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Health Watch December 2006
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Women's Health Watch

edited by Jo Fitzpatrick/Kristen Berger

 

Selected articles from Women's Health Watch newsletter in December 2006

Contents

Happily ever after with Herceptin

Wonder drug Herceptin is the new knight in shining armour in the breast cancer drug armoury. But do women with breast cancer need only meet and make a date with him to live happily ever after......?
Sadly, like so many fairy tales, this one is a bit of a fantasy. Real life is a lot messier. Roche, the drug company, would like you to believe that every woman with breast cancer could live happily ever after if only they could get Herceptin. They must be delighted with recent developments for indeed many people will tell you that young women bedevilled with breast cancer are battling to gain access to this drug so that they may live.
We think that most breast cancer patients are young because it is young women who get the media attention. In fact the majority are older women. In 2002, the latest year for which figures are available, only 16% of newly diagnosed women in New Zealand were under 40 and most (60%) were over 50. Around one in four were between 40 and 501. An ideal breast cancer patient for media stardom is young and balding a clear sign of a heroic battle weary warrior. She should also be raising children as this further justifies her salvation giving her so much more to live for. If she is raising her children alone, this is icing on the cake. Who will condemn her innocent children, already abandoned by their father, to a future without their loved and loving mother. The dynamic at work here is one where drug companies pedal hope to vulnerable women.
It is difficult to get any rational debate against this background. These ‘media-women’, while not typical breast cancer sufferers, are real women with real children facing an endgame that is horribly real. Only the truly heartless could deny them a drug to save their lives. We want them to live and so we are persuaded that Herceptin is the drug that will do this for them.
It is much the same process that has many of them believing that they will be saved by Herceptin. If you are deserving and want it so badly, if you have so much to live for and are absolutely determined to do so, then statistics are meaningless. The only way forward is to believe that you are the one for whom this drug will work. It has to be you and this absolute commitment to living blinds you to the bigger picture.
The not so bleak bigger picture for breast cancer
Breast cancer is the most common cancer among New Zealand women. One in ten New Zealand women will get breast cancer. For most women, this is frightening. For individual women, the news that they have breast cancer is shocking. Our ignorance of he condition and its consequences mean that our immediate reaction is to see breast cancer as a death sentence.
It is not an entirely negative bigger picture. For every 100 New Zealand women with a diagnosis of breast cancer, ninety five will be alive a year later, and eighty three will be alive five years later. Most with an initial diagnosis of early breast cancer will be among the survivors. Early breast cancer is curable and there are more women living with breast cancer than dying from it. These figures get better as time goes by and this is a trend which will continue. The report on the 2002 figures states ‘While breast cancer is the leading cause of death for females (19.8 per 100,000 age standardised population) in 2002, it had a comparatively low fatality/case ratio of 0.26.’ In 2002, the mortality rate for breast cancer in New Zealand was 20% lower than in 19952. The dramatic drops in breast cancer rates recently observed in the US, and thought to be linked to the drop in HRT use, will accelerate the drop in these figures3.
The many mutations of breast cancer
Not all breast cancers are the same. More women with a diagnosis of ductal carcinoma in situ (DCIS) will be survivors. DCIS is cancer which starts as abnormal cells in the milk ducts. They often remain there but sometimes spread into surrounding tissue. There will be fewer survivors amongst those with a diagnosis of HER-2 positive breast cancer. HER-2 is a gene which controls cell growth and women with the HER-2 gene have cancers which are more aggressive – they grow faster and are more likely to spread. Herceptin is designed to treat HER-2 breast cancer, which affects 15 to 25% of women with breast cancer, by directly targeting the HER-2 gene. See Table
In June 2006 a US breast cancer specialist predicted that new drugs would be developed which would eliminate HER2-positive breast cancer within 10 years. The competition to find drugs to treat early breast cancer is heating up amongst the drug companies. GSK, subsidises one of their drug for early breast cancer (Arimidex) and advertises it directly to patients while they lobby for it to be fully funded. They also have another drug in the pipeline – Tykerb – which promises to be a direct competitor for Herceptin. The international push for Herceptin is an attempt to get this drug established before better and cheaper drugs supplant it. Newer, cheaper and better drugs are on the horizon. This is good news for women.
The Herceptin debate in New Zealand
The news that Women’s Health Action supported Pharmac’s decision not to fund Herceptin for early stage breast cancer was shocking for many women. This was not a position we came to lightly. As a women’s health organisation, we have been following the Herceptin debate and collecting the evidence for some time. We have also watched lobbying for the drug and the Pharmac decision came as a surprise. Too often, we have seen heartbreaking personal stories make headlines knowing that the evidence base did not support them. We have watched as policymakers bow to public pressure. We did not think Herceptin would be any different.
So, why do we support Pharmac? Simply, there are too many unanswered questions. The drug is experimental with debates over the best treatment regimes still under
discussion and investigation. Treatment times range from nine weeks on the drug to two years. Given the cost of the drug and its side effects, this has implications for both the funding of the drug and its clinical use. Pharmac has the nine week trial under active review.
Herceptin has other costs as well. Added expenses include hospital care when the drug is administered and the need to monitor women for heart conditions. Herceptin increases the risk of heart failure and the studies are unclear on whether around 30% of women who suffered heart problems caused by the drug in the early trials are included in the final data sets. This can seriously skew the results. The media doesn’t give us information about the fact that there is only a small number of patients who benefit from Herceptin, the lack of long term toxicity data and the fact that heart problems are common.
If only Herceptin cured every women who was given it there would be no debate. The unfortunate truth is that HER2-positive breast cancer remains difficult to treat even with pharmaceutical advances such as Herceptin. For every one hundred women with HER-2 breast cancer, 78 will be alive and disease free two years later. With Herceptin, this number rises to 86 so around eight women in every hundred on the drug will benefit4. The studies have not been going long enough to establish whether these treatment effects persist in the long term, cut recurrence rates and decrease deaths. However, because we don’t know which eight women will benefit, all one hundred women must be given the drug with its $70,000 price tag, its 60% increase in the cancer drug budget and its potential for heart damage. Herceptin is expensive and while Roche is prepared to put $100,000 into free testing to identify HER2 –positive breast cancer women, they will not lower the price of the drug.
In October 2006, Pharmac’s clinical advisory committee (PTAC) once again reviewed Herceptin for use in early breast cancer and decided not to fund it. The reason they gave was the ‘continuing uncertainties raised by clinical trials.’ Pharmac’s deputy Medical Director, Dr Dilky Rasiah stated ‘This is a difficult, but responsible recommendation. When funding medicines, we need to be confident that the evidence supports the investment over other medicines Pharmac is evaluating. This is particularly important when investments are very large such as with Herceptin (around $20-$25 million per year). At the moment, the evidence does not provide us with that confidence.5”
Latest data on Herceptin
There is no doubt Herceptin benefits some women - it has demonstrated a reduction in breast cancer recurrence which is statistically significant and in one study has shown a 4.8% survival benefit at four years. New studies show that after three years women being treated with Herceptin are one third less likely to relapse than those on standard therapy and their risk of dying is cut by a third.
All women in this study were on other forms of chemotherapy for their cancer and the results throw some light on the heart complications. Women also on Adriamycin were five times more likely to develop heart failure and were twice as likely to lose some heart function. Some of these women also developed leukemia – which didn’t happen for any of the women who were not receiving Adriamycin. Chief researcher Dennis Slamon says the findings are significant enough to change treatment regimes “We should move Adriamycin out of this setting and reserve it for women whose cancer has spread if they have run out of other options.6”
On these results, 100 women must be given Herceptin for four years so that five or six of them may benefit.
International perspectives on Herceptin
Herceptin for treatment of early breast cancer is controversial all around the world. However, many other countries have made decisions to fund it. Dr Dilky Rasaih
acknowledges this and explains the key reasons for the difference as:

  • A stronger emphasis by PTAC and Pharmac on the uncertainty of clinical evidence given the cost;
  • The drugs cost-effectiveness compared to other drugs; and
  • Taking into account the practical implications for health services of administering the medicine.

