The Federal Emergency Management Agency supervisor who was fired after she told her staff to skip hurricane-damaged homes with Trump signs in their yards says it wasn't an isolated incident and is a "colossal event."

Tech expert Kurt “CyberGuy" Knutsson reveals four signs of compromised Social Security numbers and offers five steps to protect yourself.

Former Chelsea and Arsenal defender Ashley Cole has signed a new one-year contract to remain with the LA Galaxy for a third season in Major League Soccer..

A new species of Jurassic dinosaur related to Tyrannosaurus rex has been discovered by paleontologists in Kyrgyzstan in Central Asia.

Social media commentators claimed Jill Biden refused to look at Vice President Harris as they were seated together at Arlington Cemetery for a Veterans' Day Remembrance.

Quantum computing is a devilishly complex technology, with many technical hurdles impacting its development. Of these challenges two critical issues stand out: miniaturization and qubit quality.

IBM has adopted the superconducting qubit road map of reaching a 1,121-qubit processor by 2023, leading to the expectation that 1,000 qubits with today’s qubit form factor is feasible. However, current approaches will require very large chips (50 millimeters on a side, or larger) at the scale of small wafers, or the use of chiplets on multichip modules. While this approach will work, the aim is to attain a better path toward scalability.

Now researchers at MIT have been able to both reduce the size of the qubits and done so in a way that reduces the interference that occurs between neighboring qubits. The MIT researchers have increased the number of superconducting qubits that can be added onto a device by a factor of 100.

“We are addressing both qubit miniaturization and quality,” said William Oliver, the director for the Center for Quantum Engineering at MIT. “Unlike conventional transistor scaling, where only the number really matters, for qubits, large numbers are not sufficient, they must also be high-performance. Sacrificing performance for qubit number is not a useful trade in quantum computing. They must go hand in hand.”

The key to this big increase in qubit density and reduction of interference comes down to the use of two-dimensional materials, in particular the 2D insulator hexagonal boron nitride (hBN). The MIT researchers demonstrated that a few atomic monolayers of hBN can be stacked to form the insulator in the capacitors of a superconducting qubit.

Just like other capacitors, the capacitors in these superconducting circuits take the form of a sandwich in which an insulator material is sandwiched between two metal plates. The big difference for these capacitors is that the superconducting circuits can operate only at extremely low temperatures—less than 0.02 degrees above absolute zero (-273.15 °C).

Superconducting qubits are measured at temperatures as low as 20 millikelvin in a dilution refrigerator.Nathan Fiske/MIT

In that environment, insulating materials that are available for the job, such as PE-CVD silicon oxide or silicon nitride, have quite a few defects that are too lossy for quantum computing applications. To get around these material shortcomings, most superconducting circuits use what are called coplanar capacitors. In these capacitors, the plates are positioned laterally to one another, rather than on top of one another.

As a result, the intrinsic silicon substrate below the plates and to a smaller degree the vacuum above the plates serve as the capacitor dielectric. Intrinsic silicon is chemically pure and therefore has few defects, and the large size dilutes the electric field at the plate interfaces, all of which leads to a low-loss capacitor. The lateral size of each plate in this open-face design ends up being quite large (typically 100 by 100 micrometers) in order to achieve the required capacitance.

In an effort to move away from the large lateral configuration, the MIT researchers embarked on a search for an insulator that has very few defects and is compatible with superconducting capacitor plates.

“We chose to study hBN because it is the most widely used insulator in 2D material research due to its cleanliness and chemical inertness,” said colead author Joel Wang, a research scientist in the Engineering Quantum Systems group of the MIT Research Laboratory for Electronics.

On either side of the hBN, the MIT researchers used the 2D superconducting material, niobium diselenide. One of the trickiest aspects of fabricating the capacitors was working with the niobium diselenide, which oxidizes in seconds when exposed to air, according to Wang. This necessitates that the assembly of the capacitor occur in a glove box filled with argon gas.

While this would seemingly complicate the scaling up of the production of these capacitors, Wang doesn’t regard this as a limiting factor.

“What determines the quality factor of the capacitor are the two interfaces between the two materials,” said Wang. “Once the sandwich is made, the two interfaces are “sealed” and we don’t see any noticeable degradation over time when exposed to the atmosphere.”

