Showing posts with label Science and history. Show all posts
Showing posts with label Science and history. Show all posts

Tuesday, October 09, 2012

Infant Sleep Information Source

The September 2012 issue of Breastfeeding Briefs from the International Baby Food Action Network (IBFAN) is on the theme of "Sleeping with the baby". It is guest edited by Dr Helen Ball who has researched and written extensively on this theme.

Dr Ball explains:
Over the past year, my colleague Dr Charlotte Russell and I have been working with several organisations in the UK (La Leche League, National Childbirth Trust, UNICEF Baby Friendly Initiative) to produce an infant sleep information website (ISIS) that aims to inform parents and health care providers about the research evidence available on where and how babies sleep (www.isisonline.org.uk). This editorial will summarise some of the issues we discuss on the site, and consider how the latest research is informing parents and healthcare providers.
The editorial is a fascinating overview of questions relating to co-sleeping, possible positive and negative impacts on breastfeeding and Sudden Infant Death Syndrome and the latest evidence and advice.

You can download the issue of Breastfeeding Briefs below from the IBFAN site (where you will also find past issues) - click here.

There is information for health workers and resources for parents and carers on the ISIS site:
http://www.isisonline.org.uk/

Friday, January 14, 2011

WHO breastfeeding recommendations under attack from industry-funded scientists

The BBC, the Guardian and other media are carrying stories about a comment piece from four authors published in the British Medical Journal today. This is not a new scientific study - it is a review of existing research selected by the authors and has been published in the 'Comment' section of the BMJ. Three of the four authors of the piece, Mary Fewtrell, Alan Lucas and David Wilson, receive funding from the baby food industry. Prof Lucas in particular plays a key role in advising the UK baby food industry, and has opposed the WHO recommendation for many years. In 2003 he went so far as to appear for the defence when one of the largest baby food companies, SMA Wyeth was successfully prosecuted for illegal advertising by Trading Standards.

www.babymilkaction.org/press/press31july03.html

http://www.babymilkaction.org/update/update33.html#2

http://www.babymilkaction.org/www.babymilkaction.org/update/update29.html#2

http://www.babymilkaction.org/www.babymilkaction.org/update/update23.html#11

Baby Milk Action expects this comment piece and the media coverage it is generating to be used by companies in their attempt to weaken national policies and legislation requiring complementary foods to be labelled for use from 6 months. In the UK, baby food companies are already labelling complementary foods for use from 4 months of age despite Government policy recommending 6 months exclusive breastfeeding or formula feeding.

When looking at the authors' comment piece, the following points should be borne in mind:

  • The four authors are not attacking the recommendation that breastfeeding continue alongside complementary foods or the WHO recommendation of breastfeeding into the second year of life and beyond. Baby Milk Action is concerned about misreporting of the paper, with headlines such as, "Breastfeeding 'not always best'" or "Recommendation to breastfeed for 6 months challenged". Please post examples as comments to this articles, with links if possible.
  • This is not a new scientific study - it is a review of existing research selected by the authors and has been published in the 'Comment' section of the BMJ.
  • WHO’s policy arose from a systematic review of 3,000 studies on infant feeding. See The optimal duration of exclusive breastfeeding and Guiding principles for complementary feeding of the breastfed child. WHO has issued a statement today (14 January 2011):
WHO's global public health recommendation is for infants to be exclusively breastfed for the first 6 months of life to achieve optimal growth, development and health. Thereafter, infants should be given nutritious complementary foods and continue breastfeeding up to the age of 2 years or beyond.

WHO closely follows new research findings in this area and has a process for periodically re-examining recommendations. Systematic reviews accompanied by an assessment of the quality of evidence are used to review guidelines in a process that is designed to ensure that the recommendations are based on the best available evidence and free from conflicts of interest.

The paper in this week's BMJ is not the result of a systematic review. The latest systematic review on this issue available in the Cochrane Library was published in 2009 ("Optimal duration of exclusive breastfeeding (Review)", Kramer MS, Kakuma R. The Cochrane Library 2009, Issue 4). It included studies in developed and developing countries and its findings are supportive of the current WHO recommendations. It found that the results of two controlled trials and 18 other studies suggest that exclusive breastfeeding (which means that the infant should have only breast milk, and no other foods or liquids) for 6 months has several advantages over exclusive breastfeeding for 3-4 months followed by mixed breastfeeding. These advantages include a lower risk of gastrointestinal infection for the baby, more rapid maternal weight loss after birth, and delayed return of menstrual periods. No reduced risks of other infections or of allergic diseases have been demonstrated. No adverse effects on growth have been documented with exclusive breastfeeding for 6 months, but a reduced level of iron has been observed in developing-country settings.
  • Keeping recommendations under review is good practice and randomised controlled trials are also in progress; the four authors are pre-empting the results of these and do not refer to the 2009 review published by the Cochrane Library.
  • The four authors imply that delayed introduction of solid foods may be linked to increased obesity - this is total conflict with the studies which show that early introduction - particularly of sugary foods is an important factor behind the obesity epidemic. Breastfeeding may actually help in the development of taste receptors.
  • The argument to introduce solids at 4 months to prevent coeliac disease and allergies was summarised by ESPGHAN in late 2009 and was considered by many to be flawed. see our press release: http://www.babymilkaction.org/press/press23dec09.html
  • The UK Scientific Committee on Nutrition (SACN) and the Committee on Toxicity (COT) are reviewing the evidence on solid foods and coeliac disease. The draft opinion is NOT FINAL BUT Is on the SACN website with the Agenda papers for next week's SACN meeting. See paper SMCN/11/01 downloadable from http://www.sacn.gov.uk/meetings/sub_groups/maternal_child_nutrition/19012011.html
  • SACN use international growth charts to describe the optimal pattern of infant growth in the UK (UK-WHO charts). These are based on studies of babies in 7 countries around the world and no significant difference was found between their growth profiles. The proposal from the four scientists that babies are treated differently depending on where they live conflicts with this research evidence. The mean age at introduction of solids to this cohort of breastfed infants in the WHO studies was 5.4 months (or "..about 6-months").
  • The UK policy is to introduce complementary foods at around 6-months and progress responsively, in line with individual babies' progress and acceptance. Not all babies need solids at the same time: in every aspect of infant development there is a wide range of normal. Very importantly the introduction of the new policy in 2003 has been associated with a marked reduction in the numbers of mothers giving solids very early (i.e. before 4-months). Since it is widely accepted that very early introduction carries greater risk (particularly of coeliac disease), the UK policy could be considered from this perspective a success.
  • The practice of ‘baby-led weaning’ is becoming more widespread, where babies are allowed to play with appropriately prepared solid foods and decide for themselves when to eat. Experience in this area suggests that babies naturally start to ingest complementary foods at around 6 months of age, when various developmental factors (hand-eye coordination, mastication ability etc) come together. This may be an evolved natural behaviour that has been lost through the practice of spoon feeding prepared paps. Further research is required in this area.
  • Marianne Monie, Chair of the nationwide Breastfeeding Network, made an important point about the risk of swine flu: “The evidence supports introducing food when a baby is developmentally ready at around 6 months. Introducing food or infant formula before that time increases the risk of infections. Questioning the wisdom of the six-month guideline at a time when babies are at risk of catching swine flu is unfortunate, because exclusive breastfeeding reduces the risk of secondary infections that can be serious enough to need hospital admission. Parents should not feel pressured into rushing their baby onto solid food. Waiting until around six months gives another two valuable months of additional protection against chest and stomach infection."

Response from Joanna Moorhead:

http://www.guardian.co.uk/lifeandstyle/2011/jan/14/breastfeeding-comment-joanna-moorhead

Response from UNICEF UK:

http://www.babyfriendly.org.uk/pdfs/unicef_uk_response_to_BMJ_article_140111.pdf

Thursday, August 27, 2009

Senator Edward Kennedy - remembering his contribution to holding Nestlé and others to account

Senator Edward Kennedy passed away on Tuesday. He played a pivotal role in the baby milk campaign, calling Senate Hearings in 1978 and putting company executives on the spot about their aggressive marketing practices. The added calls for a marketing code was taken up by WHO and UNICEF and led to the International Code of Marketing of Breastmilk Substitutes three years later.

A press release on our website tells more. See:

Here's a clip of a Nestlé executive being put on the spot. The Hearings are so significant that even today Nestlé is trying to discredit them, distributing a paper with misrepresentation of what happened. See:


Senator Kennedy found that executives felt they had no responsibility for investigating the conditions under which their formula was used.

You can find transcripts and a scan of a contemporary article from the Washington Post (24 May 1978) on the Hearings at:

Here's an extract from the Washington Post: "Oswaldo Ballarin, President of the Nestlé Co. Brazil, which produces infant formula, angrily denied the charges, saying: 'The US Nestlé Co. has advised me that their research indicates this is actually an indirect attack on the world's free economic system.' A red-faced Kennedy shot back: 'Now you can't seriously expect us to accept that... that these people are involved in some worldwide conspiracy to attack the free world's economic system.' Ballarin apologised."

Tuesday, June 24, 2008

Planning for Nestle free week - 4 October 2008

Nestlé-Free Week will take place around the 4 October 2008.

This marks the 20th anniversary of the launch of the current boycott by Action for Corporate Accountability in the United States over the companies aggressive marketing of baby foods. Babies who are not breastfed are more likely to become sick and, in conditions of poverty, to die.

According to UNICEF: "Improved breastfeeding practices and reduction of artificial feeding could save an estimated 1.5 million children a year."

Nestlé failed to live up to an agreement reached in 1984 which ended an earlier boycott. Nestlé had promised to abide by the International Code of Marketing of Breastmilk Substitutes, adopted by the World Health Assembly in 1981 as a result of the first boycott.

Baby Milk Action launched the boycott in the UK in 1989, but will also be marking the 20th anniversary in the first week of October 2008. Groups in 20 countries have launched boycott and it has supporters in many other countries. An independent survey in 2005 found Nestlé to be one of the four most boycotted companies on the planet, something Nestlé finally admitted in 2007. See:
http://www.babymilkaction.org/press/press6july07.html

Mike Brady, Campaigns and Networking Coordinator at Baby Milk Action, said:

"The boycott has forced some important policy changes on Nestlé and we are able to stop specific cases of aggressive baby milk marketing thanks to public pressure, but the latest monitoring shows that Nestlé still thinks it can get away with breaking the World Health Assembly rules in many countries. In parallel to the boycott we have had a lot of success in bringing the Assembly measures into national laws and where these are enforced malpractice is stopped, showing companies can comply when compelled to do so. The boycott keeps this issue in the public eye and the pressure on Nestlé, the worst of the baby food companies."

Monitoring conducted by the International Baby Food Action Network (IBFAN) profiles the main baby food companies. See:
http://www.babymilkaction.org/shop/publications01.html#btr07

Nestlé has consistently been found to be the worst of the baby food companies. Boycott coordinators have put a four-point plan to Nestlé aimed at saving infant lives and ultimately ending the boycott. See:
http://www.babymilkaction.org/boycott/boyct4pointplan.html

Danone, which recently bought the NUMICO companies (Nutricia, Milupa and Cow and Gate) is becoming an increasing concern as it tries to compete with Nestlé in Asian markets. Danone told Baby Milk Action earlier this year that it is conducting a 'root and branch review' of NUMICO operations since the takeover and the situation is being monitored to see whether changes will be made without consumer pressure.

People interested in planning for local action can visit Baby Milk Action's websitew for support and resources. See:
http://www.babymilkaction.org/resources/boycott/nestlefree.html

The joint statement from Nestlé and the International Nestlé Boycott Committee on the end of the first boycott on 4 October 1984 can be downloaded from:
http://www.babymilkaction.org/resources/yqsanswered/yqanestle09.html#boycott

Coverage of the relaunch of the boycott on 4 October 1988 in the United States can be found in contemporary reports in the New Internationalist and the New York Times.

Note the US group included American Home Products (now part of Wyeth) in its boycott call. The boycott internationally has focused on Nestlé as global monitoring finds it to be the worst of the companies.

Monday, March 03, 2008

Cut throat competition building a US$20 billion baby food market

There is a new report out analysing the global baby food industry from the financial point of view.

There are extracts on this website:
http://www.emediawire.com/releases/baby_foods_meals/infant_formula/prweb735554.htm

---extract begins
It states: "Global baby foods and infant formula market is projected to witness steady growth through the forecast period and reach US$20.2 billion in sales by 2010. Although US and Europe are the leading markets for baby foods and infant formula products, these developed regions offer little opportunities for growth due to the declining birth rates, static market conditions, and consolidation. As a result, manufacturers are moving towards the more lucrative and populous markets in Asia-Pacific, and are currently focusing their efforts on India and China."

[...]

Companies engaged in production of baby foods face cut throat competition, particularly on the innovation platform. Each company is focused on gaining a competitive edge over rivals by introducing new products into the markets from time to time. Major companies operating in the global market for baby foods and infant formula include Nestle, Numico, Abbott Laboratories, Bristol-Myers-Squibb, Gerber, Heinz, Danone, and Hipp. Nestle, Danone, Heinz and Royal Numico. Among these, Nestle is a dominant player with global presence.

Europe represents the leading regional market for baby foods and infant formula products for 2007, capturing more than 30% share of the global sales, as stated by Global Industry Analysts, Inc. However, the large population base in developing regions, particularly India, China and Brazil, is expected to facilitate in shifting the focus of manufacturers to these regions. As a result, Asia-Pacific is projected to emerge as the fastest growing regional market over the 2001-2010 period, driven primarily by the exceptional sales in the Chinese market. Europe would continue to retain its position as the leading baby meals market by 2010, with sales projected to reach US$2.1 billion.

---extract ends

The cut throat competition between companies to grow their market share, results in the type of aggressive marketing practices exposed in the monitoring report produced by the International Baby Food Action Network (IBFAN) called Breaking the Rules, Stretching the Rules.

Nestlé comes in for special mention here too, for being the worst of the baby food companies.

We have also seen the efforts of NUMICO, now owned by Danone, to compete with Nestlé in the asian markets has led to more violations coming from its group of companies.

While the portrayal of artificial feeding as modern and helping to develop intelligence is only part of the story, it is no doubt contributing to the declining breastfeeding rates seen in China. For a recent blog on China see:
http://boycottnestle.blogspot.com/2007/08/code-china-australia.html

If you want to see the full financial analysis report you can order it here:
http://www.strategyr.com/Baby_Foods_and_Infant_Formula_Market_Report.asp

It costs US$4450 so I'm not sure we'll get to see a full copy.

The IBFAN report is much more reasonably priced. You can order it here:
http://www.babymilkaction.org/shop/publications01.html#btr07

It costs £25 for non-profit use (not including investment planning) and £75 for profit use.

Wednesday, November 14, 2007

Dr. Natividad Relucio Clavano

My colleague, Patti Rundall, has written an obituary for this inspiring campaigner from the Philippines.

A version of the obituary also appears in today's Guardian newspaper. See:
http://www.guardian.co.uk/obituaries/story/0,,2210404,00.html

The following appears in our forthcoming Update newsletter, which will be sent to all Baby Milk Action members shortly. Click here to join Baby Milk Action.

---
Dr Clavano - tiny woman who moved mountains

“We allowed the companies to touch the lives of our babies, not because we did not care, but because we did not realise the consequences of granting such a privilege. How to change all that? How to break the ‘friendly’ stranglehold that we had allowed the milk companies to have on our hospital? We closed the door of the nursery to the milk companies. We stopped giving our babies the starter dose of infant formula. Down came the colourful posters and calendars; in their place we hung the “baby killer’ posters which show an emaciated baby inside a dirty feeding bottle.”

IBFANers marked the death on October 4th of Dr. Natividad Relucio Clavano, Chief of Paediatrics, Baguio General Hospital, the Philippines. Natividad’s 10,000 baby study (which Nestlé tried to suppress) demonstrated the damaging impact that western medical practices can have on breastfeeding and child survival and gave foundation to the global movement that followed.

Her life took a dramatic turn in 1974 when she came to the UK to take Post-Graduate Studies in Pediatrics at the Institute of Child Health, London University. Initially keen to learn about asthma, she studied under Baby Milk Action Advisor, Prof David Morley. She returned home armed with practical information about how to change hospital practices and prejudices about infant feeding. Her changes resulted in an increase of breastfeeding rates from 40% to 87%, a 94% reduction in the rates of diarrhoea and a 95% reduction in the rates of infant death.

She spoke in Washington at the 1978 US Senate Inquiry under Senator Ted Kennedy which led to the Code and in 2005 at the Philippine Senate in support of the Department of Health. We send our love to her husband and sons.
---

You can find a transcript of Dr Clavano's testimony to the Senate Hearing on our website, in our analysis of an article Nestlé is using to misrepresent the history of the campaign and its current practices. See:
http://www.babymilkaction.org/resources/yqsanswered/yqanestle09.html

It is important that we do not forget what really happened, or those who have taken principled stands against corporate malpractice. They give us strength to continue.

