The Social Determinants strike again

As with most health equity problems, the root causes are deeply entrenched in how we’ve chosen to run our society. The social determinants of health, as the name suggests, determine the likelihood of health outcomes. Right now, our system is harming Indigenous American and Alaska Native (IAAN) people through social factors like racism, environmental pollution, shaky access to clean water, and limited access to nutritious foods. In fact, Indigenous American and Alaska Natives are 400% more likely to face food insecurity as compared to peers, and an estimated 20% lived in poverty before the pandemic made conditions even worse. 

Prior to COVID-19, there was already a 2 year life expectancy disparity between Indigenous American and Alaska Native populations as compared to non-hispanic white Americans. Some of the leading causes of death amongst this population include heart disease and diabetes and risk factors with high rates include obesity, mental health, and substance overuse. obesity, mental health, and substance overuse. These conditions require access and regular contact with the healthcare system – however, these populations also tend to have less access to healthcare due to the rural nature of most reservations. The Indian Health Service (IHS), meant to fix this exact problem, is chronically underfunded, leaving those who don’t live in urban areas without many options. And despite high rates of health disparities, IHS spending for patient health services per person is just a third of the national average. Many of the states with reservations have chosen not to expand Medicaid, which compounds the financial barrier to healthcare access.

Health Equity Impacts are Exponential

Going into the COVID-19 pandemic, these disparities already existed and were impacting the health and wellbeing of the Indigenous American and Alaska Native populations. When the pandemic hit, it became clear that personal health was a major factor in health outcomes. It also upended everyone’s lives and threatened the status of many people’s income, stress, housing, and food security. Given the disadvantages faced by the Indigenous American and Alaska Native populations, it’s clear to see how these issues influenced death rates and have snowballed into a drastically different life expectancy for these populations.

Few escaped COVID-19 unscathed. With the data that we have now, it’s easy to trace the link between diminished quality of social determinants and decreased life expectancy – the more healthcare hardships faced in general life, the more impactful COVID-19 is on health outcomes and death rates. 

“There is nothing weird or unusual about our population. This is simply what happens biologically to populations that are chronically and profoundly stressed and deprived of resources.”

Dr. Ann Bullock, former director at IHS and member of the Minnesota Chippewa Tribe to The New York Times

As depressing as these health inequities are, there is a clear leverage point for change. We know that the lack of investment in  Indigenous American and Alaska Native communities creates harm every day. To start, Congress could adequately fund the IHS. Congress also just passed up the opportunity to curb insulin prices for everyone, which could have had a huge impact on the 14.5% of Indigenous American and Alaska Native adults who live with diabetes. Ensuring clean water would be a huge step, especially given recent challenges around the lack of piped water in Navajo communities specifically. Easy access to affordable, nutritious foods could help with high rates of diabetes. Increasing mental health care through an increased workforce and utilization of telehealth could help bring down rates of substance overuse and, eventually, cirrhosis through counseling while simultaneously fortifying mental health and resiliency. 

We have the means to help the Indigenous American and Alaska Native population not just survive but thrive – it’s well past time that we improve on the social determinants of health that ultimately determine our lifespan.

The post Indigenous American and Alaska Natives lost 6 years life expectancy during pandemic appeared first on Lown Institute.

An overprescribing epidemic

Over the past two years, we’ve developed vaccines, treatments, and other standards of care for Covid-19 that reduce the risk of severe illness and death. But during the first waves of the pandemic, there was little evidence on the best treatments for the virus, leading many doctors to experiment with unproven therapies like malaria drugs, anti-parasitics, and blood thinners.

Antibiotics, which were commonly overused before Covid-19, became another treatment that was widely prescribed to Covid-19 patients with no evidence of benefit. In a recent research letter in JAMA, researchers from the Centers for Disease Control and Prevention (CDC) found that about 30% of Medicare beneficiaries with Covid-19 as the primary diagnosis received an antibiotic in outpatient settings such as the ED, urgent care, telehealth, and doctor’s offices, from April 2020-2021.

Rates of antibiotic prescribing were highest in the ED, with more than one third of Covid-19 patients receiving a prescription, followed by telehealth and urgent care. Rates of prescribing were highest in October 2020, leading up to the winter Covid-19 surge.

Comparing regional prescribing rates, antibiotics were most likely to be prescribed in outpatient settings in the South (37%) and least likely in the Northeast (22%). This pattern tracks with previous research showing greater rates of overuse in the South compared to other regions.

Drivers of antibiotics for Covid-19

Why did so many clinicians prescribe antibiotics for Covid-19 with no evidence to support it, especially given the harm of antibiotic resistance?

Many doctors likely prescribed antibiotics to Covid-19 patients because they feared the possibility of “secondary infections,” when damage caused to the nose or lungs from a virus leads to a bacterial infection. Early reports from China had warned about drug-resistant infections in Covid-19 patients, but doctors later found that these warnings turned out to be overly cautious.

For some doctors, using antibiotics was an act of desperation early in the pandemic, driven by a lack of effective treatments.”Many physicians were inappropriately giving antibiotics because, honestly, they had limited choices,” said Dr. Teena Chopra, director of epidemiology and antibiotic stewardship at Detroit Medical Center, in The New York Times.

Many clinicians do not see antibiotic resistance as a real threat, despite the fact that 2.8 million of these infections occur every year. Especially in the stress of a pandemic, the constant drive for clinicians to “do something” can be more powerful than the future potential threat of superbugs.

The ease of prescribing antibiotics through telehealth visits may also be a factor. Direct-to-consumer telehealth visits had high rates of antibiotic prescribing for children with upper respiratory viruses before Covid-19. The inability to do a close examination via telehealth as well as the need to keep patient satisfaction rates high may result in a “better safe than sorry” approach.

