The Health Professions Council of SA (HPCSA) has caught out another individual impersonating a doctor. Mr Tshifata Katembwe, a Congolese national, was practising illegally in Kuruman, Northern Cape while not being accredited with the Council, said spokesperson Christopher Tsatsawane.
According to IOL, since January 2022. Mr Katembwe had been working at a medical practice registered under the name of Dr TK Gopane. This was in in contravention of Section 17(1) of the Health Professions Act, 56 of 1974, said Tsatsawane.
The nationwide crackdown on health-care practitioners operating illegally is gaining momentum with arrests made around the country, Health Professions Council of SA (HPCSA) has noted.
Katembwe appeared before the Kuruman Magistrate’s Court last week, and his case was postponed. Meanwhile, Dr Gopane, registered with HPCSA as a medical practitioner, is to be reported to the Medical and Dental Professions Board for appointing an unregistered person and putting unsuspecting members of the public at risk.
In a separate incident, HPCSA announced the arrest of Mr Simba Koromani, an undocumented Zimbabwean national who applied to practise by using the credentials of Dr Lesne Pucjlowski. The doctor notified the HPCSA that someone had tried to apply for a job with her credentials, which led the Council to collaborate with police in tracking down and arresting the fraudster.
Researchers report in Nature Ecology and Evolution that human DNA traces can be found nearly everywhere, short of isolated islands and remote mountaintops. That ubiquity is both a scientific boon and an ethical dilemma, say the University of Florida researchers who sequenced this ‘errant’ DNA. The DNA was of such high quality that the scientists could identify mutations associated with disease and determine the genetic ancestry of nearby populations. They could even match genetic information to individual participants who had volunteered to have their errant DNA recovered.
David Duffy, the UF professor of wildlife disease genomics who led the project, says that ethically handled environmental DNA samples could benefit fields from medicine and environmental science to archaeology and criminal forensics. For example, researchers could track cancer mutations from wastewater or spot undiscovered archaeological sites by checking for hidden human DNA. Or detectives could identify suspects from the DNA floating in the air of a crime scene.
But this level of personal information must be handled extremely carefully. Now, scientists and regulators must grapple with the ethical dilemmas inherent in accidentally — or intentionally — sweeping up human genetic information, not from blood samples but from a scoop of sand, a vial of water or a person’s breath.
The paper by Duffy’s group outlines the relative ease of collecting human DNA nearly everywhere they looked.
“We’ve been consistently surprised throughout this project at how much human DNA we find and the quality of that DNA,” Duffy said. “In most cases the quality is almost equivalent to if you took a sample from a person.”
Because of the ability to potentially identify individuals, the researchers say that ethical guardrails are necessary for this kind of research. The study was conducted with approval from the institutional review board of UF, which ensures that ethical guidelines are adhered to during research studies.
“It’s standard in science to make these sequences publicly available. But that also means if you don’t screen out human information, anyone can come along and harvest this information,” Duffy said. “That raises issues around consent. Do you need to get consent to take those samples? Or institute some controls to remove human information?”
Duffy’s team at UF’s Whitney Laboratory for Marine Bioscience and Sea Turtle Hospital has successfully used environmental DNA, or eDNA, to study endangered sea turtles and the viral cancers they are susceptible to. They’ve plucked useful DNA out of turtle tracks in the sand, greatly accelerating their research program.
The scientists knew that human eDNA would end up in their turtle samples and probably many other places they looked. With modern genetic sequencing technology, it’s now straightforward to sequence the DNA of every organism in an environmental sample. The questions were how much human DNA there would be and whether it was intact enough to harbor useful information.
The team found quality human DNA in the ocean and rivers surrounding the Whitney Lab, both near town and far from human settlement, as well as in sand from isolated beaches. In a test facilitated by the National Park Service, the researchers traveled to part of a remote island never visited by people. It was free of human DNA, as expected. But they were able to retrieve DNA from voluntary participants’ footprints in the sand and could sequence parts of their genomes, with permission from the anonymous participants.