This lack of degradation is because around 90 percent of the electric field is contained within the sandwich structure, so the oxidation of the outer surface of the niobium diselenide does not play a significant role anymore. This ultimately makes the capacitor footprint much smaller, and it accounts for the reduction in cross talk between the neighboring qubits.

“The main challenge for scaling up the fabrication will be the wafer-scale growth of hBN and 2D superconductors like [niobium diselenide], and how one can do wafer-scale stacking of these films,” added Wang.

Wang believes that this research has shown 2D hBN to be a good insulator candidate for superconducting qubits. He says that the groundwork the MIT team has done will serve as a road map for using other hybrid 2D materials to build superconducting circuits.

The end of Moore’s Law is looming. Engineers and designers can do only so much to miniaturize transistors and pack as many of them as possible into chips. So they’re turning to other approaches to chip design, incorporating technologies like AI into the process.

Samsung, for instance, is adding AI to its memory chips to enable processing in memory, thereby saving energy and speeding up machine learning. Speaking of speed, Google’s TPU V4 AI chip has doubled its processing power compared with that of its previous version.

But AI holds still more promise and potential for the semiconductor industry. To better understand how AI is set to revolutionize chip design, we spoke with Heather Gorr, senior product manager for MathWorks’ MATLAB platform.

How is AI currently being used to design the next generation of chips?

Heather Gorr: AI is such an important technology because it’s involved in most parts of the cycle, including the design and manufacturing process. There’s a lot of important applications here, even in the general process engineering where we want to optimize things. I think defect detection is a big one at all phases of the process, especially in manufacturing. But even thinking ahead in the design process, [AI now plays a significant role] when you’re designing the light and the sensors and all the different components. There’s a lot of anomaly detection and fault mitigation that you really want to consider.

Heather GorrMathWorks

Then, thinking about the logistical modeling that you see in any industry, there is always planned downtime that you want to mitigate; but you also end up having unplanned downtime. So, looking back at that historical data of when you’ve had those moments where maybe it took a bit longer than expected to manufacture something, you can take a look at all of that data and use AI to try to identify the proximate cause or to see something that might jump out even in the processing and design phases. We think of AI oftentimes as a predictive tool, or as a robot doing something, but a lot of times you get a lot of insight from the data through AI.

What are the benefits of using AI for chip design?

Gorr: Historically, we’ve seen a lot of physics-based modeling, which is a very intensive process. We want to do a reduced order model, where instead of solving such a computationally expensive and extensive model, we can do something a little cheaper. You could create a surrogate model, so to speak, of that physics-based model, use the data, and then do your parameter sweeps, your optimizations, your Monte Carlo simulations using the surrogate model. That takes a lot less time computationally than solving the physics-based equations directly. So, we’re seeing that benefit in many ways, including the efficiency and economy that are the results of iterating quickly on the experiments and the simulations that will really help in the design.

So it’s like having a digital twin in a sense?

Gorr: Exactly. That’s pretty much what people are doing, where you have the physical system model and the experimental data. Then, in conjunction, you have this other model that you could tweak and tune and try different parameters and experiments that let sweep through all of those different situations and come up with a better design in the end.

So, it’s going to be more efficient and, as you said, cheaper?

Gorr: Yeah, definitely. Especially in the experimentation and design phases, where you’re trying different things. That’s obviously going to yield dramatic cost savings if you’re actually manufacturing and producing [the chips]. You want to simulate, test, experiment as much as possible without making something using the actual process engineering.

We’ve talked about the benefits. How about the drawbacks?

Gorr: The [AI-based experimental models] tend to not be as accurate as physics-based models. Of course, that’s why you do many simulations and parameter sweeps. But that’s also the benefit of having that digital twin, where you can keep that in mind—it’s not going to be as accurate as that precise model that we’ve developed over the years.

Both chip design and manufacturing are system intensive; you have to consider every little part. And that can be really challenging. It’s a case where you might have models to predict something and different parts of it, but you still need to bring it all together.

One of the other things to think about too is that you need the data to build the models. You have to incorporate data from all sorts of different sensors and different sorts of teams, and so that heightens the challenge.

How can engineers use AI to better prepare and extract insights from hardware or sensor data?

Gorr: We always think about using AI to predict something or do some robot task, but you can use AI to come up with patterns and pick out things you might not have noticed before on your own. People will use AI when they have high-frequency data coming from many different sensors, and a lot of times it’s useful to explore the frequency domain and things like data synchronization or resampling. Those can be really challenging if you’re not sure where to start.

