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Woman cured of Type 1 diabetes in life-changing clinical trial

Marlaina Goedel was diagnosed with Type 1 diabetes when she was just five-years-old, and not only was the disease controlling her, but it almost cost her life. "I've crashed my car into a brick building before having a diabetic attack while driving," Goedel recalled. Her condition was so extreme that she felt robbed of a normal childhood, telling the Daily Mail that she was in and out of hospital with life-threatening diabetic ketoacidosis, which causes toxic chemicals to build up in the blood due to a lack of insulin. Now 30-years-old, the Illinois woman no longer needs daily insulin shots and can finally enjoy sugar again thanks to a pioneering stem cell therapy that has cured her of type 1 diabetes. Goedel was one of three Americans who have been cured of their type 1 diabetes thanks to the clinical trial involving an islet cell transplant. It is a one-off infusion that involved transplanting islet cells into her liver to help her body produce insulin on its own. After four weeks, she no longer needed to take insulin. "[My doctor] said, ‘Mark it on your calendar. Today is the day. Stop all insulin,'" Goedel said of the life-changing moment. "I just went quiet and finally said, ‘I’m here. I’m in shock. I’m going to need you to repeat that.’" The trial was being run at the University of Chicago Medicine Transplant Institute. While Islet cell transplants isn't a new procedure, the current anti-rejection medication used can be toxic to the transplanted cells, potentially making it less effective over time. The clinical trial that ran at the university tested out a new antibody called tegoprubart, which was given to Goedel and the two other patients. Tegoprubart is made from lab-made antibodies that trick the immune system into thinking the body made the cells on its own, preventing them from being rejected. The patients were then given islet cells from a deceased donor's pancreas, which were then infused into the patient's small blood vessels in their liver. Those cells then lodged into the blood vessels and started producing insulin. For Goedel the only side effect of the procedure was "feeling like I got punched in the ribs," with the procedure lasting just an hour. "The cure is out there," Goedel told the Daily Mail. With her new lease on life, Goedel plans to go back to school and go horse riding without worrying about suffering an attack and causing an accident. "It took a while to get used to saying, 'I am cured. I am diabetes free.' It's been very freeing," she said. "No one should have to live with this disease. I know that now more than ever." Images: Good Morning America/ UChicago Medicine

Caring

How can I stop overthinking everything? A clinical psychologist offers solutions

<a href="https://theconversation.com/profiles/kirsty-ross-1513078">Kirsty Ross</a>, <a href="https://theconversation.com/institutions/massey-university-806">Massey University</a> As a clinical psychologist, I often have clients say they are having trouble with thoughts “on a loop” in their head, which they find difficult to manage. While rumination and overthinking are often considered the same thing, they are slightly different (though linked). <a href="https://www.apa.org/monitor/nov05/cycle">Rumination</a> is having thoughts on repeat in our minds. This can lead to overthinking – analysing those thoughts without finding solutions or solving the problem. It’s like a vinyl record playing the same part of the song over and over. With a record, this is usually because of a scratch. Why we overthink is a little more complicated. <h2>We’re on the lookout for threats</h2> Our brains are hardwired to look for threats, to make a plan to address those threats and keep us safe. Those perceived threats may be based on past experiences, or may be the “what ifs” we imagine could happen in the future. Our “what ifs” are usually negative outcomes. These are what we call “<a href="https://ccbhc.org/hot-thoughts-what-are-they-and-how-can-you-handle-them/">hot thoughts</a>” – they bring up a lot of emotion (particularly sadness, worry or anger), which means we can easily get stuck on those thoughts and keep going over them. However, because they are about things that have either already happened or might happen in the future (but are not happening now), we cannot fix the problem, so we keep going over the same thoughts. <h2>Who overthinks?</h2> Most people find themselves in situations at one time or another when they overthink. Some people are <a href="https://www.apa.org/monitor/nov05/cycle">more likely</a> to ruminate. People who have had prior challenges or experienced trauma may have come to expect threats and look for them more than people who have not had adversities. Deep thinkers, people who are prone to anxiety or low mood, and those who are sensitive or feel emotions deeply are also more likely to ruminate and overthink. Also, when we are stressed, our emotions tend to be stronger and last longer, and our thoughts can be less accurate, which means we can get stuck on thoughts more than we would usually. Being run down or physically unwell can also mean our thoughts are <a href="https://healthify.nz/hauora-wellbeing/m/mental-health-and-your-body/">harder to tackle</a> and manage. <h2>Acknowledge your feelings</h2> When thoughts go on repeat, it is helpful to use both emotion-focused and problem-focused <a href="https://link.springer.com/referencework/10.1007/978-1-4419-1005-9">strategies</a>. Being emotion-focused means figuring out how we feel about something and addressing those feelings. For example, we might feel regret, anger or sadness about something that has happened, or worry about something that might happen. Acknowledging those emotions, using self-care techniques and accessing social support to talk about and manage your feelings will be helpful. The second part is being problem-focused. Looking at what you would do differently (if the thoughts are about something from your past) and making a plan for dealing with future possibilities your thoughts are raising. But it is difficult to plan for all eventualities, so this strategy has limited usefulness. What is more helpful is to make a plan for one or two of the more likely possibilities and accept there may be things that happen you haven’t thought of. <h2>Think about why these thoughts are showing up</h2> Our feelings and experiences are information; it is important to ask what this information is telling you and why these thoughts are showing up now. For example, university has just started again. Parents of high school leavers might be lying awake at night (which is when rumination and overthinking is common) worrying about their young person. Knowing how you would respond to some more likely possibilities (such as they will need money, they might be lonely or homesick) might be helpful. But overthinking is also a sign of a new stage in both your lives, and needing to accept less control over your child’s choices and lives, while wanting the best for them. Recognising this means you can also talk about those feelings with others. <h2>Let the thoughts go</h2> A useful way to manage rumination or overthinking is “<a href="https://www.getselfhelp.co.uk/docs/Options.pdf">change, accept, and let go</a>”. Challenge and change aspects of your thoughts where you can. For example, the chance that your young person will run out of money and have no food and starve (overthinking tends to lead to your brain coming up with catastrophic outcomes!) is not likely. You could plan to check in with your child regularly about how they are coping financially and encourage them to access budgeting support from university services. Your thoughts are just ideas. They are not necessarily true or accurate, but when we overthink and have them on repeat, they can start to feel true because they become familiar. Coming up with a more realistic thought can help stop the loop of the unhelpful thought. Accepting your emotions and finding ways to manage those (good self-care, social support, communication with those close to you) will also be helpful. As will accepting that life inevitably involves a lack of complete control over outcomes and possibilities life may throw at us. What we do have control over is our reactions and behaviours. Remember, you have a 100% success rate of getting through challenges up until this point. You might have wanted to do things differently (and can plan to do that) but nevertheless, you coped and got through. So, the last part is letting go of the need to know exactly how things will turn out, and believing in your ability (and sometimes others’) to cope. <h2>What else can you do?</h2> A stressed out and tired brain will be <a href="https://mentalhealth.org.nz/resources/resource/stress-and-how-to-manage-it">more likely</a> to overthink, leading to more stress and creating a cycle that can affect your wellbeing. So it’s important to manage your stress levels by eating and sleeping well, moving your body, doing things you enjoy, seeing people you care about, and doing things that fuel your soul and spirit. Distraction – with pleasurable activities and people who bring you joy – can also get your thoughts off repeat. If you do find overthinking is affecting your life, and your levels of anxiety are rising or your mood is dropping (your sleep, appetite and enjoyment of life and people is being negatively affected), it might be time to talk to someone and get some strategies to manage. When things become too difficult to manage yourself (or with the help of those close to you), a therapist can provide tools that have been proven to be helpful. Some helpful tools to manage worry and your thoughts can also be found <a href="https://www.cci.health.wa.gov.au/Resources/Looking-After-Yourself/Anxiety">here</a>. When you find yourself overthinking, think about why you are having “hot thoughts”, acknowledge your feelings and do some future-focused problem solving. But also accept life can be unpredictable and focus on having faith in your ability to cope. <img style="border: none !important; box-shadow: none !important; margin: 0 !important; max-height: 1px !important; max-width: 1px !important; min-height: 1px !important; min-width: 1px !important; opacity: 0 !important; outline: none !important; padding: 0 !important;" src="https://counter.theconversation.com/content/223973/count.gif?distributor=republish-lightbox-basic" alt="The Conversation" width="1" height="1" /> <a href="https://theconversation.com/profiles/kirsty-ross-1513078">Kirsty Ross</a>, Associate Professor and Senior Clinical Psychologist, <a href="https://theconversation.com/institutions/massey-university-806">Massey University</a> Image credits: Getty Images This article is republished from <a href="https://theconversation.com">The Conversation</a> under a Creative Commons license. Read the <a href="https://theconversation.com/how-can-i-stop-overthinking-everything-a-clinical-psychologist-offers-solutions-223973">original article</a>.

Mind

Labels like ‘psycho’ or ‘schizo’ can hurt. We’ve workshopped alternative clinical terms

It is common to hear people use stigmatising, discriminatory and hurtful labels such as “psycho”, “schizo” or “totally bipolar”. Others might minimise conditions by saying they too are “a bit OCD” because they value structure and organisation. This kind of <a href="https://bmchealthservres.biomedcentral.com/articles/10.1186/1472-6963-7-97">everyday use of pseudo-clinical terms</a> can be upsetting for young people who are struggling with these conditions. Worse still, it can stop them seeking care. Clinical terms can have the same effect. For our <a href="https://www.sciencedirect.com/science/article/abs/pii/S092099642100356X">recent research</a>, we worked with young patients, carers and clinicians to develop new mental health vocabulary that carries less stigma, but remains accurate. <h2>Mental health labels have pros and cons</h2> Labels can provide concise and understandable descriptions of clinical and theoretical ideas. Diagnoses enable patients and health professionals to follow evidence-based advice for effective care, because <a href="https://www.nice.org.uk/">best practice guidelines</a> are available for all labelled medical conditions. In other words, naming a condition is the first step towards identifying the best treatment available. Labels can also help create communities of individuals who share a similar clinical description, and reassure individuals they are not alone. On the other hand, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1925070/">labels</a> can result in <a href="https://www.cambridge.org/core/journals/psychological-medicine/article/should-we-be-concerned-about-stigma-and-discrimination-in-people-at-risk-for-psychosis-a-systematic-review/0E3509EA0A8E19293077C2645D643350">stigma and discrimination</a>, poor engagement with services, increased anxiety and suicidal thoughts, and poorer mental health. The process of posing a diagnosis, may treat an individual’s strengths or their vulnerabilities as abnormalities and pathologise them. For example, a young person’s vivid imagination and artistic drive – strengths that allow them to produce wonderful artwork – might be recast as a sign of illness. Or their experience of growing up in poverty and disadvantage, could be seen as the cause of their mental illness, rather than environmental factors that may have merely contributed to it. As such, clinicians should seek to understand a person’s difficulties through a holistic, humanistic and psychological perspective, prior to giving them a label. <h2>New terms, changing approaches</h2> In the past decade, there have been efforts to <a href="https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(21)00478-8/fulltext">improve naming of psychiatric disorders</a>. Attempts to update psychiatric terms and make them more culturally appropriate and less stigmatising have resulted in renaming schizophrenia in several countries. Proposed terms such as <a href="https://onlinelibrary.wiley.com/doi/10.1111/j.1751-7893.2010.00203.x">Si Jue Shi Tiao</a> (thought and perceptual dysregulation) in Hong Kong, and <a href="https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(13)61776-6.pdf">Johyenonbyung</a> (attunement disorder) in South Korea, have been suggested as alternatives that carry less stigma and allow a more positive view of psychiatry. These new terms, however, were generated by experts in the field. Consumers and clients within the mental health system have rarely been consulted, until now. <h2>Thoughts from those ‘at risk’</h2> Currently, “ultra-high risk (for psychosis)”, “at-risk mental state” and “attenuated psychosis syndrome” are used to describe young people at elevated risk of developing psychosis. But these labels can be stigmatising and damaging for the young people who receive them. At Orygen, new, less stigmatising ways to describe the “risk for psychosis” concept <a href="https://www.sciencedirect.com/science/article/abs/pii/S092099642100356X">were co-developed</a> with young people with lived experience of mental ill-health. During focus groups, former patients were asked how they would like their experiences to be termed if they were believed to be at risk for developing a mental illness. This discussion resulted in them generating new terms such as “pre-diagnosis stage”, “potential for developing a mental illness” and “disposition for developing a mental illness”. The terms were then presented to three groups: 46 young people identified as being at risk for psychosis and currently receiving care; 24 of their caregivers; and 52 clinicians caring for young people. Most thought these new terms were less stigmatising than the current ones. The new terms were still judged as informative and illustrative of young people’s experiences. Patients also told us they wanted terms like these to be fully disclosed and raised early in their care. This revealed a desire of transparency when dealing with mental ill-health and clinicians. <h2>Names have power</h2> Labels can, and should, be revisited when stigma becomes associated with them. Co-designing new diagnostic labels with patients, their carers and clinicians is empowering for all involved. Several similar projects are underway in <a href="https://www.sciencedirect.com/science/article/abs/pii/S0920996420301572">Italy</a> and <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/pcn.12423">Japan</a> to include a cultural perspective in renaming terms related to young people at risk of developing serious mental ill health. We hope to integrate and use more terms generated by young people in mainstream early intervention psychiatric services. We hope this will have a meaningful impact on young people’s mental health by allowing better access to care and less stigmatisation. Image credits: Getty Images This article originally appeared on <a href="https://theconversation.com/labels-like-psycho-or-schizo-can-hurt-weve-workshopped-alternative-clinical-terms-179756" target="_blank" rel="noopener">The Conversation</a>.

