Are we looking at our enrollment data in the right way?

Session Details:

June 25, 1:45PM - 3:15PM

• Session Number: 241
• Room Number: 205B

1. Enrollment Analytics: Moving Beyond the Funnel
Paul Ivsin
VP, Consulting Director
CAHG Clinical Trials

2. Use of Analytics for Operational Planning
Diana Chung, MSc
Associate Director, Clinical Operations
Gilead
3. Using Enrollment Data to Communicate Effectively with Sites
Gretchen Goller, MA
Senior Director, Patient Access and Retention Services
PRA

Results reporting requirements are pretty clear. Maybe critics should re-check their methods?

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “fake fix” that was being thoroughly “ignored” by the pharmaceutical industry.

Pharma: breaking the law in broad daylight?

He makes this sweeping, unconditional proclamation about the industry and its regulators on the basis of  a single study in the BMJ, blithely ignoring the fact that a) the authors of the study admitted that they could not adequately determine the number of studies that were meeting FDAAA requirements and b) a subsequent FDA review that identified only 15 trials potentially out of compliance, out of a pool of thousands.


Despite the fact that the FDA, which has access to more data, says that only a tiny fraction of studies are potentially noncompliant, Goldacre's frequently repeated claims that the law is being ignored seems to have caught on in the general run of journalistic and academic discussions about FDAAA.

And now there appears to be additional support for the idea that a large percentage of studies are noncompliant with FDAAA results reporting requirements, in the form of a new study in the Journal of Clinical Oncology: "Public Availability of Results of Trials Assessing Cancer Drugs in the United States" by Thi-Anh-Hoa Nguyen, et al.. In it, the authors report even lower levels of FDAAA compliance – a mere 20% of randomized clinical trials met requirements of posting results on clinicaltrials.gov within one year.

Unsurprisingly, the JCO results were immediately picked up and circulated uncritically by the usual suspects.

I have to admit not knowing much about pure academic and cooperative group trial operations, but I do know a lot about industry-run trials – simply put, I find the data as presented in the JCO study impossible to believe. Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct. If anything, pharma sponsors are twitchily over-compliant with these kinds of regulations (for example, most still adhere to 100% verification of source documentation – sending monitors to physically examine every single record of every single enrolled patient - even after the FDA explicitly told them they didn't have to).

I realize that’s anecdotal evidence, but when such behavior is so pervasive, it’s difficult to buy into data that says it’s not happening at all. The idea that all pharmaceutical companies are ignoring a highly visible law that’s been on the books for 6 years is extraordinary. Are they really so brazenly breaking the rules? And is FDA abetting them by disseminating incorrect information?

Those are extraordinary claims, and would seem to require extraordinary evidence. The BMJ study had clear limitations that make its implications entirely unclear. Is the JCO article any better?

Some Issues

In fact, there appear to be at least two major issues that may have seriously compromised the JCO findings:

1. Studies that were certified as being eligible for delayed reporting requirements, but do not have their certification date listed.

The study authors make what I believe to be a completely unwarranted assumption:

In trials for approval of new drugs or approval for a new indication, a certification [permitting delayed results reporting] should be posted within 1 year and should be publicly available.

It’s unclear to me why the authors think the certifications “should be” publicly available. In re-reading FDAAA section 801, I don’t see any reference to that being a requirement. I suppose I could have missed it, but the authors provide a citation to a page that clearly does not list any such requirement.

But their methodology assumes that all trials that have a certification will have it posted:

If no results were posted at ClinicalTrials.gov, we determined whether the responsible party submitted a certification. In this case, we recorded the date of submission of the certification to ClinicalTrials.gov.

If a sponsor gets approval from FDA to delay reporting (as is routine for all drugs that are either not approved for any indication, or being studied for a new indication – i.e., the overwhelming majority of pharma drug trials), but doesn't post that approval on the registry, the JCO authors deem that trial “noncompliant”. This is not warranted: the company may have simply chosen not to post the certification despite being entirely FDAAA compliant.

2. Studies that were previously certified for delayed reporting and subsequently reported results

It is hard to tell how the authors treated this rather-substantial category of trials. If a trial was certified for delayed results reporting, but then subsequently published results, the certification date becomes difficult to find. Indeed, it appears in the case where there were results, the authors simply looked at the time from study completion to results posting. In effect, this would re-classify almost every single one of these trials from compliant to non-compliant. Consider this example trial:

• Phase 3 trial completes January 2010
• Certification of delayed results obtained December 2010 (compliant)
• FDA approval June 2013
• Results posted July 2013 (compliant)

In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5 years after completion, and therefore be considered noncompliant with FDAAA. In fact, this trial is entirely kosher, and would be extremely typical for many phase 2 and 3 trials in industry.

Time for Some Data Transparency

The above two concerns may, in fact, be non-issues. They certainly appear to be implied in the JCO paper, but the wording isn't terribly detailed and could easily be giving me the wrong impression.

However, if either or both of these issues are real, they may affect the vast majority of "noncompliant" trials in this study. Given the fact that most clinical trials are either looking at new drugs, or looking at new indications for new drugs, these two issues may entirely explain the gap between the JCO study and the unequivocal FDA statements that contradict it.

