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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

Senator Cory Booker still wants to legalize marijuana nationally by punishing prohibition states

Erik McLaren     17 November, 2017

Senator Cory Booker to Legalize Marijuana Nationally By Punishing Prohibition States 1 of 2 800x400 Senator Cory Booker still wants to legalize marijuana nationally by punishing prohibition states

Above:  WASHINGTON, DC – MARCH 10: U.S. Sen. Cory Booker (D-NJ) (3rd L) speaks during a news conference on medical marijuana as U.S. Sen. Kirsten Gillibrand (D-NY) (2nd L), U.S. Sen. Rand Paul (R-KY) (3rd R), Kate Hintz (2nd R) and Morgan Hintz (R), who suffers from a rare form of epilepsy, look on Capitol Hill, on Capitol Hill, March 10, 2015 in Washington, DC. The news conference was held to announce a new medical marijuana bill before the U.S. Senate. (Photo by Mark Wilson/Getty Images)

New Jersey Senator Cory Booker put forward a bill that would legalize weed in the United States earlier this year and has been promoting it ever since. The legislation goes further than simple legalization by punishing states with racist policing practices. With the Republican-controlled Congress, this bill is a long shot with golden intentions.

The bill would totally remove weed for the controlled substances act, making it legal on a federal level. This has been the main goal for activists since marijuana prohibition first started. “This is an important step,” Booker said in a Facebook Live post, “But it is only a beginning.”

Other issues around legalization center around what to do with people who currently have weed related criminal records. Booker’s bill would expunge criminal records for people convicted of using or possessing marijuana, even if those charges stretch back decades.

“We need to remember that these are charges that follow people for their entire lives, and make it difficult for them to do things we take for granted,” Booker said.

Even if weed was legal federally, individual states could still elect to keep cannabis prohibited. A goal of the bill is address discrimination in drug enforcement.

In order to encourage hold-out states to legalize, Booker’s bill would withhold federal funding from states that arrest black people for weed crimes at higher rates than whites.

According to the ACLU, that includes every state in which weed is illegal.

The bill would also clear people who’ve served time for use and possession. “For people in prison right now on marijuana charges, it gives them an avenue to have their sentences reduced or eliminated,” Booker said.

Booker has political aspirations greater than the Senate. There’s a lot of buzz around Booker and a 2020 presidential campaign. So, this bill could be a way to build a base for a presidential run. While Booker’s plan may seem ambitious, the bill’s message aligns with the popular and political opinion. According to a 2017 Gallup poll, 64% of Americans think cannabis should be legal. For the first time in history, the majority (51%) of Republicans support legalization. Booker will likely receive major support from his own party with 72% of Democrats on board for legal weed.

Screen Shot 2017 10 25 at 7.45.55 AM 1 Senator Cory Booker still wants to legalize marijuana nationally by punishing prohibition statesCourtesy of Gallup

This move also distances Booker from Governor Chris Christie, the wildly unpopular wildebeest that currently represents New Jersey. Christie has promised to strike down legalization. Whatever office Booker is after, his bill certainly pushes him in the right direction.

Erik McLaren

CONTINUE READING…

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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Democrats Call For Attorney General Sessions To Resign

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March 2, 20175:08 AM ET

Heard on Morning Edition

Democratic leaders want Attorney General Jeff Sessions to resign after news reports that he met with Russia’s ambassador to the U.S. twice last year.

STEVE INSKEEP, HOST:

Attorney General Jeff Sessions is defending his meetings with a Russian diplomat The Washington Post reports Sessions met twice with Russia’s ambassador during the presidential campaign and did not disclose it.

RACHEL MARTIN, HOST:

Now some Democrats want the attorney general to resign or at least keep away from the FBI investigation he’s overseeing into Russian interference in the U.S. presidential election.

INSKEEP: Here’s what we know. Sessions was a senator at the time of the reported meetings, and he was also advising presidential candidate Donald Trump.

MARTIN: The Post found Sessions met twice with Russia’s ambassador, including once in September, the height of the campaign. After the election, at his Senate confirmation hearing to become attorney general, Sessions said he didn’t know of any Trump campaign meetings with Russia.

(SOUNDBITE OF ARCHIVED RECORDING)

JEFF SESSIONS: Senator Franken, I’m not aware of any of those activities. I have been called a surrogate at a time or two in that campaign, and I didn’t have – not have communications with the Russians, and I’m unable to comment on it.

