On the nights when the mental sexual images of children were most overwhelming, Joseph Parker took cold showers and baths, hoping the shock of freezing water would push his intrusive thoughts away. Other times, he would fixate on a picture of the Sri Lankan Buddhist monk Henepola Gunaratana, so that the monk's "wrinkly face" might replace the disturbing imagery in his head.

Parker, who is using a pseudonym to protect his identity, had known he was attracted to children since he was 17, but he didn't start having overpowering sexual urges until he was 24. (He's now 26.) These urges were the worst when he was falling asleep. "As soon as I tried to release myself from wakefulness, my mind would sink into the pool of sexual energy, and I would feel this horrible sense of joy and happiness towards children, he said.

He read online about medications that could lower testosterone levels and, as a result, sex drivea process sometimes referred to as "chemical castration." When he asked a psychiatrist for these drugs, he was given Risperidone, an antipsychotic, instead. He took that for about a year, then added on Sertraline, an antidepressant, but only found these drugs mildly helpful. He turned to the internet to get what he had wanted in the first place.

From a website based in Turkey that sells pharmaceuticals, he ordered cyproterone acetate, which lowers testosterone, along with the female hormone estradiol, and now takes the two medications together. The website that processes the sales is frequently shut down because of its illicit nature: "To my knowledge this is their third or fourth website change, at least, since I came upon them 14 months ago," he said.

Parker wishes it wasn't this hard for pedophiles to get sex-drive reducing medications. But for many pedophilesand especially pedophiles who have not committed crimesaccess to even talk therapy, let alone medication, can be difficult to come by, and the process is riddled with fears about being reported to legal authorities.

In the past several decades, researchers have arrived at new understandings about pedophilia, the sexual attraction to children. Pedophilia appears to be an in-born sexual preference, something a person does not choose and cannot change. A pedophile's attraction to children is consistentnot a phaseand they develop their attraction to children around the same time that other people develop sexual attractions.

While researchers' knowledge has been evolving, access to widespread, up-to-date healthcare hasn't kept up pace. Outside of the handful of researchers who provide therapy and medication to pedophiles, the barriers to finding an informed therapist or psychiatrist remain high. This has led to a hodgepodge of therapeutic approaches in the community, or people self-medicating, like Parker did. Many pedophiles are only directed towards treatment in the context of the criminal justice system, where in some states, chemical castration is used on sex offenders.

Yet importantly, researchers have established there's a distinction between pedophilia and child molestation, a difference between the attraction itself and the crime. Most people hear these words and think that they're synonyms. They're not, said James Cantor, a Canadian clinical psychologist and neuroscientist who studies pedophilia.

Only about half of child sex offenders are genuine pedophiles. The other half prefer adults sexually, and are abusing children because theyre available or easily manipulated. (Child porn offenders, on the other hand, are nearly always pedophiles because of the ready availability of adult porn alternatives.)

The goal of any modern, preventative treatment for pedophila should be to help people manage their sexual interests rather than try to change them, Cantor said. This can involve the voluntary use of hormone-reducing medication to control urges or therapy. Since pedophilia and sexual abuse are not synonymous, treatment for pedophilia is also not solely about preventing child sexual abuseits about helping people with their overall mental health and well-being too. Thats a concept that may be hard to accept. It involves recognizing that people who are sexually attracted to children deserve to live healthy and meaningful lives.

Online support groups for non-offending pedophiles have only recently entered the public eye. The most well-known group, the Virtuous Pedophiles, was formed in 2012 as a safe place for pedophiles to discuss their struggles and commitment to not offend. Parker belongs to the Virtuous Pedophiles and is known to the community as Double22. Another organization, the Association for Sexual Abuse Prevention (ASAP) was formed by some members of the Virtuous Pedophiles, and they are currently ramping up their goal to create a platform to connect pedophiles to mental health professionals.

"In my opinion, they should not be seen as second class patients.

In April of this year, the first randomized placebo-controlled study of a hormone-reducing drug for pedophilia took place in Sweden. Published in JAMA Psychiatry, it found that the drug reduced both high sexual desire and sexual attraction to children, and that the effects were noticeable within two weeks.

The study is the first to include people who self-identified as pedophiles and were seeking help of their own accord, not just people funneled from the criminal justice system. Whats even more remarkable about the study is that it included a placebo groupthe first pedophilia study to do so. In an editorial about the study, Peer Briken, a professor of sex research at the University Medical Centre Hamburg-Eppendorf in Germany, wrote that it marks a milestone in clinical sexual science and the field of forensic psychiatry.

I think one of the biggest problems is that people just don't understand this as a mental health issue, said Fred Berlin, an associate professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. Rightfully, people are concerned about protecting children. And so we just quickly stigmatize people who are attracted to children and often don't even see them as human beings with a problem who might be deserving of help.

"In my opinion, they should not be seen as second class patients.

In 2014, journalist Luke Malone wrote an article about young people, some of them minors, who were discovering that they were attracted to children, and how they were coping with it. It was adapted as an episode of This American Life, one of several high-profile media pieces about pedophiles that explored the complicated existence of being born attracted to childrenand how hard it is to get help.

When Adam, one of the young pedophiles in Malones story, admitted to a therapist what was wrong, she just became extremely cold and harsh, he told Malone. She even, a few times, almost got to the level of shouting. She ended up telling Adams mother.

There is a huge reason [pedophiles] would avoid therapists and doctorsthose people have an obligation to report them to police if they think children might be in danger in the future, said Ethan Edwards, one of the co-founders of the Virtuous Pedophiles, who uses a pseudonym.Especially if they are not specifically trained in the issue, and with the common belief that all pedophiles molest children sooner or later, it is very perilous for a pedophile to seek out a therapist.

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Christoffer Rahm, a psychiatrist, researcher at the Karolinska Institute, and the senior author on the JAMA study from April, once worked at a clinic linked to a Swedish national helpline focused on sexuality, PrevenTell. Rahm ended up meeting some pedophiles who called in; one was a bus driver who brought children to school. The bus driver was struggling with his impulses and fantasies, but had not sexually offended in any way. Rahm looked for research to help determine the best treatment for his patient and found a gap in the literature: There were no rigorous comparisons of different medications, or recommendations about who might do best with therapy. (As far as we know, female pedophiles are rarer, and the research on treatment for them even more sparse.)

Cantor feels it's more than just a gap when it comes to pedophilia. It is a black hole, he said. This is a topic that scientists in the fields of mental health are not just uninterested init is actively repugnant."

Thats what motivated Rahm to conduct his study. If there are people seeking help for this, the best thing would be to manage it in a preventative phase before the damage is done, he said. Of course, society needs to say that any kind of abuse against a child is not okay. But it is counterproductive if these people can't even seek help with a professional.

The medication Rahm studied is Degarelix, approved by the FDA in 2006 for treatment of advanced prostate cancer. This is the first time that it's been used off-label for pedophilia. Its an injection that starts working right away and lasts for about three months. It works by shutting down signals from the brain to the body to produce testosterone.

In qualitative interviews Rahms team did during the study, they found that some of their participants experienced positive effects. They described feeling an inner calm, Rahm said. They felt less pressure, that they had a better intimate life with their partners. Some described that the annoying thoughts around children disappeared so they can focus on other things. And many described that they had lost that enervating impulse to masturbate, and were able to see children as just human beings and not sexual symbols. A majority of the participants in the group that got the active drug said that they would want to continue taking it.

Many of the therapies that have been used for pedophiles have not been validated this way, but deployed through forensic psychology and the criminal justice system. Though Berlin has prescribed hormone-reducing medications to countless patients, he feels that the legal system usually doesnt collaborate with doctors and scientists who are studying the use of these drugs. As a physician, I think that's completely inappropriate, he said.

If someone goes to prison being sexually attracted to children, theres nothing about prison that can get rid of that attraction, or enhance a persons ability to resist temptation later on, Berlin said. It also leads to a mistrust of treatment, because of a history of involuntary use of chemical castration and aversion therapya therapy that associates negative cues with images of young children to dissuade future attraction.

The idea that we can solve this simply through punishment and incarceration is very naive, Berlin said.

Talk therapy should focus on managing a person's sexual interests, with an explicit acknowledgment that those interests will likely never change. In the past, therapy sometimes focused on searching for trauma, because of the belief that a history of abuse led someone to abuse. The truth is a bit more complicated. Having been sexually abused in your own childhood could be a factor in committing sexual abuse as an adult, but is not necessarily a factor in pedophilia.

This is what Ive heard over and over, Cantor said. They knew. They always knew it. All their past therapists were telling them to focus on trauma, what happened in their childhood. But their genuine experience of it was that they were born this way.

We need to move on to the next generation of research and quality development.

Cantor said that once that basic framework of therapy changes from changing ones sexuality to managing it, people adapt very quickly. It makes more sense to his patients, and theyre able to better commit. If a person has looked at child porn or committed sexual abuse in the past, a therapist would help them examine how and why their self-control broke down, and how to set up their life so that it doesnt happen againnot how to stop being attracted to children.

For some people, this process could be paired with sex-drive reducing drugs. Some people find they would rather live in that state than with those nagging sex drive that they can't express and can do anything to do anything about, Cantor said.

Yet even in those states that have issued mandates for sex offenders to receive hormone-reducing drugs as punishment, it can be incredibly difficult for non-offending pedophiles who want it to get medication. I get letters from people around the country all the time wanting access and they can't even get access to it, Berlin said.

Rahm doesnt advocate for medication to be used for every pedophile for lifehis study explores whether this specific drug could help. He said a person may only want and need it for a few months. It could help a person through a difficult time, or be combined with the start of a behavioral therapy practice. We need to move on to the next generation of research and quality development, Rahm said. We need to evaluate our treatments and to get evidence-based treatments out there so we know what we're doing.

The word castration has a dark history, and dark connotations. It's often been wielded involuntarily: In Germany the number of involuntary castrations of sex offenders increased as a result of the Nazi German Act, with at least 2,800 sex offenders were castrated between 1934 and 1944. In the United States, Black men accused of raping or sexually assaulting white women could find themselves subject to castration. For reasons like these, Rahm is torn about calling Degarelix chemical castration." While he thinks researchers and clinicians should accurately describe what the drug is doing and its side effects, he worries that referring to it as castration could scare people away, or disregard the consent and autonomy of patients who want it.

Rahm said that every person who participated in their study did so voluntarily, and was informed in detail about any possible side effects from taking Degarelix. They had the option to quit the study at any moment. Hes also currently running another placebo-controlled study on a non-pharmacological option: therapy geared specifically towards pedophiles that they can access anonymously, through the dark web.

The mere existence of Rahm's studies is important, outside of the details of the findings. Doing placebo-controlled studies on pedophilia was previously thought to be impossible, because of the ethical implications of not giving an active treatment to a group of people attracted to children.

In Brikens editorial, he wrote that because the medication they used was fast-acting, and they allowed anyone with pedophilia into the studynot just those who were high-risk for offendingit helped make the placebo group ethically possible. Briken concluded that Rahm's study was the most important contribution to the field of pharmacotherapy of pedophilic disorders since the original study of hormone reducing drugs in 1998, and offers a starting point for a more comprehensive approach to pedophila treatment.

In Germany, Prevention Project Dunkelfeld, which offers therapy and medication, has 10 locations throughout Germany, and a person can get help while remaining completely anonymous.

The demand for their work is high: After a BBC documentary on the Dunkelfeld Institute aired, the Guardian reported that Dunkelfelds hotline was overwhelmed with calls from British pedophiles. One British man was so desperate, he moved to Germany to be able to access a Dunkelfeld programme, the Guardian wrote. In an email exchange with the Guardian, the man, who wished to remain anonymous, wrote: 'So far, all I have ever received from the NHS is doors slammed in my face.'"

There's not as well-known a center for pedophiles in the U.S. to go to. Richard Kramer, the educational director at B4U-ACT, an online community for pedophiles, said he figured out he was attracted to pubescent boys in his 20s. (His attraction is to boys around the age of 12 or 13, which is technically called hebephilia.) I was very ashamed about it and thought that I was seriously defective as a human being, Kramer said, who is using a pseudonym. I really wasn't able to find any information about it. I didn't want to go to the library for fear that people would see what I'm looking up.

When he began reading information online, he said, everything he encountered was very negative. It said that I would be a monster, I would have hundreds of victims, and that my entire life would be centered around an elaborate plot to deceive parents and to manipulate children into abusing them, he said. So I thought, well, this is what they think about me. I have no interest in seeing them and seeing a therapist.

A big part of being successful in therapy is having the support of family and friends, something that pedophiles can lack. They often are going through difficult treatments alone, and are unable to talk about it to others. You cant tell co-workers, or ask a boss for time off for your appointments. You have two choices, said Michael Seto, a forensic psychologist and sexologist at the University of Toronto. You don't do it or you lie about it.

When Kramer was ready to look for a therapist again, he didnt really care what kind of approach they used, but was more concerned about whether they understood enough about pedophiles to not treat him like a criminal. His goals didn't involve a struggle to control his impulses, but to manage the shame and sense of isolation from others because he couldnt be honest.

We have to insist that people who have this orientation not act upon it, Berlin said. If we think about that, that can be quite a burden. Its not surprising that some of these folks might be in need of mental health assistance, because of the effect of experiencing these attractions on their sense of self-esteem and self-worth.

Happy, mentally healthy people do not molest children.

Some pedophiles are attracted to adults and children; some, only children. For those who are exclusively attracted to children and dedicated to non-offending, Kramer said, there needs to be a space for helping them grieve over not being able to have romantic and sexual relationships. How do they deal with loneliness? he said. There are other concerns, some almost mundane: How, for instance, do they deal with answering questions friends and co-workers ask about their personal lives? Hes had friends who asked him if he was gay, and he said he wasnt sure how to answer.

I'm not exactly gay, but I'm definitely not straight and I'm definitely not asexual, he said. How do you respond to that?

Gary Gibson founded the ASAP as one potential solution to this problem. Through an involvement with the Association for the Treatment of Sexual Abusers (ATSA), Gibson has been curating a list of therapists to whom he can refer pedophiles. The list is now around 400 names long. ASAP primarily focuses on non-offending pedophiles, but they will also help people who have offended and want to stop. People are just desperate out there, Gibson said.

He has worked with pedophiles who were so desperate for help that they underwent physical castrations. One man traveled to Mexico to have the operation done; when he returned, he tried to find a doctor to supervise his recovery and medications. I could not find a doctor who would take him on, Gibson said. They didn't want him in the office. I did find a therapist to work with him, and I kind of lost contact with him. Im worried about what happened to him.

Until recently ASAP has been handled almost entirely by Gibson, but ASAP is currently undergoing a significant expansion. It has increased its office and volunteer staff, is making a new, online database of mental healthcare providers, and creating a 24/7 helpline. Gibson said his dream is to get a multimillion dollar grant to create a mentor program for teenagers, aged 13 to 17, who are learning that theyre pedophiles. Ive applied three times, he said. Maybe the third time's the charm, because Ive been denied twice.

The goal is to help every non-offending person attracted to children find therapy if they want or need it, said Robert Hillman, a lifelong virtuous (non-offending) pedophile, and the new president of ASAP. Hillman said that the mantra is: All pedophiles are born non-offending, and the aim is to help keep it that way. Happy, mentally healthy people do not molest children," he said.

People do the most desperate things when they feel the most desperate, Cantor said. A lot of what these groups and therapy provide is helping people lead a life that is worth protecting. When they have a life worth protecting, thats when people get the energy and the willpower to control themselves, because they dont want to risk the life that they have.

What Hillman and Gibson want is the opportunity for any person attracted to children to chart their own path, and figure out what works best for them. That may include an experimentation with medication, and it may not. ASAP doesnt control their therapiststhey all operate independently, using different methods of treatment. They're not always successful. One guy has committed suicide that I know of, Gibson said said. But I think that we have probably saved a few lives and saved many children from being abused.

These support groups and therapy networks are providing a lifeline, but alone, they don't guarantee a consistency in treatment, nor fill the gaps in the scientific literature when it comes to which treatments might be best for a certain person. There might be certain hormone-reducing medications that are less risky or work better than others; certain pedophiles that fare better without drugs; certain therapeutic practices that are more helpful than others. Those answers aren't clear-cut.

As with all medications, some people have good experiences and others do not. Pedophiles can identify as ego-dystonic or ego-syntonic. Ego-syntonic people consider pedophilia as part of their identity, and can be okay with fantasizing and masturbating about children (though not with porn), while ego-dystonic people are not. It may be that treatment should be different with those who have different attitudes towards their attraction, even if members of both groups have the same commitment to not offend.

After about five weeks, Parker said that he felt better from the medication he had ordered online. It was night and day," he said. "I can't tell you what a weight was lifted off of me, or a pressure from under me that was relieved. Whenever I think about it I just lay back in my chair and breathe a contented sigh, knowing that I won't suffer like that again. Both physical urges in my body and intrusive imagery in my mind have disappeared."

He doesnt think that medication should be thought of only as a stop-gap to a person committing sexual abuse. Offending was never a danger for me in the first place, he said. He doesnt take the medication to stop himself from molesting a child, but as a way to improve his quality of life.

When Max Weber, who helps run a peer-support website for pedophiles in Germany, realized his attraction to young girls in his early 20s, he said, he was terrified. My picture of pedophilia at the time was the same wrong impression most parts of society have: that pedophiles were bound to offend, he said.

Weber got treatment at Dunkelfeld, and said he views medication like a pair of eyeglasses. You can put [them] on to help yourself focus on things that you want to change about your life.

To Weber, pedophilia was like being surrounded by deep water; he had to struggle to stand on his toes to avoid drowning. I needed all my strength to cope with it and dont drown in my own fears and self-hate, he said. As a result sexual impulses felt very powerful since, when you are standing on your toes, even the slightest push could throw you over.

He took medication for about nine months. During that time when his sexual feelings were repressed, he regained a foothold on his life, he said, and found that even without medication he is able to be around children without issue. I now know that I am in charge, and no one can make me offend other than myself, he said.

Two years ago, David, a 22 -year-old recent college graduate from New York and a volunteer for a peer-support group including pedophiles, desperately wanted to take hormone-altering medication. I hated myself for having feelings about children, and I just wanted to be like everyone else," he said. "I was also going online and finding articles about how to raise libido, and doing the opposite of all of the advice I found. But I couldnt find a therapist I felt safe coming out to.

Since then, he said that support groups like Virtuous Pedophiles have helped him realize that being attracted to children is not something he chose, and hes not tempted towards any illegal behaviors. In the end, there was no need for me to go through such a treatment with dangerous side effects," he said.

Though he never ended up trying medication, David thinks his experience with peer support reveals something important. Medications can help reduce physical symptoms, he said, but the restthe support, the isolation, the shameall needs to be addressed outside of just taking a pill.

I struggled with serious depression, anxiety, and self-hatred as a teenager starting to understand that I was a pedophile, David said. Becoming less isolated, having people to help when I was hurting, and being able to help others in the same way is what brought me back from that.

