Virtual Bodies For Real Drugs: In Silico Clinical Trials Are The Future | LinkedIn

Yes, a body in a chip.

Traditional clinical trials are equivalent of billions of dollars and years of hard work with no guarantee for the new drug to be approved by regulatory bodies, not to speak about the dangers of testing medication on animals and/or humans. What if we could take a radical turn? What if we conducted clinical trials on virtual bodies that could perfectly mimic human physiology? With the help of artificial intelligence, enhanced computer simulations, and advances in personalized medicine, in silico trials might be a reality in the coming years.

If possible this would be a quantum leap and sea-change for pharmaceutical companies and regulatory agencies. The magic expression is in silicon.

As technologies transform every aspect of healthcare, medicine, and the pharma industry, the monstrous clinical trial enterprise cannot be left out either. One way to modernize the testing The present testing process is applying technologies to the traditional framework, for example through online platforms to seek out participants; while an alternative way is to build a completely new setting. Human organs-on-chips and in silico trials represent the second approach. Researchers of the Wyss Institute have been working on the first strand, human organs-on-chips for years. These microdevices lined by living human cells can mimic the microarchitecture and functions of human organs, and this makes them ideal for replacing clinical testing.

In silico is the term scientists use to describe the modeling, simulation, and visualization of biological and medical processes in computers. The emergence of in silico medicine is a result of the advance of medical computer science over the last 20 years.

As technologies transform every aspect of healthcare, medicine, and the pharma industry, the monstrous clinical trial enterprise cannot be left out either. One way to modernize the drug testing process is applying technologies to the traditional framework, for example through online platforms to seek out participants; while an alternative way is to build a completely new setting. Human organs-on-chips and in silico trials represent the second approach. Researchers of the Wyss Institute have been working on the first strand, human organs-on-chips for years. These microdevices lined by living human cells can mimic the microarchitecture and functions of human organs, and this makes them ideal for replacing clinical testing.  What if these cells could be replaced by software, an artificial intelligence (a virtual body) contained in code? And what if instead of using an actual drug it could be a virtual drug, coded in software.  It sounds like a fantasy, yet so was Google, the internet, and reusable rocket boosters.   Science fiction? Not for long as these futurists predict this evolution.

Certain Phase I studies involve laboratory animals, such as mice.  There is a significant cost to maintaining libraries of genetically altered animals.

No need for lab rats in the future. Source: www.gizmodo.com

We firmly believe that drug development and new therapy experimentation will largely happen through in silico trials in the future, since who would want to test new drugs on animals or humans if we have the possibility to accurately measure the consequences of novel medications or treatment paths virtually. However, we have to mention that regulators will face a new, so far unknown challenge here: they will have to let more and more personalized, cheaper, and more efficient drugs be introduced on the market without being tested on actual humans for years.

Not only clinical trials for new drugs, this also will allow for testing of medical devices, such as cardiac pacemakers in a virtual heart simulation.

FDA Seeks Virtual Heart to Test Medical Devices
By Brandi Vincent,
Staff Correspondent,  Nextgov.com

The Food and Drug Administration is looking for computational software and services modeling the whole human heart to incorporate in a project that aims to evaluate new medical devices and therapies, according to a recently released request for information.

Through an ongoing collaborative project with French software company Dassault Systèmes, the agency hopes to demonstrate how involving computer modeling and simulation, digital evidence and a virtual patient population could potentially speed up the regulatory evaluation and approval processes through which innovative medical solutions go to market.

“We will need a physics-based computational model of a whole human heart, one that includes all critical functions of the heart: electrophysiology, solid mechanics, and fluid dynamics, including all relevant anatomical features (such as ventricles, atria and vessels),” the agency said in the program’s project brief. “The FDA intends to develop a generic medical device that will be virtually implanted in the whole human heart computational model.”

In 2014, FDA initiated its collaboration with Dassault around the company’s simulated 3D heart model, which the duo used to test pacemakers and other cardiovascular devices. Through the new project, researchers will incorporate virtual patients and testing to quicken the pace in which devices are tested and adopted.

“Integration of [virtual patient] data within the clinical trial simplification framework has the power to revolutionize how device companies conduct clinical trials, sustain this paradigm shift, and satisfy patient and provider demands for safety, efficacy and improved access,” the agency said.

Through the trial, researchers will design, manufacture and physically and virtually test a generic medical device on virtual populations and new methods will be created to combine digital evidence from the simulations to physical evidence from real patients. The objective is to receive FDA concurrence on the simulated approach, not to actually obtain approval of the device.

Ultimately, the agency aims to use digital evidence and computer modeling to tackle the delays and costs that hinder patients from trying new treatments.

“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials,” Tina Morrison, deputy director of applied mechanics in the FDA’s Center for Devices and Radiological Health, said in a statement.

Interested vendors that can offer the capability to perform whole human heart computations with virtually implanted devices using high-performance cloud-computing should submit capability statements to the FDA by Aug. 12..















Virtual Bodies For Real Drugs: In Silico Clinical Trials Are The Future | LinkedIn: www.knect365.com

Researchers Push Primary Care Teams to 'Power Up'

 Researchers describe a new model that extends clinician visits to team visits by pairing each physician with highly trained nurses or medical assistants.

The authors of an article published in the July/August issue(www.annfammed.org) of Annals of Family Medicine say there's a reason why. They contend that "primary care teams are underpowered."

"They are underpowered because they do not maximally redistribute team functions," write corresponding author Thomas Bodenheimer M.D., M.P.H., and co-author Christine Sinsky, M.D., vice president of professional satisfaction at the AMA, in an article titled "Powering-Up Primary Care Teams: Advanced Team Care with In-room Support."

However, "a new team model is bubbling up across the country with the potential to reinvigorate primary care," they add.

This new model comes with a bit of twist and has been dubbed "advanced team care with in-room support." The authors explain that in this core team model, each physician is paired with two or three highly trained medical assistants or nurses -- referred to as care team coordinators.

This is not a new or radical concept. It takes place in many hospitals already whereby the physician, floor nurse and any number of allied health professionals 'round' on patients.  With the concurrent use of the electronic health record, it unitizes and bypasses the hierarchy or transmitting orders across the 'chain of command' It markedly reduces the time for delivery of care.

 "This model extends the clinician visit into a team visit," say the authors, with a care team coordinator, beginning the visit by completing a number of tasks, including taking an initial history, reconciling medications, addressing chronic and preventive care gaps, and setting the visit agenda based on patient concerns.

The physician joins the visit after 10-15 minutes, "sits face-to-face with the patient (without the computer dividing her attention)," expands the history and does a focused physical exam. The physician talks with the patient about a diagnosis and a care plan while the care team coordinator types notes and enters documentation into the EHR.

The team coordinator stays with the patient to review the care plan; set up referrals, labs, and follow-up visits; and provide health coaching as indicated.

Meanwhile, the physician moves on to the next patient, where a second team coordinator is already completing the initial tasks.

The Evidence:

That evidence is compelling. For instance, practices report benefits that include increased productivity of as much as 20%, growth in net revenue of 10.5% per encounter, increased capacity to accept new patients, improved blood pressure and diabetes control, improved performance on quality measures, and increased patient and staff satisfaction.

At Bellin Health in northeastern Wisconsin, where the model was piloted in 2014, the authors note that "clinician satisfaction went from 34% without the team model to 88% with the model."

And at the University of Colorado Health System, physician burnout dropped from 56% to 28% just one year after implementing advanced team care with in-room support.

Ripping Away Barriers

Implementing this new model requires a change in mindset that includes redistributing team functions that would "allow clinicians to shed that portion of clinical and administrative work that a well-trained, well-staffed team could easily perform," say the authors.

They discuss the downside of technology and point out that in health care, the EHR "has added rather than subtracted work." Tasks that used to take mere seconds now require minutes, they say, and "work previously done by others has now been shifted to physicians."

The authors say advanced care team with in-room support is all about creating teams in which well-trained support personnel "can assist with the clinical care of patients and assume much of the administrative burden."

"By distancing the EHR from the patient-clinician interaction, technology assumes its rightful supportive role," they add.

Additional Author Thoughts

Bodenheimer, founding director of the Center for Excellence in Primary Care(cepc.ucsf.edu) at the University of California, San Francisco, Department of Family & Community Medicine, told AAFP News that he spent 32 years as a general internist in a low-income San Francisco community. In the following Q&A, he provides additional comment about this article.

Q. Why is this discussion important at this juncture in the U.S. health care system?

A. Family physicians are dealing with large patient panels, frustrating EHRs and exhausting administrative work. The existing model is not sustainable. Physicians need teams with well-trained personnel to take on both clinical and documentation tasks.

Q. What are some of the barriers to widespread adoption of this model?

A. As the commentary argues, there are significant obstacles. First and foremost, the financial leadership of the health system in which the primary care practice is situated must understand that there is a business case for hiring two or more clinical assistants per physician.

Second, there needs to be a physician champion who pilots the new model, adapts it to his or her practice, and then creates and leads a robust training program.

Third, there needs to be an evaluation after the model is in place to determine if the physician and patient satisfaction increases, clinician burnout decreases, quality of care is preserved, and financial performance improves.

Q. Is it possible to get physician buy-in at the individual level?

A. Yes, if a few things go right (and they should): if the burden of EHR documentation is virtually eliminated from the physician's day, if clinical assistants do a good job and quality markers and patient satisfaction go up, if physicians can eliminate the burden of documentation tasks after they've put their kids to bed.  If these things happen, physician burnout will decrease, and I would expect to see almost 100% buy-in because that is what has happened in the practices that piloted the advanced team care with in-room support model. Physicians were begging to start the new model.

Q. What's the most important takeaway for family physicians?

A. It's becoming increasingly hard for family physicians to sustain a primary care practice. This model allows them to focus exclusively on their patients without the interference of EHRs and documentation tasks. Importantly, this model gets physicians out of the clinic earlier and without take-home work.

This study formally illustrates the advantages of Team-Based Care, as promoted by the American Academy of Family Practice

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Researchers Push Primary Care Teams to 'Power Up':

Multiple Hospitals Close in Wake of Fraud Allegations

When it's too good to be true, it probably is.  

I-70 Community Hospital shut its doors in February, taking with it dozens of jobs and lifesaving emergency care for the residents of Sweet Springs, Mo.

Small rural hospitals are always at risk of insolvency and closure.  These communities look to entrepreneurs (usually nonmedical venture capitalists and/or other hospitals to absorb their hospital(s)

It was his "secret sauce," the rotund Miami entrepreneur would smilingly tell people in their no-stoplight towns. The money-making ventures he proposed sounded complicated, sure, but he said they would bring in enough cash to save their hospital and dozens, even hundreds, of good jobs in rural towns where gainful employment is hard to come by.

And, in town after town, the people believed him. He offered what they could not resist: hope, and the promise of survival.

