Categories : Medical Research & Technology Mental HealthTags :

Wearable Device may Detect Skin Electrical Impulses Associated with Mood Changes in Bipolar Disorder

On By ModernMedia

Researchers have used wearable technology to measure electrical impulses in the skin and other physiological biomarkers possibly linked to mood changes in bipolar disorder. Though at an early stage, they hope their work will be able to build on these patterns to detect mood swings in bipolar disorder sufferers, so helping in diagnosis and potentially offering more rapid and personalised treatments. They presented their research at the 36th ECNP Congress in Barcelona, and more information is available on GitHub.

Bipolar disorder (formerly called manic-depressive illness or manic depression) is a mental illness that causes swings in a person’s mood, energy, activity levels, and concentration. These shifts can make it difficult to carry out day-to-day tasks and can make interactions with other people difficult. The degree of mood swing can vary from person to person, from feeling manic (very “up”) to feeling depressed. At present, these mood swings are mostly diagnosed subjectively, through interview with doctors or by questionnaires. This takes time, and requires an immediate medical presence.

Now a group of Barcelona-based psychiatrists, in collaboration with data scientist in Edinburgh, have used a research grade wearable device to continuously collect several physiological biomarkers during the diverse phases and episodes of bipolar disorder. Among the collected physiological biomarkers is electrodermal activity which uses changes in the skin’s electrical conductivity to indicate the level of stress through the reactivity of the nervous system. This is a potential immediate indicator of whether someone is in a manic, depressive or in a normal mood state.

They recruited 38 patients with bipolar disorder, and 19 healthy controls, all from the Barcelona area.

Researcher Diego Hidalgo-Mazzei said “Each participant was fitted with a commercially available Empatica E4 bracelet, which they were asked to wear for around 48 hours. This can measure a variety of physiological changes, but we were most interested in measuring small electrophysiological changes in the skin of the wearer. We found that bipolar disorder patients in their depressed phase had on average a significantly lower skin electrical activity than the rest of the bipolar group or the healthy control group. We also found that as an individual moved from manic to depressive state (or vice versa), this was detectable by a change in skin surface electrical activity.

“It is important for the patient and doctor to know how and when these mood fluctuations take place. It is important also to highlight that the treatment is different for manic or depressive states. This can help with a prompt diagnosis and early personalized treatment, but it can also help in preventing adverse outcomes, for example in alerting to an increased risk of suicide, or of mood swings which may lead to dangers with activities such as driving. It is also easier to treat patients if we know if they are in a manic phase or a depressed phase. Until now, these mood swings have mostly been diagnosed subjectively, through interview with doctors or by questionnaires, and this had led to real difficulties. Arriving at the correct drug is difficult, with only around 30 to 40% of treated individuals having the expected response. We hope that the additional information these systems can provide will give us greater certainty in treating patients.

“We are still some way from that though. This is an exploratory observational study, so we need to look at a larger sample and use machine learning to analyse all the biomarkers collected by the wearers to confirm the findings to determine patterns which might indicate a specific episode. This may not be ideal for every bipolar disorder sufferer, in every circumstance, but a potential pattern may help in the future the people hardest hit by the mood changes which affect their lives”.

For information on the wearable device see https://e4.empatica.com/e4-wristband

Source: EurekAlert!

Categories : General Interest Obstetrics & GynaecologyTags :

Interview: A Simple Device Used after Birth can Help Save Lives, Says Award-winning Young Innovator

On By ModernMedia
Last month, she won the Mandela Rhodes Foundation’s award for social impact in Africa for a device that can help save the lives of women who suffer excessive bleeding after child birth. PHOTO: Nasief Manie/Spotlight

By Biénne Huisman for Spotlight

As a child growing up in the Ugandan capital of Kampala, Maureen Etuket used a screwdriver to dismantle electronic appliances and toy trucks. “I was around eight, nine years old,” she says. “I guess it just excited me.”

Slightly over a decade later, this curiosity is driving her quest to find solutions to public healthcare challenges.

Last month, Etuket’s Smart PVD device [Postpartum Haemorrhage Volumetric Drape] won the Mandela Rhodes Foundation’s award for social impact in Africa – the 2023 Äänit Prize – with a cash grant of $38 000. At the awards ceremony in Cape Town, judges described the device as “a brilliantly practical intervention that can immediately and directly improve outcomes for patients”.

Inside the Anatomy Building on the University of Cape Town (UCT)’s Health Sciences campus, Etuket explains that she and her team devised a prototype after spending three months in maternity wards at Kawempe National Referral Hospital in Kampala.

