There’s a lot of anxiety about the AstraZeneca vaccine thanks to recent reports of incomplete data, as well as reports on blood clot risks. Let’s take a look at both issues in context, understanding the efficacy data before and after numbers were updated, and understanding blood clot risk in relation to other common situations where blood clots are a potential concern.
NEW DELHI — More than a year after the pandemic began, infections worldwide have surpassed their previous peak. The average number of coronavirus cases reported each day is now higher than it has ever been.
“Cases and deaths are continuing to increase at worrying rates,” said World Health Organization chief Tedros Adhanom Ghebreyesus on Friday.
A major reason for the increase: the ferocity of India’s second wave. The country accounts for about one in three of all new cases.
It wasn’t supposed to happen like this. Earlier this year, India appeared to be weathering the pandemic. The number of daily cases dropped below 10,000 and the government launched a vaccination drive powered by locally made vaccines.
But experts say that changes in behavior and the influence of new variants have combined to produce a tidal wave of new cases.
India is adding more than 250,000 new infections a day — and if current trends continue, that figure could soar to 500,000 within a month, said Bhramar Mukherjee, a biostatistician at the University of Michigan.
While infections are rising around the country, some places are bearing the brunt of the surge. Six states and Delhi, the nation’s capital, account for about two-thirds of new daily cases. Maharashtra, home to India’s financial hub, Mumbai, represents about a quarter of the nation’s total.
Mohammad Shahzad, a 40-year-old accountant, was one of many desperately seeking care. He developed a fever and grew breathless on the afternoon of April 15. His wife, Shazia, rushed him to the nearest hospital. It was full, but staffers checked his oxygen level: 62, dangerously low.
For three hours, they went from hospital to hospital trying to get him admitted, with no luck. She took him home. At 3:30 a.m., with Shahzad struggling to breathe, she called an ambulance. When the driver arrived, he asked if Shahzad truly needed oxygen — otherwise he would save it for the most serious patients.
The scene at the hospital was “harrowing,” said Shazia: a line of ambulances, people crying and pleading, a man barely breathing. Shahzad finally found a bed. Now Shazia and her two children, 8 and 6, have also developed covid-19 symptoms.
From early morning until late at night, Prafulla Gudadhe’s phone does not stop ringing. Each call is from a constituent and each call is the same: Can he help to arrange a hospital bed for a loved one?
Gudadhe is a municipal official in Nagpur, a city in the interior of Maharashtra. “We tell them we will try, but there are no beds,” he said. About 10 people in his ward have died at home in recent days after they couldn’t get admitted to hospitals, Gudadhe said, his voice weary. “I am helpless.”
Kamlesh Sailor knows how bad it is. Worse than the previous wave of the pandemic, like nothing he’s ever seen.
Sailor is the president of a crematorium trust in the city of Surat. Last week, the steel pipes in two of the facility’s six chimneys melted from constant use. Where the facility used to receive about 20 bodies a day, he said, now it is receiving 100.
“We try to control our emotions,” he said. “But it is unbearable.”
https://mailchi.mp/94c7c9eca73b/the-weekly-gist-april-16-2021?e=d1e747d2d8
As states rush to fully reopen businesses, and Americans leave their masks at home in greater numbers, it appears that the feared “fourth surge” of COVID is now underway in many parts of the country. Coronavirus cases are up in half of all states, and up nationally by 9 percent compared to last week. While the latest wave appears to be much less deadly—largely targeting younger people who haven’t yet been vaccinated—it adds urgency to the effort to get shots in arms as quickly as possible.
The good news: that’s happening. Today the US surpassed the milestone of 200M vaccinations given, with nearly a quarter of the population now fully vaccinated (including nearly two-thirds of those over age 65). The progress on vaccines comes as the Johnson & Johnson COVID jab is sidelined, over safety concerns stemming from a small number of rare blood-clotting cases in younger women that caused the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to urge states to pause the use of the shot. Wednesday’s inconclusive meeting of the FDA’s Advisory Committee on Immunization Practices meant an additional 7 to 10 days of limbo for the J&J vaccine, drawing criticism from experts who warned that the negative publicity could undermine confidence in vaccines among the general population, both in the US and around the world.
