Monday, June 17, 2019

Remoxy ER


Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy

AUSTIN, Texas, Feb. 05, 2019 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq: PTIE), a clinical-stage drug development company, today announced feedback from a meeting held January 31, 2019 with the U.S. Food and Drug Administration (FDA) regarding the drug candidate, Remoxy ER.  Remoxy is the trade name for a new type of abuse-deterrent, extended-release gel formulation of oxycodone (CII) with physical/chemical properties intended to deter abuse.  As previously disclosed, we requested this meeting to resolve disagreement around comments and conclusions made by FDA in 2018 during a regulatory review of a New Drug Application (NDA) for Remoxy.
During this meeting, we learned that i) FDA denies making math errors, material mistakes or misrepresentations during a June 2018 Advisory Committee Meeting for Remoxy, despite clear evidence to the contrary; ii) comparator data is irrelevant for the evaluation of abuse-deterrent properties, despite FDA written guidance which explicitly states the opposite; and (ii) that we would need to rely on the Freedom of Information Act to access additional data generated by FDA with Remoxy.  As a result of our recent meeting with FDA, we believe we are no closer today to product approval than we were over a year ago.
“Remoxy remains an odyssey without a homecoming,” said Remi Barbier, President & CEO of Pain Therapeutics. “We had hoped for a fair, neutral and impartial review of the Remoxy data. Instead, we walked out of this meeting feeling a bit disoriented by FDA’s lack of transparency, clarity or helpfulness.  It’s a rare occasion when two parties can’t agree on simple math.  We can’t work with shambolic regulations.  This is not how you win support for innovation.”
Historically, the lead candidate in our pipeline has been Remoxy, an analgesic drug that we conceived, patented, developed and tested in collaboration with corporate and academic partners.  Over the years, we have conducted a successful clinical development program for Remoxy, including a large, well-controlled pivotal Phase III efficacy study whose primary endpoints met statistical significance (p<0.05).  The clinical safety or analgesic efficacy of Remoxy for its intended purpose is not in question. Its abuse-deterrent properties, however, are subject of a difference of opinion.  Abuse deterrence refers to properties that are embedded into an opioid formulation to prevent certain common methods of abuse. During the long development history of Remoxy, we generated nearly 9,000 unique data points in over 50 studies at a cost in excess of $100 million.  Studies were designed in consultation with FDA and conducted by independent labs.  Collectively, we believe these studies adequately characterize Remoxy’s abuse-deterrent properties. In particular, we demonstrated that the two currently marketed extended-release oxycodone products -- OxyContin® and Xtampza® -- which both benefit from abuse-deterrent label claims, can both be defeated for purposes of abuse in under a minute using common household items.  In contrast, Remoxy requires a significant investment of time, effort and equipment to defeat, and even then, results in less release of oxycodone.  During our recent meeting with FDA we were informed they believe Remoxy capsules lack abuse deterrence via the injection route of abuse because “oxycodone can be extracted from the product”, regardless of how much time, effort, frustration or equipment is required to so do. We are unable to follow the logic by which a drug product should never release drug. More generally, as the regulatory requirements for Remoxy have changed frequently and suddenly over time, we have experienced significant delays and have incurred unanticipated expenses related to the overall Remoxy development program.
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We believe innovative products such as Remoxy can serve a meaningful social purpose and, potentially, may save lives during the worst drug crisis in American history.  By necessity, however, we rely on reasonably predictive regulatory pathways to guide our product candidates through development in preparation for commercialization.  We also rely on principles of good governance, in which similar drugs receive similar regulatory treatment under rules that are clear, publicized, and evenly applied.  In our experience with Remoxy, the regulatory environment around abuse-deterrence lacks these essential qualities.
There are procedures in place at the FDA and other government agencies to help promote a fair resolution of disputes.  Such procedures can be complex and may not be rapid, predictable or even viable.  Going forward, we will generally be silent regarding our plans or future expectations for Remoxy, unless a significant material event occurs that compels us to update our public disclosures around this product candidate.
About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops novel drugs.  Our focus is on neurodegeneration, including an on-going Phase II program with our drug candidate, PTI-125, in patients with Alzheimer’s disease.  We own worldwide development and commercial rights to PTI-125 and related technology, including diagnostic, without royalty or milestone obligations to any third-parties.  The FDA has not yet established the safety or efficacy of any of our drug candidates.  For 

Tazemetostat


tazemetostat
Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of
Patients with Epithelioid Sarcoma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 30, 2019-- Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. Tazemetostat is an oral, first-in-class, EZH2 inhibitor discovered by Epizyme and being developed for a range of cancers and treatment settings.
This NDA submission follows a recently conducted pre-NDA meeting held with FDA, in which the Agency considered the proposed clinical package to be sufficient for inclusion with the NDA. The submission is based on updated tazemetostat efficacy and safety data from 62 patients enrolled in the epithelioid sarcoma cohort of the Phase 2 clinical trial, which will be reported in an oral presentation at the American Society of Clinical Oncology (ASCO) 2019 Annual Meeting. The company’s ongoing Phase 2 study cohort is the largest prospective clinical trial in epithelioid sarcoma with any approved or investigational anticancer treatment to date.
“Epithelioid sarcoma is a rare and aggressive cancer that affects people in the prime of their lives, and we are very pleased to have recently submitted the NDA for tazemetostat for the treatment of people with this devastating cancer,” said Dr. Shefali Agarwal, chief medical officer of Epizyme. “If approved, we believe tazemetostat has the potential to change the care of patients with this disease. We are incredibly grateful to the physicians and clinical teams who have helped advance tazemetostat to this stage, and, most notably, to the patients and caregivers who have participated in our clinical trials along the way. We look forward to continuing to engage with the FDA as we work to bring tazemetostat to patients and physicians in the U.S.”
To support a full approval of tazemetostat for epithelioid sarcoma, Epizyme plans to conduct a global, randomized, controlled trial, that it expects to begin in the second half of 2019. The final design of the study is subject to alignment with FDA, and the company plans to disclose details once it has reached alignment with FDA and the NDA submission has been accepted for review. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
“At Epizyme, our mission is to deliver new treatments for patients with cancer and other serious diseases, and today we stand one significant step closer to achieving that,” said Robert Bazemore, president and chief executive officer of Epizyme. “This submission is the culmination of years of hard work by our entire team, and I wish to congratulate them all on this accomplishment. Our epithelioid sarcoma program is strategically valuable to Epizyme and helps streamline our planned NDA submission in the fourth quarter, for patients with follicular lymphoma. Over the coming months, we have multiple anticipated clinical data and regulatory milestones, and we are well underway with commercialization readiness activities to support the potential launch of tazemetostat and our transition to a commercial-stage organization. 2019 is set to be a transformational year for Epizyme, and I am enthusiastic for our continued progress.”
About Epithelioid Sarcoma

Epithelioid sarcoma is an ultra-rare soft tissue sarcoma characterized by a loss of the protein INI1. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age. Median overall survival from initial diagnosis is 30 months. Epithelioid sarcoma becomes more aggressive after recurrence or metastases, with a typical survival of less than one year for patients with metastatic disease.
About Epizyme, Inc.