See the link to my blog entries on the Philippines for the unfolding story of the recent battle just won to protect infants and mothers from the latest challenge by the industry.

Monday, November 12, 2007

Breastfeeding does not cause breasts to droop, says cosmetic surgeon

Does breastfeeding make your boobs sag? It's an urban myth that it does. Who would know? A cosmetic surgeon perhaps, who meets women who want the work of gravity reversed?

According to a presentation earlier this month at the American Society of Plastic Surgeons a study: "showed no difference in the degree of breast ptosis (or sagging) between women who breastfed and those who didn't".

In the study, led by surgeon Brian Rinker: "Rinker and his colleagues interviewed 132 women who came in for breast lifts or augmentation between 1998 and 2006. On average, the women were 39 years old, and 93 percent had experienced at least one pregnancy. Among the mothers, 58 percent had breastfed at least one of their children. The average duration of breastfeeding was nine months."

See the LiveScience website report at:
http://www.livescience.com/health/071102-breast-sagging.html

According to the report: " The main factors that did affect sagging were age, smoking status and the number of pregnancies a woman has had."

---article extract
Rinker says this finding should alleviate the fears of new mothers over what nursing their child might do to their breasts in the long run and will encourage them to breastfeed because of the health benefits to their infant.

"Women may be reluctant to breastfeed because of this unfounded myth that doing so means the end of youthful breasts," Rinker said. "Now, expectant mothers can relax knowing breastfeeding does not sacrifice the appearance of their breasts."
---extract ends

Phew. That's a relief.

Tuesday, November 06, 2007

Breastfeeding linked to intelligence once again - beware of industry claims for their additives

The media is full of reports today about new research on the benefits of breastfeeding when it comes to intelligence. Apparently a genetic link has been found, showing that 9 out of 10 children who are breastfed benefit from the impact of Long Chain Polyunsaturated Fatty Acids (LCPUFAs) in breastmilk.

Click here for a report in the Daily Mail.

This article states:

---

The findings appear in the journal Proceedings of the National Academy of Sciences. Professor Terrie Moffitt, based at the Institute of Psychiatry in London, said: "The argument about intelligence has been about nature versus nurture for at least a century. We're finding that nature and nurture work together.

"Our findings support the idea that the nutritional content of breast milk accounts for the differences seen in human IQ. But it's not a simple allornone connection: it depends to some extent on the genetic makeup of each infant."

---

It then considers additives made to formula:

---
In the last decade, many infant formula makers have started adding two Pufas [or LCPUFAs] - docosahexaenoic acid (DHA) and arachidonic acid (AA) to their products.

But the children taking part in the gene study were born in 1972-73 in New Zealand and 1994-95 in England, before fatty acid supplementation of infant formula began.

The jury is still out on whether Pufa supplementation has made a difference. However, in laboratory tests, animals given fatty acid supplements have performed better at learning, memory and problem-solving tests.

---

The respected Cochrane Library has conducted a review of studies on adding LCPUFAs to formula and concluded:

---
At present there is little evidence from randomised trials of LCPUFA supplementation to support the hypothesis that LCPUFA supplementation confers a benefit for visual or general development of term infants.
---

See:
http://boycottnestle.blogspot.com/2006/10/health-claims-goldmine.html

Companies have been claiming benefits from adding LCPUFAs to their products. At the turn of the year the UK Food Standards Agency told companies to stop doing so on labels of infant formula as they were in breach of the law. See:
http://boycottnestle.blogspot.com/2007/03/letters-that-took-12-years-to-write.html

In the Philippines, Nestlé has been promoting its Nestogen infant formula as containing 'Brain Building Blocks', something that is now illegal there following the Supreme Court rejection of an industry attempt to strike down Department of Health regulations. See:
http://www.babymilkaction.org/press/press10oct07.html

At the time when LCPUFAs were first being synthesized on industrial scale for adding to formula, in the additive Formulaid, market analysts Hambrecht & Quist strongly recommended investors buy shares in the producers, Martek Biosciences. They saw a goldmine.

This is what they said back in the 1990s about the additives Martek had come up with:

"The history of infant formula has shown that virtually all similar examples have led to wide-scale introduction of such additives into infant formula, even if there was no evidence that the additives were important. Infant formula is currently a commodity market with all products being almost identical and marketers competing intensely to differentiate their product. Even if Formulaid had no benefit we think that it would be widely incorporated into most formulas as a marketing tool and to allow companies to promote their formula as 'closest to human milk.'"

No doubt the industry will attempt to exploit the new findings on the benefit of breastfeeding to continue to suggest that their formula with LCPUFAs will confer similar benefits, though the indepedent review of the science finds no evidence to suggest ingredients in the different environment of formula have the same beneficial effect.

The Food Standards Agency is expected to reveal this week whether it will allow companies to continue to make idealizing claims about formula and to arget parents to promote their products. See:
http://boycottnestle.blogspot.com/2007/11/uk-under-pressure.html

On additives, the Baby Feeding Law Group takes the view that if an ingredient is necessary to reduce the health disadvantages of formula feeding, then it should be a requirement in all formulas, but the assessment must be based on an independent review of the science and much of this must be free from commercial influence. See the report: Protecting breastfeeding - Protecting babies fed on formula, available at:
http://www.babymilkaction.org/shop/publications01.html#bflgsubmission

Wednesday, October 31, 2007

Breastfeeding reduces cancer risks says expert report

"It's best for mothers to breastfeed exclusively for up to 6 months and then add other liquids and foods. Strong evidence shows that breastfeeding protects mothers against breast cancer and babies from excess weight gain."

That's one of the 10 recommendations in an expert report produced by the World Cancer Research Fund released today. See:

http://www.wcrf-uk.org/research_science/recommendations.lasso

Another cites the link between excess weight gain and cancer: "Be as lean as possible without becoming underweight. Convincing evidence shows that weight gain and obesity increases the risk of a number of cancers, including bowel and breast cancer."

As our poster on infant feeding and obesity notes, an artificially-fed infant consumes 30,000 more calories than a breastfed infant by 8 months - equivalent to 120 chocolate bars.

For a large version, with references to scientific studies, see:
http://www.babymilkaction.org/shop/posters.html#obesity

According to a Government survey, nine in ten mothers who gave up breastfeeding within six weeks said they would have preferred to breastfeed for longer, as did 40% of those who breastfed for at least 6 months. See page 211 Infant Feeding Survey 2005:
http://www.ic.nhs.uk/statistics-and-data-collections/health-and-lifestyles/infant-feeding/infant-feeding-survey-2005

We have issued a press release on how this report should give added impetus to empowering mothers to breastfeed, and, in particular, heed the advice of health experts as it revises the law on the marketing of infant formula and follow-on formula. See the report we prepared for the Baby Feeding Law Group, Protecting breastfeeding - Protecting babies fed on formula via the press release at:
http://www.babymilkaction.org/press/press31oct07.html

Wednesday, October 24, 2007

Learning from free lunches in Minnesota

A fascinating news story comes to my attention via the International Baby Food Action Network (IBFAN), which has a working group on industry sponsorship and its impact. By the simple process of limiting the amount of money pharmaceutical companies can spend on food for doctors, the authorities in Minnesota have changed the view doctors have of company representatives and the information they give and changed prescribing habits. The industry is fighting back by tageting nurses and secretaries however.

The story is reported in the New York Times (12 October 2007) and can be seen in its entirety at:
http://www.nytimes.com/2007/10/12/us/12gift.html

Two years ago a state official interpreted powers introduced in 1993 to forbid drug companies from spending more than US$50 per year on food or gifts for a doctor.

Now every health worker knows, or would claim, that they are not influenced by hospitality or gifts of any value, and, so they might say, only meet with company reps for the important product information they impart.

Except with the spending limits in place, drug companies found they could not get appointments with doctors and in some health facilities the doctors actually asked for a ban on the reps visiting.

The companies have suggested this is because doctors are busy people and only have time to meet at lunch time so providing food was to facilitate this. Yet if such meetings were the only way to obtain information then one would think that the health workers would find the time elsewhere or have the meeting anyway while munching on a sandwich. The fact is the information is available by through official channels where it will have been evaluated with competing drugs compared, not on the basis of how good the lunch was, but on their merits.

