Author Topic: Baby Formula Shortage  (Read 17548 times)

Online zh cohen

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Re: Baby Formula Shortage
« Reply #100 on: June 02, 2022, 01:36:47 PM »
The FDA planned to inspect on Dec 30, but Abbott asked to delay till Jan 31 because a lot of their factory workers were ill with covid.

How is that relevant? The factory wasn't shut down until February.

Unless your point is that if the FDA had its way this would have been going on for longer.

Offline biobook

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Re: Baby Formula Shortage
« Reply #101 on: June 02, 2022, 02:20:03 PM »
How is that relevant? The factory wasn't shut down until February.

Unless your point is that if the FDA had its way this would have been going on for longer.
The question was why did it take so long to shut down the factory. 
September 2021 the first baby got sick, but a factory isn't shut down because of the illness of one person.
 
October 19, 2021 the whistleblower sent a report that there were dangerous irregularities in the factory.  There was a delay in this reaching the proper person, but it was eventually read.  The FDA admits that this part of the delay was their fault.  It got lost in the mail or was misdirected to the wrong person... not clear what happened.

December 2021 the FDA read the whistleblower report and was notified of additional infant illness/death, and arranged to inspect the factory, but Abbott postponed the inspection.

Jan 30, 2022 FDA inspects the factory.  This means looking through a huge factory, collecting samples from the rooms and from the formula itself, both that being produced and that in cans ready for shipment, taking the samples to labs for chemical and genetic testing, reading through Abbott's own records of quality control, meeting with Abbott to discuss all this and their results... IOW, we're not talking about a one-hour in-and-out inspection.

Feb 17 the factory was closed. 

So the delay in Oct-Nov was definitely the FDA's fault.  The delay in Jan was covid's fault, at least according to Abbott.  The 2-week delay in February seems reasonable, considering the time needed for a through inspection.

ETA: Just remembered one part of the delay was that, after receiving the whistleblower report, there were problems in arranging a time for the whistleblower to meet with the FDA, so this would have been in Nov or Dec, and was the whistleblower's fault.
« Last Edit: June 02, 2022, 02:28:00 PM by biobook »

Offline skyguy918

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Re: Baby Formula Shortage
« Reply #102 on: June 02, 2022, 03:11:01 PM »

Pretty sure you're talking about different things. OP was talking about the delay in getting things opened back up, you're talking about the delay in shutting down.

Offline biobook

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Re: Baby Formula Shortage
« Reply #103 on: June 02, 2022, 03:11:54 PM »
@Yehuda57 I went through RR's video again to remind myself why I had mistrusted his analysis the first time I heard it, knowing nothing about this case.

RR claims that the shortage of formula is due to FDA’s errors, but his arguments aren't persuasive because 1) he presents himself as highly biased against FDA, and 2) he fails to give a complete picture of what happened.   

Let me emphasize that I’m not saying that FDA is blameless, and when I first started listening, I was even willing to accept that they were 100% at fault.  But I ended up feeling that I couldn't trust RR’s presentation. 
 
It’s especially ironic that it’s milk (or milk substitute) that’s the issue here, since it’s been the basis of another well-known scandal in the era before government regulations were established.  In the 1850s, beer distilleries in NYC raised milk cows next door, feeding them mash left over from their manufacturing process.  The milk from these malnourished and sickly cows was not the healthiest to start with, but to make it even worse, the businessmen diluted it with water so that they could sell more, and then added chalk to give it back a more natural color.  Society had less understanding then about disease in general, so it took a while for people to realize why so many children were ill.  But they eventually did, and it was estimated that some 8000 children had lost their lives from drinking this “milk”.  https://www.atlasobscura.com/articles/swill-milk-scandal-new-york-city

Even with our modern knowledge, similar scandals occur in regions with less robust government regulation of food and drug production.  In 2008  farmers in China were watering down milk and adding a white chemical to make it look natural.  In that case 6 babies died and over 50,000  were hospitalized.  https://en.wikipedia.org/wiki/2008_Chinese_milk_scandal

We may hear now and then about contaminated produce which sent a few people to the hospital, but we don’t hear extreme cases as in the past because of the relative success of the FDA, CDC, and USDA.

But RR gives no indication that he thinks the FDA can do anything right.  He was “CEO of a pharmaceutical company and for 24 years I did battle with FDA.”  He goes on to explain how the FDA works:

6:18  “FDA has a stranglehold on drug companies … if FDA decides to stop giving approvals then that drug company can just goes down and down it can even go out of business. So FDA has a stranglehold … and if you talk back to FDA they might just cut off your job …”  15:22 “That's how FDA speaks one little error and then they come, they slaughter”  34:20 “The number one priority of government agencies of people who work in government agencies is to protect their own jobs.  They always want to get more money for their agency so they can hire more people”

Take a minute to consider another agency that protects our food, a Kashrus Agency (KA) and a Retired Restaurateur (RR) who wants to convince us that the KA is responsible for a restaurant losing business.  How does he know this?  “I ran a restaurant for 24 years, and always had to do battle with the KA.” “The Kashrus Agency has a stranglehold on restaurants… If they decide to withdraw their hasghacha, the restaurant can even go out of business!.. One little treif product, and they’re on your case…. The number one priority of kashrus agencies is to protect their own jobs.  They always want to hire more mashgichim.”

