Friday, an FDA advisory panel recommended booster doses of Covid-19 vaccine only for older (65+) and high-risk Americans. This week, medical experts who advise the Centers for Disease Control and Prevention are expected to clarify who would fall into the high-risk category.
The FDA is not required to follow the recommendation of its advisory committees but generally does. The Vaccines and Related Biological Products Advisory Committee voted 16 to 2 against a proposal to administer a third dose of the vaccine developed by Pfizer and BioNTech to individuals 16 years and older and 18-0 to recommend a booster to people 65 years and older — as well as people who are at risk of severe Covid.
As of yesterday, 673,929 have died in the U.S. since the pandemic began last January and 94,101 Covid patients are hospitalized. The “fourth wave” is hitting younger and unvaccinated populations hardest. While 54% are fully vaccinated including 63% of those 12 or older, one in four Americans say they’ll not be vaccinated. And preventable costs for those unvaccinated who are hospitalized from Covid will continue to add up: $5.7 billion in the last 3 months alone per a Kaiser Family Foundation study.
MY TAKE
It’s time for a reality check. Where are we as the world’s most advanced and expensive health system in waging our war against Covid-19? In my view, there are noticeable flaws in our strategy.
Covid-19 Science has been Compromised by Political Self-Interests
Vaccine mandates and masking have become political issues separating blue and red states, individual rights vs. public health and those vaccinated vs. those unvaccinated. Lost in the noise is clinical evidence and trusted sources. For example, FiveThirtyEight polls show a clear, partisan divide on the Biden administration’s handling of the pandemic: overall approval/disapproval as of September 19 stood at 51.4%/42.4%, but 86.8% approval by Democrats, 45.8% approval by Independents and 19.6% approval by Republican voters. The partisan divide about the pandemic is reflected in polling by Kaiser, Gallup, Pew and others and a constant in both the Trump and Biden administrations. In the process, scientific evidence has been relegated to often misleading political soundbites more aimed at getting votes than protecting health.
The Influence of Social Media has been Underestimated
Misinformation is false information that people spread without realizing that it’s wrong, disinformation is typically defined as false information that people spread deliberately. Both are significant in social media. For example, a March study published by the nonprofit Center for Countering Digital Hate analyzed anti-vaccine posts from 10 private and 20 public Facebook groups as well as a sample of about 123,000 anti-vaccine tweets from February 1 to mid-March 2021. Their results showed that 73% of vaccine disinformation posts on Facebook and 17% of those on Twitter (about 65% overall) with the majority originating from the “disinformation dozen” (Joseph Mercola, Robert F. Kennedy Jr., Ty and Charlene Bollinger, Sherri Tenpenny, Rizza Islam, Rashid Buttar, Erin Elizabeth, Sayer Ji, Kelly Brogan, Christiane Northrup, Ben Tapper, and Kevin Jenkins). Nonetheless, one in four Americans say they’ll not be vaccinated, many sourcing their hesitance to “online experts” like these. It might be reasonably concluded that the CDC, FDA and other government agencies has underestimated and poorly navigated the impact of social media on the public’s health.
The Scientific Community has Confused the Public
Government officials have botched communication about the pandemic. Granted, scientific evidence is rarely black and white, but the pandemic exposed the ineptitude of the CDC in effectively keeping the public informed. It exposed confusing, sometimes conflicting relationships between the CDC, the FDA and NIH often requiring clarifications to save face. And every major national news organization has created its own stable of clinical experts and former government officials to counter, commend or condense what the government is saying…often followed by their book tours! While trust in Congress (12%), TV news (16%) and newspapers (21%) has shrunk during the pandemic, confidence in the health system as a trusted source for science has not picked up the slack, declining 7% to 44% in the last year. Confusion about the need for a booster based on Friday’s Advisory Committee recommendation illustrates the challenge facing scientists, public health and government leaders: communicating efficacy and effectiveness clearly and consistently needs immediate attention.
Policymakers have Misplaced Responsibility for Vaccinations on Employers
The Biden administration’s plan to fine employers with more than 100 employees who don’t require vaccinations for their employees or conduct weekly Covid-19 testing is short-sighted. It misplaces responsibility for public health on mid-size and large employers instead of individuals. Imagine employer accountability for seatbelt use, speed limits or MMR vaccinations before beginning school. The Labor Department’s determination about how to regulate the policy will encounter understandable pushback from employers who’ll face higher compliance risk and potential workforce shortages as a result. And the practical reality is that employers will pass on their added risks and costs to their customers, potentially feeding latent fear about a spike in inflation.
