Archive for the ‘Hormone Clinic’ Category

By Black Health Matters

One daily soda can heighten significantly a persons risk of developing prediabetes, a recent study finds.

A person who drinks one can of sugar-sweetened beverage a day had a 46 percent increased risk of developing prediabetes, said Senior Researcher Nicola McKeown, a scientist with the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston.

Regular sugar intake can batter a persons body on a cellular level, according to McKeown. Cells need insulin, a hormone that breaks down sugar into energy. But too much sugar in the diet can overexpose the cells to insulin.

This constant spike in blood glucose over time leads to the cells not becoming able to properly respond, and thats the beginning of insulin resistance, McKeown said.

Once insulin resistance starts, blood sugar levels rise and damage every major system in the body. Prediabetes, a precursor to Type 2 Diabetes, means a person has elevated blood sugar but has not entered full-blown Type 2 Diabetes. The condition is reversible if a person cuts back on sugar.

The studys results show limiting sugary drinks is a modifiable dietary factor that could have an impact on that progression from prediabetes to diabetes, McKeown said.

For the study, McKeown and her colleagues analyzed 14 years of data on nearly 1,700 middle-aged adults who participated in the Framingham Heart Study, a federally funded program that has monitored multiple generations for lifestyle and clinical characteristics that contribute to heart disease. Participants did not have diabetes or prediabetes at the beginning of the study, and they self-reported consumption of sugar-sweetened beverages.

Those who drank the highest amounts of sugar-sweetened beverages, on average, six 12-ounce servings a week had a 46 percent higher risk of prediabetes.

But the American Beverage Association suggests that sugar in beverages isnt the only risk factor for prediabetes. Credible health organizations such as the Mayo Clinic note that the risk factors for prediabetes include factors such as weight, inactivity, race and family history, the group said in a statement.

Authors of the new study noted prediabetes risk dropped when they included factors such as other dietary sources of sugar and the amount of body fat participants had. But it didnt fall that much, still adding up to about 27 percent.

The study was observational, and as such, it doesnt show a direct cause-and-effect link between sugary drinks and prediabetes. But experts say the association between the two makes sense. Keep in mind that a 20-ounce of bottle of regular soda may contain up to 18 teaspoons of sugar.

Earlier studies have linked diet sodas to an increased risk of type 2 diabetes, but this study didnt find a connection.

Incorporating diet soda while they are weaning themselves off the habit wouldnt have any long-term negative health effects, McKeown said. But eventually the majority of a persons fluids should come from water.

See the article here:
Prediabetes: Rethink That Daily Soda - Afro American

(Left:Elena Mazzotta/EyeEm; Right: Achim Schfer/EyeEm)In Texas, the case of James Younger points to a disturbing trend in the treatment of gender-confused youth

His mother pulling him by one arm, his father pulling him by the other, seven-year-old James Younger, dressed in a skirt, looks distressed and confused. His mom, Anne Georgulas, wins the struggle and rests him on her hip. His dad, Jeffrey Younger, calls 911. Why? asks James. She was supposed to give me custody, his father replies. A video recording of this incident, which occurred on March 8, 2018, at Jamess elementary-school open house, was played before a jury in Texas last month. It is a larger symbol of how children such as James Younger have become pawns in the transgender debate.

The Younger case has gained much media attention, in the U.S. and beyond. The New York Times, the Washington Post, and the BBC all seem to cast the father as the villain, in particular for his refusal to agree that his child is transgender. Rolling Stone opines that the Younger story has become a terrifying right-wing talking point. Vox is worried about Republican state legislators trying to introduce bills prohibiting chemical and surgical interference with the sexual development of children who say theyre transgender, and what [this] could mean for families nationwide when legislators want to have a say in whether Luna Younger should be allowed to socially transition. For the Left, the Younger story is a tale of backwards attitudes victimizing a child.

In truth, its progressive attitudes that are victimizing the child, and James Younger is not an outlier. There are many more just like him, and some in even more dire straits. For years, the medical and legal establishments have been ignoring evidence and bending their standards to please transgender activists, some of whom are clinicians. There are three clinical approaches to helping children who exhibit symptoms of gender confusion. One involves a range of talk therapies and psychotherapies to address suspected underlying causes. A second, called watchful waiting, allows the childs development to unfold as it will, which may mean that he chooses to transition later or not at all.

Then there is a third option informed by an ideology according to which it is possible for a child to be born in the wrong body. In this option, clinical activists recommend a drastic response when a child expresses confusion about gender. First, parents should tell the child, however young, that he truly is the sex he identifies with. Second, parents should consider delaying his puberty through off-label uses of drugs that can have serious (and largely unstudied) side effects. Third, parents should consider giving their child the puberty experience of the opposite sex, through cross-sex hormonal injections and gels (which result in sterility). Finally, parents should consider greenlighting the surgical removal of their childs reproductive organs.

Since there are no objective tests to confirm a transgender diagnosis, all of this is arbitrary and dependent on a childs changeable feelings. To make aggressive treatment more acceptable, its advocates have come up with a media-friendly euphemism, gender affirmation. If its affirming, activists say, its also kindness, love, acceptance, and support. The opposite, trying to help a child feel more comfortable with his body, is a rejection: abuse, hatred, transphobia, or conversion therapy likely to lead to child suicide. This is a lie a lie designed to obscure a critical truth: that neither a child, nor his parents on his behalf, can truly consent to experimental, life-altering, and irreversible treatments for which there is no evidentiary support.

Hours before the incident at Jamess elementary-school open house, Georgulas had emailed her ex-husband, Younger, whose day it was to have custody of James and his fraternal twin, Jude. She had said that she would bring James to school as Luna, since thats what everyone there knew him as. I understand that you believe you are truly doing the best thing for your child, Georgulas wrote. But in the same way a little boy with his penis removed is still a little boy, a little girl who was born with a penis is still a little girl in her brain.

In October 2016, the court had established a Standard Possession Order, in which it was decided that the boys would live with Georgulas but that Younger would have custody and access rights, especially on weekends. The order also gave Georgulas the exclusive right, after notifying Younger, to allow medical and surgical treatment involving invasive procedures as well as psychiatric and psychological treatment and education.

Georgulas claims that James chose the name Luna after communicating a desire to be a girl at a young age by showing a preference for female pronouns and Disney princesses. Younger insists that Jamess transgender status is contrived, and he possesses a video of James at age three saying that Mommy told him he was a girl. He further believes that Georgulas is unhinged and intent on vengeance, disregarding Jamess well-being.

In an email dated August 5, 2017, with the subject line Heads Up, Georgulas wrote to Younger to explain that Luna, yes (I will refer to her that way, because that is what she wants to be called at my house), has decided to tell you she has a girl brain and a boy body and that she is transgender. She explained that they had been reading I Am Jazz as well as My Princess Boy and that in these books, although other people are occasionally mean or confused, the parents are affirming.

During the trial this October, Younger was asking the court to appoint him sole managing conservator, which would give him executive rights to the boys medical and psychological care. Georgulas was asking it to restrict possession and access for Younger and enjoin him from treating James as a boy, but she was not asking to be sole managing conservator. Although the jury decided overwhelmingly against Younger, by eleven to one, having heard the recommendations of custody evaluator Benjamin Albritton, a psychologist, the judge decided not to grant Georgulas a request to be the single conservator.

Judge Kim Cooks decided that the parents would have joint rights on all medical and psychological decisions, increased Youngers possession rights, and denied Georgulass petition to enjoin Younger from treating James as a boy. Cooks relied on the United States Constitution in her decision, specifically on the due-process rights afforded by the 14th Amendment familial association, specifically parental rights or in this case a fathers rights.

She stated that it is a liberty interest for parents to have the autonomy to raise their children and added that the state of Texas had no compelling interest to justify interference. Georgulass lawyers have moved for the recusal of Judge Cooks because she mentioned the case on Facebook.

Georgulass decision to socially transition James, which means treating him as a girl (as opposed to merely allowing him to dress like one), follows a new and experimental form of social-psychological treatment for the mental condition known as gender dysphoria. Looking ahead, Jamess pediatrician indicated that James would have an evaluation at the GENECIS gender clinic when he was closer to the age of eight or nine and would plan to see an Endo[crinologist] in 23 years for hormone suppression. Albritton, the custody evaluator, noted in his report that studies suggest that once an individual is launched on this medical pathway, the gender dysphoria is more likely to persist, especially in natal boys.

The definition of gender dysphoria has long been in flux. Beginning in the latter half of the 20th century, adults (normally men) who experienced a strong desire to be the opposite sex or took measures to more closely resemble the opposite sex were known as transsexuals. Male-to-female transsexualism, especially as it related to sexuality and fetishes, was initially seen as a perversion, then a disorder. Now its an identity, covered under a much larger umbrella term, transgenderism. Transsexual inclination in children, defined in the American Psychiatric Associations Diagnostic and Statistical Manual of Mental Disorders as gender identity disorder (1994) and now as gender dysphoria (2013), was rare and poorly understood, generally manifesting itself in the form of disassociation from ones sex (in pre-pubertal children) and discomfort with ones sexual development (at puberty, especially among peers).

Other than one Dutch study looking at pubertal suppression in adolescents that suggests puberty blocker hormones might contribute to the persistence of gender dysphoria, there are no studies or long-term follow-ups in which social transition prior to puberty has been clinically examined. But we do have a significant body of eleven papers that examine desistance (that is, childrens growing out of such feelings) in children whose dysphoria began when they were between three and twelve years of age, and these children were followed up with at a later date.

Despite the differences in country, culture, decade, and follow-up length and method, notes James Cantor, a Canadian psychologist with decades of clinical and research experience in treating transsexuals, all the studies have come to a remarkably similar conclusion: Only very few trans-kids still want to transition by the time they are adults. From these studies, conducted prior to the cultural mainstreaming of gender-identity theory, it consistently appears that 80 percent of gender-confused children psychologically realign with their biological sex by young adulthood or sooner when supported through their natural puberty with non-invasive therapies such as watchful waiting. Realignment was (and, among more cautious professionals, still is) considered the ideal outcome, since it is obviously easier for a child to change his thinking than to try to change his sex.

In the 1990s, the Dutch began to experiment with puberty blockers which had originally been used to treat precocious (early) puberty for very extreme cases of childhood gender-identity disorders. The idea was that an acutely gender-distressed child would benefit from gaining extra time to come to terms with his body before puberty brought additional distress. The researchers called this the pause button. But as the first step in the gender affirmation process, it amounts to more of a nuclear button. On the gender-affirmation model, clinicians have put children as young as twelve on sterilizing cross-sex hormones, removed the healthy breasts of girls as young as 13, and peeled and inverted the penises of boys as young as 15. Is it too much to wonder why?

Humans are a sexually dimorphic species. Females produce eggs and bear offspring, while males produce sperm and impregnate females. The existence of disorders of sexual development (or, more imprecisely and potentially offensively, of intersex persons), and the need for greater social understanding of them, in no way collapses this distinction.

In the 1950s, the relationship between the terms sex and gender (the latter of which applied chiefly to grammar) began to change as sexologists coined the phrase gender identity to denote the sex that one believed one was. In the 1960s, to explore this concept, psychologist John Money conducted a twin study in which a male baby, Bruce Reimer, with a damaged penis was raised as a girl, while his brother, Brian, was raised as a boy. Money instructed the parents to raise their children to believe that Bruce was really a girl called Brenda. For over a decade, the experiment was lauded as a milestone in sexology to preserve the boys anonymity, it was called the Joan/John study and its reported success was used as a precedent for countless surgeries on children with disorders of sex development. But, decades later, a follow-up revealed that the Reimer brothers had been deeply unhappy with their treatment by Money and Bruce had reverted to his male identity in his teens, taking the name David. After going public, David and his mother (whom he forgave, believing her to have been loving but misled) appeared on Oprah Winfreys talk show in 2000:

Mrs. Reimer: During the whole journey of trying to create a feminine being, there were doubts along the way. But I couldnt afford to contemplate them because I couldnt afford to be wrong. I couldnt have faced the alternative.

Winfrey: And the alternative being what? That youd made this horrible mistake?

Mrs. Reimer: Yes.

Winfrey: Cause then what could you do?

Mrs. Reimer: Right.

After a lifetime suffering from depression, the brothers first Brian, then David killed themselves. In a tragic update, printed in a revised edition of As Nature Made Him, an investigative book on the Reimer story, John Colapinto recalls the moment when Davids father called him to say that David had shot himself: I cannot say it was a complete surprise. As more journalists shared the true nature of Moneys experiment, and as more and more intersex victims of unnecessary medical interventions came forward, the medical profession revised its standards with regard to children with disorders of sex development (in particular those with genital irregularities) so as to leave these childrens fully functioning bodies alone. But what about gender-confused children?

Today, it takes a bold and distinguished person to state the obvious answer to that question. One such person is Dr. C. Alan Hopewell, the senior clinical neuropsychologist in the state of Texas, whose decades of expertise in treating children of Jamess age led Younger to engage him as an expert witness.

At Jamess age, children cant make rational decisions and are very easily influenced, Hopewell stated in his September deposition for the trial. He also said that this settled science, pioneered by psychologist Jean Piaget, is at the level of Galileos statement of how the Earth revolves around the sun. While a child can express preferences Do I want the M&M or do I want the mushroom? a seven-year-old is incapable of decisions of the magnitude of trying to change your sex, which, at any rate, you cant do.

Georgulas testified that she felt justified in socially transitioning James into Luna by her own experience as a pediatrician, by researching the medical literature on the subject, and by the support she has received online from similarly situated parents.

In July, her lawyer, Kim Meaders, made the following opening remarks at a hearing in a Texas district court:

This case is about a little six-year-old girl. Its a little girl who knows she is a girl. Its a girl who wears cute, frilly, girlie clothes. She plays with super girlie bears and dolls and toys. . . . [Her] self-portraits of herself show herself with big, huge, ginormous eyelashes and hair down to the floor. . . . And the father in this case wants boys. He has twins, and the reality is, Luna, at birth, was given the gender identity as a boy, but she completely and totally identifies as a girl now.

But again, by all objective standards, and as acknowledged by the impartial court-appointed amicus attorney, it is clear that James Younger is not a girl but a boy. He is a little boy regardless of whether he knows he is a boy. A little boy with a penis which is referred to by Georgulas herself in one email to Younger: Luna has gotten a bug bite on the right side of her penis testes, a Y chromosome. He is a little boy regardless of how ginormous the eyelashes are in his self-portrait and irrespective of his wardrobe choices, however cute and frilly. Of course, the possibility exists that James is a little boy who fits the diagnostic criteria for gender dysphoria (more about that in a moment).

On October 17, observers in the courtroom reported seeing someone sitting by Georgulass attorneys, passing notes and advising counsel. She was Dr. Johanna Olson-Kennedy, the medical director of the largest transgender-youth clinic in the United States, one of four directors of a multi-million-dollar National Institutes of Health (i.e., taxpayer-funded) experimental study on early intervention in transgender youth, and one of the most prominent clinical activists in the United States.

It is difficult to say, exactly, how many transgender-youth clinics there are in the United States today. In 2006, there were none. But in 2014 the Human Rights Campaign, a gay and transgender lobby group, counted more than 40. It is possible, if not likely, that there are significantly more than that. Olson-Kennedys clinic in Los Angeles saw 80 young people, aged between four and 24, in 2009, and over 1,000 in 2019. The latter number comes from a Reuters report. By a crude estimate, then, there could be tens of thousands of young people being treated at such clinics. But we dont know.

The Centers for Disease Control says that 2 percent of American high-school students (around 300,000 adolescents) identify as transgender. Does that mean gender dysphoria is on the rise? Not necessarily. One board-certified psychiatrist, a graduate of a top medical school with over 15 years experience treating adolescents, told me that the numbers seem highly inflated. This is partly because gender clinics, like many specialist clinics, are essentially businesses with an interest in selling a uniform diagnosis. In his own practice, he prefers to talk big-picture first and not take a childs declared gender identity at face value.

If a patient comes in and tells me, Im having a strong desire to be the opposite sex, my next question is why? What does that mean? Whats your understanding of being the opposite sex? Are you nervous about being your own sex? Do you have anxiety? He also considers whether his patient might be on the autism spectrum, which is disproportionately common among those with gender dysphoria. Often, through talk therapy, something else comes out for example, that a girl is petrified about her menstrual cycle, or a boy about having homosexual inclinations and being bullied by his peers. The psychiatrist says that social anxiety is an underlying factor in most of these cases.

In his deposition in the James Younger case, Dr. Hopewell stated that youre not going to cut off [healthy] body parts unless somethings wrong with your thinking. But Dr. Olson-Kennedy again, the head of the largest transgender-youth clinic in the United States and one of the leaders of a publicly funded NIH study took a rather different view in her own deposition. Youngers lawyer, Logan Odeneal, asked Olson-Kennedy whether it is safe or ethical to remove healthy breast tissue from adolescent girls as young as 13, as has been recommended at her clinic.

Odeneal: Well, if you remove the breasts from a young woman, she will never be able to lactate or to breastfeed an infant; is that correct?

Olson-Kennedy: Well, I, I dont advocate removal for breast tissue from young women. I advocate for chest reconstruction in young men.

Odeneal: Well havent you referred girls to have the chest surgery from your clinic?

Olson-Kennedy: Theyre, theyre, theyre not girls. Theyre not girls. They dont identify as girls. So I have referred people who identify as transmasculine or as boys or young men for surgery, yes.

Odeneal: But do their birth certificates identify them as girls?

Olson-Kennedy: Sometimes, and sometimes theyve had their gender marker changed on their birth certificate.

Odeneal: How many patients have you referred for the chest surgery?

Olson-Kennedy: Probably about 200.

When Odeneal asked whether the procedure involved the removal of healthy breast tissue, Olson-Kennedy explained that she takes issue with the word healthy since its not healthy if its creating a lot of distress in their life. Elsewhere, she told an audience, If you want breasts at a later point in your life you can go and get them.

The National Institutes of Health study on early intervention in transgender youth that Olson-Kennedy oversees along with three others involves multiple sites and hundreds of participants. In a talk at an activist-clinician conference in September of this year, she explained that the study was observational and didnt have a control group (a group of participants receiving the standard, accepted treatment for the purposes of comparison). When we first put this grant into the NIH five years ago, they came back with primary concern that we didnt have an untreated control group. Yeah, so were not going to have an untreated control group, Im warning you right now, she said, prompting audience laughter.

Presumably, Olson-Kennedys reasoning for not having a control group is that it is unethical for a physician to treat (or not treat) a patient in a way he considers not to be in the patients best interests. Olson-Kennedy told Youngers lawyer, Odeneal, that the reason this study does not have a control group is because not treating people with gender dysphoria who are seeking treatment is unethical practice. Does this mean she considers treatments other than gender affirmation not treating patients? If so, to repeat, the evidence for gender affirmation is unclear and unconvincing, while the majority of children who have been managed under a watchful-waiting or talk-therapy strategy have apparently improved. The latter is the clinical standard for which there is the most substantial, albeit imperfect, evidence of effectiveness and safety. I have to speculate here because, although Olson-Kennedy agreed to an interview last summer, she twice failed to dial in at the appointed time to the conference number her office had emailed me. Her office has since gone dark.

Ordinarily, when investigating complicated and life-altering treatments emerging in medicine (and especially pediatrics), investigators must follow a series of steps: First, the researchers must demonstrate to their institutions Institutional Review Board that their treatment is credible and ethical. Second, the patients and parents of children must sign an informed-consent paper, with emphasis on the word informed, especially if the treatment is experimental. Third, the group of patients receiving the treatment must be paired with a control group that is treated in more standard fashion.

But why is the NIH facilitating this study on early intervention among trans youth in the first place? What do they hope to learn? What kind of information about risks has been given to parents and children? These are some of the questions to which I might have found answers if the relevant documents, which a concerned medical doctor obtained through the Freedom of Information Act, had not been so heavily redacted, most notably in the sections related to informed consent. Does the NIH, or do those in charge of this study, have something to hide? In a recent listening session held by the NIHs Sexual and Gender Minority Research Office, one activist inquired into whether it might be possible for the NIH to extend the study for another five years so that we can get even more longitudinal data, which would be helpful to show courts that the affirming parent is actually acting in the best interest of the child, since there has been a recent uptick in custody disputes involving transgender youth.

A study published in 2017 in the Journal of Sexual Medicine entitled Age Is Just a Number endeavored to investigate WPATH-affiliated surgeons views, experiences, and attitudes toward performing vaginoplasty, i.e., castration, inversion of the penis, and dilation of a cavity to form a pseudo-vaginal canal, on transgender minors in the United States. (WPATH is the World Professional Association for Transgender Health.) Of 20 surgeons who were interviewed, eleven reported having done the procedure 1 to 20 times on children under age 18. The youngest patient was 15.

One surgeon gave an indication as to why this might be a bad idea. He or she described the new clinical landscape as a new Wild West where a bunch of solo practitioners, basically cowboys or cowgirls who kind of build their little house, advertise and suck people in. In the U.K., the Times of London has covered a whistleblower scandal at Britains main clinic for gender-confused youth, from which multiple clinicians have resigned, citing dangerous, experimental, and inadequate care.

The authors of the Journal of Sexual Medicine study also remarked on the legal impossibility to obtain informed consent from the underage patient. But that isnt the only problem with relying on the feelings of minors.

Many of these underage patients are already damaged and vulnerable. At the Gender Infinity Conference (an Affirming Space to Empower Gender Diverse Individuals) in 2015 in Texas, Olson-Kennedy told an audience that a not-insignificant number of young people at her clinic have actually done sex economy, sex work, for a place to live or something to eat, and that a lot experience homelessness, precarious housing, and have been in foster care. This is consistent with her published research. A study from 2015 included transgender youths who had prostituted themselves, been homeless, and abused drugs; a follow-up study in 2018 failed to account for 41 percent of the participants, meaning that no one knows what has happened to them.

Perhaps having worked with prostitutes and homeless and drug-using youth has made Olson-Kennedy sensitive to the importance of mental-health screening for patients before they undertake life-altering hormone interventions or surgery. But on Facebook, she once wrote that the uptick in insurance companies asking for mental health NOTES and signed consents prior to covering blockers [is] ridiculous!! Still, she is considered a leader in the field. Her method is now finding popularity in the U.K. She was recently brought there on a teaching fellowship by the University of Bristol and invited by the British gender-youth charity Mermaids, which promotes child sex-change treatments, to partake in a Facebook livestream event titled If Your Child Thinks Theyre Transgender, They Probably Are. This event also featured Helen Webberley, a British doctor who, the Times of London reported, was criminally convicted for operating an unlicensed clinic that charged between 75 and 150 an hour to prescribe . . . sex-change hormones, which cause irreversible bodily changes and permanent loss of sexual function. Her husband, Mike Webberley, also a doctor, was similarly suspended and banned from practicing medicine in the U.K. after a tribunal found that his work for three young trans patients fell below the standards of care expected of a registered doctor. The Webberleys have now moved to Spain, where their private clinic will continue to dispense drugs online from its new base in Malaga, the Times of London reports.

In response to the James Younger case, the Pediatric Endocrine Society, which has a membership of 1,300 doctors, distributed a statement against public discourse that risks the well-being of transgender and gender diverse youth and their families. It wrote that this concerns a 7-year-old transgender girl in Texas whose mother (a pediatrician) is supportive of her gender identity but whose father is not. The statement continued:

The parents are involved in a custody battle that has drawn significant media attention. The father has reached out to conservative groups and lawmakers who are spreading misinformation about care of gender variant youth and are threatening to introduce legislation prohibiting the use of puberty blockers in transgender patients.

This is simply ill-disguised advocacy, but it is nonetheless of a piece with a recent policy statement on transgender and gender diverse children and adolescents from the American Academy of Pediatrics. Fewer than 30 committee members at the AAP, which represents 67,000 doctors, approved the statement, written by a doctor with (according to the PubMed database) no published papers in gender dysphoria. It favors affirming any childs self-expressed identity, disparages watchful waiting, and suggests that therapies designed to reconcile a child with his or her body are outside the mainstream of traditional medical practice.

In a rebuttal that has completed peer review and will appear in the Journal of Sex and Marital Therapy, James Cantor, the Canadian clinical psychologist, who describes himself as openly gay and politically liberal (not that it ought to be relevant), explains:

Although almost all clinics and professional associations in the world use whats called the watchful waiting approach to helping gender diverse (GD) children, the AAP statement instead rejected that consensus, endorsing gender affirmation as the only acceptable approach. Remarkably, not only did the AAP statement fail to include any of the actual outcomes literature on such cases, but it also misrepresented the contents of its citations, which repeatedly said the very opposite of what AAP attributed to them.

Cantor told me that the AAP policy statement could be interpreted as malpractice writ large and that it calls into question their entire decision-making process. Kenneth Zucker, a clinical psychologist and expert in youth gender dysphoria whose work is among the most cited in the field and who has over 40 years of clinical and research experience, told me that the AAPs advice is so fundamentally flawed that one wouldnt even know . . . where to start.

How can this be possible? What or who is influencing these professional committees that advise and represent hundreds of thousands of doctors in the United States? During the James Younger trial, this question was answered during the deposition of Dr. Hopewell by Georgulass lawyer. The lawyer, Kim Meaders, asks whether Hopewell is familiar with the American Academy of Pediatrics stance on supporting and treating transgender individuals and that of the American Psychological Association, which also favors gender affirmation. He says that he is familiar but disagrees.

Meaders then asks how he can possibly disagree if he is a fellow of the American Psychological Association. Hopewell explains that, while most of the real doctors are out earning a living working, many of those who run the boards do so for political reasons: Just because an organization takes a stand really doesnt have anything to do with either science or the membership of the body itself.

Besides subjecting individual children to an ordeal, the gender-affirmation approach may be contributing to a social pathology. Lisa Littman, an assistant professor at Brown University, wrote a 2018 paper in the science journal PLOS ONE that reported the new phenomenon of teen girls suddenly identifying as boys despite having no prior history of gender dysphoria as a possible peer and social contagion.

The pertinence of Littmans observation is shown in the number of children reporting gender dysphoria to Britains largest gender youth clinic, a public institution. It is now around 2,500 a year. In 2009, it was fewer than 100 a year. There has been a 42-fold increase in the number of females at the clinic in the last decade.

A mother is now taking legal action against the clinic in an attempt to prevent it from giving puberty-blocking drugs to her 15-year-old autistic daughter. Her claim is that the clinic misinforms families and puts highly vulnerable children at risk. A former therapist at the clinic, who resigned for ethical reasons, has become a whistleblower, saying that staff in the clinic were under huge pressure to rush children into medical treatment after substandard evaluation, according to the Times of London.

Sky News reported that hundreds of young transgender people are seeking help to return to their original sex. The report focused on a woman, Charlie Evans, 28, who was born female but identified as a man for nearly ten years before returning to her original identity, a process that is called detransitioning. Similar stories of regret are receiving significant media attention in the U.K. Marcus Evans, the former governor of the British National Health Services London-based adolescent and adult clinical services, which oversees the largest gender youth clinic in the country, warned that the treatment of gender-dysphoric youth has become highly politicised and, in many ways, operates outside good medical practice. Evans handed in his resignation after 35 years, citing the gender clinics woeful care and saying it was not fit for purpose.

As with the clinicians who resigned from the London clinic, Lisa Littman, who was first to research the social contagion in teen girls, recently told me of her serious concerns about whether those being diagnosed with gender dysphoria actually have an underlying issue such as trauma, sexual assault, homophobia, homophobic bullying, misogyny, or a mental-health condition.

But both inside and outside the profession, clinical activists are ruthless in pursuit of their aims, and they accept no criticism. At the website of Psychology Today, a Harvard psychiatrist and medical researcher, Jack Turban, recently published a summary of some research that he said showed a link between conversion therapy by which he means therapies geared at helping a person psychologically accept his biological sex and suicide. Medical professionals posted their critiques of his work, suggesting the studies were fundamentally and dangerously flawed in their methodology and conclusions, but Psychology Today appears to have deleted their comments.

Sharon Dunski-Vermont, a pediatrician and member of the clinical advocacy group USPATH (U.S. Professional Association for Transgender Health) and the American Academy of Pediatrics who has written an op-ed for the Washington Post about her female-to-male transgender teenager, has posted misinformation elsewhere. In a Facebook group with over 8,000 members for parents transitioning their children, one parent expressed concerns about a report that an eight-year-old had been included in the NIH studys cross-sex-hormone cohort. NONE of this is true, Dunski-Vermont stated. We start Puberty blockers in early puberty, which at times could be 8-9 years old but NEVER cross gender hormones.

A group administrator then disabled further comments, offering the explanation that this story falls into the realm of flat-earthers and holocaust-deniers and is triggering to many. However, a 2017 progress report for the NIH study, which a doctor obtained through a freedom-of-information request, did state that the minimum age for the cross-sex hormone cohort inclusion criteria was decreased from 13 to 8 to ensure that a potential participant . . . could be eligible for cross-sex hormones. In such a new and exploratory field of medicine, certainty and censorship are a dangerous combination.

To give an idea of the vulnerability of the children in this Facebook group, consider that one parent posted a picture of a teen girl with Down syndrome who appears to have had her breasts removed. The parent asks to connect with the parents of other Down, trans children. Another picture shows a boy, seeming no older than six years old and wearing a dress, with his arm in a cast. His mother explains that her ex-husband (who was ambivalent about the childs gender transition) broke her arm. Another mother describes in detail how her ex-partner sexually abused her twelve-year-old daughter, who now thinks she is a transgender boy. The mother writes, My question is (and I dont know if this is allowed), has anyone else been through this? I feel like his dysphoria may have been amplified by the sexual abuse.

James Younger was first diagnosed as having gender dysphoria by his pediatrician. The diagnosis was confirmed by a solution-focused therapist serving the LGBT community at Rainbow Counseling, in Texas, and by the GENECIS gender clinic, which specializes in medical interventions for gender-confused youth. In his psychological assessment of Jeffrey Younger, Albritton, the custody evaluator, noted that James showed no signs of distress when dressed as a boy or as a girl.

Distress is one of the diagnostic criteria for gender dysphoria. Yet in his assessment of James, Albritton noted that while James is consistently described and observed as playful, kind and creative, he is clearly at risk for social and psychological difficulties and challenges given his gender dysphoria. In an interview, James told Albritton that he is a boy at his fathers house and a girl at his mothers house. His mother brought him to interviews with Albritton dressed in high heels and stick-on earrings. His father brought him dressed in boys clothes and appropriately groomed.

Strikingly, however, Albrittons takeaway was that it is difficult, if not impossible, to entirely ferret out pressure from his father to conform with male ideals. He noted that Jeffrey Youngers profile fits that of someone experiencing a disconnection from reality, as well as psychotic symptoms of paranoia. He reported that Anne Georgulas presented as a friendly, outgoing woman who appears to be aware of her childrens needs and attempts to advance appropriate development. Albritton recommended that James be allowed to continue socially transitioning.

Though the jury was swayed by such arguments, Judge Cooks ultimately decided that both parents were fit to parent and they should work out Jamess medical care between them. But the deeper issue is that its impossible to sensibly adjudicate such cases when misinformation is being enshrined systematically in the medical and legal establishments and the mainstream media are failing so dismally to report on it accurately.

I am currently in contact with parents across America and Europe who face circumstances similar to Jeffrey Youngers and whose extensive documentation I have reviewed. One father in Minnesota has been denied a say in his ten-year-old autistic sons medical care. This boys mother is taking him to a gender therapist who has told the boy that he is not only a transgender female but a lesbian.

The Kelsey Coalition, a new nonpartisan grassroots organization, has collected testimony from parents of children identifying as transgender who have been harmed. Some of these parents are in custody battles in closed-door trials, such as two gay parents who are having a fight over a child the same age as James Younger and in which the contested claims are almost identical. Others have had their children placed in foster care because they refused to consent to medicalizing their childs treatment. Many parents are afraid to talk to the media for fear of being reported to child-protective services or held in contempt of court gag orders.

And so it goes. In a better world, James Younger wouldnt be the object of a tug-of-war between two parents. But it is beyond cynicism to accept that the legal and medical establishments may forcibly try to change a childs sex, against his interests, without the consent of both his parents, and in spite of the scientific evidence.

Editors Note: This article has been updated since its publication in print.

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The Tragedy of the 'Trans' Child - National Review

Dont ride the highs too high and the lows too low I cant express enough how important this is. There can be very high highs and very low lows in business, especially in the startup phase. Let me give an example. Danielle and I recently had a call with a major celebritys buyer & assistant. It was a call revolving around a significant opportunity that could take our company to the next level. It was incredibly exciting, and all the energy was flowing! The next day we had a call with our (past) shipping company. During our transition to a new one that would take a few weeks, they had completely stopped shipping out our orders with no notice. This fulfillment situation caused immediate panic as we wondered how we would fulfill our customers orders in a timely manner and not lose their trust in the brand. Its important to stay realistically optimistic but not let highs hit too high and the lows hit too low or else it could crush your confidence as a leader and entrepreneur.

For my series on strong female leaders, I had the pleasure of interviewing Danielle Gronich and Kayleigh Clark of CLEARstem. Danielle Gronich, known as the acne guru, is a skin care expert, author and pioneer of the successful treatment of acne. Her clinic, San Diego Acne Clinic takes a holistic approach with a 98% success rate for getting people clear, and keeping them clear. Together with Kayleigh Clark, she is the co-founder of CLEARstem Skincare, a groundbreaking anti-aging, hormone balancing, scar revising and anti-acne skin care line. Gronich established the San Diego Acne Clinic after battling her own cystic acne for some 10 years. None of the typical methods antibiotics, lasers, hormonal modifiers, prescription creams, peels and even two rounds of Accutane worked for her, and the many physicians and dermatologists she consulted could not seem to crack the code. She left the corporate world, dove into clinical research, and went back to school to find the answers for herself, earning her license as a clinical esthetician and acne specialist. She learned that acne has multiple triggers that operate in tandem, and that thoroughly evaluating each case in a holistic way both internal and external is the only way to help truly manage skin. Today, her clinic has thousands of success stories to tell including celebrity clients. Gronich is a regular contributor for numerous health and wellness publications. Kayleigh Clark,the co-founder of CLEARstem Skincare, holistic nutritionist, and wellness expert with a keen understanding of the ingredients we put in our bodies for better or worse. She developed severe cystic acne in her mid-twenties and tried in vain to find a cure until she discovered the San Diego Acne Clinic, where she met Gronich. Not only did her acne clear up, but through their sessions, the duo discovered their mutual passion for helping other acne sufferers achieve clear skin without sacrificing their health. Thats when CLEARstem Skincare was born. Guided by a passion to make a positive impact, she studies the latest research and is a regular contributor for numerous health, wellness, and lifestyle media outlets. Clark is also a published author and the co-host of the Balancing Your Hustle podcast on iTunes and GooglePlay, which focuses on balancing career, passions, and wellness.

Thank you so much for doing this with us! Can you tell us a story about what brought you to this specific career path?

Covered in bright red, inflamed, painful cystic acne, I was a year out from my wedding feeling completely overwhelmed and at a loss with how to fix my skin.

I was overly stressed and spending thousands of dollars on skincare products, going to estheticians, and doctors I hoped and prayed would fix my skin. The worst part, I was a holistic nutritionist! Shouldnt I know how to fix my own skin?!

Thats when I met Danielle (my now co-founder in CLEARstem). Danielle owns San Diego Acne Clinic and is well known for having a 98% success rate for getting people clear among thousands of clients (including some celebrities!).

We immediately bonded over our love for whole body wellness and skincare. With Danielle, I learned all about the internal and external triggers for acne. This included supplements, secret pore clogging ingredients, foods, and a ton of other triggers that I had no idea about!

After achieving the clear skin I had been struggling with for years and learning so much in the process, Danielle and I decided to develop our own line for others who were dealing with the same issues and searching for real solutions.

Danielle had a connection with a world renowned chemist that took our idea on! We set out to create the very first anti-aging and anti-acne line with zero toxins. We wanted to help others get clear skin, especially because (despite what many think) people are not just dealing with acne as teens, but continue to struggle with it in their 20s, 30s, 40s, 50s, and even 60s!

Our founding belief: That people shouldnt have to choose between anti-aging products that clog your pores or acne products that age your skin. Why not have both??

Can you share the most interesting story that happened to you since you began leading your company?

In the beginning, before we had a packaging and fulfillment center, we had to fill, seal, package, and ship every bottle by hand. In the first year of business our largest amount of sales was on Amazon, and since we were doing Amazon FBA to get Prime status, that meant we had to fill, seal, package, and ship hundreds of bottles at a time to Amazon to keep up inventory.

On one occasion, we were cutting it really close to selling out on Amazon (which is a huge no-no). Our bottles were arriving just in time to hand-fill and get them shipped off (when I say just in time, I mean we had literally hours to fill and ship them back out).

The bottles arrived, I open up the boxes, and instead of our white and blue packaging, they were BRIGHT PINK! Panic set it. Amidst a minor panic moment- there was a silver lining. I ended up sharing this entire experience on social media and it was a HIT! Everyone loved the pink bottles and begged us to sell them.

We were able to fill all the bottles and get them off to Amazon in time, made a quick new image with the pink bottles that we switched out on Amazon. Crisis averted!

Moral of the story: Not everything will go to plan. You need to ready for bumps in the road, flexible and solutions oriented. Sometimes what seems like a problem can actually turn into an opportunity.

Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?

There is nothing more humbling than filling 2,500+ bottles of your own product by hand! When we first started with a packaging and fulfillment center for our line, we were rookies. Neither Danielle nor I come from a product development or cosmetics background. So literally everything was new to us! When having our bottles filled, we did not know there was a choice between a cosmetic fill and a regular fill. Our facewashes automatically were filled regular. Which meant in a 6oz bottle (which we later found out holds 7.5oz of product), was filled with 6oz of product. Makes sense right? Wrong.

We had the majority of product shipped to our warehouse with a few bottles sent personally to us. When we opened up the box, our bottles looked half empty! Even though the 6oz bottles were filled with 6oz of product, the bottles didnt look filled all the way. We knew our customers would NOT be pleased.

What did Danielle and I do? We had thousands of bottled pulled from inventory, shipped to us, and we personally topped off and resealed every single bottle.

Lesson learned: There is a regular fill and a cosmetic fill in the beauty world! When working with a new packaging & fulfillment center, its always a good idea to have a person with expertise look over your order before its placed to ensure you are not making any rookie mistakes. Also, there is no such thing as too many questions, especially when starting out!

What do you think makes your company stand out? Can you share a story?

It is engrained in our companys DNA to provide education first and products second. We are here to make a difference and create positive change in peoples skin.

Danielle and I both are genetically prone to acne which means even though we manage our breakouts through nutrition, skincare, and wellness practices, we are still easily triggered to breakout. This is why we have devoted our lives to not only healing our own skin, but taking the knowledge we have gained and sharing it with everyone who needs it. We are our customer, we understand the major hits to self-esteem and confidence that acne causes, we get the bring-you-to-tears frustration that happens when you try everything possible, and we recognize the dedication it takes for a lot of people to create positive change in their skin.

Even though we sometimes wish we were not so acne prone, it brings us that much closer to our customer and allows us to support them in ways we may not have been able to if we didnt understand their skin battles.

Are you working on any exciting new projects now? How do you think that will help people?

We are! We cant share too much, but we are teaming up with an incredible Nutritional Therapy Practitioner and creating a clear skin course! Our goal is to help more people clear their skin, and skincare is just 1 aspect of achieving amazing skin. Since we sadly cant have everyone come visit San Diego Acne Clinic to clear their skin, we want to bring all the educational benefits of the clinic to them! Our course will take you step-by-step through everything that affects your skin: nutrition, hormones, supplements, pore clogging ingredients, stress, and give you action steps within each module to make positive changes. We are so excited for this course to launch and know it will be a game-changer for many individuals looking to positively change their skin from the inside out.

What advice would you give to other female leaders to help their team to thrive?

Culturally as women we have been told to take care of everyone else around us first, then ourselves. Things have changed. I am a huge believer in always putting your oxygen mask on first. You cannot be of service or positively lead anyone if you yourself are burning out. There will always be endless to-do lists, those will never go away, so make sure you set aside time for yourself every single day. Even if you can only commit 1to 0 minutes some days, do it. The more you can manage your own stress, the more you can show up as your best self, and lead others to help them and their team thrive.

What advice would you give to other female leaders about the best way to manage a large team?

We are always evolving and learning. Its so important to realize that we are powerful, but we dont know everything. When managing a team, make sure that everyone voices are heard and valued. There is always something to learn, and other perspectives can be so valuable. I also highly suggest learning each team members enneagram, it is so helpful to know how people best receive information and how you can communicate best so both parties are heard and understood. Communication can be a make or break when managing teams!

None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story about that?

Danielle and I both value other leaders in the wellness and business community taking time to answer our questions and provide mentorship. It is how we have been able to learn so much and continue to grow. There have been three people that really stand out who I have been incredibly grateful for throughout our journey. It would be an injustice to leave any of these women out.

Christina Rice

Christina has been a CLEARstem supporter since day 1. Literally from the beginning of even forming the company, she was there encouraging, asking questions, and a huge supporter of both Danielle and I. Christina is extremely respected and an authority figure in the wellness space, she has used her platforms on social media and her podcast to educate about CLEARstem. We have had so many men and women transform their skin and when we ask where they heard about us, many times its from Christina. She has been a pivotal part of reaching and educating more people to positively change lives!

Glenn Rich

Glenn headed up all of marketing for Liquid IV and is now more on the brand strategy side.

She has been with Liquid IV from the very beginning so she has been a part of the process of going from startup to a multimillion dollar company. She had been an invaluable contact who evolved into a close friend over the years. Anytime we have questions about new marketing channels, ideas, or contact connects Glenn is always willing to hop on a call or make an introduction. We are forever grateful for her knowledge, guidance and support.

Kacia Fitzgerald

When you are feeling low in need of a You got this, you are changing the world and impacting so many people text. Kacia is there before you even know you need it yourself. I truly have never met anyone in my entire life that shows up so authentically herself, brings a high level of energy and gives 100% of herself to the people she supports. Kacia has an innate ability to see things from such unique perspectives and can completely transform any situation into a powerful learning lesson. She has been such an impactful part of our journey over the last year.

How have you used your success to bring goodness to the world?

Success is not achieved alone, and we are full believers in giving back what we have received. Since we are entrenched in the startup and wellness space, we have used our success to support other startups and individuals in our space. This can be through collaborations, mentorship sessions, or simply giving 5 minute favors which is making a quick connection that helps someone else grow.

Support is incredibly important to us because when you feel supported you are less stressed, not operating out of fear, and motivation increases.

What are your 5 Leadership Lessons I Learned From My Experience and why. (Please share a story or example for each.)

1. You dont know everything Having an open mind to other perspectives and being self-aware that you do not know everything is one of the single most important pieces of advice I have ever received. This has come into play many times, especially in Danielles and my business partnership. One of the reasons Danielle and I work so well together is because we know and understand each others strength and weaknesses, and we always take both of those into consideration when making decisions. For example, when we first started to focus heavily on social media, we didnt see exactly eye to eye. Instead of battling back and forth who was right vs who wasnt, we discussed reasons why we each felt certain ways, and understood we both had unique points of view on this topic. Each of us surrendered to understanding we didnt know everything when it came to social media and looked for guidance in others when building our platforms.

