Coronavirus drugmakers’ latest tactics: Science by press release

https://www.politico.com/news/2020/06/05/drugmakers-media-coronavirus-303895

Coronavirus drugmakers' latest tactics: Science by press release ...

Pharmaceutical companies are using the media to tout treatments that are still under review.

Vaccine maker Moderna attracted glowing headlines and bullish investors when it revealed that eight participants in a preliminary clinical trial of its coronavirus vaccine had developed antibodies to the virus. The company’s share price jumped nearly 20 percent that day as it released a massive stock offering.

But the full results of the 45-person safety study haven’t been published, even though Moderna began a second, larger trial in late May aimed at determining whether the vaccine works. Several vaccine researchers say the scant public information on the earlier safety study is hard to evaluate because it addresses less than 20 percent of participants.

Call it science by press release — a tactic that pharmaceutical companies are increasingly relying upon to set their experimental coronavirus drugs and vaccines apart in a crowded field, shape public opinion and court regulators. Public health experts say the approach could increase political pressure on federal health officials to green-light drugs and vaccines before it is clear they are safe or effective, with potentially dangerous consequences.

“There’s a long history of pharmaceutical manufacturers putting out self-serving press releases related to clinical trial data that they’re developing that present an overly rosy picture of the data, usually with a boilerplate disclaimer at the end, which is fairly useless,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug regulation and pricing.

There are already signs of hype and political pressure influencing the U.S.’ coronavirus response. The Food and Drug Administration authorized emergency use of the malaria drug hydroxychloroquine in March without any proof that it was safe or effective for coronavirus patients — but with the backing of President Donald Trump, who had begun touting the treatment during daily White House briefings.

Subsequent studies have found that hydroxychloroquine doesn’t help those with Covid-19 and can cause potentially fatal side effects. And a top government scientist, Rick Bright, filed a whistleblower complaint in May alleging that he was ousted from his job leading the Biomedical Advanced Research Authority after he resisted political pressure to greenlight widespread use of the drug.

“The FDA has remained an unwavering, science-based voice helping to guide the all-of-government response,” agency Commissioner Stephen Hahn said in a statement. “I have never felt any pressure to make decisions, other than the urgency of the situation around COVID-19.”

But observers aren’t so sure. “From the outside looking in, there seems to be more political pressure than ever,” said Marc Scheineson, a former associate commissioner at the FDA and head of the FDA group at Alston & Bird. “The example in the White House is trickling down and there is a lot of pressure on the FDA … to color information on the optimistic side for political purposes and that is a hugely disturbing trend.”

A spokesperson for Moderna, which has received nearly a half billion dollars from the U.S. government and praise from Trump, said the company previewed its vaccine trial results by press release because it was concerned that the data might leak. The National Institutes of Health’s top infectious disease expert, Anthony Fauci, had hinted at the results in an interview with National Geographic, and data from a trial of the experimental drug remdesivir had leaked in April.

“You had this data moving widely around NIH and the remdesivir leak was also in our minds,” the Moderna spokesperson said.

But Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, said Moderna’s effort to preview its findings in the press “could be construed as an effort to make sure they are part of the conversation — and it worked on that front.”

Other groups have also previewed their hotly anticipated vaccine studies in the press. In late April, The New York Times revealed that six monkeys given a vaccine developed by researchers at the U.K.’s University of Oxford had stayed healthy for 28 days despite sustained exposure to the coronavirus. The article quoted Vincent Munster, a researcher at the NIH’s Rocky Mountain Laboratory, which conducted the monkey study at the British scientists’ behest.

The Oxford researchers, who signed a deal with AstraZeneca two days later to develop the experimental vaccine, did not publish a formal scientific analysis of the monkey data until mid-May. The study revealed that the noses of vaccinated monkeys and unvaccinated monkeys contained similar levels of coronavirus particles, suggesting that the vaccinated animals could still spread the disease — and the vaccine might not be as effective as the earlier data had hinted.

AstraZeneca has since inked a $1.2 billion deal with the U.S. government to provide 300 million vaccine doses, and a £65.5 million ($80 million) agreement with the U.K. government to supply 30 million doses.

Liz Derow, a spokesperson for Oxford’s Jenner Institute, where the vaccine researchers are based, said they did not give the monkey data to The New York Times. The NIH’s National Institute of Allergy and Infectious Disease, which operates the Rocky Mountain Laboratory, said it did not provide the data to the newspaper — but one of its researchers, Vincent Munster, spoke to a Times reporter about the monkey findings at the request of the Jenner Institute.

“I was really disturbed by not just Moderna, but the Oxford group as well, presenting a press release without data, without a scientific review, without knowing what the press release was based on,” said Barry Bloom, an immunologist at the Harvard School of Public Health. “And very positively enough to raise the stock price so two days later officials within the company sold their stock and made a whole lot of money, whether or not the vaccine works.”

Four of the pharmaceutical firm’s top executives together saw gains of $29 million from prescheduled sales of shares in the company in the two days following the vaccine announcement. The company has not yet responded to a request for comment on the stock sales.

Neither the Oxford nor Moderna vaccines are available to the public. But some drugs whose safety and efficacy are now being studied have already been repurposed or authorized for emergency use during the pandemic. The rush to release snippets of information on drug trials to the press ahead of full results has left some doctors wondering how to best treat their patients.