The Pandemic has Widened the Gap between Private Insurers and Hospitals and Nursing Homes
Insurers have benefited from the pandemic and plan to continue: a Kaiser Family Foundation study in August found 72% of the two largest insurers in each state and DC (102 health plans) are no longer waiving these Covid treatment costs, and another 10% of plans are phasing out waivers by the end of October. By contrast, hospitals and nursing homes, especially those in low vaccination states, already face workforce tension for restrictive masking and vaccination policies. Nurses in Houston sued their hospital for forced vaccinations. Only 61% of nursing home workers are vaccinated despite vaccination directives. And half of the hospital emergency rooms and ICUs are occupied by patient populations originating from public health clinics and other settings where electronically exchanged information is unavailable. Health insurers enjoy advantages in the pandemic that others don’t.
The Senate and House resume debate this week about the $3.5 trillion budget reconciliation package and the $1.2 trillion Infrastructure Investment and Jobs Act of 2021 while facing a federal debt ceiling in mid-October. But handling the pandemic is arguably more important. The data below in “Coronavirus News” underscores its urgency.
It’s time for fresh thinking about how we tackle pandemics. That process should begin by acknowledging the five flaws sans partisan finger-pointing, learning what has worked and what hasn’t at home and abroad, and making changes.
Each of the flaws is fixable. None should be set aside out of political expedience or health industry self-interest.
Paul
RESOURCES
“How Americans View Biden’s Response To The Coronavirus Crisis”; September 19, 2021; FiveThirtyEight
McGarry et al “Association of Nursing Home Characteristics with Staff and Resident COVID-19 Vaccination Coverage”; September 16, 2021; JAMA Internal Medicine
“Vaccine Skepticism Among Young Adults has Declined Notably Across the Globe”; September 16, 2021; Morning Consult
“Unvaccinated COVID-19 hospitalizations cost billions of dollars”; September 14, 2021; Peterson-KFF Health System Tracker
“Challenges to Public Health Reporting Experienced by Non-Federal Acute Care Hospitals, 2019” ONC Data Brief | No.56 | September 2021; HealthIT.gov
CORONAVIRUS NEWS
Data Update (CDC, Hopkins, HHS)
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41 million confirmed COVID-19 cases and more than 666,000 deaths in the U.S. and 226 million cases and 4.6 million deaths globally (Hopkins).
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179 million Americans (54% of the population) have been fully vaccinated (CDC)
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About 150,000 Americans are contracting COVID-19 infections per day–down 8% over the past two weeks. The virus is killing 1,888 Americans per day, on average — a 33% jump over the past two weeks. (CDC)
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30.1% of COVID-19 deaths in the U.S. involved individuals ages 85 and older despite only making up 2% of cases and an equal portion of the population. (CDC)
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Those who were unvaccinated were 4.5 times more likely than the fully vaccinated to get infected, 10 times more likely to be hospitalized and 11 times more likely to die per an analysis of 600,000 cases in 13 states between April and July 2021 (CDC)
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CDC Study: Moderna’s Covid-19 Vaccine Best Prevents Hospitalization, CDC Study Indicates
In a study published by the Centers for Disease Control and Prevention on Friday, researchers studied more than 3,600 adults who were hospitalized in 21 U.S. hospitals between March and August of 2021. Findings:
Moderna vaccine’s effectiveness against hospitalization was 93%, compared with 88% for Pfizer-BioNTech’s and 71% for J&J’s. The Moderna vaccine’s effectiveness against hospitalization dropped to 92% after 120 days, while Pfizer-BioNTech’s dropped to 77%. After just 28 days, the J&J vaccine’s effectiveness fell to 68%.
“Interim Estimates of COVID-19 Vaccine Effectiveness Against COVID-19–Associated Emergency Department or Urgent Care Clinic Encounters and Hospitalizations Among Adults During SARS-CoV-2 B.1.617.2 (Delta) Variant Predominance — Nine States, June–August 2021” MMWR September 10, 2021; CDC
Morning Consult: 28% Remain Vaccine Hesitant
Morning Consult conducted 49,233 interviews in the United States and between 2,290 to 6,615 interviews in 14 other countries between September 7 and 13, 2021. Highlights:
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28% of US population uncertain/unwilling to get vaccination—second only to Russia (46%) among the 15 countries surveyed.
