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Sarasota, FL, May 26, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire-- CyberloQ Technologies, Inc. (OTC PINK: CLOQ) of Sarasota, Florida is engaging a panel of industry players to assist CyberloQ in marketing their one-of-a-kind patented platform for preventing cyber fraud.

Chris Jackson, Chief Executive Officer stated, After several years of development and testing we are now highly confident that we have a unique solution for credit unions, banks and other institutions to substantially eradicate credit and debit card transaction fraud.

The CyberloQ platform is proactive, not reactive. Choose your metaphor: implementing the CyberloQ system is very much like having a sentry outside your door to prevent fraudulent activity before it can begin; implementing CyberloQ is the equivalent of the Card Issuer donning a bullet-proof vest; implementing CyberloQis opting for preventative medicinerather than treatment of an established disease.

And such prevention is a game-changer when you consider the financial and reputational damage that the occurrence of such fraud inflicts on both the bank and the holder of the card.

Given its extensive opportunity for positive impact, said Jackson, we are assembling a world class team of market-savvy individuals with deep inside knowledge of key financial markets where CyberloQ can easily be adopted and integrated into any organizations existing cyber-security best practices.The primary focus of this newly formed team of advisors will be assist us in capturing these opportunities.

About CyberloQ Technologies Inc.

CyberloQ Technologies Inc. (OTC: CLOQ) secures clients sensitive data and valuable information with a patented, aggressive and proactive approach. CyberloQ's advanced authentication algorithms, private blockchain and industry-leading geofencing capabilities give clients complete control of their data for real-time authentication and dedicated fraud protection. For more information, visithttps://CyberloQ.com/.

About TurnScor

TurnScor helps consumers fix their credit scores by helping them apply the Fair Credit Reporting Act to verify the accuracy of their credit reports across all three agencies. TurnScor removes the need for consumers with no or low credit scores to work with attorneys and other firms to build or repair their credit. For more information, visithttps://turnscor.com/.

Forward-Looking Information

This news release contains "forward-looking statements" which are not purely historical and may include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities and words such as "anticipate", "seek", intend", "believe", "estimate", "expect", "project", "plan", or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects, the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations regarding the use and development of cannabis-based products. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission. For more information, please visitwww.sec.gov.

CLOQ Contact:Chris JacksonTel: 1.612.961.4536Email:info@cyberloq.com

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Dr. David Katz, Preventive Medicine Specialist & True Health Initiative President, joined Yahoo Finance to discuss the latest on covid-19.

ADAM SHAPIRO: Let's bring in Dr. David Katz. He is a Preventative Medicine Specialist, also the President of the True Health Initiative. Good to have you here. I want to start with that Moderna news. How quickly do you think it could be before we see, perhaps, teenagers and younger getting the Moderna vaccine?

DAVID KATZ: Yeah, good to be with you. I think it really is more a matter of enthusiasm for vaccine uptake in that population than it is a matter of availability. I think the current administration has done a good job making vaccines available and deploying them. And from what I'm hearing from colleagues and various access points to public health, I'm not finding that a lot of people eager to get the vaccine are having difficulty accessing it.

I think the slowdown is mostly related to the fact that people eager to be vaccinated have been. I'm not sure how most parents are feeling about vaccinating their teens and tweens. And I think that that case needs to be made. I think we'll have particular difficulty in communities that trust public health, trust science a bit less. So I think we need an effective communication, along with the distribution of vaccine.

I can't say. I don't-- if it were a simple matter of logistics, supply chain, do we have the vaccine, can people access it-- it would be a simpler projection. But a lot of this really comes down to attitude, vaccine resistance. So I'm not sure how the average person feels about vaccinating younger people who obviously are at lower risk of severe reactions to the virus.

That said-- and this is a decisive issue for me-- as a physician, as a public health professional, and as a parent of now five grown kids, but I've been in this situation, the vaccine is clearly much safer even for young people than the virus is. So it would be a really good idea to get vaccinated if you are in the newly eligible age group. But I don't know how that message is going to go over.

Story continues

SEANA SMITH: Dr. Katz, we heard from New York City this week that they will no longer be having remote learning in the fall. Everyone will be going back in-person. To those parents who have kids that will then be returning to school here in the fall, should they feel 100% safe in sending their kids? Should they have, I guess, any hesitation at all?

DAVID KATZ: Seana, good to see you. They cannot feel 100% safe, but that's simply because, Seana, their kids were not 100% safe before the pandemic. I think one of the critical issues here is that the pandemic has invited risk distortion in every direction. So there are many people who've underestimated the threat of the virus, there are many people who have overestimated the threat of the pandemic, and now there's the notion that having experienced risk associated with SARS-CoV-2, we can only go back to the world when the risk of something bad happening to us or anybody we care about is zero.

It was never zero before, right? There's risk in putting your kid on a school bus. So, no, they should not be hesitant. And the risks, essentially, are at that level. They fall below the threshold where they are in the background. I wish the risk to all children of anything bad happening were zero. I do. But that's a perfect world, and we don't live in a perfect world, and miscellaneous bad things happen to people every day in this country of 330 million people.

The risks of COVID affecting kids, given where we are in the pandemic, given the approach to herd immunity, given the level of immunization is extremely low. There should be no hesitancy about sending kids back to school.

ADAM SHAPIRO: But when we see these surges in different parts of the world-- I mean, we got the news out of Japan that the hospital system is just almost at the point of crumbling-- should they cancel the Olympics?

DAVID KATZ: You know, my heart goes out to the athletes, Adam. The Olympics are such a rarefied thing, right-- so essentially, you're training your whole life and aiming to peak at just the right time. From a public health perspective, given what's going on in Japan, given that the latest news there is only about 2% of the population has been immunized, this looks to me like a super-spreader event.

And if vulnerable people who are not immune come from all over the world and take the virus back, we could have outbreaks in many parts of the world again. So it's a bad idea from a public health perspective to have mass congregation in a part of the world where the virus is spreading at a pretty high level and rates of immunity are low. Obviously, it's well above my pay grade to decide whether or not to cancel the Olympics, but again, looking at this through the lens of public health, it's a dangerous situation for sure.

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Half of all U.S. adults are now fully vaccinated against covid-19 - Yahoo Finance

Lauren Villagran, El Paso Times Published 3:30 p.m. MT May 24, 2021 | Updated 9:26 a.m. MT May 25, 2021

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Chihuahua state health authorities began a second round of public vaccinations Monday in Jurez, inoculating people age 50 to 59 with a Pfizer shot.

Hundreds of people began lining up in cars or on foot at five vaccine distribution sitesbefore 7 a.m., including at a children's museum, baseball stadium, university campus and convention center.

State health authorities expected to apply about 30,000 first doses over four days.

Chihuahua Public Health nurse Lorena Vazquez administers COVID-19 vaccines to factory workers that were bused in to El Punto en el Chamizal during a vaccination drive for 50-to-59 year-olds on May 24, 2021.(Photo: Omar Ornelas/ El Paso Times)

Vaccines have been trickling into Jurez, as Mexico struggles to distribute the roughly 26 million doses it has secured on the global market.

More: 'The world's haves and have-nots': Global vaccine disparities on display at El Paso-Jurez border

Somemaquiladora factories sent workers to a drive-in vaccine site near the U.S.-Mexico border Monday. They arrived byruta,on the old school buses that serve as personnel transport in Jurez. Health care workers boarded the buses to administer the vaccine to the workers.

"We can't just live with the fear of this disease," said Csar Avalo Zamora, 53, who stood fifth in line, in glaring sun,to receive his first doseof the vaccine at the Indios stadium in Jurez.

"It's also a civic duty," he said, "to prevent creating more contagion."

More: A year into border restrictions over COVID-19, still no public plan for reopening

Avalo Zamora said he was worried, though, about the Jurez seniors who received a first dose of the AstraZeneca vaccine in early April. Second doses for those over age 60 haven't arrived in Jurez, nor have health authorities publicly announced a schedule for second shots.

"It's worrisome because they are the most vulnerable," he said.

Vehicles line up for COVID-19 vaccinations at El Punto en el Chamizal on May 24, 2021 as 50-to-59 year-olds receive the first dose in CIudad Juarez.(Photo: Omar Ornelas/ El Paso Times)

The state health authority is distributing the vaccine in alphabetic order. People in the designated age bracket with a last name beginning with A, B, C or D could show upMonday.

Wendyvila, deputy director of preventative medicine for the state health department, described the logistics of the distribution as "extraordinary" in a statement. Wait times were averaging 10 to 15 minutes on Monday.

"Thanks to everyone, the fact that people are respecting their time slots means that the wait time is short and the logistics are extraordinary," she said in the statement.

Remaining first doses of the Pfizer vaccine would be available on Friday to pregnant women over 18 in their ninth month of gestation, health authorities said.

Lauren Villagran can be reached at lvillagran@elpasotimes.com.

Read or Share this story: https://www.elpasotimes.com/story/news/2021/05/24/covid-19-vaccine-juarez-health-authorities-begin-pfizer-shot-residents/7416780002/

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Residents line up in Juarez to receive second round of COVID-19 vaccine - El Paso Times

Last week, Rep. Cindy Axne (IA-03) co-led the introduction of legislation to ensure every child in America has access to high-quality full-day kindergarten, a cause she originally championed in West Des Moines, Iowa when her oldest child was denied that option at their local school district.

