Monday, July 14, 2014

Medical marijuana research stalls after Arizona professor is let go

By Saundra Young, CNN

(CNN) -- A well-known medical marijuana researcher at the University of Arizona says a study she's been planning for four years has cost her her job.
Dr. Sue Sisley, a clinical assistant professor in the college of medicine, has been with the university for nearly eight years in several capacities. She has been planning a pioneering study on marijuana's effect on veterans with chronic post-traumatic stress disorder, or PTSD.

"I was on the forefront of the most controversial research happening at the university," said Sisley, the study's principal investigator, said. "And they did not like the optics of veterans smoking and vaporizing marijuana on their campus, even in the context of a rigorous, FDA-approved, randomized controlled trial."
That trial was designed to look at the safety and efficacy of using marijuana to treat veterans who suffer from PTSD and aren't responding to other approved treatments. Seventy veterans were to participate in the randomized, triple-blind study, in which five different potencies would be used; some would be placebos and others would contain doses of up to 12% tetrahydrocannabinol, or THC, the psychoactive ingredient in pot.

For decades, studies to determine the medical benefits of cannabis have been few and far between because the Drug Enforcement Agency classifies it as a Schedule I drug -- the most dangerous class of drugs. That puts it in the same category as heroin, LSD and ecstasy. Schedule I drugs are defined by the agency as "drugs with no currently accepted medical use and a high potential for abuse."

Last year, a search of the U.S. National Library of Medicine revealed 2,000 recent papers on marijuana. But the majority explored the harm of marijuana; only 6% investigated the benefits. It's yet another reason, Sisley says, that this research is important for veterans all over the world.

"All the countries that have vets suffering with PTSD are looking for new treatment options, so the eyes of the world have been on this study for years now and have propelled it forward."

Sisley, a psychiatrist, has been working with vets with PTSD for 15 years. She claims that even with the various government approvals of the study, dating back three years, it was all contingent on the university providing a study location -- something she says they failed to do.

Then last month Sisley says she received notice that her three contracts would not be renewed and she feels politics is behind the move.

Sisley said: "They won't give us a reason and they certainly don't want to admit it's political." She also said her job evaluations and performance have been excellent, adding: "Job performance is not the issue here. It's about the university being fearful of the word 'marijuana' and not wanting their brand aligned with this research."

But now the university is talking about it. While they will not discuss Sisley specifically, Chris Sigurdson, a university spokesman, told CNN Thursday that several employees, who were not involved in marijuana research, also received non-renewal notices.

In a statement they say, "The University of Arizona does not comment on personnel issues. In regard to marijuana research, in general, in 2013, the UA championed state legislation to ensure that universities could perform medical marijuana research on campus ... The UA has not received political pressure to terminate any employee as has been suggested in some media and other reports."

In fact, Sigurdson says, the university is committed to the study and has reached out to the Multidisciplinary Association for Psychedelic Studies (MAPS), which is funding the study. "We have been in contact with MAPS, assured them that we want to continue the research and will forward the candidate for the principal investigator."

But MAPS is standing by Sisley:

"We told them that we are glad they are interested in the research, but we haven't agreed to do it with them," said Rick Doblin, founder and executive director of MAPS. "Our goal is still to get Dr. Sisley back her job and we will continue to support her in that. That's our preference."

Right now, they are still working with her.

"We'll be supporting her and her lawyers' efforts to submit an appeal for her reinstatement at the university," Brad Burge, MAPS' communications and marketing director, added. "We expect to receive that proposal for the principal investigator candidate from the University of Arizona, but we are going to continue focusing on Dr. Sisley's appeal to the university."

In the meantime, Sisley, who hopes to get her job back, has hired a lawyer.
Politics dealt the research a blow in April. State Sen. Kimberly Yee, who chairs the Senate Education Committee, singlehandedly blocked a bill that would allow the use of surplus state funds toward the study -- and others on the beneficial effects of medical marijuana -- by refusing to allow a hearing for the House-passed bill.

Yee would not discuss Sisley's dismissal but said in a statement to CNN: "This $9 million of state money could otherwise be used for much needed K-12 education programs and drug abuse prevention. There was significant opposition from the Arizona county prosecutors and veteran-led drug prevention groups. I could not in good faith hear the bill in committee when it came to the Senate."

Sisley says veterans deserve this research and she will not give up.