One of the things I would say is, use the tools that are available. There’s a vast community of people working on these things, and you can find lots of examples [of applications and techniques] on GitHub or MATLAB Central, where people have shared nice examples, even little apps they’ve created. I think many of us are buried in data and just not sure what to do with it, so definitely take advantage of what’s already out there in the community. You can explore and see what makes sense to you, and bring in that balance of domain knowledge and the insight you get from the tools and AI.

What should engineers and designers consider when using AI for chip design?

Gorr: Think through what problems you’re trying to solve or what insights you might hope to find, and try to be clear about that. Consider all of the different components, and document and test each of those different parts. Consider all of the people involved, and explain and hand off in a way that is sensible for the whole team.

How do you think AI will affect chip designers’ jobs?

Gorr: It’s going to free up a lot of human capital for more advanced tasks. We can use AI to reduce waste, to optimize the materials, to optimize the design, but then you still have that human involved whenever it comes to decision-making. I think it’s a great example of people and technology working hand in hand. It’s also an industry where all people involved—even on the manufacturing floor—need to have some level of understanding of what’s happening, so this is a great industry for advancing AI because of how we test things and how we think about them before we put them on the chip.

How do you envision the future of AI and chip design?

Gorr: It’s very much dependent on that human element—involving people in the process and having that interpretable model. We can do many things with the mathematical minutiae of modeling, but it comes down to how people are using it, how everybody in the process is understanding and applying it. Communication and involvement of people of all skill levels in the process are going to be really important. We’re going to see less of those superprecise predictions and more transparency of information, sharing, and that digital twin—not only using AI but also using our human knowledge and all of the work that many people have done over the years.

Like many innovators, Hagit Messer-Yaron had a life-changing idea while doing something mundane: Talking with a colleague over a cup of coffee. The IEEE Life Fellow, who in 2006 was head of Tel Aviv University’s Porter School of Environmental Studies, was at the school’s cafeteria with a meteorological researcher. He shared his struggles with finding high-resolution weather data for his climate models, which are used to forecast and track flash floods.

Predicting floods is crucial for quickly evacuating residents in affected areas and protecting homes and businesses against damage.

Hagit Messer-Yaron

Employer Tel Aviv University

Title Professor emerita

Member grade Life Fellow

Alma mater Tel Aviv University

Her colleague “said researchers in the field had limited measurements because the equipment meteorologists used to collect weather data—including radar satellites—is expensive to purchase and maintain, especially in developing countries,” Messer-Yaron says.

Because of that, she says, high-resolution data about temperature, air quality, wind speed, and precipitation levels is often inconsistent—which is a problem when trying to produce accurate models and predictions.

An expert in signal processing and cellular communication, Messer-Yaron came up with the idea of using existing wireless communication signals to collect weather data, as communication networks are spread across the globe.

In 2006 she and her research team developed algorithms that process and analyze data collected by communication networks to monitor rainfall. They measure the difference in amplitude of the signals transmitted and received by the systems to extract data needed to predict flash floods.

The method was first demonstrated in Israel. Messer-Yaron is working to integrate it into communication networks worldwide.

For her work, she received this year’s IEEE Medal for Environmental and Safety Technologies for “contributions to sensing of the environment using wireless communication networks.” The award is sponsored by Toyota.

“Receiving an IEEE medal, which is the highest-level award you can get within the organization, was really a surprise, and I was extremely happy to [receive] it,” she says. “I was proud that IEEE was able to evaluate and see the potential in our technology for public good and to reward it.”

A passion for teaching

Growing up in Israel, Messer-Yaron was interested in art, literature, and science. When it came time to choose a career, she found it difficult to decide, she says. Ultimately, she chose electrical engineering, figuring it would be easier to enjoy art and literature as hobbies.

After completing her mandatory service in the Israel Defense Forces in 1973, she began her undergraduate studies at Tel Aviv University, where she found her passion: Signal processing.

“Electrical engineering is a very broad topic,” she says. “As an undergrad, you learn all the parts that make up electrical engineering, including applied physics and applied mathematics. I really enjoyed applied mathematics and soon discovered signal processing. I found it quite amazing how, by using algorithms, you can direct signals to extract information.”

She graduated with a bachelor’s degree in EE in 1977 and continued her education there, earning master’s and doctoral degrees in 1979 and 1984. She moved to the United States for a postdoctoral position at Yale. There she worked with IEEE Life Fellow Peter Schultheiss, who was known for his research in using sensor array systems in underwater acoustics.

