What pathogen might spark the next pandemic? How scientists are preparing for ‘disease X’

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Before the COVID pandemic, the World Health Organization (WHO) had made a list of priority infectious diseases. These were felt to pose a threat to international public health, but where research was still needed to improve their surveillance and diagnosis. In 2018, “disease X” was included, which signified that a pathogen previously not on our radar could cause a pandemic.

While it’s one thing to acknowledge the limits to our knowledge of the microbial soup we live in, more recent attention has focused on how we might systematically approach future pandemic risks.

Former US Secretary of Defense Donald Rumsfeld famously talked about “known knowns” (things we know we know), “known unknowns” (things we know we don’t know), and “unknown unknowns” (the things we don’t know we don’t know).

Although this may have been controversial in its original context of weapons of mass destruction, it provides a way to think about how we might approach future pandemic threats.

Anna Shvets/Pexels

Influenza: a ‘known known’

Influenza is largely a known entity; we essentially have a minor pandemic every winter with small changes in the virus each year. But more major changes can also occur, resulting in spread through populations with little pre-existing immunity. We saw this most recently in 2009 with the swine flu pandemic.

However, there’s a lot we don’t understand about what drives influenza mutations, how these interact with population-level immunity, and how best to make predictions about transmission, severity and impact each year.

The current H5N1 subtype of avian influenza (“bird flu”) has spread widely around the world. It has led to the deaths of many millions of birds and spread to several mammalian species including cows in the United States and marine mammals in South America.

Human cases have been reported in people who have had close contact with infected animals, but fortunately there’s currently no sustained spread between people.

While detecting influenza in animals is a huge task in a large country such as Australia, there are systems in place to detect and respond to bird flu in wildlife and production animals.

Scientists in a lab.
Scientists are continually monitoring a range of pathogens with pandemic potential. Edward Jenner/Pexels

It’s inevitable there will be more influenza pandemics in the future. But it isn’t always the one we are worried about.

Attention had been focused on avian influenza since 1997, when an outbreak in birds in Hong Kong caused severe disease in humans. But the subsequent pandemic in 2009 originated in pigs in central Mexico.

Coronaviruses: an ‘unknown known’

Although Rumsfeld didn’t talk about “unknown knowns”, coronaviruses would be appropriate for this category. We knew more about coronaviruses than most people might have thought before the COVID pandemic.

We’d had experience with severe acute respiratory syndrome (SARS) and Middle Eastern respiratory syndrome (MERS) causing large outbreaks. Both are caused by viruses closely related to SARS-CoV-2, the coronavirus that causes COVID. While these might have faded from public consciousness before COVID, coronaviruses were listed in the 2015 WHO list of diseases with pandemic potential.

Previous research into the earlier coronaviruses proved vital in allowing COVID vaccines to be developed rapidly. For example, the Oxford group’s initial work on a MERS vaccine was key to the development of AstraZeneca’s COVID vaccine.

Similarly, previous research into the structure of the spike protein – a protein on the surface of coronaviruses that allows it to attach to our cells – was helpful in developing mRNA vaccines for COVID.

It would seem likely there will be further coronavirus pandemics in the future. And even if they don’t occur at the scale of COVID, the impacts can be significant. For example, when MERS spread to South Korea in 2015, it only caused 186 cases over two months, but the cost of controlling it was estimated at US$8 billion (A$11.6 billion).

Coronavirus statistics on a screen.
COVID could be regarded as an ‘unknown known’. Markus Spiske/Pexels

The 25 viral families: an approach to ‘known unknowns’

Attention has now turned to the known unknowns. There are about 120 viruses from 25 families that are known to cause human disease. Members of each viral family share common properties and our immune systems respond to them in similar ways.

An example is the flavivirus family, of which the best-known members are yellow fever virus and dengue fever virus. This family also includes several other important viruses, such as Zika virus (which can cause birth defects when pregnant women are infected) and West Nile virus (which causes encephalitis, or inflammation of the brain).

The WHO’s blueprint for epidemics aims to consider threats from different classes of viruses and bacteria. It looks at individual pathogens as examples from each category to expand our understanding systematically.

The US National Institute of Allergy and Infectious Diseases has taken this a step further, preparing vaccines and therapies for a list of prototype pathogens from key virus families. The goal is to be able to adapt this knowledge to new vaccines and treatments if a pandemic were to arise from a closely related virus.

Pathogen X, the ‘unknown unknown’

There are also the unknown unknowns, or “disease X” – an unknown pathogen with the potential to trigger a severe global epidemic. To prepare for this, we need to adopt new forms of surveillance specifically looking at where new pathogens could emerge.

In recent years, there’s been an increasing recognition that we need to take a broader view of health beyond only thinking about human health, but also animals and the environment. This concept is known as “One Health” and considers issues such as climate change, intensive agricultural practices, trade in exotic animals, increased human encroachment into wildlife habitats, changing international travel, and urbanisation.

This has implications not only for where to look for new infectious diseases, but also how we can reduce the risk of “spillover” from animals to humans. This might include targeted testing of animals and people who work closely with animals. Currently, testing is mainly directed towards known viruses, but new technologies can look for as yet unknown viruses in patients with symptoms consistent with new infections.

We live in a vast world of potential microbiological threats. While influenza and coronaviruses have a track record of causing past pandemics, a longer list of new pathogens could still cause outbreaks with significant consequences.

