Category: Ethics

Medical Bodies Push Back against Commission for Gender Equality’s Statement

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The South African Medical Research Council (SAMRC), along with other professional medical and scientific institutions released a statement  distancing themselves from the Commission for Gender Equality’s (CGE) press release of 16 January, 2022, titled “Warning Against Imposing Mandatory Covid-19 Vaccination on Employees and Students”. [PDF]

The CGE cited an article published in Obstetrics and Gynaecology which found that women receiving Pfizer-BioNTech, Moderna or J&J COVID vaccines, vaccine administration was associated with less than a one-day change in cycle length for both vaccine-dose cycles compared with pre-vaccine cycles. The article concluded that clinically meaningful change in menstrual cycle duration associated with COVID vaccination was found. 

The CGE used this study as justification, cautioning businesses and institutions against mandatory vaccination and recommended against sanctions for employees who chose to remain vaccinated.

The signatories expressed their concern at the contents of the statement which is at odds with the scientific understanding of COVID vaccinations, a concern which is compounded by the “enormous influence” of the GCE.

They accept that the vaccine mandates are subject to legal scrutiny, but take issue with the commission “trying to bolster its argument by wrongly insinuating that COVID vaccination has the potential to harm women’s health.”

They also point out that the commission seems to disregard the much greater risks to women and their unborn babies of COVID infection, while misinterpreting evidence on minor menstrual cycle lengthening. This creates fear and confusion in vaccinated women, and may increase vaccine hesitancy.

“It fails to appreciate that one in six unvaccinated pregnant women admitted to hospital in South Africa with COVID infection requires mechanical ventilation, and one in 16 has a fatal outcome,” the signatories stated.

They noted that COVID vaccination provides upwards of 80% protection against severe disease, hospitalisation and death.

They endorse the view of the College of Obstetricians and Gynaecologists of South Africa, which draws on research of the highest quality, that the menstrual effects are minor.

The evidence is “indisputable” that COVID vaccination is safe, does not negatively affect women’s bodies and saves the lives of women, they stress. Statements to the contrary are strongly repudiated.

“We are of the view that the CGE, like all state institutions, medical and scientific bodies, social partners and civil society formations working in the fields of women’s rights, empowerment and equality, should urge women to get vaccinated and advance and defend their rights to all relevant information about and access to vaccination.”

The signatories call on the CGE to withdraw its 16 January statement and to share with it scientific facts on COVID vaccination and women’s health.

Source: South African Medical Research Council

‘No NGOs Were Ready’, Life Esidimeni Inquest Reveals

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The former Gauteng deputy director-general for mental health services, Hannah Jacobus, has the process to move Life Esidimeni patients was rushed. She was being cross-examined by the State’s Advocate Willem Pienaar.

The much-delayed inquest meant to determine any criminal liability for the deaths of 144 mental health patients in the 2016 Life Esidimeni disaster continued virtually on Monday.

Jacobus’ role was in downscaling of patients at Life Esidimeni for cost savings, and says there was no indication of it closing at the time. When its closure was announced, these downscaling plans were not implemented and there was no timeframe given for when patients were to move out.

The former deputy DG admitted to writing false licences for NGOs, under pressure from then head of Gauteng mental health services, Dr Makgoba Manamelashe. However, Jacobus maintained that while she assessed their suitability, she ultimately did not issue any licences.

Dr Manamela signed licences authorising inexperienced‚ underfunded‚ poorly equipped NGOs to look after patients with profound mental illnesses.

After the Gauteng health department terminated the contract with Life Esidimeni, NGOs were used to care for the 1712 patients.

Dr Manamela admitted to Solidarity advocate Dirk Groenewald that the NGOs to which she gave authority did not comply with the legal requirements. In 2017,  it was found that patients were transferred to NGOs that had been issued “unlawful and knowingly fraudulent” licences.

Many NGOs were subsequently found to be entirely unprepared for the patients they received, some lacking sufficient food, water, medication, staff or blankets.  According to Jacobus, the process have only been completed by 2020 according to the downscaling schedule.

“From December 2015 to the end of March 2016 [is not] a sufficient period to determine and appoint suitable NGOs to receive mental healthcare [patients]. No NGOs were ready by the end of March. We needed more time,” she said.

