J&J postpones medical device review

Citing COVID-19 disruptions, Johnson & Johnson (NYSE:JNJ) has decided to reschedule its May 13 Medical Device Review. It says it will closely monitor the situation and follow guidance from health authorities to determine a new date.
https://seekingalpha.com/news/3557541-j-and-j-postpones-medical-device-review

COVID-19 Slows Drug Studies, Curbs Clinical Trials

When patients with terminal diagnoses run out of hope, they often turn to clinical trials for one more “Hail Mary pass” at a successful treatment or cure.
Many in this situation have been extremely anxious over the last few weeks, with COVID-19 fears on top of the anxiety of having a fatal illness. Then they began to worry that their clinical trial would be canceled.
The good news is that most companies and researchers seem to be continuing trials for life-threatening conditions. The bad news: Most studies not considered critical are being deferred. This won’t have much effect in the short term, but if this continues, it could delay patient care and the federal approval of drugs that treat a wide range of conditions.
At Dana-Farber Cancer Institute in Boston, roughly 10% to 20% of patients are taking part in clinical trials at any one time.
“We consider the treatment through clinical trials as part of the therapy, and oftentimes, it is the best therapy for people with cancer,” says Bruce Johnson, MD, chief clinical research officer for the Harvard-affiliated institute.
He says patients will continue to be placed on trials as long as Dana-Farber has enough of the drug being tested, the patient can travel as needed for treatment and checkups, their doctor can monitor them for side effects, and there are enough healthy doctors and nurses to provide that care.
“I registered someone yesterday,” Johnson says. “We haven’t taken anybody off a study because of problems so far.”
The institute has shut down studies that don’t involve treatments that could be life-saving. And it’s too soon to tell, Johnson says, whether fewer patients are volunteering for clinical trials. “We’re looking at this multiple times a week to make sure we can continue to do this safely,” he says. “This information is unfolding by the day.”

Major Drug Companies React

Like many companies, Eli Lilly, of Indianapolis, recently announced it would delay the start of most new studies, pause enrollment in most ongoing studies, but continue clinical trials for patients who are already enrolled.
Biogen is “continuing the clinical trials we have underway in sites across the globe,” according to an email from a spokesperson. “We are monitoring this dynamic situation closely and expect that COVID-19 precautions may impact the timeline of some of our trials, particularly those that are actively enrolling and monitoring patients.”
Other companies have similar policies, with most delaying recruiting into new or ongoing trials — to avoid putting any burden on health care facilities and doctors during the pandemic. At Pfizer, for instance, studies for patients with life-threatening conditions will continue, the company told Reuters. Bristol Myers Squibb has said that it will not start any new trials or add trial sites until at least April 13, though it will continue most research trials that have already begun meeting with patients.

Testing Returns to China

The best place in the world for clinical research right now appears to be China.
COVID-19 apparently originated from a market in Wuhan, China, that sold meat from wild animals, including the pangolin, a scaly creature resembling an anteater. The virus exploded from there, infecting more than 80,000 people in China, mostly in the province that includes Wuhan, but also in other hot spots across China, before taking off across the world. But China, as well as other Asian countries, have been largely successful at bringing their epidemics under control over the last month.
Now, companies like Swiss pharmaceutical giant Novartis are seeing Asia as a place to do clinical trials.
“Through the end of February, we were actually rotating and moving patients away from China and looking at moving those patients in terms of recruitment to Europe and the U.S.,” says John Tsai, head of global drug development and chief medical officer at Novartis. Now, the company is rotating its clinical trial recruiting back to Asia and China; Pfizer and Merck also said they are resuming research trials in Asia.
“I won’t say we’ve not been impacted by COVID-19, but what it has allowed us to do,” he says, “is we’ve been able to come up with contingency plans of how we’d actually make changes along the way.”
About 240 of the company’s 30,000 drug trials were affected as of March 22, “which is not in the grand scheme of things that significant,” Tsai says. Similarly, only 645 people out of 93,000 taking part in trials worldwide had missed safety check-ins, he says.

