Covid inquiry: Failure to consider 'potentially massive impact' of lockdown pre-pandemic

Published13 JuneShareclose panelShare pageCopy linkAbout sharingImage source, Getty ImagesBy Jim Reed and Michelle RobertsBBC NewsThe “potentially massive impact” of lockdowns on society was not thought through before the pandemic, the lead lawyer for the Covid inquiry has said.As the probe into the government’s handling of the pandemic began hearing evidence, Hugo Keith KC said the UK may not have been well prepared “at all”.It was “extraordinary” that lockdowns had received little thought, he added.Government figures show 227,321 people have died in the UK with Covid mentioned on their death certificate.Mr Keith told the first public hearing that the virus had caused “death, misery, and incalculable loss”.He said while Covid could not have been avoided, the key issue was whether its impact on the UK was inevitable. There was “very little debate” about whether a national lockdown could be needed ahead of the pandemic or whether it could be avoided, Mr Keith told the inquiry, adding that there was a failure to think through the consequences for education and the economy.On Tuesday, Mr Keith was addressing the inquiry as it prepares to take oral evidence from its first witnesses later in the week. Its first topic – or module – will examine how well prepared the UK was for Covid up to January 2020. Mr Keith said: “Even at this stage, before hearing the evidence, it is apparent that we might not have been very well prepared at all.”What is the UK Covid-19 inquiry?It is about going through what happened and learning lessonsNo-one will be found guilty or innocentAny recommendations made do not have to be adopted by governmentsThe inquiry has no formal deadline but is due to hold public hearings until 2026Scotland is holding a separate inquiry in addition to the wider UK oneWhat is the UK Covid inquiry and how long will it take?This video can not be playedTo play this video you need to enable JavaScript in your browser.Chair Baroness Hallett pledged that the inquiry into the handling of the coronavirus pandemic would be the “thorough investigation” that the public deserves.The former High Court judge paid tribute to a “dignified vigil” of bereaved family members holding a silent protest outside of the building. Lady Hallett said there were three key questions to be answered for the “millions of people who have suffered and continue to suffer”: Was the UK properly prepared for a pandemic? Was the response to it appropriate? And can we learn lessons for the future?This first part of the inquiry will hear from key politicians, civil servants, scientists, unions, health and care organisations, groups representing victims and their relatives and more. The Covid-19 Bereaved Families for Justice group has criticised the inquiry’s timetable and says people have been “excluded from sharing key evidence”.They branded the inquiry’s Every Story Matters project – where members of the public can share their experience with the inquiry through a website – an “inadequate” process because stories will be anonymised and summarised and possibly “open to bias and interpretation by third parties”.Addressing critics of the inquiry, Lady Hallett said she hoped they would understand the difficult balance she has had to strike.”I am listening to them, their loss will be recognised, they will be able to contribute to the inquiry.”Mr Keith, counsel to the inquiry, said UK was “taken by surprise” over “significant aspects” of the pandemic, including lockdowns. “Extraordinary though it may seem, given that it’s a word that’s forever seared in the nation’s consciousness, there was very little debate pre-pandemic of whether a lockdown might prove to be necessary in the event of a runaway virus, let alone how a lockdown could be avoided.”Very little thought was given to how, if it proved to be necessary, how something as complex, difficult and damaging as a national lockdown could be put in place at all.”Equally, there appears to have been a failure to think through the potentially massive impact on education and on the economy.”He said the UK had been preparing for an outbreak more similar to flu, and questioned how well placed and funded the NHS was to cope.”No amount of foresight or planning can guarantee that a country will not make mistakes when a disease strikes, but that does not mean that we should not strive to be as ready as we sensibly can be,” Mr Keith said.”No country can be perfectly prepared, but it can certainly be underprepared.”Mr Keith highlighted “shocking” data showing that Covid mortality was two-and-a-half times higher in some of the most deprived parts of the UK than the richest, with people in some ethnic minority groups or with a disability far more likely to be infected or die of the disease.To what extent those outcomes could and should have been foreseen and mitigated would be a “big question” in module one, he said. The wider political environment will also be considered including the possible impact of Brexit on emergency planning.”Did the attention paid to the risks of a no-deal Brexit – Operation Yellowhammer as it was known – drain resources and capacity that should have been continuing the fight against the next pandemic?” Mr Keith asked.”Or did that generic and operational planning, in fact, lead to people being better trained and well-marshalled, and in fact better prepared to deal with Covid?”On the evidence so far… we very much fear that it was the former.”The inquiry will also examine if the collapse of the power-sharing agreement in Northern Ireland damaged the ability of authorities to plan and respond to the pandemic. Mr Keith said it was unlikely we will ever know how Covid started – whether it emerged from a lab leak or from farmed wild animals that were sold in Wuhan. Nor when the first human infection happened, he said. “For this inquiry’s purposes, this knowledge does not matter.” In his opening remarks, Pete Weatherby KC, counsel for the Covid-19 Bereaved Families for Justice group, said the “closest to an overall plan” to deal with Covid in 2020 was a 2011 document drawn up to protect the UK from an outbreak of influenza. “With a pandemic, time is of the essence and lost time is measured in lives,” he said. “The families expect the evidence will show… little or no ministerial leadership and the chaos of committees which led to poor planning and ultimately a reactive rather than a proactive response to the virus.” In response to the Brexit claims, a spokesperson for the prime minister said the government would not be responding to every issue raised in the inquiry.He added that it would be up to the government to respond at the appropriate stage. WhatsApp MessagesLady Hallett has asked to see ex-prime minister Boris Johnson’s unredacted WhatsApp messages between him and around 40 politicians and officials, but this is being challenged by his successor, Rishi Sunak.The Cabinet Office launched a legal challenge against the request, arguing some of the messages were irrelevant. This is thought to be the first time a government has taken legal action against its own public inquiry.Mr Johnson said he was “perfectly content” for the inquiry to have WhatsApp messages sent after May 2021. Earlier messages are not available because his mobile phone was involved in a security breach and has not been used since.Former Health Secretary Matt Hancock also said he was happy to share his messages, although many of these have already been leaked by the journalist Isabel Oakeshott, who helped Mr Hancock write his book, Pandemic Diaries.In a statement about the back-and-forth over the messages, Rishi Sunak’s spokesperson said it “is still ongoing” and will “obviously… be resolved through the normal process”.”Broadly, we continue to provide tens of thousands of pieces of information to the inquiry, 55,000 documents over the past 11 months and we will do so in the spirit of transparency and candour.”Covid WhatsApp message rowHow many Covid deaths have there been?The UK saw one of the worst first waves of Covid in Europe in spring 2020. In April and May that year, about 160,000 deaths were registered: 60,000 more than you’d expect based on the years just before the pandemic. But by that winter the UK had been overtaken by many countries in eastern Europe who had seemed to escape the first wave. The UK’s Office for National Statistics has continued to analyse these figures for Europe and, as of July last year, put the UK in the middle of the pack. According to Department of Health figures, 227,321 people died across the UK with Covid recorded on their death certificate.Covid vaccines have prevented many deaths and serious illness from the virus – more than 151m doses have been given in the UK. More on this storyThe questions we want the Covid inquiry to answerPublished13 JuneWhat is the UK Covid inquiry and how does it work?Published1 hour agoRelated Internet LinksUK Covid-19 InquiryThe BBC is not responsible for the content of external sites.