Inspired by Schultheiss’s passion for teaching, Messer-Yaron decided to pursue a career in academia. She was hired by Tel Aviv University as an electrical engineering professor in 1986. She was the first woman in Israel to become a full professor in the subject.

“Being a faculty member at a public university is the best job you can do. I didn’t make a lot of money, but at the end of each day, I looked back at what I did [with pride].”

For the next 14 years, she conducted research in statistical signal processing, time-delay estimation, and sensor array processing.

Her passion for teaching took her around the world as a visiting professor at Yale, the New Jersey Institute of Technology, the Institut Polytechnique de Paris, and other schools. She collaborated with colleagues from the universities on research projects.

In 1999 she was promoted to director of Tel Aviv University’s undergraduate electrical engineering program.

A year later, she was offered an opportunity she couldn’t refuse: Serving as chief scientist for the Israeli Ministry of Science, Culture, and Sports. She took a sabbatical from teaching and for the next three years oversaw the country’s science policy.

“I believe [working in the public sector] is part of our duty as faculty members, especially in public universities, because that makes you a public intellectual,” she says. “Working for the government gave me a broad view of many things that you don’t see as a professor, even in a large university.”

When she returned to the university in 2004, Messer-Yaron was appointed as the director of the new school of environmental studies. She oversaw the allocation of research funding and spoke with researchers individually to better understand their needs. After having coffee with one researcher, she realized there was a need to develop better weather-monitoring technology.

Hagit Messer-Yaron proudly displays her IEEE Medal for Environmental and Safety Technologies at this year’s IEEE Honors Ceremony. She is accompanied by IEEE President-Elect Kathleen Kramer and IEEE President Tom Couglin.Robb Cohen

Using signal processing to monitor weather

Because the planet is warming, the risk of flash floods is steadily increasing. Warmer air holds more water—which leads to heavier-than-usual rainfall and results in more flooding, according to the U.S. Environmental Protection Agency.

Data about rainfall is typically collected by satellite radar and ground-based rain gauges. However, radar images don’t provide researchers with precise readings of what’s happening on the ground, according to an Ensia article. Rain gauges are accurate but provide data from small areas only.

So Messer-Yaron set her sights on developing technology that connects to cellular networks close to the ground to provide more accurate measurements, she says. Using existing infrastructure eliminates the need to build new weather radars and weather stations.

Communication systems automatically record the transmitted signal level and the received signal level, but rain can alter otherwise smooth wave patterns. By measuring the difference in the amplitude, meteorologists could extract the data necessary to track rainfall using the signal processing algorithms.

In 2005 Messer-Yaron and her group successfully tested the technology. The following year, their “Environmental Monitoring by Wireless Communication Networks” paper was published in Science.

The algorithm is being used in Israel in partnership with all three of the country’s major cellular service providers. Messer-Yaron acknowledges, however, that negotiating deals with cellular service companies in other countries has been difficult.

To expand the technology’s use worldwide, Messer-Yaron launched a research network through the European Cooperation in Science and Technology (COST), called an opportunistic precipitation sensing network known as OPENSENSE. The group connects researchers, meteorologists, and other experts around the world to collaborate on integrating the technology in members’ communities.

Monitoring the effects of climate change

Since developing the technology, Messer-Yaron has held a number of jobs including president of the Open University of Israel and vice chair of the country’s Council for Higher Education, which accredits academic institutions.

She is maintaining her link with Tel Aviv University today as a professor emerita.

“Being a faculty member at a public university is the best job you can do,” she says. “I didn’t make a lot of money, but at the end of each day, I looked back at what I did [with pride]. Because of the academic freedom and the autonomy I had, I was able to do many things in addition to teaching, including research.”

To continue her work in developing technology to monitor weather events, in 2016, she helped found ClimaCell, now Tomorrow.io, based in Boston. The startup aims to use wireless communication infrastructure and IoT devices to collect real-time weather data. Messer-Yaron served as its chief scientist until 2017.

She continues to update the original algorithms with her students, most recently with machine learning capabilities to extract data from physical measurements of the signal level in communication networks.

A global engineering community

When Messer-Yaron was an undergraduate student, she joined IEEE at the suggestion of one of her professors.

“I didn’t think much about the benefits of being a member until I became a graduate student,” she says. “I started attending conferences and publishing papers in IEEE journals, and the organization became my professional community.”

