Genetic Testing for Cancer Lacking for Women on Medicare: Study

FRIDAY, Aug. 17, 2018 — Testing for gene mutations linked to breast and ovarian cancer is rare among some Medicare patients who have the cancers and qualify for such tests, a new study finds.

Researchers analyzed data from 12 southeastern states between 2000 and 2014. Only 8 percent of 92 women who met Medicare criteria for BRCA1 and BRCA2 gene testing received it within five years of their cancer diagnosis, the study found.

No patients in Arkansas, Louisiana, Tennessee, Virginia and West Virginia got the tests, according to the study published Aug. 14 in the Journal of the American Medical Association.

Breast cancer patients with BRCA mutations are more likely to develop cancer in a second breast and are also at increased risk for ovarian cancer. Ovarian cancer patients with the gene changes are more likely to get breast cancer.

Relatives who also have the mutations also face a higher cancer risk, the Vanderbilt University Medical Center researchers said.

“Women who carry one of these mutations but don’t know their mutation status are not able to take advantage of preventive or early detection interventions that we have available, so they miss out on the opportunity to reduce their risk for these cancers and potentially reduce their overall mortality,” study author Amy Gross said in a university news release.

“They are also not able to inform family members who might be affected,” Gross added. She is an epidemiologist at the Vanderbilt Institute for Clinical and Translational Research in Nashville.

The study covered a broad age range: More than half of the women were under age 65 and qualified for Medicare due to disabilities.

The researchers said lack of patient interest and physician recommendations might explain the low genetic testing rate. None of the patients had received a doctor referral for genetic counseling, they added.

More information

The U.S. National Cancer Institute has more on BRCA gene mutations.

Posted: August 2018

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Can you get pregnant while on the pill: 5 ways it can happen

In this article, we look at how effective the birth control pill is, and five reasons why the pill might fail. We also give tips on how to prevent pill failure and describe some early signs of pregnancy.

How effective is the pill?

The combined pill contains hormones that prevent ovulation, which is when the ovaries release an egg for fertilization. Another type of pill, known as the minipill, causes a person’s cervical mucus to thicken and the uterine lining to thin, which reduces the likelihood of sperm reaching an egg.

The birth control pill is very effective if a person takes it correctly and does not miss any pill days. According to the Centers for Disease Control and Prevention (CDC), the pill is 99.7 percent effective with perfect use. This means that less than 1 out of 100 women who take the pill would become pregnant in 1 year.

However, with typical use, the effectiveness of the pill is 91 percent. This means that around 9 out of 100 women would become pregnant in a year of taking the pill.

It is essential to start a new pack of pills the day after finishing the previous one. However, sometimes a person may not have their new package yet. Missing a few days between packs can make the pill less effective at preventing pregnancy.

According to the CDC, anyone who misses two or more pills in a row should use a backup contraceptive method or avoid sexual intercourse until they have taken the birth control pill for 7 consecutive days.

Medications that interfere with the pill

Some medications can make the pill less effective. Medications include certain antibiotics, such as rifampicin, and anti-fungal drugs, such as griseofulvin.

A person should use backup contraception while taking these medications and for 48 hours after finishing the course.

Other more long-term medications and supplements may also affect how well birth control pills work. These can include:

  • epilepsy drugs, such as phenobarbital, phenytoin, and carbamazepine
  • anti-viral medications used to treat HIV
  • St. John’s Wort, which is a herbal remedy

If a person is concerned about contraceptive failure and the possibility of being pregnant, they should speak to their doctor. However, there are also some early signs that can indicate pregnancy:

  • Bloating. While bloating is often a symptom of premenstrual syndrome, it can sometimes also be a sign of early pregnancy.
  • Breast tenderness. Raised levels of the hormones estrogen and progesterone can cause breast tenderness early in pregnancy. Some women may also experience symptoms, such as tingling, heaviness, or feelings of breast fullness.
  • Light spotting. A small amount of bleeding or spotting can occur when an egg attaches to the uterine lining. If spotting occurs outside of an expected menstrual cycle, it may be an early symptom of pregnancy.
  • Unexplained fatigue. Hormonal changes that occur in the body during pregnancy can make a person feel tired, even during the early stages.
  • Urinating more often. Hormonal changes can increase a woman’s need to urinate during early pregnancy.

