Tag: 14/5/24

Ramaphosa to Sign NHI into Law: What does This Mean for SA Doctors – and Can We Fix It?

President Cyril Ramaphosa has finished “looking for a pen” to sign the National Health Insurance (NHI) bill into law, and is set to approve the legislation on Wednesday, May 15.

While this “electioneering” move comes as a surprise to many, some experts anticipated this timing. With its signing, the legal battles over it will now begin. An array of medical and professional associations are readying their court papers, armed with numerous expert objections and petitions finding fault with the bill, widely criticised as unaffordable, demoralising and disastrous. But what will it look like in the end? Is it in fact an opportunity to fix public and private healthcare for the better?

To understand the NHI bill’s consequences and possible remedies better, Quicknews asked medico-legal specialist Martin Versfeld of Webber Wentzel & Associates about the legal aspects of the NHI bill, what it means for doctors in private practice, what can be done to ensure it fixes SA healthcare instead of damaging it further, and what its likely outcomes will be.

“The inequality of South Africa’s healthcare situation is not lost on anyone, least of all those in healthcare,” Martin says. “I think every healthcare professional, every hospital group, every healthcare provider recognises a need to assist South Africans more generally and to ensure there is better access to healthcare.”

Examination of the NHI bill has shown that it will simply exacerbate the problem, with possible wider consequences for the country’s economy (If Eskom’s load shedding is anything to go by – Ed). Viable alternatives towards repairing the beleaguered public healthcare system have been suggested, but political pressures have seen the bill signed into law. At this point, it is a certainty that it will face a barrage of litigation.

NHI, the mirage on the horizon

While the NHI is now set to be signed into law, there were efforts to persuade President Ramaphosa to not sign it. Recently, a South African Health Care Practitioners (SAHCP) petition was presented that contains a number of points and precedent to other laws that were rejected due to serious concerns. This petition had gathered 23 000 signatures from healthcare professionals.

Martin believes that it is a very effective petition, and it may have ‘resonated’ except for its timing. “The challenge that we face here is that it is an election year,” he points out. So while this petition and other appeals to the President to reject the legislation might have merit, and may have otherwise succeeded, it is extremely unlikely that Ramaphosa could go against his party’s goals.

“The NHI is a centrepiece, arguably, of the ANC’s election manifesto and they will be very reluctant to signal a climb-down at this point. So I think Cyril, as much as he might personally take a view that, under different circumstances, would be appropriate – I think he’d be under enormous pressure simply to sign the legislation into law.”

The time to act, with the most impact, will be after the elections.

As soon as NHI is signed into law, there will be a tidal wave of litigation, predicts Martin. This will be the next best time to challenge it. There are two avenues; whether the entire legislation is struck down as unconstitutional, or when it comes to the nitty gritty of implementation, when “the plethora of regulations are introduced.”

Even absent the court battles that will be waged, it will take years to fully implement NHI. Martin points out the length of the process, “The NHI is not going to be implemented to the full extent of what the legislation provides from the get go,” he says – it simply can’t be.

“It will be introduced incrementally by way of the introduction of regulations. So what I would expect as a first step would be to introduce the infrastructure required in order to create this collective pooling of funds.

“They will also be regulations which empower Nicholas Crisp and others to employ the essential staffing required to start to implement NHI.

“So it’s envisaged that there will be a very long process.”

‘Decades of litigation’

“Once the legislation takes effect, of course, the doctors and other stakeholders, including the medical schemes, will have an opportunity to carefully review the legislation and take a view as to whether or not they wish to, at this juncture, challenge certain aspects of that legislation on the basis of the – amongst other things – lack of constitutionality thereof.”

Martin stresses that the objections that have been lodged and engagements made to-date are not wasted effort. “It’s very important that the court sees and appreciates all the efforts that the industry has made in order to engage practically and meaningfully with the government. If nothing else, it puts the government on the back foot and the healthcare providers on the front foot.”

“This is not a matter which anyone is going to take lying down,” he says.

The South African Medical Association (SAMA) is one of the organisations that have already signalled intent to litigate against the NHI if it is signed into law.

Speaking at a media briefing, SAMA’s chairperson, Dr Mvuyisi Mzukwa, said that the NHI bill will impact not only health professionals, but the country as a whole.

“SAMA has, on various platforms, made its position known that, as doctors, we swore an oath of service to those who seek healthcare from us. We do not believe this Bill will achieve what it purports to do,” he said.