Count us among those skeptical of the decision to pull back on the J&J vaccine, which plays a pivotal role in the campaign against COVID, given that it’s a single-dose vaccine that can be stored at normal refrigerator temperatures, making it more easily distributed than the two-dose mRNA vaccines. While the blood clotting cases are serious, and merit investigation, the odds of suffering a vaccine-related blood clot are far outweighed by an individual’s risk of death or severe complications from COVID itself, let alone the chances of getting a blood clot from other medications (such as oral contraceptives).
It was a big week for innumeracy, unfortunately: headlines abounded about the CDC’s discovery of 5,800 “breakthrough” COVID cases, in which fully vaccinated people still contracted the disease. Unsurprisingly, the numerator got the headlines, not the denominator—the 80M people who’ve been fully vaccinated. Your chances of hitting a hole-in-one as an amateur golfer are better than the chances of getting COVID after being fully vaccinated. Furthermore, of those 5,800 people infected after being fully vaccinated, only 7 percent were hospitalized, and 74 died. Each a tragedy, to be sure—but we’ll take those odds any day.
Get vaccinated as soon as you can.
In this last episode of our six-part series on vaccinations, supported by the National Institute for Health Care Management Foundation, we cover vaccine development – particularly in the context of the current global pandemic. We discuss the timeline of Covid-19 vaccine development and the mRNA vaccine approach.
— Study in U.S. Marines stresses importance of vaccination, author says
Young adult men who were previously infected with COVID-19 were not completely protected against reinfection, a study of U.S. marines found.
Among 189 Marines who were seropositive but free of current SARS-CoV-2 infection at baseline, 10% tested positive for SARS-CoV-2 via PCR during a 6-week follow-up period, reported Stuart Sealfon, MD, of Icahn School of Medicine at Mount Sinai in New York City, and colleagues.
Not surprisingly, viral loads were about 10 times lower compared with initially seronegative participants who tested positive, and those who tested positive again were more likely to have a weaker immune response, Sealfon and colleagues wrote in Lancet Respiratory Medicine.
Participants were nearly all men, and most were ages 18-20. Notably, only three of 19 seropositive Marines were symptomatic.
The question of natural infection conferring immunity has been central in the discussion over whether to vaccinate previously infected people. Sealfon’s group said most individuals do mount a “sustained serological response” after initial infection, but prior research found that about 10% of individuals with antibodies to SARS-CoV-2, with a weaker immune response, failed to develop measurable neutralizing activity.
They noted that a high proportion of young adults are infected asymptomatically and “can be an important source of transmission to more vulnerable populations.”
“As vaccine rollouts continue to gain momentum, it is important to remember that, despite a prior COVID-19 infection, young people can catch the virus again and may still transmit it to others,” Sealfon said in a statement. “Immunity is not guaranteed by past infection, and vaccinations that provide additional protection are still needed for those who have had COVID-19.”
Sealfon and colleagues examined data from the COVID-19 Health Action Response for Marines (CHARM) study, in which U.S. Marine recruits had a 2-week unsupervised home quarantine, followed by a Marine-supervised 2-week quarantine on a college campus or in a hotel. They were then assessed for baseline SARS-CoV-2 IgG seropositivity and completed a questionnaire that included demographic history, risk factors, medical history, and symptoms. Participants were tested via PCR at weeks 0, 1, and 2 of quarantine and completed follow-up questionnaires about symptoms since last visit.
After quarantine, those testing negative for current SARS-CoV-2 infection entered basic training, and were tested for new infections every 2 weeks for 6 weeks and completed a follow-up symptom questionnaire. Baseline neutralizing antibody titers were performed on all newly infected seropositive participants and selected seropositive uninfected participants.
From May 11 to Nov. 2, 2020, 3,076 participants were followed up after quarantine for 6 weeks. There was a higher proportion of Hispanic and Black participants in the seropositive group.
Nineteen of 189 seropositive participants had at least one positive PCR test for SARS-CoV-2 (1.1 cases per person-year), as did 1,079 seronegative participants (6.2 cases per person-year), for an incidence rate ratio of 0.18 (95% CI 0.11-0.28).
