Year: 2023

Categories : Expert Opinion Healthcare Politics and RegulationsTags :

Opinion Piece: From Crisis to Cleanliness – CSI Initiatives Have the Power to Eliminate Pit Latrines in South African Schools

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By Robert Erasmus, Managing Director at Sanitech

The continued use of pit latrines presents grave risks in South Africa, particularly within school environments where the safety and well-being of children are compromised. Recent government statistics from March 2023 reveal a staggering reality: out of 23 000 public schools, over 3300 still rely on pit latrines, necessitating urgent action.

Private sector involvement through Corporate Social Investment (CSI) emerges as a critical player in tackling this pressing issue. In 2022, a substantial R10.9 billion was designated for CSI, with half of the funds directed to the education sector. By reallocating a portion of these resources towards sanitation initiatives, companies could act as a powerful force for meaningful change, especially if invested in innovative solutions like the Khusela dry sanitation unit. This advanced solution not only holds the potential to resolve the sanitation crisis in schools but also provides an avenue for businesses to elevate their Environmental, Social, and Governance (ESG) ratings simultaneously.

CSI can bypass burdensome bureaucracy

With approximately 14% of public schools still relying on hazardous facilities, urgent action is essential; but eradicating pit latrines from South African schools is no small feat. While close collaboration between the private and public sector will be required, government has been slow to address this health and safety crisis as promised, and their burdensome procurement and tender processes have only served to hinder progress, making it evident that relief will have to be sought elsewhere. This is where a beacon of hope emerges through the coordination of CSI and ESG initiatives in the private sector. One of the key advantages of leveraging CSI and ESG initiatives is their potential for rapid, impactful change. The private sector, with its focused CSI efforts, can target key areas for high-impact intervention. Schools, being the cornerstone of a child’s daily life, stand to benefit the most. Imagine the profound difference proper sanitation facilities could make in the lives of students who spend most of their day within these school premises. A rapid transformation in these facilities, facilitated by private sector involvement, can significantly improve the learning environment and overall, well-being of these young minds.

A swift and strategic approach to school sanitation

Measuring the success of CSI initiatives is crucial, and this is where a collaborative approach truly shines. Conducting nationwide surveys and prioritising schools most in need will allow for a strategic and targeted allocation of resources. Instead of waiting for bureaucratic processes to run their course, CSI initiatives can swiftly address the pressing issues of inadequate sanitation facilities. The results will be tangible, the impact immediate, and the benefits will reach those in need, without delay or diversion. Furthermore, ongoing collaboration with waste management providers will oversee these sanitation solutions to ensure initiatives remain purpose-fit, providing not just a one-time fix but a sustained relationship for ongoing positive change.

A safe, cost-effective sanitation solution

At the forefront of revolutionising sanitation in South African schools stands the Khusela dry sanitation unit. Unlike traditional pit latrines, the Khusela unit offers a safer and more hygienic alternative, eliminating the inherent health risks associated with dangerous, unsanitary facilities. Its design focuses on promoting a healthier environment by efficiently managing waste, mitigating contamination, and significantly reducing unpleasant odours. The introduction of Khusela units in schools will not only address a critical health concern but also empower students, especially girls, by providing a discreet and dignified space for personal hygiene, ensuring that the barriers to regular school attendance are diminished. Additionally, the ESG advantages of sanitation upgrade projects are significant, spanning environmental preservation, enhanced social well-being, and improved governance, aligning clearly with fundamental ESG principles that emphasise dedication to a sustainable future.

CSI and ESG: win-win for public schools and the private sector

In short, effective CSI initiatives focused on sanitation offer a dual advantage: they align with corporate CSI objectives while directly addressing essential ESG aspects like environmental and social responsibility. This unique synergy creates a win-win scenario, where the private sector can fulfil its societal and environmental obligations and ultimately contribute to a sustainable and equitable future. The call to action is clear – businesses must recognise the power they possess to expedite change and must engage with organisations in the waste management, hygiene, and sanitation space for impactful partnerships. Together, we can replace pit latrines in South African schools with safer, more hygienic alternatives and create healthier environments that are conducive for the growth and development of our youth. 

Categories : CancerTags :

Resounding Success for New Personalised Treatment for Adult Leukaemia

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Photo by Tima Miroshnichenko on Pexels

Personalised treatment for the most common form of adult leukaemia helps patients survive for longer and stay in remission, a phase III trial has found. The trial, by the University of Leeds, has been identified as groundbreaking research by the New England Journal of Medicine and the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, where the results were presented.