In Britain and Australia, there have been clinical approvals for Herceptin in the treatment of early breast cancer, but questions have been raised about the funding impact of this decision. In these countries, the clinical decisions are separated from funding decisions. In a recent BMJ
article, clinicians from Norfolk and Norwich University Hospital discuss the problems this raises for them: :
“In the case of Herceptin, high profile patients, media bias, industry support, and political gaming put considerable pressure on the NHS to offer this drug for early stage breast cancer.”
They argue that the sum of 1.9 million pounds would enable them to treat 75 patients with Herceptin, but at four times the cost of treatments for other cancers. They point out these other treatments ‘have been proved to be clinically effective and their estimated cost-effectiveness is far greater than that currently expected for Herceptin. The cost of giving adjuvant Herceptin is double that of all the palliative treatments. So we could fund Herceptin if we did not treat 355 patients receiving adjuvant treatment (16 of whom would be cured) or 208 patients receiving palliative chemotherapy, and if we found half a million pounds from another source. These untreated patients will be people we know. We will be the ones to tell them they are not getting a treatment that has been proved to be effective, which costs relatively little, because it is not the ‘treatment of the moment.”’
NICE, the body which has approved Herceptin for use in early breast cancer, does not have any responsibility for funding the drug on the frontline. This must change, say the Norfolk and Norwich clinicians: “This organisation must be given responsibility to decide what should be cut … or the ability to allocate extra funds for implementation (or both). Without these changes, Herceptin will not be the last controversial case of ‘rationing by media.’”7
Have your say: funding high cost medicines
In an ideal world, cost would be irrelevant and clinical considerations alone would guide all our treatment decisions. However, we live in the real world and as the British example demonstrates, there is no fairy tale ending. Decisions we make on one drug impact on our ability to provide others and this is particularly true if the medicine is ‘high cost.’ In New Zealand high costs drugs are classified as those which cost more than $20,000 per patient a year. Pharmac has called for public submissions on the way it funds high cost medicines and chief executive, Matt Brougham acknowledges that the debate on whether to review the way decisions are made on high cost drugs was fuelled by the controversy over Herceptin. He says it is impossible to know whether Herceptin would now be funded, if it had been assessed according to special high cost drug criteria. ‘It wasn’t proven that the assessment process disadvantaged high cost medicines by treating them the same as low cost drugs. What is clear is that under any system where you’ve got a budget and you’ve got to make choices, at the end of the day it’s going to lead to some unpopular decisions being made.’
The comprehensive discussion paper makes interesting reading and is a useful background to the way Pharmac makes decisions. It also
explores the many issues this raises. This is not an easy or comfortable discussion but it is a crucial one and we urge you to engage with it. The paper is available at : www.pharmac.govt.nz. Submissions are due on March 5th and Pharmac hopes to have completed its review by mid-20078.

For more information on Herceptin and WHA, see ‘The Hype over Herceptin’
References
1NZHIS. 2006. Cancer:New Registrations and Deaths 2002. See: http://www.nzhis.govt.nz/publications/cancer.html
2 Ibid
3San Antonio Breast Cancer Symposium News: Decline in Breast Cancer Diagnoses Follows Decline in Hormone Therapy Use, Recent Data Confirms. See: http://www.prnewswire.com/cgi-bin/micro_stories.pl?ACCT=638741&TICK=SABCS&STORY=/www/story/12-14-2006/0004491633&EDATE=Dec+14,+2006
4 Romond, EH at al (2005) Trastuzumab pluds adjuvant chemotherapy for HER-2 positive breast cancer. New England Journal of Medicine. 353 (16) 1673-84
Piccart-Gebhart, MJ et al (2005) Trasuzumab after adjuvant chemotherapy in HER-2 positive breast cancer. NEMJ 353 (16) 1659-72
5 http://www.pharmac.govt.nz/pdf/161006.pdf
6 Laino, C. 2006. Taxane Plus Trastuzumab Better for the Heart Than Anthracycline Regimens: Presented at SABCS : http://www.docguide.com/news/ content.nsf/news/85257102 0057CCF6852572490074710B
7Barrett et al; (2006). How much will Herceptin really cost? BMJ 2006;333:1118-1120 (25 November), doi:10.1136/bmj.39008.624051.BE
8 See: http://www.pharmac.govt.nz/highcostmeds.asp

Table 1

  No in study arm Mortality (%) % alive at 4 years Relapse (%)

Standard treatment (Adriamycin)

 1073 7.5 86 17.9

Standard treatment and Herceptin*

 1074 4.6 92 11.9

Herceptin ttmt with no Adriamycin)

 1075 5.2 91 13.2

* Women in this arm were five times more likely to develop heart failure.

 

Breast Cancer trials in NZ
Details of clinical trial for new drugs can be found at: http://www.clinicaltrials.gov – a website which also has useful information for people who may want to be part of any trials.
Currently there are six breast cancer studies listed on the website. A study looking at different combination chemotherapy regimes after surgery is in progress at Auckland, Christchurch, Dunedin, Palmerston North and Waikato hospitals. Contacts for the lead researchers are supplied.
A comparison trial of letrozole and anatrozole for post-menopausal women with hormone receptor and node positive breast cancer is recruiting in Auckland and Hamilton
The role of new drug Tykerb in treating patients with newly diagnosed inflammatory breast cancer is part of a GSK sponsored clinical trial.
For more information on current clinical trials in New Zealand, see: http://www.clinicaltrials.gov/ct/action/GetStudy. Type in the condition and New Zealand.

