💉 Moderna goes free in the US; Moderna's flu vaccine works, and doesn't; US doctors thumb their noses at biosimilars
Aurobindo gets a kiss from the US FDA; Lessons on female health from animals; Plastic, plastic everywhere
Hello, and welcome to The Friday Kable, the perfect weekend reading for everybody you know.
True to what we predicted yesterday, Moderna has announced that in the US, at least, its Covid vaccine will continue to be available for free.
Moderna also shared trial data from its mRNA-based flu vaccine, saying it works very well against Influenza A but not so much against Influenza B.
In a welcome new chapter in the US FDA's relationship with Indian manufacturing, three of Aurobindo Pharma's units in Telangana get VAI classification from the agency.
Cuba continues its spate of healthcare agreements in Africa with a new collaboration with Algeria.
The Africa CDC hopes to receive Mpox vaccines soon, even as rich nations sit on stockpiles of vaccines they ordered when they had cases in the 100s.
Unsurprisingly, the head of UNAids calls on Big Pharma to value African lives above profits too.
Cardiovascular healthcare in Uganda gets a massive boost in the form of a $20 million loan from the OPEC Fund.
And finally, NASA is using AI to help design lighter parts. We think it would've been a better use of the AI and NASA's time to ask the AI to help design rocket parts instead. Okay fine. Excuse us for trying to find some #fridayfunnies.
Since we've been writing about bird flu pretty much every day this week, what do you think?
Newsworthy
Cheaper, but at what cost? That’s how several doctors feel about biosimilars, according to a new survey. The first biosimilar was launched in the US in 2015, but physicians still have concerns.
AbbVie’s Humira – an injectable for rheumatoid arthritis and other autoimmune diseases – will soon have competition from biosimilars like the recently launched Amjevita by Amgen. These biosimilars are more economical, but their uptake is uncertain. The survey above on Sermo, a social media network for physicians, found that 77% of respondents did not favour pharmacists’ ability to switch prescribed products with biosimilars. Trust plays a big role here. Doctors prefer drugs made by companies they know and whose products they are familiar with; they’re not keen for their patients to take biosims made by companies they’ve never heard of.
Regulation surrounding the interchangeability of biosimilars with reference products differs across locations. In Europe, once a biosimilar is approved, it is considered interchangeable with the reference product. But in the US, biosimilars have to go through long, expensive studies to verify comparable efficacy and safety to the reference product before a pharmacist can choose to switch between the two. The survey data revealed that US doctors remained sceptical, with evidence from switching studies being a key factor when deciding to go for biosimilars. This may seriously hinder manufacturers’ progress in the biosimilar market, the entry barrier for which is already fairly high.
(Fierce Pharma)
No female stands alone. Did you watch Rihanna’s Super Bowl halftime performance? Were you amazed by all she could do while pregnant? A giraffe, zebra or any other animal would likely be unimpressed.
As it turns out, the belief in human exceptionalism may be holding back medical science. Dr Barbara Natterson-Horowitz, a cardiologist and evolutionary biologist studies animal health with the notion that studying their biology could lead to insights into human health as well. Specifically, she investigates women’s health challenges by researching female health across species. Thanks to her, studying lactation in cows can shed light on breastfeeding problems in human women; understanding breast cancer in whales and menstrual difficulties in bats can help understand risk factors and treatments for the same conditions in people.
Scientific research only fairly recently began to include female participants in human and animal trials. Unsurprisingly, we know so little about female health in humans and other creatures. As a woman, in some regards, you have more in common with a lioness or a female beluga than with males of your own species. Giraffes, for instance, have evolved to adapt to the high blood pressure they need to pump blood up their long necks. In humans, this can cause heart failure, especially among women. But by learning from the mechanisms that giraffes have evolved (including against gestational hypertension), we could potentially tackle heart disease in human women and even reduce foetal and maternal mortality.
Solutions to female health concerns are out there. We just have to look at the right species for the answers.
