“We Knew the Coronavirus Was Coming, Yet We Failed”

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NY Times: We Knew the Coronavirus Was Coming, Yet We Failed

“The vulnerabilities that Covid-19 has revealed were a predictable outgrowth of our market-based health care system.”

Here’s Why:

1. Ventilators. Operated as businesses, hospitals have zero incentive to stockpile.  A vast storeroom in the basement filled with ventilators that might be needed once in a generation or never?…They are unlikely to do so unless government requires them. We’ve long required ocean liners to have lifeboats and life preservers even though their operators hope to never hit an iceberg.

2. Testing has proved the persistent Achilles’ heel in the U.S. response…[Early on] With requirements for Food and Drug Administration approval expensive and cumbersome, developing a test was a business non-starter…In contrast, South Korea, with its national health system, engaged its private test manufacturers with a plan in January, promising them quick approval for a coronavirus test and the widespread use of it in nationally organized and financed testing.

3. Testing components and P.P.E.  …Conducting tests involves access to a number of components — kits, chemical reagents, swabs, personal protective equipment, sometimes custom cartridges for machines. Miss any one of those things and testing becomes impossible. It’s like trying to make bread with all the ingredients except yeast….Without a national system for such purchases in a crisis, we are essentially forcing hospitals and states to negotiate the price of water during a drought. (Alternatively, we could require all hospitals to have a 90-day supply of essential response items on hand, as Gov. Andrew Cuomo of New York has now done.)

4. Hospitals did not coordinate...In our market-based system, hospitals are primed to compete, not coordinate

5. The hospital rescue... [is needed] partly because they have delivered extraordinary treatment of Covid-19 (which doesn’t pay well) but also because they’ve had to cancel high-profit procedures like joint replacements and sophisticated scans to make room for this low-profit-margin illness…In a functioning health system, pandemic preparedness and response would be part of the expected job.

Whether regulated or run by the government, or motivated by new incentives, we need a system that responds more to illness and less to profits.

Related article: NY Times: How Health Insurers Can Be Heroes. Really.

“The industry is profiting from the pandemic. It needs to pay back by cutting premiums and co-payments, help private practices and finance more protection and care…A great paradox of this pandemic is that while Covid-19 is overwhelming the health care system, health care spending is down a whopping 18 percent. ”

Economic Burden of Inflammatory Bowel Disease, Fewer Operations and Emerging Treatments

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Pouillon, L., Travis, S., Bossuyt, P. et al. Head-to-head trials in inflammatory bowel disease: past, present and future. Nat Rev Gastroenterol Hepatol (2020). https://doi.org/10.1038/s41575-020-0293-9 (Thanks to KT Park for this reference)

An excerpt:

This Perspective provides an overview of the past, current and future concepts in IBD trial design, with a detailed focus on the role of comparative research and the challenges and pitfalls in undertaking and interpreting the results from such studies.

Related blog posts:

GR Lichenstein et al. Clin Gastroenterol Hepatol 2020; 18: 889-97.  Using Truven MarketScan Insurance Claims data (2008-2015) from more than 160,000 patients with inflammatory bowel disease (IBD), the authors estimated economic burdens from Crohn’s disease (CD) and ulcerative colitis (UC).

  • For CD, lifetime incremental cost was $416,352 on average, but was $707,711 if diagnosis was established between 0-11 years of age. The lifetime costs, $622,056, consisted of $273,056 for outpatient care, $164,298 for inpatient care, $163,722 for pharmacy costs, and $20,979 for emergency room care.
  • For UC, lifetime incremental cost averaged $230,102, but was $369,955 if diagnosis was established between 0-11 years of age. The lifetime costs, $405,496, consisted of $153,670 for outpatient care, $123,190 for inpatient care, $105,142 for pharmacy costs, and $13,493 for emergency room care.
  • The lifetime costs for UC and CD were both greater than that for rheumatoid arthritis ($100,273) and for type 2 diabetes ($89,064).
  • Related blog post: IBD Shorts 2020  Cost of IBD Care is Increasing. From Healio Gastro: Chronic inflammatory disease expenditures nearly double over last 2 decades

T Shinagawa et al. Clin Gastroenterol Hepatol 2020; 18: 898-907.  In this study from Japan with 1871 patients with CD, the 5- and 10-year reoperation rates were 23.4% and 48.0% respectively.  However, reoperation rates were significantly lower after 2002 than prior with HR 0.72.  Postoperative use of immunomodulators (OR 0.60) and anti-TNF therapy (HR 0.71) were associated with a reduced the risk of reoperation.

