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Chronicle AM -- March 27, 2014

No marijuana legalization in New Hampshire this year, neurologists recommend cannabis oil for MS, New Mexico pharmacists will start prescribing naloxone, Russian-US drug cooperation is at risk over the Crimea crisis, and more. Let's get to it:

Coat of arms for the Russian Federal Drug Control Service. It's getting the cold shoulder from the US these days. (kremlin.ru)
Marijuana Policy

California PPIC Poll Has Support for Legalization at 53%. A new Public Policy Institute of California poll has support for marijuana legalization at 53% among registered voters, with 60% of independents and 57% of Democrats in favor. On the other hand, 62% of Republicans were opposed.

New Hampshire House Kills Legalization Bill. A bill to legalize marijuana in New Hampshire died in the House yesterday on a 192-140 vote. The House had passed the bill once in January, but support has eroded since then. The measure was House Bill 492.

Medical Marijuana

California Supreme Court Ruling Upholds Local Cultivation Bans. The state Supreme Court Wednesday denied review of an appellate court decision upholding the rights of local governments to completely ban personal cultivation by medical marijuana patients. The ruling came in a lawsuit sponsored by California NORML, which had asked the high court to "depublish" the decision. "We are deeply disappointed by the court's decision," said CANORML Director and Prop 215 coauthor Dale Gieringer, "They have effectively undermined Prop. 215's stated purpose 'to ensure that seriously ill Californians have the right to obtain and use marijuana for medical purposes.'"

American Academy of Neurology Recommends Cannabis Oil for Multiple Sclerosis. The American Academy of Neurology is recommending oral cannabis extract to help ease spasticity symptoms and pain in patients with multiple sclerosis, along with other therapies, in new evidence-based complementary and alternative medicine (CAM) recommendations. Click on the link for more details.

Kentucky CBD Medical Marijuana Bill Passes House. The House voted 98-0 Wednesday to approve a bill allowing the use of high CBD cannabis oil to treat seizures in children. Senate Bill 124 has already passed the Senate, but must return there for approval of minor changes made in the House version of the bill.

Heroin

Kentucky Heroin Bill Wins House Committee Vote. A bill that would address heroin use with a combination of increased penalties for trafficking and harm reduction measures for users squeaked through the House Judiciary Committee on a one-vote margin. But Senate Bill 5 faces an uncertain future; civil libertarians oppose some law enforcement provisions, while some elected officials oppose some harm reduction provisions.

Harm Reduction

New Mexico Pharmacists to Start Prescribing Overdose Reversal Drug. New Mexico pharmacists are the first in the nation to be certified to prescribe the overdose reversal drug naloxone (Narcan). The first batch of 60 pharmacists have been trained and certified by the state Health Department. New Mexico law allows pharmacists to prescribe certain drugs.

Law Enforcement

Detroit Drug Sweep Nets Arrests, Not Many Drugs. Yesterday's sweep of poor Detroit neighborhoods, the most recent in a series of mass drug sweeps, yielded 44 felony and 19 misdemeanor arrests, two grams of cocaine, three grams of heroin, 25 pounds of marijuana, 4,000 prescription pills, $14,500 in cash, and about two dozen illegal weapons. Similar raids in November, December, and February have netted similar results.

International

US Drug Official Rejects Invitation from Russian Counterpart. Deputy director of the Office of National Drug Control Policy (ONDCP) Michael Botticelli has rejected an invitation to meet on drug issues in Moscow, citing the ongoing Crimea crisis. "Given the continued violation of the sovereignty and territorial integrity of Ukraine by Russia, we are suspending some bilateral discussions with the Russian Federation, including this one," Rafael Lemaitre, ONDCP communications director, told Itar-Tass news agency. Russian Federal Drug Control Service chief Viktor Ivanov is one of the Russia political figures sanctioned by the US as a result of the Crimea conflict.

International Ibogaine Providers Conference in South Africa in May. The 4th International Ibogaine Provider's Conference will take place between May 7 and 10 in Durban, South Africa. Discussions will cover a broad spectrum of topics, from developments in research, treatment protocol, and legislation. The featured topic of interest for the conference will be the sustainability of tabernanthe iboga, the implications of ibogaine treatment on regional practices in Africa, and ways that international collaborations can help to ease the effects of demand on iboga's availability. Click on the link for more details and registration information.

Chronicle Book Review: High Price

High Price: A Neuroscientist's Journey of Self-Discovery That Challenges Everything You Know About Drugs and Society, by Dr. Carl Hart (2013, Harper/Harper Collins Publishers, 340 pp., $26.99 HB)

Dr. Carl Hart grew up black and poor in Miami in the 1970s and 1980s, learned discipline from his desire to be a professional athlete, joined the armed forces, and wandered almost by happenstance into a career in the neurosciences. Now, Hart is at the pinnacle of his field -- a respected researcher in drug effects, the first African-American to become a tenured professor in the sciences at Columbia University, and a member of the National Advisory Council on Drug Abuse and Dependency. And he has some things to say.

