U.S. Appeals Court To Hear Oral Arguments In Case Challenging DEA's Denial Of License For Medical Marijuana Production Facility
On Friday, May 11, the United States Court of Appeals for the First Circuit in Boston, Mass., will hear oral arguments in a federal lawsuit against the Drug Enforcement Administration for denying University of Massachusetts-Amherst Prof. Lyle Craker a license to grow marijuana for privately funded medical research. The arguments are the culmination of nearly 11 years of legal and administrative proceedings seeking to end the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana for research.
The lawsuit is a response to an August 15, 2011, final order issued by the DEA rejecting a DEA Administrative Law Judge's 2007 recommendation that it would be in the public interest to grant Craker the license. A laboratory at the University of Mississippi funded by the National Institute on Drug Abuse is currently the only facility in the U.S. permitted to grow marijuana for research.
Craker is represented in the case by Washington, D.C., law firm Covington & Burling LLP and the American Civil Liberties Union.
Craker first applied in June 2001 for a DEA license to start a marijuana production facility at the University of Massachusetts-Amherst under contract to the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research and educational organization whose mission includes developing marijuana into an FDA-approved prescription medicine. Prior to Craker's application, NIDA had refused to sell marijuana to two FDA-approved MAPS-sponsored protocols, preventing them from taking place.
In September 2011, NIDA refused to sell marijuana to a third FDA-approved MAPS-sponsored protocol, this one of 50 U.S. veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD), preventing it from taking place. MAPS and Craker are working to open the door for privately funded drug development studies conducted under FDA regulations.
Despite increasingly widespread recognition of marijuana's therapeutic benefits and formal policies in 17 states and the District of Columbia, the federal government still insists that marijuana is a dangerous drug with no medical value. Even if MAPS and Craker's efforts to open the door for privately funded, federally regulated non-profit medical marijuana research are successful, it will likely take a decade for marijuana to become an FDA-approved prescription medicine. In the meantime, getting PTSD patients access to the treatments they need will depend on the continuing success of state-based medical marijuana policy reform.
DOCKET TO BE CALLED FRIDAY, MAY 11, 2012 AT 9:30 A.M
COURT OF APPEALS PANEL COURTROOM, 7TH FLOOR
BEFORE JUDGES: Torruella, Lipez, Howard09-1220 Lyle E. Craker v. Drug Enforcement AdministrationAppellant 15 min. Appellee 15 min.
The Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) nonprofit research and educational organization that works with government regulatory agencies to develop whole-plant marijuana into an FDA-approved prescription medicine.
More information is available at www.maps.org/research/mmj .
The Petitioner's Reply Brief in Lyle E. Craker v. Drug Enforcement Administration is available at www.maps.org/mmj/dealawsuit/2012.05.04_Craker_Reply.pdf .
Fed agency blocks pot research
By Brian Vastag
The Washington Post
Obtaining weed from the government? That’s a lot harder.
In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.
But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.
The agency did leave the door open to eventually providing 13 pounds of the weed, which is grown at the University of Mississippi. But the HHS committee that rejected the request provided such conflicting criticisms that the person directing the study, MAPS Director Rick Doblin, is unsure how to address their concerns.
“Their goal at higher levels, I think, is to block the study,” said Doblin, who for 25 years has been jumping through regulatory hoops to launch human studies of marijuana, LSD and MDMA, known as ecstasy, which are all illegal.
The HHS official in charge of the review, Sarah A. Wattenberg, declined to answer questions when reached by phone. Tara Broido, a spokeswoman for the agency, wrote in an e-mail that “the production and distribution of marijuana for clinical research is carefully restricted under a number of federal laws and international commitments.”
The study proposes testing five doses of marijuana in 50 combat veterans with PTSD whose symptoms have not improved despite conventional treatments — typically talk therapy, antidepressants and anti-anxiety medicines.
Many veterans already use marijuana to calm their PTSD, said Mary Tendall, a licensed therapist in Nevada City, Calif., who has treated “hundreds” of traumatized Vietnam, Afghanistan and Iraq veterans.
“It does mellow out the triggered response in a certain population,” said Tendall, referring to hair-trigger anxiety reactions. “But with some, it made them very, very paranoid — it had the opposite effect.”
For Paul Culkin, a 32-year-old Army veteran living in Albuquerque, small daily doses of pot offer a release from sleepless nights and high anxiety.
In November 2004, Culkin suffered neck injuries when a car bomb exploded 30 feet from him in southern Kosovo.
When Culkin returned home, he had “really bad nightmares and insomnia, lots of cold sweats,” he said. He rarely left the house.
Culkin began taking anti-depressants, and he eventually received a medical separation from the Army. He now receives Veterans Affairs disability payments.
New Mexico is one of two states, along with Delaware, that explicitly allows the use of marijuana to treat PTSD. Culkin got state approval in 2008 to use it. “It really gets rid of your nightmares if you smoke before you go to bed,” he said. “You feel like you got some rest finally.”