When examining immune response within the seropositive group, Sealfon’s group found a strong link between lower titers of IgG antibodies to full-length spike protein and a subsequent positive PCR test. They also found neutralizing activity above the limit of detection in 83% of seropositive participants who never tested positive again, and in 32% of participants who were reinfected.
“Overall, these results indicate that COVID-19 does not provide an almost universal and long-lasting protective immunity, unlike that seen in measles, for example,” wrote Marìa Velasco, MD, PhD, and Carlos Guijarro, MD, PhD, of Hospital Universitario Fundación Alcorcón in Madrid, in an accompanying editorial.
However, they offered some caveats to the study, namely that a positive PCR test is most likely a new infection, but could also be “viral persistence with reappearance of virus in mucosae, or non-viable viral debris.”
“In the absence of viral sequencing with phylogenetic analyses, viral cultures, or information regarding different SARS-CoV-2 variants, a positive PCR test cannot be assumed to represent new viral infections in all settings,” the editorialists wrote, though they added that strict scientific criteria may also be underestimating the real rate of reinfection, and suggested a “pragmatic approach” for classifying cases as either reinfection, relapse, or “PCR re-positivity.”
Sealfon’s group noted that despite the closed setting, the population is representative of U.S. men ages 18-20, though it is unclear how generalizable it is to young women or older adults.
Other limitations include potential missing data, such as infections occurring between sampling every 2 weeks. The authors added that the study is also likely underestimating risk of reinfection, as the seronegative group “included an unknown number of previously infected participants who did not have significant IgG [titers] in their baseline serum sample.”
She grew up in Hungary, daughter of a butcher. She decided she wanted to be a scientist, although she had never met one. She moved to the United States in her 20s, but for decades never found a permanent position, instead clinging to the fringes of academia.
Now Katalin Kariko, 66, known to colleagues as Kati, has emerged as one of the heroes of Covid-19 vaccine development. Her work, with her close collaborator, Dr. Drew Weissman of the University of Pennsylvania, laid the foundation for the stunningly successful vaccines made by Pfizer-BioNTech and Moderna.
For her entire career, Dr. Kariko has focused on messenger RNA, or mRNA — the genetic script that carries DNA instructions to each cell’s protein-making machinery. She was convinced mRNA could be used to instruct cells to make their own medicines, including vaccines.
But for many years her career at the University of Pennsylvania was fragile. She migrated from lab to lab, relying on one senior scientist after another to take her in. She never made more than $60,000 a year.
By all accounts intense and single-minded, Dr. Kariko lives for “the bench” — the spot in the lab where she works. She cares little for fame. “The bench is there, the science is good,” she shrugged in a recent interview. “Who cares?”
Dr. Anthony Fauci, director of the National Institutes of Allergy and infectious Diseases, knows Dr. Kariko’s work. “She was, in a positive sense, kind of obsessed with the concept of messenger RNA,” he said.
Dr. Kariko’s struggles to stay afloat in academia have a familiar ring to scientists. She needed grants to pursue ideas that seemed wild and fanciful. She did not get them, even as more mundane research was rewarded.
“When your idea is against the conventional wisdom that makes sense to the star chamber, it is very hard to break out,” said Dr. David Langer, a neurosurgeon who has worked with Dr. Kariko.
Dr. Kariko’s ideas about mRNA were definitely unorthodox. Increasingly, they also seem to have been prescient.
“It’s going to be transforming,” Dr. Fauci said of mRNA research. “It is already transforming for Covid-19, but also for other vaccines. H.I.V. — people in the field are already excited. Influenza, malaria.”
For Dr. Kariko, most every day was a day in the lab. “You are not going to work — you are going to have fun,” her husband, Bela Francia, manager of an apartment complex, used to tell her as she dashed back to the office on evenings and weekends. He once calculated that her endless workdays meant she was earning about a dollar an hour.
For many scientists, a new discovery is followed by a plan to make money, to form a company and get a patent. But not for Dr. Kariko. “That’s the furthest thing from Kate’s mind,” Dr. Langer said.