Source: Times Live

UK Surgeon Who Branded Initials on Livers Struck Off

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A liver surgeon in the UK who branded his initials on the livers of two patients has been struck off the medical register.

The incidents, which occurred in 2013, involved the surgeon using an argon beam machine to write his initials “SB” on the livers of two anaesthetised patients while working at Birmingham’s Queen Elizabeth Hospital. In liver transplants, the argon beams are normally used for cauterisation and to highlight areas to work on.

His actions came to light when 4cm initials were discovered by another surgeonon an organ that had been transplanted by Bramhall and failed about a week after the operation. Pictures of the branding were taken with a mobile phone.

Bramhall tendered his resignation at the Birmingham hospital in 2014.

In a review of the case, the UK’s Medical Practitioners Tribunal Service (MPTS) said it was an “act borne out of a degree of professional arrogance”, adding that his actions “undermined” public trust in the medical profession.

In December 2017, Simon Bramhall, admitted two counts of assault by beating at Birmingham Crown Court and was fined £10 000 (R210 000). In December 2020 , he was suspended from the profession for at least five months, but a report from the latest tribunal on Monday said a review hearing on 4 June found his fitness to practise was no longer impaired by reason of his criminal convictions and his suspension lifted.

After an appeal from the General Medical Council (GMC), the sanction was quashed and then the case resubmitted to MPTS for its consideration.

On Monday, MPTS found Bramhall’s actions “breached” the trust between patient and doctor, and he was struck off.

The MPTS tribunal concluded that a suspension order would be “insufficient to protect the wider public interest” and said erasure from the medical register would be an “appropriate and proportionate sanction”.

Source: The Guardian

Should Unvaccinated-by-choice COVID Patients Get Less Priority?

Credit: ATS

A new opinion piece provides an exhaustive examination of the ethics of using hospital resources on unvaccinated-by-choice COVID patients with pneumonia, versus patients with other serious but slower illnesses.

In his article published online in the Annals of the American Thoracic Society, William F. Parker, MD, PhD, looked at cases in which hospitals delayed time-sensitive and medically necessary procedures for vaccinated adults when they were overwhelmed with unvaccinated patients who had severe, life-threatening COVID pneumonia and suggested an ethical framework for triaging these patients.

“These vaccinated patients are directly harmed when hospitals use all their resources to care for the many unvaccinated patients with COVID,” he wrote.  “For example, delaying breast cancer surgery by just four weeks increases the relative risk of death from the disease by 8%.”

Dr Parker argues for a contingency care standard prioritising emergency life-support, regardless of vaccination status, in order to save the most lives.  “Simply rejecting the use of vaccination in prioritisation of medical resources without analysis ignores the very real tradeoffs at play during a pandemic.  The pain and suffering of the vaccinated from deferred medical care require a deeper defense of caring for the unvaccinated.”

Eliminating double standards
He stated: “Even though the vast majority of patients who develop life-threatening COVID pneumonia are unvaccinated, hospitals still have ethical obligations to expand capacity and focus operations on caring for them—even if it means making vaccinated patients wait for important but less urgent care like cancer and heart surgeries.”

“If tertiary care centers turn inward and stop taking transfers of COVID patients from overwhelmed community hospitals, this will result in de facto triage in favor of lower benefit care and cause systematic harm to both the vaccinated and unvaccinated in vulnerable communities,” he adds.  “Hospitals must justify their nonprofit status by accepting transfers and prioritizing life-saving care during a pandemic surge.”

He cited the example of a surge in Los Angeles, when the public health department had to issue an order forcing elite hospitals to stop doing financially lucrative elective procedures and accept patient transfers from community hospitals with ICUs overwhelmed by COVID.

Reciprocity and proportionality
The principle of reciprocity supports a possible tiebreaker role for vaccination status when two patients have equivalent survival benefit from a scarce health care resource. However, a universal exclusion of the unvaccinated from life support during a pandemic surge fails the test of proportionality for reciprocity, according to Dr Parker.

Reciprocity is rewarding one positive action with another. One example of this principle is giving vaccinated people access to sporting or entertainment events that are off limits to the unvaccinated (even if negative for COVID). Proportionality is the principle that ‘payback’ should be proportional to the magnitude of the act.  For example, living kidney donors get moved way up the waitlist- the equivalent of four years of waiting time on dialysis.  This satisfies the proportionality principle.