Turning to Tech

The company has a digital platform that allows Tsai and other company executives to see the status of their trials and patients in real time. If they notice that new recruits are backing out of appointments in one area, they can quickly shift recruitment elsewhere, he says.
Novartis has also moved to at-home care and monitoring wherever appropriate, Tsai says.  Quick check-ins can be done by video chat or phone; medication can be shipped to homes, instead of doled out by nurses.
In Wuhan during the worst of the outbreak, for instance, Novartis was able to continue a trial of the breast cancer drug Kisqali (ribociclib). The company tracked down participants’ home addresses through their databases and used couriers to get them their drugs within a week, “so we wouldn’t have any drug interruptions,” Tsai says.
He says he sees the crisis as an opportunity for those who do clinical trials to streamline the process. Novartis is now helping the Gates Foundation set up a similar electronic system for its ongoing trials.
“I think this has been a really good learning case for the entire industry,” Tsai says.
https://www.medscape.com/viewarticle/927887#vp_1

FCC chief unveils $200M program to boost telehealth services amid COVID-19

Federal Communications Commission (FCC) Chairman Ajit Pai wants to use $200 million from the economic stimulus package to expand telehealth services across the country.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, passed by Congress and signed into law by President Donald Trump last week, earmarks the funds for the FCC to help healthcare providers offering telehealth.
The COVID-19 Telehealth Program, which Pai proposed as a draft order Monday, would have to be approved by the commission before launching.

Pai said the program will provide immediate support to healthcare providers using virtual care in combating the COVID-19 pandemic.
“As we self-isolate and engage in social distancing during the COVID-19 pandemic, telehealth will continue to become more and more important across the country. Our nation’s health care providers are under incredible and still increasing, strain as they fight the pandemic,” Pai said in a press release.
If adopted by the commission, the program would offer qualified healthcare providers full funding to buy “telecommunications services, information services and devices necessary to enable the provision of telehealth services during this emergency period.”

The use of telehealth services is surging as the coronavirus outbreak expands across the country. Private companies like Teladoc and Amwell have reported massive spikes in visit volume. Teladoc is averaging 15,000 patient visits a day in the U.S., 50% higher than in February. Amwell has seen a 350% increase from the normal expected volume of calls this time of year.
Many hospitals and physician practices are ramping up their own telehealth services to continue caring for patients while limiting exposure to the virus from face-to-face patient encounters.
The new  COVID-19 Telehealth Program won’t benefit for-profit hospitals, according to Chip Kahn, president and CEO of the Federation of American Hospitals.
In a tweet, Khan said Pai’s proposed program “leaves millions of patients without access to vital telehealth.”
Pai also circulated final rules for a pilot program that would steer $100 million of its universal service funds over three years toward providers to help cover telehealth costs,
The Connected Care Pilot Program, proposed in 2018, is a broader, longer-term initiative to support telehealth and remote patient monitoring services to improve healthcare access to underserved populations.
In July 2019, FCC commissioners voted to adopt a notice of proposed rule-making (PDF) calling for public comment on testing the new program.
Pai proposed final rules for the Connected Care Pilot Program on Monday to move that initiative forward. He said the program could be a broader study on how connected care can be permanently integrated into the universal service fund.
The CARES Act, passed by Congress and signed into law by Trump last week, also includes many provisions to lift barriers for providing telehealth services and relaxed guidelines for Medicare coverage.
The $2 trillion relief package loosened many restrictions which paved the way for the Centers for Medicare and Medicaid Services to announce Monday that it will begin paying physicians for virtual visits that take place by audio telephone only.
Under the law, Federally Qualified Health Centers and rural health clinics can serve as distant sites for telehealth during the COVID-19 emergency period.

The CARES Act also provides $14.4 billion to support increased demand for healthcare services at Department of Veterans Affairs facilities and through telehealth, including the purchase of medical equipment and supplies, testing kits and personal protective equipment.
The law helps eliminate barriers to full-scale adoption and will provide much needed support to healthcare providers who are migrating patients to virtual care platforms to reduce exposure to COVID-19, Ann Mond Johnson, CEO of the American Telemedicine Association (ATA), said.
“We believe the bill reflects the scale of challenges we face as a country and recognizes that expanding virtual care is necessary to defeat COVID-19,” Johnson said. “We commend Congress for recognizing the power of telehealth, and the bipartisan effort to lift telehealth barriers in the Medicare program while prioritizing federal funding for telehealth access and infrastructure during this emergency.”
The ATA offers a summary of key telehealth provisions in the CARES Act on its website.
https://www.fiercehealthcare.com/tech/fcc-chief-unveils-200m-program-to-boost-telehealth-services-amid-covid-outbreak-0

HCA CEO donates salary to employee aid fund as hospital system cuts hours

The CEO of major hospital system HCA Healthcare announced he will donate the next two months of salary to a fund to help system workers struggling with reduced hours during the COVID-19 pandemic.
The senior leadership team of the system also will take a 30% cut in pay for the duration of the pandemic, CEO Sam Hazel announced in a letter to employees Tuesday.
He added the board has waived cash compensation for the rest of the year.