2. Learn to pivot Remember my story above about the pink bottles? I can tell you right now there are tons of times just like that one where we had to pivot. We were hit with something unexpected and instead of dwelling on something we couldnt control we quickly changed and took back control of the situation. In the pink bottle story, we pivoted by marketing and selling the bottles that our customers ended up loving. We were also able to partner with Holy Matcha Caf in San Diego to sell our pink bottles in their retail location and it was a huge hit!

3. Dont ride the highs too high and the lows too low I cant express enough how important this is. There can be very high highs and very low lows in business, especially in the startup phase. Let me give an example. Danielle and I recently had a call with a major celebritys buyer & assistant. It was a call revolving around a signficiant opportunity that could take our company to the next level. It was incredibly exciting, and all the energy was flowing! The next day we had a call with our (past) shipping company. During our transition to a new one that would take a few weeks, they had completely stopped shipping out our orders with no notice. This fulfillment situation caused immediate panic as we wondered how we would fulfill our customers orders in a timely manner and not lose their trust in the brand. Its important to stay realistically optimistic but not let highs hit too high and the lows hit too low or else it could crush your confidence as a leader and entrepreneur.

4. Focus on your strengths, delegate your weaknesses I recently was having a conversation with my friend Brandin Cohen (CEO of Liquid IV). He said tell me your pain points. I told him how we were struggling to really crush it and figure out Facebook/Instagram advertising. Then Brandin gave me some of the best advice. He said, Kayleigh, you could lock yourself in a room for a weak, learn everything there is to know about Facebook/Instagram advertising, and at the end of the day you would be a media manager. Is that what you want your roll to be? I said no. He responded by saying I know what I am good at, and I know what my weaknesses are, I choose to delegate my weaknesses so they are accomplished as strengths, and it leaves me time to focus on what I am best at day in and day out..

5. Always ask for referrals before signing a contract This has been a lesson learned and very tangible business advice. When Danielle and I were first looking for a warehouse to ship all of our online orders we were given a recommendation. We were so excited and on a bit of a time crunch, so we had a call, signed a contract, and started working with them. This ended up being one of our worst business decisions. This shipping company and CLEARstem were not a good match for one another. It led to significant profit margin being eaten up and severely stunted our cash flow. The reason for this mistake? We took one recommendation as truth and didnt ask for other referrals or do our own background research on the company. We have since changed shipping companies and now before committing to work with any other company or signing a contract we ask for 35 referrals that we can speak with before making a decision.

You are a person of great influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger.

Something we have had in mind for a long time as individuals and as a company is to work with women coming out of domestic violence, poverty, and sex trafficking. All three of these situations severely damage a womans confidence. These women are rebuilding their lives, finding themselves, and many times starting out on their own. It is our goal to work with these women in some capacity whether it is partnering with an organization supporting these women, mentoring, or teaching business fundamentals classes to give women the confidence and skillset to pursue meaningful careers. This is still an aspect of our brand we are really looking to build out because of its deep importance to our hearts.

Can you please give us your favorite Life Lesson Quote? Can you share how that was relevant to you in your life?

If you dont love what you are doing, leave Gary Vaynerchuck

This statement really hit home for me. Life is so short. I was once in a job that was not where I wanted to be, actually this happened with multiple jobs. I wondered for so long if I would ever find a career I could stick with, one that made me happy. I thought, maybe if I have an okay job with flexible hours, I could just have passions that I love and let my job just be a job. I quickly realized that I care way too much about being happy and living every day pursuing my passions to do this. There is such a cycle in society of I hate my job, but it pays, gives me security and benefits, so I will just stick it out until I retire mentality. The problem with this is, what if something happens before you retire? What if your life ends? And why should we suffer day in and day out in the prime of our lives In jobs that make us miserable? I dont want to live every day for the weekend and then dread when Monday comes. I want to live every day excited for what we are building, growing, learning, and pursuing what makes me happy. If you dont love what you are doing, leave.

Some of the biggest names in Business, VC funding, Sports, and Entertainment read this column. Is there a person in the world, or in the US with whom you would love to have a private breakfast or lunch with, and why? He or she might just see this if we tag them

Without a doubt, Sophia Bush. She is such an inspiration to us. I recently saw her speak and was blown away by her passionate for supporting women and diversity. She is creating change, breaking down barriers, and starting conversations that need to be had. Her undeniable passion for inclusion, women advancement, and entrepreneurship is incredibly inspiring. I look up to her as a leader, powerful businesswoman, and change-maker.

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Danielle Gronich & Kayleigh Clark of CLEARstem: Don't ride the highs too high and the lows too low - Thrive Global

Thanksgivingis a special time of year to get together with family and friends and think about what youre most grateful for. But lets be honest its really all about the food, from the roast turkey, which typically takes center stage, and cranberry sauce to stuffing and mashed potatoes with gravy. And lets not forget pumpkin pie.

With so many delicious dishes within reach, its hard not to get carried away by filling your plate and your belly to capacity. In fact, a typical holiday dinner like Thanksgiving can have around 3,000 calories, according to theCalorie Control Council, which is well above thetotal calorie recommendationsfor women and men in an entire day. So what happens when you overdo it at the Thanksgiving table?

Your stomach is about the size of a standard American football,Alaina Castro, clinical dietician with the Stanford Bariatric and Metabolic Clinic, tells Yahoo Lifestyle. When your stomach is empty, it typically only has room for about 2 ounces. The good news is that the stomach can definitely stretch, Diane Vizthum, registered dietitian and research nutritionist forJohns Hopkins University School of Medicine, tells Yahoo Lifestyle.

When you eat, the stomach can typically stretch to hold 1-1.5 liters (about the size of a quart and a half of milk), or even more depending on the individual. There are folds in your stomach called rugae, explains Vizthum. Theyre crumpled up and can expand when you eat. When the rugae have expanded enough, that sends a signal from the digestive system to the brain saying that youre getting full. Everyones capacity of where you start to feel that is a little bit different, says Vizthum. If you habitually eat large volumes, you can stretch it out a bit.

One of the first telltale signs that youve overdone it at Thanksgiving dinner is feeling physically uncomfortable. If you eat a really large meal and your stomach is really full, you can have discomfort from having your stomach stretched beyond its normal size, says Vizthum.

Along with gas, you can also experience some heartburn and acid reflux as the contents in your stomach push against the lower esophageal sphincter, which is like a portal that opens and shuts the top of your stomach, says Vizthum.

Of course, your body has to do the work of digesting, absorbing and storing all the nutrients you just ate. So your heart rate will go up a little bit to increase blood flow in your digestive system, explains Vizthum. Your body will have a lot of work to do, and that can make you feel tired, she says.

Talk turkey and its only a matter of time before someone brings up tryptophan an essential amino acid, which is a building block of protein, thats often blamed for Thanksgivingsleepiness. The tryptophan molecule itself is converted to [the feel-good hormone] serotonin and melatonin the hormone that regulates sleep, explains Vizthum. Thats how it gets the reputation for making you sleepy.

But heres the thing: Turkey isnt the only form of protein that contains tryptophan. Chicken, fish and shellfish, beef, pork and lamb all have similar tryptophan levels, points out Vizthum. So unless you start yawning after eating those other sources of protein, your Thanksgiving drowsiness may have more to do with the overall effect of eating a largeholidaymeal and not the turkey per se, says Vizthum.

Samantha Cochrane, registered dietitian atThe Ohio State University Wexner Medical Center, agrees, telling Yahoo Lifestyle: Its a common myth that the tryptophan found in turkey is the reason we are all so tired after a Thanksgiving dinner. She adds: Very little of the tryptophan that we eat makes it to our brain and really shouldnt have an effect on our energy level. Whats really making us feel tired, however, is not tryptophan, but the quantity of food we eat. With a lot of food, comes a lot of digestion, making us want to rest.

Also, getting in some turkey or any form of lean protein is your ally on Thanksgiving. Thats because including protein in a meal can stabilize how quickly you digest carbohydrates for a slower release of energy, notes Vizthum.

Dinner rolls, other white breads and stuffing are often simple carbohydrates made from refined grains that are more easily and quickly digested than complex carbohydrates. High amounts of simple carbohydrates can cause blood sugar to rise more quickly than complex carbohydrates, explains Cochrane, which will require more insulin produced by your pancreas to allow the cells in your body to use that sugar for energy.

That quick rise and fall in blood sugar levels can leave people feeling tired or looking for more food for another pick-me-up, notes Vizthum. But, again, eating those carbs along with some protein, fat and fiber, such as from vegetables, helps slow down digestion and lets the body absorb sugar more slowly, she says. So if you eat turkey for your protein, plus one white roll for your carbohydrates whole wheat would be better and a side of green beans cooked in olive oil for your fat, you will have less of a blood glucose spike and stay fuller longer, explains Castro.

That influx of sugar can give you a quick energy boost, but thats usually followed by a rapid drop in energy. The influx of sugar causes the pancreas to produce insulin quickly to move the sugar from the bloodstream into the cell, explains Cochrane. Anything that isnt used fairly quickly for energy can be stored as fat, says Vizthum, who adds that were less likely to burn off that sugar since were typically relaxing, rather than being physically active, on Thanksgiving.

We tend to overdo it, says Vizthum. But there are some painless ways you can prevent yourself from overeating on the holiday. A good guideline, in general, for a healthy plate is to fill half of it with vegetables and some fruit, and the other half with protein and whole grains. For Thanksgiving, its a little tricky because its one meal and often a time when theres very special food around, says Vizthum.

She recommends being selective about what youre putting on your plate. Skip foods that arent that special to you, get some protein and non-starchy vegetables on your plate, and stick with small portions of the foods you really love. I am a big fan of people having a little bit of everything, says Castro. Make sure the main part of the plate is a protein turkey is great and some non-starchy vegetables like Brussels sprouts, green beans, salad, carrots, etc. Add some of the holiday favorites like stuffing or mashed potatoes, but try to limit their portions. Castro also says that adding some cranberry sauce and gravy is completely appropriate on Thanksgiving, too.

Also, pay attention to your bodys cues that youre getting full and know when to step away from the Thanksgiving feast. The big thing is not eating to the point of discomfort, says Vizthum, who recommends eating slowly since it takes about 20 minutes for signals to reach the brain that youre getting full, as well as munching mindfully, paying attention to flavors and textures.

And if you do get carried away? Dont beat yourself up. This is one meal out of the entire year, says Vizthum.

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Heres what eating Thanksgiving dinner does to your body - Yahoo Lifestyle

LEXINGTON, Ky. (Nov. 15, 2019) Students face challenges today that generations before them couldnt even dream of. From using technology in the classroom to the pressures they feel from social media, the college experience today is monumentally different than it used to be.

Students come to college to express themselves in a way that they may have always wanted to, but never thought they could. With open hearts and minds, they leave their routine theyve always known, ready to find themselves whatever that means to them.

Today, more and more teens are identifying as transgender or gender nonconforming. Somestudents say they feel unwelcome even before they set foot on a college campus. Joanne Brown, a nurse practitioner at University Health Service (UHS), is making it her mission to support students through their transitions.

UK is a leader in transgender health, definitely, but we can always do better. I can always do better, said Brown.

Brown is a provider who never stops learning. She often attends conferences and informational events about student health to learn how to better care for patients. Shortly after starting at UK, she attended a meeting where some medical students were sharing experiences theyve had in the health care system, and it inspired her.

One of the students who identified as lesbian said their provider had just assumed they were sexually active with a male partner and asked, What are you doing for birth control? Arent you afraid of getting pregnant? And I went, Oh ouch, Ive done that before. And I can do better, said Brown.

So she started to do better. She reached out to other providers for guidance and advice. She began cultivating a more inclusive environment by speaking to patients differently and replacing outdated signage in her exam room. But it didnt seem to be enough.

She had a new patient, a graduate student from Washington, D.C., come see her.

Theyd been to four providers before they came to see me, said Brown. Four other providers in Lexington, and couldnt get anybody to prescribe PrEP. Which is absurd, because PrEP is so effective in preventing HIV infection. So I figured things out. I looked at the guidelines, and I wrote that prescription.

From then on, Brown was determined to put LGBTQ* health at the forefront of her career. In 2016, a task force of UK HealthCare providers and individuals from campus organizations came together and created the UK HealthCare Transform Health Clinic.

Transform Health was created with the goal of providing and improving care for the LGBTQ* population. It also trains health sciences students and residents in LGBTQ* health best practices and offers mental health counseling support. The group consists of providers from several different UK HealthCare institutions, including UHS, Family and Community Medicine and the Counseling Center.

The original task force that created Transform Health wanted to bring attention to one particular marginalized population people who identify as LGBTQ*. Brown said starting there helped her realize there are many other populations that need attention in health care too.

This understanding led to the establishment of the UHS Inclusive Care Committee. This group meets to improve care for all populations of students first-generation, students of color, veterans, international students and several other marginalized groups.

The intersectionality of a patients identity has such a large impact on their overall health, said Brown. Im hopeful that this understanding helps us take better care of all our patients, not just LGBTQ* students.

Brown considers herself lucky to work in student health, especially at UK. Dr. Ann Hays, a provider and clinical director at UHS, played an influential role in Browns push for better LGBTQ* care.

Dr. Hays support demonstrated that UHS and UK HealthCare aligned with my goals of providing more inclusive health care, said Brown. Its clear its a priority here at this institution.

Student health also appealed to Brown because of how it allows her to put her patients first in every way. Students dont have a co-pay for every appointment, so if Brown wants to see them sooner than normal for a follow-up, theres no hesitation.

Im thinking about all the other things that are involved in their transition, said Brown. Not just the medical piece of it, but whats going on at home? Whats going on in their classes? Whats going on with their roommates and their peers?

Brown said shes often been inspired by her patients. For a lot of students, going to see Brown is the first step of becoming who theyve always wanted to be.

I think its taken everything they have towalk through our door and talk to me for the first time, said Brown. Theyre afraid this step is going to alienate them from their families of origin. It might mean those families withhold financial support, they cant continue in school, that they lose a relationship with somebody.

Jace Peters-White, a UK student and patient of Browns, is an exemplary model for what the right kind of care can do. They have been seeing Joanne since their first semester here in 2017.

Ive never had any doubts or worries being here at UK, said Peters-White. The campus is such a welcoming and affirming place to be my true self.

White had already been receiving hormone therapy before coming to UK. They feel lucky to have Brown here to continue their care.

Its so difficult to find affirming transgender health care anywhere; I used to travel two hours to go to an office that had the expertise in the type of care I needed, said Peters-White. Having Joanne as a resource this close to me is a complete blessing.

Brown is proud to be a representative of this university and what we do for our LGBTQ* students. However, she says theres much more to be done, like including LGBTQ*-centered health in more of the curricula here. In the future, she wants UK to be known as the place to go, for inclusive care.

As Brown continues to advocate for her patients, she also celebrates with them.

The most rewarding thing is when I see my patients out in public, particularly after theyve been on hormones for a while theyre happy, theyre smiling, theyre whole, said Brown. The exciting thing is theyre graduating with their undergraduate degrees. Theyre completing graduate programs. Theyre becoming.

Click here for more information on Joanne Brown, or to request an appointment with her. Students can also make an appointment with her through their myUK portal.

More:
UHS Nurse is Changing the Narrative Surrounding Transgender Health - UKNow

The Medical Health Institute offers the Bio identical Hormone Replacement Therapy Miami, allowing people to redesign their health and get back their energy and vitality.

Men and women living in Miami may not have to worry a lot about their growing age. The age related complications can be delayed with the help of the Hormone Replacement Therapy Miami that The Medical Health Institute is offering now. The

Medical Health Institute specializes in HRT for men and women, allowing them to redesign their health with the advanced medical science. The anti-aging clinic is located in two places in North and South Miami, and their treatments help men and women to restore their bodies to optimal health. Besides HRT, the clinic also offers a variety of advanced medical services, which also includes addressing the problem of erectile dysfunction.

The clinic offers Bio identical Hormone Replacement Therapy Miami that could prove a holistic approach to anti-aging. The spokesperson of the clinic reveals that they try to address the whole system of a patient rather than treating just the symptoms. This holistic approach brings a long-lasting result or a permanent cure by eliminating the root cause of the problem. The doctors of the clinic focus on personalized treatment programs for each individual patient. They closely monitor each patients health and improvement throughout the treatment process. The HRT is an ideal therapy for men and women experiencing the problem of hormonal imbalance.

With the growing age, both men and women often suffer from the low level of testosterone. This hormone is essential to help maintain energy and vigor of the human body. The HRT Clinic in Miami offers Testosterone Replacement Therapy Miami that can improve the physical stamina and sex drive for one to experience the same youthful energy despite the growing age.

For all men suffering from the problem of erectile dysfunction, the clinic has an effective ED Treatment Miami. The clinic takes advantage of the latest GainWave technology in which sound acoustic waves are used that stimulate mens tissues, helping them to achieve a full erection, and which also lasts for a longer period of time. This is a tried and tested ED treatment, and numerous men have been treated in the Miami Clinic to regain their sexual strength.

The spokesperson talks about one more important treatment of their clinic, which is the IV Therapy Miami. In this therapy, one can absorb nutrients bypassing the bodys digestive system. The clinic delivers Vitamins and proteins to ones body through an intravenous system. These nutrients, thus directly reach a humans bloodstream, to help improve health conditions. The spokesperson reveals that IV therapy could be useful not only for aging people, but people with an active lifestyle can also choose it for their better health.

To know more about these cutting-edge treatments offered by the Medical Institute, one can visit the website https://hormone-replacement-miami.com.

About The Medical Health Institute

The Medical Health Institute is an HRT Clinic with 2 locations in North Miami and South Miami. As a full service anti-aging clinic, The Medical Health Institute specializes in Bio-Identical hormone replacement therapy. Not only are they treating low energy levels in men, but also erectile dysfunction and hair loss.

Media ContactCompany Name: Medical Health InstituteContact Person: Michael BertonattiEmail: Send EmailPhone: +1 (786) 401-5244City: MiamiState: FLCountry: United StatesWebsite: https://hormone-replacement-miami.com

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Hormone Replacement Therapy Miami Now Available for Improving Health & Overall Life - Press Release - Digital Journal

Women are desperate to figure out why they dont feel good. By the time they come to see me, theyve been dismissed so many times, says Heather Hirsch, lead physician of Brigham and Womens Hospitals Menopause and Midlife clinic, set to open early next year. When we think about womens health, we talk about puberty, pregnancy and postpartum. The menopause transition is really important, and it gets no attention.

Hirsch, 37, is part of a new generation of doctors, tech developers and investors determined to change that, and aiming to replace stigma with public conversation, better medical research and more accessible training. Research for treatment of common symptoms like hot flashes, low libido, sleep disruption and weight gain is notoriously underfunded, they note, even as an estimated 38 million American women are menopausal and account for approximately 20 percent of the American work force.

The lack of medical research is coupled with a lack of clinical training, even for gynecologists.

In many family medicine, internal medicine and OB/GYN residency programs, there is perhaps an hour of instruction on menopause, at best, says Stephanie Faubion, medical director of the North American Menopause Society (NAMS) and director of the Mayo Clinic Center for Womens Health, where she co-authored the report Menopause Management Knowledge in Postgraduate Family Medicine, Internal Medicine, and Obstetrics and Gynecology Residents.

Anna Barbieri

Frustrated by misconceptions and shame surrounding the topic, doctors have found new ways to communicate with the women they say are deeply underserved. Hirsch has her own podcast series, Health by Heather Hirsch, with accessible and irreverent segments like Perimenopause, what the HEL! [sic]. In New York, a new telemedicine start-up called Elektra Health is recruiting doctors like Anna Barbieri and hosting frequent salon discussions with titles like Hormonal Harmony: Thriving in Perimenopause and Beyond.

Its important to provide current and valid information about symptoms and their management, and to discuss how this phase of life is so strongly related to other health factors, says Barbieri, 46, an assistant clinical professor of OB/GYN at Mount Sinai. We know, for example, that the time of menopause marks an increase in cardiovascular risk, diabetes risk and risk of dementia for women. How can we optimize this transition, and by doing so optimize other aspects of health? Menopause can vary widely from woman to woman, and were interested in how to practice patient-centered medicine based in evidence and rational treatments.

A reasonable approach, to be sure, but one hampered by myths and misunderstandings.

Among them, Hirsch says, is the fear of hormone replacement, largely stemming from media reporting on the early closure of a 2002 Womens Health Initiative study. That study, which examined one combined oral dose of estrogenand progesteronein a population of women whose average age was 63.5, was widelyandincorrectly interpreted as indicating that the hormones led to a significant increase in the risk of breast cancer and heart attacks.

WHI was an incredible research study with lots of information, but it was a skewed population of older, non-symptomatic women, Hirsch says. When the media spun the results, it made a huge impact in most peoples mind that estrogen is dangerous and harmful, and this idea is still very much ingrained into society.

Today, NAMS-trained providers say that hormone therapy, given to symptomatic women within 10 years of menopause (typically starting in their 50s), often has benefits.

Story continues

Recent studies, Hirsch notes, say that women who take estrogen and progesterone within 10 years of menopause have a tendency to live longer, die less from all causes and have less heart disease. These are results from several large clinical trials ofdifferent preparations ofhormone therapy in women who start within 10 years of their last menstrual period.

Even when women are willing to take hormones, they are often confused about the best sources, struggle to find well-informed doctors and are susceptible to marketing of unregulated, compounded hormones, Hirsch says.

The compounded hormone therapy industry is extremely profitable, as they are preying off the insecurities of patients and then providers who are otherwise uncomfortable discussing the risks and benefits of FDA-approved hormone therapy, with the risks being overestimated, she notes. There are approximately 15 million women on hormone therapy, of which about two-thirds use unregulated and one-third use FDA-approved medications. However, this number could be larger if there are women using compounded HT we cannot account for. Therein lies another risk of inadequate education and counseling: women taking unregulated HT with the idea that it is safer.

Theres confusion, too, about how to use and source supplements like Chasteberry and Vitex, which some women take for PMS and irregular periods; silymarin, which supports liver function; and melatonin and valerian, which may help with sleeplessness and anxiety.

