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Friday, March 3, 2023

Scientific revolt against gender ideology has begun

 Gender activists often defend the physical transition of gender-confused children by citing scientific research that supposedly backs up the efficacy and safety of these experimental treatments. But one close look at this research proves the exact opposite — and a number of experts are finally coming forward to say so.

A new in-depth report by the British Medical Journal reveals just how flimsy the “science” behind sex-change treatments is.

The Endocrine Society commissioned two systematic reviews for its clinical practice guideline, Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: one on the effects of sex steroids on lipids and cardiovascular outcomes, the other on their effects on bone health. To indicate the quality of evidence underpinning its various guidelines, the Endocrine Society employed the GRADE system (grading of recommendations assessment, development, and evaluation) and judged the quality of evidence for all recommendations on adolescents as “low” or “very low.”

The report goes on to cite several systematic reviews of the World Professional Association for Transgender Health’s (WPATH) sex-change recommendations. It says:

One of the commissioned systematic reviews found that the strength of evidence for the conclusions that hormonal treatment “may improve” quality of life, depression, and anxiety among transgender people was “low,” and it emphasised the need for more research, “especially among adolescents.” The reviewers also concluded that “it was impossible to draw conclusions about the effects of hormone therapy” on death by suicide.

Despite this, WPATH recommends that young people have access to treatments after comprehensive assessment, stating that the “emerging evidence base indicates a general improvement in the lives of transgender adolescents.”

WPATH has even admitted that the evidence supporting medical transition is so limited that “a systematic review regarding outcomes of treatment in adolescents is not possible," according to BMJ. Yet its public guidance offers no hint of this uncertainty. Indeed, one would think from reading WPATH's public statements on this issue that chemical and physical transition is always the right solution for the patient and that it never leads to unwanted or unexpected consequences.

"We state that when gender affirming medical treatment is provided with a standardized multidisciplinary assessment and treatment process, thorough informed consent, and ongoing monitoring and psycho-social support, the rate of regret of gender-affirming medical treatment commenced in adolescence has been observed to be very low and the benefits of treatment in adolescence are potentially greater than the benefits of gender-affirming treatment commenced in adulthood," WPATH claims. "Hence, the harms associated with obstructing or delaying access to wished for and indicated treatment for the majority, appear greater than the risks of regret for the few."

But the supposed "benefits" to which WPATH refers simply are not reflected in the scientific data. In fact, one of the only studies claiming to show a connection between better mental health and social and physical affirmation had to be publicly revised to clarify that there is no such connection. And every single other conclusive study on this topic has found that the evidence in support of "gender-affirming care" is, at best, inconclusive.

From the BMJ:

Cochrane, an international organisation that has built its reputation on delivering independent evidence reviews, has yet to publish a systematic review of gender treatments in minors. But The BMJ has learnt that in 2020 Cochrane accepted a proposal to review puberty blockers and that it worked with a team of researchers through 2021 in developing a protocol, but it ultimately rejected it after peer review. A spokesperson for Cochrane told The BMJ that its editors have to consider whether a review “would add value to the existing evidence base,” highlighting the work of the UK’s National Institute for Health and Care Excellence, which looked at puberty blockers and hormones for adolescents in 2021. “That review found the evidence to be inconclusive, and there have been no significant primary studies published since.”

Likewise, a review from Florida's Agency for Health Care Administration on the outcomes that are “important to patients” with gender dysphoria, including mental health, quality of life, and complications, found that the body of evidence from the 61 systematic reviews they looked at was "not sufficient" to support puberty blockers, cross-sex hormones, or surgeries in young people.

Robert Garofalo, chief of adolescent medicine at Lurie Children’s Hospital in Chicago, admitted that scientists who support "gender-affirming care" are more or less throwing crap at the wall and hoping that it sticks. "It is a discipline where the evidence base is now being assembled,” he said last year. “It’s truly lagging behind [clinical practice], I think, in some ways.”

There is far more evidence that physical interventions in gender-confused children make things much worse. The Endocrine Society, for example, acknowledged that chemical treatment, in particular, places “a high value on avoiding an unsatisfactory physical outcome when secondary sex characteristics have become manifest and irreversible, a higher value on psychological well-being, and a lower value on avoiding potential harm.”