The decision comes as some hospital systems across the country are reducing hours or furloughing workers due to low patient volumes and a lack of revenue from elective procedures that have been canceled.
HCA Healthcare, which has 184 hospitals, has had to reduce hours for employees.
“Many of our outpatient facilities, clinics and departments have closed,” Hazel wrote.

Any employee that can’t be redeployed can be eligible for a pandemic pay program that continues paying 70% of their base salary for up to seven weeks.
“This is not a furlough,” Hazel said. “Instead, it is a pay continuation program to assist colleagues until we better understand the long-term implications of this pandemic on the organization.”
He added that the patient volume declines are likely temporary and that “we hope we can return to taking care of more patients sometime in May, which should lead to scheduling work for you.”
The HCA Healthcare Hope Fund helps with financial needs and also has counseling services.
https://www.fiercehealthcare.com/hospitals-health-systems/hca-s-ceo-donates-salary-to-employee-assistance-fund-as-hospital-system

Feds offer advice to providers on how to split use of ventilators

The Trump administration offered guidance to providers on how to properly split a ventilator to serve two patients at once but cautioned the modification should only be used as an “absolute last resort.”
The U.S. Public Health Service Corps sent out guidance and technical documents to providers Tuesday on how to split ventilators as well as a guide on the anticipated problems a hospital could face employing the strategy.
A lack of ventilators has been a major issue for providers as the number of COVID-19 cases has surged throughout the country, threatening to overwhelm many systems. Some hospitals and experts have floated the idea of having one ventilator take on two patients in order to shore up capacity, but the practice is controversial.

The administration cautioned that splitting ventilators should only be used as an “absolute last resort.”
“These decisions must be made on an individual institution, care-provider and patient level,” the guidance said. “However, we do know that many institutions are evaluating this practice and protocols are being developed and tested, and some places, preliminarily implemented.”
The guidance includes a statement by the Centers for Disease Control and Prevention that the infection control implications for splitting ventilators aren’t “firmly established since it would not meet general established standards for infection control for ventilated patients.”
However, if a facility employs the currently established infection control interventions needed to reduce ventilator-associated infections then any additional risk from splitting is “likely to be small and would likely be appropriate in a crisis standard of care,” the guidance said.
The Food and Drug Administration also added that it doesn’t object to creating a T-connector outlined in instructions to providers to split a ventilator.
But while the administration appears to be fine with splitting ventilators as a last resort to shore up capacity, not all providers are.

Adam Schlifke, M.D., a board-certified anesthesiologist and a clinical assistant professor at Stanford University in California, said sharing ventilators is a bad idea as patients cannot be properly monitored.
“I’ll tell you, it’s a Pandora’s box,” he said, with a preferred solution to re-purpose anesthesia machines from operating rooms or increasing the supply of ventilators.
Schlifke leads a group of anesthesiologists and other professionals called CovidVent that has called for turning operating rooms and surgery centers into critical care units for patients in order to free up hospital beds and ventilators.
“It is dangerous,” Schlifke said, about the idea of splitting ventilation between two patients. With only one way to monitor the split, there’s a risk of causing trauma or hypoventilating patients. “It’s a very hard thing to manage and it’s not something providers are used to doing because it’s never really been done before.”
“At the end of the day, of all the ways we could increase the supply of ventilation, that would be my last choice,” he said.
https://www.fiercehealthcare.com/hospitals-health-systems/trump-administration-offers-advice-to-providers-how-to-split-use

Amarin jumps 18% on possible patent win

Amarin (AMRN +18.0%) is up on massive turnover of over 63M shares in apparent reaction to a call between a patent lawyer and Jefferies’ Jared Holtz about the adverse patent ruling on Vascepa (icosapent ethyl) that caused the stock to plummet almost 71% yesterday.

The attorney said the company has an even-money chance to win on appeal citing a possible procedural error in the case.

https://seekingalpha.com/news/3557411-amarin-jumps-18-on-possible-patent-win

Stanford launches an accelerated test of AI to help care for Covid-19 patients

In the heart of Silicon Valley, Stanford clinicians and researchers are exploring whether artificial intelligence could help manage a potential surge of Covid-19 patients — and identify patients who will need intensive care before their condition rapidly deteriorates.
The challenge is not to build the algorithm — the Stanford team simply picked an off-the-shelf tool already on the market — but rather to determine how to carefully integrate it into already-frenzied clinical operations.
“The hardest part, the most important part of this work is not the model development. But it’s the workflow design, the change management, figuring out how do you develop that system the model enables,” said Ron Li, a Stanford physician and clinical informaticist leading the effort. Li will present the work on Wednesday at a virtual conference hosted by Stanford’s Institute for Human-Centered Artificial Intelligence.

