Friday, October 05, 2007

Ruling in Belgium : deaths from contaminated formula are to be accepted

News arrives from Belgium that a family has lost its legal action against Nestlé and the hospital that put their new-born child onto infant formula that turned out to be contaminated with bacteria. The effect of the ruling is to suggest that deaths from intrinsic contamination of formula, which are rare, are to be expected and accepted.

The couple's son became ill with meningitis and died at 5 days old. This was linked to Enterobacter Sakazakii contamination in Nestlé Beba infant formula, prompting a recall. See the International Baby Food Action (IBFAN)'s press release from 10 May 2002.

This death and others in France prompted action at the World Health Assembly. IBFAN called for improved labelling to warn of the risks and how to reduce them. This call was reflected in the Resolution adopted shortly afterwards (WHA 55.25) and more explicitely in 2005 (WHA 58.32) after the World Health Organisation had held an expert meeting.

We are now working for improved labelling standards at the Codex Alimentarius Commission, whose standards are seen to carry greater weight than World Health Assembly Resolutions in that the World Trade Organisation looks to them if evaluating whether national measures are proportionate should there be a trade dispute. The baby food industry is at Codex in force, attempting to weaken measures that could impact on its profits. We have called for greater transparency on conflicts of interest in the past, much to the annoyance of the Chair (see Update 37 for example).

The issue of contamination of powdered infant formula has been known about for decades and the Food and Drug Administration in the United States quotes a study that shows it is worryingly common, found in 14% of tins surveyed. See my earlier blog on Enterobacter Sakazakii for links to references.

In 2005 the UK Food Standards Agency (FSA) issued guidance for parents saying to use water of at least 70 Deg. C to make up the formula to kill any pathogens. As we reported in Update 38 the Northern Ireland Department of Health and the Welsh Assembly Government issued booklets giving this information and stating clearly that formula is not sterile and may contain harmful bacteria.

As we have exposed, companies have still not brought their labels into line, despite issuing new labels this year in response to a crackdown on the use of illegal health claims. See our press release:

The UK Government is revising the Infant Formula and Follow-on Formula Regulations and last week we submitted a report on behalf of the Baby Feeding Law Group (BFLG) which calls for a statutory requirement for warnings and instructions on labels to be in line with official guidance. The Food Standards Agency had proposed a voluntary agreement. As the companies didn't bring their labels into line when they had the chance, it is clearly not sensible to rely on their good intentions.

The BFLG report refers to a spot check of company carelines we conducted. This found that advisors are giving advice to parents that contradicts the independent, expert guidance from the Food Standards Agency and World Health Organisation. We have heard claims on carelines that powdered formula is sterile until opened and to make up formula using water at room temperature, which has been pre-boiled. This is dangerous information. The fact is the water needs to be added to the formula at high temperature to kill any bacteria. We will issue a full report on the monitoring in due course.

My view is that it should be a criminal offence for companies to deny parents critically important information about reducing risks from formula on the label.

I understand the Judge in the Belgium case cleared the hospital of negligence as it was not the source of the infection and cleared Nestlé as it had complied with the relevant legislation. No matter that Nestlé was well aware that powdered infant formula is not sterile and may contain harmful bacteria, which it did not warn about on its labels. The parents are in my view justifiably aggrieved at only learning this information after their child died.

If more infants die from contaminated formula prepared using the advice from the carelines or labels a UK judge may well rule company had complied with the law. This is why we think it is so dangerous for the FSA to pursue a voluntary agreement with the industry about warnings and instructions instead of setting out in the legislation that they must comply with official guidance to parents.

Fortunately deaths from contaminated formula are rare, though it is unknown how much the higher incidence of gastroenteritis and other illness is due to contamination as this has not been monitored.

Personally I think the idea that deaths from contaminated formula are to be expected and accepted, as the Belgian ruling suggests, is not the correct response to the tragedies that have occurred. Action must be taken to ensure parents have the information they need to reduce risks.

If you agree please support our work and sign up to receive information from our making formula use safer campaign.

1 comment:

Anonymous said...

The wild, varying,& usually emotive opinions on breast v formula never cease to amaze, but basing this on logic rather than emotion who in their right mind would ever give precedence to opinions over medical and scientific facts? Most mothers are of the opinion that infants who die from the use of formula are those in developing countries where sanitation is poor and water unclean, those of us that have done the research know that this is not the case and that infants in developed countries can also die from various illness' that are attributed to formula use, but this is not common knowledge. Should the public be kept in the dark about upto date medical facts regarding infant feeding in order to spare the 'guilty' feelings of some formula feeders? Answer this honestly without emotion and we all know deep down that the correct answer is a very resounding and ethical NO! - How could medically beneficial progress be accomplished & breastfeeding rates improved if facts were kept hidden so as not to offend those that use/d formula? In denying the public at large evidence based knowledge by watering down the risks of formula feeding, health professionals themselves are guilty of colluding with the untruth, contributing to infant/mother illness, death and a denial of a mothers right to fully informed choice. Would any of us believe it appropriate if the government chose not to disclose the results of recent research that food additives, E numbers, colourings etc actually do affect kids - with hyperactivity etc? Or that the health risks of tobacco were never made public?
The fact of the matter is that the UK's very beleagured education and health systems are failing mothers and infants with lack of support and education regarding breastfeeding and risks of using formula - any guilt and vitriol a mother feels at not succeeding with breastfeeding should be directed at a system that has failed them and their infant rather than at those who are positively outspoken about being pro-breastfeeding - these people are not trying to bully or guilt trip mothers, they are just trying to help and educate to give women confident belief in themselves, their bodies capability to nourish their infants and motivation to succeed, something which formula manufacturers continually attempt to undermine in pursuit of profit at the expense of infant and mother health - knowing the real facts about the risks of artificial feeding can provide women with real conviction to make breastfeeding successful. Being pro-breastfeeding is certainly not about making formula users feel like bad mothers, its about providing facts to try and help ensure the healthiest outcomes for infant and mother.
With hindsight I'm pretty sure the Belgian parents would have preferred to be in possession of ALL the facts prior to unwittingly using unsterile powdered formula to feed their infant. The judge may have cleared the hospital and nestle of direct negligence ruling that deaths from contaminated formula are to be expected and accepted - this could be interpreted by many to mean that the judge ultimately lays the blame with the parents for choosing powdered formula to feed the child - grossly unfair if health professionals and formula manufacturers do not make parents fully aware of the risks that accompany artificial feeding. The judge could have used this case as an opportunity warn health professionals and formula manufacturers worldwide to improve the education and information given to parents about the vast differences between breastmilk and formula feeding. In a similar vein to cigarette packaging health warnings on all cans / cartons of formula should be routine throughout the world accompanied by strict preparation instructions. The Belgian case is a desperately sad one that re-iterates the importance of providing factual information regarding infant feeding methods.