After leaked data from a trial of Gilead’s experimental antiviral remdesivir suggested the drug might be the first shown to help coronavirus patients, the company put out a press release in late April teasing results from a larger, government-run study. Hours later, Fauci revealed some findings of the study during an Oval Office press spray.

But the full analysis of the NIAID trial results was not published until three weeks later. Until that point, frontline physicians had no way to know that patients on ventilators did not benefit from remdesivir treatment — meaning that doctors may have inadvertently wasted some of the United States’ limited stock of the drug.

This lack of understanding on how to use remdesivir was evident in a recent survey more than 250 hospitals by the American Society of Health-System Pharmacists, which found that just 15 percent planned to use their remdesivir doses as described in the FDA’s emergency authorization for the drug.

Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center who led the NIAID trial, told POLITICO that physicians could have patterned their use of remdesivir on the dosages given during the trial.

Others say doctors using experimental treatments should have as much information as possible.

“If we want doctors to make rational medical decisions based on data, then before an authorized product reaches patients, the data should be available to review in some way, not just a press release,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing.

Kesselheim, too, said that clinical trial data should be made public alongside any emergency authorizations to give physicians “the maximum amount of help they need in figuring out how to prescribe the drug.”

Gilead did not respond to a request for comment. But NIAID said that the urgency of the coronavirus prompted Fauci to share initial results before a full analysis was ready for publication.

Ivan Oransky, a professor of medical journalism at New York University and co-founder of the blog Retraction Watch, which monitors errors and misconduct in scientific research, told POLITICO he fears that the temptation to conduct science by press release will get “worse before it gets better.”

The world is growing more desperate for drugs and vaccines that could bring the coronavirus to heel. And many members of the public and politicians are treating every scrap of scientific information about the pandemic equally, he said — whether data comes from a peer-reviewed study or a company press release.

“There have been mechanisms to review science critically that, given the speed of Covid, have gone out the window,” said Bloom.

And interpreting results of clinical trial data can be difficult under the best of circumstances — especially when that data concerns a virus that was unknown to science until December of last year. When to end a trial and which conclusions to highlight are in many cases a matter of discretion, said Scheineson.

“It’s an art, not a science, in that respect,” he said. “I, for one, will not be the first in line to the new Moderna vaccine.”

 

 

 

 

Industry Voices—Healthcare has a plus-size problem from consolidation. Here are 9 ways to respond

https://www.fiercehealthcare.com/hospitals/industry-voices-healthcare-has-a-plus-size-problem-from-consolidation-here-are-9-ways-to?mkt_tok=eyJpIjoiWlRJMk9UYzVZVFl4Tm1VMSIsInQiOiJ0aElzSllzTkpISWNIcU13ZXErNVdPSzU3K05cLzRVY2FEWFMycDNHZTZcLzlTYUo3UVNNQXd3ZjlwZXlFbVA3c3NQTHI0NFhqcjhFNk1VUXc4aVlnYW9aSnFVOVIydEFqWG5weWdEc2Viall1elwvK0RIRWtEajhPWGw3TEFTNDlkUCJ9&mrkid=959610

Industry Voices—Healthcare has a plus-size problem from ...

For two decades, healthcare consolidation has been a strong industry trend. But in the COVID-19 era, big healthcare is proving to be a big problem.

Once the community spread of COVID-19 became apparent, large systems turned off the spigot of specialty and nonessential services almost immediately. Now, as these organizations try to entice patients back into services, they face consumers who have good reason to fear the large, populated spaces these systems are built on.

As patients return for care and treatments, large hospitals and health providers need targeted approaches to overcome risk and obstacles. Here are nine strategies to consider for restarting patients:

1. Identify patients and instances with care disruption and high risks associated with care deferral. Knowing which patients are at high risk due to missed appointments plus other risk and time-based analytics will be useful in targeting efforts to bring patients back. Use various technologies to identify prior scheduled procedures and diagnostics.

2. Create a clinical flow for patients in each treatment or appointment category so communication to patients is clear as they are recruited back into the system. The clinical flows should determine which patients will receive telehealth services and who will need physical exams, along with how imaging or laboratory services will be handled to safely address patient time and access to services.

3. Use population health technology to target patients by risk level for services and deferral reasons. Patients who were infected with COVID-19 should be indicated and targeted for services, since this calls for additional surveillance of new risk factors associated with the disease.

4. Contact patients for pre-appointment discussions prior to actual telehealth or personal visits and services. Identify data to collect from patients on symptoms, social determinants and concerns about healthcare or COVID-19 infection so patients can vet their concerns and upcoming discussions with physicians can be more informative.

5. Reimagine the role and functions of some specialists. Because specialty practices are often located in close proximity to many diagnostic services, primary care physicians, who tend to be off campus, can provide initial services in a low-density setting and leave the procedures to specialists.

6. Consider aligning with smaller or more localized services for diagnostics, or provide wearable devices that capture needed clinical data.

7. If feasible, consider whether physical access to some care locations should be redetermined in the short or midterm for patient ease of access.

8. For physical visits or treatments, adjust scheduling to accommodate patient and staff density in clinical or waiting areas.

9. Involve specialists in care and space redesign as well as designing risk criteria. Every specialty will have unique issues that should be accommodated in the design of restarting services.

Planning to improve and strengthen connections to patients in larger healthcare operations will go far toward helping them gain confidence to return during this phase of the pandemic. Now more than ever, we can’t afford a systemwide hit or miss.