Mind

Jury’s in for ivermectin: “No clinical significance.”

At last, one of the largest and most rigorous clinical trials to test ivermectin as a COVID treatment has published its results in the prestigious New England Journal of Medicine. The fervent belief for many was that ivermectin – originally a worming medication – would protect infected people from progressing to severe disease requiring hospitalisation. The trial found that ivermectin given in the first seven days after symptoms had no significant effect. For those in the know, the finding comes as little surprise. The so-called <a href="https://www.togethertrial.com/" target="_blank" rel="noreferrer noopener">TOGETHER trial</a> reported its primary results in seminars to other scientists and policy makers in <a href="https://c19ivermectin.com/togetherivm.html" target="_blank" rel="noreferrer noopener">early August</a> last year. The question is why it has taken so long to publish those results for the rest of us. The lack of clarity over the effectiveness of ivermectin has wreaked havoc. Many have foregone vaccination and even refused tested medical treatments, preferring to take ivermectin at <a href="https://www.npr.org/sections/coronavirus-live-updates/2021/09/04/1034217306/ivermectin-overdose-exposure-cases-poison-control-centers" target="_blank" rel="noreferrer noopener">unsafe</a> high doses or even veterinary pastes in the belief that it was a cure. These beliefs have been propped up by doctors around the world, including those in Britain’s <a href="https://bird-group.org/who-are-bird/" target="_blank" rel="noreferrer noopener">BIRD,</a> the US-based Front Line COVID <a href="https://covid19criticalcare.com/" target="_blank" rel="noreferrer noopener">Critical Care Alliance</a>, or <a href="https://www.theguardian.com/australia-news/2021/oct/18/doctor-who-advocated-covid-19-therapy-including-ivermectin-applied-for-patent-on-same-unproven-treatment" target="_blank" rel="noreferrer noopener">Thomas Borody</a> and colleagues in Australia. “It is puzzling that the important and completed ivermectin arm has not reported its results [till now], says Paul Glasziou ,a professor at the <a href="https://iebh.bond.edu.au/" target="_blank" rel="noreferrer noopener">Institute for Evidence Based Healthcare</a> at Bond University, Gold Coast. “The use of preprints to rapidly provide clinicians and policymakers with results is vital for uptake of effective treatments as well as stopping ineffective and potentially dangerous treatments like ivermectin.” When the COVID pandemic hit in the early months of 2020, doctors were helpless to treat the patients dying in overflowing emergency rooms. A number of randomised clinical trials (RCTs) were urgently rolled out to test drugs on the shelf – so-called ‘repurposed drugs’. These included everything from <a href="https://www.thelancet.com/article/S0140-6736(20)32013-4/fulltext" target="_blank" rel="noreferrer noopener">HIV drugs</a> to anti-inflammatory medications to tamp down friendly fire from a raging immune system. The fastest and most successful trial – dubbed RECOVERY and based at Oxford – focused on saving the lives of hospitalised patients whose death rate was 25% or 40% if they needed to be placed on ventilators. In June 2020 RECOVERY posted a <a href="https://www.medrxiv.org/content/10.1101/2020.06.22.20137273v1" target="_blank" rel="noreferrer noopener">preprint</a> – a paper hosted by a website but yet to be peer reviewed and published in a journal. It reported that the inexpensive steroid dexamethasone could cut the deaths of those on ventilators <a href="https://www.nature.com/articles/d41586-020-01824-5" target="_blank" rel="noreferrer noopener">by a third</a>. The rapid dissemination of the results by preprint is estimated to have saved the lives of thousands of people. Another RECOVERY <a href="https://www.medrxiv.org/content/10.1101/2020.07.15.20151852v1" target="_blank" rel="noreferrer noopener">preprint</a> also saved lives by reporting that the repurposed malaria and rheumatoid arthritis drug hydroxychloroquine – much feted by Donald Trump – not only failed to help hospitalised patients but appeared to make them worse. “Patients allocated to hydroxychloroquine were less likely to be discharged from hospital alive within 28 days,” the preprint reported. The TOGETHER trial led by Ed Mills at McMaster University in Ontario, Canada, was initiated in <a href="https://www.togethertrial.com/trial-specifications" target="_blank" rel="noreferrer noopener">June 2020</a>. It also tested repurposed drugs but focussed earlier, in patients who were still in the first week of their illness. The idea was to find medications that would stop them going to hospital, to contain COVID as the mild-ish disease that was experienced by 90% of patients. Unlike RECOVERY, which sourced patients from British hospitals at the height of their pandemic, the TOGETHER trial sourced its patients from Brazil. This was necessary because the pandemic seems to move in waves and by the time the time RECOVERY started, the first wave in Canada had moved on, leaving few patients to recruit to the study. TOGETHER tested some of the same drugs as RECOVERY for infected people to use at home, including hydroxychloroquine and the HIV drug combination lopinavir/ritonavir. They were not effective, as reported in a paper published in the Journal of the American Medical Association in April 2021. Ivermectin was not included in the initial line-up of repurposed drugs. TOGETHER team member Craig Rayner, a Monash University-based clinical pharmacologist who modelled the effective drug doses for the trial, <a href="https://www.smh.com.au/national/how-a-false-science-cure-became-australia-s-contribution-to-the-pandemic-20211013-p58zp3.html" target="_blank" rel="noreferrer noopener">advised against it</a> since the ivermectin dose required to kill the virus was <a href="https://theconversation.com/ivermectin-is-a-nobel-prize-winning-wonder-drug-but-not-for-covid-19-168449" target="_blank" rel="noreferrer noopener">more than 20</a> times the maximum approved dose. That was based on the reports of ivermectin’s virus-killing effects in the test-tube. But by mid 2020, ivermectin had replaced hydroxychloroquine as a popular COVID ‘cure’. Some trials showed it was effective; other didn’t – not a surprising situation in the early stages of testing of a drug. Expert pharmacologists like Andrew McLachlan at the University of Sydney declared a state of clinical ‘equipoise’, meaning the jury was out. Larger, gold standard RCTs were needed. (At the time, it had not yet been revealed that many of the studies showing ivermectin was effective <a href="https://cosmosmagazine.com/health/covid/data-detectives-dig-into-ivermectin-studies/" target="_blank" rel="noreferrer noopener">were fraudulent</a>.) Given the situation on the ground, the TOGETHER team decided to include ivermectin in their trial. “We had an obligation,” says Rayner. “We realised the answer was unknown.” The triallists recruited 3515 Brazilian patients from 12 health centres in the state of Minas Gerais. To raise their chances of detecting an ivermectin