Alpha-1-Antitrypsin Deficiency

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A recent terrific review on Alpha-1-Antitrypsin (A1AT) Deficiency: P Strnad et al. NEJM 2020; 382: 1443-55

Background:

  • 95% of A1AT deficiency is due to homozygosity for the Z allele; prevalence of 1 in 2000 in those of European descent.
  • A1AT protects the lung tissue against attack by the enzyme neutrophil elastase.
  • The presence of A1AT genetic variants suggests that these mutations may confer a selective advantage, perhaps by amplifying the inflammatory response to invasive respiratory/gastrointestinal infections.

Pathophysiology/Clinical Features:

  • Table 1 lists the key alleles/mutations associated with A1AT deficiency -17 deficiency/null listed including: F, I, Iners, King’s, M-malton, M-procida, Pittsburgh, Queen’s, S, S-iyama, Z, QO-bellingham, QO-granitefalls, QO-hongkong
  • S allele deficiency often results in disease (emphysema, cirrhosis) in the setting of SZ heterozygotes.  The disease is typically less severe than in ZZ disease.  This allele is the most common deficiency variant (1 in 5 in Southern Europe, 1 in 30 in U.S.)
  • Z allele deficiency is the most common severe deficiency variant.  Carrier frequency: 1 in 27 persons in Northern Europe, 1 in 83 in the U.S. It is NOT seen in China, Japan, Korea, Malaysia, or Northern and Western Africa.

PI ZZ Genotype:

  • 73% of infants with PI ZZ genotype had elevated ALT level in the 1st 12 months of life
  • Cholestatic jaundice noted in 10% of infant; 15% of these infants progress to juvenile cirrhosis
  • Only 15% with abnormal ALT values by 12 years of age
  • 35% of adults with ZZ genotype show clinically-significant liver fibrosis. Risk factors for advanced fibrosis: male gender, metabolic syndrome/obesity, and alcohol consumption.

Lung Disease Due to A1AT Deficiency:

  • The clinical features of lung disease due to A1AT deficiency are “mainly indistinguishable from those of nonhereditary emphysema…this is partly why severe A1AT deficiency remains undiagnosed in approximately 90% of case, with an interval of 5 to 7 years from the onset of symptoms to diagnosis.”  When the diagnosis is late, lung disease has become irreversible.
  • Early diagnosis allows lifestyle changes (eg. smoking cessation), reduction in occupational risks, and access to therapies.

MZ Phenotype:

PI MZ genotype is more susceptible to multiple disorders, including a predisposition to COPD (at least among smokers) with odds ratio of 1.4.  Other conditions with increased risk: NAFLD-related cirrhosis (OR 3-7), Alcoholic cirrhosis, and CF-associated liver disease

Treatment:

  • Smoking cessation
  • Plasma-purified A1AT infusions.  “Randomized, controlled trials have focused on decreased loss of lung density as the primary efficacy outcome;” however, augmentation therapy has not been to shown to effect other measures, “such as FEV1, quality of life, or exacerbation of COPD.”

Related blog posts:

Also, this study was previously alluded to by this blog, but now is in print:

Briefly noted: X Lu et al. SARS-CoV-2 Infection in Children (NEJM 2020; 382: 1663-5). In 171 Chinese children with confirmed SARS-CoV-2 infection, 41.5% had fever during illness; 27 (15.8%) had no symptoms of infection or radiographic findings. Three required ICU/ventilator support; all had coexisting conditions.  One 10 month old child with intussusception died.

IBD Updates: Depression and Crohn’s Disease, Blood Tests in Pediatric IBD

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LW Gaines et al. Inflamm Bowel Dis 2020; 26: 423-8. In this study with 3307 adults with Crohn’s disease (CD) and baseline demographics, CD activity and an affective-cognitive index of depression, the authors used structural equation models to determine the likelihood of whether depression triggers CD activity or whether CD activity triggers depression.  Key findings: “The hypothesis that an affective-cognitive depression predicts patient-reported exacerbation of CD is 218 times more likely to account for the data than the converse.”   (Depression is likely to increase CD activity rather than be due to CD activity).

