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.
The health department in the Eastern Cape has been ordered to reinstate a “whistleblower”. She was removed from her job in a district human resources office after she raised the alarm about a colleague attempting to get her niece short-listed for a job.
Eastern Cape Labour Court Judge Zolashe Lallie found that “an occupational detriment” had been committed against Vuyelwa Thelma Tanda. The judge ruled that in terms of the Protected Disclosures Act, Tanda had made a “protected disclosure” when she reported the attempted nepotism to her boss.
The judge ordered that she be compensated with R162 402 and that she must be given back her job.
Tanda was initially employed as a data capturer at the Motherwell Community Health Centre. In January 2014, she was seconded to the human resources department in the district office, where she, and two fellow employees, were responsible for managing recruitment and selection processes. They had to report to the deputy director of human resources management, Charmain Jaggers, who in turn reported to the director, Mzoli Njalo.
In January 2018, the department advertised several administrative clerk posts and received a large number of applicants. Njalo’s wife, Phumla Njalo, who was also employed by the department, chaired the shortlisting panel.
The following day, Tanda’s colleague, Princess Makhulume, “got upset” and questioned why her niece had not been shortlisted.
A few days later Tanda was contacted by Mrs Njalo, who said there had been an oversight in the shortlisting process and instructed her to add the niece’s name to the shortlist.
Tanda refused, saying that HR policies and procedures did not permit her to comply with such an instruction. She explained that the correct procedure was to reconvene the selection panel.
Tanda said she reported the instruction to Jaggers, but she did not want to intervene. Jaggers advised her to call a meeting of the selection panel.
When the meeting was held, the issue remained unresolved, because only Mrs Njalo wanted Makhulume’s niece to be shortlisted.
Tanda again spoke to Jaggers, who again expressed unwillingness to intervene. Ultimately, the selection panel took a final decision not to shortlist Makhulume’s niece.
Shortly after the incident, Tanda said she was reprimanded by Jaggers for attending a memorial service for a nurse and taking files home.
She said Jaggers had given her permission to attend the service – and she denied taking files home.
She was then barred from attending HR staff meetings, removed from the department’s WhatsApp group, and her files were taken away from her.
After Tanda launched a grievance, it was recommended that she be “removed from the HR department”. She left at the end of March 2019 and was given a job as a data capturer at the information section of the district office.
Judge Lallie said Jaggers denied ill-treating or victimising Tanda after she reported Mrs Njalo’s conduct. She said Tanda had become rebellious and failed to perform her duties properly.
Lawyers for the health MEC argued that in terms of the Protected Disclosures Act, a disclosure made in the normal scope of employment could not be protected.
However, Judge Lallie said the argument that Tanda had not made a protected disclosure was not supported by the evidence that Mrs Njalo was “intentionally acting in breach of recruitment procedures” and attempting to give Mkhuluma’s niece an unfair advantage.
“In the circumstances of this case … the report that Mrs Njalo was instructing Tanda to be complicit in nepotism in violation of the recruitment policy constituted a protected disclosure. The report was made in good faith to Jaggers.”
Judge Lallie said it was common cause that Jaggers had refused to intervene in the matter.
Tanda had given a detailed account of how Jaggers victimised her shortly after she made the disclosure. “I cannot accept the version that the relationship between Tanda and Jaggers changed because of Tanda’s misconduct and incompetence. Tanda had worked in the HR office for four years without any complaint,” said the judge.
Judge Lallie said Tanda had been “punished” and that Jaggers had abused her seniority.
“Tanda has proved that solatium (compensation) is due to her as a result of humiliation, hurt and the violation of her right to dignity which she suffered in the hands of Jaggers for making the protected disclosure.”
Judge Lallie ordered compensation equivalent to the pay she would have earned over a period of ten months, at the rate she was earning when she made the protected disclosure, and that she be given back her job, and that the MEC pay her costs.
The High Court in Gqeberha has found that the Eastern Cape MEC for Health and Livingstone Hospital are liable to pay damages to the widow of a man who died after falling from the fifth floor of the hospital.
In the ruling last week, Acting Judge Ivana Bands found that the patient, George Williams, had not been properly medicated or monitored. She said that had this been done, Williams would not have been “pacing up and down the ward, in confused, restless and disoriented state”, and would not have fallen to his death from the window.
