Posts Tagged ‘cannabis research’

The FDA Wants Your Feedback on CBD!

FDA_BuildingThe U.S. Food and Drug (FDA) is asking for input from patients who have experience using Cannabidiol (CBD) to treat medical conditions.

CBD is a non-psychoactive compound found in cannabis that’s proven therapeutic for treating pain, seizures and epilepsy. The FDA is putting together a recommendation for the United Nations’ World Health Organization (WHO) regarding CBD and several other substances, including ketamine.

The feedback will help WHO determine international drug restrictions under the 1971 Convention on Psychotropic Substances. The treaty seeks to curb drug trafficking and abuse by restricting imports/exports, limiting use to scientific and medical settings, and compelling member nations to punish infractions of the treaty.

Here’s what the FDA had to say about CBD (emphasis added):

Cannabidiol (CBD) is one of the active cannabinoids identified in cannabis. CBD has been shown to be beneficial in experimental models of several neurological disorders, including those of seizure and epilepsy. In the United States, CBD-containing products are in human clinical testing in three therapeutic areas, but no such products are approved by FDA for marketing for medical purposes in the United States. CBD is a Schedule I controlled substance under the CSA. At the 37th (2015) meeting of the ECDD, the committee requested that the Secretariat prepare relevant documentation to conduct pre-reviews for several substances, including CBD.

Declaring CBD beneficial puts the FDA at odds with the Drug Enforcement Agency (DEA), which ruled CBD to have no medicinal value, categorizing it as a Schedule I drug.

The FDA is asking for “interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances.”

The deadline for public comment is September 13.

Want to submit your comments to the FDA? Click here to go the Regulations.gov web site and click on the blue “Comment Now!” button.

 

Justice Department Blocks DEA Cannabis Research

cannabis-researchA year after the US Drug Enforcement Agency (DEA) began accepting applications to grow cannabis for research it appears that the Department of Justice (DOJ), with the pressure of Attorney General Jeff Sessions, are blocking researchers from moving ahead with their proposals.

The DEA has received 25 research proposals, but so far none of them have been able to move forward. As part of the approval process, researchers must get final sign-off from the DOJ–and it’s no secret that Sessions is not a fan of weed.

“They’re sitting on it,” one law enforcement official told the Washington Post, “They just will not act on these things.”

A senior DEA official said that, “the Justice Department has effectively shut down this program to increase research registrations.”

The marijuana that researchers currently have access to is not what most people would consider weed. Since the late 1960s, all marijuana used in clinical research is required to come from a single government-run marijuana farm at the University of Mississippi. The problem is that the marijuana grown there doesn’t even really resemble the weed that’s sold at dispensaries, making it difficult for researchers to reach conclusions that are applicable to real-world use.

The quality of the government grown cannabis was so bad that Johns Hopkins University, which planned to begin a multiyear clinical trial studying cannabis and PTSD, backed out of the study.

One of the researchers who submitted a proposal to the DEA is Lyle Craker, a professor at the University of Massachusetts at Amherst. Craker submitted his last application in February but hasn’t heard back on his yet. He’s hoping to do research into whether other parts of the cannabis plant have medicinal value.

“I’ve filled out the forms, but I haven’t heard back from them. I assume they don’t want to answer,” said Craker. “They need to think about why they are holding this up when there are products that could be used to improve people’s health. I think marijuana has some bad effects, but there can be some good and without investigation we really don’t know.”

Marijuana Boosts Memory in Aging Brains

According to a study released in Nature Medicine, marijuana may boost cognitive function and memory in elderly brains–at least in mice.

In past years, the focus of marijuana research has looked at effects of cannabis consumption in teenagers and young adults. Findings concluded that cannabis use in young brains is detrimental–and this most recent study did corroborate those findings.

However, when it comes to elderly brains and cannabis, it’s a completely different story.

Andreas Zimmer, a professor of molecular psychiatry at the University of Bonn in Germany, along with a team of researchers, found “a dramatic improvement in cognitive functions” in mice given daily, low doses of THC for a month.

Researchers included young, mature, and elderly mice in the study and performed a number of behavioral experiments. In some of the experiments, THC seemed to improve the memory in the older mice to such a degree that their cognitive function appeared to be as good as those of young mice.

In one of the tasks, mice were placed in a water maze with a hidden platform that allowed them to escape. In the control group, (mice who were not given THC) the mature and old mice took longer to climb out than the young mice. Among mature and elderly mice that had been given THC, they found the platform faster than the control mice in corresponding age groups. Young mice given THC took longer to learn where the platform was hidden.

The findings raise the possibility that cannabinoids might act as anti-aging molecules in the brain. “That is something we absolutely did not expect: the old animals [that received] THC looked most similar to the young, untreated control mice,” Zimmer said.

However, other scientists cautioned that extrapolating findings in mice to humans is premature. “This well-designed set of experiments shows that chronic THC pretreatment appears to restore a significant level of diminished cognitive performance in older mice, while corroborating the opposite effect among young mice,” Susan Weiss, director of the Division of Extramural Research at the National Institute on Drug Abuse who was not involved in the study, wrote in an e-mail to Scientific America. Nevertheless, she added, “While it would be tempting to presume the relevance of these findings [extends] to aging humans…further research will be critically needed.”

Zimmer and his colleagues have already been awarded funding to begin a clinical trial studying the effects of THC in elderly adults with mild cognitive impairments.

“If we can rejuvenate the brain so that everybody gets five to 10 more years without needing extra care, then that is more than we could have imagined,” study co-author Andras Bilkei-Gorzo told The Guardian.

Ending Marijuana Prohibition Would Save Lives and Taxpayer Money

A father-daughter duo of public policy researchers from the University of Georgia have published a follow-up to their 2016 research that found in states with a medical marijuana program, prescriptions for medications like painkillers, antidepressants and anti-anxiety medications dropped sharply.

That means that among adults 65 and older who are enrolled in Medicare, many are choosing to self-medicate with cannabis rather than taking medications prescribed by a doctor. It’s a significant shift in approaches to healthcare, and is especially relevant given the opioid epidemic in the U.S. Numerous studies have found that opiate abuse and overdose rates fell in states with medical marijuana laws.

The Bradfords’ new study applies the same analysis as the Medicare study, but this time they looked at Medicaid prescriptions. Medicaid covers low-income people of all ages. The results were similar to the Medicare research: in states with a medical marijuana program, prescriptions for certain drugs fell significantly.

Anti-nausea prescriptions fell by 17 percent, anti-depressants fell 13 percent, and anti-seizure and psychosis drugs fell 12 percent. Prescriptions for painkillers, including opiates, fell by 11 percent.

“Patients and physicians in the community are reacting to the availability of medical marijuana as if it were medicine,” the Bradfords concluded.

They also concluded that a nationwide medical marijuana program would save taxpayers about $1.1 billion on Medicaid prescriptions annually. However, while Medicaid and Medicare see cost savings, medical marijuana must be purchased outside of the insurance system, essentially shifting the burden of cost to low-income and senior patients.

Last summer the DEA affirmed marijuana’s status as a Schedule 1 drug–categorizing cannabis as an addictive drug with no medical benefits. The Bradfords warned that, “This decision was made despite the substantial and growing evidence that the requirements for Schedule I status involving ‘no currently accepted medical uses’ are no longer met by marijuana.”

How Cannabis Saves Medicare Millions of Dollars

marijuana-bankingA new study has found that states with access to cannabis have reduced costs to Medicare Part D, as well as reduced prescription drug use. The study was published in Health Affairs and looked at drugs like antidepressants, muscle relaxants, opioids, and sedatives for which cannabis is used as an alternative treatment.

Researchers examined Medicare Part D spending from 2010 to 2013 and found that cannabis saved Medicare about $165 million in 2013–if  cannabis was legal nationwide, it would save the program about $470 million per year. 25 states and the District of Columbia currently have cannabis laws, a number that’s expected to increase in November elections.

As well as saving taxpayer money, the study found that the annual number of daily doses prescribed by doctors for conditions like anxiety, depression, pain, nausea, and sleep disorders, was also greatly reduced. Cannabis use reduced the number of painkiller prescriptions, including opioids, by about 1,800 daily doses filled each year per doctor. Critics say that while cannabis may be saving Medicare money, patients still have to pay for it out-of-pocket. However, as Colorado and other states show, an ounce of cannabis is hundreds, sometimes thousands of dollars less with far more effective results. Those costs could possibly even become lower with less regulation, less black market influences, and expanding supplies with market growth. In an interview with NPR, one of the authors of the study, W. David Bradford, said that should “marijuana become a regular part of patient care nationally, the cost curve would bend because marijuana is cheaper than other drugs.”

Cannabis is still a Schedule I drug. It is considered to have a high potential for abuse without medical benefits. However, since it is a natural wellness food product with no deaths and countless lives helped, it would seem the greater threat of abuse without medical benefit are pharmaceuticals which have both a long list of deaths and abuses.

 

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