 

 

 

 

Gladwell: COVID-19 should push healthcare to consider its ‘weak links’

https://www.fiercehealthcare.com/payer/malcolm-gladwell-covid-19-should-push-healthcare-to-consider-its-weak-links?mkt_tok=eyJpIjoiWlRJMk9UYzVZVFl4Tm1VMSIsInQiOiJ0aElzSllzTkpISWNIcU13ZXErNVdPSzU3K05cLzRVY2FEWFMycDNHZTZcLzlTYUo3UVNNQXd3ZjlwZXlFbVA3c3NQTHI0NFhqcjhFNk1VUXc4aVlnYW9aSnFVOVIydEFqWG5weWdEc2Viall1elwvK0RIRWtEajhPWGw3TEFTNDlkUCJ9&mrkid=959610

Gladwell: COVID-19 should push healthcare to consider its 'weak ...

The coronavirus pandemic has shown the healthcare industry that it needs to decide whether it’s playing basketball or soccer, journalist and author Malcolm Gladwell said. 

Gladwell, the opening keynote speaker at America’s Health Insurance Plans’ annual Institute & Expo, said the two sports exemplify the differences in thinking when one tackles problems using a “strong link” approach versus a “weak link” approach.

In basketball, he said, the team is as strong as its strongest, most high-profile players. In soccer, by contrast, the team is only as strong as its weakest players.

For healthcare organizations, that means making investments in the “weakest links”—such as harried clinicians who may need more training and low-income communities that cannot afford or access coverage—rather than the stronger links, like building out teaching hospitals and physician specializations.

“In healthcare, this is a chance for us to turn the ship around and say we can benefit far more from making health insurance more plentiful and more affordable,” Gladwell said. 

Gladwell emphasized that healthcare is far from the only industry to largely follow a “strong link” approach to improvement. In higher education, for example, much of the investment and funding goes to Ivy League institutions and other wealthy, top-performing universities.

Meanwhile, the education system could see significant benefits if it invested in the “weak links” like community colleges and bringing down tuition, Gladwell said. 

It’s a similar story in national security—and that “strong link” thinking led to two of the largest security breaches in American history, Gladwell said. Both Edward Snowden and Chelsea Manning were relatively low-ranking people within the security apparatus, but they were able to access critical files and release them.

“I would argue that ‘strong link’ paradigm has dominated every part of American society,” Gladwell said. “We have really put our chips down on the ‘strong link’ paradigm.” 

How could a “weak link” approach have impacted the response to the COVID-19 pandemic? Gladwell argues that, for instance, widespread testing is hampered by a lack of supplies like nasal swabs. Investment in the supply chain could have mitigated that challenge, he said.

The virus also disproportionately impacts people with certain conditions, notably diabetes. A broader focus on preventing and treating obesity could have had a large impact on how the pandemic played out, he said. 

“With this particular pandemic, I think we’re having a wake-up call,” Gladwell said.

 

 

 

Highmark, HealthNow New York enter affiliation agreement

https://www.fiercehealthcare.com/payer/highmark-healthnow-new-york-enter-affiliation-agreement?mkt_tok=eyJpIjoiWlRJMk9UYzVZVFl4Tm1VMSIsInQiOiJ0aElzSllzTkpISWNIcU13ZXErNVdPSzU3K05cLzRVY2FEWFMycDNHZTZcLzlTYUo3UVNNQXd3ZjlwZXlFbVA3c3NQTHI0NFhqcjhFNk1VUXc4aVlnYW9aSnFVOVIydEFqWG5weWdEc2Viall1elwvK0RIRWtEajhPWGw3TEFTNDlkUCJ9&mrkid=959610

Insurers Highmark, HealthNow New York join forces, predict better ...

Highmark is expanding its reach into New York through an affiliation with HealthNow New York.

The acquisition is pending regulatory approval, the two Blues insurers announced Tuesday. Should it be finalized, HealthNow’s plans will continue to operate locally as Highmark BlueCross BlueShield of Western New York and Highmark BlueShield of Northeastern New York.

HealthNow will bring nearly 1 million additional members into the Highmark fold and boasted $2.8 billion in revenue for 2019. It will join the fourth largest Blues organization in the country, building on Highmark’s 5.6 million members and $18 billion in operating revenue for 2019.

David Holmberg, Highmark’s CEO, said on a call with reporters that Highmark has been pursuing a “focused growth strategy of working with like-minded partners” to improve care quality and affordability.

“We believe together Highmark and HealthNow can be transformational as we prepare healthcare for the next generation of people in all of our regions,” Holmberg said.

Highmark entered intro similar affiliations to expand into Delaware and West Virginia.

HealthNow will maintain its Buffalo headquarters as well as offices in the Albany area and will maintain a significant amount of local autonomy, executives said on the call. The boards of both insurers have unanimously signed off on the deal.

Dave Anderson, CEO of HealthNow, will remain at the helm once the two insurers have integrated. Anderson told reporters that uniting with Highmark allows it to maintain its community-based presence and approach while tapping into the scale of the larger health plan.

He said the affiliation has been in the works for more than two and a half years, but the COVID-19 pandemic highlighted just how critical the additional scale would be to filling some of the gaps exposed as the virus spread.

So while COVID-19 wasn’t on either company’s radar as talks began, the pandemic did play a key role in underscoring the value of uniting, Anderson said.

“COVID has essentially emphasized the strategy that we put in place,” he said.