To be clear, gender activists don't really care whether the science backs up their agenda or not. But it does give them a claim to authority on this issue, which they have used aggressively in recent years to convince every one of our powerful institutions, from the education establishment to the healthcare sector to the White House, to accept gender ideology as fact. Debunking their bogus scientific claims brings us one step closer to breaking this ideological grip.

https://www.washingtonexaminer.com/restoring-america/courage-strength-optimism/the-scientific-revolt-against-gender-ideology-has-begun

Nonprofits that Help Pregnant Women Under Attack

 In the past year since the shocking leak of the Dobbs U.S. Supreme Court decision, 81 nonprofits that support pregnant women and new mothers have been attacked and vandalized. Violent pro-abortion groups have broken windows, sprayed graffiti and started fires at these centers that provide medical and financial support to women caring for new life. Despite the ugly acts of hatred these organizations have endured, pregnancy centers are overwhelmingly supported by the American public and seen as essential to our communities.

More and more states are stepping up in the Dobbs era to propose crucial support for pregnancy centers and the women they serve. Tennessee Governor Bill Lee has a proposal to send $100 million to pregnancy resource centers, one of the boldest displays of public support for these life-affirming organizations to date. The action follows a stream of other generous pro-life provisions at the state level: West Virginia’s bill funding pregnancy resource centers which was just overwhelmingly passed by the majority-Republican House of Delegates; Texas’ $100 million investment in their Alternatives to Abortion program; Florida Governor Ron DeSantis’ budget proposal removing sales tax for baby items; not to mention other supportive measures taken by legislators in Georgia, Indiana, Louisiana, Mississippi, Alabama, and more.

These state-led pro-life efforts show the movement’s enthusiasm and readiness to step up when it comes to helping women in need - both during and after pregnancy. They also put a spotlight on how we as a nation must help the organizations that do it best: pregnancy centers.  

Pregnancy centers are working harder than ever amid the current rash of threats, vandalism, and relentless violent attacks from pro-abortion extremists. Adding fuel to that fire are radical Democrats like Elizabeth Warren and Alexandria Ocasio-Cortez who have made plain their intention to “shut down” these beautiful centers. And news recently surfaced that the Associated Press style guide now mandates that journalists use negative and politically charged terminology like "anti-abortion centers."

The reality is that pregnancy centers exist solely to help women in need, without coercion and typically at no charge. Serving more than two million people in 2019 alone, they offer critical medical services like pregnancy tests, ultrasounds, and medical exams in addition to support services like counseling, parenting classes, financial classes, and more. They also provide access to essential resources including food, diapers, clothing, and many other items, not to mention financial assistance to help women with housing, utilities, and other costs where needed.  

While a vocal pro-abortion minority desperately tries to vilify these organizations, polling shows pregnancy centers couldn’t have stronger support from the American people. They enjoy a 99% satisfaction rate from women they have helped. According to Marist, these centers are also supported by 91% of Americans, and an overwhelming majority of both Republicans (78%) and Democrats (73%) nationwide want to see public funding for their efforts.

Yet instead of supporting centers that provide real options and help, including healing for women who suffer trauma from abortion, Democrats have spent years fighting tooth and nail to keep taxpayer dollars flowing to the abortion industry. Planned Parenthood alone rakes in more than half a billion dollars a year in government grants, contracts, and Medicaid reimbursements while committing an ever-increasing share of America’s abortions. From 2019-2020 they also ended a record-breaking 383,460 unborn lives.

And Democrats don't want to stop there. With every chance they get, they seek to expand abortion on demand using taxpayer dollars. The long-standing Hyde Amendment, a lifesaving pro-life provision that shields American taxpayers from funding even more abortions, is under constant attack from pro-abortion lawmakers. And for the first time in its history, acting illegally, the Department of Defense under Biden and Harris will provide time off and pay travel expenses for both servicemembers and their dependents to have elective abortions.

