For 2022 updates on covid-19 and how it has affected the health care industry and hospitalists, click here: Special report: Covid-19.
December 23, 2020
Study halted on therapeutic anti-clot meds for severe disease
Giving therapeutic heparin dosing for prophylaxis to covid patients in the ICU may be unsafe, according to three international randomized trials. The strategy also appears to be futile in that ICU patients receiving therapeutic vs. prophylactic dosing showed no reduced need for organ support. The three trials, which are collaborating, halted enrollment in ICU patients. However, a press release from the University of Manitoba states that enrollment continues for hospitalized covid patients with moderate disease to compare outcomes between the two dosing strategies. The three trials are being funded by the NIH and its counterparts in Canada, the U.K., Australia and the European Union.
France fast-tracks citizenship for health care workers, others
About 700 front-line immigrant workers in France who were potentially exposed to coronavirus through their jobs are now receiving expedited reviews for citizenship. The New York Times reports that those include not only health care workers, but those in child care, social workers, garbage collectors, cashiers and housekeepers. France has seen its number of naturalized citizens decrease in the last few years, and citizenship applications get routinely bogged down in paperwork. The government first initiated the fast-track program in September; this week, it announced that 700 workers were being included.
December 22, 2020
More infectious? Or are people more reckless?
British researchers and politicians are sounding the alarm about a new virus variant making the rounds in the U.K. that, officials say, is substantially more contagious. The same news is coming out of South Africa where a similar variant has apparently been the cause of most new cases there since mid-November. According to the New York Times, scientists expect the virus to continue to mutate, particularly as more potential hosts stave it off through vaccination and immunity. While British officials say the new variant is 70% more transmissible, some experts remain to be convinced, saying that finding hasn’t been confirmed in the lab and that the rise in new cases may be driven more by human behavior. Experts also say that the current mutations are not substantial enough to affect the efficacy of current covid vaccines. So far, STAT reports, the mutations don’t appear to make infected patients more sick. European countries are already suspending air travel to and from the U.K.
So you got the vaccine. Can your life return to normal?
If you’re among the few who’ve already received a dose of vaccine, you’re not fully vaccinated until you get the second dose in a couple of weeks. At that time, your risk of becoming infected should be significantly lower—but it’s not zero, so you will have to continue to wear masks, physically distance, and avoid large get-togethers and travel. Several questions about the vaccine and those who receive it remain, including: Can you spread virus to others, and how long does immunity last? The New York Times reports that in a survey of epidemiologists, fewer than one-third said their behavior will change after they’re vaccinated. Instead, they intend to take the same precautions they are taking already—until about 70% of the country has received the vaccine. Once you and those you want to socialize are all vaccinated, it should be easier to gather together, even indoors.
December 21, 2020
States start receiving the Moderna vaccine
With the FDA issuing an EUA late last week, the Massachusetts biotech Moderna is now shipping out vaccine, with its first vaccinations taking place today. The Washington Post reports that a combined total of about 7.9 million doses of both the Moderna and Pfizer vaccines are shipping this week. But states have reported a sharp—and unexplained—drop in the number of Pfizer vaccine doses they had expected to receive this week. The drug manufacturer pushed back against the administration’s claims that the delays were due to production problems. Instead, the company said, it had millions of doses warehoused and waiting for shipping instructions from the government. Last week, Pfizer shipped 2.9 million doses. The CDC reportedly told states that the number of Pfizer doses being shipped this week was being cut by 40%.
“First in the room! Back of the line!”
Stanford University last week issued an apology for a botched vaccination rollout that prioritized stay-at-home faculty over front-line residents. As originally drawn up, the university’s allocation policy for its first 5,000 doses was leaving out all but a handful or two of residents and fellows, many of whom work with covid patients, while vaccinating faculty not involved in direct care and some administrators. That sparked a demonstration at the hospital and a commitment from the university to correct the botched allocation. NPR reports that the stand-off was due to an algorithm that prioritized allocation by recipients’ age and the units they work; because of their young age and not having a set assignment, residents dropped to the bottom of the list.
December 18, 2020
Ten-day “heightened risk” post-discharge
Hospitalized covid patients face a higher risk of readmissions and death within the first 10 days post-discharge than matched non-covid patients. That’s the conclusion of research that looked at data on close to 2,200 index covid hospitalizations in 132 VA hospitals. Researchers measured those patients’ readmission and death rates for up to 60 days and compared them to patients hospitalized with either non-covid pneumonia or heart failure. Within 60 days of discharge, 19.9% of covid patients were readmitted while 9.1% had died. Compared to patients with non-covid pneumonia or heart failure, covid survivors had lower overall rates of 60-day readmissions and deaths. But that was not the case within the first 10 days when rates for both readmissions and deaths for covid patients were higher. The findings, the authors write, suggest “a period of heightened risk of clinical deterioration.” The authors also note that focusing exclusively on inpatient death tolls “may substantially underestimate burdens of COVID-19.”
Covid: what science gained and lost
Scientists this year produced more than 74,000 covid-related papers, with one-third of researchers in the U.S., Canada and Europe reporting that they had suspended their previous work and pivoted to covid research. An article in The Atlantic compares the efforts of the scientific community around covid to the Manhattan Project and the Apollo program—and finds that covid beats them both in terms of focused scientific attention. But while much of the coverage in the U.S. targeted the political failures in covid response, many scientific missteps have been made. Some successes: fast-forming alliances, freely accessible preprints, an extraordinary and apparently successful race to find vaccines. Some low points: shoddy studies with sometimes misleading results, trials launched in haste with too small samples, women’s research hours falling more than men’s, and covid’s single focus leaving other topics neglected. “At its best, science is a self-correcting march toward greater knowledge for the betterment of humanity,” the author writes. “At its worst, it is a self-interested pursuit of greater prestige at the cost of truth and rigor.”
Nurses get the superhero treatment, plus a worthy cause
A health system has teamed up with Marvel to illustrate the true stories of nurse “superheroes.” Medpage Today reports that the Pittsburgh-based Allegheny Health Network wanted to thank its nurses. The health system worked with Marvel to create a comic, “The Vitals: True Nurse Stories,” with three stories of eight hospital nurses caring for covid patients. While they don’t wear capes or suffer genetic mutations, they do go above and beyond, and the health system has distributed thousands of copies of the comic throughout Pittsburgh schools. And Michael Osterholm, PhD, who heads up the University of Minnesota’s Center for Infectious Disease Research and Policy, worked with a local charity council and foundation to launch the Frontline Families Fund, which is collecting donations for families of health care workers who have died in the pandemic. Since its launch in mid-November, the fund has raised close to $750,000, with donations going to direct grants and scholarships.
December 17, 2020
Baricitinib-remdesivir combo speeds up recovery
While a randomized trial of more than 1,000 hospitalized covid patients didn’t
post blockbuster results, the findings were still positive and promising. Writing in NEJM, the authors note that adding the antiinflammatory baricitinib to remdesivir (vs. placebo plus remdesivir) produced slightly faster median recovery times: seven vs. eight days. Shorter recovery was especially marked with combination therapy in patients on high-flow oxygen or non-invasive ventilation: 10 vs. 18 days. Use of the therapeutic combo was also linked to better clinical status and fewer adverse events. Another plus: Baricitinib, which is approved for treating rheumatoid arthritis, is an oral drug with few drug-drug interactions that is already being used in more than 70 countries. The FDA has already issued an EUA for the combo therapy, and the NIH’s treatment guidelines panel has weighed in. Among its recommendations: Panel members don't find enough data to recommend either for or against using baricitinib with remdesivir in hospitalized patients where corticosteroids can be used. But in rare cases when corticosteroids can’t be used, the panel recommends the combination therapy in hospitalized, nonintubated covid patients who need supplemental oxygen. However, baricitinib should not be used to treat covid without remdesivir, except in clinical trials.
December 16, 2020
First vaccinations begin (updated Dec. 17)
The FDA last Friday issued an EUA for the Pfizer vaccine, with the first doses shipped earlier this week and delivered to hospitals and nursing homes. The FDA’s advisory panel is meeting Thursday to decide whether to recommend authorizing use of the Moderna vaccine as well. The FDA also released data on the Moderna candidate, indicating that it achieved 95% efficacy in enrollees age 18-64, 86% efficacy in those age 85 and older, and 100% efficacy against severe disease. In interim guidance, the CDC notes that patients with acute covid should wait until they’ve recovered to be vaccinated. Further, pregnant or immunocompromised patients may still be vaccinated if they don’t have other contraindications, while patients with a history of anaphylaxis should be observed for 30 minutes after vaccination and those with a history of allergic reactions should be observed 15 minutes. One health care worker in Alaska had a severe reaction to the vaccine and was hospitalized overnight. According to the Washington Post, the worker had no history of allergic reactions. As scientists explain in a Huffpost article, the vaccines were developed so quickly because funding—usually a huge hurdle—was abundant and the testing and manufacturing phases overlapped to save time. Also, development was a global effort and the research didn’t start from scratch, as some vaccine development took place during earlier SARS and MERS outbreaks. Vaccine developers could also use early research about mRNA vaccines; both the Pfizer and Moderna vaccines are mRNA vaccines. Much of the pioneering research on mRNA vaccines was done by Katalin Kariko, PhD, an Hungarian immigrant whose 40-year research career included being fired, demoted and passed over for grants.
