Category Archives: Health

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Kratom-Opioid

For Immediate Release

February 6, 2018

Summary

FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties.

Statement

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

The FDA’s PHASE model used to assess kratom

Federal agencies need to act quickly to evaluate the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available. This is why the FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool to help us simulate, using 3-D computer technology, how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. In effect, PHASE uses the molecular structure of a substance to predict its biological function in the body. For example, the modelling platform can simulate how a substance will affect various receptors in the brain based on a product’s chemical structure and its similarity to controlled substances for which data are already available.

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

Next, our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).

The new data provides even stronger evidence of kratom compounds’ opioid properties.

The computational model also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.

The third aspect of the model is the 3-D image we generate to look at not just where these compounds bind, but how strongly they bind to their biological targets. We found that kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.

So what does this body of scientific evidence mean? The FDA relies on this kind of sophisticated model and simulation to supplement its data on how patients react to drugs; often as a way to fully elucidate the biological activity of a new substance. The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.

Furthermore, this highlights the power of our computational model-based approach to rapidly assess any newly identified natural or synthetic opioids to respond to a public health emergency.

Learnings from reports of death associated with kratom

We’ve been carefully monitoring the use of kratom for several years, and have placed kratom products on import alert to prevent them from entering the country illegally. We have also conducted several product seizures. These actions were based, in part, on a body of academic research, as well as reports we have received, suggesting harm associated with its use. And we are not alone in our evaluation and our public health concerns. Numerous countries, states and cities have banned kratom from entering their jurisdictions. We described some of this information in a public health advisory in November 2017, in which we urged consumers not to use kratom or any compounds found in the plant.

Now, I’d like to share more information about the tragic reports we have received of additional deaths involving the use of kratom. Looking at the information we have received – including academic research, poison control data, medical examiner reports, social science research and adverse event reports – we now have 44 reported deaths associated with the use of kratom. This is an increase since our November advisory, which noted 36 deaths associated with these products. We’re continuing to review the newly received reports and will release those soon. But it’s important to note that these new reports include information consistent with the previous reports.

Today, we’re releasing the reports of the 36 deaths we referenced in November. These reports underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug. Overall, many of the cases received could not be fully assessed because of limited information provided; however, one new report of death was of particular concern. This individual had no known historical or toxicologic evidence of opioid use, except for kratom. We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide. Cases of mixing kratom, other opioids, and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids.

However, unlike kratom, FDA-approved drugs have undergone extensive review for safety and efficacy, and the agency continuously tracks safety data for emerging safety risks that were previously unknown. So we have better information about the risks associated with these products; and can better inform the public of new safety concerns. For example, in August 2016, the FDA required a class-wide change to drug labeling to help inform health care providers and patients of the serious risks (including respiratory depression, coma and death) associated with the combined use of certain opioid medications and benzodiazepines. In June 2016, the agency also issued a warning that taking significantly high doses of loperamide, including through abuse or misuse of the product to achieve euphoria or self-treat opioid withdrawal, can cause serious heart problems that can lead to death. We also recently took steps to help reduce abuse of loperamide by requesting packaging restrictions for these products sold “over-the-counter.”

Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s “just a plant” is shortsighted and dangerous. After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.

Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms. We recognize that many people have unmet needs when it comes to treating pain or addiction disorders. For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider. There are safe and effective, FDA-approved medical therapies available for the treatment of opioid addiction. Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety. There are also safer, non-opioid options to treat pain. We recognize that some patients have tried available therapies, and still have unmet medical needs. We’re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions.

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.

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LIVE! Medicare for All National Town Hall–with Sen. Bernie Sanders!

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Medicare for All National Town Hall

Public

· Hosted by The Young Turks and U.S. Senator Bernie Sanders



Details

With the introduction of the Medicare for All Act last year, Sen. Bernie Sanders and 137 of his colleagues in Congress began the long struggle to end the international embarrassment of the United States being the only major country not to guarantee health care to all its people.

Already, 60 percent of the American people want to expand Medicare to provide health insurance to every one, but many Americans still do not know how a Medicare-for-all, single-payer health care system would work in the United States.