Continued surveillance for new pathogens, improving our understanding of important virus families, and developing policies to reduce the risk of spillover will all be important for reducing the risk of future pandemics.

This article is part of a series on the next pandemic.

Allen Cheng, Professor of Infectious Diseases, Monash University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Homeopathy: Evidence So Tiny That It’s Not there?

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    Homeopathy: Evidence So Tiny That It’s Not There?

    Yesterday, we asked you your opinions on homeopathy. The sample size of responses was a little lower than we usually get, but of those who did reply, there was a clear trend:

    • A lot of enthusiasm for “Homeopathy works on valid principles and is effective”
    • Near equal support for “It may help some people as a complementary therapy”
    • Very few people voted for “Science doesn’t know how it works, but it works”; this is probably because people who considered voting for this, voted for the more flexible “It may help some people as a complementary therapy” instead.
    • Very few people considered it a dangerous scam and a pseudoscience.

    So, what does the science say?

    Well, let us start our investigation by checking out the position of the UK’s National Health Service, an organization with a strong focus on providing the least expensive treatments that are effective.

    Since homeopathy is very inexpensive to arrange, they will surely want to put it atop their list of treatments, right?

    ❝Homeopathy is a “treatment” based on the use of highly diluted substances, which practitioners claim can cause the body to heal itself.

    There’s been extensive investigation of the effectiveness of homeopathy. There’s no good-quality evidence that homeopathy is effective as a treatment for any health condition.❞

    The NHS actually has a lot more to say about that, and you can read their full statement here.

    But that’s just one institution. Here’s what Australia’s National Health and Medical Research Council had to say:

    ❝There was no reliable evidence from research in humans that homeopathy was effective for treating the range of health conditions considered: no good-quality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment❞

    You can read their full statement here.

    The American FDA, meanwhile, have a stronger statement:

    ❝Homeopathic drug products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations.❞

    You can read their full statement here.

    Homeopathy is a dangerous scam and a pseudoscience: True or False?

    False and True, respectively, mostly.

    That may be a confusing answer, so let’s elaborate:

    • Is it dangerous? Mostly not; it’s mostly just water. However, two possibilities for harm exist:
      • Careless preparation could result in a harmful ingredient still being present in the water—and because of the “like cures like” principle, many of the ingredients used in homeopathy are harmful, ranging from heavy metals to plant-based neurotoxins. However, the process of “ultra-dilution” usually removes these so thoroughly that they are absent or otherwise scientifically undetectable.
      • Placebo treatment has its place, but could result in “real” treatment going undelivered. This can cause harm if the “real” treatment was critically needed, especially if it was needed on a short timescale.
    • Is it a scam? Probably mostly not; to be a scam requires malintent. Most practitioners probably believe in what they are practising.
    • Is it a pseudoscience? With the exception that placebo effect has been highly studied and is a very valid complementary therapy… Yes, aside from that it is a pseudoscience. There is no scientific evidence to support homeopathy’s “like cures like” principle, and there is no scientific evidence to support homeopathy’s “water memory” idea. On the contrary, they go against the commonly understood physics of our world.

    It may help some people as a complementary therapy: True or False?

    True! Not only is placebo effect very well-studied, but best of all, it can still work as a placebo even if you know that you’re taking a placebo… Provided you also believe that!

    Science doesn’t know how it works, but it works: True or False?

    False, simply. At best, it performs as a placebo.

    Placebo is most effective when it’s a remedy against subjective symptoms, like pain.

    However, psychosomatic effect (the effect that our brain has on the rest of our body, to which it is very well-connected) can mean that placebo can also help against objective symptoms, like inflammation.

    After all, our body, directed primarily by the brain, can “decide” what immunological defenses to deploy or hold back, for example. This is why placebo can help with conditions as diverse as arthritis (an inflammatory condition) or diabetes (an autoimmune condition, and/or a metabolic condition, depending on type).

    Here’s how homeopathy measures up, for those conditions:

    (the short answer is “no better than placebo”)

    Homeopathy works on valid principles and is effective: True or False?

    False, except insofar as placebo is a valid principle and can be effective.

    The stated principles of homeopathy—”like cures like” and “water memory”—have no scientific basis.

    We’d love to show the science for this, but we cannot prove a negative.

    However, the ideas were conceived in 1796, and are tantamount to alchemy. A good scientific attitude means being open-minded to new ideas and testing them. In homeopathy’s case, this has been done, extensively, and more than 200 years of testing later, homeopathy has consistently performed equal to placebo.

    In summary…

    • If you’re enjoying homeopathic treatment and that’s working for you, great, keep at it.
    • If you’re open-minded to enjoying a placebo treatment that may benefit you, be careful, but don’t let us stop you.
    • If your condition is serious, please do not delay seeking evidence-based medical treatment.

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  • Why scrapping the term ‘long COVID’ would be harmful for people with the condition

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    The assertion from Queensland’s chief health officer John Gerrard that it’s time to stop using the term “long COVID” has made waves in Australian and international media over recent days.

    Gerrard’s comments were related to new research from his team finding long-term symptoms of COVID are similar to the ongoing symptoms following other viral infections.

    But there are limitations in this research, and problems with Gerrard’s argument we should drop the term “long COVID”. Here’s why.

