Month: May 2022

The problems with Abbott's infant formula plant in Sturgis just get mysteriouser and mysteriouser. The New York Times reports that Abbott has finally agreed with the FDA to reopen the Sturgis plant:

The agreement stems from a U.S. Department of Justice complaint and consent decree with the company and three of its executives. Those court records say the F.D.A. found a deadly bacteria, called cronobacter, in the plant in February and the company found more tranches of the bacteria later that month.

According to the complaint, the same Sturgis factory had also produced two batches of formula in the summer of 2019 and 2020 on different production equipment that tested positive for the bacteria.

Abbott staff “have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants,” leading to the need for legal action, the documents state.

....The agreement said Abbott must hire a qualified expert to oversee a variety of improvements at the Sturgis facility.

The problems at the Sturgis plant appear to have been more severe than we've been led to believe:

Problems at the Abbott Sturgis plant surfaced in September during the F.D.A.’s first routine inspection there since the Covid-19 pandemic began. Inspectors discovered standing water inside the plant and personnel working directly with formula without proper hand hygiene, according to agency documents.

The following month, a whistleblower who worked at the plant filed a complaint under the Food Safety Modernization Act claiming that plant leaders celebrated concealing information from the F.D.A. and omitted key information from official documents.

The F.D.A. returned to the plant on Jan. 31 and discovered persistent problems, including the presence of cronobacter bacteria near production lines, according to agency records.

Obviously there's still information that none of us know. But tentatively, this sure sounds like an Abbott problem, not an FDA problem. Instead of stonewalling, Abbott could have fixed its problems in September—or, for that matter, in 2019 or 2020. But they didn't. Beyond that, they could have agreed to do what the FDA wanted back in February when they were first shut down. But it sounds like instead they argued and argued and argued, finally caving in only when the whole thing started getting lots of media attention.

It may be a while before we get the real story about Abbott's Sturgis factory, but for now all I see is the FDA trying to do its job and Abbott trying to take advantage of the FDA's limited resources in order to avoid having to do anything. Nor does it look like the FDA was being all nitpicky and unreasonable here. Abbott's plant in Columbus appears to be doing fine, after all.

Beyond this, maybe the FDA should deploy the threat of prison time for more than just three QA folks at Sturgis. Perhaps they should set their sights a little higher on the executive food chain?

Good news today. Last month I started a new chemo regimen and my M-protein level has already started to turn around:

This is only a small drop, but what matters is that my M-protein levels have been slowly rising for over a year and now they're headed in the other direction.

In other good news, all my other lab work looks pretty good, too. There were a bunch of miscellaneous items that had suddenly gone above their recommended values, but every one of them is now back in the normal range.

Most spectacular of all is my neutrophil level, which is a proxy for the strength of my immune system. The normal range is roughly 2000-7000, and I've almost never been within that range during the past seven years. On a few occasions I've been as low as 500. But last week's labs pegged me around 3000 and this week's labs have me at 5300. For now, at least, my immune system appears to be back to normal.

I was planning to skip last night's lunar eclipse because I've already got plenty of pictures of lunar eclipses. But then when the time came, naturally I had to go outside to see it. And then I had to take some pictures.

So here it is, about 90% full, which is all we got in California. According to EarthSky:

The eclipse belongs to Saros 131 in the catalog of lunar eclipses [which began in 1427]. It is number 34 of 72 eclipses in the series. All eclipses in this series occur at the moon’s descending node. The moon moves northward with respect to the node with each succeeding eclipse in the series.

The star right above the moon is Zubeneschmali. The star at about 45 degrees is  Zubenelgenubi. The star to the far right of the moon is, um, Zubenelhakrabi? I'm not sure. But they're all in Libra, since that's where the moon was.

Generally speaking, infants are fed formula only during their first year. So at any given time, the number of infants of "formula age" equals the total number of babies born in the previous twelve months. Here's what that looks like:

The number of live births had been trending downward for years and then dropped more sharply at the beginning of the pandemic. As a result, during the first half of 2021 the number of infants aged 0-12 months plateaued at a record low of 3.57 million.

But in the second half of 2021, that number increased sharply to 3.66 million, an increase of 90,000, and has probably increased another 50,000 since then. According to the CDC, approximately half of these babies are fed formula rather than being breastfed.

This prompts a bit of speculation: Lots of US corporations seem to have decided in 2020 to cut back on production but then never made plans for the pandemic to end and demand to go back up. In the case of infant formula companies, that mistaken inclination would have been reinforced by the fact that the US birth rate had been steadily declining for years even before the pandemic.

