Category Archives: Evidence-based Leadership
Cartoon – Evidence Based Decision Making
The KISS Principle
An unsettling start to the school year
As a long hoped-for sign of the “return to normal”, most children went back to in-person learning this fall. And with the patchwork of COVID safety protocols and masking policies across school districts, classrooms became a learning lab for scientists studying the efficacy of masking and other precautions.
Unsurprisingly, getting a bunch of unvaccinated kids back together caused a surge in pediatric COVID cases. But recent Centers for Disease Control and Prevention (CDC) data from 500 counties demonstrate just how effective mask mandates have been at mitigating outbreaks.
The graphic above shows that cases in counties without school mask mandates increased at nearly three times the rate of those with mask mandates. In the five-week period spanning the start of the school year, cases in counties without a mask mandate rose by 62.6 cases per 100K children, while cases in counties with a mask mandate rose by only 23.8 per 100K. COVID outbreaks are incredibly disruptive to learning; according to a recent KFF survey, nearly a quarter of parents report their child has already had to quarantine at home this school year following a possible COVID exposure.
Even once vaccines are approved for children under 12, recent data suggest that a majority of parents will be hesitant to vaccinate their child. Just over half of 12- to 17-year-olds have received at least one dose of the vaccine so far, and only a third of parents of 5- to 11-year-olds plan to vaccinate their child right away, once the shot is approved.
Many want more information, or are worried about side effects—concerns that will best be assuaged by their pediatricians and other trusted sources of unbiased information.
A new antiviral pill shows promise, as do vaccine mandates
Two pieces of hopeful news on the COVID front this week.
First, pharmaceutical manufacturer Merck announced this morning that molnupiravir, the oral antiviral drug it developed along with Ridgeback Biotherapeutics, reduced hospitalizations among newly diagnosed COVID patients by 50 percent. A five-day course of the drug was so successful in Merck’s clinical study that an independent monitoring group recommended halting the study and submitting the pill to the Food and Drug Administration (FDA) for emergency use authorization. Molnupiravir is activated by metabolism, and upon entering human cells, is converted into RNA-like building blocks, causing mutations in the COVID virus’s RNA genome and interfering with its replication. For that reason, the drug is unlikely to be prescribed during pregnancy, but otherwise the therapy seems to hold great promise in adding to the limited armamentarium available to fight the pandemic. One possible concern: the drug’s price tag. The federal government has agreed to purchase 1.7M courses of the drug at $700 per course, and with most insurance companies having returned to normal cost-sharing for COVID treatments, the drug may be out of reach for some patients. Still, a major clinical development to be celebrated, and more to come as Merck’s drug is vetted by the FDA.
At $20 to $40 per dose, with costs fully absorbed by the federal government, and remarkable effectiveness at preventing severe disease, hospitalizations, and deaths, vaccines remain far and away our best frontline weapon for fighting the COVID pandemic. Promising, then, that the much-debated vaccine mandates have begun to demonstrate success in increasing vaccination rates, even among those who have thus far resisted getting the shot.
Despite concerns about massive staffing shortages among hospitals resulting from the implementation of its mandate, the state of New York found that 92 percent of healthcare workers had been vaccinated by Monday, when the mandate went into effect. That was a 10-percentage-point increase from a week earlier, holding promise that the Biden administration’s planned federal mandate for healthcare workers could have the desired effect.
California’s mandate for healthcare workers went into effect yesterday, and was credited with boosting vaccination rates to 90 percent at many of the state’s health systems. Among private employers considering mandates, the experience of United Airlines may also be instructive: its employee mandate led to the vaccination of more than 99 percent of its workers, resulting in the termination of only 700 of its 67,000 employees. Of course, everyone prefers carrots to sticks, but sweepstakes and bonuses have only gotten so far in encouraging people to get vaccinated—now it appears mandates have a useful role to play as well.
With 56 percent of the population fully vaccinated, the US now ranks 43rd among nations, just ahead of Saudi Arabia and far behind most of Europe. In the next few days we’ll reach the grim milestone of 700,000 COVID deaths in this country—anything that helps stop that number from growing further should be welcome news.
Cartoon – State of the Union (Unvaccinated)
The Research on Ivermectin and Covid-19
Interest in the antiparasitic drug Ivermectin has increased drastically as of late thanks to the belief that it can help to prevent and/or treat Covid-19. In today’s episode we examine recent data on the efficacy of Ivermectin as an antiviral and discuss the history behind how it gained this reputation.
