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Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

Here on Drug Channels, we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall.

Novel transparency information reveals that this good news doesn’t always translate into savings. Below, we rely on a unique data set from Turquoise Health to examine how much four national commercial health plans—Aetna, Anthem, Cigna, and UnitedHealthcare—paid hospitals for Avastin and its two most significant biosimilar competitors.

As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars. What’s more, plans can pay hospitals more for a biosimilar than for the higher-cost reference product. The U.S. drug channel system is warping hospitals’ incentives to adopt biosimilars, while simultaneously raising costs for commercial plans.

The namesake of my alma mater once said: “Sunlight is said to be the best of disinfectants.” What would happen if we disinfected the entire channel?
Read more »
       




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FTC Finalizes “Click-to-Cancel” Rule to Make It Easier for Consumers to End Recurring Subscriptions and Memberships

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Regulator looking at 'flexibility' that would allow overseas candidates to sit registration assessment

The General Pharmaceutical Council has said it is “double, treble, quadruple-checking” for any “flexibility” that would allow all overseas candidates to sit the March 2021 registration assessment exam in their countries of residence.




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Overseas candidates will be allowed to sit registration assessment remotely, regulator says

The General Pharmaceutical Council has said most candidates living in countries with a two-hour or more time difference from the UK will be able to apply to sit the registration assessment at home.




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New drug cuts the risk of death in bladder cancer by 30% compared with chemotherapy, study suggests

A new type of drug that targets chemotherapy directly to cancer cells reduces the risk of death from the most common type of bladder cancer by 30%, a phase III trial in the New England Journal of Medicine has suggested.




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Can FDA's New Transparency Survive Avandia?

PDUFA V commitments signal a strong commitment to tolerance of open debate in the face of uncertainty.

I can admit to a rather powerful lack of enthusiasm when reading about interpersonal squabbles. It’s even worse in the scientific world: when I read about debates getting mired in personal attacks I tend to simply stop reading and move on to something else.

However, the really interesting part of this week’s meeting of an FDA joint Advisory Committee to discuss the controversial diabetes drug Avandia – at least in the sense of likely long-term impact – is not the scientific question under discussion, but the surfacing and handling of the raging interpersonal battle going on right now inside the Division of Cardiovascular and Renal Products. So I'll have to swallow my distaste and follow along with the drama.

Two words that make us mistrust Duke:
 Anil Potti Christian Laettner

Not that the scientific question at hand – does Avandia pose significant heart risks? – isn't interesting. It is. But if there’s one thing that everyone seems to agree on, it’s that we don’t have good data on the topic. Despite the re-adjudication of RECORD, no one trusts its design (and, ironically, the one trial with a design to rigorously answer the question was halted after intense pressure, despite an AdComm recommendation that it continue).  And no one seems particularly enthused about changing the current status of Avandia: in all likelihood it will continue to be permitted to be marketed under heavy restrictions. Rather than changing the future of diabetes, I suspect the committee will be content to let us slog along the same mucky trail.

The really interesting question, that will potentially impact CDER for years to come, is how it can function with frothing, open dissent among its staffers. As has been widely reported, FDA reviewer Tom Marciniak has written a rather wild and vitriolic assessment of the RECORD trial, excoriating most everyone involved. In a particularly stunning passage, Marciniak appears to claim that the entire output of anyone working at Duke University cannot be trusted because of the fraud committed by Duke cancer researcher Anil Potti:
I would have thought that the two words “Anil Potti” are sufficient for convincing anyone that Duke University is a poor choice for a contractor whose task it is to confirm the integrity of scientific research. 
(One wonders how far Marciniak is willing to take his guilt-by-association theme. Are the words “Cheng Yi Liang” sufficient to convince us that all FDA employees, including Marciniak, are poor choices for deciding matter relating to publicly-traded companies? Should I not comment on government activities because I’m a resident of Illinois (my two words: “Rod Blagojevich”)?)

Rather than censoring or reprimanding Marciniak, his supervisors have taken the extraordinary step of letting him publicly air his criticisms, and then they have in turn publicly criticized his methods and approach.

I have been unable to think of a similar situation at any regulatory agency. The tolerance for dissent being displayed by FDA is, I believe, completely unprecedented.

And that’s the cliffhanger for me: can the FDA’s commitment to transparency extend so far as to accommodate public disagreements about its own approval decisions? Can it do so even when the disagreements take an extremely nasty and inappropriate tone?

  • Rather than considering that open debate is a good thing, will journalists jump on the drama and portray agency leadership as weak and indecisive?
  • Will the usual suspects in Congress be able to exploit this disagreement for their own political gain? How many House subcommittees will be summoning Janet Woodcock in the coming weeks?

I think what Bob Temple and Norman Stockbridge are doing is a tremendous experiment in open government. If they can pull it off, it could force other agencies to radically rethink how they go about crafting and implementing regulations. However, I also worry that it is politically simply not a viable approach, and that the agency will ultimately be seriously hurt by attacks from the media and legislators.

Where is this coming from?

As part of its recent PDUFA V commitment, the FDA put out a fascinating draft document, Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. It didn't get a lot of attention when first published back in February (few FDA documents do). However, it lays out a rather bold vision for how the FDA can acknowledge the existence of uncertainty in its evaluation of new drugs. Its proposed structure even envisions an open and honest accounting of divergent interpretations of data:
When they're frothing at the mouth, even Atticus
doesn't let them publish a review
A framework for benefit-risk decision-making that summarizes the relevant facts, uncertainties, and key areas of judgment, and clearly explains how these factors influence a regulatory decision, can greatly inform and clarify the regulatory discussion. Such a framework can provide transparency regarding the basis of conflicting recommendations made by different parties using the same information.
(Emphasis mine.)