Duffy also tested the technique in his native Ireland. Tracing along a river that winds through town on its way to the ocean, Duffy found human DNA everywhere but the remote mountain stream where the river starts, far from civilization.
The scientists also collected room air samples from a veterinary hospital. They recovered DNA matching the staff, the animal patient and common animal viruses.
Now that it’s clear human eDNA can be readily sampled, Duffy says it’s time for policymakers and scientific communities to take issues around consent and privacy seriously and balance them against the possible benefits of studying this errant DNA.
“Any time we make a technological advance, there are beneficial things that the technology can be used for and concerning things that the technology can be used for. It’s no different here,” Duffy said. “These are issues we are trying to raise early so policy makers and society have time to develop regulations.”
In the US, drug approval needs “substantial evidence” of effectiveness – but an investigation by The BMJ into the recent approval of the antibiotic Recarbrio from Merck suggests that these standards are being bypassed.
Recarbrio is a combination therapy made up of a new beta-lactamase inhibitor (relebactam) and a decades old Merck antibiotic (imipenem-cilastatin) to treat complicated infections. It costs $4000–$15 000 for a course, compared with a couple of hundred dollars for the generic version of Merck’s old antibiotic.
Peter Doshi, senior editor at The BMJ, describes how US Food and Drug Administration (FDA) scientists had serious doubts about its highly expensive Recarbrio but the agency approved it anyway.
Did the FDA break its own rules in approving this antibiotic, and what does this case tell us about problems within the agency, he asks?
In its FDA application, Merck submitted results from two clinical trials comparing Recarbrio with imipenem in adults with complicated urinary tract infections and in patients with complex intra-abdominal infections.
But FDA reviewers noted that Merck had studied the wrong patient population to evaluate the added benefits of the new drug, and said the trial for urinary tract infections showed that Recarbrio was as much as 21% less effective than the older, cheaper imipenem.
The FDA concluded that “these studies are not considered adequate and well-controlled.” And of a third clinical study, the FDA called it a “very small,” “difficult to interpret” “descriptive trial with no pre-specified plans for hypothesis testing.”
Yet despite all three clinical studies not providing substantial evidence of effectiveness, FDA approved Recarbrio.
“Instead of basing its decision on the clinical trials in Merck’s application, FDA’s determination of Recarbrio’s efficacy was justified on past evidence that imipenem was effective, plus – to justify the new relebactam component – in vitro (lab) studies and animal models of infection rather than evidence from human trials as required by law,” writes Doshi.
Others are concerned that Recarbrio’s approval essentially amounts to a return to a way of regulating medicines that the FDA abandoned a half century ago prior to the agency’s “substantial evidence” standard.
Doshi explains that, under specific circumstances, the Director of the Center for Drug Evaluation and Research (CDER) can waive in whole or in part the FDA’s “adequate and well-controlled studies” approval criteria. But the FDA told The BMJ ”there was no center director memo in the file” for Recarbrio.
And when The BMJ contacted Janet Woodcock, CDER Director at the time, and now the FDA’s Principal Deputy Commissioner, she said she was not aware that clinical studies showed Recarbrio did not provide substantial evidence of effectiveness.
Woodcock was also unable to confirm that approvals of new drugs require at least one clinical study of the drug itself that demonstrates substantial evidence – evidence lacking in the case of Recarbrio.
A spokesperson for CDER told The BMJ that FDA “applied regulatory flexibility” in approving Recarbrio.
It is unclear whether this regulatory flexibility enabled FDA to conclude Recarbrio had met the legal “substantial evidence” standard without “adequate and well-controlled investigations” of Recarbrio, says Doshi. FDA declined to answer the question, saying “We have no additional information to provide.”
The decline of science at the FDA has become unmanageable, argues David Ross, associate clinical professor of medicine at George Washington University, School of Medicine and Health Sciences, and former FDA medical reviewer, in a linked commentary.
He describes Recarbrio’s approval as “shocking” and says while much of the blame must go to the FDA’s reliance on industry paid user fees for around two-thirds of its annual drugs budget, “the corruption of the FDA’s scientific culture remains the primary culprit driving the deterioration of safety and effectiveness standards.”