Howard Stern blasts unvaccinated Americans, casting vaccine mandate as ‘freedom to live’
Howard Stern was reflecting this week on the coronavirus deaths of four conservative talk-radio hosts who had espoused anti-vaccine and anti-mask sentiments when he took aim at those who have refused to get vaccinated.
“I want my freedom to live,” he said Tuesday on his SiriusXM program. “I want to get out of the house. I want to go next door and play chess. I want to go take some pictures.”
The shock jock, who advocated for the coronavirus vaccine to be mandatory, then turned his attention to the hesitancy that has played a significant role in the U.S. spread of the virus, leading to what Rochelle Walensky, director of the Centers for Disease Control and Prevention, has called a “pandemic of the unvaccinated.”He pointed to unvaccinated people who are “clogging” up overwhelmed hospitals, calling them “imbeciles” and “nut jobs” and suggesting that doctors and nurses not treat those who have not taken a coronavirus vaccine.
“I’m really of mind to say, ‘Look, if you didn’t get vaccinated [and] you got covid, you don’t get into a hospital,’ ” he said. “You had the cure and you wouldn’t take it.”
Stern’s comments come after several other celebrities expressed to their large social media audiences their frustration with the ongoing lag in vaccinations when hospitals are being pushed to their limits by the highly transmissible delta variant.
More than 185,000 coronavirus infections were reported Wednesday across the United States, according to data compiled by The Washington Post. Nearly 102,000 people are hospitalized with covid-19; more than 26,000 are in intensive care units. A slight decline in hospitalizations over the past week has inspired cautious optimism among public health leaders.
While there is not a nationwide vaccine mandate, President Biden is expected to sign an executive order Thursday requiring that all federal employees be vaccinated, without an alternative for regular coronavirus testing to opt out of the mandate, The Post reported. The order affecting the estimated 2.1 million federal workers comes as Biden plans to outline a “robust plan to stop the spread of the delta variant and boost covid-19 vaccinations,” the White House said.
Health officials, doctors and nurses nationwide have urged those still hesitant to get vaccinated — and some have gone a step further. Jason Valentine, a physician in Mobile, Ala., informed patients last month that he would not treat anyone who was unvaccinated, saying there were “no conspiracy theories, no excuses” preventing anyone from being vaccinated. Linda Marraccini, a doctor in South Miami, said this month that she would not treat unvaccinated patients in person, noting that her office would “no longer subject our patients and staff to unnecessary risk.”
The summer surge also has led celebrities to use their platform to either call on unvaccinated people to get vaccinated or to denounce them for not doing so. Actor and activist Sean Penn said the vaccine should be mandatory and has called on Hollywood to implement vaccination guidelines on film sets. Actors Benicio Del Toro and Zoe Saldana were part of a vaccine video campaign this year to help debunk misinformation about coronavirus vaccination. When actress Melissa Joan Hart revealed her breakthrough coronavirus case last month, she said she was angry that the nation “got lazy” about getting vaccinated and that masking was not required at her children’s school.
Late-night talk host Jimmy Kimmel suggested Tuesday that hospitals shouldn’t treat unvaccinated patients who prefer to take ivermectin — a medicine long used to kill parasites in animals and humans that has soared in popularity despite being an unproven covid-19 treatment and the subject of warnings by health officials against its use for the coronavirus. After noting that Anthony S. Fauci, the chief medical adviser to Biden, warned that some hospitals might be forced to make “tough choices” on who gets an ICU bed, the late-night host quipped that the situation was not difficult.
“That choice doesn’t seem so tough to me,” Kimmel said. “Vaccinated person having a heart attack? Yes, come right in; we’ll take care of you. Unvaccinated guy who gobbled horse goo? Rest in peace, wheezy.”
Stern has featured front-line workers on his show and has advocated for people to get vaccinated against the coronavirus. In December, the host interviewed Cody Turner, a physician at the Cleveland Clinic, about how the front-line doctor struggled with his mental health while treating infected patients when a vaccine was not widely available.
“We are drowning and we are in hell, and people don’t understand, not only what’s happening to people, you know, but patients across this country,” Turner said.
Stern was a fierce critic of President Donald Trump’s response to the pandemic, saying last year that his former friend was “treasonous” for telling supporters to attend large rallies, despite the risk of infection, in the run-up to the presidential election.
On his eponymous program this week, Stern referred to four conservative talk-radio hosts who bashed the vaccine and eventually died of the virus: Marc Bernier, 65; Phil Valentine, 61; Jimmy DeYoung, 81; and Dick Farrel, 65. In the weeks and months leading up to their deaths last month, all four men had publicly shared their opposition to mainstream public health efforts when coronavirus infections were spiking.
