pitolisant

pitolisant
Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant

PLYMOUTH MEETING, PA, February 12, 2019 — Harmony Biosciences, LLC (Harmony), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its investigational product, pitolisant, and has granted Priority Review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent

and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy. A Priority Review designation by the FDA indicates that, if approved, pitolisant would provide a significant improvement in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments. Harmony’s goal is to obtain FDA approval to market pitolisant in the U.S. in 2019.
“The impact of narcolepsy can be significant and severely disruptive to everyday life for up to 200,000 Americans living with this disorder,” said John C. Jacobs, President and CEO at Harmony. “This is an important step for patients and for our company, whose mission is to develop novel treatment options for people living with rare and orphan diseases.”
“Pitolisant offers a novel approach to the treatment of both EDS and cataplexy in patients with narcolepsy, for which there have been no new treatment options in over 15 years,” said Jeffrey M. Dayno, M.D., Chief Medical Officer at Harmony. “We look forward to working with the FDA during its review of the pitolisant NDA, with our hope of being able to offer this new treatment option to help address an important unmet medical need for people living with narcolepsy.”
The NDA submission is based on results from the clinical development program in narcolepsy, which included over 300 patients, some of whom were treated for up to five years. It also included safety data in over 1500 patients across multiple patient populations.
About Pitolisant

Pitolisant is an investigational medication in the U.S. that is not approved by the FDA. It was granted orphan designation for the treatment of narcolepsy, Fast Track designation for the treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy, and Breakthrough Therapy designation for the treatment of cataplexy in patients with narcolepsy. Pitolisant, a first-in-class medication, is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist; it enhances the activity of histaminergic neurons in the brain that function to improve a patient’s wakefulness and inhibit attacks of cataplexy. It was designed and developed by Bioprojet, who has marketed the product in Europe since its approval by the European Medicines Agency in 2016. Harmony’s goal is to obtain FDA approval to market this new medication in the U.S. in 2019. If approved, pitolisant would represent the first new therapy in the U.S. in over 15 years for the treatment of both EDS and cataplexy in adult patients with narcolepsy.
About Narcolepsy

Narcolepsy is a rare, chronic, debilitating neurologic disorder of sleep-wake state instability that impacts up to 200,000 Americans and is primarily characterized by EDS, cataplexy, and other manifestations of REM sleep dysregulation, which intrude into wakefulness. In most patients, it is caused by the loss of hypocretin, a neuropeptide in the brain that supports sleep-wake state stability. This disorder affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. Narcolepsy can cause significant burden for patients and their families, affecting their ability to perform routine tasks, limit achievement at school and work, impact social relationships and cause impairment in overall quality of life.
About Cataplexy

Cataplexy is one of several symptoms of narcolepsy that represent elements of REM sleep state intruding into wakefulness, characterized by sudden temporary loss of muscle tone. Cataplexy can be subtle, such as drooping of eyelids, or severe, such as knee buckling or total body collapse. Often times, symptoms of cataplexy may go unrecognized because of the subtle nature of the symptoms in some patients, variability of how cataplexy is expressed, and/or lack of patient complaints or physician recognition of the symptoms as manifestations of cataplexy. This symptom of narcolepsy can often cause significant impact on a person’s ability to carry out normal daily functions. Up to two-thirds of all patients with narcolepsy have cataplexy (known as Type 1 narcolepsy); cataplexy is one of the most debilitating symptoms of this chronic, rare neurologic disorder.
Harmony Biosciences, LLC

Harmony Biosciences, LLC, is a private biopharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare and orphan diseases, with an emphasis on central nervous system disorders, starting with patients living with narcolepsy. Harmony is committed to advancing the understanding of narcolepsy and providing information and resources to individuals who live with, and healthcare professionals who treat patients with, this disorder. For 

lemborexant

lemborexant
New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States


TOKYO and STAMFORD, Conn. – January 15, 2019 – Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, “Purdue Pharma”) today announced that a new drug application has been submitted to the U.S. Food and Drug Administration (FDA) for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for the treatment of insomnia, a sleep-wake disorder.
This application was based on the results of two pivotal Phase 3 clinical studies in patients with insomnia, SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303), enrolling approximately 2,000 patients, as well as important safety studies, including assessment of postural stability after middle-of-the-night awakening and a next-morning driving study. SUNRISE 1, a one-month, double-blind, placebo-controlled study, included the first ever Phase 3 head-to-head comparison versus zolpidem ER and objectively assessed sleep parameters (time to sleep onset, sleep efficiency, and wake after sleep onset) resulting in the largest (objective) polysomnography dataset collected to date in patients with insomnia. SUNRISE 2 was a 12-month study and subjectively assessed for ability to fall asleep and stay asleep based on patient self reports (sleep diaries).
Lemborexant, which acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli, is being jointly developed by Eisai and Purdue Pharma for the treatment of multiple sleep-wake disorders, including insomnia disorder. In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway. Information about ongoing clinical studies is available at clinicaltrials.gov.
Eisai and Purdue Pharma are striving to address new unmet medical needs and to improve the lives of patients and their families.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval.
 About Lemborexant

Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with sleep-wake disorders, it is possible that orexin signaling which regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep.
About SUNRISE 1 (Study 304)

SUNRISE 11 was a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study evaluating the efficacy and safety of lemborexant in 1,006 male or female adult patients 55 years and older (45 percent of patients were 65 years and older) with insomnia disorder conducted in North America and Europe. SUNRISE 1 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a 30-day treatment period and a minimum two-week period without treatment prior to the end-of-study visit. In this study, patients were randomized to receive placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg). The primary objective for SUNRISE 1 was to demonstrate using polysomnography that lemborexant at either the 5 mg or 10 mg dose is superior to placebo on objective sleep onset, as measured by latency to persistent sleep after the last two nights of one month of treatment. Key secondary objectives included change from baseline in sleep efficiency and wake after sleep onset (WASO) for both lemborexant doses compared to placebo, and WASO in the second half of the night (WASO2H) for both lemborexant doses compared to zolpidem ER, each after the last two nights of one month of treatment.
About SUNRISE 2 (Study 303)

SUNRISE 22 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 male or female adult participants 18 to 88 years of age with insomnia disorder. SUNRISE 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of only active treatment and a two-week period without treatment prior to the end-of-study-visit. In this study, during the placebo-controlled treatment period, patients were randomized to receive placebo or one of two treatment regimens (lemborexant 5 mg or 10 mg). During the active-only treatment period, patients who received placebo during the first period were re-randomized to receive lemborexant 5 mg or 10 mg. Patients who received active treatment during the first period continued on the treatment to which they were originally randomized. The primary objective was to determine the efficacy of lemborexant 5 mg and 10 mg compared to placebo on patient-reported (subjective) sleep onset latency after six months of treatment. Key secondary endpoints were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset (sWASO) for lemborexant 5 mg and 10 mg compared to placebo after six months of treatment.
About Sleep Disorders

Population studies show that sleep disorders affect many more people worldwide than previously thought.3 Insomnia disorder is the most common sleep disorder affecting approximately 30 percent of the adult population worldwide.3,4 Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences such as fatigue, difficulty concentrating and irritability.5,6
Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.5,7
Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.8 Studies suggest an optimal sleep duration between seven and eight hours.9
Women are 1.4 times more likely than men to suffer from insomnia.10 Older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking and early waking, that can lead to less sleep time.11
About Eisai Co., Ltd

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.
Furthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.
For 

