Kevin Kunzmann

David Ho, MD, does not mince words on the 

In fact, the world-leading virologist begun a discussion with 

on the matter with as frank an assessment as there could be: the US is in a disastrous situation right now.

“The country is doing very poorly,” Ho, an HIV/AIDS pioneer researcher and founding director of the Columbia University Aaron Diamond AIDS Research Center, said. “What we’re confronting here in the US is what we would have expected in a developing country, not a rich and strong nation.”

These are among the opening statements Ho had on Lungcast, the new monthly respiratory health podcast from 

and the American Lung Association (ALA). As the show’s very first guest, Ho set a stage for addressing COVID-19 in both public health and scientific parameters—by first stressing its burden and reach thus far.

As he stressed, despite the US making up about 4% of the world’s population, approximately one-quarter of all COVID-19 cases and mortality apiece are from US citizens.

Though Ho—along with Lungcast host and ALA chief medical officer Al Rizzo, MD—spent the majority of the episode discussing strategies to resolve COVID-19, he also presented a quartet of reasons that explain just how the US failed in its initial response, leading to this current “disastrous situation.”

When asked for perspective on the regulatory and advisory infrastructures in place for COVID-19 response—from the World Health Organization (WHO) to the US Food and Drug Administration (FDA)—Ho offered lesser criticism than the agencies have heard in recent months.

That said, he did point to early failures in facilitating, regulating, and distributing effective SARS-Cov-2 assays at the very initial US spread. He estimated the US lost about 1-2 months in progress from use of inaccurate testing kits alone.

The issue continues today—in both inadequate testing use, and limited supply of reliable assays. As such, the country is still reactive to what its true burden of infection is.

This also hinders the US’ capability in establishing proactive measures of data collection, including contact tracing, a practice Ho praised regions of western Europe in executing early on.

Contact tracing is indeed a very necessary practice to work ahead of the virus—to actually set strategies that will definitely reduce its spread and isolate strains from the public. But the country is nowhere near position where it could be done feasibly.

“At 70,000 cases per day, it’s pointless,” Ho said.

A portion of the US population, as well some key legislators, emphasized the vitality of the economy as a key issue when stay-at-home orders and business closures were enforced at the beginning of the pandemic.

This issue was mostly unique to the US—at least in its severity of rhetoric. What was lost in these mixed priorities, or was potentially harmed due to their presence, was the matter of comprehensive public health response.

Ho stressed the need for a politically-based message and commitment toward bringing the virus under control.

He understood the significance of a reopened and mostly returned society for the sake of the country’s economic health, but, “there is not going to be economic health without public health.”

Unlike most countries with better control of new daily COVID-19 cases, the US has been susceptible to great, regional spikes which have continually and sharply raised the national wave.

Already, there’s been 2 different peaks in the first US COVID-19 wave—and descents from both waves have not been substantial enough to warrant progress toward reduced social distancing responses.

As Ho explained, it’s like pushing a rock up a hill—mistakes could mean restarting the entire process.

“For every week we slip, it would take 4-6 weeks to regain position,” he explained.

“Overall, I don’t think we’re very good at prevention,” Ho said.

From influenza (flu) vaccination dissent, to public health response among non-viral crises—skyrocketing obesity and diabetes rates, among other metrics of overall health—the US has continually failed at reducing disease threats.

The issue is one that expands beyond having effective prophylaxes and access to preventive care; it reaches community health and clinical outreach to at-risk populations. Failed healthcare prevention is an indictment of resourcing, education, research, pharmacological development, and prioritization.

Overcoming that failure is not simple, but very necessary. The earliest opportunity the US will get will be in vaccine candidates—will they seek preventive care?

“It requires a lot of persistence and tenacity,” Ho said. “For the entire public to buy into that is going to be a struggle, but one we must take on.”

Articles

A famed virologist weighs in on the country's earliest shortcomings—and how they can still be resolved today.

The 4 Mistakes Made by the US in COVID-19 Response

The US Food and Drug Administration (FDA) has approved opioid agonist oliceridine (Olinvyk) for the management of 

 in adults in instances where pain is severe enough to require an intravenous (IV) opioid.

The indication, granted to Trevena, is for short-term IV use in hospitals or other controlled clinical settings including inpatient and outpatient procedures. 