“We went almost every day. We had day shifts and night shifts,” she recalls. “I started asking the question to nurses and midwives, how do you know that a woman is likely to get to PPH?” PPH or post-partum haemorrhage is excessive bleeding after a baby’s birth, which could cause a severe drop in blood pressure leading to shock and death if not treated.

“Like, how do you tell? What criteria do you use? And the nurses told me that they had been doing this for a long time. They said they just observe and know. And I thought to myself, if that was working, we would have [fewer] women dying from PPH.”

How does the Smart PVD device work?

“There’s something already on the market – an under-buttock drape bag attached to the bed while a woman is giving birth, which measures amount of blood loss,” says Etuket. “[It’s] basically a bag where the blood flows into. We then created an electronic module that has a probe and a buzzer, which we put inside this bag, and it gives a beeping sound when the blood has reached a certain level. This alarm alerts a midwife to recognise the need to attend to a particular case. So the blood collection module is disposable. And the electronic module, which has the probe and the buzzer, is reusable.”

Etuket declines to share pictures, citing intellectual property rights.

“I really think that this is one of the simplest innovations,” she says. “We’ve been pitching it and talking about it, and everyone that listens is just like it’s common sense, right?” Apart from the Äänit Prize, they have received $16 000 from the Makerere University’s research and innovations fund and $55 000 from the science and technology secretariat in Uganda.

Moving to Cape Town

Etuket moved to Cape Town in 2021, courtesy of a Mandela Rhodes Foundation scholarship. “I applied for a Masters in health innovation at UCT under the Mandela Rhodes Foundation. So, I’m Christian. I believe in the hand of God in everything I do. I made just that one application. Like, there were options to put three universities, three courses, all that. I just wanted health innovation at UCT, and I got it.”

Her Masters supervisor was Professor Sudesh Sivarasu, internationally renowned for medical device innovation and head of UCT’s MedTech laboratory.

“There were so many questions we had at Pumzi Devices about how to transition an innovation to the market and no one really had the answers because it’s a new space. At a certain point, some of us had to travel to Scotland just to sit with experts to guide us through a protocol design process. No one in Uganda really had a clear picture of [this] so that’s what prompted me to do the Masters in health innovation,” says Etuket.

Find your purpose

Presently, she is pursuing a PhD in industrial engineering at Stellenbosch University under the supervision of Professor Sara Grobbelaar and Dr Faatiema Salie. Yet she spends most of her time at UCT, where Sivarasu is her external co-supervisor. Etuket’s PhD’s working title is “Exploring the development of a localisation roadmap for medical devices in South Africa using an Innovation Systems Framework”. She explains that this line of study – systems engineering – is drawing her thinking wider to understand the systems around biomedical design and innovation.

Going forward, Etuket will continue to lecture students back home in Uganda – online – while being open to further her learning and practice where it is apt or required around the world.

At 28 years old, Etuket’s drive and achievements make her a role model for many. However, she is reluctant to wear the label of “a pioneering young black woman,” voicing caution over mantels based on race and gender. “I notice that when we start to have those mindsets, we may end up trampling on people, on men. We have to work together. There is room for all of us,” she says.

The first born of four siblings, Etuket’s father was a computer engineer and her mother an accountant and businesswoman. Elaborating on leadership, she says, “I think it’s important to pray for people. That’s where we get guidance on how to lead. I tell people, not everyone should do a PhD, maybe not everyone should do a Masters, but find your purpose and fulfil it.”

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Categories : Medical Industry Mental HealthTags :

Rollout of Coaching Programme Reduces Burnout in Medical Residents

On By ModernMedia
Photo by SJ Objio on Unsplash

Researchers found that a national level programme to reduce burnout levels, which disproportionately affects women, was even more successful than its pilot programme two years prior. They published their findings in the journal JAMA Network Open.

“We did a pilot programme in 2021 to see if it would work and it did,” said study co-author Tyra Fainstad, MD, associate professor at the University of Colorado School of Medicine. “Then we expanded it to 26 graduate medical institutions in 19 states. There were 1017 participants. We saw significant improvement in every wellbeing outcome we assessed including all three subscales involved in burnout.”

Burnout within the health care community is a national epidemic disproportionally affecting women. Last year, the US Surgeon General declared it a `crisis’ deserving ‘bold, fundamental change’ though little was known about scalable, effective solutions to the problem.

Women are hit harder by burnout for reasons that include bias and sexism at work, pay disparities as well as a disproportionate burden of home management and child/elder care, the researchers said.

Fainstad and co-author Adrienne Mann, MD, both faculty in the CU Department of Medicine, created the web-based Better Together Physician Coaching Program at CU Anschutz with the goal of reducing that burnout. Then they replicated it to a national level and published their findings.

While the pilot programme saw improvements in `imposter syndrome’ (feeling as if you ‘don’t really belong in the job’) and self-compassion, the expanded national study also showed significant improvements in outcomes across the board including moral injury and flourishing, offering actual evidence that the program works.

“Physician trainees who received online group coaching over four months had substantial reductions in multiple dimensions of professional distress (burnout, moral injury and imposter syndrome) and improvements in well-being (self-compassion and flourishing),” said Mann.

Mann and Fainstad are both certified life coaches. Better Together is owned and operated by the University of Colorado. It’s not a business, they said, and they don’t personally profit financially from it. The program is available to any heath care institution, school of medicine, department, or residency program wishing to meaningfully support the wellbeing of their clinicians and trainees.

Better Together is web-based. Participants take part in two videoconferencing coaching calls per week where up to five people can be coached live on any topic with an unlimited audience. Calls are recorded for later listening on a private podcast.

Participants can also access unlimited, anonymous written coaching in a forum by submitting a narrative reflection and receive a coach’s response published to Better Together’s secure, members-only website. There are also weekly self-study sessions using videos and worksheets. They focus on topics pertinent to the physician lifestyle such as goal setting, cultivating a growth mindset, receiving critical feedback, imposter syndrome and perfectionism.

The researchers use the Maslach Burnout Inventory (MBI) to measure their work. The MBI has three subscales: emotional exhaustion (EE) or feeling emotionally exhausted from work; Depersonalisation (DP), detached and impersonal treatment of patients; Professional accomplishment (PA), beliefs around competence and success at work.

The EE score is a key construct in health care related burnout. A one point increase in the EE scale has been associated with a 7% increase in suicidal ideation and a 5-6% increase in major medical errors.

The researchers said a reduced mean EE score among those that took part in the training and an increased EE score in those that did not.

“From what we see in this study, coaching helps in every aspect of burnout,” Fainstad said. “The multi-modal nature of our program is unique. You can interact in many ways. That partially explains the powerful impact -that and the group nature of our coaching.”

Mann said the majority are watching others being coached and share in the experience.

“That is deeply connecting. They try to see themselves in someone else’s story,” she said. “When someone is on a view screen you have compassion and empathy for them and, by extension, learn to practice compassion and empathy for yourself.”

While few strategies to address burnout have shown much overall effect, Fainstad said this study demonstrates that group coaching works.

“We’re now showing that we have an actual evidence-based answer to burnout,” she said.

Fainstad and Mann said burnout is a product of the current, often toxic, medical culture pervading every aspect of the profession.

“Culture is a belief system,” Fainstad said. “And while structural changes are absolutely necessary to fix our medical system, working with individuals who have been harmed along the way will be imperative to healing.”

Mann suggested a step towards healing the culture would be making coaching programs like Better Together accessible to everyone – not necessarily mandatory but at least made available by institutions.

“There are other coaching programs in this space but this one is rigorously evidence-based. We studied it,” Mann said. “There are no downsides. It helps in all aspects of burnout.”

Source: University of Colorado Anschutz Medical Campus

Categories : VaccinesTags :

Vaccine Acceptance is Sometimes Influenced in Unexpected Ways

On By ModernMedia
Photo by Mika Baumeister on Unsplash

Using simulations, researchers at Vanderbilt University have uncovered new insights into vaccine hesitancy have shown that external factors such as vaccine mandates and availability have varied and sometimes contradictory influences on people’s willingness to get vaccinated. The research was published in the journal PLOS Global Public Health, and the simulations are available to be reviewed on GitHub.

Building on a new mathematical model that represents vaccine hesitancy as a belief that can influence whether parents vaccinate their children, Nicole Creanza, assistant professor of biological sciences, and postdoctoral scholar Kerri-Ann Anderson extended their work to include the effect of external factors that affect vaccine availability, such as vaccine mandates and vaccine inaccessibility.

“Instead of modelling vaccine mandates and inaccessibility as a physical driver or barrier to vaccination, respectively, we considered their effects from a cultural perspective,” Anderson said. “We model the effects of these external factors by considering how beliefs interact with them to shape vaccination behaviours. Our data shows that a vaccine mandate has a lesser consequence on a person’s motivation to vaccinate if they already had very positive feelings about vaccines.”

The findings also demonstrate that when large groups trust vaccines, they usually get vaccinated. But if there aren’t enough vaccines, even those who trust them might not get them. In addition, when vaccine mandates are in place, it can seem like everyone is getting vaccinated. But more people than researchers expected might still be unsure about vaccines and not get them.

“We hope that our research emphasises how important it is to not generalise populations based on a single characteristic or assume populations behave similarly or beliefs have similar influences across varying circumstances,” Anderson said.

“This research provides a better understanding of how public health policies could interact with cultural dynamics to bring about unexpected outcomes,” Creanza said. The research was funded by the John Templeton Foundation, and both researchers are members of the Evolutionary Studies Initiative.

Next, Creanza and Anderson aim to make a model to explore how people respond when a new vaccine (eg for COVID), is introduced. When a novel vaccine is initially introduced, people tend to exhibit more unpredictable behaviour, even those who have confidence in established vaccines, Creanza said.

Source: Vanderbilt University

Categories : COVID Pain ManagementTags :

Does COVID Infection or Vaccination Worsen Migraines?

On By ModernMedia
Photo by Usman Yousaf on Unsplash

Headaches are a frequent complaint of those with a COVID infection, or have received a COVID vaccination, and it is thought that it may subsequently increase the frequency of migraines. To put this to the test, an observational study published in the European Journal of Neurology investigated the effects on migraine frequency of having had either been infected with COVID or having received a COVID vaccination.

Among 550 adults who had received migraine-related care at a Spanish headache clinic, 44.9% (247) reported COVID at least once and 83.3% (458) had been vaccinated; 61 patients (24.7%) reported migraine worsening since COVID and 52 (11.4%) since vaccination.

In participants who perceived that their migraines worsened, those who had been infected were 2.5-times more likely to be concerned about migraine worsening and patients who had been vaccinated were 17.3-times more likely to have this concern.

When investigators examined patients’ e-diary information, they observed no significant difference in headache frequency one month before and after infection or vaccination, even when comparing patients with and without self-reported migraine worsening.

“In the case of COVID-19, we reported previously that indeed headache is a frequent and disabling symptom of the infection; yet, it may not necessarily be linked to an increase in migraine frequency,” the authors wrote. “In light of our results, we believe that clinicians should deliver to patients a more reassuring message that COVID-19 and COVID-19 vaccines may marginally affect migraine course and that probably the impact of the infection and vaccines is less than the individual rhythmicity to have attacks. This information may help minimise their worry.”

Source: Wiley

Categories : Gastrointestinal Metabolic DisordersTags :

For Weight Loss, the Side Effects of GLP-1 Agonists can be Hard to Stomach

On By ModernMedia
Photo by Andres Ayrton on Pexels

GLP-1 agonists are being lauded as game-changers in the fight against obesity, but GLP-1 agonist drugs like semaglutide may come with a heightened risk of severe gastrointestinal problems, according to new research published in JAMA.

Designing their study for the side effects rather than the efficacy of the drugs, the researchers found that GLP-1 agonists are associated with an increased risk of serious medical conditions including gastroparesis (stomach paralysis), pancreatitis and bowel obstruction.

While previous studies highlighted some of these risks in patients with diabetes, this study from the University of British Columbia is the first large, population-level study to examine adverse gastrointestinal events in non-diabetic patients using the drugs specifically for weight loss.

“Given the wide use of these drugs, these adverse events, although rare, must be considered by patients thinking about using them for weight loss,” said first author Mohit Sodhi, a graduate of UBC’s experimental medicine program and fourth year UBC medical student studying the adverse events of commonly prescribed medications. “The risk calculus will differ depending on whether a patient is using these drugs for diabetes, obesity or just general weight loss. People who are otherwise healthy may be less willing to accept these potentially serious adverse events.”

GLP-1 agonists have exploded in popularity over the past decade as an off-label weight-loss tool, reaching approximately 40 million prescriptions in the US in 2022.

It was only in 2021 that some forms of the medications were approved as a treatment for obesity. However, randomised clinical trials examining the efficacy of the medications for weight loss were not designed to capture rare gastrointestinal events due to their small sample sizes and short follow-up periods.

“There have been anecdotal reports of some patients using these drugs for weight loss and then presenting with repeated episodes of nausea and vomiting secondary to a condition referred to as gastroparesis,” said senior author Dr Mahyar Etminan, an epidemiologist and associate professor in the department of ophthalmology and visual sciences at the UBC faculty of medicine. “But until now, there hasn’t been any data from large epidemiologic studies.”

