Medicine

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

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 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

 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

"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

"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.

More DEA raids in Los Angeles, federal prison bureaucrats ignore a Michigan medical marijuana prisoner's medical needs, federal drug bureaucrats prevail in a medical marijuana research case, and there is lots of action in state legislatures, including a Wednesday afternoon victory in the Illinois House. Let's get to it:

On Monday, a federal appeals court rejected Prof. Lyle Craker's appeal to overturn a DEA decision to not allow him to grow medical marijuana for research purposes.The appeals court sided with the DEA, finding its decision to maintain the federal marijuana cultivation monopoly was reasonable and in line with the Controlled Substances Act. Craker first sought approval in 2001.

California

On Monday, a hearing on a Lake County lawsuit challenging the county's cultivation ordinance was postponed when the judge hearing the case recused himself. Judge Richard Martin recused himself because his son is running for sheriff against Sheriff Frank Rivero, who is a defendant in the case. As a result, the lawsuit against the county and its sheriff will be sent to Lake County Superior Court Presiding Judge Stephen Hedstrom for reassignment. Lake County resident Donald Merill is suing over the Board of Supervisors' decision last summer to approve an ordinance limiting the number of pot plants allowed in outdoor cultivation, banning commercial cultivation of medical marijuana and prohibiting growing on vacant lands in the unincorporated areas of the county. Now, a case management conference set for next week has been pushed back until late August, too late for this year's outdoor growing season.

On Tuesday, supporters of a Los Angeles dispensary initiative kicked off their campaign with a city hall press conference. Proposition D is one of three dispensary initiatives going before city voters on May 21. The measure would cap the number of dispensaries at 135, as would Proposition E, whose backers have switched to supporting Prop D. A third initiative, Proposition F, has no caps on dispensaries, but imposes other restrictions. Both Props D and F would impose a gross tax receipts of 2% on medical marijuana dispensary revenues.

Also on Tuesday, DEA and local law enforcement raided four Los Angeles area dispensaries. Hit were the Zen and Alternative Herbal Health Services dispensaries on Santa Monica Boulevard in West Hollywood, La Brea Compassionate Caregivers in Los Angeles, and Marina Caregivers in Marina del Rey. Law enforcement also executed search warrants at seven other locations and arrested three people. Those arrested are accused of selling marijuana outside of California and various other offenses.

Illinois

On Tuesday, nearly 250 doctors signed on to support medical marijuana legislation pending at the state house. Several of them, along with patients, spoke at a Chicago press conference one day before a vote on House Bill 1 was expected in the House. The bill would create a pilot medical marijuana program, including a dispensary system.

On Wednesday, the bill passed the House on a 61-57 vote. It now goes to the Senate.

Michigan

Late last week, the federal Bureau of Prisons refused to house an ailing medical marijuana patient at one of its medical facilities even though he is a kidney-pancreas transplant candidate, suffers coronary artery disease, and requires a strict medication regime. Jerry Duval, 53, must report to federal prison on June 11 and must serve his sentences at a federal correctional facility in Ohio. His sentencing judge had recommended that he be "placed in a Federal Medical Center or other facility deemed to be appropriate in consideration of the Defendant's medical needs." Last August, Montana medical marijuana prisoner Richard Flor, 68, died in federal prison after his medical conditions were given short shrift.

Nevada

Last Thursday, a medical marijuana dispensary bill won a Senate committee vote. Senate Bill 374 was approved by the Senate Judiciary Committee on a unanimous vote. The bill now goes to the Senate Finance Committee. Because the bill includes fees, it must win two-thirds approval to pass the Senate.

On Saturday, the state's first medical marijuana school opened. The Cannabis Career Institute launched its Budtender School with a workshop for about 40 students on Saturday in Henderson. The school will teach all aspects of the medical marijuana business, including how to grow marijuana legally and bake it into brownies, cookies and cakes. The institute has held similar workshops in other cities across the US, and more than 1,500 people hold certificates from it.