She grew up in the small Hungarian town of Kisujszallas. She earned a Ph.D. at the University of Szeged and worked as a postdoctoral fellow at its Biological Research Center.
In 1985, when the university’s research program ran out of money, Dr. Kariko, her husband, and 2-year-old daughter, Susan, moved to Philadelphia for a job as a postdoctoral student at Temple University. Because the Hungarian government only allowed them to take $100 out of the country, she and her husband sewed £900 (roughly $1,246 today) into Susan’s teddy bear. (Susan grew up to be a two-time Olympic gold medal winner in rowing.)
When Dr. Kariko started, it was early days in the mRNA field. Even the most basic tasks were difficult, if not impossible. How do you make RNA molecules in a lab? How do you get mRNA into cells of the body?
In 1989, she landed a job with Dr. Elliot Barnathan, then a cardiologist at the University of Pennsylvania. It was a low-level position, research assistant professor, and never meant to lead to a permanent tenured position. She was supposed to be supported by grant money, but none came in.
She and Dr. Barnathan planned to insert mRNA into cells, inducing them to make new proteins. In one of the first experiments, they hoped to use the strategy to instruct cells to make a protein called the urokinase receptor. If the experiment worked, they would detect the new protein with a radioactive molecule that would be drawn to the receptor.
“Most people laughed at us,” Dr. Barnathan said.
One fateful day, the two scientists hovered over a dot-matrix printer in a narrow room at the end of a long hall. A gamma counter, needed to track the radioactive molecule, was attached to a printer. It began to spew data.
Their detector had found new proteins produced by cells that were never supposed to make them — suggesting that mRNA could be used to direct any cell to make any protein, at will.
“I felt like a god,” Dr. Kariko recalled.
She and Dr. Barnathan were on fire with ideas. Maybe they could use mRNA to improve blood vessels for heart bypass surgery. Perhaps they could even use the procedure to extend the life span of human cells.
Dr. Barnathan, though, soon left the university, accepting a position at a biotech firm, and Dr. Kariko was left without a lab or financial support. She could stay at Penn only if she found another lab to take her on. “They expected I would quit,” she said.
Universities only support low-level Ph.D.s for a limited amount of time, Dr. Langer said: “If they don’t get a grant, they will let them go.” Dr. Kariko “was not a great grant writer,” and at that point “mRNA was more of an idea,” he said.
But Dr. Langer knew Dr. Kariko from his days as a medical resident, when he had worked in Dr. Barnathan’s lab. Dr. Langer urged the head of the neurosurgery department to give Dr. Kariko’s research a chance. “He saved me,” she said.
Dr. Langer thinks it was Dr. Kariko who saved him — from the kind of thinking that dooms so many scientists.
Working with her, he realized that one key to real scientific understanding is to design experiments that always tell you something, even if it is something you don’t want to hear. The crucial data often come from the control, he learned — the part of the experiment that involves a dummy substance for comparison.
“There’s a tendency when scientists are looking at data to try to validate their own idea,” Dr. Langer said. “The best scientists try to prove themselves wrong. Kate’s genius was a willingness to accept failure and keep trying, and her ability to answer questions people were not smart enough to ask.”
Dr. Langer hoped to use mRNA to treat patients who developed blood clots following brain surgery, often resulting in strokes. His idea was to get cells in blood vessels to make nitric oxide, a substance that dilates blood vessels, but has a half-life of milliseconds. Doctors can’t just inject patients with it.
He and Dr. Kariko tried their mRNA on isolated blood vessels used to study strokes. It failed. They trudged through snow in Buffalo, N.Y., to try it in a laboratory with rabbits prone to strokes. Failure again.
And then Dr. Langer left the university, and the department chairman said he was leaving as well. Dr. Kariko again was without a lab and without funds for research.
A meeting at a photocopying machine changed that. Dr. Weissman happened by, and she struck up a conversation. “I said, ‘I am an RNA scientist — I can make anything with mRNA,’” Dr. Kariko recalled.
Dr. Weissman told her he wanted to make a vaccine against H.I.V. “I said, ‘Yeah, yeah, I can do it,’” Dr. Kariko said.
