Archive for the ‘Hormone Physician’ Category

With the normal pressures of work compounded by the pandemic, stress and burnout are proliferating in the business world. Even before Covid-19, stress and burnout were ravaging the health of Americans. The number of hours worked is said by the non-profit American Institute of Stress to be the main source of job stress and this makes work especially problematic in the United States where Americans have a work ethic that is second to none.

A report a few years ago by the International Labor Organization showed that US workers averaged nearly 2,000 hours of work every year (40 hours per week x 52 weeks = 2,080 hours), or nearly 350 more hours per year (nine more weeks) than Europeans.

This is important because reducing stress is still the most important thing we can do for our health. Among other things, stress increases the risk of heart disease by 40 percent and the risk of stroke by 50 percent, and the American Institute of Stress tells us that three out of four doctors visits are for stress related ailments, and that stress is the basic cause of 60 percent of all disease and illness.

Whats the solution?

Many advocate shortening the work week. In Iceland, a trial from 2015 to 2019 of almost 3,000 people found that shortening the work week from 40 hours to 35 or 36 hours with no reduction in pay resulted in productivity either remaining the same or increasing over the working period, while perceived stress and burnout went down.

Microsoft Japan tried a four-day work week without a pay reduction over five weeks and reported happier workers and a 40% increase in productivity. And in 2018 Perpetual Guardian in New Zealand tried a four-day work week over 8 weeks for 240 of its staff. Employees there reported enjoying a better work-life balance and reported their stress levels decreased by 7%. The studies show that the workers reported less stress, but, of course, workers are motivated to praise shorter work weeks without pay reductions, and they may even be inspired to greater productivity during their working hours.

But there are doubters about this as a permanent solution, and, of course, some people find happiness in their work and dont want or need a shorter week. In all events, shortening the work week isnt a complete solution to stress and stress-induced disorders because of the myriad potential sources of stress that we encounter at work, at home, and in all our interactions. Is there then something we can add to better equip people to deal with the stresses and strains of life?

First, we should define stress to understand how we can best overcome it. Conversationally, we speak of the stress of the job or the stress of a divorce, ascribing the stress that people experience to an external event. However, more scientifically, stress refers to the internal bodily reactions to those events that are so disruptive to health.

The external events that are potentially stress-producing in the body are known as stressors or just stressful situations, to which individuals react very differently. One person in a given situation may suffer a stressful reaction such as a fight-or-flight response or a hormonal imbalance that can precipitate disease, whereas at least some people handle the situation with ease. Unfortunately, the latter appear to be in the minority.

A recent article in the Washington Post (What burnout really means, and what bosses and employees can do about it) tells us that the pandemic has caused prolonged stress to many, leading to burnout. Technically burnout is a combination of emotional exhaustion, and a reduced sense of personal accomplishment, and often a take this job and a shove it attitude. The author of the Post article says that experts say companies need to allow staff to set their own schedules, have meeting free days, proactively address rude workplace behavior, and avoid praising or normalizing working around the clock.

But these strategies, and even a shorter work week, seek to eliminate the stressors, but dont directly address the internal disorder that is stress, and they dont enhance our resilience to stressful stimuli. While eliminating stressors (if we can) may help in reducing future disruptions of the employees physical state, it does nothing to address the current internal disorder that leads to the headaches, stomach problems, high blood pressure, insomnia, and other stress-related disorders. And, of course, changing the work environment wont succeed for those companies unwilling or unable to change their environment. So, how do we overcome workplace stress?

Much stress is eliminated through night-time sleep. Although our bodies incur a heavy stress load on a regular basis, stress is a physical abnormality, which the body normalizes or heals whenever it is given the opportunity. When we become ill, we may relieve the symptoms with medicines, but Sir Hans Krebs, a Nobel Laureate in physiology, says The physician and the patient can do no more than assist nature, by providing the very best conditions for your body to defend and heal itself.

The rest we gain during sleep is a crucial requirement for assisting nature and allowing the body to heal itself. In fact, sleep is so important, it is part of every physicians prescription for virtually every disorder. However, while we naturally eliminate a lot of stress through sleep, the statistics tell us that most people are not winning their fight against stress and have come to accept being stressed as normal. We manage our stress with an increasing number of pharmaceuticals as we get older and think nothing of a full medicine cabinet to deal with our many disorders. If assisting nature is the key, what more can we do to help our bodies eliminate stress? How do we supplement our sleep if rest is so beneficial to health? This is where the yogis approach comes into play.

Research by co-author Dr. Wallace first published in Science and Scientific American in the 1970s showed that the meditation technique he analyzed, the Transcendental Meditation (TM) technique, produced a unique state of rest and orderliness in the mind and body, correcting physical disorders beyond what sleep had accomplished. His research showed that during the TM meditation session, the body gained a profound and unique state of rest. During the TM practice, even though the meditator was alert, the research showed remarkable decreases in oxygen consumption and respiration, reduced concentrations of blood lactate levels (high blood lactate is associated with anxiety), and a marked increase in skin resistance (associated with relaxation).

Later studies by Wallace and his colleagues showed reductions in cortisol (the stress hormone), as well as increases in serotonin (the happiness hormone), increases in blood flow to the brain, and perhaps most importantly, a marked coherence in the functioning of the brain. Sleep heals by creating order where there is disorder, but, interestingly, the rest during the Transcendental Meditation practice has been found to create more coherence, so in some respects it is more profound than what occurs during sleep.

The charts above show EEG brain wave measurements during sleep and the Transcendental Meditation technique. The mountains or spindles show periods when there is especially high coherence in the brain wave activity. High brain wave coherence is associated with memory, concept learning, creativity, high self-esteem, and reduced anxiety, depression, and other disorders, whereas abnormally low brain wave coherence is associated with autism, schizophrenia, Alzheimers, and other mental disorders. This is why researchers are so interested in studying brain waves.

And as can be seen from the charts, the individual who has been practicing TM for four months has significantly more brain wave coherence during the TM session than during sleep. And the five-year meditator has extremely high levels of brain wave coherence both during the meditation session and before and after meditating when just sitting with the eyes closed (see the EC or eyes closed period in the meditators charts). This is a level of coherence not found in other meditation practices.

Being resilient in the face of stress is also important since we cant possibly eliminate all the stressors in our lives. An article by Dr. Wallace recently published in Medicina describes a series of studies on TM that investigated the meditators response pattern to stressful stimuli as compared to a relaxation control group.

The meditators heart rates and other physiological measurements increased appropriately in response to stressful stimuli, but the meditators recovered much more quickly than the non-meditators, basically brushing off a situation that would tend to have a lasting effect on the non-meditators and disrupt their nervous systems. Dr. Wallace coined the phrase neuroadaptability to refer to the more resilient physiology that can better withstand stressful events.

Another interesting analysis by Dr. David Orme-Johnson, a former professor at Maharishi International University in Iowa (where all the students learn TM), determined that the number of medical visits of about 2,000 TM meditators were just a fraction of the number of visits of non-meditators of comparable age, gender, and profession, who had similar health insurance policies. Over the five-year study period, the TM meditators had significantly fewer incidents of illness in 17 medical treatment categories, including 87 percent less hospitalization for heart disease, 87 percent less for nervous system disorders, 73 percent less for nose, throat and lung diseases (including virus caused diseases), 65 percent less for metabolic disease, including diabetes, and 55 percent less for cancer.

Our new book, The Coherence Effect (Armin Lear Press, 2020), has many personal accounts of business people overcoming stressful work situations. Josh Griffith is one good example. He went from being burned out on the job to having the enthusiasm of a new hire. Josh has been the head writer for the popular daytime TV shows Days of Our Lives and The Young and the Restless. In 2013, he was having serious stress issues at work, and he started looking into meditation practices. Co-author Marcus interviewed Josh a few years ago after he had tried other techniques and had been practicing TM for a year. Josh said:

I saw a celebrated doctor on television and decided to try a meditation he said would help. So, I tried his meditation for about a year . . . . It was kind of helping, but then the work issues got worse and I was still feeling the same way that I had before.

Then Josh saw an interview about TM on television, and he decided to try it. He said:

In the world of daytime TV, youre having to create five shows a week. As head writer [The Young and the Restless] I was responsible for all the stories that aired. I walked away from it a few years ago because I felt burned out. It was too much of an output, and I didnt feel the quality of the output was something I could be proud of. It was taking such a toll on me that I walked away.

Then I started doing TM. I thought I was a meditator before starting TM. Boy, was I wrong. I was offered the head job on Days of Our Lives, and I agreed to take it because with TM I already felt sort of a creative energy bubbling back inside of me. So, I stepped back in, and it was sort of the case where I felt like Im back at the beginning of the career.

I felt like I had the energy that I had when I first started doing daytime. I was able to come in and the ideas flowed nonstop, whereas before I didnt know if I would be able to finish this. I was thinking I dont know what Im going to do Ive hit a wall. TM allowed me to generate so many story ideas that it was, in a way, sort of like a rebirth. You know Ive had a 30-year career. And the changes happened within a month of practicing TM. I feel like Im starting [my career] now. I feel like a 25-year-old again.

In years past, businesses have been slow to adopt meditation as a tool. That is changing and will change even more once businesses use brain-wave coherence as a means of evaluating different meditation programs. We have referred to some of the findings on Transcendental Meditation, a technique that we have each practiced for about 50 years. If you are interested in trying a meditation program, there are many to choose from, but we suggest letting science be the guide in selecting one, and we say the principal criterion needs to be the degree to which the program creates coherence in the mind and body, especially in the brain. Because the brain is the control center of the body, when the EEG activity is coherent, it has a maximum effect in creating the orderly and neurologically adaptive state that counteracts stress and makes us more resilient.

Written by Jay B. Marcus.

Read more from the original source:
A Yogi's Take on Stress and Burnout - CEOWORLD magazine

Females in Action South Coast is a Fall River-based organization for women that formed11 months ago during the COVID-19 pandemic.

Its member work out together at North Park in Fall River twice a week, Wednesdays at 6:15 p.m. and Saturdays at 8 a.m. There is no registration fee; just show up and get involved.

In addition to the workouts, members are also building friendships and helping their community along the way.

Organizer Caitlin Botelho and member Andrea Silvasaid this week on Townsquare Sunday that Females in Action is all about fitness, friendships, and philanthropy. The group has been involved in various charitable efforts during its first year.

Now the organization is looking to increase its numbers and expand to New Bedford.

Females in Action is actually a national programwith active groups in 20 states. It first began in North Carolina in 2013.

Caitlin Botelho, a Fall River native, was living in Tennessee at the time and became involved. She returned home in 2019 and started what's believed to be the first FiA chapter in the Northeast.

Both Caitlin and Andrea spoke about their experiences with FiA, and their hopes of getting more women involved. Their interview can be heard here:

Townsquare Sunday is a weekly public affairs program which airs Sunday at 6 a.m. and 11 am. on 1420 WBSM. The program highlights individuals and organizations working to make the SouthCoast a better place to live and work.

If you would like your organization featured on Townsquare Sunday, please e-mail the host at jim.phillips@townsquaremedia.com.

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Fall River's Females in Action Hopes to Expand [TOWNSQUARE SUNDAY] - wbsm.com

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Disclaimer

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TestoPrime Reviews - Testo Prime Testosterone Booster - The Ritz Herald

For Keith Wexelblatt of Massachusetts, it was walking into a full-capacity playoff ice hockey game for his beloved Boston Bruins.

For Eileen Fetterolf of New Jersey, it was smiling at strangers and seeing their whole face smile back.

For Katie Black of California, it was seeing her medical specialists in person.

For many of us, feelings of euphoria are coming quickly as we move back into the things we could do before the COVID-19 pandemic began.

That feeling of joy is chemically based, experts say.

Is it good for us? Like many scientific questions, the answer reads like this: yes, no, or maybe.

There was a layer placed between us and pleasure, Dr. Gail Saltz, a clinical associate professor of psychiatry at the NewYork-Presbyterian Hospital/Weill-Cornell Medical College, told Healthline.

The absence of pain is pleasure, she said. And so many people have been constrained (the basis for much of the pain). The removal of that limitation the unpleasant stimulus is pleasure.

Which means, she said, as we all re-enter normal life, you dont have to summit Mount Everest on your first venture out in the world to feel that joy. With the way weve been locked down and layered away from the world, she said, just about anything triggers joy right now.

For some people, food shopping is pleasure, she said. Looking at the fruits and vegetables set out for us, touching them without worry, when you can do it unrestricted, it is a pleasure for many.

What happens chemically?

Saltz said that the body releases dopamine, which she calls the reward hormone, when it senses a new and pleasurable experience.

This often requires something relatively exciting.

Often in couples counseling, Saltz advises couples to share a new activity or experience for just that reason. Dopamine can trigger that euphoric vibe, something that can help them enjoy one anothers company again.

Dopamine can also pump through the body when a long-time pleasurable experience, simple or grand, is withheld from a person for some time.

The joy we feel is probably intense, too, from the setup we may have experienced over the pandemic year leading up to the experience.

We dont fully realize the toll the loss has taken on us. There is a residue that has built up over the last year, Karen Doll, PsyD, a licensed psychologist in Minnesota, told Healthline.

Lack of stimulation and lack of variety of inputs creates a fog in the brain, she said. As humans, we have a strong need to connect with people in person.

Thats why, beyond dopamine, we may also have more good hormones pumping, and we may feel excited to see just about anyone we know in real life.

The isolation and loneliness have been significant, Doll said. Reconnecting with individuals is having a powerful impact on people and relationships. The increase in oxytocin (love hormone) that occurs when we are connected with people is so important for well-being.

Its not all dopamine and hugs, though.

First, said Saltz, its important we all amp up our compassion mode in real time.

Why? Because, she said, not everyone is at a place of joy.

Its very individual, she said. How close is someone to loss? What psychology did they have heading into this?

She points out that loss has many incarnations. Theres the loss of lives, of jobs, of income, of financial security, and more. Top that off, she said, with the non-pandemic concerns such as racial inequality, and you can see that many may still be having a difficult time.

Realizing and owning that is not only crucial, she said, its humane.

The person you may see who isnt joyful like you, she said, can feel really bad, thinking something is wrong with them (when everyone else seems so happy).

Her advice? As much as you may want to dance through the market aisle hugging everyone you pass, Give yourself and others a lot of space. If youre not feeling it and everyone around you seems to be going woo hoo! it can seem pretty awful.

We could also, said Doll, take the joy vibe too far.

There are risks to letting loose after operating with such restrictions in our environment, Doll said.

She points out that over the pandemic year, our social skills were not put into practice as much and may be languishing a bit.

I heard someone describe it as letting a bunch of caged animals out can be dangerous, she said.

So, we may not be as accurately in tune with our senses and cues that will tell us when we are on the verge of poor choices. Its like our social judgments in public havent been exercised or utilized, so are likely out of tune, Doll said.

What to do? She suggests we remember to take a pause and check in with ourselves, to ensure that we dont overdo it or lose sight of the risks and impact of our behaviors.

It could also, Doll said, lead to letdown.

To avoid a post-joy crash, she said, It can also be helpful to increase our emotional awareness and literacy. Being aware of what we are feeling, how intensely, and what are the triggers can be useful for healthy emotional regulation.

The message? As we savor those hormone highs, we should also take time to adjust.

Coming out of this is going to take time, Saltz said. The idea that we are just flipping a switch is not correct. Set smaller goals.

And if you dont feel a shift toward joy over time? Take action.

The good news? We all, for the most part, should get to joy in time.

These are treatable conditions, she said.

For now, many are savoring the joy of even the most basic.

Its making me so happy to smile at strangers and friends, said Fetterolf.

She works with first graders and has realized a new joy there as well.

I did not realize how much I missed toothless grins and wiggly teeth, she said.

Wexelblatt marvels at how something as joyful all his life as a Bruins playoff game could feel even better. But, he said, it did and it does.

There was an unreal pent-up energy that exploded with fans, he said. A huge sense of almost normalcy. Immense joy.

And for Erin Duggan of Massachusetts, total joy joins with wearing makeup once more.

I can wear lipstick and not just leave it on my mask now, she said. Its the simple things.

Originally posted here:
Post-Pandemic Joy: Why It Feels So Good to Do Simple Things Again - Healthline

Regulators on Friday said a new version of a popular diabetes medicine could be sold as a weight-loss drug in the U.S.

The Food and Drug Administration approved Wegovy, a higher-dose version of Novo Nordisk's diabetes drug semaglutide, for long-term weight management.

In company-funded studies, participants taking Wegovy had average weight loss of 15%, about 34 pounds (15.3 kilograms). Participants lost weight steadily for 14 months before plateauing. In a comparison group getting dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.

