Tag: healthcare industry

Fraud Trial of Theranos Boss Begins

Photo by Tingey Injury Law Firm on Unsplash

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

Sleep Deprivation Common in Surgeons, Impacting Performance

Photo by Mulyadi on Unsplash

New research has found that surgeons were sleep deprived prior to on-call shifts and afterwards even more so, and crucially, that sleep deprivation impacted surgical performance. 

The study is the first to focus on Irish surgeons and is published in the Journal of Surgical Research. A separate study found that short naps of 30 to 60 minutes do little to reduce sleep deprivation.

Focussing on the effects of being ‘on-call’, a frequent state for surgeons, the study explored subjective and objective metrics around sleep and performance using ‘on-call’ as a particular influencer for increased fatigue.

Surgeons frequently work 24 straight hours (or more) resulting in unavoidable sleep disturbance. This is partly due to historical associations of the Halstedian Era of Surgery to ‘reside’ in the hospital in order to properly learn, but also current staffing levels mandating surgeons to complete regular on-call work.

Participants were hooked up to electroencephalogram (EEG) machines and a validated modified Multiple Sleep Latency Test testing was used to objectively measure sleep on the morning of their on-call shift. The researchers also record other validated tests for subjective sleep and fatigue measurement. ‘Sleep latency’ refers to the time it takes to go from being fully awake to sleeping and is often an indicator of sleepiness. The surgeons in the study had early onset sleep latency before on-call, which was exacerbated further in post-call settings.

Performance was measured with standardised and validated tools. Technical performance of surgeons was assessed using the validated Simendo © surgical simulator, while cognitive performance was measured using the Psychomotor Vigilance Task (PVT) to assess objective alertness and reaction time, a known aspect of cognitive performance.

The study is the first to attempt to control for a series of confounding variables such as experience, quality and quantity of sleep, the influence of caffeine and circadian rhythm influences.

The study found that:

  • Surgeons had poor baseline sleep quality and were objectively sleep-deprived, even pre-call, when they should be in a ‘rested state’.
  • In all study participants, early onset sleep latency was seen in pre-call settings and worsened in post-call settings.
  • Early onset sleep latency was worse in trainees compared to consultants, though both groups experienced early onset sleep latency post-call.
  • As sleep-deprivation increased, diminished performance was seen in cognitive tasks and surgical tasks with greater cognitive components.
  • Higher levels of self-reported fatigue and daytime sleepiness were recorded post-call.

Technical skill performance was relatively preserved in acutely sleep deprived states but may be influenced by learning curve effects and experience in surgical tasks.

Existing models of surgical on-call were not conducive to optimising sleep for surgeons, the research found. But making changes for better sleep has challenges, such as loss of continuity of patient care, loss of trainee exposure, and reduced service delivery.

Dale Whelehan, PhD researcher in Behaviour Science at the School of Medicine and lead researcher commented: “The findings of this study tell us that current provision of on-call models preclude the opportunity for surgeons to get enough rest. Similarly, surgeons are sleep deprived before going on-call which further perpetuates the issue. The implications for performance suggest aspects of surgeons performance is diminished, particularly tasks which might be more cognitively demanding. 

“We need meaningful engagement from all stakeholders in the process, working towards the common goal of optimising performance in surgeons. This involves looking at the multifactorial causes and effects of fatigue. Part of that discussion involves consideration around how current models of on-call influence sleep levels in healthcare staff, and how it creates barriers to fatigue management in staff.”

Professor Paul Ridgway, Department of Surgery at Trinity, who supervised the study, said: “Our study is further evidence that the way we deliver emergency work alongside normal work in Ireland has to change. We need to learn from our colleagues in aviation who have mandatory rest periods before flights.”

Source: Trinity College Dublin

Council for Medical Schemes Recommends a Limit on Contribution Hikes

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In a circular sent to medical insurance schemes this week, the Council for Medical Schemes (CMS) has recommended that contribution increases be limited to 4.2% in 2022.

