The European Medicines Agency (EMA) recommended that heavy menstrual bleeding should be added to the product information as a side effect of unknown frequency of the mRNA COVID vaccines Comirnaty (Pfizer/BioNtech) and Spikevax (Moderna).
Heavy menstrual bleeding may be defined as bleeding characterised by an increased volume and/or duration which interferes with the person’s physical, social, emotional and material quality of life. Cases of heavy menstrual bleeding have been reported after the first, second and booster doses of Comirnaty and Spikevax.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) assessed this safety signal after reviewing the available data, including cases reported during clinical trials, cases spontaneously reported in Eudravigilance and findings from the medical literature.
After a review of the available data, the PRAC concluded that there is at least a reasonable possibility that the occurrence of heavy menstrual bleeding is causally associated with these vaccines and therefore recommended the update of the product information.
The available data reviewed involved mostly cases which appeared to be non-serious and temporary in nature.
There is no evidence to suggest the menstrual disorders experienced by some people have any impact on reproduction and fertility. Available data provides reassurance about the use of mRNA COVID vaccines before and during pregnancy. A review carried out by EMA’s Emergency Task Force showed that mRNA COVID vaccines do not cause pregnancy complications for expectant mothers and their babies, and they are as effective at reducing the risk of hospitalisation and deaths in pregnant people as they are in non-pregnant people.
Surgical care experts published two important studies in The Lancet that will help to provide safer surgery for thousands of patients around the world – particularly in Low- and Middle-income Countries (LMIC) such as South Africa.
Researchers found that routinely changing gloves and instruments just before closing wounds could significantly reduce Surgical Site Infection (SSI), the most common post-operative complication. This switch could prevent as many as 1 in 8 cases of SSI.
Secondly, they tested a new toolkit that can make hospitals better prepared for pandemics, heatwaves, winter pressures and natural disasters that could reduce cancellations of planned procedures around the world.
Surgical infections
Patients in LMICs are disproportionately affected by wound infections. The ChEETAh trial was run in Benin, Ghana, India, Mexico, Nigeria, Rwanda and South Africa. With the publication of their findings in The Lancet, researchers are calling for the practice to be widely implemented – particularly in LMICs.
Co-author Mr Aneel Bhangu, from the University of Birmingham, commented: “Surgical site infection is the world’s most common postoperative complication – a major burden for both patients and health systems. Our work demonstrates that routine change of gloves and instruments is not only deliverable around the world, but also reduced infections in a range of surgical settings. Taking this simple step could reduce SSIs by 13% – simply and cost-effectively.”
Patients who develop SSI experience pain, disability, poor healing with risk of wound breakdown, prolonged recovery times and psychological challenges. In health systems where patients have to pay for treatment this can be a disaster and increases the risk of patients being plunged into poverty after their treatment. The simple and low-cost practice of changing your gloves and instruments just before closing the wound is something which can be done by surgeons in any hospital around, meaning a huge potential impact.
Surgical Preparedness Index
Experts from the NIHR Global Research Health Unit on Global Surgery also unveiled their ‘Surgical Preparedness Index’ (SPI) in The Lancet. This is a key study assessing the extent to which hospitals around the world were able to continue elective surgery during COVID.
Researchers identified different features of hospitals that made them more or less ‘prepared’ for times of increased pressure. Using COVID as an important example, they highlighted that health systems are put under stress for all sorts of reasons each year – from seasonal pressures to natural disasters, and warfare. A team of clinicians from 32 countries designed the SPI which scores hospitals based on their infrastructure, equipment, staff, and processes used to provide elective surgery. The higher the resulting SPI score, the more prepared a hospital is for disruptions.
After creating the SPI tool, the experts asked 4714 clinicians in 1632 hospitals across 119 countries to assess the preparedness of their local surgical department. Overall most hospitals around the world were poorly prepared, and suffered a big drop in the number of procedures they were able to provide during COVID. A 10-point increase in the SPI score corresponded to four more patients that had surgery per 100 patients on the waitlist.
Lead author Mr. James Glasbey, from the University of Birmingham, commented: “Our new tool will help hospitals internationally improve their preparation for external stresses ranging from pandemics to heatwaves, winter pressures and natural disasters. We believe it help hospitals to get through their waiting lists more quickly, and prevent further delays for patients. The tool can be completed easily by healthcare workers and managers working in any hospital worldwide – if used regularly, it could protect hospitals and patients against future disruptions.”
Professor Dion Morton, Barling Chair of Surgery at the University of Birmingham and Director of Clinical Research at the Royal College of Surgeons of England commented: “Although not all postoperative deaths are avoidable, many can be prevented by increasing investment in research, staff training, equipment, and better hospital facilities. We must invest in improving the quality of surgery around the world.”
The urge to vomit after eating contaminated food is the body’s natural defensive response to get rid of bacterial toxins. However, exactly how the brain initiates the response has remained a mystery. Now, researchers have mapped out the detailed neural pathway of the defensive responses from the gut to the brain in mice. The study, published in the journal Cell, could help scientists develop better anti-nausea medications for cancer patients who undergo chemotherapy.
Many foodborne bacteria produce toxins in the host after ingestion. After sensing their presence, the brain will initiate a series of biological responses, including vomit and nausea, to expel the substances and develop an aversion toward foods that taste or look the same.
“But details on how the signals are transmitted from the gut to the brain were unclear, because scientists couldn’t study the process on mice,” says Peng Cao, the paper’s corresponding author at the National Institute of Biological Sciences in Beijing. Rodents cannot vomit, so scientists have been studying vomit in other animals like dogs and cats, but these animals are not comprehensively studied and thus failed to reveal the mechanism of nausea and vomiting. However, Cao and his team noticed that while mice don’t vomit, they retch – meaning they also experience the urge to vomit without throwing up.
The team found that after receiving Staphylococcal enterotoxin A (SEA), which is a common bacterial toxin produced by Staphylococcus aureus that also leads to foodborne illnesses in humans, mice developed episodes of unusual mouth opening. Mice that received SEA opened their mouths at angles wider than those observed in the control group, where mice received saline water. Moreover, during these episodes, the diaphragm and abdominal muscles of the SEA-treated mice contract simultaneously, a pattern seen in dogs when they are vomiting. During normal breathing, animals’ diaphragm and abdominal muscles contract alternatively.
“The neural mechanism of retching is similar to that of vomiting. In this experiment, we successfully build a paradigm for studying toxin-induced retching in mice, with which we can look into the defensive responses from the brain to toxins at the molecular and cellular levels,” Cao says.
In mice treated with SEA, the team found the toxin in the intestine activates the release of serotonin, a type of neurotransmitter, by the enterochromaffin cells on the lining of the intestinal lumen. The released serotonin binds to the receptors on the vagal sensory neurons located in the intestine, which transmits the signals along the vagus nerves from the gut to a specific type of neurons in the dorsal vagal complex – Tac1+DVC neurons – in the brainstem. When Cao and his team inactivated the Tac1+DVC neurons, SEA-treated mice retched less compared with mice with normal Tac1+DVC neuron activities.
In addition, the team investigated whether chemotherapy drugs, which also induce defensive responses like nausea and vomiting in recipients, activate the same neural pathway. They injected mice with doxorubicin, a common chemotherapy drug. The drug made mice retch, but when the team inactivated their Tac1+ DVC neurons or serotonin synthesis of their enterochromaffin cells, the animals’ retching behaviours were significantly reduced.
Cao says some of the current anti-nausea medications for chemotherapy recipients, such as Granisetron, work by blocking the serotonin receptors. The study helps explain why the drug works.
“With this study, we can now better understand the molecular and cellular mechanisms of nausea and vomiting, which will help us develop better medications,” Cao says.
Next, Cao and his colleagues want to explore how toxins act on enterochromaffin cells. Preliminary research shows that enterochromaffin cells don’t sense the presence of toxins directly. The process likely involves complex immune responses of damaged cells in the intestine.
“In addition to foodborne germs, humans encounter a lot of pathogens, and our body is equipped with similar mechanisms to expel these toxic substances. For example, coughing is our body’s attempt to remove the coronavirus. It’s a new and exciting field of research about how the brain senses the existence of pathogens and initiates responses to get rid of them.” Cao says, adding that future research may reveal new and better targets for drugs, including anti-nausea medicines.
Fikile (Sr Fikx) Dikolomela-Lengene, a nurse activist says she has had a front-row seat to corruption unfolding in Gauteng’s public health sector. PHOTO: Supplied/Facebook
Fiery nurse activist Fikile Dikolomela-Lengene says she has had a front-row seat to corruption unfolding in Gauteng’s public health sector, and she is not afraid to speak out.
Dikolomela-Lengene grew up in the corridors of Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg – Africa’s largest health facility.
The youngest of nine siblings and the only daughter, her father died when she was three years old. After this, her mother, a nurse at Baragwanath Hospital, would take her along to work.
“There were times when my mum didn’t have a nanny so she would take me to Bara [a nickname among healthcare workers for Baragwanath], where she worked in the same surgery theatre for 40 years,” says Dikolomela-Lengene. “I was actually sleeping on stretcher beds. I would accompany her to go fetch patients. This was a single mom with a little girl and nobody to look after her and she needed to work.”
At the hospital, a young Dikolomela-Lengene grew inspired to become a nurse, while cultivating her first inkling of justice. “I saw what was happening, and I thought, this is something I would like to do,” she says. “It came with a lot of context of the profession. I mean, I saw my mom and how the profession didn’t upskill her, how she suffered because of having a child, the shifts, and all of that. And I think it’s where the love for professional activism came in. To say, if I go into this profession, I wanted to be in a place where I could influence change.”
Nurse activist
Today, with a string of qualifications behind her name, including a Bachelor’s degree in nursing from North West University and a Mandela Washington Fellowship for Young African Leaders, 36-year-old Dikolomela-Lengene describes herself as a “nurse activist” and calls herself ‘Sr Fikx’ because she is passionate about influencing change in the public health sector. Currently based at the Stretford Community Health Centre – which serves the township of Orange Farm in the south of Johannesburg – she is passionate about HIV care and heads several public health campaigns at community level.
“What is interesting to me is the non-acquiring of condoms, today in an era when HIV is so rife
Commenting on the report findings of the Stop Stockouts Project (the SSP monitors shortages in essential medicines across South Africa) launched in August, Dikolomela-Lengene laments the shortfall of contraceptives – particularly injectable contraceptives and condoms – in the country’s public health sector.
“What is interesting to me is the non-acquiring of condoms, today in an era when HIV is so rife,” she says. “We ran out of [government-issued] condoms in May. And they actually don’t even have a new tender yet. And this shocked me. We should plan, right?”
She points out the ripple effects of this shortfall, such as an increase in required abortions. “Since there are none of these types of contraceptives, how has it impacted on our TOP [termination of pregnancy] services, you know? Especially in clinics where these services are burdened as it stands?”
“rot of corruption”
Dikolomela-Lengene says “the rot” of corruption in Gauteng’s health sector runs deep.
In 2015, she was a founding member of The Young Nurses Indaba Trade Union (YNITU), which represented over 10 000 workers, who pay R70 per month for membership.
Speaking to Spotlight, Dikolomela-Lengene alleges that the union’s leadership was “hijacked” at a congress in October last year and that millions of rands from the union’s coffers disappeared. In the midst of the clash, the union’s FNB business account was frozen in November 2021. However, allegedly membership fees are still being paid into private accounts. AmaBhungane reported on the alleged hijacking of the trade union in September. The new leadership rejected claims of wrong-doing.