Opioids Prescribed in Hospital Often Tied to Long-Term Use

 People given opioids for the first time in the hospital are likely to continue getting them for months after, a new study reports.
A University of Pittsburgh team found that those first-timers are twice as likely to receive more opioids after discharge than patients who were not given opioids (such as oxycodone) in the hospital.
"I was surprised by the level of opioid prescribing to patients without a history of opioid use," said lead author Julie Donohue, a professor of health policy and management.
Nearly half of patients admitted to the hospital are given opioids, she said. And while doctors are prescribing fewer opioids outside the hospital, "we didn't see that in inpatient prescribing," she added in a university news release.
For the study, Donohue and her colleagues studied electronic health records of more than 191,000 patients who had not been prescribed opioids during the year prior to their hospitalization.
Opioids were prescribed to 48% of these patients for just over two-thirds of their hospital stay, on average, the study found. Three months later, 6% of those patients were still being prescribed opioids, compared with 3% of others.
Nearly 8% of those given opioids within 12 hours of discharge were still taking them three months later, compared with 4% of those who had not used them in 24 hours before leaving the hospital, the findings showed.
Non-opioid painkillers, such as ibuprofen (Advil, Motrin), aspirin or naproxen (Aleve), were rarely tried first -- about 8% of the time for some conditions, the researchers found.
"Inpatient opioid use has been something of a black box," Donohue said. "And, while our study could not assess the appropriateness of opioid administration, we identified several practices -- low use of non-opioid painkillers, continuous use of opioids while hospitalized, opioid use shortly before discharge -- which may be opportunities to reduce risk of outpatient opioid use, and warrant further study."
The report was published June 17 in the Annals of Internal Medicine.

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Compared with insulin glargine, initial injectable therapy with a combination of insulin degludec and liraglutide aids achievement of blood glucose goals for a longer period of time in patients with uncontrolled type 2 diabetes on oral antidiabetic drugs, according to a study published online June 9 in The Lancet Diabetes & Endocrinology to coincide with the annual meeting of the American Diabetes Association, held from June 7 to 11 in San Francisco.

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Zygel

Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS)

Devon, PA, May 6, 2019 — Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track Designation for the Company’s lead development candidate Zygel™ (ZYN002 CBD gel) for treatment of behavioral symptoms associated with Fragile X Syndrome (FXS). FDA’s Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs, and can lead to expedited review by FDA in order to get new important drugs to the patient earlier.
“The FDA’s decision to grant Fast Track Designation for Zygel underscores the significance and severity of the unmet medical need that exists for patients living with Fragile X Syndrome and their caregivers,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We believe that Zygel has the potential to be the first treatment indicated to directly address the core behavioral symptoms of this syndrome, and we look forward to working closely with the FDA to obtain approval to market Zygel as soon as possible.”
Zynerba is conducting a pivotal trial to assess the efficacy and safety of Zygel as treatment for the behavioral symptoms of FXS in pediatric and adolescent patients (three through 17 years of age). Zygel is a pharmaceutically-manufactured CBD formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled transdermal drug delivery into the bloodstream.
About Fast Track Designation

Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions so that a product can reach the market expeditiously. A drug that is intended to treat a serious or life-threatening condition that demonstrates the potential to address an unmet medical need may qualify for Fast Track designation. Features of this designation include opportunities for frequent interactions with the review team. These include meetings with the FDA to discuss items such as study design, extent of safety data required to support approval, dose-response concerns, accelerated approval, the structure and content of an NDA, and other critical issues. In addition, such a product could be eligible for priority review if supported by clinical data at the time of NDA.
About Fragile X Syndrome (FXS)

Fragile X syndrome is a rare genetic developmental disability that is the leading known cause of both inherited intellectual disability and autism spectrum disorder, affecting 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000 females. It is the most common inherited intellectual disability in males and a significant cause of intellectual disability in females. FXS is caused by a mutation in the Fragile X Mental Retardation gene (FMR1) located on the X chromosome and leads to dysregulation of the endocannabinoid pathway including the reduction in endogenous cannabinoids (2-AG and anandamide). The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. In the US, there are about 71,000 patients suffering with FXS.
About Zygel

Zygel (CBD gel) is the first and only pharmaceutically-manufactured CBD formulated as a patent-protected permeation-enhanced clear gel, designed to provide controlled drug delivery into the bloodstream transdermally (i.e. through the skin). Recent studies suggest that FXS and other neuropsychiatric conditions may be associated with a disruption in the endocannabinoid (EC) system. Clinical and anecdotal data suggest that CBD may modulate the EC system and improve certain core social and behavioral symptoms, including social avoidance (prefers isolation from others, prefers solitary activities, avoids new social activities), irritability (aggressive to others, tantrums/outbursts, and stubbornness), and social unresponsiveness/lethargy (lack of attention/interaction, inactive/lack of movement and can resist physical contact).
Enrollment is ongoing in the multi-national, randomized, double blind placebo controlled Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X (CONNECT-FX), a pivotal clinical trial of ZYN002 in FXS (https://www.connectfxtrial.com/); topline data from CONNECT-FX are expected in the second half of 2019. Additionally, Zynerba expects topline data from its Phase 2 Open Label Study to Assess the Safety and Efficacy of ZYN002 Administered as a TransdermalGel to Children and Adolescents with Developmental and Epileptic Encephalopathy (BELIEVE 1) clinical trial in the third quarter of 2019. Zynerba has also initiated a Phase 2 study of Zygel in Autism Spectrum Disorder, with data expected in the first half of 2020.
About Zynerba Pharmaceuticals, Inc.

Zynerba Pharmaceuticals is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X Syndrome, Autism Spectrum Disorder, 22q11.2 Deletion Syndrome, and a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies. Learn more at www.zynerba.com and follow us on Twitter at @ZynerbaPharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. For example, there can be no guarantee that the Company will obtain approval for Zygel from the U.S. Food and Drug Administration (FDA) or foreign regulatory authorities; even if Zygel is approved, the Company may not be able to obtain the label claims that it is seeking from the FDA. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the Company’s ability to obtain additional funding to support its clinical development programs; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; clinical results for the Company’s product candidates may not be replicated or continue to occur in additional trials and may not otherwise support further development in a specified indication or at all; actions or advice of the FDA and foreign regulatory agencies may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional clinical trials; the Company’s ability to obtain and maintain regulatory approval for its product candidates, and the labeling under any such approval; the Company’s reliance on third parties to assist in conducting pre-clinical and clinical trials for its product candidates; delays, interruptions or failures in the manufacture and supply of the Company’s product candidates the Company’s ability to commercialize its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates; and the Company’s expectations regarding its ability to obtain and adequately maintain sufficient intellectual property protection for its product candidates. This list is not exhaustive and these and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Source: Zynerba Pharmaceuticals, Inc.

Has America's Fight Against HIV Stalled?

