Sunday, September 11, 2016

A Mother's Tears: Revisiting the intrinsic contamination of powdered infant formula

"We never heard of this infection, ever."  "Nobody has." 
Media comments made by the parents of baby, Axel who died in June 2016 from meningitis and sepsis caused by Cronobacter/Enterobacter sakazakii.  The parents believe that this bacteria was in the powdered infant formula that they fed to their son.

I am not surprised that Axel's parents never heard of Cronobacter/Enterobacter sakazakii.  I am sure that very few people have heard of this bacteria and the fact that it is often found in powdered infant formula. There are no "clear" labels warning parents about this particular risk of infant formula.  Nor are there regular government broadcasts warning parents of this risk.  In small print on the labels of powdered infant formula is the statement that powdered infant formula is not sterile and should not be used by premature or immunocompromised infants.  What does that statement mean to the average parent, particularly when their infant is full term and as far as a parent understands their infant is not immunocompromised?  (Although infant formula patents often state that young formula fed infants are immunocompromised because unlike breastfed infants they are not receiving a milk that has protective antibodies that inactivate pathogens).  

In response to this infant health threat,  the World Health Organization(WHO) and the CDC recommend that water used to prepare infant formula be boiled to a temperature of 158 degrees F/70 degrees C, instructions on the powdered infant formula products make no such statement.  Instead the recommendation is, "Ask your baby's doctor about the need to boil or sterilize water for formula."  And on some infant formula labels they further state, "Pour desired amount of warm water (approximately 100 degrees F/40 degrees C) into bottle."  It seems the infant formula companies are only recommending warming the water.  Confusing?  You bet!  Are parents going to ask the baby's doctor about this?  Are pediatricians aware of this issue and its importance?

While the labels state that "failure to follow these instructions could result in severe harm," the label does not state what kind of harm or that the harm might cause hospitalization, brain damage or death.  How many people read labels on the foods they buy?  How many people can read or comprehend what they read? How many bother to read labels with small print? 

Some years ago I was helping a mom with a breastfeeding problem and because of various issues the mom was also using powdered infant formula.  I watched as she used cold water from the tap to mix with the powdered infant formula.  I asked her about it.  Her response was that it mixed easier with cold water than hot water.  At that time (mid 90's), I had never heard of Enterobacter sakazakii or Salmonella in powdered infant formulas and its damaging health effects on infants.  Watching this mom prepare infant formula, I thought how times had changed. When I had my babies everything needed to be sterilized, but now by some miracle of modern science mothers need not go through such work to feed their babies.  In the 90's in Florida the use of cold water from the tap to make infant formula seemed to be a common practice.  Now I wonder how did this practice get started?  Was it belief that all water supplies are safe?  Curiosity made me do a search on Goggle and I found this from the website of Wayne State University Physicians Group on using powdered infant formula, "Most city water supplies are safe.  If you are making one bottle at a time you can use fresh, cold water from the tap."  This website is the "largest nonprofit multi-specialty physician group in southeast Michigan and is affiliated with Wayne State University School of Medicine.

A physicians group doesn't understand that powdered infant formula is not sterile.  I must question the infant formula industry's "ask your doctor whether to boil your water," because it seems that physicians may not be up-to-date on the current recommendations by the CDC and WHO.  They may be unknowingly recommending a practice that increases the risk of feeding a contaminated food to infants.

In a recent paper (2014) published in Research Excellence Framework entitled, "Safer feeds for babies:  international recognition and detection of Cronobacter spp. as an emergent bacterial pathogen associated with neonatal meningitis," by researchers, Steve Forsythe et al, it has a statement that "microbiology research at NTU has helped worldwide to lower the risk of severe infections among newborn babies from consuming bacterially contaminated powdered infant formula."  It discusses the research that has lead to increased safety of powdered infant formula with a culture agar developed specifically for Cronobacter spp called the Druggan-Forsythe-Iversen chromagenic agar.  While this paper discusses the studies done to detect this bacterium, it does make this odd comment, 

"Uncertainties about quality of product have dramatic financial consequences for formula producers.  For example in December 2011 Mead Johnson's share prices fell by 11% due to product withdrawal by Wal-Mart Stores Inc following a publicized baby's death from Cronobacter infection."