The Menopause Industry Fights Back

The menopause industry is alive and well and appears to be recovering from the major setback resulting from the publication of the risks associated with the use of HRT (Hormone Replacement Therapy) in 2002.
At the end of September members of the Australasian Menopause Society gathered in Wellington for their 10th Annual conference, “A cultural change – health beyond the menopause.” The conference began by exploring issues around sexuality and sex after 50 in particular. Other issues on the agenda were breast and other cancers, healthy life from womb to tomb, post-menopausal bone health and life after WHI. What was even more interesting were the unacknowledged agenda items that included discrediting the Women’s Health Initiative study findings, and promoting new hormones/drugs to manage women’s sexuality.
Lynda Williams looks at issues raised by a radio NZ interview of one of the conference presenters.
Life after WHI
The Women’s Health Initiative (WHI) study caused immense damage to the menopause industry which had been reaping the benefits of promoting HRT to women as the elixir of youth and the cure to a growing list of menopause symptoms for several decades. The WHI is the largest and most comprehensive study of post-menopausal women’s health ever conducted in the USA. The 15-year project involved 161,808 women aged 50-79 and results from the clinical trials replaced conventional “wisdom” about women’s health with evidence-based research findings, revealing that the risks outweighed the benefits and women had been badly misinformed about HRT.
However it wasn’t long before the pharmaceutical industry – dismayed at the rapid drop in sales of their wonder drugs – and the health professionals who had jumped on the bandwagon and set up menopause clinics peddling these drugs to menopausal women, began to fight back. Among other strategies they began casting doubt on the findings of the WHI.
On Friday 22 September Professor Susan Davies, one of the Australian presenters at the conference went on National Radio to talk about menopause and sex after 50.
During the interview the talk inevitably turned to the role of hormones in sexual functioning and the decline in hormonal activity that occurs with age. The male
hormone testosterone is now getting a makeover and women are now being fed a line about the need for testosterone and its importance as a hormone essential for sexual functioning. Unfortunately for women – but potentially very fortuitous for the pharmaceutical industry – levels of both testosterone and its precursor or parent hormone DHEA decline from the early 20s. Professor Davies described how testosterone levels in 40 year old women are only 50% of what they are in women in their early 20s, and how DHEA levels also drop steeply with age so that by the time women are in their 70s they have less than one third of the levels of DHEA they had in their 20s. She admitted that there have been no large or long-term studies on DHEA so there is no safety data on this hormone. In fact there is no data to even suggest that DHEA improves quality of life. But rest assured they are looking!
Professor Davies is part of a team undertaking research into this hormone. They are currently recruiting postmenopausal women in Melbourne for a large study and according to Ms Davies women are volunteering in droves. If the levels of DHEA start declining in women in their early 20s, just think how much money could be made by getting women on DHEA pills before they hit 30! Why, the mere thought is enough to bring on a hot flush!
DHEA
Dehydroepiandrosterone or DHEA is a steroid hormone which is easily converted into other hormones, especially testosterone and oestrogen. Production peaks in the mid-20s when DHEA is the most abundant hormone in circulation. From then on there is a steady decline in DHEA production, so the average 75-year-old has only 20% of the DHEA in circulation that he or she had 50 years earlier. At all ages, men tend to have higher DHEA levels than women.
For a number of years DHEA supplements were marketed and sold as an aid for weight loss. In the late 1980s the American Food and Drug Administration ordered companies to stop selling DHEA and classified it as an unapproved new drug, obtainable only by prescription. Then in 1994 DHEA was
reclassified as a dietary supplement which allowed sales over the counter. It then became extremely popular among athletes partly as a result of marketing which referred to DHEA as a “hormonal superstar” that rejuvenates the body, upgrades overall energy, and promotes faster recovery from physical stress. There is little evidence that DHEA actually does any of these things.
In the mid 1990s a group of researchers led by Dr Yen conducted a number of studies on DHEA. In one study eight men and eight women aged 50 to 65 took either 100mg of DHEA or an identical placebo pill each night for three months. For three months after that they took the opposite pill. Within two weeks of starting DHEA, circulating levels of the hormone were a bit higher than normally found in young adults. Lean body mass increased slightly in both sexes as did muscle strength which also improved with the placebo. Fat body mass decreased in men but increased a bit in women. An earlier study from Dr Yen’s group had showed that three months of daily 50-milligram doses of DHEA significantly improved the sense of “well-being,” but did not improve sex drive as advertisements for DHEA often claimed.
Dr Yen, professor of reproductive medicine at the University of California, is one of a number of researchers in the field who have raised concerns about the hype
surrounding this hormone and urged extreme caution in the use of “a drug we know very little about.”
Much of the popular and scientific interest in DHEA stems from our culture’s emphasis on youthfulness, sex, and preventing or reversing the sign of aging. If levels of this hormone decline with age, then the thinking is that maybe we could prevent or reduce the health problems that accompany aging by keeping DHEA levels high. Taking a potent steroid hormone that we know little about has the potential for far-reaching side effects throughout the body. As researchers like
Professor Susan Davies have admitted, there are no proven benefits of taking DHEA. There are, however, some potentially serious risks and some of the side effects of the drug may be irreversible.
Since DHEA is converted into testosterone some women who take it grow body or facial hair and if they are pre-menopausal can stop menstruating. Some studies have shown that DHEA decreases levels of HDL or “good” cholesterol in women and could increase the risk of heart disease. In men, the increased levels of testosterone resulting from daily DHEA pills could stimulate the growth of a tiny prostate tumour that would otherwise have remained dormant. Excess testosterone could also cause the prostate to enlarge, making urination difficult.
Of course, the risks associated with DHEA could take a decade or two to become evident. Hence the need for long-term studies that last more than a few years. Whether the pharmaceutical industry is willing to wait that long is another mater.
Discrediting WHI
After touting the potential wonders of testosterone and DHEA the conversation with Professor Davies turned to the discrediting of the results of the WHI study. Despite there being no evidence to back up her claims she stated repeatedly that the results of the WHI study were published precipitously and the authors were now not standing by their published results.
She said the WHI papers were not critiqued properly by the reviewers before they went to press because it “was a massive multi-million dollar investment of government money” and the researchers were under pressure to get the results out. “Because this came from such a massive, massive machine, the reviewers just didn’t pick it to pieces, and a lot of it got published with a level of critique that was much lower than you’d get for the average paper.” She went on to say that “People have subsequently gone back and looked at it and are saying it isn’t as bad as we thought.”
Furthermore she claimed “the data has been very misconstrued” and “there is absolutely still no evidence that the use of HRT around the time of menopause increases the risk of heart disease.” In fact “the authors were now coming out at academic meetings across America saying “in retrospect that it’s not quite like that.”
Well, of course there are excellent websites devoted to the research results on the Women’s Health Initiative – www.whi.org/ for WHI participants and the government website www.nhlbi.nih.gov/whi/ - which do not back up any of Professor Davies’ claims. Results are published regularly on the many facets of the WHI study. I guess it just depends on which “massive machine” you are part of.
Then came the marketing spiel for the testosterone patch which has yet to be approved for use in either Australia or New Zealand. Her final comment: “Women have the right to therapeutic options.” Yeah, right!

Violence Against Women

As the headlines become swamped with more harrowing tales of violence across all aspects of society it appears that we have lost the focus on violence against women. Father’s rights groups grab attention by blaring music, honking horns, protesting against judges and tell us that they are the victims.
Meanwhile the policy discussion has shifted from domestic violence to family violence taking in an even greater array of violence issues including child and elder abuse. Television and media focus attention on the women who lash out in violence. Violence against women is no longer seen as an
issue of power and control but is framed in the discourse of relationships. Fixing the relationship will also fix the violence. It’s time to refocus on the violence perpetrated against women.
Are women no longer victims?
The data shows that women are still overwhelmingly the victims in situations of violence. More than 90% of applicants for protection orders under the Domestic Violence Act 1995 are women and most respondents are men. A recent survey of 2674 ever-partnered New Zealand women revealed that 33-39% have experienced physical and/or sexual violence from their male partner in their life-time. A third of New Zealand men admitted to using at least one form of violence against their female partner at some time in their lifetime. This is supported by overseas data such as the extensive US National Violence Against Women Survey which found that women reported significantly more intimate partner violence than men. Twenty-five percent of women had experienced rape and/or physical assault during their lifetime as contrasted with 8% of men.
Personally and anecdotally those involved in all aspect of the domestic violence field know this to be true. Judge Peter Boshier, principal family court judge, noted that “family court judges know that violence is first of all perpetrated by men against women”. The level of violence between partners is stark, it is most often women who are killed. The critical incidents’ reporting that comes through the courts overwhelmingly shows that more severe violence is performed at the hands of men. About half of all murders in New Zealand are domestically related.
Public Perceptions
Relying on media reporting alone however you may question men’s violence. The media seems to feel the need to mention at every turn that women are capable of being violent towards men. Although we have no doubt that this may occur and that all forms of violence should be condemned, it shifts the dynamic of the debate and makes it more difficult for a woman to receive the protection she needs.
In recent local press coverage of the International Day for the Elimination of Violence Against Women (White ribbon day) almost all of the coverage came with the caveat that ‘top health researchers accused the Families Commission of “being ideologically driven”. This included a full article on David Fergusson and Richie Poulton’s accusations. It appears nearly impossible to mention violence against women without being accused of bias. In the end of 2005 and beginning of 2006 a sharp dialogue erupted in the New Zealand Medical Journal over Janice Giles examination on research claiming women’s violence is equivalent to men’s, prompting a series of replies to the journal.
Ferguson and Richie cowed Families Commission chief executive Paul Curry to back down from his statement on White Ribbon Day in 2005 that “almost all family violence is carried out by men on women and children”. His office now says he made a mistake and they have limited the statement by drawing attention simply to the fact that the worst domestic violence is perpetrated by men. It is absolutely shameful if we are not allowed to state the obvious.
The rise of fathers rights groups
Part of the public pressure that diminished the focus on violence against women comes from men’s rights or fathers’ rights groups. Groups such as Jim Bagnall’s Union of Concerned Fathers protest outside of the courts and conferences and turn up at judges homes hounding them and harassing their families to respect ‘father’s rights’. Anne Morris of the University of Adelaide quite rightly points out that these tactics reflect the tyrannical behaviour that many of these same men are accused of domestically. Charlotte Cummings, wife of a family barrister who had the protesters at her house earlier this year commented that they behave like playground bullies. The success of this bullying behaviour is sobering. If an individual’s response to accusations of threatening or harming their partner is to immediately threaten and harass those responsible in the courts it should tell us quite a lot about their modus operandi.
In an attempt to influence court outcomes men have been encouraged to affix blue dots (small stickers) onto all of their court documents so that everyone handling them is aware that they are members of the Union of Concerned Fathers. The September 2001 MENZ newsletter says: “We urge all fathers filing anything with the Family Court to place a blue dot on each page which signals that you are not alone and that you are working with others and the court’s handling of your case will be observed.”
Internationally fathers’ rights movements have been successful in capturing media attention through dramatic stunts such as the UK’s Father’s 4 Justice who dress as superheroes and climb prominent sites like Buckingham Palace. The father’s rights movement often accuse the courts and the media of bias in favour of women. The harassment of members of the family court has become a common occurrence in New Zealand. In November Ina Kara-France was charged with assault after spraying the protesters at her home with a hose and throwing rocks at them. In press release she said “you left me hugging my sons, and they me, in shock, fear, tears and disbelief. You all have no idea how much pain and ruin the above mentioned had impacted on our lives”
Impact on the courts
Wendy Davis, a family lawyer, has examined the influence of fathers’ rights groups on the Family Court. She contends that these groups have exerted undue influence with frequently unfounded claims. Davis observes that between 1998 and 2004 it became increasingly difficult for women to obtain protection orders without notice. This reflects the increased pressure and presence of father rights groups since the turn of the millennium. Despite the argument that women use the family courts as a way to extract revenge, Davis notes that very few applications for protection orders fail because of lack of credibility. The claim that large numbers of fathers are being denied access to their children is completely inaccurate. Loss of access after protection orders are generally temporary and very few completely suspend access.
In 2003 the Law Commission suggested that the threshold for the provision of temporary protection orders be raised from ‘harm’ and ‘undue hardship’ to involve ‘substantial harm’ and further that protection orders be put on notice ‘whenever possible’. Davis raises concern that this may result in fewer applications for protection orders. The number of without notice applications which were changed to proceed on notice doubled from 12% to 24% between 1998 and 2001.
In Towns and Scott’s research participants noted the increased influence of fathers’ rights groups on the courts. One men’s programme provider commented “I would say that the kind of men’s rights movement has influenced the judiciary, how they look at the orders”. In their interviews with key informants Towns and Scott find that women requesting protection orders are positioned differently then in the past. The request for a protection order is an issue of safety. However, in response to the discourse that has depicted these women as simply vindictive, consideration of protection orders now examines the woman’s motivation.
Much of the slippage in women’s access to protection has been in the shift in discourse from one of power and control to the discussion of relationships. The changing attitude toward protection orders is one by which men have argued that the key issue is the break down of a relationship rather than the abuse of power within that relationship.
In a presentation to the Taking Action to Overcome Violence Conference, Peter Bosher expounded on the benefits of Family Group Conferences. These are meetings that include the perpetrator, the victim and the family or community members thought to be able to influence them. Presumably this would work because the family or community exert peer pressure or shame the perpetrator into better behaviour. Heather Henare, of the National Collective of Independent Women’s Refuges, quickly responded to this idea saying that such a meeting serves to further victimise the woman. Putting
violence in the context of relationship ‘difficulties’, takes the focus off the issues of power,
control and violence against women. Too often, it introduces unrelated issues such as the mother’s parenting or domestic abilities.
Where to now
The focus must be brought back to gendered nature of this violence. If we fail to recognise the dynamics of power behind domestic violence we have little chance of addressing the root causes and turning the tide on the 63,000 domestic violence incidents recorded in New Zealand a year.