She is an active volunteer and a member of the IEEE Signal Processing Society. From 1994 to 2010 she served on the society’s Signal Processing Theory and Methods technical committee. She was associate editor of IEEE Signal Processing Letters and IEEE Transactions on Signal Processing. She is a member of the editorial boards of the IEEE Journal of Selected Topics in Signal Processing and IEEE Transactions on Signal Processing.

In the past 10 years, she’s been involved with other IEEE committees including the conduct review, ethics and member conduct, and global public policy bodies.

“I don’t see my career or my professional life without the IEEE,” she says

A collaboration between a space company and a fashion company yields something elegant.

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Humane first reported overheating problems with the portable charger in June.

The huge spacecraft is headed toward the icy moon Europa, where it will use an array of instruments to survey for geologic activity, magnetism and more

The Archbishop of Canterbury's position is now untenable, according to the Bishop of Newcastle who joined the growing calls for Justin Welby to resign.

We spoke to Dr Ian Paul, who is a reverend and member of General Synod and the Archbishops’ Council.

Justin Welby's resignation as the Archbishop of Canterbury came after days of mounting pressure following a damning report into the cover-up of horrific abuse.

We spoke to one of John Smyth’s victims, Mark Stibbe, a former vicar and now an author.

We spoke to Reverend Doctor Stephen Cherry, Dean of Chapel at King's College, Cambridge.

Signal decoders are vital components in radio broadcasting. Without them, the transmission and reception of clear audio or data would be impossible. They take what is essentially noise and turn it into coherent, useful information. Having worked with radio broadcasting systems for some time, I’ve seen firsthand how essential decoders are to maintaining communication networks. […]

The post How Signal Decoders Are Used in Radio Broadcasting appeared first on Chart Attack.

The Federal Emergency Management Agency supervisor fired for telling workers to avoid homes with Trump signs or flags said in an interview Tuesday that "senior leadership" at FEMA was well-aware of this guidance and it was not an isolated incident.

The post Ex-FEMA Worker Claims Leadership Knew Workers Were Avoiding Homes with Trump Signs appeared first on Breitbart.

NPR's Neal Conan reflects on his 11 years of hosting Talk of the Nation and thanks some of the influential contributors to the show along the way. After 36 years at NPR, Conan signs off.

In today’s rapidly evolving digital landscape, managing IP infrastructure has become increasingly complex and critical for organizations of all sizes. As networks

The post Don’t Ignore What You Can Easily Control: Your IP Infrastructure appeared first on Gigaom.

While some fake videos made by actors with Russian ties received millions of views, researchers say there's so far no indication that these efforts swayed U.S. election results.

1. Church of England head Justin Welby who married Prince Harry and Meghan Markle resigns over pedophile scandal  Hindustan Times
2. Archbishop of Canterbury, Trump critic Justin Welby resigns. What is the sex abuse scandal?  The Times of India
3. Video | UK Church Abuse Scandal: Head Of Church Of England Steps Down  NDTV
4. ‘Church in crisis’: what the papers say about the archbishop of Canterbury’s resignation  The Guardian
5. World News Today Live Updates on November 13, 2024 : Archbishop of Canterbury Justin Welby resigns amid sexual abuse case—Who is he? What's the scandal? All you need to know  Mint

Another mobile reveal from Gamescom Opening Night Live 2024 was the latest trailer for the open world dress up game …

Continue reading "Open World Dress Up Game ‘Infinity Nikki’ Gets New Trailer With Closed Beta Sign Ups Now Live, Pre-Registrations Also Available"

Archbishop of Canterbury Justin Welby has resigned over accusations that he failed to report physical and sexual abuse to the police.

A voyage in this kind of spacecraft — while still conceptual — would take multiple lifetimes, crossing unimaginable gulfs of interstellar space. The theoretical exercise puts aside technical problems, including the propulsion system, and focusses on the design of the habitat and society.

A dome-shaped device floating in Halifax’s Northwest Arm could easily be confused with a buoy, but it is actually a contraption meant to turn ocean water into fresh water. Two Dalhousie University researchers hope it can help with water scarcity in the real world.

Media figures making that claim are blaming everyone but the bad candidate herself.

Rode has announced the Wireless Micro, a two-mic kit with a smartphone receiver and charging case that costs just $149. The idea is to help TikTok and other creators capture much better-quality audio than their smartphone's microphone can offer. 