Then a few major health insurance companies got suspicious, as did some government officials. How could Unionville, Mo? — a town of 1,790 — generate $92 million in hospital lab fees for blood and urine samples in just six months? Why had lab billings at a 25-bed hospital in Plymouth, N.C., nearly tripled to $32 million in the year after Perez's company took control?

At the height of his operation, Perez and his Miami-based management company, EmpowerHMS, helped oversee a rural empire encompassing 18 hospitals across eight states. Perez owned or co-owned 11 of those hospitals and was CEO of the companies that provided their management and billing services.  Their website contains the slick marketing quotes of venture capitalists.

Desperate hospitals and desperate communities take desperate measures when a local isolated hospital may close.  "Creative" revenue streams are an opportunistic measure to fund hospitals from sources including Medicare and private insurance companies.

This is not an unusual occurrence and has been seen previously.

The staggering collapse left hundreds of employees without jobs and many more owed months of back pay. Only in recent months did they learn that their medical coverage had been terminated because EmpowerHMS had stopped making payments, according to interviews and bankruptcy documents.

At some of the hospitals, EmpowerHMS stopped paying employee payroll taxes, Perez acknowledged in an interview. Some of the shuttered hospitals owe hundreds of thousands in property taxes, according to local officials.

How companies run by this Miami businessman and his associates were able to drive so many hospitals into the ground so quickly, devastating their communities, is a story about the fragility of health care in rural America and the types of money-making ventures that have flourished in legal gray areas of America's complicated medical system.

The scheme involved laboratory referrals to labs owned by Perez and his partners. It was a convoluted trail of self-referrals to companies owned by Perez.

The analysis found 80% of that money was flowing to laboratory companies, including some in which Byrns had a financial stake; another 6% to a Perez-controlled billing company; and a major portion to 33 out-of-state phlebotomists — blood draw specialists — they had put on the hospital payroll.

I-70 Community Hospital in Sweet Springs, Mo., is one of eight hospitals owned or managed by Miami businessman Jorge A. Perez that closed in recent years. Twelve Perez-affiliated hospitals are in bankruptcy.

"What was astounding to me was that the hospital was not better off during and after this lab activity," Galloway told KHN.

The reaction was explosive. Dozens of major insurers banded together to file lawsuits against Perez-affiliated hospitals in Missouri and other states, demanding hundreds of millions in restitution. The lawsuits, still ongoing, describe the lab-billing operation as a "widespread fraudulent scheme" that aimed to enrich Perez, some of his associates and affiliated companies, as well as participating labs.

The department of justice in Missouri is still investigating, however, the town of Unionville, MO is now without a hospital.  Perhaps it could not be saved.  However, there were other solutions to this challenge.

With the increasing use of health information technology and telemedicine, mobile ambulances and urgent care centers health care could still be present in Unionville, MO.

Multiple Hospitals Close in Wake of Fraud Allegations: Jorge A. Perez and his management company, EmpowerHMS, helped run an empire of rural hospitals. Now, 12 of them have entered bankruptcy and eight have closed their doors. So, what happened?

The Secret of Health Care Prices: Why Transparency Is in the Public Interest - California Health Care Foundation

Katherine L. Gudiksen, University of California Hastings College of the Law
Samuel M. Chang, University of California Hastings College of the Law
Jaime S. King, University of California Hastings College of the Law


In 2018, California lawmakers sought to design and create a state Health Care Cost Transparency Database, an all-payer claims database (APCD), which would collect information on the cost of health care in the state. The law tasks the Office of Statewide Health Planning and Development (OSHPD) with designing a database to best fit the needs.  California’s APCD may collect information about amounts paid for health care services, including data about negotiated rates between insurance plans and providers. Many health care providers and payers seek to maintain the confidentiality of these paid amounts as trade secrets, claiming their secrecy provides a competitive advantage.

There are some issues regarding the public release of health care prices. 

Economists and antitrust enforcers have theorized about how disclosure of negotiated rates in health care markets could facilitate price collusion and drive price increases. To date, however, no US
state with an existing APCD has experienced competitive harm, and, in fact, a decade of public disclosure of negotiated health care rates in New Hampshire resulted
in increased competition and reduced prices for health care services. Although, in some markets, disclosure of negotiated health care rates could theoretically result
in price collusion and increased prices.
  

The Secret of Health Care Prices: Why Transparency Is in the Public Interest (PDF)

Policy Brief — The Secret of Health Care Prices: Why Transparency Is in the Public Interest (PDF)

The Secret of Health Care Prices: Why Transparency Is in the Public Interest - California Health Care Foundation:

Beating the Prior Authorization Blues -- FPM

The Federal budget is impacted by rising health care costs. There are several factors in play.

1.  Due to increased length of life and successes in treating acute and chronic illness our population is aging. The percentage of patients over the age of 65 increases annually due to bursts of immigration, and birth rates as well as innovations of care resulting in lower mortality rates.

2. There are and will be fewer workers paying into Social Security and Medicare, as well as the effects of automation requiring fewer workers.

Medicare (CMS) attempt to control expenses by limiting procedures.  Private insurance does the same via a complex time-consuming process known as prior authorization.

The enclosed video illustrates the process, time-consuming, as well as non-productive work required by clinicians.

Like many family physicians, W. Ryan Neuhofel, DO, has spent his share of time on the phone asking insurers for prior authorization of medications or medical procedures for his patients.

Unlike many physicians, Neuhofel decided to videotape it. The Lawrence, Kan.-based physician recorded a 21-minute call of himself seeking approval for computerized tomography (CT) scan for a patient with a palpable mass on his skull and then posted the video on several social media platforms, where it attracted thousands of views.