(Scientific American)
Viruses or bacteria? Try not to get infected by both simultaneously because, apparently, you can only fight one at a time. Battling a viral infection limits the immune system’s ability to fight invading bacteria, which means that patients of Covid are potentially at higher risk of bacterial infection. Streptococcus pneumoniae, which ordinarily harmlessly inhabits our throats, can cause pneumonia and other life-threatening infections. But a new study suggests that during the pandemic, whether S. pneumoniae existed asymptomatically or caused ill health, there was a growth in the proportion of this bacteria that were antibiotic-resistant. In reality, the situation could be worse than this model suggests because it focused only on non-hospital settings and presumed that Covid-positive people will be quarantined – something people apparently don’t believe in doing anymore.
(bioRxiv)
Poor pharma. They spend so much on developing life-saving medicines and vaccines, and then people demand affordable drugs and patent waivers. How will they ever make any money?
By charging shit tonnes of $$$ for drugs. $2 million for a single dose of a spinal muscular atrophy drug. $3.5 million per dose of a haemophilia B therapy. The US government found price rises well above inflation in over 1200 products from July 2021 to July 2022. Sounds ridiculous, right?
Researchers have now analysed drug companies’ spending and product prices. The conclusion? Not even high R&D costs justify current prices. Even after accounting for R&D spending, drug companies are quite profitable. A study has found no association between the amount spent on R&D and the cost of new medicines. What’s more, public investments also finance some of the basic research which contributes to drug development; this means that, effectively, people are paying even more than the cost of the drug that companies charge.
If companies’ investment in R&D is not eating into their budgets as much as we thought, where is the rest of their money going? Selling, general and administrative activities not directly attributable to manufacturing. Also, share buybacks. Between 2016 and 2020, the 14 largest pharma companies spent hundreds of billions on share buybacks – more than they did on R&D.
Oh, you thought drug companies wanted to improve innovation, access and affordability? Why do that when you can focus on maximising shareholder value instead? This analysis in the BMJ includes potential government actions that could maximise innovation and control costs.
(BMJ)Â
R&D
Identity theft. Conducting experiments with real viruses is the best way to find effective vaccines for them, but naturally, that poses a threat to the people handling the virus. A team of researchers from the Indian Institute of Technology – Delhi have come up with a nice solution: they’ve created virus-like particles (VLPs) or molecular mimics of the SARS-CoV-2 virus to generate an immune response. Unlike vaccines that use only the spike protein, this one contains all 4 structural proteins of the coronavirus, making it effective against spikes with mutations. Also, since it isn’t the real deal, the VLP is non-infectious and minimises the chances of side effects like blood clotting. This nano-vaccine has shown promising results in animal trials, and the same mechanism can also be used to fight dengue.
(IIT-D, ACS Infectious Diseases)
Prime editing. No, this isn’t Bezos’ next venture. Prime editing is a gene-editing technique allowing scientists to replace a DNA nucleotide with any of the other four nucleotides. This opens up a number of opportunities to treat genetic diseases, but so far, researchers haven’t been able to clearly predict the success of any particular edit. This is where machine learning comes in. A new ML algorithm can predict the chances of success of a gene-edited DNA insertion, making researchers’ efforts to treat genetic diseases more efficient than the earlier trial-and-error.
(Nature Biotechnology)
Filling the gaps. Putting together the jigsaw puzzle of a genome sequence is no easy feat. Teams of highly skilled scientists have taken years to assemble genome fragments. National Institutes of Health researchers claim that their new software called Verkko can now complete such a task in a few days, making genome sequence assembly affordable and accessible. Verkko may verk work not only for human genome sequencing but also for mice, zebrafish, fruit flies and a number of other organisms, improving the scientific community’s understanding of comparative genomics.
(Nature Biotechnology)
The Kibble
Gluten intolerant? Not a problem. The world may soon be able to produce a lot more psyllium, a substance which mimics some of gluten’s functions in your gluten-free bread. Right now, the plant is very sensitive to environmental changes and diseases which affect its yield and, consequently, its quality and price. But now some desperate scientists, who probably missed eating baked goods too much, have constructed the reference genome for the plant, which can help increase yield and feed the growing gluten-free fad.
