“Those who don’t know history are destined to repeat it.” Edmund Burke
This quote was used by John J Farmer III in his paper, “My 40 year history with Cronobacter/Enterobacter sakazakii—lessons learned, myths debunked, and recommendations.” Believe it or not, the history of the now named Cronobacter is long and tragic with infants at high risk for this serious bacterial infection that is intrinsic to powdered infant formula. This history appears to be forgotten or ignored by the US Congressional hearings. Ignoring the history of the research and recommendations by many research scientists, including the recommendation to breastfeed in order to avoid the serious problem of contamination of powdered infant formula is an ominous sign.
A Brief History from 2015-2022
“The powdered infant formula industry still cannot produce powdered formula that is free of bacterial contamination with Cronobacter, other Enterobacteriaceae, other pathogenic bacteria, and other microorganisms. Until this happens, infants and others will be at risk of becoming infected when they ingest contaminated formula.” John J. Farmer III, “My 40 year history with Cronobacter/Enterobacter sakazakii—lessons learned, myths debunked, and recommendations.” 2015 https://www.frontiersin.org/articles/10.3389/fped.2015.00084/full
“Cronobacter is ubiquitous, but it is profoundly linked with infant formula powders which are implicated in infant infections. Intrinsic contamination reports are coming up frequently that indicates the product is not sterile.” GM Abebe, “Cronobacter sakazakii in Infant Food Contamination and Its Survival Strategies in Hostile Conditions.” 2020 https://clinmedjournals.org/articles/ijpr/international-journal-of-pediatric-research-ijpr-6-067.php
“Reporting illnesses helps health officials understand how disease occurs and to identify outbreaks. Botulism, E. coli, Listeria, Salmonella, and Vibrio are all reportable diseases. Cronobacter is not. The main reason for this is that Cronobacter isn’t considered a threat to the general population. Most adults don’t get sick from Cronobacter. But babies do and the main vehicle of transmission is powdered infant formula.” Carla Gillespie, “Minnesota Cronobacter Case Spurred Federal Investigation.” https://foodpoisoningbulletin.com/2022/minnesota-cronobacter-case-spurred-federal-investigation/ 2022
My impressions of the Congressional hearings on infant formula supply chain issues.
First, the focus of the hearings seemed to be only on supply chain issues not on the issue of babies sick and dying because a manufacturing plant disregarded hygienic standards. Congresswoman Rosa DeLauro, Chair of the House Energy and Commerce subcommittee on Oversight and Investigation made the following statement on the revelations of the Abbott whistleblower on Abbott’s behavior.
“…falsifying records, turning a blind eye to safety and product concerns, and retaliating against any employees who brought this to light. It is not enough to simply focus on supply chain issues.”
I agree with her assessment. Focusing only on supply chain issues, is in my opinion a great way to minimize the tragedy of babies dying and maimed by infant formula. The reality that is staring at us, in which a lot of Congressional leaders are blind to, is that powdered infant formula is not a sterile product. If the medical community and others state that parents should consult the label for safe preparation of powdered infant formula, then those labels need to be correct and safe. In a previous blog post I have discussed the varied instructions on the safe preparation of infant formula of the FDA, CDC, WHO, infant formula companies, etc. Which instructions should a parent follow to protect their infant from Cronobacter? https://vwmcclain.blogspot.com/2022/03/the-scandal-of-cronobacter.html
The infant formula industry cannot produce powdered infant formula that is free of bacteria. And there is only one state, Minnesota, which has made Cronobacter a reportable disease. They call it a rare problem, yet it is not a reportable disease in 49 states. So how rare is it among US infants?
Who watched the Congressional hearings of the infant formula shortage? It appeared from the data that I saw that only some 300-400 people watched the Senate hearings on C-SPAN.
I thought I’d share my thoughts and feelings as I watched the Senate hearings. C-SPAN had video and print copies of the two hearings from Wednesday and Thursday of this week. I was able to watch all of the Senate hearing yesterday. I saw some videos of the House subcommittee meeting. The testimony of the Abbott Labs President of US and Canadian Nutrition, Christopher Calamari was that, “the shortages were heartbreaking,” “he was deeply sorry,” “and he was committed to it never happening again.” His comments reminded me of the often used statements by politicians in response to mass gun violence, thoughts and prayers. Apologies are not enough when babies die or are hospitalized due to a product that is supposed to be safe, just as thoughts and prayers are no longer enough in regard to gun violence.
Senate hearing just Political Theater of the Absurd
The first absurdity is that it appeared to me that most of the Senators blamed the FDA. The second absurdity is that Senator Burr seemed to be praising Abbott for their apology. When a person gets in a car accident while drunk and kills a family, is just an apology acceptable? Likewise a product that is advertised as a safe substitute for breastfeeding, killed innocent babies and hospitalized others.
Meanwhile the FDA Commissioner Dr. Robert Cardiff stated that the Abbott manufacturing plant was “egregiously unsanitary.” The third absurdity was Cardiff’s inability to explain why it took so long for the FDA to respond to the unsanitary conditions of the manufacturing plant. It seemed like everyone was passing the blame back and forth from Abbott to the FDA, from the FDA to Abbott. Around and around never discussing real issues relevant to parents and grandparents regarding the safety of infant formula. No one discussing how often in the past babies have died or maimed from bacterial contamination of powdered infant formula. Instead it seemed like the concern was to convince the American public that “these products are safe,” that this was just a one-time occurrence. Abbott had learned its lesson and apologized. Yet researchers on this issue know that Cronobacter infections from powdered infant formula are not a one-time occurrence. It will happen again and again, like the school mass shooting, because we live in a society governed by people who are unwilling to do what is necessary to protect the next generation. A society that is unwilling to protect its young is essentially doomed.
The #4 absurdity--How quickly people forget past cases of bacterial contamination of powdered infant formula.
The CDC discusses 4 cases of Cronobacter in 2011 in the USA. Presumption was that there was only 4 cases but eventually believed to be 12 cases of Cronobacter. How many cases that were unreported, since only one state in US required to report Cronobacter? And a decade later we still have only one state required to report this serious infection of infants with a 40-80% mortality rate. https://www.cdc.gov/media/releases/2011/s1230_Cronobacter.html
Cronobacter isn’t the only bacteria to contaminate powdered infant formula. In France in 2017 the company, Lactalis was found to have Salmonella in its manufacturing plant, causing a massive recall. Contamination of Salmonella had previously occurred in 2005 to the same manufacturing facility with many infant deaths. https://www.foodwatch.org/en/news/2018/lactalis-the-scandals-within-the-scandal/?cookieLevel=not-set
Back to the Senate hearing:
Senator Rand Paul, MD of Kentucky sweeps into the meeting. He appears to be impatient, in a hurry to get his 5 minutes done. He immediately states that since there is “no direct link of Cronobacter” in the manufacturing facility to the sick and dead babies, it means that Abbott’s infant formula was not the cause. This is despite Dr. Robert Cardiff statement that despite the lack of evidence, “health agencies cannot rule it out either, calling the confluence of events ‘highly unusual.’ It appears that Senator Rand Paul had dismissed Cardiff’s statements on this issue, and appears to not know that powdered infant formula is not a sterile product (despite the fact that he is a doctor who graduated from Duke Medical School).
The scientist, John J. Farmer III, responsible in 1980 for the naming of Enterobacter sakazakii, which is now called Cronobacter, made the following statement in his 2015 paper.
“The existence of Cronobacter strains in the ‘viable but non-culturable state’ is a possible explanation for why a sample of powdered infant formula or other product can be tested and found ‘negative for Cronobacter contamination’ but is actually contaminated with Cronobacter.” https://www.frontiersin.org/articles/10.3389/fped.2015.00084/full
Senator Rand Paul talked about the need for stockpiling infant formula, so this never happens again. My impression is the only concern is that the shelves are empty of infant formula, and that is unacceptable. He was not happy about the FDA closing the Abbott facility for so long, and seemed to think it was far too long. One almost got the impression that he was more concerned about Abbott Labs than about safety. He was not happy about the 17% tariffs imposed on formulas from Canada and Mexico. He seemed to think the FDA’s concern about labels from other countries as ridiculous. I wonder how parents who only speak and read English, read a label that is written in Spanish or French or German? What about the instructions on safe preparation of formula? Oh yes I forgot US citizens don’t read, so reading instructions are unnecessary
One of the interesting things about US government agencies like the FDA (Reagan-Udall Foundation), CDC (CDC Foundation), NIH (NIH Foundation), etc is that they each have foundations which corporations can donate to. Thus foundations pass that corporate money along to the agency for various programs. The FDA has the Reagan-Udall Foundation, and corporations can support the FDA. On the BOD of the Reagan-Udall Foundation is an employee of Nestle. https://reaganudall.org/about-us/board-directors/molly-fogarty
Does having a corporate employee of Nestle on the BOD of the FDA foundation influence the FDA? Why was Nestle of Switzerland chosen in the first shipment flown to the USA by the US air force of specialty formulas? Who is paying for the fuel used by the air force or the time of the pilots? Abbott? All US infant formula companies? Or are we, the taxpayers paying for that flight? My guess is Abbott won’t be billed, it will probably be the taxpayer who ultimately foots the bill.
I found it interesting that one of the senators (I did not catch his name) made his very last comment about breastfeeding (a positive comment). First and last time I heard the word, breastfeeding in the 2 ½ hour hearing. The stony look from Dr.Califf to this senator was remarkable, and somewhat amusing to me. Dr. Califf immediately changed the subject, with no response to the Senator’s comment about breastfeeding.
It appears that the FDA will probably get more money from Congress, because more money always solves problems (yes sarcasm). But I wonder where they will get it from since we are sending the Ukraine $40 billion+ in bombs, bullets, and missiles? Oh yes they can just print more money.
As a breastfeeding advocate, I certainly believe that supply-chain issues need to be resolved. But I also recognize that this desire to stockpile infant formula to safeguard supply-chain problems comes at a cost to breastfeeding. What governmental agency will protect breastfeeding? Historically, it has been recognized that bringing in a ton of infant formula in disaster situations jeopardizes breastfeeding. It’s called the spillover effect. Breastfeeding mothers are given free formula, and then their own milk supply diminishes (since the more a baby breastfeeds the more milk is produced) from the introduction of infant formula. I would call what the US is facing in this situation is definitely a disaster. And if policy is about overstocking this product, then it would seem likely that the infant formula industry will eventually have to get rid of their overstock. What we will see is intense marketing/advertising of infant formula. Since the US appears oblivious to the WHO Code on Marketing of infant formula (despite Clinton signing on to it in 1994), we are more than likely to see breastfeeding plummet.
Derek Thompson writes in the Atlantic the article, “What’s Behind America’s Shocking Baby-Formula Shortage,”
“…uptick in births in early 2022 with a dramatic decline in rates of breastfeeding among new mothers.”
I am not sure that breastfeeding is declining, I’d like to see the data. But certainly one thing is for sure and that is that until we make Cronobacter a reportable disease in every state, we will continue to have babies at risk for Cronobacter infections because of powdered infant formula. The legislators talked about creating a system to monitor supplies of infant formula that would give an alert when supplies are low. But equally important is making Cronobacter a reportable disease in every state. And equally important is the value of encouraging, protecting, and promoting breastfeeding. The value of breastfeeding is well understood by many infant feeding researchers, but obviously not well understood by many legislators.
Copyright 2022 Valerie W McClain
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