Category: Medical Industry

SA Healthcare Bolstered With Vaccine Lab Investment and Loans

Photo by Louise Reed on Unsplash

Last week, South African healthcare received a double shot in the arm with the opening of a local vaccine manufacturing facility and the approval of a World Bank loan to bolster social safety nets and health systems.

On Wednesday, President Cyril Ramaphosa and health technology billionaire Dr Patrick Soon-Shiong officially opened a new vaccine manufacturing facility in Brackenfell, Western Cape.

The South African-born entrepreneur has been strongly supporting local healthcare, with R3 billion invested to help SA share vaccine technology with the rest of Africa. His company, ImmunityBio, is developing a T-cell based universal COVID vaccine, currently in Phase III trials in SA. The same adenovirus vector technology it uses is also being tested in cancer vaccines.

“It has been a dream of mine, since I left the country as a young physician, to bring state-of-the-art, 21st century medical care to SA and to enable the country to serve as a scientific hub for the continent,” Dr Shoon-Siong had previously said. The technology transfer will help “establish much-needed capacity and self-sufficiency.”

The hub will transfer technology, know-how and materials for DNA, RNA, adjuvant vaccine platforms and cell therapies to SA.

“There is no reason we couldn’t make 500 million doses a year,” said Dr Soon-Shiong, who is also a Wits alumnus. “Subject to the raw material being available.”

He said he wants to tap the country’s expertise on prevalent diseases such as HIV and cervical cancer. “There are fantastic scientists with deep knowledge about these diseases,” he said. “More so than in America because they see these patients every day.”

President Ramaphosa and Dr Soon-Shiong also launched the Coalition to Accelerate Africa’s Access to Advanced Healthcare, which aims to drive the development of innovative therapeutics and ensure the continent is prepared for future pandemics.

The coalition aims to manufacture a billion doses of the COVID vaccine by 2025 and to develop treatments for conditions including cancer, COVID, tuberculosis and HIV.

South Africa also received approval from the World Bank for a US$750 million COVID relief loan aimed at reducing the worst of the pandemic’s impact on the poor.

“The World Bank budget support is coming at a critical time for us and will contribute towards addressing the financing gap stemming from additional spending in response to the COVID crisis,” said Dondo Mogajane, Director General of the National Treasury. “It will assist in addressing the immediate challenge of financing critical health and social safety net programs whilst also continuing to develop our economic reform agenda to build back better.”

Meanwhile, Health Minister Dr Joe Phaahla warned that South Africa will likely enter a fifth wave when cold temperatures in May, though what COVID variants may drive it remain to be seen.

Health Tech Startup Set to Grow in Africa

Photo by Ivan Samkov from Pexels

Ghanaian health tech startup mPharma is building a network of community pharmacies across Africa as it plans to be the go-to primary healthcare service provider for millions of people. Drug supply in Africa is often unaffordable and counterfeits are rife.

The startup’s community (Mutti) pharmacies are essentially mini-hospitals offering affordable services, ranging from medical consultation to diagnostic and telehealth services. 

The company plans more Mutti pharmacies to extend its reach ater raising $35 million, bringing the total amount raised by mPharma to $65 million.

According to mPharma co-founder and CEO Gregory Rockson told TechCrunch, the new financing will be used to ramp up its infrastructure, staff and expansion into African markets.

“We are hiring over 100 engineers to build all our technology in-house and this includes a massive data infrastructure we are creating. We are also investing in other skilled talent like doctors and nurses, professionals that are critical in the work we do,” Rockson told TechCrunch.

Originally founded in 2013, mPharma aims to manage prescription drug inventory for pharmacies and their suppliers, retail pharmacy operations and to provide market intelligence to hospitals, pharmacies and patients.

In October 2021, the startup added telehealth services to its portfolio, catching the telemedicine wave brought in by the COVID pandemic. Rockson told TechCrunch the startup was planning to have 100 virtual centres after six months. The number of virtual centres is primed to grow further alongside mPharma’s plan to increase its community pharmacies from 200 to over 2000 in three years.