Unnecessary antibiotics and race

In the CDC study, the authors found that antibiotics were more often prescribed to non-Hispanic white Medicare patients with Covid-19 (31%) compared to Black (23%), Hispanic (29%), Asian American/Pacific Islander (27%), or American Indian/Alaska Native (24%) patients with Covid-19.

This result is counterintuitive because prior to Covid-19, Black and Hispanic patients were more likely to receive inappropriate antibiotics. A recent study from researchers at the University of Texas at Austin found between 2009 and 2016 in outpatient settings, almost 64% of antibiotic prescriptions written for Black patients and 58% for Hispanic patients were inappropriate, compared to 56% for white patients. The University of Texas researchers posited that lack of access to follow-up care in communities of color may drive overprescription of antibiotics; if providers feared patients may get an infection and that they wouldn’t be able to come back to receive medications, they would be more likely to prescribe antibiotics.

The opposite pattern found in the CDC study may reflect the inequality of resources available in white neighborhoods during Covid-19, compared to communities of color. Hospitals serving more people of color were overwhelmed during the pandemic and at times ran out of beds and supplies. Providers serving white communities may have been able to offer more in the way of Covid-19 treatments — both beneficial and non-beneficial ones. Throughout the pandemic, the most privileged Americans have received the “more is better” treatment, while the most marginalized are denied basic lifesaving care.

The overprescription of antibiotics for Covid-19 patients provides several lessons on overuse in general: 1) uncertainty and lack of evidence can be major drivers of overuse, 2) care setting and location matter (and “virtual” settings matter as well), and 3) structural racism can lead both to underuse and overuse for people of color.

The post Thirty percent of Covid-19 patients were prescribed antibiotics in outpatient setting appeared first on Lown Institute.

Americans live shorter lives than residents of other wealthy countries.

In 2019, the average American could expect to live for nearly 79 years. In 2020, that number dropped to 77 years. This shift is the largest ever recorded in the United States, marking an additional 530,000 deaths during the first year of the COVID-19 pandemic. The United States already ranked 29 out of 38 comparable countries for average life expectancy in 2019, and the 2020 data shows that the decrease was especially pronounced here as compared to elsewhere in the world. While our life expectancy dropped by nearly 2 years, peer countries experienced only a 0.58 year drop. This becomes even more egregious when you consider that the United States also spends nearly three times as much on healthcare as comparable countries.

Men and people of color experienced greater drops in life expectancy.

The decrease in life expectancy was not even across different demographics. Males experienced a drop of 2.1 years compared to females, who experienced a drop of 1.5 years, further growing the gap between male and female life expectancy. Hispanic males had the highest death rate increase of 42.7%, followed by Hispanic females at 32.4%, when adjusting for race, ethnicity, and sex. Non-Hispanic white females had the lowest increase in death rate at 12.1%. All age groups 15 and above experienced a 15-21% increase in death rates.

What’s killing us?

Unsurprisingly, COVID. A brand-new killer virus, it claimed the third spot for leading causes of death in the United States. The remaining nine spots stayed relatively consistent, with heart disease and cancer leading the pack. While none of the leading causes other than COVID had a drastically increased rate, it’s worth considering how COVID exacerbates the risk of mortality from other causes.

A study published earlier last month found that contracting COVID increased the risk of various cardiovascular diseases, even increasing the rate of major adverse cardiovascular events such as strokes and heart attacks. This means that individuals who get COVID are at greater risk for cardiovascular-caused mortality, even if they were never hospitalized for it — especially those with long COVID. 

COVID outcomes have been linked to gaps in health insurance coverage, racial bias, and other factors affected by an individual’s social determinants of health. In fact, research suggests that a person’s health is primarily determined by these social factors. Investing in community projects that target hunger and nutrition, homelessness, and infectious disease provides a myriad of long-lasting health benefits that may even reduce the risk of multiple leading causes of death. Yet our social care spending is lower than most other wealthy countries.

We pay the most money into a healthcare system that is giving us some of the worst results. One of the best ways to measure the success of a society is life expectancy, and ours took a major hit during the pandemic while other nations seemed able to cushion the blow. We must truly consider whether we are making the right investments in our society and healthcare system — this most recent data suggests we are not.

The post When it comes to life expectancy, we don’t get what we pay for appeared first on Lown Institute.

At Boston University Center for Antiracist Research’s symposium earlier this month, Dr. James Feigenbaum, Assistant Professor of Economics at BU, Dr. Lance Laird, Assistant Professor of Family Medicine at the BU School of Medicine, and Dr. Jayakanth Srinivasan, Research Associate Professor of Information Systems at the BU School of Business shared their insights into how “digital redlining” keeps some of the most vulnerable patients from accessing telehealth.

The practice of “redlining,” government-led discrimination in home loan offers based on neighborhood racial makeup, was made illegal in the 1960s. But more than 60 years later, internet providers still discriminate against customers based on where they live, a practice referred to as “digital redlining.” Comparisons of broadband internet access and poverty rates by census tract show that network providers systematically exclude low-income neighborhoods from broadband service, giving them much slower internet access.

The switch to telehealth makes these digital divides much more apparent, experts noted. When Boston Medical Center asked their patients if they had access to a reliable internet connection, more than 20% said no. Some may have internet access, but not have the technological skills or knowledge to navigate programs easily. Others may have access and knowledge, but they have competing priorities — for example, their children needed to use the internet to attend virtual classes.

“We’re asking families to ration broadband, to choose between closing the education gap or the health gap.”

