With the US Supreme Court’s overturning the Roe v Wade decision, abortion rights are now up to individual US states. However, while there are no legal implications for the rest of the world, it will undoubtedly have a huge influence on other countries’ abortion campaigning and lawmaking decisions. Future anti-abortion efforts in the US may also impact the country’s funding of reproductive services in regions such as Africa.
Without access to legal, safe abortion, many pregnant people will turn to unsafe methods. According to the World Health Organization, 97% of all unsafe abortions happen in developing countries. Some 4.7–13.2% of maternal deaths are attributable to unsafe abortion.
Although Roe v Wade does not have a legal effect in Africa, it was frequently invoked in abortion. Tunisia liberalised its abortion law just nine months after the Roe v Wade ruling – allowing women to access the service on demand. Additionally, in 1986, Cape Verde allowed for abortion on request prior to 12 weeks gestation which aligns with Roe v Wade holding of the same.
In South Africa, the right to abortion is not directly enshrined in the Constitution, but the 1996 Choice in Termination of Pregnancy Act greatly widened accessibility to safe, legal abortions, causing a 90% drop in abortion mortality from 1994 to 2001. The previous apartheid-era laws and their enforcement were predictably stained by racism: abortion was limited to encourage white population growth while contraceptives were promoted to control the population growth of black and coloured people. Wealthy whites could fly to England for an abortion there if they could not arrange one. The 1996 Act was met with significant opposition on religious grounds, and it is speculated that had the ANC done this with an open vote, it would not have passed with such a wide margin.
Even today, research shows that abortion remains highly stigmatised among South Africans, with 75.4% of people surveyed indicating that it was “always wrong” in case of family poverty, and 52.5% indicating the same for either foetal abnormality or family poverty. Provincial splits are apparent, with Gauteng and Limpopo having a > 1 odds ratio of being against abortion.
The 2003 Maputo Protocol adopted by the African Union requires countries to authorise medical abortions in cases of sexual assault, rape, incest, or where the health of the mother is endangered. This specific provision draws from the 1979 United Nations Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW), whose clause on access to safe abortion was based on on Roe v Wade. However, 12 AU members have not ratified the protocol, and many of those who did have not fully brought their laws into line. South Africa is only one of six African nations that effectively allow elective abortions. Of these, Mozambique and Benin only fully changed their laws in 2020 and 2021.
Abortion opponents led by the Catholic Church and its affiliates enjoy widespread political and social support in many African countries. In 2020, Bhekisisa investigated African pregnancy crisis centres funded by US anti-abortion groups. These centres actively discourage abortion, exerting pressure on girls and women and are rife with misinformation, such as grossly exaggerating the size and development of the foetus in early stages of pregnancy. One NGO offered training to say that abortion would “turn” women’s partners gay if they got an abortion.
Thus, while the legal outcome of Roe v Wade being overturned will have no bearing on South Africa, it will conceivably embolden anti-abortion groups both domestically and abroad and likely to increase the influence they already exert in the country.
The Constitutional Court has declined to confirm the constitutional invalidity of sections of the Births and Deaths Registration Act. This comes after the Pretoria High Court found that the Act denied parents the right to bury the remains of a foetus less than 26-weeks.
The application was brought by The Voice of the Unborn Baby NPC and the Catholic Archdiocese of Durban against the ministers of Home Affairs and Health.
The applicants argued that the Act was “insensitive, hurtful and disrespectful” as it only allows for a death certificate to be issued in “stillborn” cases when the foetus is more than 26-weeks.
High Court Judge Nomonde Mngqibisa-Thusi agreed and ruled that sections of the Act are unconstitutional on the basis it “deemed a foetus less than 26-weeks to be medical waste that must be incinerated”.
However, the Constitutional Court, in a unanimous judgment, said the judge was wrong. Acting Judge Pula Tlaletsi said the applicants had submitted that the provisions of the Act had the effect that no burial order could be issued for foetuses lost through miscarriage before the 26-week mark, and that the regulations only made provision for the burial of corpses and human remains, but not foetal remains.
“While it may be true, as the applicants argued, that throughout the years the practice has been to deny parents this right in the apparent belief that this is what the law provides, matters not. The Act contains no such prohibition,” Judge Tlaletsi said.
“The relevant sections cannot be declared inconsistent with the Constitution because of such omission … the Act does not stand in the way of that burial,” he said, noting that the Act only regulated the burial of “dead human bodies or still-born children”.
The Judge said that the court was not in a position to grant the relief.
The question as to what medical staff at public hospitals must do if parents expressed the wish to bury or cremate pre-viable foetal remains was not clear, he said.
