Tag: 16/10/25

Categories : Ethics and Law Substance UseTags : Leave a comment

INHSU 2025: Global Drug Policy and Harm Reduction Leaders Meet in Cape Town

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With drug use projected to rise 40% in Africa by 2030, a global conference will amplify pioneering policy responses and proven health interventions from across Africa and beyond.

14–17 October 2025 | Century City Conference Centre, Cape Town

By 2030, the number of people who use drugs in Africa is projected to rise by 40%, according to the United Nations Office on Drugs and Crime (UNODC). Without stronger drug policy and harm reduction responses, the region faces escalating rates of overdose, HIV, hepatitis C, and other harms.

The warning signs are already here: around 11% of the estimated 1.26 million people who inject drugs across sub-Saharan Africa are living with HIV and an estimated 15% currently have hepatitis C, a liver condition that can cause liver cancer and death.

New research also shows that more than 40% of people who inject drugs in sub-Saharan Africa have experienced a recent non-fatal overdose – more than double the global average of 18.5%.

“While the scale of the challenge is undeniable, pioneering efforts by a few African governments show what harm reduction leadership can look like,” says Angela McBride, Executive Director of the South African Network of People Who Use Drugs (SANPUD), INHSU board member, and co-convener of INHSU 2025. “Harm reduction means putting health and human rights before punishment – shifting away from criminalisation and towards evidence-based, rights-affirming policies.”

These evidence-based policies include decriminalising drug use, expanding needle and syringe programs (NSP) to provide sterile equipment to prevent the spread of blood-borne viruses, increasing access to opioid agonist therapy (OAT) – medication to treat opioid dependence and reduce cravings and withdrawal from opioids like heroin – and ensuring access to HIV and hepatitis B and C testing and treatment.

Africa responds to the crisis

Across the continent, examples of this leadership are starting to emerge – from new legislation in Kenya to large-scale service delivery in Mauritius.

  • In South Africa, the Central Drug Authority is implementing the National Drug Master Plan, acknowledging that the country’s drug crisis is worsening and calling for stronger cross-sector responses. The plan recognises harm reduction and OAT must be expanded if HIV and hepatitis C are to be contained. Ms Nandi Mayathula-Khoza, Chairperson of the Central Drug Authority, will be presenting on the new plan during the conference.
  • In Kenya, parliament is currently debating a Harm Reduction Bill. If passed, it would be a landmark move, embedding access to NSP, HIV-related healthcare services, and other evidence-based services into national law for the first time.
  • Finally, in Mauritius, government-backed harm reduction has already achieved coverage levels rarely seen in the region. More than half of people who inject drugs are receiving OAT, supported by a pioneering “social contracting” model that channels government funds directly to NGOs to deliver NSP and other services on the ground.

Learning both ways

These policy shifts will be a focus of INHSU 2025’s Policy Day, which will bring together decisionmakers from across Africa to debate and share reform strategies. The wider conference will then welcome more than 600 global experts – including researchers, clinicians, policymakers, and people with lived experience of drug use – to showcase African-led harm reduction successes alongside international innovations such as long-acting depot buprenorphine (LADB), a monthly treatment for opioid dependence, and community-led hepatitis C testing and treatment programs that are transforming outcomes worldwide.

“The evidence consistently shows that harm reduction works – what we need now is political will,” says Dr Andrew Scheibe, medical doctor and technical advisor with TB HIV Care in Cape Town, INHSU board member, and fellow co-convener of INHSU 2025. “Harm reduction reduces infections, prevents overdose, and connects people to healthcare, yet access across Africa remains the exception rather than the rule. INHSU 2025 will showcase how we can bridge that gap and deliver the services people urgently need.”

Funding, prisons, and women’s health

Beyond drug policy reform and harm reduction, the conference will focus on other areas with profound impacts on the lives of people who use drugs, including incarceration, gender specific health disparities, and shifts in funding.

Prisons and detention settings will feature prominently, with Professor Louisa Degenhardt (National Drug & Alcohol Research Centre, Australia) presenting a multistage systematic review on the global epidemiology of injecting drug use, HIV, viral hepatitis, and tuberculosis among people who are incarcerated.

Women face extreme stigmatisation and complex barriers to healthcare, especially during pregnancy. Women who use drugs will also be a core focus, with multiple presentations from speakers across Africa and globally. Neliswa Gogela (Groote Schuur Hospital/University of Cape Town, South Africa) will present on HIV and HCV Care for Women Who Use Drugs with other presentations from Tanzania and Kenya.Finally, Kennedy Kipkoech (University of Cape Town and University of Bristol, UK) will present new modelling on the potential impact of the suspension of US PEPFAR funding for OAT on HIV and hepatitis C transmission among people who inject drugs. PEPFAR has saved an estimated 26 million lives, prevented 7.8 million babies from being born with HIV, and supported millions of orphans and vulnerable children across sub-Saharan Africa (Lancet EClinicalMedicine, 2025).

“These issues go to the heart of what drives health inequities for people who use drugs,” says Emma Day, Executive Director of INHSU. “Incarceration increases risk of acquiring HCV, HIV and other infectious diseases. Women who use drugs are among the most stigmatised populations and gender responsive models are needed to appropriately support them. And without sustainable funding, harm reduction progress across Africa is at risk. INHSU 2025 is about confronting these systemic challenges head-on and building a stronger, more equitable response.”

View the full program here

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#InsideTheBox with Dr Andy Gray | Public Participation in Medicines Selection and Regulation – Lacking?

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#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)

By Andy Gray

In several countries, the public is given an opportunity to share their views with regulators before new medicines are registered or to engage with those choosing essential medicines. In South Africa, however, opportunities for such public participation remains limited. In his latest #InsideTheBox column, Dr Andy Gray takes a look at how public participation is handled elsewhere and how it could be improved here.

One of the rallying cries of patient and community-based organisations has long been “nothing about us, without us”. The “patient voice” is, however, not always heard in medicines selection or medicines regulation.

How it works in the US and Europe

Recent highly contested medicines regulatory decisions in the United States, such as the warnings about paracetamol use in pregnancy, have highlighted the role of advisory committees to the Food and Drug Administration (FDA). The FDA relies on a number of such committees to provide advice on regulatory questions, such as whether to approve a new medicine or how to manage emergent safety signals. The FDA usually follows the advice provided by these independent structures, but is not bound to do so.

The fact that advisory committees meet in open session, and that their recommendations are transparent to the public, means that the final decision by the FDA can be contrasted with the scientific advice. The curricula vitae of advisory committee members are posted on the FDA website and updated annually. Critically, when an advisory committee meeting is scheduled, the date and time is announced at least 15 days in advance of the meeting, and this serves as an invitation to interested parties to register to make oral submissions during the Open Public Hearing portion of the meeting.

In addition to providing opportunities for public engagement in this manner, the FDA has also operated a Patient Representative Program since 2024. FDA Patient Representatives are appointed, provided with training, and may then engage with the scientific and other expert members of the advisory committees. Among the criteria applied in their selection are personal experience with a particular disease as a patient or primary caregiver, knowledge about the treatment options and research in that area, and the willingness and ability to communicate in public, as well as being objective while representing the concerns of others affected by the disease.

Similar mechanisms have been put in place in Europe. The European Medicines Agency (EMA) has enabled the appointment of patients as members of its management board and scientific committees. In addition, the EMA Patients’ and Consumers’ Working Party provides a venue for ongoing engagement. The EMA engagement framework explicitly aims to ensure “access to patients’ real-life experiences of living with a condition, its management and the current use of medicines, complementing the scientific evidence provided during the evaluation process” and “the generation, collection and use of evidence-based patient experience data for benefit-risk decision-making”.

How it works in South Africa

Section 3(9) of the Medicines and Related Substances Act, 1965, instructs the chief executive officer of the South African Health Products Regulatory Authority (SAHPRA) to appoint advisory committees. The wording is peremptory, but also broadly enabling: “The Chief Executive Officer shall, in consultation with the Board, appoint committees, as he or she may deem necessary, to investigate and report to the Authority on any matter within its purview in terms of this Act.” Provided there is consultation with the Board of the Authority, the number of committees and their membership is left to the CEO to decide.

To date, however, there has been no deliberate effort to include patient or consumer representatives on any of the advisory committees.

More importantly, meetings of the committees are not open to the public, nor are their recommendations to the regulatory authority placed in the public domain. The “patient voice” is therefore potentially missed, and stakeholders are unable to determine when or how final decisions taken by the Authority may differ from the recommendations made by the technical advisory committees. In that sense, SAHPRA is no more transparent than its predecessor the Medicines Control Council, which also laboured under the same antiquated secrecy provision in the Act. Section 34 of the Act is actually labelled “Preservation of secrecy”.

Similar concerns with medicines selection

Medicines regulators determine whether medicines should be allowed onto the market and how those should be controlled. Similar dynamics are at play in determining which medicines are “essential” and should be procured or reimbursed by health systems.

At a global level, the World Health Organization (WHO) updates its Model List of Essential Medicines every two years. The Model List is a starting point for many countries’ efforts to develop national essential medicines lists, guiding procurement in their public sectors. Although the expert committee responsible for this work does not explicitly include patient representatives, all proposals submitted are placed in the public domain, as are the reviews conducted, and an account of the final decisions. On the first day of the meeting, an open session is held at which stakeholders are invited to apply to present.

One of the most trusted medicine selection bodies is the UK National Institute for Health and Care Excellence (NICE), which also has a deliberate process for stakeholder engagement at multiple steps in its guideline development. For example, right at the outset, this invitation is issued: “NICE invites all stakeholder organisations to attend a scoping workshop. You will be sent a first draft of the scope, which will be discussed at the meeting. We encourage you to send someone who knows about and can represent patients and carers’ interests.”

Medicines selection in the South African public sector is evolving, embracing the challenge of health technology assessment. While there are as yet no patient representatives on either the Expert Review Committee or the National Essential Medicines List Committee, there are opportunities for stakeholder engagement with draft guidelines and increasing transparency, with medicines evaluation reports posted on the Department of Health website.

Full medicine reviews follow an evidence-to-decision framework that was first piloted during the height of the COVID-19 pandemic. One of the questions posed reads: “Is there important uncertainty or variability about how much people value the options?” This question is aligned with what the WHO Handbook for Guideline Development refers to as “values and preferences”. For example, the WHO guidance calls for evidence of the “values and preferences of the people receiving the intervention or experiencing the outcomes the intervention can affect”. While that evidence may sometimes be reported in the scientific literature, all too often it is lacking.

Ultimately, “nothing about us, without us” should not only be a demand made by patients, but also by those who care about the quality, reliability and acceptability of medicines selection and regulatory decisions. Improving the transparency of decision-making processes is critical, but so is creating, promoting and protecting the spaces for an effective “patient voice”. Doing so is a critical investment in building trust, which is so easily eroded.

*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of #InsideTheBox columns he is writing for Spotlight.

Disclosure: Gray is a member of South Africa’s National Essential Medicines List Committee and co-chairs its Expert Review Committee.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons licence.

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GP Researchers Call for Further Improvement of Hospital Discharge Summaries

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Photo by National Cancer Institute on Unsplash

A new review of existing practice and policy, led by experts at the University of Nottingham, has highlighted the need to improve hospital doctors’ understanding of how GPs operate as ‘expert generalists’ as the key to tackling long-term issues around communication at hospital discharge.

When patients leave hospital, their GP receives a discharge summary to assist with their ongoing care. Missing information can affect the safety and quality of future care that the GP can provide and even lead to avoidable harm. Over 40 million summaries are produced every year in the English NHS, meaning that even small improvements could have significant effects.

Since the mid 2000’s, UK hospitals have been encouraged to use summary templates with standard headings to improve their quality. This has helped in many ways, but research shows that a ‘one-template-fits-all’ approach does not always work well for the GPs who receive and use the summaries.

The development paper, led by Dr Nicholas Boddy in the School of Medicine – and supported by the National Institute for Health and Care Research Greater Manchester Patient Safety Research Collaboration (NIHR GM PSRC) – acknowledges that although standard templates have improved discharge summaries, communication needs to become more orientated to the patient’s future care to achieve further progress.

The article, published in the journal Primary Health Care Research & Development this week, describes some of the key foundations for advancements, which need to be built upon with new research and later developed with patients, hospital and community staff.

Dr Boddy, who is a NIHR In-Practice Fellow in the Centre for Academic Primary Care at the University of Nottingham’s School of Medicine, and a practicing GP, said:

Standardised templates can lead to important details being left out, especially for patients with more complex health needs. For example, GPs often need to know not just what happened in hospital, but why certain decisions were made, what the patient’s views were, and how treatments are expected to work in future.”

Dr Nicholas Boddy, School of Medicine

The paper – written with co-authors Anthony Avery, Professor of Primary Health Care in the School of Medicine, and colleagues from the Universities of Hull and Warwick – argues for a more future-focussed, ‘purpose-driven’ approach to writing discharge summaries. This means considering what the summary will be used for and tailoring the content to the patient’s future care.

Dr Boddy adds: “Too little information can put patients at risk, while too much irrelevant detail can also be unhelpful: the GP may have very limited time to read the summary. To find the right balance of information, hospital doctors writing the summaries will need a strong understanding of what GPs (and other community-based clinicians) will want to know, and how generalist care differs from specialist hospital care.

“Improving this understanding can be difficult, and so more feedback, new training sessions, and placements that combine community and hospital work could help. New guidance that helps authors to look beyond the standard headings will also be very important.

“The overall picture shows that standardised templates have improved discharge summaries, but the next step is to encourage communication to become more tailored to the patient’s future care. Hospital teams will need to understand the GP’s perspective better to do this effectively.”

Source: University of Nottingham

Categories : Metabolic Disorders UrogenitalTags : Leave a comment

Promising New Breakthrough for Preventing Kidney Damage in Type 1 Diabetes

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Chronic kidney disease (CKD). Credit: Scientific Animations CC4.0

A new gene therapy approach aimed at protecting people with type 1 diabetes from developing diabetic kidney disease – a serious and common complication of the condition, has shown promising results in a University of Bristol study.

One in three people with type one diabetes will develop kidney damage during their lifetime, which can develop silently over many years, often going undetected until it becomes severe.

Current treatments can slow kidney damage but there are none that act on the root cause: a tiny filter called the glomerulus. A new study published in Molecular Therapy, demonstrated a 64% reduction in a damage indicator for kidney disease, paving the way for a potential new treatment.

The study, driven by first author, Dr Aldara Martin Alonso and led by Dr Rebecca Foster, Associate Professor of Microvascular Medicine at Bristol Medical School: Translational Health Sciences, explored the potential of delivering a protein called VEGF-C directly into kidney cells.

Previous studies have shown VEGFC could protect against kidney disease as it helps keeps blood vessels in the kidney filter healthy, repairing early signs of diabetes-related kidney damage.

To test whether this new approach could be used to treat or slow down kidney disease, the team used a harmless virus to deliver VEGF-C directly into the kidney cells of diabetic mice.

Their results showed that this approach not only helped the kidneys work better, but also protected a key part of the kidney filter that normally helps prevent damage. It led to a 64% reduction in albuminuria. Importantly, this reduction is more than twice the reduction recommended by the American Diabetes Association to slow the progression of chronic kidney disease.

Dr Foster, the study’s senior author, explained: “Currently, there are no drugs specifically available to protect people with type 1 diabetes from kidney disease, despite their higher risk of developing kidney disease. This gap in treatment highlights the urgent need for new therapeutic approaches. Our goal was to investigate whether gene therapy could offer a viable solution by delivering VEGFC in a more targeted way.”

Dr Foster added: “This gene therapy approach has not been explored before in pre-clinical models and offers a long-term solution for these patients who are at risk of developing kidney disease.”

Source: University of Bristol

Categories : GastrointestinalTags : Leave a comment

New Expanding Pill for Weight Loss Reduces Hunger Cravings

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An illustration showing how Sirona works. Image credit: Oxford Medical Products

An innovative new pill could soon offer a new and affordable weight management treatment, following a successful clinical trial involving University of Bristol researchers and supported by the National Institute for Health and Care Research (NIHR). The results are published in the journal Obesity.

Sirona by Oxford Medical Products is a hydrogel-based pill that is designed to aid weight loss by reducing hunger.  After it is swallowed, the pill expands in the stomach, leading to faster satiety. This helps individuals to eat less without needing strong medications or injections.

Thirty-nine participants in Southampton took part at the NIHR Southampton Clinical Research Facility.

In the trial, funded by Innovate UK, participants lost up to 13.5% of their body weight in just six months. On average, people with class 1 obesity (BMI 30-35) lost 6.4% of their body weight.

Participants also ate on average 400 fewer calories per day compared to those taking a placebo. For context, recent Government-led research suggests that even a 216-calorie daily reduction could cut the UK’s obesity rate in half.

The trial was led by chief investigator Professor James Byrne in the NIHR Southampton Biomedical Research Centre.

Mr Byrne, a consultant surgeon at University Hospital Southampton, said: “Obesity is a chronic and often progressive disease. With obesity rates continuing to rise, these results are an important step towards providing a different treatment option.

“This trial demonstrated Sirona could be a safe, affordable, and non-pharmacological treatment to support long-term weight management.”

Sirona will be accessible to anyone with a BMI 25-40, which means Sirona is particularly well-suited to help two key patient types. Firstly, for patients with an overweight BMI (25–30), allowing them to proactively manage their weight and to avoid progressing into obesity and the serious health problems it can bring. Secondly, it is suitable for use as an ‘off-ramp’ for GLP-1 users looking to come off treatment but prevent weight regain, which often occurs once GLP-1 medication ceases.

GLP-1 medications have become very popular for weight loss, with around 1.5 million users in the UK. However, a significant proportion of users pay out of pocket and prices have recently doubled in the UK for some doses of Mounjaro.

Camilla Easter, CEO of Oxford Medical Products, added: “GLP-1 medications perform an important role in helping those with a BMI in the obese range to lose weight and reduce weight-related health risks. There is, however, a real opportunity for a new style of treatment to work in a complementary way to GLP-1s, in a format that is significantly less expensive, and with better tolerability and therefore more accessible for the majority.

“Sirona has demonstrated amazing results during testing with UK hospitals, which have now been externally peer-reviewed. Next, we are setting sights on commercial UK release plans, targeting 2027 to make Sirona available.”

Sirona is a dual-polymer hydrogel pill. That means it’s made from two types of safe materials that expand in the stomach. It doesn’t use drugs or chemicals to change how your body works.

The pill was well tolerated during the 24-week study. There were no serious adverse events. Participants lost up to 13.5% of their body weight in just 24 weeks, and individuals with class 1 obesity (BMI 30-35) lost 6.4% of their body weight on average.

Importantly, no serious adverse events were reported during the trial. Sirona was well tolerated (95 percent of patients adhered to the dosing regimen at 12 weeks) and demonstrated a fantastic safety and side effect profile. This makes Sirona appropriate for patients who have struggled with adverse side effects when using GLP-1 medications. 

OMP is planning a pivotal study in the UK and USA to further assess the effectiveness of Sirona and confirm these results. The novel weight loss treatment will aim for a 2027 UK commercial launch.

Source: University of Bristol

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Categories : Neurodegenerative DiseasesTags : Leave a comment

X-Chromosome Gene Behind Greater MS and Alzheimer’s Risk in Women

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Mouse study reveals how females’ double X chromosomes drives brain inflammation and identifies diabetes drug as potential treatment

Photo by Karolina Grabowska on Pexels

New research by UCLA Health has identified a sex-chromosome linked gene that drives inflammation in the female brain, offering insight into why women are disproportionately affected by conditions such as Alzheimer’s disease and multiple sclerosis as well as offering a potential target for intervention. 

The study, published in the journal Science Translational Medicine, used a mouse model of multiple sclerosis to identify a gene on the X chromosome that drives inflammation in brain immune cells, known as microglia. Because females have two X chromosomes, as opposed to only one in males, they get a “double dose” of inflammation, which plays a major role in ageing, Alzheimer’s disease and multiple sclerosis.  

When the gene, known as Kdm6a, and its associated protein were deactivated, the multiple sclerosis-like disease and neuropathology were both ameliorated with high significance in female mice.  

“It has long been known that there are sex differences in the brain. These can impact both health and neurological diseases,” said study lead author Dr Rhonda Voskuhl, director of the Multiple Sclerosis Program at UCLA Health and lead neurologist for the UCLA Comprehensive Menopause Program. “Multiple sclerosis and Alzheimer’s disease each affect women more often than men, about two to three times as often. Also, two-thirds of healthy women have ‘brain fog’ during menopause. These new findings explain why and point to a new treatment to target this.”  

When first author Dr Yuichiro Itoh of the Voskuhl lab genetically “knocked out” the gene Kdm6a in brain immune cells, the inflammatory molecules shifted from being activated to a resting state. Additionally, the Voskuhl team performed a pharmacologic “knock down” of the protein made by this gene using metformin. Metformin is widely used as a treatment for diabetes, but is currently being researched for potential anti-ageing properties.  

While these interventions were highly significant in female mice, their effect was almost undetectable in males, Voskuhl said. 

“This is consistent with there being ‘more to block’ in females due to having two copies of the X-linked gene,” said Voskuhl, who is also a professor of neurology at UCLA Health. “It’s also why females are more likely to get MS and AD than males. This has implications for the clinic. Women may respond differently to metformin treatment than men.” 

Voskuhl said the findings may also have implications for explaining a connection to brain fog in healthy women during menopause.  

“Sex chromosomes and sex hormones achieve a balance through evolution,” Voskuhl said. “There is a selection bias to do so. Females have a balance between X chromosome-driven inflammation that can be good to fight infections at child-bearing ages. This is held in check by oestrogen, which is anti-inflammatory and neuroprotective. As women age, menopause causes loss of oestrogen, unleashing the proinflammatory and neurodegenerative effects of this X chromosome the brain immune cell.”  

Voskuhl says together, these findings may support use of oestrogens that target the brain to keep the balance, and thereby protect the brain, during menopause.

Source: UCLA Health