I hope that, given the importance of transparency in research, the authors will be willing to post their data set publicly so that others can review their assumptions and independently verify their conclusions. It would be more than a bit ironic otherwise.
Thi-Anh-Hoa Nguyen, Agnes Dechartres, Soraya Belgherbi, and Philippe Ravaud (2013). Public Availability of Results of Trials Assessing Cancer Drugs in the United States JOURNAL OF CLINICAL ONCOLOGY DOI: 10.1200/JCO.2012.46.9577

This new 10-minute TEDMED talk is getting quite a bit of attention:


 (if embedded video does not work, try the TED site itself.)

In it, Roger Stein claims to have created an approach to advancing drugs through clinical trials that will "fundamentally change the way research for cancer and lots of other things gets done".

Because the costs of bringing a drug to market are so high, time from discovery to marketing is so long, and the chances of success of any individual drug are so grim, betting on any individual drug is foolish, according to Stein. Instead, risks for a large number of potential assets should be pooled, with the eventual winners paying for the losers.

To do this, Stein proposes what he calls a "megafund" - a large collection of assets (candidate therapies). Through some modeling and simulations, Stein suggests some of the qualities of an ideal megafund: it would need in the neighborhood of $3-15 billion to acquire and manage 80-150 drugs. A fund of this size and with these assets would be able to provide an equity yield of about 12%, which would be "right in the investment sweet spot of pension funds and 401(k) plans".

Here's what I find striking about those numbers: let's compare Stein's Megafund to everyone's favorite Megalosaurus, the old-fashioned Big Pharma dinosaur sometimes known as Pfizer:

	Megafund (Stein)	Megalosaurus (Pfizer)
Funding	$3-15 billion	$9 billion estimated 2013 R&D spend
Assets	80-150	81 (in pipeline, plus many more in preclinical)
Return on Equity	12% (estimated)	9.2% (last 10 years) to 13.2% (last 5)

Since Pfizer's a dinosaur, it can't possibly compete with the sleek, modern Megafund, right? Right?

These numbers look remarkably similar. Pfizer - and a number of its peers - are spending Megafund-sized budget each year to shepherd through a Megafund-sized number of compounds. (Note many of Pfizer's peers have substantially fewer drugs in their published pipelines, but they own many times more compounds - the pipeline is just the drugs what they've elected to file an IND on.)

What am I missing here? I understand that a fund is not a company, and there may be some benefits to decoupling asset management decisions from actual operations, but this won't be a tremendous gain, and would presumably be at least partially offset by increased transaction costs (Megafund has to source, contract, manage, and audit vendors to design and run all its trials, after all, and I don't know why I'd think it could do that any more cheaply than Big Pharma can). And having a giant drug pipeline's go/no go decisions made by "financial engineers" rather than pharma industry folks would seem like a scenario that's only really seen as an upgrade by the financial engineers themselves.
A tweet from V.S. Schulz pointed me to a post on Derek Lowe's In the Pipeline blog. which lead to a link to this paper by Stein and 2 others in Nature Biotechnology from a year and a half ago. The authors spend most of their time differentiating themselves from other structures in the technical, financial details rather than explaining why megafund would work better at finding new drugs. However, they definitely think this is qualitatively different from existing pharma companies, and offer a couple reasons. First,

[D]ebt financing can be structured to be more “patient” than private or public equity by specifying longer maturities; 10- to 20-year maturities are not atypical for corporate bonds. ... Such long horizons contrast sharply with the considerably shorter horizons of venture capitalists, and the even shorter quarterly earnings cycle and intra-daily price fluctuations faced by public companies.

I'm not sure where this line of though is coming from. Certainly all big pharma companies' plans extend decades into the future - there may be quarterly earnings reports to file, but that's a force exerted far more on sales and marketing teams than on drug development. The financing of pharmaceutical development is already extremely long term.

Even in the venture-backed world, Stein and team are wrong if they believe there is pervasive pressure to magically deliver drugs in record time. Investors and biotech management are both keenly aware of the tradeoffs between speed and regulatory success. Even this week's came-from-nowhere Cinderella story, Intercept Pharmaceuticals, was founded with venture money over a decade ago - these "longer maturities" are standard issue in biotech. We aren't making iPhone apps here, guys.

Second,

Although big pharma companies are central to the later stages of drug development and the marketing and distributing of approved drugs, they do not currently play as active a role at the riskier preclinical and early stages of development

Again, I'm unsure why this is supposed to be so. Of Pfizer's 81 pipeline compounds, 55 are in Phase 1 or 2 - a ratio that's pretty heavy on early, risky project, and that's not too different from industry as a whole. Pfizer does not publish data on the number of compounds it currently has undergoing preclinical testing, but there's no clear reason I can think of to assume it's a small number.

So, is Megafund truly a revolutionary idea, or is it basically a mathematical deck-chair-rearrangement for the "efficiencies of scale" behemoths we've already got?

[Image: the world's first known dino, Megalosaurus, via Wikipedia.]

• How to Catalyze a Clinical Trial - My inaugural post introducing the blog and its purpose
• Video: Predicting Referral Conversion in Clinical Trial Advertising - A somewhat technical but very important topic, how to visualize and model the “real time” results of recruitment advertising at the sites.
• The Crystal Ball is on the Fritz - What to do with a broken enrollment feasibility process, and how asking will never be as good as measuring

• The New Breed of Clinical Trial Matchmakers - A (hopefully pretty complete, thanks to knowledgeable commenters) listing of services looking to match interested patients to clinical trials
• Rethinking Patient Enrollment, in One Graphic - The perils of predictability in site-based enrollment
• Seize the Data! Will Big Data Save Us from Ourselves? - My take on what I consider to be the large and serious obstacles in the way of “Big Data” solutions for patient recruitment

Please take a look, and I will see you back here soon.

