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Marijuana study for veterans with trauma faces hurdle

Brian Vastag / The Washington Post

Posted: 10/03/2011 06:46:07 AM MDT

WASHINGTON — Getting pot on the street is easy. Just ask the 17 million Americans who smoked the federally illegal drug in 2010.

Obtaining weed from the government? That’s a lot harder.

In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.

But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.

The agency did leave the door open to eventually providing 13 pounds of the weed, which is grown at the University of Mississippi. But the HHS committee that rejected the request provided such conflicting criticisms that the person directing the study, MAPS Director Rick Doblin, is unsure how to address their concerns.

“Their goal at higher levels, I think, is to block the study,” said Doblin, who for 25 years has been jumping through regulatory hoops to launch human studies of marijuana, LSD and MDMA, known as ecstasy, which are all illegal.

The HHS official in charge of the review, Sarah A. Wattenberg, declined to answer questions when reached by phone. Tara Broido, a spokeswoman for the agency, wrote in an e-mail that “the production and distribution of marijuana for clinical research is carefully restricted under a number of federal laws and international commitments.”

The study proposes testing five doses of marijuana in 50 combat veterans with PTSD whose symptoms have not improved despite conventional treatments — typically talk therapy, antidepressants and anti-anxiety medicines.

Many veterans already use marijuana to calm their PTSD, said Mary Tendall, a licensed therapist in Nevada City, Calif., who has treated “hundreds” of traumatized Vietnam, Afghanistan and Iraq veterans.

“It does mellow out the triggered response in a certain population,” said Tendall, referring to hair-trigger anxiety reactions. “But with some, it made them very, very paranoid — it had the opposite effect.”

For Paul Culkin, a 32-year-old Army veteran living in Albuquerque, small daily doses of pot offer a release from sleepless nights and high anxiety.

In November 2004, Culkin suffered neck injuries when a car bomb exploded 30 feet from him in southern Kosovo.

When Culkin returned home, he had “really bad nightmares and insomnia, lots of cold sweats,” he said. He rarely left the house.

Culkin began taking anti-depressants, and he eventually received a medical separation from the Army. He now receives Veterans Affairs disability payments.

New Mexico is one of two states, along with Delaware, that explicitly allows the use of marijuana to treat PTSD. Culkin got state approval in 2008 to use it. “It really gets rid of your nightmares if you smoke before you go to bed,” he said. “You feel like you got some rest finally.”

Doblin thinks marijuana can help many more veterans. A 2004 study in the New England Journal of Medicine estimated that 18 percent of returning Iraq combat veterans had PTSD. And a 2008 report from the Rand Corp., a government contractor, estimated that up to 225,000 veterans will return from the Middle East clinically traumatized.

Medical marijuana is legal in 16 states and the District of Columbia. But obtaining it from the federal government for research requires surmounting an extra regulatory hurdle that is not required for any other drug.

That’s because one government agency, the National Institute on Drug Abuse, controls the nation’s supply of research marijuana. Any non-government researcher wanting access to it needs to satisfy the special HHS committee.

On Sept. 14, Wattenberg, the official in charge of the committee, wrote to Doblin detailing “a number of concerns related to the proposal’s approach, feasibility, and documentation of human subjects’ protection.”

But written comments from the five committee members paint a jumbled picture of sometimes contradictory concerns.

One member wrote that the study should exclude veterans who have previously smoked marijuana. And another committee member asked for the opposite, that the study should only include people who have smoked the drug, as those naive to it might suffer anxiety or panic attacks.

A third reviewer wrote that study participants should be monitored closely — presumably in a hospital — rather than letting them smoke the marijuana at home.

“Turning this into an in-patient study ends the study,” Doblin said. “Nobody will live in-patient for three months, and that increases the study costs astronomically.”

Other comments expressed skepticism that the marijuana in the study — given in weekly batches — could be kept from getting “diverted,” meaning given or sold to non-participants.

In a phone interview, Doblin pointed out that the study’s design satisfied FDA drug-diversion officials.