Despite her bravado, her research on mRNA had stalled. She could make mRNA molecules that instructed cells in petri dishes to make the protein of her choice. But the mRNA did not work in living mice.
“Nobody knew why,” Dr. Weissman said. “All we knew was that the mice got sick. Their fur got ruffled, they hunched up, they stopped eating, they stopped running.”
It turned out that the immune system recognizes invading microbes by detecting their mRNA and responding with inflammation. The scientists’ mRNA injections looked to the immune system like an invasion of pathogens.
But with that answer came another puzzle. Every cell in every person’s body makes mRNA, and the immune system turns a blind eye. “Why is the mRNA I made different?” Dr. Kariko wondered.
A control in an experiment finally provided a clue. Dr. Kariko and Dr. Weissman noticed their mRNA caused an immune overreaction. But the control molecules, another form of RNA in the human body — so-called transfer RNA, or tRNA — did not.
A molecule called pseudouridine in tRNA allowed it to evade the immune response. As it turned out, naturally occurring human mRNA also contains the molecule.
Added to the mRNA made by Dr. Kariko and Dr. Weissman, the molecule did the same — and also made the mRNA much more powerful, directing the synthesis of 10 times as much protein in each cell.
The idea that adding pseudouridine to mRNA protected it from the body’s immune system was a basic scientific discovery with a wide range of thrilling applications. It meant that mRNA could be used to alter the functions of cells without prompting an immune system attack.
“We both started writing grants,” Dr. Weissman said. “We didn’t get most of them. People were not interested in mRNA. The people who reviewed the grants said mRNA will not be a good therapeutic, so don’t bother.’”
Leading scientific journals rejected their work. When the research finally was published, in Immunity, it got little attention.
Dr. Weissman and Dr. Kariko then showed they could induce an animal — a monkey — to make a protein they had selected. In this case, they injected monkeys with mRNA for erythropoietin, a protein that stimulates the body to make red blood cells. The animals’ red blood cell counts soared.
The scientists thought the same method could be used to prompt the body to make any protein drug, like insulin or other hormones or some of the new diabetes drugs. Crucially, mRNA also could be used to make vaccines unlike any seen before.
Instead of injecting a piece of a virus into the body, doctors could inject mRNA that would instruct cells to briefly make that part of the virus.
“We talked to pharmaceutical companies and venture capitalists. No one cared,” Dr. Weissman said. “We were screaming a lot, but no one would listen.”
Eventually, though, two biotech companies took notice of the work: Moderna, in the United States, and BioNTech, in Germany. Pfizer partnered with BioNTech, and the two now help fund Dr. Weissman’s lab.
Soon clinical trials of an mRNA flu vaccine were underway, and there were efforts to build new vaccines against cytomegalovirus and the Zika virus, among others. Then came the coronavirus.
Researchers had known for 20 years that the crucial feature of any coronavirus is the spike protein sitting on its surface, which allows the virus to inject itself into human cells. It was a fat target for an mRNA vaccine.
Chinese scientists posted the genetic sequence of the virus ravaging Wuhan in January 2020, and researchers everywhere went to work. BioNTech designed its mRNA vaccine in hours; Moderna designed its in two days.
The idea for both vaccines was to introduce mRNA into the body that would briefly instruct human cells to produce the coronavirus’s spike protein. The immune system would see the protein, recognize it as alien, and learn to attack the coronavirus if it ever appeared in the body.
The vaccines, though, needed a lipid bubble to encase the mRNA and carry it to the cells that it would enter. The vehicle came quickly, based on 25 years of work by multiple scientists, including Pieter Cullis of the University of British Columbia.
Scientists also needed to isolate the virus’s spike protein from the bounty of genetic data provided by Chinese researchers. Dr. Barney Graham, of the National Institutes of Health, and Jason McClellan, of the University of Texas at Austin, solved that problem in short order.
Testing the quickly designed vaccines required a monumental effort by companies and the National Institutes of Health. But Dr. Kariko had no doubts.
On Nov. 8, the first results of the Pfizer-BioNTech study came in, showing that the mRNA vaccine offered powerful immunity to the new virus. Dr. Kariko turned to her husband. “Oh, it works,” she said. “I thought so.”