Meanwhile, pregnancy centers and community-based health clinics outnumber Planned Parenthoods 14:1. What’s more, studies show they offer superior services at lower costs than abortion businesses – no surprise considering they are staffed by thousands of devoted volunteers, including medical personnel, on a mission of love. The abortion industry can’t abide competition, but our country would be a far better place if we redirected precious resources away from profit-driven, life-ending abortion businesses to centers that work to save lives and truly empower mothers. With pro-life states leading the way, the tide is finally turning.

There is still much work to be done in the nation and in the culture to ensure every pregnant woman in need has the resources necessary to choose life. But many tangible efforts are already underway. It is encouraging to see elected representatives in the states paving a bold new path for creating a strong pro-life safety net. Pregnancy centers are the building blocks of a culture that welcomes all women and children - they deserve our steadfast and unwavering support.  

Marjorie Dannenfelser is president of Susan B. Anthony Pro-Life America. 

https://www.realclearpolicy.com/articles/2023/03/03/nonprofits_that_help_pregnant_women_under_attack_885143.html

Silvergate suspends crypto payments network

  Silvergate Capital Corp said on Friday it made a "risk-based decision" to discontinue the Silvergate Exchange Network, its crypto payments network, two days after the digital asset-focused bank raised doubts about its viability.

"Effective immediately Silvergate Bank has made a risk-based decision to discontinue the Silvergate Exchange Network (SEN). All other deposit-related services remain operational," Silvergate said in a statement posted on its website.

The Silvergate Exchange Network, one of the bank's most popular offerings, enabled round-the-clock transfers between investors and crypto exchanges, unlike traditional bank wires, which can often take days to settle.

Silvergate shares on Friday slumped more than 2% in after-hours trading, after closing up 0.9% at $5.77 in regular trade. The shares on Thursday had fallen to a record low, ending the day down more than 97% from their all-time high in November 2021.

Silvergate on Wednesday warned in a filing that it was evaluating its ability to operate as a going concern, disclosing that it had sold additional debt securities this year at a loss and that further losses mean the bank could be “less than well capitalized.”

After the warning, cryptocurrency heavyweights including Coinbase Global Inc and Galaxy Digital dropped Silvergate as their banking partner. Stablecoin issuers Paxos and Circle, Cboe’s digital asset exchange, and crypto exchanges Bitstamp and Gemini also suspended their partnerships with Silvergate.

https://finance.yahoo.com/news/silvergate-suspends-crypto-payments-network-001919716.html

Pushing Transgender ‘Care’ While Quietly Bankrolling Research Showing Risks

 As the Biden administration pushes the Department of Health and Human Services to make “gender-affirming health care” more widely available, HHS’s own National Institutes of Health is funding multiple studies premised upon how little research has been conducted on the long-term risks of taking cross-sex hormones and whether they improve mental health. The NIH research on transgender issues also emphasizes intersectionality and about half has been on HIV prevention. 

The NIH Reporter database, which lists active federally funded research projects, shows 74 with “transgender” in the title, totaling more than $26 million of taxpayers’ money annually. Several NIH-funded studies examine specific health risks of cross-sex hormone treatment — such as associated bone loss and possible increased risk of thrombosisdrug overdoseheart attack, and stroke.

Only a few studies evaluate the risk of infertility, even though “the impact of long-term cross-sex hormone therapy on reproductive health is largely unknown,” as one such project states and experts have warned. In contrast, seven studies examine stigma and disparities in health care for transgender people, in response to NIH’s Notice of Special Interest in understanding the role of alleged intersectional stigmas and how they harm health.

Many studies address higher incidence of sexually transmitted infections in transgender people, and whether hormone therapy might increase that risk. About half of all NIH-funded research on transgender health, including that which has been completed, relates to HIV prevention among the transgender population, totaling approximately $80 million since 1985.

Transgender males “have some of the highest concentrated HIV epidemics in the world, with a pooled global prevalence of 19% and a 49-fold higher odds ratio of acquiring HIV than non-transgender adults,” according to one project summary. Behavioral factors contribute, another project says, but the role of sex hormones needs further study, since they “are known to modulate the immune response, resulting in changes in host susceptibility to pathogens, vaccine efficacy and drug metabolism.”

