Is Cannabis Science's Pain Patch for Real?

By Pat Anson, Editor

A California company that claims to be developing a cannabis-based skin patch to treat chronic pain is “a fundamentally unsound company” with a long history of misleading the public and its own shareholders, according to analysts. The founder and former CEO of Cannabis Science has even accused the company’s current management team of fraud and deception.

At various times in its history, Cannabis Science has gone under the name Patriot Holdings, National Healthcare Technology, Brighton Oil & Gas, and Gulf Onshore. Now it has a slick new website, and is passing itself off as a pharmaceutical development company with a pipeline of cannabis-based drugs to treat asthma, HIV and chronic pain.

“I'm not sure if Cannabis Science is a biotech firm, an oil and gas exploration company, an educational university or a pot distributor, the only thing I am certain of is that Cannabis Science is in the business of moving money from public investors to executives' pockets,” wrote John Brody Gay in a lengthy analysis published by Seeking Alpha, an investing website.

Gay and other analysts say Cannabis Science is a classic “pump and dump” penny stock that produces little revenue, but a steady stream of press releases to promote its business activities, which never seem to come to fruition.

Often other websites are hired by pump and dumpers to publish their press releases or write glowing reviews about a company known as “advertorials.” Others are simply ignorant and don't do their homework. The publicity and fake news generates a brief flurry of interest in the company’s stock, which is when executives and other insiders often sell their shares. By raising the stock price by a few pennies, company insiders can double or triple the value of their holdings.

On November 2, Cannabis Science issued a press release saying it was developing skin patches to treat pain caused by fibromyalgia and diabetic neuropathy.

"The development of these two new pharmaceutical medicinal applications are just the tip of the iceberg for what we see as the future for Cannabis Science. While we strive to increase our land capacity for growth and facilities to produce our own product to supply our scientists with proprietary materials to make these formulations, we are also busy researching more potential needs for Cannabis related medical applications,” Cannabis Science CEO Raymond Dabney was quoted as saying in the news release.

Dabney is no stranger to accusations of deception and stock manipulation. In 2005, he admitted issuing 22 bogus news releases to promote another penny stock. For that he received a five year trading ban from British Columbia’s Securities Commission, according to Forbes and the Vancouver Sun.

A former CEO and president of Cannabis Science has also accused Dabney of fraud. Steve Kubby and other directors resigned after learning that Dabney, who was then working for Cannabis Science as a consultant, diverted company funds into a private account.

“When it became clear that our company had become entangled in fraud and deception, we demanded answers. Instead, those behind the fraud illegally removed me. Yes, we could have fought it and won, but attorneys repeatedly warned us that it is only a matter of time before the SEC will be investigating the company’s many questionable activities,” said Kubby in the Independent Political Report. “Actually, these guys have done me a great favor, because they have removed me from a stinking mess and assumed the liability for themselves.”

Kubby himself was accused by the company of "using unauthorized company shares as collateral or consideration for his personal gain."

Calls to Cannabis Science and Dabney for comment on the allegations were not returned.

‘Substantial Doubt’ About Company

The bottom line in all of this is that Cannabis Science is nearly broke and considers its own future questionable, which it discloses in its most recent financial statement to the Securities and Exchange Commission.

“The Company is not currently in good short-term financial standing. We anticipate that we may only generate limited revenues in the near future and we will not have enough positive internal operating cash flow until we can generate substantial revenues,” the company said. “There is substantial doubt as to the Company's ability to continue as a going concern without a significant infusion of capital.”

In the first six months of 2016, Cannabis Science reported revenue of only $5,787, and debt and liabilities of over $5 million.

What the company has plenty of is stock. Nearly two billion shares of Cannabis Science are currently trading on the over-the-counter “pink sheet” market, and the company is authorized to release another billion shares whenever it wants. It pays its executives, debtors and vendors in newly issued shares, which are typically sold at opportune times.  

Chief Financial Officer Robert Kane, for example, was paid with 20,000,000 shares on March 8. In October, Kane sold over 9 million shares for $384,000.

Nice work if you can get it.

With more and more states legalizing both medical and recreational marijuana, the cannabis industry is estimated to be worth $7 billion and growing quickly. So is the opportunity for fraud.

The Financial Industry Regulatory Authority (FINRA) warned about a profusion of marijuana stock scams three years ago, advice that still holds true today for investors, as well as pain patients.

“Like many investment scams, pitches for marijuana stocks may arrive in a variety of ways – from faxes to email or text message invitations, to webinars, infomercials, tweets or blog posts,” FINRA said. “The con artists behind marijuana stock scams may try to entice investors with optimistic and potentially false and misleading information that in turn creates unwarranted demand for shares of small, thinly traded companies that often have little or no history of financial success.”

Cannabis Science was out with yet another press release today, this one talking about its plan to build a 33,000 square foot marijuana greenhouse in Nevada. No details were offered on when the greenhouse would be built, how much it would cost, or who would pay for it.

"It is such an incredible feeling to see our great plans finally coming to fruition," Dabney was quoted as saying.

Marijuana Legalized in Several More States

By Ellen Lenox Smith, Columnist

As we ponder the results of the presidential election, let’s not forget to celebrate the success throughout the country in increasing the number of states allowing access to medical and recreational marijuana.

Congratulations to voters in Florida, North Dakota and Arkansas for approving medical marijuana and providing a choice for patients to turn to. Also, Montana succeeded in expanding its medical marijuana program to include post-traumatic stress as a qualifying medical condition, along with raising the limit on the number of patients a doctor can certify from 3 to 25.

We are so happy for patients in these states! It will take time for them to get their programs up and running. Patience will be needed, but at least they are now on the right road. It will involve years of tweaking the program as patients learn to navigate the system.

Voters in California, Nevada, Massachusetts and Maine also approved the legalization of marijuana for recreational use. A recreational ballot proposal in Arizona was defeated.

It is very important that we keep and improve the integrity of medical marijuana programs as states expand into recreational use. This will become a big money maker for states and I assume the movement will grow fairly quickly as more states realize they can make billions of dollars in tax revenue.

I have always felt that recreational use was not our battle, preferring instead to focus on patients having access to medical marijuana. I appreciate that some want marijuana for use socially, but there are many of us struggling to live life with more dignity, which the use of medical marijuana provides for us. All citizens in the United States deserve the same rights and we are now over halfway there.

Our dream is for all people in this country to have medical marijuana as a choice. All deserve proper education on its use, a variety of strains to accommodate their various needs, patients and caregivers should be allowed to grow their own plants, and marijuana should be available at compassion centers or dispensaries at affordable prices. Also, we look forward to more consistency in qualifying medical conditions, which vary widely from state to state.

If you are in need of advocating in your state to improve your program or to try to get legislation to move forward, feel free to be in touch.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Researchers Unveil 3-D Image of ‘Marijuana Receptor’

By Pat Anson, Editor

An international team of researchers has released the first three-dimensional image of a human cannabinoid receptor – a discovery expected to advance research into the medical and recreational use of marijuana.

The research findings, published in the journal Cell, focused on how tetrahydrocannabinol (THC) -- the chemical in marijuana that makes people “high” -- binds to a cannabinoid receptor known as CB1, which is embedded in the surface of many nerve cells.

Cannabinoid receptors are part of a large class of receptors known as G protein-coupled receptors (GPCR), which account for about 40 percent of all prescription pharmaceuticals on the market.

"As marijuana continues to become more common in society, it is critical that we understand how it works in the human body," said Zhi-Jie Liu, a professor and deputy director of the iHuman Institute at Shanghai Tech University, who is also affiliated with the Chinese Academy of Sciences.

"We need to understand how marijuana works in our bodies; it can have both therapeutic potential and recreational use, but cannabinoids can also be very dangerous."

At the beginning of the study, researchers struggled to collect enough data to produce a crystal form of the CB1 receptor, which was needed to create the high-resolution image.

When they finally succeeded in crystalizing the receptor, they found a complex structure of pockets and channels to various regions of the receptor.

The discovery could help explain why synthetic marijuana and medicines designed to mimic cannabis have had unexpected and sometimes harmful side effects.

For example, a cannabis-based drug developed to treat obesity was found to cause depression, anxiety, and suicidal tendencies, so the medication was pulled off the market.

And synthetic marijuana, such as Spice and K2, can have severe side effects such as seizures, hallucinations, anxiety attacks and even death.  

Yekaterina Kadyshevskaya, Stevens Laboratory, USC

"With marijuana becoming more popular with legislation in the United States, we need to understand how molecules like THC and the synthetic cannabinoids interact with the receptor, especially since we're starting to see people show up in emergency rooms when they use synthetic cannabinoids," said study co-author Raymond Stevens, a professor at the iHuman Institute and a professor of Biological Science and Chemistry at the University of Southern California.

The findings could also guide the development of cannabis-based drugs to treat pain, inflammation, obesity, fibrosis and other medical conditions.

"Researchers are fascinated by how you can make changes in THC or synthetic cannabinoids and have such different effects," says Stevens. "Now that we finally have the structure of CB1, we can start to understand how these changes to the drug structure can affect the receptor."

Keeping Kids Safe from Medical Marijuana

By Ellen Lenox Smith, Columnist

Frequently, someone will mention to me that they want to medicate with cannabis but won’t even consider trying it due to their children living in the house.

I can certainly understand their concern, but feel there are still ways to administer the medication, get control of your pain and also keep your children safe.

What are the biggest concerns a parent has about using marijuana around children?

1. The danger of cannabis getting into the children’s hands.
2. The smell from smoking marijuana alerting children to what you have in the house.
3. The still lingering issues of society’s judgment of it

How can you comfortably still make use of cannabis with children in the house?

As with all medications kept at home, you always have to be alert for the safety of children. Cannabis is no different. For any medication, parents (and grandparents) should consider locking it up to keep it out of the wrong hands. 

To still be able to enjoy the benefits of marijuana, but without the smell, there are ways to administer it that are just as successful as smoking. Many wrongly assume that is the only way you can use it. 

I only take cannabis as an oil. It is kept in a medicine bottle, measured out nightly and mixed with some applesauce. This is not something that children are attracted to. I always make sure it is a secure spot. I sleep through most nights and generally during the day never need to take any other forms of the cannabis, since it continues to offer me benefits from the nightly teaspoon.

Another effective option is to use it topically. The results are soothing and have shown tremendous relief, even for those suffering with Complex Regional Pain Syndrome (CRPS). We make ours with a peppermint oil extract added to mask the smell. The peppermint also helps  open the pores in the skin to allow for absorption.

Tinctures containing cannabis can be made in either a glycerin or alcohol base. They can be stored in a medicine bottle and used as frequently as needed. One simple teaspoon in the cheek or under the tongue allows for absorption and pain relief. You can also take cannabis as a pill or suppository, and many have learned to make it as a drink or steeped as a tea. 

For more on the different ways to use cannabis, see my column: “How to Use Medical Marijuana Without Smoking.”

Finally, as far as societal judgement goes, as your children grow older, it doesn’t hurt to be honest with them about the benefits you have found from using cannabis to improve the quality of your life.  It is no different than any illness you are coping with where there is a need to medicate. As time progresses, this conversation will get easier as society embraces this safe alternative.

If you are one of those people who is putting the benefits of medical cannabis on hold because of your children, you might want to reconsider your options and allow yourself the relief you need. Remember, unless you take too much, you do not experience the high that people associate with marijuana. A body in pain does not react to marijuana like a body using it socially. You get pain relief and the others get the high.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Do Men Get More Pain Relief From Marijuana?

By Pat Anson, Editor

Experts tell us that women are more likely to experience chronic pain than men, feel pain more intensely, and are more likely to be undertreated for pain than men are.

The gender gap in pain grew a little wider this week with a new study, published in Drug and Alcohol Dependence, which claims women get far less pain relief from smoking marijuana than men do.

"These findings come at a time when more people, including women, are turning to the use of medical cannabis for pain relief," said lead author Ziva Cooper, PhD, associate professor of clinical neurobiology at Columbia University Medical Center. "Preclinical evidence has suggested that the experience of pain relief from cannabis-related products may vary between sexes, but no studies have been done to see if this is true in humans."

Cooper and her colleagues conducted two double-blinded, placebo-controlled studies that looked at the analgesic effects of cannabis in 42 healthy recreational marijuana smokers – half of them men and half women.

All smoked marijuana at least four times a week prior to enrolling in the study. Participants were excluded if they had pain.

After smoking the same amount of cannabis or a placebo, the participants immersed one hand in a cold-water bath until the pain could no longer be tolerated. Following the immersion, the participants answered a short pain questionnaire.

Among those who smoked cannabis, men reported a significant decrease in pain sensitivity and an increase in pain tolerance. But the women who smoked cannabis did not experience a significant decrease in pain sensitivity, although they did report a small increase in pain tolerance shortly after smoking.

No gender differences were found in how intoxicated the participants felt or how much they liked the effect of cannabis.

“These results indicate that in cannabis smokers, men exhibit greater cannabis-induced analgesia relative to women,” said Cooper.  “Sex-dependent differences in cannabis’s analgesic effects are an important consideration that warrants further investigation when considering the potential therapeutic effects of cannabinoids for pain relief.”

A marijuana advocate and caregiver for patients in Rhode Island said she was shocked by the study findings.

"This study concerns me that some women will read this and not even try the most magical pain relief out there," said Ellen Lenox Smith, a columnist for Pain News Network. "We have never, in the nine years of growing for myself and as caregivers for patients, ever had a time that this was not successful because of one's sex. We have had equal amounts of men and women and the only person that did not have success was an elderly woman that was not able to follow the directions due to her anxiety of using it. That was due to the stigma from society, not the product."

Do women really respond differently to marijuana or is there a flaw in the study itself?

Previous research has found that women respond differently to the cold water test and have far less tolerance for pain induced by cold water immersion than men.

“Most studies have used some form of the cold pressor test in which subjects immerse their arm or hand in circulating cold water for a defined period of time, and their results support the hypothesis that cold pain sensitivity is more pronounced in females,” researchers reported in a 2009 review of nearly two dozen studies that used the cold water test.  “Based on the present set of studies, it appears that sex differences in cold pain are consistent, particularly for suprathreshold measures such as tolerance and pain ratings.”

The Columbia University study was funded by the U.S. National Institute on Drug Abuse. Ziva Cooper also received salary support from Insys Therapeutics, which is developing cannabis-based drugs.

DEA: No Schedule Change for Marijuana

By Pat Anson, Editor

After weeks of rumors about a major change in policy, the U.S. Drug Enforcement Administration has announced that it will not reclassify marijuana as a Schedule II controlled substance, a move that would have essentially made medical marijuana legal in all 50 states.

Marijuana will remain classified as Schedule I drug – along with other illegal drugs such as heroin and LSD – meaning it has “no currently accepted medical use.”

"This decision isn't based on danger. This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine. And it's not," Chuck Rosenberg, acting administrator of the Drug Enforcement Administration told NPR.

The DEA did say it would loosen the rules to make marijuana more available for research, allowing researchers to register with the agency to “grow and distribute marijuana for FDA-authorized research.” Until now, only the University of Mississippi has held a license to grow marijuana for research purposes.

"As long as folks abide by the rules, and we're going to regulate that, we want to expand the availability, the variety, the type of marijuana available to legitimate researchers," Rosenberg told NPR. "If our understanding of the science changes, that could very well drive a new decision."

Although still technically illegal under federal law, 25 states and the District of Columbia have approved the use of medical marijuana.  Colorado and Washington have also legalized it for recreational use.

Earlier this summer, the Santa Monica Observer and the Denver Post published reports speculating that marijuana would soon be rescheduled. The Observer even set a date for the announcement – August 1st – and cited an unnamed “Los Angeles based DEA Attorney” as the source of the information.

The two stories fueled rampant speculation in blogs and on social media that a rescheduling of marijuana was imminent. Snopes.com even published its own take on the rumors, calling them “unproven.”

Canadians Can Grow Their Own

The DEA’s announcement came the same day Health Canada said it would allow Canadians to start growing their own marijuana when it updates regulations governing Canada’s medical cannabis program on August 24.

On that date, Canadians who have been authorized by their doctor to use cannabis for medical purposes will be able to produce a limited amount of cannabis or designate someone to produce it for them, provided they register with Health Canada.  Cannabis users will also continue to have the option of purchasing cannabis from one of the 34 producers licensed by Health Canada.

Additional information on how to register and legally purchase starting materials for marijuana cultivation will be available on Health Canada's website on August 24.

Medical Marijuana Lowers Prescription Drug Costs

By Pat Anson, Editor

Prescriptions for pain relievers and other medications have fallen significantly in states where medical marijuana is legal, according to a new study published in the journal Health Affairs.

Researchers at the University of Georgia analyzed data from Medicare’s Part D prescription drug program in 2013 – a year when 17 states and the District of Columbia had legalized medical marijuana -- and estimated there was a cost savings of $165 million in prescription drug claims.

The results suggest that if all 50 states had medical marijuana laws that year, the overall savings to Medicare would have been around $468 million.

“Generally, we found that when a medical marijuana law went into effect, prescribing for FDA approved prescription drugs under Medicare Part D fell substantially,” said lead author Ashley Bradford, a recent graduate from the University of Georgia who will pursue her master's degree in public administration this fall.

"The results suggest people are really using marijuana as medicine and not just using it for recreational purposes.”

Compared to Medicare Part D's 2013 total budget of $103 billion, the $165 million in estimated savings only amounts to half of one percent. But it shows the potential for medical marijuana as an alternative to prescription drugs for a wide range of ailments, including pain. Until now, little was known about the impact medical marijuana was having on healthcare spending.

"We realized this question was an important one that nobody had yet attacked," said co-author W. David Bradford, who is the Busbee Chair in Public Policy in the UGA School of Public and International Affairs.

Researchers studied data on all prescriptions filled by Medicare Part D patients from 2010 to 2013, and then narrowed down the results to focus only on nine conditions for which marijuana might serve as an alternative treatment:  anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders and muscle spasticity (stiffness).

The biggest reduction in prescriptions was for analgesics used to treat pain. Doctors in states where medical marijuana was legal wrote an average of 1,826 fewer daily doses for analgesics in 2013.

Currently 24 states and the District of Columbia have laws allowing for medical marijuana. The federal government still considers marijuana illegal, however the Drug Enforcement Administration is reviewing marijuana’s status as Schedule I controlled substance. Reclassifying marijuana could make it legal for medical use in all 50 states.

“Our findings and existing clinical literature imply that patients respond to medical marijuana legislation as if there are clinical benefits to the drug, which adds to the growing body of evidence suggesting that the Schedule I status is outdated,” said Bradford. “Lowering the costs of Medicare and other programs is not a sufficient justification for approving marijuana for medical use, a decision that is complex and multidimensional. Nonetheless, these savings should be considered when changes in marijuana policy are discussed.”

Previous studies have found a significant decline in use of opioid pain medication in patients who use marijuana and that marijuana users are not at greater risk of alcohol and drug abuse.        

Marijuana Based Drug Effective in Treating Epilepsy

By Pat Anson, Editor

A British pharmaceutical company has released positive results from a Phase 3 clinical study of an experimental drug derived from marijuana.

GW Pharmaceuticals (NASDAQ: GWPH) reported that the drug – called Epidiolex – significantly reduced seizures in patients with Lennox-Gastaut syndrome, a rare form of childhood epilepsy. Epidiolex contains cannabidiol (CBD) a chemical compound found in marijuana that does not produce the “high” associated with cannabis plants.

“From a physician’s perspective, the positive outcome in this trial of Epidiolex in patients with Lennox-Gastaut syndrome is very exciting. Lennox-Gastaut syndrome begins in early childhood, is particularly difficult to treat, and the vast majority of patients do not obtain an adequate response from existing therapies,” said study investigator Linda Laux, MD, Director of the Comprehensive Epilepsy Center at Ann & Robert H. Lurie Children's Hospital of Chicago.

“I am excited about the prospect of Epidiolex being made available on prescription in the future and believe it has the potential to make an important difference to the lives of many patients.”

The placebo controlled study involved 171 patients with Lennox-Gastaut syndrome. Epidiolex reduced the number of seizures in a month by 44 percent, compared with those taking a placebo medication that reduced seizures by 22 percent.

In March, another Phase 3 trial of Epidiolex also showed positive results in children with Dravet syndrome, another form of childhood epilepsy. GW is also conducting a Phase 3 trial of Epidiolex in Tuberous Sclerosis Complex and expects to initiate a Phase 3 trial of Epidiolex in infantile spasms in the fourth quarter of this year.

If approved by the Food and Drug Administration, the drug would be the first cannabis derived drug to win approval for the treatment of childhood epilepsy. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the FDA. GW plans to formally file for FDA approval later this year.

GW is already marketing a marijuana-based oral spray called Sativex that is being sold in Europe, Canada and Mexico to treat muscle tightness and contractions caused by multiple sclerosis. Canada also allows Sativex to be used for the treatment of neuropathic pain and advanced cancer pain.

Sativex is not currently approved for use in the U.S. for any condition. It is estimated that over 400,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications. However, two recent Phase 3 studies found that Sativex worked no better than a placebo in treating cancer pain.

DEA: Decision Not Made on Marijuana Legalization

By Pat Anson, Editor

The U.S. Drug Enforcement Administration is considering, but has not yet made a final decision on whether to reclassify marijuana as a Schedule II controlled substance, a move that would essentially make medical marijuana legal in all 50 states.

Last week two media outlets, the Santa Monica Observer and the Denver Post published reports speculating that marijuana could be rescheduled sometime this summer. The Observer even set a date for the announcement – August 1st – and cited an unnamed “Los Angeles based DEA Attorney” as the source of the information.

"Whatever the law may be in California, Arizona or Utah or any other State, because of Federal preemption this will have the effect of making THC products legal with a prescription, in all 50 states," the Observer quoted the DEA lawyer as saying.

The two stories fueled rampant speculation in blogs and on social media that a rescheduling of marijuana was imminent. Snopes.com even published its own take on the rumors, calling them “unproven.”

“There is as yet no indication that the information published on the topic was accurate, and there has been no official confirmation the DEA would moving in that direction on 1 August 2016,” Snopes said.

“We don’t have anything official to report,” DEA spokesman Rusty Payne confirmed to Pain News Network.

Like many rumors, there is some truth in the details. In a letter sent several months ago to Sen. Elizabeth Warren and seven other U.S. senators, a DEA official said the agency was finally getting around to making a decision on a five year old petition to reschedule marijuana.

“And in that letter we said we hoped to have a decision around July first. That’s certainly not a deadline, that’s just neighborhood ballpark, around that time. So people are getting antsy as the time is getting nearer,” said Payne, adding that DEA would not be making the decision alone.

“The agency that determines whether or not something is a medicine is the FDA, not the DEA. That’s why we have to rely on their portion of an in-depth study to determine whether or not something should be rescheduled or essentially determined to be a medicine. And if the FDA rules something is not a medicine, we’re bound by that. We cannot move it ourselves. We can’t overrule or override FDA on that,” said Payne.

The DEA has already received a recommendation from the FDA on whether to reschedule marijuana, but has not disclosed it. In the past, both agencies have resisted any attempt to legalize marijuana at the federal level, even as dozens of states moved to legalize medical marijuana.

In 2011, the DEA rejected a similar petition, saying “the known risks of marijuana use have not been shown to be outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy.”

Marijuana is currently classified as Schedule I drug – along with heroin and LSD – because it is considered to have no medical benefit and has a high potential for abuse. Moving it into the Schedule II classification, along with opioids such as hydrocodone and oxycodone, could potentially make marijuana available by prescription in all 50 states.    

Such a decision would upend the $40 billion medical marijuana industry, which is mostly composed of small companies and dispensaries that have created a niche for themselves while dealing with a cornucopia of state laws and municipal regulations. Rescheduling would open the door for pharmaceutical companies and pharmacies to get into the marijuana business.

"Schedule II would be a nightmare for the cannabis industry," Andrew Ittleman, a lawyer for a Miami law firm that advises marijuana companies, said in Inc.

Most Medical Marijuana Patients Benefit From Treatment

By Pat Anson, Editor

Over 90 percent of long term medical marijuana patients reported significant improvement in their pain and nausea while using cannabis, according to researchers at Israel’s Ben-Gurion University of the Negev.

Medical marijuana has been legal in Israel for over 10 years, but this was the first in-depth study of patients who have a cannabis prescription from Israel’s Ministry of Health.

"Although medical cannabis has been legal for a decade and is licensed to patients to relieve pain and other symptoms, there has been no information about the users themselves," said Pesach Shvartzman, a professor at Ben-Gurion’s Faculty of Health Sciences.

The study examined more than 2,000 cancer and non-cancer patients using medical marijuana. Almost all said they sought a cannabis prescription after trying conventional treatments that were ineffective. Patients were interviewed by telephone in the first three months of treatment and subsequently every four months for two years. 

Users reported that their pain, nausea, anxiety, appetite, and general feeling had improved. Fewer than one in 10 stopped using marijuana due to side effects or ineffectiveness after the first interview, and only six percent after the second interview.

About three out of four patients experienced minor side effects that included dry mouth, hunger, sleepiness or “high” sensations.

Three-quarters of the patients smoked marijuana, while one in five used a vaporizer or cannabis oil.

Israel still considers cannabis a “dangerous drug” and it is not registered as a medicine. However, the Ministry of Health says “there is evidence that cannabis could help patients suffering from certain medical conditions and alleviate their suffering.”

There are over 20,000 registered marijuana users in Israel. About 50 new users are approved each week by the Health Ministry.

Ministry of Health regulations allow for medical marijuana to be used to treat cancer symptoms and to reduce the side effects of chemotherapy. Eight farms have Ministry of Health permission to grow cannabis for medicinal use, and four companies have permission to deliver cannabis to cancer patients.

Teenage Marijuana Problems Declining

By Pat Anson, Editor

A large survey of nearly a quarter of a million adolescents indicates the number of American teenagers with marijuana related problems is declining – despite the fact that nearly half the states have legalized medical marijuana or decriminalized it.

Researchers at Washington University School of Medicine in St. Louis studied a national database on drug use by over 216,000 young people, ages 12 to 17, and found that the number dependent on marijuana or having trouble in school and in relationships declined by 24 percent from 2002 to 2013.

During the same period, the number of kids who said they used marijuana in the previous 12 months fell by 10 percent. The drops were accompanied by reductions in behavioral problems, such as fighting, shoplifting and selling drugs.

Researchers believe the two trends are connected -- as kids became less likely to engage in problem behavior, they are also less likely to have problems with marijuana.

"We were surprised to see substantial declines in marijuana use and abuse," said lead author Richard Grucza, PhD, an associate professor of psychiatry at Washington University School of Medicine

"We don't know how legalization is affecting young marijuana users, but it could be that many kids with behavioral problems are more likely to get treatment earlier in childhood, making them less likely to turn to pot during adolescence. But whatever is happening with these behavioral issues, it seems to be outweighing any effects of marijuana decriminalization."

The new study is published in the Journal of the American Academy of Child & Adolescent Psychiatry. The data was gathered as part on ongoing study called the National Survey on Drug Use and Health, which surveys young people in all 50 states about their drug use, abuse and dependence.

In 2002, just over 16% reported using marijuana during the previous year. That number fell to below 14% by 2013. Meanwhile, the percentage of young people with marijuana-use disorders declined from around 4% to about 3%.

"Other research shows that psychiatric disorders earlier in childhood are strong predictors of marijuana use later on," Grucza said. "So it's likely that if these disruptive behaviors are recognized earlier in life, we may be able to deliver therapies that will help prevent marijuana problems -- and possibly problems with alcohol and other drugs, too."

A similar survey, the University of Michigan's Monitoring the Future Study, found that marijuana use by teens has leveled off since 2010, but was still at stubbornly high rates. In 2015, about 35% of 12th­ graders reported using marijuana at least once in the past year.

The same survey found that teenage abuse of prescription opioids declined for the fifth year in a row. Only about 5% of 12th graders reported using an opioid pain medication in the last year, and the number reporting that prescription opioids were “fairly easy” or “very easy” to get also continues to drop.

Medical marijuana is legal or decriminalized in 24 states and the District of Columbia, and several states are considering legalization. Opponents have long maintained that legalization would have harmful effects on young people.

“Perhaps the biggest public health concern around medical marijuana liberalization and legalization concerns the potential impact on teenagers, who could have greater access to it as a drug of abuse and who may increasingly see marijuana as a ‘safe, natural’ medicine rather than a harmful intoxicant,” wrote Nora Volkow, MD, director of the National Institute on Drug Abuse, in Alcoholism & Drug Abuse Weekly.

“Although there is still much to learn about marijuana’s impact on the developing brain, the existing science paints a picture of lasting adverse consequences when the drug is used heavily prior to the completion of brain maturation in young adulthood. In teens, marijuana appears to impair cognitive development, may lower IQ and may precipitate psychosis in individuals with a genetic vulnerability.”

According to a recent report from the Colorado Department of Public Safety, where marijuana has been fully legalized since 2013, nearly a third (31%) of young adults, ages 18 to 25, have used in marijuana in the last 30 days, up from 21% in 2006. The number of juveniles on probation testing positive for THC has also increased since legalization.  

Legalizing Marijuana? Don’t Forget its Medical Use

By Ellen Lenox Smith, Columnist

At least half a dozen states may be joining Colorado and Washington in the full legalization of marijuana. As a medical marijuana patient in Rhode Island, that has never been my battle. I have tried to stay focused on improving medical marijuana laws in Rhode Island and 23 other states, such as expanding the conditions for which it can be prescribed to include chronic pain and other medical issues.

It is mind boggling to me that some states have not yet approved marijuana’s medical use, but seem to be jumping right into legalization, most likely because they see it as a way to generate tax revenue.

We must hold onto the medical programs and be sure they are not mixed into the rules for full legalization. That would be like allowing medication from the pharmacy available to anyone to enjoy for pleasure. This is our medicine.

I have no problem with others having the pleasure of using cannabis socially, but let’s make sure we maintain the integrity of the medical programs.

This is our vision for every state in this country in the near future:

1) Medical marijuana is approved in all states and it includes reciprocity from state to state so we are safe to medicate legally when we travel.

2) Patients qualify when their doctors confirm they have a need and cannabis is no longer limited to specific conditions. There are many less common ones that can be treated effectively with this medication. 

3) Patients have a choice of growing, which is both therapeutic and helpful for those who find strains they are compatible with.

4) Each state offers compassion centers or dispensaries that are strategically placed so all have access within a reasonable distance.

5) Prices at these centers are affordable and on a sliding scale. Many who are afflicted with health issues already have massive medical bills. We do not want to have the mindset of making a large profit off the sale of their medication.

6) When all states are legal, we then conquer the battle of being reimbursed for our medicine from our insurance companies.

7) Allow centers to grow the plants they need to accommodate patients with all of the various strains. 

      8) Allow centers to sell various forms of medical marijuana, including dry product, oils, tinctures, topicals, edibles, etc.

      9) Allow a delivery system for those seriously ill and a gifting program to those financially unable to pay.

     10) All centers grow organically, keeping us safe from pesticides and other chemicals.

     11) People using medical marijuana will have the legal right not be drug tested, discriminated or fired from employment.

As the demand for full legalization continues to spread across the country, please help your state maintain the integrity of its medical program. Medical marijuana is intended to help us with quality of life, not to make a huge profit from. Let those that are using it for recreation be the ones to pay taxes and bring in the revenue for your state.

Let’s keep this medicine affordable for those in need.  For those that do not need it for medical reasons, be glad you are able to use cannabis socially and not have to face issues like us!

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis.  Ellen and her husband Stuart are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana or to contact the Smith's, visit their website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Big Decline in Opioid Use by Marijuana Users

By Pat Anson, Editor

A new study has found that use of opioid pain medication declines dramatically when chronic pain patients use medical marijuana.

The small study by researchers at the University of Michigan involved 185 pain patients at a medical marijuana dispensary in Ann Arbor, who were surveyed in an online questionnaire about their use of marijuana and pain medications.

Nearly two-thirds (64%) reported a reduction in their use of prescription pain medications and almost half (45%) said cannabis improved their quality of life. Patients also had fewer side effects from marijuana than they did from opioids.

"We're in the midst of an opioid epidemic and we need to figure out what to do about it," said lead author Kevin Boehnke, a doctoral student in the School of Public Health's Department of Environmental Health Sciences. "I'm hoping our research continues a conversation of cannabis as a potential alternative for opioids."

Last week the Centers for Disease Control and Prevention issued new guidelines that recommend non-pharmalogical therapy and non-opioid drugs for chronic pain. The guidelines do not endorse medical marijuana as a pain treatment, but they do discourage doctors from testing patients for marijuana and from dropping them from their practices if marijuana is detected.

Currently, 23 states and the District of Columbia have legalized marijuana for medical purposes and four states allow it for recreational use.

The University of Michigan researchers found that patients with less severe chronic pain were more likely to report less use of opioids and a better quality of life.

"We would caution against rushing to change current clinical practice towards cannabis, but note that this study suggests that cannabis is an effective pain medication and agent to prevent opioid overuse," Boehnke said.

Researchers said their findings, published in the Journal of Pain, also suggest that overdose death rates would decline dramatically if marijuana was used more widely for pain relief.

“We are learning that the higher the dose of opioids people are taking, the higher the risk of death from overdose. This magnitude of reduction in our study is significant enough to affect an individual's risk of accidental death from overdose," said senior study author Daniel Clauw, MD, a professor of pain management anesthesiology at the U-M Medical School.

Previous research has found that opioid overdose rates declined by nearly 25 percent in states where medical marijuana was legalized. Another recent study of cannabis use by pain patients in Israel found a 44% reduction in opioid use.

One limitation of the current study is that it was conducted with people at a marijuana dispensary, who are more likely to already be believers in the medical benefits of marijuana.

CDC Guidelines Urge Doctors Not to Test for Marijuana

By Pat Anson, Editor

One of the less publicized provisions in the Centers for Disease Control and Prevention’s opioid prescribing guidelines is a recommendation that doctors stop urine drug testing of patients for tetrahyrdocannabinol (THC), the psychoactive ingredient that causes the “high” for some marijuana users. The guidelines also discourage doctors from dropping patients if marijuana is detected.

Urine drug screens are conducted almost routinely by pain management physicians and other opioid prescribers for a variety of drugs, both legal and illegal.

Some doctors use a positive result for THC as an excuse to discharge patients from their practices, even in states where medical marijuana is legal.

While the CDC guidelines encourage physicians to conduct urine drug tests before starting opioid therapy and at least annually afterwards, they draw the line at THC.

“Clinicians should not test for substances for which results would not affect patient management or for which implications for patient management are unclear. For example, experts noted that there might be uncertainty about the clinical implications of a positive urine drug test for tetrahyrdocannabinol (THC).” the guidelines state.

"Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the clinician missing opportunities to facilitate treatment for substance use disorder."

As Pain News Network has reported, “point-of care” (POC) urine drug tests, the kind widely used in doctor’s offices, frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. One study found that 21% of POC tests for marijuana produced a false positive result. The test was also wrong 21% of the time when marijuana is not detected in a urine sample.

Not mentioned in the CDC guidelines is evidence that opioid overdose rates declined by nearly 25 percent in states where medical marijuana was legalized.

"We applaud the CDC's reasoned approach to the use of urine testing and its drawbacks when used on pain patients," said Ellen Komp, Deputy Director of California NORML. "Considering that opioid overdose deaths are significantly lower in states with medical marijuana programs, we are sorry the agency apparently didn't read the letter Elizabeth Warren recently sent to its chief calling for marijuana legalization as a means of dealing with the problem of opiate overdose."

That letter by Sen. Warren encouraged the CDC to adopt the guidelines and its restrictive approach to opioids “as soon as possible,” but also encouraged the agency to further study the impact legalization of medical and recreational marijuana could have on opioid overdose deaths.

The annual cost of drug testing in pain management is estimated at $2 billion per year. While POC tests are relatively cheap, more expensive laboratory testing can cost thousands of dollars and is often not covered by insurance.

Results of Cannabis Drug Study Cause Market Frenzy

By Pat Anson, Editor

A British pharmaceutical company has reported positive results from a Phase 3 clinical study of a marijuana-based medication for Dravet syndrome, a severe form of children’s epilepsy.

The study found that Epidiolex, a liquid formula containing a plant-derived cannabinoid (CBD), significantly reduced the number of seizures in children with Dravet syndrome. CBD is a compound in cannabis that does not produce the “high” caused by marijuana.

The study findings caused shares of GW Pharmaceuticals (NASDAQ: GWPH) to more than double in trading Monday, much of it fueled by speculation that the company’s cannabinoid products would eventually be approved by the Food and Drug Administration for pain relief.

“If they get this, doctors will say, here’s a cannabinoid prescription,” said CNBC’s Jim Cramer. “This will be the pure cannabis that a lot of people who have been waiting for, an actual painkiller that is not addictive. This will replace, I believe, the terrible, terrible wave of death that oxycodone has caused.

image courtesy gw pharmaceuticals

“If you want to prescribe actual medical marijuana, a real doctor is reluctant to do it because there are no uniform standards, and what you really want is the pure cannabinoid. There will be use of this galore.”

In a statement to CNBC, GW said it was not investigating Epidiolex for pain relief.

"Today's Phase 3 results of Epidiolex (cannabidiol) were not studying the medicine as a possible treatment for pain. Epidiolex is being investigated for Dravet syndrome, Lennox-Gastaut syndrome and Tuberous Sclerosis Complex (TSC), three rare, extremely debilitating epilepsy syndromes that begin in infancy or early childhood," the company said.

The Phase 3 placebo controlled study involved 120 children with Dravet syndrome, who were averaging about 13 seizures a month before the trial began. Seizures declined by over a third in patients treated with Epidiolex, with few side effects.

“The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy,” said Orrin Devinsky, MD, of New York University Langone Medical Center’s Comprehensive Epilepsy Center.

“These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future.”

Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration. There are currently no approved treatments for Dravet syndrome in the U.S.

“We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families,” said Justin Gover, GW’s CEO. “In light of this positive data, we will now request a pre-NDA (new drug application) meeting with the FDA to discuss our proposed regulatory submission.”

GW is recruiting 150 patients for a second Phase 3 trial of Epidiolex for Dravet syndrome and is currently conducting a Phase 3 study for Lennox-Gastaut syndrome. Another study of Epidiolex is scheduled to begin soon for a third form of epilepsy, Tuberous Sclerosis Complex.

The company is already marketing a marijuana-based oral spray called Sativex that is being sold in Europe, Canada and Mexico to treat muscle tightness and contractions caused by multiple sclerosis. Canada also allows Sativex to be used for the treatment of neuropathic pain and advanced cancer pain.

Sativex is not currently approved for use in the U.S. for any condition. It is estimated that over 400,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications. Two recent Phase 3 studies found that Sativex worked no better than a placebo in treating cancer pain.