Categories : General Interest Surgeries & ProceduresTags : Leave a comment

This World-class Scientist from Cape Town Used to Cut up her Dolls and Perform Imaginary Transplant Surgeries

On By ModernMedia
UCT’s Professor Liesl Zühlke has won a global women in science award for her groundbreaking work in improving care for children with cardiovascular disease. (Photo: Supplied)

By Sue Segar for Spotlight

Long before she became a pioneering scientist, Professor Liesl Zühlke insisted on seeing her tonsils after they were removed when she was just five years old. Today, paediatric cardiology is close to her heart, and her research has helped answer critical questions in the entire pipeline of heart disease.

In the mid-2000s, while working as a trainee in paediatric cardiology at the Red Cross War Memorial Children’s Hospital, Liesl Zühlke helped treat a 12-year-old patient who had an unusual congenital heart condition.

“His heart was so weak that he was dying,” she says. “He was thin, short of breath and very tired. He’d had multiple admissions to hospital and numerous health folders, tied together with elastic. On the front of his folder, the letters DNR (meaning do not resuscitate) were written in black khoki-pen.”

Zühlke recalls requesting an ultrasound of the heart, among other tests that eventually led to a diagnosis of a coronary artery anomaly. “This is a structural heart defect, present at birth, where the major coronary artery supplying the heart itself has the wrong origin, resulting in oxygen-poor blood supplying the heart muscle, causing it to die,” she explains. (See this Cleveland Clinic page for more on the condition.)

Fortunately, the defect is treatable with cardiac surgery to move the coronary artery to the correct place. Within a year of having this operation, the boy’s heart function had returned to normal.

A journey to research

This encounter was something of a turning point in Zühlke’s life. Till then, she’d only done clinical work, but the case piqued her interest in this particular lesion.

This experience, she says, was a lesson in looking beyond the obvious, re-examining a patient with a fresh approach, and asking new questions. “By thinking differently, we changed the trajectory of his life and many others.”

Zühlke did a small study looking at 30 cases of this lesion, and found it was more common than thought. “Our work led us to being able to diagnose this condition much earlier, before heart damage could happen, and children with the lesion could get surgery earlier. It made me realise why research and evidence-based medicine are so important … if one wants to impact not just the patient in front of you but multiple patients.”

A lifetime steeped in medicine

Zühlke, who was born and raised in Athlone, Cape Town, was from childhood fascinated about the inner workings of the human body.

“My siblings remember me cutting up my dolls and doing transplants with pieces of chicken,” she recalls with amusement.

When she had her tonsils removed at a tender five years old, she insisted on seeing the fleshy lymph node masses.

“My grandmother worked as a domestic worker in a residence at the University of Cape Town (UCT) and told us stories about students and what was happening there. Apparently, from when I was three or four, I said I wanted to study medicine,” says Zühlke.

It thus came as no surprise that she ended up studying medicine and surgery at the UCT. In 2015, she completed her PhD on the outcomes of asymptomatic and symptomatic rheumatic heart disease, which was supervised by the late Professor of Cardiology Bongani Mayosi. She calls him her “academic father” and “the man who saw something in me that I didn’t”.

In 2019, Zühlke was the first woman in South Africa to be appointed as a full professor in paediatric cardiology.

“It was always going to be paediatrics,” she says, adding “there was always a kid on my hip during ward rounds. With children, it’s not about status but about caring, and meeting them at their level.”

Losing patients, Zühlke says, is part of any doctor’s experience, “but it’s terrible telling a mother their child hasn’t got a normal heart and that there’s a possibility of death. To do that with compassion … is what we’re put in this world for.”

She says while her work started with research into rheumatic heart disease, her focus later evolved. “I started looking more at the reasons why we have the outcomes we do; the overarching determinants of why people are diagnosed late, why they don’t have enough treatment, and enough surgery; and why they have poorer outcomes.”

Today, Zühlke is vice-president of the South African Medical Research Council, and at Red Cross she is director of the Children’s Heart Disease Research Unit and a paediatric cardiologist in the Division of Paediatric Cardiology.

What types of things go wrong in children’s hearts?

Heart disease in children refers to any problem with the structure or work of the heart, explains Zühlke. There are two main types: congenital heart disease which relates to structural problems with the heart that are present at birth; and acquired heart disease that develops later.

“The heart is complete between six and eight weeks in utero. With congenital heart disease, the structural abnormalities are there already,” she says.

“The heart can be viewed as a house with four rooms or chambers, with walls that separate them, and veins or arteries going in or out to allow blood to move from one chamber to the next, through four valves or doors. There can be problems with any of those, for example, a hole in the heart, which is one of the most common things we see. If there’s a hole in one of the walls separating these chambers, then oxygen-rich and oxygen-poor blood can mix, making the heart and lungs work harder,” Zühlke says.

She says that a much more serious problem is when, instead of being born with four parts of the heart, a child is born with three or there’s obstruction to blood flow to the body. “This critical cardiac lesion requires surgery to reorganise the circulation. No surgery almost certainly means death. The range of structural abnormalities ranges from mild to critical. Congenital heart disease is the most common birth defect, affecting one in 50 children,” Zühlke says.

