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9 July 2022
Welcome to the Medical Week in Review for the week ending 9 July 2022. It's a packed weekly round-up – we hope you enjoy the read.
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Matters COVID
Infectious Disease Update
Ageing and Age care
Focus on Paediatrics
Ophthalmology
Ethics, Legalities and Medical Practice
Tech Talks
The Healthcare Market in Numbers
Emerging and Novel Therapeutics
Medical Trivia
Matters COVID
This week, our rolling 7-day average was 735 cases, a slight increase of 99 patients from two weeks ago, so no dramatic increase there.
Onto our neighbours and for the seven-day rolling average Namibia recorded another dramatic drop with only 7 cases; Botswana’s caseload has also shown a steady decline, with 198 cases reported for their 7-day average. Kenya, Zimbabwe and Nigeria similarly are all recording a decline recording 208, 48 and 50 cases respectively for their 7-day averages.
In COVID matters in the news: this week saw President Rhamaposa re-inforcing his message regarding the TRIPS waiver, to leaders at the G7 summit in Schloss Elmau, Germany.5
You may recall the TRIPS waiver was the result of campaigning – mainly on the part of South African and India – which resulted in the World Trade Organisation suspending the intellectual property rights of international pharmaceutical companies over their Covid therapeutics and diagnostics, enabling developing countries to manufacture these without the authorization of the patent holders.
However, the TRIPS waiver is not a cure-all for ensuring vaccine equality in the region. According to our source article, Stavros Nicolaou, Aspen’s group senior executive for strategic trade, pointed out that, while important, the waiver is only the first step in the process: we need manufacturing capacity to deliver on those released patents and, perhaps more crucially, we need African countries to buy from African countries, or the whole exercise is pointless.5
It remains to be seen if we, as the African continent, can indeed pull off this ‘drug-equity’ renaissance. The full story as always is covered in-depth in the Daily Maverick.5
In other news matters COVID, and this week saw increasing reports of the BA.5 subvariant which is driving the substantial surge in COVID cases we are seeing in the US and the UK. Dr Eric Topol, a professor of molecular medicine wrote an article on the 27th of June in which he stated….”The Omicron sub-variant BA.5 is the worst version of the virus that we’ve seen. It takes immune escape, already extensive, to the next level, and, as a function of that, enhanced transmissibility, well beyond Omicron.”3
He points to the sub-variant's rapid rise to become the dominant variant in countries such as Portugal, and many other European countries, as cause for concern.
He argues that the rise of the variant has, to all intents and purposes, been largely unreported, partly due to declining testing rates and partly due to the masking of the sub-variant by the waning and fluctuating levels of the BA.2 variant in different countries. More importantly, he believes that the BA.5 variant may reach 100% dominance in the US as early as mid-July.
Of significant concern then, is that the current vaccines do not protect against these new variants. To address this situation, the FDA said last week that it would look to approve the inclusion of the newer strains ( BA.4 and BA.5) in vaccines for use in the US.4 Both Pfizer and Moderna have already tested the efficacy of the B.1 variant in their booster vaccines and presented those findings to the FDA, indicating that the structure of that vaccine may achieve “superior antibody response” when compared to the existing boosters.”6
The jury, however, is out, regarding what will offer more effective coverage: a booster now which contains the BA.1 strain coverage and which would offer broader coverage, or a booster sometime in the future which would include the BA.4 and BA.5 variants. 2,4,6
The WHO advisory committee that considered the modified shots said the group “…preferred BA.1-based boosters, arguing that the variant is more distinct and could generate a broader response than the more recently circulating subvariants. The FDA also supports this approach stating the boosters containing the BA-1 variant will be ready much earlier than those with the BA.4 or 5 variants.” 2
If Eric Topol is right, and this variant is indeed more virulent than what we are currently experiencing, we could see our figures rise beyond our health system’s capacity to cope. We could even see the return of some form of lockdown restrictions, something we as a country can ill afford.
1. COVID-19 Data Repository by the Center for Systems Science and Engineering ( CSSE) at Johns Hopkins University
2. What the BA.5 Subvariant Could Mean for the United States
3. The BA.5 story,The takeover by this Omicron sub-variant is not pretty
4. Omicron-specific COVID shots could increase protection as boosters, European Medicines Agency says
5. Ramaphosa warns G7 leaders of new aim for patent waiver on Covid therapeutics and diagnostics
6. Pfizer says its Omicron-containing boosters outperform current vaccine
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Infectious Disease Update
This week saw the report of 2 cases of the Marburg virus in Ghana. Samples obtained from two deceased patients in the southern Ashanti region have been sent to the WHO collaboration testing laboratory in Senegal for confirmation. If confirmed, this is only the second time Marburg has been detected in West Africa.