To address this “dismal situation” he suggests tapering the FDA’s dependence on user fees and improving public access to the information received by the FDA, its reasoning, and its decisions.
“The Recarbrio approval is a sentinel event, warning of a return to an era when drug effectiveness was an afterthought,” argues Ross. “Although the FDA crowed about this approval, it would have been better advised to remember that “for a successful technology, reality must take precedence over public relations, for nature cannot be fooled,” he concludes.
A Bloomberg investigation has revealed that Glaxo, which went on to form pharmaceutical giant GSK, was aware of the possible carcinogenic content of its popular heartburn drug Zantac for over 40 years.
The once-popular heartburn drug Zantac (ranitidine) was developed in the 1970s by the then-small British pharmaceutical company Glaxo. It was marketed as better and safer than Tagamet (cimetidine) and it soon outsold it and became one of the company’s best-selling drugs.
NDMA belongs to a class of compounds known as nitrosamines, came to light in cancer research when it was found that nitrites could combine with amines in the stomach, giving rise to cancer-causing compounds. This led to calls for restrictions of sodium nitrites, found in various cured foods, but the food industry has resisted this.
This all came to an end in 2019, when Zantac was found to be contaminated by the chemical N-Nitrosodimethylamine (NDMA), a pale yellow liquid at room temperature. NDMA is a known carcinogen at high concentrations and a possible one at low concentrations. This contamination was not due to a manufacturing error, however: NDMA can form from other reactions and in this case came from within the drug itself. Around the world, Zantac was pulled from shelves, and in 2020 the drug was banned by the FDA. NDMA currently is only produced in small amounts to induce cancer in rats. Whether it is carcinogenic at very low levels is still a matter of debate, but Zantac products contained NDMA at levels which could increase over time.
According to Bloomberg, Glaxo was aware of this, as the possibility of ranitidine being converted in the stomach to nitrosamines being raised in 1980. Tests with human subjects taking ranitidine showed this. Even though NDMA is widely held to be a carcinogen in humans, it is difficult to prove that a particular chemical is responsible for mutations leading to cancers. Glaxo simply took the view that ranitidine did not cause cancer in rodent studies, and that any possible cancer risk was minimised by short exposure. In fact, users would take Zantac for extended periods, even years or decades.
The company was thus warned over 40 years by its own scientists as well as independent researchers, with thousands of pages of documentation seen by Bloomberg for the first time. One 1981 Lancet study showed that Zantac mixed with nitrite in the stomach (as from a meal) would produce nitrosamines. Glaxo scientists countered by saying that the nitrite levels in the study were far above those found in a human stomach, a defence which would become their standard response.
While Glaxo was preparing for FDA approvals in 1982, another study came to their attention. Concerned, Glaxo asked one of their scientists, Richard Tanner, to replicate it and he found that some samples contained 232 000ng of NDMA – the FDA approved limit for each drug was 96ng, though with lower nitrite levels, no NDMA was detected. The daily FDA exposure limit from all sources for NDMA is 190ng, which includes NDMA from all sources, including other medications (which may produce their own NDMA over time) as well as biological processes.
This report would remain secret for more than 40 years. More trouble came from the fact that NDMA could be formed from exposure to either heat or humidity. When it went through the FDA approval process, it did not mention the Tanner report and the notion of storage was glossed over: approved in 150mg doses for eight weeks, storage requirements were listed as a dry place at a temperature no higher than 86°F (30°C).
Zantac surged in popularity, turning the company into a multi-billion dollar enterprise, though the FDA took action over Glaxo’s claims. An over-the-counter 75mg version was launched in 1996. It was coloured pink due to issues of discolouration with white pills turning yellow or brown over time.
While discolouration issues were briefly investigated, it was only in 2019 when there were concerns over NDMA contamination, spurred by recalls of a blood pressure drug, valsartan. A private laboratory warned the FDA over NDMA discovery in Zantac and ranitidine generics, and after the FDA conducted its own tests, the company that was now GSK turned over its documentation.
Within a month, distribution of ranitidine was halted nearly worldwide, and the FDA took the drastic further stop of ordering its production halted. Shortly afterward, the FDA stated that the evidence for NDMA in ranitidine was inconclusive, and clarified that the NDMA concerns were from contamination being produced during its storage, not production in the stomach.
For GSK, the damages from the thousands of plaintiffs may range from US$5 to 17 billion, but damages are likely to be reduced and previous lawsuits of this type have struggled to prove that the relevant compound caused cancer. For Zantac, however, this will be less of an obstacle as NDMA is almost universally accepted as a carcinogen.
The Hive ransomware group that has targeted more than 1500 victims in over 80 countries around the world, including hospitals, has been disrupted in a months-long campaign against, the US Justice Department has announced.
Hive ransomware attacks have caused major disruptions in victim daily operations around the world and hindered responses to the COVID pandemic. In one case, a hospital attacked by Hive ransomware had to fall back to pen and paper to treat existing patients and could not take new admissions shortly after the attack.
The Justice Department revealed that the FBI had penetrated Hive’s computer network and captured its decryption keys, which were then offered to victims around the world. This saved them $130 million in ransom they would have had to otherwise pay to get their networks back.
Finally, the department announced that, in coordination with German and Dutch law enforcement, it has seized control of the servers and websites that Hive uses to communicate with its members, disrupting Hive’s ability to attack and extort victims.
Since June 2021, the Hive ransomware group has targeted more than 1500 victims around the world and received over $100 million in ransom payments.
Hive used a ransomware-as-a-service (RaaS) model featuring administrators, and affiliates. RaaS is a subscription-based model where the administrators develop an easy-to-use ransomware strain and then recruit affiliates to deploy the ransomware against victims. Affiliates identified targets and deployed this readymade malicious software to attack victims and then earned a percentage of each successful ransom payment.
Hive actors used a double-extortion model of attack: before encrypting the victim’s system, the affiliate would steal sensitive data. The affiliate then sought a ransom for both the decryption key necessary to decrypt the victim’s system and a promise to not publish the stolen data – usually the most sensitive, such as hospital patient data. After a victim pays, the affiliates and administrators split the ransom 80/20. Victims who do not pay on the Hive Leak Site. After Consulate Health Care was unable to pay the ransom, since its insurance did not cover such cyber crimes, Hive posted 550GB of personally identifiable information on its patients and employees online.
For more information about the malware, including technical information for organisations about how to mitigate its effects, is available from CISA, visit https://www.cisa.gov/uscert/ncas/alerts/aa22-321a.
From Shakespeare’s Macbeth to Star Wars’ Darth Vader, people love fictional villains. No matter how despicable they may be, audiences are still drawn to the dark side. In fact, according to a new behavioural experiment published in the journal Cognition, both adults and children more often reported that villains were inwardly good than that heroes were inwardly bad.
“In other words, people believe there is a mismatch between a villain’s outward behaviours and their inner, true self, and this is a bigger gap for villains than for heroes,” said study lead author Valerie Umscheid, University of Michigan psychology doctoral student.
Inside, villains are a little less evil than they outwardly seem while heroes are fully good guys inside and out.
Umscheid and colleagues conducted three studies with 434 children (ages 4–12) and 277 adults to determine how individuals make sense of antisocial acts committed by evil-doers. They focused on participants’ judgments of both familiar and novel fictional villains and heroes, such as Disney’s Ursula from The Little Mermaid and Pixar’s Woody from Toy Story.
Study 1 established that children viewed villains’ actions and emotions as overwhelmingly negative. This suggests that children’s well-documented tendency to judge people as good does not prevent their appreciation of extreme forms of villainy.
Studies 2 and 3 assessed children’s and adults’ beliefs regarding heroes’ and villains’ moral character and true selves, using an array of converging evidence, including how a character felt inside, whether a character’s actions reflected their true self and whether a character’s true self could change over time.
Across these measures, the research indicated that both children and adults consistently evaluated villains’ true selves to be overwhelmingly evil and much more negative than heroes’. At the same time, researchers also detected an asymmetry in the judgments, wherein villains were more likely than heroes to have a true self that differed from their outward behaviour.