 The battle against new HIV infections has lost some steam in recent years, a new report shows.
After about five years of significant declines, the number of new HIV infections began to level off in 2013, at about 39,000 infections per year, the U.S. Centers for Disease Control and Prevention found.
Why the slowing? Effective HIV prevention and treatments are not reaching those who could most benefit, according to the CDC.
These shortfalls in prevention and treatment are most glaring in rural areas and in the South, and they disproportionately affect blacks and Hispanics.
The report found that HIV infections declined in some groups, but increased in others. From 2010 to 2016, annual HIV infections were stable among gay and bisexual men, who continue to account for the largest portion (about 70 percent) of new infections.
But infection trends varied by race, ethnicity and age.
Infections remained stable among all black gay and bisexual men, increased 30 percent among all Hispanic gay and bisexual men, and fell 16 percent among all white gay and bisexual men.
Infections decreased more than 30 percent among black gay and bisexual males aged 13 to 24, and remained stable among Hispanic gay and bisexual males aged 13 to 24. Meanwhile, they rose 65 percent among black and Hispanic gay and bisexual males aged 25 to 34.
Infections fell 17 percent among heterosexual men and women combined, including a 15 percent decrease among heterosexual black women.
Infections decreased 30 percent among people who inject drugs, but appear to have stabilized in more recent years, according to the report released Wednesday.
"After a decades-long struggle, the path to eliminate America's HIV epidemic is clear," said Dr. Eugene McCray, director of CDC's Division of HIV/AIDS Prevention.
"Expanding efforts across the country will close gaps, overcome threats and turn around troublesome trends," he said in an agency news release.
In his State of the Union address to the nation on Feb. 5, President Donald Trump called for support of a national plan to: diagnose HIV as early as possible; treat HIV rapidly and effectively; protect at-risk people with proven preventive measures, including a daily pill to prevent HIV infection; and respond rapidly to growing clusters of HIV infections.
The initiative is designed to accelerate use of these strategies in the 48 U.S. counties with the highest HIV burden, as well as in Washington, D.C.; San Juan, Puerto Rico; and seven states with a disproportionate rural HIV burden.
Intensified local efforts have already produced promising results, according to the CDC. Public health officials in New York City and Washington, D.C., set plans in motion to eliminate their local HIV epidemics -- and they seemed to have worked. From 2010 to 2016, new HIV infections decreased about 23 percent in New York City, while they dropped about 40 percent in Washington, D.C.
The national goal under Trump's proposal is to reduce new HIV infections by 90 percent over 10 years.
"We have an historic opportunity to improve the precision of prevention," said Dr. Jonathan Mermin, director of the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.
"This infusion of resources will finally relegate America's HIV epidemic to the pages of history," Mermin added.

Poor Asthma Control Tied to Worse School Performance

 Kids with poorly controlled asthma struggle in school, especially those who are ethnic minorities, a new study reports.
Researchers evaluated asthma and allergy status, lung function and school performance of 216 black, Hispanic (Latino) and white children in a U.S. city.
Those with a greater number of daily asthma symptoms had more absences, less school work completed and poorer quality work, according to the study published March 11 in Annals of Allergy, Asthma and Immunology, the journal of the American College of Allergy, Asthma and Immunology (ACAAI).
"We found associations between poor asthma status, poorer asthma control, lower lung function, more asthma symptoms and decline in academic performance," lead author Daphne Koinis-Mitchell said in an ACAAI news release.
"These associations were stronger in ethnic minority children, particularly Latino children," she added. Koinis-Mitchell is a research professor of pediatrics, psychiatry and human behavior at Brown University in Providence, R.I.
Poor asthma control could help identify children who might be at risk for problems at school, according to the researchers.
The same team previously found that urban Hispanic children with asthma have special sources of stress.
"Factors such as higher levels of fear of asthma, language barriers, stress related to fitting in to the culture, poorer symptom perception, greater concerns regarding medications and lower medication adherence may put Latinos at greater risk for poor academic performance," Koinis-Mitchell said.
ACAAI president Dr. Todd Mahr, an allergy specialist, noted that asthma is the most common chronic illness in childhood, accounting for 13.8 million missed school days each year in the United States.
"A very low proportion of the children in this study saw specialists, such as allergists," he said in the news release. Many of the kids also had undiagnosed hay fever, which can contribute to poorer asthma outcomes and lower academic success.
"Kids with asthma -- especially in urban areas -- need access to specialty care because anyone with asthma should be able to feel good, be active all day and sleep well at night," Mahr concluded. "No one should accept less."

"Because depression is such a common problem, finding effective and widely available ways to prevent depression at a population level is an important goal," said study co-author Ed Watkins.

He's a professor of experimental and applied clinical psychology at the University of Exeter in England.
"Diet and nutrition held promise as one means to reach large numbers of people. However, this trial convincingly demonstrates that nutritional supplements do not help to prevent depression," he said in a university news release.

Blacks, Hispanics Bear Burden of Air Pollution: Study

 Air pollution caused mainly by white Americans has the greatest impact on black and Hispanic Americans, a new study says.
"Similar to previous studies, we show that racial-ethnic minorities are exposed to more pollution on average than non-Hispanic whites," said lead author Christopher Tessum, a research scientist at the University of Washington in Seattle.
"What is new is that we find that those differences do not occur because minorities on average cause more pollution than whites -- in fact, the opposite is true," he said.
This is a case of "pollution inequity" -- the difference between the pollution caused by a racial-ethnic group and the harm experienced by that group.
For this study, University of Washington and University of Minnesota researchers focused on fine particulate matter (PM2.5) air pollution. It causes more than 100,000 deaths a year in the United States from heart attack, stroke, lung cancer and other diseases.
But exposure to this type of bad air is not equal among Americans, and not all are equally responsible for causing it, the study showed.
The researchers explained that whites consume more pollution-creating goods and services and therefore are responsible for more PM2.5 pollution than other groups. Also, blacks and Hispanics often live in locations with higher pollution concentrations than whites.
On average, whites have 17 percent less exposure to PM2.5 pollution than they create. Blacks, meanwhile, are exposed to about 56 percent more PM2.5 pollution than they create, and Hispanics to 63 percent more.
"Our work is at the intersection of many important and timely topics such as race, inequality, affluence, environmental justice and environmental regulation," Jason Hill, a bioproducts and biosystems engineering professor at the University of Minnesota, said in a university news release.
Julian Marshall, a professor of civil and environmental engineering at the University of Washington, said the approach used in this study could be extended to other pollutants, locations and groups of people.
"When it comes to determining who causes air pollution -- and who breathes that pollution -- this research is just the beginning," Marshall said.
The study was published March 11 in the journal Proceedings of the National Academy of Sciences.

Healthy Diet Might Not Lower Dementia Risk

 A long-running study questions the conventional wisdom that a healthy diet may help ward off dementia.
European researchers followed more than 8,200 middle-aged adults for 25 years -- looking at whether diet habits swayed the odds of being diagnosed with dementia. In the end, people who ate their fruits and vegetables were at no lower risk than those who favored sweets and steaks.
The findings, published March 12 in the Journal of the American Medical Association, stand in stark contrast to many past studies.
Those studies have linked heart-healthy diets to lower odds of mental decline and abnormalities in the brain that can foretell dementia. Currently, groups like the Alzheimer's Association suggest that people adopt those diets as one potential way to stave off dementia.
Most studies, though, have followed people for only a fairly short time -- less than 10 years, said lead researcher Tasnime Akbaraly, from the French national research institute INSERM.
This study is the first to look at diet quality starting in middle age and the long-term risk of dementia, explained Akbaraly.
Her team found that 344 people were diagnosed with Alzheimer's over the quarter-century they were followed. And the rates were similar among the one-third of study participants with the "best" diet quality and the one-third with the "worst."
People in that first group typically had several servings of fruits, vegetables and whole grains every day; at least a couple servings of nuts and legumes each week; regularly had unsaturated fats, like olive oil; and put limits on red meat, sodium and sugary drinks.
No one is advising people to give up on that type of eating, however.
"I would certainly not want anyone to come away from this thinking a healthy diet is futile," said Keith Fargo, director of scientific programs and outreach for the Alzheimer's Association.
"This study has to be viewed within the context of the larger scientific literature on diet and cognition -- which does suggest there's a benefit [from healthy eating]," said Fargo, who was not involved in the study.
According to the Alzheimer's Association, the best evidence is for two heart-healthy diets: the traditional Mediterranean diet and the DASH diet -- which is a standard recommendation for lowering high blood pressure.
The diets differ, but both emphasize a familiar refrain: Get plenty of fruits, vegetables, legumes, fiber-rich grains, "good" fats, and fish and poultry -- and limit red meat, sweets and added salt.
Akbaraly also stressed that her findings do not imply "diet doesn't matter."
For one, diet clearly is vital to overall health -- physical and mental. Akbaraly noted that in an earlier study of this same group, middle-aged adults with the healthiest diets had a lower risk of depression over the next two-plus decades.
And, she said, these findings still leave many questions unanswered -- such as whether diet is more powerful when combined with other lifestyle measures, like regular exercise.
In reality, Fargo said, studies like this one -- which ask people about their usual lifestyle habits -- cannot answer the major question: Will changing my diet -- or any other habit -- lower my risk of dementia?
"You can't rely on observational studies like this to tell you what to do," Fargo said, because they do not prove cause and effect.
More definitive answers, he said, come from clinical trials -- which randomly assign people to adopt a lifestyle change or not.
The Alzheimer's Association is sponsoring an ongoing trial that is testing the effects of diet changes along with other measures -- including exercise and mental-stimulating activities. It is focusing on older adults at increased risk of mental decline.

ADHD Meds Safe With Epilepsy, Study Finds

 Attention-deficit/hyperactivity disorder (ADHD) often occurs in people with epilepsy. Now, new research provides reassurance that taking ADHD medications won't raise their risk of seizures.
For the study, researchers analyzed data from thousands of epilepsy patients in Sweden. Taking ADHD medications such as Ritalin (methylphenidate), was associated with a 27 percent reduction in seizures, compared with not taking the medications, the investigators found.
"When you compare risk between individuals, there's a lot of factors that might explain associations that have nothing to do with the medication itself," said study author Kelsey Wiggs, a Ph.D. candidate at Indiana University, in Bloomington.
The study was published online recently in the journal Epilepsia.
"It's a good feature of this study that we were able to compare the same individual on and off the medication -- we could rule out a lot of other confounders," Wiggs said in a journal news release.
Another expert said the results are reassuring.
"This study provides another piece of evidence that medications for kids with ADHD do not increase the risk for seizures," said Kimford Meador, a professor of neurology and neurosciences at Stanford University.
"I think that physicians should feel safe prescribing these medications within standard doses," said Meador, who was not involved in the study.
Another expert, Torbjorn Tomson, a professor of neurology and epileptology at the Karolinska Institute in Stockholm, pointed out in the news release that people with epilepsy are often denied effective treatment for their psychiatric conditions out of fear the medications might negatively affect seizure control.
A study published last year in the journal Neurology found no evidence that taking ADHD medication increased seizure risk in people with and without epilepsy. The findings were based on data from more than 800,000 people in the United States.
Approximately 9 percent of children aged 2 to 17 have had an ADHD diagnosis, according to the U.S. Centers for Disease Control and Prevention. And ADHD is more common in people with epilepsy than in the general population. Among epilepsy patients, as many as half of children and 20 percent of adults have been diagnosed with ADHD, the researchers noted.

Bipolar Disorder a Risk Factor for Parkinson's?

 Struggling with bipolar disorder is hard enough, but now a new study from Taiwan suggests these patients are seven times more likely to develop Parkinson's disease.
But U.S. experts cautioned that the absolute risk of developing Parkinson's -- an incurable movement disease -- is still very low for those with the mood disorder.
"I wasn't surprised [by the study's findings], because similar disorders like major depression and anxiety disorder convey a similar increased risk of Parkinson's later in life," said Dr. Gregory Pontone, director of the Parkinson's disease research center at Johns Hopkins Medicine in Baltimore.
"This gives you two reasons to treat bipolar disorder aggressively," he added.
Also known as manic-depressive illness, bipolar disorder is a mood disorder marked by swings from elated, energized behavior to feelings of sadness and hopelessness. It affects about 2.6% of American adults, according to the U.S. National Institute of Mental Health.
Parkinson's is a progressive condition causing tremors, rigid muscles and slowed movement, among other symptoms. By 2030, the Parkinson's Foundation projects 1.2 million Americans will be living with the disease.
For the study, researchers led by Dr. Mu-Hong Chen of Taipei Veterans General Hospital, reviewed health records for 56,000 people in Taiwan who were diagnosed with bipolar disorder between 2001 and 2009. They were compared to 225,000 people with no history of bipolar or Parkinson's. Both groups were tracked until late 2011.
During the study period, 372 people with bipolar disorder -- or 0.7% -- developed Parkinson's. This compared to 222 -- or 0.1% -- of those who didn't have bipolar disorder.
Those with bipolar who developed Parkinson's were nine years younger -- average age 64 -- than others who also developed Parkinson's, the study found.
"When you say there's seven times the risk, it gets scary. But it's still very few [bipolar] patients who get Parkinson's," said Dr. Justin Martello, who reviewed the findings. He's a neurologist specializing in movement disorders and Parkinson's disease at Christiana Care Health System in Wilmington, Del.
Martello pointed out that while the study was large, it was limited by including only people in Taiwan.
"We don't know how this would apply more globally or broadly," Martello said. "I think it's more interesting for physicians to know this and be more aware of the association."
The study was published online May 22 in the journal Neurology.
Pontone, who cowrote an accompanying editorial, and Martello said scientists have many theories -- still unproven -- about how bipolar disorder might be connected to the development of Parkinson's.
"A depressive or manic episode may do something to the brain that renders it more vulnerable" to Parkinson's over time, Pontone said.
And Martello noted that many medications used to treat bipolar disorder can trigger Parkinson's-like symptoms.
Many experts think Parkinson's is active years or decades before movement problems show up, and mood disorders such as bipolar may actually be an early symptom of Parkinson's, Pontone and Martello said.
Much more research is still needed, they agreed.
"We definitely need to look more at a global population," Martello said. "The researchers here did follow patients for 10 years, but it needs to be extended longer to see how many of these patients convert to Parkinson's down the road."

Health Tip: Causes of Swollen Lymph Nodes

-- Swollen lymph nodes often occur after exposure to bacteria or viruses, says Mayo Clinic.
Common triggers include:
Strep throat.
Measles.
Ear infection.
An abscessed tooth.
Mononucleosis.
Skin infection.
To diagnose what might be causing your swollen lymph nodes, visit your doctor.

Colon Cancer Screenings Increase When Medicaid Arrives

 There were greater increases in colon cancer screening rates in states that expanded Medicaid than in those that did not, a new study finds.
It also found that expansion resulted in hundreds of thousands more people getting screened for colon cancer through colonoscopy, stool testing or sigmoidoscopy.
"Health insurance is a strong predictor of cancer screening, and the uninsured and those with lower socioeconomic status are more likely to be diagnosed at late stage and die from screen-detectable cancers, including colorectal cancer," study leader Stacey Fedewa said in an American Cancer Society news release. Fedewa is senior principal scientist for the society's Surveillance and Health Services Research.
The Affordable Care Act let states expand Medicaid insurance coverage to low-income adults, who tend to have poor access to preventive health services.
Five states and the District of Columbia were very early adopters and expanded Medicaid eligibility in 2010-2011. Another 21 states expanded Medicaid in 2014, five states expanded in 2015-2016, and 19 states did not expand.
American Cancer Society researchers analyzed data from the U.S. Centers for Disease Control and Prevention and found that in states that were very early adopters of the expansion, the rate of low-income adults ages 50-64 who were up to date with colon cancer screening rose from 42.3% in 2012 to 51.1% in 2016.
Rates increased from 49.6% to 52.5% in states that expanded Medicaid between 2014 and 2016, and from 44.2% to 48% in non-expansion states.
Rates of recent colon cancer screening (in the past two years) increased from 30.1% to 38.1% in very early adopters and from 29.1% to 31.8% in non-expansion states.
The increase in screening rates in very early adopters led to nearly 236,600 additional low-income adults with recent colon cancer screening in 2016.
If the same increase had occurred in non-expansion states, more than 355,000 more low-income adults would have had recent colon cancer screening, according to Fedewa and her colleagues.
The report also found that breast cancer screening increased only modestly among low-income women in the states that expanded Medicaid coverage.
But the authors say that there is more widespread support for mammography in low-income populations through programs like the CDC's National Breast and Cervical Cancer Early Detection Program, as well as programs offered by nonprofits and mobile mammography clinics.
Also, they added, mammography is cheaper and requires less preparation than colon cancer tests.
The study was published online May 22 in the American Journal of Preventive Medicine.