Anyone who thinks they could be pregnant may wish to take an at-home pregnancy test. These tests have become more sensitive to a person’s hormone levels and better at detecting pregnancy in its earliest stages.

However, at-home pregnancy tests still may not reliable if an individual takes it too early or does not follow the instructions correctly. According to the United States Food and Drugs Administration (FDA), for most reliable results, a person should take the test 1–2 weeks after their first missed period.

Outlook

While birth control pills are generally very effective, they can sometimes fail to prevent pregnancies if a person does not use them correctly and consistently.

Anyone who is concerned about the effectiveness or convenience of their method of contraception should speak to a doctor.

If a person misses taking more than one pill, they should use a backup contraceptive method for at least 7 consecutive days of retaking the pill.

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Immune cells in the brain have surprising influence on sexual behavior

Researchers have found a surprising new explanation of how young brains are shaped for sexual behavior later in life.

Immune cells usually ignored by neuroscientists appear to play an important role in determining whether an animal’s sexual behavior will be more typical of a male or female, according to research led by Kathryn Lenz, an assistant professor of psychology and neuroscience at The Ohio State University.

The study, which was done in rats, appears in the Journal of Neuroscience.

To better understand the role of the mast cells in sexual behavior, Lenz and her colleagues silenced the cells in male fetal rats and then observed the rats’ development later in life.

The researchers paired one of these male animals with a female that was receptive to mating and watched to see whether the male sexually pursued the female—basically, whether he chased her and mounted her.

The experimental males were far less interested than typical males, acting almost like females.

The researchers also manipulated female newborn rats, activating the mast cells with a stimulating chemical.

As adults, they acted like males.

“It’s fascinating to watch, because these masculine females don’t have the hardware to engage in male reproductive behavior, but you wouldn’t know it from the way they act,” said Lenz, a researcher in Ohio State’s Institute for Behavioral Medicine Research. “They appear to be strongly motivated to try to engage in male sexual behavior with other females.”

The researchers found that estrogen (which plays a major role in development of masculine traits in rats) activates mast cells in the brain and that those mast cells drive the animal’s sexual development.

Though scientists know that sex differences are programmed by hormones during early development, they have limited information about the cellular-level changes that contribute to the manner in which the brain and behavior are formed.

“We’re really interested in the fundamental mechanisms that drive brain development and sex-specific brain development, and this study found that mast cells—immune cells involved in allergic responses—play a key role,” Lenz said.

If human development mirrors what was seen in this animal study, it’s possible that relatively minor influences—such as an allergic reaction, injury or inflammation during pregnancy—could steer sexual behavior development in offspring, Lenz said. It’s even conceivable that taking antihistamines or pain relievers during pregnancy could play a role, she said.

Furthermore, this discovery could help explain risks for psychiatric and neurological disorders that are more common in males, including autism, she said.

“These mast cells in the brain appear crucial for life-long brain development, even though there are relatively few of them, and this should really open our eyes to the potential role of different immune cells in the human brain. There’s so much we don’t know, and we need to pay attention to all the cells in the brain and how they talk to each other,” she said.

The study focused on the pre-optic area of the brain, which is part of the hypothalamus.

“This is the most sexually dynamic area of the brain—we know that it’s highly important for male-type reproductive and social behaviors such as mounting and for initiating maternal behavior in female animals,” Lenz said.

Previous work by the researchers uncovered the role of another type of brain cell, microglia, in directing sexual behavior. In the new study, they found that mast cells activate the microglia.

“This new mast cell discovery is really one of those accidents of science,” Lenz said, explaining that another researcher was conducting some unrelated work on sex differences in gene expression and noticed that there appeared to be some differences in mast cell genes depending on whether the brains were from a male or female.

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Over-the-counter drugs, dietary supplements and their effect on lab test results

Over-the-counter (OTC) drugs and dietary supplements are widely used and popular, with US households spending an average of almost USD 350 annually on OTC products. In 2006 an average of EUR 67.50 was spent per person on OTC products in Germany.

The use of various OTC drugs and dietary supplements is highly prevalent in Europe and patients are often not willing to disclose this information to laboratory staff and the ordering physician as a survey published in Clinical Chemistry and Laboratory Medicine, published by De Gruyter in association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), shows.