Epizyme, Inc. is a late-stage biopharmaceutical company committed to rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. Epizyme is broadly developing its lead product candidate, tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both solid tumors and hematological malignancies, as a monotherapy and combination therapy in relapsed and front-line disease. The company also is developing a novel G9a program with its next development candidate, EZM8266, which is targeting sickle cell disease. By focusing on the genetic drivers of disease, Epizyme's science seeks to match targeted medicines with the patients who need them. For 

Sunday, June 16, 2019

Health Highlights: March 11, 2019


Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Approves 1st Immunotherapy Drug for Breast Cancer
The U.S. Food and Drug Administration has given its blessing to the first immunotherapy regimen for breast cancer.
The combination of immunotherapy (Tecentriq) and chemotherapy (Abraxane) was given accelerated approval for triple-negative breast cancer that is locally advanced or has spread, cannot be surgically removed, and has cells that have a protein called PD-L1, CNN reported.
A study
ed last October in the New England Journal of Medicine found that median progression-free survival (length of time a patient's cancer does not worsen) was 7.4 months among patients who received the combination therapy, compared with 4.8 months among those who received chemotherapy with a placebo, the FDA said Friday.
The study was funded by Genentech Inc., the maker of Tecentriq.
"This is the first time immunotherapy has worked in such a difficult to treat cancer, and is a huge step forward for these breast cancer patients," study author Dr. Peter Schmid, from Queen Mary University of London, said in a statement last October, CNN reported.
The accelerated approval is just the start, noted Dr. Otis Brawley, professor of oncology and epidemiology at Johns Hopkins University.
"The FDA has approved it based on progression-free survival with the hope that later on ... data will show that the treatment actually makes women live longer," Brawley told CNN.
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Flu Season May Have Peaked: CDC
It looks like the flu season has peaked in the United States, though there's been a recent rise in the number of cases involving a more severe flu strain.
Flu was widespread in 48 states last week, down from 49 the previous week, according to a U.S. Centers for Disease Control and Prevention update released Friday. CDC experts believe there's a 90 percent chance the flu season has peaked, the Associated Press reported.
Several flu strains often circulate in the United States at the same time, but one strain typically dominates.
A milder strain of flu has been the most common cause of cases this flu season. But over the last two weeks, about 60 percent of flu virus samples tested were a strain called Type A H3N2, which tends to cause more hospitalizations and deaths, especially in the elderly, the AP reported.
There have been 20,000 to 30,000 flu-related deaths in the United States so far this winter, about 300,000 flu-related hospitalizations, and around 25 million flu illnesses, according to the CDC.

Nutritional Supplements Don't Ward Off Depression: Study

 Taking vitamin pills and other supplements won't prevent depression, but promoting better eating habits might help, new research suggests.
The study included more than 1,000 overweight or obese people in the United Kingdom, the Netherlands, Germany and Spain who were at risk for depression, but were not currently depressed.
Excess weight is often linked with depression, the researchers noted.
Half of the study participants took daily supplements containing folic acid, vitamin D, omega-3 fish oils, zinc and selenium. Half took a placebo pill.
Half were also counseled about their eating habits and urged to limit snacking and follow a healthy Mediterranean-style diet.
In a one-year follow-up, the researchers discovered that the supplements worked no better than the placebo in helping ward off depression.
Similarly, the counseling was not effective overall, though it seemed to help prevent depression in participants who attended a recommended number of sessions.
That suggests counseling works only if people get an adequate "dose" of therapy and make significant changes in their diet, according to the study
ed March 5 in the Journal of the American Medical Association.
"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.

Saturday, June 15, 2019

Vets Who Get Opioids From VA, Medicare at Higher Overdose Risk

 Many military veterans can get prescription opioid painkillers from both the VA and Medicare, putting them at nearly triple the risk for an overdose, new research warns.
The finding could have implications for a huge number of vets: Roughly eight in 10 VA-covered patients have additional private or public health insurance coverage. About 51 percent have Medicare, and about one-third of those receive Medicare Part D drug benefits.
But the problem may be more about poor oversight than addicted patients trying to game the system, noted study author Dr. Walid Gellad, a researcher with the VA Pittsburgh Healthcare System.
"Only in some limited circumstances -- and we don't know how many -- is this purposeful behavior by a patient to try and get additional opioids," he explained.
"I would not think of this as 'double-dipping' or 'being caught,'" Gellad added. "In some cases, receiving opioids from both systems could have happened at different times, as veterans got care in one system first, and then in another system later, or they go back and forth between VA and the private sector. In some cases, the opioids are prescribed at the same time, sometimes unintentionally, and sometimes intentionally."
Gellad and his team found that more than 3 million veterans filled at least one opioid prescription (either through the VA or another insurer) during the time period from July 2011 through December 2013.
To see how dual health insurance coverage might influence overdose risk, the team first examined the records of 215 veterans who died from an overdose between 2012 and 2013.
Their average age was 57, most (90 percent) were male and most (84 percent) were white. All had both VA and Medicare Part D health care coverage for at least six months prior to their deaths.
For comparison, the investigators also assessed opioid prescription patterns among a "control group" of more than 800 living vets of a similar age, race, health status and gender.
About 28 percent of those who had died due to an opioid overdose had obtained their meds from both the VA and through Medicare Part D. This compared with just 14 percent of the control group, the researchers found.
Still, Gellad stressed that systemic changes that curtail getting opioids from multiple sources have been implemented by the U.S. Department of Veterans Affairs since the study ended in 2013.
For example, he noted that "the VA has instituted requirements to check prescription drug monitoring programs, which should alert physicians to instances when opioids are prescribed in different systems."
But, "for this to work to reduce the risk of overdose, clinicians have to actually check, and they have to do something with the information when they find it," Gellad added.
"Ultimately, I think we will see automated alerts that will alert clinicians to a medication prescribed in one system if it, or an interacting medication, is also being prescribed in another system," Gellad said. "But for that to have an impact, it has to alert at the point of prescribing, which is not possible yet within [the] VA or outside [the] VA."
The report was
ed online March 12 in the Annals of Internal Medicine.
Dr. Carolyn Clancy, Deputy Under Secretary for Discovery, Education and Affiliate Networks with the VA in Washington, D.C., co-authored an accompanying journal editorial.
Clancy pointed out that "because of VA's existing robust and extensive patient record system, the department has had significant success in reducing opioid use and overdose risk."
The VA has been tracking problems related to dual access to medications "for some time," she said.
"That's why the department is constantly working to improve coordination with community providers," Clancy noted. "Especially through the implementation of electronic health record modernization."
And going forward, she said, the VA hopes to augment the current screening process afforded by state prescription drug monitoring programs, by "seeking to develop [its own] electronic system to automatically check all state prescription drug monitoring programs for each veteran to further improve care coordination."

Chickens Help Scientists Pinpoint Origin of Rare, Deadly Virus

 Much like a canary in a coal mine, Florida chickens have warned researchers of a rare but deadly mosquito-borne virus in their midst.
These sentinels have revealed that eastern equine encephalitis virus (EEEV) originates in the state's panhandle and then spreads as far north as Nova Scotia, Canada, the new study found.
"In the region of the panhandle, this is year-round. You can get exposed to this virus by infected mosquitoes year-round," said lead researcher Suman Das, an associate professor of infectious diseases at Vanderbilt University Medical Center in Nashville, Tenn.
Now that scientists know where the virus comes from, they can focus prevention efforts in mosquito-ridden areas of the panhandle, Das said.
"This is, I would say, the deadliest virus we are potentially exposed to in the United States," Das said. "It's been lurking around in the country about 20 to 30 years, and the mortality rate is about 40 percent."
EEEV, which sickens humans and horses, is rare in people, with only about 70 cases reported since 2008. But experts fear the infection rate could rise as global warming extends the reach of mosquito populations farther north.
The virus causes brain swelling in its human victims, and even survivors can pay a long-lasting price, Das said.
"Even when people don't die, in those cases, there is a lot of neurological disease and ultimately, they die earlier," Das said.
EEEV infection can result in severe intellectual impairment, personality disorders, seizures and paralysis, according to the U.S. Centers for Disease Control and Prevention.
Previous research had shown that EEEV spreads outward from Florida, but up to now no one had been able to say what part of the state served as the virus' wellspring, Das said.
Northern states track mosquito-borne viruses by using insect traps and then directly testing the pests for the presence of pathogens, but that method doesn't work in mosquito-beclouded Florida, Das said.
"There are much fewer mosquitoes in the northeastern states compared to Florida. You'd be looking for a needle in a haystack," he explained.
So, Florida turned to chickens to help track the progress and source of EEEV and other viruses.
Between 2005 and 2016, 38 of Florida's 67 counties participated in the state's sentinel chicken surveillance program. Flocks of chickens are strategically placed in coops around the counties, and their blood is regularly tested for viral infection, Das said.
"If a chicken is exposed to EEEV, it doesn't kill the bird but they will make antibodies" against the virus, he explained.
Over 12 years, the chickens demonstrated that the virus is a year-round phenomenon in the panhandle but occurs only seasonally in northern and north-central regions of Florida, Das said.
That probably means EEEV spreads from the Florida panhandle.
"We think that the panhandle, the source of the activity, seeds to the rest of the state, and Florida is the source for the Northeastern United States," Das said.
Thus, mosquito control efforts focused on the Florida panhandle might stand a chance of killing EEEV in its crib, he said.
"That the Florida panhandle appears to be a year-round nexus of transmission is important for epidemiological understanding of this virus and its mosquito vector," said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.
Adalja, who wasn't involved with the research, said the findings underscore the importance of aggressive mosquito control in at-risk areas and the need for eastern equine encephalitis to be considered in patients who live in or travel to areas where it has been shown to flourish.
The new study was
ed March 11 in the American Journal of Tropical Medicine and Hygiene.