Hillman was a patient of Berlins about 25 years ago. I was on the brink of madness from the desires and from the shame and self-hatred and loathing, he said. "It was crushing me and I was not going to survive it. He took hormone-reducing medication with Berlin's help, and said that combined with therapy, it saved his life. Since I was at that time and have always been non-offending, my anti-androgen therapy was not mandatory in any way and thus I started and stopped it several times, because of the affordability issues, Hillman said. But I can attest that the medication did reduce my thoughts and therefore some of my distress.

Then he found the Virtuous Pedophiles group about one year ago, and the support hes culled from the others there has given him a new gusto for life, without medication. Now I am dedicated to living. And I am dedicated to making sure no one else has to waste their life just to be virtuous, he said.

Hillman said that these narratives reveal how all pedophiles are different. Some will benefit from meds and some will not, he said. Some are against medication, some are not.

Rahm hopes to continue studying treatment options for pedophilia, in a rigorous way. In his view of a forthcoming modern pedophile treatment, each person would get an individual assessment and be offered an evidence-based treatment. It would work with helping a pedophile address both their personal feelings and concerns, and also their risk of offending.

In my vision, some people need therapy, some need medication, some need both, and some won't have any effect on any of these. They need something else, Rahm said. This is nothing novel or groundbreaking, he added. I would just like to apply modern psychiatric thinking to this group.

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Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the In-vitro Diagnostics (IVD) market.

Trusted Business Insights presents an updated and Latest Study on In-vitro Diagnostics (IVD) Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the In-vitro Diagnostics (IVD) market during the forecast period (2019-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ In Vitro Diagnostics Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2020-2029 (Includes COVID-19 Business Impact)

The global in vitro diagnostics market size was USD 61.22 billion in 2018 is projected to reach USD 87.11 billion by 2026, exhibiting a CAGR of 4.5% during the forecast period.

We have updated In-vitro Diagnostics (IVD) Market with respect to COVID-19 Impact.Inquire before buying

IVD are medical devices and accessories used to perform tests with the help of samples such as blood, urine, and tissue to help detect infection, prevent disease, monitor drug therapies and diagnose a medical condition.In vitro diagnostics industry is consolidated in nature and demonstrates increasing adoption rates of diagnostic devices along with use of IVD instruments in clinical laboratories and hospitals. The industry has perceived significant developments over the recent years. Introduction of new techniques for rapid and fast disease diagnosis are anticipated to surge the demand for in vitro diagnostic services, subsequently, driving business growth during the forecast period.The market is anticipated to witness the growth owing to technological advancements in healthcare, improved and efficient diagnostic tools, and increased availability of over the counter tests. Increasing demand for advanced, personalized and rapid diagnostic system is anticipated to propel the market.Additionally, increased funding by government and other organizations in the healthcare sector is one of the factors likely to boost the global market during the forecast period. Various initiatives undertaken by the government to provide information and education on personalized medicine and IVD tools for effective patient management is anticipated to drive the in vitro diagnostics market growth.

MARKET DRIVERS

Rising Prevalence of Chronic and Infectious Diseases to propel the Global Market.The rising prevalence of infectious diseases, leading to increasing demand for disease diagnosis is one of the factors anticipated to propel the market growth. According to the National Institute of Health (NIH), in 2017, around 23.5 million cases of autoimmune diseases were reported in America and this is expected to increase in the forthcoming years.Additionally, increasing prevalence of cardiovascular diseases in developed and developing countries is one of the major factor driving the growth of the in vitro diagnosis. For instance, according to U.S. Department of Health & Human Services, around 735,000 Americans suffer from a heart attack every year. Additionally, as per the Heart Disease and Stroke Statistics, 2019 Update from the American Heart Association, around 116.4 million, or 46% of the US adults are estimated to have hypertension. The increasing number of patients suffering from cardiovascular diseases is likely to increase the demand for the in vitro diagnostics tools, subsequently propelling market growth.The rising consumption of tobacco and alcohol, adoption of a sedentary lifestyle, unhealthy dietary habits, etc. are the major factors responsible for increasing prevalence of chronic diseases. The rising prevalence of the chronic disorders is likely to increase the demand of the in vitro testing.

Increasing Use of Point-of-care (POC) and Technological Advancements in IVD Tools to Drive the In Vitro Diagnostics Market.

Increasing adoption and demand for point-of-care (POC) devices is expected to fuel market growth. Additionally, the introduction of advanced technologies, such as biochips and nano-biotechnology, and miniaturization of microfluidic tools is likely to boost the demand for point-of-care (POC) devices. These advanced techniques have facilitated easy access to point-of-care diagnostic tests and offer quick and valid test results, thereby fueling the demand for in vitro diagnostic instruments . These factors are subsequently anticipated to drive the growth of the market during the forecast period.

For instance, In June 2019, Abbott launched, Afinion HbA1c Dx assay, its first rapid point-of-care test for diagnosis of diabetes among general population. The increased investment by key market players in the development of technologically advanced and rapid testing devices is likely to drive the growth of the market.Recently, adoption of rapid and accurate tests for diagnosis of infectious diseases and other chronic diseases is driving the market. In March 2018, Sekisui Diagnostics announced the launch of Silaris point-of-care (POC) for the diagnosis of infectious diseases. Such product launches will shift the patient preference from traditional diagnostic tools towards advanced IVD services.

SEGMENTATION

By Product Type Analysis

Reagents & Consumables Segment to Generate the Highest Revenue

As with the help of advanced technologies and rapid diagnosis, the in vitro diagnostics market is anticipated to grow at a faster rate. Increasing prevalence of chronic and infectious diseases, is projected to fuel the demand for diagnostics tools, that is projected to drive the growth of the market.

Reagents and consumables segment dominated the product type owing to their high usage in the in vitro diagnosis. Increased number of research and development activities for the diagnosis of chronic diseases is one of the major factor fueling the demand for reagents and consumables.

Rising demand and adoption of the self-test and point-of-care devices will subsequently increase the demand for these products. An increasing number of IVD tests is one of the major factors driving the growth of the reagents and consumables segment.

The instruments segment is expected to grow at a slower pace. Technologically advanced instruments and introduction of rapid testing tools are some of the factors propelling the segment growth. For instance, in April 2018, Altona Diagnostics GmbH, launched a CE-IVD marked AltoStar Molecular Diagnostics Workflow. It is a flexible and efficient automatic system that automates the entire workflow from sample preparation upto analysis.

By Application Analysis

Oncology to Exhibit a Significant CAGR During the Forecast Period.Infectious diseases dominated the application segment and is anticipated to exhibit lucrative growth over the forecast period. Rising prevalence of cardiovascular diseases such as coronary artery disease, arrhythmias, and stroke globally is likely to increase the demand for IVD tools. These factors are expected to drive the growth of the cardiology segment subsequently, which will boost the in vitro diagnostics market.

Oncology segment held a substantial share and is projected to witness significant CAGR during the forecast period. Availability of advanced home care kits such as fecal occult blood test (FOBT) for diagnosis of colon cancer in homecare settings is one of the major factors likely to drive this segment.

The increasing prevalence of infectious disease and cancer are major factors boosting the demand for in vitro diagnosis. Increasing investment by research institutes and key market players in the development of the rapid and easy in vitro testing tools in the oncology is one of the major factor propelling the growth of the oncology segment.

By Technique

Immunodiagnostics to hold a Leading Position in the Market

The various techniques used in IVD are immunodiagnostics, clinical chemistry, molecular diagnostics, point-of-care, hematology, and others. The immunodiagnostics segment accounted for the largest share in the market.Rising prevalence of chronic and infectious diseases and rising need for early diagnosis are some of the primary key factors attributed to the growth of the technique segment. Molecular diagnostics is expected to grow at a significant CAGR during the forecast period. This technology facilitates early detection of cancer, infectious diseases, and genetic disorders by using genetic technologies that helps in the detection of abnormalities in the prenatal stage.Clinical chemistry segment accounted for the second-largest share in the technique segment. Attributing to various applications of clinical chemistry, including detection of hormone fluctuations and blood glucose levels is anticipated to propel the segment growth. Point of care segment is anticipated to grow at a significant CAGR during the forecast period owing to increased demand for the point of care testing diagnosis. The demand for rapid and accurate diagnosis globally is one of the major factor likely to accelerate the segment growth.

By End User Analysis

Clinical Laboratories to Hold the Highest Share.Followed by clinical laboratories, hospitals are anticipated to hold the second-highest global market share. High demand for IVD tests as a result of increased in hospitalization is one of the factors propelling their use in the hospital segment.

Increasing demand for biosensors, pregnancy kits, and glucose meters to ensure quick and accurate results are some of the major factors propelling the growth of the physicians offices segment at a faster rate.Increasing incidence of cardiac diseases and diabetes and the rising prevalence of infectious diseases in developing countries are the major factors driving the demand for point-of-care tests. The growing use of point of care devices within hospitals and physicians office, especially in remote and rural areas, is also fueling the demand for point of care tests and subsequently driving the growth of the hospitals and physicians office segments.

REGIONAL ANALYSIS

North America generated a revenue of USD 23.09 billion in 2018 and is anticipated to emerge dominant in the global in vitro diagnostics market during the forecast period. Adequate and favorable government regulations, well-established diagnostic infrastructure, adoption of technologically advanced diagnostic techniques, and presence of prominent key market players in this region are some of the significant factors anticipated the drive the market in North America.

Asia Pacific is expected to grow at a significant CAGR during the forecast period. Increasing prevalence of cardiovascular diseases and infectious diseases and rapid development in the healthcare infrastructure of developing countries such as India and China is anticipated to rise the demand for the IVD tools. These factors are expected to subsequently drive the market growth in the Asia Pacific at a faster pace.

On the other hand, Europe is projected to witness significant growth in the global market. The high-income countries, including Germany U.K., and Spain, are anticipated to contribute to the growth of this market in the region. Rising healthcare expenditure and increasing adoption of POC testing devices are some of the major factors driving the growth of the market in Europe.

The Middle East and Africa is anticipated to register high growth in the market owing to the technological developments, rapidly expanding hospital infrastructure, and entry of global players in the region through direct and indirect presence. The region is significantly heading towards the modernization and technological developments. Latin America is also expected to grow at a significant CAGR during the forecast period.

INDUSTRY KEY PLAYERS

F. Hoffmann-La Roche Ltd, Abbott Laboratories, Thermo Fischer Scientific Inc., and Siemens Hold Dominant Shares by Providing IVD Tools

The top key market players focus on strategies, such as mergers and acquisitions, collaborations, and new product developments and launches to strengthen their market position globally and increase their market share. For instance, in August 2018, Sysmex Corp. and JVCKENWOOD Corp. jointly established a new manufacturing company Creative Nanosystems Corp. to develop and manufacture bio-devices. These strategic collaborations strengthened the companys product portfolio and reinforced its market position.

Siemens Healthcare is one of the most significant market players in the healthcare industry and major player in laboratory diagnostics, medical information technology, and medical imaging. The diagnostics division of the company includes products for clinical chemistry, drug testing, hematology, coagulation, immunoassay, infectious diseases, molecular diagnosis, point of care testing and many others. Having a strong product portfolio and supply chain makes the company dominant in the market. Siemens Healthcare, Abbott Laboratories, F. Hoffmann-La Roche Ltd, and Thermo Fischer Scientific Inc., hold a dominant market share by providing a wide range of tools for the disease detection and analysis.

IN VITRO DIAGNOSTICS MARKET COMPANIES:

REPORT COVERAGE

A growing trend observed in the penetration of the in vitro diagnostics market across the industries.The report provides qualitative and quantitative insights on the global market and detailed analysis of market size & growth rate for all possible segments in the market. Along with this, the report provides an elaborative analysis of the global market dynamics and competitive landscape. Various key insights presented in the report are the price trend analysis, recent industry developments such as mergers & acquisitions, the reimbursement policies, SWOT analysis, and key retail industry trends, competitive landscape and company profiles.Report Scope & Segmentation

Segmentation

By Product Type

By Technique

By Application

By End User

By Geography

Looking for more? Check out our repository for all available reports on In-vitro Diagnostics (IVD) in related sectors.

Quick Read Table of Contents of this Report @ In Vitro Diagnostics Market Size, Share & Industry Analysis, By Product Type (Instruments, Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Point of Care, Hematology and Others), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, Others), By End User (Clinical Laboratories, Hospitals, Physicians Offices, Others) and Regional Forecast, 2020-2029 (Includes COVID-19 Business Impact)

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Global in vitro diagnostics market size was USD 61.22 billion in 2018 is projected to reach USD 87.11 billion by 2026, exhibiting a CAGR of 4.5%...

Recommendation and review posted by Bethany Smith

This report studies the Stem Cells market size (value and volume) by players, regions, product types and end industries, history data 2013-2017 and forecast data 2018-2025; This report also studies the global market competition landscape, market drivers and trends, opportunities and challenges, risks and entry barriers, sales channels, distributors and Porters Five Forces Analysis.

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Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: Embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and Adult tissue (adult stem cells).

Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).

Stem Cells market, by technology, is Cell Acquisition, Cell Production, Cryopreservation, Expansion, and Sub-Culture. Stem Cell Therapy in China is not mature, so in this report we mainly cover Stem Cell Banking market.

Stem Cells market, by technology, is Cell Acquisition, Cell Production, Cryopreservation, Expansion, and Sub-Culture. Stem Cell Therapy in China is not mature, so in this report we mainly cover Stem Cell Banking market.

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Geographically, this report is segmented into several key regions, with sales, revenue, market share and growth Rate of Stem Cells in these regions, from 2013 to 2025, covering

North America (United States, Canada and Mexico)

Europe (Germany, UK, France, Italy, Russia and Turkey etc.)

Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)

South America (Brazil etc.)

Middle East and Africa (Egypt and GCC Countries)

The various contributors involved in the value chain of the product include manufacturers, suppliers, distributors, intermediaries, and customers. The key manufacturers in this market include

CCBC

Vcanbio

Boyalife

Beikebiotech

By the product type, the market is primarily split into

Umbilical Cord Blood Stem Cell

Embryonic Stem Cell

Adult Stem Cell

Other

By the end users/application, this report covers the following segments

Diseases Therapy

Healthcare

We can also provide the customized separate regional or country-level reports, for the following regions:

North America

United States

Canada

Mexico

Asia-Pacific

China

India

Japan

South Korea

Australia

Indonesia

Singapore

Malaysia

Philippines

Thailand

Vietnam

Rest of Asia-Pacific

Europe

Germany

France

UK

Italy

Spain

Russia

Rest of Europe

Central & South America

Brazil

Rest of Central & South America

Middle East & Africa

GCC Countries

Turkey

Egypt

South Africa

Rest of Middle East & Africa

The study objectives of this report are:

To study and analyze the global Stem Cells market size (value & volume) by company, key regions/countries, products and application, history data from 2013 to 2017, and forecast to 2025.

To understand the structure of Stem Cells market by identifying its various subsegments.

To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).

Focuses on the key global Stem Cells manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.

To analyze the Stem Cells with respect to individual growth trends, future prospects, and their contribution to the total market.

To project the value and volume of Stem Cells submarkets, with respect to key regions (along with their respective key countries).

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

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Precision Business Insights is one of the leading market research and management consulting firm, run by a group of seasoned and highly dynamic market research professionals with a strong zeal to offer high-quality insights. We at Precision Business Insights are passionate about market research and love to do the things in an innovative way. Our team is a big asset for us and great differentiating factor. Our company motto is to address client requirements in the best possible way and want to be a part of our client success. We have a large pool of industry experts and consultants served a wide array of clients across different verticals. Relentless quest and continuous endeavor enable us to make new strides in market research and business consulting arena.

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Stem Cells Market is Expected to Thrive at Impressive CAGR by 2025 - Scientect

Recommendation and review posted by Bethany Smith

Medical skin care products are used for beautifying or to address some other skin care problems. The cosmetic industry is booming and skin care forms a very huge part of this industry. The aesthetic appearance is so important that people spend a lot on skin care products and treatment. People being more technologically aware of the various new skin care products trending in the market. In addition to the aesthetic application, the medical skin care products are also used to address issues such as acne, pimples or scars.

Medical Skin Care Products Market: Drivers and Restraints

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

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Medical Skin Care Products Market: Segmentation

On the basis of product type the medical skin care products market can be segmented as:

On the basis of application, the medical skin care products market can be segment as:

On the basis of distribution channel, the medical skin care products market can be segment as:

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Medical Skin Care Products Market: Overview

Medical skin care products are used to address basic skin problems ranging from acne to scars. There are various advancements in the ingredients used to offer skin care products to the consumers. For instance, the use of hyaluronic acid and retinoids is the latest development in the industry. The anti-aging creams are at the forefront as the help treating issues such as wrinkles, scars, acne, and sun damage. Another, product in demand is the probiotic skincare which include lactobacillus and bifidobacterium.

Medical Skin Care Products Market: Region-wise Outlook

In terms of geography, medical skin care products market has been divided into five regions including North- America, Asia- Pacific, Middle-East & Africa, Latin America and Europe. North America dominated the global medical skin care products market as international players are acquiring domestic companies to make their hold strong in the U.S. LOral is accelerating its U.S. market by signing a definitive agreement with Valeant Pharmaceuticals International Inc. to acquire CeraVe, AcneFree and Ambi skin-care brands for US$ 1.3 billion. The acquisition is expected LOreal to get hold of the brands in the price-accessible segment. Asia Pacific is expected to be the fastest growing region owing to the increasing disposable income and rising awareness towards the skin care products.

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Medical Skin Care Products Market: Key Market Participants

Some of the medical skin care products market participants are Avon Products Inc., Beiersdorf AG, Colgate-Palmolive Company, Kao Corporation, LOral S.A., Procter & Gamble, Shiseido Company, The Estee Lauder Companies Inc., Unilever PLC, Revlon, Clinique Laboratories, llc., Murad, LLC., SkinCeuticals, RMS Beauty, J.R. Watkins and 100% PURE.

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Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics andmarket research methodologyto help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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Demand for Medical Skin Care Products Market Driven by Shifting Consumer Perceptions and Growing Awareness - Scientect

Recommendation and review posted by Bethany Smith

When nurse Neri Pucci suddenly felt ill during a hospital shift his first thought was that hed picked up Covid-19.

Working long shifts on an A&E ward, the 28-year-oldpresumed being exposed to patients with the virus was the reason he was suffering a fever, night sweats, a cough, a sore throat, breathlessness and a headache.

But several tests for coronavirus were negative and blood analysis showed his white blood cells had sky rocketed.

Medics quickly determined he had acute lymphoblastic leukaemia, a cancer that progresses quickly and aggressively and requires immediate treatment.

And so instead of finishing the shift he was due to work, the Italian, who has worked for the NHS for five years, was kept in hospital as an in-patient.

Hes been undergoing gruelling chemotherapy over the last 12 weeks and remains isolated in a room with restricted visitors.

Because Neri took a career break and returned as temporary staff, he is not entitled to NHS sick pay. His colleague has set up a GoFundMe appeal to support him which has so far raised more than 9,400.

Ive had a lot of love and support from family, friends, colleagues and people around the world, its fantastic, said Neri.