Dr. Jayakanth Srinivasan, Research Associate Professor of Information Systems, at the BU School of Business

Some families had to choose which meeting or class to attend, or use their phone data to access both, which can be expensive. In some cases, families who had previously missed an internet bill were not given access even when the school system subsidized it. “For some patients, seeking health care is taking away their wages,” said Baird.

Another challenge is fragmentation of care through telehealth. A clinician and patient may have a long-standing relationship, but when it comes to virtual visits during Covid-19, patients were not always given a choice of provider. They had to see whichever doctor was available, not their doctor. This breaks apart the continuity and trust that is so important to high-quality care.

The issue of privacy in tech is another challenge. It’s one thing to see your doctor in the clinic, it’s another to let them into your house through video calls. Especially if you don’t get to choose which doctor you see, this can further create tension and reduce trust.

What can we do to solve the problem of digital redlining? First of all, we need to recognize that internet access is a necessity, not a luxury. “The federal government is accountable,” said Srinivasan, “The US government should be able to fund broadband access for everyone.” Federal and local officials must ban digital redlining and demand the same speed and quality of internet access for all.

Health systems should also be sure to ask their patients about their internet access and knowledge, to see where there are gaps in access. Health systems should work toward making patients’ preferred clinicians available for virtual visits, and think about how to create more private virtual spaces to build trust.

The rapid rollout of telehealth led to disparities in access, some more avoidable than others. As the pandemic recedes in certain regions, now is the time to make sure that these inequalities do not become embedded in the health system. “We have to correct these inequalities before it calcifies,” said Srinivasan, “Don’t let the concrete set.” Telehealth presents a massive opportunity to expand health care access — but it will only work if we can expand digital health equitably.

The post Digital redlining: How telehealth can exacerbate inequalities appeared first on Lown Institute.

Benefits of reduced preventive care

Postponing preventive services like vaccinations or care for chronic conditions is likely to cause harm. However, the decline of routine medical care is not always a bad thing, argue Dr. Alan Roth, chair of family medicine at the Jamaica Hospital Medical Center, and Dr. Andy Lazris, primary care physician in Columbia, MD, in the latest episode in the “Right Care Series” in American Family Physician. Because certain types of routine care are unnecessary, avoiding this low-value care can actually help patients avoid the stress from false positives, additional out-of-pocket costs, harm from cascade events, and other overuse-related harms.

“The pandemic has provided an opportunity to evaluate which medical services are truly necessary and what patients can do without.”

Dr. Alan Roth and Dr. Andy Lazris, in American Family Physician

Here are a few low-value services Roth and Lazris identify as commonly overused:

• Diagnostic imaging, like MRIs and CT scans, for patients without serious symptoms (almost all hospitals in the US perform these tests, according to the Lown Institute Hospitals Index)
• Cancer screening in older adults (nearly half of older adults are overscreened for cancer)
• Pain management procedures like vertebroplasty and spinal fusion

Roth and Lazris also point out that “adult wellness examinations,” annual preventive check-ins for Medicare patients, have not been shown to measurably improve health outcomes and often lead to low-value screening tests, such as thyroid function testing, urine culture testing.

Wellness visits also can lead to cardiac testing and subsequent stenting, which has shown to be no better than medical therapy for stable heart disease. (Dr. Lown himself discovered how giving patients cardiac tests almost always led to unnecessary coronary interventions.) Roth and Lazris cite a study of 12 hospitals showing that 47% fewer patients received elective cardiac catheterizations in Spring 2020 compared to 2019.

The financial burden of low-value preventive care

Another study on low-value preventive care published last month in the Journal of General Internal Medicine shows the scope and financial harm from just a few of these services. Dr. Carlos Irwin A. Oronce, fellow at the VA Greater Los Angeles Healthcare System, and colleagues looked at how often Medicare beneficiaries received seven preventive services that have been given a “D” Grade by the US Preventive Services Task Force (USPSTF). The USPSTF gives a “D” grade to services they recommend against because they are at least moderately certain that “the service has no net benefit or that the harms outweigh the benefits.”

Just seven low-value services were performed more than 30 million times each year — that’s 13 low-value services per 100 visits.

The Grade D services measured included screening for urinary infections and cardiovascular disease for asymptomatic adults, screening for certain cancers in older adults, and vitamin D supplements for older women to prevent fractures. Oronce et al. used a sample of about 95,000 patient visits from 2007-2016, in the National Ambulatory Medical Care Survey (NAMCS). From the frequencies of the Grade D services in the sample, they estimate that these seven services were performed more than 30 million times each year — that’s 13 low-value services per 100 visits.

The total estimated cost of these services for Medicare was $477,891,886 per year. They note that three services in particular —screening for asymptomatic bacteriuria, vitamin D supplements for fracture prevention, and colorectal cancer screening for adults over 85 years— alone made up about two thirds of this cost.

Advanced cancer crisis?

Decreased cancer screenings during Covid-19 in particular have gotten a lot of attention. Oncologists have reported seeing more patients than usual in advanced stages of cancer, which is concerning. Many patients avoided seeking medical care for concerning symptoms, like serious pain and swelling, because they were either afraid of viral spread or they had suffered financial consequences from the pandemic. It’s clear that the lack of access to diagnostic services and care early in the process has led to unnecessary suffering, borne disproportionately by people of color, as the ProPublica article points out.

Yet, we have to be careful not to conflate diagnostic cancer tests (performed when someone has symptoms) and screening cancer tests (performed when someone has no symptoms). As we’ve written on this blog extensively, cancer screening often leads to false positives, overdiagnosis, and other harms. Screening tests are also given too often to patients who are too young, too old, or at too low-risk to benefit. This pause in screening tests should be seen not as a crisis but as an opportunity to see whether we can reduce low-value screening.