I find that the use of supplements in the U.S. can be controversial and polarizing, similar to hormone therapy, with many sharing either the extreme view that no FDA oversight means that herbs and supplements are mostly ineffective and can be dangerous, and others believing the opposite, that anything that is natural is safer and gentler than regular medications, says Barbieri. I fall in the middle and believe we should apply regular scientific principles to both drugs, many of which have botanical origins, and herbs/supplements.

This fraught climate, investors say, is ripe for growth.

Last year, market research firm Frost & Sullivan predicted that the market for femtechtechnology products that focus on female wellness, everything from reproductive health to general wellnesswill be $50 billion by 2025.

Jill Angelo

Women control the majority of healthcare dollars spent, and are so influential in their spending power, but I was really taken by the lack of attention to womens health in the second half of life, says former Microsoft executive Jill Angelo, 46. This is a huge opportunity, and in terms of how much is capitalized or consumed, were just getting started.

In September 2016, Angelo launched the online platform Gennev, initially focused on selling hygiene products geared toward easing menopausal symptoms. With her partner Jacqueline Brandwynne, a retired Neutrogena executive, Angelo has branched out to providing services to its 16,000 registered users. It now offers $35 telemedicine appointments with NAMS-certified physicians and a $10 monthly subscription to unlimited consultations with health coaches, dietitians and nutritionists specifically trained to counsel menopausal women. Gennev currently partners with physicians in 30 states and expects to cover all 50 states and the District of Columbia by the end of 2020.

We interviewed 1,500 women, and they said, I have no idea who to go see. My doctor brushes me off, Angelo says. Were still growing our product line into dietary supplements but have also expanded to telemedicine and on-demand coaching. Theres a lot you can do from a lifestyle perspective to alleviate symptoms.

Amy Domangue

Amy Domangue, cofounder and CEO of the virtual medical care aggregator Jessie, calls Angelo a pioneer. The opportunity for virtual care for menopause and perimenopause is finally giving women a place so they know exactly where to turn. The way our healthcare system works is outdated, Domangue says. We have primary care and OB/GYN doctors, but what if instead of general doctors you have specialists uniquely trained to your gender and age? How can we segment healthcare better, so people know where to turn?

And while some women in their 50s and 60s may be wary of virtual visits, Domangue and other menopause entrepreneurs predict the approach will soon become normalized.

Alessandra Henderson

Telemedicine has been around for a very long time, so the technology itself is nothing new, but user behavior is very much a consideration. How do you onboard women in a way that feels comfortable and natural and that builds trust from the get-go? As we grow over time, and continue to get more women on to the platform, well continue to see more digitally native women join, says Alessandra Henderson, 34, the cofounder and CEO of Elektra Health, a new company set to debut telemedicine services in 2020, starting with a beta test group of 30 women in New York state.

Elektras model is to focus on building a virtual care practice with a dedicated care team of gynecologists on staff.We believe dedicated Elektra providers trained in our proprietary care protocol is the best way to deliver an optimal customer experience, real healthcare results, as well as to foster a long-term relationship over the seven-to-10-year menopause journey, says Henderson. Another focus for Henderson: fostering community and accountability.

Elektra checks in regularly with women in the first week, month and beyond on not only their health goals but also their symptoms. Well then use that information to inform their next meeting with the gynecologist. We also plan to add women to private, curated groups for support and accountability, she says. One hundred percent of women go through this. Its nothing to be ashamed about. Its a natural, universal experience. We want to give women the tools to live really well during this time.

This perspective is long overdue, says Faubion, noting that despite the fact that most menopausal women will suffer symptoms, theres not a great deal of new research. One area that does look promising: phase three trials on drugs inhibiting receptors in the hypothalamus that are linked to brain pathways responsible for hot flashes and night sweats. They block the NK3 receptors believed to be in the hot flash neural pathway, but an exact mechanism hasnt been determined, Faubion explains.

Doctors emphasize that menopause should also be assessed in terms of how it may relate to other health issues, particularly cardiovascular disease and dementia.

There is basically a disruption in brain energy metabolism during the menopausal transition linked to decline in estrogen, Barbieri says, adding that the decline can leads symptoms like insomnia, disturbed sleep, hot flashes, depression and short-term memory impairment. It is this metabolic change, as well as recognized vascular changes that occur with menopause, including the impact on the brains vascular system, that may be linked to higher risk of dementia for women.

Ideally, Barbieri says, technology will help researchers target womens symptoms more precisely.

Id love to see research that focuses more on precision medicine for menopause and the choice of intervention based on ones particular genetic makeup and individual situation. That could translate to different types of medicines, dosing or modalities, she says. Id also love to see more research devoted to non-pharmaceutical approaches, including natural and mind-body approaches.

These are exactly the possibilities inspiring entrepreneurs like Elektras Henderson.

The more women that we treat, the faster we can help identify what is and is not going to work, she says. We have a lot of independent research studies on diet, acupuncture and meditation, but we are aiming to build an incredibly rich data set to help informwith hard, science-based evidencewhat has helped treat symptoms, as well as what are best practices.

The post The Womens Health Issue Thats Finally Starting to Get Recognition appeared first on Worth.

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Doctors have been sued out of medicine for a lot less than what was done to Nathaniel, a teen boy wholl never be the same again. Having undergone sex-change surgery a year ago including, of course, his genitalias removal he now calls it a Frankenstein transition that has ruined his life.

Nathaniel is a 19-year-old whose story was told Sunday, with his permission, by author, public speaker, and proprietor of website SexChangeRegret.com Walt Heyer.

The young man, whose last name was withheld, relates that he was bullied by other boys in grade school because he had some characteristically female passions such an affinity for girl games. Then, when he was a bit older, Heyer writes at the Daily Signal, he discovered internet pornography, heard about transgenderism, and as he says, convinced myself thats what I was.

After mustering the courage to reveal this to his mother the summer following eighth grade, she scheduled an appointment for him with a doctor at an informed-consent clinic, as Heyer says he put it.

The medical visits started just after Nathaniel turned 15 and sparked a downward spiral. From then on,' he says, I slowly detached from everything until I was just staying home, playing video games, and going on the internet all day, Heyer relates. I stopped reading, drawing, riding my bicycle. I surrounded myself in an echo chamber that supported and validated my poor decisions, because the others were also, unfortunately, stuck in that pit, too.

A month after his 18th birthday, Nathaniel had whats euphemistically called bottom surgery, Heyer continued. For a male like Nathaniel, that means refashioning the male genitalia into a pseudo-vagina. He suffered some complications that required a second surgery a few months later, and he had facial surgery to further feminize his appearance. The result?

Now that Im all healed from the surgeries, I regret them, Nathaniel laments nine months later. The result of the bottom surgery looks like a Frankenstein hack job at best, and that got me thinking critically about myself. I had turned myself into a plastic-surgery facsimile of a woman, but I knew I still wasnt one. I became (and to an extent, still feel) deeply depressed.

I feel as though I have ruined my life, he sadly confesses.

Sadder still is that Nathaniel is hardly alone. Transgender ideology is destroying lives, writes PJ Media. In 2016, two women spoke about how they werepermanently scarredby taking male hormones and having top surgery the removal of their breasts, the site continues, providing an example.

I myself have provided a great number of such examples over the years, a good one being the case of Australian Patrick Mitchell. In 2015, at age 12, Mitchellinsisted he was a girland wanted to transition; his mother and other authority figures pandered to him, but after two years of female-hormone treatments he changed his mind. Of course, if the adults had tried early on to change his mind and not his body, both would be in better shape today.

Another example is Heyer himself. He once identified as female, but now says that the reckless gender medical practitioners have blood on their hands. By turning a blind eye to the scientific and ethical aspects of their chosen profession, he elaborates, they are directly responsible for poor outcomes, regret, detransitioning, suicides, and families torn to shreds by unnecessary surgeries.

This is no exaggeration. After many years of studying and writing about this issue, just as striking to me as the transgender agenda itself is that we dont hear about malpractice suits filed against its physician enablers. It seems like an open-and-shut case, too.

Consider an example I use to illustrate the point: If you tell a cardiologist youre concerned you may have heart disease, hell perform medical tests confirming the problems existence before prescribing any interventions, let alone invasive ones. Imagine, though, you tell him youre certain based on your feelings that youre a heart attack waiting to happen. Now imagine he asks, Have the feelings been strong and persistent? Have they lasted for more than six months? Yes? Alright, then Ill cut open your chest and perform a bypass!

This would be gross malpractice. Any doctor thus proceeding and operating on a healthy heart would be sued into oblivion. Of course, nothing this preposterous would ever happen in cardiology.

Yet this is, incredibly, precisely the basis on which physicians make the transgender diagnosis: feelings. Really.

Its called a diagnosis of gender dysphoria, made based only on the presence of strong and persistent feelings of cross-gender identification that have lasted more than six months. Theres no blood test for gender dysphoria, no genetic test, no brain scan, no physiological marker at all indicating that at issue is anything but a psychological problem.

Nonetheless, a pediatrician Heyer quotes has observed that children and adolescents are put on the path to puberty blockers, cross-sex hormones, and sex reassignment surgery at gender clinics while receiving no psychological counseling all on this basis. Relying on a psychological phenomenon, feelings, and with no proof of an underlying biological one, bodies are broken with an irreversible biological fix. If this isnt classic and egregious malpractice, what is?

Buttressing the case, note that theres no conclusive evidence that sex change operations improve the lives of transsexuals, with many people remaining severely distressed and even suicidal after the operation, according to a medical review conducted exclusively for Guardian Weekend, the left-wingGuardianreportedin 2004.

Is this surprising? The unpopular truth, which Nathaniel unfortunately learned the hard way at a young age, is a man is not a woman and cant ever become a woman, even with surgically refashioned genitals and feminizing facial surgery, Heyer explains. Or as Australian Alan Finch, another former transsexual, put it, You fundamentally cant change sex. Transsexualism was invented by psychiatrists.

Transgender is not a legitimate medical status, but an ideological one. Yet this truth wont stop our times Lysenkoists from performing our ages version of lobotomies. What will is being sued into irrelevancy.

These medical professionals are ruining lives the least they should endure are ruined careers.

Selwyn Duke (@SelwynDuke)has written forThe New Americanfor more than a decade. He has also written forThe Hill,Observer, The American Conservative, WorldNetDaily, American Thinker, and many other print and online publications. In addition, he has contributed to college textbooks published by Gale-Cengage Learning, has appeared on television, and is a frequent guest on radio.

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Teen Regrets Sex Change, Says: I Feel I Have Ruined My Life - The New American

The City of Johannesburg is reminding its citizens that November is Diabetes Awareness Month a time to focus on creating awareness about the symptoms and causes of diabetes and how to reduce the chance of developing it.

According to the Citys statement, the City of Johannesburgs Health Department is increasing its effort to help residents understand diabetes and the importance of improving the health and lives of those who are affected by it.

The City said that the World Health Organisation observes World Diabetes Day annually on 14 November. The theme for this year is Family and Diabetes and aims to raise awareness on the impact diabetes has on the family and the support network of those affected by it.

Joburg Health conducts health education in clinics about diabetes. Nurses and health promoters are also being trained about diabetes and its link to nutrition. The health education focuses on the range of free services available at the Citys clinics and on healthy lifestyle choices to mitigate and control diabetes, the City said.

Hlubikazi Ntamehlo, the deputy director of Public Health in the City of Johannesburg, said, The aim is to make people aware of the social and economic effects of diabetes on the family and to promote the role of the family in the management, care, prevention and education of diabetes.

You can control diabetes by going for simple tests at your local clinic. This will show if you have diabetes and require additional examination and treatment. Talk to a healthcare worker about your health results. They will explain how your diabetes can be controlled. Some people need pills, other injections and some dont need medicine at all.

The City added that last year, it was reported that about 6 per cent of South Africans (about 3.5 million) people suffer from diabetes and 5 million more are estimated to have pre-diabetes, which is when blood sugar levels are higher than normal but not high enough to be considered as diabetes.

Diabetes is an endocrine disorder in which the bodys ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and elevated levels of glucose in the blood. Types of diabetes are Type 1 insulin-dependent DM-insufficient levels of insulin and Type 2 non-insulin dependent DM-unresponsiveness or resistance of cells to insulin, said the City.

The signs and symptoms of diabetes include, among others, excessive thirst; frequent urination; feeling very hungry; fatigue; blurred vision; irritability; weight loss even if you eat more and slow healing wounds.

We want to encourage residents to do free screening for diabetes at our clinics. Let us work together families, communities, and government to beat diabetes, said Ntamehlo.

Related article:

https://midrandreporter.co.za/229098/world-diabetes-day-symptoms-complicated-sometimes-difficult-diagnose-diabetes/

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How to reduce your chances of developing diabetes this #DiabetesAwarenessMonth - Northcliff Melville Times

On a rainy November morning last year, a few days before Thanksgiving, I stuck my 11-month-old daughter in her car seat and took her with me to the obstetricians office. I had stopped breastfeeding her exactly six weeks before. I was pregnant again.

My appointment was with an obstetrician Id never met before, at a practice affiliated with our citys Catholic hospital. It was the largest practice in town, and the first appointment I could get.

Last menstrual period? the medical assistant asked as she wrapped a blood pressure cuff around my arm.

I dont know, I said, blowing out a breath.

She glanced at me, then at my daughter, who was kicking and babbling in her car seat. So, she said, This is unplanned. I knew her tone; I had heard it a thousand times.

Im just here for an ultrasound, I said, holding my voice steady. I just want to know how far along I am.

A recent trend in anti-abortion legislation has been the passing of so-called heartbeat bills, which ban an abortion after a heartbeat (the flicker of cardiac activity in an early embryo) can be detected on ultrasound. In 2019, such bills passed in six states including Georgia, Kentucky, Louisiana, Missouri, Mississippi and Ohio. Abortion rights advocates correctly point out that such legislation constitutes an outright abortion ban, because this early cardiac activity is detectable on a vaginal ultrasound at about six weeks, a time when most women do not even know theyre pregnant.

I often cringe when I hear this language when most women dont even know theyre pregnant because I imagine how anti-abortion individuals, particularly men, must read it: as evidence that women are clueless and careless. (I can see a white-haired male politician scoffing, How could a womannot knowthat shes pregnant for afull six weeks?)

But in reality, the technology used to detect a pregnancy and the counterintuitive method of pregnancy dating makes it almost impossible for any woman to know for sure that shes pregnant before such cardiac activity appears. I know from experience and not just my own.

What I didnt tell the nurse that day was that I am a doctor. A large part of my job is detecting early pregnancies, determining whether the pregnancy is normal and viable, and counseling women about their options. (In my home state of California, thankfully, my patients have options to terminate the pregnancy, for any reason, up to about 24 weeks.) So if anyone could have known she was pregnant at the earliest possible moment, it should have been me.

After giving birth to my first child Id made a conscious decision not to re-start birth control. I was 34 years old; I expected it might take several months or longer to conceive, but I was certain I wanted to be pregnant again. I breastfed my daughter until she was 10 months old, gradually introducing solid foods and formula until she was completely weaned. She was a good sleeper, and my husband and I were having sex again. I knew I could become pregnant at any moment but I had no idea when that moment would be.

Like many women at various points in life (or throughout their lives), I wasnt getting a regular period. I had never resumed my menses while breastfeeding (not uncommon, although not as many believe a reliable indicator of whether a woman has regained fertility). So I had no cue to watch for, no missed period to signal that I might be pregnant.

Sometime in early November, I just had a feeling. There were no classic symptoms: no sore breasts, no moodiness, no light spots of blood in my underwear. It was more like a premonition, a flutter in my chest, a suspicion.

Fortunately at my job, pregnancy tests are stacked on my desk like post-it notes. I took one home with me and peed on it: Positive. I was thrilled. The next afternoon on a walk with my husband, pushing our daughter in the stroller, we stepped into the lobby of a local hotel. I ordered two glasses of champagne at the bar and told him the news. He kissed me. When? He asked. I told him I didnt know.

I needed an ultrasound. So the following week, back at work, I asked a nurse practitioner colleague to perform one for me between patients. It took her five minutes. But what we saw was concerning.

In a very early pregnancy, before enough cells have clustered together to form an embryo, there is only a tiny sac of fluid, called the gestational sac, which appears as a black oval inside the uterus. This sac appears just before five weeks. Just before six weeks, a white halo appears, called the yolk sac, which is the early nutritional source for the embryo. The embryo itself appears a day or two later. At six weeks give or take a day or two the earliest flicker of cardiac activity, what anti-abortion groups call the heartbeat, appears, confirming a viable, growing pregnancy.

The important thing to emphasize is that these weeks do not tally the amount of time the woman has been pregnant. They tally the number of weeks since her last period if she was having a regular period at all. Ovulation, conception and implantation all take place at least two weeks after the menstrual period. Pregnancy hormone levels the ones that produce that double blue line on a home pregnancy test dont become reliably detectable for another several days after that.

So, the six weeks at which the heartbeat appears is clinically standard but misleading language. The amount of time that has passed since a woman could possibly have known she was pregnant (if she could get her hands on a pregnancy test) is less than two weeks. Very few women can get into a doctors office for an ultrasound within two weeks of a home pregnancy test, let alone arrange for an abortion procedure.

But I was not seeking an abortion procedure. I just wanted to know something about this pregnancy how long I had been pregnant and whether everything was okay.

That day in my clinic, because I didnt know how far along I was, I didnt know what I should expect to see on the ultrasound screen. What I saw was: nothing. Or, rather, only an empty gestational sac, with no yolk sac or embryo inside. I realized I was seeing either a very early pregnancy i.e., about five weeks, before the emergence of an identifiable embryo. Or I was seeing something else, a pregnancy that had started growing and then stopped, something that would never grow into a fetus. This very common occurrence is sometimes called a blighted ovum, a chemical pregnancy, or, more correctly, an anembryonic gestation.

I tried not to panic. That night, I told my husband there was only one thing to do: wait.

A week later, I was at the ob-gyns office. I had decided if I was going to get bad news, I wanted it from a dispassionate professional, someone I didnt know or work with.

The doctor breezed into the room and whisked out the vaginal ultrasound probe, coating it with a thick dollop of gel. He asked me again about my last period. I told him I hadnt had one and had no idea how far along I was. He glanced at my daughter, now asleep in her car seat, her little chin tucked to her chest. So, you werent planning on this, huh? he said.

I disclosed to him that I was a doctor, and that I had done an ultrasound a week earlier, but hadnt seen an embryo.

Where do you practice? he asked, I havent heard your name in town.

I named a clinic in a nearby city, well-known for its abortion care.

Look, he said, I understand youve got a very young kid already. I know how it is. You mean to plan these things, its harder than you think. The female body has a mind of its own. But you know I dont do terminations here.

I told him that I understood, said again that I wanted to be pregnant I just want to know if I really am or not.

He seemed unconvinced, but he slid the probe between my legs. Okay then, you know the drill: pressure, but not pain.

An image appeared on the screen: My uterus; inside it, a black oval the gestational sac and at its center, a white blob, the embryo, with a tiny flicker inside of it.

There you go, he said.

A spreading warmth rose behind my eyes and nose. Something like a gasp caught in my throat.

With his digital calipers, he measured the embryo. Six weeks and one day, he said. He mustve known I could see exactly what he did, but he said it anyway. So, weve got a heartbeat. Thats a viable pregnancy. Is this what you wanted?

I beamed at him, not caring about his patronizing tone, his stubborn insistence on judging me. The only possibility in that moment was that the whole world including this smirking doctor who knew nothing about me, my family, my choices shared in my relief and joy.

This was my experience as a family planning doctor: a pregnancy that I wanted and planned, but still didnt see coming. It wasnt a miracle that I detected the pregnancy this early: it was due to the pregnancy tests stacked on my desk at work, the colleague who could perform an ultrasound for me on request and when I finally sought care through the usual channels the fact that I was well-insured with relatively easy access to an obstetricians office, albeit one that offered limited services.

This was in a medically well-served suburban area of California. Imagine if I had been in rural Louisiana. Imagine if I hadnt been a doctor. Imagine how any woman can possibly confirm a pregnancy and have a chance to decide whether she can or should continue it before, according to her states laws, it is too late.

The answer is simple: She cant.

Christine Henneberg is a doctor and a writer.

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It Took Me More Than 6 Weeks To Figure Out I Was Pregnant -- And I'm A Doctor - HuffPost

Calgary Nov 21, 2019 (Thomson StreetEvents) -- Edited Transcript of Oncolytics Biotech Inc earnings conference call or presentation Tuesday, November 12, 2019 at 10:00:00pm GMT

* Andrew R. de Guttadauro

Oncolytics Biotech Inc. - Global Head of Business Development & President of Oncolytics Biotech (U.S.) Inc

* Kirk J. Look

Oncolytics Biotech Inc. - CFO

* Matthew C. Coffey

Oncolytics Biotech Inc. - President, CEO & Director

Oncolytics Biotech Inc. - VP of IR & Corporate Communications

Canaccord Genuity Corp., Research Division - Principal & Senior Healthcare Analyst

Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology

Good day, ladies and gentlemen. My name is Kat, and I'll be your conference operator today. At this time, I would like to welcome everyone to Analytics (sic) [Oncolytics] Biotech Third Quarter 2019 Results Conference Call. (Operator Instructions) I will now turn the call over to your host, Michael Moore, Vice President, Investor Relations and Corporate Communications. Sir, the floor is yours.

Thanks, Kat. Good afternoon, ladies and gentlemen, and thank you for joining us on our call today to discuss our third quarter and corporate update, including our updated catalyst milestones. With me on the call this afternoon from Oncolytics are Dr. Matt Coffey, President and Chief Executive Officer; Kirk Look, Chief Financial Officer; and Andrew de Guttadauro, Global Head of Business Development.