"With existing drugs, you're going to get maybe 5% to 10% weight reduction, sometimes not even that," said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the Obesity Medicine Association's chief science officer, helped run studies of the drug.

In the U.S., more than 100 million adults about 1 in 3 are obese.

Dropping even 5% of one's weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn't satisfy patients who are focused on weight loss, Bays said.

Bays said Wegovy appears far safer than earlier obesity drugs that "have gone down in flames" over safety problems. Wegovy's most common side effects were gastrointestinal problems, including nausea, diarrhea and vomiting. Those usually subsided, but led about 5% of study participants to stop taking it.

The drug carries a potential risk for a type of thyroid tumor, so it shouldn't be taken by people with a personal or family history of certain thyroid and endocrine tumors. Wegovy also has a risk of depression and pancreas inflammation.

Wegovy (pronounced wee-GOH'-vee) is a synthesized version of a gut hormone that curbs appetite. Patients inject it weekly under their skin. Like other weight-loss drugs, it's to be used along with exercise, a healthy diet and other steps like keeping a food diary.

The Danish company hasn't disclosed Wegovy's price but said it will be similar to the price of its Saxenda, a weight loss drug injected daily that now typically costs more than $1,300 per month without insurance.

Dr. Archana Sadhu, head of the diabetes program at Houston Methodist Hospital, said Wegovy's usefulness "all depends on what the price will be." She noted patients' health insurance plans sometime don't cover weight-loss treatments, putting expensive drugs out of reach.

Sadhu, who has no connection to Novo Nordisk, plans to switch patients who are obese and have Type 2 diabetes to Wegovy. It makes patients feel full sooner and increases release of insulin from the pancreas to control blood sugar, she said. Patients would then be more likely to get motivated to exercise and eat healthier, she added.

Wegovy builds on a trend in which makers of relatively new diabetes drugs test them to treat other conditions common in diabetics. For example, popular diabetes drugs Jardiance and Novo Nordisk's Victoza now have approvals for reducing risk of heart attack, stroke and death in heart patients.

Phylander Pannell, 49, of Largo, Maryland, joined a patient study after cycles of losing and then regaining weight. She said she received Wegovy, worked out several times a week and lost 65 pounds over 16 months.

"It helped curb my appetite and it helped me feel full faster," said Pannell. "It got me on the right path."

Shortly after she finished the study and stopped receiving Wegovy, she regained about half the weight. She's since lost much of that, started exercise classes and bought home exercise equipment. She's considering going back on Wegovy after it's approved.

Novo Nordisk also is developing a pill version.

___

Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.

___

This story has been corrected to show the length of time study participants lost weight before plateauing was 14 months, not 16 months, and the last name of the Houston physician to Sadhu, not Sudhu.

The rest is here:
FDA approves obesity drug that helped people cut weight 15% - Minneapolis Star Tribune

On June 1, Florida Gov. Ron DeSantis signed a bill into law that would ban trans athletes from participating on female sports teams at the high school and college level. It states that individuals with a biological sex indicated as male on their birth certificates cannot participate on girls sports teams. Several other states have proposed or passed similar legislation, including Mississippi, Minnesota, Idaho, Ohio and Tennessee.

Politicians who support the bans say that this is an issue of fairness and of protecting girls sports. Experts say that this fear is not well supported.

This argument that trans people are somehow going to ruin sports as we know it is not based on anything connected to fact, said Vinnie Pompei, who conducted a survey of LGBTQ+ youth in California for the Human Rights Campaign Foundation, to The Mercury News.

Physician and geneticist Eric Vilain, who has studied sex differences in athletes and advised the International Olympic Committee and the NCAA, said to NPR that the proposed laws are not based in scientific evidence and "target women who have either a different biology or ... simply look different."

Biologists who study genetics, hormones and performance of the human body haveexaminedthis issue for many years. There might be some advantage that biological men have on average, but this does not mean that there is always such an advantage or that there is a benefit to taking a hard line on banning individuals from sports.

We know that men have, on average, an advantage in performance in athletics of about 10% to 12% over women, which the sports authorities have attributed to differences in levels of a male hormone called testosterone, says Vilain to NPR. But the question is whether there is in real life, during actual competitions, an advantage of performance linked to this male hormone and whether trans athletes are systematically winning all competitions. The answer to this latter question, are trans athletes winning everything, is simple that's not the case.

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Although experts have been researching hormones and athletic ability for years, theres no consensus on what really affects a persons ability to perform.

The science of whether testosterone in real life is actually providing an advantage in competition is not clearly established, says Vilain to NPR.

Theres no scientific evidence that someone who was assigned male at birth would definitively have a competitive advantage over someone who was assigned female at birth. Both women and men have a wide range of physical capabilities, and its likely that athletic performance is much more complex than hormones and genetics.

Another important point is that women who may look different may be asked to prove their sex in order to compete under these laws. In a letter to South Dakota Gov. Kristi Noem (R), the National Womens Law Center writes, the proposed ban for the state would not only exclude transgender students from sports but would also harm cisgender girls and women who fall outside stereotypical notions of femininity, simply because they are very tall or muscular, have short hair, wear masculine clothing, or otherwise choose to present in more traditionally masculine ways.

If, as many of these lawmakers claim, fairness is their goal, they should turn their attention to the unfair advantages many cisgender, white athletes receive by virtue of little more than their zip codeincluding the remaining gap in resources between boys and girls programs, according to the National Womens Law Center.

Trans youth are hearing powerful politicians say that their identities are invalid and that they are a threat to their peers, says Jack Turban, a Fellow in Child & Adolescent Psychiatry at the Stanford University School of Medicine, to The Mercury News. Though they may know this is not true, hearing it over and over takes a serious toll and can drive anxiety and depression. As a therapist who treats these young people, it is heartbreaking to see.

In Florida, the Human Rights Campaign plans to sue Gov. DeSantis over the new legislation.

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Laws banning trans athletes from competing in girls' and women's sports not grounded in science, say experts | TheHill - The Hill

Two weeks after saying the breast cancer hopeful amcenestrant could be at the forefront of future treatments, Sanofi has secured partners for a phase 3 trial to study the drug versus the hormone therapy tamoxifen.

The Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and the Alliance Foundation Trials (AFT) will initiate the pivotal trial with the French Big Pharma.

The AMEERA-6 study will look at amcenestrant versus tamoxifen, a hormonal therapy approved by the FDA in 1998 for women with estrogen receptor-positive breast cancer who prematurely ended standard therapy and are susceptible to a return of the disease.

Amcenestrant, which is an oral selective estrogen receptor degrader (SERD), has the potential to become a best-in-class oral endocrine backbone therapy, said Peter Adamson, M.D., global head of oncology development at Sanofi, in a statement.

RELATED: Sanofi says early amcenestrant data could see it be endocrine backbone therapy in breast cancer

The add-on therapy aims to prevent and slow down disease progression. Current adjuvant therapies, like aromatase inhibitors, have side effects that lead some women to end medication early, said David Cameron, BIG executive board chairman, in a statement.

Sanofi will provide funding and the investigational drug for the global study as the sponsor, while Brussels-based BIG will do the study within its network. EORTC, an academic contract research organization, will manage the study, data analysis and medical management. AFT, a cancer clinical trial research organization, will handle the U.S. portion of the study.

Two weeks ago, Sanofi presented pooled data of amcenestrant from the phase 1 AMEERA-1 trial, which hit an objective response rate of 34% and a clinical benefit rate of 74% when combined with Pfizers approved breast cancer med Ibrance.

As part of the American Society of Clinical Oncology presentation last month, Sanofi said AMEERA-3, a potential registrational study attempting to show amcenestrant is superior to physicians choice in a second-line setting, was delayed from the second quarter to the latter half of this year.

Analysts from Jefferies have been impressed by the early data from the AMEERA-1 program but said the AMEERA-3 delay "does not help build confidence in establishing belief in the pipeline."

Sanofi will not be first in the SERD gameAstraZeneca'sFaslodex holds that titlebut the French drugmaker hopes to avoid the pitfalls of the 20-year-old med that had to be delivered through intramuscular injection. This painful delivery mechanism held back sales.

Jefferies estimates the SERD market is a $2 billion to $3 billionopportunity.Sanofi is going up against Roche in trying to bring a new SERD through the clinic as well as AstraZeneca, which has a second-generation therapy in the works.

Read more here:
Sanofi inks partners for phase 3 pivotal trial of add-on breast cancer therapy - FierceBiotech

Dispatches from the Reproductive Revolution 2. At the request of a leading abortion provider, a doctor in the UK has been banned by the Medical Practitioners Tribunal Service from helping women to reverse the effects of their chemical abortions. He could be deregistered.

As often happens, this story is a tangled one. Bear with us.

During the UKs first lockdown, abortion providers lobbied to send chemical abortion drugs to women through the postal service. They would never see a doctor; instead, they just took two pills and waited for the foetus to be expelled.

Some women regretted their impulsive decision as soon as they had taken the first pill. For them, Dr Dermot Kearney prescribed progesterone, a hormone for treating natural miscarriages, in an attempt to cancel the effects of the abortifacient, mifepristone. This is an off-label use of progesterone.

He claims that of 73 women, 38 of them managed to hold on to their babies -- a success rate of almost 50%.

According to the Daily Mail, MSI Reproductive Choices, formerly known as Marie Stopes International, filed a complaint. It claimed that Dr Kearney inappropriately prescribed progesterone to a patient for a use not backed by evidence, failed to present a balanced picture of its benefits and risks, and imposed his anti-abortion beliefs on her.

Andrea Williams, chief executive of the Christian Legal Centre, said: Babies are alive today because mothers reached out to Dr Kearney and he provided effective and safe abortion rescue. This ruling punishes the life saver, is deeply wrong and needs to be overturned.

Dr Kearney, a cardiologist and emergency physician and the president of the Catholic Medical Association, has been told by the MPTS that he must not prescribe, administer or recommend progesterone for abortion reversal treatments. Otherwise, he can continue practicing until the hearing.

Michael Cook is editor of BioEdge

Read more here:
UK doctor banned from reversing chemical abortions - BioEdge

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Trodelvy More than Doubled Overall Survival as Second-Line Treatment in New ASCENT Subgroup Analysis

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the Phase 3 ASCENT study evaluating Trodelvy (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC). In this subgroup analysis of brain metastases-negative patients who received only one line of prior systemic therapy in the metastatic setting in addition to having disease recurrence or progression within 12 months of (neo)adjuvant chemotherapy, Trodelvy improved progression-free survival (PFS), with a 59% reduction in the risk of disease worsening or death (HR: 0.41; 95% CI: 0.22-0.76) and a median PFS of 5.7 months (n=33) versus 1.5 months with chemotherapy (n=32). Trodelvy also extended median overall survival to 10.9 months versus 4.9 months with chemotherapy (HR: 0.51; 95% CI: 0.28-0.91). The results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1080).

In patients with relapsed or refractory metastatic triple-negative breast cancer, outcomes are typically poor especially among patients who progress within 12 months of (neo)adjuvant chemotherapy, said Lisa Carey, MD, Medical Director of the UNC Breast Center, the Physician-in-Chief of the North Carolina Cancer Hospital and Associate Director of Clinical Research at UNC Lineberger Comprehensive Cancer Center. In the Phase 3 ASCENT study, Trodelvy was the first treatment to demonstrate a proven survival advantage in pre-treated patients with locally advanced or metastatic TNBC, and the analysis presented at ASCO reaffirms this benefit over standard of care with important new data in the second-line setting.

Additional results showed Trodelvy demonstrated a higher overall response rate compared with chemotherapy (30% versus 3%). Efficacy results from this subgroup were consistent with those observed in the overall ASCENT study population.

The safety profile of Trodelvy in this subgroup was consistent with prior reports. The most frequent Grade 3 treatment-related adverse reactions for Trodelvy compared to chemotherapy were neutropenia (61% versus 21%), leukopenia (9% versus 0%), diarrhea (6% versus 0%), anemia (3% versus 6%), and fatigue (3% versus 0%). One patient in this subgroup who received Trodelvy experienced febrile neutropenia. Adverse reactions leading to treatment discontinuation were low across both groups (6% in each). There were no treatment-related deaths with Trodelvy in this subgroup. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.

With Trodelvy, we continue to challenge the standard of care in locally advanced and metastatic TNBC. The efficacy observed in the second-line metastatic setting with Trodelvy is highly meaningful, since many patients will progress quickly following chemotherapy. Among these patients, we see median overall survival more than doubled where need is particularly great, said Daejin Abidoye, MD, Senior Vice President, Head of Oncology Clinical Development, Gilead Sciences. We are committed to improving the prognosis for people with this aggressive cancer, and as we continue to study Trodelvy, we are encouraged by this proven efficacy in TNBC.

Two additional ASCENT subgroup analyses that support the efficacy benefit of Trodelvy were also presented at the meeting one evaluating Trodelvy efficacy by patients age (Abstract #1011) and the other comparing Trodelvy with specific single-agent chemotherapy chosen by the patients treating physicians (Abstract #1077).

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive type of breast cancer, accounting for approximately 15% of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is more prevalent in African American and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Medicines targeting these receptors therefore are not typically effective in treating TNBC.

About the ASCENT Study

The Phase 3 ASCENT study, an open-label, active-controlled, randomized confirmatory trial, enrolled more than 500 patients with relapsed/refractory metastatic triple-negative breast cancer who had received two or more prior systemic therapies, including a taxane, at least one of them for metastatic disease. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients treating physicians. The primary efficacy outcome was PFS in patients without brain metastases at baseline, as measured by a blinded, independent, centralized review using RECIST v1.1 criteria. Additional efficacy measures included PFS for the full population, including all patients with and without brain metastases, and overall survival. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including metastatic triple-negative breast cancer and metastatic urothelial cancer, where high expression is associated with poor survival and relapse.

In the U.S., Trodelvy is indicated for the treatment of:

Beyond the regulatory approvals of Trodelvy in the U.S., regulatory reviews for Trodelvy in metastatic triple-negative breast cancer are currently underway in the EU, U.K., Canada, Switzerland and Australia, as well as in Singapore through our partner Everest Medicines. Trodelvy is also being investigated as potential treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

U.S. Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 61% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 47% of patients. Febrile neutropenia occurred in 7%. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever.

Diarrhea: Diarrhea occurred in 65% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion medication is recommended. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 66% of all patients treated with Trodelvy and Grade 3 nausea occurred in 4% of these patients. Vomiting occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.

ADVERSE REACTIONS

In the ASCENT study (IMMU-132-05), the most common adverse reactions (incidence 25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence 25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPHY study (IMMU-132-06), the most common adverse reactions (incidence 25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite, constipation, vomiting, abdominal pain, and rash. The most frequent serious adverse reactions (SAR) (5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence 25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.

Please see full Prescribing Information, including BOXED WARNING.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gileads ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Trodelvy; the possibility of unfavorable results from ongoing or additional trials, including those involving Trodelvy; Gileads ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of Trodelvy for the treatment of metastatic TNBC, metastatic breast cancer, metastatic UC, metastatic non-small cell lung cancer and other solid tumors, and the risk that any such approvals may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

U.S. Prescribing Information for Trodelvy including BOXED WARNING, is available at http://www.gilead.com.

Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the companys website at http://www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210604005059/en/

Jacquie Ross, Investors(650) 358-1054

Nathan Kaiser, Media(650) 522-1853

Source: Gilead Sciences, Inc.

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Trodelvy Demonstrates Superior Outcomes to Standard of Care in Second-Line Treatment of Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT...

You're about to hear advice from the last people you'd ever want to meet. Oncologists specialize in the diagnosis and treatment of cancer. If you're talking to one, and you're not at a dinner party, you might be one of the 100 million folks around the world who have it. With those staggering stats, you might think getting cancer is an inevitably. It isn't. Read onand to ensure your health and the health of others, don't miss these 19 Ways You're Ruining Your Body, Say Health Experts.

"I am very careful about keeping up with proven cancer screening interventions," says Amy Tiersten, MD, clinical breast medical oncologist at Mount Sinai. She stays current on preventative tests like colonoscopy, skin cancer exams, and gynecologic follow-ups.

Late diagnoses are a leading cause of premature death due to cancer. Interventions, like those Dr. Tiersten recommends, allow for early detection and diagnosis where patients can start treatment earlier. This is especially impactful in breast, cervical, and colorectal cancers.

The American Cancer Society recommends:

Ten years after the HPV vaccine was introduced, there is "compelling evidence" that we're on track "to eradicate cervical cancer within decades." A June 2019 study reviewed 60 million individuals', mostly girls and women, eight-year post-vaccination status and found that the vaccine has exceeded expectations.

