Effort supports marijuana to treat PTSD
PORTLAND — Medical marijuana supporters in Oregon are seeking to add post-traumatic stress disorder to the list of conditions that qualify patients in the state to use medical marijuana.
According to advocates, many people with PTSD are already in the state program because they have other medical conditions that allow them to legally use marijuana.
But supporters want PTSD to be recognized as a standalone condition as more veterans return home and struggle to resume their lives, The Oregonian reports. Oregon is home to an estimated 300,000 veterans. They include more than 20,000 from the Iraq and Afghanistan conflicts, according to the Oregon Department of Veterans’ Affairs.
Two earlier attempts to add PTSD to Oregon’s program have failed.
Law enforcement entities in the state generally oppose expansion of the program.
Medical marijuana’s potential to help sick veterans deserves serious examination, according to Jason Hansman, senior program manager for the Iraq and Afghanistan Veterans of America.
“We treat it like any other new treatment technique: We want to see it studied. We want to see increased research to see if it’s a viable solution," said Hansman, whose group represents 145,000 veterans.
Darryl Inaba, director of clinical and behavioral health services at the Addictions Recovery Center in Medford, opposes expanding Oregon’s medical marijuana program to include PTSD saying the drug “causes both physical and emotional addiction."
For some veterans, medical marijuana helps them function.
Jared Townsend, a 27-year-old Iraq War veteran, said the drug helps him sleep and “balance life out a little bit better."
Townsend, of Hillsboro, qualifies for medical marijuana because of severe pain from a ruptured disc and injured shoulder from his 2007-08 combat tour. Medical marijuana is a bigger help with his PTSD symptoms, he said.
“If I get racing thoughts and real worked up, it can break a panic attack pretty quick," Townsend said.
Seventeen states and Washington, D.C., have medical marijuana laws. Only a few, however, list PTSD as a qualifying condition.
In New Mexico, which legalized medical marijuana in 2007, the state’s Department of Health said 40 percent of medical marijuana patients list PTSD as their qualifying condition, far more than any other condition.
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White House: No marijuana for PTSD
By Patricia Kime, Military Times
WASHINGTON – An effort to persuade the Obama administration to legalize marijuana for sufferers of post-traumatic stress was met with rejection from the White House.
Responding to a petition signed by 8,258 people on the White House website, Director of the Office of National Drug Control Policy Gil Kerlikowske wrote last month that marijuana is not a "benign drug" and does not meet standards of safe or effective medicine.
"When the President took office, he directed all his policymakers to develop policies on science and research, not ideology or politics," Kerlikowske wrote.
The White House usually requires 25,000 signatures before it will respond to such petitions.
The "Allow United States Disabled Military Veterans Access To Medical Marijuana To Treat Their PTSD" petition was launched last year by former Air Force sergeant Mike Krawitz, executive director of Veterans for Medical Cannabis Access.
Krawitz said he launched the drive partially out of concern that veterans sometimes risk losing their Veterans Affairs Department medical coverage if they are found to smoke pot.
"For many, cannabis not only treats PTSD, it's a lifesaver," Krawitz told Military Times in October.
Seventeen states and the District of Columbia allow doctors to prescribe marijuana for medicinal purposes, but it remains illegal under federal law.
The Obama administration has held steadfast in enforcing federal laws applicable to medical marijuana production, sales and distribution. Kerlikowske said the administration maintains that marijuana use is associated with cognitive impairment, respiratory illnesses and addiction.
"We know from an array of treatment admission information and federal data that marijuana use is a significant source for voluntary drug treatment admissions and visits to emergency rooms," he wrote.
He added that the administration supports research on the phytochemicals in marijuana that might have medicinal value.
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Pro-marijuana group draws ire for name, POW logo use
By Rick Maze, Military Times
A website advocating on behalf of legalized marijuana has offended some veterans by using the acronym for the nation's largest group of combat veterans and by modifying a famous logo showing a soldier being held as a prisoner of war in Vietnam as smoking a joint.