effect, the patients had to have at least one risk factor for serious disease, such as obesity or diabetes. These recruits were randomly allocated into different arms of the trial to test a number of different repurposed drugs against a placebo. The ivermectin arm treated 679 people and gave 679 people a placebo. Based on what appeared to be positive findings from smaller trials, ivermectin was used at a cumulative dose six times higher than the maximum approved dose – 400 micrograms per kg of body weight per day for three days. The maximum dose that’s prescribed for the parasitic disease strongyloidiasis is a single dose of 200 microgram per kg of body weight. The measurement endpoint for the trial was hospitalisation 28 days after treatment by the drug. By the beginning of August 2021, the researchers had their results. Ivermectin did not reduce the risk of hospitalisation. By contrast the cheap antidepressant drug <a href="https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext" target="_blank" rel="noreferrer noopener">fluvoxamine did</a>, reducing the risk of hospitalisation <a href="https://www.openaccessgovernment.org/fluvoxamine-can-cut-covid-19-hospitalisations-by-30/123301/" target="_blank" rel="noreferrer noopener">by 30%</a>. So, why did TOGETHER take until the end of March 2022 to deliver the coup de grace for ivermectin? RECOVERY by contrast delivered its verdict for hydroxychloroquine in July 2020, letting the world know it was pointless and dangerous to use it as a treatment for COVID. <div class="newsletter-box"> <div id="wpcf7-f6-p187042-o1" class="wpcf7" dir="ltr" lang="en-US" role="form"> <form class="wpcf7-form mailchimp-ext-0.5.56 resetting spai-bg-prepared" action="/health/covid/jurys-in-for-ivermectin-no-clinical-significance/#wpcf7-f6-p187042-o1" method="post" novalidate="novalidate" data-status="resetting"> <input class="wpcf7-form-control wpcf7-text referer-page spai-bg-prepared" name="referer-page" type="hidden" value="https://cosmosmagazine.com/" data-value="https://cosmosmagazine.com/" aria-invalid="false" /> </form> </div> </div> One reason is that the TOGETHER trial had a much tougher remit than RECOVERY. RECOVERY tested hospitalised patients, who were easy to find being ‘captive’ in their hospital beds. Their death rate of 25% also made it easy to achieve statistically significant results. By contrast TOGETHER had to rope in the mildly ill from out in the community within seven days of their first symptoms. And given only 10% of them would ever develop severe disease, they needed to be picky, selecting those with a risk factor for severe disease such as obesity or diabetes. “We needed to have the potential to detect an effect,” said Mills. Moreover, while RECOVERY managed to roll out at lightning speed to catch the first COVID wave in the UK, by the time TOGETHER rolled out Canada’s COVID wave had receded, so they had to recruit in Brazil. And here they ran up against the problem of finding people who weren’t already self-medicating with ivermectin. That was partly circumvented by running the trial in Minas Gerais, a state in southeast Brazil where the use was not as widespread, says Rayner. However, once the TOGETHER group overcame all these obstacles, why did they not publish a preprint like RECOVERY? Mills says they decided to go the route of publishing in a major journal and that they did ‘air’ the data in talks. But journalists find it challenging to report on unpublished data since the scientists they rely on to provide independent opinions are loathe to comment on unpublished data. And the airing of the TOGETHER results did not have the necessary force to quell a degree of ivermectin hysteria that was seeing people eat veterinary worming pastes. In late August, the US FDA felt compelled to tweet: “You are not a horse. You are not a cow. Seriously, y’all. Stop it. … Using the Drug ivermectin to treat COVID-19 can be dangerous and even lethal.” Rayner adds they did not expect it would take eight months till publication and were bound not to disclose a publication date or discuss the paper with journalists. “Had we known it would take this long, we might have considered a different route,” he says. Another reason for keeping their data out of the limelight till now is that the TOGETHER scientists’ reward for carefully carrying out these difficult trials has been harassment and threats from ivermectin devotees. “This is not a matter of science but psychology,” says Mills. “It’s not unusual to see a <a href="https://www.science.org/content/article/overwhelmed-hate-covid-19-scientists-face-avalanche-abuse-survey-shows" target="_blank" rel="noreferrer noopener">death threat</a> in my inbox,” adds Rayner. “I’ve had to change my phone number. It’s pretty traumatising. We’re all feeling that way.” Being under siege has left the researchers media shy. “This report was not something I wanted to get ahead of. I fear what the release of the paper will bring,” says Rayner. The secrecy and drawn-out reporting of ivermectin trials is not limited to the McMasters group. Chris Butler, the leader of the ‘Principle’ ivermectin trial at Oxford, is similarly tight-lipped as is the leader of an NIH trial known as Activ-6. Neither of these groups responded to this journalist’s inquiry as to an expected report date. Perhaps these trials, which are based in the in the UK and US, have also found it difficult to recruit enough patients to get a statistically meaningful result. But their results, based in Western populations, will be important to compare to those of TOGETHER. Because TOGETHER did actually find a small, but not statistically significant effect, of ivermectin on hospitalisation. Could it be a true but tiny signal in the noise? Mills suspects that in some Brazilian patients, ivermectin was actually treating the underlying parasitic infections – and that improved the person’s ability to fight COVID. That’s a theory suggested by <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2790173" target="_blank" rel="noreferrer noopener">this recent analysis</a>. If that’s the case, this tiny effect of ivermectin would be restricted to people who are fighting parasitic infections. But we will have to wait – again – for the PRINCIPLE and NIH trials to be sure.  <img id="cosmos-post-tracker" style="opacity: 0; height: 1px!important; width: 1px!important; border: 0!important; position: absolute!important; z-index: -1!important;" src="https://syndication.cosmosmagazine.com/?id=187042&title=Jury%E2%80%99s+in+for+ivermectin%3A+%E2%80%9CNo+clinical+significance.%E2%80%9D" width="1" height="1" data-spai-target="src" data-spai-orig="" data-spai-exclude="nocdn" />  <div id="contributors"> <a href="https://cosmosmagazine.com/health/covid/jurys-in-for-ivermectin-no-clinical-significance/" target="_blank" rel="noopener">This article</a> was originally published on <a href="https://cosmosmagazine.com" target="_blank" rel="noopener">Cosmos Magazine</a> and was written by <a href="https://cosmosmagazine.com/contributor/elizabeth-finkel" target="_blank" rel="noopener">Elizabeth Finkel</a>. Elizabeth Finkel is editor-at-large of Cosmos. Image: Getty Images </div>