To celebrate, she ate an entire box of Goobers chocolate-covered peanuts. By herself.
Dr. Weissman celebrated with his family, ordering takeout dinner from an Italian restaurant, “with wine,” he said. Deep down, he was awed.
“My dream was always that we develop something in the lab that helps people,” Dr. Weissman said. “I’ve satisfied my life’s dream.”
Dr. Kariko and Dr. Weissman were vaccinated on Dec. 18 at the University of Pennsylvania. Their inoculations turned into a press event, and as the cameras flashed, she began to feel uncharacteristically overwhelmed.
A senior administrator told the doctors and nurses rolling up their sleeves for shots that the scientists whose research made the vaccine possible were present, and they all clapped. Dr. Kariko wept.
Things could have gone so differently, for the scientists and for the world, Dr. Langer said. “There are probably many people like her who failed,” he said.
We’re a year into the coronavirus pandemic, so the math that undergirds its risks should by now be familiar. We all should know, for example, that the ability of the virus to spread depends on it being able to find a host, someone who is not protected against infection. If you have a group of 10 people, one of whom is infected and nine of whom are immune to the virus, it’s not going to be able to spread anywhere.
That calculus is well known, but there is still some uncertainty at play. To achieve herd immunity — the state where the population of immune people is dense enough to stamp out new infections — how many people need to be protected against the virus? And how good is natural immunity, resistance to infection built through exposure to the virus and contracting covid-19, the disease it causes?
The safe way to increase the number of immune people, thereby probably protecting everyone by limiting the ability of the virus to spread, is through vaccination. More vaccinated people means fewer new infections and fewer infections needed to get close to herd immunity. The closer we get to herd immunity, the safer people are who can’t get vaccinated, such as young children (at least for now).
The challenge the world faces is that the rollout of vaccines has been slow, relatively speaking. The coronavirus vaccines were developed at a lightning pace, but many parts of the world are still waiting for supplies sufficient to broadly immunize their populations. In the United States, the challenge is different: About a quarter of adult Americans say they aren’t planning on getting vaccinated against the virus, according to Economist-YouGov polling released last week.
That’s problematic in part because it means we’re less likely to get to herd immunity without millions more Americans becoming infected. Again, it’s not clear how effective natural immunity will be over the long term as new variants of the virus emerge. So we might continue to see tens of thousands of new infections each day, keeping the population at risk broadly by delaying herd immunity and continuing to add to the pandemic’s death toll in this country.
But we also see from the Economist-YouGov poll the same thing we saw in Gallup polling earlier this month: The people who are least interested in being vaccinated are also the people who are least likely to be concerned about the virus and to take other steps aimed at preventing it from spreading.
In the Economist-YouGov poll, nearly three-quarters of those who say they don’t plan on being vaccinated when they’re eligible also say they’re not too or not at all worried about the virus.
That makes some perverse sense: If you don’t see the virus as a risk, you won’t see the need to get vaccinated. Unfortunately, it also means you’re going to be less likely to do things like wear a mask in public.
Or you might be more likely to view as unnecessary precautions such as avoiding close-quarter contact with friends and family or traveling out of state.
About a quarter of adults hold the view that they won’t be vaccinated when eligible. That’s equivalent to about 64 million Americans.
Who are they? As prior polls have shown, they’re disproportionately political conservatives. At the outset of the pandemic, there was concern that vaccine skepticism would heavily be centered in non-White populations. At the moment, though, the rate of skepticism among those who say they voted for Donald Trump in 2020 and among Republicans is substantially higher than skepticism overall.
That shows up in another way in the Economist poll. Respondents were asked whose medical advice they trusted. Among those who say they don’t plan to get the vaccine, half say they trust Trump’s advice a lot or somewhat — far more than the advice of the Centers for Disease Control and Prevention or the country’s top infectious-disease expert Anthony S. Fauci.
If we look only at Republican skeptics, the difference is much larger: Half of Republican skeptics say they have a lot of trust in Trump’s medical advice.
The irony, of course, is that Trump sees the vaccine as his positive legacy on the pandemic. He’s eager to seize credit for vaccine development and has — sporadically — advocated for Americans to get the vaccine. (He got it himself while still president, without advertising that fact.) It’s his supporters, though, who are most hostile to the idea.
Trump bears most of the responsibility for that, too. Over the course of 2020, worried about reelection, he undercut containment efforts and downplayed the danger of the virus. He undermined experts such as Fauci largely out of concern that continuing to limit economic activity would erode his main argument for his reelection. Over and over, he insisted that the virus was going away without the vaccine, that it was not terribly dangerous and that America should just go about its business as usual — and his supporters heard that message.
They’re still listening to it, as the Economist poll shows. One result may be that the United States doesn’t reach herd immunity through vaccinations and, instead, some large chunk of those tens of millions of skeptics end up being exposed to the virus. Some of them will die. Some may risk repeat infections from new variants against which a vaccine offers better protection. Some of those unable to get vaccinated may also become sick from the virus because we haven’t achieved herd immunity, suffering long-term complications from covid-19.
Trump wants his legacy to be the rollout of the vaccine. His legacy will also probably include fostering skepticism about the vaccine that limits its utility in containing the pandemic.
About 1 in 10 nursing homes in California and nationwide are owned by private equity (PE) investors, and new research suggests that death rates for residents of those facilities are substantially higher than at institutions with different forms of ownership.
Researchers from New York University, the University of Chicago, and the University of Pennsylvania found that the combination of subsidies from Medicare and Medicaid alongside incentives for PE owners to increase the value of their investments “could lead high-powered for-profit incentives to be misaligned with the social goal of affordable, quality care [PDF].” The researchers — Atul Gupta, Constantine Yannelis, Sabrina Howell, and Abhinav Gupta — reported that nursing homes owned by private equity entities were associated with a 10% increase in the short-term death rate of Medicare patients over a 12-year period. That means more than 20,000 people likely died prematurely in homes run by PE companies, according to their study, which was published in February by the National Bureau of Economic Research (NBER).
In addition to the higher short-term death rates, these homes were found to have sharper declines in measures of patient well-being, including lower mobility, increased pain intensity, and increased likelihood of taking antipsychotic medications, which the study said are discouraged in the elderly because the drugs increase mortality in this age group. Meanwhile, the study found that taxpayer spending per patient episode was 11% higher in PE-owned nursing homes.
The researchers were stunned by the data. “You don’t expect to find these types of mortality effects. And so, you know, we double-checked it, triple-checked it, quadruple-checked it,” Atul Gupta, a coauthor of the NBER study, told NPR reporter Gabrielle Emanuel.
There’s nothing new about for-profit nursing homes, but private equity firms are a unique subset that in recent years has made significant investments in the industry, Dylan Scott reported in Vox. PE firms typically buy companies in pursuit of higher profits for shareholders than could be obtained by investing in the shares of publicly traded stocks. They then sell their investments at a profit, often within seven years of purchase. They often take on debt to buy a company and then put that debt on the newly acquired company’s balance sheet.
They also have purchased a mix of large chains and independent facilities — “making it easier to isolate the specific effect of private equity acquisitions, rather than just a profit motive, on patient welfare.” About 11% of for-profit nursing homes are owned by PE, according to David Grabowski, professor of health care policy at Harvard Medical School. The NBER study covered 1,674 nursing homes acquired in 128 unique transactions.
While the owners of many nursing homes may not be planning to sell them, they also have strong incentives to keep costs low, which may not be good for patients. A study funded by CHCF, for instance, found that “early in the pandemic, for-profit nursing homes had COVID-19 case rates five to six times higher than those of nonprofit and government-run nursing homes. This was true of both independent nursing homes and those that are part of a corporate chain.”
Nationally, about 70% of nursing homes are operated by for-profit corporations, 24% of nursing homes are nonprofit, and 7% are government-owned. Corporate chains own 58%. In California, 84% of nursing homes are for-profit, 12% are nonprofit, and 3% are government-owned, according to the CHCF report.