The data shows that the duration of therapy can be individualised for each patient by using regular blood tests to monitor their response. In the trial, this approach resulted in significant improvements in both progression-free and overall survival in patients with previously untreated chronic lymphocytic leukaemia (CLL). The effect was stronger among patients with poorer outcomes to standard treatments, such as those with some genetic mutations.

Adult patients were given a combination of cancer growth blocking drugs over varied durations depending on how rapidly their disease responded.

The trial found that this approach significantly improved progression-free and overall survival compared to the standard treatment for CLL, with more than 19 in 20 patients in remission three years after starting treatment.

The study, named FLAIR, is a phase III randomised controlled trial for untreated CLL, taking place in more than 100 hospitals across the UK.

Lead author Peter Hillmen, Professor of Experimental Haematology in the University of Leeds’ School of Medicine, and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, said: “Our findings show that, for this group of patients, the treatment is very effective at tackling their disease and is well tolerated by them. This means that patients on our trial had better outcomes while also enjoying a better quality of life during their treatment. Most patients treated with the new combination have no detectable leukaemia in their blood or bone marrow by the end of treatment which is better than with previous treatments and is very encouraging.”

Dr Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK, said: “We are delighted to see these results from the FLAIR trial which show the importance and effectiveness of tailoring cancer treatment to the individual patient. Not only this, but the trial has found a way to do so without requiring frequent bone marrow tests which are more invasive and can be painful.

“The collaborative effort that went into this trial – involving researchers, healthcare professionals, funders and dedicated patients and their families – point to a new standard of care which could see real progress made against leukaemia.”

Chronic lymphocytic leukaemia is a type of cancer that affects the blood and bone marrow. It cannot usually be cured but can be managed with treatment. More than nine in 10 people are aged 55 and over when they are diagnosed.

Current treatments include chemotherapy, immunotherapy, or cancer growth blockers.

The FLAIR trial tested cancer growth blockers called Ibrutinib and Venetoclax (I+V), which are usually administered either continuously or for the same fixed duration rather than tailored to each patient’s response. This means that many patients may stop treatment too early, missing the full potential benefit from their therapy or continue therapy for longer than necessary. This could lead to a greater chance of relapse of their leukaemia and/or of treatment side effects.

FLAIR researchers aimed to discover whether it was possible to personalise I+V treatment duration for patients based on regular blood sampling and / or bone marrows, and whether this was as effective or better than standard treatment (FCR).

This regular blood and bone marrow monitoring gave researchers a more up-to-date picture of how patients were responding to I+V, and meant that the duration of I+V treatment could be tailored accordingly to each patient. In addition, it was found that basing the duration of treatment on less invasive, quicker blood samples was just as effective as using bone marrows, which can be painful and sometimes require sedation.

FLAIR was launched in 2014, recruiting 1509 patients with CLL. They were randomised to four treatment groups, each receiving a different treatment.

This part of the FLAIR trial compared two of the groups, placing 260 patients on I+V and 263 on the standard treatment, known as FCR. Almost three quarters were male, which was to be expected as CLL occurs more frequently in males. The average age was 62, and just over a third had advanced disease.

At the end of this stage of the trial, 87 patients had seen their disease progress, 75 of which were on FCR, and 12 on I+V.

To date, 34 of these patients have died during the trial. Of these, 25 were treated with FCR and only nine with I+V.

The patients on I+V underwent blood tests and bone marrows to monitor their response to treatment. The technique used is known as measurable residual disease (MRD) which allows clinicians to see the number of remaining cancer cells. The number of cells may be so small that the patient is asymptomatic. An MRD positive test result means that there are remaining cancer cells.

The research team now hope that this more personalised therapy approach, guided by blood test monitoring will be adopted as a new standard of care for patients needing first line CLL treatment.

Professor Hillmen said: “The results of the FLAIR Trial, led by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds, are exceptional and herald a change in the way chronic lymphocytic leukaemia will be treated. FLAIR has been a huge collaborative effort over the last decade by the UK’s leading CLL specialists and by the haematology teams in over 100 hospitals throughout the UK. The participation of patient groups, individual patients and their families were critical to delivering such progress particularly through the challenges of the pandemic.”

The trial was co-ordinated by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds. Deputy Director Professor David Cairns said: “The vision of the Leeds Cancer Research UK CTU is to improve the length and quality of survival for cancer patients on a worldwide scale. Our strategy to do this is to ensure that we build evidence to identify the correct treatment, for the correct duration, for the correct patient. FLAIR is a trial well aligned to our strategy, and reflects team science including clinicians, laboratory scientists, methodologists and operational experts working together to deliver important trial results. None of this would be achieved without the selfless commitment of trial participants who contribute their time and data.”