The path forward

Will patients benefit overall from less low-value care? It’s likely, but we won’t know for sure until we study it. Fortunately, there are some trials in progress now to evaluate how less preventive care (and potential cascade events) have impacted health. For example, the federally-funded Breast Cancer Surveillance Consortium is collecting data from 800,000 women at 100 mammography centers across the country, to evaluate the long-term health impacts of fewer routine mammograms during the pandemic. The National Cancer Institute will also be using two national cancer tracking systems to research how less cancer screening during Covid-19 has impacted the stage at which cancer is diagnosed, STAT reports.

However, doctors don’t have to wait to deliver the right care to patients now. Roth and Lazris acknowledge that “the temptation to go back to normal will be difficult to resist,” but they encourage clinicians to use Covid-19 as a turning point to “stop providing ineffective services that have not been demonstrated to improve patients’ health.”

The post Less routine care during Covid-19 is not a crisis appeared first on Lown Institute.

A new report from Families USA, a nonprofit organization dedicated to achieving high-quality, affordable health care for all, estimates that health insurance gaps were associated with 44% of the Covid-19 infections and 32% of the Covid-19 deaths that occurred from late January 2020 to the end of August. However, the extent to which coverage affected Covid-19 rates varied widely by state: In Texas, 66% of Covid-19 illnesses were linked to health insurance gaps, while in Massachusetts (which has a system of universal coverage), only 16% of cases were associated with insurance gaps.

Measuring the impact of coverage gaps

How were researchers able to link Covid-19 infections and deaths to gaps in coverage? The Families USA report builds on research conducted by John McLaughlin, Senior Medical Director and Epidemiologist at Pfizer and colleagues. (Families USA received no funding from Pfizer for their report).

McLaughlin and colleagues used county-level data to analyze associations between a broad set of sociodemographic, economic, and health-status characteristics and Covid-19 burden. They found many characteristics were correlated with COVID-19 cases and deaths on a county-wide level, including population density, crowded housing, air pollution, proportion of racial and ethnic minorities, residential segregation, income inequality, proportion of uninsured people, and more.

Their analysis showed a strong correlation between uninsured status and Covid-19 infections and deaths: Even when controlling for all other variables (and there were a lot of variables included), they found that each 10% increase in the proportion of county residents without health insurance was associated with a 70% increase in the county’s COVID-19 cases and a 48% increase in COVID-19 deaths. The FamiliesUSA report applied these findings to estimate the impact of insurance gaps on a national and state level. They caution that the analysis is not a randomized trial and thus cannot prove causation between uninsurance and Covid-19 burden, just association.

Why insurance gaps drive Covid-19

Why are gaps in health insurance coverage associated with higher rates of illness and death? One clear reason is because people who don’t have health insurance often delay or go without necessary care, because they are concerned about the cost. Uninsured patients may not know that their hospital bills will be covered under the CARES Act because some hospitals don’t tell them. There have been reports of uninsured people dying at home or on their way to the hospital because they either sought care too late, or were turned away.

About half of people without insurance do not have a regular care provider — someone who could help them recognize symptoms, get tested, isolate, and advise when or if they should go to the hospital. Insurance status also makes a difference in the care patients with Covid-19 receive and their ability to transfer to hospitals with more resources.

But health insurance gaps not only harm those without insurance; they impact the entire community. Being able to test and trace depends on people seeking care and cases being recorded by a clinician, so if people avoid or can’t access the health care system, infections will spread uncontained. And if those without insurance avoid getting tested because they are worried about the cost (which is a valid concern) they might not be able to get time off work, and could spread the virus to more people.

The report provides a compelling case that inequality in access to care is a public health hazard for us all. The authors conclude, “Leaving millions of people without health insurance can endanger our nation’s overall health and economic security. It is time, finally, to guarantee necessary health care for everyone who lives in the United States.”

The post One in three Covid-19 deaths may be linked to health insurance gaps appeared first on Lown Institute.

Now, it is clear that in our haste to get “shots in arms,” we are leaving behind many people who are most at risk of Covid-19 infection and death. According to the Kaiser Family Foundation’s latest analysis of state-level data on race and ethnicity of Covid-19 vaccinations, Black and Hispanic/Latinx people are receiving fewer vaccinations proportionally compared to their shares of Covid-19 infections and deaths. In Texas, 20% of vaccinations have gone to Hispanic/Latinx people, even though they account for 42% of cases and 47% of deaths in the state. In Massachusetts, 81% of vaccinations have gone to white people, even though they only account for 49% of cases in the state.

Drivers of vaccine disparities

Why is this happening? The CDC’s recommendations to prioritize older people, essential workers, and those with multiple health conditions are well-targeted. Given that people of color make up a large share of the health care workforce and other essential workers, and have higher rates of chronic conditions, one would expect that they would be getting vaccinated at high rates. The continued disparities show that creating an order for distribution is not enough to ensure that distribution is actually equitable.

There are many other barriers that come between eligibility and actually receiving the vaccine. As Dr. Muriel Jean-Jacques, associate professor of medicine and associate vice chair for diversity, equity, and inclusion at Northwestern University and Dr. Howard Bauchner, editor-in-chief of JAMA, write in a recent viewpoint piece, the essential elements of “time, technology, and trust” that it takes to get access to the vaccines are very unevenly distributed in the US. People not only need to be eligible for a vaccine, they need internet access, ability to use technology, ability to understand English, time to be online refreshing appointment pages, and a car or other transportation to get to the appointment.

For people to receive the vaccine, they also have to have faith in the vaccine’s benefits, which takes outreach and time from health care workers and community leaders to address concerns, answer questions, and dispel misinformation. This outreach process is incredibly important, but it hasn’t been undertaken on a national scale. The result? Even when vaccine centers are set up in low-income communities, wealthier people from nearby suburbs are overly represented.