The New York Times reports that there is interest from legislators elsewhere to impose spending limits and it has conducted is own research on the impact of sponsorship:

---extract begins

The interest in legislation to register or limit the food, gifts and money that drug and device makers lavish on doctors stems from growing concerns that these benefits lead doctors to prescribe more, and more expensive, drugs and devices, raising the costs of health care and changing care to patients.

Few studies have shown that patients are harmed when their doctors accept gifts or money from drug makers, in part because data comparing the prescribing trends of doctors who accept money and gifts with those who do not have for years been available only to drug makers, not to the public.

In one of the few public analyses of the prescription patterns of doctors, The New York Times found that Minnesota psychiatrists who received money from makers of atypical antipsychotics tended to prescribe the drugs to children the most often despite the profound risks from these drugs.

---extract ends

The industry has tried to get around the restriction on promotion to doctors as the New York Times reports: "Food has not entirely disappeared from the marketing efforts of drug makers in Minnesota. The companies still rent out private dining rooms in restaurants and still hire influential doctors to deliver educational talks about drugs during dinner. But instead of doctors, the companies now invite nurses and secretaries to dine, drink and listen."

Doctors are paid to give the presentations and can earn substantial sums for doing so. As one doctor who has earned US$16,000 from such talks said in the article: "Maybe they’re trying to keep me loyal to those drugs."

We have included references to studies showing the impact of promotion to health workers in the report we produced for the Baby Feeding Law Group on the UK formula law consultation: Protecting breastfeeding - Protecting babies fed on formula, available at:

http://www.babymilkaction.org/shop/publications01.html#bflgsubmission

This also includes monitoring evidence of how the industry targets health workers in the UK.

Let us see if the UK authorities look to the experience of Minnesota and accept that a free lunch comes with strings attached.

Thursday, October 18, 2007

Will the UK Government deliver on its claimed commitment to tackling obesity through breastfeeding?

A new UK report was launched by the Government Office for Science this week. The report is called 'Tackling Obesities: Future Choices' and originates from what is called the 'Foresight programme'. It can be downloaded at:
http://www.foresight.gov.uk/Obesity/Obesity_final/Index.html

The report cites the role of breastfeeding in tackling the obesity epidemic (page 47):

---quote begins
There is evidence that the period soon after birth is a time of metabolic plasticity. Factors in the environment, such as nutrition, can have long-lasting consequences in that they appear to set the baby on a particular developmental trajectory. There is strong evidence, for instance, that low birth weight is associated with increased risks of heart disease and diabetes and, while there is less evidence of a direct link between birth weight and obesity, weight gain in early life appears to be critical. Some low-birth-weight babies may be especially susceptible to catch-up growth (that is, rapid weight gain), while others experience this as a direct consequence of their diet. Breast-fed babies show slower growth rates than formula-fed babies and this may contribute to the reduced risk of obesity later in life shown by breast-fed babies. Weaning practices are also thought to be important, given the association between the characteristic weight gain seen in early childhood at approximately five years of age (early adiposity rebound) and later obesity. Despite the uncertainties surrounding this evidence, and the need for additional research, the work suggests that early life is a critical period for healthy development.
---quote ends

The criteria checklist for an effective obesity strategy includes (page 130)

---quote begins
The intention to increase rates of breast-feeding:

• at an individual level includes support networks to help new mothers to breast-feed

• at a local level means positive breast-feeding policies at local hospitals and initiatives such as Sure Start to inform and educate mothers

• at a national level means regulation to give women the right to breast-feed in public places or to protect employment rights and maternity leave entitlements.
---quote ends

While these are amongst the 7 goals of the Breastfeeding Manifesto campaign we support, a fundamentally important one is missing: the protection of breastfeeding through the implementation of the International Code of Marketing of Breastmilk Substitutes and subsequent, relevant Resolutions of the World Health Assembly.

As the report we have submitted to a government consultation on revising the UK Infant Formula and Follow-on Formula Regulations shows, promoting breastfeeding has little impact if there is not protection. The UK formula industry advertising spend is already ten times that of breastfeeding promotion and the industry attempts to co-opt health workers to recommend its products through a range of strategies from idealizing claims to giving of gifts.

Companies encourage parents to look to them for information on infant care. You can see examples of the promotion in the submission report: "Protecting breastfeeding - Protecting babies fed on formula" which contains the legislative recommendations of the Baby Feeding Law Group, a broad coalition of UK health worker organisations and mother support groups. It is endorsed by the Breastfeeding Manifesto Coalition, which is an even broader group of organisations. See:
http://www.babymilkaction.org/shop/publications01.html#bflgsubmission

Government efforts to increase breastfeeding duration in the UK is failing - indeed rates have stayed still or even fallen in some regions, according to the latest Infant Feeding Survey. Contrast that with Brazil where median breastfeeding duration has increased from 3 months to 10 months.

The big question is will the Secretary of State for Health have the courage to heed the advice of health experts and implement the International Code and Resolutions? Or is he scared of pressure and a possible legal challenge by the baby food industry? If the Secretary, Mr. Alan Johnson, is feeling nervous he could gain courage from his counter part in the Philippines, Dr. Francisco T. Duque III.

In the Philippines, the Department of Health issued strong regulations last year and when challenged by the baby food industry fought a legal battle at the Supreme Court, which was won last week when the Court lifted the Temporary Restraining Order on the regulations.

Dr Duque stated: "By reinforcing the power of the DOH to more strongly regulate milk company sponsorships and advertisements and upholding the independence of the health community in scientific research and policy, the Supreme Court has shown the country’s sovereignty in protecting public health above the narrow trade interests"

See:
http://boycottnestle.blogspot.com/2007/10/philippines-health-trade.html

Mr. Johnson should also learn from the difficulties encountered by the Philippines attempting to address new aggressive marketing tactics through Department of Health Regulations rather than primary legislation. In two areas the Court ruled that the DoH would have to seek changes in primary legislation first.

It concerns us that the UK Food Standard Agency is apparently intending to rely on 'guidelines' published alongside the law to address some practices, rather than legislating. This approach could involve more legal challenges, expense and delay in the future than would showing courage now and introducing strong legislation as everyone whose focus is infant health is advising.

The UK Government claims to be commited to tackling the obesity epidemic. The Public Health Minister, Dawn Primarolo MP, has put her name to the preface of the 'Forsight programme' report, which states:

---extract begins
An unhealthy weight is often seen as a result of individual choice on diet, exercise and lifestyle. However, this report maps the complex web of societal and biological factors that have, in recent decades, exposed our inherent human vulnerability to weight gain. If we fail to tackle this ‘obesogenic environment’ the consequences for individuals, families, communities and society as a whole are grave.

We will therefore jointly be acting on the findings of this project, taking a system-wide approach with Ministers across Government and with professionals and policy makers on a local level. An Expert Panel, drawing on the breadth and depth of expertise that contributed to the report will help us with this. As the report demonstrates, there is no quick and easy solution to tackling obesity. However, we have the long-term commitment – and the learning now – to work together to create a 21st century society better in tune with our biology.
---extract ends

We will soon learn whether this stated commitment is genuine or not. Does the government really want to empower women to breastfeed? Remember 9 out of 10 mothers who stopped breastfeeding by 6 weeks said they wanted to breastfeed for longer, as did 40% who breastfed for at least 6 months. Or will it continue with its current failing approach of promotion without protection?

Will the government listen to expert advice on the Infant Formula and Follow-on Formula Regulations, including that of its own Scientific Advisory Committee on Nutrition, which has called for the legislation to be strengthened in several areas?

If it does not act on this advice it will not only show its commitment to public health is empty words, it will have failed another generation.

Friday, October 12, 2007

How was protection for infant health in the Philippines achieved?

This is a story with pictures about the ruling by the Philippines Supreme Court on the Department of Health's marketing regulations, as reported in our press release at:
http://www.babymilkaction.org/press/press10oct07.html

In lifting the Temporary Restraining Order on the regulations the Supreme Court said in its ruling:

"The Court and all parties are in agreement that the best nourishment for infant is mother's milk. There is nothing greater than for a mother to nurture her beloved child straight from her bosom. The ideal is, of course, for each and every Filipino child to enjoy the unequaled benefits of breastmilk. But how should this end be attained?"

So let us remember what it took to face down the greed and power of the baby food transnational who wanted the regulations to die for ever and called in the power of the US Chamber of Commerce to threaten the very economy of the Philippines if the President didn't join their cause.