Of course, the tactic has real costs for physicians and their practices. One study estimated that primary care physicians spend an average of 3.5 hours a week dealing with insurers, and the entire medical community spends the equivalent of between $23 billion and $31 billion annually in time on insurance matters, including prior authorization.1

Prior authorization can also negatively affect the quality of care. According to an American Medical Association survey, two-thirds of physicians said they waited at least a few days for preauthorization on tests, procedures, or medications, and between 10 percent and 13 percent said they waited for more than a week.  Insurers and other payers have long used prior authorization as a valuable tool. Lydia Bartholomew, MD, of Edmonds, Wash., is a medical director for a national insurer and a member of the American Academy of Family Physician's (AAFP's) Commission on Quality and Practice. She said insurers require prior authorization to confirm that the treatment prescribed by the physician is covered by the patient's health plan and is the most appropriate care in the best setting. This helps insurers control health care costs by reducing duplication, waste, and unnecessary treatments, as well as identifying patients who might benefit from case management services, she said.

Whether insurers are increasingly requiring prior authorization is difficult to assess. Anthony Akosa, MD, MBA, chief medical officer of HealthEC, which advises accountable care organizations and other large provider groups, believes insurers are reining in their prior authorization requirements to some degree. They are responding to customer frustration over delays or denials of medical treatment, he said. However, growth in high-deductible health plans, which tend to have more coverage limitations, might be contributing to a perception that prior authorization requirements are increasing when in fact more services are being denied for lack of coverage, he said.










Beating the Prior Authorization Blues -- FPM: Getting insurer approval for treatment can take hours out of your week. Here are some ways to reduce the pain.

The New West: Smoke In The Sky, A Purifier At Home | California Healthline

If you live in the West an air purifier should be on your 'must-have' list.  During a wildfire, you may see smoke, but even if you don't see it, you are still at risk.  Amid forecasts for increasingly unhealthy air due to wildfire smoke, residents in Western states are snatching up home air purifiers. With good reason.

Downtown San Francisco was obscured by smoke from the Camp Fire burning about 90 miles north of Sacramento on Nov. 16, 2018

An announcement in California HealthLine 

By Mark Kreidler
August 6, 2019


When the Camp Fire began to rage in Paradise, Calif., last November, the owners of the family-run Collier Hardware store in nearby Chico faced a situation unlike any they’d seen.

A business that might welcome 200 customers on an average day, Collier was suddenly dealing with five times that number — “and they all wanted the same thing,” co-owner Steve Lucena said.

Alarmed by dense smoke, shoppers were snapping up portable air purifiers and breathing masks in staggering numbers. Collier Hardware sold nearly 60,000 adult-sized masks in a couple of weeks, and gave away thousands more that were specially designed for children.

“With the purifiers, we had multiple people unloading them from the truck, and they were sold before we could get them all the way into the store,” Lucena said. “People didn’t care what model it was or how much it cost. We’d normally sell four to six in a year, and we sold 100 in a day.”

Sales of portable air purifiers in California alone are expected to rise dramatically over the next few years, from roughly 469,000 units in 2017 to a predicted 720,000 in 2023, according to a study by TechSci Research presented at a recent meeting of the California Air Resources Board.

Across the country, annual sales of home air filters are expected to cross $1 billion by 2023, according to a report by Research and Markets.

“Interest in effective air purification has significantly risen in recent years due to wildfires,” said Jaya Rao, chief operating officer and co-founder of Molekule, a maker of a $799 purifier. Sales of the unit have doubled each year since it debuted in 2017, Rao said.

Researchers from Harvard and Yale in 2016 produced a list of more than 300 counties throughout the West that will be at the greatest risk of dangerous pollution in the coming decades due to “smoke waves” emanating from increasingly intense wildfires. Among the most vulnerable are heavily populated areas such as San Francisco, Alameda and Contra Costa counties in Northern California, and King County in Washington.

Wildfire smoke is dangerous because of its concentration of noxious fine particles, which measure 2.5 micrometers or less (a human hair, by comparison, measures 70 micrometers) and which, unlike common dust, can be inhaled into the deepest recesses of the lung.

In addition to eye and respiratory tract irritation, this particulate matter — PM2.5 in scientific shorthand — can exacerbate heart and lung issues, including asthma and chronic obstructive pulmonary disease (COPD), and may lead to premature death. Children, older people and those with respiratory illnesses are, particularly at risk.

While much is still unknown about the long-term effects of exposure to wildfire smoke, the microscopic particles are regulated as an air pollutant. A study published last year in the journal GeoHealth found that the number of deaths linked to the inhalation of wildfire smoke in the U.S. could double by the end of the century, to nearly 40,000 per year.

Air purifiers essentially function as scrubbers, removing bacteria, viruses, and PM2.5 as the air passes through them. The air resources board recommends its use to limit the effects of wildfire smoke in the home. It maintains a list of devices approved for use in California.

AIR PURIFIER RATINGS, PERFORMANCE, AND VALUE

Portable air-cleaning units were once considered specialty purchases, but sales-driven competition has flooded the market, forcing prices down. Where a high-end portable purifier might cost $800 or more, several models now cost less than $100. Shoppers can find models with well-known consumer appliance names like Dyson, Hunter, Honeywell, and Whirlpool as well as scores of more obscure manufacturers. Several websites have attempted to evaluate air purifiers, including the size of the room they can effectively clean.

















The New West: Smoke In The Sky, A Purifier At Home | California Healthline:

First Black Female AMA President Talks Policy, Health Equity | Chicago News | WTTW

The Chicago-based American Medical Association is the country’s largest association of doctors and medical students. Now, for the first time ever, the organization has an African American woman as its president.