Of course, the structured framework here is designed to reflect rational disagreement. Marciniak’s scattershot insults are in many ways a terrible first case for trying out a new level of transparency.

The draft framework notes that safety issues, like Avandia, are some of the major areas of uncertainty in the regulatory process. Contrast this vision of coolly and systematically addressing uncertainties with the sad reality of Marciniak’s attack:
In contrast to the prospective and highly planned studies of effectiveness, safety findings emerge from a wide range of sources, including spontaneous adverse event reports, epidemiology studies, meta-analyses of controlled trials, or in some cases from randomized, controlled trials. However, even controlled trials, where the evidence of an effect is generally most persuasive, can sometimes provide contradictory and inconsistent findings on safety as the analyses are in many cases not planned and often reflect multiple testing. A systematic approach that specifies the sources of evidence, the strength of each piece of evidence, and draws conclusions that explain how the uncertainty weighed on the decision, can lead to more explicit communication of regulatory decisions. We anticipate that this work will continue beyond FY 2013.
I hope that work will continue beyond 2013. Thoughtful, open discussions of real uncertainties are one of the most worthwhile goals FDA can aspire to, even if it means having to learn how to do so without letting the Marciniaks of the world scuttle the whole endeavor.

[Update June 6: Further bolstering the idea that the AdCom is just as much about FDA's ability to transparently manage differences of expert opinion in the face of uncertain data, CDER Director Janet Woodcock posted this note on the FDA's blog. She's pretty explicit about the bigger picture:
There have been, and continue to be, differences of opinion and scientific disputes, which is not uncommon within the agency, stemming from varied conclusions about the existing data, not only with Avandia, but with other FDA-regulated products. 
At FDA, we actively encourage and welcome robust scientific debate on the complex matters we deal with — as such a transparent approach ensures the scientific input we need, enriches the discussions, and enhances our decision-making.
I agree, and hope she can pull it off.]




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Can a Form Letter from FDA "Blow Your Mind"?

Adam Feuerstein appears to be a generally astute observer of the biotech scene. As a finance writer, he's accosted daily with egregiously hyped claims from small drug companies and their investors, and I think he tends to do an excellent job of spotting cases where breathless excitement is unaccompanied by substantive information.


However, Feuerstein's healthy skepticism seems to have abandoned him last year in the case of a biotech called Sarepta Therapeutics, who released some highly promising - but also incredibly limited - data on their treatment for Duchenne muscular dystrophy. After a disappointing interaction with the FDA, Sarepta's stock dropped, and Feuerstein appeared to realize that he'd lost some objectivity on the topic.


However, with the new year comes new optimism, and Feuerstein seems to be back to squinting hard at tea leaves - this time in the case of a form letter from the FDA.


He claims that the contents of the letter will "blow your mind". To him, the key passage is:


We understand that you feel that eteplirsen is highly effective, and may be confused by what you have read or heard about FDA's actions on eteplirsen. Unfortunately, the information reported in the press or discussed in blogs does not necessarily reflect FDA's position. FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular.


Feuerstein appears to think that the fact that FDA "has reached no conclusions" may mean that it may be "changing its mind". To which he adds: "Wow!"
Adam Feuerstein: This time,
too much froth, not enough coffee?


I'm not sure why he thinks that. As far as I can tell, the FDA will never reach a conclusion like this before its gone through the actual review process. After all, if FDA already knows the answer before the full review, what would the point of the review even be? It would seem a tremendous waste of agency resources. Not to mention how non-level the playing field would be if some companies were given early yes/no decisions while others had to go through a full review.


It seems fair to ask: is this a substantive change by FDA review teams, or would it be their standard response to any speculation about whether and how they would approve or reject a new drug submission? Can Feuerstein point to other cases where FDA has given a definitive yes or no on an application before the application was ever filed? I suspect not, but am open to seeing examples.


A more plausible theory for this letter is that the FDA is attempting a bit of damage control. It is not permitted to share anything specific it said or wrote to Sarepta about the drug, and has come under some serious criticism for “rejecting” Sarepta’s Accelerated Approval submission. The agency has been sensitive to the DMD community, even going so far as to have Janet Woodcock and Bob Temple meet with DMD parents and advocates last February. Sarepta has effectively positioned FDA as the reason for it’s delay in approval, but no letters have actually been published, so the conversation has been a bit one-sided. This letter appears to be an attempt at balancing perspectives a bit, although the FDA is still hamstrung by its restriction on relating any specific communications.

Ultimately, this is a form letter that contains no new information: FDA has reached no conclusions because FDA is not permitted to reach conclusions until it has completed a fair and thorough review, which won't happen until the drug is actually submitted for approval.

We talk about "transparency" in terms of releasing clinical trials data, but to me there is a great case to be made for increase regulatory transparency. The benefits to routine publication of most FDA correspondence and meeting results (including such things as Complete Response letters, explaining FDA's thinking when it rejects new applications) would actually go a long way towards improving public understanding of the drug review and approval process.




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A human bird flu case is thought to be found in Canada for the first time

A person has tested positive in British Columbia, Canadian health officials said, though the results must be sent to another lab for confirmation.