Why is a paper on safer feeding of infants concerned with the infant formula industry's financial consequences, particularly using Mead Johnson's situation as an example?  The agar test developed to detect Cronobacter spp. (once known as Enterobacter sakazakii) is named after researchers:  P. Druggan, employed by Oxoid Thermo Fisher Science-manufacturer of this particular culture test of Cronobacter spp.;  Steve(n) Forsythe, professor at Nottingham Trent University, also paid expert witness used by Mead Johnson in USA court cases against lawsuits initiated by parents whose babies either died or were maimed by Cronobacter/Enterobacter sakazakii;  and Carol Iversen, professor at University College of Dublin at the Centre for Food Safety, previously employed by Nestle Research Center in which she lead an international group of researchers who proposed the genus Cronobacter (previously called Enterobacter).

The infant formula industry appears to have direct and indirect financial interests in how this organism is detected. The company that manufactures the culture, Oxoid, is owned by ThermoFisher Scientific who has partnered with DuPont Nutritionals (another company that sells infant formula to distribute various rapid testing kits for pathogens in food in Western Europe.  

One of the ongoing issues with Cronobacter/Enterobacter sakazakii complex contamination of powdered infant formula is the difficulty of detecting this organism and lack of mandatory reporting for it in the USA (only one state-Minnesota-has mandatory reporting).   And the confusion for those of us unfamiliar with the Bacteriological Code which brought about a second proposed reclassifying of the genus, Enterobacter, to Cronobacter (with 7 species/subspecies with the most important being Cronobacter sakazakii). According to "My 40-year History with Cronobacter/Enterobacter sakazakii--Lessons Learned, Myths Debunked, and Recommendations, a paper written by John J Farmer III, 

"Every identification of a Cronobacter strain should be taken with 'a grain of salt' or even better the entire box of salt."

JJ Farmer also states that some of the commercial test kits are just not sensitive enough to detect all the strains within the family Enterobacteriaceae.  He also discusses the experiments done by Dr. Angelica Lehner in which, "Cronobacter seems to enter a viable but non-culturable state."  Thus it appears that at this point in time this bacterium is far more complex and difficult to detect.  And is an explanation of why powdered infant formula may appear to not be contaminated with Cronobacter but is actually contaminated.  These issues could mean that a infant formula manufacturer may be at fault despite testing showing no evidence of contamination.

It has been known since the first documented case in 1958 that Cronobacter/Enterobacter sakazakii complex can cause neonatal meningitis.  And has been the documented cause of outbreaks in various hospitals around the world. It causes bacteremia/sepsis. And some experts believe it can cause necrotizing enterocolitis (NEC).

It has been known since 1988 that commercial powdered infant formula is often contaminated with Cronobacter/Enterobacter sakazakii complex.   It was cultured from 52.5% of samples in 35 countries, including the USA. 

The oddest part of this issue is that despite the recognition of a problem with powdered infant formula, the CDC has very little data.  In fact they state that, "Analysis is constrained by the use of retrospective and often incomplete data."
Since only one state mandates reporting of Cronobacter/Enterobacter sakazakii complex, it should not be surprising that data is incomplete or in fact non-existent.  One of the interesting statements made at the CDC website on this issue says, "overall incidence rates of invasive infections among infants was in Minnesota."  Not surprising since they are the only state in the US that has mandatory reporting.

The CDC has a list of cases of invasive (sterile-site) Enterobacter sakazakii infections.  The study was published in 2006 in Emerging Infectious Diseases entitled, "Invasive Enterobacter sakazakii Diseases in Infants," authored by Ana Bowen and Christopher Braden, both from the CDC.

The table does not show all the cases, particularly when compared with another study published in 2009 the European Journal of Clinical Microbiology & Infections Diseases, entitled "Epidemiology of invasive neonatal Cronobacter (Enterobacter sakazakii) infections," by M. Friedemann.  The Bowen et al data misses one case in 1992 in India, 10 cases in 1994 in France, 12 cases in Belgium and 4 cases in Brazil, 1 case in 1999 in USA, 2 cases in Israel, 4 cases in 2001 in USA, one case in 2002 in Brazil, 5 cases in 2002 in USA-CDC data only shows 2 cases, in 2004 CDC data shows 2 cases in France and 2 in USA, the Friedemann data shows 4 cases in France, 1 cases in USA, 1 case in New Zealand and 1 case in Netherlands, in 2005 the Friedemann data shows 1 case USA but Bowen et al data states 2 cases "CDC (unpublished data).