Dr. Patrice Harris, a psychiatrist from Atlanta, was inaugurated in June to the yearlong position. And while the AMA doesn’t represent all U.S. doctors, the organization is an influential advocacy group for a wide range of issues across the health and medical industries.

Looking ahead to her priorities over the next year, Harris says she hopes “to elevate the importance of mental health into overall health care, to elevate the importance of health equity, and making sure we have a diverse physician workforce … we need to work toward the faces of physicians matching the faces of our patients.”

As a lobbying group, the AMA has had an active presence in the health care debate, staunchly supporting the Affordable Care Act since it was passed under President Barack Obama in 2010.

The group has also held a longstanding opposition to single payer health care. But at its June meeting, the AMA House of Delegates only narrowly voted down a motion to overturn that policy.

“Certainly in our huge House of Delegates, you have a wide range of opinions, all towards getting to coverage for everyone,” Harris said. “But at the end of the day, after the debate, there’s a vote, and the vote this year has been to maintain our current policy.”

The AMA also recently waded into the abortion debate, filing a lawsuit earlier this month to block two laws in North Dakota the association says threaten the underlying trust between doctors and their patients.

The laws, Harris said, “compel physicians to provide information that is false, and misleading, and not science-based. And so that would be a violation of our duty to our patients … it is our obligation to give patients accurate information, and that is why we filed that lawsuit.”

Another issue Harris is prioritizing is health equity. That comes as a recent study in Chicago found a 30-year life expectancy gap between residents of the affluent Streeterville neighborhood and the low-income Englewood neighborhood on the South Side.

Harris says discrepancies like this aren’t just about access to doctors and hospitals.

“It is about your physical environment, whether you have access to healthy, nutritious foods. Even looking at some of the more structural policies in place, such as past discrimination and racism, all of those impact a person’s health, and that’s why you see those differences in zip code,” she said.

This comes at a time when diversity is a major challenge as well as a goal in all businesses.











First Black Female AMA President Talks Policy, Health Equity | Chicago News | WTTW: Meet Dr. Patrice Harris, the new leader of the Chicago-based American Medical Association, the country’s largest association of doctors and medical students.

This spray-on nanofiber 'skin' may revolutionize wound care

Imagine if bandaging looked a little more like, well, a water gun?

Shaped like a gun, Nanomedic’s SpinCare device emits a web of electrospun polymer nanofabric that stays put for weeks—no dressing changes required.

Israeli startup Nicast, has invented a new mechanical contraption to treat burns, wounds, and surgical injuries by mimicking human tissue. Shaped like a children’s toy, the lightweight SpinCare emits a proprietary nanofiber “second skin” that completely covers the area that needs to heal.

All one needs to do is aim, squeeze the two triggers, and fire off an electrospun polymer material that attaches to the skin.

The Nanomedic spray method avoids any need to come into direct contact with the wound. In that sense, it completely sidesteps painful routine bandage dressings. The transient skin then fully develops into a secure physical barrier with tough adherence. Once new skin is regenerated, usually between two to three weeks (depending on the individual’s heal time), the layer naturally peels off.

“You don’t replace it,” explains Nanomedic CEO Dr. Chen Barak. “You put it only once—on the day of application—and it remains there until it feels the new layer of skin healed.”

The SpinCare holds single-use ampoules containing Nanomedic’s polymer formulation. Once the capsule is firmly in place, one activates the device roughly eight inches towards the wound. Pressing the trigger activates the electron-spinning process, which sprays a web-like a layer of nanofibers directly on the wound.

The solution adjusts to the morphology of the wound, thereby creating a transient skin layer that imitates the skin structure’s human tissue. It’s a transparent, protective film that then allows the patient and doctor to monitor progress. Once the wound has healed and developed a new layer of skin, the SpinCare “bandage” falls off on its own.

The Nanomedic spray method avoids any need to come into direct contact with the wound. In that sense, it completely sidesteps painful routine bandage dressings. The transient skin then fully develops into a secure physical barrier with tough adherence. Once new skin is regenerated, usually between two to three weeks (depending on the individual’s heal time), the layer naturally peels off.

“You don’t replace it,” explains Nanomedic CEO Dr. Chen Barak. “You put it only once—on the day of application—and it remains there until it feels the new layer of skin healed.”

The product is already being tested in hospitals. In the coming year, following FDA clearance, Nanomedic plans to expand to emergency rooms, ambulances, military use, and disaster relief response like fire truck companies. 




This spray-on nanofiber 'skin' may revolutionize wound care

Evaluation of a Remote Diagnosis Imaging Model vs Dilated Eye Examination in Detecting Macular Degeneration | Diabetic Retinopathy | JAMA Ophthalmology | JAMA Network

ADVANCES IN MEDICINE

JUST WHAT THE DOCTOR ORDERED:
IMPROVING PATIENT CARE WITH AI

Artificial Intelligence is transforming the world of medicine. AI can help doctors make faster, more accurate diagnoses. It can predict the risk of a disease in time to prevent it. It can help researchers understand how genetic variations lead to disease.

Although AI has been around for decades, new advances have ignited a boom in deep learning. The AI technique powers self-driving cars, super-human image recognition, and life-changing—even life-saving—advances in medicine.

Deep learning helps researchers analyze medical data to treat diseases. It enhances doctors’ ability to analyze medical images. It’s advancing the future of personalized medicine. It even helps the blind “see.”