When my oldest son was getting ready to start kindergarten, I discovered that access to full-day kindergarten in West Des Moines was determined by a lottery leaving some kids behind despite overwhelming evidence of the value of a full kindergarten education. As a mother, that wasnt something I could accept and I pushed the school district to change that, successfully securing all-day instruction for the entire district, said Rep. Axne. Now, Im joining my colleagues to push for that fix nationwide because Ive seen firsthand the benefits that our kids get from that change, and want to see it offered to the forty percent of students that dont currently have that full-day option. With my own familys experience, I will be pushing to advance this bill by telling my story, and the story of the Iowa students that Ive fought to help.

The Universal Full Day Kindergarten Act creates a grant program in which States and Tribes that apply will receive funding to carry out no-cost, high-quality, full-day kindergarten programs taught by qualified teachers. The bill would also require the Department of Education to release an annual report on the availability of full-day kindergarten across the United States.

Only 17 states and the District of Columbia require school districts to offer full-day kindergarten leaving an estimated 40 percent of kindergarten-age students without access to these critical programs.

Research has shown that full day kindergarten increases academic achievement for elementary students. Full-day kindergarten students were shown to make greater improvements in math and reading comprehension than students enrolled in half-day.

Additional advantages of full-day kindergarten include more positive social interactions, higher self-esteem, greater creativity, and more.

The positive gains for children enrolled in full-day kindergarten extend beyond just academic success. The American Journal of Preventative Medicine found that full-day kindergarten students were more likely to have long-term benefits that would improve their health over their lifetimes.

The bill was introduced with Reps. Ruben Gallego (AZ-07), Sara Jacobs (CA-53), and Ritchie Torres (NY-15).

As we recover from the COVID-19 pandemic, it is more important than ever to make sure that all students, no matter where they live, have access to high-quality education and start their academic experiences on equal footing,said Rep. Gallego.I am proud to reintroduce the Universal Full-Day Kindergarten Act, the first-ever legislative effort in the House to achieve universal full-day Kindergarten. Not only is ensuring access to full-day Kindergarten the right thing to do to set students up for success, it also would increase economic opportunities for parents and families and provide a lifeline for underfunded and low-income school districts across the country. I am grateful to my colleagues Rep. Jacobs, Rep. Axne, and Rep. Torres for joining me to make access to Kindergarten a reality for all American families.

This bill is endorsed by the National Education Association.

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Rep. Axne Introduces Bill to Expand Full-Day Kindergarten Nationwide - Cindy Axne

In many areas, Intermountain Healthcare and University of Utah Health are competitors. But recently, the two most prominent health care organizations in the state have come together for a very important reasonyour health.

For centuries, medicine was pretty straightforward: you go to the doctor when youre sick to receive a diagnosis and treatment. But a new movement is changing the way doctors and other providers look at medicine. Its called population health, and it means physicians are now finding new ways to meet their patients medical needs by looking at all aspects of life in order to provide the most comprehensive care. Its all about preventing illness, rather than only treating people when they get sick.

Providers and caregivers across our state provide exceptional and compassionate care to Utahns when they are ill, says Marc Harrison, MD, president and CEO of Intermountain Healthcare. But we know that keeping Utahns healthy needs to be a critical component in our delivery of health care. The pandemic has put that in sharp focus.

Intermountain Healthcare will invest $50 million spread over multiple years to partner with U of U Health on a new medical education program at the Us School of Medicine. The Population Health Student Scholars Program will be the first of its kind in the United States.

Designed to train future physicians to consider a persons immediate medical needs along with their life circumstances, the program centers the social determinants of health, which play a key role in preventing illness and injury. These social determinants of health include racism, housing, neighborhoods, transportation, food security, personal security, and the opportunity to have meaningful work.

Heres a simple way to think of it. Suppose a patient has diabetes and needs insulin. But what if that patient doesnt have refrigeration in his or her home to keep that insulin viable? Under a population health model of health care, physicians will be now asking patients questions like: Do you have a refrigerator to store your insulin for your diabetes? Can you afford healthy food? Are you getting daily exercise? Can you walk safely around your neighborhood? Can you get in to see a doctor when you need to?

This approach to patient care has the potential to advance the doctor-patient relationship in many positive ways, says Michael L. Good, MD, CEO of University of Utah Health, executive dean of U of U School of Medicine, and senior vice president for Health Sciences. It could lead to a metamorphosis of medical care that better addresses the emerging social and health needs of patients in the 21st century.

While better health outcomes are optimal reasons to move to a population health program, another benefit is the financial savings for Utahns. For example, a Utahn suffering a heart attack with complications will run up an average bill of $39,000. He or she might recover completely but not be 100 percent the same after the cardiac event. A heart attack is considerably less likely to occur, though, if one controls blood pressure, exercises regularly, maintains a healthy weight, and eats wisely. In that case, the $39,000 could be applied towards even more preventative measures, such as a gym membership and access to healthy food.

As part of this new partnership, educators at the School of Medicine are already developing a curriculum for medical students around these concepts. As students enter their clinical rotations, they will spend longer periods of time in communities, which will help them to see things even more through a patients lens.

Im proud that these two organizations are leading the nation in developing a cadre of physicians specifically prepared to deliver this innovative approach to communities, Harrison says. Working with patients holistically will improve the health of all, most notably the vulnerable and underserved, who are too often left behind. This is the future of health care.

JayBee is excited about the new facility. In some ways, working in treatment and care reminded him of sports. You dont make decisions independently. You work as a team, he says. What he came to learn was, You cant help everyone, unfortunately, but the ones you do help, patient care makes an immense difference in their lives.

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U of U Health and Intermountain Healthcare are partnering to create more inclusive training for medical stude - Deseret News

May 25, 2021

By Nate Smelle

On the edge of summer in North Hastings, we usually expect a series of returns to arrive with the season and change our routines. Right on schedule, the annual influx of blood-suckers showed up over the long weekend to make their presence known.

With the sun shining and a long list of work outdoors to be done, there was no avoiding the seasonal bloodletting that was due. Before stepping outside Sunday morning to begin the day of chores ahead, it appeared by the swarm of mosquitoes literally knocking on the door that my donation of plasma was highly anticipated.

As every resident of North Hastings knows, it doesnt take long to form a collection of homegrown remedies to help ease the the pain and suffering caused by these tiny, yet ferocious creatures. From spraying vinegar on bites to numb the itch, to planting beebalm or marigolds to keep the thirsty insects at bay; there are more than enough recipes for homemade repellents and medicines to fill a newspaper. In my experience, however, the most effective way to limit the necessary suffering caused by these winged-armies of mosquitoes and blackflies invading our airspace is the same remedy used to repel vampires garlic.

Since my time spent at the family cottage near Fenelon Falls as a child, I can recall my grandparents selling me on the value of this potent and precious plant. While there are a multitude of ways to prepare and use garlic as an eco-friendly bug spray, I have always found it most powerful when it is ingested.

For this reason, during the past month and a half I have been eating as much garlic as humanly possible. A big fan of its flavour, an extra clove or two of garlic can redefine the taste of any dish on the menu. A highly nutritious plant, garlic is known to: boost the functioning of the immune system; help fight a variety of illnesses, including the common cold; reduce blood pressure; improve cholesterol levels; contain antioxidants that are said to help prevent Alzheimers disease and dementia; improve bone health; and, detoxify the body. Complimenting its medicinal abilities, is the fact it can be grown relatively easily here in North Hastings.

Walking out my front door and into the shape-shifting clouds of insects on Sunday, I watched as the overwhelming majority of these creatures of the night caught a whiff of my exposed limbs, and decided to keep searching for another donor. Of course not everyone of the insects was deterred by my preemptive dosing of preventative medicine.

Despite my long-term strategy when it comes to biting insect control, I have made it part of my routine over the years to allow the first brave mosquito of the season to have its fill. Watching as this lucky diner began to feed, I laughed as I thought of how much energy and resources we humans invest in the avoidance of this timeless interaction. I guess His Holiness the Dalai Lama was correct when he said, If you think you are too small to make a difference, try sleeping with a mosquito.

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Often, messages that pose as health promoting are actually the opposite. There are obvious examples, like the doctor pushingan all-meat diet, or the celebrity wellness influencer telling the world that voluntarily getting stung by bees will reduce inflammation. But the more dangerous messaging is subtler, more insidious, and widespread: that fat bodies are inherently unhealthy.

In a recent New York Times article, healthcolumnist Jane Brody points out that Americans have been hit harder by COVID than most other countries, then blames this on our personal health habits, namely diet and exercise. She spends most of the column raising alarm bells about quarantine weight gain,high-calorie foods, and fatness in general.

In doing so, shes not promoting healthier habits. The truth is, health and weight are not nearly as entwined as we think they are. (Not to mentiontheres far more to Americas COVID crisis than personal health; limited access to health care, systemic discrimination and inequality, and thepoliticizationof the virus have all played huge roles.) Overemphasizing weight loss is stigmatizing and can actually be detrimental to individual health. Heres why we need to rethink this kind of messaging.

Brody talks of the many people in her life who have packed on quite a few pounds of health-robbing body fat this past year. This isan undeniably stigmatizing statement, andit also makes a major assumption that happens to be false: that gaining weight, or being naturallybigger-bodied, is inherently unhealthy. (As a journalist, Im constantly irritated that other journalists can writethings like this without citing a shred of evidence, whereas I have to add an entire paragraph with several citations every time I suggest that weight loss isnt always a helpful or realistic goal.)

Its possible to be healthy at a higher weight, just as its possible to be unhealthy at a lower one. One 2016 study in theJournal of the American Medical Associationeven found that Danish adults in the overweight BMI category actually lived the longest. Being at a higher weight is associated with a higher risk of certain diseases, yes, but that doesnt mean someone at a higher weight is necessarily unhealthy. You absolutely cannot infer health information or information about ones health behaviors based solely on their weight, says Mary Himmelstein, a researcher at the University of Connecticuts Rudd Center for Food Policy andObesity. Someone in a thin body may be completely sedentary and eat a diet of mostly processed foods and very few fruits and vegetables, while someone in a larger body might be extremely active and eat loads of nutrient-rich foods.

