Executive Branch

Access to medical marijuana continues to expand as more and more states embrace the healing power of the herb. At the same time, hundreds of thousands of veterans of America's decade of wars are returning home burdened with Post Traumatic Stress Disorder (PTSD), a condition as old as war itself, but that in years past went either unrecognized or was seen as a soldier's personal failure, his "shell shock" or "battle fatigue." Could medical marijuana help?

Scott Murphy of Newton, Massachusetts, is an Iraq combat veteran who uses medical marijuana for chronic pain. "I use medical cannabis for chronic pain from a motorcycle accident that was aggravated by my military service," Murphy said. "I had a severe accident when I was 18, I have a rod in my femur and four plates in my hip. The pain is to the point where it is affecting my walk."

But Murphy also wants to ensure that his state's new medical marijuana law provides for access to the plant for PTSD. A man Murphy described as his "best friend," a fellow veteran, committed suicide at age 22 after being kicked out of the Army for misconduct related to his mental issues rather than being given a medical discharge as promised.

"He had been showing signs of PTSD," Murphy recalled. "He was a good soldier, but when he got back from his second deployment he was having problems. When they kicked him out of the Army, he went home and killed himself."

Amid increasing evidence that medical marijuana can have a beneficial impact in helping people cope with PTSD, the push is on to expand access to the healing herb. Murphy spent Monday morning testifying at a public hearing on draft regulations for the Massachusetts medical marijuana program. Although voters voted for the initiative that listed specific qualifying conditions -- not including PTSD -- as well as "and other" conditions, state regulators are considering changing that to "and other debilitating" conditions, a change that Murphy and others fear could limit access to medical marijuana for PTSD patients.

In some medical marijuana states, adding PTSD requires going through a medical marijuana regulatory commission; in others, it is being pushed through the legislature. In Oregon, for example, Senate Bill 281, which would add PTSD to the list of treatable conditions, was approved by the state Senate last Thursday, and now moves to the House. In Michigan, by contrast, hearings on PTSD and medical marijuana were held recently by Michigan's Advisory Committee on Medical Marijuana (ACMM).

State legislatures are proving to be an easier path than unelected medical marijuana overseers, said activists. "There have been a number of states that have tried to petition to get it added to the list that have so far failed," said Kris Hermes, media liaison for Americans for Safe Access.

Air Force veteran Michael Krawitz of Veterans for Medical Cannabis Access (VCMA) and a plaintiff in Americans for Safe Access v. Drug Enforcement Agency, a case which seeks to see marijuana moved out of the Controlled Substance Act's Schedule I, agreed. "That Oregon effort is moving in the legislature because the state oversight panel was so intractable," said Krawitz, who was deeply involved in the effort there. "Any time we've had to go through the process provided by the state to address expanding access to medical marijuana, we've had trouble. Michigan is another example. There, there was a petition to add PTSD, but there was no actual process to do so. They were essentially keeping the process from moving forward until [vaunted Michigan marijuana attorney] Matt Abel sued them. Now, we have hearings before the advisory committee."

The need to do something for veterans is a major impetus behind the push, but PTSD effects lots of people who aren't veterans as well. "It isn't just veterans who suffer from PTSD," Krawitz said. "At that hearing, there were many veterans, but also other people who had suffered trauma -- child abuse survivors, rape survivors, emergency response workers."

Still, veterans mustering out after more than a decade of US wars in Iraq and Afghanistan are coming home with PTSD in record numbers. A 2004 study in the New England Journal of Medicine estimated that 18% of returning Iraq combat veterans had PTSD. And a 2008 RAND Corporation report estimated that up to 225,000 veterans will return from the wars with PTSD.

The trauma of war is reflected not only in the number of vets suffering from PTSD, but even more ominously, in sky-high suicide rates. US military veterans are committing suicide at a rate of 22 per day, up 20% from just five years ago. And according to a Veterans Administration study released in February, that number almost certainly undercounts the number of veteran suicides because of data limitations.