Some of those things contradict the conventional wisdom, but Hart has the cred -- both street and academic -- to state them. Although it is the addict or problematic drug user who is too often the media's face of drug use or the subject of scientific research, he notes, the vast majority of drug users are not addicts or problematic. And yes, that even extends to the most demonized drugs, like crack. While we were told one hit could get you strung out, it turns out only a small fraction of crack consumers are addicts, he points out.

Hart also has good, practical advice -- naive drug users shouldn't take drugs the same way experienced users do, for example, or get enough sleep! -- based not only on scientific research, but also personal observation and experience. Now at the pinnacle of his profession, he also wants to restore some sanity to our drug policies.

Dr. Hart has come a long way from the mean, if sun-splashed, streets of Miami, and with High Price, he takes you along for the ride. The journey is well worth it. Part memoir, part social history, part drug science, part plea for sanity on the issues of drugs, race, and class, High Price is revelatory as well as readable, illuminating as well as incisive, as impassioned as it is important.

While Hart grew up the wrong color and in a family scrabbling to hang on to its lower middle class status, his is, above all, an American story -- a story of coming of age, overcoming adversity, and striving for success and understanding in a world seemingly stacked against him. It's also the story of the American working class, buffeted by the de-industrialization that began in the 1970s, targeted by Reagan Republicans with cuts in social programs in the 1980s, and mostly dealt with by "tough on crime" and "tough on drugs" policies that have been in place ever since. That the malignant swelling of the nation's prison population is tied to Reagan era policies ( though many of them enacted by Democratic legislators) too often goes unnoted.

But of course, Hart isn't an unhyphenated American, he's African-American, and that means he carries an additional burden, the assumption too many make of criminality based on little more than his skin color. He wasn't expected to succeed, but to become a number, like so many of his peers. And, as he notes, but for the grace of god he could have gone down that path. He recounts the teenage criminality of he and his peers, making the stark point that a single arrest could make the difference between a career as a scientist and a career as an ex-con car washer. Some of his friends, no better or worse than he, had that unfortunate first encounter with law enforcement and the criminal justice system and never recovered: Educational opportunities blocked, job opportunities lost, they were essentially assigned to the scrap heap.

For some of them, it was a drug bust. Slinging dope was and is a way of life for the marginalized poor, an income, although not a great one, and a way to achieve status and respect. But of course, it's also a ticket to the slammer, particularly if you're poor and of color, without the resources available to middle class white folks. One thing Hart makes crystal clear is just how stacked the deck is against the urban poor, and that alone makes his book worth noting.

Hart grew into young adulthood imbibing the conventional wisdom about how drugs had had such a devastating impact on his community, but he also began to start thinking critically about the mismatch between rhetoric and reality. At some point along the way, he had a Chris Rock moment.

"You know what they say, crack is destroying the ghetto," Rock once famously observed. "Yeah, like the ghetto was so nice before crack. They say that shit like everyone in the 'hood had a yacht, a mansion, and a swimming pool, and crack came by and dried it all up."

As Hart began studying psychology and eventually neuroscience, he began noticing that the effects of crack cocaine widely touted in media and political discourses didn't match the science. In fact, he observed, most of the devastating effects attributed to crack could more fairly and accurately be attributed to poverty. Crack didn't bring guns to the ghetto; they were already there. Crack didn't bring broken families to the ghetto; they were already there. It may not have helped, but it was not the root cause of the problem.

"The effect of crack, when it had one, was mainly to exacerbate the problems that I'd seen in my home and in the hood since the 1970s," he wrote. "The drug's pharmacology didn't produce excess violence."

The studies on which he embarked, moving on from observing the effects of drugs on rats to observing their effects on people, led him to a startling -- and eye-opening -- conclusion: "Much of what we are doing in terms of drug education, treatment and public policy is inconsistent with scientific data."

Hart's critique extends to the science itself. He describes famous experiments where rats or monkeys alone in a cage will repeatedly press a lever to get more drugs, up to the point of death itself. But he then explains how those doses are many times higher than those any human would use, and he makes the crucial point that obsessive drug-taking behavior is reduced when the lab animals are part of a community and when they have other options.

Based on his scientific research, as well as his own observations and historical research (and musical and lyrical inspiration from the likes of Bob Marley and Public Enemy), Hart decided he needed to speak out against the injustices of the war on drugs. He became a board member of the Drug Policy Alliance, he began speaking to groups large and small, and High Price is part of that same education project.