To help fill this knowledge gap, UBC researchers examined health insurance claim records for approximately 16 million US patients and looked at people prescribed either semaglutide or liraglutide, two main GLP-1 agonists, between 2006 and 2020. They included patients with a recent history of obesity, and excluded those with diabetes or who had been prescribed another antidiabetic drug.

The researchers analysed the records to see how many patients developed one of four gastrointestinal conditions, and compared that rate to patients using another weight-loss drug, bupropion-naltrexone. Compared to bupropion-naltrexone, GLP-1 agonists were associated with a:

  • 9.09 times higher risk of pancreatitis, which can cause severe abdominal pain and, in some cases, require hospitalisation and surgery.
  • 4.22 times higher risk of bowel obstruction, resulting in symptoms like cramping, bloating, nausea and vomiting. Depending on the severity, surgery may be required.
  • 3.67 times higher risk of gastroparesis, limiting the passage of food from the stomach to the small intestine and results in symptoms like vomiting, nausea and abdominal pain.

Additionally, the study found a non-significant higher incidence of biliary disease.

The researchers say that although the events are rare, with millions around the world using the drugs, it could still lead to hundreds of thousands of people experiencing these conditions.

“These drugs are becoming increasingly accessible, and it is concerning that, in some cases, people can simply go online and order these kinds of medications when they may not have a full understanding of what could potentially happen. This goes directly against the mantra of informed consent,” said Sodhi.

In the meantime, the researchers hope that regulatory agencies and drug makers will consider updating the warning labels for their products, which currently don’t include the risk of gastroparesis.

“This is critical information for patients to know so they can seek timely medical attention and avoid serious consequences,” said Sodhi.

Source: University of British Columbia

Categories : Environmental EffectsTags : 2 Comments

Opinion Piece: The Harsh Reality of South Africa’s Ongoing Sewage Crisis and its Undeniable Link to Drinking Water Quality

On By ModernMedia
Photo by Hush Naidoo Jade Photography on Unsplash

By Gerhart Britz, Director at Sanitech

South Africa’s sewage crisis has dire consequences for public health, waterways, and ecosystems. Outdated and poorly maintained wastewater infrastructure due to insufficient investment is one factor that results in poor waste management. The strain of rapid urbanisation with inadequate sanitation facilities in informal settlements and the exacerbating impact of climate change through increased rainfall events are also factors that contribute to poor waste management. Despite these challenges, there is room for optimism. Collaborative efforts between government and the private sector have the potential to address this dire situation, bringing forward practical, affordable solutions that hold the promise of a cleaner, healthier future for all communities.

A public health crisis: deadly waterborne diseases

South Africa’s persistent sewage crisis recently sparked a new cholera outbreak, primarily stemming from dysfunctional municipal sewage systems. Over 90% of the nation’s 824 treatment plants discharge untreated or partially treated sewage into our limited water resources. As of June 2023, the Department of Health had documented 1,045 suspected cholera cases across five provinces, with 197 cases confirmed by laboratory testing, directly linked to compromised water supply.

This crisis disproportionately impacts both urban and rural regions, where access to clean water and sanitation remains a pressing concern. Impoverished communities often rely on highly polluted water sources contaminated by sewage from overwhelmed treatment plants, further straining water purification efforts to meet safety standards. Recognising the intrinsic connection between drinking water quality and wastewater treatment is crucial, necessitating immediate attention and resolution.

However, a significant challenge faced by South African communities is the prohibitive cost of implementing waterborne sanitation solutions everywhere. With over four million latrines and roughly 50 million people lacking adequate sanitation, conventional waterborne systems are neither viable nor cost-effective comprehensive solutions.

South Africa’s water quality reports: red flags aplenty

The Blue Drop Report 2023, released in June 2023, paints a concerning picture of South Africa’s drinking water quality. While major cities maintain safe water, outlying areas face contamination and infrastructure challenges. Key statistics from the report reveal that the average Technical Site Assessment (TSA) score for water treatment systems is 69%, indicating partial functionality. About 15% of water supply systems are in poor or critical condition, with only 33% having Water Safety Plans, posing significant risks to water quality. Additionally, 50% of municipalities struggle with bad or poor microbiological water quality.

Wastewater and water wasting: two major risks

The 2023 Green Drop Report assesses wastewater treatment systems, showing a decline with an average score of 50%. Regional disparities persist, with Eastern Cape and Limpopo scoring lowest, while the Western Cape and Gauteng lead. The No Drop Report examines water losses, revealing a decline in overall performance in 2023, with an average score of 65%, which means that one-third of supplied water is wasted before it reaches consumers.