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Serotonin booster leads to increased functional brain connectivity

Cognitive deficits accompany mood disorders and other psychiatric conditions, often with debilitating effects. Limited treatments currently exist, but studies in animals and humans have pointed to drugs such as the laxative prucalopride that activate serotonin receptors as a potential therapeutic for the symptoms. It has remained unclear, however, how the medication affects resting brain activity. Now, a new study in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, published by Elsevier, examines the drug’s effects in healthy human adults.
Serotonin receptors and the 5-HT4-type receptors in particular are found in areas throughout the brain, including the frontal cortex, basal ganglia, and hippocampus, that are known to mediate cognitive function and regulate mood. Serotonin receptors are the primary targets of antidepressant medications, but resolving mood disturbances often does not resolve cognitive symptoms.
The researchers enlisted 50 healthy volunteers, half of whom received a six-day course of prucalopride, a highly selective agonist of the 5-HT4 type serotonin receptor, whereas the other half of the participants received a placebo. Participants underwent scanning with functional magnetic resonance imaging, including a “resting scan,” in which they relaxed in the scanner.
Lead author Angharad de Cates, PhD, MRCPsych, at the University of Oxford, said of the work, “Our previous studies on prucalopride demonstrated that even at low clinical doses it can improve cognition and memory in healthy volunteers. This latest research provides a neurological mechanism by which this might occur.”
Participants who received the medication displayed more functional connectivity in their resting-state (rsFC) between major cognitive networks. This included more rsFC between the central executive network, a brain network used for processing thoughts, and the posterior and anterior cingulate cortex (ACC), brain areas that regulate information processing and attention in the brain. There was also more rsFC between regions of the ACC and the lateral occipital cortex, a region that helps us pay attention to objects that matter. In addition, medicated participants compared to placebo controls showed decreased rsFC in the default mode network, a brain network that is activated during mind wandering.
Dr. de Cates added, “This provides further evidence that prucalopride is having an effect in areas of the brain that improve cognitive function — both by increasing and reducing connectivity between specific brain regions as required.”
Susannah Murphy, PhD, Associate Professor and joint senior author of the study, said, “Appropriate connectivity between and within these brain networks is needed to think properly, and this connectivity has been shown to be abnormal in depression. Here, the participants taking prucalopride had better scores on cognitive tests the day of the scan compared to the placebo participants. That suggests that the changes in rsFC that we saw with prucalopride may serve as a ‘signature’ of a drug that improves cognition.”
Dr. Murphy continued, “Untreated cognitive problems have a significant impact on the quality of life of people with depression. This study adds to the growing evidence base that drugs affecting the 5-HT4 serotonin receptor hold promise as a novel way to treat depression and cognitive impairment.”
Catherine Harmer, PhD, Professor of Cognitive Neuroscience and joint senior author of the study, said, “This study adds to the evidence base that the common laxative treatment prucalopride can have important effects in the brain, particularly affecting circuits which are important for learning and memory. Together with previous data, this suggests that this drug might be useful as a pro-cognitive treatment in disorders such as depression.”
Cameron Carter, MD, Editor of Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, said of the work, “These data, showing modulation of resting state connectivity in the brain by the 5HT4 receptor agonist and putative cognitive enhancer prucalopride, add to previous evidence that the agent modulates brain systems that are engaged during focused, higher cognitive activity and might have therapeutic potential.”

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Scalpel, Forceps, Bone Drill: Modern Medicine in Ancient Rome

Doctors are generally held in high regard today, but Romans of the first century were skeptical, even scornful, of medical practitioners, many of whom ministered to ailments they did not understand. Poets especially ridiculed surgeons for being greedy, for taking sexual advantage of patients and, above all, for incompetence.In his “Natural History,” Pliny the Elder, the admiral and scholar who died in 79 A.D. while trying to rescue desperate villagers fleeing the debris of Mt. Vesuvius, endeavored to speak out against the medical profession “on behalf of the senate and Roman people and 600 years of Rome.” Their fees were excessive, their remedies dubious, their squabbling insufferable. “Physicians gain experience at our peril and conduct their experiments by means of our deaths,” he wrote. The epitaph on more than one Roman tombstone read: “A gang of doctors killed me.”Medical remedies have improved since those times — no more smashed snails, salt-cured weasel flesh or ashes of cremated dogs’ heads — but surgical instruments have changed surprisingly little. Scalpels, needles, tweezers, probes, hooks, chisels and drills are as much part of today’s standard medical tool kit as they were during Rome’s imperial era.Archaeologists in Hungary recently unearthed a rare and perplexing set of such appliances. The items were found in a necropolis near Jászberény, some 35 miles from Budapest, in two wooden chests and included a forceps, for pulling teeth; a curet, for mixing, measuring and applying medicaments, and three copper-alloy scalpels fitted with detachable steel blades and inlaid with silver in a Roman style. Alongside were the remains of a man presumed to have been a Roman citizen.The site, seemingly undisturbed for 2,000 years, also yielded a pestle that, judging by the abrasion marks and drug residue, was probably used to grind medicinal herbs. Most unusual were a bone lever, for putting fractures back in place, and the handle of what appears to have been a drill, for trepanning the skull and extracting impacted weaponry from bone.Some of the newly excavated instruments included forceps, a curet and three copper-alloy scalpels fitted with detachable steel blades and inlaid with silver in a Roman style.Rusznák Gábor/ELTEThe instrumentarium, suitable for performing complex operations, provides a glimpse into the advanced medical practices of first-century Romans and how far afield doctors may have journeyed to offer care. “In ancient times, these were comparatively sophisticated tools made of the finest materials,” said Tivadar Vida, director of the Institute of Archaeology at Eötvös Loránd University, or ELTE, in Budapest and leader of the excavation.Two millenniums ago Jászberény and the county around it were part of the Barbaricum, a vast region that lay beyond the frontiers of the Empire and served as a buffer against possible outside threats. “How could such a well-equipped individual die so far from Rome, in the middle of the Barbaricum,” mused Leventu Samu, a research fellow at ELTE and a member of the team on the dig. “Was he there to heal a prestigious local figure, or was he perhaps accompanying a military movement of the Roman legions?”Similar kits have been found across most of the Empire; the largest and most varied was discovered in 1989 in the ruins of a third-century physician’s home in Rimini, Italy. But the new find is described as one of the most extensive collections of first-century Roman medical instruments known. Until now, the oldest was thought to be a trove of objects dug up in 1997 at a burial site in Colchester, England, that date to around 70 A.D., very early in the Roman occupation of Britain. The most renowned set turned up in the 1770s at Pompeii’s so-called House of the Surgeon, which was buried under a layer of ash and pumice during the eruption of Mount Vesuvius.Colin Webster, a classics professor at the University of California, Davis, and president of the Society for Ancient Medicine and Pharmacology, said the discovery illustrated the porousness of cultural boundaries in the ancient world. “Medicine has long been one of the most active vectors for intercultural exchange,” he said. “And this finding certainly helps show the physical evidence of these dynamics.”No license neededThe remains of the first-century man found accompanying the medical instruments, on display during a presentation of the team’s findings.Rusznák Gábor/ELTEThe Romans had high hopes for their medical experts. In his treatise “De Medicina,” or “On Medicine,” the first-century Roman encyclopedist Aulus Cornelius Celsus mused that “a surgeon should be youthful or at any rate nearer youth than age; with a strong and steady hand that never trembles, and ready to use the left hand as well as the right; with vision sharp and clear.” The surgeon should be undaunted and empathetic but unmoved by a patient’s screams of pain; his greatest desire should be to make the patient well.A majority of these undaunted Roman physicians were Greek, or at least speakers of the Greek language. Many were freedmen or even slaves, which may account for their low social standing. The man buried in the Hungarian necropolis was 50 or 60 when he died; whether he actually was a medical practitioner is unclear, researchers said, but he probably was not a local.“Studying medicine was only possible, at the time, in a large urban center of the empire,” Dr. Samu said. Doctors were peripatetic and medical traditions varied by territory. “Ancient medical writers, such as Galen, advised that physicians should travel to learn about diseases that were common to certain areas,” said Patty Baker, former head of archaeology and classics at the University of Kent in England.Would-be surgeons were encouraged to apprentice with recognized doctors, study at large libraries and listen to lectures in such far-flung places as Athens and Alexandria, a hub of anatomical learning. For firsthand experience in treating combat wounds, medics frequently interned in the army and gladiatorial schools, which might explain the presence of medical tools in the Barbaricum.“There were no licensing boards and no formal requirements for entrance to the profession,” said Lawrence Bliquez, emeritus archaeologist at the University of Washington. “Anyone could call himself a doctor.” If his methods were successful, he attracted more patients; if not, he found another career.Surgeries included many performed in the body’s orifices to treat polyps, inflamed tonsils, hemorrhoids and fistulas. Beside trepanning, the more radical surgeries included mastectomy, amputation, hernia reduction and cataract couching. “Surgery was a male domain,” Dr. Bliquez said. “But there were certainly many female midwives, so who can say they knew nothing about surgery, especially as it pertains to gynecology.”Contrary to myth, cesarean sections did not enter medicine until long after Julius Caesar’s birth in 100 B.C. The Romans did, however, practice embryotomy, a surgery by which a knife was used to cut the limbs from an infant while it was stuck in the birth canal. “A hook was used to withdraw the limbs, torso and head from the birth canal once they had been cut,” Dr. Baker said. “It was a gruesome procedure used to save the life of a mother.”Surgery was often the last resort of all medical treatments. “Any of the tools found in the Barbaricum grave could have caused death,” Dr. Baker said. “There was no knowledge of sterilization or germ theory. Patients were likely to die of sepsis and shock.”Second opinions welcomeTivadar Vida, director of the Institute of Archaeology at Eötvös Loránd University in Budapest, with camera, at the excavation site, about 35 miles outside Budapest.Samu Levente/ELTEThe tool-laden grave was discovered last year at a site where relics from the Copper Age (4500 B.C. to 3500 B.C.) and the Avar period (560 to 790 A.D.) had been found on the surface. A subsequent survey with a magnetometer identified a necropolis of the Avars, a nomadic peoples who succeeded Attila’s Huns. Among the rows of tombs, the researchers uncovered the man’s grave, revealing a skull, leg bones and, at the foot of the body, the chests of metal instruments. “The fact that the deceased was buried with his equipment is perhaps a sign of respect,” Dr. Samu said.That is not the only possibility. Dr. Baker said that she often cautioned her students about interpreting ancient artifacts, and asked them to consider alternative explanations. What if, she proposed, the medical tools were interred with the so-called physician because he was so bad at his practice that his family and friends wanted to get rid of everything associated with his poor medical skills? “This was a joke,” Dr. Baker said. “But it was intended to make students think about how we jump to quick conclusions about objects we find in burials.”