To answer that question and more, Sen. Sanders and leading digital outlets NowThis, ATTN: and The Young Turks are partnering on a groundbreaking Medicare for All Town Hall event January 23 from 7 to 8:30 p.m.

For the first time, leading digital outlets will come together to do what cable channels and network news will not– engage in an in-depth conversation about one of the issues that matter most to Americans, their health care. Streamed live across multiple social media channels, Sen. Sanders and leading health care experts will take questions about Medicare for All from people around the country and discuss how universal health care would change the American system.

Location: Capitol Visitors’ Center Congressional Auditorium (CVC-200)

Seating is first-come, first-served. Please arrive early to ensure a seat. No posters or signs will be permitted. ASL interpreters will be present at the event.

SOURCE LINK

https://www.facebook.com/events/923471961163492/

https://www.sanders.senate.gov/download/medicare-for-all-act?id=6CA2351C-6EAE-4A11-BBE4-CE07984813C8&download=1&inline=file

We the undersigned, Americans who join the millions of our fellow citizens who responsibly use the botanical plant kratom…

CONTINUE OUR VIRTUAL
MARCH ON WASHINGTON
DAY TWO
PLEASE CO-SIGN OUR
OPEN LETTER TO ROBERT W. PATTERSON

ACTING DIRECTOR, U.S. DRUG ENFORCEMENT ADMINISTRATION

Please Sign Letter Here

Dear Administrator Patterson,
We the undersigned, Americans who join the millions of our fellow citizens who responsibly use the botanical plant kratom as a part of our health and well-being regimens, join the American Kratom Association (AKA) in strongly urging the Drug Enforcement Administration (DEA) to conduct a thorough and independent 8-Factor Analysis on kratom to test the credibility of the scheduling recommendation submitted by the US Food and Drug Administration (FDA).
In its enactment of the Controlled Substances Act, Congress has wisely required the DEA to do its own independent review on scheduling recommendations submitted by the FDA to provide a 2nd opinion on important substance scheduling issues.  That 2nd opinion is desperately needed in the evaluation of kratom because the science directly refutes the FDA claims.
Specifically, we respectfully ask the DEA to carefully examine the following issues in its own 8-Factor Analysis on kratom:

  • Kratom is a safe botanical that does not kill people.  The deaths the FDA claims are caused by kratom are actually fatalities associated with underlying health issues of the decedent, or caused by the use of other toxic doses of substances that are co-administered or mixed with kratom. Kratom has a long history of safe use over centuries when responsibly consumed, and the FDA claims are simply unsupportable based on the science.
  • If kratom is banned, opioid deaths will increase.  The opioid crisis in America kills more than 90 people every day.  Credible studies show that many people manage pain using kratom as an alternative to dangerously addictive and potentially deadly prescription opioids.  If it is banned, those people will be forced to opioid use, or to the black market for products that are contaminated or adulterated, and therefore very dangerous.  The perverse public health outcome from any ban on kratom will result in more deaths.
  • Kratom is an alternative to opioids, not a gateway to opioid abuse.  Kratom does not produce a high like opioids; kratom does not suppress the respiratory system like opioids; and kratom does not produce opioid-like effects.  Kratom is safely and responsibly used by millions of Americans, including some for alleviating pain. Without kratom, many will be forced to opioid use to alleviate pain.
  • The AKA, and we agree, strongly supports appropriate FDA regulations to protect consumers.  Protecting consumers from adulterated and contaminated kratom products; assuring children cannot purchase or consume kratom; imposing good manufacturing standards to ensure product purity; product packaging standards to prevent tampering; and clear labeling and health claims restrictions similar to other dietary supplement products, are important roles for the FDA to have in protecting consumer safety, and we welcome such restrictions to ensure continued safe and responsible use of kratom products by consumers.

The DEA has received an independent 8-Factor Analysis on kratom authored by one of the leading experts on addiction and substance safety, Jack Henningfield, Ph.D., and we believe that data will be critically important to the DEA’s own analysis of kratom.  In addition, there are four other key studies on kratom use that the DEA should consider that clearly demonstrate the harm that will be done by any scheduling order on kratom.
Respectfully submitted,

Please Sign Letter Here

FDA News Release FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

For Immediate Release

November 1, 2017

Release

As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer’s and other serious diseases.