“Such a burial or cremation would no doubt require the cooperation of healthcare professionals and public hospitals would be expected to allocate the necessary resources.
“Because of the way the case was pleaded, we do not have the necessary evidence to evaluate considerations relating to how hospitals would manage this … There may be other restrictions, for example, limitations imposed by municipal regulations (regarding cemeteries and crematoriums).”
The Catholic Church, arguing that its members held “sincere religious beliefs” that they become parents from the moment of conception, said the burial right should also extend to lost pregnancies “due to human intervention”, including termination of pregnancies.
But two amici in the case — the Women’s Legal Centre Trust and the Sexual and Reproductive Justice Coalition — said this would have a profound impact on the termination of pregnancy services offered to women, and the attached confidentiality.
This burden, they said, would lead to a decrease in facilities offering termination and a diminution of sexual and reproductive rights.
A Swedish court has convicted Paolo Macchiarini, a formerly lauded trachea surgeon, of causing bodily harm to a patient through negligence during a highly experimental stem-cell trachea transplant. For this, the court handed down a two-year probational sentence. He was acquitted of assault charges on two other patients; all three died in the months and years after the surgeries.
In 2010, Macchiarini was hired by the Karolinska Institute (KI) and the Karolinska University Hospital to support Sweden’s regenerative medicine innovation. His specialty was replacing damaged tracheae with artificial ones that combined stem cells with polymer scaffolds or decellularised donor tracheae. Starting in 2011, he began operating on patients as an experimental life-saving measure but his work at at KI was suspended in 2013 after the second of his three patients died. However, he continued performing surgeries in Russia.
Yet there were already hints that something was amiss even before the first surgeries. In 2011, another academic, Pierre Delaere of UZ Leuven in Belgium accused Macchiarini of misrepresenting research findings in published articles. In 2012, Macchiarini was arrested in Italy and charged with fraud and attempted extortion.
By 2014, after the death of his first patient, three separate allegations were raised of scientific misconduct in reporting the cases. He would later be cleared of these, but in 2016 a TV documentary called ‘The Experiment’ described the suffering and deaths patients of failed artificial tracheas transplants, and raised many issues concerning care and research ethics. The severe public backlash caused KI to launch another investigation into Macchiarini, amid an upheaval which saw a string of resignations and an overhaul of hiring and ethics. He was found to have falsified his CV, and published papers with false or misleading data that were subsequently retracted. By March, he had been fired and criminal charges filed against him.
BBC News reported that at least seven people had died following the surgeries. In 2018, KI found seven researchers guilty of academic misconduct. Swedish authorities decided to reopen investigations into the three deaths.
Matthias Corbascio, a cardiac surgeon at KI who testified in the trial, told SVT Nyheter that he doesn’t believe justice has been done. “My reaction is that it is very meager. It is a terrible scandal and terrible for the patients’ families that he could get away so easily,” he said.
Chief judge Bjoern Skaensberg said the court had agreed with prosecutors that the surgery had not been consistent with “science and proven experience”. However, he told public broadcaster SVT that it had concluded that “two of the interventions were justifiable, but not the third”.
The court had found that all three patients had suffered serious bodily injury, Judge Skaensberg said. But Macchiarini was cleared of assault as no intent to harm had been proven.
Macchiarini had always denied any wrongdoing, arguing that the transplants were aimed at saving the patients’ lives.
However, whistleblower Dr Matthias Corbascio told SVT that the verdict was a scandal and there had never been any chance of the operations succeeding.
The suspended sentence means he will be on probation for the next two years.
A new research paper has signalled a crisis in medical research: “over 60% of trials are so methodologically flawed we cannot believe their results”. Researchers estimate that 88% of trial spending is wasted.
Dodgy research design and bad statistical methodology mean that most randomised trials are a waste of time, money and effort, and of no or dubious scientific value, say Stefania Pirosca, Frances Shiely, Mike Clarke and Shaun Treweek, in a new paper published in the journal Trials in early June.
Their paper examined 1659 randomised trials, involving 400,000 participants, that took place between May 2020 and April 2021 in 84 countries as well as 193 multinational trials.
The majority of trials (62%) showed a high risk of bias. More than half of trial participants were in these high risk of bias trials. Trials where the risk of bias was unclear accounted for 30% of those reviewed, while trials with a low risk of bias – those that can be trusted – accounted for just 8% of the total.
Bad trials – ones where we have little confidence in the results – are not just common, they represent the majority of trials in all countries and across most clinical areas. For instance, all trials looking at drugs and alcohol exhibited a high risk of bias. The most reliable field was anaesthesia, with 60% of trials exhibiting a low risk of bias.