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More young people are surviving cancer. Then they face a life altered by it

More people are getting cancer in their 20s, 30s, and 40s, and surviving, thanks to rapid advancement in care. Many will have decades of life ahead of them, which means they face greater and more complex challenges in survivorship. Lourdes Monje is navigating these waters at age 29.




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Patrick Dempsey aims to raise awareness of cancer disparities and encourage screening

NPR's Leila Fadel talks with actor Patrick Dempsey about his efforts to raise money for cancer treatment and prevention.




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Noise Cancellation for Your Brain



Elemind, a 5-year-old startup based in Cambridge, Mass., today unveiled a US $349 wearable for neuromodulation, the company’s first product. According to cofounder and CEO Meredith Perry, the technology tracks the oscillation of brain waves using electroencephalography (EEG) sensors that detect the electrical activity of the brain and then influence those oscillations using bursts of sound delivered via bone conduction.

Elemind’s first application for this wearable aims to suppress alpha waves to help induce sleep. There are other wearables on the market that monitor brain waves and, through biofeedback, encourage users to actively modify their alpha patterns. Elemind’s headband appears to be the first device to use sound to directly influence the brain waves of a passive user.

In a clinical trial, says Perry [no relation to author], 76 percent of subjects fell asleep more quickly. Those who did see a difference averaged 48 percent less time to progress from awake to asleep. The results were similar to those of comparable trials of pharmaceutical sleep aids, Perry indicated.

“For me,” Perry said, “it cuts through my rumination, quiets my thinking. It’s like noise cancellation for the brain.”

I briefly tested Elemind’s headband in May. I found it comfortable, with a thick cushioned band that sits across the forehead connected to a stretchy elastic loop to keep it in place. In the band are multiple EEG electrodes, a processor, a three-axis accelerometer, a rechargeable lithium-polymer battery, and custom electronics that gather the brain’s electrical signals, estimate their phase, and generate pink noise through a bone-conduction speaker. The whole thing weighs about 60 grams—about as much as a small kiwi fruit.

My test conditions were far from optimal for sleep: early afternoon, a fairly bright conference room, a beanbag chair as bed, and a vent blowing. And my test lasted just 4 minutes. I can say that I didn’t find the little bursts of pink noise (white noise without the higher frequencies) unpleasant. And since I often wear an eye mask, feeling fabric on my face wasn’t disturbing. It wasn’t the time or place to try for sound sleep, but I—and the others in the room—noted that after 2 minutes I was yawning like crazy.

How Elemind tweaks brain waves

What was going on in my brain? Briefly, different brain states are associated with different frequencies of waves. Someone who is relaxed with eyes closed but not asleep produces alpha waves at around 10 hertz. As they drift off to sleep, the alpha waves are supplanted by theta waves, at around 5 Hz. Eventually, the delta waves of deep sleep show up at around 1 Hz.

Ryan Neely, Elemind’s vice president of science and research, explains: “As soon as you put the headband on,” he says, “the EEG system starts running. It uses straightforward signal processing with bandpass filtering to isolate the activity in the 8- to 12-Hz frequency range—the alpha band.”

“Then,” Neely continues, “our algorithm looks at the filtered signal to identify the phase of each oscillation and determines when to generate bursts of pink noise.”

To help a user fall asleep more quickly [top], bursts of pink noise are timed to generate a brain response that is out of phase with alpha waves and so suppresses them. To enhance deep sleep [bottom], the pink noise is timed to generate a brain response that is in phase with delta waves.Source: Elemind

These auditory stimuli, he explains, create ripples in the waves coming from the brain. Elemind’s system tries to align these ripples with a particular phase in the wave. Because there is a gap between the stimulus and the evoked response, Elemind tested its system on 21 people and calculated the average delay, taking that into account when determining when to trigger a sound.

To induce sleep, Elemind’s headband targets the trough in the alpha wave, the point at which the brain is most excitable, Neely says.

“You can think of the alpha rhythm as a gate for communication between different areas of the brain,” he says. “By interfering with that communication, that coordination between different brain areas, you can disrupt patterns, like the ruminations that keep you awake.”

With these alpha waves suppressed, Neely says, the slower oscillations, like the theta waves of light sleep, take over.

Elemind doesn’t plan to stop there. The company plans to add an algorithm that addresses delta waves, the low-frequency 0.5- to 2-Hz waves characteristic of deep sleep. Here, Elemind’s technology will attempt to amplify this pattern with the intent of improving sleep quality.

Is this safe? Yes, Neely says, because auditory stimulation is self-limiting. “Your brain waves have a natural space they can occupy,” he explains, “and this stimulation just moved it within that natural space, unlike deep-brain stimulation, which can move the brain activity outside natural parameters.”

Going beyond sleep to sedation, memory, and mental health

Applications may eventually go beyond inducing and enhancing sleep. Researchers at the University of Washington and McGill University have completed a clinical study to determine if Elemind’s technology can be used to increase the pain threshold of subjects undergoing sedation. The results are being prepared for peer review.

Elemind is also working with a team involving researchers at McGill and the Leuven Brain Institute to determine if the technology can enhance memory consolidation in deep sleep and perhaps have some usefulness for people with mild cognitive impairment and other memory disorders.

Neely would love to see more applications investigated in the future.

“Inverse alpha stimulation [enhancing instead of suppressing the signal] could increase arousal,” he says. “That’s something I’d love to look into. And looking into mental-health treatment would be interesting, because phase coupling between the different brain regions appears to be an important factor in depression and anxiety disorders.”