All of this to say:the relationship between weight and health is far too complicated to make blanket statements like health-robbing body fat. Both weight gain and weight loss can be healthful or harmful.It all depends on context.

For years, Brody has presented herself as a living example of sustainable weight lossabout 50 years ago, she lost 40 pounds in twoyears and has kept that weight off since.In this particular column, she offers up her personal eating regimen as the solution to pandemic weight gain (and fatness in general): eat a diet based primarily on vegetables, with fish, beans, and nonfat milk [as ones]main sources of protein, along with a bit of portion-controlled ice cream, the occasional burger, and daily exercise. But while that approach may seem realistic compared to all the fad diets out there, experts warn that its not as accessible as Brody makes it sound.

This I can do it, so can youattitude is out of touch with many peoples reality, says Jennifer Jackson, a dietitian based inAlbuquerque, New Mexico. The nonprofit Feeding Americaestimates that 15 percent of Americans cant afford enough nutritious food to meet their needs, and Bloomberg reported earlier this year that 12 percent of Americans live in poverty. Stressors like working multiple jobs, raising children (especially as a single parent), lacking health insurance, and living in unsafe neighborhoods alsomake prioritizing good nutrition more complicated. Health behaviors often have more to do with someones privilege than their motivation, Jackson says.

Even if everyone did eat according to Brodys recommendations, it doesnt mean we would all magically be at what Brody and the BMIscale (theheight-to-weight ratio used to group people into weight categories)deema healthy weight.Weight is not simply calories in, calories out, Himmelstein says. In fact, the bodyactively resists weight loss: a2015 literature review published in the International Journal of Obesity explains that the body generally adapts to calorie deficits by burning fewer calories, using less stored fat for energy, decreasing the fullness-signaling hormone leptin, and increasing the hunger-signaling hormone ghrelin. Its also widely accepted that theres a genetic component to obesity, and a 2018 review in Current Obesity Report outlines the significant amount of evidence suggesting that stress plays a big role in body weight as well.

Weight and weight gain are the result of our genetics, our physiology, our environment, our personal stress levels, and our behaviors,the authors write. Assuming that weight is impacted only, or primarily, by our behaviors, is wildly inaccurate. Andmaintaining weight loss long-term is even harder than acheiving it in the first place. A 2020 review in The BMJ found that while diets lead to weight loss and health improvements in the first six months, these benefits typically disappear by the one-year mark.

Relentlessly encouraging weight loss does more harm than good. Fat-shaming messaging increases weight stigma, which increases stress and inflammationwhich are negative health outcomes, says Amee Severson, a dietitian and the owner of Prosper Nutrition in Bellingham,Washington.A 2015 study in Obesity, ofwhich Himmelstein was the lead author, found that individuals who reported experiencing weight stigma had higher levels of cortisol, a stress hormone, than those who did not. Chronically elevated levels of cortisol have repeatedly been linked to an increased risk of many diseases, as outlined in this 2017 review published in the EXCLI Journal.And a 2018 study in Health Psychology, also authored by Himmelstein, found that coping with weight stigma can negatively impact both physical and mental health.

While articles like Brodys are presumably meant to promote health and healthy behaviors, they actually do the opposite. A small 2014 study of 93 college-agewomenin the Journal of Experimental Social Psychology found that thosewho saw themselves as overweight felt less capable of controlling their eating and consumed more calories after reading a weight-stigmatizing news articlethan those who read a non-stigmatizing article. A larger 2017 study in Preventative Medicine found that experiencing weight stigma as an adolescent significantly increased a persons risk for binge eating and unhealthy weight-control behaviors as an adult. And, as Severson points out, it makes bigger-bodied people less likely to seek out health care, too.

No one owes it to the world to be healthy. I think that every single person has the right to choose how important health is to them, Severson says. People are allowed to have different values, and healthy behaviors like eating nutritious foods and getting regular movement are not a moral obligation.

Health is personal, and what is considered healthy when it comes to eating and other behaviors varies between individuals. Its incredibly difficult to give effective health advice to a large audience, but theres still room for health-promoting messages in the media. We need to thinkcritically about the harmcertain messages may cause. Mandating fruits and vegetables for people who cant afford them is offensive and misguided. Demonizing fat and weight gain is demoralizing and harmful to people who live in larger bodies. We know that shame doesnt motivate healthy behaviorsand itabsolutely harms health.

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Fat-Shaming People Won't Improve Their Health | Outside Online - Outside

Americas Health Rankings reports that almost 50% of pregnant women in the U.S.did not originally intend to conceive. Furthermore, it states that over half of the nations female population will experience an unexpected pregnancy by the time they are 45 years old. The unintended conception rate (and birthrate in the U.S. in general) has actually declined in the past few years and may continue to drop, but it remains high at the moment. This is largely due to failure to utilize proper contraception or incorrect usage of it. Many younger individuals are not fully educated on the matter but continue to participate in sexual activities regardless, often acting on incorrect information gleaned from less than credible sources such as peers. Others lack access to preventative measures. There are three main options for women in this situation, keeping the baby, giving it up for adoption and getting it aborted. The latter is one many choose for a variety of reasons, including health concerns, personal trauma and life circumstances. However, some regret making this decision. There is an option for those who had a medical abortion and fall into this category calledabortion pill reversal.

A medical abortion consists of two phases in which two kinds of pills are taken, one type in each phase. The first is called mifepristone; it keeps the hormone progesterone, which helps the womb get ready for and nurture the baby, from being absorbed by taking up bonding spots on receptors so the chemical cannot attach to them. The reversal process works by essentially overriding this effect. The body is flooded with progesterone in the hope that there will be so much of it that mifepristone cant prevent all of it from being taken into the womb.

The process only works if the woman has only taken the first medicine; after the second dose of pills, it is ineffective. It is also best done as soon as possible after beginning the abortion, preferably within 24 hours. There have been a few cases where it worked when done within 72 hours, but in general the faster the reversal starts, the higher the likelihood is of it taking effect.

The reversal of the abortion pill is a relatively new concept, thought up within the past two decades. There has been a great deal of controversy over it as many people claim that it does not work. These individuals argue that there is not enough scientific evidence to support it as a viable method and cite incidents where it didnt produce the desired effects as proof that progesterone does not reverse the effects of mifepristone. Since there have been situations where women successfully remained pregnant after the progesterone process, the answer to the conflict has yet to be fully settled. There have also been ones where those who only took the first pill and not the second but did not choose reversal carried their babies to term, adding another factor to the complex issue. The American Association of Pro-Life Obstetricians and Gynecologists does support the validity of the procedure, though.

The process of reversing the abortion pill with progesterone is a controversial one. It has, however, appeared to be successful in many real-life cases.

Image byArek SochafromPixabay

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Abortion Pill Reversal: Answering Your Questions About the Controversial Treatment - Medical News Bulletin

More than half of all American adults have now received at least one dose of the three available COVID-19 vaccines, according to the the Centers for Disease Control and Prevention (CDC). Cases of the novel coronavirus have been plummeting since February, and theyll likely keep falling if people continue lining up for their shots, according to Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases.

One thing that is quite certain is that when you have a vaccine, or a group of vaccines, that are as highly effective in the real world ... as these vaccines are, and you get a substantial proportion of the population vaccinated, the chances of there being a surge are extraordinarily low, Dr. Fauci told The Washington Post this week.

The COVID-19 vaccines, which have been proven to prevent serious and symptomatic SARS-CoV-2 infections, are like a positive wild card on our side. The most recent and serious COVID-19 peak occurred at the end of 2020 and the beginning of 2021, a point when virtually no one in the country was vaccinated, Dr. Fauci said.

Now, the vaccines have the power to keep it from happening again. I really dont foresee there being the risk of a surge, provided we continue to get people vaccinated at the rate we have now, Dr. Fauci said.

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Experts agree. Just look at the numbers, which have been dropping steadily as vaccinations have ramped up, says Stephen Gluckman, M.D., an infectious disease expert and medical director of Penn Global Medicine. That really can only be attributed to the vaccine, because the other preventative measureswhich are very effective, by the waywere already in place and were not effective enough.

Masking, social distancing, and hand-washing have still been invaluable in the fight against COVID-19 and other seasonal illnesses; for example, flu activity has been much lower than in previous seasons, likely due to these practices, experts say.

The available vaccines are remarkable, even if theyre not 100% effective, because they decrease the number of serious, symptomatic infections. By keeping people less sick, the vaccines also reduce the risk of mutations, Dr. Gluckman explains, meaning that deadlier or more infectious variants (like the ones that were first identified in the U.K. and California) are less likely to develop and spread.

Earlier this month, President Joe Biden announced he aims to administer at least one dose of the COVID-19 vaccines to 70% of American adults by July 4. Nine states, including New Jersey, Hawaii, and New Mexico, have already met this goal at the time of publication. About 62% of American adults have received one dose of the COVID-19 vaccine, and about 50% of adults are considered to be fully vaccinated, per the CDC. (Note that these figures only reflect vaccination rates in adults, not the full U.S. population.)

Although the exact percentage of vaccinated people necessary to achieve herd immunity remains unclear, Dr. Fauci has previously estimated that 70% to 85% of the population must be fully vaccinated to significantly prevent community spread. Bidens plan focuses only on adults, but children are crucial to herd immunity as well; vaccine approval for kids under 12 could hopefully come in the next few months.

Although we dont know exactly how long individual immunity will last post vaccine, Dr. Fauci isnt worried about the effects wearing off soon: I think [the vaccines] will be effective long enough that we will get to the point where we are not going to be necessarily worrying about a surge, he said in the interview. (Plus, Pfizer, Moderna, and Johnson & Johnson are already in the process of testing booster doses to maintain protection.)

In some areas, face coverings are becoming less common due to the CDCs updated masking guidancebut thats dangerous for unvaccinated people, for those who are immunocompromised, and for anyone in a crowded area. Its still crucial to become fully vaccinated before you go without a mask in high-risk spaces, like hospitals or public transportation.

Somehow, that might have gotten lost in the announcement about masks, Dr. Gluckman says. If you choose to wear a mask because you want to, theres no harm in doing so. It helps keep you and those around you safe.

But ultimately, doing your part for your community means lining up for your dose. Theres still enough [COVID-19] around for yet another surge, says Dr. Gluckman. The way to prevent that is by getting vaccinated.

This article is accurate as of press time. However, as the COVID-19 pandemic rapidly evolves and the scientific communitys understanding of the novel coronavirus develops, some of the information may have changed since it was last updated. While we aim to keep all of our stories up to date, please visit online resources provided by the CDC, WHO, and your local public health department to stay informed on the latest news. Always talk to your doctor for professional medical advice.

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Dr. Fauci Explains How We Can Avoid Another COVID-19 Surge This Winter - Prevention.com

AUSTIN, TX / ACCESSWIRE / May 20, 2021 / SmallCapVoice.com Inc. ("SCV") announces the availability of a new interview with Troy Grogan, CEO of USA Equities Corp. (OTCQB:USAQ), to discuss the Company's digital medicine and virtual care platform designed to make healthcare encounters more efficient, cost-effective and comfortable for both the physician and patient.

Speaking with SCV's Stuart Smith, Grogan outlined the five focal points that drive USAQ's business model and growth trajectory. This structure generates recurring revenue for both USAQ and its physician clients, while the Company's remote-patient monitoring technology meets greater demand for virtual care in post-pandemic healthcare.

The full interview can be heard at: https://www.smallcapvoice.com/interview-usa-equities-corp-usaq/.

"Only 15 or so months ago, we wouldn't have thought virtual care technologies and digital medicine would come to the forefront but they are here and they're here to stay," Grogan explained. "A lot of patients have really felt the benefit of not having to go into a doctor's office and sit in a waiting room to get good, quality care. We're a part of that new ecosystem."

Healthcare providers also benefit from efficient digital care. USAQ's target market is a growing field of solo, independent practices looking for ways to generate revenue and become more efficient with their services. The Company's reimbursable Software-as-a-Service (Saas) technology enables these small businesses to achieve recurring revenue at high gross margins while addressing the preventative care of multiple chronic conditions, said Grogan.

As a public company, USAQ has the obvious advantage of access to capital markets, but it's the individual healthcare professional and retail investor that the Company seeks to obtain as key stakeholders.

"Instead of going to [venture capitalists] and institutional investors, we've gone to our clients and let them have an opportunity to invest in the future of medicine and join us alongside in the future upside that we have," Grogan stated. "We're a publicly traded company as opposed to being privately held to give retail investors to have a piece of the future of medicine."

Grogan's diverse experience in healthcare in the U.S. and abroad has given him a well-rounded perspective of the healthcare industry. This insight is the foundation of the tactical manner used to assemble the Company's management and advisory board.

"Along this journey of 10 years, I've built a very solid team around me of medical educators, doctors, business development experts in network development for physicians and growing physician networks," he said. "As an early-stage company, you can't just gain authority and credibility overnight. Often, you have to bring a team around you that brings credibility to the forefront."

In 2020, USAQ leveraged this expertise to launch two apps and present at the University of Miami Allergy Diagnostics and Allergen Immunotherapy Virtual CME Event, a continuing education course for over 100 doctors to demonstrate that the future of medicine is headed toward physician-directed digital medicine and preventative health technologies that streamline the care process.

Next month, USAQ will participate in a second workshop at the University of Miami's Miller School of Medicine to further educate medical practitioners on the Company's solutions and to continue to build its client base.

"This is a key point," said Grogan. "This is the type of doctor that we're getting as a client. Their behavior is that they want to be educated in these new areas, they want to do things that are slightly out of the scope of their practice but want to make sure they have the right credentials to do it, and they're looking to make more revenue."

Moving into the second half of 2021, Grogan said the Company will add more products to its customer base, more efficiently amortizing its sales and marketing. He concluded the interview with a recap in USAQ's recent financial performance and its ability to double revenues sequentially from one quarter to the next.

The full interview can be heard at: https://www.smallcapvoice.com/interview-usa-equities-corp-usaq/.

About USA Equities Corp.

USA Equities Corp. (OTCQB:USAQ) is focused on providing value-based healthcare solutions, clinical informatics and algorithmic personalized medicine including digital therapeutics, behavior-based remote patient monitoring, chronic care and preventive medicine. The Company's products are intended to allow general practice physicians to increase their revenues by cost effectively diagnosing and treating chronic diseases that are generally referred to specialists. The Company's products and information service portfolio are directed toward prevention, early detection, management and reversal of cardio-metabolic and other chronic diseases. Our principal objectives are to develop proprietary software tools, devices and approaches, providing more granular, timely and specific clinical decision-making information for practicing physicians and other health care providers to address today's obese, diabetic and cardiovascular disease population.

For additional information, visit the Company's website at http://www.USAQCorp.com

Forward-Looking Statements

Certain matters discussed in this press release are forward-looking statements' intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company's statements regarding trends in the marketplace, future revenues, future products and potential future results and acquisitions, are examples of such forward-looking statements. Forward-looking statements are generally identified by words such as may', could', believes', estimates', targets', expects', or intends' and other similar words that express risks and uncertainties. These statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of the introduction of new products, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company's control. The factors discussed herein and expressed from time to time in the Company's filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

About SmallCapVoice.com

SmallCapVoice.com, Inc. is a recognized corporate investor relations firm, with clients nationwide, known for its ability to help emerging growth companies, small cap and micro-cap stocks build a following among retail and institutional investors. SmallCapVoice.com utilizes its stock newsletter to feature its daily stock picks, podcasts, as well as its clients' financial news releases. SmallCapVoice.com also offers individual investors all the tools they need to make informed decisions about the stocks in which they are interested. Tools like stock charts, stock alerts, and Company Information Sheets can assist with investing in stocks that are traded on the OTCMarkets. To learn more about SmallCapVoice.com and its services, please visit https://www.smallcapvoice.com/small-cap-stock-otc-investor-relations-financial-public-relations/.

Socialize with SmallCapVoice and their clients at

Facebook: https://www.facebook.com/SmallCapVoice/Twitter: https://twitter.com/smallcapvoiceInstagram: https://www.instagram.com/smallcapvoice/

CONTACT:

Investor & Media Contact

Olivia GiamancoUSA Equities Corp.(929) 379-6503[emailprotected]

SmallCapVoice.com

Stuart T. Smith512-267-2430[emailprotected]

SOURCE: SmallCapVoice.com

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USA Equities Corp. (OTCQB:USAQ) Discusses its Digital Medicine as the Future of Healthcare in Audio Interview with SmallCapVoice.com - GuruFocus.com

Editor's Note: We at POPSUGAR recognize that people of many genders and identities, including but not limited to women, may or may not have female sex organs, such as a cervix or vagina. This particular story includes language from experts, government agencies, and studies that generally refer to people with female sex organs as women.

It's been roughly two decades since the US launched a nationwide vaccination effort against the human papillomavirus (HPV), a sexually transmitted virus that increases the likelihood of developing certain cancers. While the campaign is widely viewed as a success, it has led only to a stagnant reduction in infection rates in the Black and Latinx communities and not just because, historically, these communities have been more likely to express vaccine hesitancy. The first two vaccines created to slow HPV transmission did not address the strains of the virus that are most common in women who researchers identify as Black or Hispanic, the demographic that is also most likely to be diagnosed with HPV-associated diseases, including cervical cancer.

Young millennials like myself and older members of Gen Z may recall getting Gardasil-4 or Cervarix-2, the first vaccines that were developed to curb the spread of HPV. Gardasil-4 and Cervarix-2 were administered to young people and children as young as 9 years old, and required a two- or three-dose regimen, depending on the person's age at the time of their first dose. However, despite the success of these vaccines following their rollout in 2006, the Black and Latinx communities have continued to experience disproportionate levels of HPV-associated cancers. Thus, the creation of the Gardasil-9 vaccine the latest HPV vaccine that expands protection against multiple strains of high-risk HPV is essential in addressing this disparity.

Gardasil-9 is now the primary HPV vaccine in the US and has proven to be nearly 100 percent effective at preventing HPV-associated diseases, especially when administered early in life. But what does this mean for those who were already vaccinated, or are perhaps considering it for the first time? Here's what you need to know to protect yourself and those you care about most.

First, let's talk about the basics. Though most HPV infections resolve on their own within two years of transmission, nearly 80 million Americans are currently living with the virus, with 14 million HPV infections occurring annually. The 37 known strains of HPV are divided into "high-risk" and "low-risk" categories. Low-risk strains are known to carry a lower risk of a person who contracts HPV later being diagnosed with HPV-associated cancers, and their symptoms are typically milder in nature. In contrast, high-risk strains present the highest risk of causing cervical, oropharyngeal, anal, and other types of cancers. Overall, 14 of the 37 strains of HPV are considered high-risk strains, with strains 16 and 18 causing 70 percent of cervical cancers and precancerous lesions.