Dr Parker points out that while the increased relative risk of death of 8% from deferring breast cancer surgery is awful, the absolute increase in risk is only one per 100, and perhaps only one per 200 for a two-week deferral.
“After the surge is over, the hospital can catch up on deferred elective surgeries,” he wrote. “The harm from a coronary artery bypass or cancer surgery delayed two weeks is real, but tiny in comparison to certain death from denying life support for respiratory failure.”

He concluded that: “There is a defensible role for vaccination status in triage as a limited tiebreaker, not as a categorical exclusion, but only in the context of a well-defined and transparent triage algorithm.  Despite the enormous financial pressure to do otherwise, elite academic centres are obligated to prioritise life support for emergency conditions to save as many lives as possible during COVID surges.”    

Source: EurekAlert!

Healthcare Organisations Urge Review of Culpable Homicide Law

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Nine of South Africa’s leading healthcare organisations have joined together in urging the Government to begin a review of culpable homicide law and its application in a healthcare setting.

In a letter to the Minister of Justice and Correctional Services, Hon Ronald Lamola, the coalition said there is a very low threshold in South African law for blameworthiness when a patient dies while under medical care, which has resulted in errors of judgement in complex healthcare environments being criminalised, and healthcare professionals being convicted regardless of their intent.

The joint letter calls for the review to be carried out by the South Africa Law Reform Commission, due to the complexity of criminal law in a healthcare setting and the importance of achieving a long-term solution for healthcare professionals and patients alike.

The letter says: “It is hard to see who benefits from the current system. As well as families losing a loved one through tragic circumstances, doctors risk losing their career and liberty, and the fear of criminal charges also has a negative knock-on effect on patient care. The current system stands in the way of patients receiving an early apology and a full explanation of events, and thereby denies closure.

In a recent survey of 500 doctors, 88% are worried about investigations after an adverse patient outcome, and 90% think the prospect of criminal investigation affects their mental health. Due to the prospect of criminal investigation means nearly half of all doctors in South Africa have considered leaving the profession. The letter further notes that  4 in 5 doctors surveyed think the criminal justice system in South Africa has an inadequate understanding of medical practice.

Pointing out the need for a “long-term solution”, they write: “Healthcare professionals need to be held accountable, however, criminalising errors of judgement – particularly in this fast moving and complex healthcare environment – seems unreasonably severe. Criminalisation in the absence of any clear intention to cause harm is overly punitive, leaving healthcare professionals vulnerable to criminal charges. Lessons can be learned from other jurisdictions – for example, in Scotland, where charges are only brought against doctors if an act is proved to be intentional, reckless, or grossly careless.

“Our organisations are committed to the highest level of safety for all patients in South Africa. This will however require replacing the current culture of blame and fear with one of learning, where healthcare professionals feel able to apologise and learn from mistakes, which will help to reduce the number of errors and thus enable progress on improving patient safety. When healthcare professionals are allowed and supported to learn from mistakes, lessons are learnt, and patients are better protected in the future.

Highlighting the complexity of these matters, “Patients and clinicians want the same thing, for those in need to receive the best care,” the letter concludes.

The letter was signed by Medical Protection Society, Association of Surgeons of South Africa, Federation of South Africa Surgeons, Radiological Society of South Africa, South African Medical Association, South African Medico-Legal Association, South African Private Practitioners Forum, South African Society of Anaesthesiologists and South African Society of Obstetricians and Gynaecologists.

Source: Medical Protection Society

‘Extensive Network’ of Opaque Medical Industry Ties

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A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!

Violence in the ED: A Critical Issue in Healthcare

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A study by the Mayo Clinic found that most healthcare workers experience violence in emergency departments (EDs), but they seldomly report it to anyone.

Over six months prior to being surveyed, 72% of healthcare workers and other ED staff said they had personally experienced violence (71% verbal abuse and 31% physical assault), Sarayna McGuire, MD, chief resident of Mayo Emergency Medicine in Rochester, Minnesota, reported in a series of three studies at the American College of Emergency Physicians annual meeting.