The military and public health workers are keenly aware of the problem, and are attempting to address it through means both conventional and unconventional. The military and the Veterans Administration have been open to therapeutic interventions including yoga, meditation, and the use of companion dogs; they have also armed themselves with the arsenal of psychotherapeutic drugs -- anti-depressants, anti-psychotics, tranquilizers -- available in the standard pharmacopeia. But those drugs can have some nasty side effects, and their utility in treating PTSD is questionable; noting reports of negative consequences, the Army has warned against over reliance on them.

In the search for succor, more and more vets and other victims of PTSD are turning to medical marijuana. But there is a problem. Not only do a majority of states not recognize medical marijuana, even in those states that do, many of them do not allow its use for PTSD. Despite mounting evidence that medical marijuana can help with PTSD, only a handful of medical marijuana states have approved its used. According to Americans for Safe Access, only California, Connecticut, Delaware, New Mexico and Massachusetts would allow for its use for PTSD, and as we have seen above, it's still up in the air in the Bay State.

"As we find more and more people, especially veterans, benefiting from its use, we see the unfortunate absence of availability for patients across the country," said ASA's Hermes, "It's only approved in five states; that means well below half the medical marijuana states recognize the need for patients to use it for PTSD."

Americans for Safe Access supports expanded access to medical marijuana for PTSD, according to Hermes. "We wholeheartedly support the efforts to petition where patients can do so to get PTSD added to the list of conditions, and we're also pushing for recognition inside the Veterans Administration, but that's an uphill slog," he said.

And it isn't only PTSD treatment that's at stake for veterans. "I'm not only pushing for chronic pain and PTSD, but other stress-related combat issues, and that language is one of the things I asked [the Massachusetts Department of Public Health] to clarify today," Murphy said in an interview following the hearing. "Does their definition of 'debilitating' include PTSD? If they're going to use a broad definition of 'debilitating' so that it covers the full spectrum of vets' injuries, that would be one thing. But it's unclear if PTSD or other mental conditions will be covered. I think we should leave the wording with "and other" -- that's what the voters voted on. I don't think we should have to wait until someone's PTSD is so bad it's life-limiting to be able to get access."

Massachusetts regulators were supposed to have their draft regulations ready by May 5, but in the wake of the Boston bombings, that is now up in the air.

Part of the problem with winning acceptance of using medical marijuana for treatment of PTSD is the relative paucity of clinical studies on its safety and efficacy. When the state of Arizona considered adding PTSD to its list of qualifying conditions, researchers hired by the Department of Human Services found very little of use in their review of the literature.

But studies do exist. Krawitz and Veterans for Medical Cannabis Access compiled an impressive set of studies suggesting marijuana is safe and effective in treating PTSD and anxiety for Michigan regulators. (They are downloadable as submitted at the following links: Packet 1, part 1 of 3, Packet 1, part 2 of 3, Packet 1, part 3 of 3, Packet 2, Packet 3). That same packet also went out to New Mexico, where an effort to remove PTSD from the list of treatable ailments was foiled, and to Oregon, where the PTSD bill moved forward this week.

"While we don't have a lot of studies titled 'PTSD Response to Cannabis Therapy,' we do have a preponderance of evidence that shows cannabis works in various ways, including for symptoms of PTSD," said Krawitz.

One important reason the hard science officials would like to see on the efficacy and safety of marijuana for PTSD is federal government obstructionism. The Multidisciplinary Association for Psychedelic Studies (MAPS), for instance, has been attempting for years to win approval for its study of PTSD and medical marijuana. But it's still waiting and still patiently trying to satisfy the endless niggling of the National Institute on Drug Abuse and the Department of Health and Human Services. The DEA and the courts haven't helped either -- the agency in 2011 denied a request by UMass scientist Dr. Lyle Craker to grow marijuana for research purposes, disregarding its own administrative law judge's recommendation to approve it, and a court last week sided with DEA.

