💉 Bloomberg's drug quality investigation; Extreme heat's effects on women; Merck's pneumococcal vaccine success
#394 | Metformin moonlights; Nigeria's doctors strike; Human-on-chips potentially save lab rats
Hello, dear reader. Welcome back to The Kable. Our special free Friday edition looks back at all the most important life science events from the past week. Save your boss, work bestie and teammates some precious weekend time by sharing this with them?
But first, everyone at The Kable is positively buzzing with the excitement of our collaboration with Pharmaconex, the beating heart of African pharmaceutical manufacturing that binds the entire supply chain in Egypt, proudly the crown jewel of the pharmaceutical market in the MENA region.
The 10th-anniversary edition of Pharmaconex cordially invites you to network with your peers across the African continent. And the icing on the cake? A free, year-long subscription to The Kable is all yours. Claim your free year.
Africa and West Asia will lead the worldwide pharma story in the forthcoming decade; this is your chance to get a headstart. Ensure you're in the know. Sign up for Pharmaconex today to claim your year of The Kable.
And now for the news; in Nigeria, doctors are continuing to strike for improved working conditions and compensation that will actually pay the bills. About 15,000 doctors are striking, practically shutting down public hospital services. What about the others? They’ve likely already left the country in search of better remuneration.
In Peru, there are typically not more than 20 suspected cases of Guillain-Barré Syndrome per month. But between June 10 and July 15 this year, there have been 130 cases and 4 deaths in the country. This brings the 2023 tally for the paralysing neurological disorder in Peru to 231. It is suspected that the gut bacteria Campylobacter jejuni – which was responsible for a similar-scale GBS outbreak in 2019 – might also be the culprit this year. But the cases are spread in geographically disparate regions (just like in 2019), so researchers are puzzled about how exactly this bacteria is spreading.
The WHO Local Production and Assistance Unit is conducting the fourth “Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice” from 12 September to 10 October this year. The event will provide manufacturers and regulators with a comprehensive understanding of current WHO and international GMP standards, industry practices, technological advancements, and regulatory expectations specifically for vaccine manufacturing. You can register here; registrations from LMICs will be prioritised.
We don’t particularly like rats, but it is a bit sad how much pain humans inflict on them in the name of science. In the past 10+ years, organ-on-chip systems have been particularly useful in modelling human diseases and facilitating drug development, presenting a pathway to end preclinical animal testing. Now DLOC Biosystems and 42 Technology have gone one step further. They are working to connect multiple chips to create an automated human-on-chip system.
And finally, in competition with Pfizer’s Prevnar 20, Merck’s pneumococcal disease vaccine V116 has cleared two phase 3 trials. The shot, which covers 21 pneumococcal bacterial strains, even resulted in a stronger immune response than Prevnar in some cases.
The Week That Was
Monday, this week, brought you a look at all that the Gambia has been up to to ensure accountability in the cough syrup tragedy. The government has hired a US law firm to explore avenues for legal action against Maiden Pharmaceuticals, which produced the syrups and Atlantic Pharmaceuticals, a local distributor of the drugs. The country has fired the executive director and deputy director of its Medicines Control Agency, with whom the cough syrups should have been registered by law but were not. The matter has also been referred to the police. The Health Ministry has brought on board a firm to review all health-related legislation in the country. And the country is also taking the help of the World Bank to build a quality control laboratory where proper testing of all pharmaceutical products can be conducted.
Also, the WHO warned that global warming could push dengue fever cases to near-record highs this year. Earlier this year, the WHO had already warned about the pandemic potential of the disease, with about 50% of the world’s population now at risk of contracting the mosquito-borne disease.
Climate scientists from UC Santa Barbara claimed that climate science can now predict climate change-induced extreme weather events, like droughts in the Horn of Africa, much more accurately. In fact, the University’s Climate Hazards Centre had predicted these droughts 8 months before they happened, urging USAID to contribute millions to humanitarian efforts.