[Photo credit: detour sign via Flikr user crossley]

Hospitals have been forced to innovate with new ways of hydrating patients and giving them medications, after a key factory that produces IV fluid bags flooded during Hurricane Helene. (This story first aired on Morning Edition on Nov. 7, 2024.)

Participant reported relief from chronic low back pain and reduced need for pain-relief medications.

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Magnetic resonance imaging (MRI) has revolutionized healthcare by providing radiation-free, non-invasive 3-D medical images. However, MRI scanners often consume 25 kilowatts or more to power magnets producing magnetic fields up to 1.5 tesla. These requirements typically limits scanners’ use to specialized centers and departments in hospitals.

A University of Hong Kong team has now unveiled a low-power, highly simplified, full-body MRI device. With the help of artificial intelligence, the new scanner only requires a compact 0.05 T magnet and can run off a standard wall power outlet, requiring only 1,800 watts during operation. The researchers say their new AI-enabled machine can produce clear, detailed images on par with those from high-power MRI scanners currently used in clinics, and may one day help greatly improve access to MRI worldwide.

To generate images, MRI applies a magnetic field to align the poles of the body’s protons in the same direction. An MRI scanner then probes the body with radio waves, knocking the protons askew. When the radio waves turn off, the protons return to their original alignment, transmitting radio signals as they do so. MRI scanners receive these signals, converting them into images.

More than 150 million MRI scans are conducted worldwide annually, according to the Organization for Economic Cooperation and Development. However, despite five decades of development, clinical MRI procedures remain out of reach for more than two-thirds of the world’s population, especially in low- and middle-income countries. For instance, whereas the United States has 40 scanners per million inhabitants, in 2016 there were only 84 MRI units serving West Africa’s population of more than 370 million.

This disparity largely stems from the high costs and specialized settings required for standard MRI scanners. They use powerful superconducting magnets that require a lot of space, power, and specialized infrastructure. They also need rooms shielded from radio interference, further adding to hardware costs, restricting their mobility, and hampering their availability in other medical settings.

Scientists around the globe have already been exploring low-cost MRI scanners that operate at ultra-low-field (ULF) strengths of less than 0.1 T. These devices may consume much less power and prove potentially portable enough for bedside use. Indeed, as the Hong Kong team notes, MRI development initially focused on low fields of about 0.05 T, until the introduction of the first whole-body 1.5 T superconducting scanner by General Electric in 1983.

The new MRI scanner (top left) is smaller than conventional scanners, and does away with bulky RF shielding and superconducting magnetics. The new scanner’s imaging resolution is on par with conventional scanners (bottom).Ed X. Wu/The University of Hong Kong

Current ULF MRI scanners often rely on AI to help reconstruct images from what signals they gather using relatively weak magnetic fields. However, until now, these devices were limited to solely imaging the brain, extremities, or single organs, Udunna Anazodo, an assistant professor of neurology and neurosurgery at McGill University in Montreal who did not take part in the work, notes in a review of the new study.

The Hong Kong team have now developed a whole-body ULF MRI scanner in which patients are placed between two permanent neodymium ferrite boron magnet plates—one above the body and the other below. Although these permanent magnets are far weaker than superconductive magnets, they are low-cost, readily available, and don’t require liquid helium or to be cooled to superconducting temperatures. In addition, the amount of energy ULF MRI scanners deposit into the body is roughly one-thousandth that from conventional scanners, making heat generation during imaging much less of a concern, Anazodo notes in her review. ULF MRI is also much quieter than regular MRI, which may help with pediatric scanning, she adds.

The new machine consists of two units, each roughly the size of a hospital gurney. One unit houses the MRI device, while the other supports the patient’s body as it slides into the scanner.

To account for radio interference from both the outside environment and the ULF MRI’s own electronics, the scientists deployed 10 small sensor coils around the scanner and inside the electronics cabinet to help the machine detect potentially disruptive radio signals. They also employed deep learning AI methods to help reconstruct images even in the presence of strong noise. They say this eliminates the need for shielding against radio waves, making the new device far more portable than conventional MRI.

In tests on 30 healthy volunteers, the device captured detailed images of the brain, spine, abdomen, heart, lung, and extremities. Scanning each of these targets took eight minutes or less for image resolutions of roughly 2 by 2 by 8 cubic millimeters. In Anazodo’s review, she notes the new machine produced image qualities comparable to those of conventional MRI scanners.

“It’s the beginning of a multidisciplinary endeavor to advance an entirely new class of simple, patient-centric and computing-powered point-of-care diagnostic imaging device,” says Ed Wu, a professor and chair of biomedical engineering at the University of Hong Kong.

The researchers used standard off-the-shelf electronics. All in all, they estimate hardware costs at about US $22,000. (According to imaging equipment company Block Imaging in Holt, Michigan, entry-level MRI scanners start at $225,000, and advanced premium machines can cost $500,000 or more.)

The prototype scanner’s magnet assembly is relatively heavy, weighing about 1,300 kilograms. (This is still lightweight compared to a typical clinical MRI scanner, which can weigh up to 17 tons, according to New York University’s Langone Health center.) The scientists note that optimizing the hardware could reduce the magnet assembly’s weight to about 600 kilograms, which would make the entire scanner mobile.