Most of us will probably be thinking, “Uh… yeah… Isn’t that exactly how it’s supposed to work?”  We want our supervising agencies to supervise, whether it’s for kashrus or health and safety of our food and drugs. 

RR seems to be so strongly biased against the FDA that he can’t admit they do anything right, so I don’t consider him a reliable interpreter of the current situation.

2. Dr. RR tells us that no cronobacteria were found in the formula and the crono found elsewhere in the factory were a different strain from that in the infants, so there was no reason to close the factory.  This left me wondering why they did close it, and what RR is leaving out.  He only briefly mentions what else was found in the investigation:  Abbott “did not establish a system of process controls covering all stages of processing” and “did not ensure that all surfaces that contact infant formula were maintained to protect infant formula from being contaminated.“

This is like a mashgiach checking out a complaint that the restaurant was cooking chicken in milk, and discovers it was non-dairy creamer, so all is good.  So why would he remove hashgacha?  While looking around, he finds that there was no system in place to ensure kashrus at all stages of purchasing, storing and cooking the food.

Okay, that seems like a good reason. There was clearly something important going on in the FDA’s decision, but RR wasn’t telling us.

Offline biobook

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Re: Baby Formula Shortage
« Reply #104 on: June 02, 2022, 03:20:19 PM »
Pretty sure you're talking about different things. OP was talking about the delay in getting things opened back up, you're talking about the delay in shutting down.

I was responding to this particular post:

The bigger question is the part that's not quoted, "why did the FDA take so long to interview the people in the plant and then so long to approve the reopening plan?".

I believe that "interview" refers to what went on during the 2 week period, from the start of the on-site inspection through the shut down. 

I'm not sure if @yelped was asking why did it take so long from the first illness to the interview, or from the whistleblower complaint to the interview, or from the start of the interview to the shutdown, so I tried to put all of those in one post.

You're right that I didn't research the second part.  Do you have any insight into that?

Offline Yehuda57

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Re: Baby Formula Shortage
« Reply #105 on: June 02, 2022, 04:06:15 PM »
@Yehuda57 I went through RR's video again to remind myself why I had mistrusted his analysis the first time I heard it, knowing nothing about this case.



Thanks for this. I shared your distrust based on his very clear and obvious bias against the FDA. But, I've heard from other medical professionals (one instance that comes to mind is a leading fertility researcher whose name escapes me right this moment) who have heavily criticized the FDA for their often nonsensical rules or application of rules, and how they are hindered from things like safe off label uses in their studies. Of course, the FDA is a life-saving agency, and if I had to pick between a pharmaceutical exec or an FDA employee, I'd go with the latter 101 times out of a 100.

The kashrus agency example was especially apt for me, as that was my father's field of work for 40+ years, and I've heard virtually every side and angle of that relationship.

I do think he explained what was found to be wrong with the processes of preventing contamination unless I'm misremembering. But even if he didn't, you are implying there was *no* plan to prevent contamination, like in your kashrus analogy, but the far more likely scenario is that the processes were not robust enough. It still seems like an overreaction to close the plant rather than keep it running while implementing improvements, which is exactly what a kashrus agency would do. Considering the far-reaching impact of the closure, it seems like an even bigger blunder at damage assessment.

Offline aygart

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Re: Baby Formula Shortage
« Reply #106 on: June 02, 2022, 04:16:14 PM »
For those who do not wish to rely on RR (some opinion, some reporting, and some analysis)

https://www.wsj.com/articles/the-cruelest-shortage-11652217835
https://www.wsj.com/articles/one-bad-choice-and-a-baby-formula-crisis-factory-shutdown-shortage-infant-cronobacter-fda-11653080306

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.
https://www.wsj.com/articles/bidens-baby-formula-shortage-11652467290
https://www.wsj.com/articles/abbott-could-restart-baby-formula-production-within-two-weeks-11652293871?mod=article_inline
https://www.wsj.com/articles/why-baby-formula-shortage-11652188230?mod=article_inline
Feelings don't care about your facts

Offline biobook

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Re: Baby Formula Shortage
« Reply #107 on: June 02, 2022, 04:54:52 PM »
who have heavily criticized the FDA for their often nonsensical rules or application of rules, and how they are hindered from things like safe off label uses in their studies.
And in response to similar criticisms, the FDA has evolved over the century of its existence.  There's reason to criticize every large organization, from FDA and CDC to BMG and 770.  But some people criticize in order to bring about improvement, while others simply want to disparage and discredit, and RR seems to be in the latter category.  Unfortunately, some listeners will just believe what he says and come away with the message "FDA = Bad".  A closer examination makes it clear that there's something fishy about that video, in more ways than one.

Quote
I do think he explained what was found to be wrong with the processes of preventing contamination unless I'm misremembering. But even if he didn't, you are implying there was *no* plan to prevent contamination, like in your kashrus analogy, but the far more likely scenario is that the processes were not robust enough. It still seems like an overreaction to close the plant rather than keep it running while implementing improvements, which is exactly what a kashrus agency would do. Considering the far-reaching impact of the closure, it seems like an even bigger blunder at damage assessment.
The latter part of his talk became rather rambling, and the parts I quoted seemed to summarize his argument there.  What you're saying is correct, that the processes to prevent contamination were not as robust as needed to meet the FDA's standards.  Could they implement improvements while keeping it running?  That would depend on the extent of the problem.  I can imagine a situation where a kashrus agency feels they have to re-kasher the entire kitchen, and so the restaurant has to close for a while.  I don't know how much of the agreement with Abbott is public, but one of the problems was a leaking roof, and repairing that might make it impossible to have a safe work environment beneath it.

Offline Kobe Bryant

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Re: Baby Formula Shortage
« Reply #108 on: June 02, 2022, 05:22:25 PM »

Offline YitzyS

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Re: Baby Formula Shortage
« Reply #109 on: June 09, 2022, 06:02:49 PM »
Another video from Dr. Rich Roberts


Offline biobook

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Re: Baby Formula Shortage
« Reply #110 on: June 09, 2022, 07:14:45 PM »
Another video from Dr. Rich Roberts
RR says that FDA shut down the plant because of bacteria in the formula, but in fact no bacteria were found in the factory.
THIS IS MISLEADING. 
Although there was no evidence that the bacteria in the babies came from the formula, there was substantial evidence of unsafe and unhealthy conditions in the factory that could potentially cause future problems, and these led to the shut down.

RR claims to be disclosing a cover-up by FDA.
THIS IS UNCLEAR
RR is reporting on information plainly displayed on the FDA website.  It's not clear what he thinks has been covered up.

RR says that the FDA is lying when it says that Abbott shut down "voluntarily" and that FDA should admit that they forced Abbott to shut down.
BOTH FDA AND ABBOTT ARE TELLING THIS FACE-SAVING "LIE"
If the FDA were to announce all the unsanitary conditions that caused the shutdown, will the public want to feed its formula to their infants?  FDA allows the company to claim that they are voluntarily shutting down, giving the impression that Abbot is responsible and cares only to protect your baby's health and can be trusted in the future. 

Offline biobook

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Re: Baby Formula Shortage
« Reply #111 on: June 09, 2022, 07:42:37 PM »
Abbott's website describes some of the issues they had to correct: https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-update-on-powder-formula-recall.html
    We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We've also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.
Installing a new floor might have required disassembling the machinery, and this could be the reason that production had to stop for so long.


Other problems mentioned at the Senate hearings:

Calamari (Abbott) repeatedly sidestepped questions about whether any employees were disciplined or fired over the problems at the plant, which included standing water, a leaky roof and damaged equipment....  Califf (FDA) also struggled to explain delays in following up on a whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to test formula before shipment.
« Last Edit: June 09, 2022, 07:50:52 PM by biobook »

Offline YitzyS

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Re: Baby Formula Shortage
« Reply #112 on: June 12, 2022, 10:55:50 AM »
Part 2 of 3


Offline rbs-g1.5

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Re: Baby Formula Shortage
« Reply #113 on: June 12, 2022, 02:33:05 PM »
does anybody know if there is a way to make money off of bringing back baby formula in suitcases when i come in from eretz yisroel?

Offline Yehuda57

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Re: Baby Formula Shortage
« Reply #114 on: June 12, 2022, 02:51:18 PM »
does anybody know if there is a way to make money off of bringing back baby formula in suitcases when i come in from eretz yisroel?
 


Wrap them up in face masks, hand sanitizer, and toilet paper
« Last Edit: June 12, 2022, 03:04:25 PM by Yehuda57 »

Offline rbs-g1.5

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Re: Baby Formula Shortage
« Reply #115 on: June 12, 2022, 02:54:49 PM »

??????????
i dont get it u r making me feel kinda dumb

Offline biobook

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Re: Baby Formula Shortage
« Reply #116 on: June 12, 2022, 02:59:57 PM »
Part 2 of 3

@YitzyS What's your response to this video?

Offline Ver hut gazugt

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Re: Baby Formula Shortage
« Reply #117 on: June 12, 2022, 04:30:16 PM »
does anybody know if there is a way to make money off of bringing back baby formula in suitcases when i come in from eretz yisroel?
people been doing way before the shortage. Last I heard the was a glut on the market.

Just make sure you have buyers before you bring it in.

Offline rbs-g1.5

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Re: Baby Formula Shortage
« Reply #118 on: June 12, 2022, 04:35:15 PM »
people been doing way before the shortage. Last I heard the was a glut on the market.

Just make sure you have buyers before you bring it in.
if you know specifics on how to find a buyer  please let me know

Offline YitzyS

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Re: Baby Formula Shortage
« Reply #119 on: June 12, 2022, 06:55:33 PM »
@YitzyS What's your response to this video?
I haven't had a chance to watch this one yet.

I post it here because I know that a number of DDFers like to watch it (me included). Not necessarily because they agree with everything he says, but it is still interesting to get his take on things, with his cute video edits.