Marburg viral disease(MVD) is caused by the same zoonotic viral family that causes Ebola – namely - Filoviridae. The reservoir for MVD is thought to be Egyptian fruit bats, and it is believed that entry into caves of mines where the bats naturally reside may be associated with the outbreaks.8 A quick google search turned up that the Ashanti area is indeed associated with mining – gold mining to be exact - so this latest outbreak seems to fit that assertion. 9 The WHO has its teams on the ground and has already begun preparing to ramp up the detection and contact tracing process as part of an outbreak response preparedness. 7
Continuing with the Filoviridae virus and this week, there was good news out of the Democratic Republic of Congo, with a report from the WHO that the 14th outbreak of Ebola in that country has been officially declared over.14
This outbreak was restricted to four confirmed patients and a possible fifth patient, all of whom subsequently died. The containment of the disease is credited to the swift action by the WHO and the health authorities in the region, the result, according to the WHO, of learnings from previous outbreaks.14
This brings us to our last story, and that is the launch on Tuesday of this week of the Pandemic Science Institute at Oxford University. The institute aims to “..reduce the risks posed by infectious diseases by improving data collection, strengthening surveillance and helping to create vaccines and other countermeasures.”15 It aims to learn from the global response to COVID, and harness its global partnerships and research capacity to improve pandemic preparedness. One area the institute will focus on is vaccine manufacture globally, and, alluding to our earlier story regarding the TRIPS waiver, look to technology transfer in underserved regions. The institute hopes to “fill the gaps” to enable a more proactive approach to pandemics, as opposed to what happened during COVID.
In other news, Monkeypox continues to spread globally, with over 6000 cases reported in 58 countries. Europe is the epicentre of this outbreak, while in South Africa, we are still sitting with just two cases. 12 There is speculation that the number of cases globally may be higher, as there is believed to be significant underreporting, and testing remains a challenge. At Wednesday’s press briefing, the WHO’s Director-General Dr Tedros indicated that the organization may reconsider its decision to classify the condition as a public health emergency of international concern should the caseload continue to rise.
Links
7. Ghana reports first-ever suspected cases of Marburg virus disease (WHO)
8. Ebola and Marburg virus diseases in Africa: Increased risk of outbreaks in previously unaffected areas?
9. Central Ashanti Gold Project
10. The Democratic Republic of the Congo declares 14th Ebola outbreak over (UN)
11. Oxford University Takes Aim at Future Pandemic Threats (Bloomberg)
12. Monkeypox case identified in South Africa (NCID)
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Age and Age Care
Keeping with matters ageing, and the need for the early detection of chronic conditions such as Alzheimer's and dementia is becoming ever more pressing if we are to be in a position to effectively manage our ageing population from a social and economic perspective.
To this end, recently there has been a flurry of studies that have looked at the early detection of at-risk patients in several age-related conditions. As always, prevention is better than cure: if you can detect an at-risk patient, you can intervene to either prevent the condition from occurring or implement early therapeutic strategies to mitigate the severity of the disease course.
We chose a new study out of Canada for this week’s feature, that has looked at the link between low muscle mass and subsequent cognitive decline over a 3-year follow-up period.
The study reviewed 8279 participants, who had a mean age of 72.9 [5.6] years. The participants were predominantly white (97%), and 48% were female Appendicular lean soft tissue mass (ALM) was assessed using dual-energy x-ray absorptiometry. Neurological function was determined using the “auditory verbal learning test. Executive function was assessed using the mental alternation test, Stroop high interference (words/dot) test, the animal fluency test, and the controlled oral word association test. Psychomotor speed was assessed using the computer-administered choice reaction time.”13
The study concluded that there was sufficient evidence to support the conclusion that there is a longitudinal association of low ALM and cognition in aging. The researchers hypothesize that it may be that improved physical activity, which results in higher muscle mass, simultaneously results in increased blood flow to the brain, thereby reducing the cognitive decline. Alternatively, or perhaps in addition to, the release of myokines and the interleukins 9 and 15, together with brain-derived neurotrophic factor ( BDNF) that happens during skeletal muscle activity may have anti-inflammatory effects, which may explain the effects of preserving muscle mass and brain health. Regardless of whether low muscle mass is an indicator or a causative agent, it certainly adds more fuel to the fire that keeping active is key to staving off cognitive decline.
Then we were alerted by STAT News, to the publication of a new trial in the BMJ this week, which look at viscosupplementation of knee osteoarthritis. Osteoarthritis is a leading cause of disability in older people. According to the researchers of this paper, there are over 560 million people living with knee osteoarthritis worldwide.14 There is no cure for the condition, and intervention mostly focuses on pain reduction and physical therapies to retain some form of mobility.