December 11, 2020
FDA committee green-lights Pfizer-BioNTech vaccine
FDA advisors yesterday endorsed the use of the Pfizer-BioNTech vaccine, paving the way for the FDA to issue an emergency use authorization within hours or days. CNBC this week reported that the government plans to distribute 2.9 million doses of the vaccine as soon as the FDA authorizes its use. In related news, state health departments are leaving it up to individual hospitals to figure out how, when and who among their workforce to vaccinate first. A Business Insider article provides details on how four large health systems—Intermountain, Northwell Health, McLaren Health Care in Michigan and Yale New Haven Health—plan to vaccinate staff. Some will stagger vaccinations within departments in case some doctors and nurses are out with side effects, which can include headache and fatigue. Others wanted to let clinicians themselves decide who to be vaccinated first; they have scrapped that approach because initial vaccine supplies will be limited. Instead, most health systems will prioritize those on the front lines with covid patients, including workers in environmental services. While some hospitals intend to vaccinate their own staff, McLaren will partner with Walgreens. Vaccine candidates from both Pfizer and Moderna are getting close to an EUA from the FDA, although Pfizer may not be able to provide more than 100 million doses—enough to vaccinate 50 million people—before next summer.
Outsized risks for health workers
A study from the U.K. puts in stark relief the risk of severe covid that health care workers run. Writing in BMJ Occupational & Environmental Medicine, the authors looked at severe covid risk by occupation and found that health care workers’ risk is more than seven times greater than non-essential workers. Overall, the risk of essential workers is 1.6 times that of non-essential workers, while those providing child or elder care run 2.5 times the risk of non-essential workers and those in transport run 2.2 times the risk. The study also found substantial racial disparities in the risk of severe covid, with non-white essential workers having 2.4 times the risk of white essential workers. In better news: Most employees with Advocate Aurora Health in the Midwest will find extra cash in their next paycheck. In a video message, the health system CEO said that employees would share $66 million in bonuses in recognition of their “remarkable work, commitment and sacrifices throughout the unprecedented year of 2020.” With the tiered bonuses, administrative and corporate personnel will each receive $500, those providing onsite support to clinical staff will receive $800 and direct patient-care providers will each be given $1,300. Bonuses will go to close to 69,000 employees, about 90% of the health system’s staff.
A (mostly) slow flu season, fewer hospital-acquired infections
New data indicate that flu activity in November was low compared to last year, with some exceptions. The data, from Walgreens, looked at patterns in antiviral medications being ordered in stores. Flu activity was highest in Nevada and Mississippi and had taken hold of some communities particularly in Texas and parts of the South and Midwest. In other news, the CDC reports that hospitals last year made progress in tamping down hospital-acquired infections. The report found that the incidence of bloodstream infections in hospitals fell 7%, while hospitals had 8% fewer hospital-acquired UTIs (ICUs saw a 12% decrease) and 18% fewer cases of C. diff. The report did find a 2% increase in ventilator-association infections and no significant change in surgical site infections or those caused by MRSA.
How speaking up (and out) can hurt clinicians
Recent news highlights the dangers of clinicians going public about ignoring pandemic rules and restrictions. At the same time, other health workers find themselves in trouble for speaking out against what they see as unsafe practices in their hospitals. One Oregon family physician who bragged at a post-election rally that he and his office staff refuse to wear masks has had his license suspended. Oregon state law requires providers to wear face masks in health care settings. Meanwhile, a nurse—also in Oregon—who posted a video on social media saying she rarely wears a mask, travels often and allows her kids to have play dates has reached an agreement with her employer to no longer work there. But at the other end of the safety spectrum: A nurse who was fired after raising concerns about the scrubs that nurses have to wear at a hospital in St. Paul, Minn., may find his license on the line. When the hospital told nurses to wear and launder their own scrubs, the nurse instead wore hospital-issued (and washed) scrubs and filed an OSHA complaint, alleging the policy was unsafe. According to MedPage Today, he was fired for violating the hospital’s dress code, and he then sued the hospital for whistleblower retaliation and wrongful termination. Now the state’s nursing licensing board is investigating his conduct, putting his license at stake—while a union steward at the hospital says that nurses are still required to wear and clean their own scrubs.
December 10, 2020
A single day death record, and ICUs are filling up
Wednesday’s death toll in the U.S.—3,123—exceeded the number of lives lost on 9/11 and at Pearl Harbor, and was the single highest death count in the country since the pandemic began. The New York Times released an interactive map that allows you to gauge the capacity left at an ICU near you. The accompanying article points out that one third of Americans last week lived near hospitals with fewer than 15% of their ICU beds available, while one in 10 lived in areas where remaining ICU capacity was down to 5%. Both the map and article were based on facility-level data on hospitalized covid patients that the federal government released for the first time. Who’s fueling the explosive spread? Less than one in five people. An Axios-Ipsos index finds that 18% of the population is driving most of the out-of-home, indoor activity that’s behind many transmissions. During a week, members of this group spend at least one hour in three or more indoor settings including bars and restaurants, gyms, places of worship, entertainment centers, and other people’s homes. Only 44% of those people report wearing a mask at all times—and group members are more likely to be under age 55, male and Republican.
December 9, 2020
Finally. a national plan?
The CDC last week released what the New York Times called “a battle plan,” spelling out 10 public health measures that, with the current high levels of transmission, are now essential nationwide. In its starkest language yet, the agency noted that rising case numbers call for a uniform national approach. While all 10 recommendations have been issued before, it was the first time the CDC had issued a summary of it guidance. Along with universal mask use (including on mass transportation), the agency advised physical distancing and limited contacts; avoiding nonessential indoor spaces and crowded outdoor ones; increased testing, diagnosis and isolation; prompt investigation and contact tracing; safeguarding high-risk populations; protecting essential workers, including providing adequate PPE; postponing travel; increased ventilation and enhanced hand hygiene; and achieving widespread vaccine availability. The guidance also gave top priority to keeping K-12 schools open, recommending that schools be the last to close and the first to re-open. In-door restaurant dining was flagged as “particularly high-risk,” and the agency recommends that all exercise be done outdoors. In other news, the incoming administration is nominating Rochelle Walensky, MD, MPH, chief of infectious diseases at Massachusetts General Hospital and Brigham and Women’s Hospital, to run the CDC.
Hospitals make plans to vaccinate staff
A CDC committee has recommended that health care workers be the first to receive vaccine. But state health departments are leaving it up to individual hospitals to figure out how, when and who among their workforce to vaccinate first. In a Business Insider article, representatives from four big health systems—Intermountain, Northwell Health, McLaren Health Care in Michigan and Yale New Haven Health—shared some of their strategies to vaccinate staff. Some plan to stagger vaccinations within departments in case some doctors and nurses are out with side effects, which can include headache and fatigue. Others wanted to let clinicians themselves decide who wanted to be vaccinated first, but have scrapped that approac because initial vaccine supplies will be limited. Instead, most health systems are prioritizing those on the front lines with covid patients, including workers in environmental services. While some hospitals intend to vaccinate their own staff, McLaren will partner with Walgreen’s throughout the state. Vaccine candidates from both Pfizer and Moderna are getting close to an EUA from the FDA, although Pfizer may not be able to provide more than 100 million doses—enough to vaccinate 50 million people—before <a href=https://www.washingtonpost.com/health/2020/12/07/pfizer-vaccine-doses-trump/>next summer</a>.
December 7, 2020
You became infected. Should you get vaccinated?
For the thousands of health care workers who’ve already been infected with covid, should they be vaccinated when a vaccine becomes available? Clinicians are falling on different sides of that debate, according to MedPage Today. Some who’ve recovered believe they’ve developed some immunity and think that scarce vaccine resources should instead go to others who’ve never been exposed. But others point to the fact that long-term immunity is still an open question and that no one knows how long antibodies may persist. That camp believes they should be included in the first wave to receive vaccine to avoid becoming re-infected and perhaps taking the virus home to their families. Still others hold that, while clinicians who’ve recovered should eventually be vaccinated sooner rather than later, they may want to hold off until colleagues who have never been infected receive the vaccine first. That raises another question: Given how many people remain asymptomatic after being infected, should people first be tested for antibodies before being vaccinated?
Remdesivir: shrinking indications?
