women’s health update
Formula company flouts food safety boundaries This month New Zealand was treated to an interesting spectacle. Food safety warnings about artificial baby milk were followed by an aggressive counter attack from the industry with huge quarter page advertisements in the major dailies proclaiming: 10 million babies can’t be wrong. Breastfeeding advocate, Louise James, gives us some background to the current case and the issues it raises. In March, Women’s Health Action became aware that Nutricia was marketing a new product. Ads appearing in April’s Littlies magazine claimed that Karicare Toddler Gold Plus “provides better digestion, safer more regular stools and supported baby’s natural immune system” We felt this was misleading and Women’s Health Action made a complaint to the Advertising Standards Authority. The complaint was not upheld. Our concerns grew as over the ensuing months it was obvious that mothers who were using the new product were observing changes in their baby’s stools, which seemed very similar to diarrhoea. As Nutricia had advertised that it was ‘more like breastmilk’, the runny stools were not taken seriously and mothers were told that this was indeed more like a breastfed baby’s stools. Not one of the health professionals who had been approached by mothers forwarded the concerns onto the New Zealand Food Safety Authority (NZFSA). Some parents made direct contact with NZFSA and a competitor in the market also made a complaint. There is a risk assessment process for any new proposed ingredient in infant formula and this is well known to industry. Recently an application went through the appropriate channels for the addition of Medium Chain Triglycerides in infant formula. As part of the application process the public has the opportunity to make their concerns known,
Never let a chance go by! Industry takes every opportunity to advertise - a recent Parent and Child Show promotion. In Hamilton this year, one company secured the rights to naming the whole show but consumer opposition means this is unlikely to happen again. which Women’s Health Action generally does by making a submission. In this particular case the ingredient was allowed. Nutricia’s decision not to go through the safety assessment for fructo-oligosaccharides (FOS) and just add the ingredient anyway is incredibly arrogant and sets a potentially
vol 11 no 3 • August 2007
I n s i d e Drug, device and therapeutic products agency ‘on hold.’ ● HRT media rollercoaster leaves women confused AGAIN! ● Morning tea celebrates World Breastfeeding Week 2007 ● Noticeboard ●
dangerous precedent. The Infant Feeding Association of New Zealand (IFANZ) accurately states that it throws doubt on what other formula manufacturers may be doing without NZFSA approval and without telling the public. They have called on the NZFSA to “make a full safety assessment of all infant formulas sold in New Zealand to reassure the consumers who may be switching to another brand that unknown additives aren’t lurking in them as well!” (IFANZ Press Release 17/7/07) On Wednesday the 18th of July and for the following week, Nutricia placed an advertisement in New Zealand’s major newspapers saying “current discussions with the NZFSA regarding FOS are about how it is classified, and not about any safety issues.” This is in contrast to what the NZFSA say “FOS has not been subject to the required risk-based safety assessment for the purposes of permitting their addition to infant formula products for sale in New Zealand” continued on page 2
Women’s Health Update features women’s health news, policy and scientific findings, to enable health care professionals and community-based workers to be at the forefront in women’s health. Women’s Health Update is published by the Women’s Health Action Trust
2 • Women’s Health Update • vol 11 no 3 • August 2007 continued from page 1 (NZFSA Press Release 16/7/07). Not only has Nutricia not adhered to the correct processes to add a new ingredient they have also used their disclaimer as an opportunity to advertise their infant formula and seek support for their campaign. The Code of Marketing of Breastmilk Substitutes, an industry generated self-regulatory guidelines for advertising, contains Article 5.1 which states: “There should be no advertising or other form of promotion to the general public of products within the scope of this code.” So the current campaign runs very close to a breach of the Code. Nutricia defends FOS in the formula on the basis that it is an approved food ingredient. New Zealand has a large number of approved food ingredients but they are not all suitable for new babies and infants – which is the point of the approval process. When infant formula is the sole food source for infants under 6 months, there are very different food safety issues. Food forming part of a mixed adult or childhood diet in a mature or maturing immune system has a reduced impact. NZFSA’s stance is to be commended and Nutricia should adhere to the standards required in each country. Of course, this is an issue they have chosen to ignore in their current high profile advertising campaign. Instead they are falling back on the emotional catch cry common in the pharmaceutical industry today – New Zealand babies are missing out! And they invite people to email them to ‘register your support and help us fight for the rights of New Zealand babies.’ Feel free to use the same contact to register your outrage at their flouting of our food safety guidelines at careline@nutricia.co.nz Under the present law, NZFSA can not have the product withdrawn as there has to be proof of harm. Anecdotal evidence is very difficult to use in cases like this. What is needed is proof of harm verified by a doctors’ certificate. This can be passed onto the NZFSA to help them progress making formula’s in New Zealand as safe as they can be. You can call NZFSA on 0800 693 721 or visit their website for more information: http://www.nzfsa.govt.nz/.