'Daddy-Do-Overs': Men Increasingly Getting Plastic Surgery

 A face-lift for Father's Day, anyone?
It could happen: A new report finds many more men are taking advantage of the same plastic surgeries that have long been associated with women.
The midlife decision by men to try a face-lift or other procedure has been nicknamed the "Daddy-Do-Over" -- referencing the "Mommy Makeover" for women.
Whatever it's called, "men are embracing the idea of surgery more than before," said Dr. Alan Matarasso, president of the American Society of Plastic Surgeons (ASPS).
He stressed that the average man approaching or in middle age might have different reasons for wanting a nip or a tuck, compared to his female peers.
"Obviously, men don't go through the same physical changes that women experience during pregnancy and post-pregnancy, but their lifestyle does change, which can impact their appearance," Matarasso said in a society news release.
"Diet and exercise patterns fluctuate, and they don't sleep as much," he added. "Men notice their body changes due to aging and parenting, and it starts to look completely different in their 30s and 40s. That is the point of a Daddy-Do-Over."
In fact, according to the ASPS, more than 1 million men had cosmetic surgery in 2018, a 29% increase since 2000.
Like women, men are typically getting body contouring and facial procedures to enhance their physique and keep the dreaded "dad bod" at bay. The most popular procedure for men was rhinoplasty -- a "nose job" -- with 52,000 of the procedures performed on men in 2018, the ASPS said. That was followed by eyelid surgery, liposuction, breast reductions (24,000 cases) and hair transplants.
Botox injections are also popular with men, with nearly half a million procedures performed last year. Another 100,000 "filler" procedures were performed on men in 2018, the ASPS said.
One case in point is 57-year-old Scott, a restaurateur in New York City who said he couldn't get rid of his spare tire.
"I realized I was never going to lose the weight on my own," he said in the news release. "Plastic surgery is a personal decision, but I know guys my age who have done different cosmetic procedures. I think an open dialogue about plastic surgery is becoming more acceptable, especially for men."
Men are increasingly getting plastic surgery to help them advance their careers and compete in the workplace, Matarasso said.
Dennis, 59, is a creative director working in the New York City fashion industry. He was lean and fit, but still struggled with fat accumulating in certain areas.
"I've been in fashion my entire career, and it makes me feel good when I walk in the room and I don't feel as if I look 60 in a room of 25- to 30-year-olds," Dennis said in the news release. "I always carried weight in my neck and chin, and my droopy eyelids made me look more tired than I actually was."
He underwent an eye lift and chin surgery and says he's "gained unexpected confidence from the small changes."
Of course every surgery comes with risks, plastic surgery included, so Matarasso stressed that men consult at length with an accredited, experienced surgeon to maximize safety.

5 Easy Ways to Cut Back Your Salt Intake

 About two-thirds of Americans have taken steps to cut back on salt, according to the International Food Information Council Foundation.
This often starts with comparing labels and choosing foods -- from soups to canned veggies -- with less sodium. Here are four more steps that you can take to reduce your salt intake.
You know that processed red meats and lunch meat of all kinds are loaded with salt, but also be aware of less obvious sources, like packaged breads. If you have toast at breakfast, a sandwich at lunch and a roll at dinner, all that salt will add up. Prepared and packaged dinners can be high in salt, especially pizza, chicken nuggets and many ethnic foods, the American Heart Association warns. The same goes for poultry that's been "pre-basted" or injected with a sodium solution.
Make more food from scratch. Restaurants, and fast-food establishments in particular, add a lot of salt and sodium-based flavor enhancers to foods. When you do the cooking, you control the salt. Besides herbs, use spices to add flavor. Try various pepper-based ones like ancho and chipotle chilies and paprika. Using garlic and onions adds sweetness and depth. Just beware of spice blends with hidden salt, like taco seasoning -- look for no- and low-salt varieties.
Track your salt intake on the same app or website that you use to track calories. Watching the numbers add up should motivate you to cut back.
Even though the salt added from a salt shaker is only a small part of the average person's added salt, get into the habit of tasting the food on your plate before you reach for it, whether you're at home or eating out. Add flavor with black pepper, fresh lemon juice or a sprinkling of a no-salt blend.

Education, Intelligence Might Protect Your Brain

 Being smart and highly educated may not prevent Alzheimer's disease, but it appears to delay the disease's impact on everyday life, a new study suggests.
Researchers can't prove that that's the case, but their data suggests it might be.
"Our study was designed to look for trends, not prove cause and effect, but the major implication of our study is that exposure to education and better cognitive performance when you're younger can help preserve cognitive function for a while, even if it's unlikely to change the course of the disease," said study author Dr. Rebecca Gottesman. She's a professor of neurology at the Johns Hopkins University School of Medicine in Baltimore.
For the study, Gottesman and her team collected data on 331 middle-aged and older people without dementia who were followed for 20 years and had brain scans as part of a separate study. The scans revealed how much plaques were in their brains, a hallmark of Alzheimer's. The group included people with less than a high school education and those who went to college.
The researchers found that those with more education scored better on tests of memory and language than those with less education, no matter how much plaque their brains contained.
They also found that cognition scores in midlife did not affect the amounts of plaque found later in life.
"Our data suggest that more education seems to play a role as a form of cognitive reserve that helps people do better at baseline, but it doesn't affect one's actual level of decline," Gottesman said in a university news release.
The report was
ed in the April issue of the Journal of Alzheimer's Disease.

Friday, June 14, 2019

AHA News: Are Transgender Men and Women Who Take Hormones at Risk for Heart Disease?


FRIDAY, June 14, 2019 (American Heart Association News) -- The impact of hormone therapy on the heart health of transgender men and women has been the subject of several studies
ed within the last year. But medical experts and researchers aren't ready to sound the alarm just yet.
"We have to recognize that hormones can be lifesaving therapy for trans people," said Dr. Richard Greene, an associate professor at New York University School of Medicine. "The answer is figuring out how to give them safely and how to modify some of these cardiovascular risk factors in the best way possible."
One study found that transgender women who take hormones were more than twice as likely to have a stroke and deep vein clots compared to cisgender men and women -- or people who identify as the sex they were assigned at birth. In addition, both trans women and trans men had a higher risk of heart attack than cisgender women.
Still, the findings aren't enough reason for doctors to stop prescribing hormones -- primarily estrogen to transgender women and testosterone to transgender men. Greene said he found some of the science behind the more recent research "problematic."
Many of the studies don't ask how long a person has identified as transgender or consider the kinds of hormones being used. Some older types of estrogen are associated with higher risk for stroke, he said. In addition, most studies did not ask whether the individuals taking hormones considered themselves non-binary, or not identifying as either man or woman.
But Greene applauded the overall focus of the latest research and described the studies as significant.
"What's amazing is that we're actually asking a question about trans people and their health that's not about their gender and not about their psychosocial well-being," he said. "We're asking questions that say trans people are in our clinics and are in our health care system, and we need to take the best evidence-based care of them that we can."
He said transgender individuals undergoing hormone therapy can best reduce their cardiovascular risks through heart-healthy basics and by meeting regularly with a primary care physician.
Transgender individuals, however, don't engage in preventive care at the same rate as cisgender people, primarily because they fear discrimination or lack resources and easy access.
"There are certainly plenty of (trans) people who only see an endocrinologist for hormones and don't have other medical providers engaged in their care," said Zil Goldstein, a family nurse practitioner and the associate medical director at New York's Callen-Lorde Community Health Center. "That means there's not really anyone whose job it is to focus on things like getting a flu vaccine, or getting cholesterol and health screenings."
Goldstein said transgender patients also should be screened for substance abuse, depression and psychological distress, all contributors to heart disease.
Greene agreed. He said recent research has helped raise awareness among some medical professionals.
"Have that conversation with a trans person in primary care and say, 'Let's talk about how we can get you to quit smoking.' Talk to them about their weight, about their diabetes, about their high blood pressure, their cholesterol – all those things are going to make the biggest difference in someone's cardiac risk when we get to the bottom line," Greene said.
"Real engagement with the health care system and engagement with good quality primary care that's affirming for trans people is the most important thing people can do."
Goldstein said more long-term research is needed to provide additional insights into the cardiovascular health of transgender men and women.