Then, on Tuesday, the Africa CDC and the African Society for Laboratory Medicine released 14 new reports, providing detailed study representations of the antimicrobial resistance situation in the African Union Member States of Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia and Zimbabwe.
Vietnam approved the world’s first commercial vaccines against African swine fever. The current approval is for domestic commercial use and could potentially pave the way for sales of the shots abroad.
On Wednesday, we had more cough syrup news. India suspended QP Pharmachem’s manufacturing license. The Central Drugs Standard Control Organisation (CDSCO) declared that about 3.7% of all the drug samples it tested in June were Not of Standard Quality (NSQ). But reports suggested that India’s pharma exports are still on a steep upward trajectory, with sales predicted to touch $27 billion this fiscal year.
If the prospect of a dengue fever outbreak doesn't give you the heebie-jeebies, the possibility of tick-borne encephalitis (TBE) might. In 2022, the first confirmed case of tick-borne encephalitis virus (TBE) was recorded in the United Kingdom, marking a worrying trend as the disease expands into new regions, primarily driven by climate change.
Yesterday, this comment in The Lancet Infectious Diseases assessed the challenges to malaria vaccine rollout in Africa and the measures to ensure greater uptake. Misinformation did its fair share of damage when it came to Covid vaccines. And researchers are concerned that vaccine hesitancy might spill over to malaria vaccination programmes as Gavi allots 18 million doses of malaria vaccines to 12 African countries over the coming two years.
And finally, obesity drugs will not be granted a spot on the WHO’s latest Essential Medicines List. Treatments for Ebola, MS, alcohol-use disorder, and malnutrition are some of the lucky fellows on the list. But obesity drugs aren’t alone in the rejected pile; they have sunscreen for company.
And now for today's stories.
Newsworthy
Learning from past mistakes. Or not. As part of an investigation into unsafe drugs sold globally, earlier this year, Bloomberg went shopping for India-made syrups, buying 33 samples from pharmacies in Cambodia, Ghana, Georgia, Iraq, Kenya and India itself. These syrups made cross-continental journeys to Valisure, an independent lab in the US, where they were tested using gas chromatography-mass spectrometry. Want to place your bets on what they found?
A bottle of Cold Out – manufactured by Fourrts, India, in January 2022 and purchased in Baghdad, Iraq, in March 2023 – contained 2.1% EG (21 times the accepted limit) and 0.25% DEG (twice the permissible limit). Bloomberg shared the test results with the WHO, Iraqi officials, and Indian officials on July 8. While Iraq tries to source samples to confirm whether the product is in the country and where it is being sold, the WHO finds Valisure’s test results to be acceptable and is awaiting confirmation from Iraq before it can raise a definitive alert.
Meanwhile, in India, the manufacturer named on the Cold Out label has claimed that it had subcontracted the product’s manufacture to another Indian company called Sharun Pharmaceuticals. Fourrts' own tests of Cold Out found no contamination. But Indian regulators have seized other samples, the results of which haven’t yet been released.
(Bloomberg)
Protecting those who protect us. A new report by the World Bank and Resolve to Save Lives examines the economic burden of Covid infections amongst healthcare workers (HCW) in the first year of the pandemic in Kenya, Colombia, Eswatini and South Africa. Covid or otherwise, healthcare workers face a disproportionate risk of illness and death. In the early stages of the pandemic, insufficient infection prevention and control protocols – the basic measures that should be in place in every health facility – failed not only health workers but also their patients. So far, the economic effects of this have not been quantitively estimated. But this report changes that.
Key takeaways from this report? That the costs of secondary infections and deaths due to Covid transmission from HCWs were significant – touching 70% of total economic costs linked to HCW infection in KwaZulu-Natal, South Africa. Excess maternal and child deaths due to disrupted health services created additional long-term costs, accounting for 82% of total costs in Kenta. HCW were likelier than the general population to contract Covid; 10x more likely in Kenya and 7-8x in South Africa.