INSKEEP: Sessions was answering Senator Al Franken, who now says if The Post report is true, Sessions must recuse himself from any decisions about the Russia probe. Republican Senator Lindsey Graham said the same last night on CNN.

(SOUNDBITE OF ARCHIVED RECORDING)

LINDSEY GRAHAM: If there is something there and it goes up the chain of investigation, it is clear to me that Jeff Sessions, who is my dear friend, cannot make this decision about Trump. So they may be not – there may be nothing there, but if there is something there that the FBI believes is criminal in nature, then for sure you need a special prosecutor.

MARTIN: Attorney General Sessions and other officials do not appear to explicitly deny meeting Russia’s ambassador. They do suggest the meetings were not relevant to the election. In a statement last night, Jeff Sessions said he has, quote, “never met with any Russian officials to discuss issues of the campaign. I have no idea what this allegation is all about. It is false.”

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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)

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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.)

How LSD Makes Your Brain One With The Universe

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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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Apparent overdose in Ohio McDonald’s parking lot captured on Facebook live

 

 

 

Alyssa Raymond, WKYC 12:30 PM. CST November 19, 2016

SANDUSKY – A desperate search for help from the man seen in a Facebook Live stream who overdosed in a McDonald’s Parking lot in Sandusky Thursday evening.

The video and the man’s story are a powerful reminder of the heroin and opioid epidemic here in Northeast Ohio. The problem is real and so we want to warn you that we wanted to show you a clear picture, which some of you may find hard to watch. 

But the man on the ground and his family say they are glad this video is out there.

This is real life and people are dying. 

There have been 30 overdoses in 30 days in Sandusky.  Four people died. 

The family of the man you see on the ground wants everyone to share this story and this video.  They want the truth about heroin out there.

In an eleven and a half minute Facebook Live stream, you see a 27-year-old man gasping for air after overdosing on heroin.  That man lying there, seemingly lifeless, is Michael Williams.  Like so many, he watched the video over and over again.

“I was fighting back the tears,” said Michael Williams.  “I got goosebumps and teary eyed.  Like I said, I am a strong individual, and it was hard to watch.”

His older sister, Amber Roesch, found it hard to watch too.

“Watch that video and share it because that is terrifying,” said Roesch.

She hopes users all over the country see what happened to her brother.

“I do not want to have to bury him,” said Roesch.  “He needs help now.”

Amber says a week ago he told her he needed help, and he said it again today.

“I definitely have a problem,” said Williams.  “If I could get the help right now, I would definitely go.  I need it I want it.”

Michael’s family expected the worse when they received that phone call.  But EMS and Narcan saved his life.  Amber says they tried to thank everyone including Eddie Wimbley, the man who recorded it all.

“I hope it is like a wakeup call,” said Wimbley.  “I just do not understand how people can do something knowing that they could possibly die.”

Michael says he started using heroin four months ago.  Before that, he drank a lot and took pain pills.  But when he lost his job, he turned to something cheaper.  Michael will tell you, he never thought it would happen to him, but it did.

You might be wondering why Williams can’t just go out and get the help he needs.  He says he recently lost his job so he does not have insurance and he was told a lot of places would not take Medicaid.  His family told me it costs around $800 a day for him to go to an inpatient facility, which they say that’s what he needs, but cannot afford.

CONTINUE READING AND TO SEE VIDEO!

New Study Confirms Marijuana Use Up Drastically in Workforce

Cully Stimson / @cullystimson / October 12, 2016 / comments

This November, there are a record number of ballot initiatives in at least nine states regarding so-called medical marijuana or outright legalization of the Schedule I drug. The pot pushers, both small businesses and large, want more people smoking, eating, and consuming more pot because it is good for their bottom line.

Before voting yes, voters—and, in particular, employers—should take a look at more disturbing data that was released two weeks ago at a national conference.

At the annual Substance Abuse Program Administrators Association conference, Quest Diagnostics—one of the nation’s largest drug-testing companies—unveiled the results of its Drug Testing Index. The index examines illicit drug use by workers in America each year.

In 2015, Quest examined more than 9.5 million urine, 900,000 oral fluid, and 200,000 hair drug samples. Following years of decline in overall illegal drug usage, the results showed that the percentage of employees testing positive for illicit drugs has steadily increased over the last three years to a 10-year high.

The Drug Testing Index is an analysis of test results from three categories of workers—including federally mandated, safety-sensitive workers, the general workforce, and the combined U.S. workforce

Oral fluid drug testing results—best at detecting recent drug usage—showed an overall positivity rate increase of 47 percent over the last three years in the general workforce to 9.1 percent in 2015 from 6.7 percent in 2013.