This is not your typical drug policy tome. It's not a paean to pot, nor is it a dry academic treatise. But it is important, not only because it provides a voice for the voiceless peers he left behind, but also because it is a science- and evidence-based clarion call for a smarter and more human approach to drugs, one that situates drugs and problematic drug use within the broader social context. And it's a damned good read, too.

Drug Prohibitions Hurt Science, Researchers Charge

In a paper published Wednesday in the journal Nature Reviews Neuroscience, a group of leading scientists argue that global drug prohibition has not only compounded the harms of drug use, but also produced the worst censorship of research in centuries. They likened the banning of psychoactive drugs and the subsequent hampering of research on them to the Catholic Church banning the works of Copernicus and Galileo.

Prof. David Nutt (gov.uk)
The paper, Effects of Schedule I Drug Laws on Neuroscience Research and Treatment Innovation (abstract only), was written by Professor David Nutt of Imperial College London and Leslie King, both former government advisors, and Professor David Nichols of the University of North Carolina-Chapel Hill.

The possession of marijuana, MDMA (ecstasy) and psychedelics are stringently regulated under national laws and international conventions dating back to the 1960s, but those laws are not based on science, and the global prohibition regime is rigid and resistant to change, they argued.

"The decision to outlaw these drugs was based on their perceived dangers, but in many cases the harms have been overstated and are actually less than many legal drugs such as alcohol," said Nutt, professor of neuropsychopharmacology at Imperial College London. "The laws have never been updated despite scientific advances and growing evidence that many of these drugs are relatively safe. And there appears to be no way for the international community to make such changes."

In the paper, Nutt and his colleagues argue that the scheduling of psychoactive drugs impedes research into their methods of action and therapeutic potentials and sometimes makes it impossible.

"This hindering of research and therapy is motivated by politics, not science," said Nutt. "It's one of the most scandalous examples of scientific censorship in modern times. The ban on embryonic stem cell research by the Bush administration is the only possible contender, but that only affected the USA, not the whole world."

Research in psychoactive drugs should be free of severe restrictions, the scientists argued.

"If we adopted a more rational approach to drug regulation, it would empower researchers to make advances in the study of consciousness and brain mechanisms of psychosis, and could lead to major treatment innovations in areas such as depression and PTSD," Nutt said.

Nutt headed Britain's Advisory Committee on the Misuse of Drugs until 2009, when he was forced out by the Labor government of Prime Minister Gordon Brown. Nutt was sacked after publicly criticizing the government for ignoring the committee's scientific advice on marijuana on ecstasy. He then became chair of the Independent Scientific Committee on Drugs, which aims to review and investigate the harms and benefits of drugs free from political interference.

London
United Kingdom

The Push is On for PTSD and Medical Marijuana [FEATURE]

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?

http://stopthedrugwar.org/files/scott-murphy-iraq-deployment-200px.jpg
Scott Murphy Iraq deployment photo
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."

Michael Krawitz testifying in support of Oregon bill
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.

Scott Murphy at 2013 press conference (courtesy ASA via YouTube)
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.

Psychedelic Science Conference Examines MDMA Treatment for PTSD [FEATURE]

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.

Psychedelic art, MAPS 2013
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.

Dr. Michael Mithoefer describes his MDMA PTSD research protocol
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."

Indigenous Huichol shaman from Mexico
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."

Peyote-infuenced Huichol art
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."

Psychedelic Homer Simpson, MAPS 2013
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.

Oakland, CA
United States

Did You Know? "Ranking 20 Drugs and Alcohol Based on Overall Harm," on ProCon.org

Did you know that the harmfulness of a drug can be rated with at least 16 different criteria? Read the details in "Ranking 20 Drugs and Alcohol by Overall Harm," on the web site medicalmarijuana.procon.org, part of the ProCon.org family.

This is the second in a six-part series of ProCon.org teasers being published in Drug War Chronicle. Keep tuning in to the Chronicle for more important facts from ProCon.org the next several weeks, or sign up for ProCon.org's email list or RSS feed. Read last week's Chronicle ProCon.org piece here.

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Did You Know? 105 Medical Studies Involving Cannabis and Cannabis Extracts, on ProCon.org

Did you know there were 105 peer-reviewed medical studies involving cannabis and cannabis extracts between 1990 and 2012? Read the details at 105 Peer-Reviewed Studies on Marijuana -- Medical Studies Involving Cannabis and Cannabis Extracts (1990 - 2012), on the web site medicalmarijuana.procon.org, part of the ProCon.org family.

This is the first in a six-part series of ProCon.org teasers being published in Drug War Chronicle. Keep tuning in to the Chronicle for more important facts from ProCon.org the next several weeks, or sign up for ProCon.org's email list or RSS feed.

ProCon.org is a web site promoting critical thinking, education, and informed citizenship by presenting controversial issues in a straightforward, nonpartisan primarily pro-con format.

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