The CDC recommends both boys and girls get the HPV vaccine at ages 11-12, with the second dose within a year. It's recommended up to age 26 for women and age 21 for men.

Newer versions of the vaccine require two doses instead of three, ensuring adherence to the full vaccination schedule. As well, it's gender-neutral and targets more HPV strains.

Exercise every single day that's the walk Kathryn Schmitz, Ph.D., a leading exercise oncology researcher at Penn State University, walks and talks. "We oncologists run, walk, or roll our way to cancer prevention," she said, citing research that supports a relationship between physical activity and cancer prevention. She's the biggest proponent of strength training, something she introduced in the chemo lab at Penn State Cancer Institute and shares as "exercise snacks" each week on her Instagram. "I try to exercise 30 minutes a day to stay fit. We know that regular physical exercise does reduce cancer risk in many cases. Decreasing your body weight, even by 5%, can make a big difference in terms of cancer risk," says Xavier Llor, MD, Medical Director of the Cancer Screening and Prevention Program.

RELATED: The #1 Reason You Could Get Cancer, According to Science

"Embrace your social networks; recognize who loves you and let them in," is how Dr. Don Dizon, MD, FACP, FASCO, director of medical oncology at Rhode Island Hospital and Professor of Medicine at Brown University prevents cancer. He says it's well-established that whether your social network includes a spouse, kids, best friend, or church, these connections are key to good health and that social isolation is associated with an increased risk of death.

"In one study, social isolation scores were associated with risk of death from heart disease and in all-cause mortality. This was true for men and women, Blacks and whites."

As an oncology clinical pharmacist, there are several things Allison Baxley, PharmD, BCOP of Stephenson Cancer Center does to prevent cancer. She recognizes that many elements are out of our control, like genetics, so she does all she can to reduce the risk through things she can control.

"Working primarily in GI oncology, I'm very aware of the link between colon cancer and processed and red meat consumption. I eat these in moderation, and rarely if ever eat highly processed meat like hot dogs and bacon."

She avoids what Micahel Pollen has called "edible food-like substance," which is the majority of what's in the center aisles of the grocery store.

RELATED: Signs You're Getting One of the "Most Deadly" Cancers.

Our daily diet choices play a powerful role in cancer prevention, reminds Dr. Terry Wahls, author of The Wahls Protocol series. For optimal cancer prevention, she aims for 9 cups of plant-based foods each day: 3 cups of greens, 3 cups of sulfur-rich foods like cabbage, onions, or mushrooms, and 3 cups of color from berries.

"We can choose to eat more greens and non-starchy vegetables and berries to markedly reduce the risk of developing cancer (and surviving cancer if it is diagnosed)," she explains. "Or we can choose the standard American diet, full of sugar and flour, which drives up insulin and insulin-like growth hormone and have a much higher risk of pre-cancers and overt cancers."

LaShyra "Lash" Nolen, an MD candidate at Harvard Medical School, points out that Black women have a disproportionately higher rate of mortality from breast cancer than white women, according to 2016 research.

"Therefore, I think it is so important for me, as a young Black woman, to take agency over my body," shared Nolen. "One way I do this is by regularly performing a physical exam of my breasts to search for abnormalities or unusual lumps."

She adds that, sometimes, women allow others to know their bodies better than they do themselves, but that this has to change in order to detect cancers at earlier stages and improve outcomes.

As an American Cancer Society Research Professor and Associate Dean for Oncologic Sciences at Brown University, Dr. Wafik El-Deiry says it's important to remember that half of all cancer is preventable. One of his preventive efforts is to limit or moderate alcohol consumption, as alcohol has been linked to cancers of the mouth, throat, liver, colon, breast, and others.

"Be aware and keep in the back of your mind that this is a substance that can do harm," he advises. El-Deiry says there's a lot of evolving and emerging data on the association between alcohol and cancer, but that the relationship does exist.

How much is too much? The American Cancer Society advises no more than 2 drinks per day for men and 1 drink per day for women.

Jeffrey Meyerhardt, MD, MPH, medical oncologist for the Dana-Farber Cancer Institute, works hard to maintain a healthy body weight. He cites consistent evidence in observational studies that link obesity and higher BMI with a variety of cancers, including colorectal, ovarian, and pancreatic.

In particular, he cited a 2003 study that analyzed the relationship between body weight and mortality from cancer in nearly one million American adults. When the heaviest participants had a BMI of 40, death rates from all cancers were 62% higher in women and 52% higher in men when compared to those of "normal weight."

RELATED: The #1 Cause of Obesity, According to Science

"I eat a balanced diet of real food. The less processed, the better!" says Allison Betof Warner, MD, Ph.D. of Memorial Sloan Kettering Cancer Center. Of course, this melanoma medical oncologist splurges and doesn't always eat healthy (like the rest of us!), but when she does, moderation is key.

While no single food can prevent cancer, a well-rounded diet with a variety of vegetables, fruits, and grains can go a long way toward risk reduction.

"I try to live by the 80/20 rule," she caveats. That's 80% whole, healthy foods in balanced proportions and 20% treats and other "less" healthy stuff.

"I make sure to get plenty of Vitamin D," says Kevin Dawravoo, MD, hematologist and medical oncologist at Northwestern Medicine Cancer Center Warrenville. He cites numerous studies that support the anti-cancer effects of this nutrient. Anyone can check for a vitamin D deficiency with a simple blood test at their doctor's office. That deficiency was linked in a 2014 study to a greater risk for more aggressive prostate cancer.

The best source for vitamin D is the sun, but new research says sunblock does not compromise the absorption of the vitamin. Fish is the best food source for vitamin D, including salmon, rainbow trout, and swordfish, as well as fish oil/cod liver.

Most Americans are "woefully sleep deprived," says Dr. Stephen C Schimpff, MD, MACP. Board certified in medical oncology, Schimpff is sure to "get enough sleep" each night. It's a subject important enough that he addresses it in his book, Longevity Decoded The 7 Keys to Healthy Aging.

"Inadequate sleep predisposes to high blood pressure, stress, overeating [in general] and the wrong foods, obesity, and hence predisposes to cancer," he continued

Monisha Bhanote, MD, FASCP, FCAP meditates regularly, a practice she says can "help balance life's daily stressors." The most benefit is gained from daily practice, even if just five minutes, than if done sporadically.

The triple board certified physician at Baptist MD Anderson Cancer Center says, "Managing stress is important for preventing chronic disease and predisposing one to cancer. Stress weakens the immune system and lowers its defenses to fight diseases." Consistent meditation can move the body into a parasympathetic state (rest and energy conservation) as opposed to a continuous sympathetic state (aka fight or flight).

Bhanote cited a 2004 study that found chronic stress can impair the body's immune response and contribute to the development of cancer.

A variety of sources like cell phones, wifi, power lines, and battery-powered cars bombard us every day with EMFs, or electromagnetic fields. Dr. Jonathan Stegall, an integrative oncologist and medical director of The Center for Advanced Medicine in Atlanta, says he tries to limit his exposure to EMFs.

"I recommend that my patients not hold a cell phone up to the ear, and instead hold it away from the body using speaker phone. This significantly minimizes the amount of radiation absorbed by the body," advises the author of the bestselling book Cancer Secrets. He also recommends installing a timer on any WiFi modem/router at home so that it turns off while you are sleeping.

RELATED: The #1 Reason You Could Get Cancer, According to Science

It's family first for Dr. Timothy S. Pardee, chief medical officer, Rafael Pharmaceuticals and oncologist and director of Leukemia Translational Research at Wake Forest Baptist Health. He believes this time is super important, and notes that familial relationships can reduce stress and increase overall well being.

A global study found that larger families, those with many children, have a reduced risk of cancer. And that's not just the nuclear family. Larger household sizes with multiple generations living together enjoy that same protective benefit. The study authors cite the "special emotional environment" as having a positive effect that contributes to disease resistance, as well as the benefit of family members supporting each other in a healthy lifestyle.

Did you know you can get paid to prevent cancer? Roshni Rao, MD, Chief of the Division of Breast Surgery at New-York Presbyterian Hospital and Columbia University Medical Center and says even she participates in clinical trials. "I was part of an MRI trial where I was in [the] machine for over an hour, and I got paid $25!," she said.

She's also participating in the T-MIST trial, a national study working to identify how often women should get mammograms and what type of mammogram to get. Rao says this trial is currently open at Columbia and seeking up to 165,000 women to participate.

"I drink a few cups of green tea or coffee every day," says William W. Li, MD, author of Eat to Beat Disease: The New Science of How Your Body Can Heal Itself. After 20 years of cancer prevention research, he says he's well aware of the scientific evidence that points to tea and coffee doing the body good.

They each "contain different types of polyphenols (micronutrients from plant-based food), but they all activate our body's key health defense systems (starving cancer, feeding our healthy gut bacteria, repairing damaged DNA, improving immunity) that help us resist cancer. From lab studies to clinical trials to large-scale public health studies showing that tea or coffee lowers risk across different forms of cancers, I consider it a no-brainer to drink these beverages." And it's a cherry on top that he loves the taste!

The lead authors of a large-scale study from the University of Glasgow in 2018 now know it's best to keep screentime to a minimum. They analyzed nearly 400,000 people and found a strong correlation between higher screentime and a higher risk of all-cause mortality, cardiovascular disease, and cancer. This was independent of known cancer-causing factors like smoking, BMI, and diet.

The more discretionary, or leisure, time spent on tablets, smartphones, and other media devices directly contributes to a sedentary lifestyle, the result of which is lower physical fitness, grip strength, and overall poor health.

RELATED: I'm A Doctor And Warn You Never Take This Supplement

Nearly half the deaths from an astounding 12 different cancers can be attributed to smoking cigarettes: liver, colorectal, lung, oral and throat, esophageal, larynx, stomach, pancreas, bladder, kidney, cervix, and acute myeloid leukemia. That's why it's a smoke-free life for Dr. Wafik El-Deiry, Associate Dean for Oncologic Sciences at Brown University. While fewer people smoke in 2019, plenty are still addicted to one of the single-most unhealthy habits.

He does note that quitting smoking can have a positive impact, but that the risk never fully goes away compared to the general population. It can take 8-10 years to truly minimize the risks associated with cigarette smoking.

Likewise, Dr. El-Deiry isn't vaping, either.

"The message needs to get out that [vaping] is potentially cancer causing and we have to be aware," he warns. "The more we talk about itto save anyoneis worth it."

He says the more we learn about vaping the more we realize how unsafe it is in different ways. The vapor exposes users to chemicals known to cause cancer, for instance. And while e-cigs have their place for smokers trying to quit, the vape pens aren't benign. El-Deiry reminds that no substantial research has yet been completed on the relationship between vaping and cancer.

The National Institutes of Health warns that teens are vaping in record numbers; higher than opioid or marijuana use.

Dr. Katherine Crew, director of the Clinical Breast Cancer Prevention Program at New York-Presbyterian and Columbia University Medical Center, walks at least a mile every day. "For a busy oncologist, it's not always easy to find time to lead a healthy, active lifestyle, but I try to incorporate it into my daily routine."

Each of those steps is worth the time. Walking a single mile each day at a moderate 20-minute pace can reduce mortality in breast cancer patients by as much as 40% and almost 30% in prostate cancer patients. Risk for endometrial cancer is also reduced by a moderate intensity walking regimen.

Dr. Crew also takes the stairs "whenever it's humanly possible" to gain an extra burst of physical activity in her day.

RELATED: 9 Everyday Habits That Might Lead to Dementia, Say Experts

As an exercise oncologist, Kathryn Schmitz, PhD gets as much movement as she recommends. Before heading outdoors though, "I slap on the sunscreen, since exercise increases the risk of melanoma by 28%." While this 2016 study found that exercise reduces the risk for 10 different cancers, it increased risk for malignant melanoma significantly.

Schmitz echoed the researchers' assumption that increased time exercising or enjoying leisure physical activity increased exposure to the sun, which in turn increased the incidence of skin cancer. If you're spending time outside, be sure to wear a broad spectrum sunblock with SPF 30 or higher and remember that "water resistant" is not the same as "waterproof."

Making "greener" choices can ultimately support everyone's goal to reduce their risk of cancer. Climate change is having a negative impact on more than just the earth's health and sustainability. Human life is taking a negative toll, too.

Stratospheric ozone depletion is implicated in an increase in skin cancer incidence, like melanoma, and scientists expect to see a continuation over the next couple of decades.Exposure to air pollution increases the risk of breast cancer in premenopausal women. And the very air we breathe has been deemed carcinogenic by WHO, citing a direct correlation to nearly a quarter-million lung cancer deaths in 2010 alone.

How much "good" fat do you have in your diet? It's something Dr. Stephen C Schimpff, MD, MACP, author of Longevity Decoded The 7 Keys to Healthy Aging, prioritizes in his own diet. He recommends avocado, nuts and seeds, olive oil, and fish like tuna and salmon.

What makes a fat good for you? These unsaturated fats remaining liquid, not solid, at room temperature and are generally derived from plants.

Tree nuts like almonds, walnuts, and pecans can decrease your risk of colon cancer, which is why Kevin Dawravoo, MD, hematologist and medical oncologist at Northwestern Medicine Cancer Center Warrenville, makes them a regular part of his diet.

For men and women, a 2018 study found a "statistically significant" link between eating nuts three times per week and a reduction in colorectal cancer risk.

Another 2018 study found that stage 3 colon cancer patients who had two 1-ounce servings of tree nuts (which included walnuts, cashews, almonds, pistachios, hazelnuts, pecans macadamia nuts, and Brazil nuts) each week were 42% more likely to experience disease-free survival and 57% greater chance of overall survival.

Turn up the flavor experience of roasted vegetables, rice, soup, smoothies, and tea by adding turmeric. This Indian spice, most common in curries, has an earthy sweet-pungent flavor and bright orange hue that can truly transform any food. That, and the cancer-preventative benefits, are why Roshni Rao, MD, Chief of the Division of Breast Surgery at New-York Presbyterian Hospital and Columbia University Medical Center, loves to eat turmeric-laden foods.

"Most of the studies do show a benefit from this anti-inflammatory, and there is no study that shows that it is detrimental," she says.

A 2015 study reviewed the multifaceted role of curcumin (the source of turmeric) in cancer prevention, and found that it can "suppress initiation, progression, and metastasis of a variety of tumors."

The plastics we brush our teeth with, eat and drink from, build toys with, type on, and so much more inundate every aspect of our lives, but the chemicals within are taking away our health and mortality. Especially when plastics are heated or scratched, they can leach the chemicals used to develop the products. Once inside our bodies, these chemicals, like BPA, disrupt the natural role of hormones and create an imbalance that can ultimately lead to cancer.

"BPA has been shown to play a role in the [development of]hormone-dependent tumors such as breast and prostate cancer," states a 2015 study that reviewed the health risks associated with exposure to bisphenol A.

Avoid plastics whenever possible by looking for BPA-free products and carrying reusable glass or steel drinking vessels. Do not cook or reheat food nor store hot food in plastic containers.

"Especially important in the summertime is decreasing charred food consumption," says Kevin Dawravoo, MD of Northwestern Medicine Cancer Center Warrenville. Reminding that the blackened char marks on grilled meat is a known carcinogen. It's something he rarely eats.

The concern is that when meat is cooked over open flame, and burned or blackened, chemicals known as HCAs and PAHs develop. When consumed these can alter a person's DNA which increases the risk of cancer.

In rodent studies, HCAs developed tumors breast, colon, liver, skin, lung, prostate, and other tumors. Similar rodent studies found that PAHs caused leukemia, and identified gastrointestinal and lung tumors. In epidemiologic studies, higher consumption of well-done and "barbecued" meat was linked to increased risk of colorectal, pancreatic, and prostate cancers.

RELATED: Everyday Habits That Make You Look Older, According to Science

You might be bored answering all of your doctor's questions about your parents' and grandparents' health, but it truly matters. Dr. Wafik El-Deiry, Associate Dean for Oncologic Sciences at Brown University, knows his family history and strongly recommends that you do the same.

"Illnesses that are found in the family can be a major clue to what risks there are," he says, adding that a history of cancer is usually well known and not difficult to learn about.

Sharing your family history with your doctor means they can do additional screening sooner, and work to catch symptoms and tumors earlier, which is key in treating and curing cancer.

"This knowledge may also direct patients to genetic testing that can further help to figure out different options to manage the risks," he added.

