“Shared expectations lead to predictability.”
96. Children may be “silent spreaders” of coronavirus-19
Q: Is the report I read true that children might be more infectious than sick adults?
A: Cells in many organs of the body exude a particular enzyme (angiotensin-converting enzyme 2) referred to as “ACE2”). This enzyme serves many different important functions. In the epidemiology of cofonavirsu-19, it responds to the spikes on the individual virions to permit it to cross the membrane entering into a healthy cell. It is inside healthy cells that this virus replicates into thousands of new virions that later exit that cell to infect other healthy cells. In studying children, the current scientific hypothesis has been that children are less likely to get sick with COVID-19 because they have reduced ACE2 available thus reducing the expansion of an infection.
A recent study conducted by the Massachusetts General Hospital was published this month in the Journal of Pediatrics. The study confirmed this hypothesis, but went a step further. Researchers studied 192 children ages 0-22. Of this group, 49 (26%) tested positive as having the virus. Another 18 (9%) had late onset of symptoms. The study then found that symptomatic and asymptomatic children who were infected also had a significantly higher levels of virus in their airways than hospitalized adults in intensive care units. Lael Yonker, MD, lead author of the study, stated, “I was not expecting the viral load to be so big. You think of a hospital and all of the precautions taken to treat severely ill adults, but the viral loads of these hospitalized patients are significantly lower than a ‘healthy child’ who is walking around with a high (coronavirus-19) viral load.”
The risk of contagion is greater with a high viral load. Findings from nose and throat swabs and blood samples from this study carry implications for the reopening of schools, daycare centers and other places with a high density populations of children. “Kids are not immune from this infection, and their symptoms don’t correlate with exposure and infection,” says Alessio Fasano, MD, one of the authors of this study. “During this COVID-19 pandemic, we have mainly screened symptomatic patients, so we have reached the erroneous conclusion that the vast majority of people infected are adults. However, our results show that kids are not protected against this virus. We should not discount children as potential spreaders for this virus.” Silent spreaders!
- Early FDA approvals before scientific analysis is completed.
Q: Are Emergency Use Authorities (EUAs) by the FDA being given out too early?
A: Last week, president Trump accused the FDA chief Stephen Hann of bureaucratic delays in approving treatments and vaccines while they are being studied. The president’s chief of staff Mark Meadows stated, “The president is about cutting red tape.” In a published newspaper report, “Trump aides have been banking on… an ‘October surprise’ that could help the president make up ground in the polls.”
On Sunday, August 23, president Trump announced an Emergency Use Authority had been granted by the FDA for the use of convalescent plasma. This was announced as a “breakthrough” and was reported to reduce COVID-19 deaths by over 30%. However, the Mayo Clinic study, yet to be published, stated in an observational study that some groups of patients showed a 3% reduction of fatality rates, and for other groups up to 5%. Formal studies were being planned to identify the point in a course of treatment this has a greater effectiveness, and what role a single or more than one dose might play. It is now felt that a formal study won’t now be possible. Few volunteers will volunteer because they know they can get this as an approved therapy. It is significant to note that the chief scientist for the FDA, Denise Hinton, noted “Convalescent plasma should not be considered a new standard of care for COVID-19 patients.”
In separate recent political announcements, it is now anticipated that an “approved” vaccine will be announced soon during the presidential campaign. This contradicts the anticipated completion of the current clinical trials until at least January 2021. These trials will define a safe and effective vaccine. With the increasing presence of political influence over science, Peter Marks, director of the FDA Center for Biologics Evaluation and Research announced he has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective. Peter Marks has an essential role in approving vaccines. If a vaccine is authorized for an untested vaccine, and it turns out to be unsafe, or if it doesn’t provide immunity beyond a few weeks, the credibility of the FDA and the NIH could be permanently destroyed.
- Recommendations for voting during this pandemic..
Q: What concise recommendations exist for voting this year?
A: The Secretary of state for Connecticut has a website that is very useful for all Connecticut voters. Using this website, you can find out right now if you are registered to vote. Later, you can check there to verify that your absentee ballot has been received by your Town Clerk – hence you won’t have to vote in person.
Another excellent resource for information is NBC.newsPlanYourVote.
Finally, the CDC has published recommendations for visiting polling places. In addition to the usual guidelines (masks, social distancing, etc.), the following is offered:
- Fill out a sample ballot at home to spend less time at the voting booth;
- Bring in your own black pen to use, if allowed.
- Bring your own stylus or similar object if touchscreen machines are used.
- Do not disinfect any electrical devices at the voting place – it can damage them.
Rising costs for treating COVID-19 patients
Q. Will it cost more for hospital care once donated medications are stopped?
A: As there was initially a rapid increase in hospitalized patients, many pharmaceutical companies developed drugs. To gain formal approval, companies produced large quantities of these and donated them to hospitals. This allowed studies to advance more rapidly leading to licensing authority for future sales. IllumiCare is a health data firm that recently completed a study. This study identifies where many patients will soon find themselves financially. Remdesivir, once offered patients at no cost is now charged at $3,120 per treatment course ($2,340 for Medicare patients). Tocilizumad, a drug for treating arthritis, when in hospital care of COVID patients, its use jumped 29% during July compared to June. The cost per patient is now $2,200. The most frequently prescribed drug for COVID-19 patients is an anti-coagulant called enoxaparin. It was given to 50% of COVID patients last month at a cost of $322 each. The steroid dexamethasone costs $8.78. The study did recognize some areas of cost savings – fewer patients now require ventilators, reducing the costs of painkillers and sedatives that would otherwise have been used. Also, the average length of stay is becoming less over time.
- Testing capacity is abundant, but falling short of effectiveness.
Q: With all the testing capability available, why isn’t the number of cases less?
A: Reuters News Service recently published an article surveying 16 testing facilities run by commercial, state, hospital and academic labs. It also analyzed several state and city procurement plans. The roadblock was identified is that laboratories are locked into separate and unique proprietary supply chains. Just a few companies dominate the market with laboratory equipment that require their separate chemical kits, small plastic parts, plates and pipettes that only they sell. “The vendors are in an impossible situation right now where they can’t say yes to everyone,” said Geoffrey Baird who runs the medical lab at the University of Washington. The US processes about 800,000 diagnostic tests daily, but scientists estimate that from 6-8 million tests are required per day to effectively combat the high number of infections now present. Congress has earmarked $11 billion to support testing, but current planning at the national level shows the core issues of supply chain problems have not been addressed. With several competing propriety tests currently in use, and more on the way, It will be nearly impossible to officially select one as “the winner” and enact the Defense Production Act to manufacture the needed supplies in sufficient quantity to meet the demand. Those not selected would certainly not accept the loss of their investments. To invoke the Defense Production Act to require all manufacturers to produce their individual supplies required would require the government to establish the quotas normally defined by the free market place Gary Kobinger, a Canadian researcher best known for his work on Ebola, argues that all diagnostics should be done on an open platform” This is not where testing for coronavirus-19 started. Solving this problem will not be easy.