FDA allows silicone breast implants


In what US congresswoman Rosa DeLauro has called “another example of the FDA dismissing scientific evidence in order to appease corporate interests” the US Food and Drug Administration has approved two brands of silicone breast implants. This overturns a 14-year ban on the use of silicone gel breast implants.
The change in regulation comes after a long struggle between manufactures and regulators. Silicone breast implants were introduced in the western world in the 1960s and by the late 1980s there was increasing recognition of the health hazards posed by these devices. By 1992 the FDA had called for a moratorium on silicone implants and in 1994 the first of many class action lawsuits against manufactures was settled. New Zealand still does not regulate medical devices; therefore silicone implants have remained available here while they were banned around the world. Since 2004 legislation has required that sponsors notify Medsafe (the NZ regulatory agency) when importing silicone breast implants but it does not control their use.
FDA approval is sending a powerful message internationally that these devices are safe, however the numerous caveats placed on their use and approval indicates that even the FDA is dubious about their safety (See box). Public Citizen, a US based consumer advocacy group says ‘the approval makes a mockery of the legal standard that requires “reasonable assurance of safety.” Public Citizen claims that silicone breast implants are ‘the most defective device ever approved by the FDA’.
Risks
The recent approval comes despite the fact that many lingering questions remain about the safety of silicone implants. Potential risks with silicone implants include: hardening of the breast, leakage, implant rupture, scarring and fibromyalgia (similar to chronic fatigue syndrome). Additional questions remain on the impact of implants on breast feeding and potential birth defects, as well the implants impact on mammography. The FDA recognises all of these potential risks (See box) and believes that placing a warning and recommending monitoring for implant recipients is enough to keep the public safe. Amy Allina, of the National Women’s Health Network points out that requiring women to have regular MRI examinations ‘assumes that women can avoid suffering any ill effects caused by silicone leaking into the body by removing implants after they have ruptured. We just don’t know if that is true.’
Women’s Health Action feels that warnings and ongoing monitoring are hardly enough for a product for which we still do not have clear safety data. The manufacturers have submitted their studies to date to the FDA for approval. These studies have only been conducted for a limited time and therefore long term data is still not available. It is premature for the FDA to approve the product whilst still requiring that current studies continue for 10 years. Perhaps, after they had that 10 year data the regulatory agencies may look at approving the device and there is the fact that silicone breast implants have been in use outside the US and the opportunities for studies have hardly been lacking.
Additional questions have been raised about the veracity of these industry sponsored studies. A scientist working for Mentor (one of the two manufactures to gain approval) wrote a public letter in June to the FDA accusing the company of fraudulently representing the data and leaving out crucial contrary findings. The FDA responded that Mentor had included all of the requested information and no investigation proceeded.
In New Zealand Medsafe spokesperson Stewart Jessamine said that there is insufficient data to ban these implants in NZ but that the agency still stands by its 1994 statement the “the use of breast implants is not endorsed by the New Zealand Government, whether through the Ministry of Health, or otherwise, and the safety of such implants cannot be confirmed or refuted”
In the best interests of women
Daniel Schultz, director of FDA’s centre for devices and radiological health heralded the decision to approve the silicone implants as in the best interests of women. This rather curious conclusion seems to be totally unsupported. How can access to a device with so many unanswered questions be in the ‘best interest of women’? It is estimated that the silicone implants will sell for about $600 each in the U.S and the manufactures anticipate an increase in worldwide sales of about $100 million next year alone. This would suggest that this is a decision in the best interest of the makers of breast implants rather than the women who receive them. It is in the best interest of women to protect the public from products that carry so much potential danger and trade on so much false hope. Both the FDA and Medsafe should halt the sale of silicone implants until they can be sure that the products are not dangerous. That would be in the best interest of women.

It is extremely unusual to read of product approval from the FDA that comes with so many requirements and caveats. Generally a drug, or device is approved or banned with a listing of possible side effects, complications and contraindications. Silicone breast implants, however, have been approved with many requirements around them. We thought it was helpful to simply reprint some of what the FDA has to say.

Potential complications noted include:

  • Hardening of area around implant
  • Breast pain
  • Changes in nipple sensation
  • Implant rupture and need for additional surgery

Information to be provided to women considering silicone breast implants include the warning that ‘breast implants are not lifetime devices and a women will likely need additional surgery at least once over her lifetime’
All women who receive silicone breast implants will need ongoing monitoring to check for ‘silent rupture’. Women are urged to have their first MRI three years after initial implant and the every two years thereafter. If an implant rupture is noted on the MRI, the implant should be removed and replaced, if needed. It is noted that ‘the cost of MRI screening over a women’s lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance’

Conditions of approval:

  • Each company required to run large post approval study
    • These studies are to gather information about the safety and effectiveness of implants. Information to include rates of complications, rates of connective tissue disease, rates of neurological disease, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference with mammography, MRI compliance and rupture rates.
  • Continue its core study through 10 years
  • Conduct a focus group study of patient labelling
  • Continue laboratory studies to further characterize types of device failure
  • Track each implant in the event that health professionals and patients need to be notified of updated information.

