Releaf Magazine

DEA Loosens Restrictions On Scientists Studying Marijuana

By Dan Nosowitz on January 12, 2016

Martijn, Flickr

Legalization of cannabis is generally moving quite a bit faster than research on how cannabis actually affects the body; scientists who have been hamstrung by the law from studying the plant are still, despite its increasing legality, subject to the same laws.

That scientists are playing catch-up is basically unavoidable; all it takes to overturn a law is a vote, but adequate research can take years or decades. This is an important ongoing story; news regularly comes that we don’t really have any idea what’s in cannabis products, let alone how the body metabolizes it all. In place of decades of research (which other substances, like alcohol, have), cannabis has hearsay and guesswork.

A significant step forward was announced last month by the Drug Enforcement Administration (DEA) to address a problem regularly felt by scientists studying cannabidiol, a cannabis extract. Cannabidiol researchers are subject to all kinds of regulations because marijuana and all its derivatives remain listed as a Schedule I drug by the Controlled Substances Act, written way back in 1970. That means that the DEA has control over any scientists wishing to study any of those substances, and the DEA maintains an awfully tight grip on them.

Until now, any researchers wishing to study cannabidiol would have to be certified by both the FDA (because cannabidiol research falls under the heading of new drug research) and the DEA. The latter decides who is fit to study cannabidiol and exactly how much they’re allowed to possess.

This is a problem because if a researcher changes the scope of his or her investigation, or simply runs out of cannabidiol, they’re required to apply via a written application to the DEA for more material. This process can take weeks or months, delaying or even outright disabling the study. It’s one of those little red tape things that can actively harm our understanding of a substance used by a huge percentage of the population.

The DEA’s announcement changes all that, stating that any researcher who is previously approved to study cannabidiol can do away with that extra application process: If you’re approved to study it, you can have as much as you need, when you need it. And with any luck, this will free up researchers to learn more about marijuana and its extracts as laws banning them are steadily lifted throughout the country.


VIA Modern Farmer

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New Report Blasts DEA For Spending 4 Decades Obstructing Marijuana Science

via neboagency

The Drug Enforcement Administration has been impeding and ignoring the science on marijuana and other drugs for more than four decades, according to a report released this week by the Drug Policy Alliance, a drug policy reform group, and the Multidisciplinary Association for Psychedelic Studies, a marijuana research organization.

“The DEA is a police and propaganda agency," Ethan Nadelmann, executive director of the Drug Policy Alliance, said Wednesday. “It makes no sense for it to be in charge of federal decisions involving scientific research and medical practice."

The report alleges that the DEA has repeatedly failed to act in a timely fashion when faced with petitions to reschedule marijuana. The drug is currently classified as Schedule I, which the DEA reserves for the "most dangerous" drugs with "no currently accepted medical use." Schedule I drugs, which include substances like heroin and LSD, cannot receive federal funding for research. On three separate occasions -- in 1973, 1995 and again in 2002 -- the DEA took years to make a final decision about a rescheduling petition, and in two of the cases the DEA was sued multiple times to force a decision.

The report criticizes the DEA for overruling its own officials charged with determining how illicit substances should be scheduled. It also criticizes the agency for creating a "regulatory Catch-22" by arguing there is not enough scientific evidence to support rescheduling marijuana while simultaneously impeding the research that would produce such evidence.

A spokesperson at the DEA declined to comment on the report.

The feds have long been accused of only funding marijuana research that focuses on the potential negative effects of the substance, but that trend appears to be changing.

According to The Hill, the National Institute on Drug Abuse has conducted about 30 studies to date on the potential benefits of marijuana. NIDA oversees the cultivation, production and distribution of marijuana grown for research purposes at the University of Mississippi in the only federally legal marijuana garden in the U.S. -- a process through which the only federally sanctioned marijuana studies are approved.

The joint report comes less than two weeks after the House approved three amendments taking aim at the DEA and its ability to enforce federal marijuana and hemp laws in states which have legal marijuana operations and industrial hemp programs. The medical marijuana amendment was sponsored by Rep. Dana Rohrabacher (R-Calif.).

"Nobody should be afraid of the truth," Rohrabacher said Wednesday. "There's a lot of other drugs that have harmful side effects. Is the downside of marijuana a harmful side effect? Or is there a positive side that actually does help? That needs to be proven."

The federal government's interest in marijuana certainly appears to be growing. Since 2003, it has approved more than 500 grants for marijuana-related studies, with a marked upswing in recent years, according to McClatchy. In 2003, 22 grants totaling $6 million were approved for cannabis research. In 2012, that number had risen to 69 approved grants totaling more than $30 million.

"The DEA has obstructed research into the medical use of marijuana for over 40 years and in the process has caused immeasurably suffering that would otherwise have been treated by low-cost, low-risk generic marijuana," Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, said in a statement. "The DEA’s obstruction of the FDA approval process for marijuana has -- to the DEA’s dismay -- unintentionally catalyzed state-level medical marijuana reforms.”

Currently, 22 states and the District of Columbia have legalized marijuana for medical use. Eight other states -- Alabama, Iowa, Kentucky, Mississippi, South Carolina, Tennessee, Utah and Wisconsin -- have legalized CBD oils, made from a non-psychoactive ingredient in marijuana frequently used to treat epilepsy, for limited medical use or for research purposes.

A number of recent studies have shown the medical potential of cannabis. Purified forms may attack some forms of aggressive cancer. Marijuana use also has been tied to better blood sugar control and may help slow the spread of HIV. One study found that legalization of the plant for medical purposes may even lead to lower suicide rates.

Nadelmann said the DEA has "demonstrated a regular pattern of abusing its discretionary powers."

"We believe this authority would be better handled by another government agency in the health realm, or even better still, by an organization that is truly independent, perhaps something that involves the National Academy of Sciences," he said. "We will be working to encourage greater congressional oversight and also to call for reforms of federal law."


Via Huff Post

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Medical Marijuana For Migraines?

Migraines are a severe form of headache that are estimated to affect 15% of the worldwide population. Patients describe the attacks as throbbing sensations in a specific area of the head, usually accompanied by nausea, vomiting and extreme sensitivity to light and sound.

Unfortunately, the cause of migraine attacks remain a mystery to researchers and many patients fail to obtain relief from currently available treatments.

On the other hand, the use of medical marijuana as a migraine treatment dates back to the 19th century and – despite modern-day prohibition – has gradually rebounded in recent years.

In fact, surveys conducted in California suggest that around 5% of medical marijuana patients use the substance for migraine relief.

What Causes Migraines?

Migraine headaches involve a complex array of underlying factors that researchers have yet to unravel. Still, studies have made some progress towards identifying the source of migraines.

In addition to genetic factors, migraines have been linked to inflammation and abnormalities of specific areas of the brain, including the brain stem. Dilation of blood vessels in the brain and high serotonin levels are also believed to contribute to migraine headaches.

19th Century Medicine

Sir William Osler (1849-1919)

Sir William Osler (1849-1919) is regarded as the founder of modern medicine

Cannabis was widely prescribed by Western doctors throughout the latter half of the 19th century. Specifically, the use of cannabis as a treatment for migraines was supported by a number of prominent physicians of the time, including Sir William Osler.

In 1915, Sir Osler wrote that ‘Cannabis indica is probably the most satisfactory remedy’ for migraines and cited others in recommending a ‘prolonged course’ of cannabis treatment.

In the following year, Dr. Dixon, Professor of Pharmacology at the Kings’ College and the University of Cambridge, also wrote about the therapeutic benefits of smoked cannabis for headache sufferers.

Interestingly, cannabis was included in various 19th century pharmacopoeias as a treatment for migraines.

Unfortunately, modern-day research has yet to investigate the effectiveness of marijuana-based treatments in migraine patients. However, numerous studies conducted on animal models provide strong support for its therapeutic potential.

The Role of Cannabinoids in Migraines

The endocannabinoid system consists of cannabinoids produced naturally by the human body as well as the receptors they bind to in order to achieve their effects. These receptors are known as cannabinoid receptors and are found in high concentrations throughout the brain.

The brain stem contains a high number of sensory nerves

The brain stem contains a high number of sensory nerves

Activity of cannabinoid receptors has been shown to have a positive impact on a wide range of factors involved with migraine headaches. As well, experts have suggested that a lack of endocannabinoids may contribute to the development and severity of migraine attacks.

For instance, studies have identified low levels of endocannabinoids in patients with chronic migraine, which experts suggest could increase blood vessel dilation as well as pain from migraine attacks.

Interestingly, an animal study published in 2007 found that increased activity of the endocannabinoid system led to a reduction in pain signals sent by the brain stem. The authors concluded that cannabinoids showed promise as a treatment for sufferers of migraines and other headaches, although psychoactive effects could be a problem for some users.

“The data suggest that CB receptors may have therapeutic potential in migraine, cluster headache, or other primary headaches.” (Akerman et al., 2007)

In another animal study published in 2011, researchers found further evidence of the potential for cannabinoids to relieve pain associated with migraines as well as the possible role of endocannabinoid system abnormalities in migraine attacks.

“The study confirms that a dysfunction of the endocannabinoid system may contribute to the development of migraine attacks and that a pharmacological modulation of cannabinoid receptors can be useful for the treatment of migraine pain.” (Greco et al., 2011)

Studies also suggest that endocannabinoids may reduce activity of specific serotonin receptors (5-HT3) involved with symptoms of nausea and pain. Other studies have found endocannabinoids and CBD to be effective at decreasing the activity of serotonin itself. THC has also been shown to minimize the release of serotonin from blood cells, all of which suggests a role for marijuana compounds in regulating serotonin levels in migraine patients.

Finally, numerous studies show that cannabinoids found in marijuana – including THC and CBD – can have strong anti-inflammatory effects. In fact, an animal study published in 1973 found that THC was 20 times stronger than aspirin and nearly twice as strong as hydrocortisone in reducing acute inflammation.

Human Case Studies

Over the years, a number of researchers have published case reports documenting the effectiveness of medical marijuana in treating migraine headaches.

Dr. Grinspoon is a Harvard Medical School graduate and professor.

Dr. Grinspoon taught at Harvard Medical School

In 1993, Dr. Lester Grinspoon co-wrote and published a book entitled Marihuana: The Forbidden Medicine, in which the use of marijuana for migraines was covered in detail. One story involved a migraine sufferer who had repeatedly failed to obtain relief from standard pharmaceuticals, eventually finding that small doses of marijuana worked best for managing their symptoms.

Interestingly, migraines have also been reported by patients after regular cannabis use is stopped. A paper entitled ‘Marijuana and Migraine’ (El-Mallakh, 1987) presented 3 of such cases, noting that one patient was able to relief their migraine attacks by using cannabis again while the other 2 found standard drugs to work effectively.

Finally, a more recent case study published in 2009 described the ability of marijuana to stop cluster headaches in a patient who had failed to obtain relief from traditional medications. Remarkably, the patient found marijuana to work within 5 minutes of taking the drug.

But despite strong historical and anecdotal evidence of the effectiveness of medical marijuana for migraine headaches, clinical trials involving human patients have never been conducted. As such, migraine sufferers who turn to cannabis for relief are likely to face resistance from the medical community over the ‘unproven’ safety and effectiveness of this alternative headache treatment.



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Oh cool, now its medicine…..

Buzz Kill: Marijuana Genome Sequenced For Health, Not Highs

Hey there, please don't call me a stoner. -UA

by Eliza Barclay

Stoners and scientists alike may be stoked to learn that a startup biotech company has completed the DNA sequence of Cannabis sativa, or marijuana. But here's something that could ruin a high: The company hopes the data will help scientists breed pot plants without much THC, the mind-altering chemical in the plant. The goal is instead to maximize other compounds that may have therapeutic benefits.

Kevin McKernan, founder and chief executive officer of the company, called Medicinal Genomics, says Cannabis sativa has 84 other compounds that could fight pain or possibly even shrink tumors. But anti-marijuana laws make it difficult for scientists to breed and study the plant in most countries. That's one reason he decided to publish his data for free on Amazon's EC2, a public data cloud.

McKernan, who has an office in Massachusetts and a lab in the Netherlands, where he can legally gather DNA from marijuana plants, has spent most of his career studying tumors in humans. But he tells Shots he had several friends with cancer who asked him about medical marijuana and whether it might do them some good. That got him interested in the emerging medical research on pot's healing properties.

Then he heard about a drug called Sativex, a Cannabis-derived drug developed by a German pharmaceutical company to treat muscle stiffness from multiple sclerosis. Sativex contains THC and another cannabanoid called CBD, which the company says keeps the psychoactive effects of THC in check. The drug is now available in the United Kingdom, Spain and Germany, and it's in trials to see if it works for cancer pain.

McKernan says Sativex might just be one of the first in a line of future pharmaceuticals using cannabis compounds for a variety of serious illnesses.

"We know which genes govern CBD and THC, but not the other 83 compounds," McKernan tells Shots. "Now that we've sequenced this genome, we can sequence other strains, and then we can tie the differences in DNA to different traits."

Opening up access to the data is especially important for a plant like Cannabis, McKernan says, because many scientists who'd like to study it in the U.S. and other countries can't get a license to grow it.

"A lot of people who want to contribute to this field can't, but now that this information is available, a lot of research can get done without growing any plants," McKernan said.

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Let the nose dive begin……

Marijuana DNA Sequenced by Startup in Search for Medical Uses

By Meg Tirrell

Once big pharma gets this, its lights out for most of us.-UA

Kevin McKernan was leading Life Technologies Corp. (LIFE)’s Ion Torrent DNA-sequencing research when a new business opportunity caught his eye: marijuana.

A year later, McKernan, 38, has quit his job, formed a startup run from his house in Marblehead, Massachusetts, and announced today that the company had sequenced the entire genome of the cannabis plant.

The project, which cost about $200,000, may lead to the development of treatments for cancer, pain and inflammatory diseases, he said. McKernan’s company, Medicinal Genomics, is making the data public using Inc. (AMZN)’s EC2 cloud- computing system. McKernan called the work a “draft assembly,” and it hasn’t yet been published in a peer-reviewed academic journal.

“This is the beginning of a more scientific approach to the genetics of the species,” Richard Gibbs, director of the Human Genome Sequencing Center at the Baylor College of Medicine in Houston, said in a telephone interview yesterday. “This is not really about marijuana; it’s about pharmacology.”

An important step to find a species’ potential utility is to map its DNA, the building block of life, according to Gibbs, who said he has known McKernan for more than 15 years.

McKernan worked on the Human Genome Project from 1996 to 2000, and started a commercial laboratory with his two brothers called Agencourt Bioscience, which was sold to Beckman Coulter Inc. in 2005. A spin-out of Agencourt that made sequencing technology, called Agencourt Personal Genomics, was acquired by Applied Biosystems Inc., which combined with Invitrogen Corp. in 2008 to become Carlsbad, California-based Life Technologies. Life Technologies bought Ion Torrent last year for $375 million in cash and stock.

Open Access

McKernan said his company’s goal is to allow researchers to find ways to maximize the cannabis plant’s therapeutic benefits and minimize its psychoactive effects.

“These pathways can be optimized in the plant or cloned into other hosts for more efficient biologic production,” Medicinal Genomics said in a statement. “It may be possible through genome directed breeding to attenuate the psychoactive effects of cannabis, while enhancing the medicinal aspects.”

The plant makes chemical compounds called cannabinoids, a class that includes tetrahydrocannabinol, or THC, the main psychoactive substance in marijuana. Another such compound called cannabidiol, or CBD, has shown promise in shrinking tumors in rats without the psychoactive effects, McKernan said.

Medical Uses

“That one has been predominantly bred out of the plant as it’s been bred for recreational use,” he said. His company’s business model is to develop assays to enable regulators, government agencies or pharmaceutical companies to research cannabis’s gene pathways.

Donald Abrams, a professor of medicine at the University of California, San Francisco, who has done research into medical cannabis since 1997, said scientists have been able to study the plant without knowing the genome.

“We know what the active ingredients of the plant are already,” Abrams, chief of oncology at San Francisco General Hospital, said in a telephone interview. “You don’t need the genome; you need the plant.”

Companies such as GW Pharmaceuticals Plc (GWP), based in Salisbury, England, have developed cannabis-based medicines. GW sells Sativex for muscle spasms related to multiple sclerosis, using THC and CBD.

McKernan said he was initially convinced to pursue the research after seeing papers published in academic journals including Nature on the plant’s tumor-shrinking effects in rats.

“One in three people are going to get cancer, and one in four are going to die with it or from it,” he said. “So any compound, as preliminary as this may be, that’s nontoxic and shows hope there, we should be all over.

“The only way I knew how to do that was to sequence the genome.”

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