Despite variable guidelines - a number of which actively discourage its use - injectable viscosupplementation with intra-articular hyaluronic acid derivatives has increased in popularity. In the US for example, the growth in its use as a primary treatment has been substantial. According to the study, between 2012 to 2018, one in every seven patients with knee osteoarthritis received injections of hyaluronic acid derivatives as first-line treatment.
Against this background, the researchers set out to determine firstly, whether there was any appreciable difference in pain relief between patients treated with viscosupplementation and those given a placebo, and secondly what the outcomes were in relation to function and serious adverse events.169 trials, providing a sample of 21163 patients with knee osteoarthritis were reviewed. The researchers found that those patients who were treated with viscosupplementation experienced a small reduction in pain when compared to the placebo, but the difference was less than the minimal clinical difference. In studies from 2009 onwards, however, they found that pain reduction from the viscosupplementation equalled that of the placebo.
Concerningly in light of this lack of clinical differentiation in pain elevation, there was a strong correlation between viscosupplementation and serious adverse effects, which the researchers classified as those were which had resulted in a “...hospital admission, prolongation of hospital stay, persistent or major disability, congenital abnormality of offspring, life-threatening events, or death.” 14
They concluded their study strongly, indicating that the study was sufficiently large to conclude that “...viscosupplementation is not only ineffective compared with placebo but might also be seriously harmful and therefore should be used cautiously in any ongoing trial.”14 As always you should read the trial to make your own mind up.
Links
13. Association of Low Muscle Mass With Cognitive Function During a 3-Year Follow-up Among Adults Aged 65 to 86 Years in the Canadian Longitudinal Study on Aging (JAMA)
14. Viscosupplementation for knee osteoarthritis: systematic review and meta-analysis (BMJ)
15. Common injections don’t help knee osteoarthritis more than placebo, large data review finds (STAT NEWS)
Focus on Paediatrics
Sickle cell anaemia (SCA) is the most prevalent genetic condition in the African region.18 The WHO’s strategy document, which details measures for the management of sickle cell disease in the region, indicates that in some countries in Africa, between 10-40% of the population carry the SC gene, resulting in an SD prevalence of at least 2%. Deaths related to complications from the disease are high, particularly in children under five years of age, young adolescents and pregnant mothers.18
Similarly, the African region carries the highest malarial disease burden, with at least 95% of all malarial cases reported on the continent and a staggering death rate of 98%. Children accounted for 80% of those deaths.19 Given that severe, complicated malaria has similar clinical features to SCA when it occurs in children, the challenge of quantifying the true impact of both diseases becomes evident.
The researchers of this week’s study, Udugo, et al., wanted to establish whether measuring the levels of parasite-derived enzyme P falciparum histidine-rich protein 2 (PfHRP2) in the microcirculation would help distinguish the impact of malaria in children with SCD from the impact in children without SCD. The study was conducted as a secondary analysis of data obtained from the TRACT study.16 In case you are not familiar with TRACT, the 2015 study investigated the management of both complicated and uncomplicated severe anaemia - defined as HB <6.0d/l - in children in Uganda and Malawi. A link to that study is included below for your reference.17
Using the info obtained from the TRACT study, the researchers analysed measures of P falciparum parasite burden, features of severe malaria, and mortality at day 28 in malaria-positive children. Among 3483 children enrolled in the TRACT study in Uganda, who presented with all-cause severe anaemia, 30% were found to have SCA.
When compared to children with normal HbAA, a significantly lower portion of children with SCA tested positive for “…P falciparum malaria, and both total parasite burden and levels of inflammation, a correlate of clinical severity were significantly lower in those with SCA who tested positive compared with HbAA children who tested positive. Only a small proportion of the children with SCA presented with the clinical or laboratory features of classic severe malaria.” 16 These observations suggest that malaria infections are “…both less frequent and less severe among children with SCA than they are in HbAA children.” 16
The researchers concluded that although their study supported evidence that children with SCA were innately protected from high-density malaria infection, other clinical impacts should be considered. These included the findings that malaria was a likely trigger for an anaemic crisis in these SCD children, many of whom already had low haemoglobin concentrations. Such a crisis could result in a high mortality rate in these children, particularly in instances where sufficient blood supplies are lacking.