The researchers note their new device is not meant to replace conventional high-magnetic-field MRI. For instance, a 2023 study notes that next-generation MRI scanners using powerful 7 T magnets could yield a resolution of just 0.35 millimeters. Instead, ULF MRI can complement existing MRI by going to places that can’t host standard MRI devices, such as intensive care units and community clinics.

In an email, Anazodo adds this new Hong Kong work is just one of a number of exciting ULF MRI scanners under development. For instance, she notes that Gordon Sarty at the University of Saskatchewan and his colleagues are developing that device that is potentially even lighter, cheaper and more portable than the Hong Kong machine, which they are researching for use in whole-body imaging on the International Space Station.

Wu and his colleagues detailed their findings online 10 May in the journal Science.

This article appears in the July 2024 print issue as “Compact MRI Ditches Superconducting Magnets.”

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.

In the United States alone, more than 100,000 people currently need a lifesaving organ transplant. Instead of waiting for donors, one way to solve this crisis in the future is to assemble replacement organs with bio-printing—3D printing that uses inks containing living cells. Scientists in Israel have found that origami techniques could help fold sensors into bio-printed materials to help determine whether they are behaving safely and properly.

Although bio-printing something as complex as a human organ is still a distant possibility, there are a host of near-term applications for the technique. For example, in drug research, scientists can bio-print living, three-dimensional tissues with which to examine the effects of various compounds.

Ideally, researchers would like to embed sensors within bio-printed items to keep track of how well they are behaving. However, the three-dimensional nature of bio-printed objects makes it difficult to lodge sensors within them in a way that can monitor every part of the structures.

“It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them.” —Ben Maoz, Tel Aviv University

Now scientists have developed a 3D platform inspired by origami that can help embed sensors in bio-printed objects in precise locations. “It will, hopefully in the future, allow us to monitor and assess 3D biostructures before we would like to transplant them,” says Ben Maoz, a professor of biomedical engineering at Tel Aviv University in Israel.

The new platform is a silicone rubber device that can fold around a bio-printed structure. The prototype holds a commercial array of 3D electrodes to capture electrical signals. It also possesses other electrodes that can measure electrical resistance, which can reveal how permeable cells are to various medications. A custom 3D software model can tailor the design of the origami and all the electrodes so that the sensors can be placed in specific locations in the bio-printed object.

The scientists tested their device on bio-printed clumps of brain cells. The research team also grew a layer of cells onto the origami that mimicked the blood-brain barrier, a cell layer that protects the brain from undesirable substances that the body’s blood might be carrying. By folding this combination of origami and cells onto the bio-printed structures, Maoz and his colleagues were able to monitor neural activity within the brain cells and see how their synthetic blood-brain barrier might interfere with medications intended to treat brain diseases.

Maoz says the new device can incorporate many types of sensors beyond electrodes, such as temperature or acidity sensors. It can also incorporate flowing liquid to supply oxygen and nutrients to cells, the researchers note.

Currently, this device “will mainly be used for research and not for clinical use,” Maoz says. Still, it could “significantly contribute to drug development—assessing drugs that are relevant to the brain.”

The researchers say they can use their origami device with any type of 3D tissue. For example, Maoz says they can use it on bio-printed structures made from patient cells “to help with personalized medicine and drug development.”

The origami platform could also help embed devices that can modify bio-printed objects. For instance, many artificially grown tissues function better if they are placed under the kinds of physical stresses they might normally experience within the body, and the origami platform could integrate gadgets that can exert such mechanical forces on bio-printed structures. “This can assist in accelerating tissue maturation, which might be relevant to clinical applications,” Maoz says.

The scientists detailed their findings in the 26 June issue of Advanced Science.

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.”

Neuralink’s visual prosthesis Blindsight has been designated a breakthrough device by the U.S. Food and Drug Administration, which potentially sets the technology on a fast track to approval.

In confirming the news, an FDA spokesperson emphasized that the designation does not mean that Blindsight is yet considered safe or effective. Technologies in the program have potential to improve the current standard of care and are novel compared to what’s available on the market, but the devices still have to go through full clinical trials before seeking FDA approval.

Still, the announcement is a sign that Neuralink is moving closer to testing Blindsight in human patients. The company is recruiting people with vision loss for studies in the United States, Canada, and the United Kingdom.

Visual prostheses work by capturing visual information with a video camera, typically attached to glasses or a headset. Then a processor converts the data to an electrical signal that can be relayed to the nervous system. Retinal implants have been a common approach, with electrodes feeding the signal to nerves in the retina, at the back of the eye, from where it travels on to the brain. But Blindsight uses a brain implant to send the signal directly to neurons in the visual cortex.

In recent years, other companies developing artificial vision prosthetics have reached clinical research trials or beyond, only to struggle financially, leaving patients without support. Some of these technologies live on with new backing: Second Sight’s Orion cortical implant project is now in a clinical trial with Cortigent, and Pixium Vision’s Prima system is now owned by Science, with ex-Neuralink founder Max Hodak at the helm. No company has yet commercialized a visual prosthetic that uses a brain implant.

Elon Musk’s Claims About Blindsight

Very little information about Blindsight is publicly available. As of this writing, there is no official Blindsight page on the Neuralink website, and Neuralink did not respond to requests for comment. It’s also unclear how exactly Blindsight relates to a brain-computer interface that Neuralink has already implanted in two people with paralysis, who use their devices to control computer cursors.

