Steve Koonin: Is There a Climate Emergency?

Nov 29, 2021 | Sci-Tech

The FDA & CDC: Why The U.S. Fails in COVID Testing

Nov 9, 2021 | Sci-Tech

From "Here’s Why Rapid COVID Tests Are So Expensive and Hard to Find", ProPublica:

....Companies trying to get the Food and Drug Administration’s approval for rapid COVID-19 tests describe an arbitrary, opaque process that meanders on, sometimes long after their products have been approved in other countries that prioritize accessibility and affordability over perfect accuracy.

On the FDA treating private bio-tech companies like criminals:

After the FDA put out a call for more rapid tests in the summer of 2020, Los Angeles-based biotech company WHPM, Inc. began working on one. They did a peer-reviewed trial following the agency’s directions, then submitted the results this past March. In late May, WHPM head of international sales Chris Patterson said, the company got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be “deprioritized,” or moved to the back of the line. “We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,” said Patterson. Meanwhile, the WHPM rapid test has been approved in Mexico and the European Union, where the company has received large orders.

An FDA scientist who vetted COVID-19 test applications told ProPublica he became so frustrated by delays that he quit the agency earlier this year. “They’re neither denying the bad ones or approving the good ones,” he said, asking to remain anonymous because his current work requires dealing with the agency.

On FDA micro-managing how the tests can be used making them expensive, and banning the private sale of cheap tests to the public:

FDA officials were particularly concerned about allowing tests to be administered outside the purview of a trained health care provider. “To mitigate the impact of false results, all Covid-19 tests authorized to date have been made available only by prescription, so that clinicians can interpret results for patients,” wrote Shuren and his deputy Dr. Tim Stenzel in an October 2020 column in The New England Journal of Medicine.

That cautious approach persisted all through the winter and early spring, despite rising agitation from the White House and Congress around the availability of tests.

“I actually have been saying that for months and months and months, we should be literally flooding the system with easily accessible, cheap, not needing a prescription, point of care, highly sensitive and highly specific” tests, White House chief medical advisor Dr. Anthony Fauci said under questioning from Schrier in a hearing on March 17.

On the FDA standing in the way of innovation and experimentation:

The FDA has been particularly circumspect with more novel approaches to testing, such as an olfactory test that detects the common COVID-19 symptom of loss of smell. The agency’s reviewers deprioritized an application for the scratch-and-sniff card even though it had been proven to stem transmission, said inventor Derek Toomre, a professor at the Yale School of Medicine.

On how the FDA bans tests approved in Europe:

For example, the biopharmaceutical giant Roche told ProPublica that it submitted a home test in early 2021, but it was rejected by the FDA because the trials had been done partly in Europe. The test had compared favorably with Abbott’s rapid test, and received European Union approval in June. The company plans to resubmit an application by the end of the year.

[...]

A smaller company, which didn’t want to be named because it has other contracts with the U.S. government, withdrew its pre-application for a rapid antigen test with integrated smartphone-based reporting because it heard its trial data from India — collected as the delta variant was surging there — wouldn’t be accepted. Doing the trials in the U.S. would have cost millions.

On how the central planning approach of "putting your eggs in one basket" fails:

In May, the CDC leaned hard into the message that vaccines were almost completely protective, mitigating the need for frequent testing. Manufacturers took that as a bad sign for testing volume. Abbott ramped down manufacturing of its popular home test.

[...]

“It has taken more than a year for the American public, scientific experts and academia to accept the important role of rapid testing in the U.S.,” Koval said. “Overseas, that was not the case, because the value of rapid testing was better understood prior to the pandemic.”

Read the rest.

• Cheap One Dollar 15 Minute Result COVID-19 Tests Can End The Need for National Lockdowns Permanently

Peikoff & Chayes: What To Do About Facebook

Oct 10, 2021 | Sci-Tech

"For years, congressional hearings pertaining to all (un)imaginable evils of social media have amplified a persistent argument that they must be regulated, controlled – even declared public utilities. Now the groundwork is laid to fully implement Orwell's "1984" by the stroke of a pen."[...]"But most importantly – and this is where we part ways with Haugen – we must prevent the government from obtaining any further control over instruments that apparently cannot be responsibly handled, even by a bunch of gifted Whiz Kids in the Valley.""We should staunchly oppose any legislation that puts not only personal data, but also manipulative algorithms at the disposal of politicians or bureaucrats, as some of the laws proposed during Tuesday’s hearing might entail. Private lawsuits, made more practicable by a narrower interpretation of Section 230, would help redress grievances of users of all ages.  "Big Brother, which is precisely what a public-private "partnership" with Facebook might look like, isn’t any less pernicious if it’s spawned "for the children."