Lack of Research

While suicide prevention is often cited as a major reason to give dysphoric children puberty blockers and cross-sex hormones, only one of the current studies is focused specifically on suicide risk, although several emphasize the lack of long-term studies of cross-sex hormones administered to children and their relation to mental health.

Medical professionals “say more specific research is needed to determine whether medically transitioning as a minor reduces suicidal thoughts and suicides compared with those who socially transition or wait before starting treatment,” according to Reuters.

One NIH-funded project summary acknowledges that the long-term effect of puberty suppression on mental health needs further study and will evaluate children already taking puberty blockers.

During puberty, hormones change the structure and organization of the brain. Puberty blockers “may also disrupt puberty-signaled neural maturation in ways that can undermine mental health gains over time and impact quality of life in other ways,” the Nationwide Children’s Hospital project summary says. “The overall impacts” of puberty blockers “have not been systematically studied,” the summary says.

One of the larger NIH-funded transgender studies, funded at $743,000 annually, is at Boston Children’s Hospital. It notes, “Little is known [emphasis added] about how pubertal blockade, the first step in the medical management of a young transgender adolescent, affects bone health and psychological well-being. … In an exploratory aim, we will also consider the effect of pubertal blockade on anxiety, depression, and health-related quality of life.”

Another research project, “Psychological consequences of medical transition in transgender youth,” begun last year at Princeton University and anticipated to end in 2025, notes the lack of quality research in this area:

Five studies to date have longitudinally examined the relationship between one or both of these interventions [puberty suppression and hormone therapy] and mental health in transgender youth. However, these studies have had relatively small samples, none have been able to isolate the effects of endocrine interventions, none have included a cisgender [non-transgender] comparison group, and none have examined the mechanisms by which endocrine interventions might improve mental health.

longitudinal study that began in 2015 and will run through at least 2026 acknowledges, “Transgender children and adolescents are a poorly understood and a distinctly understudied population in the United States. … Continuing our current research is imperative to expand the scant evidence-base currently guiding the clinical care of TGD [transgender and gender diverse] youth and thus, is of considerable public health significance.”

As the summary of one ongoing NIH-funded research project on sex hormones’ effects on the developing brain says, “There is little to no empirical data guiding clinical practices” of cross-sex hormone therapy in early pubertal adolescents, “highlighting the need for further research to address the critical knowledge gap.” The research, funded at $3 million so far to Stanford University, “will provide a much-needed foundation for understanding the longitudinal impact of treatments that are already being used [emphasis added] in clinical settings.”

The project will elucidate “how sex hormone therapy alters sex-specific risk for disease … and [its] impact on neural networks implicated in psychiatric disorders.” The research proposed “has never been conducted in early pubertal adolescents,” the summary reads.

Little Evidence, No Approval

The NIH, the largest public funder of biomedical research in the world, told Reuters that “the evidence is limited on whether these treatments pose short- or long-term health risks for transgender and other gender-diverse adolescents.” Additionally, the Food and Drug Administration has not approved puberty blockers and sex hormones for children’s transgender medical interventions. As Reuters reported:

No clinical trials have established their safety for such off-label use. The drugs’ long-term effects on fertility and sexual function remain unclear. And in 2016, the FDA ordered makers of puberty blockers to add a warning about psychiatric problems to the drugs’ label after the agency received several reports of suicidal thoughts in children who were taking them. More broadly, no large-scale studies have tracked people who received gender-related medical care as children to determine how many remained satisfied with their treatment as they aged and how many eventually regretted transitioning.

Countries such as Finland, Sweden, and the United Kingdom have begun to limit children’s access to transgender health interventions. Early, foundational research from 2011 on transgender medical interventions has been criticized as failing to meet basic research standards.  

Before 2012, “there was no scientific literature on girls ages eleven to twenty-one ever having developed gender dysphoria at all,” according to Abigail Shrier’s book “Irreversible Damage.” Studies show most children grow out of gender dysphoria, Shrier says.There are no good long-term studies indicating that either gender dysphoria or suicidality diminishes after medical transition,” according to Shrier.