The insurers did not offer an estimated timeline for the affiliation to be completed.

 

 

 

7 health systems report $1B+ losses in Q1

https://www.beckershospitalreview.com/finance/7-health-systems-report-1b-losses-in-q1.html?utm_medium=email

The Dollar Total For 1996's Top Verdict Awards Continues On A ...

Health systems across the U.S. saw revenue decline, expenses rise and investment gains dwindle in the first quarter of this year due to the COVID-19 pandemic. 

For the three months ended March 31, some of the biggest nonprofit health systems in the U.S. reported losses. Below are seven health systems that reported net losses of $1 billion or more. 

Ascension (St. Louis)
Revenue: $6.1 billion
Operating loss: $429.4 million
Net loss: $2.7 billion

CommonSpirit Health (Chicago)
Revenue: $7.8 billion
Operating loss: $145 million
Net loss: $1.4 billion

Kaiser Permanente (Oakland, Calif.)
Revenue: $22.6 billion
Operating income: $1.3 billion
Net loss: $1.1 billion

Providence (Renton, Wash.)
Revenue: $6.3 billion
Operating loss: $276 million
Net loss: $1.1 billion

Sutter Health (Sacramento, Calif.)
Revenue: $3.2 billion
Operating loss: $236 million
Net loss: $1.1 billion

Advocate Aurora Health (Downers Grove, Ill., and Milwaukee)
Revenue: $3.1 billion
Operating loss: $85.6 million
Net loss: $1.3 billion

Intermountain Healthcare (Salt Lake City)
Revenue: $2.3 billion
Operating income: $115 million
Net loss: $1 billion

 

 

Beaumont, Advocate Aurora explore merger

https://www.beckershospitalreview.com/hospital-transactions-and-valuation/beaumont-advocate-aurora-explore-merger.html?utm_medium=email

Advocate Aurora Health, Beaumont Health Exploring Partnership ...

Beaumont Health announced it is in partnership talks with Advocate Aurora Health on June 17, less than one month after canceling a plan to merge with Akron, Ohio-based Summa Health. 

Southfield, Mich.-based Beaumont and Advocate Aurora, which has dual headquarters in Downers Grove, Ill., and Milwaukee, said they began partnership discussions in late 2019 but paused talks to allow both organizations to focus on the COVID-19 pandemic. On June 17, the health systems signed a nonbinding letter of intent to create a health system that would span across Michigan, Wisconsin and Illinois.

Though talks are still in early stages, the health systems have already agreed to an equal one-third governance representation of any future partnership between Beaumont, Advocate Health Care and Aurora Health Care, which merged in 2018 to create Advocate Aurora Health.

Beaumont President and CEO John Fox said the system is excited to explore the partnership with Advocate Aurora.

“The potential opportunity to leverage the strength and scale of a regional organization while maintaining a local focus and strong presence in Michigan as a leader and major employer is important to us,” Mr. Fox said in a news release.

Advocate Aurora President and CEO Jim Skogsbergh described the potential deal as a “unique opportunity.”

“Beaumont Health has built a strong reputation for clinical excellence, education and research,” Mr. Skogsbergh said in a news release. “This is a unique opportunity to explore a partnership with a like-minded, purpose-driven organization.”

 

 

 

 

Supreme Court’s LGBTQ ruling may sideline Trump’s health care rules

https://www.axios.com/supreme-court-lgbtq-trump-health-care-e1328769-3e2f-4dc8-986d-f167de65191e.html

Supreme Court's LGBTQ ruling may sideline Trump's health care ...

The Supreme Court’s historic ruling on LGBTQ nondiscrimination could sideline the Trump administration’s new policies on health care and adoption.

Why it matters: The ruling’s ripple effects will be felt immediately, and could ultimately derail regulations the administration had finalized just days ago.

The big picture: Federal civil rights law prohibits discrimination on the basis of sex, and the Supreme Court said Monday that “sex” includes sexual orientation and gender identity.

  • Monday’s case was specifically about employment, but the same legal interpretation will likely carry over to other areas, most notably health care — and that could cause problems for some of the Trump administration’s policies.

Between the lines: Just a few days before the Supreme Court’s ruling, the Department of Health and Human Services rolled back Obama-era rules that banned health care providers from denying care to trans patients.

  • That was based on the Trump administration’s interpretation of what constitutes “sex” discrimination — that it only encompasses biological traits defined at birth. That is, broadly, the same interpretation the high court rejected on Monday.

What’s next: The court’s ruling does not automatically invalidate the health care rules, but would make them much harder to defend in court. And if the administration doesn’t withdraw the rules, those lawsuits are coming.

  • “The court here today clearly articulated that discrimination based on sexual orientation, discrimination based on gender identity, are forms of sex discrimination,” said Alphonso David, president of the Human Rights Campaign.
  • “So, we are expecting the administration to rescind their rule immediately,” he said. “If they don’t, we are prepared to continue to use all of our resources, including litigation, to sue them and make sure that the rule is never implemented,”

HHS declined to answer questions about the regulations in light of Monday’s ruling.

Federal adoption guidelines could also be affected by the court’s decision.

  • The Trump administration has been working on rules that would make it easier for adoption and foster agencies to refuse to work with same-sex couples. Those rules would also face lawsuits if and when they’re finalized.
  • The specific legal foundations at issue there are somewhat different, but now that the Supreme Court has said civil-rights law prohibits discrimination on the basis of sexual identity and gender identity, any policy allowing such discrimination is going to face a steeper climb in the courts.