Neri has worked at Londons The Royal Free Hospital A&E since 2014 and last year, for a change of scene, took a post as a nurse on a cruise ship. He returned to the hospital in June and took ill after just six weeks.

I knew my colleagues were struggling during the pandemic and I felt I should come back and help, he said. Wearing full PPE for a 12-hour shift is quite exhausting, it makes you hot and sweaty. I had seen patients who had Covid, and of course took all precautions. So when I got ill I thought it must be the virus. I felt dizzy, short of breath and my heart was racing and then my knees went purple.

It was a lot to take in when they said it was leukaemia and I needed to stay in hospital.

Acute lymphoblastic leukaemia is rare, with around 790 people diagnosed with the condition each year in the UK, according to the NHS. Most cases develop in children, teenagers and young adults.

The disease is caused by a genetic mutation in the stem cells, although why this happens is not yet fully understood but there are certain risk factors.

Symptoms of acute lymphoblastic leukaemia

The disease usually starts slowly before rapidly becoming severe. Symptoms listed by the NHS are pale skin, feeling tired and breathless, repeated infections over a short time, unusual and frequent bleeding, such as bleeding gums or nosebleeds, high temperature and night sweats.

Sufferers can also get bone and joint pain, easily bruised skin, swollen lymph nodes, tummy pain) caused by a swollen liver or spleen, unintentional weight loss and a purple skin rash.

In some cases, the affected cells can spread from your bloodstream into your central nervous system. This can cause neurological symptoms, including headaches, seizures or fits, being sick, blurred vision and dizziness.

Neri was transferred to University College Hospital and his parents left their home town of Florence to stay in London to support their only child.

He has suffered side effects from the chemotherapy including nausea, fatigue, numb fingers and headaches and says hes found isolation difficult.

Im extremely vulnerable to infections and even more so with Covid around, he said. Im in a side room and there is strict visitation.Im allowed one visitor a week for just two hours, so that means only my mum can come one week and then my dad the next. Its very hard. The nurses have been so kind and I feel very well looked after.

Neri is now waiting on a bone marrow transplant, which will leave him immunocompromised for months. He will likely need at least a year off work, depending on how soon he has the procedure.

His friend who set up the fundraising appeal, Miguel Montenegro, wrote: The funds we raise will be used to support his accommodations costs and bills so that he can carry on focusing on his recovery and can remain in the country to obtain the best care possible.

He is looking forward to getting better as soon as possible as he wishes to return to work promptly and continue providing people with the best care he is capable of.

Do you have a real life story? Email claudia.tanner@inews.co.uk.

Read more:
Nurse working on Covid-19 frontline had 'virus symptoms' that turned out to be leukaemia - iNews

Recommendation and review posted by Bethany Smith

Billionaire Patrick Soon-Shiongs radical cancer treatments made him one of the wealthiest physicians on Earth. Now the master of medical marketing believes his drug therapies could defeat the crisis of our time.

Patrick Soon-Shiong knows when he realized that the Covid-19 pandemic was going to pose a serious threat. It was February 24, and the part-owner of the L.A. Lakers was at the Staples Center in Los Angeles for Kobe Bryants memorial service.

With sudden, untimely demise on his mind, he found himself thinking about the emerging pandemic. Even though Covid-19 hadnt yet caused a single reported death in the United States, Soon-Shiong was worried. He recalls turning around to California Governor Gavin Newsom and telling him, Were in trouble.

His sense of urgency hasnt gone away. If I thought I was scared on February 24, he says, Im more scared now. The reason, he explains, is that what weve learned is that this virus acts like cancer. He says he has left his house only once since Bryants memorial, and that was to film a video about the coronavirus for the Los Angeles Times, which he bought, along with The San Diego Union-Tribune, for $600 million two years ago. I shut myself off from the world, he says.

And so one of the planets richest medical doctors, who made a $6.7 billion fortune developing breakthrough treatments for cancer and diabetes, seeks to battle the pandemic. The weapons in his arsenal: the cancer treatments he has spent the past decade and a half developing. Hes aiming them at all aspects of the coronavirus, from a vaccine to treatments for mild cases to therapies targeted toward patients on ventilators.

Its an enormously ambitious plan from a man who has often been accused of being a hype artist. In an earlier incarnation, Soon-Shiong was a respected surgeon and professor at UCLA Medical School, but throughout his wildly successful entrepreneurial second act, he has been derided as more showman than scientist, thought guilty of overinflating results and taking undue credit. A few years ago, for example, he boasted about using a breast cancer drug to treat a patient with cervical cancerbut other groups were already seeing similar successes. As we wrote in a 2014 cover story, While hes undeniably brilliant, Soon-Shiong is equally undeniably a blowhard.

But he also has fierce defenders of his approach to both cancer and Covid-19, including former Senate majority leader Harry Reid, who says the 68-year-old South Africaborn doctor saved my life in 2019 by providing an experimental treatment for his stage IV pancreatic cancer. Researchers say his methods are conceptually grounded in good science, though the verdict on his work will ultimately depend on results.

Weve been tracking and seeing an increase in the number of these cell-based therapies, whether theyre being repurposed from oncology or even other disease conditions, says Esther Krofah, a senior analyst who monitors the clinical development pipeline for Covid-19 vaccines and therapies for the Milken Institute. A number of themfrom large pharmaceuticals and small biotech startups alikeare going into clinical trials. For many of the latter, the pandemic offers a chance to show what their treatments can do in a shorter time frame than cancer drugs typically require. For small companies, its a worthwhile exercise to see if its successful, Krofah says.

It may seem counterintuitive, but advances in knowledge about the immune system, and how it might help kill cancer, have real applications for infectious diseases. To me, a cancer cell and a virus-infected cell are one and the same, says Dr. Wayne Marasco, an immunologist at Harvard Medical School who is currently researching coronavirus treatments. The immune system, he adds, seems to think the same way. Which is a good reason to take Patrick Soon-Shiong seriously.

Born in Port Elizabeth, South Africa, in 1952, Soon-Shiong is no stranger to the intersection of the immune system, cancer and infectious disease. Having graduated from medical school at age 22, he focused his early surgical career on transplants and cancer, both of which involve a complex pas de deux with the immune system. Crossing disciplines, he says, led him to look at the body as a system, not a single little cell. We are a biological system.

Such interdisciplinary thinking may be what led to the medicine that made his fortune: Abraxane, which took an existing chemotherapy drug, Toxol, but wrapped it in protein that made it easier to deliver to tumors. Its now used to treat advanced cases of lung, breast and pancreatic cancer. In 1998, to develop Abraxane, he purchased Fujisawa, a small, publicly traded business that sold injectable generic drugs. Soon-Shiong used its revenues to quickly move Abraxane through the regulatory process. The FDA approved it in 2005, and in 2007 Soon-Shiong split the business in two, spinning out a company called Abraxis that focused on the new cancer drug. He sold the generics business to Fresenius in 2008 for $4.6 billion. Two years later, he sold Abraxis to Celgene for $4.5 billion. Celgene, itself acquired by Bristol Myers Squibb in November 2019, reports that sales of Abraxane exceed $1 billion annually.

Soon-Shiong at Nants Los Angeles headquarters in 2017. I see [the complexity of the immune system] like an orchestra, but the challenge is to separate the violin from the cello from the drums.

The complex business deals that went into Abraxane, however, left Soon-Shiong with a reputation as more of a wheeler-dealer than a scientist, as we noted in 2014. Back then, he posted to Twitter under the grandiose handle @solvehealthcare, but today he simply uses his name. Over several recent Zoom conversations, he evinces very little showmanship. Hes visibly tired, exhibiting the most excitement when he starts talking about intricate scientific details. Im burning out a little bit, he candidly admits, adding that hes been getting only about four to six hours of sleep a night since February. Over that time, he says, his companies have concentrated on both continuing to develop his cancer treatments and working to employ them against Covid-19. He peppers his statements about his companys approach to both cancer and the coronavirus with qualifiers about the results of pending studies, carefully avoiding seeming to overpromise.

Soon-Shiong has multiple interrelated businesses organized in a complex corporate structure that would have puzzled the Byzantines. But his Covid-19 efforts come from the two companies he founded that work on developing cancer immunotherapies: NantKwest, a publicly traded outfit based in San Diego, and the privately held ImmunityBio.

Cancer immunotherapy is based on the notion that the bodys own immune system can be stimulated to treat the disease. That idea dates to the 19th century, when scientists first observed tumors getting smaller after patients developed a type of skin infection. This led to some of the first experiments in which the immune system of cancer patients was stimulated. Early efforts proved difficult to reproduce, though, and the field got sidetracked by advances in chemotherapy and radiation. Interest spiked anew in 1959, when a paper showed that the tuberculosis vaccine inhibited tumor growth in mice. After decades of intense research, the first cancer immunotherapy was approved by the FDA in 1986.

Other types of immunotherapies followed, ranging from purified antibodies that attack cancer to drugs that turn off the chemical switches that let tumor cells hide from the immune system. The latest advances involve CAR-T cell therapy, which first gained FDA approval in 2017 and involves genetically engineering immune cells from patients so that they attack certain targets found in tumor cells.

Founded in 2002, Soon-Shiongs company NantKwest focuses on developing so-called natural killer (NK) cells, which the immune system uses to destroy virally infected cells as well as early-stage tumors. The company has been working to develop a line of off-the-shelf NK cells called NK-92, which can be used to treat certain cancers as well as viral infections.

The company, which has yet to post any meaningful revenue, has lost nearly $400 million since it went public at $25 a share (a $2.6 billion market cap) in 2015. The stock has recently traded in the $10.50 range, off a bottom of around $1 a share in 2019. One reason for the stocks surge, says Jefferies analyst Biren Amin, is the companys reported research into the coronavirus pandemic. The second, he suggests, involves former Senator Reids cancer treatment, which made use of the companys products.

Harry Reid, who represented Nevada in the upper chamber from 1987 to 2017, was diagnosed with pancreatic cancer in 2018 and started chemotherapy that July. He didnt respond well. I was so sick they stopped the chemo that October, he says. In July 2019, a scan of his liver showed that the cancer had spread. That meant his only option was more chemotherapy. Around the same time, Joe Kiani, founder and CEO of Irvine, Californiabased health IT company Masimo, met with Soon-Shiong to discuss acquiring $50 million worth of assets from NantHealth. During that initial meeting, the conversation turned to Soon-Shiongs other projects, which later led Kiani to phone the former senator. I called up Harry and I said, Look, I just left this meeting. This person could have the cure. I dont know if he does, but what do you have to lose? Reach out to him and see what happens, Kiani recalls.

Two weeks later, Soon-Shiong and a doctor from NantKwest named Leonard Sender were working with Reid, using treatments from NantKwest as well as Soon-Shiongs ImmunityBio. Those treatments arent yet officially approved but were permitted under the FDAs compassionate-use rules. Reid was treated with a combination of Abraxane, NantKwests natural killer cells and a drug from ImmunityBio called N-803, which stimulates the immune system to produce its own killer cells. Soon-Shiong compares it to the triangle offense often employed by the Lakers. In November 2019, Reid reported that his scans were completely clear, showing no signs of cancer. I admire Dr. Soon-Shiong a great deal, he tells Forbes. Both for what hes done for me personally and what hes done for the health-care delivery system in this country.

Former Senator Harry Reid, pictured the same month he began treatment for pancreatic cancer with Soon-Shiong, says being in remission a few months later was kind of like a miracle.

Reids is an extraordinary story, as pancreatic cancer remains one of the deadliest forms of the disease. Within five years of diagnosis, it kills some 90% of patients, accounting for 7% of cancer deaths globally. Jeopardy! host Alex Trebek, who also suffers from pancreatic cancer, has received the same treatment, as have two other unidentified patients. But Sender cautions against declaring a cure. Its too early to tell, because this is a very nasty form of cancer, he says. Thats why NantKwest is now focused on a new randomized clinical trial, he adds, which is looking to recruit nearly 300 pancreatic cancer patients with advanced forms of the disease. Those who sign up will be given a course of treatment similar to the one Reid received.

As part of these treatments development, Soon-Shiong has spent the past five years working with the National Cancer Institute. His companies have a collaborative agreement with the NCI involving several types of treatments, including NK-92 and N-803, as well as some vaccines against two kinds of tumors. Dr. Jeffrey Schlom, chief of the NCIs laboratory of tumor immunology and biology, recalls being in sync with Soon-Shiong from the start. At our first official creative meeting, we presented our slides of our approach, he says. And then he got up and presented his approach, and they were almost identical. Schloms group has since published in peer-reviewed journals 15 papers regarding Soon-Shiongs treatments, in both preclinical and clinical settings.

Since February, NantKwest and ImmunityBio have redirected some of their attention toward the coronavirus pandemic, using a number of weapons in their collective arsenal. The first is a vaccine, based on the system Soon-Shiongs companies are developing for cancer, that has already shown positive results against Covid-19 in a study involving mice. Its also being studied in monkeys as a part of the federal governments Operation Warp Speed. As for human trials, Soon-Shiong says hes ready to go. My timeline is now dependent on the FDA letting me get out of the gate, he says. Im in the gate, the bell hasnt rung and the racehorse is frothing at the mouth.

This vaccine is delivered to the body in a common cold virus called an adenovirus that has been stripped of all the parts that can cause harm to people or trigger the body to attack it. That modified virus contains two individual segments of the Covid-19 coronavirus: the spike protein, the surface protein on the virus that triggers an antibody response; and a nucleocapsid protein, which is found in the center of the virus. Most of the more than 100 vaccines that are currently in clinical development for Covid-19 focus on the spike protein to generate an immune response. Soon-Shiong thinks that wont be enough, though, which is why hes including the nucleocapsid protein. My concern is that the spike protein mutates, he says. Its mutated even through this pandemic.

Beyond potential mutations, another concern about merely eliciting an antibody response is that from the data seen so far, antibodies to the Covid-19 virus just dont last very long. Levels of antibodies in the blood are really low after a few months, says Marasco, whos not associated with Soon-Shiongs companies or their vaccine research. I think its uncertain how long immunity will remain after successful vaccination. Using the nucleocapsid protein couldnt hurt, he adds, and it could elicit not only antibodies but virus-killing T-cells as well.

The second weapon is the application of NantKwests NK-92 and ImmunityBios N-803 against Covid-19. NK-92 is being adapted to directly attack virus-infected cells, while the N-803 stimulates the patients immune system to produce its own natural killer cells against the virus. The treatments might be used either together or separately depending on the particular patient, Soon-Shiong says. Human trials of these treatments have already begun. Its a fantastic thing that theyre applying them to infectious disease to see how patients fare, says Gigi Gronvall, an immunologist at Johns Hopkins Center for Health Security, who is not involved in the research. The concept is great, she adds, cautiously, but we need to see what the data says.

The third weapon NantKwest and ImmunityBio are developing to combat Covid-19 involves the use of mesenchymal stem cells, which are derived from bone marrow. This type of stem cell has been investigated over the past decade for diseaseslike Covid-19that can cause the bodys immune system to go into overdrive and attack itself. This treatment would be for the most severely sick Covid-19 patients, who are experiencing a cytokine storm, in which the immune system overreacts. Small-scale studies have suggested this might be an effective treatment, and several companies, including Melbourne, Australiabased Mesoblast, are already in late-stage clinical trials for severe Covid-19 patients. Soon-Shiongs companies are working with hospitals to recruit patients for human trials.

If Soon-Shiongs approaches to Covid-19 bear fruit in clinical trials, the next step may prove harder still: getting those treatments to needy patients. This is especially so for the vaccine, because at the moment neither NantKwest nor ImmunityBio has the resources to scale up manufacturing. Im now behind the eight ball, Soon-Shiong admits, because theres no way I could have 100 million doses unless somebody supports me. Maybe I have a million doses or 2 million doses. He expresses some frustration at the government: Billions of dollars are going to companies that have billions [in] revenues. Hes not wrong about that. In July, pharma giant Pfizer (2019 revenue: $51.8 billion) received a $2 billion federal contract to manufacture a vaccine its developing.

Things are brighter for the companies N-803 and NK-92 products, as NantKwest has the ability to manufacture at scale, but these treatments will face certain competition from others being developed by a number of pharmaceutical companies. I think there are a lot of alternatives that are more practical than a cellular therapy for an acute infectious disease, Marasco says, though he does acknowledge that the companies plans to use stem cells against the more severe cases of disease have potential.

Despite his frustrations, Soon-Shiong appears determined to do his part in the health-care industrys war against the coronavirus. This is the crisis of our time, he says. Its almost existential. The United States could have 20 to 30 million infected. You could have a million deathsthis is not a joke.

Link:
The Inside Story Of Biotechs Barnum And His Covid Cures - Forbes

Recommendation and review posted by Bethany Smith

Although one can surmise the name of the lead character (Grazyna Misiorowska) in Maryoaround, it takes some time for her ever to be bothered to speak it aloud, staying largely anonymous as she works in a minimart in Poland. Shes led a quiet life, devoting herself to the lord so thoroughly that shes prone to carrying a Virgin Mary in her purse and longingly looks at the nuns that walk across the courtyard of her apartment building, though director Daria Woszek and co-writers Sylwester Piechura and Aleksandra Swierk are careful not to ever go into why she didnt ever join the ministry herself, reaching 50 without incident as a trip to the doctor reveals that shes never needed contraceptives nor will she ever now that shes hit menopause.

Still, life is only beginning for Mary when her physician recommends some light hormone therapy drugs to ease her into a new phase of womanhood, and similar to another recent Polish breakout, Agnieszka Smoczynskas lavish musical The Lure, that dabbled in the fantastical to express the frenzy of coming of age, Marygoaround inventively summons the fear and excitement of her increasing sexual consciousness. Filled with bold colors and a murderously deadpan sense of humor, the dark comedy sees Mary start to behave in ways that she only has read about in the trashy romance novels that have been brought home by her niece Helena (Helena Sujecka), who stops by for her birthday and seems to never leave thereafter.

Youve always impressed me with this composure of yours, says Helena, who typically wakes up hungover after partying the night away and cant possibly imagine her aunt indulging in the same behavior. Yet she cant help but notice that the drugs that Mary has begun taking has some side effects (perhaps emanating from the unpronounceable ingredients she sums up as horse piss) and after Mary quite literally closes the door on Jesus, not wanting to be spied upon by the portrait in the hallway of her flat as she gets frisky in her bubble bath, all bets seem to be off.

Woszek playfully finds all sorts of amusing expressions of this sexual awakening, with the wonderfully stone-faced Misiorowska breaking character to gorge on caviar for the first time as if shes having an orgasm to watching the impossible gyrations of dancers clowning in Rize and appearing as if the contortions going on in her mind are even more impressive. Whether Mary will ever find the confidence to act on her desire to bed her boss, a western-wear aficionado who appears to be as lonely in the archetypal life he adopted as she is in hers, becomes the films slender narrative thread, but the thrills to be found her self-discovery are more than enough, particularly when the film fully explores the idea of chaos commencing when she allows a man to enter her home. All of it is a bit cheeky, as it should be, but theres always something real behind it, whether its Marys growing awareness of her power or the considerable craft of Woszek, production designer Alicja Kazimierczak and cinematographer Michal Pukowiec, who make the world come alive with evocative lighting and sets as much for an audience as it does for Mary.