The FLAIR trial was funded by Cancer Research UK, Janssen Research & Development, LLC, and AbbVie Pharmaceutical Research and Development.

Source: University of Leeds

Categories : Expert OpinionTags :

The NHI Will Enforce the Use of EHRs – Resulting in a Steep Learning Curve for 60% Of SA’s GPs

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Photo by National Cancer Institute on Unsplash

As the development of the National Digital Health Strategy for South Africa (2019 – 2024) progresses, and the implementation of the National Health Insurance (NHI) implementation looms closer, it is clear that digital health will be the significant driver behind transforming our health system.

To date, a Health Patient Registration System (HPRS) Project has been started as an initial requirement before developing a template for what a patient Electronic Health Record (EHR) would include. Although the diagnostic, treatment and billing modules necessary for EHR’s within the NHI still need to be developed, one thing is certain: a complete, shareable, electronic health record for each patient will be key.  

How will it work

CompuGroup Medical South Africa, (CGM SA), a leading MedTech company describes an EHR as a portable, interactive, digital set of health records for a patient that assists healthcare providers in managing their care. The wealth of information provided in each EHR – from a patient’s medical history, demographics, their laboratory test results over time, medicine prescribed, a history of medical procedures, X-rays to any medical allergies – offers endless opportunities for real time patient care.

EHRs have the potential to play a role in closing the healthcare gap in South Africa by improving affordable access to healthcare and reducing health disparities. This is particularly important for marginalised populations who may have limited access to healthcare services.

GPs must adapt

Although the adoption of EHRs in South Africa is very low, with an estimated 40%* of healthcare professionals currently using digital health records in their practice or hospital, the looming National Health Insurance (NHI) Bill will encourage the adoption of EHRs, potentially improving care coordination, enhancing population health management, increasing efficiency and cost savings.

Globally, EHRs are responsible for improving efficiency by reducing duplicates within patient records, reducing unnecessary interventions such as repeat prescriptions and duplicate referrals. Of those using any form of healthcare technologies daily, 69% have found an improvement in the quality of care and 59% have seen a positive impact on patient outcomes.

Looking at the usage of technology by patients in South Africa, the statistics show that we lag behind the world average, with less than a third of our population using digital health technologies to track their health. It appears this is partially due to a distrust for the security of their health data and an affordability consideration.  

“One of the major challenges from a general practitioner perspective is that there is currently a lack of government policy and guidelines for patient data security, which in turn, affects their willingness to adopt EHRs as a standard,” says Dillip Naran, Vice President for Product Architecture at CGM SA.  

“If these hurdles can be overcome, the adoption of EHRs by GPs is predicted to have a positive impact on healthcare outcomes, and improve efficiency in the long run. The successful implementation and utilisation of EHRs will require careful planning, investment, and collaboration across the proposed NHI healthcare system, “ he goes on to mention.

Here are the seven main ways EHRs will contribute to the success of a National Health Insurance (NHI) programme in South Africa:

  • Improved patient safety: Reducing adverse effects related to medication prescription errors, dispensing errors, labelling errors and even, wrong site surgery.
  • Improved care coordination: Helping healthcare providers share patient information easily and more accurately, improving the coordination of care across different providers and settings, and eliminating the duplication of services.
  • Enhanced population health management: Providing data on health outcomes and trends to identify and address public health issues, such as disease outbreaks or health disparities, potentially informing policy decisions and resource allocation within the NHI.
  • Increased efficiency and cost savings: Reducing the administrative burden and streamlining processes, which can improve efficiency and reduce costs within the healthcare system.
  • Enhanced decision-making: Providing healthcare professionals with immediate access to relevant patient data, including medical history, allergies, medications, and test results. This information empowers clinicians to make well-informed decisions about patient care, leading to better diagnosis and treatment options.
  • Efficient claims processing: Streamlining the claims process, in the context of the NHI model, with the electronic submission of medical information leading to faster claims processing and reducing the chances of errors or fraud.
  • Early detection and management of chronic conditions: Flagging individuals who may be at a higher risk for chronic conditions, and monitoring the management of their care. 

It is important to realise that the implementation of EHRs can’t be expected to be solely responsible for closing the gap in healthcare. Other factors such as access to healthcare services, poverty and education need to be addressed, along with solving challenges such as data privacy, security concerns and improving digital literacy within certain previously disadvantaged population groups.

By Andrea Desfarges on behalf of CompuGroup Medical SA.

*. *Statistics taken from “Adapt as you adopt: Adjusting to digital health tech to drive access to care” by Jasper Westerlink, Dec 2019.  