The study reports on the results of a survey of patients in 18 European countries which shows that those taking OTC products and dietary supplements are not aware of the potential effects on laboratory test results they may have. In addition, patients do not believe that they need to disclose this use to medical and/or laboratory staff.

The study shows that dietary supplements and OTC drugs are more frequently used by middle-aged patients – especially women – with the most common being multivitamins, multiminerals, cranberry and aspirin. All of these compounds, if consumed shortly before blood sampling, may cause changes in lab test results, thus leading to interpretation difficulties and possibly incorrect diagnoses.

Although more data is needed about the frequency of the consumption of various dietary products, vitamins or OTC drugs, the authors believe that a multifaceted approach is necessary to draw attention to the issue using educational interventions which target both healthcare professionals and patients.

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Twin study highlights importance of both genetics and environment on gene activity

New research highlights the extent to which epigenetic variation is influenced by both inherited and environmental factors.

Epigenetic processes affect the expression or activity of genes without changing the underlying DNA sequence and are believed to be one mechanism by which the environment can interact with the genome.

Now, an international group of researchers including teams from the University of Exeter, King’s College London, and Duke University in the USA have published a study in PLOS Genetics, using a unique cohort of over 700 pairs of twins to identify the factors influencing chemical modifications to DNA across the genome. In the study, funded by the Medical Research Council, the team compared the similarities between identical and non-identical twins, and found that epigenetic marks are more similar between identical twins—highlighting the role of DNA sequence variation in regulating gene activity. They also found that sites at which epigenetic variation is strongly linked to environmental exposures—such as smoking and obesity—are also partly under genetic control.

Professor Jonathan Mill, of the University of Exeter Medical School, led the study. He said: “These results highlight how both heritable and environmental factors can influence the way in which genes are expressed and function, with important implications for studies of health and disease.”

Dr. Eilis Hannon, of the University of Exeter Medical School, was first author on the paper. She commented “Our study provides a useful framework for interpreting the results of epigenetic epidemiological studies and shows that epigenetic differences are a potential mechanism linking genetic variation to gene regulation.”

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8 effects of psoriatic arthritis on the body

Psoriatic arthritis or PsA is a type of arthritis that affects up to 30 percent of people who have the skin condition psoriasis.

Here, we explore the many effects of PsA on the body, including on a person’s vision, digestion, breathing, and movement. We also discuss treatment options for the condition.

1. Effects on the skin, hair, and nails

The skin, hair, and nails are also known as the integumentary system.

People with PsA tend to experience the classic symptoms of psoriasis, including rough, red patches on the skin and thickened nails.

Psoriasis causes these effects by speeding up the life cycle of skin cells. New cells move to the outer layer of skin in a few days rather than weeks.

Doctors think this process occurs because the body tries to heal a wound or fight an infection that is not there.

These new cells rapidly build up on the skin to form the itchy, scaly patches that characterize psoriasis. The skin may feel warm and turn red due to widened or dilated blood vessels. The patches may sometimes be painful.

When psoriasis affects the skin on the scalp, the flakes may be mistaken for dandruff or seborrheic dermatitis.

PsA usually impacts the joints closest to the nail in a person’s fingers and toes. Nails can turn thick, rough, and rigid. They discolor or develop pits. In some cases, the nail can separate from the nail bed, known as onycholysis.

2. Effects on the musculoskeletal system

PsA occurs when the immune system mistakenly launches an attack on the body.

Along with skin changes, this abnormal immune reaction causes inflammation of the joints, affecting the musculoskeletal system in several ways.

Inflammation causes pain, stiffness, and swelling in one or more joints, making it difficult to move the joints. Fingers and toes may swell and take on a sausage-like appearance known as dactylitis.

People with PsA will often experience neck and back pain and have difficulty bending their spine. When these symptoms occur, it is known as spondylitis.

How does it affect cartilage?

The cartilage at the end of the bones can become damaged by long-term, chronic inflammation. The bones eventually rub against each other, causing further pain and joint damage. Inflammation can also lead both to bone erosions and extra bone growth.

In addition to bone damage, chronic inflammation affects the surrounding ligaments and tendons.

There is a link between inflammatory bowel disease (IBD) or colitis disease and PsA because inflammation underlies both conditions.

Crohn’s disease is another type of inflammatory bowel disease that causes diarrhea and other gastrointestinal problems.