FDA Warns of Infections From Fecal Transplants After 1 Death

 Fecal transplants -- transferring fecal matter from a healthy person into an ill person with a compromised "microbiome" -- is an increasingly used new treatment for a variety of ills.
But on Thursday federal health officials announced that a patient died after such a procedure, highlighting the potential for severe infections linked to fecal transplants.
"While we support this area of scientific discovery, it's important to note that fecal microbiota for transplantation does not come without risk," said Dr. Peter Marks, director the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration.
After reports of serious, antibiotic-resistant infections linked to the procedures, the FDA wants "to alert all health care professionals who administer FMT [fecal microbiota transplant] about this potential serious risk so they can inform their patients," Marks said in an agency news release.
Fecal microbiota transplant is a still-experimental procedure, as yet unapproved by the FDA. It's been primarily used to treat serious infections of antibiotic-resistant forms of the Clostridium difficile (C. difficile) bacterium.
The transplant involves taking stool from a healthy donor and placing it in the ill patient's colon. The aim is to help replace an unhealthy "microbiome" -- the trillions of bacteria that reside in the human gut -- with a more robust, disease-fighting microbiome from the donor.
Once delivered via the fecal transplant, this new microbiome repopulates the patient's microbiome with healthier microorganisms, which effectively crowd out dangerous C. difficile.
Researchers are also looking into the use of fecal transplants to treat chronic gastrointestinal illnesses such as ulcerative colitis or irritable bowel syndrome.
But every therapy comes with risks, and the FDA said that two patients who received fecal microbiota transplants as part of a clinical trial developed life-threatening infections from multidrug-resistant bacteria delivered in the transplants. One of the patients has died.
Both patients had weakened immune systems, making them more vulnerable to germs that are resistant to multiple antibiotics. So, the FDA is now mandating that special screening and testing of the stool used in these procedures be done, to ensure that no drug-resistant bacteria are in the donated material.
Also, when fecal microbiota transplants are used, doctors need to have adequate informed consent from the patient, the FDA said. Patients need to be warned of any potential risks associated with the treatment and be told that the treatment is still considered experimental.
Marks stressed that the FDA still supports research into fecal transplant therapy.
"The medical community is actively engaged in exploring the potential uses of fecal microbiota for transplantation," he said. Although the therapy isn't approved by the FDA, the agency supports the use of this treatment and is looking to "strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs," Marks said.
To that end, "we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise," Marks said.

Turn Up the Heat With Healthy Hot Chili Peppers

 Red or green, sweet or hot, peppers are a great source of vitamins A, C, E and many of the B vitamins, plus minerals like calcium, iron and potassium.
These and other nutrients are jammed into a low-calorie "package" that's perfect for stuffing with other healthful foods. Chili peppers, such as jalapenos and serranos, also add zesty spice to dishes. They get their heat from a special compound called capsaicin that may also have health properties, including pain relief. (All peppers except bell peppers contain some capsaicin.)
When shopping for peppers, look for firm, unblemished skins with no soft spots. Store them in produce bags in the fridge for up to three days.
One of the tastiest Mexican chili peppers is the poblano. It looks similar to a green bell pepper, but has a slightly darker skin, longer shape and spicier, deeper flavor. Like bell peppers, poblanos can be heartily stuffed to make a complete meal. Here's a meatless recipe that delivers on flavor as well as satisfaction.
Stuffed Poblanos
4 poblano chili peppers
4 cups baby spinach or 10-ounce package of frozen spinach, thawed
1/4 cup raisins, red or golden
2 tablespoons pine nuts or chopped walnuts
4 tablespoons mild or medium salsa
1 cup grated Colby or Jack cheese
Roast poblanos under the broiler on an ungreased baking tray for three to four minutes, turning often until their skins start to blacken and blister. Transfer the peppers to a glass bowl and cover with plastic wrap to loosen the skins. When cool, remove skins and place chili peppers in a baking dish.
Steam spinach if using fresh and chop coarsely. Combine with raisins and nuts, and use mixture to stuff chili peppers. Top with salsa and grated cheese.
Place under the broiler for one minute to melt the cheese. Serve immediately.
Yield: 4 servings

Health Tip: Preventing Falls on Crutches

-- To use crutches safely, be sure they fit you properly. Also use care when carrying objects, says the Ohio State University Medical Center.
To prevent falls, the center encourages those on crutches to:
Clean the crutch tips often.
Put away all throw rugs on the floor.
Take your time. Do not try to walk too fast.
Look ahead. Do not look at your feet while walking.

When Healthy Eating Turns Into a Dangerous Obsession

 When eating healthy becomes an around-the-clock obsession, it could be a sign of trouble.
An extreme preoccupation with clean eating is an eating order called orthorexia nervosa. Though less well-known than anorexia nervosa or bulimia -- and not as well-documented -- a new study review says orthorexia can also have serious emotional and physical consequences.
"Orthorexia is really more than just healthy eating," said review co-author Jennifer Mills, an associate professor of health at York University in Toronto. "It's healthy eating taken to the extreme, where it's starting to cause problems for people in their lives and starting to feel quite out of control."
The review of published research from around the world on the disorder was recently published in the journal Appetite.
Mills and her colleague Sarah McComb looked at risk factors and links between orthorexia and other mental disorders. Orthorexia, unlike some other eating disorders, is not yet recognized in the standard psychiatric manuals.
Healthy eating to the extreme
No clear line divides healthy eating from orthorexia's extreme eating.
The foods someone with orthorexia might avoid are the same as those someone with healthy habits might avoid -- such as preservatives, anything artificial, salt, sugar, fat, dairy, other animal products, genetically modified foods or those that aren't organic.
It boils down to whether avoiding foods leads to obsession -- excessive time and energy thinking and fretting about what to eat. Some people may eliminate numerous categories of food and eat only a very small number of things. People with orthorexia are typically less concerned about cutting calories than with the perceived quality of their food.
"They often are taking more and more time thinking about the foods they're needing to purchase, particular foods, that makes it really difficult for them to just live their lives," said Lauren Smolar, who wasn't involved with the review. She is director of programs for the nonprofit National Eating Disorders Association (NEDA). "It can result in malnutrition or weight loss in a really difficult and potentially dangerous way."
A person with orthorexia might be so focused on types of food and how that food is prepared that it becomes impossible to eat anything not made at home.
"It can lead to all kinds of related problems, like isolation, or not being able to eat at other people's houses or not being able to eat in a restaurant for fear that the food won't have been prepared in a very pure, clean way," Mills said. "Those are the kinds of things that might lead someone to feel that it's taking over their life."
Cultural trends could be fueling those fears, Mills said. With the internet and social media, people have unlimited access to information -- some of it good and some not based on scientific evidence.
Eating trends that restrict certain foods are concerning, said Smolar, who added that dieting is one of the biggest triggers for eating disorders. All foods are good in moderation, she said, and a diverse diet is best.
Though many think of eating disorders as a problem affecting young women, orthorexia appears to be experienced equally by men and women, the study found.
People who follow a vegan or vegetarian diet or who have a poor body image are at a higher risk.
For some, the underlying cause is another eating disorder, and clean eating is seen as a socially acceptable way to restrict calories, Mills said. For others, obsessive-compulsive or anxiety disorder may manifest in the need to eat in this very rigid way.
"In that sense it is very similar to what we see in other kinds of obsessive-compulsive disorder, where somebody might be afraid that they're going to get sick or they're going to be getting exposed to germs if they don't wash their hands enough or if they don't do something in a very particular way," Mills said.
Getting help
Orthorexia should be taken seriously, Mills said. Talk to your primary care doctor about any concerns. Meeting with a psychologist who specializes in anxiety disorders, eating disorders or body image also can be helpful, she said.
NEDA offers an online screening tool that assesses risk and a helpline where you can talk through concerns and learn about resources.
"As awareness grows, more people are recognizing symptoms and seeking opportunities for help," Smolar said. "It's something that I think we still have a lot to learn about."

Health Tip: Preventing Swimmer's Ear

-- Swimmer's ear is an infection of the outer ear that is caused by water remaining in the ear canal after swimming or showering.
To help prevent swimmer's ear, the Children's Hospital of Philadelphia suggests:
Teach children to use a towel to dry their ears after water activities.
Encourage children to wear ear plugs while swimming.
Keep your child's ears clean.
Avoid excessive showering.

Can Racquet Sports Give You a Fitter, Longer Life?

 When you think of effective cardio exercise, the activities most likely to come to mind are aerobics classes, running, swimming and cycling. But racquet sports like tennis may hold even greater benefits, according to research published in the British Journal of Sports Medicine.
And, as a bonus, they could also be more fun, making it easier to meet your fitness goals.
After reviewing data from 80,000 people, researchers found that participants in racquet sports reduced their risk of early death by 47%. Racquet sports beat out swimming and aerobics, the second and third most-protective exercises, by double digits. Cycling came in fourth.
The numbers were even higher for reducing the risk of death from heart disease or stroke, though swimming and aerobics were still beneficial because they work the upper and lower body, which helps train the heart. Also, whatever activity the study participants chose, the more often they exercised, the more their risk of early death dropped.
Exercise and Risk of Early Death
47% lower risk of early death with racquet sports
28% lower with swimming
27% lower with aerobics
15% lower with cycling
Never picked up a racquet? The U.S. Tennis Association has information to help you get started, including where to find programs in your area. Besides being a great exercise, tennis helps with balance, strength and flexibility, all essential for lifelong fitness. Whether you play singles or doubles, the social aspect of tennis is another important benefit.
Also consider squash and racquetball. These sports use different-sized racquets and balls, and the courts are enclosed. Both games are played within a smaller area than tennis, but the play is often more intense.

AHA News: When Dancer Kept Fainting, an EKG Finally Revealed Why

WEDNESDAY, June 12, 2019 (American Heart Association News) -- Looking back, Daniela Leonhardt's first indication something was amiss with her heart happened in December 2010, when she fainted before an Irish dance competition.
At the time, she was 30 years old, the mother of two little boys and in jaw-droppingly good shape. Why would she have thought the dizziness and nausea that followed her fainting spell could be a sign that her life was in danger?
"I had been a competitive dancer a long time, then after having kids, I decided to go back to it," said Leonhardt, who lives in Virginia. "I wanted to prove that at age 30 I could still compete with younger women."
She was well on the way, until she fainted.
"I wrote it off as maybe being under the weather," she said. "A lot of people had gotten sick at that competition."
To be sure that's all it was, she went in for a checkup. Her doctor attributed her symptoms to anxiety or possibly a virus. Two months later, Leonhardt fainted at a conference in Louisiana. Again, her symptoms were thought to be anxiety, or maybe something hormonal.
The episodes continued, eventually occurring about once a week. Leonhardt would feel lightheaded at a grocery store and sit down in the middle of an aisle. At home, she'd hold onto furniture and try to breathe through the dizziness.
In May 2012, Leonhardt went to an urgent care clinic. The physician's assistant gave Leonhardt her first electrocardiogram.
The PA rechecked the leads, as if they might have been out of place. He then asked the nurse to run the test again.
Looking at the results, the PA said, "I'm amazed you're sitting here acting totally normal." Her heart rate was only 32. A normal rate is 60 to 100.
Doctors diagnosed her with a condition that keeps her heart rate low. A pacemaker was implanted in June 2012 to help sustain a healthy rhythm.
Waking up from that procedure, she felt better than she had in years. She looked at her husband and said, "This is what it feels like to be normal."
The next day, she told herself, "This is not happening to another woman," and began volunteering for the American Heart Association.
In February 2014, while in Atlanta for work, Leonhardt didn't feel right. She eventually was diagnosed with a type of fast heart rate called supraventricular tachycardia. She had heart surgery that November.
Four months later, Leonhardt woke up and fell out of bed. Her left side wasn't functioning. She was having a stroke.
Her son Ciaran Donovan was 8 at the time. Because of the family's involvement with the AHA, he recognized the warning signs.
"Mom," he told her, "I'm going to call 911."
She hung up the phone and called her sister instead -- a move her neurologist told her could have killed her.
Leonhardt was fortunate; the stroke seemed to have "resolved itself." While her left hand doesn't grip as strong, and she occasionally mixes the three languages she speaks -- English, German and French -- there are no other long-term effects. Doctors determined the stroke was caused by atrial fibrillation, a common irregular heartbeat, so they put her on blood thinners.
Ciaran is now 12; his brother Landen Donovan, 9. They keep an eye on her, making sure she rests and doesn't overdo it.
"There are a lot of doctor trips and worrying about our mom," Ciaran said. "The pros are that we learned a lot from this. We know heart disease is out there and it can do to others what it did to my mom."
Said Landen: "The positive is that we know about heart disease and we get to go to the Heart Walk, which is really fun. The negative is that at any moment it could happen again."
But like their mother, the boys are optimistic. And, like her, they've gleaned lessons from the ongoing experience.
"They're more aware. They have a little more mitgefühl, as they say in German," said Leonhardt. "It's an understanding of a situation and having true empathy, even if you're not living it."

Drug ODs, Suicides Soaring Among Millennials: Report

 So-called "deaths of despair" are skyrocketing among millennials, with thousands of 18- to 34-year-olds losing their lives to drugs, alcohol and suicide each year, a new report says.
During the past decade, drug-related deaths among that age group increased by 108%, alcohol-induced deaths by 69%, and suicides by 35%, according to the report from the Trust for America's Health and Well Being Trust.
Millennials are more heavily affected than older generations by each of these causes of death, the report states:
In 2017, there were nearly 31 drug overdose deaths for every 100,000 18- to 34-year-olds, but fewer than 23 drug deaths per 100,000 across all age groups.
Alcohol-induced death rates doubled for millennials between 1999 and 2007.
Young adults experienced a 35% increase in suicide rates between 2007 and 2017, compared with a 14% increase for 35- to 54-year-olds; a 24% increase for those 55 to 74; and 14% uptick for people older than 75.
"We lost over 150,000 lives last year to drugs, alcohol and suicide. When we dive down deep into those data, the millennial generation just pops out," said Benjamin Miller, chief strategy officer of Well Being Trust, a national foundation focused on mental, social and spiritual health.
"This is a call to action," Miller said of the new report. "It's unacceptable for us to continue to lose as many lives as we are losing to preventable causes. We have to do something different. What we are doing is simply not working."
The opioid epidemic cannot be overlooked as a contributing factor, Miller said.
Opioid overdose death rates among millennials increased by more than 500% between 1999 and 2017, and deaths caused by synthetic opioids increased by a staggering 6,000%.
It's a terrible coincidence that millennials came of age "at a time when the medical profession was led down the wrong path in terms of opioid prescribing," said Dr. Andrew Saxon, director of the Addiction Psychiatry Residency Program at the University of Washington in Seattle.
But the increases in alcohol deaths and suicides point to something darker within the psyche of millennials, who typically are defined as people born between 1981 and 1996.
They grew up with a succession of shattering events for the United States -- the 9/11 terror attacks, the Iraq and Afghanistan wars, and the Great Recession prompted by the housing bubble, Saxon said.
They graduated college saddled with heavy student debt at a time "our economy was near collapse," he said. "The expectations that they would have jobs waiting for them and their skills would be wanted -- sort of suddenly all of those prospects disappeared."
Since then, they've had to grapple with the exploding costs of education and housing.
"We can track economic trends with suicides, and as long as we've been studying it, suicides have gone up during times of economic dislocation," Saxon said.
Miller, meanwhile, said the rise of social media likely has also had an impact on millennials' sense of their prospects.
Social media can "make them feel more lonely -- how come I don't have that, or how come no one likes my picture?" he said. "In those cases, the negative effects of social media are seen."
At the same time, mental health services continue to be doled out in a way that makes it unlikely many will get the help they need, Miller said.
"We know that 6 in 10 folks are seeking mental health care, yet if you look at the data, 96 million Americans last year had to wait over a week to get access to a mental health provider," Miller said.
"When someone says to you that you're going to have to come back next week or tomorrow or in two weeks, the likelihood you show up is relatively small," he added.
To help stem these deaths of despair, the report recommends:
Making mental health care, including screenings for substance use and depression, a routine part of primary care.
Improving insurance coverage for medication-based treatments for substance abuse.
Adopting pricing strategies to reduce alcohol consumption among teens and young adults.
Offering suicide prevention programs throughout the health care system.
Making sure hospitals connect patients in crisis with behavioral health services in a timely manner.

Exercise Rates Rising for Urban, Rural Americans: CDC

 The trend towards Americans getting off their couches and into gyms is hitting city and country folk alike, according to a new report.
Overall, the percentage of all adults who now meet or exceed federal exercise guidelines rose from 18.2% in 2008 to 24.3% by 2017, researchers at the U.S. Centers for Disease Control and Prevention said.
And the study finds that trend in both rural and urban areas. Among adults living in rural America, 13.3% were exercising in 2008 at recommended rates, but by 2017 that number had risen to 19.6%. And in cities, rates went even higher -- from 19.4% to 25.3%.
Federal physical activity guidelines advise at least 150 minutes of moderate aerobic exercise per week, or 75 minutes of vigorous aerobic exercise, as well as at least a moderate-intensity muscle-strengthening workout two days per week.
The rise in exercise rates is heartening, the CDC team said, but of course more progress is needed, because "in 2017, only 1 in 4 urban residents and 1 in 5 rural residents met the combined [exercise] guidelines."
The new study was based on 2008-2017 federal health data involving sample sizes of up to 37,000 adults surveyed nationwide each year. Researchers were led by Geoffrey Whitfield of the CDC's National Center for Chronic Disease Prevention and Health Promotion.
Two health care experts offered theories on why more Americans are getting more active.
It could be due to "increased stress with social, political and financial strains increasing over last few years," suggested Dr. Theodore Strange, associate chair of medicine at Staten Island University Hospital in New York City.
"Additionally, more gyms have popped to meet that need as well as other group exercising facilities, like martial arts centers, CrossFit and spin classes," he said. "Even employers are encouraging wellness and well-being by offering their employees opportunities to exercise daily and even offering financial/perk incentives."
But another expert noted that not everyone is benefiting equally.
"In particular, Americans who live in rural areas exercise less than Americans that live in urban areas," noted Dr. Teresa Amato. She directs emergency medicine at Northwell Health's Long Island Jewish Forest Hills in New York City. She also noted that the study found lower exercise rates in the U.S. South versus other regions.
Amato agreed that sometimes workplaces can play a big role in boosting exercise rates. Large employers often sponsor "employee wellness and employee well-being initiatives," she said.
"Many of these come in the form of forming exercise "teams" that have friendly competitions and awards for meeting certain exercise goals," Amato added.
"Studies do conclude that individuals are more likely to begin and sustain exercise habits when they are done with an additional partner or 'exercise buddy.' In addition, exercise in a group may lead to longer exercise times and more mental well-being," she said.
The study was published June 14 in the CDC journal Morbidity and Mortality Weekly Report.

Exercise Rates Rising for Urban, Rural Americans: CDC

The trend towards Americans getting off their couches and into gyms is hitting city and country folk alike, according to a new report.
Overall, the percentage of all adults who now meet or exceed federal exercise guidelines rose from 18.2% in 2008 to 24.3% by 2017, researchers at the U.S. Centers for Disease Control and Prevention said.
And the study finds that trend in both rural and urban areas. Among adults living in rural America, 13.3% were exercising in 2008 at recommended rates, but by 2017 that number had risen to 19.6%. And in cities, rates went even higher -- from 19.4% to 25.3%.
Federal physical activity guidelines advise at least 150 minutes of moderate aerobic exercise per week, or 75 minutes of vigorous aerobic exercise, as well as at least a moderate-intensity muscle-strengthening workout two days per week.
The rise in exercise rates is heartening, the CDC team said, but of course more progress is needed, because "in 2017, only 1 in 4 urban residents and 1 in 5 rural residents met the combined [exercise] guidelines."
The new study was based on 2008-2017 federal health data involving sample sizes of up to 37,000 adults surveyed nationwide each year. Researchers were led by Geoffrey Whitfield of the CDC's National Center for Chronic Disease Prevention and Health Promotion.
Two health care experts offered theories on why more Americans are getting more active.
It could be due to "increased stress with social, political and financial strains increasing over last few years," suggested Dr. Theodore Strange, associate chair of medicine at Staten Island University Hospital in New York City.
"Additionally, more gyms have popped to meet that need as well as other group exercising facilities, like martial arts centers, CrossFit and spin classes," he said. "Even employers are encouraging wellness and well-being by offering their employees opportunities to exercise daily and even offering financial/perk incentives."
But another expert noted that not everyone is benefiting equally.
"In particular, Americans who live in rural areas exercise less than Americans that live in urban areas," noted Dr. Teresa Amato. She directs emergency medicine at Northwell Health's Long Island Jewish Forest Hills in New York City. She also noted that the study found lower exercise rates in the U.S. South versus other regions.
Amato agreed that sometimes workplaces can play a big role in boosting exercise rates. Large employers often sponsor "employee wellness and employee well-being initiatives," she said.
"Many of these come in the form of forming exercise "teams" that have friendly competitions and awards for meeting certain exercise goals," Amato added.
"Studies do conclude that individuals are more likely to begin and sustain exercise habits when they are done with an additional partner or 'exercise buddy.' In addition, exercise in a group may lead to longer exercise times and more mental well-being," she said.
The study was published June 14 in the CDC journal Morbidity and Mortality Weekly Report.

50 Years After Ban, Canadian Lakes Still Have High Levels of DDT

 Although DDT was banned in the 1970s, the toxic pesticide still lurks in the sediment of lakes in New Brunswick, Canada, researchers report.
To control insects, airplanes sprayed nearly 6,300 tons of DDT onto New Brunswick forests between 1952 and 1968.
Sprayed DDT can enter lakes and rivers, and find its way into the food chain, researchers say.
To see if DDT had an effect on these Canadian lakes, the researchers collected sediment samples from five lakes in New Brunswick.
The sediment reflected conditions from about 1890 to 2016. Analysis showed that DDT levels peaked in the 1970s and 1980s.
But in the current layer of sediment, concentrations of DDT were still higher than considered safe for fish, frogs and other aquatic life, the investigators found.
Joshua Kurek, of the department of geography and environment at Mount Allison University, in Sackville, New Brunswick, led the study.
His team also found that starting in the 1950s, life in the lakes shifted to favor species more tolerant to contaminants. DDT is banned in most countries.
The report was published June 12 in the journal Environmental Science & Technology.