    A bit about the research

    The study involved texting a survey to 5,112 Queensland adults who had experienced respiratory symptoms and had sought a PCR test in 2022. Respondents were contacted 12 months after the PCR test. Some had tested positive to COVID, while others had tested positive to influenza or had not tested positive to either disease.

    Survey respondents were asked if they had experienced ongoing symptoms or any functional impairment over the previous year.

    The study found people with respiratory symptoms can suffer long-term symptoms and impairment, regardless of whether they had COVID, influenza or another respiratory disease. These symptoms are often referred to as “post-viral”, as they linger after a viral infection.

    Gerrard’s research will be presented in April at the European Congress of Clinical Microbiology and Infectious Diseases. It hasn’t been published in a peer-reviewed journal.

    After the research was publicised last Friday, some experts highlighted flaws in the study design. For example, Steven Faux, a long COVID clinician interviewed on ABC’s television news, said the study excluded people who were hospitalised with COVID (therefore leaving out people who had the most severe symptoms). He also noted differing levels of vaccination against COVID and influenza may have influenced the findings.

    In addition, Faux pointed out the survey would have excluded many older people who may not use smartphones.

    The authors of the research have acknowledged some of these and other limitations in their study.

    Ditching the term ‘long COVID’

    Based on the research findings, Gerrard said in a press release:

    We believe it is time to stop using terms like ‘long COVID’. They wrongly imply there is something unique and exceptional about longer term symptoms associated with this virus. This terminology can cause unnecessary fear, and in some cases, hypervigilance to longer symptoms that can impede recovery.

    But Gerrard and his team’s findings cannot substantiate these assertions. Their survey only documented symptoms and impairment after respiratory infections. It didn’t ask people how fearful they were, or whether a term such as long COVID made them especially vigilant, for example.

    A man sits on a bed, appears exhausted.
    Tens of thousands of Australians, and millions of people worldwide, have long COVID.
    New Africa/Shutterstock

    In discussing Gerrard’s conclusions about the terminology, Faux noted that even if only 3% of people develop long COVID (the survey found 3% of people had functional limitations after a year), this would equate to some 150,000 Queenslanders with the condition. He said:

    To suggest that by not calling it long COVID you would be […] somehow helping those people not to focus on their symptoms is a curious conclusion from that study.

    Another clinician and researcher, Philip Britton, criticised Gerrard’s conclusion about the language as “overstated and potentially unhelpful”. He noted the term “long COVID” is recognised by the World Health Organization as a valid description of the condition.

    A cruel irony

    An ever-growing body of research continues to show how COVID can cause harm to the body across organ systems and cells.

    We know from the experiences shared by people with long COVID that the condition can be highly disabling, preventing them from engaging in study or paid work. It can also harm relationships with their friends, family members, and even their partners.

    Despite all this, people with long COVID have often felt gaslit and unheard. When seeking treatment from health-care professionals, many people with long COVID report they have been dismissed or turned away.

    Last Friday – the day Gerrard’s comments were made public – was actually International Long COVID Awareness Day, organised by activists to draw attention to the condition.

    The response from people with long COVID was immediate. They shared their anger on social media about Gerrard’s comments, especially their timing, on a day designed to generate greater recognition for their illness.

    Since the start of the COVID pandemic, patient communities have fought for recognition of the long-term symptoms many people faced.

    The term “long COVID” was in fact coined by people suffering persistent symptoms after a COVID infection, who were seeking words to describe what they were going through.

    The role people with long COVID have played in defining their condition and bringing medical and public attention to it demonstrates the possibilities of patient-led expertise. For decades, people with invisible or “silent” conditions such as ME/CFS (myalgic encephalomyelitis/chronic fatigue syndrome) have had to fight ignorance from health-care professionals and stigma from others in their lives. They have often been told their disabling symptoms are psychosomatic.

    Gerrard’s comments, and the media’s amplification of them, repudiates the term “long COVID” that community members have chosen to give their condition an identity and support each other. This is likely to cause distress and exacerbate feelings of abandonment.

    Terminology matters

    The words we use to describe illnesses and conditions are incredibly powerful. Naming a new condition is a step towards better recognition of people’s suffering, and hopefully, better diagnosis, health care, treatment and acceptance by others.

    The term “long COVID” provides an easily understandable label to convey patients’ experiences to others. It is well known to the public. It has been routinely used in news media reporting and and in many reputable medical journal articles.

    Most importantly, scrapping the label would further marginalise a large group of people with a chronic illness who have often been left to struggle behind closed doors.The Conversation

    Deborah Lupton, SHARP Professor, Vitalities Lab, Centre for Social Research in Health and Social Policy Centre, and the ARC Centre of Excellence for Automated Decision-Making and Society, UNSW Sydney

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • The first pig kidney has been transplanted into a living person. But we’re still a long way from solving organ shortages

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    In a world first, we heard last week that US surgeons had transplanted a kidney from a gene-edited pig into a living human. News reports said the procedure was a breakthrough in xenotransplantation – when an organ, cells or tissues are transplanted from one species to another. https://www.youtube.com/embed/cisOFfBPZk0?wmode=transparent&start=0 The world’s first transplant of a gene-edited pig kidney into a live human was announced last week.

    Champions of xenotransplantation regard it as the solution to organ shortages across the world. In December 2023, 1,445 people in Australia were on the waiting list for donor kidneys. In the United States, more than 89,000 are waiting for kidneys.

    One biotech CEO says gene-edited pigs promise “an unlimited supply of transplantable organs”.

    Not, everyone, though, is convinced transplanting animal organs into humans is really the answer to organ shortages, or even if it’s right to use organs from other animals this way.

    There are two critical barriers to the procedure’s success: organ rejection and the transmission of animal viruses to recipients.

    But in the past decade, a new platform and technique known as CRISPR/Cas9 – often shortened to CRISPR – has promised to mitigate these issues.

    What is CRISPR?

    CRISPR gene editing takes advantage of a system already found in nature. CRISPR’s “genetic scissors” evolved in bacteria and other microbes to help them fend off viruses. Their cellular machinery allows them to integrate and ultimately destroy viral DNA by cutting it.

    In 2012, two teams of scientists discovered how to harness this bacterial immune system. This is made up of repeating arrays of DNA and associated proteins, known as “Cas” (CRISPR-associated) proteins.

    When they used a particular Cas protein (Cas9) with a “guide RNA” made up of a singular molecule, they found they could program the CRISPR/Cas9 complex to break and repair DNA at precise locations as they desired. The system could even “knock in” new genes at the repair site.

    In 2020, the two scientists leading these teams were awarded a Nobel prize for their work.

    In the case of the latest xenotransplantation, CRISPR technology was used to edit 69 genes in the donor pig to inactivate viral genes, “humanise” the pig with human genes, and knock out harmful pig genes. https://www.youtube.com/embed/UKbrwPL3wXE?wmode=transparent&start=0 How does CRISPR work?

    A busy time for gene-edited xenotransplantation

    While CRISPR editing has brought new hope to the possibility of xenotransplantation, even recent trials show great caution is still warranted.

    In 2022 and 2023, two patients with terminal heart diseases, who were ineligible for traditional heart transplants, were granted regulatory permission to receive a gene-edited pig heart. These pig hearts had ten genome edits to make them more suitable for transplanting into humans. However, both patients died within several weeks of the procedures.

    Earlier this month, we heard a team of surgeons in China transplanted a gene-edited pig liver into a clinically dead man (with family consent). The liver functioned well up until the ten-day limit of the trial.

    How is this latest example different?

    The gene-edited pig kidney was transplanted into a relatively young, living, legally competent and consenting adult.

    The total number of gene edits edits made to the donor pig is very high. The researchers report making 69 edits to inactivate viral genes, “humanise” the pig with human genes, and to knockout harmful pig genes.

    Clearly, the race to transform these organs into viable products for transplantation is ramping up.

    From biotech dream to clinical reality

    Only a few months ago, CRISPR gene editing made its debut in mainstream medicine.

    In November, drug regulators in the United Kingdom and US approved the world’s first CRISPR-based genome-editing therapy for human use – a treatment for life-threatening forms of sickle-cell disease.

    The treatment, known as Casgevy, uses CRISPR/Cas-9 to edit the patient’s own blood (bone-marrow) stem cells. By disrupting the unhealthy gene that gives red blood cells their “sickle” shape, the aim is to produce red blood cells with a healthy spherical shape.

    Although the treatment uses the patient’s own cells, the same underlying principle applies to recent clinical xenotransplants: unsuitable cellular materials may be edited to make them therapeutically beneficial in the patient.

    Sickle cells have a different shape to healthy round red blood cells
    CRISPR technology is aiming to restore diseased red blood cells to their healthy round shape. Sebastian Kaulitzki/Shutterstock

    We’ll be talking more about gene-editing

    Medicine and gene technology regulators are increasingly asked to approve new experimental trials using gene editing and CRISPR.

    However, neither xenotransplantation nor the therapeutic applications of this technology lead to changes to the genome that can be inherited.

    For this to occur, CRISPR edits would need to be applied to the cells at the earliest stages of their life, such as to early-stage embryonic cells in vitro (in the lab).

    In Australia, intentionally creating heritable alterations to the human genome is a criminal offence carrying 15 years’ imprisonment.

    No jurisdiction in the world has laws that expressly permits heritable human genome editing. However, some countries lack specific regulations about the procedure.

    Is this the future?

    Even without creating inheritable gene changes, however, xenotransplantation using CRISPR is in its infancy.

    For all the promise of the headlines, there is not yet one example of a stable xenotransplantation in a living human lasting beyond seven months.

    While authorisation for this recent US transplant has been granted under the so-called “compassionate use” exemption, conventional clinical trials of pig-human xenotransplantation have yet to commence.

    But the prospect of such trials would likely require significant improvements in current outcomes to gain regulatory approval in the US or elsewhere.

    By the same token, regulatory approval of any “off-the-shelf” xenotransplantation organs, including gene-edited kidneys, would seem some way off.

    Christopher Rudge, Law lecturer, University of Sydney

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Could ADHD drugs reduce the risk of early death? Unpacking the findings from a new Swedish study

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    Attention-deficit hyperactivity disorder (ADHD) can have a considerable impact on the day-to-day functioning and overall wellbeing of people affected. It causes a variety of symptoms including difficulty focusing, impulsivity and hyperactivity.

    For many, a diagnosis of ADHD, whether in childhood or adulthood, is life changing. It means finally having an explanation for these challenges, and opens up the opportunity for treatment, including medication.