Marygoaround will screen once more at Fantasia Fest on August 31st at 5:30 pm EST, available digitally to Canadian audiences.

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Fantasia Fest 2020 Review: Menopause Leads to a Turn for the Better in Daria Woszek's Frisky Marygoaround - The Moveable Fest

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Most people think of shingles as a rash, but thats only the tip of the proverbial iceberg. Sure, its painful and downright disturbing to look at, but thats nothing compared to the number shingles can do on your nerve cells if you dont deal with those oozing, angry blisters immediately. Weve got the doctor-approved scoop on what to look for when it comes to shingles, plus how to avoid the uncomfortable scenario altogethertheres a vaccine for that!so you can return to your regularly scheduled program.

Think of shingles as that cousin you kinda sorta remember from childhood but havent seen in years. Then suddenly one day, she shows up on your doorstep and gets all territorial, hanging around and wreaking havoc on your very existence. She may have been annoying when you were younger, but now shes downright mean. Shingles is that grown-up cousinthe adult version of chickenpox that you vaguely remember from your childhood.

Weird but true: You cant get shingles unless youve first had chickenpox, as the virus that causes the former must be introduced into your system by the later. Heres what happens. Chickenpox is caused by varicella zoster, a virus that takes up residence in the roots of your nerve cells. Once the pox outbreak is over, the virus doesnt leave your bodyinstead it hibernates in those nerve cells. Then, decades later it can wake up and cause shingles (known as herpes zoster in this second phase). Since 98% of Americans over the age of about 40 have had chickenpox at some point, that means they are carrying the virus that causes shingles. Creepy, no?

If youre young enough to have had the varicella vaccine that prevents chickenpoxits been available for about 25 yearsyou should never have to worry about contracting shingles either. It will take a few more decades to say for sure, however, because we have to see what happens when the vaccinated population reaches the age when they become vulnerable to a shingles outbreak.

Meanwhile, one million people in the United States who are too old to have been vaccinated for chickenpox develop shingles each year, usually after age 50. Close to one in three people will get shingles in their lifetime, and that increases to 50% of people who live to age 85. Shingles gets its name from the thick band of blistering rash that literally looks like a shingle on a house. Shingles usually occurs on your torso, often in a belt-like pattern around the midsection, but it can show up anywhere on the body.

For most people, shingles resolves in three to five weeks with treatment and no further complications. About 20% of the time, however, it progresses to serious nerve damage and chronic pain in the area where the rash was, a complication known as postherpetic neuralgia or PHN. The older you are when you get shingles, the higher your risk of PHN, which can be so debilitating that it results in depression, anxiety, sleep deprivation, weight loss, and difficulty with daily activities. If shingles occurs on the face or head, it can seriously impact your vision, andrarelycause hearing loss, facial paralysis, and swelling of the brain.

So weve established that you have to have the chickenpox first, but not everyone who had chickenpox is destined to get shingles. What makes the virus spring back to life in some people and not others? Scientists have been trying to figure that out forever and the only thing we know for sure is that the virus takes advantage of a weakened immune system to reassert its presence. For that reason, folks with a weaker or compromised immune system are at a higher risk. That includes:

Anyone over age 50. Our immune system gets sluggish and less effective at protecting us as we age.

People with certain medical conditions. People with cancer, HIV, autoimmune disorders, and organ transplant recipients are more vulnerable to shingles because the conditions themselves drag down immunity, and they often require treatment with medications that further suppress it.

People under chronic daily stress. The death of a loved one, divorce, or job loss are highly stressful eventsand can raise your risk of getting shingles. Why? Because stress causes the body to produce copious amounts of the hormone cortisol, which lowers the effectiveness of your immune system. Physical stress can also be a factor, and your odds of developing shingles is higher when your body is fighting another type of infection, or if you have an injury that irritates a nerve in which the virus is hanging out.

Shingles is also not contagious in the traditional sense: Its not airborne so you cant cough or sneeze it onto someone, or transmit it via saliva by sharing food or drink. It is possible to transmit it if someone who never had the chickenpox (or the vaccine) makes direct contact with the fluid in the blisters.

Thats going to be pretty rare though because the vast majority of the population has had either the virus or the chickenpox vaccine. And even if it happened, the unprotected person who touched the blisters would get chickenpox, not shingles. The bodys first exposure to the virus always causes chickenpox, and shingles is the consequence of the virus reactivating later on.

Given that this virus is painful, and that the complications from it can be significant, its natural to want to keep an eye out for any early indications that you could have shingles. That may prove trickier than youd think, since the signs and symptoms of shingles can vary: The pain may be mild or severe, and some people have mostly itching while others have intense sensitivity to even the gentlest touch, such as the weight of sheets on a bed.

Shingles does, however, follow a fairly predictable pattern if you know what you are looking for. In fact, doctors usually diagnosis it simply by sight. Common symptoms of shingles include:

The key to recognizing shingles is not just the list of symptoms, but the very specific pattern they follow. In fact, you can usually feel some shingles symptoms before you see themand your chances of a full recovery are better if you do. Heres how the illness unfolds, usually over a period of three to five weeks.

First, you experience the sensation of burning, tingling, numbness, itching, or sensitivity in a patch of skin. It may feel like theres a cut or burn on the skin even though it still looks normal. Some people also have flulike symptoms such as fatigue, headache, fever, or upset stomach.

Between one and five days later, an angry, painful rash made up of small red spots will appear at the same site.

After a few more days, the rash turns into fluid-filled blisters that weep or ooze.

About 7 to 10 days later, the blisters dry up and crust over.

In a few more weeks, the scabs disappear.

The other big hint that youre dealing with shingles is that everything happens in one patch of skin on one side of the body. Docs call these patches dermatomes: An area of skin that is supplied by a single nerve coming out of the spine. Your body has 31 such spinal nerves between your neck and the tailbone, each of which run horizontally from one side of your spine around to the front of your body, without ever crossing the midline. For that reason, you wouldnt get a shingles rash that starts on, say, the left of your waist and spreads across to the right side of the waist. The rash is always going to stop by the mid-point of your abdomen or back (where the nerve terminates or begins).

The primary job of these nerves is to send sensations like pain or itching to the brain, but when the virus become active and disrupts the signal, the nerves overreact and cause all the discomfort that accompanies the rash. Usually all this happens on the torso, but shingles can occur anywhere. The face is the second most common area for shingles to appear.

The short answer? As soon as possible. Any type of board-certified primary care physician (family physician, internal medicine, geriatrician) or a dermatologist can diagnose and treat shingles. The really important thing is that you want to get an early diagnosis, ideally before you even see the rash. Thats because the antiviral medications used to treat shingles are significantly more effective if taken within 72 hours of the rash appearing.

So focus on getting an appointment quickly. Dont worry about not being able to see a rash yetthese pros typically treat several cases of shingles every week and will not think youre a hypochondriac when you describe an unpleasant sensation without anything to show for it. The shingles presentation is so textbook predictable that they know exactly whats coming next.

If you miss that 72-hour window, dont panic. After that point, an antiviral may still help if new blisters are continuing to appear. Also, antivirals can help the blisters dry up faster, limit your pain during the illness, and lessen the chances that you will develop PHN.

The bottom line: Its entirely possible that 20 years from now, the chickenpox vaccine will make shingles obsolete. But for right now, the best thing you can do if youre 50 or older is the get the shingles vaccine. There are plenty of unpleasant conditions out there that youll be faced with as you get older. If you can eliminate one painful illness from the mix, why wouldnt you?

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Let's Talk About Shingles Signs and Symptoms - HealthCentral.com

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The skin is often a window into what's going on in the bodyincluding the immune system, which can regulate inflammation and affect the barrier function and microbiome of the skin.

"Recent research has highlighted that the immune system influences the types of microorganisms that live on your skin and affect your risk for disease," says Keira Barr, M.D., holistic and board-certified dermatologist. "So when the immune system is weakened, it can show up on the skin as eczema; allergic reactions; poor wound healing; bacterial, fungal, and viral infections such as herpesand, depending on how weak the immune system is, the area affected could be localized or widespread."

Skin symptoms related to the immune system could be manifesting for a number of reasons. For example, a poor diet and stress, which can cause immunosuppression and make your skin more vulnerable to problems, says Barr.

Try this: Address these issues at the skin level and from within. Using gentle, unscented personal care products including cleansers and detergents, and keeping skin moisturized, can help support a healthy skin microbiome. Taking steps to reduce stress and improve your diet will also help support the immune system and boost the skin's ability to be resilient.

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8 Signs You May Have A Weakened Immune System & What To Do About It - mindbodygreen.com

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From birth control to menopause, when it comes to womens health, Dr. Eric Feinberg, an OB/GYN with Lee Health, says its important for patients to address any and all medical concerns with their physician. Its important to provide a safe comfortable, nonjudgmental environment. And I find that although initially, its probably a little uncomfortable, its almost as if a flood gate opens up of relief once they realize that they are in a safe place.

OB/GYNs can educate their patients on the benefits of hormone therapy, birth control, and sexual health. One of the most common things Ill see is pain related to sexual activity. There should not be a pain. Pain can be a hallmark of something minor, such as an infection. It can be the hallmark of something more major such as endometriosis or scar tissue, so theres a lot of different things so evaluating that pain whats the underlying cause, how do we get past it, and how do we get to a sexually satisfying life, said Dr. Feinberg.

Regular visits with your gynecologist can also help to prevent diseases, infections, and screen for certain cancers. Cervical cancer should be almost preventable if its screened at the correct interval, we do breast cancer screening as well, making sure mammograms are done at the appropriate time, he said.

Helping women address any medical concerns while educating them on how to protect their overall health.

View More Health Matters video segments at LeeHealth.org/Healthmatters/

Lee Health in Fort Myers, FL is the largest network of health care facilities in Southwest Florida and is highly respected for its expertise, innovation and quality of care. For more than 100 years, weve been providing our community with personalized preventative health services and primary care to highly specialized care services and robotic assisted surgeries. Lee Health Caring People. Inspiring Care.

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Waking up at night to urinate is by far the most bothersome lower urinary tract symptom, wrote Gopal H. Badlani, MD, in an editorial for Urology Times.1 He further added that nocturias impact on quality of life and health is profound. In this interview, Badlani spoke with Jeffrey P. Weiss, MD, PhD, who discussed how he defines nocturia, how to separate the symptom from

overactive bladder, and how he conducts patient work-ups for nocturia. Weiss is professor and chair of urology at SUNY Downstate Health Sciences University, Brooklyn, New York. Badlani, an editorial consultant for Urology Times, is professor and vice chair of urology at Wake Forest Baptist Medical Center, Winston-Salem, North Carolina. Disclosure: Weiss is a consultant/study investigator for Ferring.

How do you define nocturia? Is it the number of times someone awakens to pass urine, or is it the bother related to it?

Nocturia is just a symptom. It means that somebody has arisen from intended sleep time because of the desire to pass urine. That could be once or any number of times. In terms of how many times it takes for it to be bothersome enough to merit treatment, it's up to the patient. We know from epidemiological studies that moderate to severe bother really begins at 3 times. Most of the literature considers 2 times to be significant. There are patients for whom nocturia times 1 is a chief complaint.

What if you get up at night for some other reason, without the desire to urinate, and then you urinate? That is basically a convenience void with no desire and antecedent whatsoever. Technically, that would not be nocturia, but from a practical standpoint, it's always going to be captured as a nocturic episode when analyzing a voiding diary.

If a person is bothered by getting up at night to urinate and they see their primary care physician, what should do that physician do for the patient?

They should take a history and physical examination. Nocturia is a symptom that has so many different causes. Questions should cover drinking habitstypes of fluids, amount of caffeine, amount of alcohol. Patients should also be asked about general sleep architecturesome people nap a lot during the day or have trouble sleeping at night. These things should be elicited by the primary care physician.

Do they have hypertension? Could they have nondipping hypertension, which can cause natriuresis at night and nocturnal polyuria. Do they have peripheral edema? A routine physical exam would disclose, for example, peripheral edema, that could be due to third spacing. Even dependent edema, which is not related to venous insufficiency, can cause nocturnal polyuria. People who stand a lot and people who eat a lot of sodium may get some fluid accumulation in the lower extremities during the day and excrete that at night.

Assessing a patient for peripheral edema, heart failure, and venous disease is general medicine. If they have renal insufficiency and they have problems with excretion of free water at certain times during the night, do they take diuretics? Are they taking long- or short-term thiazides? These are all basic internal medicine principles.

The real question is, who's responsible for synthesizing all of that? Is it general medicine, or is it urology? It's not a turf battle; it's whoever is going to take an interest in it. I would purport that none of these require the skill set of a urologist. As urologists, we certainly pay attention to lower urinary tract symptoms (LUTS), but nocturia typically is not a normal lower urinary tract symptom.

From the urologist's point of view, what is the key question that they should be asking in order to separate nocturia from overactive bladder?

It's very simple; you go right to the definition of overactive bladder. The hallmark is urgency. If a patient has urgency, day or night, then they have overactive bladder symptoms. Now, it is true that if they have nocturnal urgency, there is some evidence that they might benefit from an antimuscarinic. Otherwise, if they have no urgency, the chances are that antimuscarinics, which are so overused for nocturia, will not work.

It's important to distinguish between daytime and nighttime LUTS. Many patients are referred for LUTS/BPH and you talk to them and they say, "I'm getting up at night." When you ask, how about during the day, they say, "No, during the day there's no problem." That's not really going to be OAB unless there's a strong urgency component.

It's incumbent upon all of us, including primary care providers, to examine the lower abdomen and make sure that we're not dealing with urinary retention. Admittedly, it's hard to palpate a bladder even when it's fairly full, but you wouldn't want to miss the ones that are grossly overdistended.

What is your working algorithm when evaluating a patient for nocturia?

As I mentioned earlier, a history and physical exam should be performed. You should obtain an accounting of medications, behavior, underlying medical conditions, and physical exam findings that may relate to nocturnal polyuria. A urinalysis should be done, as you don't want to miss hematuria and bladder cancer. PSA screening may or may not be something that you wish to undertake as part of the nocturia workup. I don't think it's central.

However, what is central and is unequivocal is a voiding diary, which includes a frequency voiding chart, accounting for time and amount of voiding. You should also include subjective sensations, such as an urge perception grade, or a degree of incontinence. Now, you're talking about a diary, which adds some subjective findings to the objective time and amount on the frequency volume chart.

The gold standard for a frequency volume chart is a 24 hourtechnically 3 full 24 hours, because there is considerable variability. Will a nocturnal only diary suffice? Yes, if you have excluded 24-hour polyuria. No matter how good you are, no matter how much you talk to a patient, even if they're on medications that cause polyuria, such as lithium, you won't know that a patient has global polyuria until they do the 24-hour collection. That doesn't necessarily have to be a frequency volume chart. A simple 24-hour collection to assess their 24-hour output would exclude global polyuria, which would be defined as 24-hour volume in excess of 40 milliliters per kilogram. Let's say in an average person, that would be around 3 liters. If they are putting out 3 liters, they're drinking at least 3700 milliliters, which is a lot. Why is that? Are they thirsty? Are they doing it because they think it's good for their kidneys? Are they dieting? Do they have a behavioral problem, or do they actually have a thirst problem?

What instructions do you give patients when you send them home to do the voiding diary?

I think it's reasonable to tell patients that they can drink in accordance with thirst, and no more. Thirst is rarely abnormal in any patient. If you tell patients to restrict themselves to a certain volume and they are able to stick to it, but that volume is insufficient to cover obligatory losses, they will fall behind and they can become hypotensive. Therefore, it's dangerous to tell patients to take in a fixed low amount of fluids without knowing whether they can actually concentrate urine.

I will ask patients, when you take your medications, do you take a pill with an 8-ounce glass of water because you need that much to get it down? Could you get that pill down with a gulp or sip of water? If your mucous membranes are dry, do you drink a glass of water, or do you just wet your mucous membranes? I'm trying to get patients to minimize intake. I explain to them that the dumbest kidney is smarter than the smartest doctor, and try to get them to realize that they don't necessarily have to "flush" their body to keep their kidneys going properly, that their kidneys will be just fine even with less intake.

A frequent complaint I hear from patients is that they are always thirsty at night, whether they breathe through their mouth or wake up and drink more during the night. How do you address this?

Look at the medications they're taking and see if any of them cause xerostomia. If they are taking one of these medications, can they be exchanged for ones that do not cause xerostomia? If it's just a case of waking up and being thirsty, I tell patients to just wash their mouth out and maybe take a little sip, rather than drink an entire glass. That will make a big difference.

What about excess urine output at night? How do you treat that?

That's nocturnal polyuria, which has 2 definitions. One is when, on a 24-hour voiding diary, more than 33% of urine volume is made at night. The other definition is a urine volume greater than 90 milliliters per hour; that's an absolute measurement that is not determined by 24-hour output. Once you find that they have nocturnal polyuria, you look for a cause. It could be behavioraldrinking too much fluids at night.

It could be sleep apnea. Sleep apnea causes nocturnal polyuria due to the fact that hypoxemia causes pulmonary artery vasoconstriction, which causes increased pressure in the right heart. The heart thinks there is too much stuff in the vessels and it excretes atrial natriuretic peptide, which is a very potent natriuretic and it turns off antidiuretic hormone and causes tremendous diuresis. That can be treated with continuous positive airway pressure.

It could also be peripheral edema. One of the first things I do in the office when someone says they're getting up at night to pass urine is lift up their trouser legs and see if they have pitting edema. I ask them: Do you have swelling in the legs? Do your shoes start to get tight at night? Some of them know they've got swelling. Some don't know it at all, and then you push in on their pre tibial area and you'll see the pit and they go, "Wow, that's amazing."

Peripheral edema can be due to heart failure. It can also be due to venous insufficiency, which is probably more common. It could be due to dependent edema, which you'll see in people who stand all day; for example, people who work in a department store or surgeons. Some people just love salt, and eating too much sodium will cause fluid retention in the legs, which returns as gravity no longer is the factor to the central circulation and results in nocturnal diuresis.

Of course, medications can also play a role. Taking a diuretic at night might cause nocturnal polyuria because you're inducing diuresis during the hours of sleep. Short-acting diuretics, such as furosemide or hydrochlorothiazide, are given first thing in the morning. If you are accumulating fluid in your legs, and you're waking up dry and take your diuretic first thing in the morning, you can't get any drier than you're going to be. Therefore, it's best to take a diuretic in midday, if it's a short acting drug, or in the morning, if it's a long acting drug such as chlorthalidone, which probably is a better drug for nocturia. Taking the wrong diuretic and the wrong antihypertensive at the wrong time will clearly exacerbate nocturia, as was found in a recent study published in the New England Journal of Medicine.2

It seems as though there is no "quick fix" for addressing the problem.