Vitamin D Supplements Don't Prevent Type 2 Diabetes: Study

 Vitamin supplements don't appear to prevent type 2 diabetes in those at highest risk for the disease, a new study finds.
Some studies have suggested that low vitamin D levels might increase the odds of developing diabetes and that boosting levels could prevent it, but these findings throw cold water on these assumptions.
In this study funded by the U.S. National Institutes of Health (NIH), more than 2,400 people aged 30 and older across the United States were involved. Researchers randomly assigned half of them to take 4,000 units a day of vitamin D and the other half to take a placebo.
After nearly three years, 24.2% of those taking vitamin D developed diabetes, as did 26.7% of those taking the placebo. This difference isn't statistically significant, researchers said.
"In addition to the study's size, one of its major strengths is the diversity of its participants, which enabled us to examine the effect of vitamin D across a large variety of people," lead author Dr. Anastassios Pittas said in an NIH news release. "When the study ended, we found no meaningful difference between the two groups regardless of age, sex, race or ethnicity."
Pittas is a professor and co-director of the Diabetes and Lipid Center at Tufts University Medical Center in Boston.
The report was published June 7 in the New England Journal of Medicine to coincide with its presentation at a meeting of the American Diabetes Association, in San Francisco.

Concussion Often Hits Elementary School Kids, Too

 Concussions aren't only a concern for high school and college athletes -- they're also a leading injury risk for kids as young as age 5 who play sports.
That's the upshot of a new study of injury risk among 1,500 elementary school athletes in one Florida county. For the study, University of South Florida researchers focused on 5- to 11-year-olds who play recreational football, soccer and baseball/softball.
Over two years, 26 athletes were injured. Twelve had concussions. Ten of those occurred during boys' and girls' soccer, and two happened during recreational softball games, the study found.
"To date, research on sports injuries has been largely focused on high school and collegiate athletes," study author Karen Liller said in a university news release. "For child athletes, many sports/recreational activities are not organized for reporting injuries, so almost no data for this group have been collected."
Liller, a professor of community and family health, noted that the lack of information has been a barrier.
"No effective prevention strategies can be properly developed without the knowledge of the mechanisms related to these injuries including concussions," she said.
Liller and her colleagues collected information about each child's neurological state before and after practice sessions and games. That allowed them to assess each player's ability to pay attention, remember words and things they saw, and to react quickly.
The researchers also hired certified athletic trainers to track when, where and how injuries occurred, as well as how often each child played sports.
Liller said having such trainers could help schools be better prepared to get young children the right care quickly when they need it.
She and her team recently outlined their findings in the journal PLOS ONE.

When Fido Comes Along on Your Vacation

 Summertime is vacation time, and plenty of people bring their pets along on their adventure, so one expert offers tips on how to make the trip fun for all.
"Before attempting a car ride, acclimate your pet to the harness or crate," said Kit Darling, infection control coordinator at the Texas A&M College of Veterinary Medicine & Biomedical Sciences.
Start by giving your pet short car rides and gradually increasing the length of the rides, she suggested. Pets should have a break from the car every few hours to get exercise and relieve themselves.
As you would with your kids, make sure pets are strapped in to stay safe. Pets can be secured with a harness attached to a seat belt or in a well-ventilated crate, Darling said in a university news release.
Pets shouldn't be untethered in the truck bed, or left alone in a parked car. Summer heat can quickly kill a pet left in a hot car, Darling noted.
"Do not allow your pet to ride with his head outside of the window, as dirt and other debris can enter the eyes, nose and ears, causing injury or infection," she added.
If you're taking your pet by air, be sure to contact the airline to find out about their specific policies. Small pets can usually be kept under your seat. Larger pets will be crated and placed in the cargo hold.
Also, check with the hotel or resort you're staying at to be sure you understand their pet policies, Darling advised.
Don't forget to take along all the pet supplies you'll need, including something your pet is familiar with, and be sure they have ID tags in case they run off.
Darling also wants to remind you to show your pet lots of love and attention, which can make their trip happier.

Facial aging results from a combination of changes to the skin, muscle, fat and bones.
 people age, the loss of mineral density causes bone loss. Bone loss can affect the shape of the nose, lower jowl area, cheekbones, and middle and lower areas of the eye sockets, the researchers explained.
"As bones change, they affect the soft tissue around them, resulting in perceived decreases in facial volume," Paskhover said. "Treatment should consider the underlying bone structure."
The report was published online recently in JAMA Facial Plastic Surgery.

AHA News: When Dancer Kept Fainting, an EKG Finally Revealed Why

WEDNESDAY, June 12, 2019 (American Heart Association News) -- Looking back, Daniela Leonhardt's first indication something was amiss with her heart happened in December 2010, when she fainted before an Irish dance competition.
At the time, she was 30 years old, the mother of two little boys and in jaw-droppingly good shape. Why would she have thought the dizziness and nausea that followed her fainting spell could be a sign that her life was in danger?
"I had been a competitive dancer a long time, then after having kids, I decided to go back to it," said Leonhardt, who lives in Virginia. "I wanted to prove that at age 30 I could still compete with younger women."
She was well on the way, until she fainted.
"I wrote it off as maybe being under the weather," she said. "A lot of people had gotten sick at that competition."
To be sure that's all it was, she went in for a checkup. Her doctor attributed her symptoms to anxiety or possibly a virus. Two months later, Leonhardt fainted at a conference in Louisiana. Again, her symptoms were thought to be anxiety, or maybe something hormonal.
The episodes continued, eventually occurring about once a week. Leonhardt would feel lightheaded at a grocery store and sit down in the middle of an aisle. At home, she'd hold onto furniture and try to breathe through the dizziness.
In May 2012, Leonhardt went to an urgent care clinic. The physician's assistant gave Leonhardt her first electrocardiogram.
The PA rechecked the leads, as if they might have been out of place. He then asked the nurse to run the test again.
Looking at the results, the PA said, "I'm amazed you're sitting here acting totally normal." Her heart rate was only 32. A normal rate is 60 to 100.
Doctors diagnosed her with a condition that keeps her heart rate low. A pacemaker was implanted in June 2012 to help sustain a healthy rhythm.
Waking up from that procedure, she felt better than she had in years. She looked at her husband and said, "This is what it feels like to be normal."
The next day, she told herself, "This is not happening to another woman," and began volunteering for the American Heart Association.
In February 2014, while in Atlanta for work, Leonhardt didn't feel right. She eventually was diagnosed with a type of fast heart rate called supraventricular tachycardia. She had heart surgery that November.
Four months later, Leonhardt woke up and fell out of bed. Her left side wasn't functioning. She was having a stroke.
Her son Ciaran Donovan was 8 at the time. Because of the family's involvement with the AHA, he recognized the warning signs.
"Mom," he told her, "I'm going to call 911."
She hung up the phone and called her sister instead -- a move her neurologist told her could have killed her.
Leonhardt was fortunate; the stroke seemed to have "resolved itself." While her left hand doesn't grip as strong, and she occasionally mixes the three languages she speaks -- English, German and French -- there are no other long-term effects. Doctors determined the stroke was caused by atrial fibrillation, a common irregular heartbeat, so they put her on blood thinners.
Ciaran is now 12; his brother Landen Donovan, 9. They keep an eye on her, making sure she rests and doesn't overdo it.
"There are a lot of doctor trips and worrying about our mom," Ciaran said. "The pros are that we learned a lot from this. We know heart disease is out there and it can do to others what it did to my mom."
Said Landen: "The positive is that we know about heart disease and we get to go to the Heart Walk, which is really fun. The negative is that at any moment it could happen again."
But like their mother, the boys are optimistic. And, like her, they've gleaned lessons from the ongoing experience.
"They're more aware. They have a little more mitgefühl, as they say in German," said Leonhardt. "It's an understanding of a situation and having true empathy, even if you're not living it."

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