Category: Ethics and Law

Healthcare Organisations Urge Review of Culpable Homicide Law

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

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

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

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

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

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

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

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

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

Source: Medical Protection Society

‘Extensive Network’ of Opaque Medical Industry Ties

Image: Pixabay CC0

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Source: EurekAlert!

Violence in the ED: A Critical Issue in Healthcare

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Source: MedPage Today

Former Health Minister Mkhize Hits Back at SIU

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

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

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

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

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

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

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

Source: IOL

Inquiry Accuses Brazilian President of ‘Crimes Against Humanity’

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

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

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

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

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

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

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

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

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

Source: BBC News

Surveys Reveals Mistrust over Facial Recognition Tech in Healthcare

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

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

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

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

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

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

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

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

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

The Rise of Phony Stem Cell COVID Treatments

SARS-CoV-2 virus. Source: Fusion Medical Animation on Unsplash

The global race to develop new stem cell-based COVID treatments during the pandemic was filled with violations of government regulations, inflated medical claims and distorted public communication, according to an article appearing in Stem Cell Reports.

While stem cell therapy has treatment applications for a limited range of diseases and conditions, at present no clinically tested or government-approved cell therapies are available for the treatment or prevention of COVID or long COVID.

Despite this, some clinics have started offering unproven and unsafe “stem cell” therapies that promise to prevent COVID by strengthening the immune system or improving overall health, according to lead author Laertis Ikonomou, PhD, associate professor of oral biology in the University at Buffalo School of Dental Medicine.

The article explores the negative effects that misinformation about cell therapies has on public health, as well as the roles that researchers, science communicators and regulatory agencies should play in curbing the spread of inaccurate information and in promoting responsible, accurate communication of research findings.

“Efforts to rapidly develop therapeutic interventions should never occur at the expense of the ethical and scientific standards that are at the heart of responsible clinical research and innovation,” said Prof Ikonomou.

Other investigators include Megan Munsie, PhD, professor of ethics, education and policy in stem cell science at the University of Melbourne; and 

Many of the studies on possible stem cell-based COVID treatments are at an early stage of investigation and further evaluation on larger sample sizes is required, says Munsie. However, the findings from preliminary studies are frequently exaggerated through press releases, social media and uncritical news media reports.

“Given the urgency of the ongoing pandemic, even the smallest morsel of COVID science is often deemed newsworthy and rapidly enters a social media landscape where—regardless of its accuracy – it can be widely shared with a global audience,” said Aaron Levine, PhD, associate professor of public policy at Georgia Institute of Technology..

Clinics selling such treatments sometimes use these findings and news reports to exploit the fears of vulnerable patients by unethically advertising unproven stem cell treatments benefits of boosting the immune system, regenerating lung tissue and preventing transmission of COVID, said co-author Leigh Turner, PhD, professor of health, society and behaviour at the University of California, Irvine.

Reportedly some harm to patients resulted from unproven stem cell therapies, including blindness and death. Patients suffer financially as well, said Prof Ikonomou, as the products range in price from a few thousand to tens of thousands of dollars, and people are often encouraged to receive the expensive treatments every few months.

Patients who COVID may decline vaccines, stop wearing masks and stop other COVID safety measures, Prof Turner warned. They may also be less likely to participate in ethically conducted clinical trials.

“The premature commercialisation of cell-based therapeutics will inevitably harm the field of regenerative medicine, increase risks to patients and erode the public’s trust,” said Prof Ikonomou.

Despite warnings, many offending companies continue to make false claims. The authors recommend that regulatory agencies consider implementing stronger measures.

They also suggest that scientific and professional societies lobby regulatory agencies to increase enforcement of laws and regulations. The authors recommended that science communicators and journalists can combat misinformation by not engaging in hyperbolic coverage of research results and conveying study limitations.

Source: University at Buffalo

Health Dept Suspends DG Buthelezi over Digital Vibes Tender

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In the latest development of the R150 million Digital Vibes tender fallout, Health department director-general Dr Sandile Buthelezi has been placed on precautionary suspension 

On Sunday, health ministry spokesperson Foster Mohale  confirmed Buthelezi’s suspension following a Special Investigating Unit (SIU) report into the alleged tender fraud. Deputy DG Dr Nicolas Crisp will take over as acting DG until the completion of Buthelezi’s hearing process. Buthelezi had previously been on leave.

Mohale said that while the R150m Digital Vibes communications contract was already secured when Buthelezi assumed the DG role, it was his inaction in his role as heady of accounting authority regarding the contract that led to the suspension, said Mohale. 

The tender process was rife with irregularities, involving fictitious companies and doctoring scores of bidding companies.

“The procurement process was … a sham, designed and conducted to reach the predetermined result that Digital Vibes would be appointed,” lead investigator Rajendra Chunilall said in the SIU’s founding affidavit.

Former health director-general Precious Matsoso told the SIU that Tahera Mather, a friend of Dr Mkhize’s and a beneficial owner of Digital Vibes, began work at the department straight after Dr Mkhize’s appointment as minister. Matsotso had been pressured by Dr Mkhize to ensure that Mather was hired. Instead of a public tender for the National Health Insurance (NHI) communications contract as advised by the Treasury, it was issued as a closed tender to ten companies.

Two of these companies did not exist and six of which, including a computer equipment supplier and a graphic design company, did not respond as the tender was out of their scope, according to forensic accountant Hesti le Roux’s investigation.

Mather is also alleged to have created a fraudulent profile for Digital Vibes with the relevant skills and experience, including a fake team some of whom never worked for Digital Vibes and were not paid. 