Despite the Gardasil-4 and Cervarix-2 vaccines being responsible for massive decreases in HPV and HPV-associated cancers, more recent studies have shown that not all Americans benefited equally. A 2013 study conducted by researchers at Duke University School of Medicine found that white people tend to primarily contract HPV strains 16, 18, 33, 39, and 59, while Black participants in the study carried strains 31, 35, 45, 56, 58, 66, and 68. Moreover, a study published in 2015 by the American Association For Cancer Research found that some of the same strains that affected Black women at higher rates were even more common in Hispanic women living along the Texas-Mexico border.

The original Gardasil, a quadrivalent vaccine, was designed to prevent HPV strains 6, 11, 16, and 18; Cervarix, a bivalent vaccine, only targeted strains 16 and 18. By contrast, Gardasil-9 protects against HPV strains 6, 11, 16, 18, 31, 33, 45, 52, and 58 widening the net for the communities that are most at risk for HPV-associated cancers.

"I think the original vaccines not covering more high-grade strains is not necessarily a failure of medicine or research. I think it's just a function of how science and discovery go," Ukachi Emeruwa, MD, MPH, an ob-gyn and clinical fellow in maternal-fetal medicine at Columbia University Irving Medical Center in New York, told POPSUGAR. "Medications and vaccinations should change not because they were unsafe when they came out, but because we make them available as soon as we find something helpful and then change them to make them even better every time we can."

Gardasil-9 is recommended for young people ages 11 to 26, as well as adults up to age 45 who, after discussing their risk factors with their doctor, decide that they could benefit from being vaccinated. However, Chinedu Nwabuobi, MD, an ob-gyn at a large health system in Columbus, OH, explained that people who have already received the required doses of the Gardasil-4 or Cervarix-2 vaccines are not advised to undergo an additional course with Gardasil-9. I, personally, chose to get the Gardasil-9 vaccine recently at 28 years old, because I never completed my third dose of the HPV vaccine after receiving my first at age 11. I was informed by my own doctor that there's no specific amount of time that needs to pass before you begin your course of Gardasil-9 should you choose to do so.

If you're unvaccinated and still skeptical or hesitant to add the vaccine to your to-do list, know that there are benefits beyond cancer prevention (which is a massive one). "HPV is also associated with genital warts," Dr. Nwabuobi told POPSUGAR. "In addition, management of abnormal pap smears which may be attributed to high-risk HPV may include a procedure called a cone biopsy. During this procedure, a portion of your cervix that contains abnormal cells is removed surgically," which may increase your risk for premature delivery if you decide to have a baby later on. "As a maternal-fetal medicine doctor, I deal with preterm birth issues frequently, and prevention of this condition is very paramount whenever possible," Dr. Nwabuobi explained.

Experts generally agree that more work needs to be done to ensure equitable healthcare and public health education for those who are most affected by HPV. The fact that such disparities exist suggests that preventive strategies including identification of and treatment for precancerous lesions aren't reaching the Black and Latinx communities the way they should, Dr. Emeruwa explained. "Until we can get to a point in which the way we share knowledge, build trust, and distribute interventions is equitable, I don't see us making a dent in that disparity."

As we've seen during the COVID-19 pandemic, vaccination efforts are futile when a population isn't properly informed about the vaccine and granted equitable access to it. "Ultimately, I think the first step in closing the gaps is for healthcare providers to engage women of color through education and unbiased counseling," Dr. Nwabuobi said, adding that the government can also address these disparities by engaging communities of color with awareness campaigns focused on cervical cancer and by expanding healthcare coverage. It's well-documented within public health research that Black and Latina women are least likely to have health insurance coverage and access to healthcare and by extension, preventative treatments due to issues like poverty and systemic and medical racism.

"I think the future of women's health is understanding and respecting that medicine and health do not operate in a vacuum," Dr. Emeruwa explained. "Access to care and infrastructure that promotes healthy behavior, policy, financial resources, discrimination, racism, cultural competency, historical context all of these and more directly impact any intervention or treatment that we develop. It's not all genetics and biology the way we used to or would want to believe." She continued: "If we want to mend and close the gaps in healthcare, our research and care have to start to investigate women's health through this more holistic lens."

Though a major overhaul is needed within the medical and public health communities, the development of the Gardasil-9 vaccine to specifically address the HPV strains that are most prevalent in Black and Latina women is indicative of an era of healthcare dedicated to addressing both bodily and societal ills.

While that work continues, you should do everything you can to reduce your risk. "Other than getting the HPV vaccine, the best way to lower your chance of getting HPV is to use latex condoms and dental dams the right way every time you have sex," Dr. Nwabuobi said, noting that you should also get routine cervical cancer screenings, starting at age 21. In the battle against HPV, it's important to arm yourself with every resource available.

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The HPV Vaccine Now Targets the Strains That Are Most Common in Black and Latina Women - POPSUGAR

When Uddhab Gautam got his first vaccine dose back in February, Covid-19 cases in Nepal were low.

Now, three months later, coronavirus infections in the Himalayan nation have spiraled out of control, leading to a shortage of hospital beds and oxygen, and sending most of the country into lockdown.

But despite needing it more than ever, the 67-year-old retired banker has no idea when he'll get his second dose of Covishield, the AstraZeneca vaccine manufactured by the Serum Institute of India (SII).

Gautam's predicament is similar to one shared by millions worldwide: asIndia's own coronavirus crisis has spiraled, SII --the world's largest vaccine maker-- can no longer export its goods.

Last week, the SII said it wouldn't restart deliveries to COVAX, a worldwide initiative aimed at distributing vaccines to countries regardless of wealth, until the end of thisyear.

While SII's decision will be a lifeline for India, which is still reporting about 200,000 new cases a day, the delay poses a huge problem for developing countries that depend on COVAX to control large outbreaks of their own.

The world is already 140 million doses short -- and by the end of June, that gap will have reached190 million shots, the United Nations children's agency, one of the partners in COVAX, said last week. There is currently no timeframe for resolving the shortage, UNICEF said.

That creates a very real problem, not just for countries with limited access to vaccines where cases are exploding, but also for the whole world.

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(1) Current approach to preventing Covid-19 at the Olympics is "dangerous," US expert says - CNN

Ryan Stewart| Special to The Oklahoman

The coronavirus has never been a problem limited to people. Since the pandemic's start, the virus's potential to impact pets, livestock and wildlife has been a global concern.

But will the four-legged friends we share our homes with need vaccines? It's unlikely in the short term, said Oklahoma Medical Research Foundation attending veterinarian Jennie Criley, D.V.M.

"Although there are a few reports of dogs and cats testing positive for SARS-CoV-2, the virus that causes COVID-19, they typically show no or very mild symptoms," said Criley, who is also the director of comparative medicine at OMRF. "Currently, there is no evidence that dogs and cats play a significant role in transmitting the virus to humans or other animals."

According to the American Veterinary Medical Association, livestock like horses, pigs and poultry don't appear to be naturally susceptible to SARS-CoV-2, the virus that causes COVID-19. While results of studies of the virus in cattle are conflicting, the AVMA notes it doesn't appear they can be easily infected either.

More: What to know about the COVID-19 variant identified in Oklahoma

But there is one notable exception, Criley said: Mink. Millions of the small, weasel-like mammals are bred on farms worldwide, and they can be infected by and potentially transmit the coronavirus to humans.

"The concern is that the virus could thrive in animals, mutate, and then pass back to humans," said OMRF physician-scientist Hal Scofield, M.D. "Given that the probable origin of COVID-19 was an animal likely a bat it's important that this be monitored."

In response, numerous vaccines for mink are in development. If the U.S. Department of Agriculture and health experts determine a companion animal SARS-CoV-2 vaccine is necessary, a vaccine developed for mink could eventually be adapted and approved for household pets.

More: Oklahoma's slowing COVID-19 vaccination rate could leave state vulnerable

Criley added that if research shows a COVID-19 vaccine for our pets is needed to protect animal and human health, it wouldn't be the first time.

"Rabies is a classic example of a vaccination given to our pets that keeps them safe and that saves human lives," Criley said. But, she added, it's best not to worry. Current work is all preliminary when it comes to man's best friends.

"Keep your pet up to date with all preventative health care recommended by your veterinarian," Criley said. "And remember, pets have become used to people being home more while we have been working remotely. Be sure to give them some extra TLC if you are transitioning back to working outside of the home office."

Ryan Stewart is media relations coordinator for Oklahoma Medical Research Foundation.

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Will the four-legged friends we share our homes with need vaccines? - Oklahoman.com

ROCKAWAY, N.J.--(BUSINESS WIRE)--electroCore, a commercial stage bioelectronic medicine company, has developed a non-drug and non-invasive alternative to pharmaceuticals that safely and effectively stimulates the vagus nerve to communicate with the brain and help optimize the bodys own ability to control problems impacting its health. While vagus nerve stimulation (VNS) has been available for decades, electroCore has transformed the industry with non-invasive vagus nerve stimulation (nVNS) therapy which taps into the power and potential of the vagus nerve via a portable device.

For quite awhile the scientific and medical research community has been captivated by the vagus nerve, the bodys longest nerve which connects information between the brain and important parts of the body including, the heart, lungs, voice box, stomach, ears, and other organs. By activating the vagus nerve with a safe and comfortable electrical stimulation through the skin, we believe we can neuromodulate, or adjust the brain signals to safely treat a variety of conditions, says JP Errico, founder at electroCore.