Patients in Ghana, Nigeria, Kenya, Zambia, Malawi, Rwanda and Ethiopia, where mPharma has a presence, can access these virtual services. Startups like mPharma aim to address healthcare gaps in Africa. 

Sub-Saharan African countries have an average of 0.23 doctors for every 10 000 people against the best ratio of 84.2 doctors in some of the most developed countries. In addition, healthcare infrastructure remains critically underdeveloped.

“COVID showed us that the best form of care is local, it is in the community, and the closest thing in communities are pharmacies. We believe that the pharmacy of the future, which is what we are creating, is one built around longitudinal care not episodic care,” said Rockson.

“We are transforming community pharmacies into the foundation of a modern health system in Africa. We will have a Mutti pharmacy in every community on the continent, guarantee the availability and safety of medicines for each community and utilise the physical infrastructure of Mutti pharmacies to expand Mutti Doctor (the telemedicine service), creating the largest network of doctor offices and diagnostic centres.”

Source: TechCrunch

‘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!

Review Looks at The Evidence for Cannabis in Paediatric Epilepsies

Photo by Crystalweed Cannabis on Unsplash

A review published in Developmental Medicine & Child Neurology investigates the knowledge base of cannabis-based medicinal products in paediatric epilepsies, highlighting areas in need of additional research.

Following reports in the media of children with epilepsies apparently deriving benefits from medical marijuana (or cannabis-based medicinal products) accessed abroad, the UK government allowed clinicians to prescribe these products. A previous review found that there was some benefit in certain drug-resistant epilepsies in children.

In the review, the authors also looked at the prescribing environment surrounding these products. They found that the major obstacle to prescribing is a lack of quality evidence for efficacy and safety.
The authors stress that unlicensed cannabis-based medicinal products should not circumvent the usual regulatory requirements before being prescribed. They are also concerned that children with epilepsy are at risk of being exploited as a “Trojan horse” for the cannabis industry, with widespread acceptance of medicinal cannabis accelerating the wider legalisation of marijuana and opening up a highly lucrative commercial market.

Source: News-Medical.Net

Novel Nasal Spray for Migraines Approved by FDA

Impel NeuroPharma announced that the US Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults.

The innovative system delivers dihydroergotamine mesylate (DHE) through the vascular-rich upper nasal space, bypasses the gut and potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after a migraine attack starts. 

During the Phase 3, open-label, pivotal safety study, STOP 301, more than 5,650 migraine attacks were treated over 24 or 52 weeks during the study. The primary objective of the study was to assess the safety and tolerability of TRUDHESA. TRUDHESA was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief. STOP 301 reported TRUDHESA offered consistent efficacy even when taken late into a migraine attack.

“Many of my patients need more from their migraine treatment, and TRUDHESA offers a non-oral, fast-acting, reliable option that overcomes many current medication challenges,” said Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor in the Department of Neurology, and Program Director of the Headache Medicine Fellowship Program, Thomas Jefferson University. “Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments. And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack, so patients don’t need to worry about missing the opportunity to benefit from using TRUDHESA within a certain timeframe. I think patients will be very receptive to this treatment, because it pairs the long-proven benefits of DHE with a patient-friendly delivery system.”

There were no serious adverse events were observed in the study, and most adverse events were mild and transient in nature.

In the STOP 301 study, patient-reported efficacy showed that 38% of patients had pain freedom, 66% had pain relief, and 52% had freedom from their most bothersome migraine symptom at two hours after their first dose of TRUDHESA. In 16% of patients, pain relief started as early as 15 minutes. Of patients who were pain free at two hours, 93 percent were still pain free at 24 hours, and 86 percent were still pain free through two days. The great majority of patients (84%) reported that TRUDHESA was easy to use10 and preferred it over their current therapy.

Source: Impel NeuroPharma

Mistreatment at Med School Leads to Later Exhaustion, Regret

Photo by SJ Objio on Unsplash

Medical students who experienced mistreatment during medical school were more likely to become exhausted or disengaged, have less empathy, and have career regret, a new study has revealed.