“Four of them were like ranting on the air — they will not get vaccinated,” Stern said Tuesday. “They were on fire … they were all dying and then their dying words were, ‘I wish I had been more into the vaccine. I wish I had taken it.’ ”
After he played a clip of Bernier saying he would not get vaccinated, Stern suggested that the coronavirus vaccine be considered as normal as a measles or mumps vaccine.
“When are we going to stop putting up with the idiots in this country and just say it’s mandatory to get vaccinated?” he asked.
Worried About Breakthrough Infections? Here’s How to Navigate This Phase of the Pandemic.
Many people are seeking definitive answers about what they can and can’t do after being vaccinated against Covid-19. Is it OK to travel? Should I go to a big wedding? Does the Delta variant make spending time with my vaccinated grandmother more risky?
But there’s no one-size-fits-all answer to those questions because risk changes from one individual to the next, depending on a person’s overall health, where they live and those they spend time with.
The bottom line is that vaccines are highly protective against serious illness, and, with some precautions, will allow people to return to more normal lives, experts say. A recent study in Los Angeles County showed that while breakthrough infections can happen, the unvaccinated are 29 times as likely to end up hospitalized from Covid-19 as a vaccinated person.
Experts say anxiety about breakthrough infections remains pervasive, fueled in part by frightening headlines and unrealistic expectations about the role of vaccines.
“There’s been a lot of miscommunication about what the risks really are to vaccinated people, and how vaccinated people should be thinking about their lives,” said Dr. Ashish K. Jha, dean of the Brown University School of Public Health. “There are people who think we are back to square one, but we are in a much, much better place.”
While the Delta variant is causing a surge in infections in various hot spots around the country, including Florida and Louisiana, there will eventually be an end to the pandemic. Getting there will require ongoing precautions in the coming months, but vaccinated people will have more freedom to enjoy life than they did during the early lockdowns. Here are answers to some common questions about the road ahead.
What’s my risk of getting Covid if I’m vaccinated?
To understand why there is no simple answer to this question, think about another common risk: driving in a snowstorm. While we know that tens of thousands of people are injured or killed each year on icy roads, your individual risk depends on local conditions, the speed at which you travel, whether you’re wearing a seatbelt, the safety features on your car and whether you encounter a reckless driver on the road.
Your individual risk for Covid after vaccination also depends on local conditions, your overall health, the precautions you take and how often you are exposed to unvaccinated people who could be infected.
“People want to be told what to do — is it safe if I do this?” said Dr. Sharon Balter, director of the division of communicable disease control and prevention at the Los Angeles County Department of Public Health. “What we can say is, ‘These are the things that are more risky, and these are the things that are less risky.’”
Dr. Balter’s team has recently collected surveillance data that give us a clearer picture of the difference in risk to the vaccinated and unvaccinated as the Delta variant surged from May 1 through July 25. They studied infections in 10,895 fully vaccinated people and 30,801 unvaccinated people. The data showed that:
- The rate of infection in unvaccinated people is five times the rate of infection in vaccinated people. By the end of the study period, the age-adjusted incidence of Covid-19 among unvaccinated persons was 315.1 per 100,000 people over a seven-day period compared to 63.8 per 100,000 incidence rate among fully vaccinated people. (Age adjustment is a statistical method used so the data are representative of the general population.)
- The rate of hospitalization among the vaccinated was 1 per 100,000 people. The age-adjusted hospitalization rate in unvaccinated persons was 29.4 per 100,000.
- Older vaccinated people were most vulnerable to serious illness after a breakthrough infection. The median age of vaccinated people who were hospitalized for Covid was 64 years. Among unvaccinated people who were hospitalized, the median age was 49.
- The Delta variant appears to have increased the risk of breakthrough infections to vaccinated people. At the start of the study, before Delta was dominant, unvaccinated people became infected 10 times as often as vaccinated people did. By the end of study period, when Delta accounted for almost 90 percent of infections, unvaccinated people were five times as likely to get infected as vaccinated people.
What’s the chance of a vaccinated person spreading Covid-19?
While unvaccinated people are by far at highest risk for catching and spreading Covid-19, it’s also possible for a vaccinated person to become infected and transmit the illness to others. A recent outbreak in Provincetown, Mass., where thousands of people gathered in bars and restaurants, showed that vaccinated people can sometimes spread the virus.