People with PsA are at substantial risk of developing IBD disease in comparison to the general population, according to research. Other studies suggest that psoriasis is eight times more common in people with Crohn’s disease.

6. Effects on the respiratory system

If inflammation spreads to the lungs, it can cause a condition called interstitial lung disease. However, interstitial lung disease has a stronger association with rheumatoid arthritis, which is another form of inflammatory arthritis, than with PsA or psoriasis.

Nevertheless, inflammation in the lungs causes scarring over time. The scarring or fibrosis is irreversible and eventually affects breathing and the ability to get enough oxygen into the body. Other symptoms include coughing and fatigue.

7. Effects on the cardiovascular system

According to the American College of Cardiology, cardiovascular disease is a major cause of illness and death in people with chronic inflammatory disorders, such as psoriasis and rheumatoid arthritis.

Chronic inflammation damages blood vessels by making them thicker, harder, and causing scarring. These effects increase the risk of heart attack and stroke.

Also, people with PsA often have other risk factors that put added stress on the blood vessels and the cardiovascular system, such as obesity, high blood pressure, diabetes, and high cholesterol.

There is no cure for PsA, but people with the condition can work with their doctor to formulate a treatment plan. A robust treatment regimen can control symptoms and improve quality of life.

Treatment options include:

  • Medication, primarily nonsteroidal anti-inflammatory drugs or NSAIDS, to control pain, treat skin symptoms, and prevent joint damage.
  • Steroid injections to ease inflammation.
  • Joint replacement surgery to replace damaged joints.

Lifestyle changes and home remedies are also beneficial for people with PsA. These include:

  • changing the way everyday tasks are done to protect joints
  • maintaining a healthy weight
  • engaging in regular exercise
  • resting and relaxing when necessary
  • eating an anti-inflammatory diet
  • seeking support from others, such as family, friends, or a therapist

Takeaway

PsA results in symptoms of both arthritis and psoriasis. It causes widespread, chronic inflammation that affects the joints, entheses, the skin, and other body systems.

Although there is no cure for the condition, people can improve their quality of life by managing their symptoms by finding the correct medical treatments and making lifestyle changes.

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HerbList app launched to provide information on herbal products

(HealthDay)—The National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) has announced the launch of an app for easy access to research-based information on the safety and effectiveness of herbal products.

HerbList allows users to access information about the science of more than 50 popular herbs and herbal supplements, including kava, acai, ginkgo, turmeric, and others marketed for health purposes. Information on potential safety problems, side effects, and herbal-drug interactions can be also be accessed via additional links for more information. Favorite herbs can be marked for quick recall and offline accessibility.

The app, which was built using the Herbs at a Glance webpage of the NCCIH, includes scientific, research-driven information to provide users with unbiased information, allowing informed decisions to be made. The app can be downloaded for iPhones or iPads and for Android devices.

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New research focuses on treating non-cognitive symptoms of people with dementia

New research presented at the Alzheimer’s Association International Conference (AAIC) 2018 in Chicago focuses on the recent successes and ongoing challenges of drug and non-drug treatments for the non-cognitive symptoms experienced by people living with Alzheimer’s dementia.

While the memory and thinking symptoms associated with the disease are the most well known, it is the behavioral and psychological symptoms of dementia (BPSD)—agitation, anxiety, apathy, depression, wandering, hallucinations, insomnia, incontinence, disinhibition—that often cause the greatest caregiving challenges and are the leading causes for placement in assisted living or nursing homes. Left untreated, these symptoms can accelerate decline and reduce quality of life.

At this time, the U.S. Food and Drug Administration (FDA) has not approved any drug treatments for these symptoms in people with Alzheimer’s dementia. All drug treatments currently used are approved for other indications and prescribed for people with Alzheimer’s “off-label.”

“These underrecognized and undertreated symptoms in people with Alzheimer’s and other dementias are often very difficult to live with and challenging to treat,” said Maria Carrillo, Ph.D., Alzheimer’s Association Chief Science Officer. “One of the ‘untold stories’ of Alzheimer’s is the regular occurrence and overwhelming impact of these symptoms on the lives of people with Alzheimer’s, their family members and caregivers.”

“It is very important that as we continue to make advances in treating and preventing the memory and thinking symptoms of Alzheimer’s and other dementias, we also focus on therapeutic strategies for the behavioral and other non-cognitive symptoms,” Carrillo added.