Implanted Vagus Nerve Stimulation (iVNS), which involves the surgical implantation of a device, was one of the first major breakthroughs highlighting how electrical stimulation could be used to treat conditions such as depression, epilepsy, infectious disease, and heart disease. In 2008, electroCore joined this medical exploration and two years later created a non-invasive way of delivering VNS therapy. Between 2011 and 2017, nVNS received CE Marks, which means it fulfilled the requirements of relevant European product directives in addition to performance and safety standards, for the treatment of multiple conditions in neurology, psychiatry, and gastroenterology. In 2017, electroCores nVNS received its first FDA clearance for the acute treatment of episodic cluster headache. Since then, electroCores game changing nVNS therapy received four additional FDA clearances as well as growing acknowledgement from health care providers and patients as a front-line, non-drug option for the treatment and prevention of migraine and cluster headache.

nVNS has not only transformed the way healthcare providers treat migraine and cluster headache but has also advanced how doctors treat veterans, adolescents, athletes, and long haul COVID-19 patients with migraine. nVNS is a safe, convenient, effective treatment for people who wish to avoid both the short and long term side effects and inconveniences that can be associated with injectable, inhaled, or pill-based medicine, states Dr. Peter Staats, chief medical officer of electroCore.

The creation of a safe, patient-controlled way of activating the vagus nerve has opened the door for the research and clinical community to study the vagus nerves potential to treat several conditions more easily and safely.

At the forefront of medicine, electroCore and other organizations are expanding research on the vagus nerve with clinical studies of nVNSs effectiveness on conditions including COVID-19, post-traumatic headache, traumatic brain injury, post-traumatic stress disorder, Parkinsons disease, epilepsy, stroke, sub-arachnoid hemorrhage and addiction as well as a number of gastrointestinal and inflammatory conditions.

At electroCore, we are looking into treating some of the most challenging diseases in the world with nVNS. What makes non-invasive nerve stimulation so exciting is the ability for the patient to self-administer the treatment, says Dr. Staats. Because the device is portable, it is empowering patients to literally take control of their condition into their own hands.

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The companys current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit http://www.electrocore.com.

About gammaCoreTM

gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patients neck over the vagus nerve, gammaCore stimulates the nerves afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore's business prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including commercialization of, and potential reimbursement for, its nVNS technology and products, the business, operating or financial impact of any clinical trials or studies, and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCores business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore, the potential impact and effects of COVID-19 on the business of electroCore, electroCores results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at http://www.sec.gov.

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The Ins & Outs of nVNS: Non-Invasive Vagus Nerve Stimulation Device Prevents and Relieves Pain From Migraines, Cluster Headaches & Other...

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Jez Hemming, local democracy reporter

A new medical school for the north could be ready by 2025 and well know what it costs by the summer, a health board chief executive has revealed.

Jo Whitehead, CEO of Betsi Cadwaladr University Health Board, revealed the news in her report to the boards monthly meeting on Thursdsay.

The new Medical and Health Sciences School will be a collaboration between the health board and Bangor University, if it gets approval from Welsh Government.

A study of what the capacity of the school should be is in the final stages and proposals should be lodged with Minister for Health and Social Care Eluned Morgan by the end of July, said Whitehead.

In her report, she said: BCUHB and Bangor University are working in partnership and have established programme arrangements in order achieve the shared ambition of developing a transformational Medical and Health Sciences School in North Wales by 2025.

Work to develop capital investment plans is progressing with an ambition initial estimates expected to be completed in June 2021 and final estimates to be available in July 2021.

An economic impact assessment will also be completed at the same time to help the business case for the new venture.

The proposed curriculum for the school will haveinter-professional, preventative and community led health and medicine at its core, she said.

Students

Students at the school will be given placements around North Wales as part of their practical experience which will hopefully lead to more doctors and future consultants settling in the health board area.

Betsi Cadwaladr has struggled to recruit to clinical positions over the past few years.

Eighteen medical students have already been undertaking a significant part of their training at Bangor University during the current academic year, as part of the C21 collaboration with Cardiff University with 19 attending the previous year.

Welsh Government said it had invested 7m into facilitatingthe course but students still have to take part of it in Cardiff.

When the idea of a North Wales MedicalSchool was first announced in September last year, former Welsh Health Minister Vaughan Gething said he wanted a task and finish group to assess if the proposal was practical and achievable.

A task and finish group chaired by Professor Elizabeth Treasure, has been looking at the idea since last autumn.

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New medical school in the north could be ready by 2025, says health board chief - Nation.Cymru

Retired firefighter Glen Midbo was enjoying a Budweiser on a recent afternoon while doing renovations on his house. His quiet suburban block on the southern tip of Staten Island is a stones throw from the beach. Standing under a flag of former President Donald Trump holding a machine gun, Midbo explained why he would be one of the last holdouts for the COVID-19 vaccine.

They came out with it too quick, said Midbo, 62, a resident of the mostly conservative, white and well-off neighborhood of Tottenville. I just want to make sure theres no side effects. I dont even feel threatened by this disease at all. I didnt even obey all the rules of this thingsocial distancing and masking and all thisand I didnt get sick.

On the opposite end of the island in Port Richmond, a neighborhood thats more than a third Latino, Selvin Vazquez Castillo expressed his own doubts about the vaccine. Ive read things on the internet that its caused people a lot of different reactions and has left people in the hospital, the 28-year-old construction worker said in Spanish. So, I said, Oh no, I dont want to be in the hospital.

Most barriers to accessing COVID-19 vaccines in New York City have come down, even on Staten Island, where theres no public hospital, and it took months of advocacy to open a city-run hub on the South Shore. But ongoing reluctance to get the shots has emerged as a key hurdle that New York, and the country as a whole, must overcome to control the pandemic. Pockets of unvaccinated people can continue to serve as a haven for the coronavirus, as evidenced by ongoing surges upstate in Lewis County and Cortland County. What is broadly deemed vaccine hesitancy encompasses a range of attitudes among people with myriad backgrounds, varying comprehension of health information and different levels of resistance.

No zip code on Staten Island is reporting more than 50% of residents with their first shot.

Reservations about the vaccineswhich are often, but not always, grounded in questions about their safety, according to Kaiser Family Foundation (KFF) surveyscut across political and cultural divides. And that research shows different strategies will change peoples minds depending on why theyve delayed their shots so far.

To explore the ways in which hesitancy can manifest, WNYC/Gothamist headed to Staten Island, the borough thats home to the most Republicans in the city as well as the solidly blue, ethnically diverse North Shore with its enclaves of Latino and African immigrants.

Retired firefighter Glen Midbo stands under a Trump flag outside his house in Tottenville, Staten Island. Midbo says he will only get the vaccine if remaining unvaccinated limits what he can do. Caroline Lewis

Staten Islands vaccination rate39% fully inoculated, 45% with at least one dosefalls just below the citywide tallies of 40% and 49%, respectively. While other boroughs have neighborhoods with very high and very low levels of vaccine saturation, much of Staten Island hovers somewhere in the middle. No zip code is reporting more than 50% of residents with their first shot, as of May 21st.

Organizers on Staten Island who have been working on getting residents vaccinated over recent months shared some of the rationales they hear from the reluctant.

Among African immigrants in Stapleton, Park Hill, and Mariners Harbor, misinformation about the virus and vaccines is spreading via Facebook and WhatsApp, said Abou Sy Diakhate, co-chair of the Staten Island Immigrant Council and a board member of the Staten Island Long-Term Recovery Organization.

Videos went viral promoting the conspiracy theory that the vaccine is part of the plot to reduce the black race, said Diakhate. This is how they look at it. And they ask me this.

This is part of the institutional racism that we're talking about.

He added that people in the communities he serves dont tend to rely on American media for information, and some dont speak English. Like others who spoke to WNYC/Gothamist, Diakhate said he thought initial barriers to finding appointments or clinics exacerbated this hesitancy. Sometimes, when they lack access, they say, OK, you know what? It's fine. We are used to this. This is part of the institutional racism that we're talking about.

Although there is no longer a vaccine shortage and everyone older than 12 is eligible, Diakhate says he has yet to get a shot himself because he wants to let those who are more vulnerable go first.

An April survey of 1,007 people in the New York metro area90% unvaccinatedfound that most were not hardline anti-vaxxers. Only 4% said they would not get a COVID-19 jab for any reason. About two-thirds of those without shots65%said they were waiting for reassurance that no serious complications would result from the vaccines. So far, hundreds of millions of Americans have taken doses of Pfizer, Moderna and Johnson & Johnson vaccines, and close monitoring has shown that they are overwhelmingly safe and effective. Long-term negative consequences are extremely unlikely.

Another 22.3% said they wanted to see how the vaccines affected other people. Nearly 10% said they preferred to let high-risk people have first dibs. The survey, conducted by the CUNY Graduate School of Public Health and Health Policy, is yet to be published.

The only reason I'll take the vaccination is if it will let me go to my house in Norway.

Asked what would make them feel more ready, 15% of the unvaccinated respondents said they would value a recommendation from their doctor. The doctors office was also by far the preferred setting for a shot, favored by 39% of respondents. KFF surveys note similar findings on trusted messengers.

A lot of the people that we contacted from our Stapleton senior center said they're waiting until [the vaccine is] available in their doctor's office, and they're waiting for their doctor to administer it, said Allison Cohen, the communications director for the JCC of Staten Island, who also headed up the organizations massive vaccination effort at its locations across the borough.

So far, primary care doctors have not been selected as major providers of the COVID-19 vaccinesa policy that needs to change as the city moves toward reaching children and potentially offering booster shots, according to Dr. Scott Ratzan, a lecturer at the CUNY School of Public Health and executive director of CONVINCE USA, an organization promoting vaccine literacy. But Ratzan also acknowledged that the clinical setting people feel most comfortable in can also vary by demographic.

Michelle Molina, executive director of El Centro del Inmigrante in Port Richmond, says Latinos from other boroughs often come to her community center for COVID vaccinations because its a trusted organization among immigrants, particularly those who are undocumented. She has been encouraged so far by all the people who started out hesitant but are now taking the vaccines. The center provides a wide range of services, including a dispatch center for day laborers, allowing Molina to offer regular reminders about the shots.

Day laborers wait to be dispatched outside El Centro Del Inmigrante in Port Richmond, Staten Island. The center has gotten many immigrants vaccinated and helped some overcome their initial hesitancy. Caroline Lewis

We still have a lot of work to do as far as the parents, Molina said. A lot of parents will say, Yes, I wanted to get vaccinated, and I did. But my kids are a different story. I'm not willing to take that chance with my kids.

Vazquez Castillo, the construction worker, says he finally booked an appointment. But it took the recent deaths of three friends from COVID-19 and a referral from an acquaintance to El Centro for him to do it.

Before his friends passed away, Vazquez Castillo admits, I didnt believe in COVID. Even now, he has questions about how the vaccines work. One questionI have read online, but I'm not that sure because the internet is not 100% trustworthydo they put the COVID inside your body? Vazquez Castillo asked. (They dont.)

Community organizers talked about the need for more forums where people could pose clinicians all their questions, especially now that parents are deciding whether to give consent for their kids. Ratzan said he is working with employers to provide accurate, actionable COVID-19 information to their employees.

Nationally, the share of people who want to wait and see on the vaccines safety or how others react to it shrank during the first couple of months of the rollout, before plateauing between March and April, according to the Kaiser Family Foundation. Those putting off their shots for these reasons include about one in five Republicans, and roughly the same share applies to Black adults, Hispanic adults, and those without a college degree. A quarter of young adults between 18 and 29 also say theyre holding off.

Notably, while Republicans have been slower to seek vaccinations than Democrats, the share that is willing continues to increase. Each person who spoke to WNYC/Gothamist had different answers for what, if anything, would ultimately motivate them toward the preventative medicine.

A woman yells as New York City Sheriffs stand guard outside of the restaurant Mac's Public House at the start of a rally against state and city mandates to stop indoor dining to control the spread of the coronavirus in Staten Island, December 2nd, 2020. JUSTIN LANE/EPA-EFE/Shutterstock

Despite vowing to wait as long as possible, Midbo, the retired firefighter in Tottenville, said hed get inoculated if it was the only way to circumvent travel restrictions or other limitations on what he could do. The only reason I'll take the vaccination is if it will let me go to my house in Norway, Midbo said. If they won't let me in a restaurant or bar or something like that because I don't have the vaccine, OK, I'll do it.

Others said incentives based on mandates wouldnt help. I'm a Libertarian, said a Tottenville retiree named Bruce, who would only give his first name. I don't believe in government overreach, and I don't want to live in a nanny state. Still, he emphasized, hes not an anti-vaxxer; he merely wants to see more data on the vaccines. I hope we do reach herd immunity, he said.

Some sitting outside the Staten Island Mall Monday said the people they knew were mostly coming around to the idea regardless of their politics. But one woman, Marie Linea, 67, said she would not take a COVID shot under any circumstances, even if it meant she had to keep wearing her mask while others shed theirs. Linea rattled off several popular myths, including that the virus was man-made and that young people shouldnt get the vaccines because they can cause infertility. They're injecting stuff that is going to change your DNA, she said, which is also untrue. You're going to have problems down the line, you know, mentally.

Not everyone who didnt rush to get a shot right away has such clear-cut reasons. On Monday, Kurt Perkert, 62, a Port Richmond resident who maintains properties in the area, said he had recently booked his first appointment.

I've been procrastinating, he said. Im busy.

From his porch, Perkert hailed a friend passing by, Stanley Federowski, 67, who said he lives alone in West Brighton and doesnt plan to get vaccinated. Asked if he worried about COVID-19, Federowski said, No, I dont worry about nothing. I just do whatever I do and that's it. I don't even think about it. He said maybe if they were offering money, hed consider it. Governor Andrew Cuomo launched an initiative this week whereby state-run vaccine sites will give out free lottery tickets for a chance to win $5 million, following in the footsteps of Ohio.

The mayor and governor continue to plead with residents to capitalize on the free COVID-19 vaccines if they havent already, insisting its the way to restore normalcy and ensure everyones safety as businesses, schools, and entertainment venues reopen. But Olivia Drabczyk, a teacher who has done vaccine outreach during her run for City Council on Staten Islands South Shore, says some people are hearing mixed messages.

Seeing that, whether or not they've gotten [vaccinated], the city is still reopening, she said, has taken away some urgency for people who are already hesitant.

Link:
Vaccine Hesitancy Greatest Hits: How Some Staten Islanders Are Overcoming The Reluctance - Gothamist

A man receives his Covid-19 vaccination at the John Scott Vaccination Centre in Green Lanes, north ... [+] London, where Hatzola, in partnership with the NHS and Hackney Council are delivering a coronavirus vaccine clinic for the local Orthodox Jewish community. Picture date: Sunday March 21, 2021. (Photo by Stefan Rousseau/PA Images via Getty Images)

The Orthodox Jewish community was hit hard by the Covid-19 pandemic. Swift community action ensued; Jewish schools were closed and synagogues were shuttered. While anticipation for the Covid-19 vaccine grew, physicians and leaders within the community wondered: will Orthodox Jews get the Covid-19 vaccine?

A new study published by Dr Ellie Carmody, Assistant Professor, Division of Infectious Diseases and Immunology at NYU Grossman School of Medicine and co-authors, surveyed 102 Orthodox Jews in Brooklyn, NY between December 2020 and January 2021. At that time, 41% were undecided about the vaccine and 47% were strongly hesitant.

While many U.S. citizens fought for access to the vaccine, others were understandably hesitant to take a new vaccine. The vaccine has had its fair share of doubt including concerns about fertility and safety monitoring (neither concern has been proven).

In the past, Shoshana Bernstein, an Orthodox community activist in NY, worked to educate community members about the measles vaccine. Her experience taught her that the majority of Orthodox Jews do indeed vaccinate.There are outliers who are openly anti-vax and the movable middle who are unsure. Unfortunately, it has become more and more the norm for the media to focus on Orthodox Jews which can and does create the erroneous assumptions.

At the same time, Ms. Bernstein explained that the insular lifestyle of many demographics in the Orthodox Jewish community limits their access to credible medical information. Many individuals in these communities dont use the internet, social media, and smartphones. There, Ms. Bernstein recommends it is imperative that culturally sensitive, written and spoken education be written and made available.Unlike the secular world, written publications are very much alive and well in the Orthodox Community.Dial-in hotlines and Yiddish language radio stations reach a large swath of the population and should be utilized.Doctors, nurses, physician assistants and urgent care centers are generally widely trusted and should be provided written material.

Dr Miriam Andrusier, MD, MPH a member of the Hasidic community in Crown Heights, Brooklyn, echoes Ms. Bernsteins concerns about targeted misinformation. Both in terms of how the virus spreads and what information people have available to them are very unique and could be quite insular. The Orthodox Jewish community is very tight knit. The ways in which information is dispensed and shared is very unique: people tend to get a lot of their information from social media and groups like Whats App where it is incredibly easy to pass along misinformation that can be forwarded thousands of times within minutes.

When the pandemic eased in the summer of 2020, anti-vax and anti-medical establishment groups made efforts to spread misinformation specifically in the Orthodox Jewish community. At an event in Crown Heights on February 16th, 2021, Dr. Simone Gold urged attendees not to get the Covid-19 vaccine because dying from Covid-19 itself is exceedingly uncommon. The second speaker, Rabbi Michoel Green told (unverified) stories of individuals who lost relatives and suffered side effects from the vaccine.

The anti-vaccine movement is finding fertile ground in people today in general because they succeed by sowing fear, uncertainty and doubt, and this pandemic is already rampant in all three, says Dr. Alissa Minkin, a pediatrician and Chair of the Jewish Orthodox Womens Medical Association (JOWMA) Preventative Health Committee. Dr Minkin also hosts the JOWMA Podcast, which covers health topics geared towards the Orthodox community. Full disclosure- I serve as president of JOWMA and have been actively involved in JOWMAs educational efforts for the Covid-19 vaccine.

Dr. Minkin believes the politicization and polarization of this pandemic is contributing to anti-vaccine sentiment across the board, not just in the Orthodox community. Because religion is not one of the metrics for vaccine uptake, we do not have exact statistics for percent vaccinated in each of these communities.

While the exacts numbers of those vaccinated in the Orthodox community isnt quite clear, informal surveys by synagogues, physicians, and schools indicate that vaccine uptake is high. Suri Kasirer, President of Kasirer LLC, the #1 lobbying firm in New York, has been working with government and community organizations like JOWMA to educate NY residents about the Covid-19 vaccine. I come from this community, which was among the most impacted by the pandemic. In reaching out to the Orthodox community with timely information about the vaccine, there are unique challenges, such as language barriers, or limited access to TV and the Internet.Were so proud to have helped effectively counter disinformation and build confidence in the vaccine as we see this vibrant community back to good health post-pandemic.

"Most of my elderly patients wanted to get the vaccine as soon as it was available. As part of my work as the medical director of Chevra Hatzalah Volunteer Ambulance Corps, we facilitated hundreds of vaccines to home-bound Holocuast survivors, said Dr Jason Zimmerman, medical director at Boro Park Center for Rehabilitation and Nursing in Brooklyn, NY.

Dr. Zimmerman cares for patients from the Orthodox community in Brooklyn, NY. He shared Many younger patients were initially hesitant to take the vaccine, but over the past few months, they've watched their healthcare providers, family and friends get vaccinated and this visibility has really helped alleviate people's initial hesitation."

Dr. Minkin believes that while we havent yet reached herd immunity, the percent of people who had Covid-19 already are contributing to the percent who are immune along with the vaccinated. There are good reasons to get vaccinated even if you had Covid-19, but public health officials should acknowledge that people who had Covid-19 are making a risk benefit decision from a different position than those who never had it.

Dr. Ellie Carmody MD, MPH, agrees that some hesitancy around the vaccine may be understood from a scientific and health perspective. Within some Orthodoxcommunities that have been very highlyimpacted by Covid-19, reasons for not vaccinating are complex.Some are wary of new technologies and are subject to similar misinformation that circulates within wider anti-vaccination discourse.But for many people who have had Covid-19, there is simplynot a sense of urgency to be vaccinated, given that they observe that symptomatic re-infections in their communities are low and they feel protected.

Dr. Carmody believes that vaccine strategies should be re-evaluated for those who have recovered from Covid-19, as more studies demonstrate that there is a robust immune memory response to one dose of either an mRNA vaccine or adenoviral vector vaccine in people who have recovered from Covid-19.

A one-dose immunity booster may be more well received than a two-dose mRNA vaccineseries, as it validates the contribution of natural immunity toward protection from disease.One-dose mRNA vaccine strategies could also help stretch the world's supply of these vaccines, said Dr Carmody.

In the meantime, educating patients about Covid-19 vaccination remains a priority.

See original here:
Hit Hard By The Pandemic, Orthodox Jews Are Choosing The Covid-19 Vaccine - Forbes

The International Society for Stem Cell Research (ISSCR) today released updated guidelines for stem cell research and its translation to medicine.

Developed in response to recent scientific and clinical advances, the revised guidelines provide a series of detailed and practical recommendations that set out global standards for how these emerging technologies should be harnessed.

Stem cell research has huge potential it could help pave the way for new therapies for ailments ranging from Parkinsons disease to childhood kidney failure. But scientific advances in this field can present unique ethical and policy issues beyond that seen in other areas of medical research.

The science is advancing at breakneck pace. Just in the past couple of months, we have seen model human embryos grown from skin cells, and the creation of human-monkey embryos for use in research.

The ISSCR has long recognised the need to set clear ethical boundaries for stem cell research. Previous guidelines have provided advice on techniques such as the use of human embryos to create stem cells, and set the required standards when using these technologies to create new medicines.

They have also explicitly banned certain practices, such as reproductive cloning and the sale of unproven therapies that claim to be made of stem cells.

The 2021 guidelines an update on the previous version, released in 2016 aim to set standards for the many recent advances in stem cell and human embryo research. These include chimeric embryos containing cells from humans and other animals, organoids grown from stem cells to create tissue that resembles particular human organs, and models of human embryos arrangements of human cells that mimic the early stages of embryo development.

The guidelines contain a clear requirement for certain new stem cell research approaches only to be conducted after a specialised review process. This review should be independent of the researchers, and include community members as well as people with expertise in the relevant science, ethics and law.

This is beyond what is typically required by a university or research institute where medical research is conducted. Besides evaluating the merit of the proposed research, the new reviews should also consider whether there are alternative ways to do the research, the source of stem cells and how they were obtained, and the minimum time required to reach the research goals, particularly in relation to human embryo and related research.

Specialised review is not a new concept. The previous guidelines required it when researchers made stem cells from human embryos or sought to culture human embryos in the lab. But now researchers will now also be required to seek higher review when they create model embryos such as blastoids, or study the development of animal-human embryos in animal wombs.

Researchers developing new therapies for mitochondrial disease will also be required to seek higher-level review before attempting to transfer to the uterus of a woman human embryos in which affected mitochondria (a part of the cells energy-production apparatus) have been replaced.

Importantly, the revised guidelines also clearly rule out certain activities. These continue to include reproductive cloning and attempts to form a pregnancy in a woman from genetically edited human embryos or from model embryos made from stem cells. Prohibited activities also now include using eggs and sperm made from human stem cells for reproduction, or transferring a human-animal chimeric embryo into the uterus of a woman or an ape.

Read more: China's failed gene-edited baby experiment proves we're not ready for human embryo modification

The guidelines also call for a public conversation about whether we should allow limited lab research on human embryos beyond the existing limit of 14 days development. Historically, it has not been possible to support human embryonic development outside the body beyond this stage. However, recent advances in human embryo culture raise the possibility that this may now be technically feasible.

Extending the amount of time in culture - in terms of days - could potentially yield new treatments for developmental conditions or infertility, but will also raise concerns about whether possible benefits justify this research. Any decisions to overturn this long-held signpost would need to be carefully deliberated and take into consideration existing law, community values and discussion around what the new limit should be.

The revised guidelines also reinforce the need for informed consent for the collection of human material and participation in stem cell clinical trials, and reiterate that no new stem cell treatment should be made available before it is tested for safety and effectiveness in well-designed and publicly visible clinical trials. The ISSCR continues to condemn the commercial use of unproven stem cell treatments.

While stem cell science holds much promise, it is paramount that research is scientifically and ethically rigorous, with appropriate oversight, transparency and public accountability.

The fact these guidelines are driven by experts including stem cell scientists, doctors, ethicists, lawyers and industry representatives from across 14 countries indicates a deep sense of responsibility and integrity within the research community, and a desire to ensure science remains in step with community values.

However, these guidelines are recommendations, not laws.

Researchers will need to abide by their respective national or state regulations and ethical standards. Some countries already have regulatory frameworks that are consistent with the new recommendations. In other places there is no national guidance around laboratory and clinical stem cell research at all, or existing law touches on some but not all of the emerging applications of stem cell research.

Read more: As scientists move closer to making part human, part animal organisms, what are the concerns?

For example, in Australia there is already an established pathway for higher-level review of embryo models created from stem cells. However, the same legislation currently bans any attempt to use mitochondrial transfer techniques to create embryos for research or to achieve a pregnancy both of which are permissible under the new ISSCR guidelines.

Rather than attempting to impose a set of hard-and-fast rules on an ever-evolving research field, the new guidelines attempt to address emerging issues and drive important discussions at domestic level. Ultimately, it is the public and the regulators who will need to set the standards.

See the rest here:
New global guidelines for stem cell research aim to drive discussions, not lay down the law - The Conversation AU

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Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Mercks anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] 10). The CHMPs recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the second quarter of 2021.

Patients with metastatic esophageal cancer currently face five-year survival rates of just 5%, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. There is a critical need for new treatment options in the first-line setting that can potentially extend their lives. Todays positive opinion for KEYTRUDA is an important step forward for patients in Europe with certain types of gastrointestinal cancers.

The positive CHMP opinion is based on results from the pivotal Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated significant improvements in overall survival and progression-free survival compared with 5-FU and cisplatin alone in patients regardless of histology or PD-L1 expression status. KEYTRUDA plus 5-FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p

Merck is studying KEYTRUDA across multiple settings and stages of gastrointestinal cancer including esophageal, gastric, hepatobiliary, pancreatic, colorectal and anal cancers through its broad clinical program.

About Esophageal Cancer

Esophageal cancer begins in the inner layer (mucosa) of the esophagus and grows outward. Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. Globally, it is estimated there were more than 604,000 new cases of esophageal cancer diagnosed and approximately 544,000 deaths resulting from the disease in 2020. In Europe, it is estimated there were more than 52,000 new cases of esophageal cancer diagnosed and approximately 45,000 deaths resulting from the disease in 2020.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Carcinoma

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

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Merck (MRK) Granted Positive EU CHMP Opinion for KEYTRUDA (pembrolizumab) in Combination with Chemotherapy - StreetInsider.com

Opinion Supports Use of KEYTRUDA in Combination With Platinum- and Fluoropyrimidine-Based Chemotherapy in Patients Whose Tumors Express PD-L1 (CPS 10)

Recommendation Based on Significant Survival Benefit Demonstrated With KEYTRUDA Plus Chemotherapy Versus Chemotherapy in Phase 3 KEYNOTE-590 Trial

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Mercks anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] 10). The CHMPs recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the second quarter of 2021.

Patients with metastatic esophageal cancer currently face five-year survival rates of just 5%, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. There is a critical need for new treatment options in the first-line setting that can potentially extend their lives. Todays positive opinion for KEYTRUDA is an important step forward for patients in Europe with certain types of gastrointestinal cancers.

The positive CHMP opinion is based on results from the pivotal Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated significant improvements in overall survival and progression-free survival compared with 5-FU and cisplatin alone in patients regardless of histology or PD-L1 expression status. KEYTRUDA plus 5-FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p

Merck is studying KEYTRUDA across multiple settings and stages of gastrointestinal cancer including esophageal, gastric, hepatobiliary, pancreatic, colorectal and anal cancers through its broad clinical program.

About Esophageal Cancer

Esophageal cancer begins in the inner layer (mucosa) of the esophagus and grows outward. Esophageal cancer is the eighth most commonly diagnosed cancer and the sixth leading cause of death from cancer worldwide. Globally, it is estimated there were more than 604,000 new cases of esophageal cancer diagnosed and approximately 544,000 deaths resulting from the disease in 2020. In Europe, it is estimated there were more than 52,000 new cases of esophageal cancer diagnosed and approximately 45,000 deaths resulting from the disease in 2020.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Carcinoma

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (

KEYTRUDA with Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen, which was at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after antiPD-1/PD-L1 treatment. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between antiPD-1/PD-L1 treatment and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly. Consider the benefit vs risks of using antiPD-1/PD-L1 treatments prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with an antiPD-1/PD-L1 treatment in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

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Merck Receives Positive EU CHMP Opinion for KEYTRUDA in Combination With Chemotherapy as First-Line Treatment for Certain Patients With Esophageal...