Explaining rheumatic heart disease, she says: “This is acquired later in life, particularly in children between the ages of five and fifteen, as a consequence of an infection called Streptococcus pyogenes (Strep A) which causes a sore throat or a skin infection and sets off an abnormal immune response. The body attacks and damages the tissue in the heart, an acute illness follows called Rheumatic fever and the permanent heart valve damage which results is known as Rheumatic Heart Disease.”

Zühlke believes not enough studies have been done to prove categorically what the prevalence of heart disease is in children in South Africa. “It’s hard to do a true birth prevalence study. But we’ve done a lot of work (through extrapolating numbers from other studies) to fill in the data gap showing that the prevalence in South Africa is similar to other parts of the world.” She says congenital heart disease is within the top five killers of children and more common than any other birth defects combined.

Unclear causes

The causes of congenital heart disease could include genetic changes, like chromosomal disorders like Down syndrome; maternal health issues like diabetes, obesity or infections; or exposure to smoke, alcohol or restricted medications during pregnancy.

The causes of acquired heart disease are similarly varied, ranging from environmental causes to and infections. It can take many forms. Kawasaki disease is a childhood illness that causes inflammation in the walls of blood vessels, resulting in fever, rashes and swelling; cardiomyopathy is a disease of the heart muscle that makes it harder for the heart to pump blood to the rest of the body. HIV-associated heart disease comes about because people living with HIV face a higher risk of developing cardiovascular disease.

The symptoms of heart disease, Zühlke says, include rapid breathing, an increased heart rate, and excessive sleepiness. Babies can be pale or blue around the fingers, toes or lips, and can tire when drinking or have problems gaining weight.

There are several possible diagnostics, but they are not always available in the public healthcare system. These include heart ultrasound, electrocardiograms, X-rays, and checking the amount of oxygen in the blood soon after birth, with a pulse oximetry test.

In addition, Zühlke says that some provinces such as the Northern Cape and Mpumalanga lack a paediatric cardiologist to make the diagnosis. “There are also issues with referrals to get diagnosed patients to centres for timeous attention. Sadly, people are dying without even knowing they had heart disease,” she says.

What we can do differently

Asked what could be done differently in the public sector to improve early diagnosis of heart issues, she says pulse oximetry screening is a simple, cost-effective, efficient test to rule out critical congenital heart disease. Zühlke says there are plans to incorporate it into the Road to Health Booklet used by health professionals and parents to monitor a child’s health and development.

“It wouldn’t be difficult to add pulse oximetry screening as a check before a baby is discharged from a hospital. It’s been well proven that it works. All that’s needed is a probe and somebody to do it; and it can tick a box on the child’s Road-to-Health chart.

“But that requires money because you need a particular newborn probe to do it … and people are busy in the clinics,” she says.

On rheumatic heart disease, Zühlke says it’s “unethical” that an entirely preventable disease is still such a problem in SA and Africa. “We need research, funding, and advocacy to change that, improving diagnosis, treatment and long-term care. Also, we need to make sure there’s a vaccine to treat strep A.”

First prize, she says, would be to enable immediate diagnosis of rheumatic fever. “Currently, there’s no one test to say a person has acute rheumatic fever.”

“Next, we need a different way of treating it (the current penicillin injection is extremely painful for children); and getting a vaccine in countries where it actually matters. In the meantime, the goal is to ensure people living with the disease get access to care.”

Zühlke says she’s following the work on a vaccine for rheumatic heart disease closely and is involved in a vaccine collaborative which is working to ensure that when the vaccine becomes available, it is accessible and affordable.

‘Some of them were my heart patients as children’

Meanwhile, her “varied, mad, interesting” life sees her overseeing numerous intra- and extramural research projects for the SAMRC and directing her childrens heart research unit at UCT. She still works in a multi-disciplinary clinic for women with cardio-vascular disease in Groote Schuur’s maternity centre which she loves.

“Some of them were my heart patients as children,” Zühlke says, adding that transitional care is a priority “because patients with congenital and rheumatic heart disease become adults, we need to ensure that they can get the best possible life-long care.”

Her big vision has always been “to integrate research into the clinical space, so that as you see patients, it goes into the research, and as you research, it goes back to the patient.” Zühlke adds: “Being part of the research landscape at the SAMRC is deeply gratifying. What I’d like to see, most importantly, is childhood onset heart disease recognised as an entity, part of policy … and in the national action plans.”

She is the 2026 laureate for Africa and the Arab States in the L’Oréal-UNESCO For Women in Science International Awards for her pioneering work in improving care for children with cardiovascular disease, particularly rheumatic heart disease. Given to the top five female scientists globally, the distinguished award recognised her for “combining cutting-edge science with social justice” and “turning the fight against childhood heart disease into a public policy priority”.

Zühlke is married to Alexander Zühlke, a plastic surgeon at Tygerberg Hospital in Cape Town, and together they have two children.

*This article is part of Spotlight’s 2026 Women in Health series, featuring the remarkable contributions of women to healthcare and science. Sign up to the Spotlight newsletter.

Categories : UncategorizedTags : Leave a comment

Coffee’s Biological Benefits Linked to Metabolic Health and Sex Hormones

On By ModernMedia
Photo by Porapak Apichodilok on Pexels

Coffee is one of the world’s most widely consumed beverages, and previous research has linked its consumption to a lower risk of conditions such as type 2 diabetes and cardiovascular disease. However, the biological mechanisms behind these benefits remain unclear. A new Finnish study links habitual coffee consumption to healthier body composition and metabolic markers, while revealing distinct associations with sex hormones in men and women.