The International Code of Marketing of Breastmilk Substitutes was adopted by the World Health Assembly in 1981 as a minimum requirement for all countries. Article 11.3 states that independently of any other measures to enforce the Code's provisions, companies should "ensure that their conduct at every level conforms to them."

People from the Philippines were campaigning to protect their babies and mothers from aggressive marketing even before the Code was introduced. Indeed, they were instrumental in achieving the Code. Dr. Navidad Clavano, then head of pediatrics at Bagaio Hospital in Luzon, Philippines, gave evidence to Senator Edward Kennedy's Senate Hearing into the baby food industry in 1978, which gave impetus to the calls for a marketing code. Dr. Clavano, who died this month, said: "Most of the health workers are aware of the havoc that bottle feeding creates.... In the Philippines it is common knowledge that we have a very high malnutrition and high infant death, and we have a lot of economic problems. You see mothers diluting their formula, because the basic salary of a Filipino father is only around - less than two dollars, and how much would a tin of feed cost? It costs more than what he earns."

Dr. Clavano encouraged mothers to breastfeed and those that did saw marked reduction in sickness and death in their children. You can find extracts from the presentations to the Senate Hearing and much more about the history of the campaign in our response to a shamefully inaccurate article by Chris Sidgewick et al published by the pseudo-scientific journal, the British Journal of Midwifery (whose peer reviewers do not even appear to have read the primary reference used by the authors who misquoted and misrepresented its data). See:
http://www.babymilkaction.org/resources/yqsanswered/yqanestle09.html

The introduction of the Code should have been enough. There should have been no Nestlé gifts to community health workers (photo from 2006):

No Wyeth events targeting parents (photo from 2007):

No Mead Johnson formula labels claiming IQ and eye development (current label):


But the industry had opposed the Code. Nestlé's Vice President, Ernest Saunders, saying prior to its adoption it was 'irrelevant' and 'unworkable'.

So it took campaigning to achieve the Milk Code implementing some of the Code's provisions in 1986 and to expose on-going aggressive marketing, an assault on the breastfeeding culture, including in 1989 the launch of a boycott against Nestlé and the other companies in the Philippines, coinciding with the re-launch of the Nestlé boycott in other countries.

The launch took place as members of the International Baby Food Action Network (IBFAN) from around the world gathered in Manila to celebrate the 10th anniversary of IBFAN’s formation and to discus progress and plan future strategy.


In 1996 IBFAN helped Dr. Imelda Ben travel from the Philippines to the Nestlé shareholder meeting in Switzerland to raise directly with the board of directors at the shareholder meeting the aggressive marketing taking place in the Philippines. The board did not want to know and dismissed the complaints. Having attended the shareholder meeting this year I can imagine how unpleasant shareholders made it for her as they boo anyone who criticises their beloved money-making machine. See:
http://boycottnestle.blogspot.com/2007/04/glimpse-of-nestls-soul.html

One of the tireless campaigners then and now is Ines Fernandez of the Philippines IBFAN group, ARUGAAN. I think I first worked with Ines soon after joining Baby Milk Action after she had appeared on television in the Philippines and spoken of the boycott. Nestlé then threatened the television with loss of advertising if it ran any more critical programmes. See:
http://www.babymilkaction.org/CEM/compsept97.html#2

On our March 1998, we exposed on our Campaign for Ethical Marketing action sheet Nestlé's strategy of promoting formula direct to mothers in the community with so-called 'Health Educators'. See:
http://www.babymilkaction.org/CEM/compmar98.html#1

Nestlé objected to our exposing this practice, which ended up causing a PR disaster for the company. It claimed in its 'Code Action Report' that our allegation was untrue, which gave us the opportunity to demand a right to reply in this publication which was distributed to policy makers around the world. Nestlé took legal advice and published my letter in its entirety - dressing it up as welcoming 'dialogue'. This is typical of Nestlé's mismanagement of the controversy - it's strategy of denials and deception results in greater attention being brought to our campaign and its malpractice.

The Code Action Report, which was launched as a monthly publication, became less and less frequent as Nestlé had to report other embarrassing news and run apologies. There hasn't been an issue for four years. See:
http://boycottnestle.blogspot.com/2006/10/searching-for-action.html

Monitoring conducted by IBFAN in the Philippines showed continued violations of the Code and subsequent, relevant Resolutions of the World Health Assembly, some of which were exposed in IBFAN's global Breaking the Rules monitoring reports.

This exposure and dedicated work by campaigners and health advocates in the Philippines led to the development of the Revised Implementing Rules and Regulations (RIRR) for the Milk Code by the Department of Health, which were introduced in July 2006 and almost immediately challenged by the pharmaceutical companies, a challenge which was almost completely rejected by the Supreme Court this week.

It would be nice to believe that the Supreme Court is independent and not subject to political pressure. We have to note, however, that the Court first rejected the industry's request for a Temporary Restraining Order on the RIRR. It was only after the President of the US Chamber of Commerce, Mr Thomas Donohue, warned President Arroyo of “the risk to the reputation of the Philippines as a stable and viable destination for investment” if she did not “re-examine this regulatory decision” that the Restraining Order was imposed - four days after Mr. Donohue's letter.

The industry has a history of not only opposing marketing regulations at the World Health Assembly, but country by country. There was a very real concern that pressure could influence the outcome of the hearing if it was not exposed.

Our IBFAN colleagues at a health conference in Sweden - the 'What next forum' - became aware of the US Chamber of Commerce letter and participants at the conference put their names to letter calling for restraint from the business community and an independent decision from the judiciary. See:
http://www.ibfan.org/site2005/Pages/article.php?art_id=434&iui=1

As sections of the media in the Philippines seemed reluctant to report on the case, perhaps fearing losing advertising revenues and recalling past threats from Nestlé, national and international events were organised. To remind us of some of them and other significant developments, here are some pictures and links.

Philippines groups Arugaan and Piglas ng Kababaihan called for mothers to attend a mass demonstration on 1 September 2006. Over a thousand turned out with decorated umbrellas. See the UNICEF press release and my earlier blog entry (which has more pictures).


Campaigners launched a national petition calling for the regulations to be implemented in October 2006.

My colleague Patti Rundall OBE (below, middle) and Elisabeth Sterken (left), Director of INFACT Canada, were able to visit the Philippines in November, travelling on from an international meeting on international baby food standards in Thailand. They gave many television, radio and newspaper interviews and spoke at a hearing in Congress. The story was now gaining increasing media coverage.


Back in the UK I launched our petition of solidarity with the Philippines. Hundreds of people and many organisations and networks around the world signed. We sent this to partners in the Philippines who passed it to the Secretary of State for Health and we presented it to the Embassy in London. See:
http://www.babymilkaction.org/press/press8dec06.html

From r-l: Right Rev. Simon Barrington-Ward (former Bishop of Coventry), Minister Leo Herrera-Lim, Patti Rundall OBE, Peter Greaves (retired Senior Nutritionist, UNICEF) and Embassy official.


Rather bizarrely, Nestlé Philippines wrote to us objecting to being included in the campaign as it was not party to the legal action by the pharmaceutical companies in the Philippines, and alleged the violations we reported were years out of date. This was untrue. For example, it's labels claiming 'brain building blocks' as ingredients were still on the market and it had been told by the authorities in the Philippines too that its gifts to community health workers were not permitted.

It later emerged that Nestlé also tried to have the UNICEF and WHO representatives in the Philippines removed from their posts for criticising aggressive marketing. See:
http://boycottnestle.blogspot.com/2007/07/nestle-war-philippines.html

Nestlé head office became involved in the correspondence, in the course of which the Global Public Affairs Manager admitted that Nestlé is 'widely boycotted', something the Chief Executive had tried to play down previously. See:
http://www.babymilkaction.org/press/press6july07.html

In December there was the shocking news of the assassination of Assistant Solicitor General Nestor J. Ballocillo who had been defending the Department of Health in the Supreme Court. He had worked on other high profile cases and no-one jumped to conclusions, but it understandably made our colleagues fearful. The Solicitor General said publicly the murder may have had something to do with the case. See:
http://boycottnestle.blogspot.com/2006/12/lawyer-defending-philippines-baby-food.html

And so the campaigning went on. With demonstrations outside the Supreme Court. See:
http://boycottnestle.blogspot.com/2007/02/misled-mothers-in-philippines-protest.html


Record-breaking mass breastfeeding events. See:
http://boycottnestle.blogspot.com/2007/05/philippines-mothers-go-for-mass.html


I took some of Nestlé's promotional materials along to our annual demonstration at Nestlé (UK) HQ in May 2007 to show how Nestlé targets health workers. See:
http://boycottnestle.blogspot.com/2007/05/exposing-nestl-malpractice-on-its.html


The case gained coverage in the UK media. See:
http://boycottnestle.blogspot.com/2007/06/wyeths-assault-on-law-and-logic-in.html
Even on Chinese television. See:
http://boycottnestle.blogspot.com/2007/07/china-tv.html

UNICEF Philippines produced its film Formula for Disaster, which can be ordered or viewed on line via:
http://www.babymilkaction.org/shop/videos.html#philippines

The crack down in the UK on health claims may have had an impact. The Supreme Court upheld the ban on these in the Philippines. This was a report of the UK action in the Manila Times:
http://boycottnestle.blogspot.com/2007/04/uk-sets-example-as-companies-remove.html

And, of course, the bare breasts demonstration outside the Supreme Court on the final day of hearings caught the interest of the tabloids in the Philippines. See:
http://boycottnestle.blogspot.com/2007/06/brave-breasts-protest-in-philippines.html

And now we have our victory. All points won bar an outright ban on advertising - advertisements have to go before a committee, which has the power to ban them - and the schedule of proposed fines.

Let's remember what was won. The Court found for the Department of Health on virtually all points:

* Coverage of products – scope including products for older children upheld

* Department of Health's right to issue regulations - upheld

* Labelling provisions - right to specify warnings and ban claims upheld

* Powers with regard to regulating advertising - upheld

* Company information for women distributed through the health care system – ban upheld

* Independence of research – requirement for ethical clearance upheld

* Independence in policy making – ban on company involvement upheld

* Donations from companies – prohibition upheld

For more details see:
http://www.babymilkaction.org/press/press10oct07.html

In its statement welcoming the ruling, WHO Philippines said:

"We congratulate the DOH for its commitment to the revised Implementing Rules and Regulations of the Milk Code. We are delighted that amidst the many challenges in the past two years to find resolve on this matter, the DOH, along with local and international breastfeeding advocates, like UNICEF Philippines, Save the Babies Coalition led by Arugaan, the World Breastfeeding Action Group (WABA), IBFAN Network, Baby Milk Action UK, La Leche League, and many others remained faithful in their role to protect Philippine children’s health and welfare."

The actions set out above were just a part of efforts of many people around the world.

There are two messages to take away from this.

If you have come to this campaign new and think that lives can be protected simply by sitting down with the companies and asking them nicely to change, then you are mistaken. Enforceable legislation is necessary. The malpractice should have stopped with the introduction of the International Code 26 years ago. As the experience of the Philippines shows, it takes concerted action by campaigners over years to hold these corporations to account. At any time they could have agreed to meet their obligations under Article 11.3 of the Code, but instead they continued to push their products, contributing to the unnecessary deaths and suffering in the Philippines. Remeber 16,000 infants die every year there because of inappropriate feeding. Efforts to promote breastfeeding are undermined by the companies.

They are still being undermined as I type this, because the companies do not stop just because the regulations are now in force. The regulations will need to be monitored and enforced. And the Philippines is just one of many countries where the same story is playing out.

The more positive message is that if you have supported this campaign in any way, in the Philippines, internationally or supporting our actions, then you share in this victory.

While there is still work to be done to enforce the regulations and achieve the outright ban on promotion, the situation in the Philippines is perhaps now more hopeful than at any point in the past 26 years or longer. We hope to see aggressive marketing stopped and breastfeeding rates to increase. Lives that would have ended with pitiful deaths from diarrhoea, dehydration and malnutrition will not be lost.

The Supreme Court said: "The ideal is, of course, for each and every Filipino child to enjoy the unequaled benefits of breastmilk. But how should this end be attained?"


In the pictures on this page you see part of the answer to that question.

Friday, September 21, 2007

How Gordon Brown could save billions of pounds by protecting mothers and babies

Gordon Brown could save the UK economy billions of pounds by showing political leadership in the area of infant feeding. That’s the indication from a study in the United States, UK Government surveys and other information. Yet this fact is ignored in the draft Regulatory Impact Assessment produced by the Food Standards Agency as part of the consultation on revising formula marketing regulations. We are calling for the FSA to do a few sums.

According to the UK Government’s national infant feeding survey (page 221), 90% of mothers who stopped breastfeeding by 6 months said they had wanted to breastfeed for longer. If obstacles were removed and better support given, then we could expect them to have their wish. Breastfeeding rates are higher in almost all European countries, markedly so in Scandinavia where the aggressive marketing of formula that occurs in the UK is absent. In Brazil breastfeeding rates have recovered from median duration of less than 3 months to ten months because of government action.

According to the UK Department of Health, breastfed infants are less likely to develop gastric, respiratory and urinary tract infections, obesity in later childhood, juvenile-onset insulin-dependent diabetes and atopic disease.

And as I have been hearing at the International Milk Bank Conference in Chester these past two days, premature infants receiving breastmilk (either from their mother or donor milk from a bank, should they be fortunate to have that opportunity in our current postcode lottery of coverage) are less likely to develop Necrotising Enterocolitis and less likely to die from it if they do develop it.

This reduction in illness and death equates not only to less suffering, but savings for the economy.

A paper cited by the UNICEF Baby Friendly Hospital training for policy makers (Powerpoint presentation) states the following:

---Extract begins
This preliminary analysis of breastfeeding and formula feeding indicates that a minimum of $3.6 billion would be saved if the prevalence of exclusive breastfeeding increased from current rates (64 percent in-hospital, 29 percent at 6 months) to those recommended by the Surgeon General (75 and 50 percent, respectively).

This figure reflects approximately $3.1 billion attributable to preventing premature deaths, and an additional $0.5 billion annual savings associated with reducing traditional medical expenditures (for example, office or hospital visits, laboratory tests, etc.) and indirect costs such as forgone earnings of parents, among others.

This figure probably underestimates the total savings likely. This figure represents only cost savings due to reduced costs to treat three childhood illness; it excludes the cost of purchases for over-the-counter medications for treatment of OM and gastroenteritis symptoms, physician charges related to the treatment of NEC, and cost savings due to reductions in long-term morbidity.
---extract ends

Ref: Weimer. The economic benefits of breastfeeding: A review and analysis, Food Assistance & Nutrition Research Report No. 13. Wash.D.C., USDA, 2001.

As it says, this is probably an underestimate because only the costs of treating three illnesses in the first year are considered. As infants who are not breastfed are more likely to be sick in the longer term, these treatment costs could also be reduced.

Another factor missing from the equation is the treatment costs due to companies not providing preparation instructions in line with Food Standards Agency and World Health Organisation guidance for parents. Powdered infant formula is not sterile, but only one company in the UK warns parents of this fact (Hipp) and it directly contradicts the expert advice on how to reduce the risks of possible contamination. If companies were forced to provide correct information to parents who use formula, as we are demanding, then there could be a reduction in illness attributable to intrinsic contamination of powdered formula with Enterobacter Sakazakii, Salmonella and other pathogens, which is worryingly common (Enterobacter Sakazakii contamination was found in 14% of tins in a survey referenced by the US Food and Drug Administration). Fortunately the steps required to reduce the risks are simple. Unfortunately the industry is loathe to say anything about the risks associated with formula feeding and so does not communicate this. See:
http://www.babymilkaction.org/press/press10aug07.html

If we scale the U$3.6 billion possible savings cited in the US study by the differences in population to gain a crude indication of possible savings for the UK, we arrive at a figure of £360 million for each year of breastfeeding rates at a higher level. A more accurate figure could be arrived at by comparing the assumptions in the paper with the UK situation.

Gordon Brown built his political reputation through being a ‘prudent’ Chancellor of Exchequer. Let us hope he will demand the Food Standards Agency conduct a proper cost-benefit analysis of bringing World Health Assembly marketing requirements into UK law so the enormous potential financial benefit is offset against any fears the government may have to spend a bit of money on lawyers to see off any challenge from the baby food industry wanting to continue aggressive marketing.

Tuesday, September 18, 2007

Infant feeding, type-1 diabetes and a patent for a new-improved formula

I wrote yesterday about the coming strategy of marketing infant formula with an insulin supplement as 'closer to breastmilk', with the claim it could reduce the higher incidence of diabetes in formula-fed infants. See:
http://boycottnestle.blogspot.com/2007/09/insulin-missing-from-formula.html

Infants who are not breastfed, for whatever reason, are at greater risk of short and long-term illness and we want to see those risks reduced. We have been working on this for years - as well as protecting breastfeeding - and recently launched a 'making formula safer' campaign to make it clearer that the regulations we want to see implemented and enforced are there to protect all mothers and babies.

