Monday, June 13, 2022

9 INFANT DEATHS DUE TO CRONOBACTER NOT 2 INFANT DEATHS


“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 Gillispie—“Minnesota Cronobacter Case Spurred Federal Investigation.” https://foodpoisoningbulletin.com/2022/minnesota-cronobacter-case-spurred-federal-investigation/

“Given the enormous risk Cronobacter poses to such a vulnerable population, reporting should be required in every state,” said Food Poisoning Bulletin Publisher and noted Food Safety Attorney Eric Hageman.”  Carla Gillispie—“Minnesota Cronobacter Case Spurred Federal Investigation.”    https://foodpoisoningbulletin.com/2022/minnesota-cronobacter-case-spurred-federal-investigation/

In September 2021 a baby in Minnesota was hospitalized with Cronobacter.  Minnesota is the only state in the United States that has made Cronobacter a reportable disease.  The State Health Department notified the CDC and the FDA with the information including the formula used and the lot number.  That baby was hospitalized and gravely ill survived but now we know that the total number of babies that died was nine NOT two as reported earlier, that there were 25 incidents of Life Threatening Illness/Injury, and 80 Non-Life Threatening Illness/Injury. https://www.foodsafetynews.com/2022/06/nine-baby-deaths-reported-to-fda-during-abbott-nutrition-investigation/

It is highly likely that there were more deaths and life threatening illnesses than is currently known because Cronobacter is only reportable in one state-Minnesota.  This is not just a US problem but also an international problem because Abbott shipped their contaminated product to many other countries.  All the money that Abbott raked in during the pandemic may go towards legal fees, and attorneys. Hopefully parents who have had to deal with hospital bills will be compensated, although no amount of money can compensate parents whose infants died. 

The only reason that this became a public issue was because the pandemic has created product shortages.  The infant formula cupboard became bare.  And when one factory that produced their infant formula shut down due to unsanitary conditions, the shortage became critical, the snowball effect.  The answer that some politicians have latched onto is to open the door to importing infant formula.  The question in my mind is that it is a known fact that powdered infant formula is not sterile, and the bacteria, Cronobacter is ubiquitous in the environment.  So dependence on other countries for infant formula means that we believe that other factories in other countries are more hygienic than here.  Which may be true, but if you look at the history of Cronobacter contamination, it has appeared in a variety of factories in various countries.  It isn’t the only bacteria to be concerned about, there is Salmonella, E.coli, and other pathogens.  Again, POWDERED INFANT FORMULA IS NOT STERILE.  It means that parents have to be ever-vigilant about the safe preparation of powdered infant formula. 

“The promotion of breastmilk substitutes damages breastfeeding.  For good and bad reasons, many babies are fed with breastmilk substitutes.  This is a high-risk process so the carers of these babies must be well-informed about the use of artificial milks and other breastmilk substitutes.”  Gabrielle Palmer,  The Politics of Breastfeeding,  p. 260-261

Physicians tell moms to read the directions on the formula container. Directions on the formula packages say consult your baby’s doctor.  So let’s look at the directions for safe preparation of infant formula on the back of Abbott’s Similac Sensitive infant formula package.

https://images-na.ssl-images-amazon.com/images/I/91WTAbJIE6L.jpg

The label is from 2017 but I looked at an image from 2020 and the instructions were exactly the same.  My focus is on the instructions regarding whether to boil water and whether they state that powdered infant formulas are not sterile. And whether they recommend breastfeeding or breast milk. The instructions state,   

“Ask your doctor if you need to use, cooled, boiled water for mixing and if you need to boil (sterilize) bottles, nipples, and rings before use.”  And

Next to warning “Powdered infant formulas are not sterile and should not be fed to premature infants who have immune problems unless directed and supervised by your baby’s doctor.” Note that infants that are formula fed do not have an optimal immune system.  Babies who are exclusively breastfed have an optimal immune system.

“Breast milk is recommended.”  Note they are not recommending breastfeeding but just breast milk.

Enfamil-Mead Johnson now owned by Reckitt instructions: https://d2ln0cvn4pv5w2.cloudfront.net/unsafe/1024x800/filters:quality(100):max_bytes(200000):fill(white)/dcmzfk78s4reh.cloudfront.net/1501531103073.jpg

They use the same or similar statements as Abbott’s instructions.  No date on the label, so do not know how old the label but since so similar to Abbott 2020 label, will assume close to that time.

“Powdered infant formulas are not sterile and should not be fed to premature infants or infants who have immune problems unless directed and supervised by your baby’s doctor.”

“Ask your doctor if you need to use cooled, boiled water for mixing and if you need to boil (sterilize) bottles, nipples, and rings before use.”

“Experts agree on the many benefits of breast milk.”  Again, the recommendation of breast milk not breastfeeding.

Gerber (owned by Nestle, SA-Switzerland) some of the instructions state, https://images.bonanzastatic.com/afu/images/bebc/364d/9fd7_7663625787/91ityloxmul.jpg

“Sterilization or boiling of tap or bottled water and sterilization of utensils recommended. Your doctor will advise if not required.”

“If boiling water bring to rolling boil for 1 minute and allow to cool to room temperature before preparing formula.”

“Warming formula above, or using water warmer than 100°F (38°C) will compromise the probiotic culture.”

“Breastfeeding is best for your baby.”

Gerber seems to have contradictory information on their label.  They recommend sterilization of water and utensils but then they state that warming formula or using water warmer than 100°F (38°C) will compromise the probiotic culture.  I just wonder how probiotics survive the manufacturing process of powdered infant formula?  Is it the last added ingredient?  Love to know the way probiotic bacteria is added to powdered infant formula so that it stays alive through the process; but also keeps the powder free of pathogenic bacteria like Cronobacter?  At least they state their motto, “Breastfeeding is Best.”  Yes, a little sarcasm.  I am somewhat humored that both Abbott and Mead Johnson-Reckitt support breast milk.  Of course many people believe that breast milk and breastfeeding are the same words.  I find it eye-opening that these US infant formula companies support breast milk.  Will anyone analyze that?  From my perspective it’s because breast milk-feeding often results in mothers’ formula feeding because the demand of pumping long-term can create many obstacles.  Long term pumping often results in lowered milk supplies.  I told moms who were long term pumping (mothers with premature infants) that occasional hand expression could help increase milk supply.  If the premature baby was home and mom still pumping, my suggestion was to hold the baby skin-to-skin and pump one side. Skin to skin contact is a mighty medicine for babies and moms.

In 2008 a study was published in Pediatrics called, “Infant Formula—Handling Education and Safety.”  The study determined “that the majority of formula feeding mothers did not receive instruction on formula preparation (77%) or storage (73%) from a health professional.”  Some 30% did not read the instructions on the package, and 38% thought powder (not sterile) and ready-to-feed (sterile) were unlikely to contain germs.

“Among the mothers of the youngest infants analyzed, 55% did not always wash their hands with soap before preparing infant formula, 32% did not adequately wash bottle nipples between uses, 35% heated formula bottles in a microwave oven, and 6% did not always discard formula left standing for >2 hours.”

This study was done in 2008, should we believe that a new study on the same subject would show that more mothers read the instructions? Do we believe that pediatricians are spending one on one time educating mothers on safe preparation of infant formula?  Do pediatricians in the US spend more than 10-15 minutes per mother and baby at visits?  So do they talk about infant formula labels or whether they need to boil their water for infant formula? 

When a product is a risk to infants, one would think that more regulation of the industry that makes the product is needed not less regulation.  The US media emphasis on empty shelves is certainly an important issue, no baby should go hungry.  But I find it frightening that the safety of infants from unsanitary manufacturing facilities seems to be a lost concern to most people.  Dependency on an industry to keep babies safely fed should mean that there are independent inspectors, and pandemics should not be an excuse to forego inspections. https://www.clickorlando.com/news/politics/2022/06/13/many-baby-formula-plants-werent-inspected-because-of-covid/

What is wrong with suggesting that breastfeeding should be supported and promoted during an emergency?  I feel like too many people believe the marketing created by Abbott Labs in which breastfeeding mothers are viewed as Nazis who push breastfeeding.  No one questions Abbott Labs or their advertising that destroys breastfeeding advocacy. They can say whatever they want to, but yes Abbott supports breast milk.  They say it on every package they sell. But breast milk is not support of breastfeeding.

The lack of US support for the WHO Code of Marketing of Breast-Milk Substitutes is a clear statement by the US Government of support of industry over babies.  https://www.who.int/publications/i/item/9241541601

The lack of support of the WHO Code means that labels on packages of infant formula on preparation of infant formula will continue to be unclear to parents (if they read the directions).  People believe that infant formula is so benign a product that anyone can fix a bottle of infant formula.  Although I do remember reading some years ago that even highly educated people do not follow the instructions on preparing powdered infant formula-they over scoop or under scoop the powder. 

The manufacture of infant formula obviously needs critical assistance during a pandemic—we might consider calling it a medical product that has certain, known risks.  One might think that as a medical product it should be distributed by prescription only in order that parents understand the risks, and get sufficient instruction on safe preparation.  Yes I know, dream on.

Copyright 2022 Valerie W McClain

Tuesday, June 7, 2022

DANCING TO THE TUNE OF THE INFANT FORMULA INDUSTRY


“The great owners ignored the three cries of history.  The land fell into fewer hands, the number of the dispossessed increased, and every effort of the great owners was directed at repression.  The money was spent for arms, for gas to protect the great holdings, and spies were sent to catch the murmuring of revolt so that it might be stamped out.  The changing economy was ignored, and only means to destroy revolt were considered, while the causes of revolt went on.”  John Steinbeck--The Grapes of Wrath

Sound familiar?  I felt like I was reading a description of current events.  I read the Grapes of Wrath many years ago and remember the ending in which Rose of Sharon feeds the starving father by breastfeeding him. Some people viewed that last scene as pornographic, as disgusting.   Rose’s own baby was stillborn, and her response was to save a starving man from certain death by breastfeeding him.  It was not a sexually act. It was a lifesaving act.

Rose of Sharon is considered by some literary critics of Steinbeck to be biblical in reference; as in the desert shall bloom like the rose.  Isaiah 35:1 in the Bible states, “The wilderness and the land will be glad; the desert will rejoice and blossom like a rose.”  The transformation of a desert into a bountiful, plant-filled land calls us to rejoice in that transformation.  Likewise, Rose of Sharon’s tragedy of losing her baby transforms into a gift of sustenance for a starving man.

 One would think that those who felt this scene disgusting would be more repulsed by a nation that allows people to starve. Rose of Sharon knew instinctively the value of breastfeeding. Many years later, our world cannot envision that breastfeeding is the saving grace during threats of hunger or starvation for babies and children.  Enamored by advertising of infant formula, and the song and dance that science is so advanced that it can duplicate breastfeeding through genetic engineering a product; a society becomes mesmerized, and enmeshed in valuing products over breastfeeding.  

Remember the Similac advertisement by Abbott Labs, “The Mommy Hood” also called, “The Mommy Wars” or “The Sisterhood of Motherhood,” in which a lot of people thought the video was a documentary?  It exploited the divisions between breastfeeding and formula feeding mothers.  The video went viral, and I believe has had a lot of influence on how people view breastfeeding supporters as pushy and dictatorial. 

The name Similac was derived from “similar to lactation.”  Similac is a brand name, not the name of the company, which is Abbott Labs.  I wonder how people feel about this company now that we all know that the company invested their Covid relief funds from the US Government in by-backs of their own stock rather than in the infrastructure of their manufacturing facilities?  Or now that we know that the FDA had to go to court to obtain a Consent Decree of Permanent Injunction against Abbott to shut down the manufacturing facility and implement cleaning up the facility before being allowed to go back to producing infant formula. https://www.marlerblog.com/legal-cases/abbott-enters-consent-decree-with-fda-on-cronobacter-infant-formula-outbreak-and-recall/

THE RISK OF PATHOGENS IN POWDERED INFANT FORMULA

“The FDA conducted a sampling assignment in 2014 to understand the prevalence of Cronobacter spp. and Salmonella in 55 US dry dairy facilities…Cronobacter was detected in 69 percent of the facilities…By contrast, Salmonella was found in only three (5.5%) of the 55 facilities sampled.”  Dave Cook, “Cronobacter:  Pathogen Considerations beyond Salmonella in Dairy Powders”  FoodSafety Magazine 2021

I find it interesting that articles on Cronobacter contamination always state that Cronobacter is rare.  Yet I recently (6/1/2022) found an article in FoodSafety News that Cronobacter was found in Numil infant formula that was sent from Poland to Moldova with a recall notice.  https://www.foodsafetynews.com/2022/06/cronobacter-found-in-numil-infant-formula/

I will suggest again that in the US, Cronobacter infections in babies are considered rare because there is only one state in the US that is required by law to report it.  If no one is required to report it to health departments, how can we say that it is rare?

The FDA found that 69% of dry dairy facilities were contaminated with Cronobacter.  That seems scary to me.  We do know that safe preparation of infant formula is required to lower the risk of infant infections.  According to one study I read, “Cronobacter sakazakii was able to grow in a wide variety of temperatures from 6 °C to 45°C (42.8°F to 113°F). https://www.researchgate.net/publication/344021490_Cronobacter_sakazakii_in_Infant_Food_Contamination_and_Its_Survival_Strategies_in_Hostile_Conditions

In US Patent #10743544 entitled, “Method for inactivating Cronobacter sakazakii,” owned by Northeast Agricultural University of Harbin, China, they state that reconstitution of powdered infant formula should be no less than 80°C (176°F).  They also state that “Powdered infant formula is a main source of Cronobacter spp. contamination and transmission.” https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=10743544.PN.&OS=PN/10743544&RS=PN/10743544

What does Abbott Labs really think about breastfeeding?  Let’s take a look at US patent #9763970 filed in 2011 called, “Nutritional compositions comprising human milk oligosaccharides and nucleotides and uses thereof for treating and/or preventing enteric viral infections.”

“Breastfeeding has been associated with enhanced development and balanced growth and maturation of the infant’s respiratory, gastrointestinal and immune systems, thereby providing protection of the infant to infections and inflammatory diseases.”

https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=2&f=G&l=50&s1=9763970,.PN.+11337990.PN.&OS=PN/9763970,+OR+PN/11337990&RS=PN/9763970,+OR+PN/11337990

Or Abbott Labs US patent #11337990 also filed in 2011 called, “Human milk oligosaccharides to promote growth of beneficial bacteria.”

“Breast milk contains components that not only act as pathogen receptor analogues, but also activate immune factors by infant intestinal epithelial cells and/or associated immune cell populations to enhance development and maturation of the infant’s gastrointestinal and immune systems.”

https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9763970,.PN.+11337990.PN.&OS=PN/9763970,+OR+PN/11337990&RS=PN/9763970,+OR+PN/11337990

Human Milk Oligosaccharides (HMOs) are present in human milk but what is manufactured by the infant formula industry is not a duplicate of the HMOs found in breastmilk.  Substances in infant formula have to withstand storage for at least 18 months at room temperatures, and are commonly genetically engineered through fermentation of various bacteria.  Infant formula contains an element of risk, when facilities that process the substance are not well-regulated.  The problem increases when parents are not aware of safe ways to prepare powdered infant formula.  And during a pandemic all these issues accelerate.  Parents believe this is a supply-chain issue.  But the reality is that what came first is a bacterial contamination issue that killed 2 infants and hospitalized other babies.  The need for greater regulation of the industry is very apparent.  Whether Congress chooses to enact more regulations is questionable, when some legislators seem to be more influenced by their stock portfolios.

Copyright 2022 Valerie W McClain