The Alzheimer’s Association recommends non-pharmacologic approaches such as psycho-social interventions as first-line alternatives to pharmacologic therapy for the treatment of dementia-related behaviors. These therapies include validation therapy, reminiscence and other personalized psychosocial interventions.

For example:

  • Validate that the person seems to be upset over something.
  • Separate the person from what seems to be upsetting.
  • Engage in regular physical activity to potentially reduce irritability and aggressive behavior.
  • Assess for the presence of pain, constipation or another physical problem.

Psychotropic medications (antipsychotics, antidepressants, anticonvulsants and others) may need to be considered when the dementia-related behavior has not responded to non-pharmacologic approaches, especially if it is causing physical or emotional harm to the person with dementia or caregiver(s), however they must be used with extreme care, and must be regularly evaluated to determine the appropriate time of cessation. The FDA found that using antipsychotics to treat dementia-related behaviors in elderly persons with dementia was associated with increased mortality.

Synthetic Cannabinoid Treatment Shows Improvement in Agitation in People with Alzheimer’s

Results of a randomized, double-blind clinical trial suggest that nabilone—a synthetic cannabinoid—may be effective in treating agitation in people with Alzheimer’s disease. “Agitation, including verbal or physical outbursts, general emotional distress, restlessness, pacing, is one of the most common behavioral changes associated with Alzheimer’s as it progresses, and can be a significant cause of caregiver stress,” said Krista L. Lanctôt, Ph.D., Senior Scientist at Sunnybrook Health Sciences Centre and Professor of Psychiatry and Pharmacology/Toxicology at the University of Toronto.

Lanctôt and colleagues investigated the potential benefits of nabilone for adults with moderate to severe Alzheimer’s dementia with clinically significant agitation. Over the 14-week trial duration, 39 participants (77 percent male, average age 87) received nabilone in capsule form (mean therapeutic dose=1.6 +/- .5 mg) for six weeks, followed by six weeks of placebo, with one week between each treatment period. In addition to measuring agitation, the researchers assessed overall behavioral symptoms, memory, physical changes and safety. They found that:

  • Agitation improved significantly in those taking nabilone, compared to placebo, as measured by the Cohen-Mansfield Agitation Inventory (p=0.003).
  • Nabilone also significantly improved overall behavioral symptoms, compared to placebo, as measured by the Neuropsychiatric Inventory (p=0.004).

The researchers also observed small benefits in cognition and nutrition during the study. More people in the study experienced sedation on nabilone (45 percent) compared to placebo (16 percent).

“Currently prescribed treatments for agitation in Alzheimer’s do not work in everybody, and when they do work the effect is small and they increase risk of harmful side effects, including increased risk of death. As a result, there is an urgent need for safer medication options,” said Lanctôt. “These findings suggest that nabilone may be an effective treatment for agitation; however, the risk of sedation must be carefully monitored. A larger clinical trial would allow us to confirm our findings regarding how effective and safe nabilone is in the treatment of agitation for Alzheimer’s.”

Note: Marijuana is not approved by the FDA for the treatment or management of Alzheimer’s disease or other dementias. As medical marijuana use becomes more common, it is important to point out that much about its use in people with Alzheimer’s or other dementias is unknown.

Marijuana is, essentially, an untested drug in Alzheimer’s. There is currently no robust, consistent clinical trial data supporting the use of marijuana for treatment of Alzheimer’s disease dementia—nor for related issues. The Alzheimer’s Association believes that more research in this area is needed.

Lighting May Improve Sleep, Mood and Behavior in People with Alzheimer’s

Many people living with Alzheimer’s disease and other dementias experience changes in their sleep patterns, insomnia, and daytime sleepiness. Mariana G. Figueiro, Ph.D., Director of the Lighting Research Center at Rensselaer Polytechnic Institute in Troy, NY, and colleagues tested whether a tailored lighting system could help to improve sleep, mood and behavior in people with Alzheimer’s disease in nursing homes.

“Given that light/dark patterns are a person’s primary cues to the current time, the constant dim light typically experienced by people living in residential care facilities may be an underlying cause of the sleep pattern disturbances so commonly found in this population,” said Figueiro.

To test this hypothesis, over a four-week period, lighting interventions were placed in areas where nursing home residents spent the majority of their waking hours and were left on from wake-up time until 6 p.m. Forty-three (43) residents (31 female, 12 male) participated in the short-term study, and 37 residents (25 female, 12 male) have completed the long-term study so far, all recruited from 10 nursing homes in the New York Capital District, Bennington, VT, and South Bend, IN.

Study participants experienced alternating periods of lighting that provided either high- or low-circadian stimulus for four weeks (short-term study) and six months (long-term study, successive four-week periods spaced by a four-week washout). The circadian stimulus (CS) metric, developed by the Lighting Research Center, characterizes a light source’s effectiveness for stimulating the circadian system as measured by its capacity for acutely suppressing the body’s production of the hormone melatonin (a well-established marker of the circadian system) after a one-hour exposure.

Both arms of the study used either a custom-designed LED light table or individual room lighting to deliver the intervention, depending on where the participants spent the majority of their time. Personal light meters were used to measure the light exposures received at the participants’ eyes. Sleep disturbance, mood and agitation were also assessed using standardized questionnaires.

With the lighting intervention, researchers found that study participants who experienced the high-circadian stimulus showed significant decrease in sleep disturbance, depression and agitation. Positive effects observed in the short-term study continued to improve over the long-term study.

Beyond Anti-Psychotics: Exploring Efficacy and Harms of Z-Drugs for Sleep Disturbance

Many people with dementia have problems sleeping. This affects their quality of life and that of the people who care for them. Non-benzodiazepine hypnotic “Z-drugs,” such as zolpidem, zopiclone and zaleplon, are often prescribed to help treat insomnia in older adults, but it is thought that they may cause problems such as falls, fractures, and increase confusion. People living with dementia are especially vulnerable and it is not clear whether Z-drugs are particularly harmful for them.

Chris Fox, MD, Professor of Psychiatry at Norwich Medical School University of East Anglia in Norwich, U.K., and colleagues analyzed existing data from the UK Clinical Practice Research Datalink, and from three clinical studies of people with dementia. They compared data for up to two years for 2,952 people with dementia who were newly prescribed Z-drugs with data for 1,651 who were not, in order to evaluate the benefits and harms of these medicines.

They found that the use of Z-drugs is associated with a 40 percent increased risk of any type of fracture, with risk increasing for those on higher doses. Z-drug use was also associated with a greater risk specifically of hip fracture. The study did not identify a higher risk of other effects, such as falls, infections or stroke.

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AHA: ER Visits, Hospitalizations for AFib on the Rise

FRIDAY, July 20, 2018 (American Heart Association) — Emergency room visits for atrial fibrillation are soaring. Added to the number of people admitted to the hospital for the condition, it’s contributing to “an alarming growth” in its economic burden to the country, according to a new study.

Annual visits to the emergency department for this heart rhythm disorder, often called AFib, increased by 30.7 percent from 2007 to 2014, or from 411,406 visits to 537,801, according to a study published Friday in the Journal of the American Heart Association.

During the same period, hospitalizations for the condition increased 15.7 percent, from 288,225 to 333,570.

The figures were drawn from a weighted analysis of 3.8 million visits to emergency departments nationwide specifically for atrial fibrillation. About two out of five patients visiting the hospital during the period analyzed in the study were age 75 or older. Women were slightly more likely to have the condition than men.

Atrial fibrillation is the most common type of arrhythmia, or irregular heartbeat, which can lead to blood clots, stroke, heart failure and other heart-related complications. At least 2.7 million — and possibly as many as 6.1 million — American adults are living with AFib.

The study, which described AFib as “a major public health challenge and socioeconomic burden,” found that hospital-related charges for patients admitted with AFib increased by 37 percent, from $7.39 billion in 2007 to $10.1 billion in 2014.

“The question we asked is, why are so many people being admitted for AFib, and are there strategies that could help patients avoid hospitalizations without compromising the quality of care or outcome in any way, and maybe even improve them,” said Dr. Jeremy Ruskin, the study’s senior author and founder and director emeritus of the Cardiac Arrhythmia Service at Massachusetts General Hospital.

“There are strategies we and others have implemented to manage a subset of stable, uncomplicated patients (with AFib) in the emergency department and avoid hospitalizations for many of them,” Ruskin said. “Patients who are unstable and have complications such as congestive heart failure will continue to require hospital admission.”