The receiver unit connects to the bottom of your smartphone via a USB-C or lightning port. Meanwhile, the microphones (aka transmitters) attach to the subject via integrated clips or magnetic attachments, then capture what Rode calls "pristine" quality sound. Specifically, they offer a 20-20 kHz frequency range and 73 dB signal-to-noise ratio, with a transmission range around 330 feet.

Rode

To use it, simply connect the receiver to your iOS or Android device and it will take over as the system microphone. From there, everything is automatic, as the transmitter mics are automatically paired to the receiver and sound will be captured to your camera app of choice. Levels are automatically controlled with the company's GainAssist technology. 

The omnidirectional transmitters weigh just 12 grams (0.42 ounces) and are tiny enough to be discreet when clipped onto your subject. The built-in microphones use what Rode calls "acoustic chambers" with a patent-pending design. That supposedly lets you capture clear and intelligible audio while reducing wind noise, though a pair of windmuffs is also included in the kit. 

Rode

The Wireless Micro also includes a charging case that delivers two full recharges for up to 18 hours of battery life, while giving you a secure place to store everything. 

There are a few things missing, though. You can't connect an external mic to the transmitters, unlike with other Rode wireless mics or the DJI Mic 2. There's no smartphone Bluetooth capability, and it doesn't offer a 3.5mm connection for cameras — a feature that will supposedly exist on the rumored DJI Mic Mini. Still, this looks like a great option for creators who primarily use smartphones. It's now available in a two mic kit with a receiver and charging case for $150. 

This article originally appeared on Engadget at https://www.engadget.com/audio/rodes-tiny-149-wireless-micro-kit-is-designed-for-smartphone-users-150040695.html?src=rss

Signal users may be familiar with the problem of creating group chats just for a group call, but that’s about to become a thing of the past. You can now share a call link and let up to 50 people hop in, all in the span of a few seconds. The days of selecting contacts one by one are over.

Now, all you have to do is create a call link after going to the Calls tab and send it to whomever you want. The link is also reusable, which is convenient if you have fixed call times. Participants can raise their hands and send emojis. Hosts can set the room up so people must be approved before joining the conversation.

Based on Signal’s blog post, the new group call experience highly resembles Zoom. Those interested in privacy yet desire a conference call-like experience may find the new update helpful. Like Zoom, the desktop app offers more options.

Besides Zoom, these features will be familiar to frequent users of Microsoft Teams, Google Meet and some WhatsApp users. Raising hands is found on all three platforms as a non-verbal way to signal the speaker. WhatsApp does have a lower participant count of 32 people after an update in June. While there’s no raise hands function, doing certain gestures can send emojis for all to see. It’s worth noting that many apps with group call functionality are adopting similar features.

These new features are available on Android, iOS, Windows and macOS. If you don’t see them yet, we recommend updating your Signal app.

This article originally appeared on Engadget at https://www.engadget.com/apps/signal-makes-it-easier-to-start-group-video-calls-153519653.html?src=rss

London, UK (SPX) Nov 13, 2024
Mangrove forests in the Maldives are facing a severe threat as they succumb to rising sea levels and climate changes, according to a new study led by Northumbria University researchers and published in *Scientific Reports*. The study highlights that the Maldives, known for its low-lying islands, experienced significant mangrove dieback since 2020 due to rapid sea-level rise and the effects

Élise Gravel est une dessinatrice québécoise qui fait des petits dessins tout mignons pour les enfants.

Des Swifties québécoises racontent leur expérience durant un concert de la tournée «Eras».

Deputy PM admits former Soviet state was until recently a 'highly corrupt country' - but insists things are changing fast.

Culture may play a role in how birds build collectively in the Kalahari Desert

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 article is part of our exclusive IEEE Journal Watch series in partnership with IEEE Xplore.

Sea turtles are remarkable creatures for a number of reasons, including the way they hear underwater—not through openings in the form of ears, but by detecting vibrations directly through the skin covering their auditory system. Inspired by this ability to detect sound through skin, researchers in China have created a heart-monitoring system, which initial tests in humans suggest may be a viable for monitoring heartbeats.

A key way in which doctors monitor heart health involves “listening” to the heartbeat, either using a stethoscope or more sophisticated technology, like echocardiograms. However, these approaches require a visit to a specialist, and so researchers have been keen to develop alternative, lower cost solutions that people can use at home, which could also allow for more frequent testing and monitoring.