The bottom line: It may take a while for some of these issues to work their way through the courts, but the Supreme Court’s ruling Monday will make many forms of LGBTQ discrimination harder to defend, and in the scheme of things, that will likely happen pretty quickly.

 

 

 

 

How America’s Hospitals Survived the First Wave of the Coronavirus

https://www.propublica.org/article/how-americas-hospitals-survived-the-first-wave-of-the-coronavirus?utm_campaign=KHN%3A%20Daily%20Health%20Policy%20Report&utm_medium=email&_hsmi=89534068&_hsenc=p2ANqtz-_ScZ5cfM_EdBiyP4jwWFycBvCn8JtmInnkxl0EQRlG5qsZADhpXleMqNI__2mSgqtsmLu3tSFHb1xe9BYu1uHhcdo3IA&utm_content=89534068&utm_source=hs_email

How America's Hospitals Survived the First Wave of the Coronavirus ...

ProPublica deputy managing editor Charles Ornstein wanted to know why experts were wrong when they said U.S. hospitals would be overwhelmed by COVID-19 patients. Here’s what he learned, including what hospitals can do before the next wave.

The prediction from New York Gov. Andrew Cuomo was grim.

In late March, as the number of COVID-19 cases was growing exponentially in the state, Cuomo said New York hospitals might need twice as many beds as they normally have. Otherwise there could be no space to treat patients seriously ill with the new coronavirus.

“We have 53,000 hospital beds available,” Cuomo, a Democrat, said at a briefing on March 22. “Right now, the curve suggests we could need 110,000 hospital beds, and that is an obvious problem and that’s what we’re dealing with.”

The governor required all hospitals to submit plans to increase their capacity by at least 50%, with a goal of doubling their bed count. Hospitals converted operating rooms into intensive care units, and at least one replaced the seats in a large auditorium with beds. The state worked with the federal government to open field hospitals around New York City, including a large one at the Jacob K. Javits Convention Center.

But when New York hit its peak in early April, fewer than 19,000 people were hospitalized with COVID-19. Some hospitals ran out of beds and were forced to transfer patients elsewhere. Other hospitals had to care for patients in rooms that had never been used for that purpose before. Supplies, medications and staff ran low. And, as The Wall Street Journal reported on Thursday, many New York hospitals were ill prepared and made a number of serious missteps.

All told, more than 30,000 New York state residents have died of COVID-19. It’s a toll worse than any scourge in recent memory and way worse than the flu, but, overall, the health care system didn’t run out of beds.

“All of those models were based on assumptions, then we were smacked in the face with reality,” said Robyn Gershon, a clinical professor of epidemiology at the NYU School of Global Public Health, who was not involved in the models New York used. “We were working without situational awareness, which is a tenet in disaster preparedness and response. We simply did not have that.”

Cuomo’s office did not return emails seeking comment, but at a press briefing on April 10, the governor defended the models and those who created them. “In fairness to the experts, nobody has been here before. Nobody. So everyone is trying to figure it out the best they can,” he said. “Second, the big variable was, what policies do you put in place? And the bigger variable was, does anybody listen to the policies you put in place?”

So, why were the projections so wrong? And how can political leaders and hospitals learn from the experience in the event there is a second wave of the coronavirus this year? Doctors, hospital officials and public health experts shared their perspectives.

The Models Overstated How Many People Would Need Hospital Care

The models used to calculate the number of people who would need hospitalization were based on assumptions that didn’t prove out.

Early data from the U.S. Centers for Disease Control and Prevention suggested that for every person who died of COVID-19, more than 11 would be hospitalized. But that ratio was far too high and decreased markedly over time, said Dr. Christopher J.L. Murray, director of the Institute for Health Metrics and Evaluation at the University of Washington. IHME’s earliest models on hospitalizations were based on that CDC data and predicted that many states would quickly run out of hospital beds.

A subsequent model, released in early April, assumed about seven hospitalizations per death, reducing the predicted surge. Currently, Murray said, the ratio is about four hospital admissions per death.

“Initially what was happening and probably what we saw in the CDC data is doctors were admitting anybody they thought had COVID,” Murray said. “With time they started admitting only very sick people who needed oxygen or more aggressive care like mechanical ventilation.”

A patient with COVID-19 is taken into Mount Sinai Hospital in New York on May 3. (Alexi Rosenfeld/Getty Images)

A model created by the Harvard Global Health Institute made a different assumption that also turned out to be too high. Data from Wuhan, China, suggested that about 20% of those known to be infected with COVID-19 were hospitalized. Harvard’s model, which ProPublica used to build a data visualization, assumed a hospitalization rate in the United States of 19% for those under 65 who were infected and 28.5% for those older than 65.

But in the U.S., that percentage proved much too high. Official hospitalization rates vary dramatically among states, from as low as 6% to more than 20%, according to data gathered from states by The COVID Tracking Project. (States with higher rates may not have an accurate tally of those infected because testing was so limited in the early weeks of the pandemic.) As testing increases and doctors learn how to treat coronavirus patients out of the hospital, the average hospitalization rate continues to drop.

New York state’s testing showed that by mid-April, approximately 20% of the adult population in New York City had antibodies to COVID-19. Given the number hospitalized in the city and adjusting for the time needed for the body to produce antibodies, this means that the city’s hospitalization rate was closer to 2%, said Dr. Nathaniel Hupert, an associate professor at Weill Cornell Medicine and co-director of the Cornell Institute for Disease and Disaster Preparedness.