Judge Bands said the conduct of the medical and nursing personnel who treated Williams after he was admitted to the hospital on 3 October 2013, “fell far short of what is regarded as sound practice” in dealing with patients suffering from alcohol withdrawal – delirium tremens which involves sudden and severe mental or nervous system changes – and secondary schizophrenia.
“Had he been properly medicated, it cannot be gainsaid [denied] that he would have been reduced to a calm and lightly dozing state. This would have enabled the medical and nursing staff to monitor his vital signs and his condition appropriately until such time that delirium tremens had abated,” Judge Bands said.
Judge Bands’s finding of negligence means that Williams’s widow Jeanine can now pursue a monetary damages claim against the MEC and hospital. This could be determined at another trial or through negotiation.
Jeanine Williams, in her papers, contended that the hospital staff were under a legal duty to provide her husband with adequate and timeous medical treatment; that they had not properly sedated him, restricted his movements and monitored his condition.
The defendants, however, argued that Williams had been treated with sedatives, including diazepam (Valium) and that he had been put in an “enclosed locked ward” close to the nurses’ station.
Bands said Wiliams was a known alcoholic who was admitted to the hospital late on 3 October 2013. In the early hours of the morning, he had been given diazepam, with little effect. During the evening of 4 October, he was given more sedatives and an antipsychotic agent, also with no effect.
Soon after, at about 10:30pm, Williams broke the outside entrance glass door of the nurses’ tearoom and fell from the fifth floor. He died about an hour later.
Two key witnesses during the trial were Dr Candice Harris, a professional nurse and general practitioner, who testified for Williams, and Dr Michelle Walsh, a general surgeon, who testified for the MEC and the hospital.
In her evidence, Harris had said delirium tremens was a “medical emergency” and, according to guidelines, immediate management of the condition was necessary. She had stressed the importance of re-orientating the patient and said it was the nurse’s duty to inform the doctor if the patient was not responding to medication.
The judge said Walsh’s evidence was that it was not that the hospital was doing nothing – “they were doing something”.
“She said the sedation prescribed is usually based on what the assessing doctor thinks will have the desired effect to calm the patient to the extent that they would sit calmly in a chair. It is common cause that this desired state was never reached,” the judge said.
“Not only was he under-sedated, there is no evidence that the initial dose, which had no effect, was ever increased as per the published guidelines, in spite of multiple entries in the hospital records that he remained confused, disorientated, restless and walking up and down – and that he had become so agitated that the nursing staff feared he would assault them,” the judge said.
Bands said Williams had not been treated according to the guidelines, thus the MEC and the hospital are liable for any proven damages.
New research has found that private equity firms that acquire physician-owned medical practices seem to be imposing measures to squeeze out more profits.After their acquisition by private equity firms, the clinics saw more patients and billed more for visits among a large, commercially insured population, according to a study published in JAMA Health Forum.
Researchers from Oregon Health & Science University and other institutions examined a total of 578 US physician practices specialising in dermatology, gastroenterology and ophthalmology that were acquired by private equity firms from 2016 to 2020.
“The reason this is of concern to patients and policymakers is that private equity is often driven by profit margins of 20% or more,” said senior author Jane M. Zhu, MD, assistant professor of medicine in the OHSU School of Medicine. “To do that, they have to generate higher revenues or reduce costs. Increasing private equity in these physician practices may be a symptom of the continuing corporatisation of health care.”
While it is unclear whether these practices hurt clinical outcomes for patients, the findings raise concerning parallels with the rapid growth of private equity acquisition of nursing homes and hospital systems.
“Private equity investment in nursing homes has been associated with an increase in short-term mortality and changes to staffing,” the authors wrote, citing previous research.
In the new study, researchers found an increase in the overall number of patients seen in these clinics. The study also reviewed commercial insurance claims data that showed an increased share of visits longer than 30 minutes, even though the complexity of cases remained similar to cases prior to being bought out.
“These billing patterns could mean more efficient documentation of services provided, or it could mean upcoding or up-charging insurance companies to make more money,” Asst Prof Zhu said.
She believes more evidence is needed about how private equity impacts practice patterns.
“Private equity ownership of physician practices has added a distinctly private and market-driven influence to the broader trends in corporate consolidation of physicians by health systems and insurers,” they concluded. “This study contributes evidence for potential overutilisation and higher spending of care that will be important for policymakers to monitor.”