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Calls for abortion law reform after mother jailed

Published33 minutes agoShareclose panelShare pageCopy linkAbout sharingImage source, Getty ImagesParliament should debate overhauling abortion rules after a woman was jailed, the chair of the Commons equalities committee has said.Caroline Nokes MP told the BBC the 1861 law used to prosecute mother-of-three Carla Foster was “out of date”.The 44-year-old was convicted of inducing an abortion outside the legal limit using pills at home.Campaigners urged reform after she received a sentence of 28 months, 14 of which will be spent in custody.Foster was between 32 and 34 weeks pregnant when she took medication acquired via the “pills by post” scheme introduced during lockdown, Stoke-on-Trent Crown Court heard.Abortion is legal up to 24 weeks, and the procedure must be carried out in a clinic after 10 weeks.Foster was initially charged with child destruction, which she denied, and later pleaded guilty to an offence under Section 58 of the Offences Against the Person Act 1861.Under the Victorian era law, women “who use drugs or instruments” that are “unlawfully administered” to cause an abortion can be “kept in penal servitude for life”, meaning that they can face life imprisonment. Abortion was legalised with the Abortion Act in 1967 but the 1861 law was not repealed, meaning that parts of the law still apply – for example when a woman carries out an abortion over the time limit.Ms Nokes, who chairs the Commons Women and Equalities Committee, said MPs should “decide in the 21st Century whether we should be relying on legislation that is centuries old”.The Tory MP told BBC Radio 4’s World Tonight programme: “This is not something that has been debated in any great detail for many years now.”And cases like this, although tragic and thankfully very rare, throw into sharp relief that we are relying on legislation that is very out of date. It makes a case for Parliament to start looking at this issue in detail.”Image source, Getty ImagesLabour MP Stella Creasy also called for urgent reform, telling BBC Two’s Newsnight programme: “I don’t understand in whose interests this case was.”Madeline Page, director of the Alliance of Pro-Life Students, agreed the case was a “sad situation” and said she would welcome a parliamentary debate on abortion, although wanting to move the law overall in a different direction to Ms Nokes.The British Pregnancy Advisory Service (BPAS) said it was “shocked and appalled” the “archaic law” had been used to prosecute Foster.It is one of 30 campaign and health groups calling for the law to be repealed to decriminalise women seeking to end their own pregnancies.Clare Murphy, chief executive of the BPAS, told BBC Radio 4’s Today programme: “We are now seeing a mother-of-three prosecuted under laws that do not exist in the same way in any other country.”She said “a growing number of women” seemed to be coming under police investigation over suspected illegal abortions, with another woman facing trial later this year. A spokesperson for the Crown Prosecution Service said cases such as that of Carla Foster were “exceptionally rare… complex and traumatic”.They added: “Our prosecutors have a duty to ensure that laws set by Parliament are properly considered and applied when making difficult charging decisions.”Prime Minister Rishi Sunak’s official spokesperson said he was “not aware” of any government plans to change abortion laws.The CPS argued in court that Foster had been aware of abortion limits and had provided false information during a remote medical consultation. Her defence said lockdown and minimising face-to-face appointments had changed access to healthcare, adding: “This will haunt her forever.” Foster went into labour on 11 May 2020 and the baby was confirmed dead 45 minutes later. If you have been affected by the issues raised in this article, help and support is available via BBC Action LineThe 44-year-old from Staffordshire had moved back in with her estranged partner at the start of lockdown while carrying another man’s baby, the court heard.Sentencing, judge Mr Justice Edward Pepperall accepted she had been “in emotional turmoil” as she sought to hide the pregnancy.He said she was a good mother to her three sons, one of whom has special needs, and that a suspended sentence might have been possible if there had been an earlier guilty plea.But he rejected appeals from women’s health organisations to pass a non-custodial sentence, saying it was the court’s duty to “apply the law as provided by Parliament”.Ahead of Monday’s hearing, a letter co-signed by a number of women’s health organisations was sent to the court calling for a non-custodial sentence.He told the defendant the letter’s authors were “concerned that your imprisonment might deter other women from accessing telemedical abortion services and other late-gestation women from seeking medical care or from being open and honest with medical professionals”.But he said it also “has the capacity to be seen as special pleading by those who favour wider access to abortions and is, in my judgment, just as inappropriate as it would be for a judge to receive a letter from one of the groups campaigning for more restrictive laws”.More on this storyMother jailed for taking abortion pills too latePublished12 hours agoAbortion rise ‘may be driven by cost of living’Published31 May