"Read your mammography results letter. In many states, including Connecticut, we, as radiologists are required to inform the patient whether or not her breast tissue is dense. If your breast tissue is dense, talk to your doctor about whether you need additional tests: a screening ultrasound or possibly even a screening MRI, the latter being a useful complementary screening tool in some women at higher than average risk of developing breast cancer. Please note that screening ultrasounds and screening MRIs do not replace mammography; rather, they are a complement to it," says Liva Andrejeva-Wright, MD, a Yale Medicine radiologist who specializes in breast imaging.

"It is important to know that screening mammograms do not prevent breast cancer. They do help by detecting cancer early in many cases, before it becomes palpable, however, and therefore prevent disease and treatment related morbidity that would have occurred if the cancer was detected later by the patient or her doctor," she added. And to get through this pandemic without catching coronavirus, don't miss this essential list: Most COVID Patients Did This Before Getting Sick.

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Slash Your Cancer Risk in Seconds, Say Cancer Experts | Eat This Not That - Eat This, Not That

Cases of type 2 diabetes have been significant and on the rise within the past decade. This condition is restrictive in some ways. Individuals are deprived of the ability to enjoy their preferred foods and are likely to experience intense symptoms (i.e., thirst, hunger, faintness, and blurred vision, among others). Several solutions have come and gone, but one natural supplement appears to have taken a unique approach that might end up reversing diabetes altogether. This supplement is none other than Glucofort.

Glucofort is an advanced blood sugar support that eliminates the supposed root cause of type 2 diabetes: ceramides. As explained by the creators of this solution, Andrew Freeman and Dr. Jun, ceramides push fat cells into the bloodstream, forcing vital organs to clog up. This prevents the pancreas from producing the insulin hormone, a crucial component that redistributes glucose to other body areas. It is only when these foreign invaders are eliminated from the body that diabetes might be reversed altogether. Hence, the reason for Glucofort.

The Glucofort formula has been split into a vitamins and minerals blend and a proprietary blend. The first includes Vitamin C (50mg), Vitamin E (15mg), Biotin (300mcg), Magnesium (125mg), Zinc (7.5mg), Manganese (1mg), Chromium (76mcg) and Vanadium. As for the proprietary ingredients blend, individuals can familiarize themselves with Guggul, Bitter Melon, Licorice, Cinnamon, Gymnema Sylvestre, Alpha Lipoic Acid, Banaba, Yarrow, Juniper, White Mulberry, L-Taurine, and Cayenne.

Guggul: According to a 2020 article in the International Journal of Research in Pharmaceutical Sciences, Guggul divided into nine groups, rats were given Diabetes mellitus, over a 28 week period, Blood collected showed that guggul did not reveal toxicity in the rats, and guggul formulations improved oral glucose tolerance in the diabetes-induced rats and after the end of the study resulted in significant reductions in serum glucose levels.

Bitter Melon: The US National Library of Medicine National Institutes of Health states that medicinal plants are important cost-effective worldwide to treat diabetes and are considered therapeutic aids in alleviating ailments in humans. Bitter melon is reported to possess pancreatic cell regeneration, insulin-releasing, and fighting insulin resistance.

Licorice Root: An herb that has been used for decades to treat many health ailments. Scientists have identified a group of natural substances with anti-diabetic effects found in the licorice root.

Cinnamon Bark: Known as true cinnamon, studies show that cinnamon can effectively manage blood sugar issues, such as lower blood sugar, and may help control high blood glucose levels in the brain.

Gymnema Sylvestre: Supports lowering of high blood sugar levels. And may play a role in diabetes treatment, as it may regenerating pancreas islet cells and stimulate insulin secretion, which help lower blood sugar levels.

Alpha Lipoic Acid: Can break down carbs and make energy for use in other organs in the body, and an antioxidant.

Banaba: The banaba leaf has been used in folk medicine for decades to treat diabetes used for its impressive anti-diabetic properties, antioxidant, cholesterol-lowering, and anti-obesity health benefits.

Yarrow: Used to regulate blood sugar in diabetes, protect the gallbladder and liver, and as immune-system support.

Juniper Berry: May hold antidiabetic properties and used in traditional medicine to treat diabetes, with recent studies confirming that they may have anti-diabetic properties.

White Mulberry: Used to treat high cholesterol, common colds, high blood pressure, joint, and muscle pain caused by arthritis. White mulberry can be used against hair loss and premature graying, constipation, dizziness, and ringing in the ears.

L-Taurine: Taurine can helps by avoiding the damaging effects of fat, glucose, and excess insulin levels; it also protects and strengthens the heart muscle cells.

Cayenne: Scientifically proven to boost metabolism, lower blood pressure with the capsaicin found in cayenne peppers can also reduce hunger.

Generally speaking, Glucofort is deemed 100% natural, safe, and effective to take. In fact, this formula has supposedly undergone testing with 160 men and women who were either pre-diabetic, diabetic, or have had diabetes for some time now. The study results suggest that glucose levels improved, weight and fat loss were attained, blood pressure and sugar levels were lowered, and cardiovascular and cognitive health bettered with time. That said, no side effects were reported. All things considered, a health practitioners opinion should be gathered before adding any extra supplements.

Given that one capsule should be taken per day and each bottle contains 30 capsules, individuals can expect to invest roughly $69 per bottle. Bulk orders such as purchasing 3 or 6 bottles at once will come out to $59 and $49 each, respectively. Luckily, all unused bottles have been protected by a 60-day money-back guarantee, making Glucofort risk-free.

Blood sugar is a health biomarker that needs to be taken care of, as it can easily worsen and lead to unwanted health implications. With a solution like Glucofort, symptoms may be eased in the short run and reversed in the long run. In this case, patience is key, and everyone will need to consider their health conditions and possible medication interactions beforehand. To find out more about Glucofort, visit here>>>.

More Like This: What is Gluco Shield Pro?

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Please understand that any advice or guidelines revealed here are not even remotely a substitute for sound medical advice from a licensed healthcare provider. Make sure to consult with a professional physician before making any purchasing decision if you use medications or have concerns following the review details shared above. Individual results may vary as the statements made regarding these products have not been evaluated by the Food and Drug Administration. The efficacy of these products has not been confirmed by FDA-approved research. These products are not intended to diagnose, treat, cure or prevent any disease.

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GlucoFort Reviews: Does GlucoFort Work? What They Won't Say! - Homer News

Introduction

Prostate cancer is the fifth most common cancer in Thai men,1 and the number of cases continues to increase despite active screening. Radical prostatectomy (RP) is the standard of care in the management of clinically localised cancer and also an option for the treatment of locally advanced prostate cancer. RP can be performed using open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), or robotic-assisted laparoscopic radical prostatectomy (RALRP) techniques.

Another recognised treatment for regional and metastatic prostate cancer is androgen deprivation therapy (ADT). ADT is also a beneficial supplement to external beam radiation therapy (EBRT).2 However, the use of neoadjuvant androgen deprivation therapy (NADT) prior to RP as a perioperative treatment is still controversial.2 Previous research has demonstrated that NADT lowers the positive margin status, but this benefit has not translated into improvements in long-term PSA-free survival.3 NADT is also associated with worrisome side effects, such as osteoporosis, hot flashes, sexual dysfunction, metabolic syndrome, gynecomastia, anaemia and cardiovascular mortality. For all these reasons, current guidelines recommend against the use of NADT prior to RP.2,4,5

In the past few years, a growing trend has emerged towards the utilization of NADT, as it can provide a pathological complete response,6 a potentially positive impact on recurrence rates,7 a significant decrease in prostate cancerrelated death8 and fewer long-term effects on quality of life.9 The aim of the present study was to determine the benefit of NADT prior to RP in terms of perioperative outcomes.

Between January 2008 and July 2018, 718 prostate cancer patients were treated by RP at Ramathibodi Hospital in Thailand. Of these patients, 138 had undergone NADT (NADT group) and 580 had not undergone neoadjuvant ADT (non-NADT group). The remaining 2 patients were excluded from the study due to incomplete data. The principles of the Helsinki Declaration were followed during the study, consent and the confidentiality of the patients data was maintained by the authority of the Committee for Research of the Faculty of Medicine, Ramathibodi Hospital, Mahidol University (date of approval: 20 February 2020, ID MURA2020/298).

The ORP was performed in a retropubic fashion via low midline incision (Figure 1). A retzius space was approached with blunt and sharp dissection along the outside of left umbilical ligament. Endopelvic fascia on both sides were bluntly opened, puboprostatic ligament was dissected and dorsal venous complex was sutured and ligated using Vicryl No.1. The bladder neck was incised with monopolar cautery then foleys catheter was pull and traction. The seminal vesicle and vas deferens were dissected. Denonvilliers fascia was opened and the posterior surface of prostate was freed. The lateral prostatic pedicles were dissected with monopolar cautery and ligated without nerve sparing, followed by incised of urethra by Metzenbaum scissor. An urethrovesical anastomosis was performed with interrupted sutures, using Vicryl 3/0 6 stitches. Before the last stitch was performed, new 20 Fr Foleys catheter was inserted via urethra into bladder. Bleeding was checked and stopped. Silastic drain was placed in cul-de-sac.

Figure 1 Incision of open radical prostatectomy.

The LRPs were performed in an extraperitoneal fashion using 5 trocars with some modification in port position to facilitate the prevention to graft injury (Figure 2). Subumbilical incision was done and extraperitoneal space was created using kidney-shaped balloons with (PDB, Covidien, United States). Retropneumoperitoneum was performed by CO2 insufflation to create at an abdominal pressure of 15 mmHg, followed by port placement as Figure 2, all trocars were inserted under direct visualization. Thirty-degree standard Trendelenburg position was used with cushioning for dependent zone. A Retzius space was developed. Endopelvic fascia on both sides were opened, followed by puboprostatic ligament was dissected and dorsal venous complex was controlled using Vicryl No.1 CT-1 needle. The bladder neck was incised with monopolar cautery then foleys catheter was pull and traction. The seminal vesicle and vas deferens were dissected. Denonvilliers fascia was opened and the posterior surface of prostate was freed. The lateral prostatic pedicles were controlled by Hem-o-lock clip and dissected with vessel sealing device (LigaSure Impact Curved, Large jaw, Medtronic, United Kingdom) without nerve sparing, followed by incised of urethra by cold scissor. An urethrovesical anastomosis was performed with continuous watertight sutures, using Vicryl 3/0. Before passing the anterior stitch, the 20 Fr Foleys catheter was passed into the bladder and the anastomosis was completed. A closed suction drain was placed in cul-de-sac. The specimen was retrieved with the use of laparoscopic bag through a subumbilical incision.

Figure 2 Port placement of laparoscopic radical prostatectomy.

The RALRPs were performed with transperitoneal fashion using the da Vinci Si Surgical System, with 5 trocars. We place the trocars medially than the standard port site to deliver sufficient access without graft injury (Figure 3). The pneumoperitoneum pressure of 15 mmHg was created after subumbilical puncture with Veress needle. A 12 mm subumbilical trocar was inserted into abdominal space and was used as a camera port. Two robotic trocars were placed on the right side with at least 8 cm apart from each other (Arm 1, Arm 3). On the left side, a robotic trocar was placed (Arm 2), and the assistance 12 mm trocar was inserted between the second port and camera port as Figure 3, all trocars were inserted under direct visualization. Each arm was equipped with Monopolar scissor (Arm 1), Bipolar Maryland (Arm 2) and Prograpse (Arm 3). Thirty-degree standard Trendelenburg position was used with cushioning for dependent zone. A Retzius space was developed. Endopelvic fascia on both sides were opened, followed by puboprostatic ligament was dissected and dorsal venous complex was controlled using barbed suture No.1 (V-Loc PBT wound closure device, Medtronic, United Kingdom). The bladder neck was incised with monopolar and bipolar cautery then foleys catheter was pull and traction. The seminal vesicle and vas deferens were dissected. Denonvilliers fascia was opened and the posterior surface of prostate was freed. The lateral prostatic pedicles were controlled by Hem-o-lock clip and dissected with monopolar and bipolar cautery with 1 case of interfacial nerve sparing and 2 case of non-nerve sparing, followed by incised of urethra by cold scissor. An urethrovesical anastomosis was performed with continuous watertight sutures, using barbed suture 3/0 (V-Loc PBT wound closure device, Medtronic, United Kingdom). Before passing the anterior stitch, the 20 Fr Foleys catheter was passed into the bladder and the anastomosis was completed. A closed suction drain was placed in cul-de-sac. The specimen was retrieved with the use of laparoscopic bag through a subumbilical incision.

Figure 3 Port placement of robotic-assisted radical prostatectomy.

Nerve-sparing RPs were performed in some cases, except when biopsy specimens revealed extensive cancer or in cases of preoperative poor-quality erections, current and future lack of a sexual relationship, or other medical conditions that could adversely affect erections (eg, hypertension, diabetes mellitus, neurologic diseases, psychiatric diseases or medications that produce erectile dysfunction). However, we shared the decision-making with the patients and the surgeon.

Six instructor surgeons participated in this study. Two surgeons always performed ORPs over 25 years, while the other four surgeons performed all three techniques as shown in Table 1. The procedure techniques were decided by shared decision-making with patients.

Table 1 Surgeons Participation

In this study, both gonadotropin-releasing hormone (GnRH) analogues, such as degarelix, and GnRH antagonists, such as leuprolide, goserelin and triptorelin, were used for the ADT. The choice of medication depended on the patients insurance and the surgeon preference. The duration of NADT was 3 months, since some evidence indicates that this is the optimum duration.10,11

The decision was made upon the discussion between patients and physicians. Since the specific criteria for selection have not been officially stated, we typically advise the NADT for those patients who a. associated with high or very high-risk disease and b. are on the waitlist for surgery longer than three months.

The following data were collected from all patients: age, body weight (kg), height (cm), body mass index (BMI), prostate-specific antigen (PSA) level, underlying disease, clinical stage (TNM classification), prostate cancer risk group (National Comprehensive Cancer Network [NCCN] classification),2 and the Gleason score (GS) of the biopsy specimen.

Perioperative outcomes included operative time (minutes); estimated blood loss (EBL) (mL); perioperative complications, including transfusion rate; adjacent organ injury of the bladder, rectum, ureter, bowel, or blood vessel; and length of hospital stay (days) (determined by subtracting the date of admission from the date of discharge).

All specimens were evaluated in accordance with the NCCN guidelines by an experienced uropathologist, who reported the prostate weight (g), pathological stage, GS of the specimen and the margin status. A positive surgical margin (PSM) was defined as cancer cells extending to the inked surface of the specimen.12

A descriptive study was performed. The data were analysed using a Wilcoxon rank-sum (MannWhitney) and Fishers exact test to identify the statistical significance of the difference in means standard deviation, median (interquartile range), and proportions. Analysis was performed using Stata version 14 software, with a p-value of <0.005 considered to be statistically significant.

The demographic data and preoperative parameters are presented in Table 2. The non-NADT and NADT groups were not statistically different in terms of median age (68 vs 68 years; p = 0.819), median body weight (67.1 vs 67.1 kg; p = 0.807), median height (165 vs 165 cm; p = 0.403) or median BMI (24.4 vs 24.3 kg/m2; p = 0.218). The pre-operative PSA level and GS of the biopsy specimens were statistically significantly higher in the NADT than in the non-NADT group (33.4 [16.256.6] vs 10.1 [7.215.2]; p = <0.001 and 8 [79] vs 7 [67]; p = <0.001). The clinical stage differed significantly between the two groups (p = <0.001).

Table 2 Demographic Data and Pre-Operative Parameters of Non-NADT and NADT

The perioperative outcomes (Table 3) showed that the operative time was significantly lower in the NADT than in the non-NADT group (185 vs 195 minutes; p = <0.018). The EBL was also significantly lower in the NADT than in the non-NADT group (300 vs 500 mL; p = <0.001), but no difference was noted in the blood transfusion rate between the two groups. No statistically significant differences were detected between the NADT and non-NADT groups for adjacent organ injury rate (2.9% vs 2.2%; p = 0.999) or length of hospital stay (6 vs 6 days; p = 0.184). The most common site of injury was the rectum (11 patients).

Table 3 Perioperative Outcomes of Non-NADT and NADT

The pathological outcomes (Table 4) revealed significant differences in pathological stage between the two groups (p = 0.001). The GS of the specimens was significantly higher in the NADT group than in the non-NADT (7 [79] vs 7 [77]; p < 0.001). The specimen weight was significantly lower in the NADT than in the non-NADT group (34.8 vs 39.5; p = 0.014). The PSM did not differ significantly between the NADT and non-NADT group (36.4% vs 43.9%; p = 0.131).

Table 4 Pathological Outcomes of Non-NADT and NADT

Subgroup analysis for perioperative and pathological outcomes of the non-low risk prostate cancer patients are presented in Table 5. The perioperative outcomes, which included operative time, EBL, blood transfusion rate and length of hospital stay, were significantly better in the NADT than in the non-NADT group. Only adjacent organ injury rate showed no significant difference in the two groups. The pathological stage was significantly different in the two groups (p < 0.001). The GS of the specimens was significantly higher in the NADT group (7.5 [79] vs 7 [78]; p < 0.001) and the specimen weight was significantly lower in the NADT group (35 [29.144] mL vs 40 [32.251.5] mL; p = 0.002). However, the PSM still did not show a significant difference between the NADT and non-NADT groups (43.6% vs 47.8%; p = 0.506).

Table 5 Perioperative Outcomes and Pathological Outcomes of PCa Non-Low Risk Group

Neoadjuvant therapy is the current standard of care for several solid tumour malignancies, including bladder, breast, and rectal cancer. NADT prior to surgery may downstage a malignancy to facilitate surgical resection, thereby lowering the positive surgical margin rate and improving perioperative outcomes.13,14 In our study, the median operative time was significantly lower in the NADT than in the non-NADT group (p=0.018) and a lower EBL was also observed in the NADT group (p<0.001).

Androgen deprivation therapy affects tumour behaviour and biology by changing the metabolic patterns of atrophy, lowering serum PSA level and reducing histopathologic atrophy.3 These tumour responses may have contributed to the smaller prostate volume in the NADT group than in the non-NADT group (39.5 vs 34.8 g, p = 0.014), since enlarged prostate glands usually have more vascularity and a wider resection margin.1517

The transfusion rate did not differ significantly between the two groups (p = 0.091). This may reflect the practice in our hospital of having the anaesthesiologist initiate transfusion when the haematocrit drops below 30. Consequently, some patients with a higher baseline haematocrit would be less likely to receive a transfusion.

The length of hospital stay also did not differ statistically between the two groups. However, the hospital stays were longer in the present study than in a previous study by Wallerstedt et al,18 who reported lengths of hospital stay of around 3.34.1 days. This discrepancy can be attributed to an institutional practice where patients are routinely discharged after the closed-suction pelvic drain is removed. However, many other factors, such as socioeconomic status, inexpensive room rates, anxiety and patient pain tolerance, might affect the length of a hospital stay.

No pathological down-staging could be demonstrated in the present study because of the limited pre-operative T clinical staging. In our setting, pre-operative imaging is not generally affordable for all patients, so many patients are classified as T1c (91.4%). Nevertheless, the data show a decrease in the median GS in the NADT group from the pre-operative biopsy specimen score of 879 to the post-operative specimen score of 7.79

The oncological control of RP in prostate cancer can be measured by the PSM, biochemical recurrence (BCR) rate, time to biochemical recurrence, local recurrence and distant metastasis.19 Sachdeva et al20 and other researchers2124 have shown that a PSM in prostate cancer is considered an adverse oncologic outcome and is associated with an increased likelihood of BCR. However, the significant predictors of BCR are tumour volume, a high GS and a high pre-operative PSA level. In our study series, no statistically significant difference was noted in PSM between both groups, which is consistent with the results of many guidelines and the current literature.2,4,5 The PSM rate in large series data ranged from 11% to 50%11 and from 12.1% to 41.3% in a recent meta-analysis.12 The PSM rate in our study was higher, which may reflect the participation of multiple surgeons in this study, as each surgeon may have had a different learning curve. For example, in the present study, two new instructor surgeons had just started performing RALRP in 2016. In addition, after the subgroup analysis, most of the PSMs were in the T3 stage, indicating that PSMs could result from the nature of the cancer that had extended beyond the prostatic capsule.

The subgroup analysis revealed that the perioperative and pathological outcomes significantly better almost all parameters in the non-low risk NADT group. This can be related to the fact that study was heterogenous and not weighted towards those who may benefit the most from NADT.

Patients with PSM are typically given two treatment options: external beam radiation therapy (proton beam radiation) with or without androgen deprivation therapy (ADT) or observation. Unfortunately, data related to the rate of conversion and catheterisation time could not be collected to determine our patient outcomes, as this study was retrospective. The functional outcomes, such as incontinence and erectile dysfunction, are presently being assembled by the authors, who will report on these findings in a subsequent study.

Author want to underline some interesting upcoming trend from the Pignot and Walz,25 and we comply with their findings that the multimodal approach including both local and systemic treatment neoadjuvant may be an option for selected patients especially with non-low risk prostate cancer. However, there is still not enough data to conclude when is the best setting for treatment (Neoadjuvant/adjuvant) and who would really benefit from treatment.

The present study has some limitations. One was its retrospective nature, which compared the effect of NADT with non-NADT but did not include data regarding the type of ADT, since no standard regimens for NADT currently exist. Consequently, the choice of treatment for each patient is highly heterogeneous and depends on patient insurance and physician preference. A second limitation is that all RPs were performed by different surgeons, raising the possibility of bias in the process of evaluating the procedure outcomes. A third limitation is that this study lacked data about the oncological and functional follow-ups. A fourth limitation is that this study had some significant differences in baseline characteristic, approach, PSA pre-op and GS from biopsy (33.4 [16.256.6] vs 10.1 [7.215.2]; p = <0.001 and 8 [79] vs 7 [67]; p = <0.001), as a result of the selection bias by physician typically offer treatment with NADT in high or very high-risk disease and the trend toward the Robotic-assisted era which can confound the effect of NADT. The findings of the present study would be strengthened by conducting a prospective randomised study with a higher case volume, as this would reduce biases and provide much more accurate results.

This study has demonstrated the long-term data on the use of NADT prior to RP and has shown an association between NADT and a positive effect on perioperative outcomes in the prostate cancer non-low risk group. Further randomized, prospective studies are needed to elucidate the true effect of NADT on perioperative outcomes, pathological outcomes and survival benefit.

This work was supported by Wijittra Matang, Yada Phengsalae and Kornkanok Somboonpun. The authors thank Wijittra Matang, Yada Phengsalae and Kornkanok Somboonpun for continued support and encouragement.

The authors declare no conflicts of interest in this work.

1. National cancer institute Doms, Thailand. Hospital base cancer registry 2015. 2017.

2. network NCC. Prostate cancer (Version 1.2020). Available from: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed May 14, 2021.

3. Meng MV. Treatment of Locally Advance Prostate Cancer. 12th ed. Partin AW, editor. Elsevier; 2020:2.

4. Sanda MG, Chen RC, Crispino T, et al. Clinically localized prostate cancer: AUA/ASTRO/SUO guideline; 2017. Available from: https://www.auanet.org/guidelines/prostate-cancer-clinically-localized-guideline#x14226. Accessed May 14, 2021.

5. Mottet N, Bellmunt J, Briers E, et al. EAU ESTRO ESUR SIOG guidelines on prostate cancer; 2020. Available from: https://uroweb.org/guideline/prostate-cancer/. Accessed May 14, 2021.

6. Montgomery B, Tretiakova MS, Joshua AM, et al. Neoadjuvant enzalutamide prior to prostatectomy. Clin Cancer Res. 2017;23(9):21692176. doi:10.1158/1078-0432.CCR-16-1357

7. McKay RR, Montgomery B, Xie W, et al. Post prostatectomy outcomes of patients with high-risk prostate cancer treated with neoadjuvant androgen blockade. Prostate Cancer Prostatic Dis. 2018;21(3):364372. doi:10.1038/s41391-017-0009-6

8. Tosco L, Laenen A, Briganti A, et al. The survival impact of neoadjuvant hormonal therapy before radical prostatectomy for treatment of high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2017;20(4):407412. doi:10.1038/pcan.2017.29

9. Chen MC, Kilday PS, Elliott PA, et al. Neoadjuvant leuprolide therapy with radical prostatectomy: long-term effects on health-related quality of life. Eur Urol Focus. 2020. doi:10.1016/j.euf.2020.03.001

10. Meyer F, Bairati I, Bedard C, Lacombe L, Tetu B, Fradet Y. Duration of neoadjuvant androgen deprivation therapy before radical prostatectomy and disease-free survival in men with prostate cancer. Urology. 2001;58(2 Suppl 1):7177. doi:10.1016/S0090-4295(01)01245-6

11. Soloway MS, Pareek K, Sharifi R, et al. Neoadjuvant androgen ablation before radical prostatectomy in cT2bNxMo prostate cancer: 5-year results. J Urol. 2002;167(1):112116. doi:10.1016/S0022-5347(05)65393-1

12. Silberstein JL, Eastham JA. Significance and management of positive surgical margins at the time of radical prostatectomy. Indian J Urol. 2014;30(4):423428. doi:10.4103/0970-1591.134240

13. Gmez Veiga F, Lorenzo Patio MJ, Daz Bermdez J, et al. [Effect of complete androgen block before radical prostatectomy for cancer of the prostate]. Arch Esp Urol. 1997;50(4):355363.

14. Polito M, Muzzonigro G, Minardi D, Montironi R. Effects of neoadjuvant androgen deprivation therapy on prostatic cancer. Eur Urol. 1996;30(Suppl 1):2631. doi:10.1159/000474242

15. Frota R, Turna B, Santos BM, Lin YC, Gill IS, Aron M. The effect of prostate weight on the outcomes of laparoscopic radical prostatectomy. BJU Int. 2008;101(5):589593. doi:10.1111/j.1464-410X.2007.07263.x

16. Hsu EI, Hong EK, Lepor H. Influence of body weight and prostate volume on intraoperative, perioperative, and postoperative outcomes after radical retropubic prostatectomy. Urology. 2003;61(3):601606. doi:10.1016/S0090-4295(02)02422-6

17. Kim MS, Jang WS, Chung DY, et al. Effect of prostate gland weight on the surgical and oncological outcomes of extraperitoneal robot-assisted radical prostatectomy. BMC Urol. 2019;19(1):1. doi:10.1186/s12894-018-0434-4

18. Wallerstedt A, Tyritzis SI, Thorsteinsdottir T, et al. Short-term results after robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy. Eur Urol. 2015;67(4):660670. doi:10.1016/j.eururo.2014.09.036

19. Akand M, Celik O, Avci E, Duman I, Erdogru T. Open, laparoscopic and robot-assisted laparoscopic radical prostatectomy: comparative analysis of operative and pathologic outcomes for three techniques with a single surgeons experience. Eur Rev Med Pharmacol Sci. 2015;19(4):525531.

20. Sachdeva A, Veeratterapillay R, Voysey A, et al. Positive surgical margins and biochemical recurrence following minimally-invasive radical prostatectomy an analysis of outcomes from a UK tertiary referral centre. BMC Urol. 2017;17. doi:10.1186/s12894-017-0262-y

21. De La Roca RL, Da Cunha IW, Bezerra SM, Da Fonseca FP. Radical prostatectomy and positive surgical margins: relationship with prostate cancer outcome. Int Braz J Urol. 2014;40(3):306315. doi:10.1590/S1677-5538.IBJU.2014.03.03

22. Meeks JJ, Eastham JA. Radical prostatectomy: positive surgical margins matter. Urol Oncol. 2013;31(7):974979. doi:10.1016/j.urolonc.2011.12.011

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Neoadjuvant Androgen Deprivation Therapy Effects on Perioperative Outc | RRU - Dove Medical Press

Many have heard about the fire that caused $1 million dollars of damage to the very large residential home called Brigadoon Cottage on Mackinac Island on the evening of Sunday, May 30, 2021. What you may not have heard is the great news of the businesses and their staffs on Mackinac Island that came together to save a wedding reception.

A couple had gotten married that day and had just started their wedding reception next door to the Brigadoon Cottage at the Mackinac Island Yacht Club. MLive is reporting just after the guest were seated about a minute into the father-of-the-bride speech they noticed the fire.

What happened next is all good news and something you would see in a movie.

The Yacht Club staff called the Mission Point Resort staff and arranged for the wedding reception to be moved to their facility down the road. They used carriages, bikes and whatever else they could to move all of the necessary items from the Yacht Club to Mission Point.

We are told that within 30 minutes the reception was back on at Mission Point.

Many pitched in to help this couple on their wedding day. Even a local restaurant opened up their kitchen so the Yacht Club chefs could finish preparing the dinner for the guests. The article even states the staff from Mission point who was not working that day heard about what happened and came to help however they could.

The bride, Elizabeth Landuyt said they were very grateful and very blessed.

Her newly minted husband, Jake Landuyt put it this way:

We were blown awayTo see all our guests basically in the same spot as we had set up before. It was disbelief and overwhelming in the positive way. To go from that same state of disbelief to the exact opposite, were just so blessed to have friends and family there that were willing to do it.

Mission Points vice president of sales and marketing, Liz Ware said:

We love being a part of the amazing Mackinac Island community, where people and fellow businesses can come together to make magic happenOur entire team at Mission Point was proud to be a part and followed our brand pillars in delivering hospitality from the heart and to always do the right thing. Our core values include going the extra mile and working hard together with a great sense of Michigan pride, and we believe this is one of the reasons the Landuyts wedding reception was a truly celebratory occasion.

What a great story they will have to remember for the rest of their lives and what a great story to start our Friday and weekend off with.

Share the love and share this story.

The Live with Renk show airs Monday through Friday from 9 a.m. tonoon, to let me know your thoughts call (269) 441-9595

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An estimated 88 million Americans have prediabetes, and just over 1 in 10 have been diagnosed with type 2 diabetes. In Kentucky, nearly 12 percent of the adult population is affected by this disease. Week after week, Kentucky physicians care for patients with type 2 diabetes and the potentially debilitating complications it can cause. Unfortunately, it is also well-documented that pre-existing conditions such as diabetes can put patients at high-risk for complications should they contract COVID-19.

March 23, is American Diabetes Alert Day, and the Kentucky Medical Association (KMA) and its thousands of physician members are encouraging Kentuckians to learn more about their risk factors and family history of the disease, and to talk to their doctor about prevention and treatment options.

Dr. Dale Toomey

Diabetes is the condition in which the body does not properly process food for use as energy. Most of the food we eat is turned into glucose, or sugar, for our bodies to use for energy. The pancreas makes a hormone called insulin to help glucose get into the cells of our bodies. When you have diabetes, your body either doesnt make enough insulin or cant use its own insulin as well as it should. This causes too much sugar to build up in your blood. In those with type 1 diabetes, the body completely stops producing insulin, and this usually occurs in childhood or early adulthood. With type 2 diabetes, the body produces insulin, but the cells dont respond to insulin the way they should.

Prediabetes occurs when a patient has a higher-than-normal blood sugar level. Its not high enough to be considered type 2 diabetes yet, but without lifestyle changes, adults with prediabetes are more likely to develop type 2 diabetes. More than 8 in 10 American adults with prediabetes dont know they have it. These patients are also at risk for developing other serious health problems like heart disease and stroke.

The first step in preventing or delaying type 2 diabetes and related health problems is to screen and test for prediabetes. Patients are encouraged to talk to their physician during their annual well-visits about being screened for type 2 diabetes. Your physician can order a simple blood test for patients with risk factors for prediabetes and type 2 diabetes, which include anyone 45 years of age or older, those who are overweight or obese, people with a family history of type 2 or gestational diabetes, and those who are physically active less than three times per week.

Patients diagnosed with prediabetes can be referred to the National Diabetes Prevention Program (DPP) lifestyle change program to prevent or delay type 2 diabetes. Programs are conducted by lifestyle coaches who are trained on an evidence-based curriculum. The coach can engage and guide you through makingand sticking withlifestyle changes. When patients join the program, they get a full year of support to make their new, healthy habits stick and keep them from slipping back into old habits. Kentucky also offers diabetesself-management education and support (DSME) groups, which can help you learnto manage your diabetes as part of your daily life. More information on these programs is available here.

Type 2 diabetes prevention is a priority of Kentucky physicians. As a focus of its AIM for Better Care: Administrative Improvements in Medicine initiative, KMA seeks to eliminate barriers to care for diabetes and to provide patients with the most updated resources and education to help prevent and manage this disease.

On American Diabetes Alert Day, consider this a wake up call to talk to your physician about diabetes prevention and treatment and get on the right path to a healthier tomorrow.

Dale Toney, M.D. is President of the Kentucky Medical Association. He is a board-certified internist in Lexington and is employed by the University of Kentucky Albert B. Chandler Hospital, is an Associate Professor at the University of Kentucky College of Medicine and serves as the Division Chief of General Internal Medicine and Womens Health.

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Dale Toney: A 'wake up call' for diabetes talk to your doctor about prevention and treatment - User-generated content

MILFORD Pelvic exams, in vitro fertilization and childbirth typically aren't comfortable procedures for any woman, but Dr.Mitchell Bellucci seeks toensure that patients are secure and that he is positive but especially calm.