The regulator said that this would be in line with the projected Consumer Price Inflation (CPI) increase.

“In instances where it is economically feasible to implement a lower contribution increase than the CMS recommended CPI-linked rate, Trustees are encouraged to adopt innovative pricing models, subject to an independent actuarial evaluation,” it said.

“The CMS is also cognizant of the heightened uncertainty regarding the impact of the pandemic on healthcare claims costs, as well as how quickly member’s health-seeking behaviour will normalise.

“As such, pricing decisions for the 2022 benefit year should be largely data-dependent and sensitive to the demographic risk profile and financial position of each scheme.”

There are roughly 4 million medical scheme members, with almost 9 million beneficiaries. This represents a little more than one in seven of South Africa’s population of nearly 60 million.

Claims may spike

Some medical schemes may experience sudden spikes in high-cost claims as the pandemic progresses over coming months – though the final economic impact of the pandemic remains uncertain, the CMS said. The schemes’ demographic risk profiles, the size of the population covered, and the extent of existing cross-subsidies within benefit options or schemes will affect the impact.

Additionally, the financial position of each medical scheme prior to the pandemic will dictate how it is able to absorb high-cost claims from the pandemic, it said.

Pent-up demand

The CMS said schemes should also be cautious of pent-up demand as South Africans aim to make use of their medical aids as concerns around COVID decrease. As treatments for some minor medical conditions were postponed, with increasing vaccination rates, many of these conditions would now require more complex and expensive treatment. The CMS also noted that some healthcare services will be completely forgone, resulting in lower than projected claims costs.

“Studies also indicate that as countries move out of different Covid-19 waves, hospital visit volumes slowly recover, although the utilisation rates of different services remain well below pre-pandemic levels.”

Source: BusinessTech

Pharmaceutical Companies Score Weak on Data Transparency

Source: Carlos Muza from Unsplash

Clinical trial data helps in deciding prescriptions and is good for science, but a new study revealed that not many pharmaceutical companies are completely transparent with the development data for their products. The study also found that large companies are much more transparent than smaller ones.

The study, co-authored by Yale researchers and published in The BMJ Open, assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics which received US Food and Drug Administration approval in 2016 and 2017. They were evaluated with the Good Pharma Scorecard, which consists of transparency measures and a ranking system.

The researchers found that only seven of the 42 companies (17%) entirely met the tool’s standards for transparency and sharing data, with smaller companies being particularly opaque.

“The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said study co-author Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International.

“The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science,” she added. “Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”

From the late 1990s, requirements for pharmaceutical companies to register and report results from clinical trials have been increasing. However, not all companies fully comply with the rules and industry guidelines vary.
In a smaller 2019 study using the transparency scorecard, 25% of companies fully met the standards, which include registering clinical trials, sharing data and study protocol publicly, and annually reporting requests for data. When given a 30-day window to improve, 33% met the standard.

For the latest study, the researchers also included biologics and smaller companies. While 17% of companies had perfect scores, 58% of the companies assessed had publicly available results for all patient trials, 42% complied with federal reporting laws, and 26% met the scorecard’s data-sharing measure.

Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices. Four companies used the window to improve data-sharing procedures

“It’s not surprising that non-large companies lag behind large as they may have fewer resources and smaller staffs with less compliance experience,” Miller said. “Our findings suggest that large companies may benefit from reviewing the transparency procedures of smaller companies before partnerships, mergers, and acquisitions so they don’t inherit any deficiencies.”

The researchers did notice improvements among large companies between the 2019 study and the latest one. For example, the median data-sharing score for large companies increased from 80% for drugs approved in 2015 to 100% for products approved in 2017.

Source: Yale University

Journal information:  Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis, BMJ Open (2021). DOI: 10.5061/dryad.r2280gbdb

Clicks Reports Losses of R5 Billion from Riots and Looting

Photo by Michael Longmire on Unsplash
Photo by Michael Longmire on Unsplash

Pharmacy and health and beauty retail group Clicks has reported estimated losses of R5 billion resulting from damage to and looting of stores at shopping malls and distribution centres across South Africa, according to BusinessTech.

Clocks said that it has been forced to close all of its 110 stores in KwaZulu-Natal and 130 of its stores in Gauteng, with long lines reported at those stores that have remained open in the province. Nationwide, 279 stores have been closed and 52 have been damaged. Guidance for those needing medication is available on its website, and online deliveries have been affected as its warehouse is in Johannesburg.

106 vaccination sites have been closed across the country, the group said in a statement, as looting and vandalism continued into Wednesday, predominantly in KwaZulu-Natal and Gauteng. They advise that all vaccination sites are now accepting walk-in appointments. Dis-Chem has advised that its vaccination sites in KwaZulu-Natal are closed, as well as three of its seven sites in Gauteng.

The group had previously been forced to close its stores in September 2020 due to threats from the EFF over allegations of racism in its advertising.

Clicks has 760 stores and over 600 in-store pharmacies around country.

“The disruption of services means affected Clicks stores will be temporarily unable to administer vaccinations and provide medication to customers, along with public sector medicine pick-up points being temporarily unavailable.

“Contingency plans are being put in place to provide alternative arrangements for delivery of chronic medication and rescheduling of vaccinations, where possible,” the group said.

The unrest began with protests against the arrest and incarceration of former president Jacob Zuma, but has since degenerated into looting and destruction.

Clicks said that the full cost of the looting and damages to stores is still to be determined given the ongoing unrest.

Source: BusinessTech

Burnout is Highly Prevalent in Healthcare Workers in Cape Town

Image by Free-Photos from Pixabay

Among Cape Town healthcare workers, burnout is highly prevalent, and worsened by the fear of infection, said City spokesperson Priya Reddy.

A year after the breakout of COVID in the Western Cape, the provincial department of health also reported significant levels of burnout among its health-care workers, especially in doctors, nurses and support staff.

Reddy said: “Burnout is highly prevalent as a result of exposure to trauma, loss, grief and compassion fatigue, and is exacerbated by the high levels of anxiety for fear of contracting the virus.”

However, she said: “The presence of Covid-19 has not diverted health-care workers from their primary responsibilities, thus the pandemic added additional levels of care and caution to the way they work and required a major adjustment.”

In response, the City has made available a number of employee assistance programmes (EAP) and wellness interventions to all employees, including City health-care workers and those supporting them in their different functions. The City is also providing workshops on burnout, compassion fatigue and resilience, and making proactive interventions to deal with stress and anxiety.

The provincial health department reported that between October and December last year, 2832 employees accessed the employee health and wellness programme. Work related problems, trauma, COVID related challenges, family challenges and relationships issues were the most common problems presented during this time.

In his review of the pandemic ‘s year in the province, provincial department of health head, Dr Keith Cloete said: “The department recognised the immense impact the pandemic has had on its staff and has initiated intentional healing and grieving sessions with our front-line workers and managers.”

“The department also recognised the need for staff to rest and recuperate, and in between the two waves we encouraged and granted staff to take leave so they can spend some time with family members,” Dr Cloete added.

SA Society of Psychiatrists (Sasop) board member Dr Renata Schoeman said: “Because people on the verge of burnout feel the need to keep going even though they are exhausted and in a state of relentless overwork, by the time they consult a health professional, burnout has often already become depression or anxiety disorder.”

She added: “Avoiding burnout is a classic case where prevention is better than cure, and lifestyle is the most effective preventative strategy. Improving your emotional and mental fitness, as well as physical fitness, helps to build resilience which means you can handle stress better and cope with setbacks.”

survey of burnout in India found that 52.8% of respondents reported pandemic-related burnout, compared to 26.9% for work-related burnout. Burnout risk was increased by 1.64 for doctors and by 5 for support staff.

Source: IOL

‘Re-Emphasise Ethical Foundation of Medicine’, ACP Urges

As healthcare services struggling under COVID are bought out by private equity, the American College of Physicians says that it is important to prioritise duty to the patients.

“Today, changing practice dynamics place greater focus on the business aspects of medicine,” the authors wrote in a position paper in the Annals of Internal Medicine. “Although employment or consolidation within larger organisations may not be problematic per se, physicians, regardless of practice setting, should challenge business concerns that are placed above the best interests of patients.”

Practices are often bought out by private equity firms that invest in them and introduce cost-cutting measures to increase market share, and then sell them on to make a profit. This results in pressures to generate financial returns at the ultimate expense of patient care.

“This desire to sell the practice soon after acquisition can create the incentive to sell off parts of the practice or undertake drastic short-term cost-cutting measures, including staff layoffs, to make a potential sale more attractive,” the authors wrote. “Insurance companies may further narrow their networks or restrict patient access to only their employed physicians.”

One example the authors cited was that of Hahnemann University Hospital in Philadelphia, which was shuttered just a year after being bought out by a for-profit corporation. This left patients without access to medical care, and some 570 medical residents and fellows were left with an uncertain future.

The authors also cautioned that private equity firms could also limit Medicaid and Medicare patients due to more complex needs and lower reimbursement. These are government medical schemes that cover lower-income individuals. Medicaid alone covers 1 in 5 Americans.
Value-based payment, the authors noted, is supposed to promote high-quality care, but there are many concerns such as influencing patient choice and creating affordability barriers to treatment. Extrinsic, financial incentives may compete with the intrinsic desire to help patients. They also noted that referral-based payment is subject to similar ethical concerns. Meanwhile, time spent with patients needs to be valued, they wrote, as this is needed to ensure effective communication, examination and to express compassion.

“The challenges to care and medical practice during and after the COVID-19 pandemic underscore the need to reemphasise the ethical foundation of medicine,” the authors wrote. “Looking anew at the environment in which care is delivered, physicians should lead in ensuring that business relationships explicitly recognise and support the fundamental and timeless commitments of physicians and medicine to patients.”

Source: MedPage Today

Journal information: DeCamp M, et al “Ethical and Professionalism Implications of Physician Employment and Health Care Business Practices: A Policy Paper From the American College of Physicians” Ann Intern Med 2021; DOI: 10.7326/M20-7093.

Failure of Joint Corporate Medical Insurance Betrays a Greater Problem

The failure of a joint corporate medical insurance venture to cover the employees of three corporate giants nevertheless holds lessons for the future, its former CEO revealed.

Headed by author, innovator, and surgeon Atul Gawande, MD, Haven was created by Berkshire Hathaway, Amazon, and JP Morgan Chase to provide revolutionary healthcare insurance for their 150 000 employees, delivering high quality at an affordable price. More than just a healthcare system, it was aimed to provide an example for the rest of the United States to follow. Its team of experts created a system of coverage with no co-insurance, no deductibles, 60 critical drugs at no cost, and low-cost mental health services and primary care.

Yet, less than three years after its inception, it is soon to shut down. Dr Gawande had already stepped down as chairman in May 2020, and in a ‘grand rounds’ discussion with Robert Wachter, MD, chair of the University of California San Francisco’s department of medicine he explained the problems behind it. He said that, simply put, the system is fatally flawed — a weakness that was laid bare by the enormous job losses of the COVID pandemic.

“We have an employer-based system. A job-based system is a broken system in a world where people are moving every couple of years to different roles and many, many, kinds of jobs,” Dr Gawande said.

“The pandemic has really brought this out in spades,” he said. The lockdowns cost many workers their jobs and the benefits that came with them. At the end of 2020, there were 9.4 million fewer jobs in the US.

“The vulnerability we have of tying your healthcare to your job, that remains still a big hill to climb, and the government has to solve it. That is a public core issue that we still have not faced up to,” Dr Gawande said.