That's what is so frustrating about nocturia. It's 1 symptom, and it has easily 20 different underpinnings, which means that it's so easy to find things that result in nocturia. But because of the multifactorial nature, we only make little increments when we fix each factor. In particular, the older the patient, the more multifactorial it gets and the more difficult it is to treat. In the younger patients, there tends to be 1 or 2 big problems that can be solved with 1 or 2 major maneuvers. For example, in a young person with sleep apnea and nocturia, there's a very high probability that treatment will resolve it. You don't find too many patients like that though.

What about a patient who has nocturia and insomnia?

That's a little tricky. Sleeping pills work great for nocturia, but I never use them. Why? They're addictive. It's just not the class of drug that I feel comfortable using to treat insomnia.

Does the patient have abnormal sleep architecture? Maybe they just like to stay up at night and read or watch television or do something stimulating. That's not going to work. I tell them, "You're upside down with regard to your life." Of course, it's hard to fix someone who's a shift worker; that's about 2% of the population.

The first step is to diagnose it properly. On my diary, for the lower urinary tract symptom score, we have an urge perception grade for each void. If the urge perception grade for most of the nocturic voids is zero, that means that they were not awakened by the desire to pass urine. That's a sleep disturbance, so I would send them to someone who practices sleep medicine.

In terms of practical advice, a little exercise at night is helpful, doing whatever it takes to make them really tired at night; for example, reading a book and then drifting off to sleep. Now, if they have a prolonged sleep latency, and if they have easy awakening, that may be a little bit above the pay grade of a urologist, and that requires intervention by a sleep specialist. Typically, they're going to give anxiolytics and sleeping pills. Anybody can do that, but I don't like it as a treatment for anybody, frankly.

When does desmopressin come in?

That's a very good question. If you're a pharma company, desmopressin is basically treatment for anyone with nocturia. But the reality is, desmopressin is for someone who has nocturia in the absence of an underlying medical condition that's contributing to it. All these conditions that we talked aboutheart failure, sleep apnea, anything causing peripheral edema, certain medicationsall of those should be addressed first. We did a study that found that the minimum number of patients who have what we call the nocturnal polyuria syndrome, which is the ideal patient to receive desmopressin, is somewhere between 17% and 40%, depending upon whether you include hypertension in the numbers and what definition of nocturnal polyuria use.3

Why is the penetration of this drug so low? Are urologists afraid to use it in adults?

I think it's less fear than the obligation that one has to spend a lot of time on that patient. You need to know their baseline sodium. If they're over the age of 65, which so many of our patients are, it's recommended that you obtain a serum sodium within the first week of starting the medication or a dose increment and then follow-up sodium thereafter. I think there's a concern, particularly on the part of urologists, that they don't necessarily have the bandwidth or the office capability to follow patients so closely regarding their sodium.

Are there any new innovations in that regard that could lessen that issue?

There is research that is ongoing with new chemicals that are antidiuretics. The approved versions of desmopressin, which would be the orally dispersible tablet (ODT, Nocdurna) and the spray (Noctiva), are probably about the same in terms of their net total bioavailability and so the incidence of hyponatremia is actually quite low. If you select your patients carefully, then you don't have to worry nearly as much about hyponatremia.

Who are those patients that you don't have to worry about? First, patients who have normal baseline serum sodium and normal renal function. If you have normal renal function, you'll be hard pressed to accumulate desmopressin to the extent that it will cause hyponatremia. Sex is another factor. Women are more sensitive to desmopressin than men, which is why there is a gender differential in terms of dosing, at least for Nocdurna. There is no gender distinction in dosing with Noctiva. That's just the way that the studies were done. Women were found to be more sensitive to desmopressin melt than men. We know that females, at least in laboratory studies using a murine model, are about 2.7 times more sensitive to desmopressin than males. That's felt to be due to the fact that the V2 receptors seem to be encoded on the X chromosome, so that there's this phenomenon of X escape that women are more resistant to. Women can actually get away with a much lower dosage of 25 micrograms, compared with the recommended dosage for males, which is 50 micrograms.

Is there anything else you'd like to add?

For me right now, the most exciting area in nocturia research is the nexus between nocturia as a symptom, and cardiovascular disease. It may turn out that nocturia is actually a symptom of hypertension. We tend to think of hypertension as being the "silent killer," but it may be that many individuals have nocturia due to pressure-natriuresis, in turn caused by failure of blood pressure to dip normally at night. This nondipping hypertension is an intriguing phenomenon that we've known about for a long time but haven't really studied so well.

Also of interest to me is what we found in terms of responders to nocturia among those who do not have nocturnal polyuria: In these patients, their nocturia did not improve because their small bladders got bigger. As you well know from many years of practice, it's virtually impossible to give a medication that increases volume per void. We have great medications for urgency, but not for low voided volumes. So it turns out that patients who improve their nocturia who do not have nocturnal polyuria got better because their nocturnal urine volume went down despite the fact that it was normal to begin with. Those patients who responded clearly had mostly behavioral modification causing their normal nocturnal urine output to go down further, but also leads me to conclude that those patients might very well be treated with an antidiuretic, which currently is indicated for nocturnal polyuria. Accordingly, it may be that desmopressin could be indicated for small bladders. This is something that definitely deserves further consideration from a research standpoint.

References

1. Badlani GH. Data shift thinking on nocturias causes, treatment. Urology Times. November 20, 2018. Accessed August 12, 2020. https://www.urologytimes.com/view/data-shift-thinking-nocturias-causes-treatment

2. Victor RG, Lynch K, Li N, et al. A cluster-randomized trial of blood-pressure reduction in black barbershops. N Engl J Med. 2018;378(14):1291-1301. doi:10.1056/NEJMoa1717250

3. Emeruwa CJ, Epstein MR, Michelson KP, Monaghan TF,Weiss JP. Prevalence of the nocturnal polyuria syndrome in men. Neurourol Urodyn. 2020; 39(6):1732-1736. doi:https://doi.org/10.1002/nau.24403

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Nocturia: How to define it, and how to treat it - Urology Times

Recommendation and review posted by Bethany Smith

SAN DIEGO--(BUSINESS WIRE)--Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, today announced positive top-line results from CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC).

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC. CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progressionfree survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC. CONTESSA is being conducted at 180 investigational sites in 18 countries in North America, Europe and Asia.

CONTESSA met the primary endpoint of improved PFS as assessed by the IRC. Median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for the approved dose of capecitabine alone, an improvement of 2.9 months. The risk of disease progression or death was reduced by 28.4% [hazard ratio=0.716 (95% confidence interval: 0.573-0.895); p=0.003] for tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone.

Tesetaxel plus capecitabine was associated with a manageable side effect profile consistent with findings from previous clinical studies. Grade 3 treatment-emergent adverse events (TEAEs) that occurred in 5% of patients were: neutropenia (71.2% for tesetaxel plus capecitabine vs. 8.3% for capecitabine alone); diarrhea (13.4% for tesetaxel plus capecitabine vs. 8.9% for capecitabine alone); hand-foot syndrome (6.8% for tesetaxel plus capecitabine vs. 12.2% for capecitabine alone); febrile neutropenia (12.8% for tesetaxel plus capecitabine vs. 1.2% for capecitabine alone); fatigue (8.6% for tesetaxel plus capecitabine vs. 4.5% for capecitabine alone); hypokalemia (8.6% for tesetaxel plus capecitabine vs. 2.7% for capecitabine alone); leukopenia (10.1% for tesetaxel plus capecitabine vs. 0.9% for capecitabine alone); and anemia (8.0% for tesetaxel plus capecitabine vs. 2.1% for capecitabine alone).

Adverse events resulting in treatment discontinuation in 1% of patients were: neutropenia or febrile neutropenia (4.2% for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone); neuropathy (3.6% for tesetaxel plus capecitabine vs. 0.3% for capecitabine alone); diarrhea (0.9% for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone); and hand-foot syndrome (0.6% for tesetaxel plus capecitabine vs. 2.1% for capecitabine alone). Treatment discontinuation due to any adverse event occurred in 23.1% of patients treated with tesetaxel plus capecitabine versus 11.9% of patients treated with capecitabine alone.

Grade 2 alopecia (hair loss) occurred in 8.0% of patients treated with tesetaxel plus capecitabine versus 0.3% of patients treated with capecitabine alone. Grade 3 neuropathy occurred in 5.9% of patients treated with tesetaxel plus capecitabine versus 0.9% of patients treated with capecitabine alone.

While overall survival (OS) data are not mature, a recent interim analysis indicated the absence of an adverse effect on OS. A final analysis of OS is expected to occur in 2022.

Tesetaxel represents a potential important clinical advance for patients with metastatic breast cancer, said Joyce OShaughnessy, M.D., Celebrating Women Chair in Breast Cancer Research, Baylor University Medical Center, Texas Oncology and Chair, Breast Cancer Research, US Oncology, and Co-Principal Investigator of CONTESSA. There remains a significant unmet medical need for novel therapies that offer quality-of-life advantages for patients with metastatic breast cancer. This need is underscored by a recent update to the National Comprehensive Cancer Network guidelines recommending oral oncolytics that can reduce the frequency of clinic visits.

The clinically meaningful PFS improvement observed in CONTESSA, along with once-every-three-week oral dosing and low rates of clinically significant hair loss and neuropathy, could make tesetaxel an important new treatment option for patients with metastatic breast cancer, said Andrew Seidman, M.D., Attending Physician, Breast Medicine Service, Department of Medicine, Medical Director, Bobst International Center, Memorial Sloan Kettering Cancer Center and Professor of Medicine, Weill Cornell Medical College, and Co-Principal Investigator of CONTESSA.

We would like to thank all of the investigators, study team personnel, and especially the patients and their caregivers who made CONTESSA possible, said Kevin Tang, Chief Executive Officer of Odonate. We look forward to working closely with global regulatory authorities to make tesetaxel available to patients with metastatic breast cancer. We plan to submit a New Drug Application for tesetaxel to the FDA in mid-2021.

The Company plans to submit the results of CONTESSA for presentation at an upcoming medical meeting.

Conference Call Information

Odonate will host a conference call today, Monday, August 24, 2020, at 8:30 a.m. ET. To participate in the call, please dial (866) 300-4090 (domestic) or (636) 812-6660 (international) and use conference ID 2881009.

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in 685 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC, and disease control rate (DCR) as assessed by the IRC.

About Odonate Therapeutics, Inc.

Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Odonates initial focus is on the development of tesetaxel, an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Odonates goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives. To learn more, please visit http://www.odonate.com.

Forward-looking Statements

This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on managements expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: expectations regarding the outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer; expectations regarding the enrollment, completion and outcome of our other clinical studies; expectations regarding the timing for our planned New Drug Application submission for tesetaxel and our ability to obtain regulatory approval of tesetaxel; the unpredictable relationship between preclinical study results and clinical study results; and other risks and uncertainties identified in our filings with the U. S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.

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Odonate Therapeutics Announces Positive Top-line Results from CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer -...

Recommendation and review posted by Bethany Smith

On the nights when the mental sexual images of children were most overwhelming, Joseph Parker took cold showers and baths, hoping the shock of freezing water would push his intrusive thoughts away. Other times, he would fixate on a picture of the Sri Lankan Buddhist monk Henepola Gunaratana, so that the monk's "wrinkly face" might replace the disturbing imagery in his head.

Parker, who is using a pseudonym to protect his identity, had known he was attracted to children since he was 17, but he didn't start having overpowering sexual urges until he was 24. (He's now 26.) These urges were the worst when he was falling asleep. "As soon as I tried to release myself from wakefulness, my mind would sink into the pool of sexual energy, and I would feel this horrible sense of joy and happiness towards children, he said.

He read online about medications that could lower testosterone levels and, as a result, sex drivea process sometimes referred to as "chemical castration." When he asked a psychiatrist for these drugs, he was given Risperidone, an antipsychotic, instead. He took that for about a year, then added on Sertraline, an antidepressant, but only found these drugs mildly helpful. He turned to the internet to get what he had wanted in the first place.

From a Turkish division of the pharmaceutical company Bayers, he ordered cyproterone acetate, which lowers testosterone, along with the female hormone estradiol, and now takes the two medications together. The website that processes the sales is frequently shut down because of its illicit nature: "To my knowledge this is their third or fourth website change, at least, since I came upon them 14 months ago," he said.

Parker wishes it wasn't this hard for pedophiles to get sex-drive reducing medications. But for many pedophilesand especially pedophiles who have not committed crimesaccess to even talk therapy, let alone medication, can be difficult to come by, and the process is riddled with fears about being reported to legal authorities.

In the past several decades, researchers have arrived at new understandings about pedophilia, the sexual attraction to children. Pedophilia appears to be an in-born sexual preference, something a person does not choose and cannot change. A pedophile's attraction to children is consistentnot a phaseand they develop their attraction to children around the same time that other people develop sexual attractions.

While researchers' knowledge has been evolving, access to widespread, up-to-date healthcare hasn't kept up pace. Outside of the handful of researchers who provide therapy and medication to pedophiles, the barriers to finding an informed therapist or psychiatrist remain high. This has led to a hodgepodge of therapeutic approaches in the community, or people self-medicating, like Parker did. Many pedophiles are only directed towards treatment in the context of the criminal justice system, where in some states, chemical castration is used on sex offenders.

Yet importantly, researchers have established there's a distinction between pedophilia and child molestation, a difference between the attraction itself and the crime. Most people hear these words and think that they're synonyms. They're not, said James Cantor, a Canadian clinical psychologist and neuroscientist who studies pedophilia.

Only about half of child sex offenders are genuine pedophiles. The other half prefer adults sexually, and are abusing children because theyre available or easily manipulated. (Child porn offenders, on the other hand, are nearly always pedophiles because of the ready availability of adult porn alternatives.)

The goal of any modern, preventative treatment for pedophila should be to help people manage their sexual interests rather than try to change them, Cantor said. This can involve the voluntary use of hormone-reducing medication to control urges or therapy. Since pedophilia and sexual abuse are not synonymous, treatment for pedophilia is also not solely about preventing child sexual abuseits about helping people with their overall mental health and well-being too. Thats a concept that may be hard to accept. It involves recognizing that people who are sexually attracted to children deserve to live healthy and meaningful lives.

Online support groups for non-offending pedophiles have only recently entered the public eye. The most well-known group, the Virtuous Pedophiles, was formed in 2012 as a safe place for pedophiles to discuss their struggles and commitment to not offend. Parker belongs to the Virtuous Pedophiles and is known to the community as Double22. Another organization, the Association for Sexual Abuse Prevention (ASAP) was formed by some members of the Virtuous Pedophiles, and they are currently ramping up their goal to create a platform to connect pedophiles to mental health professionals.

"In my opinion, they should not be seen as second class patients.

In April of this year, the first randomized placebo-controlled study of a hormone-reducing drug for pedophilia took place in Sweden. Published in JAMA Psychiatry, it found that the drug reduced both high sexual desire and sexual attraction to children, and that the effects were noticeable within two weeks.

The study is the first to include people who self-identified as pedophiles and were seeking help of their own accord, not just people funneled from the criminal justice system. Whats even more remarkable about the study is that it included a placebo groupthe first pedophilia study to do so. In an editorial about the study, Peer Briken, a professor of sex research at the University Medical Centre Hamburg-Eppendorf in Germany, wrote that it marks a milestone in clinical sexual science and the field of forensic psychiatry.

I think one of the biggest problems is that people just don't understand this as a mental health issue, said Fred Berlin, an associate professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. Rightfully, people are concerned about protecting children. And so we just quickly stigmatize people who are attracted to children and often don't even see them as human beings with a problem who might be deserving of help.

"In my opinion, they should not be seen as second class patients.

In 2014, journalist Luke Malone wrote an article about young people, some of them minors, who were discovering that they were attracted to children, and how they were coping with it. It was adapted as an episode of This American Life, one of several high-profile media pieces about pedophiles that explored the complicated existence of being born attracted to childrenand how hard it is to get help.

When Adam, one of the young pedophiles in Malones story, admitted to a therapist what was wrong, she just became extremely cold and harsh, he told Malone. She even, a few times, almost got to the level of shouting. She ended up telling Adams mother.

There is a huge reason [pedophiles] would avoid therapists and doctorsthose people have an obligation to report them to police if they think children might be in danger in the future, said Ethan Edwards, one of the co-founders of the Virtuous Pedophiles, who uses a pseudonym.Especially if they are not specifically trained in the issue, and with the common belief that all pedophiles molest children sooner or later, it is very perilous for a pedophile to seek out a therapist.

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Christoffer Rahm, a psychiatrist, researcher at the Karolinska Institute, and the senior author on the JAMA study from April, once worked at a clinic linked to a Swedish national helpline focused on sexuality, PrevenTell. Rahm ended up meeting some pedophiles who called in; one was a bus driver who brought children to school. The bus driver was struggling with his impulses and fantasies, but had not sexually offended in any way. Rahm looked for research to help determine the best treatment for his patient and found a gap in the literature: There were no rigorous comparisons of different medications, or recommendations about who might do best with therapy. (As far as we know, female pedophiles are rarer, and the research on treatment for them even more sparse.)

Cantor feels it's more than just a gap when it comes to pedophilia. It is a black hole, he said. This is a topic that scientists in the fields of mental health are not just uninterested init is actively repugnant."

Thats what motivated Rahm to conduct his study. If there are people seeking help for this, the best thing would be to manage it in a preventative phase before the damage is done, he said. Of course, society needs to say that any kind of abuse against a child is not okay. But it is counterproductive if these people can't even seek help with a professional.

The medication Rahm studied is Degarelix, approved by the FDA in 2006 for treatment of advanced prostate cancer. This is the first time that it's been used off-label for pedophilia. Its an injection that starts working right away and lasts for about three months. It works by shutting down signals from the brain to the body to produce testosterone.

In qualitative interviews Rahms team did during the study, they found that some of their participants experienced positive effects. They described feeling an inner calm, Rahm said. They felt less pressure, that they had a better intimate life with their partners. Some described that the annoying thoughts around children disappeared so they can focus on other things. And many described that they had lost that enervating impulse to masturbate, and were able to see children as just human beings and not sexual symbols. A majority of the participants in the group that got the active drug said that they would want to continue taking it.

Many of the therapies that have been used for pedophiles have not been validated this way, but deployed through forensic psychology and the criminal justice system. Though Berlin has prescribed hormone-reducing medications to countless patients, he feels that the legal system usually doesnt collaborate with doctors and scientists who are studying the use of these drugs. As a physician, I think that's completely inappropriate, he said.

If someone goes to prison being sexually attracted to children, theres nothing about prison that can get rid of that attraction, or enhance a persons ability to resist temptation later on, Berlin said. It also leads to a mistrust of treatment, because of a history of involuntary use of chemical castration and aversion therapya therapy that associates negative cues with images of young children to dissuade future attraction.

The idea that we can solve this simply through punishment and incarceration is very naive, Berlin said.

Talk therapy should focus on managing a person's sexual interests, with an explicit acknowledgment that those interests will likely never change. In the past, therapy sometimes focused on searching for trauma, because of the belief that a history of abuse led someone to abuse. The truth is a bit more complicated. Having been sexually abused in your own childhood could be a factor in committing sexual abuse as an adult, but is not necessarily a factor in pedophilia.