Due to this rigging, only Digital Vibes and Brandswell responded; the latter had the upper hand as its R69m quote was far cheaper than Digital Vibes’ R141m,

However, the department then inexplicably issued a second RFP, amending the requirements.

Brandswell was “irregularly and irrationally” marked down by the department’s five-member tender evaluation committee (TEC), which included deputy director-general Anban Pillay and head of communications Popo Maja. This was despite Brandswell being a “long-standing and reputable communication solution service provider”, Le Roux said.

“Clearly, the recommendation by the TEC to award the contract to Digital Vibes was invalid in terms of the provisions [of] the constitution, because the procurement process was not fair, equitable, transparent, competitive and/or cost-effective. Therefore, the service level agreement that was concluded with Digital Vibes should be declared invalid,” Le Roux concluded.

Source: Times Live

Many Lung Cancer Patients Choose Euthanasia Without Exploring Treatment

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A Canadian study of lung cancer patients who opted for “medical assistance in dying” often proceeded without consultation with their radiation oncologist or medical oncologist.

In a Canadian study of 45 individuals diagnosed with lung cancer who used medical assistance in dying (also known as physician-assisted suicide), about 20% did not have a radiation oncologist involved when making the decision and 22% did not have a consultation with a medical oncologist, said Sara Moore, MD, of Ottawa Hospital Research Institute of the University of Ottawa.

Since 2016, about 60% of those seeking to end their life through legal means introduced in Canada had been diagnosed with cancer, Dr Moore explained in a presentation at the virtual World Conference on Lung Cancer.

Driven by loss of autonomy, control and dignity
The designated discussant, Monica Malec, MD, a geriatric and palliative care physician at the University of Chicago, said this was the first study to evaluate medical assistance in dying in patients with lung cancer, oncologists’ involvement, and treatment history.

“The demand for medical assistance in dying is increasing and is becoming more readily available to patients,” Dr Malec said. “Patients are seeking this option despite the availability of more effective and more tolerable treatment options. Existing literature suggests that loss of autonomy, control, and dignity are the primary drivers for seeking medical assistance in dying rather than uncontrolled symptoms, and the decision to pursue medical assistance in dying may occur pre-illness.”

Moore noted that while lung cancer accounts for 20%-25% of all cancer deaths overall, in the current study 17.5% of the patients had lung cancer diagnoses. “Lung cancer comprises slightly fewer medical assistance in dying cases than expected compared to lung cancer death rates,” she said.

Improved treatments disregarded
“Biomarker-driven targeted therapy and immunotherapy offer effective and tolerable new treatments, but a subset of patients undergo medical assistance in dying without accessing — or, in some cases, without being assessed for — these treatment options,” Dr Moore continued. “Most patients were assessed by an oncology specialist, though less than half received systemic therapy.”

“Given the growing number of efficacious and well-tolerated treatment options in lung cancer, consultation with an oncologist may be reasonable to consider for all patients with lung cancer who request medical assistance in dying,” she said.

The researchers screened data from the Ottawa region, and identified 256 patients with a cancer diagnosis who had used medical assistance in dying. Of these, 45 patients had a lung cancer diagnosis.About 85% had a history of tobacco smoking, and 36% were current smokers at the time they sought medical assistance in dying, Moore reported. Thirteen of these patients had no biopsy confirmation of their disease, but almost all (91%) opting for medical assistance in dying were diagnosed with metastatic disease. Average age was 72 years, and 64% (29 of 45 patients) were women, even though men are more often diagnosed with lung cancer, Dr Moore noted. 
Limitations included being limited to only a single region, and a lack of information on patients’ decision-making process.

Source: MedPage Today

Fraud Trial of Theranos Boss Begins

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On Wednesday, the trial of Elizabeth Holmes, founder of medical technology company Theranos, began. Prosecutors alleged she “lied and cheated” for money and fame.

Ms Holmes faces 12 fraud charges over her role at the failed company which was once worth $9bn, facing up to 20 years in prison if found guilty.

She is accused of deceiving patients and investors about the company’s testing technology, which was claimed to diagnose basic illnesses from a few drops of blood. Her defence team argues that she was naive and her company simply failed.

“Failure is not a crime. Trying your hardest and coming up short is not a crime,” said defence lawyer Lance Wade in his opening statement on Wednesday.

Former Theranos executive Ramesh “Sunny” Balwani faces the same charges next year. He was romantically involved with Ms Holmes.

Ms Holmes, who founded Theranos in 2003 aged 19, was dubbed the world’s youngest self-made female billionaire and hailed as the “next Steve Jobs”.

In 2015 and 2016, investigations by the Wall Street Journal revealed Theranos’ blood-testing devices did not work and the company was doing most of its testing on commercially available machines made by other manufacturers. She initially denied these reports.

Prosecutor Robert Leach alleges that, after running out of funds, Ms Holmes and Mr Balwani turned to fraud in 2009, lying about the tests and exaggerating the firm’s performance. Mr Leach said this included falsely claiming the tests were vetted by Pfizer and being used by the US military.

The case will probably take months and Ms Holmes will likely take the stand — a necessary gamble in the face of overwhelming evidence that the technology did not work.

Ms Holmes “dazzled” Walgreens into using the company’s services, and the company brought her fame.

“She had become, as she sought, one of the most celebrated CEOs in Silicon Valley and the world. But under the facade of Theranos’ success there were significant problems brewing.”

 The defence’s Mr Wade said Ms Holmes “naively underestimated” the business challenges but did not attempt to defraud investors. Ms Holmes has also alleged years of emotional and psychological abuse by Mr Balwani, who has denied the allegations. She is likely to testify as to how this affected her.

Source: BBC News