Nevertheless, anecdotal evidence on marijuana treatment for PTSD is helping to move the issue forward. The site ProCon.org, which features a major section devoted to medical marijuana, has posted several readers' comments on the subject:

"I had severe reservations about 'smoking pot.' It is illegal and I am a health care professional," one anonymous commenter wrote. "Still, I wanted to feel better, to be myself again, and to be the person I was before the PTSD. I smoked the pot. Immediately I felt relaxed and calm. I smiled and laughed. I finally felt at peace for the first time in two years. I slept my first night in three years without the sleep medication. The next day I felt refreshed and renewed. I had hope again. My son told me that he was so happy to see the old me again."

 

"I was shot thru the right sub and supra orbital sections of the right side of my head exiting over my right ear. They rebuilt 1/4 of my skull," wrote another commenter. "Epilepsy, PTSD, and other issues such as severe anxiety, constant pain and depression... I am still alive because I smoke [marijuana] every day. Empirical evidence has proven to me that failure to utilize generally causes a seizure and at minimum I get really aggressive... I will not live on narcotics. Ibuprofen or aspirin all have side effects worse than any temporary pain. Replacement liver from the damage of man-made drugs? No thanks."

In the meanwhile, veterans and others continue to suffer from PTSD and continue to use marijuana for relief. In states that do not have medical marijuana laws, that makes them criminals. In states that do have medical marijuana laws, but don't allow it to be used for PTSD, they are criminals, too -- unless they hide what they're actually using it for.

"These state medical marijuana control boards are willing to allow vets to have it for pain, but not PTSD, so in states like Arizona, vets suffering from PTSD are using a pain diagnosis to be legal under state law, and that's problematic. We're trying to get people suffering from PTSD to actually come in and get help, and it's difficult because there's a lot of stigma around it. What are we telling our soldiers when we tell them 'tell the doc you have pain, don't say you have PTSD'"? Krawitz asked. "What are we saying about the validity of their condition?"

That leads to other problems, too Krawitz said.

"When we can't recommend medical marijuana for PTSD, we're pushing people to use chronic pain as a qualifying condition, and that leads to police and prosecutors seeing all those pain recommendations and saying there must be fraud in the system," he said. "There are a lot of patients who would otherwise have had recommendations for PTSD."

PTSD sufferers are not waiting for peer-reviewed, clinically-controlled studies to tell them what works. PTSD is a real and growing problem, and medical marijuana appears to do some good. The scientific studies that would satisfy legislators and state review boards need to be done, and that is happening, albeit too slowly, but in the meanwhile, people are suffering because the government they served at risk to life and limb is now obstructing the research that would legitimize their treatment.

At the Multidisciplinary Association for Psychedelic Studies (MAPS) Psychedelic Science 2013 conference in Oakland this weekend there were mind-boggling displays of psychedelic art; tables full of books on LSD, MDMA, peyote, ayahuasca, and other, stranger hallucinogens; weird musical interludes; holotropic breathwork workshops, and indigenous shamans.

There was also some heavy duty science. Stretching over five days of workshops and conference presentations, the MAPS conference is perhaps the premier confab of psychedelic researchers worldwide. A look at just some of the topics covered in the remarkably broad-ranging affair makes that case.

Researchers from around the country and the world presented findings on three "tracks": clinical ("LSD-Assisted Psychotherapy in the Treatment of Anxiety Secondary to Life Threatening Illness," "The Neurobiology of Psychedelics: Implications for Mood Disorders"), interdisciplinary ("Psilocybin in the Treatment of Smoking Addiction: Psychological Mechanisms and Participant Account," "Ethical Considerations in the Medicinal Use of Psychedelics"), and a special track on the South American hallucinogenic tea, ayahuasca ("Ayahuasca Admixture Plants: An Uninvestigated Folk Pharmacopeia," "Ayahuasca, the Scientific Paradigm, and Shamanic Healing").

One series of research reports of urgent and immediate relevance centered on the use of MDMA ("ecstasy") in the treatment of Post-Traumatic Stress Disorder (PTSD). Although PTSD can be caused by any number of traumas, veterans mustering out after more than a decade of US wars in Iraq and Afghanistan are coming home with PTSD in record numbers. A 2004 study in the New England Journal of Medicine estimated that 18% of returning Iraq combat veterans had PTSD. And a 2008 RAND Corporation report estimated that up to 225,000 veterans will return from the wars with PTSD.