This is what Ive heard over and over, Cantor said. They knew. They always knew it. All their past therapists were telling them to focus on trauma, what happened in their childhood. But their genuine experience of it was that they were born this way.

We need to move on to the next generation of research and quality development.

Cantor said that once that basic framework of therapy changes from changing ones sexuality to managing it, people adapt very quickly. It makes more sense to his patients, and theyre able to better commit. If a person has looked at child porn or committed sexual abuse in the past, a therapist would help them examine how and why their self-control broke down, and how to set up their life so that it doesnt happen againnot how to stop being attracted to children.

For some people, this process could be paired with sex-drive reducing drugs. Some people find they would rather live in that state than with those nagging sex drive that they can't express and can do anything to do anything about, Cantor said.

Yet even in those states that have issued mandates for sex offenders to receive hormone-reducing drugs as punishment, it can be incredibly difficult for non-offending pedophiles who want it to get medication. I get letters from people around the country all the time wanting access and they can't even get access to it, Berlin said.

Rahm doesnt advocate for medication to be used for every pedophile for lifehis study explores whether this specific drug could help. He said a person may only want and need it for a few months. It could help a person through a difficult time, or be combined with the start of a behavioral therapy practice. We need to move on to the next generation of research and quality development, Rahm said. We need to evaluate our treatments and to get evidence-based treatments out there so we know what we're doing.

The word castration has a dark history, and dark connotations. It's often been wielded involuntarily: In Germany the number of involuntary castrations of sex offenders increased as a result of the Nazi German Act, with at least 2,800 sex offenders were castrated between 1934 and 1944. In the United States, Black men accused of raping or sexually assaulting white women could find themselves subject to castration. For reasons like these, Rahm is torn about calling Degarelix chemical castration." While he thinks researchers and clinicians should accurately describe what the drug is doing and its side effects, he worries that referring to it as castration could scare people away, or disregard the consent and autonomy of patients who want it.

Rahm said that every person who participated in their study did so voluntarily, and was informed in detail about any possible side effects from taking Degarelix. They had the option to quit the study at any moment. Hes also currently running another placebo-controlled study on a non-pharmacological option: therapy geared specifically towards pedophiles that they can access anonymously, through the dark web.

The mere existence of Rahm's studies is important, outside of the details of the findings. Doing placebo-controlled studies on pedophilia was previously thought to be impossible, because of the ethical implications of not giving an active treatment to a group of people attracted to children.

In Brikens editorial, he wrote that because the medication they used was fast-acting, and they allowed anyone with pedophilia into the studynot just those who were high-risk for offendingit helped make the placebo group ethically possible. Briken concluded that Rahm's study was the most important contribution to the field of pharmacotherapy of pedophilic disorders since the original study of hormone reducing drugs in 1998, and offers a starting point for a more comprehensive approach to pedophila treatment.

In Germany, Prevention Project Dunkelfeld, which offers therapy and medication, has 10 locations throughout Germany, and a person can get help while remaining completely anonymous.

The demand for their work is high: After a BBC documentary on the Dunkelfeld Institute aired, the Guardian reported that Dunkelfelds hotline was overwhelmed with calls from British pedophiles. One British man was so desperate, he moved to Germany to be able to access a Dunkelfeld programme, the Guardian wrote. In an email exchange with the Guardian, the man, who wished to remain anonymous, wrote: 'So far, all I have ever received from the NHS is doors slammed in my face.'"

There's not as well-known a center for pedophiles in the U.S. to go to. Richard Kramer, the educational director at B4U-ACT, an online community for pedophiles, said he figured out he was attracted to pubescent boys in his 20s. (His attraction is to boys around the age of 12 or 13, which is technically called hebephilia.) I was very ashamed about it and thought that I was seriously defective as a human being, Kramer said, who is using a pseudonym. I really wasn't able to find any information about it. I didn't want to go to the library for fear that people would see what I'm looking up.

When he began reading information online, he said, everything he encountered was very negative. It said that I would be a monster, I would have hundreds of victims, and that my entire life would be centered around an elaborate plot to deceive parents and to manipulate children into abusing them, he said. So I thought, well, this is what they think about me. I have no interest in seeing them and seeing a therapist.

A big part of being successful in therapy is having the support of family and friends, something that pedophiles can lack. They often are going through difficult treatments alone, and are unable to talk about it to others. You cant tell co-workers, or ask a boss for time off for your appointments. You have two choices, said Michael Seto, a forensic psychologist and sexologist at the University of Toronto. You don't do it or you lie about it.

When Kramer was ready to look for a therapist again, he didnt really care what kind of approach they used, but was more concerned about whether they understood enough about pedophiles to not treat him like a criminal. His goals didn't involve a struggle to control his impulses, but to manage the shame and sense of isolation from others because he couldnt be honest.

We have to insist that people who have this orientation not act upon it, Berlin said. If we think about that, that can be quite a burden. Its not surprising that some of these folks might be in need of mental health assistance, because of the effect of experiencing these attractions on their sense of self-esteem and self-worth.

Happy, mentally healthy people do not molest children.

Some pedophiles are attracted to adults and children; some, only children. For those who are exclusively attracted to children and dedicated to non-offending, Kramer said, there needs to be a space for helping them grieve over not being able to have romantic and sexual relationships. How do they deal with loneliness? he said. There are other concerns, some almost mundane: How, for instance, do they deal with answering questions friends and co-workers ask about their personal lives? Hes had friends who asked him if he was gay, and he said he wasnt sure how to answer.

I'm not exactly gay, but I'm definitely not straight and I'm definitely not asexual, he said. How do you respond to that?

Gary Gibson founded the ASAP as one potential solution to this problem. Through an involvement with the Association for the Treatment of Sexual Abusers (ATSA), Gibson has been curating a list of therapists to whom he can refer pedophiles. The list is now around 400 names long. ASAP primarily focuses on non-offending pedophiles, but they will also help people who have offended and want to stop. People are just desperate out there, Gibson said.

He has worked with pedophiles who were so desperate for help that they underwent physical castrations. One man traveled to Mexico to have the operation done; when he returned, he tried to find a doctor to supervise his recovery and medications. I could not find a doctor who would take him on, Gibson said. They didn't want him in the office. I did find a therapist to work with him, and I kind of lost contact with him. Im worried about what happened to him.

Until recently ASAP has been handled almost entirely by Gibson, but ASAP is currently undergoing a significant expansion. It has increased its office and volunteer staff, is making a new, online database of mental healthcare providers, and creating a 24/7 helpline. Gibson said his dream is to get a multimillion dollar grant to create a mentor program for teenagers, aged 13 to 17, who are learning that theyre pedophiles. Ive applied three times, he said. Maybe the third time's the charm, because Ive been denied twice.

The goal is to help every non-offending person attracted to children find therapy if they want or need it, said Robert Hillman, a lifelong virtuous (non-offending) pedophile, and the new president of ASAP. Hillman said that the mantra is: All pedophiles are born non-offending, and the aim is to help keep it that way. Happy, mentally healthy people do not molest children," he said.

People do the most desperate things when they feel the most desperate, Cantor said. A lot of what these groups and therapy provide is helping people lead a life that is worth protecting. When they have a life worth protecting, thats when people get the energy and the willpower to control themselves, because they dont want to risk the life that they have.

What Hillman and Gibson want is the opportunity for any person attracted to children to chart their own path, and figure out what works best for them. That may include an experimentation with medication, and it may not. ASAP doesnt control their therapiststhey all operate independently, using different methods of treatment. They're not always successful. One guy has committed suicide that I know of, Gibson said said. But I think that we have probably saved a few lives and saved many children from being abused.

These support groups and therapy networks are providing a lifeline, but alone, they don't guarantee a consistency in treatment, nor fill the gaps in the scientific literature when it comes to which treatments might be best for a certain person. There might be certain hormone-reducing medications that are less risky or work better than others; certain pedophiles that fare better without drugs; certain therapeutic practices that are more helpful than others. Those answers aren't clear-cut.

As with all medications, some people have good experiences and others do not. Pedophiles can identify as ego-dystonic or ego-syntonic. Ego-syntonic people consider pedophilia as part of their identity, and can be okay with fantasizing and masturbating about children (though not with porn), while ego-dystonic people are not. It may be that treatment should be different with those who have different attitudes towards their attraction, even if members of both groups have the same commitment to not offend.

After about five weeks, Parker said that he felt better from the medication he had ordered online. It was night and day," he said. "I can't tell you what a weight was lifted off of me, or a pressure from under me that was relieved. Whenever I think about it I just lay back in my chair and breathe a contented sigh, knowing that I won't suffer like that again. Both physical urges in my body and intrusive imagery in my mind have disappeared."

He doesnt think that medication should be thought of only as a stop-gap to a person committing sexual abuse. Offending was never a danger for me in the first place, he said. He doesnt take the medication to stop himself from molesting a child, but as a way to improve his quality of life.

When Max Weber, who helps run a peer-support website for pedophiles in Germany, realized his attraction to young girls in his early 20s, he said, he was terrified. My picture of pedophilia at the time was the same wrong impression most parts of society have: that pedophiles were bound to offend, he said.

Weber got treatment at Dunkelfeld, and said he views medication like a pair of eyeglasses. You can put [them] on to help yourself focus on things that you want to change about your life.

To Weber, pedophilia was like being surrounded by deep water; he had to struggle to stand on his toes to avoid drowning. I needed all my strength to cope with it and dont drown in my own fears and self-hate, he said. As a result sexual impulses felt very powerful since, when you are standing on your toes, even the slightest push could throw you over.

He took medication for about nine months. During that time when his sexual feelings were repressed, he regained a foothold on his life, he said, and found that even without medication he is able to be around children without issue. I now know that I am in charge, and no one can make me offend other than myself, he said.

Two years ago, David, a 22 -year-old recent college graduate from New York and a volunteer for a peer-support group including pedophiles, desperately wanted to take hormone-altering medication. I hated myself for having feelings about children, and I just wanted to be like everyone else," he said. "I was also going online and finding articles about how to raise libido, and doing the opposite of all of the advice I found. But I couldnt find a therapist I felt safe coming out to.

Since then, he said that support groups like Virtuous Pedophiles have helped him realize that being attracted to children is not something he chose, and hes not tempted towards any illegal behaviors. In the end, there was no need for me to go through such a treatment with dangerous side effects," he said.

Though he never ended up trying medication, David thinks his experience with peer support reveals something important. Medications can help reduce physical symptoms, he said, but the restthe support, the isolation, the shameall needs to be addressed outside of just taking a pill.

I struggled with serious depression, anxiety, and self-hatred as a teenager starting to understand that I was a pedophile, David said. Becoming less isolated, having people to help when I was hurting, and being able to help others in the same way is what brought me back from that.

Hillman was a patient of Berlins about 25 years ago. I was on the brink of madness from the desires and from the shame and self-hatred and loathing, he said. "It was crushing me and I was not going to survive it. He took hormone-reducing medication with Berlin's help, and said that combined with therapy, it saved his life. Since I was at that time and have always been non-offending, my anti-androgen therapy was not mandatory in any way and thus I started and stopped it several times, because of the affordability issues, Hillman said. But I can attest that the medication did reduce my thoughts and therefore some of my distress.

Then he found the Virtuous Pedophiles group about one year ago, and the support hes culled from the others there has given him a new gusto for life, without medication. Now I am dedicated to living. And I am dedicated to making sure no one else has to waste their life just to be virtuous, he said.

Hillman said that these narratives reveal how all pedophiles are different. Some will benefit from meds and some will not, he said. Some are against medication, some are not.

Rahm hopes to continue studying treatment options for pedophilia, in a rigorous way. In his view of a forthcoming modern pedophile treatment, each person would get an individual assessment and be offered an evidence-based treatment. It would work with helping a pedophile address both their personal feelings and concerns, and also their risk of offending.

In my vision, some people need therapy, some need medication, some need both, and some won't have any effect on any of these. They need something else, Rahm said. This is nothing novel or groundbreaking, he added. I would just like to apply modern psychiatric thinking to this group.

Follow Shayla Love onTwitter.

Read more here:
Paedophilia Is a Mental Health Issue. It's Still Not Treated as One - VICE

Recommendation and review posted by Bethany Smith

From left, Declan, Cian and Rowan pose on the front porch of their Norwood home this week. Declan and Cian, identical twin brothers, and fraternal sister Rowan, were conceived through in vitro fertilization and born as micro preemies. Christopher Lenney/Watertown Daily Times

NORWOOD Expert fertility statistics and probability outcomes would never have accounted for the DeShane triplets.

Born on different days and in different years two splitting an embryo and all surviving natural births three Norwood babies have beaten the odds.

At 22 weeks, 6 days, Cian J. DeShane was born Dec. 28, 2019, at the University of Vermont Medical Centers Neonatal Intensive Care Unit. With tubing in, he spanned 11 inches and weighed 1 pound, 0.9 ounces, about the weight of a loaf of bread.

After being fully-dilated and having contractions for 5 days, Cians umbilical cord cut, Kaylie E. (Mousaw) DeShane gave birth to Cians identical twin brother Declan B. and their sister Rowan M. on Jan. 2, 2020. Declan weighed 1 pound, 7.6 ounces, and Rowan came in at 1 pound, 1 ounce.

All six eyelids were fused shut at birth, but outside their Norwood home during a brief visit this week, the DeShane triplets looked out at the world, at bicyclists passing on Main Street, with bright excitement.

Nurses at the University of Vermont Medical Center NICU awarded the DeShane triplets each a Grammy for achieving weight milestones. Christopher Lenney/Watertown Daily Times

If they had been carried to full-term, Cian, Declan and Rowan would be about 4 months old. Now nearly 8 months old, the trio is meeting all adjusted milestones expected of 4-month-olds.

But the wide-eyed, growing and curious babies were once barely bigger than an adults palm. At 15 days old, Rowans entire hand was the size of her dads index fingernail. Cian and Rowan developed an intestinal disease; Cian fought pneumonia; and all three struggled with respiratory issues, particularly in their first days and weeks of life.

During the uncertain four months the triplets spent in the NICU, Kaylie said, dozens of family, friends and strangers prayed for the miracle babies, the uterine warriors, as one UVMC specialist put it.

As the weeks rolled into months at the NICU, Kaylie and her husband Brandon J. DeShane initially stayed at the Burlington Ronald McDonald House in shifts until the COVID-19 pandemic shut down the country mid-March and Ronald McDonald families were kicked out.

The hospital, Kaylie said, covered hotel rates during the remainder of the triplets NICU stay, which totaled about $1 million in medical costs for each member of the trio, the early births qualifying the DeShanes for Medicaid.

Kaylie E. DeShane holds her son Cian for the first time Jan. 16, at the University of Vermont Medical Center NICU. Cian was born at 22 weeks, 6 days, on Dec. 28, 2019. His identical twin brother Declan and fraternal sister Rowan were born Jan. 2, 2020. Provided photo

With two children at home in the north country, 11-year-old Naveah and 6-year-old Holden, Kaylie and Brandon took turns making the 120-mile trip between Norwood and Burlington, and the babies continued vanquishing every life-threatening emergency.

The theory of their persistence, their fight, Kaylie said, became centered on the bumblebee, and a phrase popularized by the introduction to the 2007 animated Bee Movie.

According to all known laws of aviation, there is no way a bee should be able to fly, the screenplay reads. Its wings are too small to get its fat little body off the ground. The bee, of course, flies anyway because bees dont care what humans think is impossible.

Though a misconception that bees or other insects break fundamental laws of physics through flight, the idea of the impossibility originated from French entomologist and engineer Antoine Magnan. In the 1930s, he famously compared bumblebee flight to the aeronautics of powered flight to doing the unthinkable.

That concept became the lifeblood of the DeShane triplets, who didnt know they shouldnt be able to fly.

And they didnt care, Kaylie said, adding that the seeming attitude of Cian, Declan and Rowan inspired rallying hope spanning two states, and reaching an online community of thousands of mothers of micro preemies. If they believe they can make it, then we should believe them, too.

Brandon J. DeShane holds Cian, left, and Rowan, on the front porch of their Norwood home this week. Cian was born at 22 weeks, 6 days on Dec. 28, 2019. Rowan, along with Cians identical twin Declan, was born almost six days later on Jan. 2, 2020. Christopher Lenney/Watertown Daily Times

What are the odds?

Kaylie, originally from Potsdam, is a senior chemical dependency counselor for St. Lawrence County. She and Brandon, a Norwood native and current stay-at-home dad, married in 2015. Naveah is Kaylies stepdaughter, and the couple officially adopted Holden in 2017. When Kaylie and Brandon decided to begin the process of having biological children about four years ago, they worked with Northeastern Reproductive Medicine, a fertility clinic in Colchester, Vt., to address infertility issues and Kaylies Polycystic Ovary Syndrome, or PCOS.

PCOS, according to the Mayo Clinic, is a hormonal disorder causing excess production of male hormone levels, infrequent or prolonged menstruation and increased potential for the ovaries to develop fluid pockets and fail to regularly release eggs. The Centers for Disease Control and Prevention reports PCOS as one of the most common causes of womens infertility, affecting as many as 5 million women of reproductive age in the United States.

Through in vitro fertilization, the manual combination of an extracted egg and a sperm sample in a laboratory setting, two of Kaylies fertilized eggs were transferred to her uterus last year. Months and sometimes years before a transfer can be conducted, fertility medications are prescribed to stimulate egg production and adjust hormone levels. Once implanted in the wall of the uterus, one of Kaylies embryos split, leading to identical twins Cian and Declan.

Kaylie E. DeShane holds her son Declan for the first time Jan. 13, at the University of Vermont Medical Center NICU. Provided photo

To avoid a multiple pregnancy and its risks, including miscarriage, premature delivery and low birthweight, most fertility clinics prefer to transfer a single embryo to a womans uterus. Given Kaylies infertility, she said, Northeastern agreed to transfer two.

Figures of chance for twin and triplet births vary by reporting agency and method of conception, and depend on a familys fertility history and differing data collection across clinics.

But generally, the chance of carrying identical twins to term is rare for any conception method. The chance of one embryo splitting and a second successfully implanting through IVF, resulting in identical twins and one fraternal sibling, is rarer still.

Based on years of published research before it, a 2016 Columbia University study of 27 IVF providers and 10 patients indicates twins born to mothers through IVF are 12 times more likely than single babies to be born prematurely, 16 times more likely to have low birthweights and five times more likely to be born with respiratory complications.

Due April 26, 2020, the DeShane triplets fulfilled all three of those projections.

Neonatologist Deirdre OReilly, UVMC director of the Neonatal Medical and Developmental Follow-up Clinic, will see Cian, Declan and Rowan for at least the next two years. The DeShanes continue to make regular visits to their local physician, as well as UVMC specialists, including a pediatric pulmonologist for lung health and an ophthalmologist for vision.