AHA News: Many With High Blood Pressure Aren't Worried. Should They Be?


FRIDAY, May 24, 2019 (American Heart Association News) -- High blood pressure is known as the "silent killer" because there are no obvious warning signs.
That might explain why nearly half of people diagnosed with it aren't worried about having a heart attack or stroke, according to a new survey. High blood pressure, also known as hypertension, greatly increases the chances of having a heart attack or stroke.
"Even when people are educated that they're at risk, they might not be worried because they don't feel bad," said Dr. Michael Rakotz, vice president of health outcomes at the American Medical Association.
In the survey, 55% of respondents with high blood pressure said they worry they'll have a heart attack and 56% say they worry they'll have a stroke. That compares with a little more than one-third of Americans overall in the survey who worry about heart attack or stroke.
The Ipsos Public Affairs online survey was conducted for the AMA and American Heart Association. It surveyed 1,000 U.S. adults in April, with results carrying a level of 90% confidence.
Possible reasons for the disconnect include the lack of symptoms and difficulty maintaining healthy lifestyle changes that can help control high blood pressure.
Meanwhile, many people with high blood pressure might be unaware of the life-altering effects for survivors after a stroke or heart attack. In particular, stroke survivors may lose basic abilities and have to relearn basic living functions.
"You can't communicate with your loved ones, you can't care for yourself," for a while after the event and sometimes permanently, said Sondra DePalma, a physician assistant with the PinnacleHealth Cardiovascular Institute in Harrisburg, Pa.
"From society's standpoint, the cost is the loss of a worker and more support required to provide for that person," she said.
The survey also reported these figures among respondents with high blood pressure:
22% checked their blood pressure in the prior week.
40% said their most recent reading was uncontrolled, or higher than 130/80.
16% said they don't need to keep track of their readings when they're taking medication.
DePalma and Rakotz said health care providers have an important role to play to help people understand their risks and take precautions. However, they also have to find the time to do it.
"Part of the problem is that doctors are asked do so much now," Rakotz said. "Appointments are getting shorter and the list of things we have to cover for prevention and health maintenance is getting longer."
A big part of the solution is to build awareness through initiatives such as LowerYourHBP.org and stories about the real-life consequences. Such stories are showing up in a series of videos launched this spring by the AHA, AMA and the Ad Council.
Still, the survey results indicate much more is to be done.
"We need to continue to work to get real stories out there," Rakotz said. "And we need to do a better job of motivating people to take charge of their health and raising awareness that together we can create a plan to bring their blood pressure under control."

Good Blood Pressure, Blood Sugar Levels Can Prevent 'Heart Block'

 Keeping blood pressure and blood sugar levels under control might prevent a common heart rhythm disorder called "heart block."
That's the finding from a new study analyzing data on more than 6,000 people, aged 30 and older, in Finland.
In the study, the University of California, San Francisco (UCSF) researchers found that 58 of those people developed heart block over an average follow-up of 25 years.
Heart block, or atrioventricular block, occurs when electrical signals between the heart's four chambers are disrupted. Often felt as a skipped beat, it can lead to the need for a pacemaker.
Every 10 millimeter increase in systolic blood pressure resulted in a 22% greater risk of heart block, and every millimeter increase in fasting blood sugar (glucose) resulted in a 19% greater risk, the findings showed.
The researchers estimated that 47% of the 58 heart block cases could have been prevented with ideal blood pressure and 11% with normal fasting glucose.
Other factors in the Finnish data associated with increased risk of heart block were older age, being male and having a history of heart attack or heart failure.
The study was
ed online May 24 in the journal JAMA Network Open.
The researchers noted that there has been little research on whether lifestyle changes can prevent heart block, probably because the condition is widely treated with pacemakers.
"It is perhaps precisely because pacemakers so successfully and immediately address cases of heart block that we have previously failed to devote more attention to prevention of this important disease," study senior author Dr. Gregory Marcus, a UCSF Health cardiologist, said in a university news release.
"In addition to the prevention and treatment of [heart attack] and heart failure, effective treatment of hypertension and maintenance of normal blood sugars may be useful prevention strategies," he added.
"Given the prevalence of heart block in the adult male population, as well as the multiple risks associated with pacemakers, it would be worthwhile to pursue further research on this connection," Marcus added.
"This new information also may help persuade hypertensive individuals to receive and continue their prescribed treatments," he concluded.

Health Highlights: June 6, 2019


Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
U.S. Measles Cases Pass 1,000: CDC
The U.S. Centers for Disease Control and Prevention now pegs the number of measles cases at over 1,000 -- the most in 27 years.
So far this year, the CDC has counted 1,001 cases, with many occurring among New York City's Orthodox Jewish community, the Associated Press reported.
The last time America saw this many cases was in 1992 when over 2,000 cases were reported by that year's end.
Before a vaccine was available in the 1960s measles was common. But the vaccine made the disease rare in the U.S. Ten years ago there were less than 100 cases a year, the AP said.
Although most Americans are vaccinated for measles, outbreaks are now often occurring in communities where "anti-vaxxer" parents have refused to have their kids receive vaccines.
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Trump Administration Curbs Fetal Tissue Research
On Wednesday the Trump Administration stopped government scientists from using fetal tissue for medical research.
The administration also pulled a multi-million-dollar contract from the University of California at San Francisco, which was using fetal tissue to test new treatments for HIV, the Washington Post reported.
The move is seen as a victory for anti-abortion advocates and a major drawback to scientists who use tissue from elective abortions to research a variety of diseases including cancer, Zika and Parkinson's disease.
In a short statement reveling the decision, the U.S. Department of Health and Human Services said that, "promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump's administration."
Research that doesn't rely on government dollars won't be affected, the HHS statement said. But the agency also hinted that requests for federal research funding will now be vetted by a new ethics panel.
This change directly counters assurances given to scientists last year that there would be no interruption in funding so long as experiments met current government ethical guidelines, the Post said.
Scientists have repeatedly said that no research substitute for fetal tissue exists. Alternatives such as thymus tissue from newborns are being researched and look promising, however. Research into that possibility is being partly funded by a $20 million government grant.
Last year the government curtailed funding for Advanced Bioscience Resources, a main supplier of fetal tissue implanted into laboratory mice and long a target of anti-abortion groups.

