Connect with us

Science

This device attaches magnetically to a face mask to monitor the wearer’s vitals

Perhaps 2022 will be the year consumer health tracking moves beyond the wrist. We’ve seen Oura’s rise over the past few years and a CES that brought with it a couple of ring fitness trackers. Following Google’s addition to vital and sleep tracking…

Published

on

Perhaps 2022 will be the year consumer health tracking moves beyond the wrist. We’ve seen Oura’s rise over the past few years and a CES that brought with it a couple of ring fitness trackers. Following Google’s addition to vital and sleep tracking on the Nest Home, Sengled is adding the feature to a smart lightbulb.

So, why not the face mask? Health-related face coverings have long been a fixture in a number of countries, like China, and are pretty much everywhere in this pandemic world. It’s hard to say whether mainstream adoption of masks will outlive COVID-19 in the U.S., but as the pandemic drags on, it seems increasingly likely that they’ll remain a part of daily lives for the foreseeable future.

Image Credits: Northwestern University

The face is a solid position from which to monitor certain vitals, and the widespread adoption of masks offers a relatively fixed spot to collect that data. Accordingly, a team at Northwestern University is showing off FaceBit — the “FitBit for the Face” — which attaches to an N95, surgical or cloth mask via magnet. From there, it’s able to monitor respiratory and heart rate, as well as time spent in the mask.

“We wanted to design an intelligent face mask for health care professionals that does not need to be inconveniently plugged in during the middle of a shift,” team leader Josiah Hester said in a statement. “We augmented the battery’s energy with energy harvesting from various sources, which means that you can wear the mask for a week or two without having to charge or replace the battery.”

The system, which was recently detailed in a paper, can also determine mask fit — an issue for anyone not accustomed to using a mask. If the mask loosens or is bumped out of place, the connected app will send an alert to the wearer. Currently, the system’s battery lasts around 11 days on a charge, though the team is envisioning a battery-free version, powered by things like thermal and kinetic energy.

The product will need to undergo further clinical trials before proceeding, though the project has also been offered up as an open source product for those interested.

Read More

Continue Reading

Economics

Those big billion-dollar PhIII studies? Martin Landray says they can be done for a tiny fraction of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.
Bioregnum Opinion Column by John Carroll
Landray…

Published

on

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Bioregnum Opinion Column by John Carroll

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

Now, after 20 years of mounting clinical trials, the Oxford professor is building on what he’s learned from RECOVERY and scores of drug studies to take on one of the most quixotic tasks in the industry: building an organization that can take a drug — anything from a cheap generic like dexamethasone to an experimental biopharma drug — and put it through its paces in large Phase III trials. And at just a tiny fraction of the cost developers would normally spend on late-stage programs.

A lot of this depends on approaching drug data in a new way, carefully and precisely identifying the data needed, without overcomplicating matters, then working in alignment with key drug developers, patient groups, providers — the UK’s NHS, with its massive database, is a supporter — and clinical organizations to recruit en masse.

In doing that, he intends to break a decades-long trend in drug development that has steered large and small organizations away from the big population studies needed for cardio and other broad disease areas like dementia and into the rare disease field, where smaller trials are the norm.

And that makes him a radical in what he sees as a field that’s begging for a game-changing revolution.

“It’s unsustainable,” says the Oxford professor about the Phase III sector of R&D. “I mean, it’s already broken … The so-called GCP regulations, good clinical practice, the old joke goes they’re not good, they’re not clinical, and they’re not practical. And that joke has been around 25 years and hasn’t changed much.”

This is not something that needs incremental improvement. From his perspective, this is a big issue for the world.

Huge financial and public health issues were at stake when the Covid vaccines first entered the clinic, and decisions were made on those with what Landray considers “pretty scruffy evidence.”