    Although ADHD medications can cause side effects, they generally improve symptoms for people with the disorder, and thereby can significantly boost quality of life.

    Now a new study has found being treated for ADHD with medication reduces the risk of early death for people with the disorder. But what can we make of these findings?

    A large study from Sweden

    The study, published this week in JAMA (the prestigious journal of the American Medical Association), was a large cohort study of 148,578 people diagnosed with ADHD in Sweden. It included both adults and children.

    In a cohort study, a group of people who share a common characteristic (in this case a diagnosis of ADHD) are followed over time to see how many develop a particular health outcome of interest (in this case the outcome was death).

    For this study the researchers calculated the mortality rate over a two-year follow up period for those whose ADHD was treated with medication (a group of around 84,000 people) alongside those whose ADHD was not treated with medication (around 64,000 people). The team then determined if there were any differences between the two groups.

    What did the results show?

    The study found people who were diagnosed and treated for ADHD had a 19% reduced risk of death from any cause over the two years they were tracked, compared with those who were diagnosed but not treated.

    In understanding this result, it’s important – and interesting – to look at the causes of death. The authors separately analysed deaths due to natural causes (physical medical conditions) and deaths due to unnatural causes (for example, unintentional injuries, suicide, or accidental poisonings).

    The key result is that while no significant difference was seen between the two groups when examining natural causes of death, the authors found a significant difference for deaths due to unnatural causes.

    So what’s going on?

    Previous studies have suggested ADHD is associated with an increased risk of premature death from unnatural causes, such as injury and poisoning.

    On a related note, earlier studies have also suggested taking ADHD medicines may reduce premature deaths. So while this is not the first study to suggest this association, the authors note previous studies addressing this link have generated mixed results and have had significant limitations.

    In this new study, the authors suggest the reduction in deaths from unnatural causes could be because taking medication alleviates some of the ADHD symptoms responsible for poor outcomes – for example, improving impulse control and decision-making. They note this could reduce fatal accidents.

    The authors cite a number of studies that support this hypothesis, including research showing ADHD medications may prevent the onset of mood, anxiety and substance use disorders, and lower the risk of accidents and criminality. All this could reasonably be expected to lower the rate of unnatural deaths.

    Strengths and limitations

    Scandinavian countries have well-maintained national registries that collect information on various aspects of citizens’ lives, including their health. This allows researchers to conduct excellent population-based studies.

    Along with its robust study design and high-quality data, another strength of this study is its size. The large number of participants – almost 150,000 – gives us confidence the findings were not due to chance.

    The fact this study examined both children and adults is another strength. Previous research relating to ADHD has often focused primarily on children.

    One of the important limitations of this study acknowledged by the authors is that it was observational. Observational studies are where the researchers observe and analyse naturally occurring phenomena without intervening in the lives of the study participants (unlike randomised controlled trials).

    The limitation in all observational research is the issue of confounding. This means we cannot be completely sure the differences between the two groups observed were not either partially or entirely due to some other factor apart from taking medication.

    Specifically, it’s possible lifestyle factors or other ADHD treatments such as psychological counselling or social support may have influenced the mortality rates in the groups studied.

    Another possible limitation is the relatively short follow-up period. What the results would show if participants were followed up for longer is an interesting question, and could be addressed in future research.

    What are the implications?

    Despite some limitations, this study adds to the evidence that diagnosis and treatment for ADHD can make a profound difference to people’s lives. As well as alleviating symptoms of the disorder, this study supports the idea ADHD medication reduces the risk of premature death.

    Ultimately, this highlights the importance of diagnosing ADHD early so the appropriate treatment can be given. It also contributes to the body of evidence indicating the need to improve access to mental health care and support more broadly.The Conversation

    Hassan Vally, Associate Professor, Epidemiology, Deakin University

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Syphilis Is Killing Babies. The U.S. Government Is Failing to Stop the Disease From Spreading.

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    Karmin Strohfus, the lead nurse at a South Dakota jail, punched numbers into a phone like lives depended on it. She had in her care a pregnant woman with syphilis, a highly contagious, potentially fatal infection that can pass into the womb. A treatment could cure the woman and protect her fetus, but she couldn’t find it in stock at any pharmacy she called — not in Hughes County, not even anywhere within an hour’s drive.

    Most people held at the jail where Strohfus works are released within a few days. “What happens if she gets out before I’m able to treat her?” she worried. Exasperated, Strohfus reached out to the state health department, which came through with one dose. The treatment required three. Officials told Strohfus to contact the federal Centers for Disease Control and Prevention for help, she said. The risks of harm to a developing baby from syphilis are so high that experts urge not to delay treatment, even by a day.

    Nearly three weeks passed from when Strohfus started calling pharmacies to when she had the full treatment in hand, she said, and it barely arrived in time. The woman was released just days after she got her last shot.

    Last June, Pfizer, the lone U.S. manufacturer of the injections, notified the Food and Drug Administration of an “impending stock out” that it anticipated would last a year. The company blamed “an increase in syphilis infection rates as well as competitive shortages.”

    Across the country, physicians, clinic staff and public health experts say that the shortage is preventing them from reining in a surge of syphilis and that the federal government is downplaying the crisis. State and local public health authorities, which by law are responsible for controlling the spread of infectious diseases, report delays getting medicine to pregnant people with syphilis. This emergency was predictable: There have been shortages of this drug in eight of the last 20 years.

