Despite concerns about increased stimulant prescribing, nonmedical use of ADHD drugs among adolescents has declined in the last 20 years, a University of Michigan study shows.While medical use of prescription stimulants for ADHD among adolescents increased slightly between 2005 and 2023, nonmedical use declined more.
“Lifetime medical use was 2% lower in 2005 when compared to nonmedical use, and is now 2% higher,” said study co-author Philip Veliz, U-M research associate professor at the U-M School of Nursing and Center for the Study of Drugs, Alcohol, Smoking, and Health.
This reversal is important and “is what all parents want to see,” he said.
Recently, prescription stimulant dispensing has increased in the United States, especially among adults. While nonmedical prescription stimulant use has decreased among teens, no national studies have examined medical and nonmedical use patterns among US adolescents. One concern is that nonmedical use could have increased along with medical use.
To answer that question, Veliz and colleagues analysed data from 2005 to 2023 from 19 cohorts of 8th, 10th and 12th grade students in the Monitoring the Future Study, an annual survey at U-M that tracks student substance use and other related trends.
The current study, supported by the National Institute on Drug Abuse and the US Food and Drug Administration and published in JAMA, found that lifetime use of nonmedical stimulants in 2005 was at 10% and dropped to 6% in 2023. Lifetime medical use was roughly 8% in both 2005 and 2023.
“In other words, while the lifetime prevalence of medical use was relatively stable, with a modest increase in current use, we still saw a decrease in both lifetime and current nonmedical use,” Veliz said. “Accordingly, these fears of an uptick in misusing these prescriptions may be slightly overstated given the current trends shown in this study.”
The decline in nonmedical use of prescription stimulants among adolescents follows similar declines in other types of nonmedical prescription drugs use, such as opioids and benzodiazepines.
“This more than likely is linked to public health messaging, prescribing practices and stimulant shortages as it relates to these types of drugs,” Veliz said.
He said the findings were not surprising given how substance use has been declining among more recent cohorts of adolescents, and that they will help clinicians and policymakers to consider population-level trends in medical and nonmedical use patterns when weighing the risks and benefits of prescription stimulants.
Surgically isolated, seizure-causing neural tissue shows evidence suggestive of absent or reduced awareness
This metaphorical illustration reimagines a hidden view of the brain of a patient with hemispherotomy. In the absence of subcortical activating inputs, the disconnected cortex defaults to a sleep-like state, marked by slow-wave EEG activity and evocatively represented here as night. By contrast, the intact hemisphere, still integrated with subcortical structures, sustains wakefulness and a bright inner world capable of environmental interaction, reflected in faster EEG rhythms. The image underscores the divergence of cortical states after hemispheric isolation. Image credit: Michele A. Colombo (CC-BY 4.0)
Sleep-like slow-wave patterns persist for years in surgically disconnected neural tissue of awake epilepsy patients, according to a study published October 16th in the open-access journal PLOS Biologyby Marcello Massimini from Universita degli Studi di Milano, Italy, and colleagues. The presence of slow waves in the isolated hemisphere impairs consciousness, however, whether they serve any functional or plastic role, remains unclear.
Hemispherotomy is a surgical procedure used to treat severe cases of epilepsy in children. The goal of this procedure is to achieve maximal disconnection of the diseased neural tissue, potentially encompassing an entire hemisphere, from the rest of the brain to prevent the spread of seizures. The disconnected cortex – the outer layer of neural tissue in the brain – is not surgically removed and has a preserved vascular supply. Because it is isolated from sensory and motor pathways, it cannot be evaluated behaviourally, leaving open the question of whether it retains internal states consistent with some form of awareness. More broadly, the activity patterns that large portions of the disconnected cortex can sustain in awake humans remain poorly understood.
To address these questions, Massimini and colleagues used electroencephalography (EEG) to measure activity in the isolated cortex during wakefulness before and up to three years after surgery in 10 paediatric patients, focusing on non-epileptic background activity. Following surgery, prominent slow waves appeared over the disconnected cortex. This is novel evidence that this pattern can last for months and years after complete cortical disconnection. The persistence of slow waves raises the question of whether they play any functional role or merely reflect a regression to a default mode of cortical activity.
The pronounced broad-band EEG slowing resembled patterns observed in conditions such as deep non-rapid eye movement (NREM) sleep, general anaesthesia, and the vegetative state. The findings indicate absent or reduced likelihood of dream-like experiences in the isolated cortex. Overall, the EEG evidence is compatible with a state of absent or reduced awareness.
According to the authors, any inference about the presence or absence of consciousness, based solely on the brain’s physical properties such as prominent EEG slow waves, should be approached with caution, particularly in neural structures that are not behaviourally accessible. The slowing observed at the scalp level should be further characterised with intracranial recordings in cases in which clinical outcomes require postoperative invasive monitoring.
Michele A. Colombo says, “This is only the beginning of shedding light on the problem of consciousness in inaccessible systems. During the revision process, we were confronted with different perspectives, revealing the complexity of this problem.”
Marcello Massimini adds, “This pattern may provide clues to why sleep-like brain activity emerges in patients with brain lesions, and how it relates to their level of awareness.”
Anil K. Seth adds, “This has been an exciting and deeply satisfying scientific journey. It started years ago with philosophical discussions about the possibility of ‘islands of awareness’ in completely isolated neural systems, to, now, this wonderful collaboration which has shed important experimental light on this clinically important issue.”
Tim Bayne finally states, “The study of consciousness involves many puzzling cases in which it is unclear what to say about the possibility of subjective experience. As a philosopher, it’s been deeply rewarding to explore a new frontier in consciousness science with this wonderful team of scientists and clinicians.”
Scientists have uncovered a link between COVID-19 control measures and a surge in serious infections in children following the pandemic.
The findings, which come from a large European study led by researchers at Imperial, suggest that non-pharmaceutical interventions (NPIs) including lockdowns, school closures and social distancing may have inadvertently delayed the development of young children’s immunity to specific infectious diseases, leaving them more vulnerable to severe illness.
The researchers explain that while this impact was anticipated for viral infections (such as influenza and RSV), a surge in other infections, including the bacterial infection Strep A, had not been expected.
The authors advise the need to carefully weigh the impact of restrictions on children during future pandemics and stress the importance of development and delivery of vaccines to reduce the impact of severe infections across all age groups.
Associate Professor Tom Parks from Imperial’s Department of Infectious Disease, co-lead author on the study, said: “During the COVID-19 pandemic there was huge uncertainty about the spread and severity of a new disease and difficult decisions had to be made to protect vulnerable groups, as well as to maintain the health service. Restrictions like lockdowns and social distancing played a vital role in limiting the transmission of the SARS-CoV-2 virus, which undoubtedly, saved countless lives, reduced the impact on health systems including the NHS and bought countries time to roll out vaccine programmes.
“However, our study shows they also disrupted how children built immunity during these critical early years. Children aged 3-4 tested for Strep A immunity after the pandemic were approximately a year behind children tested before the pandemic. This difference in immunity appears to have contributed to the alarming rise in severe Strep A infections seen across Europe during 2022 and 2023.”
Strep A infections
Strep A (Group A Streptococcus) is a common type of bacteria that typically causes throat infections and scarlet fever. While most infections are mild, in rare cases Strep A can cause invasive infections which can be fatal. Each year, around half a million people, including many children and young people, die around the world because of serious Strep A infections.
Previous research has shown that while rates of Strep A infections fell dramatically during the pandemic, many countries recorded a surge in infection rates once restrictions were lifted.
In the latest study, the team examined immune responses in 452 children aged 0-4 year old across 10 European countries that participated in two EU-funded studies: PERFORM and DIAMONDS.
They found that children aged 3-4 who were exposed to NPIs during the pandemic had significantly lower levels of antibodies to Strep A compared to children of the same age who were sampled before the pandemic. The findings correspond exactly with the age group that experienced the greatest increase in life-threatening Strep A infections after NPIs were removed in England.
The researchers also found similar delays in immunity to respiratory syncytial virus (RSV), another common and potentially serious childhood infection, and a small reduction in immunity to some common cold viruses.
Professor Shiranee Sriskandan, co-director of Imperial’s Centre for Bacterial Resistance Biology and co-lead author said: “Strep A is one of the leading causes of unexpected death from sepsis in otherwise healthy children, and we know that sadly disease progression can be exceptionally rapid, making prevention – rather than intervention – our best option to reduce deaths. This study underlines the importance of immunity among young children in preventing outbreaks of serious strep A infections and highlights the value of developing a vaccine for Strep A.
Professor Mike Levin, from Imperial’s Department of Infectious Disease, who led the DIAMONDS and PERFORM studies, said: “Many of the children who had Strep A infections also had viral infections at the same time. Children appear to have been vulnerable to several infections all at once most likely because they had encountered fewer infections and so had little chance to build up immunity.”
Potential partnerships between the public and private healthcare sectors have largely not been harnessed. Photo by Sora Shimazaki
By Ufrieda Ho
Government and the private sector could work together much more effectively to improve healthcare services in South Africa, but the potential of such a partnership remains largely untapped, delegates heard last week at the Hospital Association of South Africa conference.
Healthcare funding in both the public and private sector is headed towards a sustainability crisis, delegates at this year’s Hospital Association of South Africa (HASA) conference heard. But potential solutions such as pooling resources, linking services and partnering smarter has proved to be elusive and far from simple to implement.
The conference was held against a backdrop of ongoing legal action brought by HASA in March this year opposing the passing of the National Health Insurance (NHI) Act. As previously reported by Spotlight, this is one of eight challenges to date against the Act since it was signed in May 2024.
HASA’s case centres on the affordability of NHI and its potential impact on the private healthcare sector.
Dr Dumisani Bomela, Chief Executive Officer of HASA, wrote on their website in September: “Government must view private healthcare as a strategic partner, a national asset that can offer significant ideas to resolve the national health delivery crisis. Private healthcare, on the other hand, faces challenges, some of which were identified in the Health Market Inquiry.”
The final report of the Competition Commission’s Health Market Inquiry was published in 2019, but as yet, most of its recommendations to bring private healthcare costs under control have not been implemented by government. Most medical aid schemes recently announced well-above-inflation increases for 2026 – such above inflation increases have been the norm for over a decade.
In February this year, government took what appeared to be a first step toward getting a grip on private sector healthcare costs when it published draft regulations that would, among others, have set up structures to facilitate tariff-setting. The way these structures were to be set up (a block exemption from the Minister of Trade, Industry and Competition was used to create new structures in the national health department) however raised questions about how well thought-through the plan was. This week, Department of Health spokesperson Foster Mohale told Spotlight that “stakeholders rejected the regulations and the legal opinion was that the draft regulations conflated roles so must be redrafted”. He said the department is busy drafting a new regulation that will work in tandem with a block exemption.
“Not only has the country spent nearly two decades in a fruitless debate about the NHI, but it appears that those in charge of the healthcare system have prioritised stagnation over progress in health reform,” Bomela wrote in September.
Last year’s HASA conference made headlines when an alternative to NHI was proposed that would, among others, see medical scheme membership be made compulsory for people earning above certain thresholds – a move it was argued would swell medical scheme membership, bring down the cost of scheme membership (through younger and healthier people joining), and reduce pressure on the public sector by diverting millions of people to the private sector. While there was some engagement with the Presidency on the proposal and it seemed for a while that there might be some flexibility on the design of NHI, the ANC eventually rejected the idea that any concessions would be made on the design of NHI. Since then, some draft regulations relating to the NHI Act have been published for public comment. Even though it is widely acknowledged that NHI is a long-term project, indications are that government intends to continue on the course set out in the NHI Act.
Better ways to pay for healthcare?
The two-day conference in Sandton this year again included speakers’ take on alternatives to NHI and ways to reform how healthcare is paid for. There was also discussion of the opportunities to leverage advances in artificial intelligence, the use of targeted therapies to remove more of the hit-and-miss of treatment plans, and better use of centralised data to speed up accurate diagnosis and be more helpful to patients in navigating the healthcare system.
At the same time though, speakers reiterated the urgency to break from the trap of talks that don’t come with action and for public-private collaborations to start delivering for more people. Several speakers did not mince their words when describing the scale and depth of the country’s healthcare crisis.
“Healthcare in South Africa is broken, in fact, it is in crisis. We are witnessing, if not participating in, the quickening implosion of our health system,” said Dr Biancha Mentoor, a health policy manager at Netcare.
“While predicting great strategy, we are just rearranging the deck chairs on the Titanic.”
In her address, Mentoor singled out poor leadership “that is out of touch with the people it is supposed to serve” as one of the biggest stumbling blocks.
“We see more homogenous leadership demographically, and it’s leadership with a preference for more established ways of thinking about and doing things in a country facing different challenges,” she said.
Mentoor’s “alternative” tackled the need for greater diversity in leadership, including gender diversity and intergenerational diversity. She also called for private sector players to organise better and be better aligned for effective cooperation.
The Western Cape mapping project
Conference delegates also heard of a collaborative project in the Western Cape that is showing some promise. Actuary Barry Childs, from Insight Actuaries & Consultants, and Suzanne Daniels, deputy director for compliance, billing systems, training and costing in the Western Cape Health Department co-presented on their work done in the Western Cape to map data, streamline data collection, and improve data analysis in order to establish diagnosis-related group (DRG) costing models as envisaged under NHI. They mapped four years of financial data from major hospitals and used this to inform the next steps for refining cost estimates and to have better case mix comparisons.
A DRG payment approach is a reimbursement model for hospital services to determine fixed fees to be paid for treatments. It categorises patients into groups based on diagnosis and the procedures and treatment patients will typically need. It is meant to be a way to standardise payments and to control costs. Unlike with a fee-for-service model, where a fee is paid for each consumable and service delivered, DRGs aim to set a flat rate for an entire treatment. Under a DRG model there might for example be a flat rate for a vaginal delivery, whereas under a fee-for-service model costs will depend on factors such as which scans were ordered and how many consumables were used in a particular case.
Daniels said: “One of the pillars to this is quality care and one of the pathways to quality care is understanding our healthcare cost, because in doing so, we can inform equitable resource distribution, and this is to guide efficiency measures.”
Childs warned though that time is being wasted. He said he had worked on versions of a DRG roadmap since around 2010, pointing out that the long limbo continues to keep the ideals of universal healthcare from being realised.
“This has been under discussion for a long time, and unfortunately, at a national level, the overall focus has been on NHI Act and NHI Bill and very little reform has been done on the ground,” he said.
Childs and Daniels said their showcase of the successes and insights from the Western Cape mapping project could offer other provinces a guide to get out of the starting blocks in standardising procedure and hospital codes, collecting better data and getting a clearer grip on costs and grouping of costs in order to move towards better healthcare funding reforms.
A model that’s working at one Gauteng hospital
Ahead of the conference, Spotlight spoke to group chief executive of Life Healthcare, Peter Wharton-Hood, about the company’s partnership with the Gauteng Department of Health. The partnership involves Eugene Marais Hospital (a Life hospital) taking oncology patients from Steve Biko Academic Hospital (a state hospital).
This comes in the context of the Gauteng health department being taken to court by the Cancer Alliance in a drawn-out legal battle to compel the department to review and update the waiting list of cancer patients in the province and also to draw up and submit to the courts their plans on how they intend to ensure cancer treatment for people who need it. This includes partnerships with the private sector. (See our previous reporting on the litigation here)
Wharton-Hood said they are not informed whether or not the patients they receive are on the Gauteng department of health’s cancer waiting list or backlog list.
However, to date only 34 patients from the public sector have benefitted with this diversion programme at Eugene Marais, with another 10 people about to start treatment. Wharton-Hood said it could and should be many more patients.
“We’ve got a whole care pathway that is up and running. The treatment protocol follows the national guidelines, so there is no compromise to care. The patients are integrated into the daily schedules running in the hospital. And government is also paying us on time. This is a model that is working, so the question is why only 34 patients? We can do more,” he said.
He added that the public and the private health sector represent two vital assets and if they worked together more patients could benefit. However, as it stands, the full potential of these partnerships is simply not being harnessed.
Wharton-Hood said there continues to be a peculiar government reluctance to buy more services from the private sector. It could be win-win-win deals, he said. For the state, it would ease congestion and backlogs at state hospitals. For private facilities, it would push up optimal utilisation and boost revenues. For patients, it would be treatment and care with fewer delays.
He added: “We’ve got something that’s working with Eugene Marais Hospital taking oncology patients from Steve Biko Academic Hospital. It should be a model that is scaled up and applied to other disciplines. If it’s good for oncology, it could be applied to renal dialysis or to orthopaedic cases, for example. The question is why this isn’t the case, why is government not entering into more of these deals when there are people we know are not getting the care they need?”
A new study, led by experts at the University of Nottingham, has found that combining certain types of dietary supplements is more effective than single prebiotics or omega-3 in supporting immune and metabolic health, which could lower the risk of conditions linked to chronic inflammation.
The findings of the study, which are published in the Journal of Translational Medicine, show that a synbiotic – a combination of naturally fermented kefir and a diverse prebiotic fibre mix – produces the most powerful anti-inflammatory effects among the three common dietary supplements tested.
The kefir and prebiotic mix contains a mx of naturally occurring probiotic bacteria and yeasts, which form during the traditional fermentation of goat’s milk with live kefir grains. These grains are living cultures that house dozens of beneficial microbial species.
When you combine kefir (rich in live beneficial microbes) with a diverse prebiotic fibre (which feeds them), there is a synbiotic effect – the fibre nourishes the microbes, helping them thrive and produce beneficial metabolites like butyrate, which has anti-inflammatory and immune-modulating effects throughout the body.
Over six weeks, healthy participants taking the synbiotic saw the broadest reduction in inflammation-related proteins compared to those taking omega-3 or fibre alone. The findings suggest that pairing beneficial microbes with prebiotic fibre could help support immune and metabolic health more effectively than single supplements.
Systemic inflammatory markers are signals in the blood that show how much inflammation is happening throughout the body, not just in one specific area like the gut or an infection. The findings of the study showed that the participants’ overall levels of inflammation across their whole body went down, suggesting an improvement in general immune balance and lower risk for conditions linked to chronic inflammation (like heart disease or other metabolic conditions).
The next stage of the research would be to test the supplements on people with certain conditions to see the effectiveness.
The study was led by Dr Amrita Vijay in the School of Medicine at the University of Nottingham.
Our study shows that while all three dietary approaches reduced inflammation, the synbiotic – combining fermented kefir with a diverse prebiotic fibre mix – had the most powerful and wide-ranging effects. This suggests that the interaction between beneficial microbes and dietary fibre may be key to supporting immune balance and metabolic health.
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.”
#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.
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.”
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.”
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.
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.
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.