“The original vaccine trials cost probably a billion dollars apiece,” Landray says. “The idea, if you turned around to one of those companies and said, ‘And now we want you to do a trial of a million people.’ They’d say, ‘Well, our pockets are just not that deep.’ If you say, ‘Well, I want to do a trial of a million people and it costs a million pounds,’ suddenly the possibilities open up. And we put the proposal together for that. I’m absolutely serious about those numbers.”

David Schenkein

Click on the image to see the full-sized version

Landray has done more than simply win over some converts to the Phase III revolution he’s plotting. He’s building a non-profit organization called Protas that has drawn some influential backers in biopharma. Sanofi came in early on with a promise to collaborate and £5 million. And today GV — Google’s venture arm — is in for another £5 million grant, with active support from David Schenkein, a high-profile researcher who helped build Agios before jumping to venture capital.

“I’ve been doing clinical trials my whole life out of grade school,” Schenkein, a Genentech alum, tells me, “and we need to see the whole ecosystem improve. And that’s good for everybody. So it is definitely a philanthropic grant, but we think it’ll improve the entire ecosystem, which we’re obviously so committed to. We’ve known Martin and his team for years and have just been incredibly impressed. And we’ve looked at the clinical trial space and we’ve talked about this before, you and I, but what Martin and his team have done have just been outpacing everybody else.”

“There’s no question that the way we do Phase III clinical trials today is largely no different than the way we did them when I first went into the industry or where we’ve been doing it for 40 years, which means we enroll patients the same way we used to. We don’t go directly to patients in many cases,” Schenkein adds. “We only go through the sites. The sites say, ‘Yeah, I’ll give you 20 patients.’ They end up giving you zero. And so you need more sites. We end up collecting way more data. We don’t know which is the right data to collect, and so we collect everything. We clean everything. And all of that drives the cost up exponentially and slows it down. And what Martin and his team have just gotten so much smarter using data to be able to say, not only how do we enroll patients in a different way, how do we know the right data to collect, not collect too much data, the right data. So all of that will just completely change the way we think about conducting clinical trials, and that has to happen.”

Dietmar Berger

“We engaged with them because we believe integration of clinical trials into everyday clinical practice can be an important new model, which offers advantages both for the healthcare system as well as for sponsors,” Sanofi development chief Dietmar Berger tells me. “Running large late-stage trials in close collaboration with practicing physicians and a large healthcare provider (for example via Protas) can lead to more efficient data generation, with representation of a diverse, ‘real world’ population. This could apply especially for large studies in common diseases, and include novel drugs.”

Right now, there are no trials underway at Protas or ones planned before 2024. Landray is using his funding to create a group that can orchestrate a variety of new methods to smash classic Phase III budgets. And his experiences running the informatics part in the early days of the UK Biobank project — with its half a million subjects enrolled in a massive genetics project — have helped.

We just need to spend those two years making sure that we’ve got all the right things in place. Part of that is technology. IT systems actually make it easier to do the right thing in terms of following the protocol. Part of that is about regulatory and other policies. And we’ve been doing a lot of work with ICH, with FDA, with all sorts of organizations around what should good clinical trials regulation look like? Part of that is building on the experiences from things like the RECOVERY trial. Part of that is partnerships with clinicians, clinical health services, and patient groups. We need those things in place before one actually starts delivering.

If you say, have we started planning? Yes, we’ve started thinking about some of those first trials. I just don’t have anything concrete to talk about today.

Landray has given this all a lot of thought, and it’s worth listening carefully to what he has to say about the many things that have skewed so far off course in drug development. And why it’s important to get on the right track.

What we’ve seen is that Big Pharma has largely opted out of developing new drugs for common diseases. That’s true in heart disease, in arthritis, and so on. Respiratory disease. It’s very true if one looks at depression. It’s substantially true if one looks at dementia, where there are two challenges to dementia. One is, can we find some potential drugs that might work? Probably. And then the second is, how are we ever going to make that commercially successful? And that’s going to be driven in large part by what’s the affordability and the practicality of doing those sorts of trials that you would need to do in dementia.