The FDA clarified in the approval that oliceridine is not indicated for at-home use.

Oliceridine's approval is based on findings from a 1535-patient series of controlled and open-label trials assessing its safety and efficacy versus placebo among participants who had undergone bunion surgery or abdominal surgery. 

The therapy was associated decreased rates of reported pain among post-operation patients.

Investigators reported a safety profile of oliceridine similar to that of other opioids, including common side effects of nausea, vomiting, dizziness, headache, and constipation. Its use is advised against patients with significant respiratory depression, acute or severe unmonitored bronchial asthma, potential gastrointestinal obstruction, or hypersensitivity to the therapy.

Marketed Olinvyk will cary a boxed warning on its label about addiction, abuse, misuse, life-threatening respiratory depression, neonatal opioid withdrawal syndrome risk, and risks from concomitant use with benzodiazepines or other central nervous system (CNS) depressants. The maximally recommended daily dose limit for oliceridine is 27 mg.

Addressing the opioid crisis, said Douglas Throckmorton, MD, FDA deputy director for regulatory programs in the Center for Drug Evaluation and Research, remains a top priority for the agency.

"We will continue to do everything we can to reduce the number of Americans who are addicted to opioids and cut the rate of new addiction through a number of cross-agency initiatives,” Throckmorton said in a 

. “Importantly, the FDA will only approve new drug applications, including those for opioid medications, following a rigorous review to evaluate the risks and benefits and ultimate determination that the data support safety and effectiveness."

Throckmorton stressed oliceridine is strictly indicated for controlled clinical setting use, without allowance for take-home prescription.

The indication limits the new opioid to clinical setting use—no take-home prescriptions.

FDA Approves Opioid Agonist Oliceridine

A pre-print article from a team of investigators at Brigham and Women’s Hospital and Harvard Medical School highlight the important of distinguishing 

 from chronic pulmonary conditions in interpreting patient risks due to 

The findings, which show evidence for risk in asthma-coronavirus overlap, also highlight the continued burden clinicians face in interpreting symptoms between asthma and other chronic respiratory diseases.

The team, led by Liqin Wang, PhD, of the Division of General Internal Medicine and Primary Care, noted respiratory viral illnesses are often associated with asthma exacerbations in both children and adults. And indeed, research from COVID-affected regions of China have suggested chronic pulmonary disease is a risk factor for COVID-19 severity and mortality.

Currently, the US reports approximately 7-9% of hospitalized COVID-19 patients have chronic lung disease—with asthma being more prevalent than 

chronic obstructive pulmonary disease (COPD).

“Recent analyses of COVID-19 cohorts suggest that chronic respiratory disease may unexpectedly be less of a risk factor for COVID-19 infection and severity than non-respiratory diseases,” they wrote. “However, most studies to date do not distinguish asthma from COPD within chronic respiratory disease, limiting identification of asthma-specific risk factors.”

Wang and colleagues used data from March 3 to June 8 from the Massachusetts-based health system’s electronic health record (EHR) to establish their case series. Patients who were COVID-19 positive, aged ≥18 years old at diagnosis, with previously diagnosed asthma and a history of care in the health system were included in assessment.

The team sought associations of demographic and clinical characteristics with hospitalization and intensive care unit (ICU) admissions among asthmatic patients hospitalized for COVID-19, as well as those who died from it. Their assessment included both univariable and multivariable adjustments via age-stratified logistic regression.

Their eligible patient population included 1827 patients, with a median age of 54 years (IQR, 37-66), and two-thirds (67.4%) being female.

Most patients were triaged to outpatient care; 30.9% were hospitalized, and of that group, 41.8 (n = 236) were admitted to the ICU. Nearly all hospitalized patients were admitted to inpatient (99.3%) or ICU (97.9%) care within 2 weeks of COVID-19 diagnosis.

Among patients with asthma, mortality rate was 5.4% among both outpatient and hospitalized patients—with greater rates being reported among asthmatic patients who were hospitalized (15.6%) and/or admitted to the ICU (23.3%). More than 71% of patients who died did so within 14 days of their diagnosis.