Given the dramatic increase in PE ownership of nursing facilities coming out of the COVID-19 pandemic, the higher death rates are troubling. The year-over-year growth between 2019 and 2020 is especially striking. Before the pandemic, 2019 saw 33 private equity acquisitions of nursing homes valued at just over $483 million. In 2020, there were 43 deals valued at more than $1.5 billion, according to Bloomberg Law reporter Tony Pugh.
And PE interest in health care is not restricted to nursing homes, explained Gretchen Morgenson and Emmanuelle Saliba at NBC News. “Private equity’s purchases have included rural hospitals, physicians’ practices, nursing homes and hospice centers, air ambulance companies and health care billing management and debt collection systems.” Overall, PE investments in health care have increased more than 1,900% over the past two decades. In 2000, PE invested less than $5 billion. By 2017, investment had jumped to $100 billion.
Industry advocates argue that the investments are in nursing homes that would fail without an influx of PE capital. The American Investment Council said private equity firms invest in “nursing homes to help rescue, build, or grow businesses, often providing much-needed capital to strengthen struggling companies and employ Americans,” according to Bloomberg Law.
A bare-bones nursing staff is implicated in poorer quality at PE-owned nursing homes, both before and during the COVID-19 pandemic. Staff is generally the greatest expense in nursing homes and a key place to save money. “Labor is the main cost of any health care facility — accounting for nearly half of its operating costs — so cutting it to a minimum is the fastest profit-making measure owners can take, along with paying lower salaries,” journalist Annalisa Merelli explained in Quartz.
Staffing shrinks by 1.4% after a PE purchase, the NBER study found.
The federal government does not set specific patient-to-nurse ratios. California and other states have set minimum standards, but they are generally “well below the levels recommended by researchers and experts to consistently meet the needs of each resident,” according to the journal Policy, Politics, & Nursing Practice.
According to nursing assistant Adelina Ramos, “understaffing was so significant [during the pandemic] that she and her colleagues . . . often had to choose which dying or severely ill patient to attend first, leaving the others alone.”
Ramos worked at the for-profit Genesis Healthcare, the nation’s largest chain of nursing homes, which accepted $180 million in state and federal funds during the COVID-19 crisis but remained severely understaffed. She testified before the US Senate Finance Committee in March as a part of a week long look into how the pandemic affected nursing homes. “Before the pandemic, we had this problem,” she said of staffing shortages. “And with the pandemic, it made things worse.”
In addition, low pay at nursing homes compounds staffing shortages by leading to extremely high rates of turnover. Ramos and her colleagues were paid as little as $12.46 an hour.
“The average nursing home in the US has their entire nursing home staff change over the course of the calendar year. This is a horrible way to provide good, quality nursing home care,” Grabowski told NPR, speaking of his March 2021 study in Health Affairs.
Loss of front-line staff leads to reductions in therapies for healthier patients, which leads to higher death rates, according to the NBER study. The effect of these cuts is that front-line nurses spend fewer hours per day providing basic services to patients. “Those services, such as bed turning or infection prevention, aren’t medically intensive, but they can be critical to health outcomes,” wrote Scott at Vox.
Healthier patients tend to suffer the most from this lack of basic nursing. “Sicker patients have more regimented treatment that will be adhered to no matter who owns the facility,” the researchers said, “whereas healthier people may be more susceptible to the changes made under private equity ownership.”
In addition to the Senate Finance Committee hearings, the House Ways and Means Committee held a hearing at the end of last month about the excess deaths in nursing homes owned by PE. “Private equity’s business model involves buying companies, saddling them with mountains of debt, and then squeezing them like oranges for every dollar,” said Representative Bill Pascrell (D-New Jersey), who chairs the House Ways and Means Committee’s oversight subcommittee.
The office of Senator Elizabeth Warren (D-Massachusetts) will investigate the effects of nursing-home ownership on residents, she announced on March 17.
The hope is that the pandemic’s effect on older people will bring more attention to the issues that lead to substandard nursing home care. “Much more is needed to protect nursing home residents,” Denise Bottcher, the state director of AARP’s Louisiana office, told the Senate panel. “The consequence of not acting is that someone’s mother or father dies.”
HENRY KOTULA 