Midlife Diabetes Can Really Raise Your Odds for Stroke Years Later

 In a finding that further confirms the link between type 2 diabetes and stroke, a new study shows that having the blood sugar disease during middle age may boost your risk of having the most common type of stroke later in life.
In addition to a 30% greater chance of an ischemic stroke, the researchers also found that people who had type 2 diabetes in their 40s or 50s were twice as likely to have narrower blood vessels in their brain in their 60s and beyond.
"Our findings highlight the need for controlling midlife type 2 diabetes mellitus to help prevent [ischemic stroke and narrowing of the blood vessels in the brain]," said study author Rongrong Yang. Yang is a Ph.D. candidate at Tianjin Medical University in China.
An ischemic stroke, which is the more common type of stroke, is caused by a blockage in a blood vessel in the brain. This damages the area of the brain that's no longer receiving enough blood. The less common type of stroke is known as a hemorrhagic stroke. That type of stroke occurs when a blood vessel bursts, causing blood to leak into the brain and cause swelling and tissue damage, the National Stroke Association says.
Type 2 diabetes has long been associated with the risk of stroke, but it's been hard to know if an increased risk of stroke comes from the diabetes or from other genetic and environmental factors, according to background information in the study.
To better tease out if diabetes itself was a likely culprit, the researchers reviewed data from the Swedish Twin Registry. More than 33,000 twin individuals met the criteria for the study.
The study participants were all born before 1958. None had evidence of narrowed brain blood vessels or stroke before age 60.
Just under 4% of the group had diabetes in midlife. More than 9% had late-life (after 60) strokes or narrowed blood vessels in their brain, the study authors said.
After adjusting the data to account for other stroke risk factors, such as smoking and obesity, the researchers noted the increased risk of ischemic stroke, but didn't find an increased risk of hemorrhagic stroke.
Yang said that genetic and environmental factors didn't appear to account for the increased risk of ischemic stroke, but noted that more research needs to be done. This study wasn't designed to prove a cause-and-effect relationship.
So why might diabetes lead to more ischemic strokes?
"The mechanisms underlying the association of type 2 diabetes mellitus with stroke are complex and not completely understood," Yang said. But, people with type 2 diabetes have abnormal cholesterol levels and that might contribute to the narrowed blood vessels in the brain.
Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said the Swedish population has significantly less type 2 diabetes than would be found in the United States.
Zonszein was not, however, surprised to see a higher risk of stroke and narrowed blood vessels in people with diabetes.
"We need to be much more alert to getting the proper diagnosis of diabetes and controlling risk factors. Focus on the things we can change to try to improve risk factors," Zonszein said.
"Smoking cessation is important, and we have to treat high blood pressure. High blood pressure puts people at high risk of stroke. People with diabetes should be on a statin to control cholesterol levels, and they should be on the proper medications to control their diabetes," he added.
Study author Yang agreed that controlling risk factors is key.
"Diabetic patients need to maintain a healthy lifestyle, such as doing regular exercise, eating a healthy diet, keeping a healthy weight, no smoking, as well as [blood sugar] control, in order to reduce the risk of [stroke] in late life," Yang said.
The findings were
ed June 5 in Diabetologia.

Health Highlights: June 14, 2019


Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
More Sickened by Salmonella From Backyard Poultry
Having chickens or ducks in your yard might carry salmonella dangers, the U.S. Centers for Disease Control and Prevention warns.
The agency says an outbreak of the gastrointestinal illness, tied to backyard poultry, has now sickened nearly 280 people in 41 states and sent 40 to the hospital. Although salmonella illness can be severe, so far no deaths have been reported.
Some of the infections have proven resistant to treatment by multiple antibiotics, the CDC noted.
The bacterial disease is being spread by having contact with the birds. People who got sick said they touched chicks and ducklings they bought from agricultural stores, websites and hatcheries.
A third of those sickened are kids under five who may have gotten too close to young poultry."Don't kiss backyard poultry or snuggle them and then touch your face or mouth," the CDC advises.
To prevent salmonella the CDC advises:
Wash your hands after touching poultry anything in their environment.
Keep backyard poultry out of the house, especially in places where food is prepared, served, or stored.
Set aside shoes to wear while taking care of birds and keep those shoes outside.
Kids under five and adults over 65 and those who have health problems that reduce the effectiveness of their immune system shouldn't touch chicks, ducklings, or other poultry.
Never eat where poultry live or roam.
When cleaning any equipment or materials used to raise or care for poultry, stay outside.
People infected with salmonella can have diarrhea, fever, and stomach cramps that usually lasts four to seven days. Most people recover without treatment.
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Maine Legalizes Assisted Suicide
Maine has become the eighth state to legalize medically assisted suicide.
"It is my hope that this law, while respecting the right to personal liberty, will be used sparingly," Gov. Janet Mills, told the Associated Press.
Under the law, doctors can prescribe a lethal dose of a drug to terminally ill patients and it will not be legally a suicide.
The bill had failed to pass in a state referendum and also a number of times in the state Legislature. It finally passed by one vote in the House and a narrow margin in the Senate.
The new law was praised by Staci Fowler, who took on the fight for the law in honor of her friend Rebecca VanWormer, the AP reported.
VanWormer died of breast cancer in 2017 and had pressed for such a law for years before her death.
"This is what she wanted," Fowler told the AP. "And now everybody has the option that she didn't have."
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New York Halts Religious Vaccine Exemption
Reacting to an ongoing measles outbreak, New York state has eliminated the religious exemption for not vaccinating children.
Most school systems require proof of vaccination to allow a child to attend class, but by claiming their religion doesn't allow vaccinations, parents could duck the requirement, the Associated Press reported.
Not everybody was happy about the new law. Parents of hundreds of unvaccinated kids protested in Albany claiming the law violated religious freedom.
"People came to this country to get away from exactly this kind of stuff," Stan Yung, a Long Island attorney, told the AP.
Those who supported the bill said that religion shouldn't trump science. In 1905, the U.S. Supreme Court said states can enforce vaccination laws.
When the bill was debated in the Assembly, members reminded their colleagues of the deadly disease prevented by vaccines.
"I'm old enough to have been around when polio was a real threat," said Assemblywoman Deborah Glick, D-Manhattan. "I believe in science.... Your personal opinions, which may be based on junk science, do not trump the greater good," the AP reported.
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How to Get the Jiggle Out: 3 Exercises to Tone Your Upper Arms

 Getting your upper arms in shape is a worthy ambition in any season, and the triceps are the muscles to target for a sleek look.
Toning them can be a challenge, but the "triceps extension" and variations of this key strength training move make up the core of an effective training routine.
For the basic triceps extension, lie flat on a mat with knees bent and hip-width apart or on a weight bench with feet flat on the floor in front of you. Hold the ends of a dumbbell or the handles of a weighted ball with both hands. Lift arms straight up to the ceiling. From this position, and without moving the upper arms, bend elbows to bring the weight toward your forehead until arms make a 90-degree angle. With control, straighten arms. Repeat.
For the first variation, from the same starting position, hold a dumbbell in each hand. Raise arms straight up to the ceiling, with palms facing away from you. Again, moving only your forearms, bend elbows until upper arms and forearms make a 90-degree angle. With control, straighten arms, but before you lower them again, rotate your wrists so that palms are facing you as you lower your forearms. Straighten arms and continue to reverse the position of your wrists with each rep.
For the second variation, from the same starting position and with a dumbbell in each hand, raise arms straight up to the ceiling. Again, moving only your forearms, bend elbows to lower the weights to the floor on either side of your head. Avoid moving your shoulders. Straighten arms to return to start.
For each exercise, aim for three sets of up to 15 reps each. Start with a weight that allows you to do eight reps per set in good form. Once you can complete 15 reps per set before reaching muscle failure, increase the weight.

'Double-Edged Sword': Lung Cancer Radiation Rx May Raise Heart Attack Risk

 Radiation treatment for lung cancer can help extend lives, but it might also raise a patient's odds for heart attacks and heart failure, a new study shows.
Many patients may have no choice but to accept the risk: For about half of people diagnosed with the number one cancer killer, radiation remains the only viable treatment, the research team noted.
"This is alarming data -- to think that one in 10 of the patients I'm treating for this type of cancer will go on to have a heart attack or other major cardiac event," senior author Dr. Raymond Mak, a thoracic radiation oncologist at the Brigham and Woman's Hospital in Boston, said in a hospital news release.
"These cardiac events are happening earlier and more often than previously thought," he added. "More patients are living long enough to experience this risk of cardiac toxicity. We need to start paying attention to this and working together with cardiologists to help these patients."
One expert unconnected to the study agreed that patients face heart risks, but in many cases it's tough to tease out why.
"Although the radiation that we give to patients for lung cancer is of course directed mainly at their tumor, there may be overlap in the beams of radiation that affect the heart," explained Dr. Adam Lackey. He directs thoracic surgery at Staten Island University Hospital in New York City.
But, "since smoking remains the most potent risk for lung cancer, and smoking also is a risk factor for heart disease, many lung cancer patients have a diagnosis of or are at risk for heart disease, as well," he noted.
In the new study, Mak and his colleagues looked at data on 748 lung cancer patients who were treated with radiation therapy. After treatment, about 10% of the patients did go on to have a heart attack or heart failure, where the heart's pumping efficiency is compromised.
While the study couldn't prove cause and effect, Mak's team found that the higher the radiation dose, the greater the risk of having a heart problem. The rate of cardiovascular events was especially high for people who didn't have heart problems before their treatment, the investigators noted.
What to do? Mak's group believes that using the lowest possible dose of radiation is the best course to take.
"When possible, we should be thinking about ways to minimize cardiac radiation dose," Mak said. "Recognizing that we may not always be able to do that, we're now collaborating with our cardiology colleagues to explore early interventions to help mitigate the effects of cardiac injury from radiation therapy."
Dr. Len Horovitz is a pulmonary specialist at Lenox Hill Hospital in New York City. Reading over the findings, he agreed that radiation therapy for lung cancer is one of medicine's "double-edged swords."
"While the mechanism of damage is unclear, it is apparent that embarking on a course of radiation for lung cancer may cause cardiac damage," Horovitz said.
For his part, Lackey agreed that, "as we have pushed the limits of what types of radiation -- and how strong of a dose we give patients who have lung cancer -- it is important to recognize the long-term effects that this radiation may have for lung cancer survivors."
The report was
ed June 10 in the Journal of the American College of Cardiology.

Later School Start Time Pays Off With More Attentive Students

 It's a no-brainer -- not getting enough sleep makes it harder for kids to learn. And a new study finds that starting school later in the morning can help teens be more alert during the day.
In 2017, the Cherry Creek School District in Greenwood Village, Colo., changed start times from 8 a.m. to 8:50 a.m. for its middle school students and from 7:10 a.m. to 8:20 a.m. for high school students.
That change gave middle schoolers 31 more minutes of sleep, while high schoolers got 48 minutes more, the researchers said.
"Biological changes in the circadian rhythm, or internal clock, during puberty prevents teens from falling asleep early enough to get sufficient sleep when faced with early school start times," said lead researcher Lisa Meltzer. She's an associate professor of pediatrics at National Jewish Health in Denver.
"This study provides additional support that delaying middle and high school start times results in increased sleep duration for adolescents due to later wake times," she added in a news release from the American Academy of Sleep Medicine.
For the study, more than 15,000 students completed online surveys about their sleep habits before and after the new starting time.
Besides getting more sleep, students said they were more alert for homework.
Before the time change, 46% of middle schoolers and 71% of high schoolers said they were too tired to do homework. After the change, that dropped to 35% and 56%, respectively.
At the same time, scores that measured academic engagement rose significantly.
"The study findings are important because getting enough sleep is critical for adolescent development, physical health, mood, and academic success," Meltzer said.
The report was
ed online recently in the journal Sleep, and the findings were presented Wednesday at a meeting of the American Academy of Sleep Medicine in San Antonio, Texas.

Thursday, June 13, 2019

Sugary Sodas Still Popular, But Warnings, Taxes Can Curb Uptake

 Eight of every 10 American households buys sodas and other sugary drinks each week, adding up to 2,000 calories per household per week, new research shows.
To put that in perspective, 2,000 calories is equal to the recommended average caloric intake for an adult for an entire day.
With the obesity epidemic continuing for Americans young and old, it's still tough to get the message out that sugary drinks may prove lethal over time, one expert said.
"It startles me how many patients of mine state that they 'understand that soda is not good' -- however, they continue to drink for the pleasure principle," said Sharon Zarabi. She directs the bariatric program at Lenox Hill Hospital in New York City.
However, Zarabi added, "when you actually sit down and spend time explaining the contribution of excess calories, inflammatory markers, elevated triglycerides, addictive properties, weight gain, etc., you paint a different picture."
The new study was led by Stephen Onufrak, of the U.S. Centers for Disease Control and Prevention. The report -- and a number of related studies -- were to be presented Sunday at the annual meeting of the American Society for Nutrition, in Baltimore.
In the soda consumption study, the CDC team looked at data from a government survey of the weekly grocery-buying habits of nearly 5,000 U.S. households, compiled in 2012.
The findings showed that on any given week, 77% of households bought sodas, sweetened juices, sports drinks or other sugary beverages. In about half of cases (47%), these drinks were bought for consumption at home.
On average, households consumed more than 2,000 calories' worth of sugary drinks each week -- about 1,200 calories while at home and nearly 760 calories outside the home, the CDC team said. Sodas were by far the leading calorie source, with 678 calories' worth consumed at home and another 472 calories taken in outside the home.
And as the number of people living in a home increased, so did the uptake of high-calorie, sugary drinks, the report found.
Healthy warnings
What can and should be done to help lower these numbers? Two innovations -- bold health warnings on drink labels and "soda taxes" -- do seem to help, other studies presented at the same meeting showed.
In one study, researchers led by Anna Grummon, of the University of North Carolina (UNC) at Chapel Hill, gave 400 soda-loving adults $10 and asked them to spend it in a mock convenience store.
One group of shoppers were sent to a store where the sodas had prominent health warnings emblazoned on their labels; while the other group went shopping in a store where sodas didn't have such labeling.
The result? Folks sent to the "warning labels" store bought an average of about 110 calories' worth of sugary beverages, compared to 143 calories among shoppers sent to the store without such warnings.
The researchers concluded that implementing policies that require sugar-sweetened beverages to carry health warnings could discourage sugar-sweetened beverage consumption.
In another study, Grummon's group conducted a computer-simulation study on how putting health warnings on sugary beverage labels might affect the obesity epidemic. Her team estimated that such a move "could reduce average sugar-sweetened beverage intake by about 25 calories per day and total calorie intake by about 30 calories per day."
Over five years, that would be "equivalent to losing about 4 pounds for the average adult," the UNC team said.
Taxing calories away
Finally, there's the notion -- already legislated in Philadelphia, Berkeley, Calif., and other U.S. cities -- of the "soda tax."
In another computer-modeling study, a team led by Christina Griecci of Tufts University in Boston estimated that a 1 cent tax per ounce on every sugar-sweetened beverage could prevent around 17,000 new obesity-associated cancer cases and 10,000 cancer deaths.
The tax would also save an estimated $2.4 billion in lifetime expenditures for cancer care nationwide, Griecci's group reported.
Another Tufts computer-modeling study, this time led by researcher Yujin Lee, found that a tax on sugar-sweetened beverages would work best if the amount of tax went up along with the amount of sugar added.
The researchers estimated that this kind of tiered tax "could prevent 460,000 cardiovascular events and 60,000 cases of diabetes, and save $28 billion in health care costs" over a decade.
Zarabi agreed that taxes and label warnings are what's needed.
"Sodas have absolutely no nutritional value and imposing a tax may have people thinking twice about their health," she said.
But another nutrition expert disagreed.
"The idea that sugar taxes will be the solution is not only short-sighted, but places the largest financial burden on low-income people, as well as discounts the multifaceted reasons for our poor eating behaviors," said registered dietitian Michelle Milgrim, who manages employee wellness at Northwell Health in Lake Success, N.Y.
"Stress, emotions, family and cultural influences, cost and convenience are among just some of the reasons why people eat the way they do," Milgrim believes. So, better food labeling, plus education on nutrition that is "early and ongoing" are the real keys to solving the obesity problem, she said.
Because all of these studies were presented at a medical meeting, their findings should be considered preliminary until
ed in a peer-reviewed journal.