    Yet federal health authorities have not prevented the drug shortages in the past and aren’t doing much to prevent them in the future.

    Syphilis, which is typically spread during sex, can be devastating if it goes untreated in pregnancy: About 40% of babies born to women with untreated syphilis can be stillborn or die as newborns, according to the CDC. Infants that survive can suffer from deformed bones, excruciating pain or brain damage, and some struggle to hear, see or breathe. Since this is entirely preventable, a baby born with syphilis is a shameful sign of a failing public health system.

    In 2022, the most recent year for which the CDC has data available, more than 3,700 babies were infected with syphilis, including nearly 300 who were stillborn or died as infants. More than 50% of these cases occurred because, even though the pregnant parent was diagnosed with syphilis, they were never properly treated.

    That year, there were 200,000 cases identified in the U.S., a 79% increase from five years before. Infection rates among pregnant people and babies increased by more than 250% in that time; South Dakota, where Strohfus works, had the highest rates — including a more than 400% increase among pregnant women. Statewide, the rate of babies born with the disease, a condition known as congenital syphilis, jumped more than 40-fold in just five years.

    And that was before the current shortage of shots.

    In Mississippi, the state with the second highest rate of syphilis in pregnant women, Dr. Caroline Weinberg started having trouble this summer finding treatments for her clinic’s patients, most of whom are uninsured, live in poverty or lack transportation. She began spending hours each month scouring medicine suppliers’ websites for available doses of the shots, a form of penicillin sold under the brand name Bicillin L-A.

    “The way people do it for Taylor Swift, that’s how I’ve been with the Bicillin shortage,” Weinberg said. “Desperately checking the websites to see what I can snag.”

    The shortage is driving up infection rates even further.

    In a November survey by the National Coalition of STD Directors, 68% of health departments that responded said the drug shortage will cause syphilis rates in their area to increase, further crushing the nation’s most disadvantaged populations.

    “This is the most basic medicine,” said Meghan O’Connell, chief public health officer for the Great Plains Tribal Leaders’ Health Board, which represents 18 tribal communities in South Dakota and three other states. “We allow ourselves to continue to not have enough, and it impacts so many people.”

    ProPublica examined what the federal government has done to manage the crisis and the ways in which experts say it has fallen short.

    The government could pressure Pfizer to be more transparent.

    Twenty years ago, there were at least three manufacturers of the syphilis shot. Then Pfizer, one of the manufacturers, purchased the other two companies and became the lone U.S. supplier.

    Pfizer’s supply has fallen short since then. In 2016, the company announced a shortage due to a manufacturing issue; it lasted two years. Even during times when Pfizer had not notified the FDA of an official shortage, clinics across the country told ProPublica, the shots were often hard to get.

    Several health officials said they would like to see the government use its power as the largest purchaser of the drug to put pressure on Pfizer to produce adequate supplies and to be more transparent about how much of the drug they have on hand, when it will be widely available and how stable the supply will be going forward.

    In response to questions, Pfizer said there are two reasons its supply is falling short. One, the company said, was a surge in use of the pediatric form of the drug after a shortage of a different antibiotic last winter. Pfizer also blamed a 70% increase in demand for the adult shots since last February, which it described as unexpected.

    Public health experts say the increase in cases and subsequent rise in demand was easy to see coming. Officials have been raising the alarm about skyrocketing syphilis cases for years. “If Pfizer was truly caught completely off guard, it raises significant questions about the competency of the company to forecast obvious infectious disease trends,” a coalition of organizations wrote to the White House Drug Shortage Task Force in September.

    Pfizer said it is consistently communicating with the CDC and FDA about its supply and that it has been transparent with public health groups and policymakers.

    The FDA has a group dedicated to addressing drug shortages. But Valerie Jensen, associate director of that staff, said the FDA can’t force manufacturers to make more of a drug. “It is up to manufacturers to decide how to respond to that increased demand.” she said. “What we’re here to do is help with those plans.”

    Pfizer said it had a target of increasing production by about 20% in 2023 but faced delays toward the end of the year. The company did not explain the reason for those delays.

    The company said it has invested $38 million in the last five years in the Michigan facility where it makes the shots and that it is increasing production capacity. It also said it is adding evening shifts at the facility and actively recruiting and training new workers. Pfizer said it also reduced manufacturing time from 110 to 50 days. By the end of June, the company expects the supply to recover, which it described as having eight weeks of inventory based on its forecast demands with no disruptions in sight.

    The government could manufacture the drug itself.

    Having only one supplier for a drug, especially one of public health importance, makes the country vulnerable to shortages. With just one manufacturer, any disruption — contamination at a plant, a shortage of raw materials, a severe weather event or a flawed prediction of demand — can put lives at risk. What’s ultimately needed, public health experts say, is another manufacturer.

    Congressional Democrats recently introduced a bill that would authorize the U.S. Department of Health and Human Services to manufacture generic drugs in exactly this scenario, when there are few manufacturers and regular shortages. Called the Affordable Drug Manufacturing Act, it would also establish an office of drug manufacturing.

