanding day for Florida's families who battle epilepsy."

Under Florida's first-in-the-nation low-THC law, health officials will select five nurseries in different regions of the state to cultivate, process and distribute the non-euphoric cannabis to patients with epilepsy, severe muscle spasms or cancer, if doctors order it.

Watkins' decision allows the department to begin implementing the law, agency officials said in a statement.

"The department remains committed to ensuring safe and efficient access to this product for children with refractory epilepsy and patients with advanced cancer. We are moving swiftly to facilitate access to the product before the end of the year," the agency said.

Watkins last year tossed health officials' first stab at a rule, finding fault with the use of a lottery system to select five "dispensing organizations" to grow, extract and distribute the non-euphoric cannabis.

But on Wednesday, the administrative law judge rejected all of the objections in a challenge filed by Baywood Nurseries, which contended, among other things, that the rule was tilted in favor of large nurseries.

"While the department's first attempt to do so was unsuccessful, the fruit of its second effort, which was well-reasoned, deliberative, and thorough, represents a rational and coherent regulatory framework," Watkins wrote.

Baywood Nurseries could not be reached for comment Wednesday evening.

The Apopka -based nursery challenged the omission of some definitions in the rule; a $63,063 non-refundable application fee and certified financial statements that have to accompany it; an application scoring and evaluation process; license revocation and testing procedures; and the way the rule dealt with a $5 million bond required in the law.

Watkins found no basis for any of Baywood's complaints, including that the application fee was too high. A committee settled on the fee by dividing the anticipated total regulatory costs --- about $990,000 --- by 15 nurseries that growers said could be expected to apply for the licenses.

The fee "is a reasonable, rational estimate based on sound input and should allow the department to recover its costs of administering the statute" as required by law, Watkins wrote.

"Baywood presented no evidence to support its theory that grower members of the committee had nefarious intent in estimating the number of potential applicants in order to inflate the application fee," he wrote.

Watkins also rejected complaints about the selection of the members of the rare "negotiated rulemaking" committee --- which spent 26 hours over two days hashing out the rule earlier this year --- selected by the health department's Office of Compassionate Use Executive Director Patricia Nelson.

"No stakeholder group represented by any committee member, the department included, got everything it wanted in the proposed rules --- which underscores that the committee was balanced, that the negotiated rulemaking process worked properly, and that the developed rules reflect the interests of all represented groups," Watkins wrote.

Watkins rejected health officials' request to dismiss the complaint because Baywood did not have 400,000 plants, required for nurseries to be eligible to apply for a license, at the time the grower filed the complaint in March. Because the nursery soon after was certified as growing more than 400,000 plants, Watkins found that Baywood would be "substantially impacted" by the rule and thus could maintain the complaint.

Health officials expect to adopt the rule on Thursday, which starts a 20-day period before applications can be accepted. Nurseries will have 21 days after the rule goes into effect to submit applications. Even if Baywood appeals Wednesday's order, the department can continue moving forward with the selection process.

Proponents of the low-THC cannabis are now worried about possible challenges by nurseries that aren't chosen.

"I am thrilled. I am one happy legislator," said Rep. Matt Gaetz, a Fort Walton Beach Republican who was instrumental in the law's passage last year. "My only hope moving forward is that we don't see more special-interest litigation when licenses are awarded."

Article and Information courtesy of the Epilepsy Foundation of America. Visit their website to learn more.

What to do about the medical use of marijuana (cannabis) as a potential treatment for a number of neurologic conditions, including epilepsy, is a hotly debated issue. There are legal issues surrounding access to cannabis, as well as a lack of scientific research on the usefulness and safety of marijuana as a treatment for seizures. Additionally, many different substances containing cannabis are being used which makes it difficult to study.

What is medical marijuana or cannabis?

Marijuana is known by many names; the most common is cannabis. This is the Latin name used most often by botanists and pharmaceutical companies. The word marijuana usually refers to the leaves and female flowers of the cannabis plant. Cannabinoids are substances in cannabis that act on cells in the body (called cannabinoid receptors) to cause some effect. Two major ingredients include:

  • Tetrahydrocannabinol, or THC, causes the psychoactive effects of "getting high."
  • Cannabidiol, or CBD, does not cause psychoactive effects but has shown some positive effects on certain body systems and may potentially affect seizures.

Does cannabis help seizures?

Evidence from laboratory studies, anecdotal reports, and small clinical studies from a number of years ago suggests that cannabidiol, a non-psychoactive compound of cannabis, could potentially be helpful in controlling seizures. However, there are conflicting reports in the literature. So far, scientifically controlled studies have not shown definitive proof of the effectiveness and safety of marijuana or cannabis in epilepsy. For example, in 2012, a literature review of clinical studies on cannabinoids for epilepsy could not give a reliable conclusion about the effectiveness of four randomized controlled trials of cannabidiol. Yet in the 48 people included in these reports, no side effects were noted. Conducting studies can be difficult as researchers have limited access to marijuana due to federal regulations and even more limited access to cannabidiol; there are also increased financial and time constraints. 

Individual reports of children with refractory (or intractable) epilepsy who have tried cannabis, usually with high ratios of cannabidiol to THC, have reported marked improvements in seizure frequency, including a report describing the results of Charlotte, a girl with Dravet syndrome.

Cannabidiol (CBD): Recently, there have been some open-labeled studies in the U.S. of Epidiolex (a drug derived from cannabidiol or CBD), which is produced by a pharmaceutical company (GW Pharmaceuticals). Epidiolex is a purified, 99% oil-based extract of CBD that is produced to give known and consistent amounts in each dose. The U.S. Food and Drug Administration (FDA) has given some epilepsy centers permission to use this drug as "compassionate use" for a limited number of people at each center. Such studies are ongoing for difficult epilepsies such as Lennox-Gastaut syndrome (in children and adults) and Dravet syndrome in children.

Results from 213 people who received Epidiolex (99% CBD) in an open label study (without a placebo control) were presented at the American Academy of Neurology, April 22, 2015 in Washington DC. Data from 137 people who completed 12 weeks or more on the drug were used to look at how helpful or effective the drug was. People who received the Epidiolex ranged from 2 to 26 years old with an average age of 11. All had epilepsy that did not respond to currently available treatments - 25 or 18% had Dravet Syndrome (DS) and 22 or 16% had Lennox-Gastaut Syndrome (LGS). 

  • Seizures decreased by an average of 54% in 137 people who completed 12 weeks on Epidiolex. 
  • Patients who had DS responded more positively with a 63% decrease in seizures over 3 months. 
  • This improvement in seizures lasted through 24 weeks on the Epidiolex, more often for people with DS than without DS. 
  • In 27 patients with atonic seizures (which are commonly seen in people with LGS as well as other types of epilepsy), the atonic seizures decreased by 66.7% on average.
  • The responder rate (the number of people whose seizures decreased by at least 50%) was also slightly better in patients with DS (about 55% at 3 months) as compared to patients without DS (50%).
  • People who were also taking the anti-seizure medication Clobazam (Onfi) seemed to respond more favorably to the Epidiolex with a greater improvement in convulsive seizures than in patients who were not taking Clobazam. The authors suggested that an interaction between Clobazam and Epidiolex may play a part in the differences seen. 
  • 14 people withdrew from the study because the drug was not effective for them. 

A controlled study on on Epidiolex involving many epilepsy centers is now being done that will compare children with Dravet syndrome or Lennox-Gastaut syndrome taking the active drug with children not receiving the drug.

Does cannabis have side effects?

Marijuana or cannabis in general has a number of effects depending on how it is ingested. For example, if smoked, the risk factors associated with smoking apply to marijuana. Side effects of the preparations used to treat seizures have not been well documented in anecdotal reports as varying doses and strains have been used. Increased appetite and memory problems have been reported.

Cannabidiol (CBD): The open-labeled study discussed above (presented at the Academy of Neurology, April 22, 2015, Washington DC)  included safety data from 213 patients at 11 different sites. Epidiolex (99% CBD) was generally well tolerated. Side effects that occurred in 10% or more of people included: sleepiness (21%), diarrhea (17%), fatigue (17%), and decreased appetite (16%). 

  •  10 people (5%) stopped treatment with Epidiolex due to side effects, though 3 of these people restarted it. 
  • Most side effects were described as mild or moderate and went away. 
  • Serious side effects happened in 52 people - 22 of these were possibly related to the drug. The most common serious possible side effect was status epilepticus, when a person has long or repeated seizures. While 2 people died while taking Epidiolex, the deaths were not thought to be related to the drug. 

Some children required a change in seizure medication to lessen sedation or sleepiness. Interactions between Epidiolex and certain seizure medications causing changes in blood levels of seizure medications were found in small numbers of people in an earlier report of this study. 

It is difficult to assess the side effects of Epidiolex (99% CBD) and other safety concerns until larger studies using a control group are done. Other side effects could occur that are simply not known yet to practicing physicians. This and confirming efficacy is why rigorous clinical trials are needed.

What are the laws governing medical marijuana?

A number of states in the U.S. have laws allowing cannabis to be recommended and dispensed to people for medical reasons. However, this does conflict with some federal laws and there are further complications for research on marijuana due to federal restrictions. This can mean physicians who choose to follow the state laws on medical use of marijuana could be breaking a federal law. Some states have acted to include protections for physicians, but they must be aware of both federal and state laws and the potential implications. A clearer understanding of the laws governing this issue is needed.

Should a person with epilepsy pursue medical marijuana if all other medications do not work?

When conventional treatments do not work, as is the case for roughly 30% of people with epilepsy, it is not unreasonable to consider cannabis. This is why some states have approved it for “compassionate access.” However, this should only be considered after a thorough evaluation at a specialized epilepsy center and once conventional treatments (pharmacologic and nonpharmacologic) have been reasonably tried.

The Epilepsy Foundation urges anyone exploring any treatment for their epilepsy, as permitted under their state law, to work with their treating physician to make the best decisions for their own care.

What is the position of the Epilepsy Foundation on cannabis?

Learn more about the Epilepsy Foundation's advocacy efforts on medical marijuana (cannabis) and compassionate access in the federal and state governments, including a statement from President and CEO Phil Gattone & Board Chair Warren Lammert and commentary from Dr. Orrin Devinsky. 

Authored by: Joseph I Sirven MD | Patricia O. Shafer RN, MN on 4/2015
Reviewed by: Selim R. Benbadis MD on 4/2015



by Catherine Wysoczanski

Imagine living each day with a vicious stalker following your every move and never knowing when they will strike. You never know if they will attack while you are sleeping, in school, at work or when simply walking down the street. No matter where you go you are being followed. This stalker, which follows more than 65 million people, is known as epilepsy. While at times it may seem like life can be overtaken by this stalker, it is possible to understand epilepsy and advocate awareness throughout the community.

Epilepsy is a neurological condition of the brain that can affect anyone at any time. It is characterized by recurring seizures, which are physical reactions to sudden, brief disturbances in the electrical activity in the brain. “When our daughter, Alexa, was 3 years old she started having seizures,” says First Coast parent, Shauna Anderson. “After I saw the first couple I was trying to figure out what was happening. We found out that she has partial complex seizures,” she says. Shauna and her husband Jonathan learned that a partial complex seizure usually starts in the small area of the temporal or frontal lobe of the brain. The Epilepsy Foundation states that this type of seizure quickly involves other areas of the brain that affect alertness and awareness. Even if the person’s eyes are open and they make movements that seem to have a purpose, in reality “nobody’s home.” If the symptoms are subtle, other people may think the person is just daydreaming. “Alexa was having seizures on the hour every hour. Now she is doing a lot better and only has seizures two to three times a week. She is in third grade and we are blessed that she is so strong,” says Shauna. In the beginning Shauna and Jonathan were unsure of where to turn to get support. “There were so many things we could have done. We probably would have felt more educated with resources and support,” says Jonathan. “About a year after Alexa was diagnosed we found out about the Epilepsy Foundation of Florida. They have resources to help parents and people learn about epilepsy. We’ve gotten very involved and I joined the board [of directors] three or four years ago,” he says. “From a father’s standpoint I would try and connect with somebody to get more understanding of what is happening. It could be a lifetime of trying to figure this out. You have to be patient, and love and support your child. You will figure it out together.”

“Currently more than 375,000 Floridians are living with epilepsy,” says Viktor El-Saieh, executive director of the Northeast Branch of the Florida Epilepsy Foundation. “The Epilepsy Foundation of Florida’s goal is to educate people about what epilepsy is.


We provide valuable services to both families and individuals that have been affected by epilepsy. It doesn’t matter what their financial circumstances are, we provide medical services, case management, counseling, support groups, education and much more,” he says. One of the biggest challenges the Epilepsy Foundation of Florida (EFOF) encounters is educating people about epilepsy. “It’s a difficult conversation to have because it’s extremely broad,” says Viktor. “Epilepsy affects everyone who has it in entirely different ways. Some people can be severely affected and others can lead a productive life.” The EFOF is one of the best resources to turn to when facing this diagnosis. There are two support groups that meet each month in Duval and Clay counties. This year, a new art therapy program launched in Gainesville with plans to move it to Jacksonville at some point in the future. The program, called Studio E, brings people who have epilepsy together for an eight-week art program. “The EFOF has brought in an art therapist for this program. The point is for people with epilepsy to be together in a group setting and let their creative sides flow. They get to do all different kinds of artwork with different mediums like painting and pottery,” says Viktor.

One of the biggest steps for those with epilepsy is spreading awareness. First Coast mom Debbie Whittle has been involved with EFOF since her daughter was diagnosed with epilepsy more than eight years ago. “One of the biggest ways that people can spread awareness is to get out there and talk about it. A lot of people are afraid of epilepsy and don’t want others to know they have it because of the stigma attached to it,” says Debbie. People often misunderstand epilepsy and others may hesitate to get help because of the stigma and stereotypes attached to epilepsy. A person may think they are experiencing an episode that they can simply shake off, while others do not seek treatment because they are concerned that
this stigma could affect their relationships with friends, coworkers and even potential employers. “My daughter’s friends were very supportive of her. The diagnosis was very difficult because she lost some of her freedom like being able to drive. She had already driven and knew what it was like, so to have it taken away was very hard,” says Debbie. “At that age you don’t want to be driven around by your mom. Right now she is doing fantastic and is seizure free,” she says. “It was such a learning experience for me, and I decided to get on board with the Epilepsy Foundation and try and educate people about epilepsy because there are so many different types of seizures. People just think of a grand mal seizure where someone is convulsing on the ground, but there are so many more types of seizures.” It is never easy for anyone to be diagnosed with epilepsy, but as long as they take the time to do research they can find a way to live a productive life and break that stigma.

“A lot is understanding what epilepsy is and what it is not,” says Dr. Harry Abram, pediatric neurologist at Nemours Children’s Clinic. “When we meet a patient for the first time, we spend an hour simply discussing it.


There is a lot of literature available to help learn about epilepsy, but it’s important to find out as much as you can and be able to have all of your questions answered. It doesn’t mean that you aren’t going to college and it doesn’t mean that you can’t have a family. Even if someone has epilepsy, it is possible to lead a normal life,” he says. “Some children do outgrow their epilepsy and it’s important to be optimistic that these kids will be okay and their seizures can be controlled with medicines. On the other spectrum, it’s important that parents have their own outlet, so joining a support group is a good idea.” Local mom and neurologist, Dr. Georgia Gianakakos has seen both sides of the spectrum as a parent and neurologist. “My husband is also a doctor, and even as health care professionals we were blindsided and bewildered by our son’s diagnosis,” says Georgia. “One of our twin boys has primary generalized epilepsy. His seizures started at age 3 and he is now almost 6. We are thankful that his epilepsy is well controlled and he is otherwise healthy. We pray that he will outgrow the seizures. One of the best ways we’ve coped, and that others can cope, is to have a strong social
support system and education. These are imperative for family and patient health,” she says.

There are now many support groups through different social media handles like Facebook (EpilepsyFLA) and Twitter (@EFOF). Another way parents can get involved with advocacy is by having their child participate in Camp Boggy Creek. “Camp Boggy Creek was founded by Paul Newman for children with serious illnesses to get to go to camp and be a normal kid,” says Dr. Abram. The promise of the camp is that “every child, no matter what their illness is, can experience the transformational spirit and friendships that go hand in hand with camp.” The camp has specific weeks for certain illnesses. “It’s for all types of children. They have a week for children with cancer…a week for liver disease…a week for epilepsy and so on. It’s a chance for kids to spend time with other kids that are experiencing the same thing,” says Dr. Abram. One issue surrounding epilepsy is how frightening it can be since many people don’t fully understand it. “It’s not like having cancer or leukemia. You don’t have physical signs like losing your hair. You look just like any other normal person, which makes it even more difficult,” he says.

You can advocate for those living with epilepsy during Epilepsy Awareness month in November and by participating in the “Walk the Talk” event in April 2015. Together it is possible to reduce the misunderstanding, fear, discrimination and isolation that coincide with the stigma by educating others and increasing awareness through schools, education and even social media. As the EFOF says, “We can reduce the fear and misunderstanding, so the lives of millions of people around the world, people living with the condition and their loved ones, will be forever changed for the better.” Visit or to learn more about how you can help end this stigma and work towards a cure.

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