Links
16. Sickle cell anaemia and severe plasmodium falciparum malaria: a secondary analysis of the Transfusion and Treatment of African Children (Lancet)
17. Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomized controlled trial (Biomedicalcentral)
18. Sickle-Cell Disease: a strategy for the WHO African Region (WHO)
19. Malaria fact sheet (WHO)
Ophthalmology
Lately, we’ve reviewed a number of articles in which advances in optical coherence tomography have seen the technology play a role in the early detection of certain diseases. This week is no different.
In their paper published in JAMA Ophthalmology, researchers Nishida T, et al. set out to determine whether the ganglion cell complex thickness changes seen in optical coherence tomography could assist in the determination of the future vision-related quality of life in patients who had been diagnosed with open-angle glaucoma.
The basis for their study was the hypothesis that faster structural changes might result in a worse quality of life for these patients. The researchers point to previous studies that found a positive association between glaucoma and a decreased visual-related quality of life score(VRQOL), including that these patients struggle to perform daily tasks and experience a reduced sense of independence. A decreasing quality of life score was most often seen in patients with a central visual field deficit, as both their perceived and actual ability to maintain their personal safety was linked to the retention of this visual field.
The importance of ongoing monitoring of visual field changes then cannot be overestimated in ensuring the overall well-being of these patients. This respective longitudinal study, reviewed “… 236 eyes of 118 participants (72 participants with bilateral POAG and 46 participants with suspected POAG/glaucoma).” 20 The mean age of the participants was 73.2 years.OCT images were obtained over 4.1 (95% CI, 4.0-4.3) years of follow-up to determine the rate of GCC thinning. 20
After adjusting for confounding factors, they found that “…faster GCC thinning and lower visual acuity was associated with a lower VRQOL. Specifically, a lower VRQOL was associated weakly with GCC thinning in the 5.6° and 6.8° central macular areas.” 20
The researchers concluded that a decline in near and peripheral vision and the resulting difficulties in driving, role limitations, and dependency issues – the QOL measures most affected by GCC thinning - strongly correlated to VF loss evidence in glaucoma.
The study highlights the importance of ongoing monitoring and careful, considered communication in the management of these patients to ensure their quality of life is as optimized as possible.
Links
20. Association Between Ganglion Cell Complex Thinning and Vision-Related Quality of Life in Glaucoma (JAMA Ophthalmology)
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Tech Talks Smart Face Masks
Researchers in China has taken mask-wearing to a new level. In a paper published in AC Nano, researchers have created a lightweight mask capable of simultaneously monitoring coughing and correct mark-wearing.22
The mask, which is easy to wear, is powered by a battery-free radio frequency harmonic transponder, which is attached to the inner layer of the mask. It is capable of detecting when the mask is separating from the face, and prompt the user to correct its position This may, according to the researchers, play a significant role in mitigating viral transfer from one person to another.By monitoring coughing frequency during the day, the device may assist in the management of certain respiratory diseases such as COPD, so says the lead researcher, associate professor Zhen Yan
Now if they could just invent a mask that stops reading glasses fogging up.
Links
21. Smart Face Mask Requires No Power to Monitor Coughs (Healthtech Insider)
22 . Breathable, Reusable, and Zero-Power Smart Face Mask for Wireless Cough and Mask-Wearing Monitoring (ACNano)
Ethics, Legalities and Medical Practice
While Minister of Health Joe Phala is nowhere to be seen in this debate, Gauteng Premier David Makhuru has come out and said: “A report that is coming to the Provincial Executive Council (Provincial Cabinet) on the hospitals tomorrow” (27 June 2022)23
In his comments addressed to the Daily Mavericks Citizen, he said he would “gladly welcome a meeting with clinicians”, adding that social justice organization SECTION27 had made “useful proposals on the reform of the public health system, with the emphasis on decentralization and devolution.”23
Which appears to be code for something we are yet to understand. At any rate, in an attempt to keep to non-biased coverage, we’ll await the outcome of those meetings.
While we wait, we recommend a read of the legal opinion penned by Professor DJ McQoid-Mason, published in the SAMJ.22 The article unpacks the legalities and ethics of Dr de Maayer's action in of taking his concerns into the public arena. This public voicing, it should be noted, seems to have been the source of the outrage from the healthcare officials. To be clear, they did not voice similar outrage regarding the needless deaths of children under their care nor the shameful state of their hospitals, which Dr de Maayer reported.