“Deep learning is revolutionizing a wide range of scientific fields,” said Jensen Huang, NVIDIA CEO and co-founder. “There could be no more important application of this new capability than improving patient care.”

Three trends drive the deep learning revolution: more powerful GPUs, sophisticated neural network algorithms modeled on the human brain, and access to the explosion of data from the internet (see “Accelerating AI with GPUs: A New Computing Model”)

Community Medicine is a term used to describe medical conditions in a large population setting. It often involves the screening of large groups to select those with disease and provide appropriate treatment to avoid further complications.  This involves an examination of large groups of patients. Often more than 100 persons will be examined with a positive finding of less than five in one hundred examinations.  This is a massive undertaking when screening perhaps as much as 1000 or more persons. It is often not cost effective. 

However, the development of image analysis, high-speed computing power, and deep learning machines can be trained to accomplish this task. Algorithms can be developed to digitize images (x-rays, CT scans, and photographs.

Artificial intelligence or machine learning is bringing a new powerful tool for rapid interpretation of medical images, such as chest x-rays, retinal fundus photography, and scans.  Images of the skin can be analyzed for suspicious moles to rule out malignant melanoma rapidly.   As the science matures there are sure to be significant cost savings as well as time. 

Machine learning is dependent upon large data stores, and accuracy improves as images are added and curated by human beings (physicians).  It is doubtful if AI will ever stand alone without human oversight.  

A study of retinal fundus evaluation (as reported JAMA) using machine learning showed
Remote diagnosis imaging and a standard examination by a retinal specialist appeared equivalent in identifying referable macular degeneration in patients with high disease prevalence; these results may assist in delivering timely treatment and seem to warrant future research into additional metrics.

The study has shown equivalency in diagnosing age-related macular degeneration using ocular coherence tomography. 

The use of deep learning has also been applied in dermatology to screen for malignant melanoma or other skin malignancy.

As radiology is inherently a data-driven specialty, it is especially conducive to utilizing data processing techniques. One such technique, deep learning (DL), has become a remarkably powerful tool for image processing in recent years. In this work, the Association of University Radiologists Radiology Research Alliance Task Force on Deep Learning provides an overview of DL for the radiologist. This article aims to present an overview of DL in a manner that is understandable to radiologists; to examine past, present, and future applications; as well as to evaluate how radiologists may benefit from this remarkable new tool. We describe several areas within radiology in which DL techniques are having the most significant impact: lesion or disease detection, classification, quantification, and segmentation. 

Some are concerned that AI, or deep learning may replace human radiologists, however, this is unlikely to occur.  But deep learning won’t be replacing radiologists anytime soon, Bratt explained, and one key reason for this is that deep neural networks (DNNs) are naturally limited by “the size and shape of the inputs they can accept.” But deep learning won’t be replacing radiologists anytime soon, Bratt explained, and one key reason for this is that deep neural networks (DNNs) are naturally limited by “the size and shape of the inputs they can accept.” A DNN can help with straightforward tasks reliant on a few images—bone age assessments, for instance, but they become less useful as the goal grows more and more complex. This limitation, Bratt explained, is related to the concept of long-term dependencies.  Another issue related to DNNs is how easily they can fall apart when introduced to small changes. A DNN can be working perfectly after being trained on one institution’s dataset, for instance, but its performance suffers when it is introduced to new data from a new institution.

“This again reflects the fact that ostensibly trivial, even imperceptible, changes in input can cause catastrophic failure of DNNs, which limits the viability of these models in real-world mission-critical settings such as clinical medicine,” Bratt wrote.

In addition to evaluating images, DNN can be applied to other tasks.

MINING MEDICAL DATA FOR BETTER, QUICKER TREATMENT

Medical records such as doctors' reports, test results and medical images are a gold mine of health information. Using GPU-accelerated deep learning to process and study a patient's condition over time and to compare one patient against a larger population could help doctors provide better treatments.

BETTER, FASTER DIAGNOSES


Medical images such as MRIs, CT scans, and X-rays are among the most important tools doctors use in diagnosing conditions ranging from spine injuries to heart disease to cancer. However, analyzing medical images can often be a difficult and time-consuming process.

Researchers and startups are using GPU-accelerated deep learning to automate analysis and increase the accuracy of diagnosticians:

Imperial College London researchers hope to provide automated, image-based assessments of traumatic brain injuries at speeds other systems can't match.
Behold.ai is a New York startup working to reduce the number of incorrect diagnoses by making it easier for healthcare practitioners to identify diseases from ordinary radiology image data.
Arterys, a San Francisco-based startup, provides technology to visualize and quantify heart flow in the body using an MRI machine. The goal is to help speed diagnosis.
San Francisco startup Enlitic analyzes medical images to identify tumors, nearly invisible fractures, and other medical conditions.

GENOMICS FOR PERSONALIZED MEDICINE

Genomics data is accumulating in unprecedented quantities, giving scientists the ability to study how genetic factors such as mutations lead to disease. Deep learning could one day lead to what’s known as personalized or “precision” medicine, with treatments tailored to a patient’s genomic makeup.

Although much of the research is still in its early stages, two promising projects are:

A University of Toronto team is advancing computational cancer research by developing a GPU-powered “genetic interpretation engine” that would more quickly identify cancer-causing mutations for individual patients.
Deep Genomics, a Toronto startup, is applying GPU-based deep learning to understand how genetic variations lead to disease, transforming personalized medicine and therapies.

DEEP LEARNING TO AID BLIND PEOPLE

Nearly 300 million people worldwide struggle to manage such tasks as crossing the road, reading a product label, or identifying a face because they’re blind or visually impaired. Deep learning is beginning to change that.