New Hampshire

Last Thursday, medical marijuana legislation got a hearing in a key Senate committee. The bill, House Bill 573, was heard in the Senate Health, Education, and Human Services Committee. Opponents suggested that a clinical study be done, but supporters retorted that such suggestions were merely a way to delay the bill. A similar measure has already passed the House. While Gov. Maggie Hassan (D) has said she would support a tightly regulated program, she has expressed concern about a home-grow option.

New York

On Tuesday, a medical marijuana bill passed the Assembly Health Committee on a 21-4 vote. The bill, Assembly Bill 6357, would allow patients suffering from severe debilitating or life-threatening conditions to use medical marijuana. A practitioner who is licensed to prescribe controlled substances would certify that a patient has a severe debilitating or life-threatening condition that should be treated with the medical use of marijuana.  Certifying and dispensing medical marijuana would be included in the I-STOP prescription monitoring system for controlled substances enacted in 2012.

Also on Tuesday, Gov. Andrew Cuomo (D) said he still opposes medical marijuana. "I do not support medical marijuana. I understand the pros and cons. I understand the argument," Cuomo said. "We are looking at it, but at this point, I don't support medical marijuana. I understand the benefits, the risks. How do you construct a system that really is that tightly controlled that you don’t have dissemination beyond the directed population?"

North Carolina

Last Friday, Rep. Kelly Alexander introduced a medical marijuana study bill. The bill, House Bill 941, would require a legislative research commission to study medical marijuana-related issues. Earlier this session, Alexander had introduced a medical marijuana bill, but that was killed by legislators who complained they were getting too much feedback from constituents.

Oregon

Last Friday, it was learned that the federal government had forced the state to release medical marijuana patient records. The Oregon Public Health Division, which keeps tabs on medical marijuana card holders, has handed over an undisclosed number of patient records as the result of a federal search warrant. The DEA executed the warrant and seized Oregon Medical Marijuana Program records in an investigation into illegal drug activity. The name and number of patients information pulled is still unknown because the investigation is ongoing and more records could be subpoenaed. Patients and activists are not pleased.

Rhode Island

Last Thursday, medical marijuana supporters protested proposed restrictions on caregivers at a rally at the state house. More than two dozen people showed up to oppose amendments to the state's law that would reduce the number of plants that a caregiver could grow from 24 to 12 and allow a patient to grow a maximum of 6 plants. Patients can currently grow twice that number. The caregivers and patients also criticized amendments that would require the growers to notify city or town zoning officials about their plans to grow marijuana.

A bi-partisan group of US representatives led by Rep. Dana Rohrabacher (R-CA) Friday introduced legislation that would end the enforcement of federal marijuana laws in states that have either legalized it or adopted medical marijuana laws. That would bring 18 medical marijuana states and two legalization states -- Colorado and Washington -- out from under the shadow of the Controlled Substances Act when it comes to marijuana law reform.

Dana Rohrabacher

"This bipartisan bill represents a common-sense approach that establishes federal government respect for all states' marijuana laws," said Rohrabacher. "It does so by keeping the federal government out of the business of criminalizing marijuana activities in states that don't want it to be criminal."

Joining Rohrabacher as cosponsors of the bill were Reps. Justin Amash (R-MI), Earl Blumenauer (D-OR), Steve Cohen (D-TN), Jared Polis (D-CO), and Don Young (R-AK).

That brings to at least five the number of marijuana reform bills introduced in the 113th Congress, six if you count an industrial hemp bill. Three of those bills deal with medical marijuana, one with the ability of states to tax marijuana commerce, and one would end federal marijuana prohibition.

Reps. Polis, Blumenauer, Rohrabacher, and others also introduced that latter bill, House Bill 499, the Ending Federal Marijuana Prohibition Act, H.R. 499, which would set up a federal regulatory process -- similar to the one for alcohol -- for states that decide to legalize. Senate Judiciary Chairman Patrick Leahy (D-VT) has said he will hold hearings to examine Colorado and Washington’s new marijuana laws and explore potential federal reforms.

Marijuana law reform efforts in the Congress are being propelled not only by the continuing spread of medical marijuana laws and the impressive victories in Colorado and Washington -- each state saw 55% of voters approve legalization -- but also by ever-mounting evidence that public opinion nationwide is swinging in favor of legalization, and against federal interference in states undertaking marijuana law reforms.