These reports collectively underline the urgent need to enhance drinking water quality in South Africa. Municipalities must focus on prioritising infrastructure maintenance and upgrades, implement risk-based water quality management, and strengthen compliance with standards. The Department of Water and Sanitation must offer more support to municipalities. Failing wastewater treatment facilities exacerbate drinking water purification, risking tap water safety and triggering further potential health and environmental crises. Therefore, they must take steps to safeguard water quality and address sewage infrastructure issues.

Rapid crisis intervention required

South Africa’s sewage crisis is a dire challenge that requires immediate action and innovative solutions. In recognising the inextricable link between sewage waste management and water quality, we must also acknowledge that this crisis cannot only be addressed by government without support from private sector industry leaders and experts. Portable water treatment package plants are available, along with small filtration and sterilisation systems for communities. Wastewater packaged treatment plants and solutions can help both alleviate immediate concerns and contribute to long-term sewage management strategies. Further neglecting the sewage problem and the critical maintenance of existing infrastructure will only deepen our water crisis. For this reason, the government needs to prioritise investment in sewage treatment infrastructure and implement practical, affordable solutions across all communities.

Mitigating South Africa’s sewage crisis

If municipal water supplies deteriorate further, sanitation specialists will be required to step in with a range of interventions. These extend from portable water treatment packaged plants to improve water quality at its source, to small-scale filtration and sterilisation systems designed for household use to ensure safe drinking water directly from the tap. From a contamination perspective, it is critical to reduce sewage entry into water courses, particularly in rural areas and informal settlements. This can be achieved through enhanced sanitation solutions, such as dry sanitation toilets, which are waste-contained alternatives to pit latrines.

From immediate relief to sustainable futures

Interventions will need to consider both immediate and long-term strategies. For short-term relief, containerised package plants can bolster sewage treatment facilities without the need for extensive infrastructure development, alleviating the strain on existing systems. Simultaneously, sanitation providers in the private sector can aid municipalities in implementing long-term solutions, including megalitre plans that feature efficiently packaged treatment plants. By adopting these smaller, cost-effective alternatives, it is possible to achieve the same capacity traditionally associated with larger concrete plants, in a fraction of the time to avert total system collapse and the impending health and economic catastrophes that would surely follow.

Categories : Healthcare Politics and Regulations Respiratory DiseasesTags :

Opinion: This Court Case will Literally Determine whether Some People Get to Breathe

On By ModernMedia
Photo by Wesley Tingey on Unsplash

By Aneesa Adams for Spotlight

In a pivotal case for access to affordable medicines in South Africa, the Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) Southern Africa – represented by SECTION27 – earlier this year came together to help champion access to lifesaving new cystic fibrosis treatments.

Cheri Nel, a South African woman living with cystic fibrosis, and the Cystic Fibrosis Association started legal action against Vertex Pharmaceuticals earlier this year, challenging Vertex’s monopoly on the treatments. The TAC and MSF approached the court to be joined as amici curiae. Vertex, an American pharmaceutical company, holds the patents for both Trikafta and Kalydeco – medicines that have the potential to significantly improve the lives of cystic fibrosis patients. However, at a price of US $311 000 per year per patient in the United States (over R5 million), it is out of reach for most people living with cystic fibrosis.

The court application is for a compulsory licence, which, if granted, will mean another manufacturer of generics for Trikafta and Kalydeco would be permitted to enter the South African market. In this case, it is likely that competition between manufacturers would affect the price of this medicine, thus making it more accessible. A compulsory licence allows the holder of the license to produce a patented product without the patent holder’s consent.

Johannesburg-based investment banker Cheri Nel is the driving force behind a court case that may result in dramatically expanded access to life-changing new cystic fibrosis (CF) medicines. PHOTO: Supplied

Spotlight previously reported that Nel’s lawyers argued that by failing to register or supply their CF medicines in South Africa, make them available in South Africa at reasonable prices, or license other companies to supply the medicines, Vertex is abusing its patents. They further argued that Vertex’s actions are violating the Constitutional rights of people with cystic fibrosis in South Africa, including the right to health care. (Spotlight previously reported on the issue here, here, and here.)

Cystic fibrosis is a devastating multi-system illness known for causing frequent and severe lung infections, liver and pancreatic damage, lung failure, and can result in the potential need for lung transplants even in children from as young as two years old.

This case will set an important precedent that can influence access to medicines not only in South Africa but around the world. The involvement of SECTION27, where I work, underscores the broader issue of affordable access to medicines and the impact of intellectual property on healthcare access.

At present, MSF and TAC are awaiting the court’s decision to be admitted as friends of the court, while in the main application, the respondent (Vertex) has filed answering affidavits.

And while the clock is ticking in the courts, many families in South Africa are waiting and holding on to the glimmer of hope access to this medicine represents. For many who live with cystic fibrosis, a successful outcome of Nel and the Cystic Fibrosis Association’s application will mean a life where they can breathe easier.

Among those waiting is 6-year-old Janco Koorts.

A journey of hope

His mother, Tanya Koorts, says living with cystic fibrosis is like fighting every day for every breath. She says Janco had been diagnosed with cystic fibrosis at the age of two. She has since been on a mission to raise awareness about this life-threatening disease. It is hope, her family, and the support from the cystic fibrosis community that has kept her going, she says.

Reflecting on the start of their journey in the Northern Cape, she says, “The knowledge about cystic fibrosis is very little. We were lucky that Dr Jooste at the Kimberly public hospital diagnosed him so early on. After that, he sent us to the Red Cross Hospital in Cape Town and so our long journey of hope started.”

Later in a new job in a new city, the Koorts began again in Pretoria. They started Janco’s treatment at the Steve Biko Academic Hospital and then moved to the Charlotte Maxeke Johannesburg Academic Hospital.

“They don’t have much, but they do everything they can there to help. They also don’t have a lot of support but the people at Charlotte Maxeke helped Janco on his journey to stay breathing,” Koorts says, applauding the public health system.

Janco now has comprehensive medical aid which covers his monthly R48 000 medication bill and Koorts says she can now “breathe easier”. That, however, is just a fraction of the cost of living with cystic fibrosis.

When the Koorts family heard about Trixacar, a generic version of Trikafta, it only strengthened their resolve to save Janco’s life. The patent rights registered by Vertex Pharmaceuticals in South Africa, however, do not allow for the import of Trixacar. Trixacar is produced by the pharmaceutical company Gador in Argentina. Koorts will thus have to travel to Argentina to buy the medicine. This will cost about R400 000 to cover the travel costs and six boxes of Trixacar that will last six months, she says. (You can help the family fund this by donating here.)

‘a thief of joy’

Apart from the financial burden, having a young child with cystic fibrosis has affected the Koorts family mentally and emotionally.

“Cystic fibrosis is a thief of joy. Nobody speaks about fighting to save someone’s life,” says Koorts.

She says her family had to adjust to some of the social changes in their surroundings as well.

“At school, he has to fight for himself to stay alive. If we go to a restaurant and there are people smoking, it affects him and we have to move. So, as much as we have tried to give Janco a normal childhood, these social aspects will always hinder progress, and he is always reminded that he is sick. But I live in hope and so does he.”

In terms of her family relationships, Tanya says that her other children are healthy and for them to see their baby brother suffering every day hurts them.

“It’s painful as parents. Janco needs all the attention. I can’t go to a parent’s evening for my other kids. It’s difficult,” Koorts says.

She says she is proud of Janco.

“My child doesn’t know that he is dying. We fight every day so that Janco can have just one more breath.”

And that is ultimately what it is all about. From one perspective the exchange of documents in the High Court may seem abstract and full of legal technicalities. But let there be no doubt, for kids like Janco it is literally their futures that are being decided.

*Adams is a communications officer at SECTION27.

NOTE: This opinion piece was written by a staff member of SECTION27. Spotlight is published by SECTION27 and the TAC, but is editorially independent – an independence that the editors guard jealously. The views expressed in this piece are not necessarily those of Spotlight.

Republished from Spotlight under a Creative Commons Licence.

Source: Spotlight

Categories : CancerTags :

High-accuracy, High-dose Radiotherapy Proves Effective against Prostate Cancer

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

Patients with intermediate risk, localised prostate cancer can be treated as effectively using fewer and higher doses of radiation therapy delivered over five treatment sessions as they can with lower doses delivered over several weeks, according to researchers from The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London.

Significant reduction in treatment time

Results from the PACE B (Prostate Advances in Comparative Evidence) phase III randomised trial showed that stereotactic body radiotherapy (SBRT) performed as well as standard radiotherapy treatment for people whose prostate cancer had not spread, demonstrating a 96% chance of no disease progression within five years, compared to 95% for conventional radiotherapy.

SBRT, which can be delivered on a CyberKnife or standard radiotherapy machines, allows clinicians to target tumours to sub-millimetre precision. This approach uses advanced imaging and treatment planning techniques to deliver radiation with pinpoint accuracy, minimising damage to surrounding healthy tissue. It delivers five high doses of radiation to patients over one to two weeks, compared to standard radiotherapy, which delivers more moderate doses over a much longer period of time – usually around 20 sessions for patients in the UK, which can take up to one month.

Drawing from 38 centres across the UK, Ireland and Canada, researchers enrolled 874 people who preferred radiation treatment or were unsuitable for surgery. Patients were randomly assigned to receive either SBRT, consisting of five doses over one to two weeks, or standard radiation consisting of 20 doses over four weeks or 39 doses over 7.5 weeks. None of the patients received hormonal therapy.

“For something as serious as a cancer diagnosis, the treatment was incredibly easy”

The trial investigated whether SBRT was non-inferior to conventional radiation for treating people with intermediate risk, localised prostate cancer. Non-inferiority was measured by whether patients remained free of biochemical clinical failure (BCF), defined as an increase in prostate-specific antigen (PSA) levels, distant metastases or other evidence the cancer was returning, or death from prostate cancer.

Five years after treatment, people treated with SBRT had a BCF-event free rate of 95.7% compared to 94.6% for those treated with conventional radiotherapy, demonstrating that SBRT was non-inferior to conventional radiation.

Side effects were low in both groups and at five years not significantly different between treatment arms.

One patient who benefited from the treatment was 64-year-old Alistair Kennedy-Rose, who was diagnosed with prostate cancer in 2014 at his local hospital following a blood test which revealed his prostate-specific antigen levels were raised. Alistair was referred to The Royal Marsden and, after being recruited to the PACE-B trial, was treated with SBRT via CyberKnife.

He said: “When I was diagnosed I had no symptoms at all, so it came as quite a shock. There can be a lot of anxiety following a cancer diagnosis, but just ten days after I was referred to the Royal Marsden, I started SBRT. I still find it unbelievable that five days later I finished my treatment, for something as serious as a cancer diagnosis it was incredibly easy. I haven’t had any side effects and I’ve been able to live my life to the full. I can’t thank The Royal Marsden enough for what they have done for me.”

Source: The Royal Marsden

Categories : Ageing NeurologyTags :

In Hearing Loss, How Hair Cells Lose Their ‘Hair’

On By ModernMedia
In some cases of hearing loss, a cochlear implant is required. Photo by Brett Sayles

With age, many people will eventually need hearing aids. In some cases, the reason for this may be a signalling pathway that controls auditory sensory cell function and is downregulated with age. In the journal iScience, researchers at the University of Basel report the clues they have uncovered about this process, which may yield potential therapies to slow its progression.

Nearly everyone eventually experiences hearing loss: loud noises or simple aging gradually cause the auditory sensory cells and their synapses in the inner ear to degenerate and die off. The only treatment option is a hearing aid or, in extreme cases, a cochlear implant.

“In order to develop new therapies, we need to better understand what the auditory sensory cells need for proper function,” explains Dr Maurizio Cortada from the Department of Biomedicine at the University of Basel and University Hospital Basel. In collaboration researchers at the Biozentrum, Cortada investigated which signalling pathways influence the sensory hair cells in the inner ear. In the process, the researchers discovered a central regulator.

This signaling pathway, known by researchers as the mTORC2-signaling pathway, plays an important role, among other things, for cell growth and the cytoskeleton. The role it plays for the hair cells in the inner ear has not previously been studied.

When the researchers removed a central gene of this signalling pathway in the hair cells of the inner ear of mice, the animals gradually lost their hearing. By the age of twelve weeks, they were completely deaf, the authors report in the study.

Shortening ‘hair’ and fewer synapses

Closer examination indicated that the sensory hair cells in the inner ear lost their sensors without the mTORC2 signalling pathway: the distinctive fibre bundles known as stereocilia. Through electron microscopes, the researchers observed the shortening of stereocilia. The number of synapses that transmit the signals to the auditory nerve was also reduced.

“From other studies, we know that the production of key proteins in this signaling pathway decreases with age,” Cortada explains. There may be a connection to the loss of synapses and the reduced function of the auditory sensory cells in the inner ear that leads to hearing loss with increasing age.

“If this is confirmed, it would be a possible starting point for future therapies,” says the researcher. The middle and inner ear, for example, would be readily accessible for locally-administered medications or gene therapies. The results could pave the way for the development of such treatment options.

Source: University of Basel