Experts who spoke with IEEE Spectrum felt that, if judged against the strong claims made by Neuralink’s billionaire co-founder Elon Musk, Blindsight will almost certainly disappoint. However, some were still open to the possibility that Neuralink could successfully bring a device to market that can help people with vision loss, albeit with less dramatic effects on their sense of sight. While Musk’s personal fortune could help Blindsight weather difficulties that would end other projects, experts did not feel it was a guarantee of success.

After Neuralink announced on X (formerly Twitter) that Blindsight had received the breakthrough device designation, Musk wrote:

The Blindsight device from Neuralink will enable even those who have lost both eyes and their optic nerve to see.

Provided the visual cortex is intact, it will even enable those who have been blind from birth to see for the first time.

To set expectations correctly, the vision will be at first be [sic] low resolution, like Atari graphics, but eventually it has the potential be [sic] better than natural vision and enable you to see in infrared, ultraviolet or even radar wavelengths, like Geordi La Forge.

Musk included a picture of La Forge, a character from the science-fiction franchise Star Trek who wears a vision-enhancing visor.

Experts Puncture the Blindsight Hype

“[Musk] will build the best cortical implant we can build with current technology. It will not produce anything like normal vision. [Yet] it might produce vision that can transform the lives of blind people,” said Ione Fine, a computational neuroscientist at the University of Washington, who has written about the potential limitations of cortical implants, given the complexity of the human visual system. Fine previously worked for the company Second Sight.

A successful visual prosthetic might more realistically be thought of as assistive technology than a cure for blindness. “At best, we’re talking about something that’s augmentative to a cane and a guide dog; not something that replaces a cane and a guide dog,” said Philip Troyk, a biomedical engineer at the Illinois Institute of Technology.

Restoring natural vision is beyond the reach of today’s technology. But among Musks recent claims, Troyk says that a form of infrared sensing is plausible and has already been tested with one of his patients, who used it for help locating people within a room. That patient has a 400-electrode device implanted in the visual cortex as part of a collaborative research effort called the Intracortical Visual Prosthesis Project (ICVP). By comparison, Blindsight may have more than 1,000 electrodes, if it’s a similar device to Neuralink’s brain-computer interface.

Experts say they’d like more information about Neuralink’s visual prosthetic. “I’m leery about the fact that they are very superficial in their description of the devices,” said Gislin Dagnelie, a vision scientist at Johns Hopkins University who has been involved in multiple clinical trials for vision prosthetics, including a Second Sight retinal implant, and who is currently collaborating on the ICVP. “There’s no clear evaluation or pre-clinical work that has been published,” says Dagnelie. “It’s all based on: ‘Trust us, we’re Neuralink.’”

In the short term, too much hype could mislead clinical trial participants. It could also degrade interest in small but meaningful advancements in visual prosthetics. “Some of the [Neuralink] technology is exciting, and has potential,” said Troyk. “The way the messaging is being done detracts from that, potentially.”

Surgical stitches that generate electricity can help wounds heal faster in rats, a new study from China finds.

In the body, electricity helps the heart beat, causes muscles to contract, and enables the body to communicate with the brain. Now scientists are increasingly using electricity to promote healing with so-called electroceuticals. These electrotherapies often seek to mimic the electrical signals the body naturally uses to help new cells migrate to wounds to support the healing process.

In the new study, researchers focused on sutures, which are used to close wounds and surgical incisions. Despite the way in which medical devices have evolved rapidly over the years, sutures are generally limited in capability, says Zhouquan Sun, a doctoral candidate at Donghua University in Shanghai. “This observation led us to explore integrating advanced therapeutics into sutures,” Sun says.

Prior work sought to enhance sutures by adding drugs or growth factors to the stitches. However, most of these drugs either had insignificant effects on healing, or triggered side-effects such as allergic reactions or nausea. Growth factors in sutures often degraded before they could have any effect, or failed to activate entirely.

The research team that created the new sutures previously developed fibers for electronics for nearly 10 years for applications such as sensors. “This is our first attempt to apply fiber electronics in the biomedical field,” says Chengyi Hou, a professor of materials science and engineering at Donghua University.

Making Electrical Sutures Work

The new sutures are roughly 500 microns wide, or about five times the width of the average human hair. Like typical sutures, the new stitches are biodegradable, avoiding the need for doctors to remove the stitches and potentially cause more damage to a wound.

Each suture is made of a magnesium filament core wrapped in poly(lactic-co-glycolic) acid (PLGA) nanofibers, a commercially available, inexpensive, biodegradable polymer used in sutures. The suture also includes an outer sheath made of polycaprolactone (PCL), a biodegradable polyester and another common suture material.

Previously, electrotherapy devices were often bulky and expensive, and required wires connected to an external battery. The new stitches are instead powered by the triboelectric effect, the most common cause of static electricity. When two different materials repeatedly touch and then separate—in the case of the new suture, its core and sheath—the surface of one material can steal electrons from the surface of the other. This is why rubbing feet on a carpet or a running a comb through hair can build up electric charge.

A common problem sutures face is how daily movements may cause strain that reduce their efficacy. The new stitches take advantage of these motions to help generate electricity that helps wounds heal.