Breastmilk is better, better, better, better by far! Mothers who are mixed feeding; breastmilk and formula may like to switch to all breastmilk, hints to increase milk supply include: • Contact a local La Leche League Leader for information and support – listed in phone book. • Encourage your baby to breastfeed frequently and for as long as he will. • Offer both breasts at each feeding. Allow baby to stay at the first breast as long as he is actively sucking and swallowing. Offer the second breast when baby slows down or stops. “Finish the first breast first,” is a good general rule. • Baby should end the feeding. She may do this by falling asleep and detaching from the breast after about 10 to 30 minutes of active sucking and swallowing. • Be sure baby is latched on and positioned correctly at the breast, that is, lips should be on the areola (the darker skin area), well behind the nipple. An LLL Leader can help fine-tune positioning as well as suggest ideas to ease soreness. Breastfeeding isn’t supposed to hurt. • A sleepy baby may benefit from “switch nursing” that is, switching breasts two or three times during each feeding. Switch breasts when baby’s sucking slows down and he swallows less often. • All of baby’s sucking should be at the breast. Limit or stop pacifier use while encouraging baby to nurse more effectively. If you are supplementing, even temporarily, you can give the supplement by spoon, cup, or with a nursing supplementer. Contact an LLL Leader for assistance in using these.
NZFSA Guidelines for parents: There is no cause for alarm. This information is being provided to help parents and caregivers make informed decisions about the care of their baby. For parents who wish to change formulas, NZFSA suggests that an alternative product be identified and a gradual change made. This could mean replacing one to two feeds a day over three to four days. It is important that infant diets are not changed suddenly as this can cause digestive upsets. If you have any concerns about the Karicare Gold Plus Infant and Follow-on formulas, or require assistance choosing a suitable alternative, you should contact your doctor or appropriate health professional.
Drug, device and therapeutic products agency ‘on hold.’ The planned Trans Tasman Agency for the regulation of therapeutic products has been put on hold after the failure of the government to get support for it in Parliament. In an announcement on July 16th this year, Minister King announced the postponement of the Therapeutics Products and Medicines Bill stating: “The Government does not have the numbers in Parliament to put in place a sensible, acceptable compromise that would satisfy all parties at this time.” She added that it would remain on the Order Paper to be revisited when sufficient parliamentary support is available. However, most people believe that the struggling legislation has received a death blow. There were two major points of difficulty with the proposed legislation. The first was the
perception by the complementary medicines industry that they would be ill served by the legislation. They organised a vigorous campaign to oppose it and received a major boost earlier this year when independent MP, Taito Phillip Field tipped the political numbers in their favour. The second major ‘bone of contention’ was direct-to-consumer advertising (DTCA) of drugs which is allowed in New Zealand but not Australia. Early hopes were that New Zealand would ban DTCA and leave the US as the only country in the world to countenance this form of advertising. In an attempt to keep the Agency alive, a number of political compromises had already been negotiated but last week proved that even these were not enough. Green MP Sue Kedgley described the postponement as ‘a victory for democracy’. Women’s Health Action supported the idea of
the Agency as, among other things, it offered the opportunity for the regulation of devices and consistency across the Tasman. We made a number of submissions on all aspects of the proposed legislation over the last seven years and represented consumers on the Advertising Committee for a short period. The Australian-based industry broadsheet ‘Pharma in Focus’ raises some interesting questions for us going forward: “It is not to be forgotten that the ANZTPA idea had potential to solve far more problems for NZ than it did for Australia, not the least of which is that as a small nation it has great and growing difficulties in funding a quality drug regulation system.” Consultation on a Medicines Strategy for New Zealand has begun. This development adds a new slant to the discussion and urgency to the debate.
