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Barriers to Study, Use of Marijuana for Epilepsy Treatment Continue to Fall

by U.S. Medicine

February 6, 2016

VA Physicians Banned from Recommending Cannabis Even Where Legal

By Annette M. Boyle

cannabis

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SANTA CRUZ, CA — In the last few months, several federal agencies and Congress have taken steps to eliminate obstacles to the study and potential use of marijuana for veterans with epilepsy and other conditions.

That the Drug Enforcement Agency (DEA), Congress and the Department of Health and Human Services (HHS) have all acted to relax marijuana restrictions recently could be good news for veterans, particularly the 30% of epilepsy patients who receive little relief from traditional medications or who find that the drugs exacerbate other common comorbidities such as post-traumatic stress disorder (PTSD) and depression.

A growing body of evidence indicates that marijuana could help reduce seizures in some of these patients who have few other choices. That, in turn, could ease some restrictions on research to determine how effective cannabidiol (CBD) is in treating epilepsy.

While epilepsy disqualifies applicants from serving in the military, servicemembers and veterans may develop epilepsy and other seizure disorders following traumatic brain injury (TBI) or as a result of other factors. More than 87,000 veterans had seizure diagnoses in 2011, according to the VA.

In early January, the Drug Enforcement Agency eased its requirement that researchers conducting clinical trials under a Food and Drug Administration Investigational New Drug Application modify their DEA research registrations — and wait for approval — if they expand the scope of their study and need more CBD than originally requested.

In a press release, the DEA said that, “because CBD contains less than 1 percent THC and has shown some medicinal value, there is great interest in studying it for medical applications.” Marijuana remains a Schedule 1 drug, meaning the DEA still considers it a substance with high potential for abuse and with “no currently accepted medical use in treatment in the United States.”

“Because there is so much need for a treatment, there has been a willingness to see isolated cannabinoids and nonsmoking delivery systems as OK,” said Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

Challenges faced by VA physicians who might want to recommend CBD or medical marijuana, where legal, to veterans with epilepsy, PTSD and other conditions might also fall soon. In November, the Senate passed the FY 2016 Military Construction and Veterans Affairs (MilCon-VA) Appropriations Bill with an amendment that would protect VA physicians who discuss therapeutic use of marijuana with their patients in states where medical marijuana is legal.

The bill cleared the Senate on a vote of 93-0 and now must be reconciled with the House appropriations bill. A similar proposal did not make it out of committee in the House in 2015, but the Senate’s action revives the possibility of a change in the federal law.

Currently, the VA specifically prohibits medical providers from discussing participation in legal medical marijuana programs. Veterans who participate in the programs and test positive for marijuana risk losing their prescription rights. The VA’s restrictions are more strict that most other federal agencies; physicians are not prohibited from discussing medical marijuana with Medicare, Medicaid or other federal program beneficiaries.

In a letter to VA Secretary Robert McDonald released in late January, a bipartisan group of Senate and House members urged the VA to allow doctors to write medical marijuana recommendations to patients in accordance with state laws.

The letter was written shortly before the expiration of a directive that prohibited VA doctors from recommending medical marijuana, even in states that have made it legal.

The Congressional members, led by Kirsten Gillibrand (D-NY), Steve Daines (R-MT), and Jeff Merkley (D-OR) in the Senate and Earl Blumenauer (D-OR), Dina Titus (D-NV), and Dana Rohrabacher (R-CA) in the House, argued that the current policy disincentivizes doctors and patients from being honest with each other, noting, “It is not in the veterans” best interest for the VA to interfere with the doctor-patient relationship.”

The letter continued, “Congress has taken initial steps to alleviate this conflict in law and we will continue to work toward this goal. However, you are in a position to make this change when the current VHA directive expires at the end of this month. We ask that you act to ensure that our veterans’ access to care is not compromised and that doctors and patients are allowed to have honest discussions about treatment options.”

Even with that change, VA medical providers in states with medical marijuana laws might still be reluctant to discuss the possible benefits of using the drug or its derivative for fear of federal prosecution or DEA enforcement actions, which continue in those states. Several bills aiming to reconcile the federal position with state laws and protect healthcare providers also were proposed in the U.S. House and Senate last year.

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Obstacle Removed

In addition, the Department of Health and Human Services has removed a major obstacle to studying the use of marijuana for treating epilepsy in adults. The Public Health Service no longer needs to review privately funded marijuana research projects.

During the summer, HHS “determined that the PHS review overlaps in several important ways with FDA’s [investigational new drug] process and is no longer necessary to support the conduct of scientifically sound studies into the potential therapeutic uses of marijuana,” according to an HHS statement. The department said it expected that removing the additional review layer will help facilitate research into the health risks and any potential benefits of medications using marijuana, as well as its chemical components or derivatives.