So it’s not just about how we get drugs cheaper, but it’s also, from my point of view, it’s can we get better drugs to treat the big issues? And if one looks at a health system and again — goes back to that point of view for a moment — the reason that everybody’s health system is creaking/broken is largely because there are very large numbers of people who are late middle aged and elderly with two or three or possibly more relatively common conditions. And if we want to actually get something that is much more sustainable in terms of an overall health system and public health, then we have to tackle common disease and we have to also tackle the prevention elements, whether that’s early detection of cancer or preventative treatments like reducing the risk of future cardiovascular events.

Schenkein agrees wholeheartedly: “I think that the most important factor here is the shift we’ve seen in our industry away from investments in the common diseases more towards the rare. I agree with Martin. The rare diseases are critically important, but that shift has to come back the other way.”

Consider the case of PCSK9, the big target that drove Amgen and Novartis out onto the market with limited data on efficacy in an attempt to reach a portion of the population that could benefit from it.

Here’s Landray:

In the PCSK9 antibodies, yes, they showed it reduced MACE, major cardiovascular events, but didn’t show an impact on cardiovascular death and they didn’t have the full range of safety information you might want to see for a new class of drugs. Then what happens was that someone had to pay back the cost of those trials. One of the many contributing factors, but a significant one, is how do we recoup our R&D costs, of which something like half or more is probably on that single late-phase trial.

And then the payers turn around…and they say, that’s all very well, but we see you’ve demonstrated efficacy in that, remember, limited population of all the patients who’ve had heart disease, but we can’t really afford to treat all of those patients. And therefore we’ll put in place some other clinical guidance. It’s all called clinical guidance or whatever, but it’s basically a form of rationing.

That can substantially be avoided if you avoid calamitous R&D costs.

That could be arguable, as drugs aren’t priced — in the US in any case — according to the cost of development. But you’ll never break through that barrier, Landray argues, until you start doing huge studies at relatively meager prices.

For Landray, this isn’t about empire building. If Protas can break the mold and essentially force the rest of the R&D world to adopt it, he’d gladly shut down a decade from now. Mission accomplished.

But first there’s a revolution to inspire.

Read More

Continue Reading

Government

A Deeper Dive Into The CDC Reversal

A Deeper Dive Into The CDC Reversal

Authored by Jeffrey Tucker via The Brownstone Institute,

It was a good but bizarre day when the CDC finally…

Published

on

A Deeper Dive Into The CDC Reversal

Authored by Jeffrey Tucker via The Brownstone Institute,

It was a good but bizarre day when the CDC finally reversed itself fundamentally on its messaging for two-and-a-half years.

The source is the MMWR report of August 11, 2022. The title alone shows just how deeply the about-face was buried: Summary of Guidance for Minimizing the Impact of COVID-19 on Individual Persons, Communities, and Health Care Systems — United States, August 2022

The authors: “the CDC Emergency Response Team” consisting of “Greta M. Massetti, PhD; Brendan R. Jackson, MD; John T. Brooks, MD; Cria G. Perrine, PhD; Erica Reott, MPH; Aron J. Hall, DVM; Debra Lubar, PhD;; Ian T. Williams, PhD; Matthew D. Ritchey, DPT; Pragna Patel, MD; Leandris C. Liburd, PhD; Barbara E. Mahon, MD.”

It would have been fascinating to be a fly on the wall in the brainstorming sessions that led to this little treatise. The wording was chosen very carefully, not to say anything false outright, much less admit any errors of the past, but to imply that it was only possible to say these things now. 

“As SARS-CoV-2, the virus that causes COVID-19, continues to circulate globally, high levels of vaccine- and infection-induced immunity and the availability of effective treatments and prevention tools have substantially reduced the risk for medically significant COVID-19 illness (severe acute illness and post–COVID-19 conditions) and associated hospitalization and death. These circumstances now allow public health efforts to minimize the individual and societal health impacts of COVID-19 by focusing on sustainable measures to further reduce medically significant illness as well as to minimize strain on the health care system, while reducing barriers to social, educational, and economic activity.