The NIH last week revised its guidelines on the use of remdesivir, further contracting the drug’s indications. In updated guidance on therapeutic management, the NIH no longer recommends remdesivir with dexamethasone for hospitalized covid patients who need either intubation or ECMO. Instead, dexamathasone alone is now recommended for those such patients. The NIH does recommend using remdesivir in hospitalized patients who need minimal supplemental oxygen, and a combination of remdesivir and dexamethasone for those requiring increasing amounts of supplemental oxygen. As for hospitalized patients not on supplemental oxygen, NIH maintains there is insufficient evidence either for or against using remdesivir. The WHO last week published interim results of a trial it sponsored, one that concluded that remdesivir—as well as hydroxychloroquine, lopinavir and interferon regimens—don’t improve hospitalized patients’ overall mortality, length of stay or need for ventilation. But editorialists have pushed back against that conclusion, noting that the WHO trial was conducted across more than 400 hospitals in 30 countries. While launching the trial was “a remarkable achievement,” they wrote, the research was conducted “in settings with varied and evolving standards of care, capacity to administer treatment, and treatment options.” The editorial also points out that other studies have found that remdesivir helps speed recover, and the authors believe the drug’s role in treating hospitalized patients is still being determined.
December 5, 2020
Former hospitalist named surgeon general—again
Vivek Murthy, MD, MBA, a former hospitalist at Boston’s Brigham and Women’s Hospital who served as the nation’s surgeon general from 2014 to 2017, has been named the surgeon general in the incoming administration. But Dr. Murthy is also being given “a broader portfolio,” according to Politico, one that will include being the top medical expert of the incoming administration’s covid response as well as its public face. As surgeon general, Dr. Murthy is expected to devote himself to the pandemic response in the coming year. Once the immediate crisis has abated, he will likely focus on substance abuse, mental health and health care disparities. Dr. Murthy currently serves as co-chair of the president-elect’s covid advisory board.
December 4, 2020
No good inpatient news in 2021 physician fee schedule
The CMS this week finalized the Medicare physician fee schedule, boosting payments for outpatient E/M visits starting in 2021. However, the final rule also busted down the conversion factor from $36.09 to $32.41, a move panned by several medical societies. (The final rule also made permanent the expansion of several telehealth services.) In response, the president of SHM this week sent a letter to several members of the House of Representatives, voicing strong support for their bipartisan bill (H.R. 8702). If passed, that bill would hold providers harmless for two years from pay cuts due to budget neutrality adjustments to the physician fee schedule. Otherwise, the letter states, those adjustments will translate to hospitalists seeing an 8% drop in their Medicare fee-for-service revenue.
Doctors, nurses appeal to state leaders
As daily hospitalization and death rates continue to break records, overwhelmed health care workers are appealing directly to state governors to take further actions to contain the virus. In Connecticut, a letter that physicians sent to the governor garnered close to 700 online signatures. That letter asked him to close gyms and indoor dining and to ban public gatherings. In response, the Washington Post reports, the governor met virtually with several of those physicians to hear their concerns. In Mississippi, however, the governor rejected a call from four leaders of health systems and medical associations in the state to re-impose a statewide mask mandate. Instead, the governor increased the number of counties in the state that have mask mandates, to 54 out of a total of 82 counties. Doctors in Tennessee have likewise appealed to their governor to put a statewide mask order in place, while physicians in Missouri have started a similar petition.
December 2, 2020
CDC advisory panel: You’re 1a (updated Dec. 4)
With more than 100,000 Americans now hospitalized for covid, a federal advisory panel this week recommended that health care workers—all 21 million—be the first in the country to receive a vaccine when one becomes available. Also at the front of the line in what the CDC is calling phase 1a of vaccine distribution: about 3 million residents of long term care facilities, a population with more than 100,000 deaths. The recommendations came in a 13-to-1 vote from the CDC’s Advisory Committee on Immunization Practices, an expert panel that helps the CDC determine how to distribute vaccine doses. The FDA may issue EUAs for vaccines next week, with the first doses available this month. Operation Warp Speed, the federal vaccine initiative, plans to vaccinate 100 million Americans, including all health care workers and high-risk patients. According to a preprint model, prioritizing health care workers and high-risk patients and vaccinating 40% of the U.S. population could decrease hospitalizations by 85% and deaths by 88%. But will being vaccinated be mandatory in hospitals? According to a write-up from the Philadelphia Inquirer, the answer is “probably not,” given that these vaccines won’t be fully licensed. Spokespeople from local health systems in Philadelphia noted that being vaccinated, at least initially, will be voluntary, while a New Jersey health department poll found that about one-third of doctors surveyed didn’t want to be part of the first round of vaccinations.
CDC revises its guidance on quarantine (updated Dec. 4)
The CDC this week recommended a shorter time for quarantine, a move that public health officials hope will encourage more exposed patients to actually stay home. While the CDC still advises a 14-day quarantine as the safest course, the revised guidance holds that exposed individuals who don’t develop symptoms need to quarantine only 10 days, while those who also test negative should stay in quarantine only seven days. The revisions come after a meta-analysis in The Lancet found that, while viral shedding may last weeks or even months, no live virus is shed longer than nine days. According to that analysis, covid patients are the most infectious from two days before symptom onset to five days later, while older patients tend to shed live virus for nine days. Another finding: Asymptomatic patients have the same viral loads as those experiencing symptoms, but they can clear those loads faster. The authors write, “These findings indicate that, in clinical practice, repeat testing might not be indicated to deem patients no longer infectious. Duration of infectiousness and subsequent isolation timelines could reflect viral load dynamics and could be counted from symptom onset for 10 days in non-severe cases.”
Olfactory mucosa may be the gateway for brain infections
Neurologists still aren’t sure if coronavirus can invade the brain directly. New findings based on more than 30 autopsies suggest that such an invasion may be happening via olfactory mucosa. Publishing in Nature Neuroscience, German researchers took images of intact virus in patients’ nasopharynx, perhaps entering the central nervous system by “exploiting the close proximity.” The authors noted that their results apply to only patients with severe disease. They also added this: “As we were able to detect SARS-CoV-2 RNA in some individuals in CNS regions that have no direct connection to the olfactory mucosa, such as the cerebellum, there may be other mechanisms or routes of viral entry into the CNS, possibly in addition to or in combination with axonal transport.”
December 1, 2020
Hospital staffing becomes “a national bidding war
It’s a staffing problem that hospitals are struggling with: an exodus of nurses being lured away to other facilities or to traveling-nurse agencies by lucrative incentives. An article from Kaiser Health News describes what its authors call “a national bidding war,” as nurses—especially those who feel they’re not adequately protected against covid in their hospitals—easily find higher-paying opportunities elsewhere. The article quotes one nurse who quit a full-time job in suburban Denver hospital where PPE was reused until it fell apart; as a traveling nurse, she saw her salary jump from $800 a week to $5,200, with a contract that guaranteed adequate PPE. Job postings, particularly for slots in Plains and Rocky Mountain states looking for ICU nurses, are offering up to $10,000 a week. Rural and urban safety-net hospitals can’t begin to afford such salaries and have the most to lose.
November 30, 2020
No good news in revised CDC forecasts
It remains to be seen if a Thanksgiving surge of cases materializes. But the CDC has crunched more than two dozen models to come up with a revised forecast for new cases in four weeks. During the week ending Dec. 19, the CDC predicts there will be between 1.1 million and 2.5 million new cases. (The Web site includes links to state and county forecasts as well.) The models used in the national forecast make different assumptions about social distancing measures. As for deaths, the CDC’s forecast relies on three dozen different models. The agency’s prediction: Covid deaths will rise over the next three weeks, with between 10,400 and 21,400 deaths the week of Dec. 19. That week, the overall death toll in the U.S., according to the CDC, will total between 294,000 and 321,000.
CMS moves to boost hospital capacity
In response to rising numbers of covid hospitalizations, the CMS has signed off on a number of relaxed regulations, all designed to increase hospital capacity. The CMS is expanding its Hospitals Without Walls program to make it easier for facilities to establish hospital at home capability to treat patients with 60 different conditions outside the hospital. Participating hospitals must have screening protocols and at-home needs assessment, and patients may be admitted only from EDs or hospital beds. Patients first need to be evaluated in person by a physician, and either RNs or paramedics must provide two in-person visits daily. (Hospitals that want to participate should file a waiver request <a href=https://qualitynet.cms.gov/acute-hospital-care-at-home >here</a>.) The CMS also announced more flexible regulations for ambulatory surgery centers, allowing them to be temporarily certified as hospitals and to provide care to patients for 24 hours or longer.
November 25, 2020
Plenty of ventilators, not enough clinicians to operate them
While hospitals were desperate to find ventilators in the spring, the national supply now seems OK. Instead, the problem is finding enough pulmonologists, respiratory therapists and clinicians with critical care experience to operate them. The New York Times reports that device manufacturers in the U.S. have produced more than 200,000 ventilators since the spring, with 155,000 of them going to the National Strategic Stockpile. Meanwhile, doctors have been using other methods to get oxygen to hospitalized patients. But now, hospitals are again strained, particularly in rural areas that don’t have ICU personnel. Currently, there are only 37,400 intensivists in the country, and close to half of the nation’s hospitals have none on staff; even in hospitals with ICU staff, that staff is burning out. In other staffing news, more than 900 staff members at Mayo Clinic’s Midwestern facilities have been infected with covid—within the last two weeks. That’s close to a third of all Mayo staff members who have become infected since the beginning of the pandemic. MedPage Today reports more than 90% of those infections were contracted in the community.