Privately funded studies must still have Food and Drug Administration approval. “Since the early 1990s, the FDA has not been the problem. They recommended resuming research with Schedule 1 drugs, including marijuana, decades ago and have previously approved studies for epilepsy and PTSD in veterans that were rejected by the Public Health Service,” Doblin told U.S. Medicine.

Marijuana was the only Schedule 1 drug that required review by both the FDA and PHS for independently financed studies. Doblin’s organization has attempted to gain approval from both agencies for a study of marijuana in adults with epilepsy for nearly 15 years. With the recent changes, MAPS expects to begin a study of marijuana and PTSD in 76 veterans in April.

The research on marijuana use for epilepsy remains largely anecdotal because of the difficulty in conducting clinical trials, but case reports and early studies show some promise. Margaret Gedde, MD, PhD, of Vibrant Health Clinic in Colorado Springs, CO, reported at the Marijuana for Medical Professionals Conference in 2014 that 72% of her patients who used CBD or other cannabinoids for epilepsy experienced some improvement and about half of those patients saw an 80% or greater reduction in seizures.1

“Studies of CBD and childhood epilepsy have started to change opinions about the use of marijuana in this area. It’s clear that it not only helps, it helps when nothing else does,” Doblin noted.

As of Dec. 31, 19 states have approved the use of medical marijuana to treat epilepsy in adults and children, and 17 others have legalized the use of marijuana-derived CBD to treat intractable epilepsy in children. Additional states are expected to pass similar legislation this year.

CBD has gained FDA orphan drug designation for treatment of two pediatric epilepsy conditions, Dravet Syndrome and Lennox-Gastaut Syndrome. Its manufacturer has also secured fast track designation for Dravet Syndrome and plans to apply for additional epilepsy-related indications.

A Phase 2 study of cannabidivarin (CBDV), another marijuana derivative structurally similar to CBD, in 130 adult patients with epilepsy is ongoing. The Phase 1 study in 66 healthy adults did not identify any serious or severe adverse events, tolerance issues or withdrawal concerns. A study published in The British Journal of Pharmacology found that CBDV prevented more seizures than current antiepileptic medications and provided additional efficacy when combined with current anti-epileptic therapies.2

One significant hurdle to clinical studies on marijuana in epilepsy remains: the need to obtain marijuana for research through the National Institute on Drug Abuse (NIDA) Drug Supply Program.

According to Doblin, NIDA is prohibited from supplying marijuana that could be used as a medicine, but Phase 3 trials must be done with the same strain and concentration that will be taken to market. “Since NIDA cannot sell marijuana that will be used as a medicine, the restrictions block marijuana from ever becoming a prescription drug,” Doblin said.

Until 2015, NIDA also grew only 20 kilograms of marijuana each year, according to a Brookings Institute study on medical marijuana research. That volume seriously restricts the ability of a large number of researchers to perform large scale studies. As of last year, NIDA was funding 28 studies on marijuana, 13 of which used human subjects. Nine of the human studies used synthetic cannabis. Brookings reported that obtaining research-grade marijuana can take years to acquire from NIDA, if the organization agrees to supply it at all.

NIDA has said it will increase its annual supply to more than 600 kilograms, which will make conducting Phase 2 studies easier. “That will allow us to try to figure out whether it works, who are responders and what is the right dose.”

The CBD manufacturer, GW Pharmaceuticals, circumvented the NIDA requirement as a UK company that was able to secure its own supplies and develop the liquid formulation of pure plant-derived CBD that it used for Phase 3 testing and will take to market for various forms of epilepsy.

  1. Gedde M. Clinical Experience with Cannabis in Pediatric Epilepsy. Presentation. Marijuana for Medical Professionals Conference. September 9-11, 2014.
  2. Hill TDM, Cascio M-G, Romano B, Duncan M, Pertwee RG, Williams CM, Whalley BJ, Hill AJ. Cannabidivarin-rich cannabis extracts are anticonvulsant in mouse and rat via a CB1 receptor-independent mechanism. Britch Journal of Pharmacology. October 2013;170(3):679-692.

 


2 Comments

  • Colette lane says:

    That’s just great but this does not work for everyone you need to do your homework on the type of seizure and the severity of this conditions. I am happy that our v.a. our receiving help, but currently at this time the civilians are not getting any type medical help, or necessary medications. Ally of them have had family members who served in the military and served this country! Congress has overlooked thousands of Americans who are currently suffering under the current health guidelines. Also you give information for v.a. but not for patients who are civilian, what’s up with that?

  • Colette lane says:

    That’s just great but this does not work for everyone you need to do your homework on the type of seizure and the severity of this conditions. I am happy that our v.a. our receiving help, but currently at this time the civilians are not getting any type medical help, or necessary medications. Ally of them have had family members who served in the military and served this country! Congress has overlooked thousands of Americans who are currently suffering under the current health guidelines. Also you give information for v.a. but not for patients who are civilian, what’s up with that?


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