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

The FDA issued warning letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC – citing unsubstantiated claims related to more than 25 different products spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded claims about their products’ ability to limit, treat or cure cancer and other serious diseases. Examples of claims made by these companies include:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

Unlike drugs approved by the FDA, the manufacture of these products has not been subject to FDA review as part of the drug approval process and there has been no FDA evaluation of whether they work, what the proper dosage is, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns. The FDA has requested responses from the companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.

“We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” Commissioner Gottlieb added. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”

This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in ‘stem cell’ centers targeting vulnerable cancer patients. The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

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SOURCE LINK / CONTINUE READING…

RE: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments

The information contained herein is from the Government website of REGULATIONS.GOV.

They are currently seeking comments on the scheduling of the above named substances.  After browsing through the information I did not see CANNABIS included in this request.

 Cannabidiol, IS INCLUDED. 

I will submit my comments and will post my response here on the website.

Image result for psychotropic substances

Summary

The Food and Drug Administration (FDA) is requesting 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. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (the CSA).

Dates

Submit either electronic or written comments by September 13, 2017.

Supplementary Information

I. Background

The United States is a party to the 1971 Convention on Psychotropic Substances (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (the U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion.

Section 201 of the CSA (21 U.S.C. 811) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.

Links to further information and to post comments:

Docket ID: FDA-2017-N-4515

Agency: Food and Drug Administration (FDA)

Parent Agency: Department of Health and Human Services (HHS)

*View all documents and comments in this Docket

*Public Comments that have already been received and posted.

*SUBMIT YOUR COMMENT THROUGH THIS LINK

*LINK TO DOCUMENTATION IN THE FEDERAL REGISTER

The DEA doesn’t see it as legal’ and that’s where he gets his medical license.”

FOX Files: Some doctors fear following Missouri’s medical marijuana law

Posted 11:15 pm, February 21, 2017, by Chris Hayes

ST. LOUIS, MO (KTVI)- A form of medical marijuana may be legal in Missouri, but patients are finding doctors afraid to even discuss it. It’s called CBD hemp oil, extracted from a type of marijuana that cannot get you high. It’s now legal in Missouri for treating intractable epilepsy, but families say some doctors are afraid to honor the new law.

Robert Tufts,  11, says it hurts when he seizes.

“It just feels like some sort of shock like, my brain, inside my head. I’ll just get a little fuzzy feeling and I’ll shake and I’ll be dizzy for a second.”

He takes a handful of pills he says sometimes make him feel worse.

“It just felt like I was so enraged and wanted to break everything.”

His mom, Stephanie, thinks CBD oil could be a better way, but she can’t convince her son’s doctor.

“His exact words to me were, ‘It’s not legal,’” said Stephanie Tufts.  “I said well the oil is legal here in Missouri and he basically came back with, ‘It’s not. The DEA doesn’t see it as legal’ and that’s where he gets his medical license.”

FOX 2 has learned only 66 families in Missouri have obtained medical cards to buy CBD oil, with potentially thousands of families asking for it.

Treasurer Eric Schmitt fought for the new law when he was State Senator.

“This idea that you’ve tried everything and it’s not working, but there may be something that is now legal in the State of Missouri to now possess and use and that a doctor and a hospital would not allow families to access that – there’s no excuse for it,” said Schmitt.

Schmitt has met with hospital administrators across the State trying to get them to reconsider.

“I know for a fact that there are neurologists in those hospital systems that want to be able to recommend, but are not being allowed to by the lawyers. And I think that that’s just…it’s unconscionable.”

There is one hospital working with patients.  It’s in St. Louis, SSM Health Cardinal Glennon Children’s Hospital.

Dr. Sean Goretzke with SSM said, “Even though there might be some negatives and some side effects, (we felt) there was a certain percentage of patients that we owed it to to do everything we could to try to help within a safe and reasonable effort.”

Dr. Goretzke is director of child neurology at SSM Health Cardinal Glennon Children’s Hospital.

“Cases where this works are really highly publicized. There’s a lot of social media attraction to it and those are great and we’re happy about those. But we know this isn’t going to work for every patient, just like every other medicine we have.”

Patients must first try three traditional prescriptions without success.  The marijuana strain that’s cultivated for its CBD oils does not contain the psychoactive THC, which hurts brain development, but Dr. Goretzke says there’s no research to answer whether CBD oil could still present risks.