That said, McQuaid-Mason considers his opinion from three angles: the Constitutional implications, the National Health Act stipulations and the Health Professions Act and HPCSA Rules and Guidelines. He finds that in relation to all three, Dr de Maayer had acted in the best interests of the patients in his care at all times, and only went public when he had exhausted all other channels. McQuaid-Mason further states that indeed it was not de Maayer who violated the Constitution, but the rather official functionaries who sought to discipline him, and it is they who should be punished for “…dereliction of duty and intentional maladministration, negligence or indifference.” 23
So the score appears to be: Dr Tim de Maayer, 1 ; Gauteng healthcare officials – 0
Links
22. Is there a legal and ethical duty on public sector doctors whose complaints to hospital administrators have been ignored to inform the public about harm to child patients due to intentional maladministration, negligence or indifference at the local and provincial level(SAMJ)
23. Premier David Makhura ‘will respond’ to Gauteng hospital crisis as more doctors speak out
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Healthcare Market in Numbers
$13.9 billion
The number the global market for x-ray devices is expected to reach by 2027
In our new feature, we look at the healthcare market in numbers and identify emerging trends in healthcare to better understand the external forces impacting how our healthcare is delivered.
This week, a report in iHealthcareanalyist – a specialist healthcare market research company - estimates that the global market for x-ray devices is expected to reach a staggering $13.9 billion by 2027.
This exponential growth is driven by an increase in the world’s elderly population, with their associated age-related injuries and diseases, together with advances in technology and changing preferences of physicians and practitioners in relation to imaging services.
Fixed x-ray equipment previously made up the majority of spend in this market, but the demand for mobile facilities such as bedside imaging facilities appears to be driving this latest surge. That said, the fastest-growing segment spurring this growth is that of imaging services for mammography. While ultrasound and MRI remain important diagnostic tools, x-ray imaging remains the “method of choice to detect early-stage breast cancer.”24
No surprise that the majority of this growth is coming from the private sector in North America and Europe. Here in Africa, we coalesce into the “Rest of the World” category.
Our non-featuring in this report is reflected in the situation here at home. A study conducted by researchers in 2017, which looked at public sector radiology resources in metro and rural areas of the Western Cape, showed that, despite imaging facilities in rural areas being double that found in metropolitan areas, there is a 30% lower usage of these services in rural facilities.24 Among other issues, the study points to a lack of personnel to run the equipment in rural areas, proving yet again that you cannot take the ‘human’ out of healthcare.25
Links >
24. Global X-Ray Devices Market $13.9 Billion by 2027 (iHealthcare Analyst)
25. Towards equity: a retrospective analysis of public sector radiological resources and utilization patterns in the metropolitan and rural areas of the Western Cape Province of South Africa in 2017(Biomedical Central)
Emerging and Novel Therapeutics
In the second of our new features, we introduce our segment on emerging and novel therapies to watch. We’ll be tracking new drug releases as they are published, and keep an eye on the FDA’s novel therapies list. And if we are really lucky, we’ll be able to have some insights into what is brewing in our local drug pipeline.
This week we’re looking at the most recent of the approved drugs on the FDA’s novel drug list, Amvuttra, which was approved for use by the FDA on the 13th of June this year (2022).
Brought to market by Alnylam Pharmaceuticals, the drug, whose active ingredient is vutrisiran is indicated for use in polyneuropathy of hereditary transthyretin-mediated amyloidosis.
If you are not aware of this rare disease, tansthyretin amyloidosis is "a slowly progressive condition characterised by the buildup of abnormal deposits of a protein called amyloid (amyloidosis) in the body's organs and tissues." 26There are three forms of the disease – neuropathic, which affects the peripheral nervous system, leptomeningeal, which affects the CNS system and cardiac form. 26
Termed a next-gen RNA drug, the treatment may be available to physicians in the US as early as July this year and is expected to see global sales of around $1.8 billion by early 2026.26
Links
26. Novel Drug Approvals for 2022 (FDA)
26. Alnylam's next-gen RNA drug Amvuttra wins FDA approval—and a Pfizer showdown may await ( FiercePharma)
26. Transthyretin amyloidosis (Mediline Plus)
Medical Trivia
Did you know that there is still a debate as to who is the father of immunology - Louis Pasteur or Edward Jenner?
In some establishments, Edward Jenner's pioneering of the smallpox vaccine makes him the clear winner in the debate. Other establishments argue that Jenner did not extend the understanding of immunology. Rather they argue, it was Pasteur - who extended the germ theory of disease and introduced the concept that vaccination could be applied to any microbial disease - who is the true father of the science of immunology.
So if you didn't know, now you do.
27 Louis Pasteur, the Father of Immunology? (Frontiers of Immunology)
And that is all for the Week in Review.
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All that's left is to say, wherever you are, stay safe, stay sane, and join us next week where we review the week in medicine.
This has been a production on the Medical Education Network – delivering quality medical education and information to Southern Africa since 2008. All thoughts and comments on this podcast remain that of its creators. Every effort has been made to fact check the information contained here. Any errors or misstatements that may occur are unintentional.
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