Categories : Injury & Trauma NeurologyTags :

Key Protein Coordinates Healing in Brain Injuries

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Image of an astrocyte, a subtype of glial cells. Glial cells are the most common cell in the brain. Credit: Pasca Lab, Stanford University NIH support from: NINDS, NIMH, NIGMS, NCATS

A new study published in PNAS Nexus provides a better understanding of how the brain responds to injuries. Researchers at the George Washington University discovered that a protein called Snail plays a key role in coordinating the response of brain cells after an injury.

The study shows that after an injury to the central nervous system (CNS), a group of localised cells start to produce Snail, a transcription factor or protein that has been implicated in the repair process. The GW researchers show that changing how much Snail is produced can significantly affect whether the injury starts to heal efficiently or whether there is additional damage.

“Our findings reveal the intricate ways the brain responds to injuries,” said senior author Robert Miller, the Vivian Gill Distinguished Research Professor and Vice Dean of the GW School of Medicine and Health Sciences.

“Snail appears to be a key player in coordinating these responses, opening up promising possibilities for treatments that can minimise damage and enhance recovery from neurological injuries.”

This study identified for the first time a special group of microglial-like cells that produce Snail. Microglial cells are found in the central nervous system. The researchers found that lowering the amount of Snail produced after an injury results in inflammation and increased cell death. During this process, the injury worsens and there are fewer connections or synapses between brain cells. In contrast, when Snail levels are increased the outcome of brain injury improves-suggesting this protein can help limit the spread of injury-induced damage.

The research raises questions about whether an experimental drug that affects Snail production could be used to limit the damage incurred after someone suffers a stroke or has been injured in an accident, Miller said.

Additional studies must be done to show that increasing Snail production could curtail injury or even promote healing of the brain.

Miller and his team also plan to study the regulation of Snail in diseases like multiple sclerosis, a disease resulting in damage to the myelin nerve sheath. If drugs targeting Snail could be used to stop that damage, many of the future symptoms of this disease could be eased, he says.

But researchers have years of work to do before new drugs targeting Snail can be tested in clinical trials. The payoff ultimately might be drugs that can lead to accelerated healing for stroke damage, head wounds and even neurodegenerative diseases like dementia.

Source: George Washington University

Categories : Ethics and Law Injury & TraumaTags :

Male Murder Rate is a National Health Priority, say Researchers

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Photo by Maxim Hopman on Unsplash

By Daniel Steyn

A study by researchers at the South African Medical Research Council (MRC) recommends that the murder of men in South Africa deserves an urgent national response.

Richard Matzopoulos of the MRC’s Burden of Disease Unit and his team, which included scientists from the UCT School of Public Health, studied postmortem reports from 2017 to compare murders of women and men. Among the factors looked at were cause of death, age, geographic location and whether alcohol played a role.

The study, published in PLOS Global Public Health, found that 87% of people murdered in 2017 were men. The authors note similar percentages in 2009 (86%) and 2000 (84%). 

According to the researchers, this is the first study on male murders in South Africa. Previous studies have focused mainly on femicide (the killing of women). The study focused on 2017 to coincide with the third national femicide study (previous femicide studies were in 2000 and 2009).

The researchers faced challenges getting the paper published in a peer-reviewed journal. Dr Morna Cornell, one of the study’s authors, told GroundUp that men’s health is generally understudied. Cornell believes “we are living in an outdated paradigm which regards all men as powerful and able to navigate health systems etc, and therefore less deserving of care”.

The most common causes of death among male murder victims were sharp stabbings and shootings. For people between the ages of 15 and 44, rates of male murders were more than eight times higher than female murders. The Western Cape has the biggest gap between male and female victims: for every female killed, 11.4 men were killed.

Male murders peaked over December and weekends, suggesting the role alcohol plays.

The study aims to challenge the idea that men are “invulnerable”.

“The fact that men are both perpetrators and victims of homicides masks the strong evidence that men are extremely vulnerable in many contexts,” the study reads.

Murder in South Africa is concentrated in poor neighbourhoods where the effects of poverty and inequality are most significant. According to the study, “violence has been normalised as a frequent feature of civil protest and political discourse”.

High levels of firearm ownership and imprisonment also contribute to violence in South Africa.

“Men are socialised into coping by externalising through anger, irritability, violence against intimate partners and others, and increased engagement in risk-taking behaviours. This, alongside the high levels of violence to which males are exposed across [life], [causes] a continuous, and often intergenerational cycle of violence,” the study says.

While the study acknowledges that “violence against women is endemic in South Africa, with rates almost six times the global figures”, it argues that “men’s disproportionate burden of homicide has not resulted in targeted, meaningful prevention”.

Interventions recommended by the researchers include stricter control of alcohol and firearms, programs to address societal norms that drive physical violence, and efforts to overcome the root causes of poverty and inequality.

Professor Richard Matzopolous, the main author of the study, told GroundUp that more research is needed to understand risks and interventions, especially in a South African context.

“Phase 2 of this study will explore victim/perpetrator and situational contexts,” said Matzopolous.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Cancer Medical Research & TechnologyTags :

Study Exposes Opportunities for Strengthening Cancer Drugs Trials in China

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Of more than four hundred phase 2 and 3 randomised trials of cancer drugs registered in China between 2016 and 2017, about sixty had suboptimal control arms

Photo by Rodion Kutsaiev on Unsplash

More than one-eighth of the randomised trials of cancer drugs seeking regulatory approval in China in recent years used inappropriate controls to test the effectiveness and safety of the drugs, according to a new study published December 12th in the open access journal PLOS Medicine by Professor Xiaodong Guan of Peking University, China, and colleagues.

In randomised trials, patients are assigned to either a control arm, in which they receive the current optimal treatment, or an experimental arm, in which they receive the new drug being tested. However, studies have previously found that control arms in cancer clinical trials (including in the United States) are not supported by relevant guidelines, instead using treatments other than the standard-of-care. Adopting a suboptimal control group may bias a study’s results in favour of the experimental arm, potentially exposing patients to substandard therapy and producing unreliable results of clinical efficacy.

In the new study, researchers analysed the control arms of 453 Phase II/III and Phase III randomised oncology trials authorised by Chinese institutional review boards between 2016 and 2021, supporting investigational new drug applications of these drugs in China.

Overall, 60 trials (13.2%) used suboptimal control arms. Of those suboptimal trials, 35 (58.3%) used comparators that were not recommended by a prior guideline. In total, 18 610 people enrolled in clinical trials (15.1% of the total number in all samples trials) were exposed to suboptimal treatments due to the control arms. Trials using suboptimal controls were more likely to report a positive result for the experimental arm. In addition, the researchers found an overall upward trend in the number of trials using inappropriate control arms.

“Trial sponsors, ethical review boards, and oncologists should make collaborative efforts to protect patients from unnecessary harm and drugs with uncertain clinical benefits over the existing standard of care,” the authors say. “Regulatory agencies should be cautious when reviewing investigational new drug applications whose supporting trial used a suboptimal control.”

The authors add, “This research highlights the necessity to refine the design of randomised trials to generate optimal clinical evidence for new cancer therapies. In November 2021, China issued the Guidance on Clinical Value-Oriented Oncology Drug Research and Development, aiming to promote a better generation of clinically relevant novel oncology drugs in China. We hope our research findings can provide empirical evidence to the stakeholders and draw regulators’ attention to this matter so that the guideline can be delivered in the manner that it set out to be.”

Provided by PLOS One

Categories : NeurologyTags :

What Happens When the Brain Loses a Hub?

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Photo by Jafar Ahmed on Unsplash

A University of Iowa-led team of international neuroscientists have obtained the first direct recordings of the human brain in the minutes before and after a brain hub crucial for language meaning was surgically disconnected. The results reveal the importance of brain hubs in neural networks and the remarkable way in which the human brain attempts to compensate when a hub is lost, with immediacy not previously observed. The findings were reported recently in the journal Nature Communications.

Hubs are critical for connectivity

The human brain has hubs – the intersection of many neuronal pathways that help coordinate brain activity required for complex functions like understanding and responding to speech. But debate has reigned as to whether highly interconnected brain hubs are irreplaceable for certain brain functions. By some accounts the brain, as an already highly interconnected neural network, can in principle immediately compensate for the loss of a hub, in the same way that traffic can be redirected around a blocked-off city centre.

With a rare experimental opportunity, the UI neurosurgical and research teams led by Matthew Howard III, MD, professor and DEO of neurosurgery, and Christopher Petkov, PhD, professor and vice chair for research in neurosurgery, have achieved a breakthrough in understanding the necessity of a single hub. By obtaining evidence for what happens when a hub required for language meaning is lost, the researchers showed both the intrinsic importance of the hub as well as the remarkable and rapid ability of the brain to adapt and at least partially attempt to immediately compensate for its loss.

Evaluating the impact of losing a brain hub

The study was conducted during surgical treatment of two patients with epilepsy. Both patients were undergoing procedures that required surgical removal of the anterior temporal lobe – a brain hub for language meaning – to allow the neurosurgeons access to a deeper brain area causing the patients’ debilitating epileptic seizures. Before this type of surgery, neurosurgery teams often ask the patients to conduct speech and language tasks in the operating room as the team uses implanted electrodes to record activity from parts of the brain close to and distant from the planned surgery area. These recordings help the clinical team effectively treat the seizures while limiting the impact of the surgery on the patient’s speech and language abilities.