National Women’s Health Annual Report 2005

National Women’s released its Annual Clinical Report for 2005 in September and held the customary public seminar examining the information contained in the report on 22 September 2006. This is the thirteenth report in the current series. Lynda Williams has written the following summary for us.
The 232-page report contains a wealth of statistical information on the 7178 women who gave birth at NWH in 2005 and the 7368 babies they gave birth to and the 16 women who gave birth before they actually got to the delivery unit. This is a further drop in the numbers from 2004 when 7471 mothers gave birth to 7659 babies. In 2005 there were 184 sets of twins (188 in 2004) and 3 sets of triplets (there were no triplets in 2004).
Normal births
The intervention rates have continued to rise with a corresponding drop in the numbers of normal births. The percentage of normal births fell from 54.4% in 2004 to 53.4% in 2005 – down from 59.4% in 2000.
Only 40% of first-time mothers had a normal birth, compared to 44% in 2004.
In terms of ethnicity, 48.4% of mothers were European, 7.6% were Maori, 13.6% were Pacific, 10.7% were Chinese, 7.6% were Indian, and 5% as other Asian.
There were two maternal deaths in 2005. One death was associated with hyperemesis during pregnancy and the other with an
amniotic fluid embolism during the birth.
The majority of the women (69%) who birthed at NWH lived in Auckland Central, 15% of women were from the Counties Manukau DHB region, and 14% of women lived in the Waitemata DHB region.
Multiple births
The percentage of babies born in a multiple pregnancy has remained much the same for the past 10 years, and represents approximately 5% of the babies born at NWH.
Out of the total of 377 babies born in a multiple pregnancy 17 died. Of the 69 twin pregnancies (out of the total of 184) that reached term, 26 were delivered by elective caesarean or prior to the onset of labour. Only 13% went into spontaneous labour.
Fifty-five of the 115 pre-term births were delivered by elective caesarean section. In total 60% of all twin pregnancies were delivered by caesarean section. In 2000 41% of twin pregnancies resulted in a spontaneous vaginal birth/vaginal breech birth of both twins. This figure dropped to 28% in 2004 and 29% in 2005, probably as a result of a flawed but at the time widely accepted study on breech births published in the Lancet in 2000. The NWH report notes that there is currently no good evidence that caesarean section is necessary or beneficial for twin pregnancy per se.
31.6% caesarean section rate
In 2005 the caesarean section rate was 31.6%, up from 29.3% in 2004 and 26.6% in 2000. There was little difference between the caesarean section rate for first-time mothers (33.4%) and for mothers having subsequent births (29.8%), and is an increase of around 2% over the rate for 2004.
The reason given for emergency caesareans for first-time mothers with babies at term was failure to progress in 55% of cases, and foetal distress in 27% of cases; the reason given for elective caesareans was malpresentation in 38% of cases and maternal request in 25% of cases. This either represents a dramatic increase in the number of mothers requesting a caesarean (in 2004 the report stated that 61 women (6%) requested and got a caesarean), or it reflects a greater level of honesty about the practice of caesareans being available on demand.
The most common indication for caesarean section overall is failure to progress (28%), followed by repeat caesarean section (18.5%), foetal distress (16.9%), and malpresentation (11.9%).
Repeat caesareans (of the elective variety) accounted for 65% of the women having a subsequent baby (compared to 43% in 2004 and 30% in 2000).
Low VBAC rate
The report also reveals that at 24.9% the rate of vaginal births after a previous caesarean section (VBAC) remains low. Among women with one prior caesarean birth who go into labour spontaneously, more than 50% achieved a vaginal birth. The report states “These data challenge whether National Women’s actively supports vaginal birth after caesarean section.”
Induction of labour
The rate of induction of labour has remained fairly stable over the past decade and was 26.3% in 2005. “Post dates” is the most common reason (26%) given for induction at term, followed by hypertension (15%) and PROM or premature rupture of membranes (12%). Maternal request was the fifth most commonly cited reason (131 inductions – 8%) with a marked increase in the incidence of maternal request for induction in women over the age of 35.
Induction of labour increased from 21% of mothers under 21 years of age to 40% of women over 40, while spontaneous onset of labour dropped from 77% to 27% in these age groups. Induction of labour is also associated with maternity care provided by private obstetricians.
For first-time mothers an induction of labour results in an emergency caesarean section rate of 35% compared to 21% in those who go into labour spontaneously. The caesarean section rate among women having subsequent births is also higher following an induction (16%) compared to 12% of those who spontaneously went into labour.
Inductions and epidurals
Epidural rates were consistently higher among induced labours (73%) than among spontaneous labours (49.9%) for all indications and is irrespective of parity.
The rate of forceps and ventouse deliveries (combined under the term “operative vaginal deliveries”) was 14.2% in 2005, down from 15.6% in 2004. 23% of first-time mothers had their baby with the aid of forceps or ventouse compared with 5.8% of mothers having subsequent babies.
Epidurals
The epidural rate has risen slightly from 62.3% of all women in 2005 compared to 61% in 2004. Almost 70% of first-time mothers had an epidural in compared to 42.8% of mothers having a subsequent baby.
Postpartum Haemorrhage
Postpartum haemorrhage (PPH) remains a cause for considerable concern and is associated with the increasing caesarean section rate. PPH has risen over the past decade from 21% in 1995 to 35.1% in 2005.
Postpartum Hysterectomy
In 2005 five women had an emergency postpartum hysterectomy compared to four women in 2004. Hysterectomies following birth are usually associated with repeat caesarean sections.
Length of Postnatal Stay
Postnatal care for women having their baby at National Women’s is now provided either at the hospital or at Birthcare which is a privately owned facility. This arrangement is the result of a contract set up with Birthcare in 2003. During the antenatal period women are informed that if there are no complications they will be expected to transfer to Birthcare for their postnatal care. In 2005 32.7% of women transferred to Birthcare after giving birth at National Women’s compared to 29.9% in 2004. 59.6% went to National Women’s Wards and 7% went straight home.
In 2005 the average length of stay at National Women’s for the 27.8% of mothers who went home after a spontaneous vaginal birth was 2 days (compared to 2.46 days in 2004), 2.8 days for mothers who went home after an operative vaginal birth (compared to 3 days in 2004), and 4.3 days for mothers going home following a caesarean section (compared to 4.7 days in 2005).
Breastfeeding
In 2005 63.9% of mothers were discharged from National Women’s exclusively breastfeeding their babies which represents a 10% increase over the past two years. The report notes that “the trend towards a reduction in artificial feeding has continued with only 3.8% of mothers artificially feeding on
discharge in 2005.”
Copies of the 2005 Annual Report can be obtained from Marjet Pot at National Women’s Health, Auckland City Hospital. Email: marjetp@adhb.govt.nz

Pregnancy police close in on women’s rights in the U.S.

pre-expectingIn a frighteningly Orwellian world women are being treated as baby machines as governments step in to regulate what a woman can do with her body1. This obsession with controlling women’s bodies is reflective of the conservative Christian discourse of family and a focus on the ostensible reason for women’s existence- reproduction. In the overwhelming focus on the baby’s health, the health of the mother is being subsumed for that of her child. This dangerous precedent allows third parties to decide what is best for both mother and child. Women are being punished for behaviours that are not considered criminal for other members of society.
U.S federal law passed the Unborn Victims of Violence Act in 2004 arguing that foetuses are separate persons under the law with rights independent of the pregnant woman. This law allowed an important exception for abortion but also extends court jurisdiction to any aspect of a pregnant women’s behaviour that might risk fetal health.
Women have been arrested in at least nine U.S. states for issues as diverse as

  • child abuse (before the child was even born),
  • endangering a fetus by not getting to the hospital quickly enough,
  • murder for refusing a caesarean section,
  • conviction as drug dealers to the unborn (via their umbilical cord)!