Body

Pain and the brain: Closing the gap between modern pain science and clinical practice

<div> <div class="copy"> Statistics show that chronic pain affects 3.4 million Australians – that’s almost 14% of the population. But while pain science discoveries have enormous consequences on chronic pain treatment, the medical community knows little about them. Pain scientists have been urging clinicians for decades to ditch the traditional biomedical approach and adopt a multidisciplinary and multimodal methodology to chronic pain treatment. This latter approach considers the biological, psychological and social factors that affect the patient’s perception of danger. Evidence-based treatment includes a <a rel="noreferrer noopener" href="https://www.sciencedirect.com/science/article/pii/S0004951414601690?via%3Dihub" target="_blank">combination</a> of pharmacological and non-pharmacological techniques, including pain education, physiotherapy management and mental health support. “We have developed a four-steps process that brings together all these ideas (drawn from modern pain science),” says Professor Benedict Wand, a pain scientist at the University of Notre Dame. The first, fundamental step of this process, he says, is modern pain neurobiology education, which helps people gain a less threatening understanding of pain. The second step is helping the person feel safe to move, while the third step includes an active progressive rehabilitation that gradually loads the body so that movement continues to feel safe. Lastly, the focus shifts towards making the body stronger. Read more: <a rel="noreferrer noopener" href="https://cosmosmagazine.com/health/medicine/chronic-pain-in-women-could-be-genetic/" target="_blank">Chronic pain in women could be genetic</a> The biomedical model in which most health professionals in Australia have been trained describes pain as a direct consequence of tissue damage – the more severe an injury, the stronger the pain. In this model, pain provides an accurate measure of the state of the tissues, and it can be ‘fixed’ by providing pain relief. “We originally thought that pain was a simple readout of noxious information from the body,” says Wand. “But that is certainly not the process that underpins complex and long-standing pain experiences.” Decades of <a rel="noreferrer noopener" href="http://www.cor-kinetic.com/wp-content/uploads/2014/04/reconceptualizing-pain.pdf" target="_blank">research</a> in pain science have led scientists to believe that the level of pain is not an indication of the level of tissue damage. Instead, scientists have discovered that pain is a vital mechanism that happens in the brain (and not in the tissues) to protect us from more severe injuries. When we get hurt, pain receptors send a ‘possible threat’ signal to the brain, which then evaluates the danger of the threat by drawing information from current and past experiences and the state of the mind. If the brain does not perceive the circumstance as dangerous, it will not cause pain. If we are anxious or frightened, our brain might perceive the situation as dangerous and produce pain to protect us. “An interaction between incoming information from the world around you and held information – things that you already think and feel and believe – gives rise to an experience of pain when you judge your body to be under threat or needing protection,” says Wand. In one <a rel="noreferrer noopener" href="https://journals.lww.com/pain/Fulltext/2007/12150/The_context_of_a_noxious_stimulus_affects_the_pain.9.aspx" target="_blank">study</a>, scientists placed an ice-cold rod on the back of volunteers’ hands while showing them either a red or blue light. The rod was at the same temperature each time, but those who were shown the red light, which in our imagery represents danger, reported more intense pain than those who saw the blue light. In another <a rel="noreferrer noopener" href="https://journals.lww.com/pain/Fulltext/1998/01000/The_role_of_prior_pain_experience_and_expectancy.24.aspx" target="_blank">experiment</a>, volunteers put their heads inside what they thought was a ‘head stimulator’. In front of them, researchers manoeuvred an ‘intensity knob’. The volunteers reported levels of pain that correlated with the intensity on the knob, although the stimulator was doing nothing at all. These studies suggest that pain is not a response to real danger or physical damage but to perceived danger, says Professor Lorimer Moseley, a pain scientist at the University of South Australia. Consequently, psychosocial factors that alter our perception of threat play a crucial role in the level of pain we experience. When pain becomes chronic, it is less about physical damage and more about a pain system that has become excessively protective. A physical cause of the pain might never be found in scans, yet the pain people feel is real, says Moseley. <h2>Go the distance for pain science</h2> While lack of access to multidisciplinary pain services is a countrywide issue, rural and regional areas are severely underserved. Pain Revolution is <a rel="noreferrer noopener" href="https://www.painrevolution.org/" target="_blank">an organisation</a> set up to close the gap between modern pain science and clinical practice in rural and regional communities. The organisation has established a Local Pain Educator Program that trains rural and regional GPs and health professionals in modern pain science and management. In turn, they support their communities by providing pain education to the public. With another project called the Local Pain Collectives, Pain Revolution helps rural and regional health professionals establish community-based, interdisciplinary networks to build their skills in contemporary pain education and management. “Two essential ingredients for recovery from persistent pain are learning and movement,” says Moseley, who is also CEO of Pain Revolution. “There is very strong evidence that movement is medicine. Our muscles, bones, ligaments, skin, tendons – you name it – love movement.” To support its work, Pain Revolution has launched a virtual challenge to raise funds called Go the Distance. “Go the Distance is challenging everyone to learn a bit more about pain and get moving, and walking, running and cycling are three easy ways to do it,” says Moseley. The initiative has replaced the annual Rural Outreach Tour, which had previously been the major Pain Revolution fundraiser. “Like many events in 2021, COVID has meant that we had to find an alternative to the tour,” says Moseley. The initiative will be held in October, and it challenges participants to walk, run or ride as far as possible to support people who suffer from chronic pain and often don’t receive medical care that is based on the latest scientific evidence. If you want to help, support our science writer Manuela Callari, who has taken the challenge, by donating <a rel="noreferrer noopener" href="https://painrevolution.raisely.com/manuela-callari" target="_blank">here</a>. If you want to sign up as an individual, or join a team, go to <a rel="noreferrer noopener" href="http://painrevolution.raisely.com/" target="_blank">painrevolution.raisely.com</a>. Image credit: Shutterstock This article was originally published by <a rel="noopener" href="https://cosmosmagazine.com/health/pain-and-the-brain-closing-the-gap-between-modern-pain-science-and-clinical-practice/" target="_blank">cosmosmagazine.com</a> and was written by Dr Manuela Callari. </div> </div>