The notion of how physicians resist unjust situations is a relatively new one, since the patient takes priority. Unlike worker resistance, which makes use of strikes and disobedience, the resistance of physicians must work within power structure and never compromise patient care. According to a study by Wyatt et al., “physician resistance includes a refusal to comply with professional expectations of limiting their concerns to the bodily care of patients.” Their review found that physicians have often engaged in resistance when their personal and professional interests were threatened, particularly around issues of autonomy.

Keep calm and carry on?

Despite its name, NHI would not actually provide healthcare insurance – instead Section 33 introduces a financing and single-supplier mechanism reminiscent of Eskom’s doomed model.

For most in the healthcare industry, section 33 is the greatest source of uncertainty and concern. It essentially eliminates medical schemes – but those reallocated funds only account for a fraction of the NHI’s true cost. However, this provision only comes into play once NHI is fully implemented – which could take decades, or just never happen, because of its sheer cost. The real threat, Martin says, is the perception and fear around NHI.

Martin has heard of “very negative consequences,” such as on the “decision on the part of students to study medicine; on professionals to stay committed to being in South Africa, leading to significant emigration on the part of healthcare professionals.

“For me, the real concern is less about whether or not NHI will ultimately be implemented in its current form, because I don’t believe it will be simply because we can’t afford it.”

Even if it is implemented, Martin suspects that many doctors will simple opt to operate on a cash basis, and wealthy individuals would be able to pay for specialists, expensive chronic medications and extended hospital stays. Though with the average age of specialists now at around 61, up from 53 in 1996, they may be in short supply in coming years.

There is also the question over what impact the mere threat of NHI will have on those with money and the ability to invest in the economy. Martin is “very anxious about the push factor associated with the perception that we can no longer get the required healthcare services.”

At some point it becomes a question of whether high net worth individuals can afford to pay for private healthcare, like they currently do for solar panels and generators to deal with the loadshedding crisis, and if that becomes a push factor to make them emigrate, taking their wealth, skills and economic contribution with them.

Implementation is still an open question

The devil is in the details, and in this case it is the thousands of specific regulations which will have to be rolled out in order to turn NHI from a law on paper into an actual functioning system.

Martin believes that it is quite likely that the NHI will end up only being partially implemented, if at all. Many of the requirements are quite steep.

All health users will need to have an electronic health record, for example – it will be a colossal undertaking to link South Africa’s 60 million plus, heavily rural, population, not far off of the UK’s 67 million. Just to get such a system running will take years. Still, a nationwide database would be extremely valuable for healthcare.

Even so, the NHI pilot projects failed to deliver on their promise of patient-centric care; the final report on the NHI Phase 1 interventions found that success was driven by factors which included “strong political will, adequate human and financial resources for implementation, good coordination and communication and good monitoring systems in place at the time of implementation.” Factors which worked against the interventions included “inadequate planning, lack of resources, inconsistent communication a lack of coordination where necessary and insufficient mechanisms to monitor progress to ensure course correction.”

(Of the two groups of factors, government initiatives have almost always landed squarely in the latter category – Ed)

In the end, where is the money?

There also is simply no money for the NHI, which is estimated by the Freedom Foundation to cost up to R1 trillion (more, even, than the much decried public wage bill) for full implementation.

Doctors in many provinces are unemployed as their health departments struggle under budget cuts. The Western Cape for example, has a hiring freeze, creating additional workload as positions go unfilled. The strain is being felt by doctors and nurses in hospitals. Already a petition of 1200 HCPs has been sent to the WC government’s offices. Centralised support from the National Department of Health has, in fact, been going backwards, with a number of wage-related issues being dropped squarely on the, already beleaguered, Provincial departments.

The NHI is also without historical precedent, as Martin says “no country that has introduced a form of National Health Insurance has sought to exclude the ability of the private sector to, in parallel, offer an insured medical service.” Ghana trialled a form of national health insurance, only for it to quietly fade away. The system involved capitation, in which a predetermined flat payment is paid to a provider to cover a defined benefit package of services for a patient. In theory, this forces cost containment onto providers.

It is important to note that schemes on the scale of NHI have only been achieved in a mere handful of countries, a list which consists almost entirely of very wealthy countries, with strong tax bases. South Africa’s situation is very different.

“We have a tiny tax base with a massive disease burden,” Martin points out.

Big in Japan

The country that successfully implemented such an initiative the fastest was probably Japan: “it took them 40 years or so,” Martin noted.

Japan, a country noted for the longevity of its people, has a massive tax base and a tiny disease burden, Martin points out. Indeed, for decades it was the world’s second largest economy. Hardly an act that a developing country like South Africa can try and follow in a matter of years, especially when a wealthy country, like the UK, has been struggling to maintain its own NHS.

The economic consequences of attempting it would be a huge tax increase, with high net worth individuals leaving.

Meanwhile, South Africa is a healthcare tourism destination for residents of wealthy countries that have national healthcare, because it has a world-class private health care industry. That source of international income would also fade away, under NHI.

Stick and carrot: building the NHI that South Africa needs

Nevertheless, there is a way forward to Universal Health Care, through successful public-private partnerships.

SAMA’s position also reflects this. “We believe that any form of health reform must be based on a health system that is built on adequate human resources for health, access to essential drugs, medicines and vaccines, suitably utilising evidence-based policies, ethical leadership and governance, as well as being built on digital and technologically integrated systems,” Mzukwa said.

Once the dust from the election settles, then the time will come for healthcare professionals and associations to properly engage with the government on NHI, as it is faced with the reality of implementation.

In that case, Martin says, once government has “considered the cost more carefully and agreed that they need to be more receptive to offers of collaboration with the private healthcare space,” then it can “accept that medical schemes as we know and understand them today can continue to exist and provide a parallel support to those who can afford to pay for medical schemes.”

What can doctors do? Martin advises that they carry on working through their associations. The various healthcare groupings are collaborating to both benefit the government and also to litigate and challenge the legislation and regulations. But these two aims should not be separated into two separate efforts, he says.

“I think there should continue to be an effort to collaborate collectively, to come up with positive solutions for the benefit of all South Africans. I think equally they will obviously have to, in parallel, to the extent necessary, litigate – I believe litigation is entirely inevitable, but they’ll need to collaborate around that.”

Study Finds Some TBI Patients Could have Recovered if Life Support was Kept on

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Severe traumatic brain injury (TBI) is a major cause of hospitalisations and deaths around the world, affecting more than five million people each year. Predicting outcomes following a brain injury can be challenging, yet families are asked to make decisions about continuing or withdrawing life-sustaining treatment within days of injury.

In a new study published in the Journal of Neurotrauma, Mass General Brigham investigators analysed potential clinical outcomes for TBI patients enrolled in the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study for whom life support was withdrawn. The investigators found that some patients for whom life support was withdrawn may have survived and recovered some level of independence a few months after injury. These findings suggest that delaying decisions on withdrawing life support might be beneficial for some patients.

Families are often asked to make decisions to withdraw life support measures, such as mechanical breathing, within 72 hours of a brain injury. Information relayed by physicians suggesting a poor neurologic prognosis is the most common reason families opt for withdrawing life support measures. However, there are currently no medical guidelines or precise algorithms that determine which patients with severe TBI are likely to recover.

Using data collected over a 7.5-year period on 1392 TBI patients in intensive care units at 18 US trauma centres, the researchers created a mathematical model to calculate the likelihood of withdrawal of life-sustaining treatment, based on properties like demographics, socioeconomic factors and injury characteristics. Then, they paired individuals for whom life-sustaining treatment was not withdrawn (WLST-) to individuals with similar model scores, but for whom life-sustaining treatment was withdrawn (WLST+).

Based on follow-up of their WLST- paired counterparts, the estimated six-month outcomes for a substantial proportion of the WLST+ group was either death or recovery of at least some independence in daily activities. Of survivors, more than 40%of the WLST- group recovered at least some independence. In addition, the research team found that remaining in a vegetative state was an unlikely outcome by six-months after injury. Importantly, none of the patients who died in this study were pronounced brain dead, and thus the results are not applicable to brain death.

According to the authors, the findings suggest there is a cyclical, self-fulfilling prophecy taking place: Clinicians assume patients will do poorly based on outcomes data. This assumption results in withdrawal of life support, which in turn increases poor outcomes rates and leads to even more decisions to withdraw life support.

The authors suggest that further studies involving larger sample sizes that allow for more precise matching of WLST+ and WLST- cohorts are needed to understand variable recovery trajectories for patients who sustain traumatic brain injuries.

“Our findings support a more cautious approach to making early decisions on withdrawal of life support,” said corresponding author Yelena Bodien, PhD, of the Department of Neurology’s Center for Neurotechnology and Neurorecovery at Massachusetts General Hospital and of the Spaulding-Harvard Traumatic Brain Injury Model Systems. “Traumatic brain injury is a chronic condition that requires long term follow-ups to understand patient outcomes. Delaying decisions regarding life support may be warranted to better identify patients whose condition may improve.”

Read more in the study, published May 13, in the Journal of Neurotrauma.

New Drug Improves Oxygen Uptake in Patients with Hypertrophic Cardiomyopathy

Photo by Ketut Subiyanto on Pexels

People with hypertrophic cardiomyopathy were able to use significantly more oxygen while exercising after taking an investigational drug in an international clinical trial, according to a study published today in the New England Journal of MedicineThe finding was also presented at the European Society of Cardiology’s Heart Failure 2024 meeting in Lisbon, Portugal.

The randomised, double-blind Phase 3 trial has 282 participants and is evaluating the experimental drug aficamten, which was developed by Cytokinetics to treat the obstructive form of hypertrophic cardiomyopathy, or HCM.

“By having more oxygen available during exercise, patients with obstructive hypertrophic cardiomyopathy can more easily walk, perform household chores, and do other everyday tasks,” said cardiologist and paper co-author Ahmad Masri, MD, MS. Masri directs the Oregon Health & Science University Knight Cardiovascular Institute’s Hypertrophic Cardiomyopathy Center. “Our latest clinical trial results suggest aficamten is a promising treatment for HCM.”

HCM affects about 1 in 500 people and is one of the most common causes of sudden death for youth and otherwise healthy athletes. Often caused by inherited gene mutations, it thickens heart muscles and makes it difficult for the heart to work as it should. It causes shortness of breath and reduces people’s ability to exercise. The obstructive form of HCM reduces blood flow out of the heart.

About half of the trial’s participants randomised to aficamten. Scientists measured the participants’ oxygen levels while they used treadmills or bicycles. Those who took aficamten had a significant increase in their maximum oxygen use – 1.7mL/kg/min more than those in the control group taking placebo.

Having an increased peak oxygen uptake can improve a patient’s ability to be physically active, whereas reduced oxygen uptake can increase the risk of experiencing heart failure, needing a heart transplant, and dying.

A safer alternative

Non-drug treatment options for obstructive HCM include surgery to remove excess heart muscle. In 2022, the Food and Drug Administration also approved mavacamten as the first drug designed to target the underlying cause of obstructive HCM. However, mavacamten may increase the risk of heart failure and it interacts with several commonly used medications. As a result, patients who use mavacamten must also undergo intense monitoring.

During the past decade, OHSU has been involved in many research studies exploring new HCM treatment options. It has been a centre for several mavacamten studies and is participating in gene therapy research. The university is also currently involved in four other aficamten trials that are evaluating it as a potential treatment for various forms of HCM and in different types of patients, including children.

“This is an exciting time for treating HCM,” Masri said. “While we continue to offer traditional surgical and procedural therapies for HCM, we are now also able to offer patients other treatment options: therapies that were recently approved by the FDA and investigational therapies that are available by participating in clinical trials.”

Source: Oregon Health & Science University

Interferons Drive Lupus Symptoms and Affect Treatment

A woman with Systemic Lupus Erythematosus. Source: Wikimedia CC0

In a new study, researchers from Johns Hopkins Medicine say they have uncovered insights as to why lupus symptoms and severity present differently in individuals with the autoimmune condition. The team says this is a crucial step forward in understanding biological mechanisms behind lupus, and may also lead to shifts in how clinicians treat patients with the condition.

The full report, published in Cell Reports Medicine, concludes that specific combinations and elevated levels of immune system proteins, known as interferons, are associated with certain lupus symptoms such as skin rashes, kidney inflammation and joint pain. Interferons normally help to fight infection or disease, but are overactive in lupus, causing widespread inflammation and damage. The study also shows that other common lupus-related symptoms cannot be explained by increased interferon levels.

“For years, we have accumulated knowledge that interferons play a role in lupus,” says corresponding author and rheumatologist Felipe Andrade, MD, PhD, associate professor of medicine at the Johns Hopkins University School of Medicine. He says this research began with questions about why certain lupus treatments were ineffective for some patients. “We have seen instances where the patient surprisingly didn’t improve – we wondered if certain interferon groups were involved.”

Some lupus treatments are designed to suppress a specific group of interferons, known as interferon I. In clinical trials for these treatments, the team observed some patients failing to improve, despite genetic tests showing high interferon I levels before treatment, or what experts call a high interferon signature. The team believed that two other interferon groups, interferon II and interferon III, may be to blame for these poor treatment responses.

To investigate, the team looked at how different combinations of interferon I, II or III, and their overactivity, may present in people with lupus. Researchers took 341 samples from 191 participants to determine the activity of the three interferon groups, and used human cell lines engineered to react to the presence of each specific interferon group to analyse the samples. Through this process, researchers determined that the majority of participants fell into four categories: those only with increased interferon I; those with a combination of increased interferons I, II and III; those with a combination of increased interferons II and III; or those with normal interferon levels.

Researchers were able to use these findings to also make several associations between these interferon combinations and lupus symptoms. In those with elevated interferon I, lupus was mainly associated with symptoms affecting the skin, such as rashes or sores. Participants with elevated levels of interferon I, II and III exhibited the most severe presentations of lupus, often with significant damage to organ systems, such as the kidneys.

Not every symptom found in lupus was associated with elevated interferons, though. The formation of blood clots and low platelet counts, which also affect clotting, did not have an association with increased levels of interferon groups I, II or III. Researchers say this indicates that both interferon-dependent and other biological mechanisms are involved in this complex disease. The study also found that genetic testing of genes associated with these interferon groups, or the interferon signature, did not always indicate elevated interferon levels. They plan to investigate this in future studies.

“What we’ve seen in our study is that these interferon groups are not isolated; they work as a team in lupus and can give patients different presentations of the disease,” says rheumatologist Eduardo Gómez-Bañuelos, MD, PhD, assistant professor of medicine at Johns Hopkins and the study’s first and additional corresponding author. Evaluating a patient’s elevated interferon combinations allows for a better understanding of how they may react to treatments, and would allow clinicians to group them into clinical subtypes of lupus, Gómez-Bañuelos explains.

Source: Johns Hopkins Medicine

THC Lingers in Breastmilk with no Clear Peak or Decline

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The psychoactive component THC of cannabis showed up in breastmilk in a study published in the journal Breastfeeding Medicine. Unlike alcohol, when THC was detected in milk there was no consistent time when its concentration peaked and started to decline.

Importantly, the researchers discovered that the amount of THC they detected in milk was low – they estimated that infants received an average of 0.07mg of THC per day. For comparison, a common low-dose edible contains 2mg of THC. The research team stressed that it is unknown whether this amount has any impact on the infant.

“Breastfeeding parents need to be aware that if they use cannabis, their infants are likely consuming cannabinoids via the milk they produce, and we do not know whether this has any effect on the developing infant,” said Courtney Meehan, a WSU biological anthropologist who led the project and is the study’s corresponding author.

Since other research has shown that cannabis is one of the most widely used drugs during breastfeeding, the researchers aimed to uncover how long cannabinoids, like THC, persisted in breastmilk.

For this Washington State University-led study, the researchers analysed milk donated by 20 breastfeeding mothers who used cannabis. The participants, who all had infants younger than six months, provided detailed reports on their cannabis use. They collected milk after abstaining from using cannabis for at least 12 hours and then at regular intervals after use. All of this was done in their own homes, at a time of their choosing and with cannabis they purchased themselves.

The researchers then analyzed the milk for cannabinoids. They found that the milk produced by these women always had detectable amounts of THC, even when the mothers had abstained for 12 hours.

“Human milk has compounds called lipids, and cannabinoids are lipophilic, meaning they dissolve in those lipids. This may mean that cannabinoids like THC tend to accumulate in milk – and potentially in infants who drink it,” said Meehan.

The research also revealed that people had different peak THC concentrations in their milk. For participants who used cannabis only one time during the study, cannabinoids peaked approximately 30 minutes to 2.5 hours after use and then started to decline. For participants who used multiple times during the study, the majority showed a continual increase in concentrations across the day.

“There was such a range. If you’re trying to avoid breastfeeding when the concentration of THC peaks, you’re not going to know when THC is at its peak in the milk,” said lead author Elizabeth Holdsworth, who worked on this study while a WSU post-doctoral researcher and is now on the faculty of The Ohio State University.

A related qualitative study by the research team revealed that many breastfeeding moms are using cannabis for therapeutic purposes: for the management of anxiety, other mental health issues or chronic pain. The mothers often chose cannabis over using other medications because they felt it was safer.

“Our results suggest that mothers who use cannabis are being thoughtful in their decisions,” said co-author Shelley McGuire, a University of Idaho professor who studies maternal-infant nutrition. “These women were mindful about their choices. This is far from a random lifestyle choice.”

While in most cases, the women were using cannabis as alternative treatment for a variety of conditions, McGuire pointed out that there is no evidence yet whether it is safer or more harmful. In fact, scientists know almost nothing about how many commonly used drugs may impact breastfeeding babies, partly because women, especially those who are breastfeeding, have historically been left out of clinical trials on medicines.

“This is an area that needs substantial, rigorous research for moms to know what’s best,” McGuire said.

Some research has been done regarding alcohol with guidelines for new mothers to wait at least two hours after consuming alcohol before breastfeeding. Nothing similar has been developed for cannabis, which has been growing in popularity.

The collaborative research team is currently working to address some of that knowledge gap with further research on cannabis use in breastfeeding moms, holistic composition of the milk they produce and its effects on infant development.

Source: Washington State University