Many of the patients who sought treatment for atrial fibrillation also had other chronic health problems, including high blood pressure, congestive heart failure, diabetes and kidney disease. Ruskin said those conditions are commonly associated with AFib and tend to be predictors of admission.

“It’s understandable that the sicker patients with more of these concomitant medical problems are likely to be admitted,” said Ruskin, a professor of medicine at Harvard Medical School.

But he also pointed out that the study found hospitalization rates for AFib in the United States were nearly twice as high as those seen in Canada and Europe.

“We also know from experience in other countries and some of our own initiatives that a sizable percentage of patients who come to the emergency room can be managed with medications and can then be discharged from the emergency room and managed safely on an outpatient basis,” he said.

Dr. Lin Yee Chen, an associate professor of medicine at the University of Minnesota Medical School and an atrial fibrillation researcher who was not involved in the study, said the findings confirm what many in the field have suspected about AFib’s growing economic burden. The study is important in putting firm figures behind it, he said.

“We know that there’s increasing incidence and prevalence of atrial fibrillation. Part of this can be explained by the growing aging population. It’s a contributor to chronic diseases in general and definitely to AFib,” said Chen, who chaired the writing committee for an American Heart Association scientific statement on atrial fibrillation.

More work needs to be done to intervene before the patient ends up in the hospital, with strategies to manage AFib, Chen said, much the way doctors are now trying to do with congestive heart failure.

“There’s a big push toward improving management of heart failure in the outpatient setting so that it will reduce ER visits and hospitalizations, which are not only expensive but also bad for the patient,” he said. “Likewise, for AFib. We need to try to improve or optimize management in the outpatient setting so that we can reduce flare-ups or exacerbations that will result in visiting the ER and hospitalizations.”

Posted: July 2018

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Novartis holds off on drug price hikes in US amid Trump pressure

Swiss pharmaceutical giant Novartis said Wednesday it would not hike drug prices in the United States this year, following a similar decision by rival Pfizer amid pressure from the White House.

“We don’t plan to take any further price increases in the United States for 2018,” Novartis chief executive Vas Narasimhan told journalists on an earnings call.

The comment came after Pfizer last week reversed price increases on some drugs in the United States after President Donald Trump threatened action and said on Twitter drug companies should be “ashamed” for boosting costs.

Trump’s administration in May outlined a plan for lower prices but critics have said it does not go far enough.

Narasimhan said Novartis’s decision to hold the line on prices in the United States was voluntary and that the company aimed to have a “system that can support breakthrough innovation … but still ensure affordability.”

He did not mention the Trump threat, but in an interview with Bloomberg said that after looking at the US “policy environment … we thought the prudent thing to do was to pull back on any further price increases in 2018.”

Positive on Trump blueprint

He also said Novartis was “very positive on the blueprint” the Trump administration has put forward on prices.

Narasimhan, who took charge of Novartis in February, spoke after the drugmaker reported better-than-expected profits.

Following the call, the company saw its share price swell 2.6 percent in mid-afternoon trading to 80.26 Swiss francs a piece, as the Swiss stock exchange’s main SMI index added 0.77 percent.

The company saw its net profit in the second quarter rise to $7.8 billion (6.7 billion euros), as net sales jumped nine percent to $13.2 billion.

During the quarter, Novartis, in the midst of a dramatic makeover, completed the sale of its stake in its consumer healthcare joint venture to Britain’s GlaxoSmithKline for $13 billion.

It also snapped up US gene therapy company AveXis for $8.7 billion, and decided to cut loose its Alcon eye care division during the second quarter.

“We made significant progress this quarter to transform Novartis into a focused medicines company,” Narasimhan said in the earnings statement.

But price erosion and sharper competition in the United States has taken a toll on Novartis’s Sandoz generics unit.

Novartis reiterated its overall full-year forecast of between one and five percent sales growth and a between five and nine percent hike in its operating profit, but revised down its expectations for Sandoz.

The company also highlighted steps taken to strengthen its ethics following revelations that it had paid Trump lawyer Michael Cohen to try to get insight into the new administration’s healthcare policy.

A report by four top Democratic senators concluded last week that the drugmaker’s ties to Cohen were deeper than it has acknowledged.

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