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Covid database: India's health ministry denies major breach

Published4 hours agoShareclose panelShare pageCopy linkAbout sharingImage source, AFPThe Indian health ministry has denied reports of a major leak of personal data from its Covid vaccination database.In a statement it said “all such reports are without any basis and mischievous in nature”, but it has ordered an official investigation into the matter.The health ministry’s CoWin database contains the personal details of millions of people. This Twitter post cannot be displayed in your browser. Please enable Javascript or try a different browser.View original content on TwitterThe BBC is not responsible for the content of external sites.Skip twitter post by Ministry of HealthAllow Twitter content?This article contains content provided by Twitter. We ask for your permission before anything is loaded, as they may be using cookies and other technologies. You may want to read Twitter’s cookie policy,

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Obamacare Mandate for Preventive Care Is Restored, for Now

Health plans must pay for all types of preventive care, including a pill to prevent H.I.V., while an appeals court deliberates whether to strike down part of the Affordable Care Act.Lawyers reached a deal on Monday to keep the Affordable Care Act’s mandate requiring health plans to cover preventive care at no cost to patients.A district court in Texas ruled in March that part of the requirement was unconstitutional. The decision took effect immediately, meaning insurers no longer had to cover certain types of preventive care, including a pill to prevent the spread of H.I.V.The Fifth Circuit Court of Appeals temporarily stayed the ruling last month, bringing the health law’s provision back into effect. The appeals court also asked the two parties — a group of Texas residents and businesses challenging the law, and the Biden administration, which is defending it — to come to a compromise on how much of the mandate should be put on hold while it weighed its decision.The deal they reached leaves the provision almost fully in tact, requiring a vast majority of health plans to continue providing preventive care at no charge. The agreement includes an exemption for the small businesses and individuals challenging the provision; these entities will be allowed to use a plan that does not cover all preventive services if they can find a health insurer who offers it.The appellate court, which is expected to rule on the preventive care mandate’s constitutionality later this year, still has to approve the lawyers’ agreement.Health policy experts describe the mandate as one of the most transformative policies of the health law, known as Obamacare, because it could prevent worsening disease and higher costs later on. It is also popular, with 62 percent of the public recently saying it was “very important” that it stay in place.Before the Affordable Care Act’s passage, in March 2010, patients sometimes faced big bills for preventive care such as birth control or colonoscopies. Since the mandate took effect, studies have shown, more Americans have received blood pressure screenings, cholesterol screenings and flu vaccines.In March, Judge Reed O’Connor of the Federal District Court for the Northern District of Texas ruled that part of the mandate was unconstitutional because an independent panel advising the government on what benefits to cover did not have the proper authority to do so.Judge O’Connor’s ruling did not undo the entire preventive services mandate, but said it should not cover services that the panel, the United States Preventive Service Task Force, had recommended since 2010.The newer services included three types of screenings: one for anxiety in children, another for unhealthy drug use and a third for weight gain in pregnant women. The mandate also included a recommendation that people at high risk for H.I.V. take PrEP, a daily pill that is highly effective at preventing the transmission of the virus.The challengers in this case objected to covering PrEP, in particular, contending that the drug could “encourage homosexual behavior or intravenous drug use.”The deal may not have much practical impact on most Americans. When the initial ruling from the district court came down in March, many health plans announced that they would not change their benefits.Health plans typically have policies that span a full year, and it is unusual for them to change their members’ benefits in the middle of a contract. And insurers may be reluctant to take away a popular benefit that, in some cases, saves them money by preventing serious disease later on.Matt Eyles, the president of AHIP, the trade group representing health insurers, said in a statement shortly after the initial ruling that there would be “no immediate disruption in care or coverage.”The Blue Cross Blue Shield Association, which has health plans across the country, said in March that it would “strongly encourage their members to continue to access these services to promote their continued well-being.”

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Can this medication reverse MS? Brain biomarker shows it can

A decade after UC San Francisco scientists identified an over-the-counter antihistamine as a treatment for multiple sclerosis, researchers have developed an approach to measure the drug’s effectiveness in repairing the brain, making it possible to also assess future therapies for the devastating disorder.
The researchers, led by physician-scientist Ari Green, MD, who together with neuroscientist Jonah Chan, PhD, first identified clemastine as a potential MS therapy, used MRI scans to study the drug’s impact on the brain of 50 participants in a clinical study.
In MS, patients lose myelin, the protective insulation around nerve fibers. This myelin loss triggers delays in nerve signals, leading to weakness and spasticity, vision loss, cognitive slowing and other symptoms.
In the brain, water trapped between the thin layers of myelin that wrap nerve fibers cannot move as freely as water floating between brain cells. This unique property of myelin allowed imaging experts to develop a technique to compare the difference in myelin levels before and after the drug was administered, by measuring the so-called myelin water fraction, or the ratio of myelin water to the total water content in brain tissue.
In their study, published May 8, 2023, in PNAS, the researchers found that patients with MS who were treated with clemastine experienced modest increases in myelin water, indicating myelin repair. They also proved that the myelin water fraction technique, when focused on the right parts of the brain, could be used to track myelin recovery.
“This is the first example of brain repair being documented on MRI for a chronic neurological condition,” said Green, medical director of the UCSF Multiple Sclerosis and Neuroinflammation Center and a member of the Weill Institute for Neurosciences. “The study provides the first direct, biologically validated, imaging-based evidence of myelin repair induced by clemastine. This will set the standard for future research into remyelinating therapies.”
Myelin Increased Even After Medication Was Stopped

In the study, patients with MS who enrolled in the ReBUILD trial were divided into two groups: the first group received clemastine for the first three months of the study and the second group received clemastine only in months three to five. Using the myelin water fraction as a biomarker, the researchers found that myelin water increased in the first group after participants received the drug and continued to increase after clemastine was stopped. In the second group, the myelin water fraction showed decreases in myelin water in the first portion of the study, under the placebo, and a rebound after participants received clemastine.
The findings corroborate the results of a previous study with the same 50 patients that had found the allergy medication reduced delayed nerve signaling, potentially alleviating symptoms.
In the current study, researchers looked at the corpus callosum, a region of the brain with a high myelin content that connects the right and left hemispheres. They found that significant repair occurred outside the visible lesions typically associated with MS. This underscores the need to focus on myelin repair beyond these lesion sites.
Clemastine works in this setting by stimulating the differentiation of myelin-making stem cells. This places the medication a generation ahead of existing MS drugs that work by dampening the activity of the immune system, calming inflammation and reducing the risk of relapse. It still isn’t ideal, though, making the water fraction measurement an important tool in developing better therapeutics.
“Clemastine can only be partially effective at the doses we can use,” said Green, who is also a neuro-ophthalmologist and chief of the Division of Neuroimmunology and Glial Biology in the UCSF Department of Neurology. “It can be sedating, which may be especially undesirable in patients with MS. We are hopeful better medications will be developed, but clemastine has proven to be the tool to show remyelination is possible.”
Proposed future research will examine clemastine’s potential in treating brain injury in premature infants, who often experience myelin damage. Pediatric neurologist Bridget Ostrem, MD, PhD, of UCSF Benioff Children’s Hospitals, is currently seeking approval from the Food and Drug Administration to initiate the first clinical trial testing clemastine to treat this debilitating and disabling condition.

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The latest weapon against cancer is … a keto diet?

Dietitians say a keto diet could help you lose up to 10% of your body weight. These high-fat, low-carb meal plans trick the body into burning its own fat. They could also help fight a variety of cancers by starving tumors of the glucose they need to grow. On the surface, this seems ideal. But research suggests these diets may have a deadly, unintended side effect for cancer patients.
In mice with pancreatic and colorectal cancer, keto accelerates a lethal wasting disease called cachexia. Patients and mice with cachexia experience loss of appetite, extreme weight loss, fatigue, and immune suppression. The disease has no effective treatment and contributes to about 2 million deaths per year.
“Cachexia results from a wound that doesn’t heal,” Cold Spring Harbor Laboratory (CSHL) Assistant Professor Tobias Janowitz says. “It’s very common in patients with progressive cancer. They become so weak they can no longer handle anti-cancer treatment. Everyday tasks become Herculean labors.”
Janowitz and CSHL Postdoc Miriam Ferrer are working to divorce keto’s cancer-fighting benefits from its lethal side effect. They found pairing keto with common drugs called corticosteroids prevented cachexia in mice with cancer. Their tumors shrank and the mice lived longer.
“Healthy mice also lose weight on keto, but their metabolism adapts and they plateau,” Janowitz explains. “Mice with cancer can’t adapt, because they can’t make enough of a hormone called corticosterone that helps regulate keto’s effects. They don’t stop losing weight.”
Keto causes toxic lipid byproducts to accumulate in and kill cancer cells by a process called ferroptosis. This slows tumor growth but also causes early-onset cachexia. When researchers replaced the depleted hormone with a corticosteroid, keto still shrank tumors but didn’t kickstart cachexia.
“Cancer is a whole-body disease. It reprograms normal biological processes to help it grow,” Ferrer says. “Because of this reprogramming, mice can’t use the nutrients from a keto diet, and waste away. But with the steroid, they did much better. They lived longer than with any other treatment we tried.”
Janowitz and Ferrer are part of an international Cancer Grand Challenges effort taking on cancer cachexia. They recently published an authoritative overview of the condition. The team is now working to fine-tune corticosteroid timing and dosage to widen the window for effective cancer therapies in combination with keto.
“We want to push back against cancer even harder, so it grows slower still,” Janowitz says. “If we can broaden this effect, make the treatment more efficient, we can ultimately benefit patients and improve cancer therapeutics.”

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The chatbot will see you now

The informed consent process in biomedical research is biased towards people who can meet with clinical study staff during the working day. For those who have the availability to have a consent conversation, the time burden can be off-putting. Professor Eric Vilain, from the Department of Paediatrics, University of California, Irvine, USA, will tell the European Society of Human Genetics annual conference today (Tuesday 13 June) how results from his team’s study of the use of a chatbot (GIA — ‘Genetics Information Assistant’ developed by Invitae Corporation) in the consent process show that it encourages inclusivity, and leads to faster completion and high levels of understanding. Since such consent is the cornerstone of all research studies, finding ways of cutting the time spent on it while continuing to make sure that participants’ understanding is not lessened is something clinicians have aimed for some time.
Working with their institutional review board (IRB), Prof Vilain’s team from across University of California Irvine, Children’s National Hospital, and Invitae Corporation designed a script for the GIA chatbot to transform the trial consent form and protocol into a logic flow and script. Unlike conventional methods of obtaining consent, the bot was able to quiz participants to assess the knowledge they had attained. It could also be accessed at any time, allowing individuals with less free time to use it outside normal business hours. “We saw that more than half of our participants interacted with the bot at these times, and this shows its utility in decreasing the barriers to entry to research. Currently, most people who participate in biomedical research have time to do so as well as the knowledge that studies exist,” says Prof Vilain
The researchers involved 72 families in the consent process during a six-month time period as part of the US national GREGoR consortium, a National Institutes of Health initiative to advance rare disease research. A total of 37 families completed consent using the traditional process, while 35 used the chatbot. The researchers found that the median length of the consent conversation was shorter for those using the bot, at 44 rather than 76 minutes, and the time from referral to the study to consent completion was also faster, at five as opposed to 16 days. The level of understanding of those who had used the bot was assessed with a 10-question quiz that 96% of participants passed, and a request for feedback showed that 86% thought that they had had a positive experience.
“I was surprised and pleased that a significant number of people would feel comfortable communicating with a chatbot,” says Prof Vilain. “But we worked hard with our IRB to ensure that it didn’t ‘hallucinate’ (make mistakes) and to ensure that knowledge was conveyed correctly. When the bot was unable to answer a question, it encouraged the participant to speak with a member of the study team.”
While it is not possible to give an accurate account of cost saving, the time savings of staff were substantial, the researchers say. Because people can pause the chatbot consent process at any time, it can be completed much more quickly — for example, four participants completed in 24 hours. Of the consent conversations that were quick (less than an hour), 83% of them were with the chatbot. The consent conversations that were longer (between one and two hours), were with a study staff member (66%).
“But it’s far from being just about speed,” says Prof Vilain. “The traditional method of consenting does not have a mechanism to verify understanding objectively. It is based on the conviction of the study staff member hosting the conversation that the consent has been informed properly and the individual understands what they are consenting to. The chat-based method can test comprehension more objectively. It does not allow users who do not show understanding to give consent, and puts them in touch with a genetic counsellor to figure out why knowledge transmission did not occur.
“We believe that our work has made an important contribution to the obtention of properly-informed consent, and would now like to see it used in different languages to reach global populations,” he concludes.
Professor Alexandre Reymond, chair of the conference, said: “The keystone to informed consent should be that it is by definition ‘informed’, and we should explore all possibilities to ensure this in the future.”
(ends)

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Blocking immune system 'messenger' may treat severe asthma

Asthma is more dangerous than many people realize. An estimated 10 Americans die every day from asthma, and the disease leads to around 439,000 hospitalizations and 1.3 million emergency room trips each year.
“Asthma is one of the most important allergic diseases to study,” says Professor Toshiaki Kawakami, M.D., Ph.D., a member of the Center for Autoimmunity and Inflammation at La Jolla Institute for Immunology (LJI).
In a new study, Kawakami and his colleagues at LJI investigated the molecular drivers of severe asthma and rhinovirus-induced asthma exacerbation (a type of asthma that can accompany a common cold). Their findings, published recently in The Journal of Allergy and Clinical Immunology, suggest people with both types of asthma may benefit from therapies that block interactions between a molecule called histamine-releasing factor (HRF) and antibodies called immunoglobulin E (IgE).
As Kawakami explains, many people with severe asthma aren’t responsive to current asthma therapies. He hopes two potential drug strategies from his laboratory might inhibit HRF and IgE interactions and deliver relief for these patients. “We hope this approach can be a means of treating severe asthma and asthma exacerbation,” he says.
The problem with histamine-releasing factor
Immune cells work as a team, and they secrete molecules to “talk” to each other. One of these molecular messengers is HRF, which is made by many types of cells, including lung epithelial cells and immune cells called macrophages. When a person encounters an allergen, these cells start churning out more HRF. The HRF then courses through the body and looks for special antibodies to bind to. HRF has several different kinds of antibody partners, however, and each interaction sends a different message to the surrounding immune cells.

Kawakami and his colleagues are working to understand how these HRF and antibody interactions drive dangerous allergic reactions. Over the last decade, the researchers have shown that HRF interactions with the IgE antibody drive harmful inflammation in mouse models of asthma.
Their new study is important because it sheds light on how this same HRF and IgE interaction triggers inflammation and drives asthma in humans. For the study, Kawakami collaborated with clinicians and scientists at the University of Pittsburgh School of Medicine; Children’s Hospital, Boston; and the University of Virginia to investigate the role of HRF across many patient groups.
The researchers examined HRF levels and IgE interactions in: healthy adult controls adults infected with rhinovirus adults with moderate asthma adults with severe asthma adults with mild to moderate asthma asthmatic children with non-viral asthma exacerbation asthmatic children with rhinovirus-induced asthma exacerbationWorking with this large range of patient samples was critical. “Asthma isn’t just one disease,” Kawakami says. There are different forms of asthma, called “endotypes,” and current asthma therapies don’t work for all patients. Truly understanding and treating asthma means gathering data from every patient group possible.
Hope for a future therapy
The team found that HRF and IgE interactions drive inflammation specifically in patients with severe asthma and patients with rhinovirus-induced asthma exacerbation. These findings in humans are in line with the lab’s previous findings in mice.

The scientists further confirmed the importance of HRF and IgE interactions in laboratory experiments using a line of human bronchial cells. Kawakami and his colleagues observed a dramatic increase in HRF secretion when they infected these cells with rhinovirus. They saw the same dramatic increase when they exposed the bronchial cells to proteins from house dust mites (a very common allergen and asthma trigger).
Kawakami now hopes to test two potential asthma therapies. The first therapeutic approach would harness a molecule developed by the Kawakami Lab. This molecule, termed HRF-2CA, appears to inhibit asthma and severe food allergy symptoms in mice, and there’s reason to think they could help treat humans as well.
The researchers are also interested in studying a therapeutic antibody called SPF7-1, which acts as a sort of HRF decoy, binding to IgE and blocking interactions with the real HRF.
“The best way forward would be to carry out clinical trials to study these two therapeutic options,” says Kawakami.
Additional authors of the study, “Histamine-releasing factor in severe asthma and rhinovirus associated asthma exacerbation,” are first author Yu Kawakami, Ikuo Takazawa, Merritt L. Fajt, Kazumi Kasakura, Joseph Lin, Julienne Ferrer, David B. Kantor, Wanda Phipatanakul, Peter W. Heymann, Chris A. Benedict, and Yuko Kawakami.
This study was supported by the National Institutes of Health (grants 1R01 HL124283-01, R01 AI146042-01, T32 AI125179, T32 HD040128, HL69174, NIH K12 HD047349, R01 AI073964, NIH K24 AI106822, NIH U10 HL098102, NIH AI139749, AI101423, UL1 TR001102) The American Medical Association (Seed Grant); Harvard Catalyst / The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences), and financial contributions from Harvard University and its affiliated academic healthcare centers.

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