With vs. From: Interpreting COVID Hospitalization Rates

Sep 14, 2021 | Sci-Tech

If you want to make sense of the number of COVID hospitalizations at any given time, you need to know how sick each patient actually is. .... yet the overall tallies of COVID hospitalizations, made available on various state and federal dashboards and widely reported on by the media, do not differentiate based on severity of illness. Some patients need extensive medical intervention, such as getting intubated. Others require supplemental oxygen or administration of the steroid dexamethasone. But there are many COVID patients in the hospital with fairly mild symptoms, too, who have been admitted for further observation on account of their comorbidities, or because they reported feeling short of breath. Another portion of the patients in this tally are in the hospital for something unrelated to COVID, and discovered that they were infected only because they were tested upon admission. How many patients fall into each category has been a topic of much speculation. In August, researchers from Harvard Medical School, Tufts Medical Center, and the Veterans Affairs Healthcare System decided to find out.

[...]

Instead of meticulously looking at why a few hundred patients were admitted to a pair of hospitals, they analyzed the electronic records for nearly 50,000 COVID hospital admissions at the more than 100 VA hospitals across the country. Then they checked to see whether each patient required supplemental oxygen or had a blood oxygen level below 94 percent. (The latter criterion is based on the National Institutes of Health definition of “severe COVID.”) If either of these conditions was met, the authors classified that patient as having moderate to severe disease; otherwise, the case was considered mild or asymptomatic.

The study found that from March 2020 through early January 2021—before vaccination was widespread, and before the Delta variant had arrived—the proportion of patients with mild or asymptomatic disease was 36 percent. From mid-January through the end of June 2021, however, that number rose to 48 percent. In other words, the study suggests that roughly half of all the hospitalized patients showing up on COVID-data dashboards in 2021 may have been admitted for another reason entirely, or had only a mild presentation of disease.

One of the important implications of the study, these experts say, is that the introduction of vaccines strongly correlates with a greater share of COVID hospital patients having mild or asymptomatic disease. “It’s underreported how well the vaccine makes your life better, how much less sick you are likely to be, and less sick even if hospitalized,” Snyder said. “That’s the gem in this study.”

“People ask me, ‘Why am I getting vaccinated if I just end up in the hospital anyway?’” Griffin said. “But I say, ‘You’ll end up leaving the hospital.’”

[...] Doron told me, referring to decisions about school closures, business restrictions, mask requirements, and so on, “we should refine the definition of hospitalization. Those patients who are there with rather than from COVID don’t belong in the metric.”

Overcounting COVID Hospitalizations For Children By At Least 40%

Sep 14, 2021 | Sci-Tech

The reported number of COVID-19 hospitalizations, one of the primary metrics for tracking the severity of the coronavirus pandemic, was grossly inflated for children in California hospitals, two research papers published Wednesday concluded. The papers, both published in the journal Hospital Pediatrics, found that pediatric hospitalizations for COVID-19 were overcounted by at least 40 percent, carrying potential implications for nationwide figures.Dr. Monica Gandhi, an infectious-diseases specialist at the University of California, San Francisco, and Amy Beck, an associate professor of pediatrics, also at UCSF, wrote a commentary for Hospital Pediatrics that accompanied the two studies. They wrote, “Taken together, these studies underscore the importance of clearly distinguishing between children hospitalized with SARS-CoV-2 found on universal testing versus those hospitalized for COVID-19 disease.” The studies demonstrate, they said, that reported hospitalization rates “greatly overestimate the true burden of COVID-19 disease in children.” Gandhi told Intelligencer that while the studies were both conducted with data from California hospitals, “there is no reason to think these findings would be exclusive to California. This sort of retrospective chart review will likely reveal the same findings across the country.” [...]“It is critical that the risks of COVID-19 to children be portrayed accurately,” Gandhi and Beck wrote. “Scientific and media reports that inaccurately portray the risk of COVID-19 to children can do harm by alarming parents and providing justification for ongoing restrictions to in-person education and other programming. Via these studies, parents and policy-makers should be reassured that pediatric hospitalization for severe COVID-19 disease is indeed rare.”