Even so, many experts believe the risk of getting infected from a vaccinated person is still relatively low. Dr. Jha noted that after an outbreak among vaccinated and unvaccinated workers at the Singapore airport, tracking studies suggested that most of the spread by vaccinated people happened when they had symptoms.
“When we’ve seen outbreaks, like those among the Yankees earlier in the year and other cases, almost always people are symptomatic when they’re spreading,” Dr. Jha said. “The asymptomatic, pre-symptomatic spread could happen, but we haven’t seen it among vaccinated people with any frequency.”
Another study from Singapore looked at vaccinated and unvaccinated people infected with the Delta variant. The researchers found that while viral loads in vaccinated and unvaccinated workers are similar at the onset of illness, the amount of virus declines more rapidly in the vaccinated after the first week, suggesting vaccinated people are infectious for a shorter period of time.
Is it still safe to gather unmasked with vaccinated people?
In many cases it will be safe, but the answer depends on a number of variables. The risk is lower with a few close family members and friends than a large group of people you don’t know. Outdoor gatherings are safer than indoor gatherings. What’s the community transmission rate? What’s the ventilation in the room? Do you have underlying health issues that would make you vulnerable to complications from Covid-19? Do any of the vaccinated people have a fever, sniffles or a cough?
“The big question is can five people sit around a table unmasked if we know they’re all vaccinated,” Dr. Jha said. “I think the answer is yes. The chances of anybody spreading the virus in that context is exceedingly low. And if someone does spread the virus, the other people are not going to get super sick from it. I certainly think most of us should not fear breakthrough infections to the point where we won’t tolerate doing things we really value in life.”
For larger gatherings or even small gatherings with a highly vulnerable person, rapid antigen testing using home testing kits can lower risk. Asking people to use a test a few days before the event, and then the day of the event, adds another layer of protection. Opening windows and doors or adding a HEPA air cleaner can also help.
How can unvaccinated children go to school safely?
Children under 12 probably will not be eligible for vaccination until the end of the year. As a result, the best way to protect them is to make sure all the adults and older kids around them are vaccinated. A recent report from the C.D.C. found that an unvaccinated elementary schoolteacher who didn’t wear a mask spread the virus to half of the students in a classroom.
Studies show that schools have not been a major cause of Covid-spreading events, particularly when a number of prevention measures are in place. A combination of precautions — masking indoors, keeping students at least three feet apart in classrooms, keeping students in separate cohorts or “pods,” encouraging hand washing and regular testing, and quarantining — have been effective. While many of those studies occurred before the Delta variant became dominant, they also happened when most teachers, staff and parents were unvaccinated, so public health experts are hopeful that the same precautions will work well this fall.
Dr. Balter noted that masking in schools, regular testing and improving ventilation will keep children safer, and that parents should be reassured by the data.
“The level of illness in children is much less than adults,” she said. “You do weigh all these things, but there are also a lot of consequences to not sending children to school.”
Can a vaccinated person visit with an elderly vaccinated person indoors without a mask?
In many cases it will be relatively safe for vaccinated people to spend time, unmasked, with an older relative. But the risk depends on local conditions and the precautions the visitor has taken in the days leading up to the visit. In areas where community vaccination rates are low and overall infection rates are high, meeting outdoors or wearing a mask may be advised.
If you’re vaccinated but have been going to restaurants, large gatherings or spending time with unvaccinated people, it’s a good idea to practice more social distancing in the days leading up to your visit with an older or vulnerable person. Home testing a few days before the visit and the day of the visit will add another layer of protection.
Gregg Gonsalves, an assistant professor of epidemiology at the Yale School of Public Health, said he recently visited his 87-year-old mother and did not wear a mask. But that is because both of them are vaccinated and he still works mostly from home, lives in a highly vaccinated area and has low risk for exposure. He is also investing in home testing kits for reassurance that he is not infectious.
“If I just came back from a big crowded gathering, and I had to go see my mom, I would put on a mask,” he said.
Is it safe to work in an office?
The answer depends on the precautions your workplace has taken. Does the company require proof of vaccination to come into the office? Are unvaccinated people tested regularly? What percentage of people in the office are unvaccinated? What steps did your company take to improve indoor air quality? (Upgrading the filters in ventilation systems and adding stand-alone HEPA air cleaners are two simple steps that can reduce viral particles in the air.)
Offices that mandate vaccination will be safer, but vaccination rates need to exceed 90 percent. Even an 85-percent vaccination rate is not enough, Dr. Jha said. “It’s not going to work because one of those 15-percent unvaccinated is going to cause an outbreak for every single person in that room,” he said. “You do not want a bunch of unvaccinated people running around your offices.”