According to Quest, the increase was “largely driven by double-digit increases in marijuana positivity.” In fact, according to the report, in 2015 there was a “25 percent relative increase in marijuana detection as compared to 2014.” The report also showed a significant increase in heroin positivity in urine tests for federally mandated safety-sensitive employees.

Another disturbing trend is the rising positivity rate for post-accident urine drug testing in both the general U.S. and the federal mandated, safety-sensitive workforces. According to the index, post-accident positivity increased 6.2 percent in 2015, compared to 2014, and increased a whopping 30 percent since 2011.

To those of us who have warned about the growing liberalization of the use of marijuana, from so-called “medical marijuana” to recreational abuse of the Schedule I drug, the results of the index are all too predictable.

It is also not surprising that none of the major organizations that push for pot legalization and decriminalization of marijuana have written major stories about the Quest Diagnostics report.

The more people use marijuana, the more likely it is that those who work and are subject to testing will pop positive for marijuana, even in safety-sensitive jobs. Think about that next time you hop on an airplane, ride Amtrak, or go about your daily life thinking everyone is focused on their job and your safety.

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Clinton Gave Thumbs Down to Legal Marijuana, Leak Shows

By Tom Angell on October 10th, 2016

 

Image result for marijuana and hillary clinton

Democratic presidential nominee Hillary Clinton spoke out against legalizing marijuana in a paid speech, hacked emails from her campaign show.

During an on-stage Q & A session with Xerox’s chairman and CEO in March 2014, Clinton used Wall Street terminology to express her opposition to ending cannabis prohibition “in all senses of the word”:

URSULA BURNS: So long means thumbs up, short means thumbs down; or long means I support, short means I don’t. I’m going to start with — I’m going to give you about ten long-shorts.

SECRETARY CLINTON: Even if you could make money on a short, you can’t answer short.

URSULA BURNS: You can answer short, but you got to be careful about letting anybody else know that. They will bet against you. So legalization of pot?

SECRETARY CLINTON: Short in all senses of the word.

The excerpt comes from an internal Clinton campaign memo highlighting potentially problematic passages from her paid speeches to Goldman Sachs, General Electric, Deutsche Bank and other major corporations.

Other excerpts from the 80-page document, published by Wikileaks after a hack on Clinton campaign chairman John Podesta’s email account, show the former U.S. secretary of state admitting she is “far removed” from the struggles of the middle class, arguing that politicians need to have separate positions on issues in public and in private and supporting “open trade and open borders.”

Over the course of the past year, the Clinton campaign forcefully refused calls to release the speech transcripts from her Democratic primary opponent, U.S. Sen. Bernie Sanders, who supports legalization and has introduced legislation to end federal marijuana prohibition.

That the campaign flagged the candidate’s opposition to legalization as a potential problem demonstrates a growing understanding by political operatives that marijuana law reform is now a mainstream issue, one which is supported by a majority of Americans and a supermajority of Democratic primary voters.

While Clinton has made no secret in public appearances that she isn’t ready to endorse full legalization, she has usually framed her position as taking a wait-and-see approach, wanting to give laws like those in Colorado and other states a chance to work before she makes up her mind about ending prohibition.

The leaked Xerox excerpt, in contrast, positions her as strongly opposed to legalization.

But the remarks were made two-and-a-half years ago, just two months after legal marijuana sales began in Colorado, so it is possible that Clinton’s personal view of legalization has legitimately softened in the interim.

During the course of her presidential campaign, Clinton has highlighted support for letting states set their own cannabis policies without federal interference and has pledged to reschedule marijuana under the Controlled Substances Act if elected.

But advocates have pushed the candidate to go even further by offering a personal endorsement for the policy of legalization, arguing that doing so could help Clinton win back support from wayward millennial voters who are supporting Libertarian Party candidate Gary Johnson or Jill Stein of the Green Party, both of whom have made support for ending cannabis prohibition centerpieces of their campaigns.

The newly-leaked documents showing Clinton’s strong opposition to legalization in a private appearance, combined with comments from the candidate’s daughter Chelsea last month implying that marijuana use can lead to death, could present an added sense of urgency for Clinton to evolve on the question of ending prohibition prior to Election Day.

To see what else Hillary Clinton has said about cannabis law reform, check out Marijuana.com’s comprehensive guide to the candidates.

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