Among a large national sample of trainees, the 22.9% of respondents who reported mistreatment on the Association of American Medical Colleges’ Medical School Year 2 Questionnaire (Y2Q) had higher exhaustion and disengagement scores on the Graduation Questionnaire (GQ) 2 years later, reported Liselotte Dyrbye, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues writing in JAMA Network Open.

Furthermore, of those who had experienced mistreatment, 18.8% reported career regret on the GQ.

Conversely, medical students who experienced a better environment more likely to:

Have lower exhaustion scores: for each 1-point increase on the Y2Q, there was a 0.05 reduction in exhaustion score
Report lower disengagement scores on the GQ: for each 1-point increase on the Y2Q, there was a 0.04 reduction in disengagement score
Further, reports of having positive interactions with faculty on the Y2Q were associated with higher empathy scores on the GQ. For each 1-point increase, there was a rise of 0.02 in empathy score. Positive student-to-student interactions were linked to having lower odds of career regret during the last year of medical school.

“The potential protective effect of positive experiences within the learning environment may provide insight into strengths that organizations can amplify to mitigate burnout, decline in empathy, and career choice regret among their students,” wrote Dyrbye and colleagues.

The team noted the opportunity for potential interventions. “Although the most effective approaches to addressing mistreatment of learners remain elusive, the frequency of mistreatment varies between educational programs, suggesting there are likely to be levers within the control of the organisation that adequate commitment, leadership, infrastructure, resources, and accountability can lead to a meaningful reduction in mistreatment.”

Average age of the respondents was 28 years, 52% were women, 72.8% were single, and 91% reported having no dependents. The study also found that older medical students reported higher disengagement scores, and that women reported lower exhaustion (by 0.27 points) and disengagement (by 0.47 points) scores on the GQ.

However, women and older medical students had higher empathy scores compared with their male peers (0.74 points and 0.05 points, respectively).

The researchers observed that conflicting findings on burnout among women in medicine have been reported. For example, a longitudinal cohort study of resident physicians across specialties in the US found that female residents were “more likely to develop burnout and have worsening in the severity of their emotional exhaustion between the second and third year of training compared with male residents, even after controlling for various forms of mistreatment.”

Limitations of their own study, the researchers noted, included unestablished differences between the exhaustion, disengagement, and empathy scale measures that were used in the questionnaires; and the varying response rates between questionnaires: 55.5% for the Y2Q and 81.5% for the GQ.

Source: MedPage Today

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

Over 100 Fast-tracked Drugs Not Confirmed Effective

Of 253 drugs approved via the FDA’s accelerated approval pathway, clinical effectiveness has been confirmed in 112, according to a new investigation by The BMJ.

Clinical reporter Elisabeth Mahase found that, as of the end of last year, 24 of those 112 drugs have been on the market for more than 5 years, and some have been on the market for more than 2 decades — often with a high price tag, according to.

Though the accelerated approval pathway allows drugs onto the market before efficacy has been established, the manufacturer has to perform confirmatory trials or else the approval will be rescinded.

However, Mahase noted that only 16 drugs authorised through the accelerated approval pathway have been withdrawn since its creation in 1992 . Most of those were shown to lack efficacy, but in some cases, confirmatory trials were simply never done. Celecoxib (Celebrex), for example, was given accelerated approval in 1999 for the treatment of familial adenomatous polyposis, a genetic disorder that carries a high risk of bowel cancer if untreated, remained on the market for about 12 years before the FDA asked Pfizer to voluntarily withdraw it for this specific indication because efficacy trials were never completed.

The BMJ asked the manufacturers of 24 drugs that have been on the market for more than 5 years if they had conducted phase IV trials. Six drugs had been withdrawn, approved, or postponed. Of the remaining 18 drugs, relevant trial information was provided for a third. Four manufacturers of those six drugs were recruiting participants, and two reported talking to the FDA about final trial design. Eleven companies representing 12 drugs did not respond.