Perry, who previously founded the wireless power startup UBeam, cofounded Elemind with four university professors with expertise in neuroscience, optogenetics, biomedical engineering, and artificial intelligence. The company has $12 million in funding to date and currently has 13 employees.

Preorders at $349 start today for beta units, and Elemind expects to start general sales later this year. The company will offer customers an optional membership at $7 to $13 monthly that will allow cloud storage of sleep data and access to new apps as they are released.




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Cat's Eye Camera Can See Through Camouflage



Did that rock move, or is it a squirrel crossing the road? Tracking objects that look a lot like their surroundings is a big problem for many autonomous vision systems. AI algorithms can solve this camouflage problem, but they take time and computing power. A new camera designed by researchers in South Korea provides a faster solution. The camera takes inspiration from the eyes of a cat, using two modifications that let it distinguish objects from their background, even at night.

“In the future … a variety of intelligent robots will require the development of vision systems that are best suited for their specific visual tasks,” says Young Min Song, a professor of electrical engineering and computer science at Gwangju Institute of Science and Technology and one of the camera’s designers. Song’s recent research has been focused on using the “perfectly adapted” eyes of animals to enhance camera hardware, allowing for specialized cameras for different jobs. For example, fish eyes have wider fields of view as a consequence of their curved retinas. Cats may be common and easy to overlook, he says, but their eyes actually offer a lot of inspiration.

This particular camera copied two adaptations from cats’ eyes: their vertical pupils and a reflective structure behind their retinas. Combined, these allowed the camera to be 10 percent more accurate at distinguishing camouflaged objects from their backgrounds and 52 percent more efficient at absorbing incoming light.

Using a vertical pupil to narrow focus

While conventional cameras can clearly see the foreground and background of an image, the slitted pupils of a cat focus directly on a target, preventing it from blending in with its surroundings. Kim et al./Science Advances

In conventional camera systems, when there is adequate light, the aperture—the camera’s version of a pupil—is small and circular. This structure allows for a large depth of field (the distance between the closest and farthest objects in focus), clearly seeing both the foreground and the background. By contrast, cat eyes narrow to a vertical pupil during the day. This shifts the focus to a target, distinguishing it more clearly from the background.

The researchers 3D printed a vertical slit to use as an aperture for their camera. They tested the vertical slit using seven computer vision algorithms designed to track moving objects. The vertical slit increased contrast between a target object and its background, even if they were visually similar. It beat the conventional camera on five of the seven tests. For the two tests it performed worse than the conventional camera, the accuracies of the two cameras were within 10 percent of each other.

Using a reflector to gather additional light

Cats can see more clearly at night than conventional cameras due to reflectors in their eyes that bring extra light to their retinas.Kim et al./Science Advances

Cat eyes have an in-built reflector, called a tapetum lucidum, which sits behind the retina. It reflects light that passes through the retina back at it, so it can process both the incoming light and reflected light, giving felines superior night vision. You can see this biological adaptation yourself by looking at a cat’s eyes at night: they will glow.

The researchers created an artificial version of this biological structure by placing a silver reflector under each photodiode in the camera. Photodiodes without a reflector generated current when more than 1.39 watts per square meter of light fell on them, while photodiodes with a reflector activated with 0.007 W/m2 of light. That means the photodiode could generate an image with about 1/200th the light.

Each photodiode was placed above a reflector and joined by metal electrodes to create a curved image sensor.Kim et al./Science Advances

To decrease visual aberrations (imperfections in the way the lens of the camera focuses light), Song and his team opted to create a curved image sensor, like the back of the human eye. In such a setup, a standard image sensor chip won’t work, because it’s rigid and flat. Instead it often relies on many individual photodiodes arranged on a curved substrate. A common problem with such curved sensors is that they require ultrathin silicon photodiodes, which inherently absorb less light than a standard imager’s pixels. But reflectors behind each photodiode in the artificial cat’s eye compensated for this, enabling the researchers to create a curved imager without sacrificing light absorption.

Together, vertical slits and reflectors led to a camera that could see more clearly in the dark and isn’t fooled by camouflage. “Applying these two characteristics to autonomous vehicles or intelligent robots could naturally improve their ability to see objects more clearly at night and to identify specific targets more accurately,” says Song. He foresees this camera being used for self-driving cars or drones in complex urban environments.

Song’s lab is continuing to work on using biological solutions to solve artificial vision problems. Currently, they are developing devices that mimic how brains process images, hoping to one day combine them with their biologically-inspired cameras. The goal, says Song, is to “mimic the neural systems of nature.”

Song and his colleague’s work was published this week in the journal Science Advances.

This article appears in the November 2024 print issue.




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Stretchy Wearables Can Now Heal Themselves



If you’ve ever tried to get a bandage to stick to your elbow, you understand the difficulty in creating wearable devices that attach securely to the human body. Add digital electronic circuitry, and the problem becomes more complicated. Now include the need for the device to fix breaks and damage automatically—and let’s make it biodegradable while we’re at it—and many researchers would throw up their hands in surrender.

Fortunately, an international team led by researchers at Korea University Graduate School of Converging Science and Technology (KU-KIST) persevered, and has developed conductor materials that it claims are stretchable, self-healing, and biocompatible. Their project was described this month in the journal Science Advances.