The trauma of war is reflected not only in the number of vets suffering from PTSD, but even more ominously, in sky-high suicide rates. US military veterans are committing suicide at a rate of 22 per day, up 20% from just five years ago.

The military and public health workers are keenly aware of the problem, and are attempting to address it through means both conventional and unconventional. The military and the Veterans Administration have been opened to therapeutic interventions including yoga, meditation, and the use of companion dogs; they have also armed themselves with the arsenal of psychotherapeutic drugs -- anti-depressants, anti-psychotics, tranquilizers -- available in the standard pharmacopeia. But those drugs can have some nasty side effects, and their utility in treating PTSD is questionable, and, noting reports of negative consequences, the Army has warned against over reliance on them.

In a Saturday clinical track devoted to MDMA and PTSD, researchers reported on success in Phase II clinical trials (after Phase I studies had proven safety), as well as efforts to get more studies up and running, and the hoops they have to jump through to do so. Canadian researcher Andrew Feldmar perhaps best summed up professional exasperation with the complexities of doing research on drugs governments view with skepticism and suspicion.

"Give me a break!" snorted Feldmar after relating how it took 2 ½ years and three visits from bureaucrats in Ottawa to inspect his pharmacy safe before it was approved before the safe and the study were approved. "This is not science, its politics. Those people from Ottawa were doing what power does -- cover its ass and make people doing what it doesn't want squirm. We are not discovering anything with these studies; we are just proving something we already know. This is all politics."

While Feldmar was at least able to report that his study had been approved, researchers in Australia and England could report no such luck.

 Australian researcher Martin Williams reported that a randomized, double-blind Phase II study there had been stopped in its tracks by a Human Research Ethics Committee.

"The proposal was rejected by the committee with no correspondence," Williams sighed. "We submitted a comprehensive letter of appeal, and it was quickly rejected. Like MAPS in 2000, we're a bit ahead of our time for Australia, where we face war on drugs rhetoric, the psychotherapy community has more a psychopharmacology focus, and we're facing funding and regulatory hurdles."

"For the past eight years, I've been slowly trying to persuade the medical establishment this is worth doing," said British researcher Ben Sessa, who is trying to get a Phase II study off the ground there. "We have lots of war casualties because like the USA, we have a peculiar obsession with imposing democracy around the world."

But his government grant was denied, with regulators saying there was insufficient proof of concept, the trial would be underpowered (because it was small), and the inclusion of patients with recreational drug histories was problematic.

"Those reasons are all rubbish," snorted Sessa, who said he was revising his protocol in hopes of it being accepted. "We went for the Rolls Royce and didn't get it; maybe we'll get the Skoda," he said.

Researchers at the University of Colorado in Boulder have gotten approval for a Phase II study of MDMA with people with chronic, treatment-resistant PTSD, but it wasn't easy. Sometimes the regulatory niggling borders on the absurd, they said.

"We started two years and were waiting on approval from the DEA," said researcher Marcela Ot'alora, who is doing the study with Jim Grigsby. "We thought they read the protocol and would let us know if we were doing something inappropriate, but that wasn't the case. We had to get a 500-pound safe and we put it in the therapists' office, but no, it had to be in the treatment room. Then, we get a second inspection by the DEA, and they said we had to install alarms. We did so, and thought we were good to go. The next day, the DEA and the city zoning department came together. The zoning department said we had to have a half bath instead of a full bath, and no kitchen."

Ot'alora showed slides of workers obediently demolishing the bath tub, but their travails weren't finished just yet.

"The zoning department said we had to find a place zoned for addiction and recovery, and my office met that criteria, so we moved the safe and alarms for a third time, then had a third DEA inspection," she related. "The local DEA said yes, but it also needed approval from headquarters. We had a congressman write a letter to the DEA to speed up the process, and now we have final approval and are screening our first participants. We hope to enroll the first one by the beginning of May."