Women’s Health Update
• vol 11 no 3 • August 2007 •3
HRT media rollercoaster leaves women confused AGAIN! History appears to be repeating itself as recent media reports on hormone replacement therapy veer between the reassuring and the alarming, reminiscent of the roller-coaster years before the Women’s Health Initiative (WHI) trial results of 2002. The WHI evidence of an increased risk for cardiovascular events and breast cancer in HRT users compared with placebo precipitated a dramatic decline in the fortunes of what had been the number one prescription drug in the world. But on April 5 the New Zealand Herald ran the headline Hormone replacement therapy found safer than thought after new analysis.1 New data from a secondary analysis of the WHI trial indicate that women aged 50 to 59 years using HRT for four or five years are not, as previously thought, at increased risk for heart attack. The 2002 WHI findings had revealed an increased risk for heart attack in all HRT users but the re-analysis confines the risk to women in the older (60+) age group.2 Much was made of this in the world media, with some menopause specialists quick to suggest that the new evidence means HRT is protective against heart attack in younger postmenopausal women, signalling a potential revival in its use. But far from indicating a u-turn on heart disease, Jacques Roussow who oversees the WHI study at the US National Institute of Health, maintains the original finding stands: HRT has not been shown to prevent heart disease. “There might be a slight reduction in the numbers getting heart disease in the younger age group” he says, “but the numbers were too small to be sure”. And, he adds, “the increased risk for stroke applies irrespective of age or years since menopause, as does the risk of breast cancer on combined hormones.”3 On April 20 the NZ Herald ran the story: HRT blamed for 1000 UK deaths.4 The Million Women Study in the UK has found that women on HRT for more than five years are more than 20 percent more likely to develop ovarian cancer than women not using HRT. This translates to one extra case of ovarian cancer in every 2,500 women who take HRT, and results in one additional death from ovarian cancer for every 3,300 women
using the hormones. HRT is believed to have caused 1,000 deaths in the UK from ovarian cancer between 1991 and 2005.5 Also on April 20 came good news. Breast cancer incidence continues to decline in the US. Data published in the New England Journal of Medicine from 2004 reveals that some 30,000 fewer women (8.7%) developed breast cancer in the US in 2003 and 2004 the lowest rate since 1987 - attributed by the authors to the more than 50 percent decline in HRT use since the WHI results of 2002. Of note, estrogen receptor positive tumours, those most likely to be affected by HRT use have declined by 14.7 percent.6 Breast cancer statistics for New Zealand are not yet available, although the NZ Herald’s Dec 20 2006 article Breast cancer drop linked to fall in use of HRT quotes national screening unit’s Breast Screen Aotearoa, Dr Madeleine Wall as saying that NZ’s breast cancer rate fell 6 per cent in 2003.7 In June, efforts to promote hormones for heart health were fuelled by yet another analysis of the WHI trial. New results showed that women in the study aged 50-59 who were taking oestrogen for seven years or more were less likely to have high amounts of calcium in their arteries than women not taking oestrogen. 8 It is currently not known whether high levels of calcium in the arteries are a risk factor for heart disease in women. The authors of the study caution that the new evidence should not be interpreted to mean that women should take oestrogen to protect their hearts, and stress that more research is needed to evaluate its effects in younger women. Importantly, the new evidence relates to oestrogen only, used only by women who have had a hysterectomy . Oestrogen alone is associated with an increased risk for strokes, blood clots, dementia, and ovarian and endometrial cancer. Women can be forgiven for feeling confused again about whether or not to take HRT. But there remain very real risks associated with its use, even for women who start taking the hormones in their 50s. In addition, the new evidence shows that cardiovascular risk increases progressively beyond 60 years, and
older women with moderate or severe hot flushes are particularly at risk for coronary events. Jacques Roussow, quoted in a recent Guardian article, has the final word for now when he calculates the effect on the lives of the vast numbers of women who stopped taking HRT after 2002: “The WHI findings have probably prevented tens of thousands of strokes, heart attacks, blood clots, and breast cancers in the US population alone.” 9 The recommendation remains that HRT be used only for the treatment of severe menopause-related hot flushes in the lowest dose for the shortest time possible. Women should look for safe alternatives for management of menopausal hot flushes, and if they decide that HRT is necessary, should not stay on it as they get older. 1 http://www.nzherald.co.nz/section/story.cfm?c_ id=204&objectid=10432685&pnum=2 2 Rossouw JE, Prentice RL, Manson JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause JAMA. 2007;297:1465-1477 3 http://www.guardian.co.uk/women/ story/0,,2096356,00.html 4 Laurence, Jeremy. HRT blamed for 1000 UK deaths. NZ Herald Friday April 20, 2007 5 Ovarian cancer and hormone replacement therapy in the Million Women Study. The Lancet published online April 19, 2007 DOI:10.1016/ S0140-6736(07)60534-0. 6 Ravdin M, Cronin KA, Howlander N, Berg CD, Chlebowski RT, Feuer EJ, Edwards BK, Berry DA. The Decrease in Breast Cancer Incidence in 2003 in the United States. NEJM. Vol. 356, No.16. April 19, 2007 7 Johnston, Martin. Breast cancer drop linked to fall in use of HRT NZ Herald. Wednesday December 20, 2006 8 Estrogen Therapy and Coronary-Artery Calcification.” Manson, J E et al. the WHI and WHI-CACS Investigators” N Engl J Med 356:2591-2602, June 21, 2007, Number 25. 9 http://www.guardian.co.uk/women/ story/0,,2096356,00.html
Morning tea celebrates World Breastfeeding Week 2007 One morning tea is all it takes to show your support for breastfeeding mothers as you join “The most women in synchronized breastfeeding around the world,” This initiative by Children for Breastfeeding and Nurturers of the Earth, in the Philippines, is a first attempt at a new Guinness World Record. Every time zone around the globe will count breastfeeders at the same local time, 10am Wednesday the 8th of August , for a period of 24 hours. The attempt kicks off in New Zealand, the country closest to the date line, with every other country following our lead. It ends in Samoa at their local time of 10am and at our (New Zealand) local time at 9am Thursday - 23 hours later. Women’s Health Action is looking for record breaking individuals and organisations to commit to one morning tea break this year on Wednesday August 8th and join us in this global record. We are looking for breastfeeding mothers to register any venue wherever they are going to be on Wednesday and invite others along to join them. There are over 60 registered venues already and it is not too late to join. One participant has registered a venue in flight! To see the registered venues list: http://www.womens-health.org.nz/breastfeed/ bfweek2007.htm Three simple steps are all you need to be part of the action: 1. Register with Women’s Health Action to receive your starter pack (http://www.womens-health.org.nz/breastfeed/breastfeedingform. htm) 2. Advertise your venue through your networks (posters will be provided in the pack).