In English: 

everyone can pretty much go back to normal.

Focus on illness that is medically significant. Stop worrying about positive cases because nothing is going to stop them. Think about the bigger picture of overall social health. End the compulsion. Thank you. It’s only two and a half years late. 

What about mass testing?

Forget it:

“All persons should seek testing for active infection when they are symptomatic or if they have a known or suspected exposure to someone with COVID-19.”

Oh. 

What about the magic of track and trace?

“CDC now recommends case investigation and contact tracing only in health care settings and certain high-risk congregate settings.”

Oh. 

What about the unvaccinated who were so demonized throughout the last year? 

“CDC’s COVID-19 prevention recommendations no longer differentiate based on a person’s vaccination status because breakthrough infections occur, though they are generally mild, and persons who have had COVID-19 but are not vaccinated have some degree of protection against severe illness from their previous infection.”

Remember when 40% of the members of the black community in New York City who refused the jab were not allowed into restaurants, bars, libraries, museums, or theaters? Now, no one wants to talk about that. 

Also, universities, colleges, the military, and so on – which still have mandates in place – do you hear this? Everything you have done to hate on people, dehumanize people, segregate people, humiliate others as unclean, fire people and destroy lives, now stands in disrepute. 

Meanwhile, as of this writing, the blasted US government still will not allow unvaccinated travelers across its borders! 

Not one word of the CDC’s turgid treatise was untrue back in the Spring of 2020. There was always “infection-induced immunity,” though Fauci and Co. constantly pretended otherwise. It was always a terrible idea to introduce “barriers to social, educational, and economic activity.” The vaccines never promised in their authorization to stop infection and spread, even though all official statements of the CDC claimed otherwise, repeatedly and often. 

You might also wonder how the great reversal treats masking. On this subject, there is no backing off. After all, the Biden administration still has an appeal in process to reverse the court decision that the mask mandate was illegal all along.

“At the high COVID-19 Community Level,” the CDC adds, “additional recommendations focus on all persons wearing masks indoors in public and further increasing protection to populations at high risk.”

The problem from the beginning was that there never was an exit strategy from the crazy lockdown/mandate idea. It was never the case that they would magically cause the bug to go away. The excuse that we would lock down in wait for a vaccine never made any sense. 

People surely knew early on of the social, economic, and cultural devastation that would ensue. If they did not, they never should have been anywhere near the control switches of public health. Badges and bureaucracies do not terrify a virus destined to spread to the whole planet. And not one person with even the most casual passing knowledge of coronaviruses could have sincerely believed that a vaccine would magically appear to achieve something never before achieved in the whole history of medicine. 

When the Great Barrington Declaration appeared on October 4, 2020, it caused a global frenzy of fury not because it said anything new. It was merely a pithy restatement of basic public-health principles, which pretty much instantly became verboten on March 16, 2020, when Fauci/Birx announced their grand scheme. 

The GBD generated mania because the existing praxis was based on preposterously unproven claims that demanded that billions of people buy into complete nonsense. Sadly many did simply because it seemed hard to believe that all world regimes but a handful would push such a damaging policy if it was utterly unworkable. When something like that happens – and there never was the hope that it could work – the regime imperative becomes censorship and shaming of dissent. It’s the only way to hold the great lie together. 

So finally, nearly two years later the CDC has embraced the Great Barrington Declaration rather than doing a “quick and devastating takedown” as Francis Collins and Anthony Fauci called for the day after its release. No, they had to try out their new theory on the rest of us. It did not work, obviously. For the authors of the GBD, they knew from the time they penned the document that it was a matter of time before they were vindicated. They never doubted it. 