"We will somehow persevere and find a home for this work. So if it's not at U of A it will be somewhere. We are negotiating with several other universities."
On Wednesday, Will Humble, the director of Arizona's Department of Health Services, wrote on his official "director's blog" that he authorized "the use of marijuana (under AMMA) for patients that are currently undergoing conventional treatment for a diagnosis of PTSD." However, he says, marijuana could only be used for palliative care of PTSD symptoms, not for the treatment of the disorder.

Science and Research of Medical Marijuana

source: Medscape

Enroll at CTU 

Dustin Sulak, DO, is a doctor on the front lines of medical marijuana.

Sulak has recommended various forms of marijuana to his patients and has seen striking results. Patients with chronic pain needed fewer prescription pain meds. Patients with multiple sclerosis had less painful muscle spasms. Patients with severe irritable bowel syndrome began to eat again.

“These responses are the most impressive to me,” says Sulak, who practices at Maine Integrative Healthcare in Manchester. Maine is one of 20 states, along with the District of Columbia, where medical marijuana is legal. “With irritable bowel syndrome, we’ll see patients who were at death’s door turn around dramatically.”

Sulak’s experience is powerful and adds to the large body of personal stories dating from 5,000 years ago -- about the therapeutic value of marijuana.

But the scientific evidence behind the drug’s benefits remains elusive, even as 10 more states consider legalizing medical uses in 2014. The problem: In 1970, the federal government classified marijuana as an illegal, highly addictive drug with no medical value, making research harder to do.

A Marijuana Discovery
Here’s what is known: About 20 years ago, scientists discovered a system in the brain that responds to 60 chemicals in marijuana, also known as cannabis. It’s called the endocannabinoid system. This system plays a role in many of the body’s functions, such as in the heart, along with the digestive, endocrine, immune, nervous, and reproductive systems. The discovery sparked interest in finding specific chemicals made from marijuana that could be targeted for specific conditions.

Since that time, scientific projects around medical marijuana worldwide have sped up dramatically. Many of the studies that have been done show that chemicals in marijuana can help treat some conditions. They have helped manage pain and reduced muscle spasms in MS patients. They’ve worked as an appetite stimulant, and as an alternative drug for brain disorders such as schizophrenia and Tourette’s syndrome.

Few of these studies, though, followed a controlled clinical trial. This is considered the best type of trial because it compares a drug to another drug, or to a placebo (a "fake" treatment).

Also, most of the studies had fewer than 200 patients. So doubt continues about marijuana’s value and who it really can help, says J. Michael Bostwick, MD. He's a psychiatrist at the Mayo Clinic and author of a review of medical marijuana research.

Based on medical science, it seems possible that marijuana-based treatments could be developed for some conditions; but federal restrictions make it hard for the research to advance, Bostwick says.

That’s because scientists in the U.S. have to get approval from the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) to do research on medical marijuana.

A series of studies allowed by the DEA came to a conclusion similar to Bostwick's. The 13 studies were done by The Center for Medicinal Cannabis Research at the University of California in San Diego between 2000 and 2010.

The conclusion: “Cannabinoids may be useful medicine for certain indications” and deserve further research, wrote Igor Grant, professor and executive vice chairman of the Department of Psychiatry at the university. The studies also showed that inhaling marijuana through a vaporizer or a spray was a better way to deliver it than by smoking.

Among the unanswered questions about medical marijuana is the risk to users. About 10% of people who smoke marijuana become addicted. It’s not known what that means if it is being used for medical reasons, Bostwick says. He adds that some patients find the effects of marijuana “intolerable.”

Dustin Sulak, D.O. Discusses Medical Cannabis.

Marijuana-Based Drugs
Despite the obstacles, three FDA-approved drugs are made from marijuana. They include:

Marinol and Cesamet (Nabilone): Both drugs are used to treat nausea and lack of appetite related to chemotherapy and in AIDS patients. They are man-made versions of THC, the primary chemical in marijuana that gives users a “high.” Both were approved in the 1980s.

Epidiolex: This drug to treat children’s epilepsy received FDA approval in 2013. Its use is highly restricted.

Another drug, Sativex, is in clinical trials in the U.S. for pain with breast cancer. It is a combination of chemicals from the marijuana herb and is sprayed into the mouth. Sativex is approved in more than 20 countries to treat muscle spasms from MS and cancer pain.

Research on Marijuana
No single organization tracks all research studies of medical marijuana and marijuana-based drugs and herbs. The following review is a summary of controlled studies since 1990. It is based on reporting; research provided by NORML, the marijuana legalization advocacy group; and data found in PubMed, the National Institutes of Health’s RePORTER, and a database maintained by the International Association for Cannabinoid Medicines, a medical marijuana research organization based in Cologne, Germany.