The research team drew trial data from 96 reviews from 49 of the 53 clinical Cochrane Review Groups. Cochrane is an international organisation that helps to gather and propagate the results of medical research to better guide medical decision-making. This is done by experts compiling and evaluating research trials and results in “standardised, high-quality systematic reviews”.
Bad science was common everywhere. “No patient or member of the public should be in a bad trial and ethical committees, like funders, have a duty to stop this happening,” the paper’s authors write.
South Africa was bad, but Spain and Germany may be worse
In the seven trials reviewed that took place in South Africa, four had a high risk of bias, two had an unclear bias risk, and one trial was “good science”. This share of bad science is roughly similar to those found in the clinical trials done in the UK and USA. The most reliable health research science was done in multinational trials – with these, 23% of trials were a low risk of bias. (The authors didn’t identify the trials.)
The least reliable science, in countries that conducted 20 or more RCTs, was done in Spain and Germany, with 86% and 83% of the trials exhibiting a high risk of bias.
While results from just one year were interrogated, the paper’s authors found that their results map to similar studies, and that bad science can be expected to be the norm, over time.
This amounts to a massive waste of money and effort.
Statisticians and research method experts have been sounding the alarm on biased research for years, since Doug Altman’s 1994 paper in the British Medical Journal, “The scandal of poor medical research”.
Doctors want to know if they can rely on a particular treatment to produce a desired outcome, and need research that confers a degree of confidence. One way to do that – the most popular – is randomised control trials.
Randomised trials are great – but you need statisticians
Randomised control trials, also known as randomised trials, or RCTs, are for many (though not all), the gold standard for achieving scientific knowledge about a medical intervention – whether a drug or another type of therapy. The way that RCTs are conducted is crucial, as it is adherence to the method that gives people relying on the research confidence that the results produce scientific knowledge. See this explainer video for more: How do we know vaccines work?
But, if there is a high risk that the results were biased by errors in how they were conducted and how results were achieved, they should not be relied on. Pirosca and colleagues did not examine the type (or domain) of bias in the studies, arguing that having a high risk in one type of bias is sufficient to undermine the trial’s results.
In short, for Pirosca and colleagues, health research in randomised trials is bad when there is an identifiable risk of bias in the way that the results were obtained.
The large number of high risk of bias trials appears to be due to “a lack of input from methodologists and statisticians at the trial planning stage combined with insufficient knowledge of research methods among the trial teams”. You would not, they say by analogy, think it appropriate that a statistician conduct surgery, just because they are doing work in a surgical domain.
Bad science during COVID
Recent medical scandals in the headlines have highlighted the risks of bad science in medicine. The Covid pandemic has brought a boom in medical research, and popular attention to the results of medical research. This environment has produced some remarkable science, but it has also created scientific fiascos, like the one that surrounded ivermectin.
As GroundUp has previously reported, a review of studies investigating ivermectin as a possible therapy for Covid initially suggested that the deworming drug led to better outcomes in those that used it. On the face of it, the small studies that supported this conclusion seemed to provide promise for a low-cost, life-saving Covid intervention. But once the methodology and statistics were looked at closely, many of these papers were deemed unscientific – for instance, patients were excluded from analysis for no good reason. And once these trials were excluded from the review, the drug’s promise as a Covid treatment vanished.
Medical research watchdog Retraction Watch currently lists 12 papers purporting to investigate ivermectin that were subsequently withdrawn or for which concerns have been expressed. According to their records, 235 Covid papers have been withdrawn to date.
But the crisis is not insurmountable. Pirosca and colleagues say that relatively simple fixes would dramatically reduce the amount of untrustworthy health research – by ensuring that methodological principles that underlie RCTs are not compromised.
More expenditure on statistical expertise will save money
A 2015 review examined 142 trials that exhibited a high risk of bias. The authors found that in half of the high risk trials, the methodological adjustments required to reduce the risk of bias would have been low or zero cost. Easy adjustments at the design stage would have made important improvements to 42% of trials that exhibited high risk of bias.
Pirosca and colleagues propose that no medical RCT should be funded or given ethical approval if it cannot prove that the team conducting the trial has a member that has methodological and statistical expertise. Every RCT should, in its design, use risk of bias tools to make sure that results are not compromised.
The expertise that could restore the worth to medical research is in short supply.
More methodologists and statisticians are needed, and money should be invested in training people with this expertise, and investing in applied methodology research and supporting infrastructure. The authors call for 10% of a funder’s budget.
This might seem like a lot of money, but, argue Pirosca and co, it would be a fraction of the cost of the wasted research in the year under review – estimated to be billions of rands.
The task is urgent: “Randomised trials have the potential to improve health and wellbeing, change lives for the better and support economies through healthier populations … Society will only see the potential benefits of randomised trials if these studies are good, and, at the moment, most are not.”
Judge Edwin Cameron, Inspecting Judge of Correctional Services, writes about the need for healthcare professionals working in prisons should be shifted to the Department of Health.
Our country’s healthcare system is a cumbersome double-deckerbus: on top are those of us who have access of some kind to private healthcare (a high estimate is around 27% of the population). The great majority of necessity rely on public healthcare. But, within public healthcare, there is a further divide, an overlooked layer at the very lowermost – the healthcare afforded to people in prison.
During apartheid, healthcare for those inside prison and in police custody was used as a “tool of manipulation and coercion”. There was medical negligence, poor quality care, false medical and autopsy reports, and warped medical ethics. (Bram Fischer, in his dying days, received no treatment for his crippling cancer).
Some doctors and other medics were complicit in abuses, turning a blind eye to what was happening before them.
The Truth and Reconciliation Commission (TRC) Special Hearings on Prisons showed how basic access to medical treatment was used to punish. Henry Magkothi recounted how difficult it was to gain access on Robben Island to the hospital. “The doctor didn’t come often enough and even then there were so many obstacles they placed in your way.”
Not only did doctors have to have security clearance to work in prisons, but there were split institutional loyalties. Some health professionals were employed by the Department of Health and others by the Department of Prisons (now the Department of Correctional Services — DCS). This led to a dilemma of “dual obligations”, where the lines of authority for healthcare and custodial care were blurred. Health professionals owed loyalty to their patients (the inmates). But they had obligations to, and pressure from, their employers (the prison authorities).
Healthcare must be separated from prison administration
This blighted history led Dr Judith van Heerden, an expert in this area, to recommend to the TRC that prison healthcare “must be separated completely from custodial care”. All healthcare professionals in prisons “should be appointed, paid and responsible to the Department of Health” – and no longer to the prison authorities.
The TRC embraced this sound advice in its recommendations. It suggested that: the Department of Health should assume control over prison healthcare; prison health responsibilities and obligations should be clearly defined with an independent line of authority.
These recommendations accord with international guidelines. The UN Mandela Rules entail a demarcation between healthcare and custodial care; there shall be “full clinical independence”. Healthcare professionals “shall not have any role in the imposition of disciplinary sanctions or other restrictive measures”. And clinical decisions may only be taken by healthcare professionals “and may not be overruled or ignored by non-medical prison staff”.
Experts have underscored the importance of providing health services in prison that are separate from the prison administration. The World Health Organisation and the United Nations Office on Drugs and Crime note that healthcare professionals should act “completely independent of prison authorities” and in “alignment with public health services.”
Furthermore, the Association for the Prevention of Torture advocates for the “integration of the prison health service into the national health service” to guard the “professional and ethical independence of the health staff” and “provide recourse to an independent body in case of conflicts.”
Did democratic South Africa heed this advice? No.
Medical ethicist Professor Solomon Benatar observes that the Department of Health “began to dismantle the District Surgeon Services” and “[i]t became possible for DCS to appoint nurses and other medical staff to deliver healthcare” in our prisons.
This is evident in the plain wording of the Correctional Services Act of 1998. Section 12(1) states that DCS “must provide, within its available resources, adequate health care services” and section 12(2)(b) outlines that medical treatment “must be provided by a correctional medical practitioner, medical practitioners or by a specialist or health care institution or person or institution identified by such correctional medical practitioner”. And according to section 12(3), if an inmate opts to be “visited and examined by a medical practitioner of [their] choice” it is “subject to the permission of the Head of Centre”.
Post-apartheid, healthcare in prisons is still not independent. Benatar slates this “retrogressive step”; “diverting some responsibilities for healthcare away from the Department of Health” and towards DCS, diminishes the “loyalty of some health professionals” as it ranks “allegiance to prison authorities higher than professional responsibility to patients.”
A special duty of care
In his book Health and Health Promotion in Prisons, Professor Michael Ross states that depriving inmates of liberty does not mean we may deprive them of access to healthcare. On the contrary, their deprivation of liberty means we owe them a “special duty of care”. Critically, Ross acknowledges that we provide “good care to bad people because we are professional, and because we, and they, are human” and if bad care is given “the humanity we degrade is also ours, not only theirs”.
Those in prison should have the same quality of healthcare as the public outside. This is the “equivalence of care” principle. It means that you don’t add poor healthcare treatment on top of imprisonment to punish. As I have written before, “prison health affects our health” and “equivalence of care” should be considered a minimum threshold. In light of the higher mortality rates in prisons; government may have to provide higher standards of healthcare in prisons.