One woman has been prosecuted with the misdemeanour of contributing to the delinquency of a minor after her healthy baby allegedly tested positive for
marijuana.
Arkansas proposed making it an offence for a pregnant woman to smoke even a single cigarette. South Carolina prosecutors have said that ‘even if a legal substance is used, if we can determine you are medically responsible for a child’s demise, we will file charges’. This may mean that a woman who ‘allows’ herself to be abused or miss prenatal care appointments may be vulnerable if something goes wrong in the pregnancy.
In 2005 a Maryland women was arrested while pregnant after failing a drug test. The judge decided sending her to jail was in the best interest of the foetus’s health. Despite being in labour for several hours and pleading for help, her son was born alone in a dirty jail cell. Shortly after the birth the boy developed an infection due to these unsanitary conditions2.
Where does it end?
The US department of health and human services put out recommendations in April for all women of childbearing age to consider themselves pre-pregnant and to take steps to ensure the health of their potential offspring. This unsurprisingly caused a huge stir. If all women are considered pre-pregnant where does jurisdiction over what a women may do with her body end? Will we have separate laws that apply to men and women? Unsurprisingly, these recommendations do not extend to the role of pre-fertilisers. Perhaps the U.S. could make it illegal for women to smoke, drink, eat fatty foods and have pet cats. Better yet lets dig down to what is
really going on here and just tell women to roll over now and get back barefoot and pregnant to the kitchen where they belong.
In the past women have been kept out of certain workplaces and some forms of employment because it was argued that this presents potential dangers to the unborn fetus. Through the millennia women’s role has been proscribed and controlled by the expressed ‘need to protect’. There are obvious questions to be asked about what is in fact in women’s best interest and what motivates the desire to dictate limitations on women’s freedom.
References
1 Taylor, D (2006) The pregnancy police are watching you. The Guardian 4 September http://www.guardian.co.uk/g2/story/0,,1864180,00.html
http://www.womensenews.org/article.cfm?aid=2894
2 Payne, J.W. (2006) Forever Pregnant Washington Post 16 May. http://www.washingtonpost.com/wp-dyn/content/article/2006/05/15/AR2006051500875.html

New technology steps around the ‘Right to Life’ debate

The stem cell debate around the world has been dominated by the right to life argument, which is primarily concerned with the destruction of embryos as a form of human life. New technologies are being developed to try to access stem cells whilst stepping around the debate about the destruction of human embryos. Although these address the most publicly controversial issues around stem cell research, they still ignore the fact that all of these techniques will require the donation of women’s eggs. See WHA’s discussion of women and stem cell research in WHW, Issue 70: June 2006.
There have been a couple of approaches to this issue. The first was the idea of ‘altered nuclear transfer’- where one gene is removed before the cell is fused with the egg. This ensures that the embryo only lives a short time, just long enough to produce stem cells. This rather dubious technique of not destroying embryos, but rather producing embryos that are not viable is not universally welcomed and raises questions about why they would be introduced in the first place.
The alternative has been Somatic Cell Nuclear Transfer or cloning. This technique has not yet been successful with humans and was subject to the fraudulent South Korean studies of Hwang Woo-Suk last year. There are however many other organisations continuing to pursue this including a recent Harvard University announcement that they are trying this technique.
The most recent development is a way of extracting embryonic stem cells without destroying the embryo1. A US biotech firm has developed a technique for removing just one cell from an embryo which can then go on to develop on its own. The first breakthroughs were last year in research on mice. In August a group of researchers found a new method which would use the same techniques used in Pre-implantation Genetic Diagnosis to collect embryonic stem cells in a way that does not destroy the embryo. This potentially side steps the ethical debate around the destruction of human embryos. The technique extracts one cell from the eight cell blastomere stage. Currently, in PGD the cell is removed to test it for some genetic diseases and the embryo is able to develop. This technique was touted by Advanced Cell Technology, a private biotech company in the U.S, but remains theoretical as in their own work all 16 embryos they were working with were destroyed in order to get two cells that would continue to divide properly2.
References
1 Klimanskaya, I et al (2006) Human embryonic stem cell lines derived from single blastomeres. Nature Aug 23
2 Lehrman, S (2006) ‘Hope, unfulfilled promises on stem cell work’ The Boston Globe 1 October

Chlamydia Screening for New Zealand?

In response to calls from sexual health professionals for a national Chlamydia screening programme for New Zealand, the National Screening Unit released a surprise report in December.
Chlamydia is now the most common treatable sexually transmitted infection amongst young adults in New Zealand and the rates seem to be rising.
Chlamydia is a bacterial sexually transmitted infection (STI) that can lead to pelvic inflammatory disease in women and potential infertility in both men and women. Discharge and pain when urinating are signs of chlamydia but because chlamydia is often asymptomatic people are usually unaware that they have the disease. Chlamydia is though to be asymptomatic in at least 70% of the acute infection in women and 50% in men.
The incidence appears to be increasing in New Zealand and growing attention has focused on a chlamydia ‘epidemic’. However clear and reliable figures on the prevalence are hard to come by. Various studies have reported prevalence in New Zealand between 2 and 12%.
This discussion paper puts forth a robust argument for the introduction of a screening programme but does not recommend proceeding at this stage. The paper assesses the introduction of a screening programme against the eight screening assessment criteria developed by the National Health
Committee. It concludes that chlamydia meets most of the criteria as it is a suitable candidate for screening, with a suitable test available; and an effective and accessible treatment for early intervention; evidence that early intervention is effective; testing and treatment is easy and has few physical or psychological harms; the social and ethical issues relate to inequalities of provision which are already present with opportunistic screening and treatment; and it is cost-effective – especially for young and/or pregnant women. The potential barriers to an effective screening are health system barriers – the chlamydia test is not yet standard in all laboratories and elements of the screening pathway need some attention.
The discussion paper recommends that, instead of a screening programme, measures are introduced within current primary care structures to increase surveillance and early intervention. This includes some potentially controversial measures which are not discussed in any depth. Increasing surveillance involves using upcoming
legislation to require more demographic information including age, gender, ethnicity and domicile. The paper also makes a number of references to better contact tracing without providing the details of what this might involve. There has been robust discussion on how contact tracing is best done and also around whether Chlamydia should be a notifiable disease. Worryingly, these issues are carefully skirted in this paper. One of the discussion recommendations is that national guidelines be established for the management of STIs, including guidelines for opportunistic screening and contact tracing. Guidelines are a first step however, it seems to assume un-problematically that contact tracing will expand the effectiveness of a chlamydia programme.
There is need for a robust discussion of the difference in efficacy and the ethics of informal and mandatory contact tracing. The pending Public Health Bill would see contact tracing expanded to situations where the person concerned does not voluntarily inform others and mandates contact tracing on public health grounds. Soster and Fitzgerald provide a thoughtful discussion document on notifying chlamydial infection which points out that many practitioners are concerned that notification may in fact be counter productive and is likely to turn people away from screening. Overall the Public Health debate about access to patient records and personal information has been polarised . Ministry sources seem to have a machiavellian view where the means justifies the ends which minimises privacy concerns about extensive collection of personal data. This is reflected in the use of legislation to access cervical screening records without explicit consent and raises our concerns in discussions such as this one.
Interestingly chlamydia screening has not had as much fan fare or widespread support as some of the other more dubious screening proposals which seems to expand monthly. There are currently a plethora of screening programmes proposed for pregnant women and their unborn or newly born children. The spectre of a pregnancy and birth dogged by frightening possibilities of morbidity loom large. Most of the proponents mean well but they justify their concerns for the innocent newborns with autocratic requirements for their mothers. (See Pregnancy Police article earlier this issue) Currently under discussion are screening for HIV, Gestational Diabetes, Downs Syndrome and new born hearing screening. Also under constant discussion is a prostate screening programme for men despite the fact the we still do not have a reliable test for prostate cancer and the test that is available has a high false positive rate and is invasive and sometimes damaging. It seems that with extensive genetic testing on the horizon, we may enter an era where we are pushed, prodded and tested to uncover potential disease at every turn.
The NHC guidelines are a useful starting point for the evaluation of a screening programme. The arguments for chlamydia screening stack up better against these criteria than many of the aforementioned screening programmes which appear to have wider support. Of course, any introduction of screening would need to overcome the hurdles identified. Chlamydia screening is not necessarily straightforward but with
attention and careful planning, it may prove to be a good use of our resources.
For more information see:
Ministry of Health, ‘Chlamydia Screening in New Zealand: Report for the National Screening Unit’ Wellington: December 2006 available at: http://www.moh.govt.nz/moh.nsf/UnidPrint/MH5642?OpenDocument

The end of the skinny runway model?