That would appear to be a good thing, because other researchers reported that when they actually got studies up and completed, they were seeing good results. Israeli researcher Keren Tzarfatyl and Swiss researcher Peter Oohen both reported promising preliminary results from their studies.

But it was US researchers Michael and Annie Mithoefer who reported the most impressive results. They reported on a 2004 Phase II clinical trial with veterans, firefighters, and police officers. The research subjects were given MDMA (or a placebo) and psychotherapy sessions. MDMA-assisted therapy resulted in "statistically significant" declines in PTSD as measured by standard scales, the Mithoefers reported.

"We're doing Phase II studies, giving the substance to people who are diagnosed with PTSD and measuring the treatment effects. The results continue to be extremely impressive," said Michael Mithoefer. "These tools have so much promise for healing and growth. There are lots of reasons to think these will be useful and promising tools."

Existing treatments for PTSD -- cognitive-behavioral therapies, psychodynamic psychotherapies, pharmacological interventions -- too often just don't work for large numbers of sufferers, Mithoefer said. He cited estimates of 25% to 50% who don't respond favorably to existing treatments.

"We have looming problems with veterans coming back from Iraq and Afghanistan, and most of them are not getting the treatment they need," said Mihoefer. "The Veterans Administration is overwhelmed, but also many vets just don't show up for treatment or stay in it. People with PTSD have a lot of trouble with trust, making it hard to form a therapeutic alliance. They can also either be overwhelmed by emotion and then drop out, or they are in avoidance, emotionally numb, and then the therapy doesn't work. If MDMA can increase trust and decrease fear and defensiveness, maybe it can help overcome these obstacles to successful treatment."

But even so, the research effort is starved for funds.

"This would not be happening if not for these remarkable non-profits supporting research," said Mithoefer, referring to groups like MAPS and the Beckley Foundation, which co-hosted the conference. "The government is not funding this, Big Pharma isn't funding this; the community is funding it. We are trying to build bridges, not be a counterculture, and we hope the government will get involved."

What they've found so far is definitely worth pursuing, Mithoefer said.

"We've established that for this kind of controlled use with well-screened people, there is a favorable risk-benefit ratio and no indication of neurotoxicity," he explained, although a small numbers of participants reported unhappy side effects, such as anxiety (21%), fatigue (16%), nausea (8%), and low mood (2%).

With a follow-up three years later, the Mithoefers found that the benefits of MDMA-assisted therapy remained largely intact.

"For most people, the benefits in terms of PTSD symptoms were maintained," Mithoefer reported. "With people who completed the assessment, 88% showed a sustained benefit, and assuming that those who didn't relapsed, that's still a 74% sustained benefit."

The Midhoefers are now in the midst of another Phase II study and are finding similar results.  They are finding reductions in PTSD symptoms as measured by standard measures. They are also finding lots of interest among PTSD sufferers.

"More than 400 vets have called us from around the country," said Mithoefer. "The need is so great. It's heartbreaking that we can't accommodate them all."

Anna Mithoefer read to the audience some of the responses from their research subjects.

"It's like PTSD changed my brain, and MDMA turned it back," reported a 26-year-old Iraq veteran.

"Being in Iraq was bad, but what was worse was having my body back here and part of my mind still in Iraq," said a 27-year-old who had served as a turret gunner in Iraq. "This helped me come home."

"MDMA helped me in so many ways, it feels like it is gradually rewiring my brain," said a female military sex trauma survivor. "The MDMA sessions were the crack in the ice because the trauma was so solid before that. It was incredibly intense around the MDMA sessions -- a lot like popping a big bubble from the unconscious."

The Phase II studies underway or completed strongly suggest that MDMA is useful in the treatment of PTSD. The Phase II studies trying to win approval around the world could strengthen that case -- if they can overcome the political and regulatory obstacles before them. In the meantime, another 22 veterans are killing themselves each day.

The US First Circuit Court of Appeals in Boston Monday sided with the Drug Enforcement Administration (DEA) in rejecting University of Massachusetts-Amherst scientist Dr. Lyle Craker's appeal of the agency's decision to deny him a license to grow medical marijuana for research purposes.