So calm thatpatients sometimes askhim if he'sabout to head out for vacation after work.

Everyone would always say, Well, geez, you look like youre going on vacation, said Bellucci during an interview in his office on Friday afternoon, wearing a loose-fitting button-up shirt withthe top fourbuttons undone. For me, it was convincing myself that everything was cool, even if sometimes it wasnt.

Hes been the doctor to more than 10,000 patients and has helped deliver more than 3,500 babies in his career, he said.Known for his cowboy boots, Bellucci, 66, also frequently wore flip flops and casual Hawaiian shirts.

He has a faded 1988 newspaper clipping from the Daily Newsof himself wearinga pair offull-quill ostrich boots. Those cost him around $400, he said. He wore cowboy boots so much, he ended up developing plantar fasciitis, which causes a lot of pain in the heel.

Thecowboy boots have been retired, and Bellucci is poised to do the same.

More: U.S. Rep. Clark aims to build child care into infrastructure debate

Bellucci is retiring next month after 40 years as an OB/GYN. He'splanning to close hiswomens health care practice at 192 West St. after opening it 33 years ago. He's selling the space, which is part of the Westview Professional Building.

Over four decades, Bellucci has made his mark in advancingwomens health care, including setting up the first bone density unit at Milford Regional Medical Center, bringing womens health innovations to local television, patenting medical devices for newborns, training medical doctors on advanced laparoscopyand establishing scholarships for nurses and pre-med students.

He's gone from the swimming pool into the delivery room a few times, too.

Ive delivered no less than two dozen kids in my Speedos... well, they were swim trunks, said Bellucci, who moved to Milford to be close to the hospital (and his practice) if he was needed immediately. He has a pool athome, and has raced from there to Milford Regional several timeswith just enough time to towel off.

It's a career field he never intended to enter, but he's glad he did, he said.

Training as a medical studentwas a pivotal time for Bellucci. While growing up onLong Island, New York, knew he wanted to be surgeon, but didn't want to docancer surgery, which he thought was depressing.

From there, it was process of elimination. He thought he would be an orthopedist performing bone surgery, but found most of his time would be spentdoing hip surgery for elderly patients who stayed at the hospital for weeks, he said. Hand surgery was too long to train forand general surgery seemed too boring, he said. He considered urology, but "didnt want to look at penises and prostates all day."

Then he tried obstetrics and gynecology.

Reproduction and bringing new life into the world especially intrigued Bellucci, who has a daughter, Laura, who's 33 and a bartender in New Orleans. But on abulletin board in the hallway of his office, she's a child, peeringinto the lensof anunderwater camera. Surrounding her are photos of dozens of other babies Belluccihas helped deliver, some also now in their 30s.

Youre there at the most important timeof their lives, man. And youre part of it, he said. What other doctor gets to be with a woman in pain for eight hours, she pushes for two hours, you catch the baby, and youre the hero?Its such a neat thing to experience.

Plus, most if not all of the patients he sees are healthy and have insurance.

I like explaining things, and you have to be direct and have to not overreact, he said about making patients feel comfortable and reassured. The office even has a therapy dog "Charlie," a cockapoo who comes in occasionallyand is adored by patients, said Bellucci.

He also has aletter froma patient, written in 1994, that still makes him smile.

Hehelped a woman deliver her first baby, but she moved and delivered her second baby elsewhere. That experiencewas very upsetting, she wrote him, and said her doctor lacked a sympathetic bedside manner.

But her experience with Bellucci in Milford,by contrast, was wonderful, she wrote.She said he remained positive throughout the ordeal and joked with her to make her feel more relaxed. She wrote that she and her husbandstill laugh years later recalling when a nurse in the delivery room strapped a maxi pad to Belluccis forehead to soak up some of his sweat.

Opinion: 2020 saw great strides for women, but it also exposed inequities we should fix in 2021

When I went into it, there were five guys to one woman. Now theres five women and no guys, said Bellucci.

In the 1970s, about 7% of American gynecologists were female, according to the American College ofObstetricians and Gynecologists.Today, about 82%of OB/GYN residents throughout the nation are women.

About a decade ago, Bellucci wasapproached by Bryant University in Rhode Island to teach male physician assistant students who weredenied access to learn inside other women's health care practices. For about nine years, he taught one student a month.

Moremen are turning away fromobstetrics and gynecology, said Bellucci, and its still difficult for them togain accessinto that space. The upside is that physician assistants aren't going into delivery rooms anymore with positions like midwives and nurse practitioners. Rather, male physician assistants today are going into settings like emergency rooms or family practices, he said.

More healthcare news: Dr. Dennis Plante, who grew up in Worcester, dies of COVID-19 in Texas

When most women hit age 50 many of his patients are about thatage their estrogen drops, he said. He realized bone density was an important component to womens health, because while estrogenis the key regulator ofbonemetabolism in both men and women, menopause leads to decreased estrogen, which is associated with decliningbonemineraldensity.

Milford Regional Medical Center didnt have a bone density unit at that time, so he helped create one, he said, and he taught primary care doctors the value of testing for it.

He also helped developthe CO2 Surgical Laser,designed to treat pre-cancerous conditions like warts and lesions, and is known for his Mona Lisa Touch.

That machine, created inItaly, is a laser treatment for symptoms somewomen experience after menopause, such as painful sex. It's an alternative to hormone treatment, which can be risky for some.

A lot of women who have these problems have had breast cancer, and what do (many doctors)do? They put you on anti-estrogen and they save your life, he said. But then you say, 'Well, what about my sex life?' I think we should address that.

If you didn't see "Dr. B" at his medical practice, you might have seen him on "Pasta Playoffs," a cooking show that aired on community access television.

I used to say, If you think you can cook good food, you should go one-on-one against Grandma," said Bellucci, who enjoys cooking Italian food. "And that was the premise of the show."

Various "grandmas" competed against Bellucci in making a pasta sauce, which was thenjudged by three randomly selected customers at Caff Sorrento in Milford, said Bellucci. The showlasted five episodes, and eventually morphed into "Cooking Against Cancer," specificallybreast cancer.

Opinion: We need to help women during the pandemic and beyond

Bellucci isexcited aboutretirement and has had a rewarding career, but said itll be a tough goodbye to his practice. After closing and selling it, he's moving toRhode Island to be with his girlfriend Mary, where hell spend most of his time boating, fishing, possibly offering consulting services in the medical device industry and writing screenplays drawing from his medical knowledge.

And finally, the next time he wears a Hawaiian shirt and pair of flip flops, he really will be on vacation an extended one.

Lauren Young writes about business and pop culture. Reach her at 774-804-1499 orlyoung@wickedlocal.com. Follow her on Twitter @laurenwhy__.

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Milford OB/GYN to close womens health care practice after over 30 years - Milford Daily News

Gov. Andy Beshear signed 13 health bills into law Monday, highlighting one that caps insulin costs for about 30% of Kentuckians who need the life-preserving hormone.

The limit is $30 for a 30-day supply. This is the right thing to do and its a game-changer for those who rely on insulin to live, Beshear said. Until now, a single dose of insulin which cost between $2 and $7 to manufacture could sell for an average wholesale price of around $300 per vial.

Beshear noted that in a lawsuit he filed against insulin companies while attorney general over their unconscionable overpricing,revealed that over 10 years, the price of one insulin product went up 311%, and another rose 285%, including a rise from $325 per package in 2011 to $530 in 2017.

While these companies work to increase bottom lines and sustain market shares, he said. Kentucky families hit hardest by this price gouging can be paying more than $1,000 a month on insulin just to stay alive.

House Bill 95, co-sponsored by Reps. Danny Bentley, R-Russell, and Patti Minter, D-Bowling Green, will cap the monthly out-of-pocket cost for a 30-day supply of insulin at $30 for Kentuckians covered by state-regulated employer health plans or plans purchased on the marketplace exchange.

Minter, whose son has Type 1 diabetes,has saidthe bill will cover about 30% of insulin-dependent Kentuckians. It doesnt cover Medicare, Medicaid or self-funded employer plans except the one for state employees.

I want to be very clear, this is only a first step, Minter said. There is much more work to do but today is a very big deal. It will save lives and it will give people hope. She said that for many families, it will make the difference between bankruptcy and keeping a child alive.

In a video, Angela Lautner,Kentucky #insulin4alllegislative lead, expressed her gratitude to the lawmakers for the bill, but she too warned that more work needs to be done, saying it will help about 22,000 people.

Much more has to be done, butHB 95is a step forward, said Lautner, My chapter is here for insulin for all and thats why we must continue this momentum into the next session with urgency, with priority.

More than half a million Kentuckians have diabetes, and Kentucky ranks seventh-highest in the U.S. for diabetes prevalence. Lautner said more than one in four insulin-dependent people ration insulin due to cost.

The price cap will apply regardless of the amount or type of insulin the person with diabetes needs.

In addition to capping the price, HB 95requires health plans to provide the equipment, supplies and outpatient training and education needed to help diabetics stay healthy, and forbids any reductions from this coverage by others involved in coverage.

Thefiscal impact statementattached to the bill says it will increase premiums for health benefit plans, not including the state employee plan, by about 80 cents a month.

Bentley said thats a small price to pay to make sure diabetics keep getting their insulin because without it they can suffer amputations, loss of vision, neuropathy, ketoacidosis and even death. The costs on the medical side is much more than the cost that were going to have by helping people with insulin, he said.

Beshear also signed bills addressing these health topics:

HB 140, sponsored by Rep. Deanna Frazier, R-Richmond, will permittelehealth servicesthat were allowed to expand due to the pandemic to remain in place. The bill requires reimbursement for telehealth to be equivalent to reimbursement for the same service provided in person. I think its one of the most important bills that have been passed, Beshear said.

HB 219, sponsored by Bentley, allows pharmacies to sell hypodermic syringes and needles without a prescription. The aim is to increase access to clean supplies for people who inject drugs, which will help to decrease the risk of blood-borne diseases such as hepatitis C and HIV/AIDS.

SB 55, sponsored by Sen. Stephen Meredith, R-Leitchfield, abolishes co-payments required by Medicaid.

HB 183, sponsored by Rep. Brandon Reed, R- Hodgenville,will allowKentucky hospitals to get more money from Medicaid, based on an average commercial rate instead of the current Medicaid rate, which is often below that amount. The program would not cost the state anything, because Kentuckys hospitals have agreed to cover the cost. To get the money, hospitals will have to abide by higher quality standards that are still being decided by theKentucky Hospital Associationand theCabinet for Health and Family Services.The bill is expected to help many of the states rural hospitals; arecent reportshows that 16 of them are at risk of closing.

HB 108, sponsored by Melinda Gibbons Prunty, R-Belton (Muhlenberg County), codifies current Medicaid coverage of colorectal cancer, including screenings starting at 45 for most people and genetic cancer-risk testing, to align Medicaid and commercial coverage.

HB 50, sponsored by Rep. Kim Moser, R-Taylor Mill, will make health-insurance plans comply with a 2008 federal law that requires them to treat mental health conditions and substance use disorders the same as physical health. It also requires health insurers to file annual reports with the state to show how they are complying with federal law.

HB 276, sponsored by Moser, allows Kentuckians trained as temporary COVID-19 personal-care attendants under an executive order to apply their supervised training toward their Registered Nurse Aide certification. About 300 personal-care attendants work in Kentucky long-term care facilities, Moser said while presenting the bill to the House in February.

SB 154, by Sen. Tom Buford, R-Nicholasville, lets advanced practice registered nurses and physician assistants prescribe and supervise home-health services, as federal law has allowed them to do in the pandemic. An emergency clause ensures there would be no gap in care if the federal rule ended.

HB 448, sponsored by Rep. Bill Wesley, R-Ravenna, expands the definition of qualified mental-health professional so that it fits the states juvenile code, allowing those who work in private agencies to testify in child-welfare hearings, especially around issues of emotional injury.

SB 74, by Sen. Ralph Alvarado, R-Winchester,createsbut does not fund a dementia services coordinator in the heath cabinet to manage theAlzheimers Disease and Related Disorders Council, the state plan to address Alzheimers in Kentucky, and apply for federal funding.

HB 75, sponsored by Rep. Shawn McPherson, R-Scottsville, prohibits insurance companies from increasing rates on organ donors or dropping their coverage. It would also encourage the cabinet to develop educational materials relating to organ donation.

SB 163, sponsored by Sen. Alice Forgy Kerr, R-Lexington, expands the definition of charitable health care provider to include those that provide invasive or surgical procedures. This change was needed to allow the non-profit surgery program Surgery on Sunday in Lexington to be reimbursed for liability insurance premiums.

Beshear alsovetoed five billsthat would strip power from the governor or the executive branch. None were related to health.

(Kentucky Health Newsis an independent news service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Media at the University of Kentucky, with support from the Foundation for a Healthy Kentucky.)

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Beshear ceremonially signs 13 health bills, including one that caps price of insulin - Hoptown Chronicle

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A potential role for insulin treatment during pregnancy in reducing postpartum psychological distress in maternal obesity: an administrative...

KENILWORTH, N.J. & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the first presentation of investigational data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial in an oral plenary session (Plenary Session #10191) at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Womens Cancer. The trial evaluated the combination of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer following one prior platinum-based regimen in any setting.

The study met the dual primary endpoints of progression-free survival (PFS), as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and overall survival (OS) as well as the secondary efficacy endpoint of objective response rate (ORR), as assessed by BICR per RECIST v1.1, in the all-comer population (mismatch repair proficient [pMMR] and mismatch repair deficient [dMMR]) and in the pMMR subgroup. Median follow-up was 11.4 months for both the all-comer population and the pMMR subgroup. A statistically significant and clinically meaningful improvement in PFS was seen in the all-comer population, in which KEYTRUDA plus LENVIMA (n=411) reduced the risk of disease progression or death by 44% (HR=0.56 [95% CI: 0.47-0.66]; p<0.0001), with a median PFS of 7.2 months (95% CI: 5.7-7.6; number of events=281) versus 3.8 months (95% CI: 3.6-4.2; number of events=286) for patients who received chemotherapy (treatment of physicians choice [TPC] of doxorubicin or paclitaxel; n=416). Additionally, a statistically significant and clinically meaningful improvement in OS was seen in the all-comer population, in which KEYTRUDA plus LENVIMA reduced the risk of death by 38% (HR=0.62 [95% CI: 0.51-0.75]; p<0.0001), with a median OS of 18.3 months (95% CI: 15.2-20.5; number of events=188) versus 11.4 months (95% CI: 10.5-12.9; number of events=245) for patients who received TPC. The safety profile of KEYTRUDA plus LENVIMA was generally consistent with the established safety profiles of the individual monotherapies.

Patients diagnosed with endometrial cancer, the most common type of gynecologic cancer in the U.S., face low survival rates when diagnosed at an advanced stage or at recurrence, especially once the disease progresses after prior platinum-based therapy and is not amenable to curative surgery or radiation, said Dr. Vicky Makker, Principal Investigator and Medical Oncologist, Memorial Sloan Kettering Cancer Center. With a 38% reduction in risk of death regardless of mismatch repair status, KEYTRUDA plus LENVIMA significantly improved overall survival compared with chemotherapy in the all-comer group of patients with advanced, metastatic or recurrent endometrial carcinoma, which is very encouraging, as this arm included an investigational patient population for which more data have been sought after by the gynecologic oncology community.

In the all-comer population, the secondary efficacy endpoint of ORR was 31.9% (95% CI: 27.4-36.6), with a complete response (CR) rate of 6.6% and a partial response (PR) rate of 25.3%, for patients who received KEYTRUDA plus LENVIMA versus 14.7% (95% CI: 11.4-18.4), with a CR rate of 2.6% and a PR rate of 12.0% for patients who received TPC (ORR difference versus TPC: 17.2 percentage points; p<0.0001). For patients who responded, the median duration of response (DOR) was 14.4 months (range: 1.6-23.7) for patients who received KEYTRUDA plus LENVIMA versus 5.7 months (range: 0.0-24.2) for patients who received TPC.

In this confirmatory Phase 3 study, KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in progression-free survival, overall survival and objective response rate versus chemotherapy, said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. We are encouraged by these results that reaffirm Mercks and Eisais commitment to explore the potential of the combination to help more patients with difficult-to-treat types of cancer.

The positive results seen in KEYNOTE-775/Study 309 help confirm the currently approved use of the KEYTRUDA plus LENVIMA combination in certain patients with advanced endometrial carcinoma, said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. As this stage of disease has been notoriously difficult to treat, Eisai and Merck remain committed to addressing the unmet need of advanced endometrial carcinoma. We are grateful to the patients and healthcare providers whose participation and persistence amid a global pandemic have made this milestone possible.