Both children and adults believed characters like Ursula had some inner goodness, despite the bad/immoral actions they regularly engage in, Umscheid said.
Senior officials at the Tembisa Tertiary Hospital, including its former CEO Dr Lokopane Mogaladi, must be disciplined for their roles in the death of a patient, an independent ad hoc tribunal has ruled.
Shonisani Lethole was admitted to Tembisa Hospital on 23 June 2020 with COVID. He had chest pains, was weak and battling to breathe. He was intubated on 27 June. He died two days later.
But before he died, Lethole took to Twitter on 25 June to describe the unbearable and uncaring conditions he was experiencing. He said he had not eaten for two days.
An Ombud investigation was prompted by a complaint by the Minister of Health.
Health Ombud Prof Malegapuru Makgoba in January last year found that Lethole had been denied food for “100 hours and 54 minutes” and that medical staff had been grossly negligent. He recommended that 18 staff members, including doctors and nurses, should face disciplinary action.
Mogaladi was suspended almost immediately afterwards.
An appeal tribunal, set up in terms of the National Health Act, consisting of three members – two doctors, Prof Rudo Mathivha and Prof Ebrahim Variava, and retired Constitutional Court Judge Bess Nkabinde – considered appeals by Mogaladi and Dr Makhosazane Ngobese, head of the COVID unit at the time, against the Ombud’s findings and recommendations.
Mogaladi and Ngobese raised several grounds of appeal, including that there was no valid complaint, that the Ombud had acted beyond his mandate and that his findings were not supported by the evidence.
The tribunal returned two decisions. Judge Nkabinde said she would have upheld the appeal in its entirety. But the majority, Professors Mathivha and Variava, while setting aside some of the Ombud’s recommendations, said Mogaladi and Ngobese should still be disciplined.
Regarding Mogaladi, they said he should be disciplined for presiding over a hospital “that on two separate occasions could not provide Lethole food for prolonged periods”, and a “health establishment that showed poor record-keeping”. He should also face charges relating to substandard care at the hospital.
Regarding Ngobese, they set aside the findings against her except one, that she should face a disciplinary inquiry for her failure to ensure that critical care equipment in the COVID ward was available and functioning properly.
The tribunal said Lethole had been described by his family as a very responsible young man, a “son of the soil” who was deeply loved and cherished.
The two professors said they differed with Judge Nkabinde on the question of accountability.
“While we recognise the immense challenges brought by the Covid-19 pandemic, the norms and standards regulations remained applicable.
“Where we find, on a fair consideration of the facts, that these norms and standards have not been fulfilled, and where there is a prima facie indication that the appellants had some responsibility in relation to their non-fulfillment, we consider it appropriate and important to recommend that an accountability process follows,” they said.
Judge Nkabinde, in her ruling, placed emphasis on the impact of the pandemic on hospitals and said based on the rationality and procedural fairness grounds of appeal, the appeals should succeed.
“This conclusion should not, however, be understood to suggest that no-one should be held accountable when a proper case is made. It is difficult to accept a loss of life … but adverse factual findings and remedial action should be rational and should be right, just and fair.”
She said her judgment did not stop the Department of Health from taking steps to fix the systematic issues at the hospital or disciplining those “properly found” wanting in upholding a high standard of professionalism.
After a trial stretching out from before the COVID pandemic, Elizabeth Holmes, the former CEO of diagnostic biotech startup Theranos, has been sentenced to 11 years after being found guilty of fraud.
In 2018, she was indicted along with Ramesh “Sunny” Balwani on four counts of wire fraud and conspiracy to commit wire fraud in connection with the collapse of Theranos, and was found guilty in January this year. She had been seeking a retrial since she had been contacted by a key witness, former Theranos lab director Adam Rosendorff, who she claimed had recanted statements made under oath.
Before Theranos’s collapse, Rosendorff had previously supplied information for an investigative series into the struggling biotech firm’s Previously, the university dropout had been widely lauded as an innovator and an inspiration for women in technology.