Kaylie E. DeShane displays a preemie diaper, one too big for her triplets when they where born weighing about 1 pound each. Christopher Lenney/Watertown Daily Times

Last month, Dr. OReilly told UVMC Childrens Hospital she had never, in her 13 years of practice, seen a baby born as early as Cian survive.

Full-term babies are carried for 39 weeks, and the World Health Organization sets the pre-term threshold at 37 weeks, with those born between 28 and 32 weeks categorized as very pre-term. Babies born alive after less than 28 weeks are considered extremely pre-term. The United States, according to the most recent WHO data, ranks sixth among countries with the greatest number of pre-term births each year, 517,400 in 2017.

For micro preemies birthed at 22 to 23 weeks, extended infant survivability is low, and some hospitals may choose not to attempt intense medical interventions or treat life-threatening conditions, depending on whether policies are in place.

The American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists both recommend families develop their own plans with clinicians, should decisions need to be made about treating extremely pre-term babies.

The DeShanes told their delivery room team they wanted anything and everything to be done for the triplets.

The New England Journal of Medicine in 2015 published data about more than 4,000 premature babies born between 2006 and 2011, all before 27 weeks of gestation. The overall rate of survival for those born at 22 weeks who did not receive active treatment was 5.1 percent. The survival rate for 22-weekers who received active treatment defined in the study as any potentially lifesaving intervention administered after birth was calculated to be 23.1 percent.

Over the last decade, support for such interventions at 22 weeks has grown, among clinicians and families with children who survived birth between 22 and 25 weeks.

Nurses at the University of Vermont Medical Center NICU logged every note and decorated photos for each of the DeShane triplets over the four months they spent in the NICU. Christopher Lenney/Watertown Daily Times

Twenty Two Matters

With each update and each minor victory, the DeShanes support network expanded the DeShane and Mousaw families led prayer and cheerleading efforts in the north country, along with mothers from the nonprofit TwentyTwo Foundation. The foundation serves as a sister organization to the online group TwentyTwo Matters, nearly 5,000 advocates and mothers celebrating micro preemies and their milestones.

But in the hours and days after she went into labor, and despite such support, Kaylie said, she felt like giving up.

Kaylie and Brandon had traveled to Burlington for a scheduled anatomy scan Dec. 27, and were staying at a hotel in Plattsburgh when her water broke.

Kaylies cervix had already failed once, meaning her cervix the tissue at the neck of the womb that opens during childbirth was weakening and opening too early. At 16 weeks, the risk of miscarriage or pre-term birth was high, and Kaylie could either miscarry intentionally or undergo a cervical cerclage procedure to close her cervix. Cervical cerclage stitches the cervix closed, but the procedure itself, coupled with Kaylies already high-risk pregnancy, was risky for both mother and babies. Kaylie could have hemorrhaged and a failed cerclage could have prompted an even earlier birth.

I wasnt going to voluntarily kill my babies by doing nothing, she said. So they stitched me up.

By the time fluid drenched the hotel room floor 6 weeks later, Kaylie was preparing for the worst. She said she even texted her family members, asking them not to call and assuming Cian, Declan and Rowan, with names picked out, wouldnt survive. Twenty-two weeks, she thought, was just too early.

At 15 days old, Rowan holds her father Brandon J. DeShanes hand for the first time Jan. 17, at the University of Vermont Medical Center NICU. Rowan was born Jan. 2, with her brother Declan, about five days after the first triplet, Cian, was born. Provided photo

Once at Champlain Valley Physicians Hospital in Plattsburgh that night, the DeShanes were told a transfer to UVMC was not immediately available, that it would be faster for the couple to drive themselves. So Brandon drove Kaylie to the western shore of Lake Champlain, where they ferried across to Vermont. The soon-to-be mother of triplets arrived barefoot in the snow.

The morning of Cians birth, Kaylie had severe pain and bleeding because the eldest triplet had torn through her cervical stitches.

Then it all happened so fast, she said.

Adorned in yellow gowns, four NICU nursing teams were at the ready, one dedicated to each baby and one to Kaylie.

Cian was successfully intubated, initially receiving oxygen 24/7 with the ventilator breathing for him. Then at 23 weeks, 4 days, and in a new year, Kaylie gave birth to Declan and Rowan.

Rowan, who had a severe brain bleed that didnt worsen and eventually resolved itself, later developed necrotizing enterocolitis, or NEC. The CDC lists NEC as a leading cause of infant mortality in the United States, and medical professionals dont fully understand the intestinal disease, though it is clear it primarily affects premature infants and presents with a swollen belly or bloody stool.

Rowan stabilized, but Cians NEC prognosis was less positive, and the DeShanes were asked to write an end-of-life plan for him. Kaylie refused, and Cian overcame.

That would mean wed be giving up, that we believed he wasnt going to make it, she said. And we couldnt believe that.

Cian also developed pneumonia and NEC more than once, most recently recovering in March, and hell eventually have surgery to remove a hernia the first surgery for any of the DeShane babies.

Bumblebee emblems gradually started to appear in the NICU, bees were pinned to nurses badges as teams diligently and quietly cared for the triplets. One word uttered too loud, one step too forceful, and the fragile beings would have suffered.

Five words floated in the air of the unit: Dont give up on them.

Kaylie E. DeShane holds Declan this week in Norwood. Declan was born Jan. 2, 2020, at 23 weeks, 4 days. Christopher Lenney/Watertown Daily Times

Eleven days after his birthday, Declan was approved to be held on Jan. 13. Cian and Rowan followed, on Jan. 16 and 17.

Naveah and Holden spent their February school break at the Ronald McDonald House with their parents, visiting their siblings for the week.

What hell they had to go through, Kaylie said of her two older children, who spent months with only one parent at a time, always prepared for a reality that their baby brothers and sister might not have come home.

Declan, born the largest and having the fewest major issues, celebrated his homecoming April 17, beating his due date by nine days. Rowan left the NICU April 30, and Cian arrived in Norwood May 4. Home aides have assisted with daily monitoring, and the babies now only receive extra oxygen while sleeping at night to foster growth, no longer needing ventilators to survive.

Declan is an active trouble maker, Cian an old man, Kaylie said, because of his noises and groans. Rowan curls into a ball, like a hedgehog, when she doesnt want to be touched.

For the DeShanes, 2019-20 has been a roller coaster year, with a pregnancy announcement, a rare triplet birth, a global pandemic and more than $3 million in medical bills.

You take it one day at a time, Kaylie said. You look back later and you have no idea how you did it.

Original post:
Norwood triplets, born on different days in different years, beat the odds - NNY360

Recommendation and review posted by Bethany Smith

When it comes to experimental cholesterol drugs, all eyes this year are on inclisiran, the $9.7 billion RNAi drug Novartis hopes will replace and vastly outsell Regeneron and Amgens PCSK9 inhibitors.

Yet Regeneron has been quietly preparing for approval of its own new cholesterol drug, a niche antibody meant to treat a narrow slice of patients not covered by Praluent, the biotechs original PCSK9 inhibitor. Last year, the company reported topline, pivotal data. Last week, a BLA submission for the drug, known as evinacumab, was accepted andgivenpriority review by the FDA.

And today, in theNew England Journal of Medicine,Regeneron published the full data from the pivotal study supporting the application, showcasing some of the first significant cholesterol reductions in patients with a rare genetic disorder calledhomozygous familial hypercholesterolemia and pointing toward a therapy that could yet have broader applications.

As far as homozygous patients, this is a great, great advance, Evan Stein, a University of Chicago cardiologist who has studied the condition for over 40 years and was not involved in the paper, toldEndpoints News, for a very difficult and high-risk group of patients who need additional therapies.

In the Phase III trial, 65 patients with the condition, often shorthanded as HoFH, were randomized to receive either placebo or evinacumab. Praluent and its Amgen-developed rival Repatha treat high cholesterol by increasing the amount of LDL receptors on the liver, where they sap up the LDL cholesterol soaking in the blood. But because patients with HoFH have mutations that leave them with no functioning LDL receptors to begin with, their cholesterol levels dont come back to normal.

PCSK9 inhibitors, statins and other drugs have helped these patients blunting what could once be a fatal disease but most have continued to have elevated cholesterol and some continue to need to filter their blood with aphersis every two weeks, Stein said.

Yet in the Regeneron study, patients who received evinacumab saw their LDL levels fall by 47% over 24 week, while those in the placebo rose by 1.9%. In an accompanying NEJMeditorial, Wageningen University Sander Kersten noted that may mean patients wont need apheresis. The results of this trial are great news for patients with homozygous familial hypercholesterolemia and may reduce the need for invasive treatment, he said.

Unlike PCSK9 inhibitors or inclisiran (which stops production of PCSK9), evinacumab targets a hormone called angiopoietin-like 3, or ANGPTL3. Although its still unclear why ANGPTL3 affects cholesterol, scientists studying mice and later humans in the early 2000s learned that it did, and researchers have since been trying to figure out how to turn that insight into medical interventions.

In 2013, Ionis and Genmab developed Kynamro, an antisense oligo-nucleotide that targeted a similar protein for HoFH, but the risk of liver damage was too high for it to be commonly used.

It was a terrible drug, Stein said, noting it was never approved outside the US.

By contrast, side effects were virtually non-existent for evinacumab, Stein said. Adverse events were more common in the placebo group, where 81% had an AE, than in the treatment, where 66% did. There were two non-fatal serious adverse events in the treatment group: a suicide attempt and urosepsis, a kind of sepsis cause by a urinary infection. Five patients on the treatment arm saw an influenza-like illness but no patients on placebo did.

Still, there was room for further research. Stein said that the group most unaddressed by current therapies was kids, yet the Regeneron study excluded patients beneath the age of 12 and only included 2 patients between ages 12 and 18.

Thats where the greatest need for treatment is, he said. It would be great, if this could be extended down to children.

For Regeneron, the immediate goal-line is the FDA decision, which is due by February 11. Still, Kersten argued the study also raises a larger question: whether evinacumab will have applications in patients beyond HoFH which affects just 1 in 160,000 to 1 in 300,000 people.

That would mean both greater sales of Regeneron and a drug for patients who, despite statins and PCSK9 inhibitors, cant get their LDL under control. Those patients could include people withheterozygous familial hypercholesterolemia i.e. people with one functioning and one fault LDL receptor who often, but not always, respond to existing treatments.

Stein, though, argued that the drug would have to be easier to administer for that to happen. It currently has to be infused by IV once per month. HoFH patients will accept that, but others more addressed by current therapies wont.

Long-term, Stein is looking at new methods that could bring a one-and-done fix. He pointed to Verve and their recent animal study using CRIPSR base editing to fix a different cardiovascular condition.

The holy grail may be doing gene replacing or knocking out a gene or modifying it, he said. But were a long way from that.

View post:
Regeneron flashes 'great advance' in the NEJM for that other cholesterol drug sitting at the FDA - Endpoints News

Recommendation and review posted by Bethany Smith

Myelofibrosis or osteomyelofibrosis is a myeloproliferative disorder which is characterized by proliferation of abnormal clone of hematopoietic stem cells. Myelofibrosis is a rare type of chronic leukemia which affects the blood forming function of the bone marrow tissue. National Institute of Health (NIH) has listed it as a rare disease as the prevalence of myelofibrosis in UK is as low as 0.5 cases per 100,000 population. The cause of myelofibrosis is the genetic mutation in bone marrow stem cells. The disorder is found to occur mainly in the people of age 50 or more and shows no symptoms at an early stage. The common symptoms associated with myelofibrosis include weakness, fatigue, anemia, splenomegaly (spleen enlargement) and gout. However, the disease progresses very slowly and 10% of the patients eventually develop acute myeloid leukemia. Treatment options for myelofibrosis are mainly to prevent the complications associated with low blood count and splenomegaly.

The global market for myelofibrosis treatment is expected to grow moderately due to low incidence of a disease. However, increasing incidence of genetic disorders, lifestyle up-gradation and rise in smoking population are the factors which can boost the growth of global myelofibrosis treatment market. The high cost of therapy will the growth of global myelofibrosis treatment market.

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As myelofibrosis is considered as non-curable disease treatment options mainly depend on visible symptoms of a disease. Primary stages of the myelofibrosis are treated with supportive therapies such as chemotherapy and radiation therapy. However, there are serious unmet needs in myelofibrosis treatment market due to lack of disease modifying agents. Approval of JAK1/JAK2 inhibitor Ruxolitinib in 2011 is considered as a breakthrough in myelofibrosis treatment. Stem cell transplantation for the treatment of myelofibrosis also holds tremendous potential for market growth but high cost of therapy is foreseen to limits the growth of the segment.

On the basis of treatment type, the global myelofibrosis treatment market has been segmented into blood transfusion, chemotherapy, androgen therapy and stem cell or bone marrow transplantation. Chemotherapy segment is expected to contribute major share due to easy availability of chemotherapeutic agents. Ruxolitinib is the only chemotherapeutic agent approved by the USFDA specifically for the treatment of myelofibrosis, which will drive the global myelofibrosis treatment market over the forecast period.

Geographically, global myelofibrosis treatment market is segmented into five regions viz. North America, Latin America, Europe, Asia Pacific and Middle East & Africa. Northe America is anticipated to lead the global myelofibrosis treatment market due to comparatively high prevalence of the disease in the region.

Some of the key market players in the global myelofibrosis treatment market are Incyte Corporation, Novartis AG, Celgene Corporation, Mylan Pharmaceuticals Ulc., Bristol-Myers Squibb Company, Eli Lilly and Company, Taro Pharmaceuticals Inc., AllCells LLC, Lonza Group Ltd., ATCC Inc. and others.

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Recommendation and review posted by Bethany Smith

Interim analysis to commence after 28 days; results anticipated by mid-October

VANCOUVER, Washington, Aug. 25, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn” or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company has reached the requisite number of enrolled patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms to perform an interim analysis following the 28-day phase of the trial.

This Phase 3 trial is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab in patients with severe-to-critical symptoms of respiratory illness caused by COVID-19. Patients are randomized to receive weekly doses of 700 mg leronlimab or placebo, administered via weekly subcutaneous injection for two weeks. The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Recently, the Data Safety Monitoring Committee (DSMC”) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study. The DSMC reviewed safety data from 149 of the 169 patients enrolled at the time of their review. The DSMC did not raise any concerns regarding safety and recommended the trial continue as planned.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very thankful for the many clinicians and their staff who have worked tirelessly to advance enrollment this quickly and for their care of these seriously ill patients. We are eager to perform an interim analysis of the data and remain optimistic the interim results will be consistent with those experienced by patients who received leronlimab through multiple EINDs (over 60) previously authorized by the FDA. And, in the event we are successful, we are well positioned with our distribution partner to accelerate distribution of leronlimab to patients throughout the U.S.”

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug” designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA has agreed to provide written responses to the Company’s questions concerning its recent Biologics License Application by September 4, 2020, in lieu of a Type A teleconference meeting for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes,” hopes,” intends,” estimates,” expects,” projects,” plans,” anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS Investors: Michael Mulholland Office: 360.980.8524, ext. 102 Mobile: 503.341.3514 mmulholland@cytodyn.com

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CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms - Stockhouse

Recommendation and review posted by Bethany Smith

NEW YORK, Aug. 25, 2020 (GLOBE NEWSWIRE) -- Cytovia Therapeuticsan emerging biopharmaceutical company and the New York Stem Cell Foundation (NYSCF) Research institute today announced the filing of a provisional patent application with the U.S. Patent & Trademark Office (USPTO) for the differentiation of Natural Killer (NK) cells from induced pluripotent stem cells (iPSCs). The NYSCF Research Institute is a pioneer and acknowledged leader in stem cell technology, having developed the NYSCF Global Stem Cell Array, the premier automated robotic platform for reprogramming skin or blood into induced pluripotent stem cells (iPSCs) and differentiating them into disease-relevant cell types.

Cytovia and NYSCF are also collaborating on the process development of Good Manufacturing Practices (GMP) of iPSC NK and CAR-NK cells with the potential to file additional patents on the engineering, expansion and GMP manufacturing processes of iPSC NK cells to treat cancer.

Dr. Daniel Teper, CEO of Cytovia commented, This first patent application filing on iPSC-NK cells is an important milestone for Cytovia, positioning us as a pioneer in this emerging field. The use of iPSC-NK cells constitutes a transformational approach to cancer treatment, enabling the use of precision cell therapy for many patients. Cytovia plans to initiate first clinical trials with iPSC NK-cells in 2021.

Susan L Solomon, Chief Executive Officer of NYSCF added, We are delighted by the progress made by the NYSCF and Cytovia team in the differentiation and expansion of NK cells from an iPSC source. These iPSC-NK cells can be genetically modified to create iPSC-CAR-NK cells. In the coming months, the collaboration will focus on developing a standardized GMP process to support Cytovias iPSC-NK and iPSC-CAR NK therapeutic candidates for cancer.

ABOUT CAR NK CELL THERAPYChimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). Induced Pluripotent Stem Cells (iPSC) - derived CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the iPSC, an innovative technology, allow large quantities of homogeneous genetically modified CAR NK cells to be produced from a master cell bank, and thus hold promise to expand access of cell therapy for many patients.

ABOUTTHE NEW YORK STEM CELL FOUNDATION RESEARCH INSTITUTEThe New York Stem Cell Foundation (NYSCF) Research Institute is an independent non-profit organization accelerating cures and better treatments for patients through stem cell research. The NYSCF global community includes over 190 researchers at leading institutions worldwide, including the NYSCF Druckenmiller Fellows, the NYSCF Robertson Investigators, the NYSCF Robertson Stem Cell Prize Recipients, and NYSCF Research Institute scientists and engineers. The NYSCF Research Institute is an acknowledged world leader in stem cell research and in the development of pioneering stem cell technologies, including the NYSCF Global Stem Cell Array, which is used to create cell lines for laboratories around the globe. In 2019, NYSCF launched the Womens Reproductive Cancers Initiative, which aims to shift paradigms in the way these cancers are studied and treated, in collaboration with leading cancer experts across the globe. NYSCF focuses on translational research in an accelerator model designed to overcome barriers that slow discovery and replace silos with collaboration. For more information, visitwww.nyscf.org

ABOUT CYTOVIA THERAPEUTICS, INCCytovia Therapeutics Inc is an emerging biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer and severe acute infectious diseases. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, and CytoImmune Therapeutics. Learn more atwww.cytoviatx.com

For more information please contact:

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Cytovia Therapeutics and NYSCF Announce Filing of Provisional Patent for iPSC-Derived NK Cells to Produce Unlimited On-Demand NK and CAR-NK Cells for...

Recommendation and review posted by Bethany Smith

Transparency Market Research (TMR)has published a new report titled, Autologous cell therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the globalautologous cell therapy marketwas valued atUS$ 7.5 Bnin2018and is projected to expand at a CAGR of18.1%from2019to2027.