Weight stigma is a negative bias known to limit both access to health services and treatments. A joint international consensus statement was recently published inNature, aiming to end weight stigma in healthcare globally.
Researchers conducted a large review of over 3700 studies to evaluate weight stigma reduction strategies in healthcare practice and healthcare education, with a view to provide recommendations for interventions, learning, and research. The findings, published in Obesity Reviews, indicate that there is a need to move away from a weight-centric approach to healthcare.
Lead author, Dr Anastasia Kalea said: “Sadly healthcare, including general practice, is one of the most common settings for weight stigmatisation and we know this acts as a barrier to the services and treatments that can help people manage weight.
“A common misconception among medics and others, is that obesity is caused by factors within a person’s control, focusing on diet and exercise without recognition of, for instance, social and environmental determinants.
“In this review, it was clear more needs to be done to educate healthcare professionals and medical students on the complex range of factors regulating body weight, and to address weight stigma, explicitly emphasising its prevalence, origins, and impact.”
Researchers undertook a systematic review of 3773 international research articles. This included 25 weight stigma interventional initiatives, comprising a total of 3554 participants.
Weight-inclusive approaches to education in healthcare were identified as effective in challenging stereotypes and improving attitudes. They identified stigma reduction strategies in healthcare, which included ethics seminars discussing patient experiences, embedding virtual story-telling of patient case studies, or empathy evoking activities in the curriculum, such as following a calorie restricted diet or participation in clinical encounters with patients living with overweight and obesity. However, other methods such as video presentations and short lectures were not equally effective in improving attitudes in the long term.
Researchers are now calling on medical schools in both the UK and globally to ensure effective and sustained weight-inclusive teaching is embedded in medical doctor training and is added to the continuing professional development of clinicians.
Dr Kalea said: “Weight stigma needs to be addressed early on and continuously throughout healthcare education and practice, by teaching the genetic and socioenvironmental determinants of weight, by discussing the sources, impact and recognising the implications of stigma on treatment. We need to move away from a solely weight-centric approach to healthcare to a health-focussed weight-inclusive one. And it is equally important to assess the effects of weight stigma in epidemiological research.”
The urgency of tackling the obesity and overweight has been brought to the fore by evidence of the link to an increased risk from COVID.
Dr Kalea added: “Stigma reduction interventions are a current research priority. Improving the ways we educate healthcare professionals early on is a starting point, keeping the focus on our patients; we need to communicate better, listen carefully to our patients needs and let these inform our teaching and research agendas.”
Weight stigma is also known to cause ‘internalised weight bias’ (IWB), which is when a person applies negative societal or cultural beliefs about body weight to themselves. This can lead to psychological distress, depression, anxiety, low self-esteem and often leads to decreased health motivation and maladaptive coping such as avoidance of timely healthcare, social isolation, reduced physical activity and disordered eating behaviours.
Weight stigma has also been shown to increase risk of developing obesity, and healthcare is one of the most common contexts where weight stigmatisation occurs. Physicians have been reported as the second most common source of weight stigma and discrimination.
Filling clinical trials and enrolling sufficiently diverse, representative groups of patients, has long been a challenge, partly due to stringent participation guidelines. In an effort to attain larger and more diverse trial groups, an international team of researchers and policymakers has written new recommendations on how to determine eligibility criteria for lung cancer clinical trials.
The group was led in part by David Gerber, MD, along with representatives from the Food and Drug Administration (FDA), National Cancer Institute, European Medicines Agency, pharmaceutical companies, and the LUNGevity Foundation.
The recommendations, published today in JAMA Oncology, offer the first publicly available outline of upcoming FDA draft guidance on lung cancer clinical trials that are expected to make it easier to include more patients.
“This paper is the public’s first look at the FDA’s proposed changes to how we determine who can participate in a lung cancer clinical trial,” said Professor Gerber in the Hematology/Oncology Division at UTSW. “If these changes are successful, they could make clinical trials for lung cancer as well as other cancers more powerful and more representative.”
Ensuring that people from diverse backgrounds join clinical trials is key to properly evaluating how a new treatment will work among patients of all races and ethnicities. But today, only about 5% of all cancer patients enrol in a clinical trial, and only 11% of cancer clinical trial participants identify as a racial or ethnic minority.
