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

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. ”

COVID-19 Posts

My wife has been receiving a lot of compliments for her daily jokes which she decided to post for all of the neighborhood walkers. “A lot of people cry when they cut an onion. The trick is not to form an emotional bond.”

This coronavirus disease has caused incredible upheaval & misery throughout the world.  In addition, it has created an “infodemic.”  This blog post is intended to collate my previous related posts/& many of the referenced links into one location, to provide GI society guidelines for PPE/endoscopy as well as to place a good image at the bottom:

Aslo, recommendations from GI societies -AGA, ACG, ASGE and AASLD

  1. Use of Personal Protective Equipment in GI Endoscopy
  2. Endoscopic Procedure Guidance

JOINT GASTROENTEROLOGY SOCIETY MESSAGE: COVID-19
Use of Personal Protective Equipment in GI Endoscopy
RECOMMENDATIONS:
  1. General measures of physical distancing and adequate hand hygiene are of critical importance and need to be practiced diligently, independent of other protective measures.
  2. All elective, non-urgent procedures should be postponed until ample supplies of PPE, hospital beds and other resources are available after the COVID-19 surge.
  3. All members of the endoscopy team should wear a full set of PPE, predicated on resource availabilities.
  4. The correct sequence of putting on and taking off PPE (“donning” and “doffing”) is critical and needs to be understood and practiced [17].
  5. All members of the endoscopy team should wear N95 respirators (or devices with equivalent or higher filtration rates) for all GI procedures performed on patients with known SARS-CoV-2 infection and those with high risk of exposure. Given the high rate of infection transmission from pre-symptomatic individuals, all patients undergoing GI endoscopy in an area of community spread need to be considered ‘high risk’.
  6. All healthcare workers should have their N95 respirators fitted by an occupational health specialist prior to the first usage.
  7. Staffing of endoscopy rooms should be reduced to the minimum number of individuals necessary, in order to conserve PPE and other resources.
  8. In some cases, shortages may require extended and limited reuse of N95 respirators. Guidance is available on how to wear, remove and store respirators to minimize contamination [18]. Decontamination of N95 respirators with hydrogen peroxide vapor has been approved by the FDA as a means of reuse in times of limited supply [19].
GASTROENTEROLOGY PROFESSIONAL SOCIETY
GUIDANCE ON ENDOSCOPIC PROCEDURES
DURING THE COVID-19 PANDEMIC
Below is guidance regarding how to manage the clinical procedural needs of patients during the COVID-19 pandemic. Any decisions should be informed by the local situation and available resources. There may be state, local and institutional rules in place that must be considered as well. This guidance is offered until more definitive data-driven information becomes available.
For those patients for whom a procedure or appointment is not deemed immediately necessary, each practice should implement mechanisms to assure appropriate follow-up once the immediate impact of the COVID-19 pandemic has eased or passed.
All Elective Procedures Should Be Delayed
  1. Screening and surveillance colonoscopy in asymptomatic patients ​
  2. Screening and surveillance for upper GI diseases in asymptomatic patients​, including surveillance for esophageal varices in patients with cirrhosis
  3. For patients needing interval endoscopy for obliteration of esophageal varices post-acute bleeding, the individual circumstances of the patient need to be taken into account to determine safety of delay (i.e., size of varices, red wale markings, CTP status of the patient, acute bleed characteristics).
  4. Evaluation of non-urgent symptoms or disease states where procedure results will not imminently (within 4-6 weeks) change clinical management (e.g., EGD for non-alarm symptoms, EUS for intermediate risk pancreatic cysts) ​
  5. Motility procedures – esophageal manometry, ambulatory pH testing, wireless motility capsule testing and anorectal manometry
Urgent/Emergent Procedures Should Not Be Delayed ​
  1. Upper and lower GI bleeding​ or suspected bleeding leading to symptoms
  2. Dysphagia significantly impacting oral intake (including EGD for intolerance of secretions due to foreign body impaction or malignancy (stent placement))
  3. Cholangitis or impeding cholangitis (perform ERCP)​
  4. Symptomatic pancreaticobiliary disease ​(perform EUS drainage procedure if necessary for necrotizing pancreatitis and non-surgical cholecystitis, if patient fails antibiotics)
  5. Palliation of GI obstruction [UGI, LGI (including stent placement for large bowel obstruction) and pancreaticobiliary] ​
  6. Patients with a time-sensitive diagnosis (evaluation/surveillance/treatment of premalignant or malignant conditions, staging malignancy prior to chemotherapy or surgery) ​
  7. Cases where endoscopic procedure will urgently change management (e.g., IBD)
  8. Exceptional cases will require evaluation and approval by local leadership on a case by case basis
Q. Should all emergent EGD patients be intubated?
A. Absent other reasons that present a threat to the airway, intubation is not indicated for all EGDs. Proper use of PPE, including N95 masks is paramount.
Q. Should procedures be performed on patients with intermediate level cases such as Iron Deficiency Anemia (IDA) or mild dysphagia?
A. Decisions regarding cases such as these will need to be made on a case by case basis, taking into account resource availability, level of community infectivity and risk to the patient.