Nurses and clinicians, along with security personnel, bore the brunt of the attacks: 94% of nurses and 90% of clinicians reported experiencing verbal abuse, and 54% of nurses and 36% of clinicians reported instances of physical assault.

“The whole team is impacted by workplace violence,” Dr McGuire said to MedPage Today. “Even people coming in to draw blood are being assaulted physically and verbally abused.”

Despite this prevalent violence and 58% reporting at least moderate awareness of reporting policies, 77% of all respondents said they never or rarely report violence, while only 10% said they often or always do.

A possible explanation could be that only 7% of non-security staff said they were “extremely familiar” with the procedures. And when participants were asked why ED abuse is not usually reported, the top four reasons given were:

  • No physical injury was sustained (53% of respondents)
  • “It comes with the job” (47%)
  • Staff are too busy (47%)
  • Reporting is inconvenient (41%)

The violence is not without consequences; 18% of respondents said they are considering leaving their position due to the violence, and 48% said violence has changed the way they view or interact with patients.

Men and more experienced staff reported feeling significantly better prepared compared with women. When asked which factors staff thought were most responsible for the violence, the following feature in at least 70% of responses: alcohol, illicit drugs, and significant mental illness.

A total of 86% of respondents said they felt at least moderately prepared to handle verbal abuse, while 68% said they felt prepared to handle physical assault.

“Everyone’s feeling right now that violence has increased in healthcare [during the pandemic], and our data have showed that,” Dr McGuire said. “How is this sustainable? …There is a critical issue in healthcare.”

She added that since reporting of violence is so low, true exposure to violence is probably much higher than the study found.

Study co-author Casey M. Clements, MD, PhD, also of Mayo Emergency Medicine, added that “we know this isn’t isolated to emergency departments.”

He explained that while the study encompassed the pandemic era, violence “has been a problem for some time in healthcare” – violence is a major threat to the healthcare workforce, Dr Clements said. He added that another problem is that physicians typically do not receive any training in de-escalation — “we learn this on the job.”

For the study, the researchers sent an anonymous survey to ED staff at 20 EDs. Also included were social workers, management, and security staff. Women made up 73% of the 833 respondents. Nursing staff (31%) made up the largest medical discipline, and 16% were clinicians.

Dr McGuire suggested that a centralised reporting system would help augment reporting of violence.

“We need to change the mindset that it’s anybody’s job to be assaulted at work,” Dr Clements said. “We cannot go on having our emergency department workers being abused and assaulted on a daily basis.”

Source: MedPage Today

Former Health Minister Mkhize Hits Back at SIU

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An impending legal battle is on the horizon between former Health Minister Dr Zweli Mkhize, the Special Investigating Unit (SIU) and President Cyril Ramaphosa over the government’s Digital Vibes scandal. Dr Mkhize has accused both of having a predetermined conclusion about his alleged involvement in the embattled government contractor.

Dr Mkhize has approached the North Gauteng Court to review and set aside findings and recommendations made against him by the SIU. He has also sought to declare the conduct of the SIU unlawful and unconstitutional. This comes after the SIU investigated alleged irregularities in a tender contract awarded by the national Department of Health to Digital Vibes.

In SIU supplementary documents dated September 30 and filed in Pretoria, the SIU claimed that Dr Mkhize had directly benefited from Digital Vibes transactions as the company paid for electrical repair work at his homes, and also that Dr Mkhize’s family and some of his close associates benefited from the tender and another contract worth R150 million.

SIU spokesperson Kaizer Kganyago confirmed receipt of 800 pages of court documents on Monday, and stated they were ready to oppose them in court.

Dr Mkhize went through some of the SIU’s key findings. alleging that they were markedly different from those put to him during its interrogation.

Dr Mkhize claims he did not derive any personal benefit from Digital Vibes or persons associated with it, and that the SIU failed to address his version of events and withheld evidence he provided to it. Furthermore, he claims he was “ambushed” during questioning as he had no advance warning of the allegations made. He claims some of the key findings by the SIU, in its referral to President Cyril Ramaphosa, were markedly different from those put to him during its interrogation, saying  the SIU failed to disclose allegations made against him by his subordinate, the former Health Department DG, Dr Sandile Buthelezi, on which the findings were drawn.
Mkhize further said that had his submissions and evidence been taken into account by the SIU, the organisation would have come to a different conclusion regarding his alleged involvement in the appointment of Digital Vibes.

Ramaphosa’s spokesperson, Tyrone Seale, said that the Presidency was aware of the matter, but had not been served with papers.

Source: IOL

Inquiry Accuses Brazilian President of ‘Crimes Against Humanity’

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A draft of a major inquiry into the Brazilian government’s handling of the COVID pandemic has recommended that the country’s President Bolsonaro should be charged with several serious crimes over his actions.

The report will be the culmination of a six-month inquiry that has revealed scandals and corruption in the country’s government.

Excerpts leaked to the media indicate that the panel wants Bolsonaro to face nine charges, though initial recommendations that the president be charged with homicide and genocide against indigenous groups were dropped on Tuesday.

The massive and highly unusual 1200 page report urges charges of crimes against humanity, forging documents and incitement to crime. It blames Bolsonaro’s policies for the deaths of 300 000 Brazilians, about half of the current COVID death toll in Brazil, which is the world’s second largest. He repeatedly pushed unproven drugs such as hydroxychloroquine long after they had found to be ineffective.

Despite the serious allegations, what this means for Bolsonaro is unclear, according to the BBC’s South America correspondent Katy Watson.

The draft report will still have to be voted on by the Senate commission, where it could be vetoed and altered. Given the political realities of Brazil, it is unclear if these will ever lead to criminal charges.
President Bolsonaro has dismissed the Congressional inquiry as politically motivated, and has frequently spoken out against COVID interventions such as lockdowns, masks and vaccinations.

In March this year, he infamously told Brazilians to “stop whining” about COVID, a day after the country saw a record rise in deaths over a 24-hour period.

However, Mr Bolsonaro’s popularity has already been dented by the pandemic, and this report could make life much harder for him if he wants to run for a second term in Brazil’s 2022 elections.

Speaking to the BBC in advance of the publication of the report, the inquiry rapporteur, Senator Renan Calheiros, said that the panel wanted to punish those who contributed to “this massacre of Brazilians”.

Source: BBC News

Surveys Reveals Mistrust over Facial Recognition Tech in Healthcare

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Most people have deep reservations about the use of facial recognition technologies in healthcare settings, a survey has found.

Facial recognition technologies – often used to unlock a phone or in airport security – is becoming increasingly common in everyday life, but how do people feel about this?

To answer this, researchers surveyed more than 4000 US adults and found that a significant proportion of respondents considered the use of facial image data in healthcare across eight varying scenarios as unacceptable (15–25%). Taken with those that responded as unsure of whether the uses were acceptable, roughly 30–50% of respondents indicated some degree of concern for uses of facial recognition technologies in healthcare scenarios. In some cases, using facial image data  – such as to avoid medical errors, for diagnosis and screening, or for security – was acceptable to the majority. However over half of respondents did not accept or were uncertain about healthcare providers using this data to monitor patients’ emotions or symptoms, or for health research. 

In the biomedical research setting, most respondents were equally concerned over use of medical records, DNA data and facial image data in a study.

While there was a wide range of demographics among respondents, their perspectives on these issues did not differ. 

“Our results show that a large segment of the public perceives a potential privacy threat when it comes to using facial image data in healthcare,” said lead author Sara Katsanis, Research Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “To ensure public trust, we need to consider greater protections for personal information in healthcare settings, whether it relates to medical records, DNA data, or facial images. As facial recognition technologies become more common, we need to be prepared to explain how patient and participant data will be kept confidential and secure.”

Senior author Jennifer K Wagner, Assistant Professor in Penn State’s School of Engineering Design, Technology, and Professional Programs adds: “Our study offers an important opportunity for those pursuing possible use of facial analytics in healthcare settings and biomedical research to think about human-centeredness in a more meaningful way. The research that we are doing hopefully will help decision-makers find ways to facilitate biomedical innovation in a thoughtful, responsible way that does not undermine public trust.”  

The research team hopes to conduct further research to understand the nuances where public trust is lacking. The findings were published in PLOS One.

Source: Ann & Robert H. Lurie Children’s Hospital of Chicago