Admin Pushes Transgender ‘Care’

Meanwhile, despite all the possible health risks, President Joe Biden has issued executive orders charging “HHS to work with states to promote expanded access to gender-affirming care.” The administration has issued directives that federal health insurance benefits must “provide comprehensive gender-affirming care.” The administration also opposes “conversion therapy — efforts to suppress or change an individual’s sexual orientation, gender identity, or gender expression.”

Taxpayers are already paying for transgender procedures, as they are covered by some insurers and Medicaid in some states

HHS’s Office of Population Affairs, which is overseen by transgender Dr. Rachel Levinestates there’s no debate: “Research demonstrates that gender-affirming care improves the mental health and overall well-being of gender diverse children and adolescents.” Other proponents acknowledge a lack of research on these hormones’ effect on brain development, but say the pros outweigh the cons.

Growing Transgender Identification

The number of transgender adults in the U.S. is estimated at 1.4 million to 2 million, with an estimated 150,000 to 300,000 transgender children. The number of American children who started on puberty blockers or hormones totaled 17,683 from 2017 to 2021 and has been increasing, according to Reuters.

From 2019 to 2021, at least 56 patients ages 13 to 17 had genital surgeries, and from 2019 to 2021, at least 776 children that age had mastectomies, not including procedures that weren’t covered by insurance, according to Reuters.

The transgender surgery industry grosses more than $2 billion annually and expects to double that by 2030.

Debate Among Medication Providers

“Puberty delay medications are safe and effective,” according to the World Professional Association for Transgender Health (WPATH), a pro-transgender organization that sets standards for trans medical interventions. “Every person, including every TGD person, deserves an opportunity to be their true selves and has the right to access medically-necessary affirming care to enable this opportunity,” WPATH says.

When WPATH recently updated its guidance, authors “were acutely aware that any unknowns that the working group acknowledged — any uncertainties in the research — could be read as undermining the field’s credibility and feed the right-wing effort to outlaw gender-related care,” The New York Times reported. The newspaper is in the midst of an internal fight about its coverage of transgender issues, with some saying it has been too critical of transgender medical interventions.

A draft of the WPATH chapter for adolescents included minimum recommended ages for hormone treatments and breast removal or augmentation, but after criticism from providers and transgender activists, “it was determined that the specific ages would be removed to ensure greater access to care for more people,” WPATH said.

The final guidelines also walked back a recommendation that preteens and teenagers should provide evidence of several years of persistently identifying as transgender, to differentiate from kids whose change in identification is recent, and changed it to a vaguer “sustained” gender incongruence. “In the end, the chapter sided with the trans advocates who didn’t want kids to have to wait through potentially painful years of physical development,” according to the Times.

The final guidelines acknowledged that because of the limited long-term research, treatment without a comprehensive diagnostic assessment “has no empirical support and therefore carries the risk that the decision to start gender-affirming medical interventions may not be in the long-term best interest of the young person at that time.”

Reuters found that gender facilities across the country are not conducting recommended months-long assessments before administering hormones to children. Parents of 28 of 39 minors who had sought transgender interventions told Reuters they “felt pressured or rushed to proceed with treatment.” Gender-care professionals also said some of their peers are “pushing too many families to pursue treatment for their children before they undergo the comprehensive assessments recommended in professional guidelines.”

Studying Causes of Gender Dysphoria

Some of the taxpayer-funded studies may bring clarity to the issue of gender dysphoria by examining its causes. One study will examine social media’s influence on children becoming transgender. A second will study “the life history calendar to examine young transgender women’s trajectories of violence, mental health, and protective processes.”

Another government-funded study will help determine how chromosomes, sexual organs, and hormones combine to create sex differences. Another will “uncover genetic underpinnings of female sexual orientation.”

https://thefederalist.com/2023/02/28/biden-admin-pushes-transgender-medical-care-while-quietly-bankrolling-research-showing-its-risks/

Focused Ultrasound Ablation Reduces Dyskinesia in Parkinson's

 An incisionless surgical procedure that uses focused ultrasound ablation (FUSA) to target the globus pallidus internus of patients with Parkinson's disease (PD) significantly reduced tremors and improved mobility for those with advanced disease, new research shows.