A representative of Veterans for Weed, a Milwaukee-based organization with a website and Facebook page, said they have no plans to stop using the altered logo created for the National League of POW/MIA Families that shows a silhouette of a soldier and a prison tower. The altered logo, which the group is selling on hats, T-shirts and other items, shows the soldier smoking a joint.
The image is not copyrighted, so there is no legal reason why the organization has to stop using the altered image, a Veterans for Weed representative said in an e-mail.
"It was not our intention to offend anyone. We apologize to those we did offend," said the spokesman, who identified himself as Hemp Solo, and said he was a Marine veteran.
Both the website and Facebook page for the marijuana group have received many complaints asking them to stop using the POW/MIA logo and VFW name.
A message posted on the website says: "We did not alter the POW flag lightly, or because we were high. We take it very seriously."
Solo, who did not provide his real name, did not address the issue of using VFW, an acronym that is copyrighted, according to a statement provided by Randi K. Law of Veterans of Foreign Wars.
Law said the legal counsel of the Veterans of Foreign Wars "immediately mailed a cease and desist letter to the group. In an effort to avoid further legal action by VFW, Veterans for Weed must immediately cease using VFW on any communication, products, and etcetera."
"The Veterans of Foreign Wars is not affiliated with, nor does it support Veterans for Weed or its initiatives," Law said.
Use of the altered POW/MIA logo and use on the website of terms such as "stoner soldier" and "semper high" are also offensive, according to Law's statement.
However, the statement agrees that the POW/MIA logo was never copyrighted and is in the public domain.
Ann Mills-Griffiths, chairman of the National League of POW/MIA Families, said in a statement that offenders usually stop using an altered logo when asked.
"In most instances, intervention by veterans and family members have succeeded in halting further use," she said. "That is all we can legally do, calling upon them to do what is right and responsible."
Solo said Veterans For Weed concentrates on trying to change laws that put marijuana users in jail. Use of the VFW name and the altered POW/MIA logo are a way of getting attention, he said.
"It was meant to get vets and non-vets to recognize the issue (of) vets jailed and lives ruined because of a little pot," Solo's statement said. "Some have even killed themselves cause of the persecution."
Acknowledging there may been complaints from veterans on the group's website and Facebook page, Solo said there also have been many positive comments.
"We get positive feedback from around the world. We will not remove it. It is stirring up conversation. When you are in prison because you smoked, or possessed some pot, then you are a POW, prisoner of weed," Solo said.
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The Case for Treating PTSD in Veterans With Medical Marijuana
By Martin Mulcahey theatlantic.com
Studies have already shown the benefits of marijuana for those suffering from PTSD, but can our government agencies be convinced?
Researchers are one bureaucratic hurdle away from gaining approval for the first clinical examination on the benefits of marijuana for veterans suffering from post-traumatic stress disorder (PTSD). The Multidisciplinary Association for Psychedelic Studies (MAPS), working under the auspices of the University of Arizona College of Medicine, are preparing a three-month study of combat veterans who served in Iraq and Afghanistan. The plan is contingent upon final approval by a Department of Health and Human Services (HHS) scientific review panel, which is likely to ratify the proposal after the project leader, Dr. Sue Sisley, alleviated the Food and Drug Administration's concerns over safety precautions. Social and political intrigue surrounding this research is far reaching, attracting opposing factions who must cede biases for the greater good and well-being of servicemen and servicewomen.
The University-controlled study Sisley advocates calls for a triple-blind and placebo-controlled environment. A meticulously prepared proposal recommends a sample base of 50 veterans, whose PTSD symptoms have not improved under current standard medical practices. All participants must agree to abstain from marijuana use for 30 days prior to participation. In two ensuing 60-day periods, the veterans are asked to either smoke or vaporize a maximum of 1.8 grams of marijuana a day (the equivalent of two marijuana cigarettes). The test group will be furnished a weekly supply of various strains of marijuana, with THC levels ranging from 0 percent to 12 percent. Sisley's study objectives are twofold. "With this research, we can actually figure out which symptoms it might help with, and what an optimal dosing strategy might look like." She is also mindful of public opinion regarding medical marijuana. "If we get a chance to do this, we're not taking liberties. This is a carefully controlled, rigorous scientific study. We're not sitting around trying to get these vets high."
If anecdotal evidence were the standard, acceptance of marijuana's calming properties among psychologically scarred soldiers would be a topic relegated to the past. Statistical evidence to support that hypothesis could be petitioned from the state of New Mexico, where medical marijuana is legally prescribed for PTSD. The state's number one diagnosis for a medical marijuana license, a noteworthy 27 percent of the total, lists PTSD as the qualifying criteria for issuance. That statistic comes as no surprise to Sisley, but she stresses circumstantial evidence is not enough to sway the wide range of government agencies she deals with. "We really believe science should supersede politics," she said. "This illness needs to be treated in a multidisciplinary way. Drugs like Zoloft and Paxil have proven entirely inadequate."
"If we get a chance to do this, we're not taking liberties. This is a carefully controlled, rigorous scientific study. We're not sitting around trying to get these vets high."
In neighboring Colorado, the state's legislature failed to pass a proposal mirroring New Mexico's. It effectively forbade Colorado's large veteran population from citing PTSD on medical marijuana applications. Brian Vicente, of the Sensible Colorado organization, became an advocate for veterans after the legislative rejection. Vicente has watched the government fight itself over this issue. "The federal government is, in some ways, divided," Vicente said. "Agencies like the Veterans Administration have taken some fairly decent stances of medical marijuana." Quickly, he adds a qualifier: "But, then you have the DEA [Drug Enforcement Administration] and NIDA [the National Institute on Drug Abuse] and organizations like them blocking research that other parts of the government are authorizing. It's another example of the federal government being schizophrenic and flat-out wrong on marijuana as medicine." This is a frustrating scenario Sisley has encountered first-hand. "I can't help but think they simply don't want to move forward," she said. "Maybe they figure if they stall long enough, we'll give up and go away."
As arguments among American government agencies continue, other nations are taking the lead generating medical arguments that advance Sisley's theory. A study at Israel's University of Haifa showed that marijuana administered to rats within 24 hours of suffering psychological trauma effectively blocked the development of post-traumatic stress disorder. Dr. Irit Akirav's study even concludes there is a time-frame that has to be taken into consideration. "There is a critical window of time after trauma, during which synthetic marijuana can help prevent symptoms similar to PTSD in rats," Akirav stated at the time. "It does not erase the experience, but can help prevent the development of PTSD symptoms." In Germany, Switzerland, and Spain there are currently programs, some government funded, utilizing MDMA (from which the "ecstasy" drug is derived) as a possible inhibitor of PTSD symptoms.
A governmental lack of decisiveness has created unintended consequences and casualties in the medical field. One is Dr. Phil Leveque, a World War II veteran who had his medical license revoked based on the large number of medical marijuana permits he issued for PTSD in Oregon. Leveque estimates he signed 1,000 permits for PTSD, and said he did so with a clear conscience. "Whether they were World War II, Korea, Vietnam or vets from the current conflicts, 100 percent of my patients said it was better than any drug they were prescribed for PTSD," he said. Sixteen states and the District of Columbia currently have laws permitting marijuana for medical use. However, Veterans Affairs physicians are expressly prohibited from recommending patients for enrollment in any state's medical marijuana program. This, again, highlights contradictions at different levels of government agencies.
Veterans Affairs data disclosed that from 2002 to 2009 one million troops left active duty in Iraq or Afghanistan and became eligible for VA care. That's a number that will rise annually, revealing a need for effective treatment of PTSD that cannot be overstated. PTSD remains an enormous consideration with combat troops still serving in Afghanistan, where an estimated six to 11 percent are currently suffering symptoms of PTSD. Statistics among Iraq War veterans are more disturbing, with between 12 to 20 percent of returning vets suffering PTSD-related anxieties. Those are government statistics, and some non-governmental studies suggest that as many as one in every five military personnel returning from Iraq and Afghanistan could suffer various forms of PTSD. Veteran Affairs recognizes these facts, and to its credit funds unconventional studies of PTSD, employing therapy dogs and yoga.
Sisley has found an ally in Rick Doblin, executive director of the leading psychedelic studies group. Doblin has the unenviable job of lobbying Congress under the umbrella of the non-profit MAPS. The pair share a common frustration dealing with the multitude of government agencies, some of whose interests are diametrically opposed. Doblin addresses apprehensions from the administrative standpoint: "We're asking for marijuana from an agency [National Institute on Drug Abuse] designed to prevent people from using marijuana. There's something fundamental that just doesn't work here," he said. Sisley's concerns revolve around medical studies in the field, which often fail to gain approval because of political motives instead of science. "The doctors I know think this war on marijuana is awful, and they're tired of being in the middle of it," she said. "They just want to do real research, or read real research, and not operate around all of these agendas."
Veterans endure a framework of care for PTSD that has not changed since 1980, when PTSD was added to American Psychiatric Association's dictionary of maladies. Federal agencies are clearly confused, unable to reconcile the illegality of marijuana with the benefits it could have on the lives of soldiers and their extended families. These issues are not being addressed in an open forum; instead, they remain hidden behind committee doors or special panels of anonymous voices with unknown prejudices. Medical marijuana remains one of the nation's biggest political hot potatoes, and when combined with our veterans' health creates a unique conundrum for politicians. Disturbingly, the people caught in this crossfire of self-interest are veterans who risked their lives for the system that may be stifling their medical options now.
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Fed agency blocks pot research
By Brian Vastag
The Washington Post
WASHINGTON — Getting pot on the street is easy. Just ask the 17 million Americans who smoked the federally illegal drug in 2010.
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.”
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Marijuana blocks PTSD in rats
Jerusalem - Marijuana administered in a timely fashion could block the development of post-traumatic stress disorder symptoms in rats, a new study conducted at Haifa University has found.
The study, which was conducted by researchers at the university's psychology department and published in the Neuropsychopharmacology journal, found that rats which were treated with marijuana within 24 hours of a traumatic experience, successfully avoided any symptoms of PTSD.
"There is a critical 'window of time' after trauma, during which synthetic marijuana can help prevent symptoms similar to PTSD in rats," said Dr Irit Akirav who led the study.
In the first part of the experiment, rats were exposed to extreme stress, and were found to display symptoms resembling PTSD in humans.
They were then divided into four groups, with the first given no marijuana, the second given a marijuana injection two hours after being exposed, the third after 24 hours and the fourth after 48 hours.
The researchers examined the rats a week later and found that the group that had not received marijuana, as well as the one that received the injection after 48 hours, displayed PTSD symptoms and a high level of anxiety.
Although the rats in the other two groups also displayed high levels of anxiety, the PTSD symptoms had totally disappeared.
"This shows that the marijuana administered in the proper 'window of time' does not erase the experience, but can help prevent the development of PTSD symptoms in rats," Akirav said.
"We also found that the effects of the cannabinoids were mediated by receptors in the amygdala area of the brain, known to be responsible for mediation of stress, fear and trauma," she noted.
While a decisive parallel between emotional states in humans and animals cannot always be drawn, Akirav was confident psychiatrists will take her research forward to implement it on humans.
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Marijuana May Be Studied for Combat Disorder
Support our troops!-UA
By DAN FROSCH nytimes.com 18 july
DENVER — For years now, some veterans groups and marijuana advocates have argued that the therapeutic benefits of the drug can help soothe the psychological wounds of battle. But with only anecdotal evidence as support, their claims have yet to gain widespread acceptance in medical circles.