The study, conducted at the University of Oulu, analysed data from 2264 participants aged 46 in the Northern Finland Birth Cohort 1966. Researchers examined how habitual coffee consumption was associated with circulating metabolites, cardiometabolic risk markers and sex hormones.

Despite having a similar body mass index (BMI), individuals with higher coffee consumption had lower total and visceral fat and greater skeletal muscle mass than those who consumed less coffee.

In both men and women, higher coffee consumption was correlated with lower circulating levels of branched-chain amino acids, biomarkers that have previously been linked to insulin resistance and an increased risk of type 2 diabetes when chronically elevated.

The strongest sex-specific associations were observed in men. Higher coffee consumption was linked to a more favourable glucose–insulin profile, higher concentrations of total and bioavailable testosterone, and increased levels of sex hormone-binding globulin (SHBG). At the same time, free testosterone and the free androgen index were modestly lower. In women, hormonal associations were more limited and were primarily characterised by higher SHBG and lower measures of free androgens.

“Coffee is consumed by millions of people every day, yet we still know surprisingly little about how it relates to our metabolism and hormones. What stood out in our findings was a distinct hormonal signature that didn’t disappear even after we took into account BMI and lifestyle factors, with several of these associations differing between men and women,” says Luca Verroest, lead author of the study and Doctoral Researcher at the University of Oulu.

The results suggest that hormonal pathways may partly explain the relationship between coffee consumption and metabolic health. However, as this was an observational study, the findings demonstrate associations rather than cause-and-effect relationships.

The study is particularly relevant in Finland, one of the world’s highest coffee-consuming countries, where annual consumption averages around 11.8 kilograms per person.

The researchers say the findings provide a foundation for future studies aimed at determining whether coffee itself drives these biological changes and identifying the compounds responsible. These questions are currently being investigated in animal models, with the long-term goal of progressing to human intervention studies. Further research will be needed before the findings could inform dietary recommendations.

The study, Associations of habitual coffee intake with testosterone and cardiometabolic markers: the Northern Finland Birth Cohort 1966 study, has been published in the European Journal of Nutrition on 16 July 2026.

Source: University of Oulu

Categories : Metabolic DisordersTags : Leave a comment

Researchers Examine Unanticipated Benefits of GLP-1 Medications

On By ModernMedia

Editorial highlights emerging benefits and questions surrounding this rapidly expanding class of medications

Photo by Haberdoedas on Unsplash

GLP-1 receptor agonists and dual agonists have transformed the treatment of obesity and other metabolic diseases, and a new editorial co-authored by Dr Steven Heymsfield of LSU’s Pennington Biomedical Research Center and Dr Adam Gilden of the University of Colorado examines what scientists are learning as these medications reach millions of people.

The editorial, “Unanticipated Effects of GLP-1 Receptor Agonists: A Net Positive,” was published in the journal Obesity and highlights additional benefits that were not fully anticipated when the drugs were initially developed.

“Most of the unanticipated side effects of GLP-1 receptor agonists have been positive,” the authors wrote.

The researchers highlight evidence suggesting GLP-1 medications may reduce inflammation and lower the risk of certain cardiovascular and musculoskeletal conditions. Emerging studies also suggest the medications may reduce alcohol consumption and the risk of certain substance use disorders, although additional clinical trials are needed to confirm these effects.

At the same time, questions remain about the medications’ effects on lean body mass and nutritional health. Weight loss associated with GLP-1 medications can include reductions in lean mass, including muscle, making it important to understand how to preserve muscle through exercise and appropriate nutrition. Reduced appetite may also increase the risk of micronutrient deficiencies in some patients.

“GLP-1 receptor agonists have already transformed the practice of medicine in the United States, and this change will continue as more medications come onto the market,” the authors wrote.

The researchers identify three key priorities for future GLP-1 research:

  • Understanding the mechanisms behind potential reductions in inflammation,
  • Conducting randomised trials to better understand changes in lean body mass and ways to preserve muscle,
  • Conducting larger randomised trials to determine whether these medications can reduce alcohol use disorders.

Despite the remaining questions, the authors conclude that the evidence available to date supports a favourable overall risk-benefit profile for GLP-1 receptor agonists and dual agonists.

Source: Pennington Biomedical Research Center

Categories : Pain ManagementTags : Leave a comment

Can Humans Regulate Acute Inflammation Through Attention?

On By ModernMedia
Source: Pixabay CC0

We usually think of bodily sensations as information the brain receives. What if the way we attend to those sensations can feed back and change the biological response itself?

Attention is already known to shape how bodily sensations are perceived. Focusing away from pain or itch, for example, can make these sensations feel less intense. A new study from the lab of Dr Liron Rozenkrantz at Bar-Ilan University’s Azrieli Faculty of Medicine, published in Nature Human Behaviour, shows that attention can also influence the body’s inflammatory response.

When people voluntarily focused their attention on sensations arising from a small area of inflammation in their arm, the inflammatory response was smaller and showed faster recovery dynamics than when their attention was directed away from those sensations.