Controversy over remdesivir
While it is now routinely used in hospitals to treat covid patients, remdesivir is not getting the WHO’s endorsement. Last week, the global health organization recommended against using remdesivir in hospitalized patients, saying evidence doesn’t uncover any mortality or outcomes benefits. Many infectious disease experts, however, back the drug’s use, saying it may improve some patients’ clinical course, especially when used early in the disease. The IDSA this week released revised guidelines that advised using remdesivir in hospitalized patients with severe disease. The guidelines also recommended against routine use of the two monoclonal antibodies the FDA recently issued EUAs for. The guidance did note that those therapies may be appropriate for patients at higher risk of covid complications.
The link between viral load and mortality
New research from the University of Washington published in Open Forum Infectious Diseases adds to evidence of an association between viral load on admission and patients’ odds of 30-day mortality. The retrospective study of more than 180 patients found that those with a high covid viral load on admission (a cycle threshold of less than 22) had more than a four-fold greater risk of dying within 30 days. The research also found that patients who were IgG seropositive had less risk of mortality, although those findings weren’t significant—which may be due, the authors noted, to the small sample size. “Our work illustrates,” they wrote, “the importance of quantitative virologic and serological testing for SARSCoV-2 infection.”
November 24, 2020
And then there were three
AstraZeneca yesterday announced that its vaccine candidate, one developed with Oxford University, was up to 90% effective, based on interim results of phase 3 trials. But the 90% rate was based on administering first a half-dose, then a full dose; when two full doses were used, the vaccine was only 62% effective. STAT reports that the U.S. trial for AstraZeneca is testing two full doses—but that regimen may soon change. This makes AstraZeneca’s the third vaccine candidate, after Pfizer-BioNTech and Moderna, to publish trial results within the last two weeks. According to reports, AstraZeneca-Oxford’s has some advantages: For one, it’s expected to be cheaper at about $2.50 a dose, while Pfizer’s may cost about $20 per dose and Moderna’s between $15 and $25. Also, it can be stored in refrigerators; Moderna’s can remain in regular refrigerator temperatures for only 30 days (otherwise, it needs to be frozen), while the Pfizer-BioNTech vaccine needs ultra-low temperatures.
Death rates are falling
Covid deaths are the rise, but at least a higher proportion of patients are surviving the disease. Experts say that falling mortality rates are due to better understanding of the disease and its potential treatments, as well as to younger patients now becoming infected vs. more older patients earlier this year. However, one factor that’s contributed to improved mortality rates is hospitals not being as inundated as they were in the spring with covid patients—an advantage that’s now evaporating. According to one analysis, the mortality rate among hospitalized covid patients fell from 11.4% in March to below 5% in June and 3.7% in September. The same analysis also found length of stay also dropping, from 10.5 days to 4.6. A recent JHM analysis based on data from three New York academic centers found that their adjusted covid mortality fell from 25.6% in March to 7.6% in August.
November 23, 2020
New treatment options
It may become known as the Trump cocktail: The FDA this weekend issued an emergency use authorization for the monoclonal antibody combination—casirivimab plus imdevimab—that the president received last month after his covid diagnosis. The treatment is not authorized for hospitalized patients or those who need supplemental oxygen. Instead, it’s intended for patients with mild to moderate disease who are at high risk of developing severe disease, including those age 65 and older. The IV antibody has been authorized for patients 12 and older who weigh at least 40 kg. The Hill reports that the combo’s manufacturer, Regeneron, believes 80,000 doses will be available by the end of this month and 300,000 by the end of January. The FDA also issued an EUA for this combination: baricitinib, an oral janus kinase inhibitor, and remdesivir. This treatment is authorized for hospitalized patients age 2 and older who need supplemental oxygen, invasive ventilation or ECMO. In a randomized trial of 1,000 hospitalized patients, patients taking that combo (vs. remdesivir plus placebo) had a shorter time to recovery and less risk of mortality or need of mechanical ventilation within 29 days.
You’re in a distinct minority
Plenty of articles have described shortages of PPE, ventilators and ICU beds. Now, as the latest covid surge bears down nationwide, new attention is being paid to another resource in short supply: inpatient physicians with experience treating hospitalized patients. UPenn researchers analyzed 2017 Medicare fee-for-service billing data on close to 600,000 physicians. They found 45% of physicians had billed hospital visits while 7% had billed for critical care. (Those billing for ED visits were excluded from the analysis.) However, many—17% for hospital visits, 43% for critical care visits—performed 50 or fewer of those visits that year. Two of the same researchers published an analysis in Healthcare that looked at regional physician workforce estimates in conjunction with predicted peak covid hospital volumes. In an article those authors wrote for STAT News, they write that 35 states may face a shortage of inpatient physicians with recent experience treating hospitalized patients. Hospitals anticipating a shortage, they write, should implement training protocol to help prepare doctors who aren’t hospitalists to work in the hospital. A UPenn brief synthesizing both studies is available here.
November 20, 2020
Considering “contingency” and “crisis standards”
As the country surpasses 250,000 covid deaths, The Atlantic reports what many of you already know: Hospitals are either at capacity, experiencing staffing shortages or both. Currently, more than one-in-five hospitals (22%) across the country expects to be short-staffed. That rises to 35% in Arkansas, Missouri, North Dakota, New Mexico, Oklahoma, South Carolina, Virginia and Wisconsin, with all indications that the number of covid hospitalizations is accelerating and will continue to rise. In an article in The New Yorker, a New York-based hospitalist writes that hospital leaders in Utah are considering new standards of care. One, the contingency standard, will take effect when ICUs are overwhelmed and clinicians from other specialties need to treat those patients. The second is the “crisis standard,” where hospitals need to ration ICU care. As part of those decisions, clinicians will weigh patients’ comorbidities and give preferential treatment to younger patients and those who are pregnant. Already, rural hospitals in the Midwest and Plains states are finding few transfer options. That’s because the larger hospitals they typically transfer to are either full themselves or are understaffed due to infections. For one critical access hospital in Kansas, the only large hospital it can transfer patients to now is six hours away.
Data reveal only modest cardiovascular complications
The first results of analyses done on the covid registry maintained by the American Heart Association delivers this good news: Hospitalized covid patients are having fewer cardiovascular complications than researchers expected to find. However, the results also underscore the high risk among minorities and patients who are obese. The database includes information on more than 22,000 patients, with data supplied by more than 100 hospitals and academic centers. What the analyses found: Eight percent of hospitalized covid patients had a composite rate of CV death, stroke, MI, heart failure and shock, with atrial fibrillation being reported in 8% as well. Less than 4% had DVT, PE or MI, while fewer than 2% of patients had stroke or new heart failure. Meanwhile, myocarditis was found in 0.3%. However, 43% of hospitalized covid patients were obese, a differential seen especially in patients age 50 and under. While African-Americans make up just over 10% of the population, they represented 26% of cases and 24% of deaths. Hispanics, who make up only 9% of the census, accounted for 33% of cases and 29% of deaths. The AHA is inviting researchers to submit research proposals to use the nationwide covid dataset. The deadline for proposals is Wednesday, Dec. 2.
Getting together for Thanksgiving?
If you’re planning an in-person Thanksgiving with friends and family, here’s the CDC’s advice: Don’t. The safest way to spend the holiday, according to the CDC, is with members of your own household only. If you do host people who don’t live with you, limit their number and eat outdoors, in addition to masking and physical distancing. If you’re going to someone else’s home, bring your own food, drinks, plates and utensils—and if you are planning to travel, you should already be in quarantine. One Mississippi newspaper went with this headline: “After Big Thanksgiving Dinners, Plan Small Christmas Funerals, Health Experts Warn.” A survey done by Ohio State Wexner Medical Center finds that almost 40% of people are planning to attend events with more than 10 people over the holidays; a third of them didn’t intend to ask guests to wear masks. And Georgia Tech has devised a real-time, interactive Web site that allows you to gauge your risk of being with infected people at events. (Find the related study in Nature Human Behaviour here.) Put in the estimated number of people at the event and click on the county where it’s being held, and you’ll see your risk of being with at least one covid-positive person.
November 18, 2020
Rural hospitals are running out of transfer options
As hospitals throughout the Midwest and Plains states become overwhelmed, Fierce Healthcare reports rural hospitals that typically transfer out patients who need higher level and critical care now find dwindling options. That’s because the larger hospitals they transfer to are either full themselves or have lost staff due to infections or quarantines. As a possible solution, some rural hospitals are considering working together to designate some facilities as covid-only hospitals while others would treat only non-covid patients. For one critical access hospital in Kansas mentioned in the article, the only large hospital it can still transfer patients to is six hours away.