The technique requires no sedation or brain implants. Surgeons use MRI to identify the globus pallidus internus, a part of the basal ganglia involved in movement disorders, and a focused ultrasound beam to heat and destroy the tissue.

Investigators performed the procedure with a device called Exablate Neuro, which was first approved by the US Food and Drug Administration in 2016 to treat essential tremor.

On the basis of the results of a multicenter, randomized, sham-controlled trial, the agency expanded the indication in 2021 to include unilateral pallidotomy to treat advanced PD for patients with mobility, rigidity, or dyskinesia symptoms.

Dr Vibhor Krishna

"In some patients with Parkinson's disease, you get dyskinesias, and ablation of the globus pallidus significantly reduces those dyskinesias and motor impairment," lead investigator Vibhor Krishna, MD, associate professor of neurosurgery at the University of North Carolina at Chapel Hill, told Medscape Medical News. "It could be used to treat patients when other surgical procedures can't be applied."

The study was published online February 23 in The New England Journal of Medicine.

Strong Response

For the study, 94 patients with advanced PD who had dyskinesias or motor fluctuations and motor impairment in the off-medication state wore transducer helmets while lying in an MRI scanner. Patients were awake during the entire procedure.

The treatment group received unilateral FUSA on the side of the brain with the greatest motor impairment. The device initially delivered target temperatures of 40° to 45° Celsius. Ablative temperatures were gradually increased following evaluations to test for improvement of motor symptoms. The maximum temperature used was 54.3° Celsius.

Patients in the control group underwent an identical procedure with the sonication energy disabled.

The primary outcome was a response to therapy at 3 months, defined as a decrease of at least three points from baseline either in the score on the Movement Disorders Society–Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, while off medication or in the score on the Unified Dyskinesia Rating Scale (UDRS) while on medication.

At 3 months, 69% of the treatment group reported a response, compared to 32% of the control group (P = .003).

When researchers analyzed MDS-UPDRS scores, they found that 29% of the treatment group and 27% of the control group showed improvement. For UDRS scores, 12% of the treatment group demonstrated improvement. In the control group, there was no improvement on this score. Improvements in both scores were reported in 28% of the treatment group and 5% of the control group.

Among those who reported a response at 3 months, 77% continued to show a response at 12 months.

"Unforgiving" Area of the Brain

While the response rate was a promising sign of this finding, it was not what interested Krishna the most.

"The most surprising finding of this trial is how safe focused ultrasound pallidotomy is in treating patients with Parkinson's disease," he said.

The globus pallidus internus is an area of the brain that Krishna calls "unforgiving."

"One side is motor fibers, and any problem with that can paralyze the patient, and just below that is the optic tract, and any problem there, you would lose vision," Krishna said. "It is a very tough neighborhood to be in."

By using MRI-guided ultrasound, surgeons can change the target and temperature of the ultrasound beam during the procedure to allow more precise treatment.

Pallidotomy-related adverse events in the treatment group included dysarthria, gait disturbance, loss of taste, visual disturbance, and facial weakness. All were mild to moderate, Krishna said.

More Study Needed

Dyskinesia is a challenge in the management of PD. Patients need antiparkinsonian medications to slow deterioration of motor function, but those medications can cause the involuntary movements that are a hallmark of dyskinesia.

The most common treatment for this complication, deep-brain stimulation (DBS), has its own drawbacks. It's an open procedure, and there is a low-level risk for intracranial bleeding and infection. In addition, the electrode implants require ongoing maintenance and adjustment.

But the findings of this study show that for patients who aren't candidates for other therapies, such as DBS and ablative radiofrequency, FUSA may be an alternative, writes Anette Schrag, PhD, professor of clinical neurosciences at the University College London, in an accompanying commentary.

"The results confirm that it is effective in reducing motor complications of Parkinson's disease, at least in the short term," Schrag writes.

However, more long-term studies are needed, she adds.

One third of patients in the treatment group had no response to the treatment, and investigators aren't sure why. Krishna noted that the benefits of the procedure waned in about a quarter of patients within a year of treatment.