On today's call, Dr. Coffey will review our clinical and operational progress, including a recap of catalyst milestones. Andrew will touch on our business development progress and our growing relationships with pharma and big biotech. And Kirk, of course, will then speak to our financial position. I'd like to point out, certain statements made on this call, such as those relating to our clinical development plans and business development plans are forward-looking within the meaning of applicable security laws. Please refer to our third quarter press release and MD&A for important assumptions and cautionary statements relating to forward-looking information.

I will now turn the call over to Dr. Matt Coffey. Matt?

Matthew C. Coffey, Oncolytics Biotech Inc. - President, CEO & Director [3]

Hello, everyone, and welcome to our third quarter 2019 and corporate update conference call. The quarter was marked by continued clinical execution as well as even more validation of our unique oncolytic virus, and specifically our entry in this route of delivery, which I believe to be a vastly undervalued differentiator and will be something I'll come back to a few times on today's call. It's just that important.

We remain on track to report a steady cadence of value-driving catalysts across our robust and growing development pipeline before the end of this year and extending into the middle of 2021. I'll describe these important value inflection points later on this call. But first, let me provide a quick overview of our lead program and update on recent highlights from the quarter.

As everyone following Oncolytics should know, we are focused on advancing pelareorep in the lead indication of metastatic breast cancer, and we're conducting 2 key clinical studies with industry leaders that will determine the design of the Phase III registrational program for pelareorep in this indication. We have an approved study design for the Phase III, but we believe these 2 studies named AWARE-1 and BRACELET-1 will provide data supporting the addition of a checkpoint inhibitor to this registration study as well as a biomarker that we believe increases the chance of success in this critical study.

AWARE-1, our window of opportunity study in early-stage breast cancer with Roche's Tecentriq, is ongoing, and we expect to announce additional data before the end of the year. The BRACELET-1 study for which we have a co-development agreement with Pfizer and Merck KGaA, focusing on metastatic breast cancer, will begin enrolling Q1 of next year with our recently announced clinical partner, PrECOG. Last quarter, we announced encouraging results from the safety run in AWARE-1, which is being conducted by SOLTI in Spain to evaluate the efficacy of pelareorep in combination with Roche's Tecentriq and the utility of our biomarker measuring T cell clonality.

This data was also updated and highlighted last week at the Society of Immunotherapy for Cancer Conference in Washington, D.C. by Principal Investigator and Lead Author, Aleix Prat, and were presented by the lead investigator from SOLTI, Patricia Villagrasa. The data from these first patients demonstrated the creation of new T cells as well as the expansion of patients' existing T cell populations. What this means is that we have a brand-new T cells that recognize and react to tumor tissue, and that has some existing T cells that were previously blind to the tumor at baseline now react to the tumor 3 weeks later.

This data is very compelling and provides clinical proof that pelareorep is able to train the immune system to engage, to target and to kill tumor cells in primary disease as well as metastatic disease.

Specifically, it demonstrated viral replication within the tumor that led to tumor inflammation marked by a robust increase in new clones of tumor-targeting CD8-positive T cells. Now to put this in perspective, the average person walking around an urban environment will produce 2 or 3 new T cell clones per month, the immune system just doesn't require anything more than this in this environment. On study, we saw as many as 450 new T cell clones in a patient, which is a significant amount of T cell clones to recognize and attack tumor tissue. Simply put, we're creating a hot tumor microenvironment that did not previously exist. The exact environment required by checkpoint inhibitors that currently only work in a little as 1 in 5 patients.

So as we've stated time and time again, what if we can make a 2 in 5 and double a $25 billion drug class?

Additional data presented at SITC demonstrated additional support for our IV delivery based on an increase in T cells within both the tumor center and at the tumor periphery or stroma. This indicates that T cells are indeed getting into the tumor, not just gathering around the outside. Importantly, we also observed a decrease in the number of regulatory T cells or Tregs, which inhibit an antitumor immunological response by suppressing inflammation. This decrease in Tregs is also observed in checkpoint combination therapy experiments in breast cancer mouse models, further highlighting the robust transformations that pelareorep is making to the tumor microenvironment.

The next patient cohort to report from AWARE-1 study focuses on patients receiving pelareorep and standard of care without Tecentriq. This cohort will allow us to compare the patient population to those patients that have already received pelareorep with the standard of care and Tecentriq. This comparison of the 2 cohorts will allow us to confirm the impact pelareorep has on enhancing the antitumor T cell response, both on its own and in combination with checkpoint inhibitors. With respect to BRACELET-1, we are pleased to announce our recent partnership with PrECOG, a leading cancer research network and perhaps the preeminent breast cancer group in North America.

The principal investigator will be PreCOG member, Dr. Kathy Miller, Professor of Oncology at Indiana University School of Medicine and Associate Director of Clinical Research at Indiana University Melvin and Bren Simon Cancer Center. I cannot overstate how happy we are to be working with this group on this critically important study in our target patient population of hormone receptor-positive metastatic breast cancer. Quite simply, PrECOG and Dr. Kathy Miller, in particular, chose when and what they work on. So to have a group of their stature choose to work with Oncolytics and demonstrate their enthusiasm to work with an IV-administered oncolytic virus is incredibly gratifying.

We recently finalized the design of BRACELET-1 in collaboration with Pfizer and Merck KGaA, as well as input from PrECOG, and the protocol is currently under FDA review. PrECOG will begin patient enrollment in Q1 2020 at 15 centers across the United States.

Before moving on, I want to remind you that examination of our biomarker of T cell clonality for predicting patient response to pelareorep in combination with immune checkpoints is at the core of everything we're doing in the clinic. Confirming the utility of this biomarker across several studies as prognostically and predictably determined with a patient that's susceptible to treatment with pelareorep will be critical as we move forward into Phase III.

Being able to select and stratify patients who are likely to respond to treatment in our pivotal study substantially improves our chance of success and enables a precision medicine approach to fighting cancer. And quite frankly, as Andrew will go into, this is what pharma is looking for before making long-term commitments to pelareorep.

The use of the biomarker for the registration study is likely to be twofold. We will first use the assay to select patients for eligibility based upon having adequate immune reserves to respond to treatment. We will then further enrich the study after the first cycle by stratifying for patients that have not demonstrated a positive vaccination-like effect from those that have not. In doing so, we can get a potentially value inflection point sooner with greater financial flexibility.

We believe our biomarker is a game-changer for Oncolytics and our future clinical programs. So we are committed to fully characterizing its use in our current and planned studies.

I want to pause for a minute and highlight the most important differentiator for pelareorep with its systemic delivery by intravenous injection. As I mentioned earlier, I believe this is a tremendously undervalued differentiator for Oncolytics. It is globally accepted in the world of oncolytic viruses that this is a goal and a huge need in this space, and no other oncolytic virus has demonstrated meaningful data on IV delivery. They are all required intratumoral, which is very different in terms of tumors that can be reached and cannot effectively address metastatic disease.

We've consistently shown across multiple clinical studies that our virus can successfully infiltrate, replicate within and inflame multiple tumor types, including both primary and metastatic disease. These findings have been further validated by meta-analysis that was recently presented during the podium presentations at the Annual International Oncolytics Virus Conference. The data demonstrated that across 13 clinical studies, IV-delivered pelareorep resulted in an impressive average of 81% of patient tumor samples testing positive for virus replication, with no infection in normal tissue. This is a fantastic result across a broad range of tumor types, including our lead indication of breast cancer. Interestingly, though, this number climbs to 96% when we exclude melanoma skin biopsies. This analysis provides definitive proof that systemically delivered pelareorep can successfully avoid neutralization to reach both primary tumors and metastatic disease, making it a valuable therapy and immune adjuvant across a wide range of cancers.

While we're focused on our lead indication of metastatic breast cancer, this certainly speaks to the potential value of our delivery, both on clinics and for future development partners based on the breadth of cancers where pelareorep can become a cornerstone in combination with multiple immunotherapies.

Additional data presented at the IOVC and the data catalyst we highlighted in today's press release, and we will discuss now with data surrounding the synergies between pelareorep and CDK4/6 inhibitors.

Now as I mentioned last quarter, we're also exploring combination studies of pelareorep with other key oncology drug classes beyond checkpoint inhibitors, and CDK4/6 inhibitors are part of our initial investigations. Preclinical work with CDK4/6 inhibitors have been conducted by our academic collaborators and are also being worked on with industry partners to confirm the activity of this treatment combination.

Our preliminary data suggests that pelareorep synergizes with CDK4/6 inhibitors by blocking cellular signal pathways and releasing more double-stranded RNA into the tumor cell. This triggers a process called immunogenic cell death. Immunic (sic) [immunogenic] cell death is a cell's way of sending out a danger signal to our immune cells saying, come and eat me or come and kill me. The result is another very effective way to make a cold tumor very, very hot. And CDK4/6 combinations may not require checkpoint blockade.

Approved CDK4/6 drugs like Pfizer, Eli Lilly and Novartis', are targeting early-stage breast cancer around clinical trials for multiple solid tumor types. Like with checkpoint inhibitors, pelareorep's synergies with CDK4/6 inhibitors have the potential to expand the use of these drug classes in their current indications and to a broader patient population. It's obviously very early, but this drug class is important enough that these advancements can definitively play a role in business development activities.

On the subject of data and validation, we also recently reported the positive results from a Phase Ib study of pelareorep in combination with Merck's KEYTRUDA in patients with advanced pancreatic adenocarcinoma have been published in a peer-reviewed journal called Clinical Cancer Research. The publication highlights a partial response of 17.4 months. Now this is considerably longer than even typical OS data in these patients, let alone a partial response, and validate our biomarker demonstrating the creation of new T cell clones during the treatment. This is the first evidence published on the ability to actually predict for progression-free survival and the ultimate goal of overall survival and is the study that led to our ongoing Phase II study in pancreatic cancer.

It was also a factor of why Merck chose to be a collaborator on this study, and we look forward to announcing data on this study next year.

The publication of our study results helped drive broader appreciation for our unique oncolytic virus and its delivery within the medical community and is another important target indication and it supports our ongoing business discussions with this program.

We will also have data presented at the Annual American Society for Hematology Conference this December. This data highlighted in our recent announcement from the abstract supports an ongoing NCI-sponsored multiple myeloma study combining pelareorep with a proteasome inhibitor, carfilzomib, a.k.a. Amgen's KYPROLIS and helps us understand why we see such dramatic tumor results in these patients. Specifically, this study is investigating the potential mechanism underlying the apparent synergy of proteasome inhibition in pelareorep, and it's reported for the first time that proteasome inhibitors increased pelareorep's entry, infection and killing of multiple myeloma cells by inhibiting or minimizing any antiviral response.

Emerging positive results from this ongoing NCI-sponsored study conducted at Emory University and the University of Utah, has led to the current multiple myeloma checkpoint combination study at Emory University. These results will be presented by Dr. Flavia Pichiorri, Associate Professor at Judy and Bernard Briskin Center at the City of Hope, Los Angeles, California.

Now before handing the call to Andrew to discuss our BD efforts, we had one more corporate highlight from the quarter. Last month, we announced a strategic addition to our Board of Directors. Leonard Kruimer joined Oncolytics Board, bringing more than 30 years of experience in corporate finance, planning and strategy and M&A, 20 of which were in senior management positions in private and publicly listed biotechnology and life science companies, including his time at Crucell, where he played a leading role in selling the company to Johnson & Johnson for $2.3 billion. We're pleased to welcome him and look forward to benefiting from his extensive executive experience.

With that, now I'll hand the call over to Andrew de Guttadauro, Global Head of Business Development, to provide a brief business development review. Andrew?

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Andrew R. de Guttadauro, Oncolytics Biotech Inc. - Global Head of Business Development & President of Oncolytics Biotech (U.S.) Inc [4]

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Thank you, Matt. As I mentioned on our last call, we've seen renewed interest among large pharma in gaining access to oncolytic viruses to potentially combine with their immuno-oncology assets. This interest is reflected by deals executed by Merck, BMS, J&J, Boehringer Ingelheim and others over the past 2 years. The majority of these deals were preceded by initial clinical collaborations designed to first evaluate the viability of the combination of the oncolytic viruses in question with the acquiring company's own immuno-oncology assets. That's exactly what Oncolytics is doing with our ongoing studies designed to demonstrate potential synergies with Bavencio, Tecentriq, KEYTRUDA and OPDIVO. Potential partners' interest is firstly driven by our demonstrating pelareorep's potential to synergize with a range of checkpoint inhibitors and tumor types.

That said, these same partners are also excited about our systemic effect and attendant IV route of administration, as the latter allows for nurses to administer pelareorep in the chemotherapy suite, much the same way they do other infused cancer therapies. Pelareorep's ease of administration is attractive to potential partners because it addresses a major drawback of most OVs, which require intratumoral administration, which is an uncommonly used approach by which to treat oncology patients and carries commercial drawbacks not experienced with IV administration.

In addition, pelareorep's systemic effect allows it to directly impact metastatic disease, a critical therapeutic aspect that IT-administered OVs have yet to prove they can similarly impact. Pelareorep's systemic effect, therefore, allows pelareorep to impact cancer across a broader range of its life cycle to include its critical metastatic stage.

As Matt previously mentioned, we're also excited about pelareorep's emerging potential synergized with the CDK4/6 therapies, one of the fastest-growing drug classes in oncology, with 2019 worldwide sales projected to exceed $4 billion. Our goal is to strike a licensing agreement with either company with checkpoint assets or a company recognizing the significant clinical and commercial potential inherent in a therapy capable of being safely and efficaciously combined with multiple checkpoints to treat a range of tumor targets with unmet clinical need.

With that, I'll turn the call back over to Matt.

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Matthew C. Coffey, Oncolytics Biotech Inc. - President, CEO & Director [5]

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Thanks, Andrew. Before I hand the call to Kirk for a quick review of our financial position, let me recap our guidance over the next 2 years in terms of upcoming catalysts.

As discussed in our most recent conference call that highlighted our robust set of catalysts and milestones for the first time, within our press release that went out earlier today, and on the call, we touched on preclinical data demonstrating the synergies between pelareorep as well as another oncology drug class called CDK4/6 inhibitors. We're also on track to announce additional AWARE-1 data before the end of the year.

Our planned Phase II study of pelareorep, in combination with Merck's KEYTRUDA in multiple myeloma, is in the hands of our Lead Investigator, Dr. Kevin Kelly at USC's Norris Cancer Center. Dr. Kelly is negotiating with the FDA to finalize the protocol, and we await updates from Dr. Kelly on the study initiation.

Now looking at the first half of 2020, we expect to complete enrollment in AWARE-1 and initiate the BRACELET-1 study and report final data from AWARE-1 as well as interim data from our ongoing Phase II study in second line pancreatic cancer with Merck's KEYTRUDA in Q2 of 2020. The study should also complete enrollment around the same time.

Now the second half of 2020 will include final data from the Phase II pancreatic study and interim data from both multiple myeloma studies with OPDIVO and KEYTRUDA as well as final data from our previously mentioned NCI-sponsored multiple myeloma study combining pelareorep and Amgen's KYPROLIS. We expect BRACELET-1 to complete enrollment in the second half of 2020 as well as report interim data before the end of the year. Final data from BRACELET-1 study is expected in the first half of 2021. Now this is without question the most robust set of data catalysts of any company in the oncolytic spire space. And it's so why we're so excited about the future.

I'll now turn the call to Kirk Look, our CFO, to discuss our financial results for the quarter.

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Kirk J. Look, Oncolytics Biotech Inc. - CFO [6]

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Thank you, Matt, and hello, everyone. At September 30, 2019, we reported cash and cash equivalents of $12.3 million to fund our continuing operations. This includes gross proceeds of USD 3.7 million from our underwritten public offering, which importantly added a full quarter to our runway, giving us a stronger financial position. Our net loss for the third quarter of 2019 was $3.5 million compared to $3.3 million in the third quarter of 2018, equating to a loss of $0.16 per share in 2019 compared to a loss of $0.20 per share in 2018. Research and development expenses for the third quarter of 2019 were $1.6 million compared to $1.9 million in the third quarter of 2018.

In the current quarter, our R&D activities centered on the continued enrollment in our AWARE-1 study, preparing for the first patient to be enrolled in our BRACELET-1 study, which continues to track towards Q1 next year, and supporting our other checkpoint inhibitor combination trials. Our operating expenses for the third quarter of 2019 were $1.8 million compared to $1.5 million in the third quarter of 2018. The increase in operating expenses are primarily due to transaction costs related to our August 2019 public offering and our continued investment in our Investor Relations and business development activities.

Subsequent to the end of the third quarter and as announced in this morning's press release, we have seen some warrants exercised with proceeds of over $1.25 million on the back of the recent share price appreciation, which has more than doubled in the last month. With our cash on hand, along with the proceeds from our warrants and our ATM, Oncolytics is positioned to capitalize on our catalysts and milestones.

With that, I'll turn it back to Matt.

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Matthew C. Coffey, Oncolytics Biotech Inc. - President, CEO & Director [7]

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Thanks, Kirk. Now before we take questions, I want to reiterate just how highly differentiated we are within the oncolytic virus world, which as Andrew highlighted, is an area that is very attractive to large pharma.

Now almost all of these in development, including the only approved OV in North America, are genetically modified and require antitumoral delivery and therefore, cannot reach metastatic disease. We are the only OV with meaningful data demonstrating efficient and selective viral replication within the tumor following systemic delivery. Now this is supported by multiple scientific publications and highlighted by the recent meta-analysis presented at IOVC.

We also feel that this is still significantly underappreciated and believe will be a great source of value as we build our critical mass of data, continuing to confirm our intravenous systemic delivery. Pelareorep remains the only viral agent to show a survival benefit in late-stage metastatic breast cancer. Now these outstanding results have generated multiple big pharma partnership opportunities where discussions remain very active.

As we continue to advance our lead clinical program in breast cancer, our goal is to continue expanding our pipeline to access additional markets with an unmet need and to explore combination therapies with checkpoint inhibitors and other drug classes in oncology.

As I described, Oncolytics is entering a rich period of data catalysts over the next 21 months. We look forward to achieving these milestones in line with our guidance and guidance supplied by that of our clinical investigators and to build additional value for our company and its shareholders.

Now before we go to Q&A, I'd like to touch on a couple of things. First, I'd like to say welcome to our newest covering analyst, Jerry Isaacson at Roth Capital. Happy to see the interest in Oncolytics and the OV space. Second, and it's very important, as I know it's been on many people's minds, today was the 10th day in a row that we closed above $1 on NASDAQ and expect to receive formal notification from them as soon as being back in full compliance. We always knew we would meet this compliance issue, but happy to have it addressed as quickly as we did. I'd now like to open the lines to take some of your questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from John Newton (sic) [Newman] from Canaccord.

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John Lawrence Newman, Canaccord Genuity Corp., Research Division - Principal & Senior Healthcare Analyst [2]

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You mentioned, I think, at the beginning of the call that you will be presenting some additional data for AWARE-1 by the end of this year. Just wondered if you could talk a little bit more about that.

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Matthew C. Coffey, Oncolytics Biotech Inc. - President, CEO & Director [3]

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Yes, John, thanks for the question. And sorry, everyone, I got a cough, I've had a cold all day, so I sound absolutely terrible, my apologies. So AWARE-1, just a reminder for everyone, AWARE-1 is the window of opportunity study. So these are women who are otherwise healthy, but they have a very small primary breast cancer lesion. Now going into this study, we first didn't know if the virus would actually access primary disease. So we were delighted that it did. But the other thing that we're very concerned about is Tecentriq is -- it can be toxic, and this is exacerbated if your immune system is completely healthy. You can imagine ramping up your immune system could potentially be harmful to the patient. So fortunately, it was tolerated in the patients when we presented all that initial data.

The next safety cohorts are in hormone receptor-positive patients only in standard of care and virus. And this cohort, I think almost all of them have either undergone surgery or are about to in the next week. So we'll do a similar analysis looking at cell TIL or inflammatory cell count, T cell characterization, both CD8 positives as well as using multiplexing to show whether Tregs are entering or exiting the tumor. And so we should have a pretty good sense from these first group of patients whether we see the diminishment of Treg in the presence of checkpoint inhibitors or if the virus can do it on itself. The number of clones, we're very interested to see whether or not the Tecentriq is expanding those as well as just looking at the cytokine profile and response in these patients.

So we're hoping to have that out, hopefully, December, if we can get everything on test quickly enough, but there'll be a DSMB meeting to review the safety of this combination as well. So we'll have that out to the marketplace with fuller data provided first quarter next year. And we're still hoping that this will be presented at ASCO 2020.

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Operator [4]

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And our next question comes from Wangzhi Li from Ladenburg.

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Wangzhi Li, Ladenburg Thalmann & Co. Inc., Research Division - MD of Equity Research of Biotechnology [5]

See the rest here:
Edited Transcript of ONC.TO earnings conference call or presentation 12-Nov-19 10:00pm GMT - Yahoo Finance

Not everyone with diabetes is able to keep their blood sugar levels within a reasonable range. When blood glucose levels fluctuate from one extreme to the other every day, the patient is diagnosed with brittle diabetes.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

As anyone who struggles with this condition knows, blood sugar levels that go up and down cause symptoms that can be severe enough to interfere with daily life. Efforts to control these unpredictable sugar swings and the symptoms they cause can be a source of frustration that only gets worse if you are made to feel responsible.

Some healthcare providers miss the diagnosis of brittle diabetes, because they think the patient is not being compliant, says endocrinologist Betul Hatipoglu, MD. However, most people try every trick in the book to bring their blood sugars in line, and nothing works.

Brittle diabetes primarily occurs in people with a long history of type 1 diabetes (juvenile diabetes), although it can occur in those with severe type 2 diabetes who take insulin.

Over the course of many years, diabetes damages the autonomic nervous system, which governs digestion. This interferes with the normal digestive process and affects how food is absorbed.

The body cannot regulate the release of insulin appropriately. Blood sugar levels swing wildly, no matter what you do to try to stop it.