Doblin thinks marijuana can help many more veterans. A 2004 study in the New England Journal of Medicine estimated that 18 percent of returning Iraq combat veterans had PTSD. And a 2008 report from the Rand Corp., a government contractor, estimated that up to 225,000 veterans will return from the Middle East clinically traumatized.
Medical marijuana is legal in 16 states and the District of Columbia. But obtaining it from the federal government for research requires surmounting an extra regulatory hurdle that is not required for any other drug.
That’s because one government agency, the National Institute on Drug Abuse, controls the nation’s supply of research marijuana. Any non-government researcher wanting access to it needs to satisfy the special HHS committee.
On Sept. 14, Wattenberg, the official in charge of the committee, wrote to Doblin detailing “a number of concerns related to the proposal’s approach, feasibility, and documentation of human subjects’ protection.”
But written comments from the five committee members paint a jumbled picture of sometimes contradictory concerns.
One member wrote that the study should exclude veterans who have previously smoked marijuana. And another committee member asked for the opposite, that the study should only include people who have smoked the drug, as those naive to it might suffer anxiety or panic attacks.
A third reviewer wrote that study participants should be monitored closely — presumably in a hospital — rather than letting them smoke the marijuana at home.
“Turning this into an in-patient study ends the study,” Doblin said. “Nobody will live in-patient for three months, and that increases the study costs astronomically.”
Other comments expressed skepticism that the marijuana in the study — given in weekly batches — could be kept from getting “diverted,” meaning given or sold to non-participants.
In a phone interview, Doblin pointed out that the study’s design satisfied FDA drug-diversion officials.
Participants will be required to videotape their every interaction with the weed, and will have to return any they do not smoke. In addition, a second person will have to witness the smoking and check in with the researchers weekly.
Doblin plans to modify the study and resubmit it to the committee, which will have to unanimously agree before the marijuana sale can move forward, Broido said. But even if HHS approves, another bureaucracy looms — that of the Drug Enforcement Administration. The nation’s drug cops also have to approve the research.
“It’s a long road,” Doblin said. “But it’s worth it. We’re the mythical American trying to play by the rules.”
FDA Accepts Protocol for Study on Marijuana and PTSD
Check out our articles on PTSD and veterans in our June issue........-UA
Research on hold until approved by PHS and NIDA
HerbalEGram: Volume 8, Number 6, June 2011 American Botanical Council
On April 28, 2011, the US Food and Drug Administration (FDA) accepted a protocol from the Multidisciplinary Association for Psychedelic Studies (MAPS) for studying marijuana and post-traumatic stress disorder (PTSD) in veterans.1 If it obtains the remaining federal government approvals, as well as funding, the study will be the “first controlled clinical trial testing the therapeutic potential of marijuana for treating PTSD.”
MAPS aims to develop psychedelics and marijuana (cannabis sativa) into prescription medicines that treat conditions for which conventional medicines have provided limited relief. It has wanted to study the effect that marijuana has in patients with PTSD since noticing that more and more veterans were reporting the use of marijuana to treat PTSD symptoms.
“The idea that marijuana could be helpful for PTSD has been around for some time,” said MAPS Founder and Executive Director Rick Doblin, PhD (e-mail, May 17-June 1, 2011). “The reports of the veterans were what drew our attention to our need to learn more about how and in what ways marijuana impacted PTSD patients.”
According to Dr. Doblin, the MAPS research crew spent 8 months designing their study protocol and going through a “friendly but rigorous” critique process for further refining. After submitting to FDA, the organization and government agency were in close communication for 6 months until the recent acceptance announcement.
“I wasn't surprised with FDA's favorable review since I have come over the last 2 decades to respect the FDA's willingness to put science over politics,” said Dr. Doblin. “Still, it's breathtaking every time FDA gives us permission for a new precedent, like conducting the marijuana/PTSD study as an outpatient study. It means we understand each other's concerns.”
But before the study can begin, MAPS must obtain additional approval from a protocol review process that exists for no other Schedule 1 drug but marijuana. It is conducted by the Public Health Service (PHS) and the National Institute on Drug Abuse (NIDA)—2 government agencies with reputations for obstructing research on marijuana’s potential medical uses.2
PHS and NIDA Review
All human clinical research using controlled substances must receive approval from the Drug Enforcement Administration (DEA) and permission from FDA to proceed with protocols assessing risks and benefits of an Investigational New Drug (IND). Approval is also required from an Institutional Review Board (IRB), which reviews the protocol and informed consent to protect the rights of the subjects. Only marijuana research proposals must additionally receive scientific merit approval from a PHS/NIDA protocol review committee, after NIDA has signified that it has sufficient cannabis to support the proposed study.2
As a result of the requirement for PHS/NIDA review, researchers encounter a tedious process that often ends in denial or delay.2 While a handful of marijuana research has been approved by PHS/NIDA, several researchers have been denied, often despite FDA and IRB approval of the studies’ designs.