Investigators plan to probe these questions in future trials.

"The results of this trial are promising," Schrag writes, "but given the nonreversible nature of the intervention and the progressive nature of the disease, it will be important to establish whether improvements in motor complications are maintained over longer periods and whether treatment results in improved over all functioning and quality of life for patients."

The study was funded by Insightec. Disclosure forms Krishna and Schrag are provided on the journal's website.

N Engl J Med. Published online February 23, 2023. Abstract

https://www.medscape.com/viewarticle/989062

APA Releases Updated Eating Disorder Guidelines

 The American Psychiatric Association (APA) has released updated practice guidelines for the management of eating disorders, the first update in 16 years.

The updated guidelines focus primarily on anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED) and include recommendations for screening and treatment.

"Eating disorders often are unrecognized and untreated," Catherine Crone, MD, chair of the guideline writing group, said in a statement from APA. "This guideline and supplementary resources are intended to serve as a practical tool for clinicians, to help with screening, diagnosis, and providing evidence-based treatment for eating disorders."

Approximately one in five children worldwide are at risk for developing an eating disorder and US medical admissions for adolescents with restrictive eating disorders more than doubled during the pandemic.

The economic cost of eating disorders in the United States from 2018 to 2019 was an estimated $64.7 billion, the report notes, with an additional $326.5 billion attributable to reductions in well-being associated with eating disorders.

The executive summary of the updated guidelines was published online February 1 in The American Journal of Psychiatry.

The practice guideline, which was approved at the 2021 APA annual meeting, features 16 recommendations for clinicians, including screening patients for eating disorders as part of an initial psychiatric evaluation and conducting comprehensive patient evaluations that incorporate laboratory tests and electrocardiograms.

Recommendations also include setting individualized weight goals for patients with anorexia and incorporating family-based therapy as part of a treatment plan for adolescents with anorexia or bulimia.

"This practice guideline aims to help clinicians improve care for their patients by reviewing current evidence and providing evidence-based statements that are intended to enhance knowledge, increase assessment, and optimize treatment of eating disorders," the authors write.

A range of other resources were released with the new guidelines to provide clinicians with support to implement the recommendations, including a pocket guide for clinicians, continuing medical education activities, and slides. The association is also launching a pocket guide for patients and families and an interactive toolkit with a screening assessment calculator.

The APA guidelines follow the 2021 release by the American Academy of Pediatrics on diagnosing and managing eating disorders in children and adolescents.

Am J Psychiatry. Published online February 1, 2023. Abstract.

The American Psychiatric Association Practice Guideline For The Treatment Of Patients With Eating Disorders, Fourth Edition.

The development of the guidelines was supported by a grant from the Council of Medical Specialty Societies.

https://www.medscape.com/viewarticle/989058

Incyte ending Phase 3 myelofibrosis program

 

  • Independent data monitoring committee advises study unlikely to meet primary endpoint, leading to decision to discontinue the study

Incyte (Nasdaq:INCY) today announced that it will discontinue the Phase 3 LIMBER-304 trial following results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. The recommendation to stop the study was not due to safety. LIMBER-304 is a randomized, double-blind study evaluating the efficacy and safety of parsaclisib plus ruxolitinib (Jakafi®) versus placebo plus ruxolitinib in adult (age ≥18 years) patients living with myelofibrosis (MF) who have an inadequate response to ruxolitinib monotherapy.

While further review of the data is conducted, Incyte will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the best interest of each patient. Data from this study will be submitted for presentation at an upcoming scientific meeting.

The primary endpoint of LIMBER-304 (NCT04551053) was the proportion of patients achieving targeted reduction in spleen volume as measured by magnetic resonance imaging or computed tomography. Secondary endpoints included the proportion of patients who have a targeted reduction in Total Symptom Score (TSS), change in TSS, time to the first ≥50% reduction in TSS, overall survival, number of treatment emergent adverse events, time of onset of targeted reduction in spleen volume and duration of maintenance of targeted reduction in spleen volume.

https://finance.yahoo.com/news/incyte-provides-interim-analysis-phase-213500563.html