Dr. Ashish Jha, director of the Harvard Global Health Institute, and his team also assumed that between 20% and 60% of the population would be infected with COVID-19 over six to 18 months. That was before stay-at-home orders took effect nationwide, which slowed the virus’s spread. Outside of New York City, a far lower percentage of the population has been infected. Granted, we’re not even six months into the pandemic.

A number of factors go into disease models, including the attack rate (the percentage of the entire population that eventually becomes infected), the symptomatic rate (how many people are going to show symptoms), the hospitalization rate for different age groups, the fraction of those hospitalized that will need intensive care and how much care they will need, as well as how the disease travels through the population over time (what is known as “the shape of the epidemic curve”), Hupert said.

Before mid-March, Hupert’s best estimate of the impact of COVID-19 in New York state was that it would lead to a peak hospital occupancy of between 13,800 to 61,000 patients in both regular medical wards and intensive care. He shared his work with state officials.

David Muhlestein, chief strategy and chief research officer at Leavitt Partners, a health care consulting firm, said one takeaway from COVID-19 is that models can’t try to predict too far into the future. His firm has created its own projection tool for hospital capacity that looks ahead three weeks, which Muhlestein said is most realistic given the available data.

“If we were held to our very initial projection of what was going to happen, everybody would be very wrong in every direction,” he said.

Hospitals Proved Surprisingly Adept at Adding Beds

When calculating whether hospitals would run out of beds, experts used as their baseline the number of beds in use in each hospital, region and state. That makes sense in normal times because hospitals have to meet stringent rules before they are able to add regular beds or intensive care units.

Workers prepare dozens of extra beds that were delivered to Mount Sinai on March 31. (Spencer Platt/Getty Images)

But in the early weeks of the pandemic, state health departments waived many rules and hospitals responded by increasing their capacity, sometimes dramatically. “Just because you only have six ICU beds doesn’t mean they will only have six ICU beds next week,” Muhlestein said. “They can really ramp that up. That’s one of the things we’re learning.”

Take Northwell Health, a chain of 17 acute-care hospitals in New York. Typically, the system has 4,000 beds, not including maternity beds, neonatal intensive care unit beds and psychiatric beds. The system grew to 6,000 beds within two weeks. At its peak, on April 7, the hospitals had about 5,500 patients, of which 3,425 had COVID-19.

The system erected tents, placed patients in lobbies and conference rooms, and its largest hospital, North Shore University Hospital, removed the chairs from its 300-seat auditorium and replaced them with a unit capable of treating about 50 patients. “We were pulling out all the stops at that point,” Senior Vice President Terence Lynam said. “It was unclear if the trend was going to go the other way. We did not end up needing them all.”

Northwell went from treating 49 COVID-19 inpatients on March 16 to 3,425 on April 7. “I don’t think anybody had a clear handle on what the ceiling was going to be,” Lynam said. As of Wednesday, the system was still caring for 367 COVID-19 patients in its hospitals.

As hospitals found ways to expand, government leaders worked with the Army Corps of Engineers to build dozens of field hospitals across the country, such as the one at the Javits Center. According to an analysis of federal spending by NPR, those efforts cost at least $660 million. “But nearly four months into the pandemic, most of these facilities haven’t treated a single patient,” NPR reported. As they began to come online, stay-at-home orders started producing results, with fewer positive cases and fewer hospitalizations.

Demand for Non-COVID-19 Care Plummeted More Than Expected

Hospitals across the country canceled elective surgeries, from hip replacements to kidney transplants. That greatly reduced the number of non-COVID-19 patients they had to treat. “We generated a lot more capacity by getting rid of elective procedures than any of us thought was possible,” Harvard’s Jha said.

Northwell canceled elective surgeries on March 16, and over the span of the next week and a half, its hospitals discharged several thousand patients in anticipation of the coming surge. “In retrospect, it was a wise move,” Lynam said. “It just ballooned after that. If we had not discharged those patients in time, there would have been a severe bottleneck.”

What’s more, experts say, it’s clear that some patients with true emergencies also stayed home. A recent report from the CDC said that emergency room visits dropped by 42% in the early weeks of the pandemic. In 2019, some 2.1 million people visited ERs each week from late March to late April. This year, that dropped to 1.2 million per week. That was especially true for children, women and people who live in the Northeast.

In New York City, emergency room visits for asthma practically ceased entirely at the peak, Cornell’s Hupert said. “You wouldn’t imagine that asthma would just disappear,” he said. “Why did it go away? … Nobody has seen anything like that.”

Undoubtedly some people experienced heart attacks and strokes and didn’t go to the hospital because they were fearful of getting COVID-19. “I didn’t expect that,” Jha said. A draft research paper available on a preprint server, before it is reviewed and published in an academic journal, found that heart disease deaths in Massachusetts were unchanged in the early weeks of the pandemic compared to the same period in 2019. What that may mean is that those people died at home.

The Coronavirus Attacked Every Region at a Different Pace

Some initial models forecast that COVID-19 would hit different regions in similar ways. That has not been the case. New York was hit hard early; California was not, at least initially.

In recent weeks, hospitals in Montgomery, Alabama, saw a lot of patients. Arizona’s health director has told hospitals in the state to “fully activate” their emergency plans in light of a spike in cases there. The Washington Post reported on Tuesday that hospitalizations in at least nine states have been rising since Memorial Day.