Typically, the recording electrodes are not needed after the surgical resection procedure and are removed. The innovation in this study was that the neurosurgery team was able to safely complete the procedure with the recording electrodes left in place or replaced to the same location after the procedure. This made it possible to obtain rare pre- and post-operative recordings allowing the researchers to evaluate signals from brain areas far away from the hub, including speech and language areas distant from the surgery site. Analysis of the change in responses to speech sounds before and after the loss of the hub revealed a rapid disruption of signaling and subsequent partial compensation of the broader brain network.

“The rapid impact on the speech and language processing regions well removed from the surgical treatment site was surprising, but what was even more surprising was how the brain was working to compensate, albeit incompletely within this short timeframe,” says Petkov, who also holds an appointment at Newcastle University Medical School in the UK.

The findings disprove theories challenging the necessity of specific brain hubs by showing that the hub was important to maintain normal brain processing in language.

“Neurosurgical treatment and new technologies continue to improve the treatment options provided to patients,” says Howard, who also is a member of the Iowa Neuroscience Institute.

“Research such as this underscores the importance of safely obtaining and comparing electrical recordings pre and post operatively, particularly when a brain hub might be affected.”

According to the researchers, the observation on the nature of the immediate impact on a neural network and its rapid attempt to compensate provides evidence in support of a brain theory proposed by Professor Karl Friston at University College London, which posits that any self-organising system at equilibrium works towards orderliness by minimising its free energy, a resistance of the universal tendency towards disorder.

These neurobiological results following human brain hub disconnection were consistent with several predictions of this and related neurobiological theories, showing how the brain works to try to regain order after the loss of one of its hubs.

Source: University of Iowa Health Care

Categories : Metabolic Disorders Obstetrics & GynaecologyTags :

Newer Diabetes Drugs don’t Increase Risk to Foetus

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Photo by SHVETS production

Newer diabetes medicines do not appear to increase the risk of birth defects. The largest comparative study to date found no increased risk compared to treatment with insulin, which is considered safe during pregnancy. The study was published in JAMA Internal Medicine.

Newer diabetes drugs such as sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors are being increasingly used, both in the treatment of diabetes, but also extended indications for several of the preparations. 

However, knowledge of the foetal effects of these drugs is still low, so women with type 2 diabetes are often advised to switch to insulin before a planned pregnancy because it is considered safe. However, not all pregnancies are planned and more and more people are becoming pregnant while being treated with these drugs.

An international research team has now investigated whether the use of these drugs during pregnancy increases the risk of birth defects. The researchers used health data from 3.5 million pregnancies in six different countries (Sweden, Norway, Finland, Iceland, USA and Israel) between 2009 and 2021. Among these 3.5 million women, nearly 52 000 were diagnosed with type 2 diabetes and more than 8000 took one of the newer diabetes drugs in the three months before or after their last menstrual period.

Diabetes itself poses a risk of birth defects. High blood sugar levels in early pregnancy, which are more common in people with diabetes, increase the risk of foetal malformations. Therefore, the researchers were not surprised to see a slightly elevated risk in this group.

Among women diagnosed with type 2 diabetes before pregnancy, 5.3% of babies were born with severe birth defects, including 2.2% with heart defects, compared to the overall group where 3.8% had severe birth defects and 1.3% with heart defects. 

No increased risk of birth defects

However, the researchers found that the women with diabetes treated with the newer diabetes drugs did not have a higher risk of giving birth to children with birth defects than the women with diabetes treated with insulin.

“It has already been shown that insulin is safe to use during pregnancy and that it does not cross the placenta. The increased risk of birth defects in the children of women with type 2 diabetes using the newer diabetes drugs is therefore very likely caused by the disease,” says first author Carolyn Cesta, Associate Professor at the Center for Drug Epidemiology at Karolinska Institutet.

Despite being the largest study in this field to date, covering more than 3.5 million pregnancies, relatively few women used the new diabetes drugs, and the researchers stress that further studies are needed to confirm the results. However, they note that the study still shows that these drugs do not pose a major risk of birth defects.

As type 2 diabetes becomes more common among women of childbearing age and as GLP-1 receptor agonists such as semaglutide (Wegovy, Ozempic) are approved to treat obesity, the number of exposed pregnancies is likely to increase. 

“Our findings provide a first indication of the safety of infants exposed to these medications during pregnancy,” says Carolyn Cesta.