The main obstacle the researchers had to surmount was developing a suture that was both thin and strong enough to serve in medicine. Over the course of nearly two years, they tinkered with the molecular weights of the polymers they used and refined their fiber spinning technology to reduce their suture’s diameter while maintaining strength, Sun says.

In lab experiments on rats, the sutures generated about 2.3 volts during normal exercise. The scientists found the new sutures could speed up wound healing by 50 percent over the course of 10 days compared to conventional sutures. They also significantly lowered bacteria levels even without the use of daily wound disinfectants, suggesting they could reduce the risk of post-operation infections.

“Future research may delve deeper into the molecular mechanisms of how electrical stimulation facilitated would healing,” says Hui Wang, a chief physician at Shanghai Sixth People’s Hospital.

Further tests are needed in clinical settings to assess how effective these sutures are in humans. If such experiments prove successful, “this bioabsorbable electrically stimulating suture could change how we treat injuries in the future,” Hou says.

The scientists detailed their findings online 8 October in the journal Nature Communications.

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 palmivora—has 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. palmivora—a 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.”

In the spirit of the Halloween season, IEEE Spectrum presents a pair of stories that—although grounded in scientific truth rather than the macabre—were no less harrowing for those who lived them. In today’s installment, Robert Langer had to push back against his field’s conventional wisdom to pioneer a drug-delivery mechanism vital to modern medicine.

Nicknamed the Edison of Medicine, Robert Langer is one of the world’s most-cited researchers, with over 1,600 published papers, 1,400 patents, and a top-dog role as one of MIT’s nine prestigious Institute Professors. Langer pioneered the now-ubiquitous drug delivery systems used in modern cancer treatments and vaccines, indirectly saving countless lives throughout his 50-year career.

But, much like Edison and other inventors, Langer’s big ideas were initially met with skepticism from the scientific establishment.

He came up in the 1970s as a chemical engineering postdoc working in the lab of Dr. Judah Folkman, a pediatric surgeon at the Boston Children’s Hospital. Langer was tasked with solving what many believed was an impossible problem—isolating angiogenesis inhibitors to halt cancer growth. Folkman’s vision of stopping tumors from forming their own self-sustaining blood vessels was compelling enough, but few believed it possible.

Langer encountered both practical and social challenges before his first breakthrough. One day, a lab technician accidentally spilled six months’ worth of samples onto the floor, forcing him to repeat the painstaking process of dialyzing extracts. Those months of additional work steered Langer’s development of novel microspheres that could deliver large molecules of medicine directly to tumors.

In the 1970s, Langer developed these tiny microspheres to release large molecules through solid materials, a groundbreaking proof-of-concept for drug delivery.Robert Langer

Langer then submitted the discovery to prestigious journals and was invited to speak at a conference in Michigan in 1976. He practiced the 20-minute presentation for weeks, hoping for positive feedback from respected materials scientists. But when he stepped off the podium, a group approached him and said bluntly, “We don’t believe anything you just said.” They insisted that macromolecules were simply too large to pass through solid materials, and his choice of organic solvents would destroy many inputs. Conventional wisdom said so.

Nature published Langer’s paper three months later, demonstrating for the first time that non-inflammatory polymers could enable the sustained release of proteins and other macromolecules. The same year, Science published his isolation mechanism to restrict tumor growth.

Langer and Folkman’s research paved the way for modern drug delivery.MIT and Boston Children’s Hospital

Even with impressive publications, Langer still struggled to secure funding for his work in controlling macromolecule delivery, isolating the first angiogenesis inhibitors, and testing their behavior. His first two grant proposals were rejected on the same day, a devastating blow for a young academic. The reviewers doubted his experience as “just an engineer” who knew nothing about cancer or biology. One colleague tried to cheer him up, saying, “It’s probably good those grants were rejected early in your career. Since you’re not supporting any graduate students, you don’t have to let anyone go.” Langer thought the colleague was probably right, but the rejections still stung.

His patent applications, filed alongside Folkman at the Boston Children’s Hospital, were rejected five years in a row. After all, it’s difficult to prove you’ve got something good if you’re the only one doing it. Langer remembers feeling disappointed but not crushed entirely. Eventually, other scientists cited his findings and expanded upon them, giving Langer and Folkman the validation needed for intellectual property development. As of this writing, the pair’s two studies from 1976 have been cited nearly 2,000 times.

As the head of MIT’s Langer Lab, he often shares these same stories of rejection with early-career students and researchers. He leads a team of over 100 undergrads, grad students, postdoctoral fellows, and visiting scientists, all finding new ways to deliver genetically engineered proteins, DNA, and RNA, among other research areas. Langer’s reputation is further bolstered by the many successful companies he co-founded or advised, like mRNA leader Moderna, which rose to prominence after developing its widely used COVID-19 vaccine.

Langer sometimes thinks back to those early days—the shattered samples, the cold rejections, and the criticism from senior scientists. He maintains that “Conventional wisdom isn’t always correct, and it’s important to never give up—(almost) regardless of what others say.”

Acadia Pharmaceuticals did not disclose the buyer of the priority review voucher. The biotech received the voucher last year alongside the regulatory decision that made its drug Daybue the first FDA-approved treatment for the rare disease Rett syndrome.

The post Acadia Pharma Sells Voucher for Speedier FDA Drug Review for $150M appeared first on MedCity News.