The biodegradable conductor offers a new approach to patient monitoring and delivering treatments directly to the tissues and organs where they are needed. For example, a smart patch made of these materials could measure motion, temperature, and other biological data. The material could also be used to create sensor patches that can be implanted inside the body, and even mounted on the surface of internal organs. The biocompatible materials can be designed to degrade after a period of time, eliminating the need for an invasive procedure to remove the sensor later.

“This new technology is a glimpse at the future of remote healthcare,” says Robert Rose, CEO of Rose Strategic Partners, LLC. “Remote patient monitoring is an industry still in its early stages, but already we are seeing the promise of what is not only possible, but close on the horizon. Imagine a device implanted at a surgical site to monitor and report your internal healing progress. If it is damaged, the device can heal itself, and when the job is done, it simply dissolves. It sounds like science fiction, but it’s now science fact.”

Self-healing elastics

After being cut a ribbonlike film was able to heal itself in about 1 minute.Suk-Won Hwang

The system relies on two different layers of flexible material, both self-healing: one is for conduction and the other is an elastomer layer that serves as a substrate to support the sensors and circuitry needed to collect data. The conductor layer is based on a substance known by the acronym PEDOT:PSS, which is short for Poly(3,4-ethylenedioxythiophene) polystyrene sulfonate. It’s a conductive polymer widely used in making flexible displays and touch panels, as well as wearable devices. To increase the polymer’s conductivity and self-healing properties, the research team used additives including polyethylene glycol and glycol, which helped increase conductivity as well as the material’s ability to automatically repair damage such as cuts or tears.

In order to conform to curved tissues and survive typical body motion, the substrate layer must be extremely flexible. The researchers based it on elastomers that can match the shape of curved tissues, such as skin or individual organs.

These two layers stick to each other, thanks to chemical bonds that can connect the polymer chains of the plastic films in each layer. Combined, these materials create a system that is flexible and stretchable. In testing, the researchers showed that the materials could survive stretching up to 500 percent.

The self-healing function arises from the material’s ability to reconnect to itself when cut or otherwise damaged. This self-healing feature is based on a chemical process called disulfide metathesis. In short, polymer molecules containing pairs of linked sulfur atoms, called disulfides, have the ability to reform themselves after being severed. The phenomenon arises from a chemical process called disulfide-disulfide shuffling reactions, in which disulfide bonds in the molecule break and then reform, not necessarily between the original partners. According to the KU-KIST researchers, after being cut, their material was able to recover conductivity in its circuits within about two minutes without any intervention. The material was also tested for bending, twisting, and its ability to function both in air and under water.

This approach offers many advantages over other flexible electronics designs. For example, silver nanowires and carbon nanotubes have been used as the basis for stretchable devices, but they can be brittle and lack the self-healing properties of the KU-KIST materials. Other materials such as liquid metals can self-heal, but they are typically difficult to handle and integrate into wearable circuitry.

As a demonstration, the team created a multifunction sensor that included humidity, temperature, and pressure sensors that was approximately 4.5 square centimeters. In spite of being cut in four separate locations, it was able to heal itself and continue to provide sensor readings.

Implant tested in a rat

To take the demonstration a step further, the researchers created a 1.8-cm2 device that was attached to a rat’s bladder. The device was designed to wrap around the bladder and then adhere to itself, so no adhesives or sutures were required to attach the sensor onto the bladder. The team chose the bladder for their experiments because, under normal conditions, its size can change by 300 percent.

The device incorporated both electrodes and pressure sensors, which were able to detect changes in the bladder pressure. The electrodes could detect bladder voiding, through electromyography signals, as well as stimulate the bladder to induce urination. As with the initial demonstration, intentional damage to the device’s circuitry healed on its own, without intervention.

The biocompatible and biodegradable nature of the materials is important because it means that devices fabricated with them can be worn on the skin, as well as implanted within the body. The fact that the materials are biodegradable means that implants would not need a second surgical procedure to remove them. They could be left in place after serving their purpose, and they would be absorbed by the body.

According to Suk-Won Hwang, assistant professor at KU-KIST, a few hurdles remain on the path to commercialization. “We need to test the biocompatibility of some of the materials used in the conductor and substrate layers. While scalable production appears to be feasible, the high cost of disulfide derivatives might make the technology too expensive, aside from some special applications,” he says. “Biocompatibility testing and material synthesis optimization will take one to two years, at least.”




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Crop Parasites Can Be Deterred by “Electric Fences”



Imagine you’re a baby cocoa plant, just unfurling your first tentative roots into the fertile, welcoming soil.

Somewhere nearby, a predator stirs. It has no ears to hear you, no eyes to see you. But it knows where you are, thanks in part to the weak electric field emitted by your roots.

It is microscopic, but it’s not alone. By the thousands, the creatures converge, slithering through the waterlogged soil, propelled by their flagella. If they reach you, they will use fungal-like hyphae to penetrate and devour you from the inside. They’re getting closer. You’re a plant. You have no legs. There’s no escape.

But just before they fall upon you, they hesitate. They seem confused. Then, en masse, they swarm off in a different direction, lured by a more attractive electric field. You are safe. And they will soon be dead.

If Eleonora Moratto and Giovanni Sena get their way, this is the future of crop pathogen control.

Many variables are involved in the global food crisis, but among the worst are the pests that devastate food crops, ruining up to 40 percent of their yield before they can be harvested. One of these—the little protist in the example above, an oomycete formally known as Phytophthora palmivorahas a US $1 billion appetite for economic staples like cocoa, palm, and rubber.