Source: Karolinska Institutet

Categories : Diet and Nutrition Neurodegenerative DiseasesTags :

Explaining the Parallels between Vitamin B12 Deficiency and Multiple Sclerosis

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This is a pseudo-colored image of high-resolution gradient-echo MRI scan of a fixed cerebral hemisphere from a person with multiple sclerosis. Credit: Govind Bhagavatheeshwaran, Daniel Reich, National Institute of Neurological Disorders and Stroke, National Institutes of Health

For decades, scientists have noted an intriguing similarity between a deficiency in vitamin B12 – an essential nutrient that supports healthy development and functioning of the central nervous system (CNS) – and multiple sclerosis (MS), a chronic disease in which the body’s immune system attacks the CNS and which can produce neurodegeneration.

Both vitamin B12 deficiency and MS produce similar neurological symptoms, including numbness or tingling in hands and feet, vision loss, difficulty walking or speaking normally and cognitive dysfunction, such as problems with memory.

In a new study, published in Cell Reports, researchers at Sanford Burnham Prebys, with collaborators elsewhere, describe a novel molecular link between vitamin B12 and MS that takes place in astrocytes – important non-neuronal glial cells in the brain.

The findings by senior study author Jerold Chun, MD, PhD, professor and senior vice president of neuroscience drug discovery, and Yasuyuki Kihara, PhD, research associate professor and co-corresponding author, and colleagues suggest new ways to improve the treatment of MS through CNS-B12 supplementation.

“The shared molecular binding of the brain’s vitamin B12 carrier protein, known as transcobalamin 2 or TCN2, with the FDA-approved MS drug fingolimod provides a mechanistic link between B12 signaling and MS, towards reducing neuroinflammation and possibly neurodegeneration,” said Chun.   

“Augmenting brain B12 with fingolimod or potentially related molecules could enhance both current and future MS therapies.”

In their paper, the team at Sanford Burnham Prebys, with collaborators at University of Southern California, Juntendo University in Japan, Tokyo University of Pharmacy and Life Sciences and State University of New York, focused on the molecular functioning of FTY720 or fingolimod (Gilenya®), a sphingosine 1-phosphate (S1P) receptor modulator that suppresses distribution of T and B immune cells errantly attacking the brains of MS patients.

Working with an animal model of MS as well as human post-mortem brains, the researchers found that fingolimod suppresses neuroinflammation by functionally and physically regulating B12 communication pathways, specifically elevating a B12 receptor called CD320 needed to take up and use needed B12 when it is bound to TCN2, which distributes B12 throughout the body, including the CNS.  This known process was newly identified for its interactions with fingolimod within astrocytes. Importantly, the relationship was also observed in human MS brains.

Of particular note, the researchers reported that lower levels of CD320 or dietary B12 restriction worsened the disease course in an animal model of MS and reduced the therapeutic efficacy of fingolimod, which occurred through a mechanism in which fingolimod hitchhikes by binding to the TCN2-B12 complex, allowing delivery of all to the astrocytes via interactions with CD320, with component losses disrupting the process and worsening disease.

These new findings further support to the use of B12 supplementation – especially in terms of delivering the vitamin to astrocytes within the brain – while revealing that fingolimod can correct the impaired astrocyte-B12 pathway in people with MS. 

The scientists said it is possible that other S1P receptor modulators on the market, such as Mayzent®, Zeposia® and Ponvory®, may access at least parts of this CNS mechanism.  The study supports B12 supplementation with S1P receptor modulators with the goal of improving drug efficacy for this class of medicines.

The study also opens new avenues on how the B12-TCN2-CD320 pathway is regulated by sphingolipids, specifically sphingosine, a naturally occurring and endogenous structural analogue of fingolimod, toward improving future MS therapies, Chun said. 

“It supports creating brain-targeted B12 formulations. In the future, this mechanism might also extend to novel treatments of other neuroinflammatory and neurodegenerative conditions.”

Source: Sanford-Burnham Prebys

Categories : General Interest Healthcare Politics and RegulationsTags :

Universal Healthcare is Possible in Our Lifetime

On By ModernMedia

Universal Health Coverage Day calls on us to reflect on the progress that we have achieved in providing healthcare for all. As the health and pharmaceutical industries, it is time to question if our strides in achieving healthcare for all are successful and identify areas for improvement. The theme “A Time for Action”, speaks to the urgency of healthcare access regardless of socioeconomic status, age, race or demographic. It is not an ambitious dream and can be attained in our lifetime, writes Bada Pharasi, CEO of the Innovative Pharmaceutical Association of South Africa (IPASA). 