During a panel discussion at the Behavioral Health Tech conference, experts shared the promise psychedelic medicines hold for mental health and why employers may want to consider offering them as a workplace benefit.

The post 4 Things Employers Should Know About Psychedelic Medicines appeared first on MedCity News.

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.

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference.

The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

By fostering collaboration and seamless data integration into healthcare systems, the industry is laying the groundwork for a future in which “personalized medicine” is so commonplace within clinical practice that we will just start calling it “medicine.”

The post Driving Genetic Testing Adoption and Improved Patient Care through Health Data Intelligence appeared first on MedCity News.

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.

Top challenges impacting specialty pharmacy outcomes, and how health systems may achieve efficiencies and enhance performance for optimal outcomes.

The post An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance appeared first on MedCity News.

By adopting a contingent workforce model and investing in the right data tools to power better informed decision-making and talent strategy, healthcare organizations can begin to address staffing challenges and turn their talent goals into reality. 

The post Closing Staffing Gaps in Healthcare by Utilizing Diverse Pipelines of Contingent Talent appeared first on MedCity News.

As radiopharmaceuticals enter a new phase, industry leaders must rethink external services and internal capabilities to master the complexities of delivering advanced therapies.

The post Unlocking the Future of Radioligand Therapy: From Discovery to Delivering at Scale appeared first on MedCity News.

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.

Breaking COVID-19’s chain of transmission requires effective physical distancing, contact tracing and rapid analyses of demographic data to reveal illness clusters and populations at high risk, such as people older than 65, Latinos and Blacks.

Between 1999 and 2014, opioid use disorder (OUD) among pregnant women more than quadrupled, risking the health of the women—before and after giving birth—and their infants. As states grapple with COVID-19’s exacerbation of the opioid crisis, several are taking innovative steps to address the needs of high-risk groups, including low-income, postpartum patients with OUD.

The Pew Charitable Trusts today commended Michigan Governor Gretchen Whitmer (D), state Senate Majority Leader Mike Shirkey (R), and Lee Chatfield (R)—whose term as state House Speaker ended last month—for passing and signing a bipartisan package of bills aimed at protecting public safety while reducing the number of people in county jails.

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.

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.

Social media has become a significant source of health-related content. But while it connects people to news, updates, […]

The post Do People Believe Misinformation on Vaccines? appeared first on World of DTC Marketing.

Watch the video and learn basic principles of modeling panel data using SAS/ETS.

This paper highlights the many enhancements to SAS/ETS software and demonstrates how these features can help your organization increase revenue and enhance productivity.

This paper begins with a look at both optimization modeling and discrete-event simulation modeling, and explores how they can most effectively work together to create additional analytic value. It then considers two examples of a combined optimization and simulation approach and discusses the resulting benefits.

This paper provides recommendations for circumventing memory problems and reducing execution times for your mixed-modeling analyses, as well as showing the new HPMIXED procedure can be beneficial for certain situations, as with large sparse mixed models.

This paper provides a high-level tour of five modern approaches to model building that are available in recent releases of SAS/STAT.

This paper provides an example that shows you how to use multiple RANDOM statements in PROC NLMIXED to fit nested nonlinear mixed models, and it provides details about the computation that is involved in fitting these models.

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. 

HONG KONG — China's National Health Commission (NHC) published its first set of guidelines to standardise the diagnosis and treatment of obesity, with more than half of China's adults already overweight and obese, and the rate expected to keep rising.  The guidelines, made public on October 17, come as China experiences an upward morbidity trend of its overweight and obese population. The rate of overweight or obese people could reach 65.3 per cent by 2030, the NHC said.   "Obesity has become a major public health issue in China, ranking as the sixth leading risk factor for death and disability in the country," the guidelines said. China is facing a twin challenge that feeds its weight problem: In a modernising economy underpinned by technological innovation, more jobs have become static or desk-bound, while a prolonged slowdown in growth is forcing people to adopt cheaper, unhealthy diets.

The US Centers for Disease Control and Prevention said on Wednesday that slivered onions served on McDonald's, opens new tab Quarter Pounder hamburgers and other menu items were the likely source of an E. coli outbreak that sickened 90 people. The outbreak linked to Quarter Pounder was first reported on Oct 22, and slivered onions were suspected to be the source of the infections. The US Food and Drug Administration and the company have confirmed that Taylor Farms was the supplier for the affected locations, and it has since recalled several batches of yellow onions produced in a Colorado facility. The FDA on Wednesday said it had initiated inspections at a Taylor Farms processing center in Colorado, a state where 29 people have fallen ill due to the outbreak. An onion grower of interest in Washington state is also being investigated, the FDA added. The CDC said the number of infected people has risen by 15 people from 75 and 27 persons have been hospitalised due to the illness, which has already killed one person.

LONDON — The world's biggest food and beverage companies on average sell products in low-income countries that are less healthy than what they sell in high-income countries, according to a new report. Products sold by companies including Nestle, Pepsico and Unilever were assessed as part of a global index published by the Access to Nutrition Initiative (ATNI), its first since 2021. The non-profit group found that across 30 companies, the products sold in low-income countries scored lower on a star rating system developed in Australia and New Zealand than those sold in high-income countries. In the Health Star Rating system, products are ranked out of five on their healthiness, with five the best, and a score above 3.5 considered to be a healthier choice.

