CYBERONICS ANNOUNCES FDA APPROVAL OF THE ASPIRE SR GENERATOR FOR VNS
Cyberonics announced FDA approval of the AspireSR generator for the VNS Therapy System - the first and only VNS Therapy System that provides responsive stimulation to heart-race increases that are often associated with seizures in people with epilepsy.
Studies have shown that 82 percent of patients with epilepsy experience rapid heart-rate increase associated with a seizure. The AspireSR generator uses a proprietary, patent protected, customizable cardiac-based algorithm to detect relative heart-rate increases and deliver automatic stimulation.
"The advantage of the AspireSR generator over the conventional VNS treatment is the ability to deliver stimulation when it may have the greatest beneficial effect," said Robert Fisher, M.D., Ph.D., Professor of Neurology & Neurological Sciences, Director, Standford Comphrehensive Epilespy Program.
Learn more about AspireSR today.
JUDGE CLEARS LEGAL WEB FOR PATIENTS TO GET MARIJUANA
By DARA KAM
THE NEWS SERVICE OF FLORIDA
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."
Medical Marijuana and Epilepsy
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.