INFANT FORMULA RECALL DUE TO CONTAMINATION FROM CRONOBACTER AND SALMONELLA

“Because of the ubiquitous nature of ES [Enterobacter sakazakii now known as a Cronobacter species] and the mystery surrounding its pathogenesis, preventive measures by parents, infant formula manufacturers, and health care providers will be important in the prevention of ES-related infections. We recommend a focus on simple preventative strategies such as the promotion of breast milk feeding , inclusion of warnings on powdered infant formula packages that they may be contaminated with ES, and abstinence from the practice of re-warming of reconstituted formula.”—“Enterobacter sakazakii:  An Emerging Pathogen in Infants and Neonates,” by Catherin J. Hunter et al, Surgical Infections, 2008. doi:  10.1089/sur2008.006

Fast forward to 2022 and the announcement by the FDA that 4 infants were hospitalized and one died. Three babies were infected with Cronobacter and one with Salmonella.  The sick babies were from Minnesota, Ohio, and Texas.  The suspected product was Abbott formulas (Similac, Alimentum, and Elecare) produced in Abbott’s Sturgis, Michigan manufacturing plant.  Cronobacter was the cause of the infant’s death.  The FDA is inspecting the Sturgis facility.  “The results show several positive Cronobacter  environmental samples and adverse inspectional observations by FDA investigators.  A review of the firm’s internal records also indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of products because of the presence of Cronobacter.” https://www.foodsafetynews.com/2022/02/urgent-warning-issued-about-infant-formula-and-cronobacter-salmonella-infections/

https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022

It has been 11 years since I blogged about babies dying, brain damaged, and hospitalized from Cronobacter in US hospitals.  I believe the final count was 11 infants sickened by Cronobacter in 2011. But actual numbers are not known because the only state in the US that is required to report Cronobacter is Minnesota (according to CDC website that was reviewed in Jan. 2022).   https://vwmcclain.blogspot.com/2011/12/questioning-enterobacter-sakazakii.html

The CDC states that Cronobacter infection is rare.  Is it considered rare because only one state in the US is required to report Cronobacter cases?  I believe that the cases in 2011 were under-counted. The CDC now states that they only see 2-4 cases a year, and the mortality rate is up to 40%.  Back in 2012 they stated they saw 4-6 cases.  I believe that some researchers from various institutions state a 40-80% mortality rate.  According to the CDC, we must be doing better than a decade ago.  But again, if the only state required to report cases is Minnesota, than how do we know how many infants are sickened by Cronobacter  in the US?

I find it hard to understand this blindness to the one of the many risks of infant formula.  Instead the US mantra appears to be that infant formula is a safe choice.  Yet 40 years of research shows a long list of health risks to babies. Formula fed infants have a much greater risk of bacterial and viral infections, higher rates of diabetes, pneumonia, respiratory infections, hospitalizations, etc. than exclusively breastfed infants.

One of the problems with the Cronobacter contamination of infant formula is the global reach of infant formula companies. Abbott exports their infant formula to many countries.  The risks are higher for countries that have unsafe water, lack of access to fuel to sanitize bottles and nipples, financial resources that are limited, and poor literacy so they can not read the instructions in tiny print.  Even in the USA, there are many families who have unsafe water (for example the lead problem in city water in Detroit), families that don't have stoves or refrigerators-or their electricity has been turned off, and many families during this covid pandemic have been evicted and made homeless.  Mothers that have low IQs may have difficulty following instructions in order to make formula safely.  I remember reading that even people who are college educated made errors in fixing formula-over scooping or under-scooping powdered formula.  Thus, infant formula can be risky in any wealthy country, and gets even riskier during times of emergencies--hm...like a pandemic.  Will this be a lesson learned? Or will this continually happen because corporations do not pay a price for their products that harm babies?

Copyright 2022 Valerie W. McClain

Ethics in infant formula research

“If the connection, say between formula milk early feeding and later obesity really is as established as researchers such as Lucas claim (see paper in the book), then public policy might adopt some very restrictive policies.  Instead of simply instructing health visitors to encourage young mothers to breast feed, they might forbid the sale of formula milk without a prescription, provide serious tax incentives for young mothers to breastfeed (an thus penalize young mothers who do not), or seek to stigmatise or even criminalize formula feeding for young babies.  But, of course, such draconian measures would seriously conflict with the ethos of many liberal, democratic societies and endanger individual rights.”  By Irene Cetin & Robin Gill from the chapter entitled, “Ethical Issues in Perinatal Nutrition Research,” in the 2005 book, “Early Nutrition and Its Later Consequences:  New Opportunities,” edited by Berthold Koletzko https://link.springer.com/chapter/10.1007/1-4020-3535-7_1

The editor, Berthold Koletzko, is on the scientific advisory board of the Family Larsson & Rosencrist Foundation, well known editor for many Nestle Nutrition Institute Workshop Series edited the above book which was funded by Danone.

One of my Facebook friends, Magdalena Whoolery, a member of IBFAN alerted me to a recent research paper. The research paper is published in PLOS, with grants from the Bill & Melinda Gates Foundation and the US National Institute of Health (NIH).  I tried to comment to the article, but either there is a wait system regarding comments, or some kind of computer glitch (my own or theirs) it has yet to be published.  So I thought I would comment here on this proposed research endeavor on low birth weight babies in 2 African Nations (Guinea Bissau and Uganda).

The research paper states that they support exclusive breastfeeding, but their proposal for this research is to introduce infant formula in the early days as a preventative to possible future malnutrition.  We have at least 40 years of research that shows the importance of exclusive breastfeeding for all babies, in order to prevent diarrhea (a know risk for death in infants) and various diseases that exclusive breastfeeding can prevent or mitigate those diseases.  The authors state, “…early, daily, small volume supplementation supported growth without interfering with overall breastfeeding duration.”  This statement was cited to footnotes #20 and #21. Those two studies are studies that one of the co-authors to the current study (Valerie Flaherman) is also listed as a co-author. 

In the two studies done in the United States, exclusively breastfed, full-term infants were given 10mL of formula by syringe after every breastfeed.  This current study will be done in 2 African nations on exclusively breastfed, low birth weight infants.  They will be given 59mL of infant formula after breastfeeding by bottles and sterilized nipples.

It has been known for some time that the early introduction of bottles/bottle nipples/teats can in some babies result in those babies refusing the breast and preferring bottles.  A care giver does not know which baby will have this particular problem, and it would seem to be a matter of logic to refrain from the introduction of bottles and bottle nipples/teats for as long as possible so that one does not interfere with exclusive breastfeeding in the early weeks.

The authors state the study will be conducted under the principles of the 2008 Declaration of Helsinki.  There is a more up-to-date Declaration of Helsinki, published  in 2013. One of the principles listed in the 2008 Declaration states, “The health of my patient will be my first consideration.” (#4) and, “Some research populations are particularly vulnerable and need special protection. They include those who cannot give or refuse consent themselves…” (9)  Babies cannot give consent to be part of an experiment, they are one of the most vulnerable in need of protection.   Babies who receive infant formula in the early days, may have short and long term health consequences like obesity, diabetes, and other unknown consequences.  And mothers who end up weaning early, may also suffer health consequences, such as a greater likelihood of breast and ovarian cancers, heart disease, and the emotional loss of closeness to their babies.

The authors state that they are, “…conservatively estimating a 20% loss to follow-up.’  Follow-up is very important and when the estimate seems to possibly be quite high, I would think that the authors may want to reconsider their approach.  The Declaration of Helsinki principle #33 states, “At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study..”  How will this research be able to follow the Declaration, if their estimate for follow-up is “conservatively a 20% loss?

Copyright 2022 Valerie W McClain

I urge breastfeeding advocates to read this study and comment to it.  Thank you to Magdalena Woolery for the following information, if you want to comment to the study.

Reporting research concerns to UCSF-sponsor of the study:

https://irb.ucsf.edu/reporting-research-concerns-and-complaints?fbclid=IwAR3E-JrvFOMEAEjlhp6z-4G-HLBhHUD5Q44diwtcU1vrqHmXuc94WTxeQ4I

and to comment to the study at PLOS:

https://journals.plos.org/plosone/article/comments?id=10.1371%2Fjournal.pone.0263129&fbclid=IwAR0mq9rJcPbC3mqmTWP_PaIV6XIsP7qnV5787U5__QuaQigA2Bu6D1D98w8