Potential solutions

What can we do to reverse these inequities? Jean-Jacques and Bauchner recommend prioritizing vaccine distribution in zip codes most severely impacted by Covid-19, partnering with local organizations for better outreach, simplifying registration, and prioritizing those with transportation barriers by using vans to deliver vaccine to homebound people or distributing vaccines near public transportation hubs.

Other health policy experts suggest going a few steps further. In a Washington Post op-ed, Dr. Uché Blackstock, emergency physician and founder of Advancing Health Equity, and Dr. Oni Blackstock, primary care physician and founder of Health Justice, recommend that the CDC specifically prioritize people of color for vaccinations, and that states bring the vaccine to where Black people are more likely to go, such as community centers, churches, and schools. “While there is urgency to vaccinate quickly, it cannot and must not be done at a cost to equity,” they write.

Data availability is also very important when it comes to equity in vaccinations. In the CDC’s national data, race/ethnicity was only known for about half of people who had received the vaccine. The CDC should mandate collection of these data, and make the data available on a public-facing website.

Global inequities

It is important to point out that disparities in who gets vaccines are playing out on a global, not just national, scale. In a recent article in the Washington Monthly, Lown senior vice president Shannon Brownlee and investigative journalist Jeanne Lenzer point out the irony of shaming Americans who skip ahead in line while the US hoards vaccines that could be given to other countries.

As of mid-February, just ten countries had administered 75% of the world’s vaccinations, and 130 countries had not received a single vaccine. At our current pace, we won’t vaccinate the world until 2023 at least. Millions will die, including health care workers who are already in short supply in many developing countries. Not only is it cruel to ignore the Covid-19 crisis in other countries, it is short-sighted, Brownlee and Lenzer write. The longer the world allows the virus to spread, the more mutations will appear, which could reinfect people across the world. No country is truly safe until the world is vaccinated.

The US needs to take leadership on making the vaccine available for all. Biden has indicated that he is using the Defense Production Act to boost Pfizer’s vaccine production. However, price is another huge factor, as many developing nations cannot afford the higher-priced mRNA vaccines. One potential solution is COVAX, a global effort to purchase vaccines on a large scale to negotiate lower prices.

Another solution, advocated by the People’s Vaccine Alliance, is to require pharmaceutical companies working on Covid-19 vaccines to share their intellectual property (IP) through the WHO’s Technology Access Pool. Because most Covid-19 vaccines and treatments have been developed with public funding, the People’s Vaccine Alliance urges governments to “impose conditions on their funding to demand the removal of patents and other intellectual property barriers, the open sharing of know-how, and the transfer of technology to as many manufacturers as possible.” Vaccine experts have recently pointed out that IP alone is not enough for companies to instantly start manufacturing vaccines. But even if it will take months for other companies to build up their manufacturing capacities, it is an important first step toward expanding the supply we need in order to vaccinate the world.

The post Vaccine distribution effort falls behind on equity appeared first on Lown Institute.

The (very) good news!

The 94.5% effectiveness rate touted in the original press release holds up in the detailed data, even across subsets of people especially vulnerable to Covid-19. Two months after the second vaccine dose, there were 9 cases of Covid-19 in the vaccine group (18,559 people) and 169 cases in the placebo group (18,708 people), which is an efficacy rate of 94.6%. Among those older than 55, the vaccine was was 93.8% effective. Among those with comorbidities that put them at risk for Covid-19 such as obesity and diabetes, the vaccine was 95.4% effective. The vaccine also showed similar or higher efficacy in racial groups that have been disproportionately affected by Covid-19 as well. Even in people over 65 with comorbidities, the vaccine was 91.7% effective in preventing symptomatic Covid-19.

The absolute reduction in risk from the vaccine is 0.852%, as 0.9% of the placebo group got Covid-19 and 0.048% of the control group got Covid-19. This makes the “number needed to vaccinate” 177 to prevent one case of Covid-19.

There are a few subgroups in which there were not enough cases in the sample to determine effectiveness. For example, in the age group of people 75 and older, no one in the vaccine group got Covid-19 and five people in the placebo group got Covid-19. This looks promising, but the small number of cases overall precludes making strong conclusions about this subgroup specifically. Similarly, there were too few cases among people under 18, Asian Americans, Native Americans, people of mixed race, and those with the specific comorbidities of cardiovascular disease or malignancy. This is not to say the vaccine “doesn’t work” in these populations, only that there isn’t enough statistical power in this trial to show efficacy within these specific subgroups.

The small number of severe Covid-19 cases in the sample also makes it more difficult to know how well the vaccine protects against severe Covid-19. Looking only at severe cases that occurred after the second dose, there were three cases in the placebo group and one in the vaccine group — not enough data to know. Looking at all severe cases that occurred after the first vaccine dose, the data are more encouraging. After the first dose there were nine severe cases in the placebo group (seven were hospitalized, three went to the ICU) and one severe case in the vaccine group (not hospitalized), which shows 88.9% efficacy for the vaccine.

Overall, the speed at which we’ve been able to develop and test Covid-19 vaccines is incredible, and those who have worked on the vaccines (and mRNA technology in prior years) and supported the efforts should be commended.

“I think if you asked 100 scientists in January, ‘Do you think that by the end of the year we will have done two large prospective placebo-controlled trials of 30,000-40,000 people…and have the kind of efficacy we’re seeing,’ no one would have believed that. It’s remarkable!” said Dr. Paul Offit, vaccine specialist and FDA vaccine advisory committee member, in a video interview with ZDoggMD.  

How safe is it?