There is currently no chemical defense that can vanquish these creatures without poisoning the rest of the (often beneficial) organisms living in the soil. So Moratto, Sena, and their colleagues at Sena’s group at Imperial College London settled on a non-traditional approach: They exploited P. palmivora’s electric sense, which can be spoofed.

All plant roots that have been measured to date generate external ion flux, which translates into a very weak electric field. Decades of evidence suggests that this signal is an important target for predators’ navigation systems. However, it remains a matter of some debate how much their predators rely on plants’ electrical signatures to locate them, as opposed to chemical or mechanical information. Last year, Moratto and Sena’s group found that P. palmivora spores are attracted to the positive electrode of a cell generating current densities of 1 ampere per square meter. “The spores followed the electric field,” says Sena, suggesting that a similar mechanism helps them find natural bioelectric fields emitted by roots in the soil.

That got the researchers wondering: Might such an artificial electric field override the protists’ other sensory inputs, and scramble their compasses as they tried to use plant roots’ much weaker electrical output?

To test the idea, the researchers developed two ways to protect plant roots using a constant vertical electric field. They cultivated two common snacks for P. palmivoraa flowering plant related to cabbage and mustard, and a legume often used as a livestock feed plant—in tubes in a hydroponic solution.

Two electric-field configurations were tested: A “global” vertical field [left] and a field generated by two small nearby electrodes. The global field proved to be slightly more effective.Eleonora Moratto

In the first assay, the researchers sandwiched the plant roots between rows of electrodes above and below, which completely engulfed them in a “global” vertical field. For the second set, the field was generated using two small electrodes a short distance away from the plant, creating current densities on the order of 10 A/m2. Then they unleashed the protists.

With respect to the control group, both methods successfully diverted a significant portion of the predators away from the plant roots. They swarmed the positive electrode, where—since zoospores can’t survive for longer than about 2 to 3 hours without a host—they presumably starved to death. Or worse. Neil Gow, whose research presented some of the first evidence for zoospore electrosensing, has other theories about their fate. “Applied electrical fields generate toxic products and steep pH gradients near and around the electrodes due to the electrolysis of water,” he says. “The tropism towards the electrode might be followed by killing or immobilization due to the induced pH gradients.”

Not only did the technique prevent infestation, but some evidence indicates that it may also mitigate existing infections. The researchers published their results in August in Scientific Reports.

The global electric field was marginally more successful than the local. However, it would be harder to translate from lab conditions into a (literal) field trial in soil. The local electric field setup would be easy to replicate: “All you have to do is stick the little plug into the soil next to the crop you want to protect,” says Sena.

Moratto and Sena say this is a proof of concept that demonstrates a basis for a new, pesticide-free way to protect food crops. (Sena likens the technique to the decoys used by fighter jets to draw away incoming missiles by mimicking the signals of the original target.) They are now looking for funding to expand the project. The first step is testing the local setup in soil; the next is to test the approach on Phytophthora infestans, a meaner, scarier cousin of P. palmivora.

P. infestans attacks a more varied diet of crops—you may be familiar with its work during the Irish potato famine. The close genetic similarities imply another promising candidate for electrical pest control. This investigation, however, may require more funding. P. infestans research can be undertaken only under more stringent laboratory security protocols.

The work at Imperial ties into the broader—and somewhat charged—debate around electrostatic ecology; that is, the extent to which creatures including ticks make use of heretofore poorly understood electrical mechanisms to orient themselves and in other ways enhance their survival. “Most people still aren’t aware that naturally occurring electricity can play an ecological role,” says Sam England, a behavioral ecologist with Berlin’s Natural History Museum. “So I suspect that once these electrical phenomena become more well known and understood, they will inspire a greater number of practical applications like this one.”




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Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place

The vast majority of older adults want to age at home. To support that goal, doctors should encourage them to consider their care options — long before they need assistance.

The post Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place appeared first on MedCity News.




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The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges.

The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.




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‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer

Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.

The post ‘Serial Killing’ Cell Therapy From Autolus Lands FDA Approval in Blood Cancer appeared first on MedCity News.




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How Can Healthcare Organizations Earn Trust with Marginalized Communities?

Access to care isn’t enough. Healthcare organizations need to build trust in order to reach underserved communities, experts said on a recent panel.

The post How Can Healthcare Organizations Earn Trust with Marginalized Communities? appeared first on MedCity News.




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Relaxed Federal Regulations Amid Pandemic Can Help Jails Better Treat Opioid Use Disorder

Few correctional facilities in the United States have treatment programs for individuals with opioid use disorder (OUD), despite clear evidence that certain medications reduce the risk of overdose and death. Even in facilities where treatment is available, the COVID-19 pandemic has complicated efforts to provide such care.




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Tools to Boost Beneficial Bacteria Can Help Poultry Farms Fight Salmonella

Chicken products cause an estimated 1 in 7 of the nation’s human Salmonella illnesses each year, partly because the pathogen can easily contaminate the environments where birds are raised. To reduce the risk that contaminated meat will reach consumers, poultry companies need measures that control the bacterium on farms where chickens are bred and raised.




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Primary Care Providers Can Help Steer People to Opioid Addiction Treatment

The United States is grappling with two severe health crises: the COVID-19 pandemic and an opioid epidemic that appears to be worsening as more people deal with stress and isolation as they face increased barriers to medical care. Preliminary numbers for 2020 show that overdose deaths were outpacing the record-setting number of more than 71,000 fatalities in 2019.