Body

Game-changing cancer treatment enters second clinical trial

Game-changing low-cost and non-toxic treatment could offer people battling cancer a new alternative to chemotherapy. Researchers at The Australian National University have discovered a way to use dead bacteria to help kickstart the body’s immune system and shrink the cancer. Aude Fahrer, lead research at ANU said ongoing clinical trials of the Complete Freund Adjuvant treatment had shown promising results and could significantly improve outcomes for patients battling the disease. “We do think it could be a game charger. If this works well, it will be a new treatment option with far fewer side effects, which will be available for cancer patients,” Associate professor Fahrer said. Complete Freund Adjuvant is made up just three ingredients: mineral oil, surfactant, and dead bacteria. Associate Professor Fahrer’s team tested the treatment on eight cancer patients at Canberra Hospital. “They were all late stages, but in one case in particular we were able to significantly improve the patients’ quality of life,” she said. The new treatment was able to reduce the amount of liquid around the patient’s lungs and shrunk their tumour. Associate Professor Fahrer said the new approach was less time-consuming and physically taxing than other cancer treatments such as chemotherapy. “The best things about this new treatment is that it requires few dosages, is simple to administer, and has how side effects,” she said. Extreme hair loss, nausea, fatigue, and physical pain are just some of the impacts of chemotherapy. And while some cancer immunotherapy treatments can cost up to $40,000, the ANU researcher’s new treatment is very affordable – clocking in at just $20 per dose. The bacterial-based immunotherapy is a simple, but unusual approach to treating tumours. “It involves injecting a slow-release solution of dead mycobacteria directly into the cancer,” Associate Professor Fahrer said. “The idea is this will bring immune cells into the cancer to attack the bacteria, even though they’re dead, and as a side effect cause the immune cells to attack the cancer as well. “Once the immune cells multiple they can travel around the body, so it would not only attack the cancer at the injection site, but any metastases – where the cancer has spread to another part of the body.” While trials have only been conducted on late-stage human cancer patients so far, Associate Professor Fahrer said the new treatment was able to eliminate some earlier stage tumours in animal studies. If the new treatment continues to show success in clinical trials, researchers say the treatment has the potential to help treat all forms of solid tumour cancer. Ms Fahrer’s research was largely funded by the Lea Chapuis Memorial Fund, a cancer patient who’s dying wish was to improve treatment options for sick Australians. “Lea asked people to contribute to the research in lieu of flowers when she passed way,” Associate Professor Fahrer said. A second clinical trial of the new treatment at the Canberra Hospital has already been approved.

Body

MasterChef judge Melissa Leong reveals struggles with clinical depression

MasterChef judge Melissa Leong has spoken up about her struggles with clinical depression. Speaking to The Australian, the new judge on the Network 10 cooking show revealed she suffered from a breakdown in her 20’s. Since then, she has turned to cognitive therapy. “For me, a big part of anxiety and depression was not knowing how to say ‘no’ and wanting to please too many people … part of this process is learning to draw the line and slow down,” Leong said. “Mental health is not a novelty; it’s part of who we are and we need to treat it as if it were a broken arm or any other kind of medical consideration.” The food writer has previously opened up about her mental health on the podcast We Are the Real Ones. “I started going to therapy in my early-to-mid-20s. I had a breakdown, I’ll be really honest,” Leong told host and Neighbours star Sharon Johal on the program, which was launched in May. “It was an instance of too much on the plate and the plate ended up breaking under the weight of all those things, so I started seeing a therapist.” She said going to therapy had helped her get in touch with her feelings and find ways to express them. She also uses exercise and meditation to help manage her depression. “The only person who can pick you up and put you back together and help you navigate all of the struggles in life, is you. I was very grateful I realised that quite young as an adult and I’ve put in a lot of work since to get to the point where I can put in touch how I’m feeling.” Leong also shared the codeword she established with MasterChef’s executive producer for when she is overwhelmed on the set. “If I need a day like that where I just need that little bubble of time, it could be 10 minutes, I will tell them and they will find the next available opportunity for me to just have a minute … just to kind of be quiet and then you gather yourself and keep going.”