St. Luke’s, a closed hospital in Phoenix, is prepared to receive overflow patients on April 23. Arizona initially wasn’t hit hard, but cases are now spiking. (Ross D. Franklin/AP Photo)

Dr. Mark Rupp, medical director of the Department of Infection Control and Epidemiology at the University of Nebraska Medical Center in Omaha, said his region hasn’t seen a tidal wave like New York. “What we’ve seen is a rising tide, a steady increase in the number of cases.” Initially that was associated with outbreaks at specific locations like meatpacking and food processing plants and to some degree long-term care facilities.

But since then, “it has just plateaued,” he said. “That has me concerned. This is a time when I feel like we should be working as hard as we can to push these numbers as low as possible.”

Rupp’s hospital has been caring for 50 to 60 COVID-19 patients on any given day. The hospital has started to perform surgeries and procedures that had been on hold because “elective cases stay elective for only so long.”

The hospital’s general medical/surgical beds are 70% to 80% filled, and its ICU beds are 80% to 90% full. “We don’t have a big cushion.”

Even in New York City, the virus hit boroughs differently. Queens and the Bronx were hard hit; Manhattan, Brooklyn and Staten Island less so. “Maybe we can’t even model a city as big as New York,” Hupert said. “Each neighborhood seemed to have a different type of outbreak.”

That needs further study but could be attributable to both social and demographic conditions and the type of jobs residents of the neighborhoods had, among other factors.

What We Can Learn From Coronavirus “Round One”

While hospitals were able to add beds more quickly than experts realized they could, some other resources were harder to come by. Masks, gowns and other personal protective equipment were tough to get. So were ventilators. Anesthesia agents and dialysis medications were in short supply. And every additional bed meant the need for more doctors, nurses and respiratory therapists.

In early February, before any cases were discovered in New York, Northwell purchased $5 million in PPE, ventilators and lab supplies just in case, Lynam said. “It turned out to be a wise move,” he said. “What’s clear is that you can never have enough.”

Northwell has spent $42 million on PPE alone. “We were going through 10,000 N95 masks a day, just a crazy amount,” he said. “One of the lessons learned is you have to stockpile the PPE. There’s got to be a better procurement process in place.”

If there’s one thing the system could have done differently, Lynam said, it’s bringing in more temporary nurses earlier. Northwell brought in 500 nurses from staffing agencies. “They came in a week later than they should have.”

Dr. Robert Wachter, chair of the department of medicine at the University of California, San Francisco, agreed. “I’ve helped run services in hospitals for 25 years,” he said. “I’ve probably given two minutes of thought to the notions of supply chains and PPE. You realize that is absolutely central to your preparedness. That’s a lesson.”

Experts and hospital leaders agree that everyone can do better if another wave hits. Here’s what that entails:

  • Having testing readily available, as it now is, to more quickly spot a resurgence of the virus.

  • Stocking up now on PPE and other supplies. “We definitely have to stockpile PPE by the fall,” Gershon of NYU said. “We have to. … [Hospitals and health departments] have to really get those contracts nailed down now. They should have been doing this, of course, all the time, but no one expected this kind of event.”

  • Being able to quickly move personnel and equipment from one hot spot to the next.

  • Planning for how to care for those with other medical ailments but who are scared of contracting COVID-19. “We have to have some sort of a mechanism by which we can offer people assurance that if they come in, they won’t get sick,” Jha said. “We can’t repeat in the fall what we just did in the spring. It’s terrible for hospitals. It’s terrible for patients.”

  • Providing mental health resources for front-line caregivers who have been deeply affected by their work. The intensity of the work, combined with watching patients suffer and die alone, was immensely taxing.

  • Coming up with ways to allow visitors in the hospital. Wachter said the visitor bans in place at many hospitals, though well intentioned, may have backfired. “When all hell was breaking loose and we were just doing the best we could in the face of a tsunami, it was reasonable to just keep everybody out,” he said. “We didn’t fully understand how important that was for patients, how much it might be contributing to some people not coming in for care when they really should have.”

Lynam of Northwell said he’s worried about what lies ahead. “You look back on the 1918 Spanish flu and the majority of victims from that died in the second wave. … We don’t know what’s coming on the second wave. There may be some folks who say you’re paranoid, but you’ve got to be prepared for the worst.”

 

 

 

Axios-Ipsos poll: Americans fear a second wave

https://www.axios.com/axios-ipsos-coronavirus-index-second-wave-87c327c2-42bb-43a5-80b2-5f2f513a24b2.html

Axios-Ipsos poll: Americans fear a second wave - Axios

Eight in 10 Americans are worried about a second wave of the coronavirus, with large majorities saying they’ll resume social distancing, dial back shopping and keep their kids out of school if it happens, in Week 13 of the Axios-Ipsos Coronavirus Index.

Why it matters: Businesses and schools around the country are trying to assess how quickly and fully they should reopen based in part on what Americans will demand and tolerate. These findings underscore the challenges in predicting how they should proceed.

  • But getting Americans to swallow a second round of 14-day self-quarantining could be tougher than getting them to go back to social distancing, with one in three saying they likely won’t do it.
  • The biggest factor is partisan identification, with 81% of Democrats but only 49% of Republicans saying they’ll self-quarantine if a second wave hits.

