Saturday, May 21, 2022

How Government caused the Baby Formula Crisis – by ignoring tradeoffs

 Here is Holman Jenkins at the Wall Street Journal.

Too often Government's decisions are meant to benefit those making them, not citizens generally. The baby formula crisis is an example. The immediate threat to the bureaucracy was criticism if the cause of sick children turned out to be due to formula and production was not stopped - resulting in the Government being blamed for children's deaths. Subsequent shortages likely could be blamed on the company. Thus, from the bureaucracy's point of view, shutting down production provided a benefit without a corresponding likely cost. The issue of larger adverse consequences to children did not enter the picture because there was little expectation that the bureaucracy would be blamed for its failure to consider their interests properly.

Here is HJ's article.

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Baby formula is a target of shoplifting rings. Its supply has been disrupted by Covid lockdowns. Its pattern of demand has been thrown for a loop by pandemic-spawned changes in retailing and baby-making. Add the fact that half the U.S. supply is consumed by welfare recipients, who are limited by regulation to a choice of three manufacturers. Add federal rules that make it hard to relieve a domestic shortage by importing foreign-made supplies.

And still the shocking baby formula crisis of 2022 is not an occasion for your perfect storm metaphors: The key factor that overwhelms all others is a government decision in February to force a factory shutdown and product recall on an Abbott Labs plant in Michigan.

The four cases of Cronobacter sakazakii infection in infants that the government cited could not be traced to the factory’s products. No contaminated baby formula was found; Cronobacter was identified on the factory grounds but lacked a genetic match to samples from affected infants. A considered response might have been to keep the factory running and carefully check its output for contaminated formula, but that’s not the response the Food and Drug Administration chose and thereby hangs a tale.

As one textbook puts it, Cronobacter is a “one product-population problem”—the product is powdered infant formula; the population is newborns, especially low-birth-weight newborns.

A bacteria common in the environment and resilient to boot, with unusual resistance to arid conditions, Cronobacter typically causes disease only in the elderly and immunocompromised. The big exception is very young infants—2 months or less or with compromised immunity—who can develop deadly complications like sepsis and meningitis.

Cronobacter’s natural reservoir is uncertain but the bacteria are readily found on plants, in soil, on meat, cheese, fruits and cereals, in sewage, in herbal teas, etc. A 2014 U.S. government study found specimens on the premises of 38 of 55 U.S. facilities for making powdered milk, with 4.4% of 5,671 “swabs and sponges” testing positive. Though contamination in factory-sealed products has rarely been found, unlike more expensive liquid versions of baby formula, the powdered variety has proved impractical to sterilize.

In the U.S., contamination in the home is clearly the big risk, “after you open the container,” as the Centers for Disease Control and Prevention puts it. Cronobacter has been found on lids, scoops and bottles and in stored water. For parents of infants in the vulnerable categories, the CDC urges mixing powdered formula with water heated to 158 degrees Fahrenheit before serving the cooled solution to an infant.

To make matters more complicated, incubation of Cronobacter is estimated to take at least four days and sometimes as long as 21, so a parent’s anecdotal intuition that a specific formula may be involved is not much to go on. Only one state, Minnesota, tracks Crononbacter infections. The CDC says it receives reports of two to four infant cases a year but has no idea of the true incidence and points to recent evidence suggesting mild infection may not be uncommon among all age groups.

With this context in hand, especially a lack of evidence that the factory was the culprit, a conclusion is hard to resist: In shutting down the Abbott plant, the FDA was acting from a zero-risk mentality in its own bailiwick—protecting infant formula from factory contamination—with zero regard for costs and risks that would be somebody else’s problem. These include a nightmare for parents and a risk of malnutrition for thousands of newborns, particularly those in need of doctor-prescribed formulas that only the Michigan factory produced.

When have we heard this story before? Almost daily during the Covid crisis, from government agencies and politicians who made blinkered decisions more in their own narrow interests rather than in the interests of the public broadly considered. Recall the FDA’s self-protecting perfectionism that delayed lab and later at-home testing for Covid long after other countries had them.

The media are often unhelpful in this regard. “Follow the science” can serve as a smokescreen for avoiding the science, often complex and uncertain, in favor of partisan stereotyping and narratives of villains and heroes. In recent days, the FDA has continued rationalizing its behavior with a labored and showy “settlement” that will allow the Michigan factory to reopen; because the Defense Production Act became a “thing” to the media during the Covid crisis, the Biden administration on Tuesday invoked the DPA and dispatched military-affiliated air carriers to deliver foreign-sourced baby-formula supplies.

Congress held hearings on Thursday. We may be witnessing only the beginning of the political circus to flow from a single act of questionable judgment by the FDA.

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