For example, MAPS, California NORML, and a private, DEA-licensed pharmaceutical industry analytical lab, Chemic Labs (Canton, MA), joined in 2003 to study vaporization as an alternative to smoking cannabis. After a 6-year process, PHS/NIDA rejected Chemic’s protocol design—disabling them from obtaining 10 grams (less than half an ounce) of marijuana—and asked the lab to conduct about $60,000 worth of studies to prove the calibration of its instruments—costs that Dr. Doblin has said were not necessary for the pilot study. Due to the frustrating process and unlikely approval, Chemic decided to stop trying to conduct the research.
Due to the PHS/NIDA protocol review procedure, when FDA accepted MAPS’ protocol, it also told the research organization that its IND application would continue to be on clinical hold until it provides information on the chemistry, manufacturing, and controls of NIDA's marijuana, also known as CMC information.1
“That information is held/owned by NIDA, which will not share it with us unless the PHS/NIDA protocol review committee approves the protocol,” said Dr. Doblin.
MAPS sent its protocol to PHS and NIDA for review on the afternoon of April 28, and has not yet received feedback on timeframes or the identities of the reviewers. “I am starting to think we have a 50/50 chance of the protocol being approved after a fair, scientific evaluation,” said Dr. Doblin. “I’m proud of the design; it's complex and will generate lots of useful data, and the patients/veterans are a socially powerful group. I expect the process will take about a year—exceedingly slow, compared to FDA, which is required to review protocols within 30 days. After it all, we could easily get rejected.”
Quality and Price of Research Material
If the MAPS protocol is approved by PHS and NIDA, it still is “deeply concerned” about the quality of NIDA’s marijuana, said Dr. Doblin. Published research, in addition to concerns voiced by respected marijuana researchers as well as Dr. Doblin, have stated that NIDA marijuana contained abundant stems and seeds; is dry and often several years old; had thick, pungent, and pervasive smoke; been of inconsistent potency and adversely affected research; and been of “such poor quality” that research could not proceed.2
The organization also has concerns regarding the price of the research material. “I’ve asked NIDA about the expected price about 6 months ago and haven't heard back,” said Dr. Doblin. “I anticipate about $7—$8 dollar per gram. In large scale medical marijuana production facilities in Israel, production cost is around $1 a gram, [and is] of a much higher quality.”
Additionally, MAPS is also troubled with spending around $10 million on medical marijuana research while being prohibited by NIDA and DEA from producing its own marijuana. Because NIDA retains a monopoly on the production of marijuana for prescription use, it could theoretically charge high prices, with no competition on quality.2
Protocol and Future of Planned Study
The research that MAPS hopes to conduct is a randomized, triple-blind, placebo-controlled, crossover study testing smoked and vaporized marijuana for management of chronic, treatment-resistant, military service-related PTSD in 50 combat veterans.1
Persons who have experienced past traumatic events—childhood abuse, natural disasters, car wrecks—can develop PTSD, which is an anxiety disorder with symptoms such as nightmares, flashbacks and intrusive thoughts and feelings, emotional numbness, sudden anger or fear, and difficulty sleeping.3 Soldiers who have fought in combat often return home with PTSD. For non-military civilians, PTSD occurs in 6-to-10% of the population; for US soldiers who fought in the Iraq War, it was 18%.1 As of 2004, the US government was sending disability payments totaling about $4.3 billion to 215,000 veterans, most of whom fought in the Vietnam War. These numbers and the financial and emotional costs associated with PTSD are expected to continue to rise with the wars in Iraq, Afghanistan, and now, also in Libya.
According to the MAPS’ protocol, THC (tetrahydrocannabinol)—one of the principal active components in marijuana—triggers a response from certain receptors in the hippocampus, amygdala, and prefrontal and anterior cingulate cortex, suggesting that THC is involved in “regulating anxiety, attention to and response to stressful situations, and may be involved in the extinction of conditioned fear.”
While a few therapies, like cognitive behavioral counseling and selective serotonin re-uptake inhibitor drugs, are used to treat PTSD, some patients are not helped by these interventions. MAPS thinks that marijuana treatment might help these types of PTSD sufferers by reducing nightmares and improving sleep and mood.
“Marijuana has the effect of suppressing dream recall,” noted Dr. Doblin. “For people with nightmares, that's a benefit. Marijuana also helps people focus on the here and now, which reduces the power of the traumas of the past. But, as with all drugs, marijuana isn't for everyone and some people with PTSD will find that it doesn't help at all, and can even make things worse. When it works, it’s mostly used on a daily basis that reduces symptoms but doesn’t cure.”
If NIDA and PHS eventually approve MAPS’ protocol, both the study’s lead researcher, Sue Sisley, MD, and the pharmacist working where the marijuana will be stored must obtain a controlled substances license from DEA. According to Dr. Doblin, MAPS would then purchase the marijuana from NIDA, submit the CMC information to FDA, seek approval from an institutional review board, raise funds, and start treating subjects.