Food & Wine

Bit off the top: Prince Harry visits hair loss clinic in London

<div class="post_body_wrapper"> <div class="post_body"> <div class="body_text "> Prince Harry caused a stir when he visited a top hair-loss clinic in London. According to insiders, he underwent thickening treatment at the prestigious Philip Kingsley Trichological Clinic in London’s Mayfair. The 35-year-old struggles with hair loss like his brother Prince William and his dad Prince Charles. One expert is claiming that his bald patch has doubled since he married former actress Meghan Markle, but others are saying that his hair has appeared to have thickened after his visit toward the end of last year. <blockquote style="background: #FFF; border: 0; border-radius: 3px; box-shadow: 0 0 1px 0 rgba(0,0,0,0.5),0 1px 10px 0 rgba(0,0,0,0.15); margin: 1px; max-width: 540px; min-width: 326px; padding: 0; width: calc(100% - 2px);" class="instagram-media" data-instgrm-permalink="https://www.instagram.com/p/B2zxgEGH_Rv/?utm_source=ig_embed&utm_campaign=loading" data-instgrm-version="12"> <div style="padding: 16px;"> <div style="display: flex; flex-direction: row; align-items: center;"> <div style="background-color: #f4f4f4; border-radius: 50%; flex-grow: 0; height: 40px; margin-right: 14px; width: 40px;"></div> <div style="display: flex; flex-direction: column; flex-grow: 1; justify-content: center;"> <div style="background-color: #f4f4f4; border-radius: 4px; flex-grow: 0; height: 14px; margin-bottom: 6px; width: 100px;"></div> <div style="background-color: #f4f4f4; border-radius: 4px; flex-grow: 0; height: 14px; width: 60px;"></div> </div> </div> <div style="padding: 19% 0;"></div> <div style="display: block; height: 50px; margin: 0 auto 12px; width: 50px;"></div> <div style="padding-top: 8px;"> <div style="color: #3897f0; font-family: Arial,sans-serif; font-size: 14px; font-style: normal; font-weight: 550; line-height: 18px;">View this post on Instagram</div> </div> <p style="color: #c9c8cd; font-family: Arial,sans-serif; font-size: 14px; line-height: 17px; margin-bottom: 0; margin-top: 8px; overflow: hidden; padding: 8px 0 7px; text-align: center; text-overflow: ellipsis; white-space: nowrap;"><a style="color: #c9c8cd; font-family: Arial,sans-serif; font-size: 14px; font-style: normal; font-weight: normal; line-height: 17px; text-decoration: none;" rel="noopener" href="https://www.instagram.com/p/B2zxgEGH_Rv/?utm_source=ig_embed&utm_campaign=loading" target="_blank">A post shared by The Royal Family (@theroyalfamily)</a> on Sep 24, 2019 at 2:25pm PDT </div> </blockquote> “Harry’s visit caused a real stir,” an insider said. “This company is so prestigious. It’s one of the best places in the world. It’s got a whole range of different treatment plans.” “The richest, most famous and well-connected use it. The meeting with Harry went well.” <blockquote style="background: #FFF; border: 0; border-radius: 3px; box-shadow: 0 0 1px 0 rgba(0,0,0,0.5),0 1px 10px 0 rgba(0,0,0,0.15); margin: 1px; max-width: 540px; min-width: 326px; padding: 0; width: calc(100% - 2px);" class="instagram-media" data-instgrm-permalink="https://www.instagram.com/p/B2bFlARniq9/?utm_source=ig_embed&utm_campaign=loading" data-instgrm-version="12"> <div style="padding: 16px;"> <div style="display: flex; flex-direction: row; align-items: center;"> <div style="background-color: #f4f4f4; border-radius: 50%; flex-grow: 0; height: 40px; margin-right: 14px; width: 40px;"></div> <div style="display: flex; flex-direction: column; flex-grow: 1; justify-content: center;"> <div style="background-color: #f4f4f4; border-radius: 4px; flex-grow: 0; height: 14px; margin-bottom: 6px; width: 100px;"></div> <div style="background-color: #f4f4f4; border-radius: 4px; flex-grow: 0; height: 14px; width: 60px;"></div> </div> </div> <div style="padding: 19% 0;"></div> <div style="display: block; height: 50px; margin: 0 auto 12px; width: 50px;"></div> <div style="padding-top: 8px;"> <div style="color: #3897f0; font-family: Arial,sans-serif; font-size: 14px; font-style: normal; font-weight: 550; line-height: 18px;">View this post on Instagram</div> </div> <p style="color: #c9c8cd; font-family: Arial,sans-serif; font-size: 14px; line-height: 17px; margin-bottom: 0; margin-top: 8px; overflow: hidden; padding: 8px 0 7px; text-align: center; text-overflow: ellipsis; white-space: nowrap;"><a style="color: #c9c8cd; font-family: Arial,sans-serif; font-size: 14px; font-style: normal; font-weight: normal; line-height: 17px; text-decoration: none;" rel="noopener" href="https://www.instagram.com/p/B2bFlARniq9/?utm_source=ig_embed&utm_campaign=loading" target="_blank">A post shared by The Royal Family (@theroyalfamily)</a> on Sep 15, 2019 at 12:19am PDT </div> </blockquote> “It would be very expensive. It’s the place to go in London and it’s right in the heart of Mayfair.” The Philip Kingsley Trichological Clinic <a rel="noopener noreferrer" href="https://www.philipkingsley.com/" target="_blank">website</a> says that they have treated royalty, actors, models and athletes in the past. </div> </div> </div>

Beauty & Style

Ray Hadley’s police officer son admitted to mental health clinic following drug bust