Dr. Rajeev Venkayya is widely credited with coming up with the idea of lockdowns while he was working for the Bush administration back in 2005. He had no training at all in public health or epidemiology. He later marveled that it fell to him, a young desk-dwelling White House bureaucrat, to “invent pandemic planning.” Maybe he should have demurred that day that George W. Bush asked him to lead the charge to inaugurate a new war on pathogens. 

Somehow his views gained converts, among whom was Bill Gates, the foundation for whom he worked for years. The rest is history. 

In April 2020, Venkayya called me to explain why I needed to stop attacking lockdowns. He said that the planners need a chance to make their scheme work. 

On the phone, I asked the same question over and over: where does the virus go? The first two times, he did not respond. I pressed and pressed. Finally he said there will be a vaccine. 

It’s hard to appreciate just how preposterous that sounded at the time, and I said something along those lines: it would be a medical miracle never before seen to have a shot for a coronavirus that was sterilizing against wild type and all inevitable mutations, and to do it in a reasonable time so that society and economy had not completely fallen apart. 

The whole approach was clearly milliennarian at best and utter madness at worst. And here I was, in the thick of global lockdowns, on the phone with the architect of the whole idea, an idea that had reduced billions to servitude, wrecked schools and churches, and sent communities and countries into complete upheaval. I wondered at the time what it would be like to be Dr. Venkayya that day. After all this ended in disaster, would he take responsibility? His LinkedIn profile today says otherwise: he is prepared to “tackle current and future epidemic & pandemic threats as the CEO of Aerium Therapeutics.”

There never was an exit strategy from lockdowns and mandates but they eventually did find an exit nonetheless. It came in the form of a heavily footnoted and opaquely written reversal, published by the main bureaucracy responsible for the disaster. It amounts to a repudiation without saying so. And thus does the great experiment in mass compulsion come to an intellectual end. If only the carnage could be cleaned up by another posting on the CDC’s website. 

By the way, the Biden administration has extended the declaration of Covid emergency. And my unvaccinated friends in the UK still can’t board a plane to come for a visit. 

All of this gives rise to the great question: what was the point? Maybe it was all a mistake and now it is gone forever but that’s unlikely. The intellectuals who pushed this project on the world have a view of the world that is fundamentally ill-liberal. They differ among themselves on the details but the general approach is technocratic central planning rooted in deep suspicion of basic tenets of freedom. 

How many people on the planet have now been acculturated to top-down control, socialized to live in fear, accept whatever comes down from above, never to question an edict, and expect to live in a world of rolling man-made disasters? And was that the point after all, to cultivate low expectations for life on earth and relinquish the soul’s desire for a full and free life? 

Tyler Durden Thu, 08/18/2022 - 09:49

Read More

Continue Reading

Science

Fake research can be harmful to your health – a new study offers a tool for rooting it out

A new screening tool to help study reviewers identify what’s fake or shoddy in research may be on the horizon. And everyday people can apply some of…

Published

on

Although most medical research is reliable, studies that are flawed or fake can lead to patients undergoing treatments that might cause harm. skynesher/E+ via Getty Images

If you are suffering with chronic pain, diabetes, heart problems or any other condition, you want to be confident that your doctor will offer you an effective treatment. You certainly don’t want to waste time or money on something that won’t work, or take something that could do you harm.

The best source of information to guide treatment is medical research. But how do you know when that information is reliable and evidence-based? And how can you tell the difference between shoddy research findings and those that have merit?

There’s a long journey to the publication of research findings. Scientists design experiments and studies to investigate questions about treatment or prevention, and follow certain scientific principles and standards. Then the finding is submitted for publication in a research journal. Editors and other people in the researchers’ field, called peer-reviewers, make suggestions to improve the research. When the study is deemed acceptable, it is published as a research journal article.

But a lot can go wrong on this long journey that could make a research journal article unreliable. And peer review is not designed to catch fake or misleading data. Unreliable scientific studies can be hard to spot – whether by reviewers or the general public – but by asking the right questions, it can be done.