More good news on vaccines
It’s another big week for vaccine news. On Monday, biotech Moderna announced (via a press release) that its mRNA vaccine candidate shows an efficacy rate of better than 94%. The company is also stressing this feature: Unlike the Pfizer-BioNTech candidate, which needs to be stored at ultra-cold temperatures, Moderna’s is stable for up to 30 days in a normal refrigerator. Pfizer-BioNTech came back today with its own announcement, saying its data indicate a 95% efficacy as well and that the two companies plan to apply for an FDA EUA within a matter of days. According to the announcement, the Pfizer-BioNTech data includes two months of follow-up. While the news and the two vaccines’ safety profiles are encouraging, it’s still unknown when either candidate (or any of the others being developed) would be available. STAT News reports that the FDA is expected to issue EUAs, which would allow some vaccine to be distributed to front-line workers and patients at high risk for severe disease before the end of the year. General distribution would have to wait until next spring.
The most hopeful answer yet to the question of how long immunity lasts after being infected with coronavirus comes in a new preprint. According to New York Times coverage, the new data are also the most comprehensive. In the study, researchers recruited close to 200 patients who’d recovered from covid; the majority had mild disease and weren’t hospitalized. Researchers analyzed subjects’ blood samples, some for eight months, and they found four immune components: antibodies, B cells and two types of T cells. While antibodies were durable, the T cells decayed only slightly over those months—and the B cells actually multiplied, a result the authors can’t explain. While a small number of recruited subjects were found to not have long-term immunity, that may have been a function of how little virus they were exposed to.
November 16, 2020
Philly-area nurses contemplate a strike
Two thousand-plus nurses in southeastern Pennsylvania may strike this week, citing their hospitals’ “unsafe staffing that seriously undermines patient safety” during the pandemic. Nurses at one Philadelphia-area hospital avoided a strike with a new contract that boosted pay and staffing levels. In North Dakota, the lack of hospital capacity is so constrained that the governor proposed allowing health care workers who’ve tested positive to continue working with covid patients; the state’s nurses association rejected that proposal. The Washington Post reports that the lack of hospital capacity is especially dire in the upper Midwest and Plains states, which lead the country in both covid deaths and new cases. That’s a preview, experts say, of what the rest of the country can expect over the next several weeks. Already, critical access hospitals in the region that want to transfer out critically ill patients can’t find anywhere to send them. An article in The Atlantic points out that exhaustion is setting in for health care workers who’ve already worked through two waves and are now looking at something worse. While the rest of America digests election results and plans Thanksgiving, health care workers “do not have the luxury of looking away.” Iowa has run out of staffed beds, and smaller hospitals can’t attract traveling and ICU nurses, who are being lured away by higher pay in cites.
November 13, 2020
A staggering surge in coronavirus cases saw more than 150,000 new cases being reported yesterday and more than 66,000 hospitalizations. While many outbreaks in the spring were linked to nursing homes and large events, public health officials say that new cases now can be traced to small private gatherings among family and friends. States are stepping up with new restrictions, including a 10-person limit in private homes in New York, while some Oregon counties are limiting gatherings to six people. The Seattle Times reports that several big hospitals in Oregon are already limiting elective procedures in an effort to free up hospital space for an anticipated surge. Earlier this week, the incoming administration of the president-elect announced the formation of its transition covid advisory board, a group of 13 doctors, scientists and public health officials.
How safe is that gown?
The bad PPE news a month ago was that up to 70% of KN95 masks didn’t meet filtration standards, according to safety organization ECRI. Now ECRI has turned to disposable gowns and filed this report: More than half the isolation gowns it tested failed safety standards. ECRI tested more than 170 gown samples that hospitals were buying outside their regular supply chains or from international sellers. Some gowns didn’t come with a specified level of protection; of those, 52% failed even the lowest industry standard. Of the ones labeled with a protection level, half didn’t meet that stated level. MedPage Today reports that the subpar gowns failed either a splatter test, a hydrostatic pressure test or both. ECRI’s advice: Don’t buy gowns from unfamiliar suppliers. The organization also supplied a link to its Gown Testing Summary with the manufacturer and model names of the gowns tested.
Preprint: Eight-day quarantine may be as effective as two weeks
The CDC recommends that people exposed to covid quarantine for two weeks. But researchers publishing in a preprint say that an eight-day quarantine, with testing on day one as well as on day seven before leaving quarantine on day eight, is just as effective as staying in isolation for 14 days without testing. To come up with that recommendation, the authors combined data on infectivity, PCR accuracy and covid incubation periods. They also validated their strategy by testing offshore drilling company employees, who need to remain quarantined in hotels before going to a drilling site. According to coverage of the study, the findings underscore the importance of testing before ending quarantine.
November 10, 2020
Vaccine breakthrough? Plus, EUA for antibody treatment
Early trial results released yesterday from Pfizer and BioNTech indicate that the vaccine the two companies are developing has a 90%-plus efficacy a week after a second dose. Experts caution that no one knows how long the vaccine may last and that key long-term safety data still need to come in. The phase 3 trial has enrolled about 44,000 volunteers, with 39,000 having received both doses. Trial enrollees need to be observed for at least two months after their second dose, and this particular vaccine is not being tested in children. The encouraging news comes at the same time as a STAT-Harris poll shows that 60% of Americans say they are likely to get a vaccine if it cuts their risk of becoming infected by at least half. While the vaccine manufacturers haven’t yet applied for an emergency use authorization, the FDA yesterday issued an EUA for Eli Lilly’s monoclonal antibody treatment. The investigational therapy, called bamlanivimab, is being authorized to treat mild-to-moderate covid in both adult and pediatric patients (age 12 and older). An FDA press release notes that the agent is not authorized for covid patients who are hospitalized or who need oxygen therapy.
Nearly one in 10 covid patients is readmitted
As if readmissions overall weren’t bad enough, a new CDC analysis finds that 9% of all covid patients are readmitted to the same hospital within two months—and that 2% of patients had multiple readmissions. Readmission risk factors include being 65 or older; having COPD, heart failure, diabetes or chronic kidney disease; being hospitalized within three months before the index covid hospitalization; and being discharged to either a SNF or home health care. The median time from discharge to first readmission was eight days. The analysis looked at about 126,000 index hospitalizations between March and July, with about 15% of those patients dying in the hospital. According to the report, the results underscore the need for careful planning, discharge disposition and post-acute follow-up.
The ACA’s (latest) day in court
The Supreme Court today will hear arguments about the ACA, the third time the 2010 law has come up in front of the nation’s highest court. This time, in the case of California vs. Texas, the court will decide whether to uphold a lower court’s ruling that the ACA’s individual mandate—one requiring everyone to maintain health insurance—is unconstitutional, thereby invalidating the entire law, or if the insurance requirement can be considered separately from the rest of the ACA. The court’s decision will come at a time when contracting covid would be a pre-existing condition and fall under the ACA’s protection for pre-existing conditions. Should the ACA be struck down, those infected could have a hard time maintaining insurance, while an additional 20 million American could lose their health insurance.
November 9, 2020
Incoming administration names covid transition advisory board
With election results called Saturday morning, the incoming administration this morning announced the formation of its transition covid advisory board. The group of 13 doctors, scientists and public health officials will be co-chaired by Vivek Murthy, MD, a former hospitalist and surgeon general; David Kessler, MD, a former FDA commissioner; and Marcella Nunez-Smith, MD, MHS, a public health researcher. Among the advisory board’s 10 other members: UPenn’s Ezekiel Emanuel, MD, PhD; Atul Gawande, MD, MPH, of Harvard and Brigham and Women’s Hospital; Michael Osterholm, PhD, MPH, from the University of Minnesota; and Robert Rodriguez, MD, a UCSF professor who works in the ED and the ICU of two trauma centers. The panel will advise on the incoming administration’s pandemic response including vaccines, testing and contact tracing. Several panel members have counseled the incoming administration during the campaign.
Nursing home cases in hard-hit states start to surge
This weekend, AP reported that nursing home cases in states with covid surges have risen more than four-fold. That’s according to an analysis of May-October data from close to two dozen states. While resident deaths in those facilities have more than doubled over that time, weekly cases have more than quadrupled. The current administration has tried to protect nursing homes, allocating $5 billion as well as fast-test machines and PPE. But experts believe that infected staffers—pre- or asymptomatic—are bringing the infection in. While residents of nursing homes and other long-term facilities make up only 1% of the U.S. population, they account for 40% of covid deaths.
November 6, 2020
Study: Ultrasound bests X-rays in screening for covid pneumonia
Findings presented by Temple University researchers at last month’s ACEP virtual meeting indicate that portable ultrasound was more sensitive than X-ray in detecting pneumonia in patients with suspected covid. According to MedPage Today, ultrasound sensitivity in patients with possible covid was 97.6% vs. 69.9% for chest X-ray. (Specificity was lower: 33.3% with ultrasound vs. 44.4% for X-ray.) The research tracked more than 140 ED patients who all received both ultrasound and X-rays. Those at high risk or with abnormal findings then went on to have a CT scan and most were admitted, while those with negative findings were typically discharged home. The authors note that patients with possible covid at their hospital now are routinely screened with ultrasound scans, not X-rays.