Results were similar across the all-comer population and the pMMR subgroup. In the pMMR subgroup, KEYTRUDA plus LENVIMA reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI: 0.50-0.72]; p<0.0001), with a median PFS of 6.6 months (95% CI: 5.6-7.4; number of events=247) versus 3.8 months (95% CI: 3.6-5.0; number of events=238) for patients who received TPC. KEYTRUDA plus LENVIMA reduced the risk of death by 32% (HR=0.68 [95% CI: 0.56-0.84]; p=0.0001), with a median OS of 17.4 months (95% CI: 14.2-19.9; number of events=165) versus 12.0 months (95% CI: 10.8-13.3; number of events=203) for patients who received TPC. The secondary endpoint of ORR was 30.3% (95% CI: 25.5-35.5), with a CR rate of 5.2% and a PR rate of 25.1%, for patients who received KEYTRUDA plus LENVIMA versus 15.1% (95% CI: 11.5-19.3), with a CR rate of 2.6% and a PR rate of 12.5%, for patients who received TPC (ORR difference versus TPC: 15.2 percentage points; p<0.0001). For patients who responded, the median DOR was 9.2 months (range: 1.6-23.7) for patients who received KEYTRUDA plus LENVIMA versus 5.7 months (range: 0.0-24.2) for patients who received TPC.

In the all-comer population, in the KEYTRUDA plus LENVIMA arm (n=406), treatment-emergent adverse events (TEAEs) of any grade led to discontinuation of KEYTRUDA in 18.7% of patients, of LENVIMA in 30.8% of patients, and of both in 14.0% of patients. In the TPC arm (n=388), TEAEs of any grade led to discontinuation of chemotherapy in 8.0% of patients. Grade 5 TEAEs of any cause occurred in 5.7% of patients in the KEYTRUDA plus LENVIMA arm and in 4.9% of patients in the TPC arm. Grade 3 TEAEs occurred in 88.9% of patients in the KEYTRUDA plus LENVIMA arm and in 72.7% of patients in the TPC arm. In the KEYTRUDA plus LENVIMA arm, the most common TEAEs of any grade occurring in at least 25% of patients were hypertension (64.0%), hypothyroidism (57.4%), diarrhea (54.2%), nausea (49.5%), decreased appetite (44.8%), vomiting (36.7%), weight decrease (34.0%), fatigue (33.0%), arthralgia (30.5%), proteinuria (28.8%), anemia (26.1%), constipation (25.9%) and urinary tract infection (25.6%). In the TPC arm, the most common TEAEs of any grade occurring in at least 25% of patients were anemia (48.7%), nausea (46.1%), neutropenia (33.8%), alopecia (30.9%), and fatigue (27.6%). Median treatment duration was 231 days (range: 1-817) with KEYTRUDA plus LENVIMA and 104.5 days (range: 1-785) with TPC.

KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. Food and Drug Administrations (FDA) 2019 accelerated approval of the KEYTRUDA plus LENVIMA combination for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.

KEYNOTE-775/Study 309 Trial Design (Plenary Session #10191)

KEYNOTE-775/Study 309 is a multicenter, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in patients with advanced endometrial cancer following one prior platinum-based regimen in any setting. The dual primary endpoints are PFS, as assessed by BICR per RECIST v1.1, and OS. Select secondary endpoints include ORR, as assessed by BICR per RECIST v1.1, and safety/tolerability. Of the 827 patients enrolled, 697 patients had tumors that were pMMR, and 130 patients had tumors that were dMMR. Patients were randomized 1:1 to receive:

About Endometrial Cancer

Endometrial cancer begins in the inner lining of the uterus, which is known as the endometrium and is the most common type of cancer in the uterus. In 2020, it was estimated there were more than 417,000 new cases and more than 97,000 deaths from uterine body cancers worldwide (these estimates include both endometrial cancers and uterine sarcomas; more than 90% of uterine body cancers occur in the endometrium, so the actual numbers for endometrial cancer cases and deaths are slightly lower than these estimates). In the U.S., it is estimated there will be more than 66,000 new cases of uterine body cancer and nearly 13,000 deaths from the disease in 2021. The five-year survival rate for metastatic endometrial cancer (stage IV) is estimated to be approximately 17%.

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 Cancer

KEYTRUDA 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 two 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 Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

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).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. 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 trial.

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 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

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 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

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 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

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 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

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 <0.1% (1) of patients.

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 <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

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 <0.1% (1) and withholding of KEYTRUDA in <0.1% (1). All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

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 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

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 <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. 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.

See original here:
KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in...

While some people whove had abortions in West Virginia regret them, and others say those decisions were best for them, they agree on the importance of accurate information.

But a bill working its way through the West Virginia Legislature would require health care professionals to provide them with one piece of information that isnt supported by research and could amount to, in the words of one state medical group, unmonitored experimentation on West Virginians seeking abortions.

Under House Bill 2982, those people would hear that it may be possible to stop a medical abortion after taking the first of two pills required for such an abortion. The bill doesnt require they be told that the assertion isnt supported by research, that its based on taking a medication that isnt approved by the U.S. Food and Drug Administration for the purpose of stopping abortions, or about the potential harm of attempting to stop an abortion.

Supporters of the bill, including some people whove had abortions, say the bill is needed because some women have regrets after beginning the procedure.

Opponents of the bill, also including people whove had abortions, say that its important for people seeking abortions to understand theyre making permanent decisions.

The bill, if it becomes law, would tell people they dont have to make a decision, that they can be wishy-washy about it, said Hunter Starks, who had an abortion while in an abusive relationship.

And you cant, Starks said. You have to make that decision, whether thats easy or hard for you. You have to make that decision.

Starks, a transgender non-binary person, said if they hadnt had that abortion, they would have been tied to that abuser for life.

Opponents of the bill also warn that its based on the unproven idea that taking progesterone after the first pill in a medication abortion can reverse the process. They note the FDA has not approved progesterone for this use, and that limited research suggests patients health and safety could be put at risk.

What does the bill do?

When a patient seeks a medical abortion, health care providers provide them with two pills. Mifepristone, the first pill, blocks the hormone progesterone. This thins the uterine lining, so the embryo wont stay implanted and continue growing. Misoprostol, the second pill, causes the uterus to contract and expel the embryo through the vagina.

The original version of House Bill 2982, sponsored by Delegate Kayla Kessinger, R-Fayette, said that providers had to tell patients that their abortion could be reversed. Lawmakers in the House of Delegates Health and Human Resources Committee changed that wording last week, so the bill now would require health care providers to tell patients that it may be possible to stop an abortion.

Delegate Todd Longanacre, R-Greenbrier and a bill co-sponsor, said the bill would help a young lady [who] realizes the error of her ways, by taking that first pill to terminate a babys life.

Its an opportunity for that young lady who may have, in a knee-jerk, emotional state-of-mind decided to take an RU-486 pill, and then woke up the next morning and thought, Oh, my gosh, what have I done? he said. This is her opportunity to save that babys life.

Its not a perfect bill, Longanacre said. But you know what, an old general from the World War II era once said and that guys name was General Patton he said a less-than-perfect plan violently executed now is better than the perfect plan executed next week. People are dying; babies are dying. This is an opportunity to save lives.

House Bill 2982 is based on the unproven idea that taking progesterone after the first pill will reverse its effects.

Research on progesterone for this use is so weak, according to a statement from the West Virginia American College of Obstetricians and Gynecologists chapter, that administering it to patients in an effort to reverse or stop abortions potentially subjects women to unmonitored experimentation, which is in direct violation of a physicians oath to care.

The bill is supported by West Virginians for Life and the National Right to Life Committee. It is opposed by both the national and West Virginia chapters of the American College of Obstetricians and Gynecologists, Planned Parenthood and the state-level reproductive rights group, WV Free.

Democrats in the House committee last week noted that a study on the effectiveness of progesterone in stopping an abortion mid-procedure was halted early because several women experienced severe bleeding, possibly because they had taken the first pill but not the second.

Researchers aimed to determine whether progesterone could be used to reverse the effects of mifepristone, preventing pregnancy termination, but three patients experienced severe hemorrhaging and had to be taken to the hospital, according to the study, published in a 2019 edition of Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists.

Delegate Barbara Fleischauer, D-Monongalia, wanted to amend the bill in committee to warn patients about possible side effects, but that amendment was rejected.

Delegate Ric Griffith, D-Wayne and a pharmacist who said he is anti-abortion, was concerned enough to oppose the bill, saying he worried taking the first pill, but not the second, could lead to birth defects.

In our desire to protect the unborn, we are potentially causing harm to the unborn, he said.

No medical professionals were called to testify during the meeting.

Karen Cross, who is from West Virginia and lobbies for the National Right to Life Committee, was present but did not testify.

Ive had two abortions, and I regret mine, Cross said in an interview following the meeting. I know so many women, who are involved in the pro-life movement even, actively, because of the decision they made to abort their children, so that they can help other women not make that mistake.

Delegate Heather Tully, R-Nicholas and an anti-abortion family nurse practitioner, voted for the bill during that meeting, but said in an interview that she did have concerns.

I would be very concerned about a non-approved FDA medication, but obviously, this procedure has been done in some places, maybe not necessarily within the state of West Virginia, or within the confines of the border, she said.

Tully, who noted that she doesnt work in reproductive medicine, said abortion pills also come with risk. Shes had patients change their minds about other procedures, she said. And patients have a right to withdraw consent, she noted.

I think that this bill, it really quite honestly strengthens the informed consent process for a patient that may change their mind, she said.

Ten states have passed similar legislation, and others are working on their own bills, according to Cross. Courts have blocked implementation in several states. Six states have the law in place, according to a March 1 statement from the pro-abortion rights Guttmacher Institute.

The House of Delegates Judiciary Committee, where delegates would normally discuss the legality of bills, passed the bill with no discussion of those court cases Thursday.

The bill is up for second reading in the House on Tuesday, during which time delegates may offer amendments. Its tentatively scheduled for a final House vote on Wednesday, and would then have to pass the state Senate and get the approval of Gov. Jim Justice to become law.

Lived experiences

While some West Virginians whove had abortions made the right decision for them and others have regrets, several people interviewed agreed on the important of being informed.

But while the bill does require doctors to tell patients about an option, it doesnt tell them anything about the lack of research supporting that option and the potential harmful effects of it.

Suzi Bragg, of Morgantown, still supports the bill. She regrets her two abortions, and would rather anti-abortion lawmakers become involved than rely on doctors.

Im 63 and to this day, I do not trust when doctors tell me things, she said.

Bragg said when she was 16 and in foster care, a young man blackmailed her into sex. She said her social workers took her to Pittsburgh for the abortion when she was about 18 weeks pregnant.

She said they injected saline into her abdomen, which was extremely painful, and held her down when she yelled for them to stop. She said the experience was extremely traumatic, because I wasnt told the truth about what would occur.

She said she was told the experience would be no more painful than menstrual cramps, and the fetus was a clump of cells. She didnt realize until seeing a Newsweek magazine later on that a fetus is more developed than that at about 18 weeks.

I remember just screaming, They lied to me, she said.

Bragg said she went on to develop post-traumatic stress disorder. She didnt want to eat. She didnt want to socialize with friends. She said the trauma was due in part to being coerced into both the act of sex, and the abortion. During a second abortion in her 20s, she declined pain medication. She felt like she deserved the pain.

Back then, information about abortion was less readily available to women, she said.

Hunter Starks, of Charleston, was 19 and in an abusive relationship when they sought their first of two abortions in 2012.

Starks, who was assigned female at birth, took pain pills for the first abortion, which was medical, so pain wasnt significant, they said, and they experienced no pain for the second, which was surgical.

Starks said they were in a fragile mindset at the time and it was mainly their partners decision, but they still dont regret the choice.

While Longanacre, the bill co-sponsor, said some abortions may be knee-jerk reactions, ACOG-WV and some West Virginians whove had abortions say the bill itself would actually encourage people to see abortion as something they dont have to be sure about.

In their statement, leaders of the state OB/GYN group wrote that if the bill becomes law, it would create an environment of confusion and stigma.

Starks already felt confused and scared going into the abortion, without doctors telling them that the decision could be stopped or reversed.

Everyone should have agency over their own decisions with their body, and doctors shouldnt be making that any more confusing or difficult, they said.

Starks does regret one thing going to the clinic alone. Protestors screamed and name-called.

Maggie McCabe, whose mother worked to start the last remaining abortion clinic in West Virginia, the Womens Health Center in Charleston, was 16 when her mother flew her to Washington, D.C., for an abortion in the days before the U.S. Supreme Court legalized abortion in its Roe v. Wade decision in 1973.

A professor at BridgeValley Community and Technical College who worked for a health insurance provider for 28 years, McCabe was just getting ready to start her life.

She said she wouldnt have wanted wishy-washy information when seeking an abortion, and said patients deserve concrete, appropriate information.

My abortion had no negative effect on me, she said. Its made me a stronger woman, because I believe in helping others in any way that I can. Telling my story is my contribution to helping other women in their decisions.

McCabe, of Charleston, criticized lawmakers for involving themselves in health care decisions and called abortion bills a form of sex discrimination.

She noted people with fewer resources and less support couldnt have flown to D.C., like she did.

The right-to-lifers are using a very offensive, very un-Christian campaign to keep women oppressed, and to keep women in a lower class controlled, she said.

Jamie Miller, an abortion rights advocate who lives in South Charleston, was almost 17 when she received an abortion.

She had already gotten approval from a mental health professional for the abortion to avoid telling her family, and saved up money.

Miller said if after all that, she arrived at her appointment and providers told her the process could be stopped or reversed, she would have wondered whether she could trust them and if she needed to attempt a possibly deadly abortion on her own.

I would have felt like they werent on my side, she said.

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Here is the original post:
West Virginians considering abortion need good information about the procedure; bill might keep them from getting the facts - Beckley Register-Herald

Although many people think otherwise, bacterial vaginosis (BV) isnt a sexually transmitted infection (STI).

Any person who has a vagina can develop it, and there are a number of factors that may lead to such an infection.

Yes, exposure to a new sexual partner is one of them. But the list also includes things like smoking and douching.

So theres no way that anyone can definitively say BV is linked to cheating.

No, BV isnt considered to be an STI even though some people have reported being told this by a clinician.

The confusion likely comes from the fact that BV can be associated with sexual activity.

For example, penetrative sexual activity can affect the natural bacterial balance in your vagina, leading to extra bacterial growth and eventually BV.

But theres little evidence that the infection can be passed between people through sexual contact, so it isnt on the STI list.

However, BV can increase your chances of contracting an STI, as the bacterial changes may lower the vaginas natural defenses.

The exact cause of BV is unknown, but its characterized by an unbalanced bacterial balance in the vagina.

However, experts have found a number of factors that may increase your risk of developing it.

This includes anything that affects the vaginas pH levels, such as douching or using irritating vaginal products.

Youre also more likely to develop BV if:

Unfortunately, there isnt an easy answer to this. Theres still much more for researchers to learn about the infection.

From using an IUD as contraception to taking up smoking or even changing the way you clean your genital area, all of these factors can lead to BV.

Because of this, theres a chance that you may not know why or even when youve suddenly developed it.

BV can go away on its own after a few days.

But if you need medical treatment, youll likely have to take a weeklong course of antibiotics. If the infections persistent, your provider may prescribe a second round.

Half of people with BV dont have any symptoms, so you may have little to deal with.

But strong-smelling vaginal discharge and irritation when urinating are typical symptoms of the infection.

Although you should seek medical advice from a doctor or other healthcare professional, you can try the following at home to lessen symptoms:

If your partner has a penis, its unlikely that theyll need treatment.

But the infection can be passed between people who have vaginas.

So if your partner has a vagina, its worth seeking medical advice for the both of you.

As doctors arent sure how bacterial vaginosis occurs or spreads, its hard to say how to prevent a recurring infection.

But there are a few simple steps you can take to help reduce your risk of developing a second bout of BV. (Most of these steps are similar to the ones you may have taken to relieve symptoms at home.)

First, its advisable to avoid putting anything that may cause irritation in or around your vagina.

This includes douches, deodorants, and perfumed cleansing products.

Instead, use water and plain soap to clean the area, sticking to showers rather than baths where possible.

When it comes to your underwear, stick to breathable, moisture-wicking fabrics, such as cotton, to avoid unwanted bacterial growth.

And wash underwear using a mild detergent, rather than a strong formula.