In February this year, Dikolomela-Lengene and fellow former union leaders put the allegations before the Department of Labour. “We told them we need assistance because the union is hijacked and is being used for activities that currently… we actually don’t even know what is happening,” she says.
Dikolomela-Lengene adds that the union had been given notice to deregister on September 28. She will continue to meet with the Department of Labour. “Let me just say it’s been a hassle,” she adds. (AmaBhungane reported on the deregistration here.)
Last year in August, Gauteng health official Babita Deokaran was assassinated shortly after flagging up to R850 million in suspicious payments authorised at Tembisa Hospital in Johannesburg. (Spotlight earlier asked the new Gauteng Health MEC Nomantu Nkomo-Ralehoko about the alleged corruption flagged by Deokaran and other corruption-related issues here.)
According to media reports, one of the people accused of capturing the YNITU – Lerato Mthunzi – is the wife of embattled Tembisa Hospital chief executive officer (CEO), Ashley Mthunzi, who was suspended on August 26 over allegations of widespread corruption – including R498 000 of the hospital budget spent on 200 pairs of skinny jeans. After his suspension, one of Mthunzi’s notable supporters had been the nursing union, now headed by his wife. Mthunzi (Lerato) has denied any wrongdoing.
‘defending and defending’
During the interview with Spotlight, Dikolomela-Lengene shakes her head, laughing. “I’m laughing, you know because it’s so sad. People are defending and defending, but there’s a family here that lost somebody. There are kids currently who don’t have a mother because there are people in positions who don’t want to do their job.
“You get to ask yourself, who authorises codes for jeans, skinny jeans, in a hospital?
“I don’t know how they’re going to get rid of corruption in health in Gauteng. You get to ask yourself, who authorises codes for jeans, skinny jeans, in a hospital? It’s like somebody’s mocking the governance.
“You have to ask yourself, how many processes are there before payment is actually made? So all those processes were flawed, or were people in those processes flawed themselves? And then, you have condoms not being on tender. You start asking yourself [how are] people able to get money for jeans, but there’s no money for a tender for condoms?”
Looted
Shaking her head, Dikolomela-Lengene says the province’s health budget is being looted.
“We’re not going anywhere unless they actually bring a lot of people to account,” she says. “R850 million, imagine! I’m looking at my clinic. Our budget is around R20 million. How many clinics could have been revamped for R850 million? How many hospitals could have been looking A-class, private style, with that money? It is possible to revamp our clinics. It is possible to revamp our hospitals. There is money. There is money, but there is no political will.”
“into the lion’s den”
On Gauteng’s new health MEC Nomantu Nkomo-Ralehoko, Dikolomela-Lengene says, “We’ll see with the new MEC. The past two MECs disappointed us and they were both health professionals. (Nkomo-Ralehoko is not a healthcare professional by training).”
“I mean, having to fight with a patient because you don’t have a Panado. You don’t have Panado! A simple thing like that.
Nkomo-Ralehoko, in response to questions by Spotlight, vowed to act on recommendations by a Special Investigating Unit (SIU) currently conducting a forensic investigation into transactions at Tembisa Hospital.
“At this moment, I’m not going to be judgmental,” says Dikolomela-Lengene. “You know, we just want to see change. I mean, having to fight with a patient because you don’t have a Panado. You don’t have Panado! A simple thing like that. And as a nurse, you have to take the brunt of it. She’s [Nkomo-Ralehoko] going into a lion’s den. She will need a thick skin.”
Earlier this year, Dikolomela-Lengene was one of 700 young African leaders who studied in the United States for six weeks as Mandela Washington Fellows. She was placed at Howard University, which counts former US President Barack Obama among its alumni.
“It’s what we call a historically black college, one of the colleges that Barack Obama went to. So I think that was an honour on its own,” she says.
As part of her training, she got to shadow and even debate with high-ranking American government officials. “I learned a lot of skills, but what stood out was the ‘huddle system’. This is a programme whereby we have meetings more frequently so that changes can be made more frequently. I think in South Africa, we stick with things that are wrong for too long. If a policy isn’t working, we wait for five years. If a system isn’t working, we wait for five years. So with the huddle approach, you continuously monitor and make changes when things are not working.”
a “downgrade” in nurse training
Dikolomela-Lengene lives in Johannesburg but says she prefers not to divulge particulars due to safety concerns.
She did, however, share about her current reading material.
The book currently on her bedside table is ‘Who Ate My Cheese? The Road to Freedom’ by Rowland Rose – a gift from the United States embassy during her recent trip.
Another issue keeping Dikolomela-Lengene awake at night is South Africa’s nurse training curriculum. In 2019, she served on the ministerial task team that oversaw amendments brought to South Africa’s nurse training strategy, as chronicled in The National Strategic Direction for Nursing Education and Practice: A Road Map for Strengthening Nursing and Midwifery in South Africa (2020/21−2025/26).
“Our qualifications have been downgraded.
She is highly critical of this new strategy, calling it a “big mistake”, and effectively a “downgrade” in nurse training in the country.
“I’ve got a four-year diploma. I’ve got a one-year post-graduate, [and] I’ve got a three-year degree. I’m not even going to talk about the side courses I’ve done. There are more than ten. Can I tell you that I cannot access a university in South Africa? Our qualifications have been downgraded. I’ve got more than nine years of formal study and I can’t do my Masters [degree] because my accreditation has been brought two to one level lower,” says Dikolomela-Lengene.
“You’ve got academia and professors making a curriculum for nurses – not nurses. It’s shocking… So there is a big fight between the National Department of Health, the South African Nursing Council, which is the regulatory body of nursing, and the Department of Higher Education.”
The nurse activist says that her salary could triple if she moved from the public sector into private, but that she wouldn’t dream of such a step. “The passion I have for what I do is what fuels me,” she says. “And it’s effortless, you know? I love what I do. Whatever time they call me, I’m ready. I just show up – always.”
Republished from Spotlight under a Creative Commons 4.0 Licence. Read the original article here.
Colon cancer cells. Source: National Cancer Institute on Unsplash
A randomised study of northern European data shows that colonoscopy screening reduces the risk of colorectal cancer by 18%, much smaller than experts previously assumed. The results of the study appear in the New England Journal of Medicine.
Prior to the publication of this study, experts assumed that screening with colonoscopy had significantly better effect than screening with faecal tests. Faecal tests are used in colorectal cancer screening programs in many countries, and other countries have introduced screening with colonoscopy based on the fact that researchers via observational and modelling studies estimated that up to nine out of ten cases of colorectal cancer could be prevented with a colonoscopy screening. With faecal tests, similar models has estimated the effect to be two to three out of ten.
In the NordICC study, the researchers investigated the extent to which colonoscopy screening actually prevents colorectal cancer. Overall, 1.2% of those randomised to no screening were diagnosed with colon cancer during ten years, compared to 0.98% in those offered screening.
This translates to an 18% reduced risk of colorectal cancer among the participants who were offered colonoscopy screening. Furthermore, 455 colonoscopies were required to prevent one single case of colorectal cancer. Colonoscopy is fairly invasive and costly procedure, involving preparation, bowel prep with laxatives, and a 30-45 minute examination of the bowel with a camera inserted via the rectum. The figure of 455 procedures to prevent one case of cancer is certainly disappointing, Louise Emilsson concluded.
Colorectal cancer mortality was also found to be lower than expected in the NordICC study. Only three in a thousand died of the disease within ten years, regardless of whether they were offered screening or not, and thus, there was no significant difference between the groups in terms of mortality. The low mortality rate is however encouraging and likely caused by significantly improved treatment options over the past ten years.