 

What is the Current Standard of Care for PPE and Endoscopy Cases?

CC Thompson et al. Gastointestinal Endoscopy (EPUB), in a letter to the editor, respond to two recent studies on SARS-CoV-2 virus/COVID-19 and provide recommendations for PPE use in this era of COVID-19.

Here’s a link to manuscript: COVID-19 in Endoscopy: Time to do more?

Key points:

  • Reduce non-urgent cases. “We have cut our daily endoscopy volume by over 80% and closed our ambulatory endoscopy practice.”
  • Increase the use of telemedicine. “At present, telemedicine or virtual visits make up 91% of our upcoming clinic appointments.”
  • Physical distancing as advocated recently by WHO throughout a patient’s time in the endoscopy unit is stressed in the papers, with a 6-foot minimum between individuals.
  • Suggests “the need for a separate toilet as part of the isolation to minimize spread of infection due to bioaerosols from the toilet plume”
  • Our hospital system has recently changed policy to mandate that all employees wear surgical masks at all times while in the hospital and attest to their wellness online before reporting to work.
  • We suggest labeling each computer so the same provider uses that computer and chair for the entire day, and separating by at least 6 feet.
  • All endoscopic procedures (upper endoscopy, colonoscopy, EUS, ERCP) are aerosol-generating, referencing studies that show contamination of the endoscopist’s face during routine procedures. This makes all endoscopic procedures high risk from an infectious standpoint, and appropriate PPE is
    recommended… It makes little sense for healthcare providers to perform
    aerosolizing procedures, with patients coughing or passing gas on them, while not wearing an N95 mask or better
  • “It is important to use full PPE for all endoscopic procedures while in a pandemic such as this especially in areas with community spread, because no one is truly low risk given our ongoing difficulties with testing.”
  • “The mask can be reused as long as it is functional, not soiled, and not used in a suspected or COVIDpositive patient. It is important to cover the N95 to prevent soiling.”
  • “A study from China showed that no medical staff working in high-risk departments who wore N95s and practiced strict hand hygiene regardless of patient’s infection status became infected.”
  • “Testing all patients before high-risk procedures such as endoscopy is likely the best approach; however, this will depend on significant expansion of testing capabilities. Hopefully, the development of point-of-care testing with rapid results and increasing testing availability will make this a reality soon”

My take (in part from authors): “We are living through an unprecedented time and are all trying our best to protect our patients and ourselves under suboptimal conditions of limited PPE, limited testing, and limited data. ”  The recommendations in this article are based mainly on expert opinion and may need modifications based on new data and circumstances.

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IOIBD (International Organization for the Study of Iinflammatory Bowel Disease) Recommendations (#76) for IBD Patients with Regard to COVID-19:

Full link: IOIBD Update on COVID19 for Patients with Crohn’s Disease and Ulcerative Colitis (3/26/20)

 

 

Pipeline Medications for Ulcerative Colitis (Part 1) & Face Mask Shortages

Before getting to today’s post, I wanted to provide a link on why we are desperately short of face masks in the midst of this crisis: NY Times: How the World’s Richest Country Ran Out of a 75-Cent Face Mask

An excerpt:

The answer to why we’re running out of protective gear involves a very American set of capitalist pathologies — the rise and inevitable lure of low-cost overseas manufacturing, and a strategic failure, at the national level and in the health care industry, to consider seriously the cascading vulnerabilities that flowed from the incentives to reduce costs…

Given the vast global need for masks — in the United States alone, fighting the coronavirus will consume 3.5 billion face masks, according to an estimate by the Department of Health and Human Services — corporate generosity will fall short. People in the mask business say it will take a few months, at a minimum, to significantly expand production…

Hospitals began to run out of masks for the same reason that supermarkets ran out of toilet paper — because their “just-in-time” supply chains, which call for holding as little inventory as possible to meet demand, are built to optimize efficiency, not resiliency.

My take: Conserve, conserve, conserve PPE -supply chains meeting the need is NOT imminent.

—————

Several articles from Gastroenterology highlight emerging medications for ulcerative colitis (UC).

Two of the studies:

  • WJ Sandborn et al. Gastroenterol 2020; 158: 550-61.
  • WJ Sandborn et al. Gastroenterol 2020; 158: 562-72.

The first study was a phase 2 randomized trial of etrasimod which is an oral selective sphingosine 1-phosphate receptor modulator.  A total of 156 patients were randomized into 3 groups: placebo, 1 mg etrasimod, and 2 mg etrasimod.

Key findings (graphical abstract):

In the second phase 3, double-blind, double-dummy study, Sandborn et al show that, after the initial 2 intravenous doses,  among patients with an initial response subcutaneous vedolizumab (108 mg every 2 weeks) had similar effectiveness to intravenous vedolizumab (300 mg every 8 weeks); both SC and IV vedolizumab resulted in higher clinical remission rates compared to placebo at 52 weeks in the 216 patients: 46.2%, 42.6%, and 14.3% respectively.

Full text link: Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis