Search Results for: National Institute on Drug Abuse

Teen Marijuana Use In Colorado And Washington Dropped More Than The National Average in 2014-2015

COLORADO: The federal government quietly published new national survey data this week that shows rates of teen marijuana use in Colorado and Washington — the first two states to legalize and regulate marijuana for adult use — decreased more than the national average in 2014-2015. Fewer teens in the two states are reportedly using marijuana than in 2012-2013, just prior to the commencement of legal adult marijuana sales.

The Substance Abuse and Mental Health Services Administration (SAMHSA) released the results of the 2014-2015 National Survey on Drug Use and Health (NSDUH) on Tuesday along with a press release that did not include any mention of marijuana.

According to the NSDUH:

  • In Colorado, the rate of 12-17-year-olds who used marijuana in the past month dropped 1.43 percentage points from 12.56% in 2013-2014 to 11.13% in 2014-2015, compared to 11.16% in 2012-2013. The rate of past-year use dropped 2.46 percentage points from 20.81% in 2013-2014 to 18.35% in 2014-2015, compared to 18.76% in 2012-2013.
  • In Washington, the rate of 12-17-year-olds who used marijuana in the past month dropped 0.89 percentage points from 10.06% in 2013-2014 to 9.17% in 2014-2015, compared to 9.81% in 2012-2013. The rate of past-year use dropped 1.92 percentage points from 17.53% in 2013-2014 to 15.61% in 2014-2015, compared to 16.48% in 2012-2013.
  • Nationwide, the rate of past-month marijuana use among 12-17-year-olds dropped 0.02 percentage points from 7.22% in 2013-2014 to 7.2% in 2014-2015, and the rate of past-year use dropped 0.42 percentage points from 13.28% to 12.86%.

The overall findings of the NSDUH are in line with those of the annual Monitoring the Future survey sponsored by the National Institute on Drug Abuse (NIDA), which were released last week and found little change in rates of teen marijuana use.

“I don’t have an explanation. This is somewhat surprising,” said NIDA Director Dr. Nora Volkow in an article published last week by U.S. News and World Report. “We had predicted based on the changes in legalization, culture in the U.S. as well as decreasing perceptions among teenagers that marijuana was harmful that [accessibility and use] would go up. But it hasn’t gone up.”

Statement from Mason Tvert, director of communications for the Marijuana Policy Project:

“Survey after survey is finding little change in rates of teen marijuana use despite big changes in marijuana laws around the nation. Colorado and Washington are dispelling the myth that regulating marijuana for adult use will somehow cause an increase in use among adolescents. Legalization opponents will surely continue to make dire predictions about teens, so lawmakers and voters need to be informed about these government reports that invalidate them.

“Decades of arresting and prosecuting countless adults failed to prevent teens from accessing and using marijuana. States like Colorado and Washington are taking a new approach and actually controlling the production and sale of marijuana. Their success has already inspired a handful of other states to adopt similar laws, and more are sure to follow.”

Drug Use Declines Among American Youth: Past-Year Marijuana Use Remains Relatively Stable

NEW YORK:  The University of Michigan’s Monitoring the Future Study (MTF), an annual survey tracking teen drug abuse among approximately 45,000 8th-, 10th- and 12th- graders, shows some positive inroads and encouraging news in substance use trends among American youth. The new survey data show a continued long-term decline in the use of many substances, including alcohol, tobacco, cocaine, Ecstasy, as well as the misuse of some prescription medications, among 8th- 10th-, and 12th graders. The MTF survey is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

Findings from the survey indicate that past-year use of any illicit drug was the lowest in the survey’s history for 8th graders, while past-year use of illicit drugs other than marijuana is down from recent peaks across all three grades. Use of several illicit drugs – including MDMA (known as Ecstasy or Molly), heroin, cocaine and synthetic marijuana – showed a noted decline in this year’s data. Marijuana use among our nation’s youth remained relatively stable; though teens’ perception of risk associated with marijuana use continue to soften.

Marijuana Use Remained Stable Among Teens in the U.S.
While the survey found that past-month marijuana use among 8th graders dropped significantly in 2016 to 5.4 percent, from 6.5 percent in 2015, almost a quarter of high school seniors (22.5 percent) report past-month marijuana use and 6 percent report daily use; both measures remained relatively stable from last year. Similarly, rates of marijuana use in the past year among 10th graders also remained stable compared to 2015, but are at their lowest levels in over two decades.

The new data also confirm that teens who live in states where medical marijuana is legal report a higher use of marijuana edibles. Among 12th graders reporting marijuana use in the past year, 40.2 percent consumed marijuana in food in states with medical marijuana laws compared to 28.1 percent in states without such laws.

Attitudes toward marijuana use have softened, but perception of harm is not necessarily linked to rates of use. For example, 44 percent of 10th graders perceive regular marijuana smoking as harmful (“great risk”), but only 2.5 percent of them used marijuana daily in 2016. This compares to a decade ago when 64.9 percent of 10th graders perceived marijuana as harmful and 2.8 percent of them used it daily. The number of eighth graders who say marijuana is easy to get is at its lowest in the history of the survey, at 34.6 percent.

Teen Misuse and Abuse of Rx Medicines Trending Downward, But Still at High Levels
MTF also found although non-medical use of prescription opioids remains a serious issue in the adult population, teen use of prescription opioid pain relievers is trending downward among 12th graders with a 45 percent drop in past-year use compared to five years ago. The past-year rate for non-medical use of all opioid pain relievers among 12th graders is at 4.8 percent, down significantly from its peak of 9.5 percent in 2004, while the past-year non-medical use of Vicodin among high school seniors is now lower than misuse of OxyContin (2.9 percent compared to 3.4 percent). Past-year non-medical use of Adderall, a prescription stimulant used to treat Attention Hyperactivity Disorder (ADHD) is relatively stable at 6.2 percent for 12th graders. However, non-medical use of Ritalin dropped to 1.2 percent, compared to 2 percent last year, and a peak of 5.1 percent in 2004.

Eighth graders alone reported an increase in misuse of over-the-counter cough medicine at 2.6 percent, up from 1.6 percent in 2015, but still lower than the peak of 4.2 percent when first measured in 2006.

“While we are pleased to see that marijuana use has stabilized among teens, 6 percent of high school seniors reporting that they smoke marijuana every day is still unacceptably high. The MTF survey also found that more teens report using marijuana edibles in states where marijuana has been legalized and a softening of attitudes about the dangers associated with this drug – this is a real cause for concern,” said Marcia Lee Taylor, President and CEO of the Partnership for Drug-Free Kids. “The recent declines in the abuse of prescription opioids among teens are also encouraging. But the persistently high percentage of teens who report abusing stimulants is also worrisome. The Partnership has been working for quite some time through our Medicine Abuse Project to help educate parents, families and communities about the risks of medicine abuse and we are glad to see continued progress.”

Taylor added, “It’s important to remember that while today’s news about substance use among teens is mostly positive, we cannot let that take our focus off of the prescription drug and heroin crisis among other age groups across the U.S. As a country, we need to focus more of our attention and resources on early intervention and addressing substance use disorders, rather than cleaning up a problem once it has reached epidemic levels.”

The 2016 MTF survey of approximately 40,000 students in 8th, 10th and 12th grades also found:

  • Inhalant use, usually the only category of drugs used more by younger teens than their older counterparts, was down significantly among eighth graders compared to last year, with past year use at 3.8 percent, compared to 4.6 percent in 2015. Past-year inhalant use peaked among eighth graders in 1995 at 12.8 percent.
  • Use of MDMA (known as Ecstasy and Molly) has been falling since 2010 and is at its lowest point for all three grades in the history of the MTF survey. Past-year use is down among 8th graders to just 1 percent, from last year’s 1.4 percent.
  • Cigarette smoking continued a decades­ long decline. A large drop in the use of tobacco cigarettes was seen in all three grades, with a long-term decline from their peak use more than 20 years ago. For example, in 1991, when MTF first measured cigarette smoking, 10.7 percent of high school seniors smoked a half pack or more a day. Twenty-five years later, that rate has dropped to only 1.8 percent. MTF indicates that marijuana and electronic vaporizers (e-cigarettes) are more popular than regular tobacco cigarettes. The past-month rates among 12th graders are 12.5 percent for vaporizers and 10.5 percent for cigarettes.
  • Alcohol use by the nation’s teens also continued its long-term decline in 2016, with the rate of teens reporting they have “been drunk” in the past year at the survey’s lowest rates ever. For example, 37.3 percent of 12th graders reported they have been drunk at least once, down from a peak of 53.2 percent in 2001.
  • The proportion of secondary school students using heroin has fallen gradually over the past few years, and it continued a gradual decrease in all three grades in 2015. Heroin rates remain low with teens still in school and in the history of the MTF survey, heroin (with a needle) rates have never been higher than 0.7 percent among 12th graders, as seen in 2010.

Former Undercover Cop & Co-Founder Of LEAP Jack Cole Wants All Drugs Legalized

MASSACHUSETTS: Jack Cole, who spent 26 years with the New Jersey State Police and the majority of his 14 years in their Narcotics Bureau undercover, co-founded the Medford-based organization Law Enforcement Against Prohibition (LEAP) with one goal in mind: To end the war on drugs by completely legalizing all taboo narcotics. [Read more…]

Former Undercover Cop & Co-Founder Of LEAP Jack Cole Wants All Drugs Legalized

MASSACHUSETTS: Jack Cole, who spent 26 years with the New Jersey State Police and the majority of his 14 years in their Narcotics Bureau undercover, co-founded the Medford-based organization Law Enforcement Against Prohibition (LEAP) with one goal in mind: To end the war on drugs by completely legalizing all taboo narcotics. [Read more…]

Federal Drug Agency Denies Marijuana Is Less Toxic Than Alcohol

DISTRICT OF COLUMBIA: The National Institute on Drug Abuse released an eyebrow-raising statement to PolitiFact on Monday, denying that marijuana is less toxic than alcohol. [Read more…]

FDA Advances Work Related To Cannabidiol Products With Focus On Protecting Public Health, Providing Market Clarity

DISTRICT OF COLUMBIA: Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.

Educating the Public About Potential Risks of Using CBD

We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.

But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.

We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.

In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.

We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.

Closing Knowledge Gaps in Both Safety and Potential Benefits

The marketplace for CBD-containing products is quickly evolving and it is critical that we work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.

To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data. This includes data on, among other things: the sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.

Importantly, the Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very low levels of the psychoactive intoxicating component of cannabis, delta-9 tetrahydrocannabinol (THC) are no longer controlled substances – has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and we are working to support drug development as much as possible.

First, given all the research and activity in this space, we are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available. To this end, in the coming days we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.

This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.

We also are working to generate data to help inform our work in this area. For example, the FDA’s Office of the Chief Scientist recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.

As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.

Monitoring the Marketplace with a Focus on Greatest Risk to Public Harm

As we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.

We have seen many CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.

We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.

As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.

Conclusion

Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Cannabis Use Among Older Adults Has Increased 75 Percent Since 2015

NEW YORK: Cannabis use continues to increase in popularity among adults 65 years of age and older in the United States, according to a new study from NYU Grossman School of Medicine.

Published today in JAMA Internal Medicine, researchers estimate that cannabis use in adults age 65 and older increased from 2.4 percent to 4.2 percent in the United States, a significant increase of 75 percent, between 2015 and 2018.

With the legalization of cannabis for medical and recreational purposes in many states, medical professions are studying its use in treating a number of chronic health conditions. Since 1996, 31 states have legalized medical marijuana, while 11 states and Washington D.C. also have legalized recreational use. Previous research has shown cannabis use has been relatively stable in recent years.

“Our study shows cannabis use is increasingly popular nationwide among older adults,” says the study’s lead author, Benjamin Han, MD, MPH, assistant professor of Geriatric Medicine, Palliative Care and Population Health at NYU Grossman School of Medicine. “As more older adults use cannabis, whether for therapeutic or recreational purposes, it is important for health care providers to counsel their patients despite the very limited evidence base on the benefits and harms of cannabis use among older adults.”

For the study, researchers analyzed data from the National Survey on Drug Use and Health, a nationally representative survey from the Center for Behavioral Health Statistics and Quality. The survey categorized cannabis use by asking whether marijuana, hashish, pot, grass, or hash oil were either smoked or ingested.

Researchers observed trends in prevalence of past-year cannabis use, broken down by socio-demographic background, chronic disease, healthcare utilization, and other substance use among adults age 65 and older, in the United States, between 2015 and 2018.

Certain subsets of this population saw an even higher rise in prevalence. For example, researchers estimated that past-year use more than doubled by older adults with diabetes, among those who have received mental health treatment, and those reporting past-year alcohol use. Women, and individuals who were married, had a college degree, and/or had higher income also significantly increased their cannabis use.

“We need to continue to study both the risks and benefits of marijuana use, especially among older individuals” says the study’s senior author, Joseph Palamar, MPH, PhD, associate professor of Population Health at NYU Grossman School of Medicine. “This survey also did not ask about vaping of marijuana or THC products, so its possible use was underestimated. We must follow vaping trends closely, among all age groups.”

Researchers say they next plan to acquire more detailed information about how medical marijuana affects older populations, as well as the risks and side-effects. Furthermore, the profiles of other cannabinoids besides THC and CBD in medical marijuana products warrant further research, according to the study authors.

“This study gives us important insights into cannabis use among key groups of older adults, particularly baby boomers,” says Caroline S. Blaum, MD, the Diane and Arthur Belfer Professor of Geriatric Medicine and director of the Division of Geriatric Medicine and Palliative Care. “Understanding how our older patients use marijuana and evaluating its risks and benefits is one of the most important questions our field must answer to provide the best care.”

Funding for the study was provided by National Institute on Drug Abuse grants K23DA043651, K01DA038800 and P30DA011041.

How ‘Gentleman Farmer’ Mike West Became The Cannabis Industry’s First Man Of Science

By Brandon A. Dorfman
@BADorfman

“I got into the [cannabis] industry because I was trying to grow plants to save my life,” Mike West told me over the phone recently. A farmer, researcher, and entrepreneur, West has an encyclopedic knowledge of cannabis that’s matched only by his passion for helping people.

“Nothing that the government’s going to do is going to prevent sick patients, sick parents from producing medicine for their children,” he continued.

I had asked West if legalization and the subsequent corporatization under the ‘Big Cannabis’ model had taken away from the art of growing, a constant lament of many of the old-school folks from the black market days. An accomplished academician that also considers himself a “gentleman farmer,” West was hesitant to see the issue in anything but shades of grey.

“We’re seeing a ton of technological innovations,” he told me. “Twenty years ago, there was traditional hash, that was about it. Over the last 10 years, we’ve come out with a couple different types of solvents — alcohol, butane, propane…” From there, he rattled off several significant steps forward taken over the past two decades, benefits that can only come from a legalized industry as opposed to a black market.

“Patient access ends up improving, [and] the cost in a lot of the recreational states has significantly decreased,” he said, ultimately making his point.

And West isn’t wrong. Aside from some high-priced craft flower, the benefits of legalization, and, in turn, corporatization, have been enormous. They include price drops as high as 80 percent in some states, making it extremely hard for groups like the cartels to stay in business.

The benefits to a scientist like West are immeasurable.

“[Access] improves, not only to more economical flower but a broader range of herbal supplements and nutraceuticals,” West told me. “And as a scientist, it opens up the door for doing that research that could potentially lead to future pharmaceuticals.”

Newlyweeds Pam Dyer and Mike West

But as much as the scientist in him loves to hear the machines purr, as he told me, the gentleman farmer understands that cannabis, legal or not, has always been about people. As legalization efforts in states like Washington opened the door for business, and really for scientific progress, patient’s rights began to fall to the wayside in many ways.

“I’ve been, pleasantly surprised the way that legalization has had and America being that laboratory of democracy,” West told me, adding in one caveat. “I love to talk about and constantly joke about … two steps forward one step back with when legalization happened.”

His main gripe, though perhaps that’s too stubborn a word to use, has to do with legislative bills that strip patients of their rights to homegrown medical cannabis. As the old-school black market crowd might say, it’s the death of the art of growing — only instead of science winning out; it’s for-profit patient care.

“As part of some of the bills, they took away some patients rights,” explained West, discussing corporate creep in the growing legalization movement. “Now there’s lots of home growers that are exporting illegally. And those are the ones that are getting clamped down on and having lots of people’s houses get raided.”

Despite his years of entrepreneurship — or, perhaps, guided by them — West has always been a patient advocate first. And I could hear that in his voice as we spoke. Even in states where home grows are allowed, patients still run the risk of being harassed by law enforcement, a terrible situation for all involved.

As for my original question, though, had forward progress spelled death for the so-called art of growing cannabis?

Mike West is positive if he’s nothing else.

“It’s something,” he told me, “you got to take the good with the bad.”

“I love the science side of it…”

West first took an interest in cannabis sometime in the late 1990s. With an epileptic sister and other family members suffering from various ailments and illnesses he became what he referred to as a ‘cannabis refugee,’ traveling from Texas to Colorado — in his case not just looking for the plant, but looking to study the plant.

“I ended up seeing a research study looking at treating epilepsy with cannabis,” he told me, speaking of his earnest beginnings that would go on to launch a now 20-plus year career. “[I] tried to go to school to study cannabis, but they didn’t allow us to study cannabis at the time. So we ended up studying kind of a mix of molecular biochemistry and international law, and I ended up focusing on trying to research biofuels.”

Unfortunately, when it comes to studying cannabis, not much has changed today. At one point in our conversation, West mentioned a few universities are now teaching horticultural classes or showing students how to run analytical testing equipment for use in the cannabis industry. Due to federal law, none of them can offer hands-on experience with the plant.

For West, however, the hands-on experience came easy. Whether he was working at dispensaries or hydro shops in college, or even, as he told me, doing a small stint at a law firm helping medical growers become medical collectives, West was always learning.

Mike West Positive Nelson

“My passion — I more than anything consider myself a research scientist,” West said. “Obviously [I] can’t do that research science at universities, currently very few allow any cannabis research. The federal government makes university research hard.”

“I focused on trying to do as much research as I can in the private sector,” he said, reminding me of the path that most people with a science-focus have to take in this industry.

To-date, according to West, he’s built medical labs in around 13 or 14 states, hemp labs in six states, and recreational cannabis labs in four states. He’s currently working with a Canadian company that’s building labs in Kansas, outside of Vancouver, and outside of Toronto — not to mention the fact that they also have some operations going on over in Australia and Europe. Then there are the hemp labs in Oregon, Colorado, and Washington, and the teams he’s training in Kentucky too.

“I love the science side of it,” he told me in the most laid back voice possible.

Since those early days in Colorado as a ‘cannabis refugee,’ Mike West has established himself as one of the preeminent researchers in the cannabis industry. As a researcher, entrepreneur, author, and adviser to numerous companies in the medical, adult use cannabis, hemp farming, extraction, and products industries his bio reads like a crossbreed somewhere between Raphael Mechoulam and Jack Herer.

But he’s never lost his initial drive nor forgotten what turned him to cannabis in the first place.

“Having family members that were medical patients really got me interested in developing products,” West said as we continued our conversation. “Unfortunately, it’s incredibly difficult to do that research under the same methodology that’s done with traditional pharmaceutical research.”

When he’s not helping to set up the next great laboratory or medical collective or hemp farm, Mike West is focusing on phytocannabinoids and working with patient-driven studies. Again though, the inability to do research at university labs makes the process difficult for West and the industry at-large.

So, he told me they use workarounds. A lot of that involves bringing university professors, doctors, naturopaths, or herbalist to him. For example, he told me, he’ll hold educational seminars, and bring these specialists into the dispensaries, saying to the patients hey if you have this medical condition these are the products that may or may not work better for you.

It’s a way to collect user surveys; to collect data.

“Being able to collect user surveys, you can start to make those correlations,” he said.

Beyond the issue of university research, West and I discussed the difficulty he and others like him have when it comes to finding an adequate product to use in testing. For those in the academy fortunate enough to work with cannabis, the quality is — well, it’s schwag.

“If you want to do research at the university, you have to get approved by the FDA, by the DEA by NIDA — the National Institute on Drug Abuse,” said West, explaining the harrowingly frustrating process. “NIDA contracts out their cultivation to currently one producer, [the] University of Mississippi and University Mississippi doesn’t have passionate cultivators.”

West told me how his team wanted to use the government schwag for a PTSD trial in Colorado. They obviously wanted to test the product to make sure that they were not providing anything dangerous to the patients first.

Under Colorado’s regulated market, the federal government’s cannabis didn’t pass the test for microbial contaminants.

“We’re seeing this weird juxtaposition where the black market or legal market or medical market is able to produce a higher quality product than the U.S. Government,” West lamented. “[It’s] nothing more than ignorance, in my opinion.”

He continued: “A lot of the universities are forced to take a hurry up and wait approach because they’re forced to wait for the federal government to hurry up and change the laws.”

“…teach them as much as we can.”

A few days or weeks before our conversation, Mike West was sitting in a classroom learning his trade. After 20-plus years in the industry, the one thing he’s learned is that he has much more to learn.

“That’s the real key to success in this industry is learning how to be as efficient as possible and as responsible as possible,” he told me towards the end of our conversation. “And if you can throw in a dash of big corporate social responsibility, ultimately, I think that a lot there’s a ton of opportunities in the cannabis industry for entrepreneurs.”

Which brought us to CANNAVAL, the first educational medical cannabis and hemp conference and expo in the U.S. Virgin Islands. The event, which will be hosted by former senator and now Agriculture Commissioner Positive T.A. Nelson, along with 420MEDIA in association with NT Media Productions looks to be one of the key gatherings of industry professionals this summer. And Mike West is scheduled to speak.

“We organized a tour of a couple of farms and retail shops and processing labs and testing labs so they can the see the steps in the political process that it goes from the time you plant the seed to the time that it goes to the retailer,” West told me, explaining how he first met then-Sen. Nelson. Without the agricultural commissioner, the Virgin Islands may very well not have medical cannabis today. The effort he put in towards helping that law pass was crucial.

“Nelson spent the last couple of years getting that law passed,” said West. “That opens up the Virgin Islands to start allowing the farmers to get licenses to do what they’ve been doing for decades.”

“We want to be able to make sure that the farmers start off on a good foot,” he continued.

Unlike other cannabis events, CANNAVAL is designed to educate and empower. It will give all those who attend, including companies and organizations an exclusive opportunity to network with government officials, entrepreneurs, medical and seasoned professionals in an open and welcoming environment that will cultivate and inspire.

And the guest list is top notch as well, including some of the cannabis industry’s biggest names such as Sierra Riddle. Dan Herer, Adam Dunn, Roz McCarthy, and, of course, Agricultural Commissioner Positive Nelson.

And Mike West.

“I think there’s a dance Friday, Saturday’s the conference, and then Sunday — what’s going to beat a networking day hanging out on the beach and enjoy some of that beautiful Caribbean sun,” West said, clearly excited to be a part of the event.

But for West, he’s going to do what he always does.

“We’re looking at trying to set up a conference,” said West, echoing what Positive Nelson told him. “To educate the consumers, educate potential business people in the Virgin Islands, teach them as much as we can.”

Statement From FDA Commissioner Scott Gottlieb On Researching Medical Uses Of Cannabis

By Scott Gottlieb, MD

DISTRICT OF COLUMBIA: Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of “medical marijuana” advertised its uses for a wide number of medical conditions, such as cancer, multiple sclerosis, post-traumatic stress disorder and anxiety – just to name a few of the touted conditions. The FDA has been supportive of research in this area for many years. But marijuana is a Schedule I compound with known risks. Research to demonstrate that marijuana or its components could be safe and effective in the treatment of medical disorders should be held to the same standard as other drug compounds. And certainly it should not be held to a lower standard, as some proponents would suggest. The FDA has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials, to demonstrate the potential for safe and effective uses.

Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older.

This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies. This new treatment provides new options for patients.

This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.

So today, in addition to celebrating this scientific achievement and the medical advance that it represents for these patients and their families, we should also reflect on the path that made this possible. It’s a path that’s available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs.

That pathway includes a robust clinical development program, along with careful review through the FDA’s drug approval process. This is the most appropriate way to bring these treatments to patients. This process also includes a review of the purity of a new drug and manufacturing controls. Before a high-quality drug can be developed, evaluated, and eventually approved by the FDA; it’s critical that the necessary work is done to identify drugs of potential medical benefit and conduct rigorous scientific research through adequate and well-controlled clinical trials. This is true for all drugs, including ones derived from plant materials, like marijuana. And the FDA remains committed to collaborating with federal and state agencies, researchers and product developers on advancing this type of important and conscientious work.

This research process – from early development through preclinical and clinical research – gives us a comprehensive understanding of a new drug. That includes an understanding of whether the new product is safe and effective for treating a particular medical condition, what the proper dosage is and for what populations it is safe and effective, how the new compound could interact with other drugs, or whether the new drug has side effects or other safety concerns.

This work also helps product developers identify the appropriate dosage needed to achieve the desired therapeutic effect while minimizing toxicity and risk. Taken in totality, the scientific evidence generated by these studies forms the basis of the FDA’s evaluation of benefit versus risk. And it’s because of this careful, scientific and evidence-based evaluation by the FDA that health care providers can rely on having a quality product that delivers a consistent, uniform dose of an effective medication that is able to deliver a predictable treatment to patients. This is especially important when considering treatment for serious medical conditions that will be utilized in the clinical care of patients who may have any number of health vulnerabilities. The purified form of the drug CBD approved today by the FDA has been shown to meet these rigorous standards.

Research on the therapeutic effects of marijuana and its components involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration.

MMJ International Holdings Pursuing Legal FDA Cannabis Medicine Approval

MMJ International Holdings Pursuing Legal FDA Cannabis Medicine Approval

The FDA has taken several specific steps to support this research.

We meet regularly with researchers as they plan and carry out their trials. We have also formed a Botanicals Team that provides scientific expertise on botanical issues for researchers developing drugs derived from plants, such as marijuana. That team published guidance for industry on clinical studies involving botanical drugs, as well as quality controls for lot-to-lot consistency. In recent years, the agency also has recommended to the DEA the approval of several hundred Schedule I research protocol licenses for research on marijuana or its constituent compounds.

Additionally, the FDA also works with companies to provide patients access to experimental therapies while clinical trials are ongoing through expanded access provisions. These approaches help protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. Through this process, hundreds of children were able to get access to investigational CBD products while this product was being studied.

Drugs derived from marijuana also are eligible for several programs that are intended to facilitate and expedite development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions. Much of the work we’ve done to encourage research in this area has led to the approval action we took today.

The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels. However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.

The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. The FDA has taken recent actions against companies distributing unapproved CBD products. These products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. We’ll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. We’re especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.

Today’s approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market. We remain committed to our gold standard for product development and review. Such a process ensures that any new therapies from marijuana and its constituents are safe, effective and manufactured to a high and consistent quality. And most importantly, that these products have been proven safe and effective for patients.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Court Rejects Challenge To DEA’s Classification Of Marijuana Extracts

CALIFORNIA: A three judge panel for the Ninth Circuit Court of Appeals has denied a petition filed by the Hemp Industries Association challenging the DEA’s authority to establish a new administrative drug code specifically for marijuana extracts. The DEA first announced the proposed rule change in 2011, but did not enact the new policy until January 13, 2017.

In a decision filed on April 30, the Court rejected petitioners’ arguments – opining the DEA’s classification of marijuana extracts does not conflict with the provisions of either the Agricultural Act of 2014 (aka the ‘Farm Bill’) or the Consolidated Appropriations Act, which limits the Justice Department from spending federal dollars to intervene in state-sanctioned activities involving marijuana or industrial hemp. The Court also dismissed petitioners’ argument that the rule substantively amended the federal Controlled Substances Act. Justices opined that such extract products, including those containing primarily CBD, were already classified under federal law as schedule I controlled substances.

The DEA has long contended that it possesses broad regulatory authority over “all parts of the plant Cannabis sativa L.,” including “the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.” The agency includesamong this definition products containing cannabidiol or any other non-THC cannabinoids derived from the marijuana plant. It further states, “[T]he Agricultural Act of 2014 does not permit entities [who are not registered with the DEA] … to produce non-FDA-approved drug products made from cannabis.”

Over a dozen states have enacted legislation in recent years exempting certain persons who possess extracts high in cannabidiol from criminal prosecution. Legislation to approve the retail sale of CBD extracts to adults in Kansas is awaiting gubernatorial action. Indiana lawmakers approved a similar law in April. Several pieces of legislation seeking to exclude CBD from the federal definition of marijuana are pending in Congress. In 2015, Nora Volkow, the Director of the US National Institute on Drug Abuse, publicly acknowledged that CBD is “a safe drug with no addictive effects.”

Petitioners say that they intend to appeal the ruling.


The case is Hemp Industries Association et al., v. US Drug Enforcement Administration et al., (No. 17-70162).