Our main focus at the moment is on responding to a UK government consultation on proposed regulations for the marketing of formula. As they stand, these would allow companies to introduce new ingredients into formula and launch them onto the market without seeking any approval, without registering any evidence on the safety or need for the new ingredients, without any independent review of evidence and without an independent monitoring system for health workers and others to report concerns. All companies will have to do is present a model label of their new product to the Food Standards Agency. In theory they have to have studies that demonstrate the safety of the ingredients, but there is no requirement to present this or for the ingredients to be approved before being put on the market. You can help us achieve better controls by supporting our safer formula campaign and our work (why not become a member of Baby Milk Action?)

The forthcoming added-insulin formulas I wrote about yesterday have prompted me to do a little more digging for this blog.

The patent awarded to the company and Dr. Naim Shehadeh (who appeared in the media report cited yesterday) for the proposed formula is No. 6399090. You can find it here:
http://www.patentstorm.us/patents/6399090-fulltext.html

In presenting the possible benefits of the invention, this states: "exposure to bovine insulin present in fresh cow milk, which differs from human insulin only by three amino acids, may break the tolerance to insulin and lead to autoimmune diabetes."

Autoimmune diabetes or type-1 diabetes is also known as insulin-dependent diabetes mellitus (IDDM). This is where the pancreas is damaged and so cannot produce the insulin needed to control blood sugar levels. Damage may occur due to a virus or it can be because the immune system attacks the cells in the pancreas. This type of diabetes can affect children.

The other type of diabetes, type-2 or non insulin-dependent diabetes (NIDDM), is more common and is associated with adults and their lifestyles.

Both are on the increase. The annual conference of Diabetes UK earlier this year heard about a new study on the increase of type-1 diabetes, as reported by the BBC. See:
http://news.bbc.co.uk/1/hi/health/6455653.stm

---Extract begins
Lead researcher Professor Polly Bingley said the rate of childhood Type 1 diabetes was increasing all over Europe, particularly in the very young.

She said the increase was too steep to be put down to genetic factors alone.

"So it must be due to changes in our environment.

"This could either mean that we are being exposed to something new, or that we now have reduced exposure to something that was previously controlling our immune responses."

She suggested that fewer mums opting to breastfeed their babies might be a factor.

Another possibility is that children are being exposed to fewer germs, affecting the development of their immune systems.
---extract ends

Dr. Shehadeh's patent suggests that exposure to bovine insulin in cow's milk, the primary ingredient of most infant formula, may provoke an immune response in the child. In other words, the suggestion is the child's body sees the bovine insulin as an infection and produces antibodies to attack it. This reaction may prompt the immune system to go on to attack insulin-producing cells in the pancreas, so causing type-1 diabetes.

While the patent talks of fresh milk, the reference cited is actually for infant formula. I find this a little curious.

It is this study: Vaarala O, Paronen J, Otonkoski T, Akerblom H K. Cow milk feeding induces antibodies to insulin in children--A link between cow milk and Insulin-Dependent Diabetes Mellitus?. Scand J Immunol 47:131-135, 1998.

You can find it here:
http://www.ingentaconnect.com/content/bsc/sji/1998/00000047/00000002/art00008

It states:

---Extract begins
Exposure to cow milk (CM)-based formulas in early infancy has been associated with an increased risk of insulin-dependent diabetes mellitus (IDDM), but studies on the possible pathogenic mechanism(s) linking CM and IDDM are contradicting. We hypothesized that if CM formulas contained bovine insulin (BI), exposure to them could lead to immunization against insulin, which is the only known β-cell-specific autoantigen in IDDM.
---extract ends

They did find higher incidence of antibodies in infants fed on cow's milk formula than infants fed on hydrolised formula (where the protein has been broken down) or breastmilk.

They suggest: "The high incidence of insulin-binding antibodies in young children with IDDM may be explained by oral immunization to BI present in CM. Exposure to BI, which differs from HI only by three amino acids, may break the tolerance to insulin."

So the higher incidence of type-1 diabetes in formula-fed infants, and the increase in this in recent years (now affecting 20,000 school-age children, notes the BBC report) may have something to do with this reaction to bovine insulin in formula. Though, as the study says, the evidence on the mechanism has been contradicting.

Dr. Shehadeh has published a paper in which he proposes the mechanism by which insulin in breastmilk protects against type-1 diabetes. The reference is: Shehadeh N, Shamir R, Berant M, Etzioni A. Insulin in human milk and the prevention of type 1 diabetes. Pediatr Diabetes. 2001 Dec;2(4):175-7.

You can find it here:
http://www.ncbi.nlm.nih.gov/

This is the abstract:

---
Although controversial, exclusive breast milk feeding was shown to exert a protective effect in preventing type 1 diabetes. In contrast, an early introduction of cow's milk-based formula in young infants may enhance the risk of disease, especially in genetically susceptible children, presumably by an increase of intestinal permeability to macromolecules such as bovine serum albumin and beta-casein, which may arouse autoimmunity.

We have shown that human milk contains insulin in substantial concentrations, while insulin is barely detectable (if at all) in infant formulas. Orally administered insulin was demonstrated to promote gut maturation and to reduce intestinal permeability to macromolecules.

Furthermore, oral insulin may induce tolerance to insulin and protect against the development of type 1 diabetes. We herewith raise a hypothesis that human milk is protective against the development of type 1 diabetes by virtue of the effects of its substantial content of insulin.
---

So the study suggests that the relatively high levels of insulin in breastmilk help the development of the gut, so preventing substances entering the blood stream to provoke an immune response. And at the same time, exposure to the insulin in breastmilk may induce tolerance to insulin, rather than an immune response.

The patent is a little more definite in its claimed benefits:

---quote begins
Addition of insulin to infant formula leads for the following beneficial effects. First, it renders the infant formula more similar to human milk. Second, it protects from the development of Type-1 diabetes. Third, it improve the development and maturation of infants intestine. The addition of insulin to infant formula is safe for at least two reasons. First, the concentration of insulin is selected similar to that found in human milk. Second, oral insulin administration is already used in several human trials
---quote ends

As I wrote yesterday, expect 'closer to breastmilk' claims and the suggestion the formula helps prevent diabetes.

The proposed UK law would allow this product onto the market. All the company has to do is send a label to the Food Standards Agency. That's all. The authorities don't have to check the science or evaluate the safety of the product. A product that will be the sole food for a child in its most critical phase of development outside of the womb can be launched without prior authorisation.

It may well be that adding insulin will mean that formula-fed infants are less at risk - but it may put them at greater risk. While the patent covers the possibility of adding insulin with the same amino acid sequence as human insulin, it covers other possibilities too. If it is true that bovine insulin, which has only three amino acids different, can provoke an immune response, what of the synthetic insulin this patent allows for?

Though the patent glosses over the fact by referring to fresh cow's milk, the study cited to show that bovine insulin may provoke type-1 diabetes is for infant formula. Is it certain that added insulin will protect against the bovine insulin in the formula that carries it?

A few years ago Dr. Shehadeh responded to a study on giving insulin to premature infants published in the British Medical Journal. See:
http://fn.bmj.com/cgi/eletters/86/2/F131

He commented:

---Extract begins
We suggest to add human insulin to infant formulas in a concentration similar to insulin concentration present in human milk. This addition may lead to the following beneficial effects: It will make infant formula similar to human milk; it may fasten gut maturation; and it may protect from the development of type 1 diabetes.
---extract ends

The lead researcher, Robert J. Shulman M.D., responded:

---Quote begins
I am familiar with the work of Dr Shehadeh et al. There may indeed be a place for insulin in infant formula. However, before such a step is taken, I believe that it is imperative that appropriate prospective studies be done, including safety monitoring. Although our human pilot study and animal studies suggest there may be a benefical effect of oral insulin, much more work needs to be done and recommending its use now is, to my mind, not appropriate.
---quote ends

There needs to be more research, something the company plans to do. However, there are a whole host of ethical issues about how to do research on new-born infants and the role that companies wishing to bring a product to market should have in them.

I hope to return to this topic with more information on current thinking on whether adding insulin will reduce the health risks of formula feeding and the ethical concerns about research.