The study, led by Dr Nofar Mizrachi and conducted in collaboration with Prof Menachem Rottem, a clinical immunologist, involved 57 healthy volunteers across three preregistered experiments. Participants underwent a standardised procedure that produced a small, temporary inflammatory response in the skin. They were then instructed either to focus on sensations from the affected area or to direct their attention elsewhere. The researchers measured the inflammatory response for 20 minutes as it unfolded, along with physiological measures such as heart-rate variability, skin temperature and autonomic activity.

The effect was substantial and highly consistent: nearly 90% of participants showed a smaller inflammatory response when they focused on the affected area, with responses approximately 1.5-fold smaller under internal attention compared with distraction. Differences emerged within minutes, with the response also showing faster return toward baseline.

“What was particularly striking was that directing attention toward the inflamed area changed not only what participants experienced, but the inflammatory response itself,” said Dr Rozenkrantz. “This raises the possibility that our subjective experience of what is happening in the body is not only a passive process, but may be actively contributing to how physiological responses are regulated.”

The researchers identified two complementary pathways that contributed to the effect. One involved sensory signals coming from the inflamed tissue. The other was a top-down mechanism through which attention continued to influence inflammation even when sensory signals were reduced using a local anesthetic.

Together, the findings suggest that attention can influence inflammation through both sensory and top-down pathways. More broadly, they suggest that the way the brain prioritises signals from the body may have consequences for how the body regulates itself.

The experiments involved healthy volunteers and a controlled model of acute skin inflammation. Whether the same mechanisms apply to chronic inflammation, autoimmune disease, wound healing or other conditions remains to be determined. The team’s next step is to identify the precise brain and immune pathways involved and determine whether similar effects occur in other physiological systems.

Source: EurekAlert!

Categories : Cancer Diet and NutritionTags : Leave a comment

Ultra-Processed Foods Linked to Notably Higher Prostate Cancer Risks

On By ModernMedia
Photo by Erik Mclean

Growing evidence links higher consumption of ultra-processed foods (UPFs) to a range of health problems. Research has identified several potential biological pathways through which UPFs may contribute to cancer. These include metabolic disruption, inflammation, oxidative stress, and changes to the gut microbiome. However, data are sparse about whether men who consume high amounts of UPFs have greater risks of prostate cancer.

Now, new research from Florida Atlantic University’s Charles E. Schmidt College of Medicine provides evidence that men with higher consumption of UPFs have increased risks of prostate cancer. Published in The American Journal of Medicine, the study analyses a large and nationally representative survey from 17 024 US adults males from 2003 through 2023. Researchers used two 24-hour dietary recalls to calculate the percentage of daily calories participants consumed from UPFs. Using the validated and widely used NOVA classification system, they divided participants into four groups, ranging from less than about 20% of calories from UPFs to more than 44%.

Men in the three higher-consumption groups of UPFs had a 29% greater risk of prostate cancer, while those in the two highest-consumption groups had a 30% greater risk, compared to those in the lowest consumption group. After adjustments for age, race and ethnicity, smoking, and poverty status, the increased risk remained significant, ranging from 24% to 31%. Men with the highest UPF intake alone had a possible 34% higher risk, although the finding did not reach statistical significance, potentially reflecting the smaller number of prostate cancer cases in that group.

“Among adult men in this nationally representative US population, those who consumed higher amounts of UPFs had significantly higher risks of the subsequent development of prostate cancer,” said Charles H. Hennekens, MD, FACPM, FACC, senior author and the First Sir Richard Doll Professor of Medicine and Preventive Medicine in the Department of Medicine and the Department of Population Health at FAU’s College of Medicine. “These findings add to emerging evidence that UPFs have major adverse health effects and underscore the need for large-scale observational studies and randomised trials to adequately test the hypothesis.”

Previous studies have shown that people who consume larger amounts of UPFs have higher risks of overweight and obesity, metabolic disease, markers of inflammation, cardiovascular disease, principally heart attacks and strokes, as well as premature death.

This original research adds to the armamentaria of a major battle in which the priorities of the food  industry do not align with the needs of the U.S. public. The authors opine that just as the dangers of tobacco began to emerge during the middle of the prior century, decades passed before the preponderance of evidence and the efforts of forward-thinking health officials prompted policy changes to discourage cigarette use. The authors believe that this is likely to be a similar path for UPFs.

“Reducing consumption of UPFs is a complex public health challenge, particularly given how prevalent and accessible these products are,” said co-author Timothy De Ver Dye, PhD, professor and chair of FAU’s Department of Population Health. “Healthcare providers should recognise that many patients face barriers to accessing and affording healthier food options. Addressing these challenges will require efforts that extend beyond individual choices to support greater access to nutritious, minimally processed foods.”

According to the International Agency for Research on Cancer, nearly 1.5 million men worldwide were diagnosed with prostate cancer in 2022, and nearly 400 000 died from the disease.

“All healthcare professionals should encourage patients to adopt healthy lifestyle practices and evidence-based therapies, while also helping them reduce their consumption of ultra-processed foods,” Hennekens said. “Patients and their healthcare providers should consider this finding as part of broader efforts to promote healthier dietary choices.”

Study co-authors are FAU medical students Hunter Scott and John Dunn as well as Yanna Willett, a doctoral student at the University of Oxford in the United Kingdom.

Source: Florida Atlantic University

Categories : NeurologyTags : Leave a comment

Workers’ Pesticide Exposure Linked to 60-70% Heightened ALS Risk

On By ModernMedia

Increased risk of amyotrophic lateral sclerosis (ALS) associated with herbicides, insecticides
Men exposed to these chemicals may be twice as likely to develop ALS as unexposed men

Photo by Arjun Mj on Unsplash

Workplace exposure to pesticides (herbicides and insecticides) is linked to a 60-70% heightened risk of the most common form of motor neuron disease – amyotrophic lateral sclerosis, or ALS for short, finds a synthesis of the available evidence, published online in Occupational & Environmental Medicine.

Men who have been exposed to these chemicals may be twice as likely to develop the condition as those who haven’t been, the analysis indicates.

Although still relatively rare, the incidence of ALS – a progressive and rapidly fatal neurodegenerative disease for which there is no cure – has increased in recent years, note the researchers.

White the short term neurotoxic effects of pesticides, particularly insecticides, have been known for decades, there’s not a great deal of evidence on their potential long term neurotoxicity, they add.

In a bid to strengthen the evidence base, the researchers scrutinised research databases for relevant studies, including peer reviewed theses and scientific reports, on workplace exposure to pesticides and ALS, published between 1990 and 2025.

Eight case-control studies involving a total of 1734 cases of ALS, and 3 studies involving 457 cases of unspecified motor neuron disease, were retained for pooled data analysis from 767 initially screened articles.

This showed that compared with no exposure, any workplace exposure to pesticides was associated with a 60% heightened risk of ALS, based on the pooled data from 6 studies.

And based on the results of 3 studies, any exposure to high levels of pesticides was associated with a near tripling in risk compared with no pesticide exposure, whereas any exposure to lower levels was associated with a doubling in risk.

Compared with no exposure, exposure to herbicides was associated with a 70% heightened risk of developing the disease; exposure to either insecticides or fungicides was associated with a 60% heightened risk.

In studies that reported risk estimates stratified by sex, the pooled data analysis showed that exposed men were twice as likely as unexposed men (3 studies) to develop ALS.

But no increased risk was apparent in women who had been exposed to pesticides compared with those who hadn’t been.

The researchers highlight various limitations to their findings: the small number of available primary studies and their crude assessment of exposure, generally based on answers to a few limited questions.

“To strengthen the evidence on risk factors for ALS, primary studies particularly need methodological improvements on exposure assessment, on the selection of reference groups, and on adjustment for potential confounders, including analysis for interactions between risk factors,” they emphasise.

But they conclude: “The findings of this review add to the evidence that occupational exposure to pesticides may increase the risk of ALS and should encourage the implementation of interventions aimed at reducing exposure during occupational pesticide use.”

Source: The BMJ Group

Categories : VaccinesTags : Leave a comment

Sepsis Survivors Don’t Respond to Vaccines in the Same Way

On By ModernMedia
Image from Rawpixel

People who have survived intensive care unit admission with sepsis don’t respond to vaccines in the same way as those who haven’t had sepsis, according to new clinical trial results. The findings suggest that more work is needed to understand why the vaccine-related immune response is altered in sepsis survivors, so that vaccination programmes can be tailored to reduce sepsis survivors’ risk of infections and improve long-term health outcomes.

Sepsis survivors can have a weakened or altered immune system, which can increase the risk of new infections and death. Fifteen per cent of sepsis survivors die within a year of leaving hospital, with a further six to eight per cent dying every year over the next five years.

The VACIRiSS trial, led by King’s College London and Guy’s and St Thomas’ NHS Foundation Trust and funded by the National Institute for Health and Care Research (NIHR), found that a vaccine that helps protect against serious illnesses like pneumonia and meningitis in the general population did not reduce the risk of future infections or re-hospitalisations in adults who had survived sepsis.

The findings were published in Science Translational Medicine.

The long-term health impacts of sepsis survivors may not be receiving enough attention in health care. In the UK, one in three sepsis survivors are re-hospitalised within 90 days, with the majority of these re-hospitalisations from infections, and one in six patients are no longer alive at the end of the first year after recovering from sepsis. Despite this, there is no routine long-term follow up care for sepsis survivors in the NHS.

Professor Manu Shankar-Hari, Professor of Critical Care Medicine at King’s College London and Principal Investigator on the trial

Sepsis, a misfiring of immune responses to infection, can cause failure of vital organs and death if not treated quickly. Globally, it’s estimated that there are about 166 million sepsis cases and 21 million deaths from sepsis each year. Those who survive (approximately 145 million patients globally every year) are at increased risk of long-term ill health, including from recurrent infections.

While sepsis survivors may receive vaccinations as part of established vaccination programmes (such as flu or pneumonia vaccinations for older adults), vaccinations are not part of standard of care for sepsis survivors.

In the trial, 214 sepsis survivors were randomly assigned to receive a vaccine, called PCV13, or a placebo injection. Participants were followed up for a year to see whether the vaccine reduced their risk of re-hospitalisation with infection or death.

Overall, the vaccine did not reduce re-hospitalisation with infection or death in sepsis survivors. While blood tests showed that many participants did produce immune responses to the vaccine, the responses varied widely from person to person. The differences in vaccine responses were linked to factors such as age, body weight, sex, and levels of altered immune system before vaccination.