    This same bill was introduced in 2018, but it didn’t have bipartisan support and was never taken up for a vote. Sen. Elizabeth Warren, the Massachusetts Democrat who introduced the bill in the Senate, said she’s hopeful this time will be different. Lawmakers from both parties understand the risks created by drug shortages, and COVID-19 helped everyone understand the role the government can play to boost manufacturing.

    Still, it’s unlikely to be passed with the current gridlock in Congress.

    The government could reserve syphilis drugs for infected patients.

    Responding to the shortage of shots to treat the disease, the CDC in July asked health care providers nationwide to preserve the scarce remaining doses for people who are pregnant. The shots are considered the gold standard treatment for anyone with syphilis, faster and with fewer side effects than an alternative pill regimen. And for people who are pregnant, the pills are not an option; the shots are the only safe treatment.

    Despite that call, the military is giving shots to new recruits who don’t have syphilis, to prevent outbreaks of severe bacterial respiratory infections. The Army has long administered this treatment at boot camps held at Fort Leonard Wood, Fort Moore and Fort Sill. The Army has been unable to obtain the shots several times in the past few years, according to the U.S. Army Center for Initial Military Training. But the Defense Health Agency’s pharmacy operations center has been working with Pfizer to ensure military sites can get them, a spokesperson for the Defense Health Agency said.

    “Until we think about public health the way we think about our military, we’re not going to see a difference,” said Dr. John Vanchiere, chief of pediatric infectious diseases at Louisiana State University Health Shreveport.

    Some public health officials, including Alaska’s chief medical officer, Dr. Anne Zink, questioned whether the military should be using scarce shots for prevention.

    “We should ask if that’s the best use,” she said.

    Using antibiotics to prevent streptococcal outbreaks is a well-established, evidence-based public health practice that’s also used by other branches of the armed services, said Lt. Col. Randy Ready, a public affairs officer with the Army’s Initial Military Training center. “The Army continues to work with the CDC and the entire medical community in regards to public health while also taking into account the unique missions and training environments our Soldiers face,” including basic training, Ready said in a written statement.

    The government isn’t stockpiling syphilis drugs.

    In rare instances, the federal government has created stockpiles of drugs considered key to public health. In 2018, confronting shortages of various drugs to treat tuberculosis, the CDC created a small stockpile of them. And the federal Administration for Strategic Preparedness and Response keeps a national stockpile of supplies necessary for public health emergencies, including vaccines, medical supplies and antidotes needed in case of a chemical warfare attack.

    In November, the Biden administration announced it was creating a new syphilis task force. When asked why the federal government doesn’t stockpile syphilis treatments, Adm. Rachel Levine, the HHS official who leads the task force, said officials don’t routinely stockpile drugs, because they have expiration dates.

    In a written statement, an HHS spokesperson said that Bicillin has a shelf life of two years and that the Strategic National Stockpile “does not deploy products that are commercially available.” In general, the spokesperson wrote, stockpiles are most effective before a national shortage begins and can’t overcome the problems of limited suppliers or fragile supply chains. “There is also a risk that stockpiles can exacerbate shortages, particularly when supply is already low, by removing drugs from circulation that would have otherwise been available,” the spokesperson wrote.

    Stephanie Pang, a senior director with the coalition of STD directors, said that given the critical role of this drug and the severe access concerns, she thinks a stockpile is necessary. “I don’t have another solution that actually gets drugs to patients,” Pang said.

    The government could declare a federal emergency.

    Some public health officials say the federal government needs to treat the syphilis crisis the way it did Ebola or monkeypox.

    Declare a federal emergency, said Dr. Michael Dube, an infectious disease specialist for more than 30 years. That would free up money for more public health staff and fund more creative approaches that could lead to a long-term solution to the near-constant shortages, he said. “I’d hate to have to wait for some horrible anecdotes to get out there in order to get the public’s and the policymakers’ minds on it,” said Dube, who oversees medical care for AIDS Healthcare Foundation wellness clinics across the country.

    Citing an alarming surge in syphilis cases, the Great Plains Tribes wrote to the HHS secretary last week asking that the agency declare a public health emergency in their areas. In the request, they asked HHS to work globally to find adequate syphilis treatment and send the needed medicine to the Great Plains region.

    During the 2014 outbreak of Ebola in West Africa, Congress gave hundreds of millions of dollars to HHS to help develop new rapid tests and vaccines. Facing a global outbreak of monkeypox in 2022, a White House task force deployed more than a million vaccines, regularly briefed the public and sent extra resources to Pride parades and other places where people at risk were gathered.

    Levine, leader of the federal syphilis task force, countered that declaring an emergency wouldn’t make much of a difference. The government, she said, already has a “dramatic and coordinated response” involving several agencies.

    The FDA recently approved an emergency import of a similar syphilis treatment made by a French manufacturer that had plenty on hand. According to the company, Provepharm, the imported shots are enough to cover approximately one or two months of typical use by all people in the U.S. (The FDA would not say how many doses Provepharm sent, and the company said it was not allowed to reveal that number under the federal rules governing such emergency imports.)

    Clinics applaud that development. But many of them can’t afford the imported shots.

    The government could do more to rein in the cost.

    Clinics and hospitals that primarily serve low-income patients often qualify for a federal program that allows them to purchase drugs at steeply discounted prices. Pharmaceutical companies that want Medicaid to cover their outpatient drugs must participate in the program.