He explained that a job-based healthcare system cares only about costs this year, not over the worker’s lifetime. “That’s why we have fights over whether we’ll pay for a hepatitis C treatment that costs $50 000 and up but avert $1 million in costs over the course of a life. We need that life-course commitment and view, and we have not aligned around that,” he said.

But that wasn’t the only reason behind Haven’s dissolution; it proved extremely difficult to make an insurance plan that worked across three different companies with different organisational cultures and employees in different cities, with different populations.

“Once that became clear, then Haven threatens to become a very expensive think tank,” Dr Gawande said. Originally, Haven was supposed to assume benefits management responsibility at the three companies, he explained. But it eventually became clear that “didn’t have the potential to say we’ll take over all of the benefits and running of the insurance for all you three organisations and then add more and more and more and more.”

However, Dr Gawande doesn’t think Haven was a failure. “It definitely did not become what we thought it would be,” he confessed. But the experience enabled him to start called CIC Health, a new venture which launched COVID testing efforts in the Boston area last fall and now has major COVID vaccination efforts underway with more coming.

Source: MedPage Today

Medical Aid Schemes to Share Cost of Nationwide Vaccination

As arrangements are being made to pay for the COVID vaccination programme for South Africa, medical aid schemes are expected to contribute to the cost towards ensuring at least 67% of the population receives a vaccine, which is the minimum number to establish herd immunity.

Across South Africa, there are some 9 million medical aid beneficiaries, making up some 16% of the population and who collectively spent R186 billion last year on healthcare. The total cost of providing sufficient vaccines for the South African population is thought to range from R5 billion to R20 billion, depending on whether the vaccine is simply bought for the commercial price or whether the distribution and administration costs are factored in as well.

Discussions into paying for the mass vaccinations have suggested that mass-employers, such as mines, ought to contribute  This week, the Council for Medical Schemes (CMS) confirmed that vaccination would be a minimum prescribed benefit, so this will not be paid for out of medical savings.”The CMS acknowledges that there may be an additional cost burden to medical schemes for the provision of the vaccine, but this is not expected to be prohibitively high,” the body said. “In addition, industry associations have assured the CMS that vaccine costs can be absorbed by most medical schemes.”

South Africa’s vaccine source is not yet clear, although President Cyril Ramaphosa has hinted that Canada may share its excess vaccine stock. Canada currently has enough vaccine pre-purchase agreements to vaccinate its population five times over.

Source: Business Insider

Amazon to Enter the Health Industry

With the launch of Amazon Pharmacy in the US last November, online pharmacy companies are worried about the industry giant Amazon’s entry into the healthcare industry.

The head of Quick Meds, an online pharmacy firm that had only recently been established, believes it will have a huge impact on the industry.

“I’m worried,” he said. “They’ll have a massive marketing budget, and they’ll definitely take a sizeable chunk out of every other pharmacy on the market. There will be closures as a direct result of it.”

Pharmacies have complex, inefficient supply chains which the online retail giant could outcompete with its massive, streamlined operations. Amazon is already purchasing its first fleet of aircraft to compete directly with large courier companies like FedEx, taking advantage of plummeting aircraft prices in the wake of the pandemic.

Scott Galloway, professor of marketing at NYU Stern, entrepreneur and author of Post Corona: From Crisis to Opportunity, believes that consumers will benefit in the short and medium term.”For the most part of Amazon’s history, as a consumer you’re getting products for near cost or sometimes even below cost and that has just been an incredible boon for consumers and shareholders,” he said.

The company would use information from its other business areas to create a database of each customer’s health, enabling it to target goods and services.

“With their new wearable Amazon Halo, the company can build a 3D image of their consumers and they can then combine this with the foods you eat through Whole Foods, data from Amazon Prime and Alexa, and information such as your post code, relationship status, demographic data,” said Mr Galloway. Compared to the largely reactive medical industry, where consumers seek out medical services, this is a sea change.

“They can use this to offer proactive healthcare services,” he said.

Source: BBC News