Symptoms caused by very high and very low blood sugar levels can be frightening, and even dangerous. The extent and severity of symptoms interfere with quality of life. Many patients are unable to hold a job, or even make advanceplans with confidence. Personal relationships can suffer. Some patients end up in the emergency department multiple times a week.

Fear of low sugar levels is compelling, because the condition can cause someone to pass out. If it happens behind the wheel of a car, the result can be tragic.

Because it may be hard to sense when blood sugar levels are falling, some patients subconsciously keep their blood sugar levels on the high side. This is unwise, Dr. Hatipoglu emphasizes.

High blood sugar can be as dangerous as low blood sugar or even more so. Over time, consistently high sugar can damage the eyes and kidneys or induce coma, she says.

If this scenario sounds familiar, Dr. Hatipoglu recommends making an appointment with an endocrinologist who specializes in diabetes.

The first step is to ensure other hormone levels are normal.

I do a blood test to make sure something else isnt going on, such as hypothyroidism or adrenal insufficiency, says Dr. Hatipoglu. These things can be easily fixed.

If the diagnosis is brittle diabetes, Dr. Hatipoglu makes a recommendation that often surprises patients: She tells them to stop worrying so much about maintaining tight glucose control.

I suggest they relax their Hba1c goal a bit. They are already very stressed, and its not necessary to be so strict, she says.

The good news is that new technologies can be effective in controlling blood sugar swings and help you feel better. These include continuous glucose monitoring systems and closed-loop insulin pumps.

We dont hesitate to recommend them, if we think they will help, says Dr. Hatipoglu.

Sometimes, a pancreas transplant is the answer. As soon as the new pancreas produces insulin, the patients diabetes is cured. Yet surgery isnt always necessary. Closed-loop insulin pumps can be almost as effective as transplantation although they dont reverse the disease, says Dr. Hatipoglu.

These options mean that brittle diabetes is no longer a life sentence. However, to take advantage of these exciting options, the problem must first be diagnosed.

If you cant get your blood sugar levels under control, dont blame yourself and dont take measures that might actually be harmful, says Dr. Hatipoglu.

See a diabetes expert to determine whether an advanced technology may be helpful for you.

This article originally appeared in Cleveland Clinic Heart Advisor.

Continued here:
Trouble Controlling Your Blood Sugar? It Could Be 'Brittle Diabetes' - Health Essentials from Cleveland Clinic

Maybe youre going through a particularly grueling period at work think tons of deadlines, responsibility on a major project or battling for a promotion. Simultaneously, youre also feeling exhausted as hell.

Most people associate stress with feeling wired. But stress and fatigue also go hand in hand. Its actually fairly common to feel the need to fall asleep when youre incredibly high-strung, although nothing has been definitively confirmed in scientific literature as to why.

Experts do have some theories, however. Stress frequently impacts your sleep cycle, said Deirdre Conroy, clinical director of the Behavioral Sleep Medicine Clinic at Michigan Medicines Sleep Disorders Centers.

When were under a lot of stress, the continuity and quality of the sleep can be affected, Conroy said. It might take longer to fall asleep, or we might have frequent or sustained awakenings during the night after we have fallen asleep. Broken sleep can increase your feelings of fatigue during the day.

Stress can also interfere with the quality of sleep while youre out, leading to a higher percentage of light stages of sleep across the night, according to Conroy. Since your body typically recharges during periods of deeper sleep repairing tissue, resting muscles and boosting immunity you might feel like youre not getting enough sleep.

You might also experience standard insomnia some nights, which will make you feel poorly rested.

Stress is a well-known contributor to insomnia, said Aric Prather, an associate professor in the Department of Psychiatry and Weill Institute for Neurosciences at the University of California, San Francisco.

Stress exposure can lead to more cognitive arousal, like rumination about what happened, and so on, Prather continued. Related to this, its thought that stress likely leads to increased activation of the sympathetic nervous system the fight-or-flight response and this can impair your ability to relax.

When Stress Leads To Extreme Fatigue

Doucefleur via Getty Images

Sleepiness is one thing, but some people experience intense fatigue during periods of high stress to the point where it can be debilitating. Experts have a few theories as to why, the first being that the fight-or-flight response simply taxes the bodys energy levels.

Because it is so metabolically expensive to keep the body on high alert, sleepiness may occur so that the body can replenish that energy, Prather said.

Others think that sleep is a coping mechanism for stress, because it can be so exhausting and unpleasant.

Under periods of stress, many people choose to spend excess time in bed, and often fall asleep, as a way of escaping from the stress, Prather explained. Because sleep, at least in the short term, can provide some relief from the distress, sleeping behavior can be reinforced.

Prather said that if you consistently use sleep as a means to escape stressful life periods, wanting to climb into your covers can become increasingly hard to resist and habitual.

The last theory is that your brain simply can only handle so much stressful content.

Theres the possibility that the brain can only hold so much emotional information, and sleep helps clear some space and help figure out which daily experiences need to be put in long-term memory storage and what can be discarded, Prather said. Stress can produce high-arousal emotional information, and thus sleep may be needed earlier than usual.

How To Handle Sleepiness When Youre Stressed

Jose Luis Pelaez Inc via Getty Images

First and foremost, if youre unsure whether your sleepiness is normal, you should get it checked out by a doctor.

Routine blood tests collected at a doctors visit are very important if you are experiencing chronic symptoms of insomnia, Conroy said. Abnormal levels of hormones, like thyroid-stimulating hormone, can affect how we feel during our waking hours.

Conroy also said to pay attention to your diet and fitness regimen. Skipping workouts and loading up on high-sugar or high-carb meals may make you sleepy or lead to an energy crash.

Make sure you are drinking enough water, and have a regular exercise routine, Conroy said.

You can also eliminate fatigue when youre stressed by pacing your activities during your waking hours.

Dont overdo it or underdo it, Conroy said. Engage in some form of relaxation, and paying attention to avoid unhelpful thought patterns. Thinking, Im never going to finish this, or, I am way too busy to take time out for myself is going to keep you in the same, tired cycle.

Prather said that you should make sure to carve out some me time no matter how many deadlines you have, or how big the project.

Stressors can feel all-consuming, but they dont have to be, Prather said. Scheduling things that you enjoy, like yoga or getting out in nature, can be really revitalizing and stress-reducing.

Yes: That midday break might help you go longer and be sharper. Prather said theres no sense ignoring how your body is feeling, as it wont go away by continuing to push yourself. Rest. Then, get back to it.

Read the original post:
Why You Struggle To Stay Awake When You're Stressed - HuffPost

The Health Promotion Office is offering free light therapy sessions to help Central Michigan University students combat the effects of Seasonal Affective Disorder.

Seasonal Affective Disorder (SAD) is a type of depression that occurs each year around the same time, usually starting in fall or winter and ending in spring or early summer, according to the Cleveland Clinic. Symptoms include fatigue, difficulty concentrating, weight gain and an increased desire to be alone.

Light therapy has been proven to help battle symptoms of SAD. According to Healthline, sunlight has beneficial effects on our body and mood. Exposure to sunlight increases the brain's release of a hormone called serotonin. Serotonin is responsible for making us feel awake and energetic. When we dont have enough serotonin, thats when we start to feel the symptoms of depression.

The Health Promotion Office offers 30-minute light therapy sessions in which the patient is exposed to a light source simulating sunlight. The student can read, do homework, play on their phone, anything theyd like during these sessions.

Regular office lighting found in classrooms is around 500 lux (unit of illuminance) and an overcast day is about 2,000 lux. The lamp used in the light therapy sessions contains about 10,000 lux, the same amount of lux as a bright sunny day.

The main objective is to expose the eyes to the sunlight, said Lori Wangberg, Director of the Health Promotion Office, The eyes are the receptors to the brain."

Wangberg said Ultraviolet rays are filtered out by a protective screen, so there will be no damage to the eyes or skin from the light.

It is safe to use every day," she said.

Wangberg said SAD doesnt affect everyone in the same way. Some students might need multiple sessions each week to start feeling better, while others may notice a difference after just one session.

Around the month of November is when Wangberg sees the most students coming in for sessions. She tries to keep her office person-centered," meaning the students get to control how often they come in for their sessions.

Wangberg also partners with the Counseling Center. If a student decides that light therapy may not be working for them, she can still give them the resources or connections that they need.

For more information, or to schedule an appointment, call the CMU Health Promotion Office in Foust 205 at (989) 774-4446.

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Health Promotion Office offering sunlight therapy to students - Central Michigan Life

The popular weight-loss trend ofintermittent fastingisnt going anywhere and has only continued to gain steam, with celebrities likeKourtney Kardashian,Hugh JackmanandChris Prattextolling its virtues. The latest stars to jump on the fasting bandwagon areJenna Bush Hager and Hoda Kotb, who decided to try intermittent fasting together (and publicly weighed themselves on camera on Today with Hoda and Jenna).

So what, exactly, is intermittent fasting? Intermittent fasting is a weight loss or weight control strategy where youre cycling between periods of eating and fasting,Sarah Adler, PhD, a psychologist with the Stanford Eating Disorder and Weight Control Clinic, tells Yahoo Lifestyle.

There are several ways to do intermittent fasting, but it typically involves choosing a specific window of time in which you can consume food or caloric drinks. It can be as simple as skipping breakfast and eating at noon or finishing your last meal earlier, says Adler.

One popular method is 16:8, where people fast for 16 hours and only eat during an 8-hour window, such as noon to 8 p.m. While fasting for 16 hours does sound like a lot, keep in mind that includes (hopefully) 8 hours ofsleep. Theres also the 5:2 method whichJimmy Kimmelfollows where people eat restricted calories (such as 500-600 calories per day) for two nonconsecutive days and then eat normally for the other five days.

For many who are able to stick with it, intermittent fasting is the magic bullet forweight loss. Ive seen a lot of people who have struggled with weight loss and have done intermittent fasting, and it seems to be the magic bullet for them,Liz Weinandy, a registered dietitian at The Ohio State University Wexner Medical Center, tells Yahoo Lifestyle. Its because people are not eating as much.

Theyre also eliminating late-night eating, which can include less-than-healthy options like chips and ice cream. Once they stop eating after dinner, that alone helps a lot of people start to lose weight, says Weinandy. For a lot of people, theyre not eating those extra 300 or 400 calories.

Intermittent fasting can also have a diuretic effect when the body gets rid of excess water which leads to some fluid weight loss as well, according to Weinandy.

However, its worth noting that some researchers say theres not enough scientific evidence on the long-term weight loss effects of intermittent fasting. The research based on the efficacy of intermittent fasting is fairly limited in humans, so most is anecdotal, says Adler. In addition, a 2018 Germanstudy described as the largest investigation on intermittent fasting to date involving 150 overweight and obese people on either intermittent fasting or conventional calorie-restricting diets, who were examined over the course of a year, found that intermittent fasting wasnt any more effective at weight loss than calorie restriction.

That said, intermittent fast has other health benefits. Insulin levels go down, says Weinandy, because if youre not taking in any food, especially carbohydrates, our blood sugar isnt going up.

Adler explains that when you eat carbs, for example, the body breaks it down and converts it into sugar (glucose). But if you eat more than your body can use for energy, the sugar gets stored in fat cells."Insulin brings sugar into fat cells and keeps it there," says Adler. "Between meals, our insulin levels go down and our fat cells release the stored sugar to use as energy. Intermittent fasting allows for insulin levels to drop so that [stored sugar] gets burned off."

There are other positive metabolic effects, including an increase inhuman growth hormone. Its important for muscle maintenance, especially as we get older, says Weinandy. Intermittent fasting also appears to help on a cellular level torepair DNA, says Weinandy, by triggering autophagy the bodys way of cleaning out damaged cells to then generate new, healthy ones.

However, not all types of intermittent fasting are created equal. Research around intermittent fasting that shows health benefits are really limited to a very specific kind of intermittent fasting basically, the 16:8 method, points out Adler. The health benefits have not been shown to be associated with other forms of intermittent fasting, like the 5:2 method.

Most side effects are fairly minimal, notes Adler. When people first start intermittent fasting, some may experience mild headaches or lightheadedness. In some cases, people who are not following the 16:8 method may find themselves overeating at other meals. With intermittent fasting, 16:8 has been shown to reduce overeating in other meals, says Adler. Outside of that is when youre getting overeating, increased hunger, and loss of energy.

The eating method also isnt right for everyone, says Weinandy. For example, some may find that skipping breakfast in the morning isnt sustainable. In that case, not snacking after dinner, such as cutting off food by 8pm (or earlier in the evening), may work better for them. Dont go hot and heavy into it, suggests Weinandy. Gradually stop eating after dinner.

Adds Adler: "People need to use an approach that works for them and is sustainable for them.

In general, its considered pretty safe for the majority of people, says Weinandy. But women who arepregnantor are trying to get pregnant, as well as women who arebreastfeeding, should not attempt to do intermittent fasting. Also, Anyone who has a history of eating disorders should not be intermittent fasting, notes Adler. People with heart conditions and diabetes who are interested in trying the method should be monitored by a physician, who is knowledgeable about metabolic conditions.

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What you need to know about intermittent fasting and who should avoid it - Yahoo Lifestyle

Addison disease occurs due to the injury of the adrenal cortex which causes insufficient generation of the hormone aldosterone and cortisol.Indications of Addisons disease are known as primary adrenal insufficiency, resulting from insufficient production of two hormones cortisol and aldosterone.

Treatment options for Addisons disease include many medications, usually in the form of tablets, depending on the specific hormones that the body is missing.

The drugs required to effectively treat Addisons depends on the hormones that are no longer being effectively produced in the adrenal glands.

Access Report Details at: https://www.themarketreports.com/report/global-addison-disease-testing-market-research-report

The global Addison Disease Testing market is valued at xx million US$ in 2018 is expected to reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025.

This report focuses on Addison Disease Testing volume and value at global level, regional level and company level. From a global perspective, this report represents overall Addison Disease Testing market size by analyzing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, China and Japan.

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Table of Content

1 Addison Disease Testing Market Overview

2 Global Addison Disease Testing Market Competition by Manufacturers

3 Global Addison Disease Testing Production Market Share by Regions

4 Global Addison Disease Testing Consumption by Regions

5 Global Addison Disease Testing Production, Revenue, Price Trend by Type

6 Global Addison Disease Testing Market Analysis by Applications

7 Company Profiles and Key Figures in Addison Disease Testing Business

8 Addison Disease Testing Manufacturing Cost Analysis

9 Marketing Channel, Distributors and Customers

10 Market Dynamics

11 Global Addison Disease Testing Market Forecast

12 Research Findings and Conclusion

13 Methodology and Data Source

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Global Addison Disease Testing Market: Development History, Current Analysis and Estimated Forecast to 2025 - Market Research Reporting

In late October, Dr. George Delgado addressed an annual gathering of doctors at a west-end Ottawa hotel. The 150 members of Canadian Physicians for Life in attendance greeted the San Diego doctors presentation on his Abortion Pill Reversal Protocol, with great enthusiasm.

According to Delgado, a medical abortion can be rewound once started, should a woman change her mind halfway through the process.

The reversal involves injecting or prescribing large doses of progesterone to women who have taken the first of two abortion medications, but not yet the second.

The highly controversial experimental practice is behind a creeping number of abortion reversal bills being introduced in the U.S. laws that compel doctors, on pain of civil or criminal penalties, to inform women that it may be possible to undo a medication-induced (but not surgical) abortion once started, a claim the American Medical Association and other leading medical groups say is patently false and wholly unsupported by scientific evidence.

We know that not all women know about this because its still relatively under-publicized

Critics say state laws as well as pro-life groups promoting reversal on the internet are playing into old political and social narratives that women cant be trusted to make choices on their own, that they choose abortion hastily and that, once the choice is made, many regret it. It introduces this feeling that women need to be protected from their own decision, which is, of course, completely untrue, said Dr. Alice Mark, medical director of the National Abortion Federation. Studies have shown that that vast majority of women who choose abortion are certain about their choice their decisional certainty is higher than for almost any other medical procedure, Mark said. They do not end up in an abortion clinic by mistake.

According to Delgado, more than 900 babies, including Canadian babies, have been born after a successful reversal since he and co-author Mary Davenport first reported a tiny case series in 2012 involving just six women. Another 100 women, he claimed, are currently pregnant. The figures, he said, are based on calls to Abortion Pill Rescue, a network of physicians prepared to initiate reversal protocols when a woman contacts the toll-free hotline. Canadian doctors are among them.

I know of one physician (in Canada) who has taken four women already through to successful births, said Canadian Physicians for Life executive director Nicole Scheidl.

We also know that not all women know about this because its still relatively under-publicized, Delgado told the National Post. And so I imagine that if every woman who started the process of medical abortion knew about the possibility of reversal there would probably be more women who would be requesting reversal.

Weve had several many anecdotal reports of women calling these abortion centres and being told that reversal is not possible, or your baby is sure to have birth defects, which is a lie.

But experts say medical abortion isnt considered a reversible procedure in any country where the two-pill abortion regimen is legal and that abortion reversal bills, which have faced successful legal challenges, are ideology wrapped in bad science government-mandated messaging that violates physicians First Amendment rights to freedom of speech, as well as their ethical duties, by forcing them to give women information about an unproven therapy.

In addition to the obvious ethical issue of claiming a treatment for which the science hasnt proven it, the bigger issue is that it once again raises suspicion about the role of abortion providers and the safety of abortion, said Dr. Dustin Costescu, a family planning specialist at McMaster University and a principal author of Canadian guidelines on the abortion pill.

Suggesting that medical abortions can be undone with treatment could also have the contradictory consequence of encouraging woman who arent certain they want to abort to take the abortion medicines, unrealistically thinking they might reverse later, said Dr. Wendy Norman, a leading researcher in reproductive health at the University of British Columbia.

Here, in theory, is how Delgados protocol works: Approved in Canada three years ago, the two-step abortion drug the unwieldy-named Mifegymiso pairs one drug, mifepristone with a second, misoprostol.

Taken first, mifepristone blocks the hormone progesterone, which normally helps prepare the lining of the uterus for a pregnancy. The lining becomes less stable, breaks down and sheds, similar to what happens during a womans menstrual period. Misoprostol, taken 24 to 48 hours later, causes the uterus to contract, expelling the pregnancy.

Under Delgados method, within 72 hours after taking mifepristone, the first pill, a woman can be prescribed progesterone to keep mifepristone from binding to progesterone receptors. Flooding the body with progesterone blunts or outcompetes the mifepristone, reversing its effects, Delgado said.

On pro-life websites in Canada, women who take the first pill are told the process CAN be reversed, but that time is of the essence. Canadian Physicians for Life tells women that if you would like to keep your baby, they have two options: contact the abortion reversal hotline to be connected to a local doctor, or, if there isnt a doctor registered with the network in their area, to take a Dear Colleague form letter immediately to their family doctor or nearest walk-in clinic for the supplemental progesterone.

Of Delgados six-case study of abortion reversal with progesterone published in in 2012, four of six women carried their pregnancies to term.

People who might be opposed to abortion pill rescue seem to have forgotten their entire purpose of promoting choice for women

More recently, the California doctor published a retrospective review in Issues in Law and Medicine, a journal co-sponsored by a pro-life organization, based on data from the abortion rescue hotline. The study initially involved 754 women who took progesterone in an effort to reverse the abortion. After excluding a quarter of the women for different reasons, Delgado and colleagues reported an overall rate of reversal of 48 per cent, rising to 64 per cent among women given progesterone via injection. There was no apparent increased risk in birth defects, they said.

Among the many troubling problems he has with the study (including the number of women excluded or lost to follow-up), Costescu pointed out that mifepristone alone is not an effective abortion-inducing drug. In studies of women who stopped after taking mifepristone only, the continuing pregnancy rate ranged from eight, to 46 per cent.

You need the second medication that brings on the actual contractions that allow for expulsion or delivery of the fetus, Costescu said. As Dr. Daniel Grossman of the University of California, San Francisco and Kari White of the University of Alabama at Birmingham wrote in the New England Journal of Medicine, There is no evidence that treatment (with progesterone) is superior to doing nothing at all. Laws promoting reversal, they wrote, essentially encourage women to participate in an unmonitored research experiment.

There is no evidence that treatment is superior to doing nothing at all

Although progesterone is considered low-risk its often given to women at danger of miscarrying the hormone has been associated with depression, high blood pressure and other problems. Progesterone also hasnt been approved in either the U.S. or Canada for use in reversing the effects of the abortion drugs.

Abortion interruption bills arent going unchallenged: Just days before Delgados presentation to the Ottawa gathering of doctors, an Oklahoma judge temporarily halted a law that threatens doctors with felony charges if they dont inform women about reversal treatment.

A North Dakota judge issued a similar ruling in September, calling that states reversal law devoid of scientific support.

Dr. Will Johnston, a Vancouver family doctor and past president of Physicians for Life, said he doesnt believe in getting laws involved in ensuring informed consent. Its an intrusion, he said, that comes too close to compelled speech.

However, women simply deserve to know whats available to them, Johnston said. If there is any chance that the progesterone could help and its not harmful, why this vociferous opposition to it, he said.

People who might be opposed to abortion pill rescue seem to have forgotten their entire purpose of promoting choice for women. Why would you say that once a woman takes a pill I approve of that she loses her choice to try to reverse its effect if she changes her mind? Its just illogical, and its unfeeling and uncaring toward women.

Mark, of the abortion federation, said reversal proponents are creating a problem where none exists, because vanishingly few women who take the first abortion pill decide not to take the second. According to data obtained by Grossman and White, (the authors of that New England Journal of Medicine article) from the American manufacturer of mifepristone, less than 0.004 per cent of patients who took the drug between 2000 and 2012 ended up deciding to continue their pregnancies.

If women are second-guessing their decision they can benefit from other forms of counselling that we can provide, Costescu said. But the medical answer would be to wait and to see what happens after taking that first medication. (Mifepristone, the first pill, is not known to cause birth defects. Misoprostol, however, has clearly been shown to cause fetal malformations.)