“The majority of kids we are treating with this substance are so delayed from the burden of their seizures, maybe from the side effects of their other medications, that we feel the potential benefit for this medicine far outweighs those risks,. But with a typically developing child we’re still just not quite sure yet.”

He acknowledged they must start somewhere, but said it would help if there was research money to help answer their concerns.  Dr. Goretzke also said this is not a mandate and the hospital will respect individual doctors who might not want to be part of it.

Follow Fox 2’s Chris Hayes on Facebook https://www.facebook.com/ChrisHayesTV/

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The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017)

THE NATIONAL ACADEMIES PRESS HAS RELEASED A NEW RESEARCH BOOK REGARDING THE HEALTH EFFECTS OF CANNABIS.  PLEASE USE LINK PROVIDED TO REVIEW.

 

The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research

 

Description

Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk.

However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively.

Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agenda—outlining gaps in current knowledge and opportunities for providing additional insight into these issues—that summarizes and prioritizes pressing research needs.

Topics

 

CONCLUSIONS FOR: THERAPEUTIC EFFECTS
There is conclusive or substantial evidence that cannabis or cannabinoids are effective:
• For the treatment for chronic pain in adults (cannabis) (4-1)
• Antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids) (4-3)
• For improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids) (4-7a)
There is moderate evidence that cannabis or cannabinoids are effective for:
• Improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea
syndrome, fibromyalgia, chronic pain, and multiple sclerosis (cannabinoids, primarily nabiximols) (4-19)
There is limited evidence that cannabis or cannabinoids are effective for:
• Increasing appetite and decreasing weight loss associated with HIV/AIDS (cannabis and oral cannabinoids) (4-4a)
• Improving clinician-measured multiple sclerosis spasticity symptoms (oral cannabinoids) (4-7a)
• Improving symptoms of Tourette syndrome (THC capsules) (4-8)
• Improving anxiety symptoms, as assessed by a public speaking test, in individuals with social anxiety disorders (cannabidiol)
(4-17)
• Improving symptoms of posttraumatic stress disorder (nabilone; one single, small fair-quality trial) (4-20)
There is limited evidence of a statistical association between cannabinoids and:
• Better outcomes (i.e., mortality, disability) after a traumatic brain injury or intracranial hemorrhage (4-15)
There is limited evidence that cannabis or cannabinoids are ineffective for:
• Improving symptoms associated with dementia (cannabinoids) (4-13)
• Improving intraocular pressure associated with glaucoma (cannabinoids) (4-14)
• Reducing depressive symptoms in individuals with chronic pain or multiple sclerosis (nabiximols, dronabinol, and nabilone)
(4-18)

PLEASE CONTINUE TO LINK HERE

New DEA Rule Says CBD Oil is Really, Truly, No-Joke Illegal

Bruce Barcott

December 14, 2016

The US Drug Enforcement Administration (DEA) this morning made CBD oil a little more federally illegal in a little-noticed bureaucratic maneuver this morning.

Today’s Federal Register (Dec. 14, 2016) contains an item (21 CFR Part 1308) that establishes a new drug code for “marihuana extract.”

“This code,” wrote DEA Acting Administrator Chuck Rosenberg, “will allow DEA and DEA-registered entities to track quantities of this material separately from quantities of marihuana.” The move, the Register entry explained, is meant to bring the US into compliance with international drug-control treaties.

There is no major change in law brought about by the Register item. Rather, it serves to clarify and reinforce the DEA’s position on all cannabis extracts, including CBD oil. That position is: They are all federally illegal Schedule I substances.

CBD oil derived from hemp is now commonly available nationwide via web sites and mail order services. Those operations survive on the assumption that cannabidiol products below the legal threshold for THC percentage in hemp (0.3 percent or less) are technically legal.

Not so, says the DEA.

In the DEA comment on the entry, Rosenberg directly addressed the question: What if it’s only cannabidiol (CBD) and no other cannabinoids? The agency’s response: “For practical purposes, all extracts that contain CBD will also contain at least small amounts of other cannabinoids. However, if it were possible to produce from the cannabis plant an extract that contained only CBD and no other cannabinoids, such an extract would fall within the new drug code” and therefore remain federally illegal. In other words: The DEA is confident that it can find enough traces of other cannabinoids in your CBD oil to arrest and prosecute. And if they can’t, they still have the option of arresting and prosecuting based on the CBD oil itself.