Horus Technology, the winner of NVIDIA’s first social innovation award at the 2016 Emerging Companies Summit, is developing a wearable device that uses deep learning, computer vision, and GPUs to understand the world and describe it to users.

One of the early testers wept after trying the headset-like device, recalled Saverio Murgia, Horus CEO, and co-founder. “When you see people get emotional about your product, you realize it’s going to change people’s lives.”

Further DNN utilizes optical diffractive circuits in lieu of electrons

The setup uses 3D-printed translucent sheets, each with thousands of raised pixels, which deflect light through each panel in order to perform set tasks. By the way, these tasks are performed without the use of any power, except for the input light beam.

The UCLA team's all-optical deep neural network – which looks like the guts of a solid gold car battery – literally operates at the speed of light and will find applications in image analysis, feature detection, and object classification. Researchers on the team also envisage possibilities for D2NN architectures performing specialized tasks in cameras. Perhaps your next DSLR might identify your subjects on the fly and post the tagged image to your Facebook timeline.  For now, though, this is a proof of concept, but it shines a light on some unique opportunities for the machine learning industry.










Dewinner of NVIDIA’s first social innovation award at the 2016 Emerging Companies Summit, is developing a wearable device that uses deep learning, computer vision, and GPUs to understand the world and describe it to users.

One of the early testers wept after trying the headset-like device, recalled Saverio Murgia, Horus CEO and co-founder. “When you see people get emotional about your product, you realize it’s going to change people’s lives.”


Evaluation of a Remote Diagnosis Imaging Model vs Dilated Eye Examination in Referable Macular Degeneration | Diabetic Retinopathy | JAMA Ophthalmology | JAMA Network: This study evaluates a retinal diagnostic device and compares its utility and outcomes with those of traditional eye examinations by retinal specialists for patients with potential retinal damage from diabetic retinopathy and age-related macular degeneration.

Opioid Prescriptions Drop Sharply Among State Workers

The recent efforts by the CDC and public media have initiated important advances in the crusade against opioid addiction.

The agency that manages health care for California’s massive state workforce is reporting a major reduction in opioid prescriptions, reflecting a national trend of physicians cutting back on the addictive drugs.

Insurance claims for opioids, which are prescribed to help people manage pain, decreased almost 19% in a single year among the 1.5 million Californians served by the California Public Employees’ Retirement System. CalPERS manages health benefits for employees and retirees of state and local agencies and public schools and their families. CalPERS is the second-largest public purchaser of health benefits in the nation after the federal government, and medical trends among its members are often reflected nationally.
Most notably, doctors reduced the daily dose and duration of opioid treatment: The number of new users who were prescribed large doses dropped 85% in the first half of 2018 compared with the same period in 2017, while new users prescribed more than a week’s supply dropped 73%, according to new CalPERS data.

The CalPERS data represents a cross-section of patients throughout California who are enrolled in Blue Shield, Kaiser Permanente, Anthem Blue Cross and other health plans.

This rapid change in prescribing habits indicates how quickly physicians reacted to the data as furnished by DEA and other regulatory bodies.

“These reductions are substantial,” said Beth McGinty, an associate professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. “They signal a reduction in the overprescribing practices that have driven the opioid epidemic in the U.S.”

Indeed, the data showing a decline in opioid prescriptions among CalPERS members mirrors a nationwide drop that has been reported in all 50 states.

About 22% fewer opioid prescriptions were written in the United States from 2013 to 2017, dropping from 251.8 million to 196 million, according to the American Medical Association, the nation’s largest physician group.

A March study by researchers at the federal government’s Centers for Disease Control and Prevention revealed a 13% decline in average opioids prescribed per person from 2016 to 2017. Maine, Massachusetts and North Dakota have experienced the biggest drops over the past decade.

One major factor is that many health insurers have imposed limits on prescriptions, as recommended by the CDC in 2016. The CDC advises doctors to prescribe new users no more than a seven-day supply and to keep daily doses under the equivalent of 50 morphine milligrams in an effort to prevent overdoses and new addictions.

In addition, the AMA created a task force in 2014 that has encouraged doctors to “start low and go slow” and use the drugs only if the benefits exceed the risks for a patient. The association also is offering doctors education programs on pain management.

Pain management courses are being emphasized in medical school curricula, as well as continuing medical education courses.

“These are very positive numbers,” said Kathy Donneson, chief of CalPERS’ Health Plan Administration Division. “But we’re all going to keep working on it. Opioids are still a national crisis.”

Declines in prescriptions have not yet led to reductions in deaths, said Dr. Patrice Harris, president-elect of the AMA and chair of its Opioid Task Force. “Reducing opioid prescriptions is important but will not by itself reverse the epidemic,” she said. “We will 

Medical experts also warned of unintended consequences of fewer opioid prescriptions: More people may suffer unmanaged chronic pain, and some may resort to illegal opioids, such as heroin or street versions of fentanyl. About 50 million Americans experience chronic pain.

“The focus on reducing opioid prescribing has likely left a large void in access to pain care,” Harris said.

Even as insurers set limits on opioids, they have not increased access to other pain care options, she said. “If policymakers solely focus on limiting access to prescription opioids for pain relief without increasing non-opioid options, the result will be increased patient suffering.”
















http://tinyurl.com/yxbh4xkl

Say Bye-bye to Aspirin: The Remarkable Story of a Wonder Drug

The Remarkable Story of a Wonder Drug, Which Now Comes to an End in the Primary Prevention Setting: Say Bye-bye to Aspirin!