A Pew poll released earlier this month had support for marijuana legalization at 52%, the highest ever for a Pew poll and the first time a Pew poll showed majority support for legalization. Five other recent opinion polls have shown support for legalization hovering at the tipping point, with two of them just under 50%, one at 50%, one at 54%, and one at 57%.

That same Pew poll also found considerable skepticism about enforcing the marijuana laws, with 72% agreeing that "government efforts to enforce marijuana laws cost more than they are worth" and 60% saying that the federal government should not try to enforce marijuana laws in states where it is legal.

"The people have spoken and members of Congress are taking action," said Bill Piper, director of national affairs for the Drug Policy Alliance. "This bill takes conservative principles and applies them to marijuana policy; in terms of the national debate it’s potentially a game-changer."

"This bill is a win for federalism and a win for public safety," said Neill Franklin, a former Maryland narcotics detective and now executive director of Law Enforcement Against Prohibition. "In a time of bitter partisanship, it is quite telling that both Republicans and Democrats are calling for respect for the reform of marijuana laws. Polls show this is a winning issue for politicians, and change is inevitable. We applaud those legislators who, rather than trying to impede this progress, stand with the vast majority of Americans who believe these laws should be respected."

"Marijuana prohibition is on its last legs because most Americans no longer support it," said Steve Fox, national political director for the Marijuana Policy Project. "This legislation presents a perfect opportunity for members to embrace the notion that states should be able to devise systems for regulating marijuana without their citizens having to worry about breaking federal law. If a state chooses to take marijuana sales away from cartels and the criminal market and put them in the hands of legitimate, tax-paying businesses, it should be able to do so without federal interference."

"We've reached a tipping point," said Jasmine Tyler, deputy director of national affairs for the Drug Policy Alliance, "and it is time Congress acknowledge what voters, law enforcement, and state officials have been telling us for years: the feds should stop wasting money interfering when the states are more than capable of regulating marijuana effectively."

Even though this and the other federal marijuana reform bills have been introduced with bipartisan support, their future in the Republican-dominated House this session is murky at best. Some key committee chairs, such as Rep. Bob Goodlatte (R-VA), head of the House Judiciary Committee, are very hostile to any reform efforts. But the pressure is mounting.

The Maryland Senate Monday passed a bill that would allow seriously ill residents to obtain medical marijuana through state-regulated research programs run by academic medical centers. The House of Delegates approved the bill last month; Gov. Patrick O'Malley is expected to sign it shortly.

Drug reform advocates had mixed views on what passage of the legislation accomplishes.

"This marks a major step forward for Maryland medical marijuana patients and their families," said Dan Riffle, deputy director of government relations for the Marijuana Policy Project, which helped shepherd the bill through the legislature. "The Assembly's overwhelming support for this important legislation reflects that of the people of Maryland and the nation as a whole. The time has come to allow seriously ill people to obtain and use medical marijuana if their doctors believe it will help them."

But some expressed skepticism about whether the bill will actually result in patients getting access to medical marijuana. The federal government has long refused to provide marijuana, even for Food and Drug Administration-approved studies, and it is unclear just when and where state-licensed growers might appear.

"Maryland has taken a small step in the right direction, but more steps are necessary for patients to actually obtain the medicine they need to alleviate their suffering," said Amanda Reiman of the Drug Policy Alliance.  "Maryland has many workable and successful models to draw from: Eighteen states and the District of Columbia have successfully legalized marijuana for medical purposes despite the ongoing federal ban. Medical marijuana is used in those jurisdictions by hundreds of thousands of patients with cancer, HIV/AIDS, multiple sclerosis, Parkinson’s disease and other serious and debilitating illnesses."

Still, it is time for academic medical research centers to step up, said Riffle.

"We hope the state's academic medical centers will take action and apply for the program so they can begin meeting the needs of Maryland residents suffering from debilitating medical conditions," he said. "Individuals suffering from cancer, multiple sclerosis, and other serious illnesses should not be forced to obtain their medicine in the underground market."