We know that injuries and the use of anti-depressants are warning signs of trouble. Many cases of claimed abuse (especially sexual violations, assaults, use of force and torture) are reported to nurses and doctors. Later, investigators, both internal and external, rely on medical reports. Ross emphasises that one must ensure health assessments of inmates are based on medical criteria and inmates ought to trust their healthcare providers and feel safe to report and speak out about abuse.
In addition, nurses, psychologists and other medical practitioners play a role in how prisons are run. For example, they are expected to visit inmates in segregation (sometimes in solitary confinement). The Act provides that segregation “must be discontinued” if medical practitioners determine that “it poses a threat to the health of the inmate”.
Further, independent healthcare can provide another significant layer of independent monitoring over our closed-off prisons.
Two parallel healthcare systems are not advisable. Does DCS have adequate training facilities to ensure training and updates on clinical care for clinicians on its payroll? The Judicial Inspectorate for Correctional Services (JICS), which I head, believes not. DCS clinicians often miss out on training opportunities. Further, DCS’s data systems are standalone – they are not linked to the Department of Health’s facilities (connecting them would ensure continuity of care when inmates are released).
And a heartening thought – why not allocate community service doctors to prisons? This would alleviate costs and skills scarcity.
The state of healthcare in our prisons
Grievously, our prisons are a microcosm of all our country’s social ills. This is true of healthcare, but perhaps it is worse, since, notoriously, prisons are epidemiologic pumps for the spread of infectious viruses and diseases.
The 2020-2021 annual report of the Judicial Inspectorate for Correctional Services paints an agonising picture of the state of prison healthcare.
Inmates do not get regular access to nurses and doctors, clinics in prisons are cramped and there is limited privacy for consultations, correctional officials are not always available to escort inmates to healthcare facilities, medications are not always dispensed on time, some medications have expired, health check-ups and screenings upon admission are not always conducted and medical files are not always updated.
Healthcare professionals in prisons, especially psychologists and social workers, are working with a desperate population. In the single year covered in the report, JICS reported 86 hunger strikes, 66 attempted suicides and 27 suicides. According to DCS’s annual report “suicide is the leading cause of [unnatural] deaths in correctional facilities”.
JICS’s recent quarterly report lists 40 unnatural deaths. We don’t know the cause of most; seemingly healthy inmates died. This requires JICS’s close investigative scrutiny of the post-mortem and medico-legal documents, which are in the hands of DCS and sometimes mysteriously go missing.
Further, there were 113 deaths as a result of natural causes, including pneumonia, cancer, meningitis, septicaemia and asthma. Could some of these deaths have been avoided with early detection, close monitoring and regular access to medical assistance? JICS thinks so.
JICS is also alarmed by the 116 declared state patients in prison; these are individuals whom the courts have found are suffering from mental unwellness challenges. As they wait indefinite periods for a transfer to a psychiatric hospital, they are wrongly housed in correctional facilities. State patients should not be a DCS responsibility. JICS has raised its voice on this: correctional facilities are not conducive for state patients, and correctional officials and fellow inmates are not trained to properly accommodate them.
To end off
While inspecting prisons, I have met passionate nurses and committed doctors. Prisons are tough, dangerous and complicated places. I acknowledge that DCS has worked hard to progress in dealing with Covid, HIV and TB behind bars. But we have to do better.
We need institutional reform. Healthcare professionals working in prisons ought to be independent of DCS. This means shifting all healthcare professionals to the Department of Health and ensuring proper channels of authority and oversight within prisons. In addition, healthcare professionals need specific and ongoing training for the prison environment. We also need more healthcare professionals working in prisons – and they must be accessible, proactive and willing to speak out.
That takes us back to where we started. Our Department of Health must be well-resourced, well-capacitated and well-run – and healthcare professionals must be trained and supported and have job security. And this goes to the heart of whether we have a capable state, strong institutions and a culture of accountability.
Judge Cameron is Inspecting Judge of Correctional Services.
Views expressed are not necessarily those of GroundUp.
In an opinion piece, Neil Tabatznik reflects on how starting the Tshemba Foundation reignited his passion for his native South Africa.
South Africa is not only the most unequal country in the world, it also does not care well enough for its weak and sick. Its inequitable access to healthcare is iniquitous in many parts of the developing world. But to me, a former South African who left the country during one of South Africa’s darkest periods in history, which was rife with government oppression at the time, it reflects the legacy of apartheid.
Having departed for England in 1971, where I practiced law before leaving for Canada, South Africa became a distant and awful memory: I had planned to leave and never come back.
I stayed away for 36 years and cut all ties with the country.