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Since tracking began, the share of vaccine skeptics has fallen by 7%in the United States and by an average of 16% in the other 14 countries.
“Vaccine Skepticism Among Young Adults has Declined Notably Across the Globe”; September 16, 2021; Morning Consult
European Study Finds Remdesivir Shows no Clinical Benefit
Background: Gilead’s remdesivir — or Veklury, has been given to about half of hospitalized Covid patients in the U.S. and generated $2.8 billion in revenue at $3000/dose. The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test treatments including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. Findings:
Researchers concluded that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.
“European study finds that Gilead’s Covid-19 antiviral remdesivir shows no clinical benefit” Endpoints September 17, 2021; Endpoints News
KFF Analysis: 287,000 Preventable Hospitalizations June-August 2021
Per HHS and CDC data, there were 287,000 preventable COVID-19 hospitalizations in June-August 2021 at an average cost of $20,000 each (total $5.7 billion avoidable costs. Key assumptions in analysis: 86% of Covid-19 admissions were unvaccinated adults,
Note: The Centers for Medicare and Medicaid Services (CMS) reports that Medicare fee-for-service COVID-19 hospitalizations average $24,033. Another study of Medicare fee-for-service enrollees found an average COVID-19 hospitalization cost $21,752.
“Unvaccinated COVID-19 hospitalizations cost billions of dollars”; September 14, 2021; Peterson-KFF Health System Tracker
INDUSTRY NEWS
Census Report: Insurance Coverage Declined from 2018 to 2020
Current Population Survey Annual Social and Economic Supplement (CPS ASEC) released this month. Highlights:
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In 2020, 8.6% of people, or 28.0 million, did not have health insurance at any point during the year.
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Employment-based insurance was the most common (54.4%) followed by Medicare (18.4%), Medicaid (17.8%), direct-purchase coverage (10.5%), TRICARE (2.8%), and Department of Veterans Affairs (VA) or Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) coverage (0.9%)
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Between 2018 and 2020, the rate of private health insurance coverage decreased by 0.8%to 66.5%, driven by a 0.7% decline in employment-based coverage to 54.4%
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Between 2018 and 2020, the rate of public health insurance coverage increased by 0.4%to 34.8%
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More children under the age of 19 in poverty were uninsured in 2020 than in 2018. Uninsured rates for children under the age of 19 in poverty rose 1.6% to 9.3%: notable increases– Black children (4.6% in 2018 to 6% in 2020) and adults who live in non-expansion states (35.6% in 2018 to 38.1% in 2020)
“Health Insurance Coverage in the United States: 2020: Current Population Reports” Census Bureau
September 14, 2021; Census Bureau
AMA: During Pandemic, Telehealth Use and Practice Sizes Increased
Between 2018 and 2020, the share of physicians in practices that used videoconferencing to provide patient visits increased from 14.3% to 70.3%. In 2020, 58.0% of physicians said their practices used telehealth to diagnose or treat patients, 59.2% to manage patients with chronic disease and 50.4% to provide care to patients with acute disease. 10.6% of weekly visits were conducted via videoconferencing and 8.1% were conducted via phone. The largest share of visits conducted on a remote basis were by psychiatrists, 36.9% via videoconferencing and 29.0% via phone.
In the same period, the size of the changes in practice arrangements shifted toward larger practices and away from physician-owned (private) practices have accelerated. 2020 was the first year in which less than half (49.1%) of patient care physicians worked in a private practice, a drop of almost 5 percentage points from 2018. 17.2% of physicians were in practices with at least 50 physicians in 2020, up from 14.7 % in 2018.
Study: Clinical Usefulness of Digital Health Understudied
Researchers conducted a systematic review of 295 US-led academic research on digital clinical measures between January 2019 and February 2021. Highlights:
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The top five research subareas included operations research (research analysis; n=225, 76%), analytical validation (n=173, 59%), usability and utility (data visualization; n=123, 42%), verification (n=93, 32%), and clinical validation (n=83, 28%).
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The three most underrepresented areas of research into digital clinical measures were ethics (n=0, 0%), security (n=1, 0.5%), and data rights and governance (n=1, 0.5%).
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Movement and activity trackers were the most commonly studied sensor type, and physiological (mechanical) sensors were the least frequently studied.