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This U.S. doctor says he can 'reverse' a medical abortion and experimental practice is used in Canada - National Post

The Enigma Wellness Clinic at College Road is successfully helping many people on their journey to parenthood and personal wellness. Located above the landmark premises of The Huntsman Inn Hotel on College Road, it is based in a beautiful, state of the art premises where we met owner and lead practitioner, Maura Farragher, to discuss her recently launched specialist fertility enhancing programmes, which support individuals and couples to prepare and plan a healthy and sustainable pregnancy.

Mother of three, Maura, a registered nurse and midwife, has more than 20 years experience of patient care and nurturing clients with a combination of complementary therapies including acupuncture, Chinese herbal medicine and energy healing. What strikes you immediately is Mauras sense of calm and obvious passion for what she does in helping individuals and couples achieve happier, healthier, lives to fulfil their life dream of having a baby and starting family life.

"It is a privilege to work with couples planning a pregnancy and seeing them overcome struggles to fulfil their desire to start their own family, said Maura. "These programmes can help ease you into being ready to conceive and to create the right conditions in which this will happen. In some cases, I see the heartache of miscarriage and I work with my clients to be able to try again. There has been a major shift over the last 10 years in peoples knowledge and openness to using complementary therapies they are now becoming more mainstream."

Clients go to Enigma Wellness Clinic with many different issues including fertility problems, miscarriage, endometriosis, polycystic ovaries and these can be discussed sensitively with Maura in the privacy of the clinic. Many present with low hormone levels which manifest themselves with symptoms of fatigue, irregular cycle, weight gain, a sluggish thyroid, unwanted hair growth, lower back weakness, clients suffering from the cold or feeling hot at night time can all indicate issues. Factors that have a big impact on fertility are poor sleep, stress, smoking, alcohol consumption, diet and lifestyle choices.

Getting the balance right

Maura is a firm believer that it is important to get the balance right in the body to assist your fertility naturally so as to increase your success rate, whether you conceive naturally or opt for IVF. She has researched and studied extensively and is passionate about the benefits of using holistic therapies acupuncture, Chinese herbal medicine and some energy healing which when combined can boost and regulate the endocrine system, restore hormone balance which in turn may help to lengthen the females reproductive cycle as well as boost hormonal production and balance in men.

Marking the launch of Enigma Wellness Clinics Fertility programmes, which assist couples to fulfil their life dream of beginning a family together and bringing a healthy baby into their lives, Maura shares some mementoes of her own. Pictured are baby shoes belonging to Mauras youngest child. Photo Julia Monard

Along with lifestyle and dietary advice, Maura listens carefully and works with the client, prescribing a plan to follow with regular therapy appointments over a four to sevenmonth period. This duration is needed to effect change in the endocrine system and to build the lining in the uterus to assist you to become baby-ready.

Maura explained that the body is the foundation for creating the baby that you are planning.

"One might imagine that it is like preparing the soil before planting as it is the quality of the soil that influences the production and health of the plant so by doing this, you are doing everything possible to prepare the first home for your future child that is your own body,"

Not only will the pregnancy become easier but it can have long-lasting benefits to your new babys health and well-being. Both females and males attend for fertility issues some individually and often as couples so the Enigma Wellness Clinic offer couples programmes as well as Dad-to-be treatments.

Maura Farragher, Lead Therapist and owner at Enigma Wellness Clinic pictured taking time out at The Huntsman where the clinic is based.

European Fertility Awareness

Week 2019 Last week was European Fertility Awareness Week which, since 2016 raises awareness across Europe about infertility and issues faced by couples with infertility. Over the past few weeks, many high profile stories featured in the media highlighting the plightof couples desperately trying to start a family, some with success, and many without.

One common thread supported by considerable scientific research on the issue is that late motherhood is on the rise in western society, the average age of all mothers at maternity for births registered in quarter 1 2019 was 33.0 years (CSO ).

With more and more couples starting their families for the first time later in life, there is no escaping Mother Natures fertility clock, making becoming pregnant naturally more difficult with medical intervention in the form of invitro-fertilisation (IVF ) sometimes becoming the only path to conceiving a new baby.

Despite the great advances in IVF over the years, there are, unfortunately, no guarantees that every couple will successfully conceive and carry to full-term the baby they so long for. High profile celebrities featured in the media, telling their own moving stories of the harrowing journey and trauma of multiple miscarriages and repeated unsuccessful IVF attempts.

The good news is that Ireland has the third highest fertility rate in the EU, although the average woman is older than 30 when she has her first child. There is also a high proportion of women who start their family in their forties compared with other nations. For increased chances of success, there is a growing trend of couples turning to traditional holistic complementary therapies and lifestyle changes to give themselves the best possible chance of conceiving naturally and giving birth to the healthy, happy, baby they have long been yearning for.

Enigma Wellness Clinic

At Enigma only high quality ethically produced products are used. Maura is determined that everything about her practice is kind and supportive both to the client and the environment. Mauras bespoke Chinese herbal remedy tinctures are formulated to each individual clients needs. She has gone to great lengths to research her suppliers of herbs which come from sustainable sources. restoring inner balance and harmony, improving energy and mood, which aids in balancing hormones and boosts endorphins and hormonal production naturally present in the body.

The use of herbal medicine which has its origins in ancient cultures, is increasing worldwide. It involves the medicinal use of plants to treat health disorders and enhance general health and wellbeing. It is a natural approach to healing, stabilising hormones and metabolism, treating disorders and avoiding the use of chemicals.

Maura is qualified in Chinese Herbal Medicine and holds a Diploma in Traditional Chinese Herbalism 2010 (Acupuncture Foundation ). She served on the Board of the Acupuncture Foundation Professional Association (AFPA ) for several years and is a member of the Irish Herbal Association.

Full details of the fertility programmes see http://www.enigmawellnessclinic.com contact Maura on 087 6486043 to book a free 20-minute consultation; or email [emailprotected]

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Enigma Wellness Clinic helping people on journey to parenthood and personal wellness - Galway Advertiser

The skin is in many ways the largest organ of the human body. It provides the first line of defense in the immune system since it helps to prevent many pathogenic organisms from gaining entry into our body. Our skin also contains many sensory receptors that allow us to sense our environment. We can sense pressure, touch, temperature changes, and pain, all through special structures in our skin which are attached to nerve fibers.

There are three main layers making up the skin. The outermost layer is the epidermis which consists of stratified squamous epithelial cells which are designed to be sloughed off. These are close-fitting cells which have no blood supply. This layer of cells provides a waterproof barrier and protection for the underlying tissue layers. There are cells present in the epidermis that make the protein keratin, these are cells called keratinocytes. The dermis is the layer of skin that occurs below the epidermis of the skin.

The dermis is the layer where you find blood vessels, nerves and also where the hair follicles grow from. Sweat and sebaceous glands are also found in the dermis of the skin.

Beneath the dermis is the hypodermis which contains areolar connective tissue and adipose tissue. The areolar connective tissue contains various cells including macrophages and fibroblasts, which are scattered in a matrix of collagen and elastin fibers. Macrophages are immune system cells and fibroblasts make fibrous proteins such as collagen. The adipose tissue consists of the fat cells, which are important in helping to protect our internal organs and as a source of stored energy for times when we may be starving.

The condition of our skin is influenced by a combination of many internal and environmental factors, including exposure to toxins in the environment. If you have fair skin you also have a greater risk of damage from the sun.

This is because people with darker skin have more melanin pigment which helps protect against the harmful effects of UV radiation. Excess UV radiation can cause genetic changes in skin cells that can lead to skin cancer, but some sunlight is important for vitamin D synthesis. In fact, vitamin D may help to prevent some illnesses such as heart disease, and thus some sunlight exposure is necessary for good health. Internal factors also influence the health of our skin, including our genetics and hormone levels, and allergies can often manifest as skin rashes or hives.

Over time, as we age, our skin tends to become thinner and may sag and droop. This can lead to aging of the face and, in the case of women, sagging of the breasts. There are cosmetic surgeries that can deal with many of the problems associated with sagging skin. You can consult with a specialist at a clinic such as the Vera Clinic to find out what procedures can be done to tighten up skin and regain a more youthful appearance to the body.

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Factors that influence your skin - CelebMix

Image: Proliferating cells in a tumour organoid of triple-negative breast cancer. Credit: Dr Rebecca Marlow

Researchers have uncovered a potential cause of sustained resistance to hormone therapy in the most common form of breast cancer.

The majority of breast cancersare hormone receptor positive these are cancers which have an oestrogen receptor on the surface of the cells. Hormone therapy is an effective treatment, but roughly 40 per cent of women relapse with a form of the disease which proves resistant to available treatments.

Scientists found that breast cancers which had become resistant to hormone therapy have a molecular advantage that helps their cells successfully evade hormone therapies, which are the best treatment option currently available for patients with hormone receptor positive (or ER+) cancers.

The study, led by researchers at Department of Experimental and Clinical Biomedical Sciences at the University of Florence, Italy, in collaboration with colleagues at The Institute of Cancer Research, London, has shown that breast cancer cells which are resistant to hormone therapy have more of a microRNA molecule called miR-23b-3p.

MicroRNA is involved in gene expression controlling whether a gene has an effect or not, and how much and the researchers found that miR-23b-3p causes a decrease in a type of protein for transporting amino acids which are either alkaline or neutral in pH.

In resistant breast cancer cells, a rise is seen in a different type of transporter which deals with the acidic amino acids glutamate and aspartate. Cells which are reliant on these acidic amino acids are able to continue to successfully resist hormone therapy treatment.

Scientists in our Division of Breast Cancer Research have been involved in some of the most famous discoveries in the history of breast cancer research. Learn how the ICR is tackling the most common type of cancer among women, which affects around one in eight women in their lifetime.

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In this study, which was published in Cell Reportsand funded by Associazione Italiana per la Ricerca sul Cancro (AIRC)and Fondazione Umberto Veronesi, researchers used multiple models of cancer including the so-called patient-derived xenografts, which originate from a patient but are then implanted into a mouse model to aid their study and monitoring.

This allowed for careful and thorough experimentation on naturally growing cancers and provides data which is relevant for the original patient.

By looking at the expression of all of the genes in the cancer cells, scientists could point out which substances were being made in excess, and which substances were made in shorter supply.

Analysis of these results led to researchers painting a picture of which molecules the cancer cells were reliant on as fuel sources, and which substances cells were not able to make use of.

Cells unable to transport neutral and basic amino acids become forced to rely on their acidic counterparts.

The scientists then showed that increasing the levels of aspartate and glutamate in ER+ breast cancer cells was related to the development of resistance to endocrine therapy.

Whats more, shutting down the cells ability to move aspartate and glutamate inside the cell reduced the ability of endocrine therapy resistant cells to spread, proving that there is a robust relationship between these molecules and the cancer cells ability to survive and thrive.

Dr Andrea Morandi, an Assistant Professor of Biochemistry and Group Leader at the University of Florence, who led the research and was previously a postdoctoral fellow in the Division of Breast Cancer Researchat the ICR, said:

It was great to collaborate with colleagues at the ICR on this paper to examine the factors that drive resistance in breast cancer in the experimental setting.

We know that 40 per cent of patients with this cancer who respond to treatment will go on to relapse with a form of the disease that is resistant to all available treatment options. Uncovering the molecular basis of this is a critical step in towards understanding what helps drive cancers resistance to treatment.

In the future we hope this research will provide valuable information to help predict the likelihood of relapse in patients with hormone therapy-resistant cancers, as well as providing insight into a potential new way to treat these cancers.

Dr Lesley-Ann Martin, former Group Leader in Endocrinologyand the lead ICR researcher on the study, said:

This analysis gives information about the key molecular players involved in ER+ cancers which are resistant to the current front-line treatments in our experimental settings.

Further work will determine whether the findings presented in this work have significance in the clinic for predicting the best treatment courses for patients, and the potential for the development of resistance in some patients.

Originally posted here:
Scientists discover change in cell logistics that helps cancer become resistant - The Institute of Cancer Research

To deal with chronic pain, Pamela Bobb's morning routine now includes stretching and meditation at home in Fairfield Glade, Tenn. Bobb says this mind-body awareness intervention has greatly reduced the amount of painkiller she needs. Jessica Tezak for NPR hide caption

To deal with chronic pain, Pamela Bobb's morning routine now includes stretching and meditation at home in Fairfield Glade, Tenn. Bobb says this mind-body awareness intervention has greatly reduced the amount of painkiller she needs.

There's new evidence that mind-body interventions can help reduce pain in people who have been taking prescription opioids and lead to reductions in the drug's dose.

In a study published this month in JAMA Internal Medicine, researchers reviewed evidence from 60 studies that included about 6,400 participants. They evaluated a range of strategies, including meditation, guided imagery, hypnosis and cognitive behavioral therapy.

"Mindfulness, cognitive behavioral therapy and clinical hypnosis appear to be the most useful for reducing pain," says study author Eric Garland, a professor at the University of Utah. The reductions in dose were modest overall, he says, but the study is a signal that this approach is beneficial.

And Pamela Bobb, who lives in Fairfield Glade, Tenn., can attest to the benefits. She's 56 and has endured decades of pain. "Oh, I had been suffering terribly for years," Bobb tells us.

Bobb was born with a malformation in her pelvis that led to pain. Over the span of two decades, she underwent more than a dozen major surgeries, yet none offered relief. "When you get to that point, you can't see beyond the pain," Bobb says. "You're just surviving." Jessica Tezak for NPR hide caption

Bobb was born with a malformation in her pelvis that led to pain. Over the span of two decades, she underwent more than a dozen major surgeries, yet none offered relief. "When you get to that point, you can't see beyond the pain," Bobb says. "You're just surviving."

She was born with a malformation in her pelvis that led to pain. Over the span of two decades, she underwent more than a dozen major surgeries, yet none of them gave her relief; each procedure left more scar tissue and nerve damage.

"I felt desperate, " Bobb says. "I didn't feel like I had any control."

She couldn't do basic things such as cook or take care of her family.

"I was completely debilitated," Bobb says. "And when you get to that point, you can't see beyond the pain you're just surviving."

She was put on high doses of opioids to ease the constant pain, but then a few years ago she thought, "There just has to be a better way." Ultimately, she found help at a clinic that specializes in complementary and alternative medicine.

"We offer a variety of things, explains Wayne Jonas, a physician who treated Bobb at the Fort Belvoir Community Hospital Pain Clinic in Fairfax County, Va.

"We offer physical therapy, behavioral medicine, acupuncture, yoga and mind body practices," Jonas says. None of these is a cure-all, he adds, but the idea is that there are lots of tools in the toolkit for people to try.

Jonas is a longtime proponent of an integrated, mind-body approach to treating pain and the author of How Healing Works, a book that describes the science behind these approaches.

He says that when someone is in severe pain, their body's normal defenses are down.

Pamela Bobb harvests some mint from her indoor herb and lemon garden at her home in Fairfield Glade, Tenn. Changes in her diet lots more greens, fruits, vegetables and herbs and spices that reduce inflammation are also part of her pain-reduction routine. Jessica Tezak for NPR hide caption

Pamela Bobb harvests some mint from her indoor herb and lemon garden at her home in Fairfield Glade, Tenn. Changes in her diet lots more greens, fruits, vegetables and herbs and spices that reduce inflammation are also part of her pain-reduction routine.

"It bumps up a variety of dysfunctions," Jonas says. Pain increases levels of the stress hormone cortisol and increases inflammatory processes in the body, too. "This starts a continual negative feedback loop that produces more pain," Jonas explains.

It's not a surprise, he says, that techniques such as meditation or yoga can be helpful. "If you engage in a deep mindfulness and relaxation it will counter those stress responses," Jonas says.

Think of meditation as a form of mental exercise.

"It's almost like weightlifting for your brain," says Garland. Just as curling a dumbbell strengthens the bicep, he says, "meditation is almost a way of, sort of curling the dumbbell of the mind to strengthen the mind's self control."

And this can change the way the brain perceives the input from the body. "If you can change the way the brain perceives signals from the body you can actually change the experience of pain," Garland says.

But there's a trick here: Learning to meditate takes time, effort and some training. It's more complicated than swallowing a pill. Pamela Bobb has stuck with it. She has tried a bunch of these alternative mind-body strategies, including acupuncture and biofeedback, and now starts every morning with a meditation practice.

"It's 4:45 in the morning and I've just awakened," she says in a recording she made of her practice, so I could listen in. She sounds centered, and calm. "I'm allowing my body to feel as relaxed as it possibly can."

After several surgeries were unable to alleviate her pain, Bobb couldn't do basic things such as cook or take care of her family, she says. "I was completely debilitated." Incorporating mind-body techniques have completely changed that, she says. Jessica Tezak for NPR hide caption

After several surgeries were unable to alleviate her pain, Bobb couldn't do basic things such as cook or take care of her family, she says. "I was completely debilitated." Incorporating mind-body techniques have completely changed that, she says.

Bobb has also overhauled her diet, now eating a lot more greens, fruits and vegetables and herbs and spices with anti-inflammatory properties. On the day we talk, she's making a spinach saute with ginger, mint and rosemary.

"I swear you can smell each of those spices. They smell so good!" she says.

Bobb is so at ease now that, just hanging out with her, you'd never guess all that she has endured. And she feels so much better, she says.

"It's empowering to [have] come all this way," Bobb says. She says she's made a fundamental transition in her mind: Instead of waiting for doctors to heal her with surgeries or injections, she now realizes that many of these alternative therapies have empowered her to help herself.

Pamela Bobb still takes medicine to help manage her pain and other health issues, but she cites meditation as key to helping her reduce the opioid dose to 25% of the amount she once took. Jessica Tezak for NPR hide caption

Pamela Bobb still takes medicine to help manage her pain and other health issues, but she cites meditation as key to helping her reduce the opioid dose to 25% of the amount she once took.

"So much of it does lie within me," she says.

Bobb accepts that she may never be completely pain-free, but now feels she has control over the discomfort.

She has reduced her opioid dose by 75%. She says she still benefits from a small maintenance dose of the medication. And her doctors say that for her, the benefits of the medicine outweigh potential harms.

In the midst of an opioid epidemic, Bobb's story may seem unlikely. But many people who have taken opioids for a prolonged period have similar stories. And last month, the Department of Health and Human Services released new guidelines urging doctors to take a deliberate approach to lowering doses of opioids for chronic pain patients.

The guidelines point to the potential harms of forcing patients off the medications.

"The goal is not necessarily to get off of all opioids but to reduce it to a dose [that is] safe," Adm. Brett P. Giroir, a physician and assistant secretary for health at HHS, told NPR. We asked him about Bobb's case. He is not her doctor, but after hearing her story he said, "The fact that she's been able to reduce her opioids substantially is a success story."

Giroir says this kind of comprehensive approach that includes alternative therapies "could be a model for what we want to do nationwide." He points out that earlier this year, the Centers for Medicare & Medicaid Services proposed covering acupuncture for Medicare patients who have chronic lower back pain.

Bobb massages her feet with sweet-smelling lavender oil another part of her morning routine. Successfully mitigating long-term pain, she finds, takes all of the tools in the toolkit. Jessica Tezak for NPR hide caption

Bobb massages her feet with sweet-smelling lavender oil another part of her morning routine. Successfully mitigating long-term pain, she finds, takes all of the tools in the toolkit.

As the evidence accumulates, Giroir says, there will be more attention placed on covering alternative therapies.

A 2017 Gallup Poll found that 78% of people would prefer to try other ways to address their physical pain before they take pain medication.

And doctors groups such as the American College of Physicians recommend that doctors offer more nonpharmacological treatments to pain patients, such as those who have chronic lower back pain.

Yet, a paper published last year finds that most insurers have not adopted policies that are consistent with these guidelines, and many don't pay for coverage of these services. An accompanying editorial argues that it's time for that to change.

It's clear that when it comes to tackling pain, it takes all of the tools in the toolkit. And when it comes to opioids, the approach needn't be all or nothing. Bobb says she has learned that, for her, the combination of medicine plus mind-body therapies works best.

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Chronic Pain Eased With Meditation And Lower Doses Of Opioids : Shots - Health News - NPR

Candy Woodworth knows shes won the lottery.

In the past five years, shes seen a daughter get married and celebrate the births of two grandchildren.

But for a while, whether the West Vancouver grandmother would be around to mark those milestones was far from certain.

Six years ago, Woodworth was a busy 65-year-old, looking after her first grandchild while her daughters took care of the family business.

It was during a Pilates class when she was lying on her stomach that she first noticed something odd an uncomfortable feeling in her lower abdomen. Woodworth didnt think much of it, but when she felt it again at next weeks class, she made an appointment to see her doctor, who sent her for an ultrasound.

When she got back home, the phone was ringing before she even had her coat off, telling her to come to her doctors office right away.

There she got the news that she had ovarian cancer.

According to the BC Cancer Agency, over 300 women in B.C. will be diagnosed with ovarian cancer this year. Its not nearly as common as breast cancer women have about a one in 70 lifetime chance of getting ovarian cancer but the prognosis can be far more serious.

You just dont feel anything, said Woodworth. Thats the difficult thing with ovarian cancer.

Because there is no way to screen for ovarian cancer, and the disease is usually without symptoms until at an advanced stage, effective treatment is often a challenge.

We have treatments that are very likely to cause the cancer to regress and improve but theres a very high risk of recurrence, said Dr. Anna Tinker, a medical oncologist at BC Cancer who is one of the leading experts in gynecological cancers and who worked on Woodworths case.

Woodworth knew she was facing a serious diagnosis. So she did some research and was referred to the expert team that specializes in gynecological cancer at Vancouver General Hospital, headed by Dr. Dianne Miller.

Woodworth had surgery to remove the tumour from her abdomen, which was confirmed as a high-grade Stage 3 aggressive cancer.

But her journey was only just beginning.

For the next four and a half months, Woodworth had 18 rounds of chemotherapy. After my third week I literally crawled on my hands and knees into the chemo clinic, she said. I was literally throwing up as I was sitting in the chair.