In his remarks during the sentencing of Holmes, US District Judge Edward Davila said, “The tragedy of this case is that Ms. Holmes is brilliant. She had creative ideas. She is a big thinker. She was a woman moving into an industry that was dominated by, and let’s face it, male ego. That young women entrepreneurs are regrettably denied access to, but she made that.”
Judge Davila sentenced her to 135 months (11 years and three months) in prison. Holmes will report to serving her sentence on April 27, 2023, at a minimum-security women’s prison less than 160km from her native Houston, Texas.
Fikile (Sr Fikx) Dikolomela-Lengene, a nurse activist says she has had a front-row seat to corruption unfolding in Gauteng’s public health sector. PHOTO: Supplied/Facebook
Fiery nurse activist Fikile Dikolomela-Lengene says she has had a front-row seat to corruption unfolding in Gauteng’s public health sector, and she is not afraid to speak out.
Dikolomela-Lengene grew up in the corridors of Chris Hani Baragwanath Academic Hospital in Soweto, Johannesburg – Africa’s largest health facility.
The youngest of nine siblings and the only daughter, her father died when she was three years old. After this, her mother, a nurse at Baragwanath Hospital, would take her along to work.
“There were times when my mum didn’t have a nanny so she would take me to Bara [a nickname among healthcare workers for Baragwanath], where she worked in the same surgery theatre for 40 years,” says Dikolomela-Lengene. “I was actually sleeping on stretcher beds. I would accompany her to go fetch patients. This was a single mom with a little girl and nobody to look after her and she needed to work.”
At the hospital, a young Dikolomela-Lengene grew inspired to become a nurse, while cultivating her first inkling of justice. “I saw what was happening, and I thought, this is something I would like to do,” she says. “It came with a lot of context of the profession. I mean, I saw my mom and how the profession didn’t upskill her, how she suffered because of having a child, the shifts, and all of that. And I think it’s where the love for professional activism came in. To say, if I go into this profession, I wanted to be in a place where I could influence change.”
Nurse activist
Today, with a string of qualifications behind her name, including a Bachelor’s degree in nursing from North West University and a Mandela Washington Fellowship for Young African Leaders, 36-year-old Dikolomela-Lengene describes herself as a “nurse activist” and calls herself ‘Sr Fikx’ because she is passionate about influencing change in the public health sector. Currently based at the Stretford Community Health Centre – which serves the township of Orange Farm in the south of Johannesburg – she is passionate about HIV care and heads several public health campaigns at community level.
“What is interesting to me is the non-acquiring of condoms, today in an era when HIV is so rife
Commenting on the report findings of the Stop Stockouts Project (the SSP monitors shortages in essential medicines across South Africa) launched in August, Dikolomela-Lengene laments the shortfall of contraceptives – particularly injectable contraceptives and condoms – in the country’s public health sector.
“What is interesting to me is the non-acquiring of condoms, today in an era when HIV is so rife,” she says. “We ran out of [government-issued] condoms in May. And they actually don’t even have a new tender yet. And this shocked me. We should plan, right?”
She points out the ripple effects of this shortfall, such as an increase in required abortions. “Since there are none of these types of contraceptives, how has it impacted on our TOP [termination of pregnancy] services, you know? Especially in clinics where these services are burdened as it stands?”
“rot of corruption”
Dikolomela-Lengene says “the rot” of corruption in Gauteng’s health sector runs deep.
In 2015, she was a founding member of The Young Nurses Indaba Trade Union (YNITU), which represented over 10 000 workers, who pay R70 per month for membership.
Speaking to Spotlight, Dikolomela-Lengene alleges that the union’s leadership was “hijacked” at a congress in October last year and that millions of rands from the union’s coffers disappeared. In the midst of the clash, the union’s FNB business account was frozen in November 2021. However, allegedly membership fees are still being paid into private accounts. AmaBhungane reported on the alleged hijacking of the trade union in September. The new leadership rejected claims of wrong-doing.
In February this year, Dikolomela-Lengene and fellow former union leaders put the allegations before the Department of Labour. “We told them we need assistance because the union is hijacked and is being used for activities that currently… we actually don’t even know what is happening,” she says.