Universal Health Coverage (UHC) means access to primary healthcare for everyone. In South Africa, this is referred to as  National Health Insurance (NHI). Regardless of its name, the objective remains the same – to ensure that all citizens, regardless of where they live or their socioeconomic status, have access to healthcare.

A 2021 report released at the Africa Health Agenda International Conference (AHAIC) revealed that 615 million, or 52%, of the people in Africa, did not have access to the healthcare that they needed¹. It was also estimated that 97 million Africans face catastrophic healthcare costs, which push 15 million people into poverty every year¹. 

The effective implementation of UHC would mean that no person would have to go without appropriate healthcare. It would also mean that no person would have to undergo financial strain to receive treatment for ill health.

UHC covers a spectrum of health needs from health promotion to prevention, treatment, rehabilitation, and palliative care across the life course². In 2015, 193 United Nations (UN) member states agreed on the 2030 Sustainable Development Goals (SDG). These goals are aimed at seeing an end to poverty and a sustainable future by 2030², and ensuring health coverage for all is an integral part of reaching these goals. 

The World Health Organization (WHO) believes that UHC can be achieved by using the primary healthcare approach as it remains the most accessible, inclusive and cost-effective method to reach the majority of the population². 

Globally, as many as 72 countries have included UHC in their national healthcare systems. The countries where UHC has been the most successful include Canada, Australia, and several European countries, such as Switzerland and Sweden. It is from these countries that we can glean valuable lessons on the importance of strong healthcare systems, well-trained healthcare professionals and a cohesive relationship between governments and the private sector³. 

Ensuring a healthier nation may seem like an exorbitant mission. However, when we consider that a healthier population will be beneficial to the economy, it makes for a worthwhile investment. The World Bank adds that UHC allows countries to make the most of their strongest asset: human capital. A nation in good health is one where children can go to school and adults can go to work⁴. 

There is a common perspective that for a country’s overall health to improve, its economy must improve first. This idea fuels the understanding of why low- to middle-income countries have such poor healthcare infrastructure. The World Bank offers an alternative perspective, suggesting that when a country’s overall health improves, so will its economy. This as more citizens will be able to contribute to its economic growth and the workplace⁵.  

Some of the reasons why the adoption of UHC in African countries has seemed to stall include inadequate financial and technology support, limited pharma manufacturing companies, and unclear policies and regulatory frameworks⁶. 

In South Africa, the greatest hindrance to people receiving the healthcare they require boils down to numbers. With a population of more than 60 million people, there is a greater need for healthcare than there is capacity to meet the demand⁷. 

At IPASA, we believe that healthcare is a basic right and that citizens in any given country should be given the necessary access to healthcare. We understand that working with key stakeholders, such as the government, is critical to the success of universal healthcare. Our ongoing work with patient advocacy groups ensures we understand what patients need from a treatment perspective.

We recently attended the Access Dialogue conference with patient advocacy groups including Rare Diseases South Africa and Campaigning for Cancer to gain an understanding of some of the concerns faced by patients and share insights on the proposed NHI Bill. 

IPASA believes that an adequate supply of medicines is a critical pillar of any healthcare scheme, and the NHI is no different. For the NHI to succeed, it must be backed by a sustainable healthcare sector to ensure the security of healthcare provision and medicine supply.

To this end, the NHI must allow for a flexible, responsive pricing model that includes alternative/innovative reimbursement models to cover the cost of medicines and health products. This allows responsiveness to the needs of geographical areas, quality and levels of care, and negotiations directly with healthcare providers.

Healthcare for all can only be achieved by the joint commitment of the health and pharmaceutical industries, government stakeholders and patient advocacy groups for the benefit of patients. No person should be faced with the obstacle of finance at a time when they need healthcare: providing healthcare for all results in a healthier society and healthier world for us all. 

References:

  1. https://healthpolicy-watch.news/only-half-of-africans-have-access-to-health-care/ 
  2. https://www.who.int/news-room/fact-sheets/detail/universal-health-coverage-(uhc) 
  3. https://wisevoter.com/country-rankings/countries-with-universal-healthcare/#:~:text=The%20countries%20with%20the%20highest,comprehensive%20coverage%20of%20healthcare%20services.
  4. https://www.worldbank.org/en/topic/universalhealthcoverage 
  5. https://widgets.weforum.org/outlook15/10.html 
  6. https://www.iqvia.com/locations/middle-east-and-africa/blogs/2023/01/getting-quality-medicines-to-patients-faster-in-africa-how-to-solve-for-access-issues 
  7. https://www.wits.ac.za/covid19/covid19-news/latest/healthcare-in-south-africa-how-inequity-is-contributing-to-inefficiency.html