However, seventeen years ago, I returned to South Africa, for personal reasons: my son’s bar mitzvah. With family dispersed across North America, Europe and Australia, South Africa felt like a central place to congregate. It was during the new, post-apartheid period in South Africa that I fell in love with the country all over again.
I started the Tshemba Foundation in Hoedspruit, Mpumalanga, out of complete selfishness initially: It was an excuse to come back to South Africa, while doing good.
At the time, The Tshemba Foundation approached the provincial health department, pitched the concept and offered to bring skilled medical volunteers to the region – and a partnership was born.
The Foundation operates a medical volunteer programme that serves as a model of public-private partnership in the healthcare sector. Initially, I had reached out to colleagues and friends approaching retirement in the UK and Canada, recognising that they had immense skills, time on their hands, and could easily be enticed to come and help while staying at a lodge we had set up on a game reserve in South Africa. The Health Professions Council of SA (HPCSA) proved to be a barrier to this idea, because they refused to register any doctor who had left SA during the Apartheid era (intending never to return) demanding that they pay membership fees accruing during the intervening years. Although this barrier remains, we have still been able to recruit hundreds of volunteers from South Africa and abroad.
Designed to connect skilled professionals from the medical and allied professions with a desire to give back to rural communities in need, we have operated out of the Tintswalo Hospital, a 423-bed public hospital, and surrounding clinics, since 2017.
The Foundation relies on medical volunteers to bridge the gaps in patient care in rural Mpumalanga: Professionals who give up their time and expertise to bring value to underprivileged and underserved communities, while supporting existing staff with training, educational opportunities and fresh perspectives. We assist volunteers with HPCSA registration, to allow them to volunteer in South Africa, but they have to make their own way to Mpumalanga and are provided with free lodging.
Tintswalo Hospital is one of the biggest in the province, serving a rural, underserved population of about 300 000. The hospital has no specialist doctor posts, and if any staff member leaves, from groundsman to senior doctor, it is extremely difficult to replace them due to severe budgetary constraints.
Our “leave of purpose” programme recruits both local and international medics to volunteer their services in these rural areas. They cover a wide range of disciplines, from generalists and dentists to ophthalmologists that perform cataract surgeries and specialist researchers who are spearheading a rural ultrasound project.
Our flagship projects, offered in partnership with the Mpumalanga Department of Health and Tintswalo Hospital, are a state-of-the-art eye clinic and cataract operating theatre, which screens and remedies common, treatable eye diseases, and the Hlokomela Women’s Clinic where pap smears, cryotherapy, and breast, pelvis, abdomen and pregnancy ultrasounds are offered. Women no longer need to travel vast distances to receive screening and treatment: they can get such specialist care at Tintswalo.
Tshemba’s eye clinic volunteers have helped over 700 elderly patients – many of whom were being cared for by grandchildren and other family members, thereby depriving them of access to education and employment.
The programme would not have been possible without the cooperation and enthusiasm of medics, the community, the Mpumalanga Department of Health and international benefactors.
To date, we have attracted about 200 local and global volunteers, mostly from the US, Canada, Europe and Australia, who have devoted the equivalent of over 9,000 healthcare professional days, treated 19,630 patients and held 294 training sessions. These training sessions not only assist local healthcare professionals with continuing professional development and informal clinical teaching, but they also ensure that the Foundation makes a lasting and sustainable impact on the quality of rural healthcare.
Now, the challenge is to make The Tshemba Foundation sustainable. We are registering it as a charity in the UK, Canada and the United States, but we need more support.
We hope to strengthen our relationship with the province to improve healthcare, without flooding hospitals with volunteers. Instead, we would like to build on the power of the clinics by posting medics to smaller healthcare centres.
Our work makes a real difference, not only in the lives of the communities who lack access to healthcare that people in urban centres take for granted, but also in the lives of those who volunteer their services.
The existing children of a woman who agrees to a surrogate pregnancy must be psychologically assessed before an agreement can be sanctioned. This is according to a recent ruling by Judge Brenda Neukircher at the High Court in Pretoria.
In her ruling, Judge Neukircher laid down further guidelines to be followed in surrogacy agreements which come before courts for approval. Some of the guidelines are in terms of the Constitutionally-entrenched principle of the “best interest of the child”.
Judge Neukircher ruled that, “Were it to be found that the surrogacy may have a harmful effect on their psychological well-being, this would be a factor that a court would be able to weigh up in the consideration of whether the agreement should be confirmed or not.”
Setting out the history of surrogacy laws in South Africa, Neukircher said that one provision was that a surrogate mother must have a documented history of at least one pregnancy, a “viable delivery”, and a living child of her own.