How to Put Limits on Your Family's Screen Time

 While kids get some benefit from using digital and social media, such as early learning and exposure to new ideas, too much of it can negatively affect their health, sleep and eating habits, and even their attention span.
But ruling out all media usage isn't the answer either.
An approach suggested by the American Academy of Pediatrics can help you strike the right balance. It involves writing up a family media use plan that everyone agrees on and follows.
The idea is for parents and children to adapt Academy-recommended guidelines on screen time, including TV, cellphones, computers, tablets and even smartwatches.
This will include deciding on screen-free areas around the house such as the dining room, time limits on use, what time gadgets need to be turned off -- and even where to charge equipment.
It's key for restorative sleep for all family members that no one sleep with any devices in their bedrooms and all use should stop at least one hour before bedtime. A family plan should include all key lifestyle habits, from getting an hour of exercise every day to getting the age-appropriate hours of sleep.
You can create your own schedule or fill out the "Family Media Use Plan" on the Academy's website. It lets you plug in your kids' daily activities and determine how much time is available for media use. Whatever format you use, update it periodically to reflect any changes in your family's schedule and your children's ages and needs.

How to Get the Jiggle Out: 3 Exercises to Tone Your Upper Arms

 Getting your upper arms in shape is a worthy ambition in any season, and the triceps are the muscles to target for a sleek look.
Toning them can be a challenge, but the "triceps extension" and variations of this key strength training move make up the core of an effective training routine.
For the basic triceps extension, lie flat on a mat with knees bent and hip-width apart or on a weight bench with feet flat on the floor in front of you. Hold the ends of a dumbbell or the handles of a weighted ball with both hands. Lift arms straight up to the ceiling. From this position, and without moving the upper arms, bend elbows to bring the weight toward your forehead until arms make a 90-degree angle. With control, straighten arms. Repeat.
For the first variation, from the same starting position, hold a dumbbell in each hand. Raise arms straight up to the ceiling, with palms facing away from you. Again, moving only your forearms, bend elbows until upper arms and forearms make a 90-degree angle. With control, straighten arms, but before you lower them again, rotate your wrists so that palms are facing you as you lower your forearms. Straighten arms and continue to reverse the position of your wrists with each rep.
For the second variation, from the same starting position and with a dumbbell in each hand, raise arms straight up to the ceiling. Again, moving only your forearms, bend elbows to lower the weights to the floor on either side of your head. Avoid moving your shoulders. Straighten arms to return to start.
For each exercise, aim for three sets of up to 15 reps each. Start with a weight that allows you to do eight reps per set in good form. Once you can complete 15 reps per set before reaching muscle failure, increase the weight.

CDC Opens Emergency Operations Center for Congo Ebola Outbreak

 The United States is stepping up its response to a historic outbreak of Ebola in two African nations.
The U.S. Centers for Disease Control and Prevention activated its Emergency Operations Center Thursday to assist in the government's response to the second-largest outbreak of Ebola on record.
The announcement came as the deadly virus crossed the border from the eastern Democratic Republic of the Congo (DRC) to Uganda, where two have died.
The outbreak, which has claimed more than 1,400 lives, is the biggest in the Congo's history. Its spread to Uganda adds to the threat of a larger outbreak, the CDC said.
The CDC's latest action is part of the overall government response, and CDC experts will be working with other agencies in the Congo.
"Through CDC's command center we are consolidating our public health expertise and logistics planning for a longer term, sustained effort to bring this complex epidemic to an end," CDC Director Dr. Robert Redfield said in an agency news release.
The outbreak is centered in a region where armed conflict and other violence complicates the public health response, the CDC said. It has been helping curb the outbreak since last year.
The CDC announcement came as a World Health Organization committee prepared to meet Friday to consider declaring a global health emergency. Such declarations typically boost attention and donor funding, according to the Associated Press.
The Ebola virus spreads quickly through close contact with bodily fluids of those infected and up to nine out of 10 cases are fatal.
The CDC emphasized that Ebola is not likely to spread around the world, and the announcement doesn't mean that its threat to the United States has increased.
As such, the CDC's guidelines for travel to the Congo or groups sending aid to fight the epidemic remain unchanged.
Those guidelines advise travelers to seek medical care immediately if they develop fever, headache, body aches, sore throat, diarrhea or vomiting, weakness, stomach pain, rash or red eyes during or after travel.

Health Highlights: June 11, 2019


Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Texas Raises Age to Buy Tobacco Products to 21
Governor Greg Abbott of Texas has signed a law raising the age to buy tobacco products -- including cigarettes and e-cigarettes -- to 21.
The one exception to the law, which goes into effect in September, is an exemption for people in the armed forces, CNN reported.
"Delaying the age when young people first begin to use tobacco -- the leading cause of preventable death -- will reduce the risk they will develop a deadly addiction," Shelby Massey with the American Heart Association told CNN affiliate KXAN-TV.
Texas is the latest state to raise the age to by tobacco to 21. Other states include Illinois, Hawaii, California, New Jersey, Oregon, Maine and Massachusetts, and laws will take effect this year in Arkansas and Virginia.
Advocates of raising the age to purchase tobacco products also hope to stem the increase of e-cigarette use among teens.
"The skyrocketing growth of young people's e-cigarette use over the past year threatens to erase progress made in reducing youth tobacco use. It's putting a new generation at risk for nicotine addiction," CDC director Robert Redfield, told CNN.
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Opioid Drug Company Insys Files for Bankruptcy
On Monday, opioid maker Insys Therapeutics filed for chapter 11 bankruptcy only days after agreeing to an $255 mullion settlement with the federal government for its marketing practices.
The announcement doesn't mean the company is closing its doors. Rather, it's looking for some breathing room as it figures out how to pay its creditors, including the government, The New York Times said. The provisions of a chapter 11 bankruptcy allow the company to stay in business as it reorganizes itself.
The specific drug in question is Subsys, an under-the-tongue spray, approved only for cancer patients already on round-the-clock opioids.
Last month, a federal jury in Boston found Insys and its founder, John Kapoor, along with the company's top executives, guilty of fueling sales of Subsys by bribing doctors and misleading insurance companies.
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Asbestos Found in Claire's JoJo Siwa's Makeup Kit Sparks Recall
Claire's stores has initiated a recall of its JoJo Siwa's Makeup Kit after the U.S. Food and Drug Administration found asbestos fibers in the kit's eyeshadow, CBS reported.
The recall is for Batch/Lot No. S180109. Although the product has been pulled from store shelves, consumers may have it at home. The kit includes eyeshadow, two lip glosses and nail polish and was sold nationwide.
Another recall is in effect for the Beauty Plus Global Contour Effects Palette 2, Batch No. S1603002/PD-C1179, which is also tainted with asbestos.
Consumers who have these products are advised to stop using them. Both kits can be returned to Claire's stores for a full refund.
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AHA News: How to Have a Heart-Healthy Pregnancy Before You Even Conceive