Finally, when having intercourse or any kind of sexual activity, ensure sex toys are clean before contact and use condoms or dental dams.

Unfortunately, recurrence is quite common, but it wont hurt to follow the above tips.

If youre worried about STIs, its better to book a test to put your mind at rest.

Symptoms to look out for include:

Thinking that your partner has been unfaithful is a little more complex.

Its natural to want to confront them, but try to take some time to think things through.

After all, your worries could be nothing more than a misunderstanding.

If you do want to speak with your partner, its often a good idea to write down the kinds of things you want to say beforehand.

You may also want to think about whether youd like to try and move forward if it turns out they have been unfaithful, or whether the relationship will have to end.

Speaking with a neutral person who has little connection to you or your partner can also help you get things straight.

When youre ready to talk, let your partner know that youd like to discuss something thats concerning you.

Try to set the conversation up in an environment that suits the both of you, whether thats in private or in public.

Start off by talking about how much the relationship means to you, as well as honesty and trust.

You can then say that you feel there might be a problem in the relationship, bringing up specific examples if needed.

Try not to be accusatory and listen to what your partner has to say. But if something doesnt feel right, dont be afraid to press them on it.

If the shoes on the other foot and your partner thinks that youre the guilty party, try to stay calm.

We tend to get defensive when were being confronted with something thats not true.

But try to put yourself in their shoes and realize that theyre likely only acting this way because they care about the relationship.

Let them talk through the issue and then attempt to understand why they think the way they do.

For example, have you been paying them less attention than usual?

Or is there something going on in their life that could be affecting their emotional state?

I hear you is a good way to start off your end of the conversation. It lets them know that youre listening and understanding where theyre coming from.

At the same time, dont be afraid to let them know if theyve upset you with such an accusation. Remember, its important for both of you to be open and honest.

Asking if youre able to move past the issue is often a good way to end things.

Itll leave you both with an understanding of where youre currently at and clear steps to take to improve the relationship if needed.

If their concern is about contracting an STI, explain that BV isnt an STI. And if theyd still like an STI test, be supportive.

Offer to go with them and get one too if youre comfortable doing so.

Most doctors recommend booking an appointment if you think you have BV, even though it can go away on its own.

This is because, if left untreated, BV can lead to pregnancy complications, pelvic inflammatory disease, or an increased risk of STIs.

So any unusual discharge, itching, burning, swelling, or soreness around the genital area warrants a call.

A healthcare professional can test vaginal discharge and fluid for the infection and prescribe the right treatment, if necessary.

Treatment usually involves a course of antibiotics, either in a pill, capsule, or cream form.

Although much more research is needed into BV, the infection is most definitely not a clear-cut sign of cheating.

So if you or a partner do experience it, try not to blame yourself or others. The cause may have nothing to do with your sex life.

Lauren Sharkey is a U.K.-based journalist and author specializing in womens issues. When she isnt trying to discover a way to banish migraines, she can be found uncovering the answers to your lurking health questions. She has also written a book profiling young female activists across the globe and is currently building a community of such resisters. Catch her on Twitter.

Originally posted here:
BV Isn't a Sign of Cheating Here's Why - Healthline

CARLSBAD, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (NASDAQ: QLGN), a biotechnology company focused on developing novel therapeutics for the treatment of cancer and viral diseases, announced today that Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen, and Amy Broidrick, EVP, Chief Strategy Officer will present on March 24, 2021 at the Benzinga Biotech Small Cap Conference being held March 24-25, 2021.

Qualigen Therapeutics, Inc. Presentation Details are as follows:

Investors and others invited to attend this conference event may request one-on-one meetings with representatives of the Company through the respective conference hosts or via email to Tony Schor, tony@investorawareness.com or David Kugelman, dk@atlcp.com.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational nucleolin-targeting DNA aptamer of ALAN, AS1411, is also a drug candidate for use in treating COVID-19 and other viral-based infectious diseases. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds.

Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC.

For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Forward-Looking Statements

This news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. Actual events or results may differ from the Companys expectations. For example, there can be no assurance that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Companys owned and in-licensed patent applications; that such patents, if any, and the Companys current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Companys prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Companys diagnostic products generally, particularly in view of COVID-19-related deferral of patients physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPack instruments on which the Company's SARS-CoV-2 IgG test kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgG test kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgG test kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Companys SARS-CoV-2 IgG test. The Companys stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available at http://www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Relations:

David Kugelman, President and CEOAtlanta Capital Partners, LLC(404) 856-9157 Office(866) 692-6847 Toll Free - U.S. & Canadadk@atlcp.com

Tony Schor, PresidentInvestor Awareness, Inc.(847) 971-0922tony@investorawareness.com

See the rest here:
Qualigen Therapeutics, Inc. to present at the Benzinga Biotech Small Cap Conference - GlobeNewswire

Minoxidil (Rogaine) is a popular product for people with thinning hair. The product comes as a gel or a foam, and is meant to be applied topically to your scalp on a daily basis.

When people first start using minoxidil to restore their hair, some notice that they actually start losing more of it at least for a short period of time.

There are plenty of clinical trials and medical evidence that support the use of minoxidil for moderate hair loss caused by alopecia. But how do you know if its actually working, especially if it looks like youre losing more hair than before?

Lets cover hair loss caused by Rogaine so you can understand how common it is, what causes it, and whether you should be concerned.

Minoxidil was a drug originally developed to treat hypertension.

Researchers observed that people who had alopecia and used minoxidil for hypertension experienced hair regrowth, and the worlds most popular over-the-counter treatment for alopecia was born. People have been using minoxidil to treat hair loss since 1986.

The way that minoxidil works isnt completely clear. Whats apparent is that minoxidil decreases hair loss in some people while also increasing hair growth. It doesnt work for everyone.

Minoxidil is also classed as a vasodilator, meaning that it dilates your blood vessels so that blood flows more easily where its applied. An increase in blood circulation to your scalp could be part of why minoxidil increases hair growth.

Your hair follicles go through four phases of growth. Not every follicle is in the same phase at once. Minoxidil is believed to affect two stages of hair growth.

The anagen phase of hair growth is its growing phase. This is when the hair is being pushed out from the root. Applying minoxidil may extend the length of the anagen phase.

The telogen phase of your hair is its resting phase, when its done growing but not yet ready to fall out. In clinical trials on rats, minoxidil shortened the telogen phase of hair from 20 days to 1 to 2 days.

Minoxidils side effects are typically mild. Common side effects include mild itching and burning as well as flaky skin. Minoxidil can also cause your hair to shed, especially when you first start using it.

As minoxidil speeds up the resting phase of your hair, sometimes it falls out more quickly than it normally would.

However, minoxidil also extends the growth phase of your hair. That means that even though some hair shedding is to be expected at first, new hair growth should soon replace the hair that youve lost.

Not everyone will experience shedding as a side effect of minoxidil, while some may experience it severely. There arent statistics currently available that explore how common this particular side effect is.

You cant do much to prevent minoxidil-related shedding or even predict if youll experience it when you first start using the product.

One thing to be aware of is that the higher the concentration of minoxidil you use, the more powerful the side effect is likely to be. Using a foam with 2 percent concentration of minoxidil, for example, could cause fewer side effects than with a 5 percent concentration.

If youre seeing a lot of hair loss, you might want to switch to a less powerful dose of minoxidil. If youre concerned about hair loss and havent started using minoxidil yet, start with a lower concentration and work up to a higher one if you need it.

Results of minoxidil vary from person to person. Generally speaking, it takes about 8 weeks of consistent use to start to see results with minoxidil. After 4 months of use, you should start to see the end of hair loss and start to see hair growth.

If its been 4 months and youre still seeing hair shedding, it may not be related to minoxidil. Its also possible that minoxidil isnt the right product for you. If you see a lot of your hair falling out after 4 months of use, speak with your doctor about alternative treatments.

Minoxidil does have some other side effects in addition to hair shedding. Side effects may include:

If youre experiencing strong side effects as a result of minoxidil, call your doctor and discontinue use.

If youve been using minoxidil for several weeks and youre still seeing more hair loss than growth, see your primary care doctor or a dermatologist. They may be able to determine if hair loss is being caused by another underlying health condition.

You should always seek medical attention if you experience the following:

Some shedding is normal when you start using any topical product that contains minoxidil. If youre concerned about hair loss, this might be alarming, but its typically no cause for concern.

If shedding doesnt stop within 4 months of starting a hair regimen with minoxidil, discontinue use and speak with your doctor about other hair regrowth options.

See more here:
Minoxidil and Shedding: Why it Happens and What to Expect - Healthline

Lets talk about a painful subject. I am of the opinion and Im far from alone that the most reliable way to determine if a possible therapy has any usefulness is a randomized, double-blinded controlled clinical trial. I can be a bit more specific than that, even: lets make that a trial that is run with sufficient statistical power to have a good chance of providing a meaningful readout.

The worldwide coronavirus pandemic has featured some well-run trials that have truly advanced our knowledge of the disease and how to treat it. But it has featured far, far more garbage. That word was chosen deliberately. There have been too many observational trials, too many uncontrolled (or poorly controlled) ones, too many open-label ones, and above all, there have been way too many trials whose number of patients would be insufficient to tell us much of anything even if everything else had been run properly.

I am not revealing any hidden tricks of the trade here. Clinical trial design is a subject with a very large literature, and there are any number of people and organizations who can provide useful guidance on both its theoretical and practical aspects. Among these aspects are the calculations that should be made for how many patients a trial is likely to need to be well-powered enough for a clean read on its clinical endpoints. You can start to learn the basic outlines of the subject online. Now, thats not to say that its an easy subject to get ahold of. Youre going to have to estimate some of your key parameters as well as you can, among them what you think the effect size of your treatment might be, what the patient-to-patient variability might be like, the time course of treatment that might be needed, and more. Just picking the proper clinical endpoints is a subject all in itself (and its one that can have a huge effect on a trials design and on its chances for success). And at the other end of things, your inclusion criteria and patient enrollment process is a place for serious thought, too. Who should be evaluated (or definitely not evaluated) in your trial, and how long will it take you to round those people up? Where are you thinking about doing all this, anyway?

There are a wide variety of trial designs out there as well, and you can find yourself sorting through some that are clearly inappropriate to the problem at hand, some that would be great if you had about ten times as much money and time as you do, and several that at first glance look like they could all work out, but which have real-world differences that its crucial that you be aware of. You would be well advised to consult with experience practitioners before you start, to make sure youre on the right track.

Unfortunately, underpowered, badly-run, and badly designed trials have been with us for a long time. Here are some well-justified concerns from 2002, for starters, and various fields of clinical research undergo periodic bouts of soul-searching over the years about these issues. But the pandemic year has really made some of our problems more obvious. Not only do we have trouble with badly run trials, but mixing in with that is a bandwagon effect. Clinicians all over the world just piled onto some of the coronavirus ideas, and kept piling on for months and months and months.Think, for example, about the hydroxychloroquine situation. Now, I still get messages condemning me as an implacable, irrational foe of the One True Coronavirus Therapy. But its worth remembering that I started out as a Huh, I dont know how that would work, but lets look into it person, which I really think should be the default setting. And in that spirit, I was all for running trials and getting more hard data.

But what did we get? A search through clinicaltrials.gov for hydroxychloroquine|coronavirus gives you 113 trials. Whats more, thirty-six of those are still listed as recruiting patients. This is ridiculous, but its not amusing. There are some large, well-controlled data sets available that indicate that HCQ is very likely not a useful therapy, but as you can see, there are also dozens of other smaller ones that say Yes! No! Maybe! Sorta! Kinda! Kinda Not! Depends! Could Be! Who Knows? And that adds up not just to a lack of knowledge, it turns into an actual hindrance to knowledge as you try to sort through the data. The heap of fuzzy indeterminate results also fuels the extrascientific political and cultural arguments about the drug, since everyone can find some sort of support for whatever opinion they might have.

You have to think that there were other therapies that deserved a look in the clinic as compared to the forty-third, sixty-seventh, or ninety-eighth hydroxychloroquine study. Youll recall that for a while, HCQ ended up mixed into other clinical trials just because everyone wanted it or imagined that it was some sort of standard of care, and that did no one much good, either. Now, HCQ isnt the only offender, but its a big one, and I think it illustrates what we should try not to do next time.

How, then, should we try not to do that? (Update: some thoughts here on this problem from a distinguished team of authors with exactly the same concerns). Its not like the US (to pick a big example) has a National Clinical Trial Authority that passes judgment on these things. To be honest, the downsides of having such an agency might worry me even more. But letting everyone go into Headless Poultry Mode and pile up overlapping crap in the clinic isnt such a good way to go, either. You would hope for a little more coordination among major medical research centers, and youd also hope for some local university/research hospital review boards to be aware that greenlighting the East Porkford Covid-19 Treatment Study with 47 patients isnt really going to advance medical science very much. Especially when its covering the same ground as the trials kicking off in Mashed Potato Falls, Rancho Malario, and Kidneystone Pass. But Im being unfair to East Porkford some of these lackluster trials were conducted at larger institutions that should have known better. The way were set up, its down to the review boards and the sources of funding to police things better, and to keep their heads while all about them are losing theirs.

And its also down to the NIH and the CDC to lead the way more than they did during 2020. The RECOVERY trial in the UK has been an example of what can be accomplished in that line. The NIH has helped run some good trials, but weve had nothing that comprehensive in the US as compared to the UK effort, and I really wish we had. I fear that some day, eventually, were going to have a chance to do better, and I hope that we take it.

More:
The Problem with COVID-19 Clinical Trials | In the Pipeline - Science Magazine

Even studies have presented that those children, who were born out of hypothyroidism mothers during pregnancy, have lower IQ and impaired psycho-motor (mental and motor) development. But, fret not! If the condition is properly controlled and treated well, then those women with hypothyroidism can also have healthier babies.

Since the thyroid gland of the unborn child takes time to function on its own, its completely dependent on the mother for the thyroid hormones. Development and functioning of babys thyroid gland do not take place until about the end of the first trimester of pregnancy. Therefore, its suggested that women should start getting their thyroid disorder managed before conceiving so that impaired neurological functioning, stunted growth and physical deformities in the children can be avoided.

There is always best to plan for pregnancy and to consult with your physician to ensure your thyroid status and treatment are optimised prior to becoming pregnant and monitored throughout your pregnancy. However, if this does not happen and you find out you are pregnant, you should contact your physician immediately to arrange for increased testing of your thyroid functions and a potential change in your medication.

Untreated or poorly controlled hypothyroidism can also lead to:- Miscarriage- Premature birth- Pre-eclampsia - StillbirthSo, it is vital for pregnant women with hypothyroidism to take the recommended thyroid medication consistently.

How Is Hypothyroidism Treated During Pregnancy? The treatment of hypothyroidism in pregnant women is similar to that of the regular treatment. Doctors recommend synthetic T4 so that it compensates the presence of essential hormones in the body. The medication should be taken regularly so that a steady blood level of thyroid hormone gets adjusted within the normal range as the requirement of thyroid hormones increases during pregnancy. Therefore, it is a routine practice to monitor the blood level of the thyroid stimulating hormone (TSH) during pregnancy. Hyperthyroidism women can have healthy pregnancy by getting early prenatal care and working with their healthcare providers in the management of their disease.

Also read: Expert Speak: How To Lower The Risk Of Neural Birth Defects

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Expert Speak: Hypothyroidism And Its Effect On An Unborn Child - Femina

The ongoing trial is enrolling patients at 62 locations in the United States and worldwide.

Neeraj Agarwal, MD, discusses the rationale for the ongoing phase 3 randomized, open-label, CONTACT-02 study (NCT04446117) of the multikinase inhibitor cabozantinib (Cabometyx) plus the PD-L1 inhibitor atezolizumab (Tecentriq) versus second novel hormone therapy (NHT; abiraterone acetate [Zytiga] or enzalutamide [Xtandi], etc) in patients with metastatic, castration-resistant prostate cancer (mCRPC) who previously received 1 NHT to treat metastatic castration-sensitive prostate cancer, non-metastatic CRPC, or mCRPC.

Primary outcomes measures are overall survival and progression-free survival, with objective response rate as a secondary outcome measure. The target enrollment is 580 patients, and there are 62 study locations for the trial in the United States and worldwide.

Agarwal is a professor of Medicine, physician and investigator at the Huntsman Cancer Institute, University of Utah. He directs the Genitourinary Oncology Program and the Center of Investigational Therapeutics, and co-leads the Experimental Therapeutic Program.

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Dr. Neeraj Agarwal discusses the ongoing phase 3 CONTACT-02 study of atezolizumab/ cabozantinib in mCRPC - Urology Times