JJ Ashton et al. Inflamm Bowel Dis 2020; 26: 469-76. Among 256 patients (dx 2013-17) in Southhampton-PIBD database, there were 151 with CD, 95 with UC and 10 IBD-unclassified.  Key findings:

  • 9% presented with all normal blood tests (tests analyzed if available: CRP, ESR, Albumin, platelets, packed cell volume, wbc, ALT)
  • Normal labs were more common with UC compared to CD: 14.4% vs 5.3%

RC Ungaro et al. AP&T; 2020; DOI: 10.1111/apt.15685.  (Thanks to Ben Gold for this reference).  Systematic review with meta-analysis: efficacy and safety of early biologic treatment in adult and paediatric patients with Crohn’s disease. A total of 18 471 patients were studied, with  a median follow-up of 64 weeks (range 10-416). Meta-analysis found that early use of biologics was associated with higher rates of clinical remission (OR 2.10 [95% CI: 1.69-2.60], n = 2763, P < 0.00001), lower relapse rates (OR 0.31 [95% CI: 0.14-0.68], n = 596, P = 0.003) and higher mucosal healing rates (OR 2.37 [95% CI: 1.78-3.16], n = 994, P < 0.00001) compared with late/conventional management. Conclusions: Early biologic treatment is associated with improved clinical outcomes in both adult and paediatric CD patients, not only in prospective clinical trials but also in real-world settings.

RS Boneh et al. Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn’s Disease Clin Gastroenterol Hepatol (online April 14, 2020, in press) Thanks to KT Park’s Twitter feed for this reference.

  • Methods: We collected data from the multicenter randomized trial of the CD exclusion diet (CDED). We analyzed data from 73 children with mild to moderate CD (mean age, 14.2±2.7 y) randomly assigned to groups given either exclusive enteral nutrition (EEN, n=34) or the CDED with 50% (partial) enteral nutrition (n=39). Patients were examined at baseline and at weeks 3 and 6 of the diet. Remission was defined as CD activity index scores below 10 and response was defined as a decrease in score of 12.5 points or clinical remission. Inflammation was assessed by measurement of C-reactive protein.
  • Results: At week 3 of the diet, 82% of patients in the CDED group and 85% of patients in the EEN group had a dietary remission (DiRe). Median serum levels of C-reactive protein had decreased from 24 mg/L at baseline to 5.0 mg/L at week 3 (P<.001). Among the 49 patients in remission at week 6, 46 patients (94%) had a DiRe and 81% were in clinical remission by week 3. In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6–25; P=.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012–0.46; P=.006).
  • Conclusions: For pediatric patients with active CD, dietary therapies (CDED and EEN) induce a rapid clinical response (by week 3).

Related blog posts:

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

 

Stratifying Cystic Fibrosis Liver Disease with Ultrasonography

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A recent multicenter case-controlled study (MJ Siegel, J Freeman, W Ye et al. J Pediatr 2020; 219: 62-9) show that ultrasonography can identify children with cystic fibrosis (CF) at increased risk for developing advanced CF liver disease; it is well-recognized that currently advanced CF liver disease occurs predominantly in children.

Among 722 participants who underwent ultrasonography as part of a planned 9 year research study, 65 had heterogeneous liver pattern and 592 had a normal liver pattern at baseline.

Key findings at planned 4-year interim analysis in a subgroup of 55 with (baseline) heterogeneous liver pattern and 116 with (baseline) normal liver pattern:

  • Those with heterogeneous liver pattern had higher median biochemical markers of liver disease: ALT 42 vs 32, GGT 36 vs 15, AST to platelet ratio index: 0.7 vs 0.4
  • Those with heterogeneous liver pattern were at ~9-fold increased risk of developing a nodular liver pattern (23% vs. 2.6%).
  • The authors did not identify specific clinical risk factors that predict the development of nodular liver ultrasound pattern

My take: Even among those with a heterogeneous pattern, the majority will not develop a ultrasonography (nodular) pattern of advanced liver disease.  Much more insight in this area is needed with the advancement in medical treatments and with the more availability of elastography.

Related blog posts:

Island Ford Nat’l Recreation Area/Chattahoochee River

COVID-19 in Children from Italy

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NEJM: Children with Covid-19 in Pediatric Emergency Departments in Italy

Key points:

  • Children younger than 18 years of age who had Covid-19 composed only 1% of the total number of patients; 11% of these children were hospitalized, and none died
  • The Coronavirus Infection in Pediatric Emergency Departments (CONFIDENCE) study involved a cohort of 100 Italian children younger than 18 years of age with Covid-19 (median age 3.3 years)
    • .Common symptoms were cough (in 44% of the patients) and no feeding or difficulty feeding (in 23%) (especially if <2 years)
    •  Fever, cough, or shortness of breath occurred in 28 of 54 of febrile patients (52%)
    •  Of the 9 patients who received respiratory support, 6 had coexisting conditions

My take: This study provides additional data indicating that severe outcomes are rare in children with Covid-19.