The middle of 2021 is about when the infant formula crisis began. Why? Manufacturers blithely wave off questions by blaming it on labor shortages, supply chain issues, packaging problems, and instability caused by the Ukraine war. These are the standard excuses offered by every company suffering from shortages and nobody ever questions them. After all, everyone knows about the pandemic labor shortages and the supply chain issues and all that. So it sounds plausible.

And maybe it is. But another possibility is that infant formula manufacturers made the same mistake so many other companies did: they cut back production and assumed demand would never return. This might have remained a modest mistake causing only a few temporary shortages here and there while production was eventually ramped back up, but then in February the Abbott recall turned a modest mistake into a catastrophe. I wonder if this is what really happened?

Here's a chart of COVID-19 deaths that has long puzzled me:

This shows COVID deaths, so it's fairly reliable. What it shows is that, generally, the US has been about average compared to other similar countries except for three specific periods:

• Summer 2020
• Autumn 2021
• Winter 2022

In two cases, we have spikes that were unique. No one else had them. In the third (the recent Omicron surge) everyone had spikes but ours was one of the worst.

These three periods account for nearly all of the fact that our cumulative death rate is one of the highest in the world even though our case rate is one of the lowest. The first one can perhaps be blamed on Donald Trump declaring the pandemic over too soon, and the third one might be the result of a low vaccination rate. But that still leaves the second one. What happened there?

The baby formula disaster is certainly peculiar. Apparently the FDA reported potentially dangerous manufacturing practices at Abbott's Sturgis plant as far back as September. But nobody did anything, and another FDA visit in February provoked the formula recall:

In February, the FDA warned parents not to use certain popular powdered infant formulas manufactured at Abbott's Sturgis plant after receiving four reports of infants who were hospitalized with bacterial infections after consuming formula from the facility. Two of the infants died.

But wait:

Last month, however, the FDA and Centers for Disease Control and Prevention told NBC News none of the bacterial strains taken at the Abbott plant matched those collected from the infants, and the agencies haven't offered an explanation for how the contamination occured. For its part, Abbott says its formula “is not likely the source of infection,” though the FDA says its investigation continues.

Not likely?

Government officials’ tests of unopened formula containers at the homes of the four sick babies were all negative for cronobacter, Abbott said, and one of three open containers from the homes tested positive. The positive one contained two different strains of cronobacter: one that matched the strain that caused the infant’s infection and another matching germs found on a bottle of distilled water used to mix the formula, Abbott said.

But new formula is coming soon—depending on your definition of soon:

Abbott said it was hoping to restart the Sturgis factory in two weeks, pending approval from the Food and Drug Administration. Abbott added that baby formula would probably take six to eight weeks to reach stores. “We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas,” it said.

So was there ever any evidence that the Abbott formula had been contaminated in the factory? Was the recall actually necessary? And what has the FDA been doing for the past three months?

I'm not saying the FDA was wrong. I don't know. But I'd certainly like to have a little more information about what really happened here.

The Wall Street Journal has an update for us. A month ago they reported that average pay for CEOs of large companies had increased to $14.2 million last year. But now we have final figures:

The median pay package for chief executives of the biggest U.S. companies reached $14.7 million in 2021, setting a sixth-straight annual record as strong profits and robust markets boosted performance measures.

That's a mind-boggling increase of 110% over the past decade measured in nominal terms. As you all know, however, I'm dedicated to fairness in all things, even CEOs. This means adjusting their pay for inflation:

Adjusted for the ravages of inflation, CEO pay has gone up only 78% in real terms. So, you know, not really all that much. And I'm sure every one of them deserved it for coasting along with a long economic expansion they had nothing to do with.

Here it is. In nominal terms—which is what people see at the pump—this week's price of $4.33 is a 30-year high, breaking March's recent high by a penny. So far.

UPDATE: Here's an update of my chart showing gasoline prices along with a trendline based on the price of WTI oil:

A month ago I predicted that gasoline prices should drop about 40 cents within a couple of weeks. But even though the price of WTI oil has dropped $2 in the past couple of months, the price of gasoline has gone up ten cents. For some reason, gasoline is not returning to its historical relationship with the price of oil. It's still selling for about 40 cents a gallon more than it should be. I don't know why.

Charlie is hard at work hunting down the hand strap on my camera. However, I am pleased to report that it survived the onslaught.

Four weeks of eye adjustments are now complete and my artificial lenses have been locked in. Starting on Friday I no longer have to wear anti-UV glasses and my eyesight will have recovered from today's dilation fest. Hooray.

Then it will just be a matter of waiting. I'm not very happy with how things turned out, but it does tend to take a while for things to settle in after each of these adjustments. Now that the last one has been done I'm going to give it 30 days and then go in for a final post-op session in mid-June. After that I'll make a decision about whether to keep what I have or see if I can switch to a different type of lens.