The economic burden of HCW infection was the greatest in countries with a low HCW density. The report estimates that each HCW infection in Columbia cost $10,000 – that is more than the country’s per capita GDP. In Kenya, the cost was 18x the per capita GDP, while in Eswatini, it was 9 times the per capita GDP. Overall, the report highlights just how important it is to prioritise the protection of healthcare workers and the enormous costs to society and the economy if we fail to do so.
(World Bank)
Down with patriarchy and climate change. The world is now hotter than it has ever been, but examining the effects of heat on people at large isn’t exactly the best way to look at it. A new report titled “The Scorching Divide: How extreme heat inflames gender inequalities in Health and Income” highlights exactly that. The report examines heat impacts on women across India, Nigeria and the United States. It found that women are disproportionately burdened – physically and financially – by extreme heat, which is costing them $120 billion annually, mainly due to missed work hours.
Taking unpaid domestic labour into account, women’s financial losses rise to 260%, compared to only 76% for men. In lower-income countries, many women work in informal sectors which don’t afford them access to fair wages, paid sick days, or health insurance. The report finds that women who work outdoors may experience health effects like rashes, urinary tract infections or miscarriages. In India and Nigeria, women work 90 and 150 minutes more, respectively, when extreme heat strikes. In the domestic realm as well, women bear the bulk of responsibilities like cooking, cleaning and collecting water – activities which expose them to higher temperatures. Extreme heat is lowering productivity in domestic work as well, reducing the time the women can put into paid work.
Beyond what economic data can account for, this disparity has spillover effects on family health, income and women’s education. The most disheartening revelation from this report is that extreme heat is pushing women in poverty even further into poverty; as for women who have come out of poverty, they’re getting pulled right back in. Read the full report here.
(Adrienne Arsht-Rockefeller Foundation Resilience Center)
Every Friday, we relax our paywall so you can see for yourself the value of paying ₹500/month (or ₹4500/year) for a concise download of the day’s top news and events at the intersection of human and animal health, climate change and environmental science. Please consider becoming a paid subscriber.
R&D
What’s soft, specialised and controllable via magnets? This teeny tiny robot – just 2 mm in diameter – which can make the expedition deep into your lungs to detect and treat the first signs of cancer. Researchers at the University of Leeds came up with this device which can access some of the smallest bronchial tubes, travelling 37% deeper than standard equipment. The innovation is more accurate in its approach. Made of silicone, it also causes less tissue damage. All around a better alternative to invasive surgical interventions, which are currently the standard of care in treating early-stage non-small cell lung cancer. Pairs of such magnetic robots could also be controlled independently in confined spaces, as demonstrated by researchers in carrying out endonasal brain surgery.
(Nature Communications Engineering)
Who said moonlighting is only a human phenomenon? When the diabetes drug Metformin is not at its day job of regulating blood sugar, it’s pursuing its side gig of preventing muscle atrophy and muscular fibrosis. Not that its day job isn’t fulfilling – keeping people’s blood sugar in check is a noble calling. But helping old people bounce back from injury or illness quickly by protecting their muscles? Now that’s what sparks joy for Metformin. It accomplishes this task by targeting zombie-like senescent cells, which affect muscle function. Metformin could be used not just for muscle recovery but also to target disuse atrophy, which is a strong predictor of disease development and death. Now researchers are exploring the clinical applications of this drug: is it possible for Metformin-type agents to make the switch completely to their other gig in some cases, say, to help the elderly recover from knee surgeries?
(Aging Cell)
In vivo in vogue. Some patients with sickle cell disease have benefitted from an experimental treatment in which the DNA of their defective blood stem cells has been edited in a lab before being reinfused into their bodies. But access is hardly a feature of this treatment. It is expensive, complex, and therefore not within the reach of many patients in low-income countries.
Enter in vivo blood cell reprogramming. Scientists from the University of Pennsylvania have demonstrated that they can reprogramme blood cells directly inside the body. What they need to do is target mRNA-loaded lipid nanoparticles, dotted with a CD117-targeting antibody, to the bone marrow. This technology is similar to the one used by mRNA-based Covid vaccines. This innovation has only been tested in mice thus far. And it hasn’t even cured the disease. But further research could bring this advance to humans and present a cheaper and quicker method to treat blood diseases.