Get PDF Sample Copy of Report: (Including TOC, List of Tables & Figures, Chart) :https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=715

Overview

Rise in Prevalence of Neurological Disorders & Cancer and Others to Drive Market

REQUEST FOR COVID19 IMPACT ANALYSIS https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=715

Bone Marrow Segment to Dominate Market

Neurology Segment to be Highly Lucrative Segment

Hospitals Segment to be Highly Lucrative Segment

North America to Dominate Global Market

Competitive Landscape

Read our Case study at :https://www.transparencymarketresearch.com/casestudies/innovative-medical-device-manufacturing-start-up

The global autologous cell therapy market has been segmented as follows:

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Autologous Cell Therapy Market Along With Covid-19 Impact Analysis and Business Opportunities Outlook 2027 - Scientect

Recommendation and review posted by Bethany Smith

When youre pregnant, you usually have to go nine months or longer without using certain active ingredients in your skin-care routine (farewell: dear, retinol). But just because a few ingredients arent recommended to be used in your regimen for a while doesnt mean that skin care has to fall by the waysidethere are plenty of barrier-boosting actives that are A-okay to use when youre expecting. For some guidance, a celebrity esthetician is sharing her entire pregnancy skin-care regimen.

Overall, Natalie Aguilar, celebrity facialist and dermatological nurse, had to swap out six of her daily skin-care staples when she got pregnant. My skin is very resilient, but easily pigments, so preventing facial discoloration and pigmentation has been my main goal before and during my pregnancy, she says. To do the brightening job during her pregnancy, Aguilar nixed her typical retinol serum, salicylic acid cleanser, stem cell moisturizer, and chemical SPF, but has effective substitutes in their place (like kojic acid, for one).

Now, Aguilars regimen still contains some complexion-evening ingredients, but shes also incorporating skin-soothing and hydrating products to balance her finicky skin. During pregnancy, our skin may experience extreme dryness, sensitivity, and even melasma that we didnt have before thanks to the shift of hormones, she says. Also, as your skin experiences hormonal changes, sensitivity increases. Keep scrolling to see whats in her beauty cabinet ATM.

Pre-pregnancy, Aguilar turned to a salicylic acid-spiked cleanser for sloughing off dead skin cells. My new substitute is this PCA Skin Pigment Bar, which uses natural skin-brightening and exfoliating ingredients such as kojic acid, which is derived from mushrooms or fermented rice, and azelaic acid, which is a naturally occurring acid found in grains, she says.

Aguilar had to change her go-to toner when she got pregnant, since her active ingredient-packed product started to burn and sting her skin. I swapped for this toning essence, which is alcohol-free and has skin-soothing ingredients like chamomile and rose extracts, she says.

Though Aguilar always used a vitamin B3 and vitamin C serum daily, she found that her skin no longer tolerated them when used together. Instead, I use this vitamin B3 serum during the day, and a vitamin C serum at night. The active ingredient, vitamin B3 (also known as niacinamide) does everything from hydrate to smooth and even out the complexion.

To aid in her skin-brightening goals, Aguilar uses a vitamin C serum every day. Though the one in her cabinet is by PCA Skin, this serum by Ghost Democracy uses a stable vitamin C derivative that works for all skin types, plus it contains bakuchiol, a plant-based retinol alternative.

I added a hyaluronic acid [to my routine] as my skin began to suffer extreme dehydration, no matter how much water I was drinking, says Aguilar. Hyaluronic acid is a safe, water-binding serum, and I began to use one twice daily and instantly felt relief. This drugstore find will give your skin moisturizing, fine line-plumping benefits, and works for the most sensitive of skin types.

My stem cell moisturizer and eye cream were swapped out, says Aguilar, noting that though there isnt much research on the safety of using topical stem cells during pregnancy, its best to avoid products you just arent sure about. Instead, she turns to peptides, which are collagen-stimulating proteins that are naturally found in your skin. I switched to using a rich, hydrating cream that contains plant peptides, which are proteins that help strengthen the skins barrier.

To stay on the safe side in her beauty regimen, Aguilar swapped her chemical-based sunscreen for this mineral-based option. This is safe enough to be used on babies and children, she says. I feel safer using a mineral sunscreen that provides a protective physical shield and that doesnt penetrate the skin. Her tip? Reapply two to three times a day for ultimate sun protection.

Our editors independently select these products. Making a purchase through our links may earn Well+Good a commission.

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How One Esthetician Has Edited Her Skin-Care Routine Through Her Pregnancy - Well+Good

Recommendation and review posted by Bethany Smith

Much like vitamin C, retinol (or retinoids, retinoic acid, or Retin-A), is a favorite ingredient for skin care professionals thanks to its renowned efficacy. It also works to help even skin tone twofold.

First up: Retinol spurs collagen production: "Retinol binds to retinoid receptors within skin cells," says board-certified dermatologist Joshua Zeichner, M.D. This "activates genes that upregulate collagen production."

Second, it also increases cell turnover at the cellular level. "Besides stimulating production of new collagen, retinol enhances cell turnover," says Zeichner. "This means it sheds dead and damaged cells that make the skin look dull." And while retinol thickens the lower layers of the skin, he says, it thins out the top layer (the stratum corneum), which creates a dewy glow.

Retinol, however, tends to have less tolerability, although modern formulas are usually more gentle and sophisticated. Adding one to your routine usually takes an adjustment period where the skin may experience peeling, flaking, redness, and dryness. Some with highly sensitive skin are never fully able to tolerate the ingredient, while others will do so quickly.

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7 Derm-Approved Tips To Even Your Skin Tone (You'll Seriously Glow!) - mindbodygreen.com

Recommendation and review posted by Bethany Smith

According to a young Mancunian woman festooned with eyeliner, tattoos and pumped-up lips, a major motivation for having cosmetic treatments is to make yourself look more like Kylie Jenner and the Kardashians. Big lips, square jaw, tiny waist, big bum, big boobs now its become commercial enough that we can get it, she explained.

This may not be an aspiration shared by everyone but you might expect that the people who provide these appearance-altering procedures would be subject to strict regulation. Not so, as medical journalist Michael Mosley was horrified to discover in the startling documentary, The Truth about Cosmetic Treatments. You dont need a licence or even any training to start injecting somebodys face with fillers, despite the risks of disfiguring infections or blindness.

The rush for self-renovation has been accelerated by social media and the way that established treatments, such as face-lifts and nose jobs, requiring full-scale surgery, are being replaced by less invasive techniques.

Teaming up with blogger Mehreen Baig, Mosley explored the freaky world of lip and nose fillers, microneedling and botox, and bravely volunteered to have his own crows feet blitzed by a gadget which, as its operator enthused, melts the skin instantaneously. Once the rawness and swelling on his face had subsided, Mosley was disgruntled to find that it hadnt made much difference.

Other customers were left similarly deflated. Julie, whose fractionated CO2 laser treatment left her face covered in tatters of dead skin, enjoyed some improved skin elasticity, but tests revealed no noticeable dermatological changes. The only treatment that seemed to have a significant effect was the stem-cell facelift undergone by Kim, who paid 6,000 for the privilege of having the cells injected into her cheekbones. She was delighted with her smoother, younger-looking face.

Mosley had assembled a panel of punters to look at before and after photos and assess whether the treatments had made the contestants look more attractive. They lost their personality, one man said. As dermatologist Tamara Griffiths warned, then, its a case of buyer beware.

THEARTSDESK.COM

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The Truth About Cosmetic Treatments was a startling and sad documentary - iNews

Recommendation and review posted by Bethany Smith

From Good Housekeeping

Mary Kay, the mega-famous beauty company founded in 1963 by entrepreneur Mary Kay Ash, has earned its stripes with its devoted fan base thanks, in part, to its effective formulas. Not only does the company known for its iconic pink Cadillacs invest millions in research and testing, but the brand has at least 1,500 patents.

Three particular areas where the brand shines are anti-aging products, moisturizing formulas, and bold cosmetics. Below were sharing the products in those categories that any MK devotee will tell you is a must-shop, whether youre looking to expand your collection or start a stash from scratch.

If youre battling dryness, genetics, the weather, and even soaking too long in a hot bath can be to blame. But regardless of the cause ask your derm what they think the culprit is for you these three wonders will come to the rescue with hydrating ingredients like glycerin, shea butter, and squalane. And the clincher? The brands high-tech formulations will help your skin stay hydrated.

Mary Kay Hydrogel Eye Patches, pk./30 pairs, $40

These pretty pink patches are the perfect slip-on fix any time your eyes could use a moisture boost. According to an independent consumer study of 157 people, these patches, loaded with the humectant glycerin, boosted skin hydration upon application. Translation: youll see the effects right away. They leave the delicate eyelid skin feeling cool and soothed, and can help reduce the look of puffiness and dullness.

Mary Kay White Tea & Citrus Satin Body Whipped Shea Crme, $22

This cream is luxe. Loaded with shea and mango butter and sunflower and apricot kernel oil, it feels unbelievably smooth and creamy and, based on biophysical testing, was proven to moisturize for 24 hours. The light, energizing scent? Thats just a bonus.

Mary Kay Naturally Nourishing Oil, $48

We love this oil not only for the hydrators it contains (squalane, sweet almond oil, sesame oil, and olive oil) but what it doesnt (parabens and synthetic dyes and fragrances). Glide it on your face, elbows, cuticles, the ends of your hair, or wherever you need an extra dose of moisture for instant relief.

Turning back the clock is all about lifting and firming to blur and soften lines while protecting the skin from collagen-depleting damage. And this is an area where MKs science-backed, award-winning family of anti-aging products shines. Read on for some of the stand-outs in the range.

Mary Kay TimeWise Miracle Set 3D, $110

If youre looking for an all-in-one skin-perfecting system, well, here you go. This set (which comes in normal/dry and combination/oily versions) contains a cleanser, SPF day cream, night cream, and eye cream, all packed with encapsulated resveratrol, vitamin B3, and peptides to both treat existing signs of aging and protect the skin against free radicals that can cause further signs of aging. And the combination is effective in a 12-week independent clinical study, participants found that there was a visible improvement of multiple signs of aging in just four weeks, with more results coming after prolonged use.

Mary Kay TimeWise Repair Lifting Bio-Cellulose Mask, $70 (pack of four)

Use this Korean beauty-inspired sheet mask just once for 20 to 30 minutes to help boost the radiance of your complexion. Use it twice weekly for 14 days and youll get visibly firmer and more lifted skin, according to clinical trials. You can address your thank you note to the blend of oat kernel extract, orchid extract, and skin-conditioning sodium hyaluronate and the plant-based bio-cellulose material that helps all that goodness absorb into the skin.

Mary Kay TimeWise Repair Volu-Firm Advanced Lifting Serum, $70

The serum was formulated to enhance what the brand dubbed the triangle of youth, meaning full cheeks, a defined jawline, and a taut neck. If the ingredients sound fancy peptides, plant stem cells derived from gotu kola, and alpinia galanga leaf and schisandra extracts thats because they are. They were specifically chosen to support your skins hyaluronic acid, elastin, and collagen levels, which are required for the firm, bouncy skin associated with youth.

Getting all done-up doesnt have to be a big production. By choosing the right high-performing products, you can make a major impact with a just few must-haves. Thats why weve selected these three Mary Kay products as your makeup MVPs they work. Theres a pigment-packed liquid shadow, a high-shine lip gloss, and a volumizing mascara, each clocking in under $20.

Story continues

Mary Kay Unlimited Lip Gloss, $16

With a shine thats out of this world and a formula thats intensely moisturizing (due to patent-pending technology), this brand new non-sticky gloss is a statement lip in the making. Oh, and it comes in 14 shades and three finishes (cream, pearl, and shimmer), so theres one to fit every mood.

Mary Kay Ultimate Mascara, $15

Ultimate, indeed. When you want LASHES in all caps, this is the mascara to reach for. This ultra-thickening, smooth formula manages to give major volume without flaking, smudging, or clumping. Its also ophthalmologist-tested to ensure that its suitable for contact lens wearers and people with sensitive eyes, so everyone can swipe safely.

Mary Kay Liquid Eye Shadow, $14

All four of the light-catching celestial-inspired shades (Pink Starlight, Light Beam, Purple Nova, and Meteor Shower) of this creamy shadow are packed with pigment for a rich pop of color, but they feel weightless on your lids. Even better: The formula is blendable, so you can sweep on with the doe foot applicator and sheer out with your finger when youre going for a more subdued look.

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Your Ultimate Guide to Shopping Some of the Best Mary Kay Products - Yahoo Canada Shine On

Recommendation and review posted by Bethany Smith

Cosmetic Skin Care market research report is generated with a nice blend of industry insight, talent solutions, practical solutions and use of technology to advance user experience. The key research methodology used in this Cosmetic Skin Care market document by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Nowadays, businesses get highly benefited with the different segments covered in the Cosmetic Skin Care market research report which provides better market insights to them with which they can drive the business into right direction.

An influential Cosmetic Skin Care market report analyses key factors of the market that gives precise and accurate data and information which is useful for the business. The scope of this Cosmetic Skin Care market report extends from market scenarios to comparative pricing between major players, cost and profit of the specified Cosmetic Skin Care market regions. The data collected to structure this Cosmetic Skin Care market document is based on the data collection modules with large sample sizes. The market data is analysed and forecasted using well established Cosmetic Skin Care market statistical and coherent models. No stone is left unturned while preparing this Cosmetic Skin Care market research report.

some of the Global Cosmetic Skin Care Market key players Involved in the study are LOral, Unilever, New Avon Company, Este Lauder Companies, Espa, Kao Corporation, Johnson & Johnson Services, Inc., Procter & Gamble, Beiersdorf, THE BODY SHOP INTERNATIONAL LIMITED, Shiseido Co.,Ltd., Coty Inc., Bo International, A One Cosmetics Products, Lancme, Clinique Laboratories, llc., Galderma Laboratories, L.P., AVON Beauty Products India Pvt Ltd, Nutriglow Cosmetics Pvt. Ltd, Shree Cosmetics.

Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026.

Complete study compiled with over 100+ pages, list of tables & figures, profiling 10+ companies. Ask for Sample @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market&SR

Keep yourself up-to-date with latest Cosmetic Skin Care market trends and changing dynamics due to COVID Impact and Economic Slowdown globally. Maintain a competitive edge by sizing up with available business opportunity in Cosmetic Skin Care Market various segments and emerging territory.

**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players**

Why Data Bridge Cosmetic Skin Care Market Research?

Analyst Support:Get you query resolved from our expert analysts before and after purchasing the report.

Assured Quality:We focus on the quality and accuracy of the report

Technically acclaimed Analysts with complete industry know how Robust research methodology followed by our publishers to arrive at market estimates, Focus on technology trends, Extensive repository of market research reports to meet our clients needs.

Customers Satisfaction:Our expert team will assist with all your research needs and customize the report.

Inimitable Expertise:Analysts will provide deep insights about the reports Global major countries (United States, Canada, Germany, France, UK, Italy, Russia, Spain, China, Japan, Korea, India, Australia, New Zealand, Southeast Asia, Middle East, Africa, Mexico, Brazil, C. America, Chile, Peru, Colombia) market size (sales, revenue and growth rate) of Cosmetic Skin Care industry

Global Cosmetic Skin Care Market: Regional Analysis

Asia Pacific: China, Japan, India, and Rest of Asia Pacific

Europe: Germany, the UK, France, and Rest of Europe

North America: The US, Mexico, and Canada

Latin America: Brazil and Rest of Latin America

Middle East & Africa: GCC Countries and Rest of Middle East & Africa

By Product: Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products

By Application: Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others

By Gender: Men, Women

Check Complete Report Details of Cosmetic Skin Care Market @ https://www.databridgemarketresearch.com/toc/?dbmr=global-cosmetic-skin-care-market&SR

Major factors covered in the report:

**Global Cosmetic Skin Care Market summary

**Economic Impact on the Industry

** Cosmetic Skin Care Market Competition in terms of Manufacturers

**Production, Revenue (Value) by geographical segmentation

**Production, Revenue (Value), Price Trend by Type

** Cosmetic Skin Care Market Analysis by Application

**Cost Investigation

**Industrial Chain, Raw material sourcing strategy and Downstream Buyers

**Marketing Strategy comprehension, Distributors and Traders

**Study on Market Research Factors

**Global Cosmetic Skin Care Market Forecast

How Research Study of DBMR helps clients in their decision making:

**Creating strategies for new product development

**Supporting & Adjust Investment/business decisions

**Benchmark and judge own competitiveness

**Aiding in the business planning process

**Serving as a credible, independent check on company internal forecasts

**Supporting acquisition strategies

Below is the TOC of the report:

Executive Summary

Contact:

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About Data Bridge Market Research:An absolute way to forecast what future holds is to comprehend the trend today!Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process. Data bridge is an aftermath of sheer wisdom and experience which was formulated and framed in the year 2015 in Pune. We ponder into the heterogeneous markets in accord with our clients needs and scoop out the best possible solutions and detailed information about the market trends. Data Bridge delve into the markets across Asia, North America, South America, Africa to name few.

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Cosmetic Skin Care Market Increasing Demand, Industry Share with Industry Study Pandemic Impact Product Overview and Scope, Opportunities, Market...

Recommendation and review posted by Bethany Smith

Attention, women genealogists! August is our month. The centennial of womens suffrage is being celebrated this month. One hundred years ago, the 19th Amendment went into effect, giving women the right to vote. National Sisters Day is also this month.

Celebrate the month by recording the health history of female relatives and ancestors. From your details, family members can learn about risk factors that exist in the family, symptoms of those conditions, lifestyle changes that can lower the risks, tests that can identify people at risk, chances of passing the condition to descendants and treatments that will be helpful. The information may save the lives of those you love.

Several online family medical charts are available free of charge. The charts have blanks where conditions can be recorded for each family member. Basic questions are name, date of birth, sex and ethnicity.

In addition, the charts list medical conditions with a space to record the date at which it developed. Some examples are: substance abuse, alcoholism, heart attacks, birth defects, mental illness, stillbirths, infertility, miscarriages, hemophilia, high blood pressure, high cholesterol, diabetes, breast cancer, Parkinsons disease, ovarian cancer, skin cancers and neurofibromatosis.

To learn about medical conditions of deceased family members, check family journals, biographies, old letters, obituaries and death certificates.Interview older family members. Are there vague stories of a family member who went to a sanitarium or insane asylum? Learn where those local institutions were located and where the records are stored.

Be aware that some family members cherish their privacy and will choose not to share health information. Use discretion when sharing medical details, and get permission from family members before doing so.

Many genetic conditions occur as a result of interactions between genetics and the environment. Breast cancer seems to run in my family, but why does it occur among some descendants and not others? In hopes of helping scientists answer that question, several years ago I became part of the sister study sponsored by the National Institute of Health and U.S. Department of Health and Human Services, along with partner organizations, such as American Cancer Society and Susan G. Komen organization. Between 2003 to 2009, the study enrolled over 50,000 women who had at least one sister with breast cancer. The study tracks the health of participants in order to learn how environmental factors influence the development of different types of breast cancer.

Similar large-scale studies are being done with other genetic conditions, such as Parkinsons disease.

Comments or suggestions? Contact Frankie Meyer at frankiemeyer@yahoo.com.

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Frankie Meyer: Celebrate women's suffrage by recording the health history of a female relative or ancestor - Joplin Globe

Recommendation and review posted by Bethany Smith