Safety is obviously an enormous concern for this vaccine, as this will ideally be taken by millions of people nationwide. The news on the safety front is also good, because there were no unusual or severe adverse events in the vaccine trial. The majority of vaccine side effects occur within two months of taking the vaccine, and the FDA (even under extreme political pressure to move faster) insisted on two months of safety data.

That said, there were fairly common mild side effects from the vaccine, which should be made clear to the public. In the vaccine group, 84.1% of people experienced injection site pain, 62.9% had fatigue, 55.1% had a headache, 38.3% had muscle pain, 31.9% had chills, and 14.2% had fever. Mild swelling of the lymph nodes occurred more often in the placebo group (58 more cases) but still very rare. The rate of mild adverse events was higher in younger trial participants, with those in the below 55 age group having a greater rate than those over 55.

These side effects show that the vaccine is working and producing an immune response, but may make people hesitant about getting the second shot, or lead people to think that the vaccine gives you Covid-19. Pfizer also recently put out a warning that people with severe allergies to food or medications should not take the vaccine, as it may cause an allergic reaction. Doctors and public health officials need to be transparent about the possible side effects, so as not to lose more public trust in vaccines.

In terms of severe adverse events, the report noted one case of shoulder injury and one case of swelling lymph nodes that could be related to the vaccine. There were also four cases of Bell’s palsy (muscle weakness in half of the face) in the vaccine group and none in the placebo group. The FDA did not perceive this as a definite causal effect of the vaccine because the number of cases was not more frequent than expected in the general population. However, others disagreed, saying that the rate of Bell’s Palsy in the vaccine group of 21/100,000 is greater than the general population rate of 13-15/100,000. In the report, the FDA recommends “surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations.” Fortunately, Bell’s Palsy usually resolves within a few months, but we still need to be clear and honest about the potential side effects.

What about very rare side effects that would not be noticed even in a trial of 35,000 people? As Dr. Gideon Meyerowitz-Katz, an epidemiologist working in chronic disease in Sydney, Australia, writes, “We do have a mechanism to detect these, called a phase 4 trial. This is the monitoring that looks at the safety of vaccines in a population once they have already been licensed and exists to make sure we haven’t missed anything concerning.” As we distribute the vaccine, making sure that we track adverse events in vaccine recipients is essential to pick up on any very rare side effects. Meyerowitz-Katz also points out, “For anyone over the age of 20, the risk of death from Covid-19 infection is higher than one in 20,000, which means that even without knowing everything, we can be pretty sure at this point that the vaccines will be safer than the disease itself.”

What we still don’t know

The FDA report is very clear on what the Pfizer trial tells us and does not tell us. The vaccine was not tested in children or pregnant or nursing women, so we don’t know the effectiveness or potential side effects for these populations. Because the trial ended after two months post-vaccination, we don’t know exactly how long the vaccine protects people against Covid-19. Hopefully, the immunity will be much longer than two months, but we don’t have data on that yet. We also don’t know whether the vaccine protects specifically against “long Covid” or Covid deaths, because there weren’t enough cases of these in the trial to conclude.

The trial was designed to show vaccine effectiveness against Covid-19 by looking at “incident cases”: people with symptoms who were diagnosed with Covid-19. However, the trial does not tell us if the vaccine prevents someone from spreading Covid-19 to someone else asymptomatically. This means we will still need to wear masks and physically distancing from others until enough people have received the vaccine. Still, the very encouraging efficacy and safety data for this vaccine provides us a light at the end of the tunnel, one that is desperately needed.

The post The Pfizer-BioNtech vaccine: Good news and what we still don’t know appeared first on Lown Institute.

“They gave me Regeneron and it was like unbelievable, I felt good immediately….I call that a cure.”

Throughout the Covid-19 pandemic, President Donald Trump has touted unproven remedies, both before and after he was diagnosed with the disease. His rhetoric sends the message to Americans that we don’t need to wait for clinical evidence before declaring that something works and waiting for evidence would unjustly deprive people of access to cures. In this framework, a single positive response to a new treatment is the same as a “cure,” and making unproven treatments available to everyone is the same as “equality.”

Even though President-elect Joseph Biden is planning a different approach to the Covid-19 pandemic, the injection of partisan politics into discussions of clinical effectiveness could have a lasting impact, making efforts to reduce low-value care more difficult (low-value care refers to health care services that offer little or no clinical benefit). Decisions involving clinical evidence with multiple stakeholders have always been political, but they generally involve specific health care groups representing their interests. As debates on evidence and effectiveness have moved more into the public view, discussions around these decisions have taken on a political tinge, to the point where they fall along party lines.

In this framework, a single positive response to a new treatment is the same as a “cure,” and making unproven treatments available to everyone is the same as “equality.”

As researchers and advocates for safe and effective care, we see the need for the “Less is More” movement to anticipate this potential division and reframe our message to improve public and bipartisan political support. We want the public, the media, and policymakers to understand that high-value care is as much about freedom from harm as it is about cost and efficiency.

More than a decade’s worth of research on low-value care has given the medical field a solid understanding of the widespread prevalence of overuse and its cost to the health system. Less well understood is the rate of preventable harm it causes to patients, but there is widespread agreement that the harm is not negligible. Despite the cost and harm, large and lasting reductions in overuse have been elusive.

If clinical evidence becomes a political — or worse — partisan issue, creating such a coalition and achieving needed reforms will be increasingly difficult.

To create a health system that avoids low-value care, we need significant changes in health care policy, as well as a cultural shift away from the “more is better” default. That will require a broad coalition of clinicians, patients, and policymakers. If clinical evidence becomes a political — or worse — partisan issue, creating such a coalition and achieving needed reforms will be increasingly difficult.

President Trump’s statements have already fueled public demand for unproven Covid-19 treatments. In the days after Trump claimed that he was “cured” by the Regeneron antibody cocktail, leaders of the clinical trials reported receiving more requests from patients to participate. Researchers found similar effects after Trump touted the curative effects of hydroxychloroquine, a drug that was later found to be harmful, and convalescent plasma.

Increased public enthusiasm for experimental treatments could create hurdles for helpful policies. One effective way to reduce low-value care is to stop reimbursing clinicians for these services. But if the standard for patients and clinicians becomes “one good outcome,” no service will ever be off the table. And if industry, hospitals, and other institutions reap financial and political gains from selling unproven therapies, they will fight against policies to reduce low-value care.

This has concerning implications for future administrations’ efforts to increase health insurance coverage, because expanding access to care will be nearly impossible if the public demands that all services be covered. Additionally, those who oppose the efforts to expand health insurance will likely use demand for unproven treatments as a weapon to attack single payer, by saying that a public health plan would restrict patients’ “freedom of choice.” The more political and health care industry interests converge around this message, the more difficult it will be to move toward affordable universal health care.

We want Americans to think about high-value care as a movement for saving lives, rather than saving money.

If we want systemic change, we need to review how clinicians, policymakers, and the public view value in health care. Avoiding overuse may be seen as just a cost-saving measure, when it is as much about preventing harm to patients. Our goal is for Americans to think about high-value care as a movement for saving lives, rather than saving money for the government and insurance companies. To that end, we should focus on framing high-value care as “freedom to receive the best care without fear of harm.”

This will require engaging the media, policymakers, and the public on the potential for low-value care to hurt patients. For every celebrity’s story in the popular media about an unproven medication or cancer screening that “saved my life,” we need another celebrity sharing a story of overtreatment. When politicians say they will protect our “right to try” unproven treatments, we need them to also say how they protect our freedom from unnecessary harm.

Rather than just telling the public to “listen to the experts,” we should empower people to think critically about claims they hear about new medical treatments (as well as the people making these claims), and give them the tools they need to do so. At the same time, clinicians should be empowered to objectively evaluate the treatments they use, and to see their job not just as serving patients, but also protecting them from unnecessary interventions.  

The pandemic gives us an opportunity to change the conversation, to make high-value care an essential element of what we consider health care quality, safety, and even freedom.

The Biden administration will need to address the political divide around low-value care, and do so quickly and clearly, in ways that acknowledge the sense shared by too many Americans that they are being shut out from care that could help them. They should avoid the temptation to create hype around untested treatments, be it new Covid-19 treatments or a cure for cancer.

Many of us in the health care field are alarmed by the increasingly political rhetoric that has developed around clinical evidence in the Covid-19 era. Yet the pandemic also gives us an opportunity to change the conversation, to make high-value care an essential element of what we consider health care quality, safety, and even freedom.

Judith Garber and Shannon Brownlee also contributed to this piece.

The post When evidence becomes politicized, how do we talk about low-value care? appeared first on Lown Institute.

Myth: Doctors are inflating the number of Covid-19 deaths to get higher reimbursements

What’s the claim? President Trump claimed at recent rallies that doctors are exaggerating the number of Covid-19 deaths so they can get paid more.

“If somebody is terminally ill with cancer and they have COVID, we report ’em and you know doctors get more money and hospitals get more money. Think of this incentive,” he said.

What’s the truth? Hospitals do get a slightly higher reimbursement from Medicare for patients diagnosed with Covid-19. The CARES Act passed in March 2020 gives hospitals a 20% increase in payment for patients diagnosed with Covid-19. This was done so that hospitals could pay for protective gear for clinicians and other workers to care for these patients, at a time in which most hospitals were struggling financially. A September update from CMS advised that patients needed a positive Covid-19 test documented in their record to receive the reimbursement bump.

Does this policy give hospitals an incentive to test more people coming to the hospital for Covid-19? Maybe, but hospitals need to do this anyway to ensure the safety of their workers and make sure they are taking the proper protocols.

Does the policy create an incentive for doctors to lie about the cause of death for patients? No, it does not. Doctors recording when patients have Covid-19 cases for patients is not the same as doctors listing Covid-19 as the cause of death on a death certificate (more on that topic in the next question).

Why is the myth believable? Hospitals are known for squeezing as much from payers as possible, by documenting comorbidities wherever they exist. In rare cases, hospitals commit fraud like “upcoding,” billing an encounter as more serious or complex than it actually was. However, as Dean of Brown University’s School of Public Health Dr. Ashish Jha explained in an interview with StatNews, the likelihood that hospitals across the US are systematically coding patients fraudulently as Covid-19 positive is next to none. Not only is it immoral for hospitals to do this, it’s “super easy to get caught,” said Jha.

“We keep looking for these explanations when the explanation for 225,000 deaths and 8 million cases is pretty straightforward. We haven’t controlled the pandemic.”

Dr. Ashish Jha, Dean of Brown University’s School of Public Health

Why does it matter? Doctors reacted strongly to Trump’s claim, because they have been on the front lines of the pandemic, and in are shouldering a large burden of the virus response. Not only have they risked their lives, most physicians have had their pay cut during Covid-19.

Myth: Only 6% of Covid-19 deaths are actually due to Covid-19

What’s the claim? A popular argument on social media has been that reports of Covid-19 deaths are inflated because people are dying “with Covid-19” and not “because of Covid-19.” One claim that went viral on Twitter in September was that only 6% of Covid-19 deaths are actually due to Covid-19.

What’s the truth? In late August, a report from the Centers for Disease Control and Prevention gave a summary of Covid-19 deaths and comorbidities. The report showed that the vast majority of people who died of Covid-19 also had other documented conditions such as respiratory failure and pneumonia. “For 6% of the deaths, COVID-19 was the only cause mentioned.”