Broadcaster Ray Hadley has revealed that his police officer son has been checked into a health clinic after his mental health struggles came to light following a drug possession charge. The 2BG radio broadcaster’s senior constable son was arrested at the Australian Hotel and Brewery in Rouse Hill on Friday, after officers allegedly found cocaine on him. "Last night my son Daniel, as you all know, was arrested in possession of 0.79 of a gram of cocaine, worth about $200," Hadley told reporters at a press conference held on the weekend. “When I was first told, I was both angry and perplexed. "I had no idea that my son, a respected police officer, would be involved in such a matter." The 28-year-old was granted conditional bail and has been charged with possession of a prohibited drug. The police officer has since been suspended from duty and his employment status is being reviewed. At the press conference, Ray Hadley emotionally revealed that his son has been battling mental struggles and has been checked into a support clinic. "I brought Daniel back home and my anger turned to shock and sadness," he said. "My son, during long conversations late into the night and early in the morning, revealed he's been battling mental health issues for quite some time. "He's also been away from work for months having dislocated his knee and waiting for an operation on a hernia. '"The serious nature of the illness is such that he’s been admitted already today to a clinic to deal with it – it is a very serious problem." While talking with his son, Ray discovered that Daniel had been seeing his GP about his mental health without his family’s knowledge. Ray said: “I’m not a medical professional and I won’t guess the nature of his illness but I will tell you it’s very serious and his family, me, his mum, sisters, aunts and uncles are very concerned. “I’m sure with expert medical advice he can recover from where he is now.” While Ray said Daniel's criminal charges were “a matter for the courts”, he appealed for everyone to consider the “things he’s dealt with over the last seven years as a police officer”. "All the time his colleagues and I thought he was coping and he obviously hasn't been coping. "Daniel accepts responsibility for his behaviour but unfortunately he's not in control of his mental health. "I now know how many parents feel when they think things are okay but they're not. I feel particularly inadequate as a father and as a spokesperson for 'R U OK?’ Day, when in fact my own son is not okay. "This is going to be a long, slow process for my son. I love him dearly and I wish to God that he'd come to me before this morning to tell me what he was battling."

Mind

Ita Buttrose: “I’m really sad to see James Packer struggling”

Ita Buttrose’s professional relationship with her former boss Kerry Packer began in 1972 when she launched Cleo magazine with the media mogul. She formed a close friendship with Kerry, with his eldest son, James, who was just five years old at the time, regularly playing with Ita’s two children, Kate and Ben – along with James’ younger sister Gretel. Since James’ recent resignation from Crown Resorts for mental health reasons in March, Ita has been understandably deeply concerned. Following his public announcement, the 50-year-old and father of three checked into a psychiatric hospital in the US to seek treatment. <img width="500" height="375" src="https://oversixtydev.blob.core.windows.net/media/7818656/screen-shot-2018-05-25-at-120344-pm_500x375.jpg" alt="Screen Shot 2018-05-25 At 12.03.44 Pm"/> Speaking exclusively to <a href="https://www.nowtolove.com.au/celebrity/celeb-news/ita-buttrose-james-packer-48619?utm_source=Sailthru&utm_medium=email&utm_campaign=AWW%20may%2025th&utm_term=list_aww_newsletter">The Australian Women’s Weekly</a>, Ita shared, “I just feel very sad for him.” “James is round about the same age as my kids and he learned to swim with my kids and Rob Henkie’s kids, who was Kerry’s cousin. “They all learned to swim together, so I’ve known James since he was a very little boy and I’m really sad to see that he’s struggling at the moment,” the concerned 76-year-old said. Referring to his time in rehab at a Boston clinic, Ita added, “Ros, his mother, was there and I’m sure Gretel, his sister, is somewhere.” Ita also noted, “He seems on very good terms with his former wives [Erica Baxter and Jodhi Meares] and his kids.” <img width="412" height="534" src="https://oversixtydev.blob.core.windows.net/media/7818657/screen-shot-2018-05-25-at-120148-pm.png" alt="Screen Shot 2018-05-25 At 12.01.48 Pm"/> Although the magazine and media queen had a very close working relationship with Kerry – and a solid friendship – Ita admits she didn’t know James professionally as they never got the opportunity to work together. “I know [James], but I don’t really know him well because I’d left the company by the time he was in charge,” Ita explained to AWW. “I would see him sometimes at a lunch or I’d run into him somewhere and we’d say ‘g’day’ and have a chat. But as I say, I’ve known him since he was little, and I can see he’s unhappy and it’s sad.”

Mind

Revolutionary study reveals best exercise for ageing

When it comes to exercise, it turns out it’s not just about working harder – but smarter as well. A ground-breaking study from the Mayo Clinic has revealed that high-intensity interval training (HIIT) is the best exercise for ageing. <a href="http://www.smh.com.au/lifestyle" target="_blank">The Daily Life</a> reports that the study found HIIT can essential stop the cellular ageing process in its tracks and in some cases, rejuvenate cells and repair body damage. The Mayo Clinic to a sample group of men and women aged between 18 and 30, and another group aged between 65 and 80, and assigned a three-month program of HIIT, strength training or a combination of the two. And the results were incredible. In both samples, the people who were assigned a three-month program of HIIT reported marked improvements in insulin levels, heart and lung health. But perhaps what was most impressive was the notable reversal of age-related decline in the microcellular proteins that are required for building muscle in the body. The study’s lead senior author, Sreekumaran Nair, said the study shows there is no substitute for exercise, “Based on everything we know, there's no substitute for these exercise programs when it comes to delaying the ageing process. These things we are seeing cannot be done by any medicine. “If people have to pick one exercise, I would recommend high-intensity interval training, but I think it would be more beneficial if they could do three to four days of interval training and then a couple days of strength training.” HIIT workouts typically last less than 30 minutes, generally involving a burst of energy followed brief low-intensity activity, repeatedly, until the participant is exhausted. Would you consider this type of training?

Body

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Bit off the top: Prince Harry visits hair loss clinic in London

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Ita Buttrose: “I’m really sad to see James Packer struggling”

Revolutionary study reveals best exercise for ageing

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