Participants will be required to videotape their every interaction with the weed, and will have to return any they do not smoke. In addition, a second person will have to witness the smoking and check in with the researchers weekly.

Doblin plans to modify the study and resubmit it to the committee, which will have to unanimously agree before the marijuana sale can move forward, Broido said. But even if HHS approves, another bureaucracy looms — that of the Drug Enforcement Administration. The nation’s drug cops also have to approve the research.

“It’s a long road,” Doblin said. “But it’s worth it. We’re the mythical American trying to play by the rules.”

Original Posting: http://www.dailycamera.com/nation-world-news/ci_19026223?IADID=Search-www.dailycamera.com-www.dailycamera.com

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Evolving List of Cannabis Terms

Clone: an antiquated (pre-July 1, 2011) way of referring to an ‘immature plant’; clones are cuttings from a cannabis plant that grow roots and have the same genetics as the host plant that it was taken from.

 

Cola: the top of a flowering plant, where there will be one large bud.  Colas often ave higher THC content than the rest ofthe flowering plant.

 

Flowering: cannabis is dioecious; each plant produces either male or female flowers, and is considered either a male or female plant.  Male plants usually start to flower about one month before the female; however, there is sufficient overlap to ensure pollination.

 

Kief: is not spelled KEIF and that really bothers me… kief is the loose, dried resin glands (trichomes) of cannabis which may accumulate on containers, in grinders, or be removed with a kiefing screen or sieve.  The term originates from the Egyptian dialect of Arabic, where the word can be translated as “being buzzed” or “liking to get high”.  Kief contains a much higher concentration of desired psychoactive ingredients, primarily THC, than ordinary preparations of cannabis bud from which it is derived.

 

Leaves: there are 3 types of leaves on a cannabis plant.  Large shade, or fan, leaves have low THC and are rarely used in other applications.  Grow tips are small, tender leaves formed during vegetation and are more potent than fan leaves.  Thirdly, trim leaves are generally coated with a layer of trichomes and can be used to make concentrates / hash.

 

Seeds: an alternative to growing with immature plants.  Seeds can be feminized, which will generally produce the most sought after female cannabis plants.

 

Trichomes: the resin glands produced by the cannabis plant that contain the majority of THC, CBN & CDB.  They can be clear, cloudy, or amber, depending on the curing and harvest times.  They resemble small stalks with bulbous heads and range from 15 to 500 microns in size.  To the naked eye, trichomes give cannabis the appearance of being covered with a white dust.

 

Vegetative Growth: the period of maximum growth in a cannabis plant.  The plant can grow no faster than the rate that its leaves can produce energy for new growth.  Each day more leaf tissue is created, increasing the overall capacity for growth.  The vegetative stage is usually completed in the third to fifth month of growth.

 

Lots more to come…

 

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Glaucoma MMJ Research Articles

I found a handful of articles (PDF downloads are available below) relating to treating glaucoma with cannabis, and thought it would be good to post ‘em here. Feel free to send a link if full & free public access to an unmentioned article is available and I will add it to the list for sure.

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Marijuana Smoking vs Cannabinoids for Glaucoma Therapy

http://archopht.ama-assn.org/cgi/reprint/116/11/1433

 

Glaucoma, hypertension, and marijuana

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2552967/pdf/jnma00062-0013.pdf

 

The human eye expresses high levels of CB1 cannabinoid receptor mRNA and protein

http://www.fuoriluogo.it/medicalcannabis/documenti/Porcella-cb1%20in%20human%20eye.pdf


Marijuana smoking and reduced pressure in human eyes: drug action or epiphenomenon?

http://www.iovs.org/content/14/1/52.full.pdf

 

Medical marijuana and the developing role of the pharmacist

http://axon.psyc.memphis.edu/~charlesblaha/7705/Papers_08/samantha_daniel_medical_marijuana.pdf

 

(THC) in the treatment of endstage open-angle glaucoma

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1358964/pdf/12545695.pdf

 