The effort is primed to be an accelerated test of whether hospitals can smoothly incorporate AI tools into their workflows. That process, typically slow and halting, is being sped up at hospitals all over the world in the face of the coronavirus pandemic.

The machine learning model Li’s team is working with analyzes patients’ data and assigns them a score based on how sick they are and how likely they are to need escalated care. If the algorithm can be validated, Stanford plans to start using it to trigger clinical steps — such as prompting a nurse to check in more frequently or order tests — that would ultimately help physicians make decisions about a Covid-19 patient’s care.

The model — known as the Deterioration Index — was built and is marketed by Epic, the big electronic health records vendor. Li and his team picked that particular algorithm out of convenience, because it’s already integrated into their EHR, Li said. Epic trained the model on data from hospitalized patients who did not have Covid-19 — a limitation that raises questions about whether it will be generalizable for patients with a novel disease whose data it was never intended to analyze.
Nearly 50 health systems — which cover hundreds of hospitals — have been using the model to identify hospitalized patients with a wide range of medical conditions who are at the highest risk of deterioration, according to a spokesperson for Epic. The company recently built an update to help hospitals measure how well the model works specifically for Covid-19 patients. The spokesperson said that work showed the model performed well and didn’t need to be altered. Some hospitals are already using it with confidence, according to the spokesperson. But others, including Stanford, are now evaluating the model in their own Covid-19 patients.
In the months before the coronavirus pandemic, Li and his team had been working to validate the model on data from Stanford’s general population of hospitalized patients. Now, they’ve switched their focus to test it on data from dozens of Covid-19 patients that have been hospitalized at Stanford — a cohort that, at least for now, may be too small to fully validate the model.
“We’re essentially waiting as we get more and more Covid patients to see how well this works,” Li said. He added that the model does not have to be completely accurate in order to prove useful in the way it’s being deployed: to help inform high-stakes care decisions, not to automatically trigger them.
As of Tuesday afternoon, Stanford’s main hospital was treating 19 confirmed Covid-19 patients, nine of whom were in the intensive care unit; another 22 people were under investigation for possible Covid-19, according to Stanford spokesperson Julie Greicius. The branch of Stanford’s health system serving communities east of the San Francisco Bay had five confirmed Covid-19 patients, plus one person under investigation. And Stanford’s hospital for children had one confirmed Covid-19 patient, plus seven people under investigation, Greicius said.
Stanford’s hospitalization numbers are very fluid. Many people under investigation may turn out to not be infected, and many confirmed Covid-19 patients who have relatively mild symptoms may be quickly cleared for discharge to go home.

The model is meant to be used in patients who are hospitalized, but not yet in the ICU. It analyzes patients’ data — including their vital signs, lab test results, medications, and medical history — and spits out a score on a scale from 0 to 100, with a higher number signaling elevated concern that the patient’s condition is deteriorating.
Already, Li and his team have started to realize that a patient’s score may be less important than how quickly and dramatically that score changes, he said.
“If a patient’s score is 70, which is pretty high, but it’s been 70 for the last 24 hours — that’s actually a less concerning situation than if a patient scores 20 and then jumps up to 80 within 10 hours,” he said.
Li and his colleagues are adamant that they will not set a specific score threshold that would automatically trigger a transfer to the ICU or prompt a patient to be intubated. Rather, they’re trying to decide which scores or changes in scores should set off alarm bells that a clinician might need to gather more data or take a closer look at how a patient is doing.
“At the end of the day, it will still be the human experts who will make the call regarding whether or not the patient needs to go to the ICU or get intubated — except that this will now be augmented by a system that is smarter, more automated, more efficient,” Li said.
Using an algorithm in this way has potential to minimize the time that clinicians spend manually reviewing charts, so they can focus on the work that most urgently demands their direct expertise, Li said. That could be especially important if Stanford’s hospital sees a flood of Covid-19 patients in the coming weeks. Santa Clara County, where Stanford is located, had confirmed 890 cases of Covid-19 as of Monday afternoon. It’s not clear how many of them have needed hospitalization, though San Francisco Bay Area hospitals have not so far faced the crush of Covid-19 patients that New York City hospitals are experiencing.
That could change. And if it does, Li said, the model will have to be integrated into operations in a way that will work if Stanford has several hundred Covid-19 patients in its hospital.

‘Human experts will make the call’: Stanford launches an accelerated test of AI to help care for Covid-19 patients