TUESDAY, June 11, 2019 (American Heart Association News) -- Taking good care of your health, especially your heart, is important during pregnancy. But preconception care – the care you get before becoming pregnant – can be just as critical for both mom and baby.
"There are demands that get placed on the heart during pregnancy," said Dr. Maria Sophocles, an OB-GYN and medical director of Women's Healthcare of Princeton in New Jersey. "Women contemplating pregnancy should optimize their cardiac health before conception to prepare for this."
That's true for every woman who gets pregnant. But good heart care prior to conception is particularly important for those who have conditions such as obesity, diabetes, high blood pressure or familial hypercholesterolemia, an inherited condition that keeps cholesterol levels high and increases cardiovascular risk.
These conditions, Sophocles said, also put women at higher risk for pregnancy complications, from pre-term labor to a potentially fatal condition called preeclampsia, characterized by high blood pressure and protein in the urine. It can harm the placenta and the mother's kidneys, liver and brain.
"If you're a diabetic going into your pregnancy, you're at higher risk for complications," she said. "And, it's additive. If you're a diabetic and a smoker and have high blood pressure, each of those things makes it that much harder for the heart to pump extra blood through your circulatory system."
Cardiovascular disease is now the leading cause of maternal death during pregnancy and the postpartum period, constituting 26.5% of pregnancy-related deaths, according to the American College of Obstetrics and Gynecologists. Women of color and those with lower incomes experience the highest mortality rates.
In May, ACOG issued guidance to doctors on screening, diagnosing and managing heart disease from prepregnancy to the postpartum period, emphasizing the need to assess women for heart disease before they become pregnant.
That doesn't mean a woman with cardiovascular risk factors shouldn't get pregnant, said Dr. Melinda Davis, assistant professor of cardiovascular medicine and part of a maternal heart team at the University of Michigan. But it does mean taking extra precautions.
"If a woman has any medical conditions, she should make sure they are optimized prior to pregnancy, so she can be in the best health possible and also be aware of any potential risks that could arise, for both mom and baby," she said.
Good preconception heart care involves managing weight, cutting back on alcohol and not smoking, Sophocles said.
Weight should be managed by eating plenty of fruits, vegetables and fiber and regular exercise, "even if that's just walking 20 minutes a day," Sophocles said. "The human body can adapt seamlessly to pregnancy, but if you are out of shape or a smoker, you will struggle more with pregnancy-related changes to your cardiovascular health."
Women with heart conditions or cardiovascular risk factors should consult with both a cardiologist and an OB-GYN before trying to get pregnant to find out what precautions they might need to take, Davis said. For example, a woman at risk for preeclampsia might be counseled to take baby aspirin or blood pressure-lowering medication if she is not currently doing so.
It's also important to discuss with a health care provider any medications you are taking to ensure they don't pose a risk to the fetus, she said.
Experts also cite the rising age of first-time mothers as one factor in the increase in maternal mortality in the United States, where pregnant women have a higher risk of death than in any other industrialized nation.
A growing number of women in the United States are waiting until they are well into their 30s or even their 40s to have children.
"Women who are older at the time of pregnancy may be more likely to have other medical conditions, such as high blood pressure or diabetes," Davis said.
Reviews of maternal deaths in Illinois and California found that 1 in 4 deaths could have been prevented. Davis co-authored a recent perspective article about the need for a new field of "cardio-obstetrics" that would involve women with high-risk pregnancies having their care managed by a team that includes cardiology, maternal-fetal medicine, obstetrics, anesthesiology and nursing.
"If you have heart disease, you should already be under the care of a cardiologist, and this pregnancy needs to be co-managed," Sophocles said. "Don't just check in with your OB-GYN and hope everything goes well."

Bones Help Black People Keep Facial Aging at Bay

 Why do so many black adults continue to look youthful as they age?
A new study says it's in their bones.
Researchers found that the facial bones of black adults retain a higher mineral content than those other races, which makes their faces less likely to reflect their advancing years.
The new study is the first to document how facial bones change as black adults age, and may help guide plastic surgeons' work.
"It is important for plastic surgeons to understand how the facial aging process differs among racial and ethnic groups to provide the best treatment," said study author Dr. Boris Paskhover. He is an assistant professor at Rutgers New Jersey Medical School, in Newark.
For the study, his team looked at medical records of 20 black adults from 1973 and 2017. The study patients had at least two face scans taken 10 years apart.
Although all of the faces changed over time, they showed only minor changes, compared to similar studies on the aging white population.
"This finding reflects other studies that show black adults have higher bone mineral density, decreased rates of bone loss and lower rates of osteoporosis as compared to the general population," Paskhover said in a university news release.
Facial aging results from a combination of changes to the skin, muscle, fat and bones.
As 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
ed online recently in JAMA Facial Plastic Surgery.

Can Playing a Sport Foster Better-Adjusted Kids?

 Getting a young child involved in organized sports may have a mental health payoff down the line, according to a new study.
Kids who had participated in athletic programs between ages 6 and 10 had less emotional distress, anxiety and shyness by age 12. They were also less likely to suffer from social withdrawal, researchers found.
"The elementary school years are a critical time in child development," said lead study author Frederic Briere. He's a professor of psycho-education at the University of Montreal.
"The results revealed that children who participated [in organized sports] consistently from ages 6 to 10 showed fewer instances of those factors at age 12 than their counterparts who did not engage in physical activity in a consistent way," Briere said in a university news release.
The researchers analyzed data on children between ages 6 and 10 who were born between 1997 and 1998 in Quebec, Canada.
Mothers reported their young child's involvement in structured sports activities during that time. And teachers commented on the child's emotional status when they reached age 12. The study only found an association rather than a cause-and-effect link.
"This involvement appears to be good on a socio-emotional level and not just because of physical benefits," Briere added. "Being less emotionally distressed at the juncture between elementary and high school is a priceless benefit for children, as they are about to enter a much larger universe with bigger academic challenges.
"This research," he noted, "supports current parental guidelines promoting children's involvement in physical activity."
The findings are in the May issue of the journal Pediatric Research.

Zerbaxa Approved for Hospital-Acquired Bacterial Pneumonia

 Zerbaxa (ceftolozane and tazobactam) has been approved for a new indication to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older, the U.S. Food and Drug Administration announced yesterday.
In 2014, the FDA first approved Zerbaxa for treating complicated intra-abdominal infections and urinary tract infections. According to the manufacturer's prescribing information, Zerbaxa is administered in a recommended dosage regimen of a 1.5-g injection every eight hours by intravenous infusion for one hour. Treatment duration should be based on the infection site and severity and the patient's progress.
In a multinational, double-blind study of 726 patients hospitalized with HABP/VABP who were injected with Zerbaxa or another antibacterial drug, researchers found similar mortality and cure rates between the two drugs. The most commonly reported adverse reactions among patients treated with Zerbaxa included elevated liver enzyme levels, renal impairment or failure, and diarrhea.
The FDA notes that Zerbaxa should not be used in patients known to have serious hypersensitivity to the drug's components or to piperacillin/tazobactam or other antibacterial drugs in the beta lactam class.
Approval of Zerbaxa for this new indication was granted to Merck and Co.

Sunday, May 19, 2019

Why male pills are important for men?

Why male pills are important for men?
If you have not lived in a cave for the past ten years, you are no doubt aware of the concept of male enhancement pills. Male improvement was a relatively unknown concept until Viagra super pills appeared. Pfizer not only helped millions of men with their revolutionary product, but they also increased awareness of the sexual problem of men. It also increased awareness of the concept and the need for natural male pills to enhance. Today in North America literally hundreds of natural male pills are sold. In European countries and in Asia, natural products for men are as common as aspirin or cough syrup.


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Breastfeeding brings

The benefits of breastfeeding seem to go far beyond maternity: new research suggests that it may reduce the risk of heart disease in women as she gets older.



And the longer a woman breastfeeds, the lower the risk.

In the study, researchers evaluated the health of the heart and blood vessels in postmenopausal women, as well as the history of their breastfeeding.

After taking into account other factors that affect heart health, such as body weight, age, cholesterol and smoking habits, the researchers concluded that women who are breastfed have cardiovascular diseases and risk factors for cardiovascular diseases. much lower.

According to a study presented on Friday at the annual meeting of the European Society of Endocrinologists in Lyon, France, this reduction was greatest for women who were breastfeeding for a longer period of time. Such a study is considered preliminary until it is published in a peer-reviewed journal.

“These data indicate that breastfeeding reduces the risk of heart disease in women. However, this is only an associative study; Now we are interested in finding out the reasons underlying this protective effect, ”said study author Irene Lambrinodaki, professor at the University of Athens in Greece.

“If we can show a causal relationship with a protective effect, women will have another reason to feed their children, besides the already documented benefits of breastfeeding, for the short-term and long-term health of theirs and their children,” Lambrinodaki told the news at the meeting. release.

Previous studies have shown that breastfeeding reduces the risk of postpartum depression and the risk of certain types of cancer in women and can help mothers maintain a healthy body weight and regulate blood sugar levels.

These health benefits are probably associated with higher levels of the hormone prolactin in nursing mothers, the researchers said.

Recent studies show that prolactin reduces the risk of diabetes, which is a major risk factor for cardiovascular disease, the leading cause of death among women worldwide.

Currently, researchers are studying the molecular mechanisms of the effect of prolactin on blood sugar levels. This study may reveal new goals in the prevention of cardiovascular diseases for all, not just for lactating women.