 Not in New Zealand! The good news that the Madrid fashion week banned runway models with a BMI (body mass index) of less than 18 was heralded as an international first. However New Zealand Fashion week- September 18-25th 2006 – did not follow suit.
Organisers of the Madrid fashion week cited a responsibility to portray healthy body images and were willing to turn underweight models away. The Madrid show turned away 30 percent of the women who took part in previous events. A minimum BMI of 18 bans models such as Kate Moss and other “thinspiration” models from the runway. The plan is that the fashion industry can begin to address health issues, including anorexia amongst its models, and portray a healthier image to the public.
A number of events in the past few months have put the super skinny trend under scrutiny. In August a model in Uruguay collapsed on the runway and died of a heart attack thought to be caused by being underweight. In November another model died of anorexia complications. Building on the Madrid ban Italy’s fashion trade group are establishing guidelines for the weight and age of models. In December the Council of Fashion Designers of America sent organisation members a letter urging them to take a stance on the issue of underweight models; President Diane von Furstenberg called dangerously thin models a ‘global fashion issue”. Unfortunately all this action is not necessarily reflected in the images we are bombarded with daily.
New Zealand fashion week followed shortly on the heels of the Madrid announcement but failed to put a ban in place. There was a great deal of press attention at the London fashion week, also in early September, about their lack of a ban. New Zealand fashion week organisers argued it was too late to put in any new rules. Carolyn Barlow, the director of a NZ modelling agency, said it is not an issue here as the New Zealand market calls for more athletic and curvaceous girls.
This may be true for some of the chain store catalogues but can you hear The Blams singing in the background as you peruse the fashion mags? That’s right “there is no depression in New Zealand...”?

The Latest on Aropax and Pregnancy

Women’s Health Action reported on the risks associated with Aropax (Paxil, or paroxetine) in January 2006. (Update, Jan 2006) Aropax, an SSRI antidepressant produced by GlaxoSmithKline was found in a large retrospective study to increase the risk of birth defects, mostly heart defects, when taken by pregnant women. A year after that study was released the American College of Obstetrics and Gynaecologists have issued a recommendation that women who are pregnant or trying to become pregnant avoid the medication. There are currently a series of lawsuits occurring in the US against GlaxoSmithKline alleging that GSK was aware of the drug’s risk before the FDA urged them to change the labelling to warn of possible birth defects in September 2005. ACOG currently recommends that “paroxetine use among pregnant women or women planning to become pregnant be avoided, if possible”.
Reference: www.acog.org/from_home/publications/press_releases/nr12-01-06-1.cfm

Herpes study putting poor women at risk
A study on valacyclovir, a herpes medication, was trialled on poor pregnant women in the US. The trial is to see if the drug can help prevent outbreaks of herpes simplex virus (HSV) while in labour. When HSV is present a caesarean delivery is generally preferred as HSV transmission to the baby during delivery can sometimes be fatal. The intervention group of 170 women received valacyclovir while the control group of 168 largely indigent women were given dummy pills. Despite the publication of a study midway through the trial that concluded giving women drug intervention could reduce the caesarean intervention rate, the trial continued putting women at risk by
giving half of them placebos. The declaration of Helsinki states that “any new methods should be tested against those of best current prophylactic, diagnostic, and therapeutic methods”
In a letter to Obstetrics & Gynaecology where the study was originally published, Public Citizen and two other researchers say “we understand that a pharmaceutical company may prefer to compare its product to a placebo rather than to a known effective therapy, but we are at a loss as to why researchers would place their patients at risk. What were the patients told as new evidence accumulated?” In our last Watch Women’s Health Action raised questions about unethical clinical trials in the developing world (WHW Issue 70). It is important however to realise that unethical trials are not confined to the developing world but are also frequently done with low-income women or women of colour. In the US context this trial was conducted in a hospital serving a predominantly low-income population, probably with a high non-white patient population, perhaps assuming that few would notice what was occurring and raise ethical concerns.
For more information see: http://www.citizen.org/hot_issues/issue.cfm?ID=1490

Sexual predators prove elusive

Two high profile New Zealand cases where women were exposed to sexual abuse by health professionals raise some serious legal and ethical issues. In the first case, the offender was a doctor and his professional body, the Medical Council, had first investigated a complaint against him for sexual violation over twenty years earlier in 1984. This was followed by a similar complaint from a different woman five years later.
The Medical Council explained that the difference between their investigation and the Court Proceedings was in the weight of evidence – twelve women and a substantial body of complaint. They qualified their comments by saying there was little evidence remaining on the initial investigations but what there was suggested that ‘it came down to the problem of one person’s opinion against another.’ It is clear whose opinion they believed and worrying those two separate complaints failed to alert them to any danger to women patients.
Dr Hiran Fernando was finally called to account in October this year. He was found guilty in the High Court in New Plymouth of 26 counts of indecent assault on 12 women over a 21 year period. Three sexual violation charges failed as the jury acquitted him on these.
The other issue raised by this case is the fact that once the charges were laid, a Medical Council review of the doctor and his danger to patients and the public resulted in an order that he could only undertake examinations with a chaperone present and need only explain the reason for this if asked. He was required to put notices up in waiting rooms and examination areas explaining the presence of the chaperones. There are no details as to how prominent these notices were and no requirement to verbally communicate this requirement to patients. He was also stopped from performing breast and pelvic examinations.
Lorraine Jans from the local sexual abuse support service, SAFER, said there were a number of lessons to be learnt from the case and the Medical Council needed more
robust processes around allegations of sexual violence which they did not appear to take seriously enough. The Medical Council has said that they will be reviewing their handling of the case.
This case was reminiscent of an earlier case. Dr Hiran Fernando was hailed as a prominent community figure and therefore above reproach. The same was said of Christchurch Deputy Mayor, Dr Morgan Fahey. What both these cases share is a history of long term abuse by men who used their power as doctors and as pillars of the community to shield them from justice until the weight of evidence became too much to ignore. For more on Morgan Fahey, see:WHA Sept 00 article
The second case raises different issues. Geoffrey Mogridge practises on the Shore as an alternative ‘healer.’ He doesn’t belong to any professional body so, despite the fact that the Health and Disability Commissioner has found against him in two cases of sexual violation and labelled him as a sexual predator, he continues to practise. The HDC has referred him to their Director of Proceedings so that his case can be brought before the Human Rights Review Tribunal and , if successful, this may finally restrict his activities.
The cases leave no doubt as to the danger this man poses. He routinely targets women who have a history of past sexual abuse and has worked with victim support. He uses massage as an entrée to sexual intercourse and has stated in a letter to one of his victims husband that:

  • His social life always centred around his work… ‘many of my girlfriends had been clients’
  • When the work was finished I felt it was OK to indulge in…my own needs and passions. Most of these liaisons were carried out simultaneously to my work.
  • Some overlapped...and I thought I could separate them
  • I gave no thought to anything but my own selfish needs

The two cases ruled on by the HDC cover the same period of time and were concurrent. Both relationships were ongoing and one began at the first appointment and ended eight months later. The second lasted at least four months, during which time, Mr Mogridge also ‘treated’ the woman’s husband for issues relating to the original rape – for which she was also seeing him.
After one relationship had finished, Mr Mogridge attempted to lure the woman and another into his bedroom to play out a long held schoolboy fantasy of ‘two women
together.’ He later described himself as ‘a sick little puppy on this particular occasion.’ In a Radio New Zealand interview, he appears to have little remorse and no insight into his behaviour and its effects on the women concerned. He sees the allegations as harassment and ‘totally denies’ being a sexual predator and states that both these cases were ‘mutually consented affairs.’ Neither of these women were ‘vulnerable at the time and at the time there was ‘nothing wrong with the actions I took.’ His advice to others is that if you offer any service to people be careful what you call it because if the HDC thinks you are offering a health service you come under their rules and may find yourself in the same position he is in.
Unsurprisingly, the first Radio NZ interview brought to light another woman who had a history of sexual abuse and had been similarly abused by Geoffrey Mogridge but had not spoken of it before. While he removed her clothes and touched her genitals, she did not have sexual intercourse with him and believes that her failure to do this is why he terminated the contact and told her she had to do further work on her own.
In her interview she makes some powerful points:

  • She ‘fell’ for him because she was incredibly vulnerable but didn’t recognise it. It is hard for people who have not been abused to understand that because people who are abused, especially when young, use the abuse as a frame of reference for future relationships - You know it’s wrong, you know it feels bad but you don’t know why.
  • It is so hypocritical and so incredibly wrong that the place you go for help is a place of further abuse.
  • Geoffrey Mogridge is ‘quite practised at it.’ and it is a massive abuse of power which he has taken advantage of.
  • The wounds he inflicts are deep because they ‘mess with your self esteem and your ability to trust others.’
  • ‘He was telling me to open my heart at the same time he was damaging it’

(See: http://www.hdc.org.nz/complaints/opinions?recent Cases 06HDC09325 and 06HDC07873
Radio NZ interviews: http://www.radionz.co.nz/nr/programmes/ninetonoon
Interview with husband and Geoffrey Mogridge: 20.12.06
Interview with another woman abused by Geoffrey Mogridge: 21.12.06

Australian Consumer Commission pings Menopause Institute

The Australian Competition and Consumer Commission (ACCC) has taken the Menopause Institute of Australia to the Federal Court charging them with making misleading and deceptive representations about their treatments.
The Menopause Institute of Australia (and here in New Zealand) offer tailored ‘natural’ therapy for the symptoms of menopause. Here in New Zealand they have been advertising heavily on television but it is difficult to get details of what they offer from their website.
In Australia, the ACCC alleged that misleading and deceptive claims included those that their Natural Hormone Replacement Therapy (NHRT):

  • Reduces the risk of cancer, heart disease, Alzheimer’s and senility
  • Is without dangerous, unwanted, reported or any side effects
  • Treats osteoporosis, premenstrual syndrome and loss of libido
  • Has a reduced risk of breast cancer and stroke when compared to conventional HRT because they use bio-identical hormones
  • Is much safer than conventional HRT
  • Is as effective as conventional HRT
  • Does not have any of the risks of conventional HRT

The Menopause Institute’s treatment programme will cause the human body to take over the oestrogen-producing function of the ovaries
The claims were made in newspaper, TV and radio advertisements, in brochures and on its website. The Court has ordered
corrective notices in the newspapers, a corrective notice on their website for three months, and letters to all women who received treatment from the Menopause Institute between September 2003 and September 2006. The notice on the website is a link from the front page and outlines the claims causing concern then states that the WHI raised questions about HRT but that no similar sized studies have been done with NHRT – ‘you should therefore be aware that the risks related to NHRT have not been proven more or less than those for HRT.’ It then advises you to contact the Institute or your general practitioner if you are concerned that you may have experienced side effects as a result of undertaking the NHRT programme. The Menopause Institute was also ordered to pay the ACCC costs of $50,000.
References:
www.accc.govt.au/content/index.phtml/ItemId/773641
www.menopauseinstitute.com.au

Voluntary caesareans more risky

A large US study has found that the risk of death to newborns delivered by voluntary Caesarean section is much higher than by vaginal delivery.
The study concludes that the neonatal mortality rate for Caesarean delivery among low-risk women is 1.77 deaths per 1,000 live births; 2.9 times the rate for vaginal delivery (0.62 deaths per 1,000).
The study looked at nearly 6 million births registered in nationally linked birth and death data in the US for birth cohorts from 1998-2001. The higher risk with caesareans found in the past was assumed to be due to the higher risk profile of caesarean birth. This study is one of the first to examine the risks for low risk mothers who have no medical reason for the operation. Even after adjustment for socioeconomic and medical risk factors, the higher mortality risk for caesarean persisted.
New Zealand continues to have climbing caesarean rates. In 2003 23 1% of mothers nationally had a caesarean section and of these 38% had the procedure electively. This study questions the safely of choosing caesareans for low risk births and argues that labour may provide enhanced safety through the release of hormones that promote healthy lung function in the baby and suggests that the compressions of the baby in labour may be useful in removing fluid from the lungs. Other risks may be due to caesarean delivery such as the risk of cuts to the baby and delayed establishment of breastfeeding.
References
MacDorman. M.F et al (2006) Infant and neonatal mortality for primary caesarean and vaginal births to women with “no indicated risk” United States, 1998-2001 birth cohorts. Birth 33(3)175-82.

Third trimester routine ultrasound does not reduce perinatal mortality

This large Scandinavian study sought to evaluate the effects of third trimester ultrasound screening on prognosis. Over 200,000 deliveries between 1985 and 1996 were evaluated by observational design using data stored on the Swedish Medical Birth Registry and the National Board of Health and Welfare. In non-screening areas SGA (small for gestational age) suspicions were based on clinical examination rather than the routine ultrasound. The study found no significant difference in outcomes at birth comparing perinatal infant mortality, Apgar score and rate of caesarean or instrumental delivery between routine screening and non-screening areas. The study concludes that routine ultrasound screening in the third trimester to detect SGA infants lacks a significant effect on perinatal/infant mortality and morbidity.
Reference
Sylvan, K et al (2005) Routine ultrasound screening in the third trimester: A population-based study. Acta Obstetricia et Gynecologica Scandinavica 84:1154-58.

Birth Control Pills and Headaches

A large population based study has just found an increased prevalence of headaches among women using oral contraceptives (OCs) that contain estrogen. The Norwegian study included over 13,000 pre-menopausal women and examined the answers to a set of two questionnaires distributed on a population basis to an entire county. Headaches (both migraine and non-migraine) were more common among both present and previous users of oral contraceptives. There was no increased prevalence in use of progestagen only contraceptives.
The study did not find a dose-response relationship among present users of estrogen containing OCs. However, the authors caution that they believe this is because the difference in estrogen levels in current low-dose OCs is small (30 ug-50ug). It is proposed that because even at the lowest dosages OCs contain four times a women’s natural menstrual cycle level of estrogen, the smaller difference between currently available dosages is less significant. Because participants in this survey registered both exposure (OC use) and disease (headaches) at the same time a causal relationship could not be established. The fact that women who had never taken OCs containing estrogen had significantly lower prevalence of headaches indicates that we should question and investigate this relationship.
Reference
Aegidius, K et al. (2006) Oral contraceptives and increased headache prevalence Neurology 66:349-53.

Higher suicide rates for women with breast implants

This surprising study set out to examine mortality among almost 25,000 Canadian women who had breast implants between 1974 and 1989. The study found that overall mortality was lower among women who had received breast implants but the suicide rate was 73 percent higher than that of the general population.
Although breast implants do not directly have an adverse effect on long-term mortality, the authors argue that self-selection to undergo an invasive medical procedure and the participants higher socioeconomic status may contribute to the better health than that seen in the general population.
The increased suicide rate among breast implant recipients is consistent with earlier studies which indicate that women who had implants were more likely to suffer low self-esteem, to have undergone therapy or to have been admitted to a psychiatric hospital.
The study authors conclude that serious consideration should be given to providing consultation for patients at high risk of psychiatric disorders considering breast implants.
Reference
Villeneuve, P.J. (2006) ‘Mortality among Canadian Women with Cosmetic Breast Implants.’ American Journal of Epidemiology 164(4)334-41.

Negative consequences of racism reflected in one’s health

This New Zealand study finds that self-reported experience of discrimination is strongly associated with various measures of poor health, independent of socioeconomic status. This study used data from the 2002/2003 New Zealand Health Survey (NZHS) which included a series of questions on people’s experiences of racial discrimination. Responses were compared with five health indicators (self-related health, physical functioning, mental health, current smoking and self-reported cardiovascular disease). There were five questions about racial discrimination covering personal experience of ethnically motivated physical or verbal attack; and unfair treatment because of ethnicity by a health professional, in work, or when gaining housing. These comparisons found that reported experience of racial discrimination is associated with poorer health and with current smoking.
Respondents who report experiencing three or more types of discrimination are up to three times more likely to report adverse health outcomes than those who do not report any discrimination.
The study concludes that racism is a major determinate of health and a driver of health inequalities: ‘as such policies designed to address racism should be included in the strategies adopted by governments to eliminate ethnic inequalities in health. This needs to involve both the health sector and wider society.’
Reference
Harris, R et al (2006) Racism and health: the relationship between experience of racial discrimination and health in New Zealand. Social Science & Medicine 63:1428-41.

Cola weakens bone for women

The intake of