Recent developments in the therapeutic potential of cannabinoids

http://prhsj.rcm.upr.edu/index.php/prhsj/article/view/404/280

 

Cannabinoids in medicine: A review of their therapeutic potential

http://www.omma1998.org/Cannabinoids%20in%20medicine.%20A%20review%20of%20their%20therapeutic%20potential.pdf

 

Marijuana (Cannabis) as Medicine

http://www.cannabis-med.org/data/pdf/2001-01-1.pdf

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Legal Resource for Colorado MMJ Laws

Here’s a listing of some of the wonderful laws which govern what we do and how we do it —
Amendment 20:

HB 1284:

SB 109:

HB 1043:

New MMED Rules (as of 7/1/11):
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Since Feds Won’t Change Policy, We Must Change Federal Law

by Morgan Fox of the Marijuana Policy Project (direct link: http://bit.ly/qdsInq)

The last two weeks have been full of announcements from the federal government about marijuana policy. None of them has been positive, and none of them should be surprising.

First, the Department of Justice stated that it retained the ability to prosecute anyone who cultivates, processes, or distributes medical marijuana, regardless of state law. As noted earlier on this blog, this is not really a change in policy, but it is certainly disappointing to see the Department of Justice is unwilling to publicly recognize the legitimacy of state medical marijuana laws and would rather have patients purchasing their medicine from dangerous, illicit dealers.

Then, in a move that shouldn’t have surprised anyone, the Drug Enforcement Administration, the agency tasked with determining the legal status of drugs according to the Controlled Substances Act, decided to keep marijuana as a Schedule I substance. This classification means that the DEA will continue to assert that marijuana has no accepted medical use and should continue to be a high enforcement priority. Never mind the growing mountain of peer-reviewed studies that show the medical efficacy and relative safety of marijuana. The DEA will only pay attention to government studies, which are not approved unless the goal is to find negative effects, not medical benefits. We should not expect them to reschedule marijuana in the foreseeable future, especially since marijuana enforcement is an easy source of cash and prestige. Americans for Safe Access is currently appealing the decision in federal court, however, and hopefully they will gain some traction on this point and force the DEA to recognize the evidence in support of medical marijuana.

All this was followed by the release of the National Drug Control Strategy, which basically states that the Obama administration will continue to use scarce resources to combat the use of marijuana through criminal justice means, as well as a slightly increased program of harm reduction (which the President has said was going to be his primary focus). The strategy admits that marijuana use is at its highest in the last eight years, yet wants to continue the same strategy it has been utilizing during that same period!

The new strategy also mentions medical marijuana and, while admitting that there may be some medical uses for individual components of marijuana, continues to say that it should pass through the FDA approval process. This would be nice, if we could get all the federal agencies whose stamps of approval are needed to actually allow such research. So far the efforts of those trying to go through the official research and approval process have been blocked. In addition, the new strategy claims that medical marijuana “sends the wrong message to children” and increases the likelihood of adolescents using marijuana. This point ignores the fact that in most medical marijuana states, teen use has actuallydecreased since passing medical marijuana laws. Data supporting this can be found in the Marijuana Policy Project’s Teen Use Report.

So what does all this mean?

It means that all we can expect from the federal government is support of the status quo. We might get some minor concessions here and there, and the fact that the Ogden Memo has been (mostly) followed by the DOJ should not be overlooked. However, we should not look to the federal government to change policy in any drastic way simply of its own free will. They must be legally compelled to do so.

This is why we don’t need statements of policy, nice as they may be. We need different laws. We need something much more binding than policy statements, which can be distorted and rescinded at any moment without legal backing. It is imperative that we convince our legislators to support bills that will weaken the federal government’s control over marijuana policy and enforcement.

Please contact your representative in Congress, and tell them to support H.R. 2306. This bill would remove the federal government’s ability to interfere with state marijuana laws and policies. Legal change is what we really need if we want to see positive change in federal behavior.

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