Another option for life-threatening allergic reactions

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 In June 2017 the FDA approved a new form of emergency epinephrine called Symjepi, which may be good news for people who must be prepared in the event of a life-threatening allergic reaction.

Keeping epinephrine at the ready

Spring-loaded autoinjectors that contain epinephrine have been manufactured by several companies since 1987. In the last 30 years, changes in pharmaceutical companies and patent transfers resulted in a near-monopoly in the production of pre-filled epinephrine products. From 2009 to 2016, one company with a 90% market share dramatically increased the consumer cost for epinephrine injectors, resulting in an investigation and eventual settlement with the US Department of Justice.

Although not a spring-loaded autoinjector, Symjepi consists of two single-dose, pre-filled syringes of epinephrine, for the emergency treatment of anaphylactic and severe allergic reactions in adults. Each pre-filled syringe contains 0.3 mg epinephrine, the recommended initial dose for emergency treatment of anaphylaxis.

At an anticipated lower cost and small size, Symjepi could be an attractive addition to this slice of the pharmaceutical world. In November 2017, the company also submitted a second new drug application to the FDA for a junior version (0.15 mg dose for children between 33 and 65 pounds).

Given the growing prevalence of life-threatening allergies, a new, lower-cost alternative should place the availability of this potentially life-saving drug within greater reach.

FDA Approves First Marijuana-Derived Drug

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The FDA approved the first drug with an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.

Cannabidiol (Epidiolex), an oral solution to treat seizures in Lennox-Gastaut Syndrome (LGS) and Dravet syndrome, was approved for patients two years of age and older.

"The FDA approval for cannabidiol is a landmark in American medicine," said Orrin Devinsky, MD, of New York University Langone Health, who helped lead the product's major clinical trials.

"This is the first time the government has approved a compound derived from the cannabis plant to treat any disorder -- in this case, severe epilepsy due to Dravet and Lennox Gastaut syndromes. This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards."

Cannabidiol (CBD) is the first FDA-approved drug derived from marijuana and the first FDA-approved drug to treat patients with Dravet syndrome. It is a chemical component of the Cannabis sativa plant and does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC). Epidiolex is a pharmaceutical-grade formulation; the approval was granted to GW Research Ltd.

LGS and Dravet syndrome are rare, severe, refractory epilepsy syndromes that emerge early in childhood. Both are linked to higher rates of mortality, primarily due to status epilepticus and sudden unexpected death in epilepsy patients (SUDEP).

An FDA advisory committee in April had recommended unanimously that Epidiolex be approved.

ER Staffing Split Along Urban-Rural Divide

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Emergency department staffing patterns have a gaping urban-rural divide, new researchshows.

In 2014 Medicare data, the distribution of emergency medicine physicians is strongly skewed toward urban areas. The researchers found that urban counties had a much higher proportion of emergency physicians -- 63.9%, compared with 44.8% in rural counties. The shortage of emergency physicians in rural areas is severe, said M. Kennedy Hall, MD, MHS, lead author of the research and an emergency department physician at Harborview Medical Center in Seattle.

"Rural area patients are now considered a disparity population, and rural areas are faced with an ongoing problem of insufficient numbers of emergency medicine-specialty physicians to staff their emergency departments."

Hall said earlier research has shown that rural areas have fewer incentives and more barriers compared with urban areas for ER physicians seeking employment. That research found that several factors influence job location choice:

  • Lifestyle
  • Access to amenities and recreation
  • ER volume and acuity
  • Family and spouse considerations
  • Access to specialists
  • Location of residency programs, which are mostly set in urban locations

In rural areas, research published in 2013 indicates that there also are budgetary and strategic factors at play in the employment of ER physicians. Some hospital executives reported that low ER patient volume and acuity did not justify hiring emergency medicine specialists. The executives also reported satisfaction with the care provided by their non-emergency medicine physicians and advanced practice providers.

Reflex Syncope: What You Need to Know

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Vasovagal syncope is one of three related syncopes that share a common pathophysiology. Together, they are called reflex syncope. The three are vasovagal, carotid sinus, and situational. Vasovagal is what just happened to your patient. Pain, seeing blood, emotional reaction, and prolonged standing are triggers of vasovagal syncope. Situational is triggered by urinating, coughing, or swallowing. Carotid sinus is triggered by stimulation of the nerve bundle located in the carotid sinus of the neck.

These neurologically induced losses of consciousness are brief and resolve without specific treatment. They are usually preceded by feeling dizzy, sweating, tunnel vision, odd feeling in the chest, or feeling very hot or very cold. The pathophysiology is an abrupt slowdown of the heart rate and a dilatation of the blood vessels leading to hypo-perfusion of the brain. Basically, the pump can’t get blood to your brain and you pass out…and you fall down.