3. Welcome breastfeeding mothers and children on Wednesday the 8th of August for morning tea, count & text numbers to organiser. Venues can be private or public – e.g. staff room, home, café, library, playgroup, hall etc and open or closed. A venue organiser from last year said: “What a huge success the big latch on was. We were wrapped with our number and it was a real buzz. Every one had a great time and everything went well.” For more information contact Louise James (09) 520 5295 louise@womens-health.org.nz Read more about World Breastfeeding Week 2007: http://www.womens-health.org.nz/breastfeed/bfweek2007.htm
Wednesday August 8th 2007 The big worldwide ‘latch on’ at 10am
Noticeboard ●
World Breastfeeding Week
1 – 8 August 2007 Women breastfeeding all over New Zealand and the world will celebrate World Breastfeeding Week with the international big latch on event on the 8th of August. See www.womens-health.org.nz/breastfeeding.htm or contact Louise James at Women’s Health Action (09 520 5295) for how you can be involved.
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WHA Annual Cartwright Anniversary event
Judge Patrick Mahony and Katharine Greig Thursday 9th August, 12 – 2pm Ferndale House, 830 New North Rd, Mt Albert $25 (includes lunch) Truth and reconciliation in the twilight zone: the story of a confidential forum for former Psychiatric Hospital inpatients. Contact Women’s Health Action to register for attendance.
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3rd Biennial Joan Donley Midwifery Research Forum
Does current midwifery research provide evidence to challenge medicalisation of the normal? 7th – 8th September Bayview, Wairakei Resort, Taupo, New Zealand. For further information see www.midwife.org.nz or contact the New Zealand College of Midwives National Office on 03 377 2732, jdmrc@nzcom.org.nz Registrations close 3rd August 2007.
● Women’s Health Action Suffrage Day Breakfast
19 September, 2007 7am Langford Hotel, Symonds St, Auckland City Join WHA to celebrate the anniversary of women’s right to vote in New Zealand. Speaker Denise Ritchie will discuss images of women in New Zealand’s sports media. Complete with excerpts from popular sports chat shows such as Sport’s Café and Game of two halves this promises to be an entertaining and interesting topic! For further information or to register contact WHA.
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Biennial Homebirth Conference
Te Ahuru Mowai - Nurturing the Numinous (in the presence of the divine) 27th – 28th September, 2007 Conference registration $175 (before 10 August) or $195 (late registration). Te Puna O Te Matauranga Marae, Raumanga Valley Rd, Otaika, Whangarei The conference will be followed by the Homebirth Aotearoa Hui on 30th September at the same venue. For further information contact Whangarei Homebirth Support Group: janecunningham@slingshot.co.nz, 09 459 5266 or visit www.homebirth.org.nz/events/conference07. pdf
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Ladies Litera-Tea
An afternoon of women’s words for New Zealand Book Month, Sponsored by The Women’s Bookshop 1pm – 5.15pm, Sunday 9th September, 2007 St Columba centre, 40 Vermont St, Ponsonby $45 includes afternoon tea. For more information see www.womensbookshop.co.nz
Women’s Health Update is produced by Women’s Health Action Trust • Edited by Jo Fitzpatrick To receive copies of Women’s Health Update, make suggestions about future contents or send items for publication please contact: Women’s Health Action Trust • PO Box 9947, Newmarket, Auckland, New Zealand • 2nd Floor, 27 Gillies Avenue • Ph (09) 520 5295 • Fax (09) 520 5731 • email: info@womens-health.org.nz Internet address: http://www.womens-health.org.nz • Women’s Health Update is published with the assistance of the Ministry of Health