Megan Fox is pregnant. The 38-year-old actress — who has Noah, 12, Bodhi, ten, and Journey, eight, with her ex-husband Brian Austin Green — has confirmed via social media that she's expecting her first child with Machine Gun Kelly.

Michelle Yeoh had never heard of Wicked before she was asked to join the cast of the movie-musical. The Oscar-winning actress plays Madame Morrible in the new film version of the hit stage show, which is based around characters first seen on screen in 1939 movie The Wizard of Oz. She's confessed she knew nothing about the popular musical before she was approached by director Jon M. Chu about joining the cast. According to The Hollywood Reporter, she said: "At that point, I had no clue what he was talking about because I had not seen Wicked the musical before. I knew Wizard of Oz, who doesn't, but not Wicked because I hadn't been going to the theatres and was not doing what I love which is watching musicals for quite a while, I hate to say." The new movie stars Cynthia Erivo as Elphaba and Ariana Grande as Glinda during their time at Shiz University in the Land of Oz with Michelle's character Madame Morrible serving as the school's headmistress. Michelle went on to say: "So I read it [the script] and called Jon back and said, 'This is a musical and she sings'. And he said, 'Oh easy, you'll have fun, you're up for the challenge.'

Denzel Washington has confirmed he will star in Black Panther 3 before his retirement. The 69-year-old actor is the first to talk about the existence of a third film in the blockbuster Marvel franchise — which will follow the 2018 original and 2022 sequel Black Panther: Wakanda Forever — and has also revealed the film will be among a handful of roles he will take on before he bows out of acting after a career spanning four decades. Confirming director Ryan Coogler has written a role just for the Oscar-winner for the third instalment, Denzel told Australia's Today show: "At this point in my career, I'm only interested in working with the best, I don't know how many more films I will make, probably not that many. I want to do things that I haven't done." Sharing the roles he has lined up before he bids farewell to his Hollywood career, he said: "I played Othello at 22, I'm now going to play it at 70. After that, I'm playing Hannibal. After that, I've been talking with Steve McQueen about a film. After that, Ryan Coogler is writing a part for me in the next Black Panther.

Sir Elton John has overhauled his diet after suffering a health scare. The 77-year-old singer has made a concerted effort to control his blood sugar levels in recent times, after being diagnosed with type 2 diabetes in the early 2000s and battling a "severe eye infection" earlier this year. Elton said on Ruthie's Table 4 podcast: "I can have an apple, I can eat a bit of melon. As long as you're sensible about it, it doesn't shoot your blood sugar up. But what I crave is chocolate and ice cream — I can't have any ice cream." Despite this, Elton revealed that his dream meal would still be full of sugar-filled desserts. The award-winning star — who is married to filmmaker David Furnish — said: "If I had a death row meal, it wouldn't contain anything except sweets, because I can't eat them now. So, I'd have ice cream, doughnuts, apple pie, rhubarb crumble." Elton has dealt with various health issues over the years, including having surgery for prostate cancer and battling a "severe eye infection". The singer detailed his most-recent problem in an Instagram post in September.

South Korean actor Song Jae-rim died yesterday (Nov 12) at the age of 39. The Seongdong Police Station in Seoul confirmed that he was found deceased in his apartment at around 12.30pm. According to media reports, a friend whom he was supposed to meet for lunch had visited his home and reported the death. A two-page letter was reportedly found at the scene but the cause of death has not been confirmed. A police official, however, stated that there are "no signs of foul play". His wake was held at Yeouido St. Mary’s Hospital Funeral Hall at 5.30pm yesterday. His funeral will be held tomorrow at Seoul City Crematorium. Jae-rim gained popularity after starring in the 2012 drama The Moon Embracing the Sun and the 2014 reality series We Got Married. This year, he starred in two dramas — My Military Valentine and Queen Woo. Following news of his death, comedian Hong Seok-cheon and other celebrities posted tributes to Jae-rim on social media.

UNITED NATIONS — The United States stressed at the United Nations (UN) on Tuesday (Nov 12) that "there must be no forcible displacement, nor policy of starvation in Gaza" by Israel, warning such policies would have grave implications under US and international law. The remarks by US Ambassador to the UN Linda Thomas-Greenfield came just hours after Washington said its ally Israel was doing enough to address the humanitarian crisis in Israel to avoid facing potential restrictions on US military aid. "Still, Israel must ensure its actions are fully implemented - and its improvements sustained over time," Thomas-Greenfield told the UN Security Council. It was also urgently important that Israel pause implementation of a law banning the operation of the UN Palestinian relief agency UNRWA, she added.

BEIRUT/JERUSALEM — The Israeli military pounded Beirut's southern suburbs with airstrikes on Tuesday (Nov 12), mounting one of its heaviest daytime attacks yet on the Hezbollah-controlled area, and struck the middle of the country where more than 20 people were killed. Smoke billowed over Beirut as around a dozen strikes hit the southern suburbs starting in midmorning. After posting warnings to civilians on social media, the Israeli military said it struck Hezbollah targets in Beirut's Dahiyeh area and later said it dismantled most of the group's weapons and missile facilities. Israel said it had taken steps to reduce harm to civilians and repeated its standing accusation that Hezbollah deliberately embeds itself into civilian areas to use residents as human shields, a charge Hezbollah rejects. In northern Israel, two people were killed in the city of Nahariya when a residential building was struck, Israeli police said. Hezbollah later claimed responsibility for a drone attack that it said was aimed at a military base east of Nahariya.