First of all, it’s important to NOT PANIC. There is nothing you can do to fix it. Prepare for it by observing your patient immediately after giving an injection or drawing blood because these are prime times for a vasovagal episode. Make sure the patient is already seated and if you notice your patient is getting pale, sweaty, stuttering, or acting odd, gently guide your patient to a lying position with the feet up. Sometimes the loss of consciousness comes with muscle twitching that looks like a seizure.  Unlike a seizure, there is no prolonged postictal period, muscle clenching, or incontinence. While the loss of consciousness will resolve as soon as the patient lies (or falls) down, he or she will probably pass out again if he or she gets up so keep the patient under observation and lying down. It’s a good idea to get serial blood pressures so you can document the resolution. Every five minutes is fine. Your first blood pressure will be low with a heart rate in the 60s or high 50s. Over the next five to 15 minutes the vasodilatation and bradycardia will resolve without intervention but if you let the person stand up…boom! Don’t let the patient get up until they have a documented normal BP and HR. You can bring them a blanket, a drink of water, some juice, anything you like. Nothing is going to make it resolve any faster.

Bariatric Patients May Need Microbiome Boost

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Microbial richness remains diminished even 5 years after gastric bypass, banding.

French researchers pointed to a need to shore up the composition of the gut's microbiota ecosystem before or during bariatric surgery after they found persistent decreased microbial richness in severely obese patients.

The study found that both adjustable gastric banding and Roux-en-Y-gastric bypass improved microbial gene richness, but that microbial abundance was only partly restored in the majority of patients. Most had persistently low richness despite major metabolic improvement and weight loss, reported Karine Clement, MD, PhD, of Pitié-Salpêtrière Hospital in Paris, and colleagues in Gut.

"The lack of full rescue post-bariatric surgery calls for additional strategies to improve the gut microbiota ecosystem and microbiome-host interactions in severe obesity," the team wrote, suggesting that specialized diets, prebiotics, probiotics, or gut microbiota transfers before or after bariatric surgery might further improve microbial gene richness and metabolic health in severely obese individuals.

MGH study finds generic drug can reverse type 1 diabetes long-term

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Research at Massachusetts General Hospital looks increasingly like a long-term cure for type 1 diabetes, with a newly released study on Thursday showing patients have normal blood sugar levels eight years after a clinical trial.

In research published Thursday in journal npj Vaccines, patients who had been treated with the bacillus Calmette-Guerin (BCG) vaccine — an inexpensive, generic vaccine used around the world to prevent tuberculosis — had normal blood sugar levels eight years after the trial ended.

While it took three years for patients to see results from the vaccine, two doses of the drug spaced four weeks apart were still having a lasting impact eight years later.

“It’s kind of big news,” said Dr. Denise Faustman, director of the Massachusetts General Hospital immunobiology laboratory and principal investigator of the trial. “It’s the first trial showing (long-term reversal of diabetes), and more trials are on the way. But scientifically it’s pretty cool.”

The recently published study also details how the vaccine genetically alters the body’s white blood cells so they process glucose, making up for the pancreas’ inability to produce insulin to do the same. In type 1 diabetes — referred to in the past as juvenile diabetes — the immune system damages the pancreas and blocks the cells from producing insulin.

“It’s not only the discovery that something cheap in new cohorts brings down blood sugar, but why. We’ve discovered new pathways for lowering blood sugar,” Faustman said. “It’s an important discovery for the basic science of diabetes care. And by the way, we have a cheap BCG vaccine that seems to be doing it.”

Walgreens Teams Up With Humana in Senior Care Clinics

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Insurance company Humana (NYSE: HUM) is partnering up with pharmacy retail business Walgreens Boots Alliance in a new pilot deal to operate senior-focused primary care clinics.

The deal will establish the clinics inside two Walgreens stores in Kansas City, Missouri, operated by Partners in Primary Care, a wholly-owned subsidiary of Humana. The venture could also expand to other markets over time, the companies announced Wednesday.

The clinics are scheduled to open this fall and will complement Walgreens pharmacy services and the the four Partners in Primary Care locations that opened in Kansas City in 2017. Partners in Primary Care is a primary medical group practice operating in South Carolina, North Carolina, Kansas and Missouri.

“This unique partnership supports Humana’s multi-faceted approach to health care in this community and is a continuation of our senior-focused care strategy which is centered on integrating care through clinical programs that intersect health and lifestyle,” Bruce Broussard, Humana president and CEO, said in a statement.

Ultra-Processed Foods Up IBS Risk

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Consumption also linked to greater risk of functional dyspepsia when IBS is present.

Adults with diets high in ultra-processed foods and beverages were at higher risk of developing irritable bowel syndrome (IBS) and concomitant functional dyspepsia (FDy), French researchers reported in the American Journal of Gastroenterology.

That suggests the need to incorporate the impact of highly processed convenience foods into nutritional guidelines, said Laure Schnabel, MPH, of Paris-Sorbonne University, and colleagues.

The team studied the consumption of ultra-processed foods -- the popular, shelf-durable packaged and convenience foods and drinks with industrial formulations and plentiful additives that are increasingly replacing freshly prepared meals, even in the haute cuisineculture of France.

Foods consisted of more than 3,000 widely consumed dietitian-analyzed items, ranging from fresh and unprocessed foods to minimally processed (canned vegetables) and ultra-processed products (fish sticks, chicken nuggets, cookies, and sweetened drinks).

For the investigation, which the researchers said they believe to be the first such study, the team assessed the association between these products and four functional gastrointestinal disorders: IBS, FDy, functional constipation (FC), and functional diarrhea (FDh), disorders estimated to affect up to 25% of the population in industrialized countries.

The study sample was 76.4% women, and the mean age was 50.4. Before taking a self-administered questionnaire centered on Rome III diagnostic criteria, participants completed at least three 24-hour food-intake records with details on breakfast, lunch, and dinner, plus up to three additional eating episodes."The low-fiber content of ultra-processed foods could be involved in the induction and/or exacerbation of digestive symptoms," the French investigators wrote. A recent systematic review and meta-analysis by Moayyedi et al found that soluble fibers supplements are effective in treating symptoms in IBS patients. Insoluble fiber -- found in fruits, vegetables, and legumes and fermented in the colon -- produce short-chain fatty acids that promote normal intestinal function.

Why Is Everyone Getting Shingles?

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The virus that causes shingles is cunning. It lies dormant inside the human body — often hiding in the nerve cells of the spinal column or the brain. Then, after decades of inactivity, it can remerge as a painful, blister-pocked skin rash.

“The way the virus is quiescent for decades and then reactivates — it’s unusual, but it makes sense from the perspective of the virus’ survival,” says Rafael Harpaz, MD, a medical epidemiologist with the CDC’s Division of Viral Diseases. Back when humans lived in small hunter-gatherer communities, Harpaz explains, viruses that depended on human hosts would have died out quickly if they infected everyone en masse. By lying in wait, shingles allows new generations of carriers to be born.

Harpaz has spent years studying the bug. A 2016 study of his in the journal Clinical Infectious Diseases helped shine a spotlight on a curious phenomenon: For at least the past 60 years, rates of shingles have been climbing. Compared to the period from 1945 to 1949, when 0.76 people per 1,000 developed shingles, rates climbed to 3.15 per 1,000 by the period from 2000 to 2007, his study found.

“[The rise] seems to be occurring across all age groups, and not just in the U.S.,” says Kosuke Kawai, ScD, an assistant professor of otolaryngology at Boston Children’s Hospital and one of Harpaz’s co-authors on the CID study. “There are studies in European countries, and also in Taiwan and Australia, that seem to show this same increase over time.”

While rates of shingles have been escalating for decades, Harpaz says the increase seems to be “plateauing” among older adults — a group that usually suffers from a higher incidence of shingles than younger people. (A new vaccine was introduced in 2006, and some experts suspect that may explain it.) But rates of shingles among those age 30 to 50 don’t seem to be leveling off.

From the late 1940s to the early 2000s, the prevalence of shingles among Americans younger than 50 more than quadrupled, Harpaz’s data shows. Some research suggests the incidence of shingles among younger adults may actually be gaining steam. At least anecdotally, shingles seems to be increasingly common among people in their twenties and thirties — a group that, historically, suffered from vanishingly low rates of the disease.

What’s fueling all this? Harpaz is stumped. “I have given this as much thought as anyone, and it remains a mystery to me,” he says.

Parkinson's drugs may lead to compulsive behavior

Increases in compulsive behavior were clear in the use of L-dope in people with Parkinson's in the 60's, but the level of the problem is evident in this research....

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The production of dopamine can be excessively stimulated by taking drugs such as alcohol, cocaine, or heroin.

So, the neurotransmitter is at the heart of addictions and impulse control disorders ranging from substance abuse to sex addiction and gambling.

Such impulse control issues have been found to be common in people with Parkinson's disease. Pathological gambling and compulsive shopping, as well as compulsive eating and sexual behavior, have all been documented among patients with Parkinson's.

The drugs often prescribed to people with Parkinson's are the main risk factor for such compulsive behavior. Because dopamine is deficient in Parkinson's, the go-to treatment is dopamine agonists — which are drugs that activate the brain's dopamine receptors — or the well known levodopa, which turns itself into dopamine.

The researchers investigated 411 people who had received a Parkinson's disease diagnosis 5 years or under before the study, and who were clinically followed for at least 3 years.

Dr. Corvol and his colleagues interviewed the participants about any symptoms of impulse control disorders, such as compulsive shopping, eating, gambling, or sexual behaviors.

Of the 411 participants, 356 (or almost 87 percent) had taken dopamine agonists at least once since their Parkinson's diagnosis. At baseline, 81 participants (almost 20 percent) reported an impulse control disorder.

Specifically, 11 percent reported binge eating, 9 percent reported compulsive sexual behavior, 5 percent said that they shopped compulsively, and 4 percent admitted to having a gambling problem.

Of the 306 participants who did not report having any impulse control problems at baseline, 94 developed such a problem during the study. According to the scientists, this amounts to a "5-year cumulative incidence" of impulse control disorders of 46 percent.

By comparison, those who had never taken the drugs had a 5-year incidence of 12 percent. What is more, 30 participants with compulsive behaviors stopped taking the drugs during the study, which put an end to their symptoms.

Finally, higher doses of dopamine agonists and the duration of the treatment correlated directly with the risk of developing impulse control disorders.