Versus the outpatient group, hospitalized patients were observed to have greater baseline use of inhaled corticosteroid (ICS) and long acting-beta agonist (LABA) combination use, as well as more anti-cholinergic controller therapy. Fewer hospitalized patients had just a short-acting beta agonist (SABA) prescription in the past year (

Wang and colleagues also observed significantly increased hospitalization risk associated with older age versus outpatient care (unadjusted OR, 1.46; 95% CI, 1.38-1.55; 

 <.001 for every 10 years). Males were also 75% more likely to be hospitalized versus outpatient care (aOR, 1.75, 95% CI, 1.36-2.24; 

 <.001), while Black (aOR, 1.65) and Asian patients (aOR, 3.19) were observed to be at greater hospitalization risk, as well.

Comorbid conditions associated with significantly greater hospitalization risk versus outpatient care included diabetes mellitus (aOR, 1.33); COPD (aOR, 1.92); or cardiovascular disease (aOR, 1.52). Investigators also observed significantly associations with obesity and chronic kidney disease; however, the findings were not robust.

“Several hospitalization risk factors for patients with asthma and COVID-19 reflect those identified in general populations of COVID-19 patients, including male sex, race, older age, and non-respiratory comorbidities,” investigators wrote. “Notably, male sex was a risk factor despite female predominance in COVID-19 testing and in positive diagnosis among asthma patients.”

Comorbid COPD was observed a strong risk factor for hospitalization—in fact, it was the only comorbidity that remained statistically significant after multiple comparison corrections. Asthma-specific variables were not predictive of neither ICU care nor mortality, and differences between risk for inpatient hospitalization and ICU admission were marked as a future avenue of assessment.

Investigators concluded that individuals with asthma-COPD overlap may be at particularly raised COVID-19 severity and mortality risk—though there is significant importance in distinguishing asthma from chronic pulmonary disease in COVID-positive patients to interpret individual risks.

“Further research examining the course of hospitalized patients is necessary to elucidate predictors of disease progression and clinical outcomes,” they wrote.

The pre-proof analysis, “Risk factors for hospitalization, intensive care and mortality among patients with asthma and COVID-19,” will be published in 

The Journal of Allergy and Clinical Immunology

New findings suggest differing chronic lung diseases are associated with varying risk factors among COVID-19 patients.

Older, Male Asthmatics at Greater COVID-19 Severity Risk

Time and time again, the worlds of public health, news, and medicine have merged on the topic of 

. In the last half-decade, matters on vaping effects, rising pollution concerns, and increasing COPD and lung cancer deaths have made headlines.

And in the last 6 months, a respiratory virus has altered global medicine, healthcare and society in unprecedented fashion. Its severity has strained ICU personnel and ventilator resources, and its highly infectious spread has sparked debate over public mask-wearing.

 pandemic has dramatically and irrevocably tipped over the public’s interest in respiratory health, and clinicians face heightened dual tasks: adapt to new parameters set by the virus, and serve as counselors on the developing research of SARS-CoV-2.

As providers of timely and topline clinical news and insights, 

 should provide content which reflects the new agenda of healthcare.

Introducing Lungcast, a new podcast series produced in collaboration with the American Lung Association (ALA). Hosted by chief medical officer Al Rizzo, MD, FACP, the monthly podcast series will feature interviews with world-leading researchers, clinicians, and healthcare experts on the biggest topics in respiratory care.

Every episode will be made available here on 

, as well as on the ALA’s website. Listeners can also subscribe to Lungcast on 

Our first guest is among the most qualified people in medicine to discuss the COVID-19 pandemic: world-leading virologist, AIDS research pioneer, 

1996 Man of the Year, and current coronavirus investigator David Ho, MD.

In an illustrious four-decade medical career bookended by observing the earliest cases of AIDS at Cedars-Sinai Medical Center and now leading his New York-based laboratory in COVID-19 vaccine pursuits, Ho has a world of perspective to share on epidemic response.

From US response failures to promising monoclonal antibodies, and from the caveats of herd immunity to the similarities between early AIDS discovery and COVID-19, listen in on Ho’s insights into the current pandemic.

Podcasts

World-leading virologist and AIDS researcher David Ho, MD, joins the inaugural podcast episode.

Author | Kevin Kunzmann

Articles

The 4 Mistakes Made by the US in COVID-19 Response

FDA Approves Opioid Agonist Oliceridine

Older, Male Asthmatics at Greater COVID-19 Severity Risk

COVID-19 Complications & Searches for a Cure with Dr. David Ho