Category Archives: Healthcare

Lawmaker says top issue for constituents is marijuana; oncologist advocates for safe access


02/12/2017 12:39 PM

Far and away the largest number of phone calls from constituents of Rep. Jason Nemes, R-Louisville, are in support of marijuana legalization, and he says he’s heard plenty of other lawmakers also getting the calls.

Nemes recently published online what voters are calling him about, and in a phone interview with Pure Politics he said the calls on marijuana come in three forms: advocating for medical marijuana in pill form, medical marijuana that can be smoked and full-scale state legalization of the federally illegal drug.

“I’m getting contacted on all three of those areas, I don’t know where I am on it, but the Kentucky Medical Association tells me there’s no studies that show that it’s effective,” Nemes said in a phone interview on Wednesday.

Dr. Don Stacy, a board certified radiation oncologist who works in the Kentucky and Indiana areas, said there’s a reason there’s no studies proving effectiveness — studies have not been allowed to take place.

“It’s one of those things where we can’t provide randomized phase three studies in cannabis without making it legal — that is the gold standard for any sort of medicine,” Stacy said. “We have a variety of studies of that nature from other countries of course, but American physicians are very particular about American data. The database we have now is plenty enough to say we shouldn’t be arresting patients for trying to help themselves.”

Stacy said he became interested in marijuana after he noticed some of his patients were doing better with treatment than similar patients. In reviewing their records and through private discussions with the patients, he learned “a significant portion” of those doing better were the patients using marijuana.

“I was surprised by that,” he said. “I’ve always been a skeptic of alternative medicines, but then I began to research the data. I was impressed with the data.”

Dr. Stacy said he’s had some particular patients who showed minor or moderate improvements or side effects, but patients who had to stop treatment because the toxicity of the treatment was so severe. The patients who had to stop treatment tried marijuana, and then they were able to complete their treatments showing “dramatic differences,” Stacy said.

Because of the improvements in patients, Stacy is advocating for safe and legal access to the drug.

Twenty-eight states and the District of Columbia allow access to medical marijuana in different forms. Through those states allowing access, Stacy said several show improvements outside of overall medical care.

In states that have legalized medical marijuana the suicide rate has dropped by 10 percent among males 18 to 40, he said.

“It says when people have serious medical or behavioral issues — if you cannot find the treatment that helps you then some people decide to end their lives, and cannabis apparently prevents a certain portion of people from doing that.”

Stacy said that there is also a 10 percent decrease in physicians prescribing narcotics in medical marijuana states. The effect of that, Stacy said is a 25 percent decrease in overdose deaths linked to narcotics in states with medical cannabis laws. With the level of heroin and opiate abuse in Kentucky, he said there would be positive effects seen here too.

“I think that one-quarter of the people who will overdose and die of narcotics in this state in this year would be alive if we had a medical cannabis law.”

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The Next Big Brain Cancer Drug Could Come from Marijuana


Sy Mukherjee

9:44 PM Central

Image result for marijuana

GW Pharmaceuticals (gwph, +2.63%) is already well on its way to winning the first-ever U.S. approval for a cannabis-derived therapy. But an early trial suggests that these treatments could also be an effective way to fight one of most devastating forms of brain cancers: glioblastoma multiforme.

The U.K.-based company unveiled preliminary data Tuesday from a mid-stage study on an experimental drug combining cannabidiol and THC, the “high” producing element of marijuana. Results so far show that the drug boosted brain cancer patients’ median survival rates by about six months compared to a placebo. Typically, this type of cancer ravages the brain and (on average) leaves 70% of patients dead within two years of being diagnosed.

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“We believe that the signals of efficacy demonstrated in this study further reinforce the potential role of cannabinoids in the field of oncology and provide GW with the prospect of a new and distinct cannabinoid product candidate in the treatment of glioma,” GW CEO Justin Gover said in a statement.

GW is already interpreting the results as a reason to expand its foray into cancer treatment. The company’s most advanced drug candidate, Epidiolex (for treatment of severe epilepsy related to a number of rare disorders), is closest to reaching the U.S. market. But the firm has staked out more far-reaching ambitions in an environment where cannabis-based products have been increasingly accepted.

For one, Gover thinks that cannabidiol-based therapies show plenty of promise in behavioral disorders like schizophrenia, he told Fortune last year.

Marijuana’s effect on cancer still isn’t all that clear. A big recent review by American scientists suggests the drug is effective for treating pain and nausea in cancer patients but doesn’t necessarily treat (or cause) cancer. However, GW’s drug isn’t just a bowl of weed to be smoked – it contains concentrated derivatives and is undergoing the kind of clinical testing that could provide insights hampered by U.S. policy towards studying cannabis.

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http://fortune.com/2016/09/26/gw-pharmaceuticals-marijuana-therapy/

Mother fighting to save daughter through medical marijuana


marijuana

By MELISSA REINERT

The Kentucky Enquirer

WILLIAMSTOWN, Ky.

Tiffany Wigginton Carnal is in the fight of her life to save her daughter.

Lyndi Carnal, 17, has Crohn’s Disease, an inflammatory bowel disease that causes inflammation of the lining of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Lyndi was diagnosed when she was 14. Since that time, she and her mother have spent three Christmases, three New Year’s Days and countless other days at Cincinnati Children’s Hospital.

The medications Lyndi has taken to control the Crohn’s and subsequent pain have negatively impacted her heart, kidneys and liver. Lyndi has also had her colon and rectum removed. The medications to control the pain keep Lyndi sedated and unable to function. One of her medications, Dilaudid, is a strong opiate that can be addictive.

“These medications are making children drug addicts. Lyndi has gone through withdrawals,” Tiffany Carnal said. “Lyndi was once a cheerleader and a beauty pageant winner, she won all over the state. Now she is bed-ridden and not able to function. As a parent, I have to ask, ‘How can I help my child?’ ”

The answer, according to Carnal, is illegal.

“I started doing my own research and learned that medical marijuana can help children who have Crohn’s Disease,” she said. “However, this is illegal in our state.”

The Carnals reside in Williamstown, Kentucky, where the use of marijuana, even for medical purposes is against the law. In 2016, Sen. Perry Clark introduced Senate Bill 13, a bill that would end marijuana prohibition for adults in the Commonwealth and create a regulated and taxed system. The legislature adjourned, however, without taking action on the bill. The bill — Cannabis Freedom Act — to legalize medical marijuana use in the state, will be presented to the legislature in 2017.

Carnal has been busy writing and calling her state representatives to encourage passage of the bill.

“I’m not at all for recreational use of marijuana, but there are facts that marijuana oil helps children with epilepsy, Crohn’s and cancer,” Carnal said.

According to the Mayo Clinic, medical marijuana is marijuana used to treat disease or relieve symptoms. Marijuana is made from the dried leaves and buds of the Cannabis sativa plant. It can be smoked, inhaled or ingested in food or tea. Medical marijuana is also available as a pill or an oil.

Also according to the Mayo Clinic, studies report that marijuana has possible benefits for several conditions. Crohn’s is on that list.

“It’s so frustrating that I can’t give my child a natural oil that could help her and not cause her other organs to fail or for her to be on a constant high,” Carnal said. “I can’t do that, but I can give her drugs that are killing her. There’s got to be a better way. There is. Things… the law… just have to change.”

This last bout with complications from Crohn’s almost took Lyndi’s life. She has been at Children’s for two months and was recently taken off life support. She’s on the mend, but the road ahead will be tough. She’s looking at two more months at Children’s.

“She has survived,” Carnal said. “She’s still here and for a reason. And that reason is not to spend her life in the hospital. Me? I’m going to fight to make sure she can get a natural treatment that will help her and not bring harm to her. That is my job as a parent.”

Read more here: http://www.heraldonline.com/news/article126600394.html#storylink=cpy

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

“Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.”


Drug-makers stand to benefit from act

By Staff Reports

1/6/17 8:19 PM

Will patients benefit from the passage of the 21st Century Cures Act? After listening to politicians and reading the headlines, most people might think it’s the best thing ever to come along for patients.

“A new day for medical research is on the horizon,” proclaimed Rep. Fred Upton, the outgoing chairman of the House Energy and Commerce Committee which had just won a major victory last week. “The House and the Senate have passed this bipartisan legislation which will ensure our health system can keep pace with incredible advances in science and technology,” Upton said in the GOP’s weekly radio address. “We needed to do better. And with 21st Century Cures, we will.”

Media headlines mirrored Upton’s victory declaration. Headlines like this from the Wall Street Journal, “House Passes Health Bill to Speed Drug Approvals, Boost Biomedical Research” seemed to say it all: faster drug approvals, more money for research, less pesky regulation.

Or was there more to the story? Not everyone thinks the Cures Act will be wonderful for patients. But their voices were drowned out in the slick public relations campaign Upton’s committee waged over the past few years using some 200 or so patient advocacy organizations to push for the bill. Most of those groups have strong ties to the drug and medical device industry.

A recent study by Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University, found that three-quarters of 68 cancer advocacy groups he studied disclosed sponsorship from pharmaceutical companies. Some groups received money from as many as 16 or 17.

Prasad told me, “Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.” Prasad and others say the Cures Act actually lowers the regulatory standards for drugs and devices. It’s a step backward for patients.

In a nutshell the Act turns current regulatory practice on its head.

Randomized trials, the gold standard for medical research, may disappear if a drug company wants to sell a medicine for a different condition than the one it’s already approved for. Instead it can use “real world evidence” to show the drug also works for a new indication. Such “evidence” could be observational studies, which are less reliable than randomized trials, but are cheaper and take less time.

The FDA can use patient experience to inform its regulatory decisions — information about the impact of a disease or related therapy on patients’ lives. The data can come from patients, family members, caregivers, patient advocacy organizations, disease research foundations and drug manufacturers.

The agency can approve new drugs on the basis of data summaries rather than requiring the FDA to independently analyze study results for a new drug indication. Drug makers would have to submit all their data, but the FDA would not have to review it.

And although the bill authorizes billions for new medical research at the National Institutes of Health (NIH), the funding is not guaranteed, and the NIH would have to fight Congress for the money.

The Cures Act is the culmination of a 20-year effort by the drug industry and Beltway think tanks to loosen standards and permit new uses for drugs already approved in order to expand their markets. It can be traced back to the 1997 FDA Modernization Act, which was then — as the Cures Act is now — sold on the promise of getting cures to market faster. The 1997 law loosened regulatory standards and reduced the number of clinical trials needed for drug approval.

Are the changes brought about by the earlier law a harbinger of what’s to come?

The reporting by John Fauber and his colleagues at the Milwaukee Journal Sentinel offers a cautionary tale. In the past few years the paper has reported how drug and device makers have spent huge sums of money to sell drugs for conditions that were once thought to be part of everyday life.

The reporters found that drug companies turned conditions such as overactive bladder, adult ADHD and premenstrual dysphoric disorder into medically treatable ailments. They reported that the latter was not even recognized as a mental disorder until 13 years after the first drug treatments were on the market. “Drugs used to treat the various medicalized conditions don’t work that well and often have side effects that are nearly as common as the benefit,” Fauber told me.

Are we turning the calendar back to 1933 when a book called “100,000,000 Guinea Pigs” was published exposing the dangers of patent medicines? Federal oversight of drugs was pretty lax then, and patients died. It’s obvious drug makers will benefit from looser regulation. It remains to be seen whether patients will, too.

Trudy Lieberman, a journalist for more than 40 years, is a contributing editor to the Columbia Journalism Review, where she blogs about health care and retirement at cjr.org. She can be reached at trudy.lieberman@gmail.com. This column was distributed by The Rural Health News Service.

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“a puff is enough”


Gary L. Wenk Ph.D.

Gary L. Wenk Ph.D. Your Brain on Food

Marijuana or Obesity: Which Is Worse?

For the majority of people who read this blog, the answer will be obesity.

Posted Jan 04, 2017

Overall, the complete answer to this question depends upon knowing whether you inherited genes that predispose you to drug addiction or food addiction. Recent research has found evidence that these two addictions are closely related to each other. What differs, and what truly matters to most people, is the consequence to smoking too much marijuana or consuming too much food. Which is worse for your body and brain? For the majority of people the answer will be obesity, not marijuana. This is why.

Obesity:

During the past three decades an obesity epidemic has been responsible for a 77% increase in death rates. The accumulation of excess body fat has been clearly shown to accelerate the progression of many age-associated diseases such as cancer, arthritis, diabetes and dementia. Why? A few years ago it became clear that fat cells produce inflammation by releasing specialized proteins called cytokines. The more fat cells you have the more cytokines get released into your blood. Essentially, obesity is associated with chronic, low-grade, body-wide inflammation, insulin resistance and many of the same metabolic conditions that underlie the aging process itself. The cytokines are capable of inducing shrinkage of brain regions (primarily gray matter- where the neurons live) that are used in the process of learning new things and recalling memories

One recent study examined the relationships between academic performance, cognitive functioning, and BMI among 2,519 young people.  BMI was inversely correlated with general mental ability even after controlling for demographics, lifestyle factors, and lipid profiles. Overall, obesity is implicated in lower performance on cognitive control tasks. The longer the inflammation is present, the more brain shrinkage occurs. Elderly obese people have more impaired learning and memory abilities than elderly thin people. Being obese at mid-life is also a strong predictor of dementia in later life. 

Today, an overwhelming body of evidence across a wide spectrum of medical disciplines strongly argues that obesity accelerates the aging process, impairs overall cognitive function and, ultimately, is responsible for numerous processes that kill you.

Marijuana:

Studies suggest that adults (this argument does not apply to young people) who use low to moderate daily amounts of marijuana show no personality disturbances. During the past few years some sensational studies have been widely featured in the national press; one suggested that daily marijuana use might decreased IQ (Meier et al., PNAS, 2012), the other suggested that daily recreational use caused shrinkage of brain areas that are critical for learning, memory and emotional control (Gilman et al., 2014, J Neurosci). The report by Meier et al. was immediately challenged (Rogeberg, 2013, PNAS) for failing to take into account the confounding effect of socioeconomic status, a factor which has been shown to a significantly impact on IQ score. The results of the second study have now been confronted by a more recent publication (Weiland et al., 2015, J Neurosci) that clearly demonstrated that daily use of marijuana produced no significant changes in the size or shape of brain regions involved in the control of emotion or learning and memory. 

Just last month another bit of nonsense derived from poor research methods was published and then debunked (see, https://www.leafly.com/news/health/does-marijuana-cause-alzheimers). Marijuana does not shrink the brain or predispose people to Alzheimer’s disease. Research in my laboratory (copies of publications can be obtained here: http://faculty.psy.ohio-state.edu/wenk/) has demonstrated that stimulating the brain’s marijuana receptors offer protection by reducing brain inflammation. Thus, later in life, marijuana might actually help your brain, rather than harm it. It takes very little marijuana to produce benefits in the older brain. My lab coined the motto “a puff is enough” because it appears as though only a single puff each day is necessary to produce significant benefit.

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I often am asked by my students whether smoking marijuana makes it more likely that to develop schizophrenia. Forty years of research has led to the following answer: if you are not genetically vulnerable to schizophrenia then marijuana use will not induce it. It appears as though stimulating endogenous marijuana receptors may be able to unmask underlying symptoms of schizophrenia as well as other mental disorders, such as bipolar disorder, if you inherited the appropriate genes from your parents.

Marijuana or Obesity?

Given recent evidence, obese people and marijuana smokers face a challenging dilemma: do they feel genetically lucky? Each person will have a different answer to the question of “which is worse.”  The answer will be determined by the genetic cards you were dealt by your parents. 

© Gary L. Wenk, Ph.D. Author of “Your Brain on Food,” 2nd Edition, 2015 (Oxford University Press)

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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

Shots – Health News
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

Shots – Health News
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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An effort to get ecstasy FDA-approved is entering a key final test


Ecstasy tablets

After veteran Tony Macie came back from Iraq in 2007, he learned he had post-traumatic stress disorder.

Macie went to the VA “on and off” and tried the standard therapy.

“And then I kind of just fell off the radar, secluded, and did my own thing and got really dependent on a lot of the meds,” Macie explains in a video by the Multidisciplinary Association for Psychedelic Studies.

The retired sergeant then became part of a clinical trial organized by MAPS that was testing an unusual substance in an attempt to heal people who hadn’t responded to traditional therapies for PTSD.

That substance, MDMA, commonly referred to as “Molly,” is the pure form of something commonly thought of as an illegal party drug — ecstasy. (Most nonresearch substances that are sold as ecstasy or Molly are not actually pure MDMA and can be significantly more dangerous.) The trial pairs MDMA with psychotherapy.

“One of the first things I said when it kicked in was, ‘This is what I’ve been looking for,'” Macie says in the video. “I reconnected with myself and did a lot of internal work, and afterwards it was like a huge weight was lifted off my shoulders.”

The trial Macie was involved in and other Phase 2 clinical studies conducted by MAPS have been so effective that the Food and Drug Administration on Tuesday agreed to allow large-scale Phase 3 clinical trials — the third and final in the three sets of human trials required before the FDA will consider a new drug for approval — to go forward, according to a report in The New York Times.

If those trials continue to show that MDMA effectively treats PTSD, ecstasy could enter clinical use as soon as 2021, fitting the timeline that MAPS has been working toward for some time now.

And so far, MDMA has consistently been very effective.

One of the early studies conducted by MAPS showed that 83% of the study participants no longer showed signs of PTSD two months after treatment, and long-term follow-ups conducted an average of four years later showed that most of those benefits stuck. That was a proof-of-concept study, with just 20 participants, all of whom had psychotherapy as well. (Twelve were given MDMA, and eight were given a placebo; 25% of those on the placebo improved, too.)

Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials, which MAPS announced were coming to an end last March. These trials consisted of at least eight studies that Brad Burge, the director of communications for MAPS, recently told Inverse treated 136 people using MDMA-assisted psychotherapy for PTSD.

Those trials dealt with patients who were struggling with PTSD from a variety of sources. They included military veterans, people who had been sexually assaulted, firefighters, and police officers, all who had not responded to traditional treatments.

The data released from those studies so far is very promising, with a large percentage of patients not showing any signs of PTSD more than a year after completing the therapy.

“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” Dr. Michael Mithoefer, a psychiatrist involved in the research, told The Times.

The final tests will involve hundreds of people and must be conducted before the FDA decides to approve a new medication. MAPS has applied for “breakthrough” therapy status, which could speed up the approval process.

“Phase 3 starts around 2017, and it will take four to five years to finish,” Burge has previously said. “So that will put it at early 2021 for FDA approval.”

MAPS is mostly raising money itself to fund what it describes as a roughly $20 million plan to complete these trials, which are largely not of interest to pharmaceutical companies since the patent on MDMA has expired. That will mean significant fundraising is required.

Last year the organization reported $9.1 million in assets, more than $5 million of which was a bequest from a longtime board member that has been earmarked specifically for those Phase 3 trials. In fiscal-year 2015, MAPS raised a combined $2.99 million from 2,500 donors. It said in its most recent annual report that “substantially increasing our donor base” would be necessary to move forward with Phase 3 trials.

It’s only after those trials wrap up that we’ll know for sure whether using MDMA to treat PTSD is safe and effective. MAPS calls making that happen its “top priority.”

The group is also conducting research testing the efficacy of MDMA-assisted therapy to treat social anxiety in autistic adults and to treat anxiety associated with life-threatening illnesses like cancer.

“It’s a really interesting and a very powerful new approach,” Thomas Insel, a former director of the National Institute of Mental Health, told the San Francisco Chronicle. “It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy.”

As Macie says in the MAPS video, “this tool, it may not be the end all, but it [could] be a tool that can help a lot of people drastically.”

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House passes medical cures bill


By Peter Sullivan – 11/30/16 06:40 PM EST

House passes medical cures bill

The House on Wednesday passed a medical innovation bill aimed at curing diseases, with the measure securing bipartisan support after months of negotiations.
The legislation, known as the 21st Century Cures Act, passed 392-26. It seeks to speed up the Food and Drug Administration’s approval of new drugs while investing new money in medical research. 

The package also includes a range of other healthcare priorities, including $1 billion over two years to fight the epidemic of opioid addiction and $1.8 billion for Vice President Biden’s cancer “moonshot.”
The opioid money releases some pressure from a long-running dispute between the parties. Congress passed a bipartisan opioid bill before the election, but Democrats criticized that measure for lacking funding.
The cures legislation also includes a mental health portion that seeks to reorganize and improve accountability for government mental health programs.
Republicans have portrayed the mental health bill, sponsored by Rep. Tim Murphy (R-Pa.), as their response to mass shootings, though that messaging has been emphasized less now that it is part of a larger package.

Democrats agree reforms are needed in mental health, though they note that the bill lacks funding. They say the bigger policy response to mass shootings should be gun control.
House leaders are hoping that the bipartisan vote Wednesday puts pressure on the Senate, which is expected to take up the cures bill sometime before leaving town next month.
The bill faces a bumpier path in the upper chamber, where Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have blasted it as a giveaway to pharmaceutical companies.
Still, enough Democrats are expected to support the measure to get it across the finish line.

“This bill, which expedites the approval of drugs and devices, includes literally billions of dollars in additional spending for health research so that we can find the cures and the answers to what patients are demanding today,” said House Energy and Commerce Chairman Fred Upton (R-Mich.), the measure’s main sponsor. 

The White House gave the measure a boost on Tuesday night by announcing that it “strongly” supports passage, pointing in particular to the opioid funding and the funding for the cancer moonshot.
The liberal detractors note that the new research funding, which is helping to bring some Democrats on board, is not mandatory funding, meaning it is not guaranteed.

Still, the $4.8 billion over 10 years is set aside in a separate fund and not subject to the usual budget caps.

Sanders and Warren have denounced the bill as helping out pharmaceutical companies, in part by lowering the FDA’s regulations for approving their new drugs, while doing nothing to deal with the hot-button issue of high drug prices.

Some consumer groups have also criticized the measure, fearing that in speeding up the FDA’s approval process, it would lower safety standards.
The measure allows for ideas like sometimes using “real world evidence,” rather than more rigorous and time-consuming clinical trials, in drug approvals.
Rep. Frank Pallone (D-N.J.), a lead negotiator on the bill in the House, rejected criticisms of the FDA changes.

“It’s just a way of trying to address these cures in a more effective way, the way the public has asked for, without sacrificing any safety,” Pallone said.

The mental health portion of the legislation establishes a new assistant secretary for mental health in the Department of Health and Human Services as well as a chief medical officer. Murphy argues that these positions will bring more accountability and medical knowledge to the Substance Abuse and Mental Health Services Administration, an agency he has criticized as ineffective.
The bill also authorizes grants for areas like suicide prevention.

The mental health measure is significantly scaled down from the more sweeping version originally proposed by Murphy, though. It does not lift restrictions on Medicaid paying for care at mental health facilities, which would have cost billions of dollars.

The measure also includes elements from a companion mental health bill in the Senate from Sens. Chris Murphy (D-Conn.) and Bill Cassidy (R-La.).
Both the Cures and mental health portions of the bill come after more than a year of bipartisan negotiations.

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