Aspirin is to date the most used drug worldwide and, in 2018, with some dispute about its real birth date, celebrated its 121st birthday; 2018 will most probably be remembered as the year when aspirin came of age, whereby multiple studies re-examined, and at least partially questioned, its risk/benefit ratio in various clinical settings.[1–4] While aspirin remains the cornerstone treatment for secondary prevention in patients with established cardiovascular disorders, three large, independent, and high quality randomized controlled trials have shed new light on aspirin in primary prevention.[2–4] These recent results now have to be incorporated within the context of previously existing evidence, which altogether questions the somewhat liberal use of aspirin that has so far been recommended by some,[5] but not by other, guidelines committees.[6]

The advent of the digital age, data analytics, and meta-analytic have exposed many accepted theories and treatments invalid.

Say Bye-bye to Aspirin: The Remarkable Story of a Wonder Drug:

Nurses are striking. Where are the physicians?

Strikes are not in the DNA of physicians.

In March, members of the New York State Nurses Association (NYSNA) at New York’s “big four” hospitals (Montefiore, Mount Sinai, New York Presbyterian-Columbia and Mount Sinai West/St. Luke’s) voted by an overwhelming 97% margin to authorize a strike. The nurses’ fight centers around conditions for patient care, including safer staffing ratios inside hospitals so that nurses can adequately care for each patient. Throughout NYC, nurses are forced to work long shifts and are chronically understaffed. The nurses who recently threatened to strike recognize that these working conditions are part of hospital executives’ push to squeeze greater and greater profits out of workers at the expense of patient health — and they have had enough. New York nurses are fighting just as teachers across the country did earlier this year — including the tens of thousands of Los Angeles teachers who struck last January for better conditions for in schools. They are also taking up the example of health care workers around the world, including the 40,000 Irish nurses who recently struck. Nurses are recognizing they have the power to fight and win better patient care. But while nurses across New York are standing up for themselves and their patients, a big question remains: Where are the doctors and why are they not threatening to strike together with nurses?

Why are the physicians on the sidelines?

Strikes are not in the DNA of physicians.

Physicians see first hand every day how our dysfunctional health care system is simply not built to adequately address patient and community health. For many doctors, these frustrations manifest in burnout and dissatisfaction within a field they once loved. Today there is an epidemic of burnout among physicians, with some studies suggesting burnout affects up to half of all physicians. After training for years with the desire to help others, doctors come to experience medical system that values profit over all else and rarely gives them the tools to make a difference in the communities where they work. This can leave doctors feeling hopeless, and combined with other factors, can lead to depression or even suicide. Today physicians are committing suicide at two times the rate of the population as a whole. Yet, even at this moment of frustration and anger, they continue to keep their heads down, providing validity to this broken system. We see nowhere, among doctors, a resistance like that now being organized by nurses.

Strikes are not in the DNA of physicians.

In order to analyze why doctors are not throwing down their stethoscopes and finally saying enough is enough, a review of the U.S. medical education process is in order. As longtime public educator John Taylor Gatto highlights in his book, “The Underground History of American Education,” the education system is built to create “tools for industry.” Gatto points out that this system conditions those who pass through it to take direction well and to not question authority. At the same time, education aims to instill the importance of profit and continually reinforces the legitimacy of the capitalist system. Health care education is not excluded from this, and both patient and community health remains secondary to profit maximization nonetheless.

Strikes are not in the DNA of physicians.

Physicians have seen themselves as managers in the past...the head of the team, executives, leaders.  Leaders do not strike.  Only until recently have physicians seen their management roles go away, and not by choice, rather by economic penalties and/or perverse incentives. Within the hospital, doctors typically adopt an individualist mentality in which they consider only how they can personally make an impact on their patients’ health while ignoring the need for systemic change. Until physicians begin to put individual endeavors aside and begin to organize collectively, they will continue to see their patients harmed by the "health care" system. though it is important to note, physician control is ever decreasing as health care becomes more corporatized.

If a physician ever thinks of organizing collectively to withhold his/her labor in order to demand better conditions for her patients, employers declare that doctors are “abandoning” those in need of care. The Hippocratic oath taken by physicians to “do no harm” is cited. This argument obviously disregards the fact that it is the employer and ownership class which is directly harming patients every day in pursuit of profit— denying care, pushing individuals into bankruptcy, pursuing unnecessary treatments, neglecting systemic causes of illness, etc. It also ignores the fact that by continuing to focus the treatment on narrow individualistic explanations for disease and illness, the physician helps to redirect the patient’s attention away from the larger issues that are truly causing his or her suffering. Physicians may consider abandonment as an issue, so too will attorneys who would have the legal means to defend innocent patients, which has been accomplished many times.  It is considered prima facie evidence for medical malpractice

Strikes are not in the DNA of physicians.

Physicians around the world have organized and withheld their labor for better conditions around patient care in the past. 

Strikes by physicians: a historical perspective toward an ethical evaluation.

It is an issue for moral and ethical reasons, for physicians and is a conundrum for most physicians.

Recent strikes in other countries indicate the real dangers to patients and the public in general.

List of health and medical strikes in the past

In the past doctors and/or nurses have threatened strikes over inferior patient care due to understaffing and other hospital issues.  Rarely has it revolved around pay.

Michael Pappas is a family medicine resident. This article originally appeared in Left Voice.

Nurses are striking. Where are the physicians?: Until physicians begin to put individual endeavors aside and begin to organize collectively, they will continue to see their patients harmed by the "health care" system.