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PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative: aims to cut the time it takes to...… Continue Reading




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J&J must pay $19m to man who says its talc caused his cancer, jury finds

Johnson & Johnson must pay US$15 million (S$19.6 million) to a Connecticut man who alleges that he developed mesothelioma, a rare form of cancer, as a result of using the company's talc powder for decades, a jury found on Tuesday (Oct 15). Plaintiff Evan Plotkin sued the company in 2021 soon after his diagnosis, saying he was sickened by inhaling J&J's baby powder. The jury in Fairfield County, Connecticut Superior Court also found that the company should pay additional punitive damages, which will be determined later by the judge overseeing the case. "Evan Plotkin and his trial team are thrilled that a jury once again decided to hold Johnson & Johnson accountable for their marketing and sale of a baby powder product that they knew contained asbestos," Ben Braly, a lawyer for Plotkin, said in an email. Erik Haas, J&J's worldwide vice president of litigation, said in a statement that the company would appeal "erroneous" rulings by the trial judge that kept the jury from hearing critical facts about the case.




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'I try not to think about myself': Woman battles breast cancer while caring for mum who has gall bladder cancer

To mark Breast Cancer Awareness Month, we speak to inspiring Singaporeans about their journey in battling and overcoming cancer.  Warda Ismail gets anxious about things easily, especially when it comes to her health.  So much so that her doctor once told her that she is a "borderline hypochondriac", she shared with AsiaOne in an interview.  For the uninitiated, hypochondria is a condition where a person is excessively and unduly worried about having a serious illness. To keep her mind at ease, the 44-year-old preschool educator has the habit of going for regular medical checkups.  Though she was vigilant, her worst nightmare came true — she was diagnosed with breast cancer on May 8 this year.  And in the midst of her recovery journey, she got more terrible news — her mother, who had been caring for her, was diagnosed with stage-three gall bladder cancer.  Despite the string of unfortunate events, Warda persevered and tried to have a more positive outlook on life and her health. 




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Canada detects its first presumptive human H5 bird flu case

OTTAWA - Canada has detected its first presumptive case of H5 bird flu in a person, a teenager in the western province of British Columbia, health officials said on Saturday (Nov 9). The teenager likely caught the virus from a bird or animal and was receiving care at a children's hospital, the province said in a statement. The province said it was investigating the source of exposure and identifying the teenager's contacts. The risk to the public remains low, Canada's Health Minister Mark Holland said in posting on X. "This is a rare event," British Columbia Health Officer Bonnie Henry said in a statement. "We are conducting a thorough investigation to fully understand the source of exposure here in B.C." H5 bird flu is widespread in wild birds worldwide and is causing outbreaks in poultry and US dairy cows, with several recent human cases in US dairy and poultry workers. There has been no evidence of person-to-person spread so far. But if that were to happen, a pandemic could unfold, scientists have said.




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Teen in critical condition with Canada's first presumptive human case of bird flu

TORONTO — A teenager is in critical condition in a British Columbia children's hospital, sick with Canada's first presumptive human case of avian influenza. "This was a healthy teenager prior to this, so no underlying conditions," said provincial health officer Bonnie Henry in a news conference on Tuesday (Nov 12). "It just reminds us that in young people this is a virus that can progress and cause quite severe illness and the deterioration that I mentioned was quite rapid." British Columbia health officials said on Saturday the province had detected Canada's first human case of H5 bird flu in a teenager.




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Cancelling the New Sea-launched Nuclear Cruise Missile is the Right Move

David W. Kearn argues that deployment of nuclear weapons cannot rectify a perceived imbalance in conventional forces in the western Pacific.




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'Our Proud Spirited Fellows' The American Navy in U.S. Public Diplomacy with South America

Using the private journals of commission secretaries Henry Marie Brackenridge and Dr. William Baldwin, as well as Captain Sinclair, this chapter will explore the establishment of American naval identity through its diplomatic experiences in South America. It will also exhibit the role of the U.S. Navy in a proto framework of the Monroe Doctrine.




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BSP candidate attacked in Delhi, receives minor injuries




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Data | India’s democratic values have eroded significantly: V­Dem

The debate around India’s erosion of democratic values has surfaced again after Congress leader Rahul Gandhi’s remarks in the U.K.




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Colin L. Powell Embodied the American Dream

Colin L. Powell was a great American. A brilliant soldier, statesman and patriot, he devoted his life to public service, and he cherished the United States, his family and his many friends. While acknowledging America’s challenges, he drew inspiration from its noble purpose and promise. “America remains the last best hope of Earth,” he said in his 1994 Howard University commencement address “You are its inheritors, and its future is today placed in your hands.” The trajectory of his life—from humble beginnings as a Jamaican immigrant’s son growing up in the Bronx to the highest levels of government—is a true American dream. 




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Putin’s Nagorno-Karabakh Calculus Can Undermine Russian Clout in FSU

Simon Saradzhyan writes that Russia’s decision not to employ leverage to stop the conflict in its early stages made a lasting impression on its allies.




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What Africa Can Learn from China about Growing its Agribusiness Sector

There is growing evidence that the Chinese economic miracle is a consequence of the rural entrepreneurship which started in the 1980s. This contradicts classical interpretations that focus on state-led enterprises and receptiveness to foreign direct investment....The lesson from China's experience is that development must be viewed as an expression of human potentialities, not as a product of external interventions.