    One factor in determining the discount price is whether a pharmaceutical company has raised the price of a drug by more than the rate of inflation. Because Pfizer has hiked the price of its Bicillin shots significantly over the years, the government requires that it be sold to qualifying clinics for just pennies a dose. Otherwise, a single Pfizer shot can retail for upwards of $500. The French shots are comparable in retail price and not eligible for the discount program.

    Several clinic directors also said they worried that drug distributors were reserving the limited supply of the Pfizer shot for organizations that could pay full price. For several days in January, for example, the website of Henry Schein, a medical supplier, showed doses of the shot available at full price, while doses at the penny pricing were out of stock, according to screenshots shared with ProPublica. When asked whether it was only selling shots at full price, a spokesperson for Henry Schein did not respond to the question.

    Local health departments that qualify for the discount program told ProPublica they’ve had to pay full price at other distributors, because it was the only stock available.

    The Health Resources and Services Administration, the federal agency that regulates the discount program, said that a drug manufacturer is ultimately responsible for ensuring that when supplies are available, they are available at the discounted price. When asked about this, Pfizer said that it has “one inventory that is distributed to our trade partners” and that hospitals and clinics that qualify for the discount program are “responsible for ensuring compliance with the program and orders through the wholesaler accordingly.” The company added, “Pfizer plays no part in this process.”

    In October, on Weinberg’s regular search for shots for her Mississippi clinic, she found doses of Bicillin for sale at the discounted price and purchased 40. “The idea that we’re supposed to be hoarding treatment is a horrific compact,” she said. Word got out that the clinic, called Plan A, has some shots, and other clinics began sending pregnant patients there.

    The clinic’s supply is dwindling. Weinberg is happy to get the shots to patients who need them. But she’s not sure how much longer her reserve will last — or if she’ll be able to find more when they’re gone.

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  • Intuitive Eating Might Not Be What You Think

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    In our recent Expert Insights main features, we’ve looked at two fairly opposing schools of thought when it comes to managing what we eat.

    First we looked at:

    What Flexible Dieting Really Means

    …and the notion of doing things imperfectly for greater sustainability, and reducing the cognitive load of dieting by measuring only the things that are necessary.

    And then in opposition to that,

    What Are The “Bright Lines” Of Bright Line Eating?

    …and the notion of doing things perfectly so as to not go astray, and reducing the cognitive load of dieting by having hard-and-fast rules that one does not second-guess or reconsider later when hungry.

    Today we’re going to look at Intuitive Eating, and what it does and doesn’t mean.

    Intuitive Eating does mean paying attention to hunger signals (each way)

    Intuitive Eating means listening to one’s body, and responding to hunger signals, whether those signals are saying “time to eat” or “time to stop”.

    A common recommendation is to “check in” with one’s body several times per meal, reflecting on such questions as:

    • Do I have hunger pangs? Would I seek food now if I weren’t already at the table?
    • If I hadn’t made more food than I’ve already eaten so far, would that have been enough, or would I have to look for something else to eat?
    • Am I craving any of the foods that are still before me? Which one(s)?
    • How much “room” do I feel I still have, really? Am I still in the comfort zone, and/or am I about to pass into having overeaten?
    • Am I eating for pleasure only at this point? (This is not inherently bad, by the way—it’s ok to have a little more just for pleasure! But it is good to note that this is the reason we’re eating, and take it as a cue to slow down and remember to eat mindfully, and enjoy every bite)
    • Have I, in fact, passed the point of pleasure, and I’m just eating because it’s in front of me, or so as to “not be wasteful”?

    See also: Interoception: Improving Our Awareness Of Body Cues

    And for that matter: Mindful Eating: How To Get More Out Of What’s On Your Plate

    Intuitive Eating is not “80:20”

    When it comes to food, the 80:20 rule is the idea of having 80% of one’s diet healthy, and the other 20% “free”, not necessarily unhealthy, but certainly not moderated either.

    Do you know what else the 80:20 food rule is?

    A food rule.

    Intuitive Eating doesn’t do those.

    The problem with food rules is that they can get us into the sorts of problems described in the studies showing how flexible dieting generally works better than rigid dieting.

    Suddenly, what should have been our free-eating 20% becomes “wait, is this still 20%, or have I now eaten so much compared to the healthy food, that I’m at 110% for my overall food consumption today?”

    Then one gets into “Well, I’ve already failed to do 80:20 today, so I’ll try again tomorrow [and binge meanwhile, since today is already written off]”

    See also: Eating Disorders: More Varied (And Prevalent) Than People Think

    It’s not “eat anything, anytime”, either

    Intuitive Eating is about listening to your body, and your brain is also part of your body.

    • If your body is saying “give me sugar”, your brain might add the information “fruit is healthier than candy”.
    • If your body is saying “give me fat”, your brain might add the information “nuts are healthier than fried food”
    • If your body is saying “give me salt”, your brain might add the information “kimchi is healthier than potato chips”

    That doesn’t mean you have to swear off candy, fried food, or potato chips.

    But it does mean that you might try satisfying your craving with the healthier option first, giving yourself permission to have the less healthy option afterwards if you still want it (you probably won’t).

    See also:

    I want to eat healthily. So why do I crave sugar, salt and carbs?

    Want to know more about Intuitive Eating?

    You might like this book that we reviewed previously:

    Intuitive Eating – by Evelyn Tribole and Elyse Resch

    Enjoy!

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