Dikolomela-Lengene adds that the union had been given notice to deregister on September 28. She will continue to meet with the Department of Labour. “Let me just say it’s been a hassle,” she adds. (AmaBhungane reported on the deregistration here.)
Last year in August, Gauteng health official Babita Deokaran was assassinated shortly after flagging up to R850 million in suspicious payments authorised at Tembisa Hospital in Johannesburg. (Spotlight earlier asked the new Gauteng Health MEC Nomantu Nkomo-Ralehoko about the alleged corruption flagged by Deokaran and other corruption-related issues here.)
According to media reports, one of the people accused of capturing the YNITU – Lerato Mthunzi – is the wife of embattled Tembisa Hospital chief executive officer (CEO), Ashley Mthunzi, who was suspended on August 26 over allegations of widespread corruption – including R498 000 of the hospital budget spent on 200 pairs of skinny jeans. After his suspension, one of Mthunzi’s notable supporters had been the nursing union, now headed by his wife. Mthunzi (Lerato) has denied any wrongdoing.
‘defending and defending’
During the interview with Spotlight, Dikolomela-Lengene shakes her head, laughing. “I’m laughing, you know because it’s so sad. People are defending and defending, but there’s a family here that lost somebody. There are kids currently who don’t have a mother because there are people in positions who don’t want to do their job.
“You get to ask yourself, who authorises codes for jeans, skinny jeans, in a hospital?
“I don’t know how they’re going to get rid of corruption in health in Gauteng. You get to ask yourself, who authorises codes for jeans, skinny jeans, in a hospital? It’s like somebody’s mocking the governance.
“You have to ask yourself, how many processes are there before payment is actually made? So all those processes were flawed, or were people in those processes flawed themselves? And then, you have condoms not being on tender. You start asking yourself [how are] people able to get money for jeans, but there’s no money for a tender for condoms?”
Looted
Shaking her head, Dikolomela-Lengene says the province’s health budget is being looted.
“We’re not going anywhere unless they actually bring a lot of people to account,” she says. “R850 million, imagine! I’m looking at my clinic. Our budget is around R20 million. How many clinics could have been revamped for R850 million? How many hospitals could have been looking A-class, private style, with that money? It is possible to revamp our clinics. It is possible to revamp our hospitals. There is money. There is money, but there is no political will.”
“into the lion’s den”
On Gauteng’s new health MEC Nomantu Nkomo-Ralehoko, Dikolomela-Lengene says, “We’ll see with the new MEC. The past two MECs disappointed us and they were both health professionals. (Nkomo-Ralehoko is not a healthcare professional by training).”
“I mean, having to fight with a patient because you don’t have a Panado. You don’t have Panado! A simple thing like that.
Nkomo-Ralehoko, in response to questions by Spotlight, vowed to act on recommendations by a Special Investigating Unit (SIU) currently conducting a forensic investigation into transactions at Tembisa Hospital.
“At this moment, I’m not going to be judgmental,” says Dikolomela-Lengene. “You know, we just want to see change. I mean, having to fight with a patient because you don’t have a Panado. You don’t have Panado! A simple thing like that. And as a nurse, you have to take the brunt of it. She’s [Nkomo-Ralehoko] going into a lion’s den. She will need a thick skin.”
Earlier this year, Dikolomela-Lengene was one of 700 young African leaders who studied in the United States for six weeks as Mandela Washington Fellows. She was placed at Howard University, which counts former US President Barack Obama among its alumni.
“It’s what we call a historically black college, one of the colleges that Barack Obama went to. So I think that was an honour on its own,” she says.
As part of her training, she got to shadow and even debate with high-ranking American government officials. “I learned a lot of skills, but what stood out was the ‘huddle system’. This is a programme whereby we have meetings more frequently so that changes can be made more frequently. I think in South Africa, we stick with things that are wrong for too long. If a policy isn’t working, we wait for five years. If a system isn’t working, we wait for five years. So with the huddle approach, you continuously monitor and make changes when things are not working.”
a “downgrade” in nurse training
Dikolomela-Lengene lives in Johannesburg but says she prefers not to divulge particulars due to safety concerns.