Alzheimer’s Disease: One 1997 trial found that synthetic THC could ease symptoms of Alzheimer’s. Patients were less agitated and ate better after treatment.... more studies

Autism: Two animal studies show that chemicals in marijuana may help symptoms of some forms of autism. A study of children with autism is underway at the ..... more studies

Cancer: Several studies on animal and human cells and a small study on 9 people suggested THC and other cannabinoids (chemicals derived from cannabis) might slow the growth of brain cancer. Multiple lab studies in human cells have also shown the potential for them to slow other kinds of cancers, such as breast cancer and leukemia; no studies in people have taken place..... more studies

Chronic Pain: More than 45 studies have looked at marijuana and pain related to chronic diseases such as cancer, diabetes, fibromyalgia, multiple sclerosis, HIV, rheumatoid arthritis, and spinal injuries. The studies have included smoked marijuana, along with herbal and man-made forms. The majority of the studies showed an improvement in pain relief in comparison to a placebo or to other traditional pain medications. About a quarter of the studies showed no improvement..... more studies

Epilepsy: Personal stories and animal studies have shown that cannabidiol, one of the chemicals in cannabis, may help seizures in children with epilepsy. New York University just announced it will do a study of children with epilepsy and marijuana..... more studies

Digestive Disorders: Personal stories and several early studies have shown that smoking marijuana can help people with digestive diseases such as colitis, irritable bowel syndrome, and Crohn’s disease. Some of the results included a reduction in bowel inflammation and reduced acid reflux.

Further, some patients were able to retain more nutrients in their bodies, and the disease went into remission..... more studies

MS: More than 24 studies have looked at smoked marijuana, cannabinoids, and MS. Most reported that it helped relax patients’ rigid muscles and helped with pain. Sativex is approved to treat MS in 24 countries, but not in the U.S..... more studies

Schizophrenia: Two clinical trials showed that THC and cannabidiol could help with psychotic and other symptoms. The National Institutes of Health is funding a small clinical trial that also aims to show whether THC and cannabidiol can ease symptoms..... more studies

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Saturday, July 12, 2014

Arizona official: Medical pot can be used for PTSD

Click here for POST TRAUMATIC STRESS DISORDER/ PTSD and cannabis studies completed

source: AZ Central

Arizona's top health official said Wednesday that people authorized to use medical marijuana may soon begin using the drug to relieve symptoms of post-traumatic stress disorder, if a physician recommends it.

The decision by state Department of Health Services Director Will Humble will allow PTSD sufferers, beginning Jan. 1, to use cannabis for palliative care -- but not as a primary treatment for the disorder.

Arizona's medical marijuana law provides two ways patients can use medical marijuana: to treat specific medical conditions or for palliative care -- to make life more comfortable for those suffering from medical ailments.

The decision is a big win for medical marijuana advocates, many whom have long said cannabis is effective in treating PTSD.

In announcing his decision, Humble cited a recent study published in the Journal of Psychoactive Drugs that provides evidence that marijuana may be helpful in the palliative care of PTSD in some patients.

"Today I issued a Director's Decision that will authorize the use of marijuana ... for patients that are currently undergoing conventional treatment for a diagnosis of PTSD," Humble wrote in a blog post to be published Wednesday on the health department's website. "Physician certifications would be valid only for the palliative care of PTSD symptoms (not treatment). Certifying physicians will be required to attest that they have reviewed evidence documenting that the patient is currently undergoing conventional treatment for PTSD before signing the medical marijuana certification."

The new policy won't take effect until Jan. 1 in order to give health officials and dispensaries time to develop policies and procedures and educational materials, as required by the rules.

Arizona joins nine states that allow medical marijuana for PTSD, including Connecticut, Delaware, Maine, New Mexico, Oregon, Michigan and Nevada, says Karen O'Keefe, director of state policies at the Marijuana Policy Project in Washington, D.C. O'Keefe said there is a growing movement by states with medical-marijuana laws to allow those suffering from PTSD to use medical marijuana because it is seen as an effective treatment.

Humble's decision comes after an administrative law judge last month recommended state officials allow those with PTSD to use medical marijuana, reversing an earlier decision by Humble.

In the past, Humble has said there was insufficient research on marijuana's effects on PTSD.

Since the inception of the state's medical-marijuana program, veterans and medical-marijuana advocates have pushed state health officials to allow PTSD to qualify as a condition. Some veterans have told The Arizona Republic that the drug regimes their doctors have put them on are ineffective and have damaged their organs.