This does not mean that 94% of the people who are reported to have died of Covid-19 actually died of other causes. In the same way that HIV weakens the immune system and leads to life-threatening pneumonia and cancers, Covid-19 causes serious illnesses like adult respiratory distress syndrome (ARDS) and sepsis, which can be fatal. For most of the people that die of Covid-19, Covid-19 will not be the only condition listed on their death certificate, because the virus induces deadly conditions like ARDS. But make no mistake, Covid-19 is to blame.

For SARS-CoV-2, the assault it elicits on the lungs can greatly exacerbate other pre-existing conditions. So things like cardiac arrest, renal failure, liver failure, sepsis, lung scarring, etc. can all occur post-infection with SARS-CoV-2, leading to death. (3/4)

— Ryan McNamara (@Ryan_Mac_Phd) August 31, 2020

It is also well established that having chronic conditions such as heart disease, diabetes, or kidney increases one’s risk of dying from Covid-19. This helps explain why so many people who have died of Covid-19 had comorbidities.

Why is the myth believable? We’ve heard a lot about asymptomatic Covid-19 cases, so it would make sense that some people who die of totally unrelated causes also happen to test positive for Covid-19. The instances in which someone died “with Covid-19” but not “because of Covid-19” are not unheard of (George Floyd is one example). But they’re not very common. According to Bob Anderson, chief of mortality statistics at the US Centers for Disease Control and Prevention, 92% of all deaths that mention Covid-19 list Covid-19 as the underlying cause of death.

“92% of all deaths that mention Covid-19 list Covid-19 as the underlying cause of death.”

Bob Anderson, chief of mortality statistics at the US Centers for Disease Control and Prevention

Why does it matter? The number of “real” Covid-19 deaths has been hotly contested from the start of the pandemic, because the higher the death rate from Covid-19, the more we need to take the virus seriously, and take action to reduce transmission. However, looking at the number of “excess deaths” shows that we are not underestimating Covid-19 deaths. From January to October, the US recorded nearly 300,000 more deaths than the typical number during the same period in previous years. About 2/3 of these deaths can be attributed to Covid-19, researchers estimate.

Myth: Masks don’t slow the spread of Covid-19

What’s the claim? Many in US do not wear masks because they don’t believe that they impact the spread of Covid-19. For example, the CDC’s finding that 71% of 150 people who contracted Covid-19 reported that they “always wore a mask,” has been cited as proof that masks don’t work.

What’s the truth? We know from many laboratory studies that wearing homemade cloth masks reduces the number of particles that are released into the air when we breathe, talk, and cough. In this way, cloth masks are recommended as a method of “source control,” helping to prevent the spread of Covid-19 from someone who has the virus to others. Because Covid-19 often spreads before someone shows symptoms, wearing masks in public is encouraged regardless of whether or not you feel sick.

Wearing a cloth mask may also protect the wearer from contracting the virus, or receiving a high viral load; however, cloth masks are not as good as surgical masks and N95 masks for this purpose, which is why it is recommended that health care workers wear more protective masks.

Besides laboratory studies, we have a lot of evidence in cohort studies, case studies, and epidemiological studies that find the masks reduce the spread of Covid-19. However, we don’t have any randomized controlled trials of masks for source control, which makes it difficult to know exactly how effective masks are at protecting ourselves and others from Covid-19.

“Clinical trials for non-pharmaceutical interventions in health are relatively rare because there is little to no money to be made from recommending them.”

Zeynep Tufekci, Atlantic contributor and Associate Professor of Sociology at University of North Carolina

While most public health experts agree that wearing a mask in public is a worthy policy given the minimal tradeoffs, some are also calling for the need for better evidence on the impact of mask policies. Doing cluster randomized trials to compare mask policies among various regions or schools would not only provide more evidence to support more mask policies, but also help us better understand some of the potential barriers to success or unintended consequences of mask mandates. For example, if masks are mandated, will people will engage in riskier behaviors because they feel more protected? Or will the mask mandate signal to the public that Covid-19 should be taken seriously and spur more social distancing? We don’t know the extent to which these and other factors could impact the effectiveness of masking on Covid-19 cases; more research could help answer these questions.

Why is the myth believable? Public health messaging around masks has shifted since the beginning of the pandemic. Most of us remember in March when the health officials urged people not to wear masks because they were “not effective.” The strategy was to avoid shortages of PPE for health care workers, but when the CDC changed course, some public trust was unsurprisingly lost.

Then when a study shows that 71% of people who wore masks still got Covid-19, it’s easy to think that masks are ineffective. However, analyzing studies like this requires a comparison with the control group. In the CDC study, 74% of people who did not get Covid-19 also wore masks. So there is not a significant association in either direction.

As many public health experts have pointed out, the primary purpose of cloth masks for the general public is source control, not personal protection. Your health may depend on whether those around you are wearing masks, not just whether you choose to wear one.

Why does it matter? Fewer aspects of the Covid-19 response has become more polarized than mask use over the past several months. As policymakers consider implementing mask mandates, advocates of masking should understand some of the arguments against masks and be honest about where we need more evidence, so we can find common ground.

Cardiologist Dr. John Mandrola put it well in a recent blog in Medscape:

“If we want people to wear masks, and we do, the answer is…to use the tools of any good doctor: humility, empathy, and common sense. The humility to tell people we don’t know—exactly—how much masks slow the spread of the virus. The empathy to say that we know that masks take away a lot of what makes us human. The common sense to say that masks are not dangerous, and, because mask-wearing probably helps reduce viral spread, and it isn’t forever, please, wear a mask—especially in confined indoor spaces.”

The post Debunking popular Covid-19 myths appeared first on Lown Institute.