She credits her support team of her husband and three daughters for getting her through it. And the chemotherapy worked at first.

But 18 months later, the cancer was back, with a tumour on her colon. She had another surgery.

Throughout the process, My attitude was always Lets get in there. Lets get the job done, she said.

When the tumour returned again in the same place, six months later, Woodworths doctors signed her up for an experimental research program, the Personalized Onco-Genomics program, run by a team of doctors and researchers at the BC Cancer Agency.

The program which is usually only open to patients after standard treatments have been tried takes a novel approach to cancer, looking for genetic mutations in a patients tumour for clues to whats causing the cancer to grow, and with that, a possible treatment.

In Woodworths case, the analysis showed her tumour had a signature similar to that seen when a BCRA gene mutation is present more usually associated with some types of breast cancer, said Tinker.

In early 2017 Woodworths results were matched with an experimental drug, Olaprib Lynparza.

In Woodworths case, the drug worked. Shes now been on it for two and a half years with no side effects and no recurrence in her cancer.

The 12 capsules she takes every day down from the number she started on have literally saved her life.

Im so grateful for every day, said Woodworth. I dont think the public realizes the scientists we have here in Vancouver.

Woodworth is among the more dramatic success stories to come out of the personalized genomic research project, falling into a small group of super responder patients.

Others include a Langley woman whose metastatic breast cancer was beaten back by a drug commonly used to treat diabetes, in addition to hormone treatment.

Another Metro Vancouver woman was saved when scientists discovered her advanced colon cancer had a protein that responded to blood pressure medication.

Since the program started in 2012, 1,136 patients, including 123 children, have been enrolled in the program.

Patients who take part need to understand the process is experimental, said Tinker. While helpful new information is gleaned in about 80 per cent of cases, the result is not always as dramatic as it was in Woodworths case and not all cancer patients are helped by the genome analysis.

In some patients, no helpful mutations are discovered that can be used as clues to treatment and in some cases, no drugs are a match.

Cancer patients start new treatments as a result of their genome results about 40 per cent of the time.

Ideally, patients who are matched with treatments can be enrolled in clinical trials that make expensive drugs available to them free of charge, said Tinker.

But thats not the always the case.

Woodworth knows shes lucky. I knew what I was up against, she said, but she remained stubbornly optimistic, describing herself as a glass half full kind of person.

These days, Woodworth who recently celebrated her 70th birthday takes delight in spending time with her grandkids.

I cant let a day go by without stopping by for a quick hug, she said. I dont stay around and clean my house. I get out there.

I dont take anything for granted. Thats the one thing you take away when you feel that mortality. You have to live every day the best that you can.

She hopes stories like hers will lead to money for research that will benefit other cancer patients.

The research at the Personalized Onco-Genome program is funded by approximately $22.7 million from the BC Cancer Foundation, largely raised through philanthropic donations, as well as by research grants, particularly through the Canada Foundation for Innovation.

Hopefully theyll find more [information on how cancers behave], and more people will survive, said Woodworth. Thats what I want for everyone. There is hope out there.

To find out how to donate to the research funded by the BC Cancer Foundation, including the Personalized Onco-Genomics program, click here.

To find out how to donate to the VGH/UBC Hospital Foundation, which benefits programs including the Ovcare research team examining gynecological cancers, click here

To view a CBC Nature of Things documentary on the Personalized Onco-Genomics program, which aired on the network in February 2017, click here

Continued here:
Genome research gave life back to West Van cancer survivor - Vancouver Courier

LAKEWOOD, Ohio -- Thanksgiving is just two weeks away, and in Lakewood that signals the annual effort by the Lakewood Charitable Assistance Corp. to ensure that those in need have a hearty meal for the holiday.

About 300 people receive food packages for Thanksgiving from LCAC, a nonprofit, all-volunteer organization dedicated to improving the quality of life of Lakewoods families in need. The organization has offered this program for more than three decades.

Collections of non-perishable food items -- including canned goods, gravy mix, pie filling, stuffing and biscuit mixes, cereal, peanut butter and more -- are taking place in schools and churches throughout the city to help provide a foundation for the holiday meal and to help families even beyond Thanksgiving.

Cash donations also are welcome to help with costs associated with the LCAC programs.

LCAC purchases perishable items, including turkeys, potatoes, butter and pumpkin pies, just before the food distribution day, which this year will be Nov. 23.

Volunteers are needed to help sort, prepare and bag the non-perishable items, as well as to help load the food into vehicles for delivery.

Non-perishable food donations will be collected and sorted from 9 a.m. to 1 p.m. Nov. 22 on the lower level of the Lakewood Masonic Temple, 15300 Detroit Ave., Lakewood.

Additional volunteers are needed from about 6 to 7:30 p.m. Nov. 22 to form an assembly line to pack the food bags.

Then, beginning at 9 a.m. Nov. 23, volunteers are needed to bag the perishable food items, load the meals into cars and help deliver the food to those on the distribution list for Thanksgiving.

Celia Dorsch, LCAC president, said the entire organization consists of volunteers. They also deliver meals for Christmas and provide cleaning supplies in the spring.

For more information on LCAC and its programs, visit lcac.info.

Junior Womens Club meets: North Olmsted Junior Womens Club will meet at 7:30 p.m. Thursday (Nov. 14) at North Olmsted Senior Center, 28114 Lorain Road, North Olmsted.

There will be a program on pain management following the meeting. The program begins with a social time from 7 to 7:30 p.m.

The club is a diverse group of women of all ages -- 21 and older -- who want to return something to the community.

For more information, visit northolmsted.wixsite.com/nojwc.

Pride Clinic: The MetroHealth System began offering Pride Clinic services this week at the LGBT Community Center of Greater Cleveland, 6705 Detroit Ave., Cleveland. MetroHealth and the LGBT Center are working together to provide safe and supportive medical care to the Cleveland LGBTQ community in the Gordon Square neighborhood. Community members can receive many health services at the clinic.

MetroHealth primary care physician Dr. Douglas Van Auken will provide care from 12:30 to 4:30 p.m. Tuesdays.

Services include primary adult care (age 13 and older), hormone therapy, family planning, smoking cessation, cholesterol control, blood pressure control, immunizations, HIV prevention and STI testing and treatment.

In addition to primary care services being offered at the LGBT Center, MetroHealths Pride Network also offers primary care services at MetroHealths Brecksville, Cleveland Heights, Middleburg Heights, Rocky River and Thomas F. McCafferty locations.

Specialty services also include plastic surgery, gynecology, ENT, behavioral health, and physical medicine and rehabilitation.

To schedule an appointment at the LGBT Center or any of the Pride Network locations, call 216-957-4905. To learn more about MetroHealths Pride Network, visit metrohealth.org/pride.

Free produce: Cleveland residents are invited to stop by Cudell Recreation Center from 11 a.m. to 1 p.m. the third Thursday of every month (Nov. 21 this month) for free, fresh produce. Cudell is at 1910 West Blvd., Cleveland.

Produce is distributed on a first-come, first-served basis, rain or shine. Those coming for produce should bring an ID and bags to carry the items home.

On display: The North Olmsted Arts Commission displays artwork from local artists on a temporary basis at City Hall. The featured artist for November is Dennis Nelson, a North Olmsted resident.

Nelsons work includes poured acrylic, also called fluid art. He uses vibrant colors and bold patterns in his work.

Stop in during business hours at North Olmsted City Hall, 5200 Dover Center Road, North Olmsted, to see Nelsons exhibit.

The rotating displays at City Hall provide an opportunity for art groups to introduce or expand the visibility of their work. For more information or for North Olmsted artists interested in applying for exhibit space, call 440-716-4134.

Welcoming a legacy: Fairview Park Mayor Eileen Patton swore in new police officer Erik Joyce recently. He is the son of James Joyce, a retired Fairview Park police officer who served the city for 34 years, from 1984 to 2014.

The proud papa pinned his old badge onto his sons shirt after he took the oath of office.

Erik Joyce started his law enforcement career in Fairview Park when he joined the auxiliary police unit at age 19. A few years later, he served briefly with the Cuyahoga Metropolitan Housing Authority as a police officer. After that, he spent six years with the Cuyahoga County Sheriffs Office as a deputy sheriff.

Friendsgiving luncheon: Area residents ages 55 and older are invited to a free Friendsgiving luncheon on Nov. 20, provided by ONeill Healthcare North Olmsted. Attendees need not live in North Olmsted.

Lunch includes turkey, mashed potatoes and gravy, vegetables, a roll and pumpkin pie. Registration is required by Nov. 15.

For more information or to register, call 440-777-8100 or stop by the North Olmsted Senior Center, 28114 Lorain Road, North Olmsted.

We Do Care awards: Fairview Park Womens Club will host the We Do Care God & Country letter-writing contest winners at 6:30 p.m. Nov. 18, prior to the Fairview Park City Council meeting in council chambers at City Hall, 20777 Lorain Road, Fairview Park.

A small reception will follow the ceremony.

The We Do Care Committee was created in 1976 by Fairview Park resident Harriet Beekman in response to diminishing patriotism during the Vietnam War era. Beekman generated community support for local military personnel and sent care packages to them. The group continues to send boxes to troops.

Seventh- and eighth-graders at Lewis F. Mayer Middle, St. Angela Merici and Messiah Lutheran schools are invited to participate in the God & Country letter-writing contest each year to express gratitude for the sacrifices made by members of the armed forces serving overseas.

The letter-writing project began in 1976, also.

Student letters are submitted to the We Do Care Committee and judged by volunteers. Winners are selected from each school and read aloud at a City Council meeting. The winning students receive a certificate.

Information, please: Readers are invited to share information about themselves, their families and friends, organizations, church events, etc. in Fairview Park, Lakewood, North Olmsted and West Park for the A Place in the Sun column, which I write on a freelance basis. Awards, honors, milestone birthdays or anniversaries and other items are welcome. Submit information at least 10 days before the requested publication date to carolkovach@hotmail.com.

Read more from the Sun Post Herald.

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Many hands needed to help LCAC prepare, deliver 300 Thanksgiving meals to the needy: A Place in the Sun - cleveland.com

NFM Secret Shopper: Im confused about whats best to boost my immunity. Is it zinc, vitamin C, vitamin D, elderberry or something else?

Retailer: Any of those can help with immunity, but it depends on when you take them. Vitamin C is good for when you already have a cold, but if you eat your fruits and veggies, you probably dont need to take a vitamin C supplement all the time. Same with zinc and elderberry. But vitamin D is a supplement you might need every day, depending on your levels.

NFM: That makes sense. Any other supplements youd recommend, especially for cold and flu season?

Retailer: Garlic is popular and seems to work pretty well for immunity.

Our expert educator: Yufang Lin, M.D., of the Cleveland Clinics Center for Integrative and Lifestyle Medicine

Immunity is very complex. As an integrative practitioner, I look at the whole picture, so the first things I suggest are getting enough sleep, hydrating well and eating healthy. As for specific foods that boost immunity, garlic and ginger are both antimicrobial, antifungal and antiviral. You can use them in your day-to-day cooking, but if you are getting sick, definitely step up your intake, whether through food or supplements. Ginger, which is also anti-inflammatory, can also be made into tea.

There is data showing that both vitamin C and zinc support the immune system when you are sick. They are particularly useful in the first few days of illness, as they can reduce the duration and severity. But use these supplements only as needed, not on a long-term basis.

Elderberry is a diuretic, so if you are running a fever, it can help you sweat it out. Another supplement, echinacea, revs up the immune system, so it is great for fighting off a cold or even for the early stages of the flu. The problem with echinacea is it can stimulate the immune system too much, which is bad if you have an autoimmune disease. But for most people, it can be very helpful, but take it only for three to five days.

Vitamin D is a hormone so it generally has many benefitsfor mood, bone health and immune support. But it is more for day-to-day care, not to start taking once you get sick.

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Secret Shopper: What supplements are best to boost immunity? - New Hope Network

STAINES-UPON-THAMES, United Kingdom, Nov. 12, 2019 /PRNewswire/ -- Mallinckrodt Pharmaceuticals plc (NYSE: MNK), a global biopharmaceutical company, today announced data on patient-reported outcomes (PROs) showing Acthar Gel (repository corticotropin injection) improved disease measures that impact rheumatoid arthritis (RA) patients with persistently active disease, as well as new data from an exploratory analysis.The data originate from new analyses from Mallinckrodt's Phase 4 study of Acthar Gelin RA patients with persistently active disease and was recently presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held Nov. 8-13 in Atlanta.

The study posters can be accessedhereon the company's website.

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. ActharGel is approved by theU.S. Food and Drug Administration(FDA) as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in RA, including juvenile RA (selected cases may require low-dose maintenance therapy).1 Please see Important Safety Information for Acthar Gel below.

"Patient-reported outcomes, like fatigue, pain, and physical functioning, are an important part of any trial assessing clinical treatment outcomes. These additional data shed light on managing this challenging patient population whose symptoms persist after use of first-line therapies and suggest Acthar Gel treatment improved PROs in patients with persistently active RA," said Dr. Nancy E. Lane, Distinguished Professor of Medicine, Rheumatology and Aging, and Director of the UC Davis Center for Musculoskeletal Health. "The data exploring the effect of Acthar Gel treatment on patient-reported outcomes may help clinicians better understand Acthar Gel's use for patients with difficult-to-manage RA, those who have continued symptoms following standard therapies. The need for additional treatment options in this patient population is critical."

Patient-Reported Outcomes and Impact of Treatment (Abstract #439)

New data from the company's two-part Phase 4 multicenter, placebo-controlled study assessing the efficacy and safety of Acthar Gel in patients with persistently active RA who were previously treated with disease-modifying anti-rheumatic drugs (DMARDs) and corticosteroids showed that Acthar Gel treatment significantly improved patient-reported pain, fatigue, physical functioning and work-related impairment as early as Week 4, and resulted in clinically meaningful improvements in PROs.

The analysis examined PRO measures as a secondary endpoint from Part 1 of the study, the 12-week open-label period, and assessed mean changes at baseline and at Weeks 4, 8 and 12.

Patient-Reported Outcomes From the 12-Week Open-label RCI Treatment Perioda,2

PRO Assessment

Baseline, Mean(SD)

Week 4

Week 8

Week 12

Mean Change From Baseline (SD)

FACIT-F

22.8 (8.4)

5.0 (8.2)*

6.5 (8.4)*

8.7 (8.4)*

HAQ-DI

1.7 (0.6)

0.5 (0.5)*

0.6 (0.6)*

0.84 (0.6)*

Patient global assessment of disease activityb,3

63.4 (20.0)

17.8 (23.6)*

25.7 (25.2)*

35.0 (27.3)*

WPAI-RA

Percent work time missed due to RAc

24.9 (27.6)

7.0 (26.6)

5.2 (28.0)

10.8 (26.5)**

Percent impairment while working due to RAc

50.3 (27.1)

18.7 (24.4)*

18.0 (23.9)*

25.2 (25.3)*

Percent overall work impairment due to RAc

58.1 (28.6)

17.6 (27.0)*

17.6 (27.5)*

25.5 (29.2)*

Percent activity impairment due to RAc

63.2 (24.2)

18.1 (24.3)*

22.5 (25.3)*

32.8 (27.4)*

Patient global assessment of paind

64.9 (20.4)3

20.8 (23.3)*

27.6 (25.3)*

37.4 (27.4)*

*p<0.001 vs baseline. **p=0.003 vs baseline.

amITT population (all patients who received study drug and had any post-treatment efficacy assessment).

bMCID = 15% absolute/20% relative improvement.

cMCID = 7% absolute change.

dMCID = 11.

Abbreviations and MCID references: FACIT-F; Functional Assessment of Chronic Illness Therapy Fatigue (MCID = 3-41); HAQ-DI, Health Assessment Questionnaire Disability Index (MCID = 0.2); MCID, minimum clinically important difference; mITT, modified intent-to-treat; PRO, patient-reported outcome; RCI, repository corticotropin injection; SD, standard deviation; WPAI-RA, Work Productivity and Activity Impairment Questionnaire Rheumatoid Arthritis.

AEs observed in the Phase 4 study were consistent with those in previous trials of Acthar Gel.

Study Limitations

"Mallinckrodt remains committed to the rheumatology community and to improving the lives of patients with autoimmune-mediated diseases like RA who continue to have debilitating symptoms and disease exacerbations despite standard treatments," saidSteven Romano, M.D., Chief Scientific Officer and Executive Vice President atMallinckrodt. "We are pleased to be at this year's ACR Annual Meeting to present new data on Acthar Gel that will broaden our understanding of its utility in rheumatology clinical practice for patients with difficult-to-manage RA and areas of high unmet need."

Assessment of Bone and Cartilage Turnover Markers (Abstract #528)

A new exploratory analysis from the Phase 4 RA study assessed bone markers associated with bone loss to evaluate the impact of Acthar Gel treatment on bone turnover in patients with persistently active RA. Bone and cartilage biomarker levels were evaluated throughout the study, at baseline and Weeks 12 and 24 and included: C-terminal cross-linking telopeptide (CTX), C-terminal cross-linking telopeptide of type I collagen (CTX-I), osteoprotegrin (OPG), N-terminal propeptide of type I collagen (PINP), and soluble receptor activator of nuclear factor kappa- ligand (sRANKL) and cartilage degradation biomarkers (C-terminal cross-linking telopeptide of type II collagen (CTX-II) and CTX-II creatinine (CRT).

At Week 12, the open-label period, significant decreases in mean levels of the bone turnover biomarker PINP (P<0.01) and mean levels of cartilage degradation biomarkers CTX-II (P<0.01) and CTX-II CRT (P<0.001) were observed. At Week 24, the end of the study's double-blind period, there was a significant increase from baseline in mean sRANKL levels at both Week 12 and Week 24 (P<0.05) compared to placebo, suggesting a potential increase in osteoclast differentiation. Mean levels of all other bone and cartilage biomarkers remained stable at all time points and markers of bone degeneration remained stable.5

Results from the full RA study were presented earlier this year at the Annual European League Against Rheumatism (EULAR 2019) in Madrid in June. More information on the Phase 4 RA study can be found here on ClinicalTrials.gov.

About Rheumatoid ArthritisRA is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the jointsall symptoms caused by inflammation.6 An estimated 1.5 million U.S. adults are living with RA.7 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.8 Nonsteroidal anti-inflammatory drugs are used to ease symptoms whereas corticosteroids, disease-modifying anti-rheumatic drugs and biologics are used to slow down the disease activity.8

Acthar Gel (repository corticotropin injection)IndicationsActhar Gel is an injectable drug approved by theFDAfor the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

Other adverse events reported are included in the full Prescribing Information.

Please see fullPrescribing Information.

ABOUTMALLINCKRODTMallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com.

Mallinckrodtuses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with theU.S. Securities and Exchange Commission(SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTSThis release includes forward-looking statements concerning Acthar Gel including expectations regarding its potential impact on patients and anticipated benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section ofMallinckrodt'smost recent Annual Report on Form 10-K and other filings with theSEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof andMallinckrodtdoes not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTSFor Trade Media InquiriesCaren BegunGreen Room Communications201-396-8551caren@greenroompr.com

For Financial/Dailies Media InquiriesDaniel YungerKekst CNC212-521-4879mallinckrodt@kekstcnc.com

Investor RelationsDaniel J. Speciale, CPAVice President, Investor Relations and IRO314-654-3638daniel.speciale@mnk.com

Mallinckrodt, the "M" brand mark and theMallinckrodt Pharmaceuticalslogo are trademarks of aMallinckrodtcompany. Other brands are trademarks of aMallinckrodtcompany or their respective owners.2019Mallinckrodt.US-1901844 11/19

References

1ActharGel (repository corticotropin injection) [prescribing information].Mallinckrodt ARD LLC.

2Data on File, Mallinckrodt, 2019. Furst D, Wan G, Liu J, Zhu J, Bartels-Peculis L, Panaccio M, Fleischmann R. Improved Patient-Reported Outcomes in Patients with Persistently Active Rheumatoid Arthritis Following Treatment with Repository Corticotropin Injection. Poster presented at: 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting November 8-13, Atlanta, GA.

3Data on File, Mallinckrodt, 2019. Furst D, Wan G, Liu J, Zhu J, Bartels-Peculis L, Panaccio M, Fleischmann R. Improved Patient-Reported Outcomes in Patients with Persistently Active Rheumatoid Arthritis Following Treatment with Repository Corticotropin Injection [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/improved-patient-reported-outcomes-in-patients-with-persistently-active-rheumatoid-arthritis-following-treatment-with-repository-corticotropin-injection/. Accessed November 8, 2019.

4Fleischmann R, Furst DE, Brasington R, Connolly-Strong E, Liu J, Barton ME. A multicenter study assessing the efficacy and safety of repository corticotropin injection in patients with rheumatoid arthritis: preliminary interim data from the open-label treatment period. Poster presented at: American College of Rheumatology and Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting; October 19-24, 2018; Chicago, IL.

5 Data on File, Mallinckrodt, 2019. Fleischmann R, Furst DE, Connolly-Strong E, Liu J, Zhu J, Brasington R. Assessment of Bone and Cartilage Turnover Markers Following Treatment With Repository Corticotropin Injection in Patients With Persistently Active Rheumatoid Arthritis. Poster presented at: 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting November 8-13, Atlanta, GA.

6 Mayo Clinicwebsite. Rheumatoid Arthritis. Overview. Available at:https://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/symptoms-causes/syc-20353648. AccessedNovember 5, 2019.

7 What is Rheumatoid Arthritis?Arthritis Foundation. Available at:http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. AccessedNovember 5, 2019.

8 Arthritis Foundation. Rheumatoid Arthritis Treatment. Available at:http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php. AccessedNovember 5, 2019.

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Mallinckrodt Announces New Clinical Data Evaluating Acthar Gel (Repository Corticotropin Injection) in Rheumatoid Arthritis (RA) at the 2019 American...