(Science)
The Kibble
Belly fat: friend or foe? This long-standing debate just got a twist from the University of Virginia School of Medicine, which suggests that our genes might turn the waistline fat into a surprising hero, protecting some from diabetes. Yes, you read that right! So, the next time you're berating that extra love handle, remember it might just be a genetic secret agent fighting off diabetes. This discovery could reshape the treatment landscape, making it more like a tailored suit than a one-size-fits-all muumuu. In this fashion-forward healthcare, your doc might just say, "Weight loss? Nah, your genes got you covered!" But don't toss your gym membership just yet; this research is still in its early stages. After all, even if the path to health is in your genes, a little exercise never hurt anyone's denim genes, right?
(eLife)
Your brain’s slick saviour. Imagine if the secret to a sharp mind and a sturdy heart was lurking in your kitchen all along, just sitting there in a bottle, looking quite slick. Yes, the hero we're talking about is the modest olive oil! A recent confab of nutrition nerds at Nutrition 2023 revealed that a mere spoonful of this elixir can reduce your risk of getting a one-way ticket to Dementialand by 28%. Who knew? The champions behind this tasty theory are the good folks at the Harvard T.H. Chan School of Public Health who've been analysing a big ol' pile of data from thousands of nurses and health professionals who clearly have a thing for drizzling their food with liquid gold. While some academics are playing the ‘correlation isn’t causation’ card, the researchers maintain that olive oil's antioxidants may pull the strings behind the brain-boosting magic. So, before you reach for that mayo, consider swapping it for a slick of olive oil – your brain might just thank you for it if it remembers to, of course!
(CNN)
Bottom line
Brace yourselves, folks; July’s (gonna be) a scorcher! In the never-ending, sizzling summer saga of 2023, the world is on the brink of setting a heat record that could make Hell feel like a decent vacation spot. From Greek isles feeling more like the inside of a brick oven to the US Southwest playing its own, less fun version of the floor is lava to China offering free spa experiences with temperatures soaring past 52.2°C, everyone's feeling the burn. UN Secretary-general António Guterres suggests we've entered "the era of global boiling," and if it's a popcorn-popping contest, we're certainly winning. Even the most optimistic weather report can't save us now; we would need a spontaneous mini-Ice Age to prevent July 2023 from smashing previous records.
(Reuters)
Sniffing out microplastics. Researchers at the Technical University of Munich (TUM) have developed an automated method to detect and quantify microplastics, providing critical insights into their size, concentration, and composition. Unlike previous methods of analysing residues from heated samples, the TUM method uses particle-based Raman microspectroscopy, examining particles directly without destroying them. This process, coupled with automation, drastically reduces analysis time and ensures reliability. To detect nano-plastics, particles with diameters under 1 µm, a modified process is being developed that uses field flow fractionation and a specially developed device. The new techniques will facilitate studies on microplastics' impact on the environment and human health.
(Analytical and Bioanalytical Chemistry)
Ice ice baby. If you've ever doubted that science fiction has a hint of truth, you might want to consider chilling out. As it turns out, the ice-cold thrillers about ancient, deadly organisms returning to life are not entirely fictional. Our icy comrades, from bacteria in a 750,000-year-old ice core to a zombie virus in Siberian permafrost, are thawing out and ready to party. Oh, and by 'party', we mean potentially wiping out modern ecosystems! The warming climate serves as an alarm clock for these hibernating horrors, releasing an estimated four sextillion (that's as many stars as in the universe, folks) microorganisms per year. While the exact ecological risk is still under investigation, some simulations suggest even a single dormant pathogen could cause environmental chaos. So, next time you enjoy your ice-cold drink, remember there might just be a million-year-old microbe plotting its comeback!
(PLOS Computational Biology)
Oh, and Gopal Nair doesn't want you to see this.