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Sunday, July 8, 2018

Medical Marijuana a Hit With Seniors


Seniors are giving rave reviews for medical marijuana.
In a new survey, those who turned to it for treating chronic pain reported it reduced pain and decreased the need for opioid painkillers.
Nine out of 10 liked it so much they said they’d recommend medical pot to others.
“I was on Percocet and replaced it with medical marijuana. Thank you, thank you, thank you,” said one senior.
Another patient put it this way: “It [medical marijuana] is extremely effective and has allowed me to function in my work and life again. It has not completely taken away the pain, but allows me to manage it.”
Study co-author Dr. Diana Martins-Welch said, “The impact of medical marijuana was overwhelmingly positive. Medical marijuana led them to taking less medications overall — opioids and non-opioids — and they had better function and better quality of life.” Martins-Welch is a physician in the division of geriatric and palliative medicine at Northwell Health, in Great Neck, N.Y.
The biggest complaint the researchers heard about medical marijuana was the cost. “It’s an out-of-pocket expense. Insurance doesn’t cover it because it’s federally illegal,” Martins-Welch explained.
As for unwelcome side effects, Martins-Welch said sedation was what she heard about the most. “A lot of people don’t like feeling sleepy,” she said.
It’s also important to work with your doctor to find the right dose, since pain experts say that too little or too much doesn’t ease pain.
Thirty-one states have some type of medical marijuana law on the books, according to the National Conference of State Legislators.
“Every state has its own laws, like what a qualifying condition is. There are a lot of differences. And you can’t take a product from one state and cross another state line,” Martins-Welch said.
According to federal law, medical marijuana is still illegal in the United States. “There are legal fears. Some practitioners worry that the DEA [U.S. Drug Enforcement Administration] might come after them,” she added.
Medical marijuana is different than just picking up some pot and smoking it.
“The goal with medical marijuana is to find the dose that gives a therapeutic benefit without a high, or slowing reaction time or causing sedation,” Martins-Welch said. “To find that right dose, we start low and go slow.”
In fact, it’s important to work with a doctor because there’s a “therapeutic window” with THC, the active component in marijuana that causes the high, according to Dr. Mark Wallace, a board member of the American Pain Society.
If you get a dose that’s within that window, the pain is relieved. If you get too little, you won’t get pain relief, and if you go over the therapeutic window, pain is actually worsened, Wallace explained.
The study included a 20-question survey of nearly 150 seniors who had used medical marijuana for chronic pain. The seniors had received their medical marijuana from dispensaries in New York or Minnesota.
The average age of the seniors was 61 to 70, and 54 percent were female. Many (45 percent) used a vaporized oil in an e-cigarette device. Twenty-eight percent used a medical marijuana pill.
Twenty-one percent said they used medical marijuana daily, while 23 percent said they used it twice a day. Another 39 percent said they used it more than twice a day, the researchers noted.
About half the time, medical marijuana had been recommended by a doctor. One-quarter of the seniors decided to try medical marijuana at the urging of a friend or family member. Almost all — 91 percent — would recommend medical marijuana to someone else.
When asked how medical marijuana affected their pain levels, the seniors reported going from a 9 (on a pain scale of zero to 10) down to 5.6 a month after starting the medical marijuana.
Wallace said he’s seen many positive results from the use of medical marijuana in his patients.
“The geriatric population is my fastest-growing patient population. With medical marijuana, I’m taking more patients off opioids,” he said.
“There’s never been a reported death from medical marijuana, yet there are 19,000 deaths a year from prescription opioids. Medical cannabis is probably safer than a lot of drugs we give,” Wallace said.
Medical marijuana can also stimulate appetite, Martins-Welch said, which is a “godsend for cancer patients,” though extra eating may not be a welcome side effect for everyone.
Martins-Welch said it’s best to discuss potential drug interactions with your doctor, but it’s usually OK to mix marijuana and opioids. She said she’d caution against mixing medical marijuana with alcohol.
The study findings were presented recently at the American Geriatrics Society meeting in Orlando, Fla. Studies presented at meetings are typically viewed as preliminary until they’ve been published in a peer-reviewed journal.
More information
Learn more about medical marijuana from the U.S. National Institute on Drug Abuse.
SOURCES: Diana Martins-Welch, M.D., physician, department of medicine, division of geriatric and palliative care medicine, Northwell Health, Great Neck, N.Y.; Mark Wallace, M.D., board member, American Pain Society, and professor, anesthesiology, University of California, San Diego, and program director, UCSD Center for Pain Medicine; May 3, 2018, presentation, American Geriatrics Society meeting, Orlando, Fla.

Occupational Exposure Limits for Heat Stress Often Exceeded: CDC


Based on recommendations from the U.S. Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health and the American Conference of Governmental Industrial Hygienists, occupational exposure limits for heat stress are exceeded in most recorded cases of outdoor occupational heat-related illness, according to research published in the July 6 issue of the CDC’s Morbidity and Mortality Weekly Report.
Aaron W. Tustin, M.D., from the Occupational Safety and Health Administration (OSHA) in Washington, D.C., and colleagues retrospectively reviewed 25 outdoor occupational health-related illnesses (14 fatal and 11 non-fatal) investigated by the OSHA from 2011 to 2016. Personal risk factors were assessed for each incident, and the wet bulb globe temperature (WBGT), workload, and acclimatization status were estimated.
The researchers found that in all fatalities and eight of 11 non-fatal illnesses, heat stress exceeded exposure limits. For the same 25 cases, a Heat Index screening threshold of 85 degrees Fahrenheit could identify potentially hazardous levels of workplace environmental heat when WBGT was unavailable. Six fatalities occurred when the Heat Index was <91 degrees Fahrenheit.
“Whenever heat stress exceeds occupational exposure limits, workers should be protected by acclimatization programs, training about symptom recognition and first aid, and provision of rest breaks, shade, and water,” the authors write.

Disordered eating behaviors up for overweight young adults


Young adults at a weight status classified as overweight or obese have increased prevalence of disordered eating behaviors (DEBs), according to a study published online June 11 in the Journal of General Internal Medicine.
Jason M. Nagata, M.D., from the University of California in San Francisco, and colleagues examined the prevalence of eating disorders and DEBs using cross-sectional data obtained from Wave III of the National Longitudinal Study of Adolescent to Adult Health for young adults ages 18 to 24 years.
The researchers found that 48.6 percent of the 14,322 young adults in the sample were at a weight status classified as overweight/obese. Those at a weight status classified as overweight/obese reported a higher rate of DEBs than young adults at a weight status classified as underweight/normal weight (females: 29.3 versus 15.8 percent; males: 15.4 versus 7.5 percent). After adjustment for all covariates, the odds of engaging in DEBs were increased for females versus males (odds ratio, 2.32), Asian/Pacific Islanders versus whites (odds ratio, 1.66), homosexual or bisexual versus heterosexual (odds ratio, 1.62), high school or less versus more than  (odds ratio, 1.26), and obesity versus normal weight (odds ratio, 2.45).
“The high prevalence of DEBs particularly in  at a  classified as overweight or obese underscores the need for screening, referrals, and tailored interventions for DEBs in this population,” the authors write.

The Carbohydrate-Insulin Model of Obesity: Beyond ‘Calories In-Calories Out’


A spate of recent reviews claim to refute the CIM,1,32,33,48 or dismiss any special metabolic effects of macronutrients,49 but these attacks are premised on a misunderstanding of physiological mechanisms, misinterpretation of feeding studies and disregard for much supportive data. In animals, dietary composition has been shown to affect metabolism and body composition, controlling for calorie intake, in a manner consistent with the CIM predictions. Admittedly, the evidence for these effects in humans remains inconclusive.
Limited evidence notwithstanding, the conventional model has an implicit conflict with modern research on the biological control of body weight. The rising mean BMI among genetically stable populations suggests that changing environmental factors have altered the physiological systems defending body weight. After all, inexorable weight gain is not the inevitable consequence of calorie abundance, as demonstrated by many historical examples (eg, the United States, Western Europe, and Japan from the end of World War II until at least the 1970s).
Diets of varying composition, apart from calorie content, have varying effects on hormones, metabolic pathways, gene expression, and the gut microbiome in ways that could potentially influence fat storage. By asserting that all calories are alike to the body, the conventional model rules out the environmental exposure with the most plausible link to body weight control. What other factors could be responsible for such massive changes in obesity prevalence? The conventional model offers no compelling alternatives.
High-quality research will be needed to resolve the debate, which has been ongoing for at least a century.5 In 1941, the renowned obesity expert Julius Bauer described a key component of the CIM (the reverse direction of causality depicted in Figure B), writing in this journal: “The current energy theory of obesity, which considers only an imbalance between intake of food and expenditure of energy, is unsatisfactory…. An increased appetite with a subsequent imbalance between intake and output of energy is the consequence of the abnormal anlage [fat tissue] rather than the cause of obesity.”50 In view of the massive and rising toll of obesity-related disease, this research should be given priority.

At least 8 million IVF babies born in 40 years since historic first


The world’s first in-vitro fertilization baby was born in 1978 in the UK. Since then, 8 million babies have been born worldwide as a result of IVF and other advanced fertility treatments, an international committee estimates.
In-vitro fertilization involves removing eggs from a woman’s ovaries and mixing them with sperm outside the body, typically in a Petri dish; “in vitro” is Latin for “in glass.” Fertilized by this process, the eggs become embryos that can be placed in a woman’s uterus, where they can develop into a fetus and eventually a baby.
While IVF births have increased over the past four decades, rates of twins and multiple births have declined, according to the report from the International Committee Monitoring Assisted Reproductive Technologies, a nonprofit that disseminates global information on assisted reproductive technologies.
The committee presented its results Tuesday at the 34th annual Meeting of the European Society of Human Reproduction and Embryology in Barcelona, Spain.

Conception through science

The society was founded in 1985 by Robert Edwards, a Cambridge reproductive biologist who helped lead the first in-vitro conception with gynecologist Dr. Patrick Steptoe.
The historic birth of Louise Brown, known at the time as a “test tube baby,” 40 years ago at Oldham General Hospital was the first to result from IVF.
“I don’t think my mother, Lesley Brown, could ever have imagined how big IVF would become and how many babies would be born,” Brown said of the 8 million who followed her.
The presentation estimates that more than a half a million babies are now born each year from IVF and intracytoplasmic sperm injection, from more than 2 million treatment cycles performed.
Intracytoplasmic sperm injection, in which conception also takes place outside the body, involves a single sperm being injected directly into an egg as opposed to being allowed to naturally fertilize an egg in a Petri dish. It was developed in the early 1990s as a treatment for male infertility, though it is now used more generally.
European fertility clinics favor sperm injection over traditional IVF by nearly two-to-one, a pattern found throughout the world, according to the report.
The presentation is based on global data collected from regional registries by the International Committee Monitoring Assisted Reproductive Technologies.
The European Society of Human Reproduction and Embryology also collected national registry data of assisted reproductive technology cycles — a single attempt at accomplishing conception — performed in Europe from 1997 through 2015. It found that Spain leads the continent in assisted reproduction, with a record 119,875 treatment cycles; followed by Russia (110,723 cycles); Germany (96,512); and former front-runner France (93,918). The UK usually performs about 60,000 treatments a year.
By comparison, the US Centers for Disease Control and Prevention reports 263,577 total assisted reproductive technology cycles performed at 463 fertility clinics during a single year (2016), which resulted in 76,930 live-born infants.
Cycles monitored by the European Society of Human Reproduction and Embryology include treatments with IVF and intracytoplasmic sperm injection as well as egg donation, which involves using an egg that was not removed from the woman implanted with the resulting embryo.
In European nations, the rate of successful pregnancy per embryo transfer is about 36% for both IVF and intracytoplasmic sperm injection, according to the report. The rate of single embryo transfers also continues to rise in Europe — from 11% in 1997 to 38% in 2015 — while the rate of multiple births has declined to 14% as of 2015, according to the report.
“The number of [assisted reproductive technology] cycles continues to increase, but utilization is still very influenced by affordable access … which is related to insurance or public funding,” the report abstract stated.
Egg donation treatments and freezing eggs have become more widespread and embryo freezing more successful with the introduction of vitrification, a more efficient and safe fast-freezing technology, according to the report. Pregnancy rates from egg donation are now at about 50%, the researchers noted.
Though there is some unmet need in Europe, overall, the total number of cycles performed across the continent is increasing by about 7% per year, the report indicated.

‘Good news’

Dr. Gillian Lockwood, a consultant in reproductive medicine at IVI Midland, a fertility treatment center in the UK, said the report is a “real good-news story.”
However, Lockwood, who was not involved in the study, believes that 8 million is “quite a conservative estimate.”
“We know there’s a huge amount of IVF going on in China and India, which isn’t necessarily reported or recorded,” she said.
The good news includes a continued rise in the rate of successful pregnancy for each IVF attempt, she said: “When I started in IVF in 1990, we thought a 15% pregnant rate was quite good. Now, most competent clinics are looking at at least 40% for good prognosis patients.” Also, she noted, the multiple pregnancy rate is coming down and is now at 14%, with a goal of “less than 10%.”
Another point made by the European Society of Human Reproduction and Embryology presentation was “what a huge unmet need there is for fertility treatments,” she said. She noted the report’s finding that only one in every three couples who tries fertility treatments ends up with a baby. The reason for this is “limited cycles” of treatment, Lockwood said.
“After six funded cycles, 70% of couples will have a baby. The UK, despite having invented IVF 40 years ago, has one of the lowest rates of fertility interventions.”
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The one woman whose very existence is central to any discussion of reproductive technology remains both humble and hopeful.
Despite the acclaim of her birth, “we are just normal people, and I lead a normal life,” Brown said of herself and her mother. “There are so many people working in the IVF industry, and they do a fantastic job bringing hope and joy to people and creating families.”

Ambulatory surgery centers, publish prices, boost bottom line


Publicly listing prices for common surgeries helped to boost revenue and patient satisfaction.
That’s the finding from a small study of ambulatory surgical centers across the country by researchers from Johns Hopkins University in Baltimore.
Consumers are increasingly demanding more control over their healthcare decisions, including how much they pay. As a result, many hospitals and health systems are placing strategic focus on their pricing strategies, including both disclosing prices upfront and offering competitively priced services.
As the researchers described in the study, published in The American Surgeon, they drew from a database held by the Free Market Medical Association, and identified eight ambulatory surgical centers that listed prices for surgical services on their websites. The team sent a data-collection form to the eight centers between April and May 2016.
Six of the centers returned completed forms, which asked for patient demographics; details of price transparency initiatives; and information on how patient volume, patient inquiries for services, patient satisfaction, and center revenue changed 1 year after the prices were made transparent.
The results showed:
  • Five of the six centers reported increases in patient volume and revenue after adopting price transparency — specifically, there was a midrange or median patient volume increase of 50% 1 year after implementing price transparency
  • Four centers reported a 30% midrange revenue increase
  • Three centers had an average increase of seven new third-party administrator contracts
  • Three centers had a reduction in their administrative burden
  • Five centers reported an increase in patient satisfaction and patient engagement after price transparency.
Brian Unell, vice president of revenue cycle for Georgia-based Piedmont Healthcare, said that Piedmont is currently working on a price transparency initiative of its own. “There are studies that show that patients who are aware of what their payment expectations are, are more likely to pay,” he said. “And we believe that it’s important our charge structures are market competitive. As a result, we now generate around 15,000 patient estimates each month, which is a 650% increase from the end of 2017.”
Although the investigators said their findings don’t “categorically prove” that the price transparency directly boosted business for the surveyed centers, “the timing of the increases suggests the impact is positive.”
In addition, the centers’ leaders said they were happy with their price transparency initiatives.
Officials at all six centers reported they would recommend price transparency as a marketing strategy to other providers. Four of the centers reported a belief that price transparency increased both their annual revenue and the demand for their services.

Zynerba rebounds after selloff driven by failed cannabis-based skin patch trial


Shares of Zynerba Pharmaceuticals Inc. rose 7% in Friday trade, recouping some of their prior-session losses that came after the company said an early-stage trial of a cannabinoid skin patch failed to meet its main goals.
Zynerba ZYNE, +6.00%  , which is developing cannabis-based therapies for rare neurospsychiatric disorders, said the trial of ZYN001, which delivers tetrahydrocannabinol (THC) through a transdermal patch, did not achieve its goal of target blood levels of 5 to 14 ng/ml THC in healthy volunteers. THC is the psychoactive ingredient in cannabis and the company was trying to find a way to deliver it without patients having to take it orally, which can make them high.
“This Phase 1 study was a single and multiple dose, placebo-controlled first-in-man study to assess the safety and pharmacokinetics of ZYN001 administered as a transdermal patch to healthy adult subjects,” Zynerba said in a statement. “Several formulations and patch wear times ranging from 24 hours to 14 days were assessed in in 60 healthy subjects who were randomized to ZYN001 or placebo.”
The company will now focus its efforts on its ZYN002 treatment for Fragile X syndrome, a genetic autism-spectrum disorder that causes intellectual disability, behavioral and learning challenges that can be accompanied by seizures.
The change will extend Zynerba’s cash runway to the second half of 2019. The company said it has $52.1 million in cash and cash equivalents.

The news disappointed those who have high hopes for medical applications for marijuana and its chemical compounds. In June, the U.S. Food and Drug Administration approved a drug developed by U.K. company GW PharmacueticalsGWPH, +0.38%  to treat two severe forms of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

That drug, called epidiolex, contains cannabidiol (CBD), as opposed to THC, which means it does not make patients high. However, the product remains a controlled substance and cannot be sold until the Drug Enforcement Administration makes a final scheduling decision, as MarketWatch’s Emma Court has reported.
Canaccord analyst Arlinda Lee reiterated her buy rating on Zynerba stock and $18 price target on Friday, and said her sum-of-the-parts valuation of the company did not include ZYN001.

Lee is optimistic about Zynerba’s pivotal Fragile X Syndrome trial of patients in the U.S., Australia and New Zealand, noting that the company has received U.S. Orphan Drug Designation for cannabinoid use to treat the disease.
“Following agreement with FDA, we expect rapid enrollment of a pivotal trial in 2018 to result in a positive outcome,” she wrote in a note.
A Phase 2b trial of ZYN002 in treating epilepsy that’s planned for the second half “is designed to show meaningful contrast in treated patients,” versus an earlier trial, she wrote. The new trial will explore higher doses after the first trial failed to meet its main goals.
Zynerba shares have fallen 22% in 2018, while GW Pharma has gained 7%. The S&P 500 SPX, +0.85%   has gained 3% and the Dow Jones Industrial AverageDJIA, +0.41%   has fallen about 1%.