The more pressing task is working to ensure the UK law will only allow products onto the market with new ingredients if they are safe and necessary. You can support our campaign for safer formula at:
http://www.babymilkaction.org/action/saferformula.html

Monday, September 17, 2007

Missing from formula - will insulin be the next 'closer to breastmilk' claim?

There is a race that I have represented a few times when I have been invited to speak at health worker conferences. It is the race between formulas to appear the best. One says it is 'closer to breastmilk', another 'inspired by breastmilk', another 'closest to breastmilk'. They boast of ingredients for eye and brain development, building the immune system and so on. When I look at what the companies say I just end up confused as to who to believe. They can't all be better than their competitors, but that is what the pseudo science in their promotional materials suggests. See:
http://boycottnestle.blogspot.com/2007/08/best-infant-formula.html

In my representation of the race (which you can hear by clicking here), the different formulas are jostling for position, diverting attention from breastmilk, way out in front. Not only does breastmilk have many times the number of 'prebiotics' (oligosaccharides) than formulas that boast of them, they are those a child needs. Breastmilk has Long Chain Polyunsaturated Fatty Acids and, unlike those in formula, they do actually appear to benefit brain and eye development. While powdered infant formula is not sterile and may contain pathogens such as Enterobacter Sakazakii and Salmonella (requiring care in preparation), breastmilk is not sterile because it is a living substance containing anti-infective properties produced by the mother in response to infections in the environment. Breastmilk is like a dose of medicine every time the child is fed.

But that is not all. Breastmilk contains factor X. Something not yet identified, but is perhaps important for the benefits breastfed children gain. Then there is factor Y, which has been identified, but cannot yet be simulated in the laboratory or in a cost-effective way to add to formula. Then we have factor Z, which can be simulated and added to formula, but does not have the same effect in the different environment of formula. LCPs are one example, but there are others, such as iron. Formula has far higher levels of iron because most of it is not absorbed by the child from formula. Virtually all of the iron in breastmilk is absorbed.

So breastmilk is way out in front in the race, but all the shouting is being done by the companies with their products in the pack behind. Which is the best? Which is the closest? They want to keep the attention focused on that part of the race.

If breastfeeding is not an option, if expressed or donor milk is not available, if wet-nursing is not culturally acceptable or discounted for safety reasons, then formula is the next best option. It is a legitimate product and we are not saying it should be banned. But it should be seen as what it is. An artificial substitute for a natural substance. The aggressive marketing generates a different perception. It suggests formula is hot on the heels of breastmilk and we should be cheering for it. "Love the milk you give" is the slogan of one of the companies in the UK.

I can imagine a diabetic using artificial insulin may love the fact it is available if he or she cannot produce his or her own. But I wouldn't want to see artificial insulin promoted on television and in celebrity magazines with a 'love the insulin you give' slogan and pictures of happy people and cuddly toys. I wouldn't want company produced materials causing me to doubt if I am producing enough insulin myself, suggesting symptoms that could indicate my insulin isn't up to the job and suggesting a little insulin supplementation may be a good idea. I wouldn't want a vocal advertising war over which artificial insulin is 'the closest to real insulin'. Certainly, I'd be grateful if it was available if I needed it, but I'd rather have my own insulin production system well checked out and medical advice before deciding I did need it or which brand to use.

Insulin is very relevant to this topic, because it is a missing factor in formula according to a recent report. This is from Israel21c:

---Extract begins
In the first 24 hours of life, a nursing baby gets a big zing of power from its mother's milk. "This is a mother's first gift to her child," says Professor Naim Shehadeh, head of the Pediatric Diabetes Clinic at the Rambam Medical Center in Haifa, describing the nutrients and vitamins that mother's milk provides the newborn.

Especially insulin.

"Insulin is 100 times more concentrated in the first milk a mother gives her baby than in the blood. Nature must have a reason for enriching the first milk and helping the newborn get over the shock of the first 24 hours," explains Shehadeh, who specializes in pediatrics and endocrinology, and is also on the faculty of the Technion Institute Medical School.
---

Now get this:

Formula does not contain insulin.

Infants who are formula-fed are more likely to suffer from diabetes in later life.

These facts may be totally unconnected, but you can see they would make a great marketing campaign for a 'new improved' infant formula.

I've not looked into this thoroughly yet, but a microbiologist tells me that insulin-type growth factors in breastmilk are thought to be important for gut development and could be part of the reason why infants not fed breastmilk, particularly premature babies, are at greater risk of necrotising enterocolitis, an illness where the gut does not develop the blood vessels it needs, meaning the child cannot absorb food properly. NEC, as it is known, can be deadly, but it is a more immediate problem than diabetes.

All the same, the report goes on:

---quote begins
An expert in juvenile diabetes, Shehadeh and others observed the higher incidence of the disease among children who had not been breastfed.

"An alarm went off in my head," he told ISRAEL21c, and the first seed was planted for an idea for a formula for non-breast-fed babies that would come closer to the benefits of mother's milk - specifically the massive amounts of natural insulin found in mother's nectar.
---quote ends

So guess what may be just around the corner. Infant formula with insulin: "The result of that alarm is InsuMeal, a bioactive insulin protein that can be added to commercial infant formulas to make them closer to mother's milk."

Remember what market analysts Hambrecht and Quist said about Formulaid, the concoction of Long Chain Polyunsaturated Fatty Acids put on the market in the 1990s:

---Quote begins
The history of infant formula has shown that virtually all similar examples have led to wide-scale introduction of such additives into infant formula, even if there was no evidence that the additives were important. Infant formula is currently a commodity market with all products being almost identical and marketers competing intensely to differentiate their product. Even if Formulaid had no benefit we think that it would be widely incorporated into most formulas as a marketing tool and to allow companies to promote their formula as 'closest to human milk.'
---quote ends

Things could go the same way with InsuMeal.

There is a problem, however, as the article explains:

---Quote begins
"We looked on the market and we did not find any baby formula with insulin. It was lacking in all," said Shehadeh. "The reason insulin is not in formula, is because it is very sensitive to heat and mechanical stress, and usually destroyed in formulas. We developed a new technology to keep the insulin bioactive. We also have a usage patent."
---quote ends

You may recall that most companies are failing to warn parents that powdered infant formula is not sterile and the need for a high temperature step in reconstituting it to kill any pathogens. Some companies directly contradict the expert guidance to parents from the World Health Organisation. See:
http://boycottnestle.blogspot.com/2007/08/formula-guidance.html

We believe part of the reluctance is that new additives just around the corner, such as so-called probiotics and perhaps this insulin supplement, may be damaged by high temperatures. Perhaps the companies don't want parents to get used to using water above 70 deg. C to kill possible bacteria contamination because it would undermine their marketing claims about these new additives when they come if they would also be damaged.

There is a debate to be had over whether the benefits of new additives is greater than the risk from pathogens. For that there needs to be careful research.

Unfortunately, the proposed regulations currently out for consultation in the UK will allow companies to add new ingredients and launch new products onto the market without proving the safety or necessity of new ingredients.

In the government's proposals, companies simply have to submit a model of the label they plan to use to be held on file. That's it.

We are saying companies should submit research studies, much of it independently funded and conducted, and that these should be independently reviewed. If new ingredients are found to be safe and necessary for infant development, then they should be a legal requirement in all formulas.

For infants who are not breastfed, we are talking about the sole food during the most important phase of development outside the womb. Formula should be as good and as safe as possible.

You can support our campaign to make formula safer and sign up for updates at:
http://www.babymilkaction.org/action/saferformula.html

At the moment the claims around InsuMeal are hype, based on a study of 8 infants. The report continues:

---Quote begins
"We believe that InsuMeal is a vital nutritional supplement. When the results of the forthcoming clinical trials are published, and the health benefits demonstrated, we will need a manufacturing base ready to meet the demand," said Shehadeh. China and India - where formula growth has been particularly high - are expected to be big demand markets.
---quote ends

The global wholesale market for infant formula is valued at US$8.5 to 9.5 billion in the article.

So what have we learned?

These 'closer to breastmilk' formulas on the market are now revealed to be missing insulin, according to this report. Why wasn't that mentioned in the company promotions?

What about factors X, Y and Z.

We have also seen that jumps in logic are made without real basis. Breastmilk has insulin. Breastfed babies are less likely to suffer from diabetes. Ergo, alarm goes off and potential big demand is spotted. The trials to show safety and health benefits are still to be done and the company is seeking investors to pay for these and the marketing, creating a conflict of interest.

In the race between formulas to appear the best and closest to breastmilk, look out for a new slogans in the years to come.

"Love the insulin you give", perhaps.