RELATED STORY

Is CBD from Cannabis the Same as CBD from Cannabis?

Is your CBD derived from hemp? Doesn’t matter to the DEA. The new extracts classification applies to all “extracts that have been derived from any plant of the genus Cannabis and which contain cannabinols and cannabidiols.” Hemp is not a separate genus. (Although it may be a separate species; lot of debate on that point.) Legally speaking, hemp is simply cannabis with no more than 0.3 percent THC content.

The new rule seems to clarify the DEA’s position on hemp-derived CBD, which entered a legal gray area following Congress’ passage of the 2014 farm bill. That legislation allowed certain states to grow hemp in pilot projects, and blocked federal law enforcement authorities (ie, the DEA) from interfering with state agencies, hemp growers, and agricultural research.

What DEA Administrator Rosenberg seems to be saying with this clarification is: You may be able to grow hemp. But if you try to extract CBD oil from it, the DEA considers that a federal crime.

The rule did not contain any hint as to when the DEA will step into the 21st century and stop using the archaic version of the word “marihuana.”

Lead Image: Brennan Linsley/AP

CONTINUE READING…

How A Psychedelic Drug Helps Cancer Patients Overcome Anxiety

December 3, 20167:00 AM ET

Robin Marantz Henig

 

Psychedelic drugs could provide relief for anxiety and depression among advanced cancer patients.

The brilliantly-colored shapes reminded Carol Vincent of fluorescent deep-sea creatures, and they floated past her languidly. She was overwhelmed by their beauty — and then suddenly, as if in a dream, she was out somewhere in deep space instead. “Oh, wow,” she thought, overwhelmed all over again. She had been an amateur skydiver in her youth, but this sensation didn’t come with any sense of speeding or falling or even having a body at all. She was just hovering there, gazing at the universe.

Vincent was having a psychedelic experience, taking part in one of the two studies just published that look at whether cancer patients like her could overcome their death-related anxiety and depression with a single dose of psilocybin.

It turned out they could, according to the studies, conducted at New York University and Johns Hopkins and reported this week in the Journal of Psychopharmacology. NYU and Hopkins scientists gave synthetic psilocybin, the hallucinogenic component of “magic mushrooms,” to a combined total of 80 people with advanced cancer suffering from depression, anxiety, and “existential angst.” At follow-up six months or more later, two-thirds of the subjects said their anxiety and depression had pretty much disappeared after a single dose.

And about 80 percent said the psilocybin experience was “among the most personally meaningful of their lives,” Roland Griffiths, a professor of psychiatry and leader of the Hopkins team, said in an interview.

That’s how it was for Vincent, one of the volunteers in Griffiths’ study. By the time she found her way to Hopkins in 2014, Vincent, now 61, had been living for six years with a time bomb of a diagnosis: follicular non-Hodgkin’s lymphoma, which she was told was incurable. It was asymptomatic at the time except for a few enlarged lymph nodes, but was expected to start growing at some undefined future date; when it did, Vincent would have to start chemotherapy just to keep it in check. By 2014, still symptom-free, Vincent had grown moderately anxious, depressed, and wary, on continual high alert for signs that the cancer growth had finally begun.

“The anvil over your head, the constant surveillance of your health — it takes a toll,” says Vincent, who owns an advertising agency in Victoria, British Columbia. She found herself thinking, “What’s the point of this? All I’m doing is waiting for the lymphoma. There was no sense of being able to look forward to something.” When she wasn’t worrying about her cancer, she was worrying about her son, then in his mid-20s and going through a difficult time. What would happen to him if she died?

Participating in the psilocybin study, she says, was the first thing she’d looked forward to in years.

The experiment involved two treatments with psilocybin, roughly one month apart — one at a dose high enough to bring on a markedly altered state of consciousness, the other at a very low dose to serve as a control. It’s difficult to design an experiment like this to compare treatment with an actual placebo, since it’s obvious to everyone when a psychedelic experience is underway.

The NYU study used a design similar to Hopkins’ but with an “active placebo,” the B vitamin niacin, instead of very-low-dose psilocybin as the control. Niacin speeds up heart rate but doesn’t have any psychedelic effect. In both studies it was random whether a volunteer got the dose or the control first, but everyone got both, and the order seemed to make no difference in the outcome.

Vincent had to travel from her home in Victoria to Baltimore for the sessions; her travel costs were covered by the Heffter Research Institute, the New Mexico nonprofit that funded both studies. She spent the day before each treatment with the two Hopkins staffers who would be her “guides” during the psilocybin trip. They helped her anticipate some of the emotional issues — the kind of baggage everyone has — that might come to the fore during the experience.

The guides told Vincent that she might encounter some hallucinations that were frightening, and that she shouldn’t try to run away from them. “If you see scary stuff,” they told her, “just open up and walk right in.”

They repeated that line the following day — “just open up and walk right in” — when Vincent returned to Hopkins at 9 a.m., having eaten a light breakfast. The treatment took place in a hospital room designed to feel as homey as possible. “It felt like your first apartment after college, circa 1970,” she says, with a beige couch, a couple of armchairs and some abstract art on the wall.

Vincent was given the pill in a ceramic chalice, and in about 20 minutes she started to feel woozy. She lay down on the couch, put on some eye shades and headphones to block out exterior sights and sounds, and focused on what was happening inside her head. The headphones delivered a carefully-chosen playlist of Western classical music, from Bach and Beethoven to Barber’s “Adagio for Strings,” interspersed with some sitar music and Buddhist chants. Vincent recalled the music as mostly soothing or uplifting, though occasionally there were some brooding pieces in a minor key that led her images to a darker place.

Your Brain On Psilocybin Might Be Less Depressed

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Your Brain On Psilocybin Might Be Less Depressed

With the music as background, Vincent started to experience a sequence of vivid hallucinations that took her from the deep sea to vast outer space. Listening to her describe it is like listening to anyone describe a dream — it’s a disjointed series of scenes, for which the intensity and meaning can be hard to convey.

She remembered seeing neon geometric shapes, a gold shield spelling out the name Jesus, a whole series of cartoon characters — a fish, a rabbit, a horse, a pirate ship, a castle, a crab, a superhero in a cape — and at some point she entered a crystal cave encrusted with prisms. “It was crazy how overwhelmed by the beauty I was,” she says, sometimes to the point of weeping. “Everything I was looking at was so spectacular.”

At one point she heard herself laughing in her son’s voice, in her brother’s voice, and in the voices of other family members. The cartoon characters kept appearing in the midst of all that spectacular beauty, especially the “comical crab” that emerged two more times. She saw a frightening black vault, which she thought might contain something terrifying. But remembering her guides’ advice to “just open up and walk right in,” she investigated, and found that the only thing inside it was herself.

When the experience was over, about six hours after it began, the guides sent Vincent back to the hotel with her son, who had accompanied her to Baltimore, and asked her to write down what she’d visualized and what she thought about it.

Griffiths had at first been worried about giving psychedelics to cancer patients like Vincent, fearing they might actually become even more afraid of death by taking “a look into the existential void.”

But even though some research participants did have moments of panic in which they thought they were losing their minds or were about to die, he said the guides were always able to settle them down, and never had to resort to the antipsychotic drugs they had on hand for emergencies. (The NYU guides never had to use theirs, either.)

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How LSD Makes Your Brain One With The Universe

Many subjects came away feeling uplifted, Griffiths says, talking about “a sense of unity,” feeling part of “an interconnected whole.” He adds that even people who are atheists, as Vincent is, described the feeling as precious, meaningful or even sacred.

The reasons for the power and persistence of psilocybin’s impact are still “a big mystery,” according to Griffiths. “That’s what makes this research, frankly, so exciting,” he says. “There’s so much that’s unknown, and it holds the promise for really understanding the nature of human meaning-making and consciousness.”

He says he looks forward to using psilocybin in other patient populations, not just people with terminal diagnoses, to help answer larger existential questions that are “so critical to our experience as human organisms.”

Two and a half years after the psychedelic experience, Carol Vincent is still symptom-free, but she’s not as terrified of the “anvil” hanging over her, no longer waiting in dread for the cancer to show itself. “I didn’t get answers to questions like, ‘Where are you, God?’ or ‘Why did I get cancer?’ ” she says. What she got instead, she says, was the realization that all the fears and worries that “take up so much of my mental real estate” turn out to be “really insignificant” in the context of the big picture of the universe.

This insight was heightened by one small detail of her psilocybin trip, which has stayed with her all this time: that little cartoon crab that floated into her vision along with the other animated characters.

“I saw that crab three times,” Vincent says. The crab, she later realized, is the astrological sign of cancer — the disease that terrified her, and also the sign that both her son and her mother were born under. These were the three things in her life that she cared about, and worried over, most deeply, she says. “And here they were, appearing as comic relief.”

Science writer Robin Marantz Henig is a contributing writer for The New York Times Magazine and the author of nine books.

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The Stakes Are High As DEA Reconsiders Waging War On The Herb Kratom

11/30/2016 04:03 am ET

Those who use and study the plant say an outright ban could do serious harm.

Seven weeks after the U.S. Drug Enforcement Administration officially withdrew its plan to ban kratom, the federal government is once again set to decide the fate of the herb and the people who rely on it for pain relief and other treatment.

The DEA had initially planned to use its emergency scheduling power to push through the ban without input from the public, despite concerns from lawmakers and scientists ― as well as kratom users ― that the move would do more harm than good. In October, however, the DEA opened a public comment period allowing individuals to weigh in on the agency’s decision to place mitragynine and 7-hydroxymitragynine, two active compounds in kratom, in Schedule I. Substances in this category include heroin and LSD and are considered to have no known medical benefit and a high potential for abuse.

With the comment period set to close on Thursday, the DEA will now have to take into account the nearly 9,000 submissions from people who wanted to voice their opinions about this proposed expansion of the war on drugs.

But kratom isn’t in the clear yet. The DEA is currently awaiting the results of a U.S. Food and Drug Administration analysis on the potential harms and health benefits of the herb, which will determine if kratom truly poses an “imminent hazard to the public safety,” as the agency initially claimed in August.

The DEA doesn’t know when it will get the results of the FDA’s review, Russell Baer, a spokesperson for the agency, told The Huffington Post.

“We’ve asked the FDA to expedite their analysis, but they’ve not given us any indication as to when that may be done, other than as soon as practical,” said Baer. “They’re involved in an exhaustive scientific review and evaluation, so these things do take time.”

Although Baer said he expects the DEA to wait for the FDA’s analysis before deciding on an appropriate schedule for kratom ― or whether it should be scheduled at all ― he noted that the agency could still proceed with emergency scheduling even in the absence of more concrete scientific evidence.

The DEA’s next steps will have huge implications for people like Joshua Levy. In the video above, Levy explains that he turned to kratom after struggling with dependence on the opioid painkillers he’d been prescribed following a hit-and-run accident. Like many kratom users, he says the herb gave him back the life that had been taken from him by addiction and other side-effects of narcotic painkillers.

“Since I started taking kratom, since I had gotten off of the pain pills, my life has basically opened up dramatically,” Levy told HuffPost. “I got a new job. I’m building a friendship up with my sister that I haven’t had in a long time. I’m not lazy anymore. I don’t want to isolate myself. I want to go out, I want to be out of the house.”

The kratom community is full of success stories like Levy’s. But together, they form only anecdotal evidence of the herb’s benefits, which is not enough to support a more official confirmation of its medicinal value.

Experts like Andrew Kruegel, an associate research scientist at Columbia University, hope the DEA will allow kratom to remain legal so they can keep working to unlock the herb’s potential.

Kruegel’s studies have shown that kratom can be used to alleviate mild pain, and that the plant’s negative side effects are relatively minor.

“As a scientist, I try to be as objective as possible and not overstate the promise of kratom,” said Kruegel. “We just don’t know that much about the plant yet.”

But Kruegel also has bigger hopes for kratom, which he believes can be used to aid in the development of safer alternatives to the prescription opioids that claimed more than 18,000 lives in the U.S. in 2014 due to overdose.

“Of course, if it’s in Schedule I, historically that greatly limits the ability to do research on it,” he said.

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