Now, however, researchers are seeking federal approval for what is believed to be the first study to examine the effects of marijuana on veterans with chronic post-traumatic stress disorder.
The proposal, from the Multidisciplinary Association for Psychedelic Studies in Santa Cruz, Calif., and a researcher at the University of Arizona College of Medicine, would look at the potential benefits of cannabis by examining 50 combat veterans who suffer from the condition and have not responded to other treatment.
“With so many veterans from the wars in Iraq and Afghanistan, there is a widely accepted need for a new treatment of PTSD,” said Rick Doblin, founder and executive director of the psychedelic studies group. “These are people whom we put in harm’s way, and we have a moral obligation to help them.”
In April, the Food and Drug Administration said it was satisfied that safety concerns over the study had been addressed by Mr. Doblin and Dr. Sue Sisley, an assistant professor of psychiatry and internal medicine at Arizona, according to a letter from the drug administration provided by Mr. Doblin.
But the letter also noted that the project could not go forward until the researchers identified where they would get their marijuana. And that cannot happen, Mr. Doblin said, until the project is approved by a scientific review panel from the Department of Health and Human Services, which includes representatives from an assortment of federal health agencies.
If the proposal is approved, Mr. Doblin said, the researchers will use marijuana grown by the University of Mississippi under a contract with the National Institute on Drug Abuse. It is the only marijuana permitted to be used in federally approved studies.
A Health and Human Services spokeswoman said the proposal was still under review. “The production and distribution of marijuana for clinical research is carefully restricted under a number of federal laws and international commitments,” the spokeswoman, Tara Broido, said in an e-mail. “Study proposals are reviewed for scientific quality and the likelihood that they will yield data on meaningful benefits.”
An institutional review board must also approve the study, as well as the Drug Enforcement Administration, Mr. Doblin said.
Getting final approval from the federal government could prove difficult, Mr. Doblin and Dr. Sisley conceded. They said it was far more challenging to get authorization for a study that examines the benefits of an illegal drug than its risks.
“We really believe science should supersede politics,” Dr. Sisley said. “This illness needs to be treated in a multidisciplinary way. Drugs like Zoloft and Paxil have proven entirely inadequate. And there’s anecdotal evidence from vets that cannabis can provide systematic relief.”
Medical marijuana is legal in 16 states and the District of Columbia. But only New Mexico and Delaware specifically list post-traumatic stress disorder as a qualifying condition for treatment, according to the Marijuana Policy Project, a Washington-based group that supports legal regulation of the drug.
Currently, nearly a third of the 4,982 patients approved for medical marijuana in New Mexico suffer from post-traumatic stress disorder, more than any other condition, according to the state’s health department. It is unclear how many are veterans.
One recent Army veteran from Texas who fought in Iraq for 18 months beginning in 2006, said he used marijuana three times a day in lieu of the painkillers and antidepressants he was prescribed after returning home. He asked that his name not be used because Texas does not allow medical marijuana.
The veteran, who said he had been shot in the leg and suffered numerous head injuries from explosions while deployed as a Humvee gunner, said marijuana helped quiet his physical and psychological pain, while not causing the weight loss and sleep deprivation brought on by his prescription medications.
“I have seen it with my own eyes,” he said. “It works for a lot of the guys coming home.”
If the study is approved, veterans who participate would be observed on an outpatient basis over three months, Mr. Doblin said. During two four-week increments, they would be given up to 1.8 grams of marijuana a day to treat anxiety, depression, nightmares and other symptoms brought on by PTSD. Researchers would also observe the veterans for periods when they are not permitted to use marijuana.
In addition to a placebo, researchers plan to use four marijuana strains in the study, each containing different levels of tetrahydrocannabinol (THC), a primary component of the drug. One of the strains will also contain cannabidiol (CBD), another ingredient thought to have an anti-anxiety effect.
Mr. Doblin said the veterans would be allowed to use the marijuana at their own discretion. Half will be instructed to smoke the drug, while the other half will inhale it through a vaporizer.
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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.
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