(Scientific Reports)
Let there be light. Like human neurons, bacteria use electrical signalling to communicate and respond to environmental cues. Scientists have now found a way to modulate these electrical changes in bacteria. All it takes is a Ziapin2 molecule, which binds to the bacterial membrane and some light, which helps the molecule change the bacterial structure. Research is still in the early stages, but it provides new approaches to studying antimicrobial resistance and bacterial hybrids, which could potentially be used for drug delivery in hard-to-access locations in the body.
(Advanced Science)
Bottom line
Climate change bad. La Niña worse. Some days, this section of The Kable is so simple. List a bunch of problems and blame them on climate change. Today is not one of those days.
Parts of Argentina, Uruguay, Brazil and Bolivia are in the midst of a multi-year drought. Soy, corn and wheat crops are failing; water supplies are scarce. Don’t get us wrong, global warming is certainly making things worse, but the primary factor to blame here is the La Niña. The La Niña – a climactic condition characterised by a cooling of the central Pacific which has global effects on weather – is sticking around a lot longer than usual. Let’s keep our fingers crossed that El Niño comes around quickly to replace La Niña. South America desperately needs it.
(AP, Reuters)
No winner, no chicken dinner. When it comes to this bird flu outbreak, nobody is winning. Not chickens, not wild birds, not sea lions, not minks, and definitely not the poultry industry.
The WHO says at least 60 countries have recently reported outbreaks of avian influenza H5N1. This is the worst animal disease outbreak ever in the US and the largest poultry outbreak experienced by the UK, Europe and Japan. A 2015 catastrophe led some companies to up their biosecurity game, but while these measures reduced cases, they weren’t able to eliminate them completely.
Of course, humans have a hand in how the virus has spread in animals. Farming animals in highly confined spaces has allowed the virus to easily jump from animal to animal. This also means more opportunities to mutate. But cutting down on animal production for food? Unthinkable. Who will feed the Superbowl audience?
The threat H5N1 poses – as the cause of a pandemic in humans – still looms. It already has a ridiculously high mortality rate in humans. A mutation here, another there, and who knows what can happen. Until then, let’s watch Okja, feel bad about factory farming, and wait around for another human pandemic to happen before we do something.
(Wired)
Unearthing hidden hydrogen. Here’s some news we could all use so that we can continue to be complacent about climate change. Hydrogen, a greener alternative to carbon-based fuels, is lying hidden in the Earth’s crust. Rock-water reactions deep underground give rise to it, and it percolates upwards, sometimes collecting in traps below the surface of the Earth. Not only is it green, but it is also renewable.
Since the presence of this hidden hydrogen has come to light some years ago, research on natural hydrogen has boomed. Startups are rushing to get the rights to explore for hydrogen. These hydrogen traps may be the best way yet to obtain this clean fuel which is currently produced using expensive or polluting methods. More importantly, it can give a new purpose to drillers to divert their expertise away from oil and gas to more environmentally-friendly activities.
Still, more information is needed on how exactly to tap these resources safely and sustainably. To understand the precise ways in which this hydrogen is generated and how it migrates. To figure out how it might work commercially. Coming up with storage and distribution systems will also be challenging. Basically, it’s still early days. Let’s see where this goes.
(Science)
Life in plastic, not so fantastic. Plastic is in our homes, our seas, our animals, our crops and our landfills. It’s in our air too, in larger quantities than we previously imagined. And it’s travelling far and wide, floating on the wind into locations it has no business being in, including your lungs.
All this plastic could be contributing to climate change. Seafoam bubbles, agricultural activity and tyres spinning wildly on streets are all blowing bits of plastic into the atmosphere – plastic which can seed clouds, absorb or reflect sunlight, and potentially affect temperature and precipitation patterns. There are a lot of unknowns still. But what is known is that this problem will probably stick around for a while. A long long long while.
(Undark)
Oh, and Gopal Nair doesn't want you to see this.