She did, however, share about her current reading material.
The book currently on her bedside table is ‘Who Ate My Cheese? The Road to Freedom’ by Rowland Rose – a gift from the United States embassy during her recent trip.
Another issue keeping Dikolomela-Lengene awake at night is South Africa’s nurse training curriculum. In 2019, she served on the ministerial task team that oversaw amendments brought to South Africa’s nurse training strategy, as chronicled in The National Strategic Direction for Nursing Education and Practice: A Road Map for Strengthening Nursing and Midwifery in South Africa (2020/21−2025/26).
“Our qualifications have been downgraded.
She is highly critical of this new strategy, calling it a “big mistake”, and effectively a “downgrade” in nurse training in the country.
“I’ve got a four-year diploma. I’ve got a one-year post-graduate, [and] I’ve got a three-year degree. I’m not even going to talk about the side courses I’ve done. There are more than ten. Can I tell you that I cannot access a university in South Africa? Our qualifications have been downgraded. I’ve got more than nine years of formal study and I can’t do my Masters [degree] because my accreditation has been brought two to one level lower,” says Dikolomela-Lengene.
“You’ve got academia and professors making a curriculum for nurses – not nurses. It’s shocking… So there is a big fight between the National Department of Health, the South African Nursing Council, which is the regulatory body of nursing, and the Department of Higher Education.”
The nurse activist says that her salary could triple if she moved from the public sector into private, but that she wouldn’t dream of such a step. “The passion I have for what I do is what fuels me,” she says. “And it’s effortless, you know? I love what I do. Whatever time they call me, I’m ready. I just show up – always.”
Republished from Spotlight under a Creative Commons 4.0 Licence. Read the original article here.
When it comes to violations of US federal law by pharmaceutical and medical device manufacturers, the US Department of Justice (DOJ) is not exercising its full authority, according to the findings of a review published in JAMA Internal Medicine.
The conviction of Elizabeth Holmes, CEO of the failed blood-testing company Theranos, has focused attention on the personal liability of corporate officers of medical companies engaging in illegal activity. Holmes was charged with defrauding and conspiring to defraud investors, patients, and physicians, each count carrying a maximum 20-year sentence. Among prosecutors’ allegations was that Theranos’ main blood-testing device failed to work as the company and Holmes had promised. While Holmes was convicted of defrauding investors, she faced no personal liability as a CEO responsible for a company knowingly selling faulty diagnostic tests.
When a drug or medical device company violates US federal law, the government can use the Park doctrine. It holds that a CEO for a health-related company has a “position of authority” in a profitable business selling “services and products [that] affect the health and well-being of the public.” The doctrine’s aim is to protect patients from harm caused by unsafe or fraudulent medical products and services. It does this by targeting the executives who run the companies that make revenues on these products while violating federal law.
This provides an alternative to having that risk borne by patients or impersonal corporate entities; however, it is rare for there to be public reports of drug and device company executives being prosecuted with Park doctrine.
The researchers sought to identify prosecutions using the Park doctrine and characterise their role in DOJ enforcement efforts related to medical product industry misconduct. To this end, they conducted a literature search.
They found 13 cases where executives from six drug and medical device companies prosecuted under the Park doctrine since 2000. These prosecutions resulted in 11 guilty pleas and two jury trials, leading to two convictions. Of the six companies, three were drug manufacturers, two were medical device manufacturers, and one was a compounding pharmacy. All three of the drug manufacturers were opioid manufacturers, of which two executives were charged for unlawful promotion, and one was charged for manufacturing errors. Both device manufacturer executives were charged with unlawful promotion. All but three prosecutions alleged the defendants’ complicity or personal involvement in the misconduct, which Park does not require. By contrast, most large settlements with the DOJ over alleged misconduct in the past two decades did not result in individual liability for executives.
“This review suggests that federal prosecutors have exercised far less than their full capacity under the Park doctrine to sanction problematic corporate behaviour that threatens patients and the public health,” the authors concluded. They suggest that enforcement under a reinvigorated Park doctrine would help to better protect patients.