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Why Executive Leadership Matters in African Agriculture

In a poignant comment, Albert Einstein once said that "an empty stomach is not a good political adviser." African leaders are starting to appreciate this message by paying more attention to the importance of high-level political support for agricultural transformation.




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How Can Africa Master the Digital Revolution?

For a summary of Prof. Juma's Twitter Q&A on this topic, click here. #AskCJuma

Digital connectivity has the potential to do for Africa what railroads did for Western economies in the 19th century. The digital revolution is not just about communication. It is about recognizing that information is the currency of all economic activities.




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Why Our Stereotypes of African Agriculture Are All Wrong

Calestous Juma (@calestous) will host a joint Twitter chat with the Elumelu Foundation on June 18, 2016, at 9:00 AM (EDT). Ask questions via #AskCJuma or #TEEPagricReport!

From newspaper editors to TV anchors to bloggers, the default symbol of African agriculture is an African woman holding a hand hoe. This imagery highlights the drudgery African women face in farming. But it also conflates family farming with the broader agricultural enterprise.




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Rebooting African Economies: The Place of Science and Technology in Society

"African countries are already at the forefront of harnessing these technologies. For example, Rwanda has set itself the ambitious goal of building the first drone airport in the world. An increasing number of African countries are leveraging drone technology to address a variety of resource mapping, delivery and agricultural services. It is through such efforts that salient basic research challenges are likely to emerge."




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Rebooting African Development: Science, Technology and Innovation Strategy for Africa

As the African Union develops its long-term agenda 2063 for the continent, science, technology and innovation will play a bigger part in development goal setting, especially in the context of social and economic growth.




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Lessons from 'The New Harvest' on How Academics Can Turn Their Work into Policy

"The goal of the book was to invest in thinking. It doesn't have a list of recommendations but generates options for action that are backed by evidence. We chose to forgo credit by adopting this approach, but it’s been very encouraging to see some key impacts that acknowledge the book."




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Important Wins Were Notched Up for African Agriculture in 2016

"2016 was a big year for agriculture in Africa with some notable 'wins' across the continent. One of the most important gains was the increased use of emerging technologies beyond the traditional use of mobile phones in agriculture. The range includes precision agriculture, sensors, satellites and drones."







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Uptick in Russian-African Diplomacy Moscow’s Evolving Geopolitical Plans

A spate of high-level diplomatic gatherings demonstrates that the Russian leadership remains keen to implement a strategy of expansion, rather than merely sustainment, of its relations with the rising Africa.




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What the West Can Learn From Singapore

When asked whether the U.S. government works, most Americans say no. According to recent polling by Ipsos, more than two-thirds of adults in the United States think the country is going in the wrong direction. Gallup reports that only 26 percent have confidence in major U.S. institutions, such as the presidency, the Supreme Court, and Congress. Nearly half of Americans aged 18 to 25 say that they believe either that democracy or dictatorship “makes no difference” or that “dictatorship could be good in certain circumstances.” As a recent Economist cover story put it: “After victory in the Cold War, the American model seemed unassailable. A generation on, Americans themselves are losing confidence in it.”




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The Middle East Conflict That the U.S. Can't Stay Out Of

Juliette Kayyem argues that the sooner President Joe Biden acknowledges that the United States will likely be drawn into a fight to protect shipping traffic through the Suez Canal, the more time the U.S. military has to plan, and the less severe the harm will be to the global economy.




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The Other Side of the Strait: The Strategic Significance of the Houthi’s Aggression for East Africa

Iranian-backed militants in Yemen are clashing with the United States and British naval forces in the Red Sea over Israel’s operations in Gaza, all in a complex dance for geopolitical leverage in the Middle East. Yet, there is another region with a stake in the conflict brewing in the Bab al-Mandab strait, one seemingly beyond the world’s purview – the Horn of Africa.




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Mapping a Way Forward with African Businesses in a Globalized World

Africa is home to approximately 1.4 billion people[1], about 16 percent of the world’s population, yet its continental share in global trade remains below 3 percent[2], according to the World Trade Organization (WTO). This suboptimal proportion of world trade is compounded by Africa's limited intra-continental trade. During the 26th Africa Business Conference (ABC) held at Harvard Business School (HBS) on the 17th of February 20, 2024, industry experts, policymakers, students, faculty members, and entrepreneurs converged to interrogate these concerns and explore opportunities for improving intra-African trade. 




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The Historical Puzzle of US Economic Performance under Democrats vs. Republicans

We have heard much about the puzzle that US economic performance under President Joe Biden has been much stronger than voters perceive it to be.  But the current episode is just one instance of a bigger historical puzzle:  the US economy has since World War II consistently done better under Democratic presidents than under Republican presidents.  This fact is even less widely known, including among Democratic voters, than the truth about Biden’s term.  Indeed, some poll results suggest that more Americans believe the reverse, that Republican presidents are better stewards of the economy than Democrats.




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Africa Beyond the Headlines: A Kaleidoscopic Exploration of Contemporary African Politics and International Cooperation

Dr. Gloria Ayee led a study group over the course of five sessions during the Spring of 2024, exploring the current pivotal moment on the African continent. Participants of the study group were invited to reflect on the role that international cooperation must play in supporting inclusive, sustainable development in Africa, as well as to move beyond outdated perspectives and learn about Africa’s profound transformation through trade, investments in clean energy and health, and youth empowerment initiatives.