CMS fines half of all hospitals
In its ninth annual round of readmission penalties, the CMS is lowering Medicare payments for almost half of all hospitals, due to excess readmissions. Retroactive to Oct. 1, Medicare will lower a year’s worth of payments to 2,545 hospitals, Kaiser Health News reports, with an average reduction of 0.69%. More than 600 hospitals will be penalized 1% or more, although the number of hospitals receiving the maximum penalty—3%—fell from 56 this past fiscal year to 39. This latest round of readmission penalties was announced despite the fact that the CMS wrote in September that it is thinking of suspending that program, given all the problems caused in hospitals by the pandemic and this spring’s suspension of elective procedures.
November 5, 2020
An horrendous milestone, and some good news on myocarditis
The number of new infections in the U.S. on Wednesday topped 100,000 for the first time, a frightening threshold–and then smashed through that record on Thursday, with more than 120,000 new cases. Those numbers are part of a seven-day average that is 108% higher than just a month ago, with more than 52,000 infected patients currently hospitalized. There is this ray of good news: Fewer covid patients than previously estimated may have myocarditis. Findings reported in Cardiovascular Pathology indicate that, among autopsies of close to 300 covid patients, the rate of heart inflammation ranged between 1.4% and 7.2%. Previously reported rates ran from 14% in athletes positive for covid to 60% in middle-aged and senior patients who recovered.d between 1.4% and 7.2%. Previously reported rates ran from 14% in athletes positive for covid to 60% in middle-aged and senior patients who recovered.
Staff exhaustion, and treacherous work for “travelers” (updated)
November 3, 2020
Where’s the hidden hospital data?
HHS continues to collect data daily from individual hospitals on everything related to covid, from the number of daily admissions to ICU capacity. But NPR now reports that the administration is no longer sharing those data with the public or researchers. Instead, the analysis of the hospital data being collected is being circulated only among “a few dozen staffers,” including those from the HHS, the CDC and the NIH. Critics say that not making those data widely available will block efforts to craft an appropriate local response and make it harder to predict which hospitals and health systems are at risk of being overwhelmed. The issue of daily hospital data has been controversial since the administration changed data collection from the CDC to HHS in July. HHS has since cracked down on hospitals that aren’t complying with daily reporting, warning that hospitals out of compliance may eventually be terminated from the Medicare and Medicaid programs.
A break room outbreak
A hospital in western Massachusetts is reporting an outbreak among 15 employees—and has noted that the cluster is probably due to staff eating together in a crowded break room. Among the infected at Holyoke Medical Center, 10 worked in the ED. The hospital has since put new capacity limits on break rooms, according to a statement from the hospital CEO. He pointed to what he called “covid fatigue,” suggesting that some staff members may be lulled into letting their guard down in terms of appropriate physical distancing and PPE. The hospital statement didn’t mention how big the break rooms are or what the new capacity threshold is.
November 2, 2020
Worst pandemic week yet
The New York Times on Friday described last week as the U.S.’ worst pandemic week yet. More than 500,000 new cases had been identified over the previous seven days, for a total of more than 9 million cases since the pandemic began, and record-breaking numbers of new cases continued over the weekend. Unlike other surges, this one isn’t confined to just a few cities or regions but is producing outbreaks around the country. As if the pandemic wasn’t overwhelming enough: U.S. hospitals are now dealing with a rash of ransomware attacks, with several hospital systems—in Pennsylvania, New York, Vermont and Oregon, among others—attacked last week. Hospitals being hacked may need to divert patients elsewhere while patients may see delays in care.
October 30, 2020
Shorter incubation period linked to more severe disease
While incubation periods show a lot of variability, new research from China concludes that clinicians should focus more attention on patients with shorter incubation periods before symptom onset. The study of 330 patients hospitalized with covid found that those with a shorter incubation period—defined as less than three days between exposure and symptom onset—were more likely to have aggravated lung involvement on CT scan than those with incubation periods of more than 10 days. While the median incubation period in the study was seven days, 17% of patients had symptoms within three days while 23% didn’t develop symptoms for more than 10 days. The study appeared in Virulence. Of note: While the authors acknowledged problems arriving at precise incubation periods, exposure times were determined via medical history—and via big data and artificial intelligence from closed-circuit televisions, smartphones, mobile payments, and high-speed rail or airplane records.
Colorado CMOs share expertise, resources, best practices
When the pandemic broke out in March. the CMOs and CCOs of seven Colorado health systems decided to band together to share best practices as well as information about their individual supply chains and staffing challenges. In a commentary they published in NEJM Catalyst, the seven CMOs write that their collaboration played a part in that state’s rapid de-escalation of infection, hospitalization and death rates. Between March and July, the seven health systems combined treated 98% of the state’s hospitalized covid patients. The physician executives met virtually for an hour every weekday and shared their hospitals’ or health systems’ dashboards on implemented policies and supply inventories and burn rates. The partnership allowed those systems to share and redeploy resources—including staff, ICU beds, ventilators and medications—to hotspots around the state
October 28, 2020
Covid surges: Can regional hospitals keep up with demand? (Updated)
The fall covid surge is here with a vengeance, as close to 70,000 new cases are being reported per day and officials in at least four states—Colorado, Texas, Massachusetts and Idaho—impose new restrictions on social gatherings, businesses and schools. With nearly 43,000 patients hospitalized around the country, regional hospitals throughout the Midwest and Plains states are being strained as rural hospitals with fewer resources keep sending patients. According to the New York Times, that strain is becoming critical in Idaho, Missouri, New Mexico and Utah, while health workers from around Texas are converging on El Paso to help with that outbreak. Research done at Vanderbilt on covid caseloads in Tennessee hospitals finds that hospitals in areas without mask mandates are seeing much higher hospitalization rates. Other findings released this week, these from the University of Kansas, found a 50% reduction in covid spread in counties in Kansas that mandate masks vs. those that don’t.
More clues on how long antibodies last (Updated)
Recent studies offer differing views on how long antibodies last in covid patients after they’re infected. One preprint out of Britain reports that antibody levels fall about 27% over a three-month period. In response, experts point out that such a reduction is normal after an infection. Another study, this one published in Nature Microbiology, had U.K. researchers following 65 covid patients for up to three months after symptom onset. They found that patients with a high-peak infective dose (ID50 of more than 10,000) maintained neutralizing antibody titers of 1,000-plus for more than 60 days, while those with lower peak infective doses had their neutralizing antibodies return almost to baseline. The findings suggest, say the authors, that people may need vaccine boosters for longer-term protection. But a third study finds that neutralizing antibodies persist for at least five months. The authors analyzed data on more than 30,000 patients with mild to moderate covid who were screened at New York’s Mount Sinai. They found that the “vast majority” had robust IgG responses, with titers remaining “relatively stable for several months.” Results were published in Science.
October 27, 2020
Can the pandemic drive creative change?
Covid’s disruptions and distress have all added up to trauma for the U.S. (and global) health workforce. Can any good come out of that? According to the authors of a recent JAMA viewpoint, the pandemic may spur posttraumatic growth, which they characterize as psychological changes achieved after going through severe adversity and accepting it as the new normal. To facilitate that growth, health care workers and organizations need to assess the impact of the pandemic, seek out role models (or best practices in groups) that have grown through their handling of the crisis, be creative when looking for new ideas and structures, emphasize altruism and connections, and deal with loss and grief. Hallmarks of that growth include stronger relationships, willingness to embrace new possibilities, improved perception of personal strength, heightened spirituality and an increased appreciation of life. “Posttraumatic growth does not minimize the seriousness and severity of what has happened,”; the authors write, “but can emerge from adversity through active management following the important process of grieving.”
October 26, 2020
Bad trends getting worse
Nothing but bad news on covid cases and hospitalizations: On both Friday and Saturday, the U.S. posted more than 83,000 new covid cases, the two highest single-day tallies since the beginning of the pandemic. As for hospitalizations, the New York Times reports that those figures have jumped 40% over the past month, rising to more than 41,000. While the overall number of hospitalizations was higher this spring, the burden of care is now falling on smaller hospitals in the Midwest and Mountain states, which have many fewer beds than urban academic centers. A modeling study released in Nature Medicine by the University of Washington’s Institute for Health Metrics and Evaluation lays out three possible scenarios for this winter. The first: States continue to ease physical distancing mandates, resulting in more than 1 million covid deaths by the end of February. The second scenario has states tightening restrictions in response to rising mortality—with more than 500,000 deaths over the same period of time. The third scenario relies on 95% of Americans wearing masks in public when their states reach a threshold of eight daily deaths per million. Under that scenario, 130,000 deaths could be prevented.
Study: No benefit found with convalescent plasma
A randomized trial testing the efficacy of convalescent plasma to treat patients with moderate covid came up empty in terms of reducing patent progression to severe covid or mortality. The trial enrolled more than 460 patients at several dozen hospitals in India. STAT reports that an earlier study, this one done at the Mayo Clinic without a control arm, did find benefit; those results were instrumental in the FDA issuing an emergency use authorization. Sources quoted by STAT note that more than 80% of the patients in the Indian trial had already developed antibodies, suggesting that they should have received convalescent plasma earlier. They also note that researchers didn’t measure antibody levels in the plasma, although later analyses of the Indian research did not find that patients given plasma with higher antibody levels fared better.