For patients with cancer, participation in clinical trials requires not just a decision to try an experimental treatment, but time and energy spent understanding the trial, enrolling in it, and often attending extra testing or clinic appointments. Many researchers agree that complicated, inconsistent, poorly explained, and overly strict eligibility requirements to join a cancer clinical trial exacerbate this problem and are a key reason for the low number of underrepresented minorities in clinical trials.
“So many clinical trials never finish enrollment, close prematurely, or don’t recruit a population that lets researchers generalise the results,” Dr. Gerber said. “I think there’s widespread recognition that eligibility criteria have become too stringent.”
Addressing this for one cancer subtype, advanced non-small cell lung cancer (NSCLC), – the LUNGevity Foundation convened a roundtable discussion with experts from academia, industry, and regulatory bodies. The team assembled a prioritised list of eligibility categories that should be included in the descriptions of all NSCLC clinical trials and recommended criteria for each category. Some suggestions were more lenient than what has typically been included in previous NSCLC trial eligibility criteria; for instance, the team recommended that most patients with prior or concurrent cancers, most patients with brain metastases, and most patients with mild liver impairment – all of whom would likely have been excluded in the past – still be included in trials.
The team also suggested that these categories be clearly laid out on public websites advertising clinical trials in an easily searchable format.
The FDA will be releasing draft guidance on NSCLC clinical trials in the near future and hold a public comment period before finalising them. Other interdisciplinary teams have already convened to standardise eligibility requirements for clinical trials of other cancer types.
If the new guidelines prove effective, Prof Gerber said that clinical trials will likely be easier to fill and provide more complete and timely data on new cancer interventions.
“If you can involve more patients in clinical trials, you’re more likely to complete those trials quickly. That’s going to lead to new treatments faster,” he said.
Following a highly critical independent report and accusations of inadequate and unsafe care, the UK will shut down the Tavistock gender identity clinic for children – the only one in the country. It will be replaced by a number of smaller facilities with closer links with mental health care.
The Tavistock and Portman NHS Foundation Trust clinic, named the Gender Identity Development Service (GIDS), had faced complaints of both long waiting lists for a burgeoning number of referrals, as well as rushing to assign puberty-blocking drugs and cross-sex hormones to children experiencing gender dysphoria.
Concerns had been voiced as early as 2005, when a nurse working at the clinic said that patients were being assessed too quickly and giving in to pressure from interest groups. Nevertheless, demand for its services skyrocketed in later years, from less than 100 per year in 2010 to nearly 2500 by 2018. In 2018, concerns were raised anew, with staff going on to make serious public accusations.
In July 2019, Dr Kirsy Entwhisle, a psychologist at GIDS Leeds hub, said that staff misled patients and made decisions about young people’s “bodies and lives” without “robust evidence”. Some of the children had suffered “very traumatic early experiences” which had not been addressed by the staff. The trust’s safeguarding lead, Sonia Appleby, won a claim from an employment tribunal after trust managers tried to stop her from carrying out her role when staff raised concerns.
One of the loudest critics of Tavistock Centre is Keira Bell, who at 16 was assigned puberty blockers, then cross-sex hormones at 17, and had a double mastectomy at 20 before later de-transitioning.
The former patient, who said she was suffering from anxiety and depression at the time she received treatment, said medics should have considered her mental health issues, “not just reaffirm my naïve hope that everything could be solved with hormones and surgery”.
Along with the unnamed parent of an autistic girl at the clinic, she won a ruling against the NHS assigning cross-sex hormones to children under 16 – but was overturned on appeal.
Helen, a parent of a patient at the clinic, welcomed its closure, but expressed concern for the future of her son’s treatments, according to LGBT site Pink News. While she said her son was treated quickly and received puberty blocking drugs, “From that point on, it felt like it was a little bit like they were winging it,” she said.
During therapy sessions at Tavistock, she said her son was asked a lot of questions and treated “almost like a little bit of an academic curiosity”. She criticised the fact that the same staff evaluated children for medical interventions and also offered therapy session, creating “a fear that they would stop access to medical support”. In contrast to the legal claims of Keira Bell’s and the unnamed patient, she said that GIDS refused to even discuss cross-sex hormones.
Dr David Bell (no relation to Keira Bell) welcomed the closure of Tavistock, telling the BBC: “Some children have got the double problem of living with the wrong treatment, and the original problems weren’t addressed – with complex problems like trauma, depression, large instances of autism.”