Craker sought to break the federal government's monopoly on the production of marijuana for research purposes. Because of hostility to research on the possible benefits of marijuana in the federal drug control and research bureaucracies, the federal monopoly on marijuana for research purposes created a bottleneck, blocking potential valuable research efforts.

The decision in Craker v. DEA caps a 12-year odyssey through federal regulatory purgatory for Craker and the Multidisciplinary Association for Psychedelic Studies, which had backed the UMass-Amherst scientist's bid to develop a source of marijuana independent of that produced under the auspices of NIDA.

"After such a long struggle, I'm disappointed that the Court failed to recognize the need for an independent source of plant material for use in research on the medical uses of marijuana," said Prof. Craker. "In doing so, they have failed the American people, especially those for whom marijuana as a medicine could help."

Craker first applied for a license from the DEA in 2001; it took the agency three years to initially deny his request. In 2007, the DEA's own administrative law judge recommended that the agency grant his application, but two years later, then DEA Deputy Administrator (and current Adminstrator) Michele Leonhart rejected that recommendation. Craker sought a formal reconsideration, which Leonhart denied in 2011.

Craker then appealed to the First Circuit, with oral arguments taking place in May 2012. In its decision Monday, the First Circuit upheld Leonhart's denial. In so doing, it dismissed Craker's claims that the DEA had changed the rules in the middle of the game and that the supply of marijuana from the NIDA facility was inadequate and uncompetitive. Leonhart's interpretation of the Controlled Substances Act was permissible and her findings were "reasonable and supported by the evidence," the court held.

"This ruling will result in sick people continuing to be denied the medicine they desperately need, and which 18 states and the District of Columbia recognize as legitimate," said Allen Hopper, criminal justice and drug policy director for the ACLU of California and one of the lawyers representing Prof. Craker. "The Obama administration must stop blocking the research necessary to take marijuana through the FDA approval process."

The Obama administration released its Fiscal Year 2014 budget proposal Wednesday, including its 2014 federal drug budget. Pundits and politicians on both sides of the aisle quickly pronounced the Obama budget dead on arrival, but it does provide both a window into administration thinking on drug policy and a starting point for negotiations.

There's not much new. The historic 2:1 ratio between law enforcement and interdiction spending and treatment and prevention spending, representing what critics have long called an over-reliance on enforcement, is slightly attenuated. The Obama 2014 drug budget allocates 58% of spending to enforcement vs. 42% to treatment and prevention. It is a slight improvement over the FY 2013 drug budget, where the figures were 62% and 38% -- starting to climb away from 2:1, if it continues, but not dramatically.

In a post on its web site, the Office of National Drug Control Policy's Rafael Lemaitre writes that treatment and prevention spending now tops domestic law enforcement spending, and "that's what a 21st Century approach to drug policy looks like," but that post does not include interdiction and international drug enforcement spending. When those are included, the Obama drug budget is clearly weighted on the side of law enforcement -- very much what a late 20th Century drug policy looked like.

Still, the budget calls for an 18% increase in treatment funding, and cuts in interdiction and international enforcement funding, as welling as reducing funding for the High Intensity Drug Trafficking Area (HIDTA) program, which generates ever more drug arrests working with state and local drug task forces. But spending for both the DEA and Bureau of Prisons is going up, and that raised the hackles of one drug reform activist.

"The administration deserves some credit for moving this ratio slightly in the right direction over the years, but a drug control budget that increases funding for the DEA and the Bureau of Prisons is simply not the kind of strategy we need in the 21st Century," said Tom Angell, spokesman for the Marijuana Majority. "At a time when a majority of Americans support legalizing marijuana, and states are moving to end prohibition, this president should be spending less of our money paying narcs to send people to prison, not more. If, as administration officials say, 'we can't arrest our way out of the drug problem,' then why are they continuing to devote so many resources to arresting people for drug problems?"

The administration also deserves "some credit" for reducing HIDTA funding, said Angell, but "still $193 million for the program is $193 million more than should be used to arrest people for drugs in the 21st Century."