Shandhi et al “Recent Academic Research on Clinically Relevant Digital Measures: Systematic Review”; September 2021; JMIR
REGULATORY NEWS
US Preventive Services Task Force Recommends Increased Screening for Diabetes
Background: According to the Centers for Disease Control and Prevention (CDC) 2020 National Diabetes Statistics Report, 13% of all US adults have diabetes, and 34.5% meet criteria for prediabetes. The prevalence of prediabetes and diabetes are higher in older adults. Of persons with diabetes, 21.4% were not aware of or did not report having diabetes, and only 15.3% of persons with prediabetes reported being told by a health professional that they had this condition.
To update its 2015 recommendation, the USPSTF commissioned a systematic review to evaluate screening for prediabetes and type 2 diabetes in asymptomatic, nonpregnant adults and preventive interventions for those with prediabetes. Findings:
Conclusions and Recommendation: “The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. Clinicians should offer or refer patients with prediabetes to effective preventive interventions.
“Screening for Prediabetes and Type 2 Diabetes US Preventive Services Task Force Recommendation Statement”; August 24/31, 2021; JAMA
Study: Half of Household Prescription Drug Spending in 2.3% of Households
This study is a cross-sectional analysis of Medical Expenditure Panel Surveys (MEPS) collected between 2001 and 2018. The MEPS is a household survey of medical expenditures weighted to represent national estimates in the US. In 2001, one-half of all expenditures on prescription drugs were concentrated in 6.0% of the US population, but by 2018, this proportion had decreased to 2.3% of the population.
The concentration of spending on prescription drugs. In 2001, one-half of all expenditures on prescription drugs were concentrated in 6.0% (95% CI, 5.6%-6.4%) of the US population, but by 2018, this proportion had decreased to 2.3% (95% CI, 2.1%-2.5%). This change does not appear to be associated with a change in the overall share of prescription drug expenses, which increased by only a small amount, from 20.4% in 2001 to 24.8% in 2018.
Holle et al “Trends in the Concentration and Distribution of Health Care Expenditures in the US, 2001-2018”; September 14, 2021; JAMA Network Open
CMS Delays Enforcement of Payer-to-Payer Interoperability Rule
Last week, the Centers for Medicare and Medicaid Services (CMS) announced a delay of enforcement of an interoperability provision that governs how payers are expected to exchange data with one another per requirements in the May 2020 Interoperability and Patient Access Rule.
When it takes effect at a later date, the payer-to-payer provision of the interoperability rule will require insurance companies that do business with CMS, including Medicare Advantage carriers and Medicaid managed care organizations, to exchange data at patients’ request. Insurers would also be required to incorporate data they receive from other payers into members’ health record.
“Policies and Technology for Interoperability and Burden Reduction”; September 15, 2021; CMS
CDC: Obesity Rate Among Children Doubled Between 2018 and 2020
Children and teens gained weight at a more “alarming” rate during the pandemic, especially those who are overweight or obese, a CDC report out last Thursday shows. Highlights:
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The average body-mass index increases for children and teens approximately doubled between 2018 and 2020. About 22% of children and teens were obese last August, up from 19% a year prior.
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Children who were a healthy weight were gaining an average of 5.4 pounds a year last year, two pounds more than before the pandemic.
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Weight gain from children with moderate obesity increased from 6.5 pounds a year to 12 pounds after the pandemic began.
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For kids with severe obesity, the anticipated annual weight gain went from 8.8 pounds to 14.6 pounds.
Lange et al “Longitudinal Trends in Body Mass Index Before and During the COVID-19 Pandemic Among Persons Aged 2–19 Years — United States, 2018–2020”; Weekly / September 17, 2021; CDC
ONC: Half of Hospitals Lack Capacity to Share Information with Public Health Agencies
To understand the challenges hospitals faced with public health reporting in the year prior to the pandemic, this report by the Office of the National Coordinator for Health Information Technology uses analyzed data from the 2019 American Hospital Association (AHA) Information Technology (IT) supplement to describe the number and types of challenges hospitals experienced when electronically reporting to public health agencies and how these challenges varied by state and hospital characteristics. Findings:
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In both 2018 and 2019, half of all hospitals reported a lack of capacity to electronically exchange information with public health agencies.
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In 2019, seven in ten hospitals experienced one or more challenges related to public health reporting.
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Small, rural, independent, and Critical Access hospitals were more likely to experience a public health reporting challenge compared to their counterparts.
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The types of public health reporting challenges experienced by hospitals varied substantially at the state-level.
“Challenges to Public Health Reporting Experienced by Non-Federal Acute Care Hospitals, 2019”; ONC Data Brief | No.56 | September 2021; HealthIT.gov