The big picture: The latest installment of our national weekly survey shows a renewed sense of risk following reports of new hospitalizations since states began lifting stay-at-home orders — but quarantine fatigue is still driving people to take their chances.

  • People’s assessment of large or moderate risk grew last week for each of these categories: returning to their normal workplace, dining out, retail shopping, going to the hair salon or participating in protests.
  • But the share of those going out to eat rose from 31% to 41%. Those visiting friends or relatives rose from 56% to 60%. Those getting their hair done rose from 26% to 31%. Those attending demonstrations rose from 11% to 14%.

What they’re saying: “People are starting to be concerned about it again,” said pollster Chris Jackson, senior vice president for Ipsos Public Affairs. “We’re not yet seeing changes in the patterns of their behavior yet, though.”

  • Their behaviors are not really catching up to their concern level.”

By the numbers: 81% say they’re concerned about a second wave — including those who are extremely (30%), very (26%) or somewhat (24%) concerned.

  • 64% of those surveyed say returning to their normal pre-coronavirus life represents a large or moderate risk, up from 57% a week ago.
  • The share of people extremely or very concerned about getting sick rose from 32% to 40% last week. Those fearing U.S. economic collapse rose from 48% to 54%.
  • There also were upticks in people’s concerns about job security and the government’s response to the outbreak.
  • Americans’ ability to afford household goods also decreased.
  • One in 10 surveyed say they’ve been collecting unemployment benefits in recent weeks.
  • 35% of Americans now know someone who’s tested positive, a new high for the survey.

Between the lines: The survey suggests an evolving understanding of the racial disparities in the pandemic.

  • The share of those saying they are extremely or very concerned that the coronavirus is doing greater damage to people of color rose from 36% to 42%.
  • The share of those extremely or very concerned that official responses are biased against certain groups also rose from 36% to 42%.

 

 

 

 

Tower Health cutting 1,000 jobs as COVID-19 losses mount

https://www.inquirer.com/business/health/tower-health-hospital-layoffs-covid-19-20200616.html

Tower Health cutting 1,000 jobs as COVID-19 losses mount

Tower Health on Tuesday announced that it is cutting 1,000 jobs, or about 8 percent of its workforce, citing the loss of $212 million in revenue through May because of the coronavirus restrictions on nonurgent care.

Fast-growing Tower had already furloughed at least 1,000 employees in April. It’s not clear how much overlap there is between the furloughed employees, some of whom have returned to work, and the people who are now losing their jobs permanently. Tower employs 12,355, including part-timers.

“The government-mandated closure of many outpatient facilities and the suspension of elective procedures caused a 40 percent drop in system revenue,” Tower’s president and chief executive, Clint Matthews, wrote in an email to staff. “At the same time, our spending increased for personal protective equipment, staff support, and COVID-related equipment needs.”

Despite the receipt of $66 million in grants through the federal CARES Act, Tower reported an operating loss of $91.6 million in the three months ended March 31, according to its disclosure to bondholders.

Tower, which is anchored by Reading Hospital in Berks County, expanded most recently with the December acquisition of St. Christopher’s Hospital for Children in a partnership with Drexel University. Tower paid $50 million for the hospital’s business, but also signed a long-term lease with a company that paid another $65 million for the real estate.

In 2017, Tower paid $418 million for five community hospitals in Southeastern Pennsylvania — Brandywine in Coatesville, Chestnut Hill in Philadelphia, Jennersville Regional in West Grove, Phoenixville in Phoenixville, and Pottstown Memorial Medical Center, now called Pottstown Hospital, in Pottstown.

Tower’s goal was to remain competitive as bigger systems — the University of Pennsylvania Health System and Jefferson Health from the Southeast, Lehigh Valley Health Network and St. Luke’s University Health Network from the east and northeast, and University of Pittsburgh Medical Center from the west — encroached on its Berk’s county base.

Tower had set itself a difficult task in the best of times, but COVID-19 has made it significantly harder for the nonprofit, which had an operating loss of $175 million on revenue of $1.75 billion in the year ended June 30, 2019.

Because health systems have high fixed costs for buildings and equipment needed no matter how many patients are coming through the door, it’s hard for them to limit the impact of the 30% to 50% collapse in demand caused by the coronavirus pandemic.

“Hospitals and all other health service providers were hit with this disruption with lightning speed, forcing the industry to learn in real time how to handle a situation for which there was no playbook,” Standard & Poor’s analysts David P. Peknay and Suzie R. Desai said in a research report last month.

Tower’s said positions will be eliminated in executive, management, clinical, and support areas.

The cuts include consolidations of clinical operations. Tower plans to close Pottstown Hospital’s maternity unit, which employs 32 nurses and where 359 babies were born in 2018, according to the most recent state data. Tower also has maternity units at Reading Hospital in West Reading and at Phoenixville Hospital.

Tower is aiming to trim expenses by $230 million over the next two years, Matthews told staff.

Like many other health systems, Tower has taken advantage of federal programs to ensure that it has ample cash in the bank to run its businesses. Tower has deferred payroll taxes, temporarily sparing $25 million. It received $166 million in advanced Medicare payments in April.

In the private sphere, Tower obtained a $40 million line of credit in April for St. Chris, which has lost $23.6 million on operations since Tower and Drexel bought it in December. Last month, Tower said it was in the final stages of negotiating a deal to sell and then lease back 24 medical office buildings. That was expected to generate $200 million in cash for Tower.