The findings suggest that established vaccination programmes may need to be modified to provide better protection to sepsis survivors. However, more needs to be done to understand the varied responses in sepsis survivors to inform what changes are needed.

Source: King’s College London

Categories : Surgeries & ProceduresTags : Leave a comment

Using Chilled Platelets Could Safely Expand Life-Saving Supply to Bleeding Patients

On By ModernMedia
Photo by Marcelo Leal on Unsplash

In a thoughtfully designed, adaptive clinical trial, University of Pittsburgh School of Medicine physician-scientists demonstrated that the United States could triple to quadruple the supply of platelets available to help save bleeding patients of all ages and extend the life-saving therapy into rural regions and community hospitals. Platelets are the component of blood that encourage clotting, plugging cuts and tears in blood vessels and stemming blood loss. 

Results from the Chilled Platelet Study (CHIPS) trial were announced Aug 17 in JAMA and under consideration by the US Food and Drug Administration and multiple other countries to revise regulations for use of refrigerated platelets stored for up to 21 days in actively bleeding patients. 

Of the 2.5 million room-temperature platelet units collected per year in the United States, roughly 10% to 20% are wasted due to the short shelf life, costing hospitals $300 million, according to recent research in the journal Hematology. 

“Our findings could result in major international public health benefits,” said lead author Philip Spinella, professor of surgery and of critical care medicine in Pitt’s School of Medicine and codirector of Pitt’s Trauma and Transfusion Medicine Research Center. “This is incredibly transformative and will dramatically improve the availability of platelets while also reducing waste, allowing hospitals that aren’t in major cities to afford to keep this life-saving blood product on hand for bleeding patients.” 

Currently, donated platelets are conventionally stored at room temperature with a five- to seven-day shelf life. Early studies conducted half a century ago in healthy volunteers led regulators to believe that refrigerating platelets to extend their shelf life made them less effective.  

Recent preclinical studies indicated the opposite, though, so Spinella and colleagues designed CHIPS to safely test using refrigerated platelets stored for increasing amounts of time up to 21 days. The trial enrolled 1000 paediatric and adult patients undergoing cardiac surgery at 27 sites in the United States and Australia from December 2021 to March 2025.  

The patients were randomised to receive either standard, room-temperature platelets stored for less than seven days or chilled platelets. At every 200 participants treated, independent data analysts looked at the results. If the chilled platelets were performing just as well as room temperature, they’d add up to another five days to the age of the chilled platelets used and enrol another 200 participants, up to a maximum of 21 days.  

The research team discovered that platelets refrigerated for up to three weeks were just as effective at treating bleeding as room-temperature platelets stored for up to one week. Since it can take two days for blood banks to process donations, the finding holds the potential to extend the lifespan of platelets for use in controlling bleeding by almost four-fold. 

“Rural and community hospitals, for the most part, simply cannot justify keeping room temperature platelets in stock – they don’t see enough severely bleeding patients, so the waste would far exceed the benefit, something our nation’s fragile blood supply chain cannot accommodate,” said coauthor Michael Boisen, cardiothoracic anaesthesiologist and medical director of the UPMC Patient Blood Management Program, who served as principal investigator for UPMC’s CHIPS trial site. “So, if we can safely extend the shelf life of platelets and reduce the waste, imagine how many more people we could help.” 

More than 97% of platelets are donated through apheresis, where a donor’s blood runs from a tube in their arm to a machine that collects the platelets and returns the rest of the blood back to the donor–a time-consuming process. The age of platelet donors has steadily increased over the past decade and younger donors are not replacing the aging donor base fast enough to keep up with demand, according to data from Vitalant, which supplied the platelets for the study and is one of the nation’s largest nonprofit blood and biotherapies services providers.  

“About 15% of hospitals can experience one or more delayed platelet transfusions within any given month due to supply shortages,” said Ralph Vassallo, Vitalant’s chief medical and scientific officer. “A 21-day shelf life for cold-stored platelets will reduce outdate rates and ensure platelets are available on hospital shelves when a surge in need occurs.” 

In addition to the civilian applications, the findings could also benefit military personnel by making it more feasible to have platelets available in conflict areas, said Spinella, who is also associate medical director of Pitt’s Center for Military Medicine Research. 

A unique facet of the trial is that it included children and babies from the start. Usually, clinical trials that aren’t specific to paediatric populations will exclude children. 

“I believe it is unethical not to include children in a trial when there isn’t a rational biological reason to exclude them,” Spinella said. “Of the 1,000 participants in our trial, roughly a third were children—which makes sense because it is the very young who bleed the most from cardiac surgery and most frequently benefit from platelets. Our trial will hopefully motivate others to include children in their trials.” 

Additional authors are listed in the JAMA article.  

Source: University of Pittsburgh School of Medicine

Categories : CancerTags : Leave a comment

Study Finds the Optimal PSA Cutoff for Evaluating Prostate Cancer Treatment

On By ModernMedia

Real-world study reveals the precise level associated with patient prognosis.

Credit: Darryl Leja National Human Genome Research Institute National Institutes Of Health

After treatment for metastatic prostate cancer, a drop in prostate-specific antigen (PSA) levels in the blood is an indicator that the treatment is working. A recent real-world study indicates that reaching a PSA level below 0.2 ng/mL is an indicator of improved patient survival. The study is published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society.

Multiple phase 3 clinical trials have shown that a PSA level below 0.2 ng/mL is the best cut-off for determining a patient’s prognosis. Real-world data are lacking, however, and physicians often use other metrics, such as percentage of PSA decline, to assess treatment response. To determine whether there is a PSA response target associated with the most favourable outcome in community-dwelling adults with metastatic prostate cancer, investigators analysed Veterans Health Administration data on 4890 patients who received testosterone deprivation therapy with or without other treatments in 2018–2023 for metastatic hormone-sensitive prostate cancer.

Over a median follow-up of approximately 2 years, 896 patients died. Patients whose PSA levels dropped below 0.2 ng/mL within 9 months of starting treatment were 54% less likely to die than patients whose levels did not drop this low, whether their PSA levels also decreased by at least 90% or not. Patients who had at least a 90% PSA decline but did not achieve a PSA of less than 0.2 ng/ml had no improvement in survival. The findings suggest that patients who do not experience a PSA drop below 0.2 ng/mL could be candidates for more aggressive treatments. Also, patients who received testosterone deprivation therapy plus another drug to further block testosterone were more likely to reach a PSA below 0.2 ng/mL.

“These data show that we need to target a PSA below 0.2 ng/ml as our metric of success to optimize outcomes for our patients with metastatic prostate cancer,” said corresponding author Stephen J. Freedland, MD, professor of Urology at Cedars-Sinai and Staff Physician at the Durham VA Medical Center.

Source: Wiley

Categories : Healthcare Politics and RegulationsTags : Leave a comment

Inside The Box with Dr Andy Gray | Are Complementary Medicines Effectively Regulated in South Africa?

On By ModernMedia
#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 Dr Andy Gray for Spotlight

The regulation of complementary and alternative medicines in South Africa has been hotly contested in recent decades, including in court rooms. In his latest column for Spotlight, Dr Andy Gray unpacks the legal background and the current state of this still unfolding regulatory saga.

Multivitamin and mineral supplements are commonly found in many South African retail outlets, from pharmacies to health shops and supermarkets. Some outlets will stock a wider range of medicines, perhaps on shelves marked as “complementary”, or among other non-prescription medicines available for self-service.

Are these medicines regulated in the same way as other medicines, including those available on prescription?

The concept of a “call-up notice”

When South Africa’s medicines legislation was first passed in 1965, there were already many medicines on the local market which had not been assessed for safety, efficacy or quality. As all such medicines could not be immediately “called up” for registration, a stepwise approach had to be followed.

Between 1967 and the mid-1980s, medicines were identified for registration by pharmacological classification. The remnant of that approach is still evident in section 14(1) and (2): of the Medicines and Related Substances Act, 1965:

(1) Save as provided in this section or sections 21 and 22A, no person shall sell any medicine, … which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered.

(2) (a) The Authority may from time to time determine that a medicine, …, or class or category of medicine, … or part of any class or category of medicine, … mentioned in the declaration, shall be subject to registration in terms of this Act.

(b) Any such declaration may also relate only to medicines, … which were available for sale in the Republic immediately prior to the date on which it comes into operation in terms of paragraph (c) or only to medicines, … which were not then so available.

The declaration that a category or class of medicine is subject to registration is referred to colloquially as a “call-up notice”. A notice could be applied to those medicines already marketed, or only to those not yet marketed. Medicines which were already marketed but exempted from a full registration process were then regulated as “old medicines”. They are still subject to control according to their scheduling status and their production still needs to be in accordance with Good Manufacturing Practice. In time, new brands of some of the “old medicines” have been registered.

By the mid-1980s, the process of working through the pharmacological classifications was concluded. Thereafter, every new medicine would need to be registered before being marketed. In other words, a manufacturer or importer would need to provide sufficient evidence of the medicine’s safety, efficacy and quality to justify registration.

However, an important exception was created in 1986, which exempted homeopathic medicines from the full registration process. Two important restrictions were included. Firstly, no medical claims could be made for the medicine. Secondly, the following wording was to be included on the label of such medicine: “Homeopathic Medicine” and “WARNING: Use only as directed by a medical practitioner, pharmacist or homeopath”. The provision applied to homeopathic mother substances and so-called “minute-dose forms” made in accordance with homeopathic principles.

Broadening the scope of complementary medicines

Homeopaths are one of several complementary and traditional health professions regulated by the Allied Health Professions Council of South Africa. Medicines legislation has been amended to accommodate this wider range of complementary and traditional medicines.

A separate South African Health Products Regulatory Authority (SAHPRA) web site is dedicated to what are termed Category D medicines, also known as complementary medicines.

The General Regulations issued in terms of the Medicines Act includes a definition of complementary medicines which has two components: health supplements and medicines used in accordance with a “discipline as determined by the Authority”. The pharmacological classifications listed in Annexures 1 (human) and 2 (veterinary) medicines list the “disciplines” as Aromatherapy, Homeopathy, Phytotherapy, Traditional Chinese Medicine, Unani Medicine, Western Herbal Medicine, Combination Products and Other Herbal. The Annexures also list the types of health supplements, including amino acids, mineral, probiotics and vitamins. Two elements are important here – the nature of the substance included in the complementary medicine and the claims made in relation to that medicine.

Since 2013, the intention has been to progressively bring all complementary medicines under effective regulation, using a risk-based approach to identify those requiring registration and full assessment of safety, efficacy and quality data. The first pharmacological classifications identified were those claiming antiviral properties, and those intended to treat diabetes, cardiac conditions and cancer. However, no complementary medicines have yet been registered and the initial “call-up notices” have been repealed.

Like much of South Africa’s medicines regulatory space, this process has been affected by litigation. A challenge of the complementary medicines regulatory scheme by the Alliance of Natural Health Products (South Africa) was finally decided by the Supreme Court of Appeal in 2022. The court confirmed the finding that SAHPRA should have no regulatory power over substances and preparations that did not meet the definition of a medicine. A preparation that seeks to supplement a diet or provide a nutritional benefit is not a medicine, but a foodstuff. Draft amendments to the 2017 General Regulations, informed by the court judgment, were published for comment in March 2023, but have yet to be issued in final form.

Not a total lack of regulation

The hiatus in finalising regulations does not mean, however, that there is no regulatory control over complementary or Category D medicines. The initial “roadmap” outlined in the 2013 regulations has been replaced by a series of guidelines. The progressive, developmental approach to the regulation of complementary medicines remains in place, albeit delayed and as yet incomplete.

The overall roadmap was updated in 2021. All manufacturers, wholesalers or distributors of complementary medicines are required to be licensed by SAHPRA, but this process relies on an applicant’s “attestation of compliance with minimum requirements at the time of application and the payment of the required licence application, and desktop evaluation fees”, rather than the full Good Manufacturing Practice inspection applied to manufacturers of other medicines. However, SAHPRA reserves the right to conduct inspections where warranted. A similar approach is applied to the regulation of medical devices and diagnostic tests.

In the meantime, while no complementary or alternative medicines have been registered by SAHPRA, there is relatively strict regulation of what companies can say about the unregistered complementary medicines that they market in South Africa.

As with the 1986 exclusion for homeopathic products, all category D products which have not been registered have to include the following statement on the label: “This unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”. The guideline also distinguishes between low risk and high-risk claims, in either labelling or advertising. Low risk claims are those for general health enhancement without any reference to specific diseases; health maintenance; or the relief of minor symptoms (not related to a disease or disorder).

The guideline is specific about a widely used wording: “Unregistered complementary medicines making use of the terms “Clinically proven” or any similar expression … shall also be considered to be HIGH RISK and may be subject to individual call-up in terms of section 14(2) of the Medicines Act.” Examples of acceptable low risk claims are provided, such as “Helps enhance/promote joint health”. Further guidance on the evidence to be relied upon for low risk and high-risk claims has been provided for the discipline-specific complementary medicines.

Manufacturers and importers of health supplements are only allowed to make low risk claims, and the relevant guideline provides Annexures (from Annexure A to O), showing the allowable levels and claims for each type of supplement. For example, a single component vitamin B3 (nicotinamide) product sold for adults may not contain more than 500mg per dose, and can only make a claim of “Helps to metabolise carbohydrates, fats and proteins”, “Contributes to normal growth and development” or “A factor in the maintenance of good health”.

A key document is the current guideline on the regulation of discipline-specific complementary medicines. An additional guideline was updated in 2022, which provides guidance on caffeine, menthol, camphor and cannabidiol. Low-dose cannabidiol can be sold as either a discipline-specific complementary medicine or a health supplement. At a dose not exceeding 20mg per day or 600mg per pack, it can be sold as a Schedule 0 product.

As no complementary medicines have yet been registered, none have as yet been specifically included in any of the Schedules, and they are therefore assumed to be controlled as Schedule 0 products, which can be sold in any retail outlet. One exception would be any injectable product, as those are automatically included in Schedule 3 and are prescription-only.

Important sources of information

The SAHPRA complementary medicines website provides a crucial resource which can be accessed by the public. The list of licensed complementary medicines manufacturers, importers and exporters is accessible here. There are currently 117 entries on the list. Each entry also provides a list of the products provided by that licensed entity, with details of ingredients, recommended doses and intended uses, whether discipline-specific or health supplement. The entire database is also searchable.

The site also enables anyone to lodge a complaint about a complementary medicine, including anonymous complaints.

Gaps in the system

While some progress has been made, the regulatory scheme for complementary medicines remains incomplete. Apart from finalising the regulations after the court challenge, a risk-based “call-up” process still needs to commence. Moving from an attestation process to confirmation that every manufacturer has met current Good Manufacturing Practice standards is still necessary.

Currently, the proprietary (brand) names used for complementary medicines are not pre-approved by SAHPRA, and many are in contravention of the naming guidelines applied to other medicines.

Effective oversight of advertising and marketing practices remains elusive, not only in respect of complementary medicines.

The dictum traditionally applied to consumer goods of “let the buyer beware” (in Latin, “caveat emptor”) is no longer considered appropriate. The Consumer Protection Act, 2008 seeks to protect the public against unsafe products and unfair marketing. Medicines are treated as a special category of goods, deserving closer regulatory control. The remaining gaps in the medicines regulatory system need to be plugged. One very particular gap, which has never been adequately addressed, is the regulation of African traditional medicines, which are not currently captured in the definition of Category D medicines.

 – 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.

Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority.

*This column was published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.