While most research has been conducted according to rigorous standards, studies with fake or fatally flawed findings are sometimes published in the scientific literature. It is hard to get an exact estimate of the number of fraudulent studies because the scientific publication process catches some of them before they are published. One study of 526 patient trials in anesthesiology found that 8% had fake data and 26% were critically flawed.

As a professor in medicine and public health, I have been studying bias in the design, conduct and publication of scientific research for 30 years. I’ve been developing ways to prevent and detect research integrity problems so the best possible evidence can be synthesized and used for decisions about health. Sleuthing out data that cannot be trusted, whether this is due to intentional fraud or just bad research practices, is key to using the most reliable evidence for decisions.

Systematic reviews help suss out weak studies

The most reliable evidence of all comes when researchers pull the results of several studies together in what is known as a systematic review. Researchers who conduct systematic reviews identify, evaluate and summarize all studies on a particular topic. They not only sift through and combine results on perhaps tens of thousands of patients, but can use an extra filter to catch potentially fraudulent studies and ensure they do not feed into recommendations. This means that the more rigorous studies have the most weight in a systematic review and bad studies are excluded based on strict inclusion and exclusion criteria that are applied by the reviewers.

Systematic reviews explained.

To better understand how systematic reviewers and other researchers can identify unreliable studies, my research team interviewed a group of 30 international experts from 12 countries. They explained to us that a shoddy study can be hard to detect because, as one expert explained, it is “designed to pass muster on first glance.”

As our recently published study reports, some studies look like their data has been massaged, some studies are not as well designed as they claim to be, and some may even be completely fabricated.

Our study provides some important ideas about how to spot medical research that is deeply flawed or fake and should not be trusted.

The experts we interviewed suggested some key questions that reviewers should ask about a study: For instance, did it have ethics approval? Was the clinical trial registered? Do the results seem plausible? Was the study funded by an independent source and not the company whose product is being tested?

If the answers to any of these questions is no, then further investigation of the study is needed.

In particular, my colleagues and I found that it’s possible for researchers who review and synthesize evidence to create a checklist of warning signs. These signs don’t categorically prove that research is fraudulent, but they do show researchers as well as the general public which studies need to be looked at more carefully. We used these warning signs to create a screening tool – a set of questions to ask about how a study is done and reported – that provide clues about whether a study is real or not.

Signs include important information that’s missing, like details of ethical approval or where the study was carried out, and data that seems too good to be true. One example might be if the number of patients in a study exceeds the number of people with the disease in the whole country.

Spotting flimsy research

It’s important to note that our new study does not mean all research can’t be trusted.

The COVID-19 pandemic offers examples of how systematic review ultimately filtered out fake research that had been published in the medical literature and disseminated by the media. Early in the pandemic, when the pace of medical research was accelerating, robust and well-run patient trials – and the systematic reviews that followed – helped the public learn which interventions work well and which were not supported by science.

For example, ivermectin, an antiparasitic drug that is typically used in veterinary medicine and that was promoted by some without evidence as a treatment for COVID-19, was widely embraced in some parts of the world. However, after ruling out fake or flawed studies, a systematic review of research on ivermectin found that it had “no beneficial effects for people with COVID-19.”

On the other hand, a systematic review of corticosteroid drugs like dexamethasone found that the drugs help prevent death when used as a treatment for COVID-19.

There are efforts underway across the globe to ensure that the highest standards of medical research are upheld. Research funders are asking scientists to publish all of their data so it can be fully scrutinized, and medical journals that publish new studies are beginning to screen for suspect data. But everyone involved in research funding, production and publication should be aware that fake data and studies are out there.

The screening tool proposed in our new research is designed for systematic reviewers of scientific studies, so a certain level of expertise is needed to apply it. However, using some of the questions from the tool, both researchers and the general public can be better equipped to read about the latest research with an informed and critical eye.

Lisa Bero is Senior Editor, Research Integrity for Cochrane, an international non-profit organization that publishes systematic reviews.

Read More

Continue Reading

Trending