FDA response

“We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible,” an FDA spokesperson said in a statement provided to MedPage Today. “The program allows the FDA to approve a drug or biologic product intended to treat a serious or life-threatening condition based on an outcome that can be measured earlier than survival that demonstrates a meaningful advantage over available therapies.”

The FDA could choose to initiate proceedings to withdraw a drug’s approval should post-marketing trials show no benefit or not be performed in time, added the spokesperson.

“Because the FDA continues to use this pathway to accelerate access to drugs for serious and life-threatening diseases for which there is an unmet medical need, at any point in time there will be drugs that are not converted because the confirmatory trials are ongoing,” the spokesperson said.

“Despite the pathway’s good intentions to accelerate ‘the availability of drugs that treat serious diseases,’ experts are concerned that it is now being exploited, to the detriment of patients — who may be given a drug that offers little benefit and possible harm — and of taxpayers,” she continued.

Fixing the accelerated approval pathway

Concerns about the accelerated approval pathway include a lack of threats from the FDA to withdraw a drug should confirmatory trials not be done, the agency’s use of indirect (or surrogate) measures of clinical benefit in some cases, and the potential for drug manufacturers to take advantage of the pathway when it comes to actual measures of safety and effectiveness, Mahase wrote.

Nevertheless, experts still agree that the accelerated approval pathway is of benefit, she noted. Suggested changes to the pathway include planning or starting confirmatory trials as part of the approval as well as closer examination of surrogate measures.

A recent example is Biogen’s controversial Alzheimer’s disease treatment aducanumab (Aduhelm) received FDA approval via the process last month, which was based on the surrogate endpoint of reduction of amyloid-beta plaque in the brain.

The drug has attracted criticism since its recent fast-track approval, with critics pointing out that the drug has not been proven effective and its $56 000 annual price is unreasonable.

Source: MedPage Today

Journal information: Mahase E “FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway” BMJ 2021; DOI: 10.1136/bmj.n1898.

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

Financial Feasibility of NHI Challenged

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Health groups are seeking detailed information on the workings of South Africa’s new National Health Insurance (NHI) scheme, particularly on its financial feasibility.

The Khayelitsha and Klipfonetin health forums said in a presentation to parliament that a proper analysis is necessary to see if South Africa can even afford to fund the NHI. This is a concern that has been echoed by experts. The analysis should also find out if the public trusts the government to be able to deliver an NHI that is fully inclusive of community participation, the forums said.

“There is a view that perhaps we need to be building our public healthcare system as a priority to ensure a successful transition to an NHI Fund,” it said.

The forums also raised concerns around what the NHI will mean for existing healthcare systems – including the future of the country’s medical aids.

“Clarity is needed with respect to how the NHI Bill will address the transition between private medical aids and a universal healthcare system for all.

“The gap between private and public healthcare needs to be bridged and how this is done is important.”

Other critics have also pointed out that the scheme does nothing to address the serious gaps and flaws in South Africa’s healthcare system.

The fate of medical aids

The NHI Bill currently states that when the system is “fully implemented”, services that are paid for by the NHI will not be covered by medical aids.

Discovery Health has said that while it is in general supportive of the structural changes being introduced through the NHI, medical aids should not be limited.

“Our strong view is that limiting the role of medical schemes would be counterproductive to the NHI because there are simply insufficient resources to meet the needs of all South Africans.

“Limiting people from purchasing the medical scheme coverage they seek will seriously curtail the healthcare they expect and demand. It poses the risks of eroding sentiment, and of denuding the country of critically needed skills, and is impacting negatively on local and international investor sentiment and business confidence.”

Crucially, by preventing those who can afford it from using their medical scheme cover, and forcing them into the NHI system, this approach will also have the effect of increasing the burden on the NHI and will drain the very resources that must be used for people in most need, the scheme said. Significantly, there is no indication by government as to how the NHI will be paid for, or whether it can even be afforded, with only mention made to payroll taxes and other revenue streams being tapped.

Source: BusinessTech