Neukircher noted the importance for the courts to consider the impact a surrogate pregnancy would have on the woman’s existing child or children. “How does a surrogate pregnancy affect the surrogate mother’s own child/children? Bearing in mind that they watch her pregnancy for nine months, know she is carrying a child and see her going to hospital to deliver a baby and then comes home without a baby in her arms. Is it important that the interest of these children be protected and, if so, how does a court do that?” she stated.
The applicants in the matter before Neukircher were financially stable. They already had a ten-month-old baby born through a previous surrogate arrangement with the same surrogate mother. The surrogate mother had previously been a surrogate for other couples and had once given birth to twins.
Neukircher said the couple had one frozen egg left and now wanted another child with the surrogate mother. “In all respects, they function as a stable family unit and I’m satisfied that they are able to care for a second child financially, emotionally, physically and educationally. Any child that will be born of this surrogacy will have his/her best interests catered to in every aspect of the (Children’s Act),” the Judge said.
Turning to the surrogate mother, Judge Neukircher said she was married and had two children of her own aged ten and seven years old. “At the time of the first surrogacy, they were six and three. Each time their mother carries a child as a surrogate, they are confronted by her pregnancy which does not end in a child being brought home to join their family. My concern was how healthy, psychologically, it is for children to go through this process?”
Neukircher said she had ordered that expert reports be compiled on the surrogate’s physical suitability to have another child, and the effect, if any, of her surrogate pregnancies on her own children.
She said the report revealed that both the surrogate’s children did not want her to have more children of her own. “Both were proud of the fact that she was helping others have a family and it seems both have adjusted to the fact that she acts as a surrogate….they do not see [the babies] as being part of their own family….they do not want their mother to bring baby home”.
She said the “invaluable report” highlighted the importance that the children of surrogate mothers needed to be prepared for the pregnancy “which goes a long way to alleviating any possible anxiety”.
The Judge said lawyers for both the commissioning parents and the surrogate mother and her husband had agreed that in not requiring such expert reports, the legislature had overlooked the “best interests” principle when it came to existing children. She said the Act laid down compliance factors for surrogacy agreements, including that a court must consider the personal circumstances and family situation of all concerned.
Going forward, Neukircher said, this must include an assessment of children already born. In this matter, she granted an order confirming the agreement.
Researchers evaluating a random selection of clinical trials done in North America found that they neglected to take into account previous or ongoing trials, which may result in researchers conducting redundant or less impactful studies. The findings were published in the journal Med.
Clinical trials are a crucial tool for assessing the safety and efficacy of medical interventions, but sponsors often provide incomplete information for assessing their ethical justification. Incomplete portrayals of supporting evidence hamper the ability of individuals or authorities to evaluate the trials’ risks, benefits, and scientific merit.
To assess the prevalence of such omissions, researchers accessed the ClinicalTrials.gov registry and evaluated 101 randomly chosen clinical trials. Among those where there was at least one previous trial testing the same drug in the same disease, 30% of industry-sponsored trials and 20% of non-industry-funded trials failed to cite related studies. “Clinical trial protocols undercite easily accessible, relevant trials and do not document systematic searches for relevant clinical trials,” the authors wrote.
“Numerous studies suggest that some clinical trials are pursued despite their clinical hypotheses having been resolved prior to study launch,” write the authors. “Failure to provide a complete and impartial account of prior and ongoing research in study protocols may enable clinical research that fails to inform clinical practice.”
The data underpinning a controversial study of the use as vitamin C as a sepsis treatment may in fact be fraudulent, according to an analysis by an Australian physician and statistician, reports MedPage Today.
PhD student Kyle Sheldrick, MBBS, alleges that the pre- and post- comparison groups involved in the 94-patient study were too similar to be realistic.
In an interview with MedPage Today, Sheldrick said the case is “extreme”, stating that “This is probably the most obviously fake data I have seen. … These groups are more similar than would be probable.”
The paper, led by Paul Marik, MD – who led another COVID protocol study that has since been retracted – has been the subject of much debate in the intensive care community since it was published in 2017. The so-called HAT protocol was a simple regimen of hydrocortisone, ascorbic acid (vitamin C), and thiamine which could have saved many lives easily if it indeed worked. Obviously, there was much excitement worldwide about the significance of the findings – but not all were convinced.
“The effect size seemed just impossible,” said Nick Mark, MD, an ICU physician at Swedish Medical Center. “It seemed too good to be true.”
The trial was followed by larger studies, and so far none have shown shown a similar reduction in mortality, raising suspicions even further, Dr Mark said. With Sheldrick’s analysis, the penny dropped: “This was under our noses for 5 years,” Mark said. “This isn’t just a mistake. We know things can be done unethically, but to actually fake it? That it’s not just flawed, but perhaps actually fraudulent?”