Junbin Zang, a lecturer at the North University of China, and his colleagues specialize in creating heart-monitoring technologies. Their interest was piqued when they learned about the inner workings of the sea turtle’s auditory system, which is able to detect low-frequency signals, especially in the 300- to 400-hertz range.

“Heart sounds are also low-frequency signals, so the low-frequency characteristics of the sea turtle’s ear have provided us with great inspiration,” explains Zang.

At a glance, it looks like turtles don’t have ears. Their auditory system instead lies under a layer of skin and fat, through which it picks up vibrations. As with humans, a small bone in the ear vibrates as sounds hit it, and as it oscillates, those pulses are converted to electrical signals that are sent to the brain for processing and interpretation.

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But sea turtles have a unique, slender T-shaped conduit that encapsulates their ear bones, restricting the movement of the similarly T-shaped ear bones to only vibrate in a perpendicular manner. This design provides their auditory system with high sensitivity to vibrations.

Zang and his colleagues set out to create a heart monitoring system with similar features. They created a T-shaped heart-sound sensor that imitates the ear bones of sea turtles using a tiny MEMS cantilever beam sensor. As sound hits the sensor, the vibrations cause deformations in its beam, and the fluctuations in the voltage resistance are then translated into electrical signals.

The researchers first tested the sensor’s ability to detect sound in lab tests, and then tested the sensor’s ability to monitor heartbeats in two human volunteers in their early 20s. The results, described in a study published 1 April in IEEE Sensors Journal, show that the sensor can effectively detect the two phases of a heartbeat.

“The sensor exhibits excellent vibration characteristics,” Zang says, noting that it has a higher vibration sensitivity compared to other accelerometers on the market.

However, the sensor currently picks up a significant amount of background noise, which Zang says his team plans to address in future work. Ultimately, they are interested in integrating this novel bioinspired sensor into devices they have previously created—including portable handheld and wearable versions, and a relatively larger version for use in hospitals—for the simultaneous detection of electrocardiogram and phonocardiogram signals.

This article appears in the July 2024 print issue as “Sea Turtles Inspire Heart-Monitor Design.”

Neurogene’s Rett syndrome gene therapy has preliminary data supporting safety and efficacy of the one-time treatment. But a late-breaking report of a serious complication in a patient who received the high dose sent shares of the biotech downward.

The post Neurogene Gene Therapy Shows Signs of Efficacy in Small Study, But an Adverse Event Spooks Investors appeared first on MedCity News.

Monday blues were non-existent at the Singapore Indoor Stadium yesterday (Nov 11) as fans of Blackpink's Lisa strolled into the venue in their Y2K-style outfits inspired by the Thai singer's Rockstar music video. Singapore was the first stop for the 27-year-old's first solo fan-meet tour and needless to say, the excitement could be felt, and heard. Once the lights turned off and Lisa appeared, the screams were deafening. The show started with a bang, fittingly with her self-titled hit song Lalisa. Usually at fan-meets of K-pop idols, the special effects are kept to a minimum unlike concerts. PHOTO: UnUsUaL Entertainment But at Lisa's, the performances were elevated with bursts of pyrotechnics and visual effects. After the first song, she sat down for a few interactive segments. During Welcome Lisa, she tried local delicacies like kaya toast and chicken rice.

May 11, 2022

When the U.S. military trains other states’ forces, it tries to impart liberal norms such as respect for human rights. But when liberal norms clash, these soldiers prioritize loyalty to their unit, the military, and shared goals.

During a March 28 meeting with Assistant Secretary or South and Central Asian Affairs Boucher, Foreign Minister-designate Shah Mehmood Qureshi confirmed that the new government wanted to work with the U.S. to combat extremism, increase trade and extend cooperation with India and Afghanistan.

Even with support from the government, serious threats against Bhutto will persist.

Spoke of DMK leader's attempted ‘blackmail' on Sri Lanka, warned that the Congress ‘will carry this grudge and retaliate at the right time'

Pakistan concern that freedom of expression be balanced with respect for religion as "we are not as advanced as you are" in terms of respect for freedom of religion and could not always control the reactions of sometimes ignorant crowds.

MG Tariq Salim Malik, Additional Secretary of Ministry of Defense Production (MODP), signed the Letter of Acceptance (LOA) to purchase 18 F-16s Saturday evening, September 30.