The Friedemann paper states that in the period between 2000 and 2008 there were more than 100 published neonatal Cronobacter infections.  Unlike the Bowen et al paper they included cases of bacteraemia and necrotising enterocolitis. But many of the cases in the Friedemann paper were meningitis cases.

In the FAO/WHO 2006 meeting report on "Enterobacter sakazakii and Salmonella in powdered infant formula," Anna Bowen of the CDC is one of the experts at this meeting and the table of cases from her and Braden's paper in Emerging Infectious Diseases is included in this document.  The following statement is made about Anna Bowen, "Fifty percent of her salary is covered by a commercial entity as part of a cooperative research & development agreement.  While the company manufactures products for infants, it does not manufacture any infant formula products." Yet they do not name the company and obviously dismiss that there could be a problem.  I am just amazed that 50% of her salary from the CDC is covered by a commerical entity! 

Yet how accurate was the Bowen et al. information in 2006 regarding the statistics of cases known regarding Cronobacter/Enterobacter sakazakii complex?  Why eliminate cases of bacteraemia and necrotising enterocolitis (NEC)?  It appears that some experts believe that this organism does not cause NEC but has an "association" with NEC.  The more one delves into this issue, the more one has to question what we think we know.  But without mandatory reporting of data, how can anyone presume to know whether there is only 4-6 cases per year, as the CDC states.  Or whether this is a far bigger problem?  And when an industry has its financial tentacles on testing kits that determine whether contamination did or did not happen, will we ever get closer to the truth of the situation?

Meanwhile a Mead Johnson patent application for an infant formula patent that solves this contamination issue. 

 "[0003] Cronobacter sakazakii, formerly referred to as Enterobacter sakazakii is an opportunistic pathogen that has been associated with outbreaks of infection in infants, especially in neonatal intensive care units.  In infants it can cause bacteraemia, meningitis and necrotising enterocolitis (NEC).  The infant mortality rate due to infection by this organism has been reported to be 40-80%.  As a consequence of bacterial invasion to the brain, infections frequently lead to developmental delays and impaired cognitive function.  Up to 20% surviving neonates develop serious neurological complications.".  
[0004] Hence there is a desire to provide a composition that is protective against or can treat infection of pathogens like C. sakazakki.  The present disclosure provides a composition that has an effect on the invasion of pathogens such as C. sakazakki into the brain and on mortality in a neonatal rat model.  It has been found that supernatant of a LGG culture reduces the invasion of C. sakazakki to the brain and liver and even completely inhibits C. sakazakki related mortality of rat pups." 
Patent Application #20130251829, filed in 2013.

Strangely the infant formula company admits to a 40-80% infant mortality rate regarding this pathogen.  But the CDC on their website states up to a "40% infant mortality rate.  So the CDC appears to be minimizing the problemAnd then on the CDC's Prevention & Control page they state, "To best protect your infant, here are some things you can do:  Breastfeed."  That certainly does not help the women who are formula feeding exclusively and who can't or won't breastfeed.  And this may be used as part of a blame game--if the mom had only breastfed, this wouldn't have happened.  When a society continues to act as, if there are no risks to formula feeding.  And that breastfeeding is just a personal lifestyle choice, one cannot blame moms/parents for making the choice to formula feed.  And who gets off the hook of the blame game?  The Infant Formula Industry.

What is more troublesome about the passage about the CDC's "To best protect your infant," is the statement, "Almost no cases of Cronobacter infection have been reported among infants who were being exclusively breastfed.."  I haven't seen any cases in the medical literature.  Then they go on to state that if you use a breast pump you must practice careful hygiene.  What evidence do they have that breast pumps are a source of infection.  We have many research papers since the 1980's that powdered infant formula is a source for this infection and now the CDC implies without research to back it up that we should be concerned about breastfeeding and breast pumps. How to confuse this issue by implication not facts. 

And so the tears of mothers who have lost babies to this infection will continue because our society believes that there are no risks to infant formula.  And because there is no mandatory reporting of this problem.  If this was any other industry that would be impacted by this information, would we so callously continue onwards, pretending we don't have a problem?  The biggest myth of Cronobacter is society's belief that infant formula is a risk-free choice.  
Copyright 2016 Valerie W. McClain 

For further news on this issue visit the IBFAN (International Baby Food Action Network) website.  

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