Sheldrick told MedPage Today the key problem with the Marik paper is “probably the most common sign of fraud that we see, which is overly similar groups at baseline.” That is, people tend to fake data which do not vary enough from the average.
Sheldrick said he first looked at the study methods, which noted a pre- and post- comparison design, rather than a randomised or matched case-control design. With such a design, one would expect a more random distribution of baseline characteristics, but that wasn’t the case for the Marik paper, he said.
A further analysis with Fisher’s test showed that most P-values were 1, meaning they were distributed perfectly evenly across two time periods – and only one fell below 0.5. Instead, an even spread should be expected with an overall value of 0.5.
Sheldrick sent his findings to the journal CHEST and to Marik’s former employer Sentara Norfolk General Hospital, but had not heard back from either.
While Sentara Norfolk General Hospital did not respond to comment, and the journal CHEST could not confirm whether an investigation was underway but that it did take ethical concerns very seriously.
A spokesperson for Dr Marik emailed a statement to MedPage Today, claiming that the conclusions had been validated in several meta-analyses, and recommended the source examine “this and other research on the data before making false allegations on social media. Such claims are harmful and do not add to the public discourse.”
This wouldn’t be the first time concerns have been raised about data in a paper that Dr Marik co-authored. In November 2021, the Journal of Intensive Care Medicine (JICM) retracted an article by Marik and others on their MATH+ protocol for COVID. The retraction followed a communication that raised concerns about the accuracy of COVID mortality data from the hospital used in the article.
“It seems a bit improbable for someone to discover two miracle cures in three years,” Dr Mark commented to MedPage Today.
Dr Mark noted that the 2017 paper is widely cited, and even if the intervention was not directly harmful, the resources invested in subsequent large, high-quality trials of vitamin C and sepsis could have been better spent.
“While I’m really glad we did high-quality studies and had brilliant people working on this, it’s kind of a shame,” he said. “Instead of studying vitamin C based on a faulty premise, we could have spent our efforts elsewhere.”
Medical experts who were under the impression they were contracted by the Road Accident Fund (RAF) to provide expert medical opinions, have written to acting chief justice Raymond Zondo to withdraw their completed opinions that have not yet been used in court because the RAF refuses to pay them or has charged penalties to reduce the amounts owed.
These qualified specialists provided expert medico-legal services, such as consultations and injury assessments, preparation of expert witness reports, attended expert witness meetings, prepared joint minutes of expert meetings, and presented expert evidence in court for the former panel of attorneys rendering this service for the RAF.
The experts say they have had enough of struggling for payments from the RAF and they state in the letter that their work “may not and should not be used as evidence in any matter” in the future because it is said to be unauthorised and not paid for. In effect, this means that RAF cases can no longer progress until these experts have been paid or until new medical expert opinions are obtained.
The RAF only recently informed all medical experts appointed by its former panel of attorneys that they were not authorised to perform these services which were conducted since 2015 and will therefore not be paid.
Mariëtte Minnie, director of MMB Made Easy, which handles medical accounts of medical-legal service providers says accounts she deals with have a total outstanding value of R63.5 million, with some accounts dating back as far as 2015. The biggest outstanding balance among her clients is R10,7 million the RAF owes to one neurosurgeon.
As a result of ongoing non-payment, some experts have shut down and sold their houses and cars due to huge overdrafts and VAT owed to SARS for opinions for which the RAF has not yet paid.
Minnie adds, “The RAF has stolen thousands of medico-legal reports from hundreds of experts which they do not intend to pay for.”
Medical experts have always been instructed by the panel attorneys as RAF representatives, but the RAF never renewed its expert contracts in time. The RAF then terminated the services of the panel of attorneys who had to obtain RAF authorisation for the experts but still asked experts to continue assessing claimants to avoid delays and send their reports directly to the RAF.
Minnie says that invoices for work done in previous years are met with delaying tactics and even denial of payment. “The RAF now implements terms of the service level agreement with the experts to fine them with 5% for every day that their reports are submitted after the due date although submission of reports is subject to factors such as obtaining necessary documentation to finalise the report.”
The RAF has also instituted steps to eradicate “irregular expenditure”, suggesting that experts assessed claimants and wrote reports without authorisation although the RAF failed to implement adequate systems to instruct and remunerate them.
Minnie comments, “The RAF is shambolic and has been unable to operate ethically or effectively since 2015. We will also be bringing this matter to the attention of the Minister of Transport, the Special Investigations Unit, the Public Protector, the National Prosecuting Authority and the National Treasury. New leadership is required to turn around the RAF.”
