Day: August 21, 2023

CMS Provides Clarity over BHF’S Court Challenges

Various stakeholders within the medical schemes value chain have sharply raised concerns over the unending court challenges brought by the Board of Healthcare Funders (BHF) against CMS. As an agile regulator, the CMS endeavours to clarify any misconception and confusion over BHF’s court challenges.

Chronology of Events

Initially, the main issue brought by BHF in this case was to request the court to grant them a general exemption for medical schemes to offer low-cost benefit options and to declare an alleged moratorium unlawful by the CMS and Ministry of Health in order to prevent medical schemes from offering low-cost benefit options.

In response, the CMS vehemently opposed the application on the basis that there was no moratorium as alleged by BHF and it would be thus unlawful to grant BHF a general exemption for medical schemes to offer low costs benefit options.

“It must be noted that while the main case/dispute was still ongoing (even after CMS submitted an extensive record of documents that were compliant with relevant information and documents having been exchanged between CMS and BHF), surprisingly BHF brought an interlocutory application alleging that CMS and the Minister were hiding certain information.”

Accordingly, the interlocutory application requested CMS and the NDOH to release an exhaustive list of documents which the CMS believed were irrelevant and had no bearing on the main application.

Despite CMS’s vehement contestation to the court on the additional requested documents by BHF, Judge Botha granted the BHF the order they sought, and the CMS, as well as the Minister of Health were ordered to produce the documents listed in Notice in terms of Rule 30A within 10 (ten) days of the Court Order, being 24 July 2023. 

Before the expiration of rule 18 of the superior court, CMS filed leave to appeal the court order of Judge Botha as CMS believed that the order was flawed in law and that the judge had no reasons for ordering CMS and the Minister to produce those documents.

While the CMS legal team was studying the order, BHF concurrently lodged a contempt of court on an urgent basis.

CMS, through its attorneys, moved swiftly and wrote to BHF urging them to withdraw the contempt application as the CMS had already lodged its leave to appeal the court order of Judge Botha and this meant that the court order by Judge Botha would been suspended. 

BHF refused to withdraw the contempt application and the application was heard on 8th August 2023 and the court dismissed BHF’s application on 10 August 2023 with costs in favour of CMS and Minister.

Citing Judge E van der Schyff who emphasised that “in the Practice Manual of the Gauteng High Court Division that while an application maybe urgent, it may not be sufficiently urgent to be heard at the time selected by an applicant” and also strongly highlighted that it does “not mean that applicants can indiscriminately approach the urgent court on the basis of extreme urgency without having regard to the context and facts of each individual application.”

Based on this order, the contempt application is now in our view moot or rather has been overtaken by the leave to appeal lodged by CMS and the Minister and CMS/NDOH. The leave to appeal will be heard somewhere September 2023.

The main application brought by BHF is likely to be heard in later parts of 2024.

An Antibiotic Alternative to Treating Kids’ Ear Infections

This illustration depicted a three-dimensional (3D), computer-generated image, of a group of Gram-positive, Streptococcus pneumoniae bacteria. The artistic recreation was based upon scanning electron microscopic (SEM) imagery.

Doctors typically treat paediatric ear infections with antibiotics, but children don’t always complete the full course, accelerating resistance to these medications. Today, researchers report developing a single-use nanoscale system that’s unlikely to generate resistance. Using a compound similar to bleach in test animals, they show it can kill off Streptococcus pneumoniae, a common cause of ear infections, and it could someday be easily applied as a gel.

The researchers will present their results at the meeting of the American Chemical Society (ACS).

“We initially conceived of this idea by looking at the household cleaner bleach. Even though it has been used since the 19th century, bacteria do not appear to have developed any widespread resistance to this cleaner,” says Rong Yang, PhD, the project’s principal investigator.

But Yang quickly warns that people should not treat infections with bleach. The solution sold at stores is highly concentrated and caustic, but when used in a properly controlled manner at extremely low concentrations, the active ingredient in bleach is considered compatible with living tissue.

After realising that the active ingredient in the household cleaner could circumvent antibiotic resistance, the Cornell University researchers, set out to tackle a nearly universal childhood scourge: acute ear infections. These infections affect more than 95% of children in the US, and treatment typically requires taking antibiotics for five to 10 days. However, these regimens can cause problematic side effects, leading some families to discontinue the medication prematurely, particularly if symptoms resolve. But using these medications improperly can speed up the development of antibiotic resistance, which makes infections more difficult, if not impossible, to treat. This issue ranks among the biggest threats to global health, according to the World Health Organization.

Bacteria have more success fighting against some substances than others. Hypochloric acid from bleach belongs to a family of compounds, known as hypohalous acids, to which bacteria have yet to develop any significant resistance; most likely because of the numerous ways these highly reactive acids damage microbial cells, Yang says.

Because these substances break down quickly, Yang and her colleagues sought to generate one of them on an as-needed basis behind the eardrum in the middle ear, where ear infections occur. They found inspiration in an enzyme from giant kelp, which converts hydrogen peroxide (H2O2) to hypobromous acid (HOBr), a chemical relative of bleach.

Streptococcus pneumoniae, a frequent cause of ear infections, produces H2O2 to fight off other microbes. To mimic the kelp enzyme, which contains the metal vanadium, Yang and her colleagues designed nanowires made of vanadium pentoxide (V2O5). These produce HOBr only in the presence of the H2O2-producing bacteria, and their rod-like shape helps to keep them in place by reducing their ability to diffuse into body fluids.

In tests on chinchillas, which contract ear infections from the same pathogens as human children, they succeeded in eliminating most of the S. pneumoniae. Yang and colleagues found that after treatment with the nanowires, the animals’ once-inflamed eardrums returned to normal. Meanwhile, tests in healthy animals found evidence that the treatment did not interfere with hearing.

For these experiments, the researchers injected the nanowires directly into the middle ear. In more recent work in chinchillas, they developed a less invasive, more practical method for delivering the wires. By decorating the nanowires with peptides known to transport small particles across the eardrum, Yang and her team found they could deliver the treatment topically as a gel deposited into the ear canal. Once the gel was applied, the nanowires within it went through the intact tissue. They are also exploring other approaches for passing the nanowires through the eardrum.

Because other ear-infection-causing bacteria do not produce H2O2, the researchers are currently examining whether this system is effective in the presence of microbes other than S. pneumoniae, and how they might adapt it to fight the other bugs.

The researchers have not yet done studies to determine how long the system stays in place, although their evidence suggests the nanowires drain out of the middle ear after the infection clears. However, Yang suspects they could adapt the nanowires’ properties to stay in place for long periods afterward. This latter approach could make it possible to prevent recurrent infections that plague many children.

“If the bacteria return, the system could restart, so children wouldn’t need antibiotics repeatedly and breed more resistance along the way,” Yang says.

A video on the research is available at www.acs.org/Earaches.

Source: American Chemical Society

Liraglutide Boosts Associative Learning in People with Obesity

Photo by Patrick Fore on Unsplash

Obesity leads to altered energy metabolism and reduced insulin sensitivity of cells. The so-called “anti-obesity drugs” such as liraglutide are increasingly used to treat obesity and have caused tremendous interest, especially in the USA. Researchers in Germany have now shown in people with obesity that reduced insulin sensitivity affects learning of sensory associations. The results, published in Nature Metabolism, showed that a single dose of liraglutide was able to normalise these changes and restore the underlying brain circuit function.

The brain must be able to form associations in order to control behaviour. This involves, for example, associating a neutral external stimulus with a consequence following the stimulus. In this way, the brain learns what the implication of handling of the first stimulus are. Associative learning is the basis for forming neural connections and gives stimuli their motivational force. It is essentially controlled by a brain region called the dopaminergic midbrain. This region has many receptors for the body’s signalling molecules, such as insulin, and can thus adapt behaviour to the body’s physiological needs.

But what happens when the body’s insulin sensitivity is reduced due to obesity? Does this change brain activity, ability to learn associations and thus behaviour? Researchers at the Max Planck Institute for Metabolism Research have now measured how well the learning of associations works in participants with normal body weight (high insulin sensitivity, 30 volunteers) and in participants with obesity (reduced insulin sensitivity, 24 volunteers), and if this learning process is influenced by the anti-obesity drug liraglutide.

Low insulin sensitivity reduces the brain’s ability to associate sensory stimuli.

In the evening, they injected the participants with either the drug liraglutide or a placebo in the evening. Liraglutide is a so-called GLP-1 agonist, which activates the GLP-1 receptor in the body, stimulating insulin production and producing a feeling of satiety. It is often used to treat obesity and type 2 diabetes and is given once a day. The next morning, the subjects were given a learning task that allowed the researchers to measure how well associative learning works. They found that the ability to associate sensory stimuli was less pronounced in participants with obesity than in those of normal weight, and that brain activity was reduced in the areas encoding this learning behaviour.

After just one dose of liraglutide, participants with obesity no longer showed these impairments, and no difference in brain activity was seen between participants with normal weight and obesity. In other words, the drug returned the brain activity to the state of normal-weight subjects.

“These findings are of fundamental importance. We show here that basic behaviours such as associative learning depend not only on external environmental conditions but also on the body’s metabolic state. So, whether someone has overweight or not also determines how the brain learns to associate sensory signals and what motivation is generated. The normalisation we achieved with the drug in subjects with obesity, therefore, fits with studies showing that these drugs restore a normal feeling of satiety, causing people to eat less and therefore lose weight,” says study leader Marc Tittgemeyer from the Max Planck Institute for Metabolism Research.

“While it is encouraging that available drugs have a positive effect on brain activity in obesity, it is alarming that changes in brain performance occur even in young people with obesity without other medical conditions. Obesity prevention should play a much greater role in our healthcare system in the future. Lifelong medication is the less preferred option in comparison primary prevention of obesity and associated complications,” says Ruth Hanßen, first author of the study and a physician at the University Hospital of Cologne.

Source: Max Planck Institute for Biology of Ageing

Mediterranean Lifestyle Linked to Lower Risk of All-cause and Cancer Mortality

in Mayo Clinic Proceedings.

People who adhere to a Mediterranean lifestyle, which involves a plant-rich diet, adequate rest, physical activity and socialisation, have a lower risk of all-cause and cancer mortality, according to a new study in Mayo Clinic Proceedings. People who adhered to the lifestyle’s emphasis on rest, exercise, and socialising with friends had a lower risk of cardiovascular disease mortality.

While many studies have established the health benefits of a Mediterranean diet and lifestyle, there are few studies on the diet outside of its region of origin. “This study suggests that it’s possible for non-Mediterranean populations to adopt the Mediterranean diet using locally available products and to adopt the overall Mediterranean lifestyle within their own cultural contexts,” said lead author Mercedes Sotos Prieto, Ramon y Cajal research fellow at La Universidad Autónoma de Madrid and adjunct assistant professor of environmental health at Harvard Chan School. “We’re seeing the transferability of the lifestyle and its positive effects on health.”

Led by La Universidad Autónoma de Madrid and Harvard T.H. Chan School of Public Health, the study analysed the habits of 110,799 members of the UK Biobank cohort, a population-based study across England, Wales, and Scotland using the Mediterranean Lifestyle (MEDLIFE) index, which is derived from a lifestyle questionnaire and diet assessments. Participants, who were between the ages of 40 and 75, provided information about their lifestyle according to the three categories the index measures: “Mediterranean food consumption” (intake of foods part of the Mediterranean diet such as fruits and whole grains); “Mediterranean dietary habits” (adherence to habits and practices around meals, including limiting salt and drinking healthy beverages); and “physical activity, rest, and social habits and conviviality” (adherence to lifestyle habits including taking regular naps, exercising, and spending time with friends). Each item within the three categories was then scored, with higher total scores indicating higher adherence to the Mediterranean lifestyle.

The researchers followed up nine years later to examine participants’ health outcomes. Among the study population, 4247 died from all causes; 2401 from cancer; and 731 from cardiovascular disease. Analysing these results alongside MEDLIFE scores, the researchers observed an inverse association between adherence to the Mediterranean lifestyle and risk of mortality. Participants with higher MEDLIFE scores were found to have a 29% lower risk of all-cause mortality and a 28% lower risk of cancer mortality compared to those with lower MEDLIFE scores. Adherence to each MEDLIFE category independently was associated with lower all-cause and cancer mortality risk. The “physical activity, rest, and social habits and conviviality” category was most strongly associated with these lowered risks, and additionally was associated with a lower risk of cardiovascular disease mortality.

Source: Harvard T.H. Chan School of Public Health

UK Nurse Sentenced to Life for Murders of 7 Babies

Photo by Tingey Injury Law Firm on Unsplash

A UK nurse has been sentenced to life in prison for murdering seven babies in a neonatal unit. In what is the longest murder trial in recent UK history, 33-year old Lucy Letby was also convicted of attempting to kill six other babies, and further investigation by the BBC has also revealed how hospital management at the time deflected concerns by doctors and actively silenced them.

Between June 2015 and June 2016, Letby deliberately injected air into babies’ parenteral nutrition lines, force-fed milk to others and administered huge doses of insulin to two others. In the years before, less than three death per year had been recorded at Countess of Chester Hospital at the neonatal unit where she worked.

According to The Guardian, Mr Justice Goss said during her sentencing: “This was a cruel, calculated, and cynical campaign of child murder involving the smallest and most vulnerable of children, knowing that your actions were causing significant physical suffering and would cause untold mental suffering.”

She was found not guilty of two other counts of attempted murder, but the jury consisting of four men and seven women were unable to reach a verdict on six additional attempted murder charges. The court will consider whether to attempt to retry these six charges.

Dr Stephen Brearey, lead consultant at the neonatal unit where Letby worked told the BBC he first raised concerns about the nurse in October 2015, but not no action was taken and she went on to attack five more babies.

He that hospital management failed to investigate allegations against her and also tried to silence doctors. An investigation by BBC Panorama BBC News revealed just how Letby was able to get away with murdering and harming the babies for so long.

The hospital’s top manager ordered doctors to make written apologies to to Letby, and two consultants had to undertake mediation with the nurse, despite their suspecting she had killed babies. Efforts to bring in the police were also quashed by senior management, who said in an email “This is absolutely being treated with the same degree of urgency … All emails cease forthwith”.

Dr Ravi Jayaram, a consultant paediatrician at the hospital, wrote on social media that he felt relief at the oft-maligned justice system working “this time”.

But he continued there were “things that need to come out about why it took several months from concerns being raised to the top brass before any action was taken to protect babies”.

He also added: “And why from that time it then took almost a year for those highly-paid senior managers to allow the police to be involved.”