October 23, 2020
Studies don’t find clear benefit with tocilizumab
Observational studies have backed the efficacy of the monoclonal antibody tocilizumab to help patients with severe covid. However, a trio of randomized studies published in JAMA Internal Medicine doesn’t deliver a solid endorsement. The first study, which was conducted in the U.S., did find an association between early use of tocilizumab (within two days of ICU admission) and lower risk of in-hospital mortality. But the authors warned of unmeasured confounding. The next trial, this one from Italy, randomized patients with covid pneumonia to tocilizumab or standard care and found no clinical benefit. The third study was done in France, randomizing covid patients with moderate to severe pneumonia to tocilizumab or standard care. While the intervention group had lower risk of death or need for high-flow oxygen or ventilation at day 14 (24% vs. 36%), neither group at day 28 had a mortality advantage. An editorialist writes that he’ll wait for more compelling randomized data. Otherwise, “findings do not support the routine use of tocilizumab for COVID-19 in most settings.” In other news on therapeutics, the FDA has given final approval to remdesivir, which will be marketed under the brand name Veklury.
CDC redefines “close contact”
If you’ve been counting on spending fewer than 15 minutes at a stretch with covid patients so you don’t get infected, the CDC this week upended that strategy. Instead, the agency detailed a case in MMWR in which a corrections officer had a series of encounters, each lasting only a minute or less, with asymptomatic inmates waiting for covid test results. While the inmates weren’t wearing masks, the corrections officer was wearing one as well as goggles and gloves—but he still tested positive within eight days. The CDC has now expanded its definition of “close contact” to include anyone who spends 15 minutes or more as a cumulative total with infected patients over a 24-hour period. The distance cited for transmission is still six feet or less.
Why the hate for DOs?
The high profile given Sean Conley, DO, the president’s physician, in the wake of the president’s covid diagnosis, had this unintended and ill-informed consequence: It produced a lot of disparaging remarks about doctors who train in osteopathic medicine. Apparently, many members of the media and the public mistakenly believe that DOs aren’t fully qualified, licensed physicians. In response, the American Osteopathic Association pushed back, targeting media figures and social media as well as connecting reporters to prominent DOs. The association also urged its members to advocate for osteopathic practitioners and for accurate information. In a commentary published by KevinMD, two prominent hospitalists both DOs—likewise rallied support for their colleagues. “(W)hen someone challenges the validity of a legitimate medical degree,” wrote Joshua Lenchus, DO, and Bradley Flansbaum, DO, MPH, “the entire house of medicine is under attack.”
October 22, 2020
Inpatient admissions are still down
Are admissions back to normal in your hospital? Authors from Sound Physicians teamed up with those from the Dartmouth Institute for Health Policy and Clinical Practice to look at admissions data from more than 200 hospitals across 36 states. Their study, which was published in Health Affairs, compared patient characteristics, diagnoses and mortality between February-July 2020 vs. the same period last year—and they found that admissions by April 2020 were down almost in half. Even months later, however, admissions were close to 20% lower. Why? This spring’s drop was due to patients avoiding hospitals for fear of becoming infected. As for the persistent decline, some studies have pointed to a sharp decrease in air pollution resulting from the shutdown, which could reduce respiratory infections, and masking and social distancing probably did the same. “Alternatively,” the authors write, “the ‘missing’ non-COVID-19 hospital admissions could have resulted in elevated out-of hospital deaths.” Their results also suggest that minority and low-income patients this spring ran into barriers to care access. In a New York Times commentary, a Boston surgeon mentions the Health Affairs study and notes that, in her hospital at least, “more than seven months into the pandemic, there are still no lines of patients in the halls.”
October 21, 2020
Caseloads rise, but mortality may be on the decline
Two preprint studies that have now reportedly been peer reviewed find that mortality rates from covid are falling, at least from their highs this spring. In the first study, researchers analyzed biweekly death rates among 5,000 hospitalized patients
between March and June in one New York City health system. They found that mortality fell from a high of 26% to just under 8%, about a 70% decrease. The second study; was conducted in the U.K. and looked at death rates from covid in ICUs, also between March and June. That analysis found that mortality likewise dropped 20 percentage points. That trend, the authors write, isn’t due to changing patient characteristics, and it persists after adjusting for demographics and comorbidities. This trend remains after adjustment for patient demographics and comorbidities suggesting this improvement is not due to changing patient characteristics.
October 19, 2020
Why have trials been halted?
Headlines last week contained some alarming news: Johnson & Johnson has put its vaccine trial—which encompasses more than 60,000 people—on hold due to an unexplained illness, while Eli Lilly has halted its trial to test an antibody. (AstraZeneca’s vaccine trial has been on hold since last month.) While not being specific about the issues that brought the trials to a halt, the FDA commissioner has said the holds were put in place “to identify safety issues.” According to Fierce Pharma coverage, Johnson & Johnson executives say such halts aren’t unusual in large trials and that they plan to complete their trial enrollment on schedule within two or three months. In other research news, the NIH is launching a trial to test the efficacy of three immunomodulators in hospitalized covid patients. The phase 3 trial will enroll about 2,100 patients and test infliximab, abatecept and the experimental ceniciviroc. All the patients in that trial will also receive remdesivir.
Studies: More links found between blood type, covid severity
Two new studies add to suggestions that blood type may be associated with both covid susceptibility and severity. Danish researchers publishing this month in Blood Advances found that patients with type O blood had less risk of developing covid, although differences in blood type weren’t linked to increased risk of being hospitalized with covid or of mortality. The study found that 38% of patients in blood group O vs. 42% in a reference population. Another smaller study, also published by Blood Advances, reported a link between blood type and disease severity. That trial, done by Canadian researchers, found blood types A or AB associated with a higher risk of being ventilated and of needing continuous renal replacement therapy or prolonged stays in an ICU. The authors collected data from six Vancouver hospitals this spring.
October 16, 2020
U.S. cases on the rise
Bad news on the case curve for covid: The Washington Post reports that the number of single-day cases in the U.S. hit their highest level since late July yesterday, surpassing 64,000 new cases. There’s also been a 23% increase in new cases over the past two weeks while over the past week, the U.S. has averaged more than 53,000 new cases a day, with uncontrolled outbreaks in the upper Midwest and Mountain states. Meanwhile, the Northeast is seeing resurgence (as is Europe) and the number of hospitalizations in the U.S. is rising. This month, average death rates are running at about 700 per day. A JAMA research letter finds that covid patients in the U.S. are dying at unparalleled rates compared to other developed countries. The study compared covid and all-cause mortality rates in the U.S. to those in 18 other countries. On average, the death rate here is 50% higher, running 85% higher than in Germany and Israel and close to 30% higher than in Sweden.
The U.S. posts its first reinfection
A patient in Nevada appears to be the first documented case of covid reinfection in North America, with positive tests first in April and then in June. Reporting in The Lancet Infectious Diseases, the authors say that genomic analysis of the samples revealed significant differences, suggesting two separate infections. The patient was 25 years old and had more severe symptoms the second time around. “Previous exposure to SARS-CoV-2 might not guarantee total immunity in all cases,” the authors write, saying that everyone should take identical precautions, even if they have previously been infected. So far, there have been only a handful of cases of reinfection worldwide, although there have been close to 39 million infections. Researchers note that the issue of reinfections has implications for the application and development of vaccines.
October 13, 2020
NIH updates its covid treatment guidelines
The NIH recently updated its covid treatment guidelines, outlining therapeutic recommendations according to disease severity. For hospitalized patients receiving supplemental oxygen (but not high-flow or ventilation), for instance, the guidelines recommend remdesivir alone or in combination with dexamethasone. However, the guidance advises against using dexamethasone in patients not receiving supplemental oxygen. The updated guidelines also include special considerations for covid patients with HIV and for patients with persistent symptoms after their acute recovery. Among those symptoms: covid brain fog, cognitive impairment that affects patients’ function and their ability to work.
The $16 trillion pandemic
Two Harvard economists have put a price tag on what the coronavirus pandemic may cost the U.S.: $16 trillion, which translates to about $200,000 per every American family of four. Publishing in JAMA, the authors write that the pandemic is “the greatest threat to prosperity and well-being the US has encountered since the Great Depression.” Their projected total costs include $7.6 trillion in lost work output during the next 10 years. And based on current mortality figures, the authors note that an additional 250,000 Americans may die from the virus within the next year; they estimate the value of expected premature deaths due to the virus at $4.4 trillion. That’s in addition to the costs related to long-term complications of many survivors and the mental health burden of those not directly infected. On the other side of the ledger, the authors point to the immense potential social and economic value of policies to reduce virus spread, writing that “increased investment in testing and contact tracing could have economic benefits that are at least 30 times greater than the estimated costs of the investment.” The authors also recommend that the government rethink its role in the pandemic response, making public health infrastructure and services as much of a spending priority as acute treatment.
October 12, 2020
More evidence that remdesivir speeds up recovery (* updated Oct. 16th)
A randomized trial of remdesivir that enrolled more than 1,000 patients finds that the antiviral seems to hasten recovery, cutting about five days off the time that patients need to recover. In a study conducted at 60 trial sites around the world and sponsored by the NIH, patients given remdesivir recovered in a median of 10 days vs. 15 for those given placebo or saline, with the greatest benefit found in patients receiving low-flow oxygen. However, remdesivir did not appear to reduce patients’ mortality odds or needing to be ventilated. The authors point out that remdesivir continues to be tested with immune modifiers and with other antivirals. “(C)ombination approaches are needed,” they write, “to continue to improve outcomes in patients with Covid-19.”
**The WHO yesterday released non-peer-reviewed results of an international study on remdesivir, as well as other repurposed drugs, enrolling more than 11,000 patients across 30 countries. That study concluded that remdesivir didn’t lower covid mortality.
October 9, 2020
How Arizona squashed its curve
A covid tracking site maintained by public health officials finds that more than 40 states have either uncontrolled spread or are trending poorly in terms of coronavirus cases. (Only Maine and Vermont are trending better.) But an early release of MMWR from the CDC details how Arizona was able to mitigate its summer surge that peaked in late June, turning around a 151% increase in daily cases that occurred after the state’s stay-at-home orders were lifted. The mitigation strategies outlined in the article should come as no surprise: implementation and enforcement of mask-wearing via county and city mandates; limiting public events and closing bars, gyms, movie theaters and water parks; scaling back in-dining capacity to 50%; and encouraging non-essential workers to stay at home. According to the reports, the state’s seven-day moving average of daily cases subsequently fell 75%.
Close to one-in-four covid patients in the ICU throws clots
While doctors have known for months that coronavirus promotes clotting, a meta-analysis provides some percentages for clotting among hospitalized covid patients. Nor surprisingly, the risk for developing clots is highest among ICU patients. The review of more than 60 studies found an overall VTE prevalence of 14%, with 8% of VTEs occurring outside the ICU among patients with mild-to-moderate disease and 23% among patients in the ICU. As for PEs, rates were 4% in non-ICU patients and 14% among the critically ill. The authors call for more research on thromboprophylaxis strategies to improve VTE prevention, and the studies included in the analysis covered about 28,000 patients. Results were published last month in Research and Practice in Thrombosis and Haemostasis.
Monoclonal cocktails, convalescent plasma and remdesivir
Physicians step—or get pulled—into the political fray
With the president hospitalized last weekend for covid, several articles discussed “VIP syndrome” (see here and here), where doctors feel pressured to deviate from standard care for prominent or celebrity patients. The president’s personal physician came under fire for issuing vague details about the president’s use of supplemental oxygen, his X-ray findings and the timeline when he first tested positive. Reports also came out this week that physicians who treated the president at Walter Reed last year during a still mysterious episode were asked to sign non-disclosure agreements, which more than one refused to do. Given the heated run-up to the election, at least one doctor is wondering about the ethics of discussing politics with patients: Are such discussions always taboo, or does he have an obligation to raise political issues that affect patients’ health and health care?
October 8, 2020
NEJM slams national leaders as “dangerously incompetent”
For the first time in the journal’s 208-year history, the editors of the New England Journal of Medicine yesterday stepped squarely into the national political fray. While they stopped short of explicitly endorsing Vice President Joe Biden for president, the editorial they penned claimed that, “We have failed at almost every step” in terms of the U.S. response to the pandemic. The editorial laid the blame for that failure on our current national political leaders, saying those leaders have squandered America’s scientific advantages. As for specific failures, the editors cited inadequate testing nationwide, with testing rates per infected person in the U.S. being lower than in Kazakhstan; inconsistent isolation measures and “lackadaisical” social distancing rules; and the politicization of wearing masks, an impasse the current administration has helped create. “(O)ur current political leaders have demonstrated that they are dangerously incompetent,” the editorial concludes. “We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.” Last month, the editors of Scientific American likewise broke that mold, backing a presidential candidate—Biden—for the first time in its 175-year history.
October 7, 2020
Covid’s hard neurologic hit
Two new studies zero in on the neurologic impact of covid among hospitalized patients. A prospective observational study of close to 4,500 patients hospitalized with covid in New York City finds that 14% developed a new neurological disorder. That development, according to research published in Neurology, came a median of two days after symptom onset and was associated with an increased risk of in-hospital mortality and of lower odds of hospital discharge. The most common diagnoses: toxic/metabolic encephalopathy (6.8%), seizure (1.6%), stroke (1.9%) and hypoxic/ischemic injury (1.4%). Another study—this one in the Annals of Clinical and Translational Neurology—looked at neurologic manifestations in more than 500 covid patients hospitalized in Chicago. Among those patients, more than 80% had some neurologic manifestation ranging from myalgias (45%) and headaches (38%) to encephalopathy (32%). The authors found an association between encephalopathy and both worse functional outcome and 30-day mortality.
Hospital data wars may be heating up
The HHS yesterday announced that it is sending hospitals notices about what the department requires in terms of daily covid reporting. Those notices come with this warning: Hospitals that don’t comply with those requirements risk being tossed out of the Medicare and Medicaid programs. According to the announcement, hospitals have 14 weeks to toe the line, with hospitals expected to report daily on a host of covid-related factors including their number of covid deaths, hospitalizations and ICU patients. In addition, CDC officials say that hospitals must also now start reporting on flu cases. The CMS released its final rule on daily data reporting requirements for hospitals in August.
October 5, 2020
Regeneron’s monoclonal cocktail in the spotlight
Hospitalized with covid, President Trump has received at least three treatments: dexamethasone, remdesivir and an experimental monoclonal antibody cocktail being tested by Regeneron, its manufacturer. The company released a press release with preliminary data about the cocktail only last Tuesday. According to that analysis, the combination (dubbed REGN-COV2) reduced viral load and alleviated symptoms in non-hospitalized patients. The first 275 patients enrolled in the trial were randomized to either a one-time high-dose infusion (8 grams, which is what the president received), a low-dose infusion (2.4 grams) or placebo. All enrolled patients were being treated as outpatients. The New York Times reports that Regeneron and Eli Lilly are “the furthest along” among a host of companies and researchers seeking to develop monoclonal antibodies to treat covid.
Study: Plasma antibodies wane within a few months
Findings published in the journal Blood indicate that covid antibodies in blood plasma begin to decline within three months. While experts are still trying to determine the role of convalescent plasma in covid treatment, a press release put out by the American Society of Hematology notes that, according to the research, donors should have their plasma collected as soon as possible after their recovery. The study, which was done by researchers in Quebec, followed 15 patients who recovered from covid and whose disease ranged from mild to severe. Each patient donated plasma between four and nine times. Half of their detectable antibodies decreased within 21 days, while all 15 showed decreased antibodies at 88 days. In addition to encouraging patients to donate plasma soon after recovery, the authors note that donor plasma should be checked for antibodies before being administered.
October 2, 2020
Home health rebounds, but not SNFs
Given the big drop in inpatient volumes during the shutdown, it’s no surprise that discharges to SNFs and to home health agencies likewise took a major hit. Now, however, an analysis finds that home health is bouncing back but that discharges to SNFs remain well below 2019 levels among Medicare fee-for-service beneficiaries. The report, which was released by health care consulting firm Avalere Health, found that the number of discharges to SNFs remains about 25% lower than before the pandemic, while home health agencies actually had close to 5% more business this June than in June 2019. As for why discharges to SNFs aren’t keeping pace with home health, the report underscores the negative impact covid has had on institutional settings. “(S)ome post-acute providers,” the report states, “may not experience a full return in volume for the remainder of 2020 and into 2021.”
October 1, 2020
Don’t let your guard (or mask) down in the hospital
Boston’s Brigham and Women’s Hospital has gone public with what it says is a nosocomial outbreak of covid that has so far affected 12 patients and 33 hospital employees. The hospital is now testing every inpatient every three days in addition to testing all patients on admission, and MedPage Today reports that the cluster may eventually include more than 650 people. Among contributing factors cited: Staff not maintaining appropriate physical distancing, particularly while they were unmasked and eating together. A hospital press release also noted that many patients weren’t masked during staff interactions and that some providers didn’t consistently use eye protection. The hospital believes the outbreak has been contained within two units, which have been closed for deep cleaning and HVAC inspections, and it is changing seating capacity in breakrooms and workrooms.
Among diabetic patients, sitagliptin linked to lower mortality
A small retrospective study from Italy finds an association between adding sitagliptin to insulin for covid patients with type 2 diabetes and significantly lower mortality. Publishing their results in Diabetes Care, the authors compared 169 covid patients receiving sitagliptin along with insulin to 169 diabetic patients given insulin alone. In the sitagliptin group, the authors found mortality of 18% vs. 37% in the insulin-only arm. The use of sitagliptin was also linked to less risk of mechanical ventilation and to fewer ICU admissions. An analysis of U.K. registry data published in August in The Lancet Diabetes & Endocrinology found a mortality rate of around 30% among covid patients with diabetes.