Should I get a booster shot, and will it help protect me against Delta?
The people who have the most to gain from booster shots are older people, transplant patients, people with compromised immune systems or those with underlying conditions that put them at high risk for complications from Covid. People who received the single-dose Johnson & Johnson vaccine may also be good candidates for a second dose.
But many experts say healthy people with normal immune systems who received a two-dose mRNA vaccine from Pfizer or Moderna won’t get much benefit right now from a third shot because their vaccine antibodies still offer strong protection against severe illness. That said, the Biden administration appears to be moving ahead with offering booster shots to the general public starting as soon as the week of Sept. 20.
Hospital mergers and acquisitions are a bad deal for patients. Why aren’t they being stopped?
Contrary to what health care executives advertise, hospital mergers and acquisitions aren’t good for patients. They rarely improve access to health care or its quality, and they don’t reduce prices. But the system in place to stop them is often more bark than bite.
During 2019 and 2020, hospitals acquired an additional 3,200 medical practices and 18,600 physicians. By January 2021, almost half of all U.S. physicians were employed by a hospital or health system.
In 2018, the last year for which complete data are available, 72% of hospitals and more than 90% of hospital beds were affiliated with a health care system. Mergers and acquisitions are increasing the number of health care systems while decreasing the number of independently operated hospitals.
When hospitals buy provider practices, it leads to more unnecessary care and more expensive care, which increases overall spending. The same thing happens when hospitals merge or acquire other hospitals. These deals often increase prices and they don’t improve care quality; patients simply pay more for the same or worse care.
Mergers and acquisitions can negatively affect clinician morale as well. Some argue they lead to providers’ loss of autonomy and increase the emphasis on financial targets rather than patient care. They can also contribute to burnout and feeling unsupported.
Considerable machinery is in place at both the federal and state levels to stop “anticompetitive” mergers before they happen. But that machinery is limited by a lack of follow through.
The Federal Trade Commission (FTC) and the U.S. Department of Justice have always had broad authority over mergers. By law, one or both of these entities must review for any antitrust concerns proposed deals of a certain size before the deals are finalized. After a preliminary review, if no competition issues are identified, the merger or acquisition is allowed to proceed. This is what happens in most cases. If concerns are raised, however, the involved parties must submit additional information and undergo a second evaluation.
Some health care organizations seem willing to challenge this process. Leaders involved in a pending merger between Lifespan and Care New England in Rhode Island — which would leave 80% of the state’s inpatient market under one company’s umbrella — are preparing to move forward even if the FTC deems the deal anticompetitive. The companies will simply ask the state to approve the merger despite the FTC’s concerns.
The reality is that the FTC’s reach is limited when it comes to nonprofits, which most hospitals are. While the FTC can oppose anticompetitive mergers involving nonprofits, it cannot enforce action against them for anticompetitive behavior. So if a merger goes through, the FTC has limited authority to ensure the new entity plays fairly.
What’s more, the FTC has acknowledged it can’t keep up with its workload this year. It modified its antitrust review process to accommodate an increasing number of requests and its stagnant capacity. In July, the Biden administration issued an executive order about economic competition that explicitly acknowledges the negative impact of health care consolidation on U.S. communities. This is encouraging, signaling that the government is taking mergers seriously. Yet it’s unclear if the executive order will give the FTC more capacity, which is essential if it is to actually enforce antitrust laws.
At the state level, most of the antitrust power lies with the attorney general, who ultimately approves or challenges all mergers. Despite this authority, questionable mergers still go through.
In 2018, for example, two competing hospital systems in rural Tennessee merged to become Ballad Health and the only source of care for about 1.2 million residents. The deal was opposed by the FTC, which deemed it to be a monopoly. Despite the concerns, the state attorney general and Department of Health overrode the FTC’s ruling and approved the merger. (This is the same mechanism the Rhode Island hospitals hope to employ should the FTC oppose their merger.) As expected, Ballad Health then consolidated the services offered at its facilities and increased the fees on patient bills.
It’s clear that mechanisms exist to curb potentially harmful mergers and promote industry competition. It’s also clear they aren’t being used to the fullest extent. Unless these checks and balances lead to mergers being denied, their power over the market is limited.
Experts have been raising the alarm on health care consolidation for years. Mergers rarely lead to better care quality, access, or prices. Proposed mergers must be assessed and approved based on evidence, not industry pressure. If nothing changes, the consequences will be felt for years to come.