Related article from NY Times: How Coronavirus Mutates and Spreads

An excerpt:

Researchers have found that the coronavirus is mutating relatively slowly compared to some other RNA viruses, in part because virus proteins acting as proofreaders are able to fix some mistakes. Each month, a lineage of coronaviruses might acquire only two single-letter mutations.

In the future, the coronavirus may pick up some mutations that help it evade our immune systems. But the slow mutation rate of the coronavirus means that these changes will emerge over the course of years.

That bodes well for vaccines currently in development for Covid-19. If people get vaccinated in 2021 against the new coronavirus, they may well enjoy a protection that lasts for years.

Related blog posts:

Why Surprise Billing Still Exists

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A piece of good news: —Doubletree Reveals Cookie Recipe

This blog does not receive any sponsorships.  That being said, my wife made a batch of these cookies and they are delicious!  My advice is to freeze half the batch and cook some later to avoid overconsumption.

A recent commentary (ECF Brown. NEJM 2020; 382: 1189-91) helps explain why surprise billing still exists despite bipartisan contempt.

Key points:

  • “An estimated 20% of U.S. emergency-department visits, 9% of inpatient admissions, and more than half of ambulance or air-ambulance transports involve an out-of-network provider.”
  • “Surprise medical billing…is more prevalent …in groups owned by certain private-equity investment companies.”
  • There are generally two approaches to solving the problem of surprise medical billing, either arbitration or using a payment benchmark, the former generally favors providers and the latter generally favors payers.
  • “Deep-pocketed private equity firms continue to oppose any legislation that cuts into their profits, as they increase their investments in physician practices…Nearly everyone else agrees that patients should be protected from surprise medical bills.”

My take (borrowed from the author): The outcome of the surprise medical billing issue “raises questions about both the role of private equity in health care and the ability of Congress to pass meaningful health care legislation.”

Related blog posts:

Blood Mountain Trail

 

AGA Guidelines: Moderate to Severe Ulcerative Colitis

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Full Text: JD Feuerstein et al. Gastroenterol 2020; 158: 1450-61. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis

Full Tex PDF: AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis

 

Associated articles included the following:

  • Clinical decision support tool (1462-63)
  • PDF: Spotlight (summary -images above) (1464)
  • Technical Review (1465-96)

Key recommendations:

  • 2a. In adult outpatients with moderate to severe UC who are naïve to biologic agents, the AGA suggests using infliximab or vedolizumab rather than adalimumab, for induction of remission. Comment: Patients, particularly those with less severe disease, who place higher value on the convenience of self-administered subcutaneous injection, and a lower value on the relative efficacy of medications, may reasonably chose adalimumab as an alternative
  • 2c. In adult outpatients with moderate to severe UC who have previously been exposed to infliximab, particularly those with primary nonresponse, the AGA suggests using ustekinumab or tofacitinib rather than vedolizumab or adalimumab for induction of remission.
  • 6. In adult outpatients with moderate to severe UC, the AGA suggests early use of biologic agents with or without immunomodulator therapy rather than gradual step up after failure of 5-ASA. Comment: Patients, particularly those with less severe disease, who place higher value on the safety of 5-ASA therapy and lower value on the efficacy of biologic agents or tofacitinib may reasonably chose gradual step therapy with 5-ASA therapy.
  • 10. In hospitalized adult patients with ASUC refractory to intravenous corticosteroids, the AGA suggests using infliximab or cyclosporine

Summary of recommendations:

Related blog posts:

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

Costly Free COVID-19 Testing and Timely Tweets

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From NPR: COVID-19 Tests That Are Supposed To Be Free Can Ring Up Surprising Charge

An excerpt:

This reality means some medical providers… must rule out other respiratory diseases before ordering a COVID-19 test, leaving some patients with a difficult choice. Do they seek medical attention and risk a high medical bill? Or do they forgo care altogether?

A second hole in these federal protections may leave patients holding the bill for their COVID-19 test. The law prohibits insurers from charging patients for testing, but it does not block medical providers from doing so. If an insurer does not cover the total amount charged by a provider, the patient may get balance-billed, or slapped with a surprise charge.

From USAToday:

Related blog post:‘Quietly’ Testing Famotidine for COVID-19

From NY Times: