Women's Health Action logo
home

 

Women's Health Action Trust

Women's Health Watch

Selections from Women's Health
Watch September 2002
necklace shell - cartwright inquiry spiny murex shell - complaints/inquiriesostrich foot shell - consumer centre volute shell - the health system Site search engine
related WHW September 2002 links: [books][WHIS][publications][newsletters]

WHW small logo
Women's Health Watch

edited by Sandra Coney

 

Selected articles from Women's Health Watch newsletters in September 2002

Contents

Hormone replacement therapy: the love affair is over

Sandra Coney takes a look at the results of the US Womenıs Health Initiative study and local reactions to them.

Hormone replacement therapy should have only a very limited role in the management of menopausal hot flushes, should not be used for the long-term prevention of heart disease, and should not be used for the long-term prevention of hip fractures, except in exceptional circumstances.
This message has been clearly articulated in the US following the publication of early results from the Womenıs Health Initiative trial. The WHI trial is one of the largest prevention trials ever conducted in the US, and anyone interested in the health of older women had been eagerly awaiting them. It was not just another study to be weighed against other results, but the first randomised controlled trial of HRT which was set up to look at disease end-points.
The WHI trial was stopped early by the National Heart, Lung, and Blood Institute of the National Institutes of Health because after 5.2 years the risks of heart disease, stroke, venous thromboembolism and invasive breast cancer were increased in healthy women using continuous combined HRT, and these risks outweighed the benefits of reduced fractures and colorectal cancer (see box). These results were valid, said the investigators, for women of all sub-groups defined by prior health status, age or ethnicity. The high drop-out rate in the treatment arm of the study (42%) could mean that the magnitude of effects, both adverse and beneficial, have been under-estimated among women who adhere to treatment (Writing Group for the Womenıs Health Initiative Investigators 2002). Deborah Grady, one of the investigators in the WHI study and on the study safety monitoring board, says that among women who adhered to treatment, the increased risk of breast cancer would be 50%.

Short-term use carries risks
One of the most startling results of the WHI trial was that even short-term use carries serious risks. Previously women were told it was safe to use HRT for up to 5 years, before serious health risks occurred (breast cancer). In the WHI study, the risks of VTE and heart disease appeared immediately use was initiated, the stroke risk in the second year, and the breast cancer risk in the fourth year. This calls into question the wisdom of prescribing HRT for hot flushes, unless these are severe and women are fully informed of the risks. It is particularly ethically unsustainable to continue prescribing HRT for such unproven benefits as looking younger or improved wellbeing.

Oestrogen-only ­ is it safe?
The oestrogen-only arm of the WHI trial is continuing because the balance of risks and benefits is not clear at this stage. However, earlier communications from the investigators stated that there were increased numbers of cardiovascular events and VTE in all users, but these did not reach statistical significance (Lenfant 2000). In 2001 they reported there were Œstill more heart attacks, strokes and blood clots in women taking active hormonesı (WHI 2001). There are fewer participants in the oestrogen-only arm of the WHI trial compared to the combined therapy arm, so that the balance of risks and benefits will take longer to emerge. At present it is not known if the risk of using oestrogen only is smaller than combined therapy, or the risk is taking longer to come out because of smaller numbers of women. In the meantime, caution would be wise.
No risk of breast cancer has emerged in users of oestrogen alone as yet. However, a very large meta-analysis (52,705 women with breast cancer and 108,411 controls) found an increased risk of breast cancer after five years of HRT use and no difference according to whether combined or oestrogen-only therapy was used (Collaborative Group on Hormonal Factors in Breast Cancer 1997).

What about younger women?
HRT is prescribed to many women who are in their forties and have not gone through menopause. This use has always been worrying, as women in this age group have higher levels of their own hormones than postmenopausal women, so you are not Œreplacingı but adding to, by using HRT. It is not clear how the WHI results would apply to this younger age-group.

Response to the WHI results
In an editorial accompanying the WHI paper, Suzanne Fletcher and Graham Colditz (2002) concluded with the clear simple statement that ŒThe WHI provides an important health answer for generations of healthy postmenopausal women ­ do not use estrogen/progestin to prevent chronic disease.ı
In the US, health care officials have moved quickly to relabel HRT with the study results. The Food and Drug Administration signalled that the label for these drugs could be further altered to recommend limited treatment for a limited amount of time as well as a black box warning that is used to warn of potentially fatal risks of drugs. The FDA has required Wyeth to remove all references to Œreplacementı. As part of a wider assessment, the FDA is examining the issue of whether pharmaceutical companies have encouraged women to believe menopause is a condition to be treated, rather than an inevitable and natural set of events to be managed (Kaufman 2002).
Even Wyeth, the company that produces the HRT products used in the WHI trial, has substantially changed its tack. In early September it said that women using HRT for symptoms should use it for the shortest possible time, not use it for prevention of heart disease, and other treatments should be considered for prevention of osteoporosis (Reuters Health 2002). Wyeth has also stopped direct-to-consumer advertising of HRT.
In New Zealand, women and their doctors have not received such clear guidance. The Ministry of Health took little action to warn women or their doctors of the risk. Women were simply advised to see their doctor on their next scheduled visit if they were concerned. Statement after statement from the Ministry downplayed the significance of the study and questioned the rigour and relevance of the WHI results.
The Ministry informed around 1000 doctors of the results electronically, but otherwise relied on letters sent to doctors by Wyeth (Medsafe 2002). The Ministryıs downplaying of the risks was echoed in media statements made by the Family Planning Association and the New Zealand Medical Association, and in articles in local doctorsı newspapers (Budd 2002).
There was a lack of consistent advice from medical opinion leaders, clinicians or public health specialists. Media statements were contradictory and these were reflected in stories from women who called the Womenıs Health Action HRT Hotline (see box on this page). In particular, there was silence from a number of local and Australian medical opinion leaders who, over many years, have improved their careers by promoting HRT use to GPs and specialists.

Why warn women about OCs but not HRT?
The lack of action from the Ministry of Health contrasted with the proactive advice it gave on the risks of third generation oral contraceptives and Diane-35/Estelle-35, where the risks are far lower. Compared to women not using oral contraceptives, there are 5 more cases of VTE per 10,000 women using third generation OCs and 7 more cases in women using Diane-35 (Medsafe, 2002). On the basis of these risks, the Ministry wrote to all doctors, and developed consumer fact sheets. For third generation OCs, the Ministry also advertised in newspapers and established a telephone helpline for women.
By contrast, the WHI found there would be 18 more cases of VTE per 10,000 women each year, as well as 7 more heart attacks, 8 more strokes and 8 more cases of breast cancer. Taking into account the benefits of 5 fewer hip fractures and 6 fewer cases of colorectal cancer, there would be 19 excess serious adverse events per 10,000 women using HRT each year. The investigators reported that within five years 1 in 100 women using HRT would have a serious adverse event.
Considering that women using HRT are well women, this is an unacceptable level of harm. It is doubtful that a drug with this risk profile would be accepted for marketing to healthy women were such approval to be sought today.
So why has there been so little action over HRT compared to OCs?
In any pharmaceutical Œscareı the knee-jerk response from health authorities is to downplay it. And indeed the words Œwomen shouldnıt panicı did appear during this controversy. There might be some justification for this paternalistic injunction where the sudden cessation of medication could have drastic consequences, such as women stopping oral contraceptives and getting pregnant. But there is no serious health consequence in stopping HRT. The worst that can happen is the return of hot flushes.
The other factor operating is what I call the complicity factor. Many health officials and doctors have been complicit in promoting HRT, before all the evidence was in. There is an element of embarrassment in admitting you have been promoting an unsafe product for years, especially when you lacked a solid foundation for doing so. The other factor is plain old ageism. The culture of the menopause industry has been so internalised that many are still viewing the WHI results in the context of the pathological menopausal woman and her need for pharmacological help to cope with ageing. They believe the Œoestrogen deficiencyı diagnosis, they believe menopause needs treating. Harm to older women from HRT is an acceptable trade-off for warding off ageing. Younger women were warned about OCs because young women are more valued than older women. Harm to older women matters less.

The New Zealand arguments about the WHI results
In general, the local reaction to the WHI results involved concerted efforts to undermine what had been previously regarded as a gold standard study. During the period people had been waiting for the results, no one criticised the design of the WHI trial, but suddenly it was full of problems.
The response has been, firstly, that the results are nothing new, and secondly, that the results are not applicable to New Zealand women as New Zealand women using HRT are younger and less obese and use HRT for menopausal symptoms (Ministry of Health 2002).
ŒWe predicted these results,ı said the Ministryıs Dr Bob Boyd on national radio, ı we thought it would take them another year or two to come up with the results, but it is in fact confirming our advice so it hasnıt rung alarm bellsŠı The contention that WHI confirmed MoH advice is not supported by the fact that the Ministry approved HRT for the prevention of heart disease in 1996 and this has never been withdrawn, even though the results of the HERS study in 1998 suggested that HRT was not effective for this purpose and might even cause harm.
In the same interview Dr Boyd even proposed informing doctors of the positive results of WHI for the prevention of colorectal cancer, an approach not recommended anywhere else in the world, and prevention of osteoporosis for older women, even though the risks of taking HRT would be much higher in older women who are already at greater risk than younger women of stroke, heart disease, blood clots and breast cancer.
The Ministry claimed that the New Zealand Guideline Group Guideline on the Appropriate Prescribing of Hormone Replacement Therapy (New Zealand Guideline Group 2001), released in May 2001, promulgated advice that mirrors that of the WHI trial (Medsafe 2002). A typical headline was the NZ Doctor banner, ŒGuidelines already in line with HRT findingsı (17 July 2002). This claim has been used to justify the Ministryıs present inaction.
In reality, the New Zealand guideline has been effectually rendered redundant by the WHI study. It was neutral on the issue of benefit or harm from using HRT for primary prevention of heart disease, did not mention any risk of strokes, and was equivocal about the risk of the breast cancer. It recommended oral HRT for other long-term uses ­ such as vaginal dryness ­ which should not be contemplated now. It did not attempt any overall assessment of risks against benefits.
Worst of all, Pharmac figures show that the Guideline had no effect on levels of HRT prescribing (Pharmac 2002). This throws into doubt the considerable effort that goes into developing guidelines for doctors, or at least the way they are promulgated, and emphasises the need to simultaneously get the same information out to the public.

Are New Zealand women different than the WHI women?
It is difficult to come up with evidence to support the Ministryıs claim that New Zealand women are different (particularly with regard to age and weight) and use HRT differently compared to women in the WHI study.
The women in the WHI study ranged in age from 50-79 years with a mean age of 63.2 years at baseline. Nearly 80% of the study participants were aged under 70 years. Mean body mass index was 28.5. Thirty-five percent of the participants had a BMI of 25-29 and 34% of 30 or over.
The only information we have on the characteristics of New Zealand users of HRT is the study by North and Sharples (2001) which surveyed women aged 45 to 64 years, but unfortunately not older age groups. This found that between 1991 and 1997 the prevalence of HRT use in older age groups increased significantly. By 1997 an equal proportion of women in the 60-64 age group were using HRT compared to women 50-54 years. This suggests that the pattern of HRT use in New Zealand might not differ significantly from that of the WHI study.
North and Sharples study does not contain information about the BMI of the women using HRT, however information about New Zealand women in this age group is available from other sources. Ministry of Health figures show that 26% of women aged 45-64 years and 22% of women aged 65-74 years have a BMI of 30 or over (Ministry of Health 1999). While this is slightly lower than the WHI figures, the lack of exact comparability in the age groups makes conclusions difficult. On the other hand, there is more comparable data on some other indicators of health. For example, the prevalence of current smoking among New Zealand women ranges from 22% for 50-54-year-olds to 10% among 75-79-year-olds (Ministry of Health 1999). In the WHI study only 10% of the study participants overall were current smokers.
The WHI participants were an active healthy group of women, so these attempts to depict them as less healthy than New Zealand women in the same age group do not stack up.
The Ministry maintained that NZ women used HRT for symptom relief as opposed to prevention ­ prevention being the purpose of the WHI trial - and implied that this would somehow make a difference to the risks.
The study by North and Sharples (2001) showed that 82% of NZ users of HRT used it for symptoms, but nearly half were also using HRT for prevention purposes: nearly half for prevention of osteoporosis and one-quarter for prevention of heart disease, a proportion that had doubled between 1991 and 1997. This refutes the claim of the Ministry that NZ women do not use HRT for prevention.
One MOH official has even claimed that the WHI women did not have menopausal symptoms. The WHI investigators were studying the safety and effectiveness of HRT when used for long-term prevention. Whether or not the WHI women had menopausal symptoms was irrelevant to this task, however, it is hard to imagine that none of the 16,000 WHI women didnıt have hot flushes. Whether or not the women had hot flushes is simply not relevant to a study of long-term effects of using HRT. Risks do not select according to the reason HRT was initiated. A woman using HRT for hot flushes runs identical risks to a woman using HRT for prevention in a comparable year of use.

Poor prescribing in NZ
An interesting aspect to note from the North and Sharples study was the level of poor prescribing. Among women with an intact uterus, 11% were using unopposed therapy, whereas it is well known that progestogen is needed to protect the endometrium, and 15% of women who had had a hysterectomy were using combined therapy. Use of continuous combined HRT (the regimen used in the WHI trial) had increased from 0.4% in 1991 to 29% in 1997, despite the lack of evidence that this regimen produced the same level of benefits and risks as unopposed or sequential HRT. New Zealand is prone to huge shifts in prescribing habits, which can be put down to the activities of medical opinion leaders having a large impact in a small country and the activities of the pharmaceutical industry.

The public health implications
The WHI results translate into a major public health concern. In the US Jacques Rossouw, acting director of WHI, stated that ŒConsidering that millions of American women might consider taking the estrogen plus progestin therapy, that could translate into tens of thousands of cases of breast cancer or cardiovascular disease over several yearsı (Rossouw 2002). Nearly half a million New Zealand women are in the age group covered by the WHI study and are therefore potential users of HRT (Statistics New Zealand 2002). In 2001, Pharmac estimated from the number of prescriptions filled that around 100,000 New Zealand women were currently using HRT. This is consistent with the finding from North and Sharples (2001) that in 1997 20% of postmenopausal women were current users of HRT, up from 12 % in 1991, and 32% has ever used HRT. Fifty-four percent were using combined therapy.
These figures would give rise each year to 40 extra cases of breast cancer (after three years of use), 35 more heart attacks, 40 more strokes and 90 more blood clots. It seems extraordinary to countenance such harm to health while at the same time putting in place expensive breast screening programmes and measures to reduce cardiovascular disease.

Lessons from the HRT saga
There are some larger lessons to be learned from the HRT saga.

  • Results from observational studies should be treated with great caution. Observational studies of HRT indicated that HRT might reduce the risk of heart disease by as much as 50%. Most studies showing a benefit of HRT on fractures were observational. More circumspect commentators argued that the heart benefit could well be the result of a Œhealthy userı effect as HRT users were known to be from higher socio-economic groups, slimmer, taller and to adopt more health- enhancing behaviours than women not on HRT. The WHI trial showed that HRT actually caused harm to hearts, not benefits.

  • Positive effects on surrogate end-points do not always translate into reduction of disease. A number of studies, principally the PEPI study, showed that HRT had a positive effect on blood cholesterols (Writing Group for the PEPI Trial 1995), and an overall benefit on cardiovascular risk was extrapolated from this. It was on the basis of the PEPI result that the Ministry of Health approved HRT for the prevention of heart disease in 1996, even though it was never approved for this indication by the US Food and Drug Administration. The WHI study also found this positive effect on cholesterol, but some other mechanism, possibly the clotting effect of HRT, caused harm to the heart.

  • Diseases were created to fit the drugs, a trend that has occurred in a number of areas of medicine over the past few decades (Moynihan and Smith 2002). Heart disease in women was put down to the lower level of oestrogen at menopause even though there is no steep increase in CHD cases in women at menopause, rather, a gradual rise beginning in the 40s. It is not clear how much oestrogen contributes to bone loss, as opposed to the effects of ageing, and the relative contribution of oestrogen-loss to hip fractures, as opposed to the effects of ageing, polypharmacy and so on, is not known. Despite this, heart disease and fractures were redefined as menopausal diseases, in need of treatment.

  • Medicines regulatory authorities need to be much more rigorous in approving indications for medications and in monitoring safety. A re-evaluation is needed as to whether trans-Tasman harmonisation of drug regulation will enhance or harm these processes.

  • More distance is needed between pharmaceutical companies and doctors, and between pharmaceutical companies and the public. In particular direct-to- consumer advertising should be halted.

  • The trend to defining well populations as pathological must be rejected. Only a small proportion of menopausal women have severe hot flushes. Many of the other psychological and physiological symptoms ascribed to menopause are found in both sexes and people of all ages. The experience of HRT should provoke re-examination of the disease labelling of other well populations.

Conclusions
One of the most disturbing aspects of the current reaction to the WHI study is the culture of menopause that has been revealed. The stereotype of menopause as a disease or deficiency state appears to have been internalised by women and their doctors alike. Many callers to the Womenıs Health Action HRT Hotline do not know why they are on HRT but are convinced they cannot cope without it. They fear they will visibly age overnight if they stop their pills; many women have become psychologically addicted to their hormones pills and lack the confidence to go hormone-free.
The situation is providing a bonanza for companies with other pharmaceuticals to promote, both prescription medicines and complementary therapies. We will have not moved forward if women are simply transferred to bisphosphonates (which lack safety and effectiveness data past 7 years) or they spend hard-earned money on unproven therapies such as progesterone creams and phyto-oestrogen supplements. We must find good evidence of alternative approaches for women with disruptive menopausal symptoms, but most women simply need affirmation of the normality of the menopausal transition and of the benefits of a healthy, active lifestyle.

References

Budd S. GPs cushion HRT shockwave. New Zealand GP 24 July 2002
Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and hormone replacement therapy: Collaborative reanalysis of data from 51 epidemiological studies of 51,705 women with breast cancer and 108,411 women without breast cancer. Lancet 1997; 350: 1047-59
Fletcher Suzanne W, Colditz Graham A. Failure of estrogen plus progestin therapy for prevention [editorial]. JAMA 2002; 288: 366-68
Kaufman M. Hormone replacement gets new scrutiny. Washington Post 14 August 2002: A01
Lenfant C. Preliminary trends in the Womenıs Health Initiative [press release], Bethesda, Md: National Heart Lung, and Blood Institute. 3 April 2000; Also see WHI HRT Update, data up to 28 February 2001.
Medsafe. See www.medsafe.govt.nz (Accessed 9 September 2002)
Ministry of Health. Our Health, Our Future: The health of New Zealanders 1999. 1999, Wellington
Ministry of Health. Media release, 10 July 2002 See www.medsafe.govt.nz. See also Radio New Zealand Morning Report 11 July 2002 (Interview with Dr Bob Boyd), Radio 3ZB Breakfast Show 11 July 2002 (Interview with Dr Bob Boyd), TV3 Nightline 10 July 2002 (Interview with Dr Bob Boyd).
Moynihan R, and Smith R. Too much medicine? [Editorial] BMJ 2002; 324: 859-60
New Zealand Guideline Group. Best Practice Evidence-Based Guideline on The Appropriate Prescribing of Hormone Replacement Therapy May 2001
North Fiona M, Sharples Katrina. Changes in the use of hormone replacement therapy in New Zealand from 1991-1997. NZMJ 2001; 114; 250-53
Pharmac. Dispensing data: HRT Progestogen and oestrogen combined: June 2000 : 314,890; June 2001 333,175; March 2002: 326,677
Reuters Health. HRT prescribing info amended. 5 September 2002
Rossouw J. Press conference remarks: Release of the results of the estrogen plus progestin trial of the Womenıs Health Initiative: Findings and implications, www.nhlbi.nih.gov/whi/hrtupd/rossouw.htm (Accessed 10 July 2002)
Statistics New Zealand. Census of Population and Dwellings 2001, www.statistics.govt.nz (Accessed 9 September 2002)
Writing Group for the PEPI Trial. Effects of estrogen or estrogen/progestin regimen on heart disease risk factors in postmenopausal women: The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. JAMA 1995;273: 199-208
Writing Group for the Womenıs Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002; 288: 321-33

Ovarian cancer

In the same issue of JAMA that reported on the WHI study, researchers reported that women using oestrogen-only HRT had an increased risk of ovarian cancer, particularly if it was used for 10 or more years. In women who used it for 10 or more years the risk of developing ovarian cancer increased by 50% from 4 per 10,000 in women not using HRT to 6 per 10,000 women taking oestrogen.

Gallbladder cancer

An Italian case-control study has found the first direct epidemiological evidence of an association between hormone replacement therapy (HRT) in menopause and an increased risk of gallbladder cancer. Subjects included 31 women between 45 and 79 with gallbladder cancer and 3,702 age-matched controls. The odds ratio for gallbladder cancer was 3.2 for women who had ever used HRT, and it tended to increase with longer use.

Back to the bad-old days of the medical protection racket

Phillida Bunkle discusses the Health Professionals Competency Assurance Bill which has finally emerged after months of secret negotiations between the Government and health professional groups, to the exclusion of consumer interests.

The Health Professionals Competency Assurance Bill ensures that the ambulance is permanently parked at the bottom of the wrong cliff.
The Bill is the final nail in the coffin of the Cartwright reform of patientsı rights. These recognized that the key to preventing abuse was to stop the profession being judge and jury of patient complaints.
Womenıs Health Actionıs submissions to the Cartwright Inquiry argued for a system of patientsı rights to end the autonomy of the medical profession by providing independent investigation and adjudication of complaints. WHAıs Final Submission of Evidence put forward a blueprint for an independent Health Commissioner modeled on the Human Rights Commission. This was to establish accountability outside the profession itself, provide a one-stop shop to simplify the complaints process, and ensure there was monitoring of the performance of individuals, institutions and the system as a whole. Although the initial handling of a complaint by the Commissioner was to be conciliatory, in serious injuries or breaches of the Code of Patientsı Rights, the Commissioner would assist complainants to take their case to an independent Tribunal which could award substantial compensation.

The medical professionıs fight back against patientsı rights
The medical profession strenuously opposed this loss of power. By the time the legislation became operative in July 1996, it had been weakened by dividing the one-stop-shop into a complex system where physical injury was sent to ACC, separating it from breaches of the Code of Health Consumersı Rights. Despite intense lobbying from consumer groups, the Code did not include the right to timely treatmentment. This meant failure to treat was not a breach.
The legislation required that cases pertaining to professional registration be passed to the registering body for action. It assumed that body would simply act on the recommendation of the Commissioner. In fact the Medical Council developed a parallel system of re-hearing cases, and coming to its own conclusions about the doctorıs competence that unnecessarily duplicates the work of the ACC and the Commissioner and so adds to the time and cost of bringing doctors to account.
The Medical Practitioners Act 1995 led to the setting up of the Medical Practitionerıs Disciplinary Tribunal. This has a majority of professionals and a judicial chair appointed by the Minister. This Act also provided for Complaints Assessment Committees (CACs) a majority of whose members are doctors chosen by the Medical Council. These CACs were intended to be preliminary committees weeding out so-called vexatious complaints to ensure that the Medical Practitioners Disciplinary Tribunal did not become bogged down.
In the event the profession developed the role of the CACs into that of effective gatekeeper. The CACs investigate, re-hear evidence, and come to conclusions about doctorsı competence and actions which are often at odds with the ACC or the Commissioner. For example, a number of Northland women took cases, where ACC had already established negligence, but these were dismis-sed by CACs and therefore never considered by the Disciplinary Tribunal at all. In the few cases they passed on they formulated charges at low levels.
CACs duplicate the work of ACC and the Com-missioner adding unnecessarily to the time and cost of bringing doctors to account.
In 2000 no complaints got to the Complaints Review Tribunal at all, and only 7 got as far as the Medical Practitioners Disciplinary Tribunal. Of these, only one case (Colleen Poutsmaıs) resulted in (partial) de-registration.
Last year this power grab by the CACs was the subject of a critical opinion by David Collins QC. He pointed out that this usurpation of power by the professional interest group had resulted in serious injustice to patients, but because the CACs were intended to be preliminary hearings committees of minor importance their findings cannot be appealed by complainants.

Patient safety and the importance of patientsı rights
Patient safety is perhaps the single most pressing issue in our health system. In New Zealand Davis and McCreadie1 report that 12.9% or one in eight admissions to a public hospital are the result of unintended medical injury. (Compared to: USA 3.5%, UK 10.8%, and Australia 16.6%). In New Zealand, Œhalf of these are both preventable and hospital incurred.ı
ŒApproximately 35 % were classified as highly preventable. Although less than 15 percent of adverse events resulted in permanent disability or death.ı
In fact 4.5% of the injured patients died of their injuries, yet this is not reflected in ACC compensation. The system ensures the dead or injured are simply not heard.
In 48.5% of medical injuries there was Œvirtually certain evidenceı that medical management was the cause of the injury. These figures indicate a different universe from that shown by the mere 7 cases which got through to the medical disciplinary system and the one half of a de-registration which resulted.
It is reasonable to conclude that the patient complaints system has not resulted in improvements to patient safety. What the figures do show is why health professionals are so defensive, even of colleagues whose performance is negligent. If 1 in 8 patients are in hospital as a result of unintended medical injury it means mistakes are a normal part of everyday practice.
This Health Professionals Competency Assurance Bill redefines the issue not as one of patientsı rights and appropriate compensation but of Œquality assuranceı. However in doing so it threatens to destroy the last vestiges of an effective patientsı rights system while failing to implement an effective quality assurance programme.
This bill:

  • Does not produce a one-stop shop under the Health Commissioner
  • Downgrades the Commissioner to a post box to pass on complaints to other bodies
  • Entrenches the self-regulation of the health professions thus ensuring their autonomy and monopoly of practice and re-establishing them as judge and jury of their own performance
  • Extends this flawed model from doctors to all registered health professionals.
  • Entrenches those monopolies of existing practice and shuts out alternative practices.
  • Leaves compensation for physical injury to ACC, thus producing neither adequate penalties for negligence nor adequate compensation for victims.
  • Does not produce proper quality assurance

What needs to be done?
The original intentions of the Cartwright reforms need to be restored.
Professional autonomy: At present, the colleges and professional bodies are trade unions, credentialing agencies and disciplinary bodies. This gives them all the power. There is a need to appropriately redistribute that power. The natural function of these bodies is as a trade union. Separate state-run organizations should credential and an independent tribunal should discipline.
Self-discipline amounts to self-protection. This bill increases and formalizes self-discipline. It creates Œresponsible authoritiesı, which control health professionals (part 6, schedule 2). Sixteen authorities are named. Each authority can appoint a Complaints Assessment Committee (secs 65-74) to investigate complaints and to decide whether they should go before the Health Practitioners Disciplinary Tribunal (secs 75-95). This self-policing power should be removed from these Œin houseı CACs. They should not exist. This is a role for the Commissioner.
This bill makes the findings of the CACs appealable but in doing so recognizes their right to conduct investigations and sit in judgement on the substance of complaints. Elevating the status of the CACs thus brings control even more firmly Œin-houseı than before. This system provides no way around this Œin-houseı judge and jury.
This bill provides nothing to stop the professionals running the complainant out of energy and money through endless delays. One Northland women was stuck in a CAC for five years of run-around before she finally got a hearing before the Tribunal, which she won. Some women have been struggling for justice even longer, but most give up.
Patient autonomy: Patients should be able to exercise their right to go directly to a Tribunal. There is no justification for these elaborate gatekeepers.
The Commissioner should be a one-stop shop, which is responsible for all complaints through to completion.
In the Bill complaints must be referred to the Commissioner (sec 58) who may investigate the complaint but is not required to. The Commissioner does not have to take charge of the complaint but may refer the complaint to the Œresponsible authorityı (secs 59,60). Once referred the Commissioner loses control of the process and does not follow it up. Having posted it off to the professional authority it isnıt his problem. The requirements on the Commissioner are minimal and his authority will be vastly diminished as real power is officially handed over to the professional organizations.
Quality assurance: This bill does not establish effective quality assurance. It establishes a secret review process conducted within the Ministry.
Secs 42-50 set out a system which allows the Minister to declare a Œquality assuranceı activity to be Œprotectedı and appoint a person to perform the activity (sec 44-50). The Director-General determines who is suitable to perform the activity (sec 44). Information is subject to confidentially and reporting requirements (sec 45, 46, and 47). The Minster may publish reports (sec 48) but is not obliged to. There is no automatic follow-up up of a statistically significant proportion of all cases.
This was precisely the secret process that Professor David Skegg objected to in Gisborne when the Ministry suggested reviewing the national cervical screening programme. Since the research is not published it is not peer-reviewed and the results not made public. It becomes another excuse to avoid public accountability and keep the real power in house.
Modern health systems are industrial processes. The days are long gone when treatment was wholly a matter between you and an individual doctor. Patients are engaged in large systems. Quality assurance of such systems must be scientifically based and a matter of course.
Manufacturers have found that the only effective system is continuous sampling during manufacture, and setting defects right as they are found. This is called the Deming system. Toyota first introduced it for car assembly lines. It is the foundation of the Japanese industryıs dominance and the reason Corollas hold their value. Its introduction slowed down assembly but made it more efficient because problems were fixed as they were found. Previously up to 30% of new cars didnıt work. They had to be stripped down and rebuilt, and even then a lot of people got a lemon.
Given the magnitude of the problem of unintended medical injury, and the cost and unreliability of stripping and rebuilding the human body, proper quality assurance is desperately needed in the medical industry. In the end it will save everyone a lot of pain, as Ford finally figured out.
If we want to prevent the toll of medical deaths and injuries, which make the road look safe, then these proposals for secret squirrel internal inquires have to be seen for the self-serving jack-ups they are.
Cartwright recommended openness and accountability; this bill re-institutes the bad old days of irresponsible power.

Secret development of bill
It is not surprising that this bill so thoroughly entrenches the power of the health professional organizations given that during its development professionals had all the say and consumers had none. Officals denied that this bill existed long after the Medical Councilıs web-site had reported the changes they had achieved in the first two drafts. The Ministry and the profession had worked together while excluding consumers. In February 2002 I could not discuss the Bill at a medico-legal conference, because it was said not to exist but I found the various lobby groups busy discussing their drafts! Worryingly, the exclusion of consumers bodes ill for the future of health consumersı rights.

Phillida Bunkle was one of the founders of Womenıs Health Action. She was a member of the Health Select Committee in the previous government and the Health Spokesperson for the Alliance.

1 Prof. Peter Davis, Adverse Events In New Zealand Public Hospitals: Principal Findings From a National Survey, Ministry of Health Occasional Paper, #3, December 2001, Wellington.

Tamoxifen may increase sarcoma risk

News recently that the IBIS study showed that tamoxifen reduced the risk of breast cancer in women at high risk of the disease. The investigators from the New Zealand branch of IBIS caution that despite this positive result, it is as yet unclear what the balance of risks and benefits will be.
Before tamoxifen is accorded Œmagic bulletı status, let us ponder the risks. The IBIS study itself found more cases of endometrial cancer and blood clots. And hereıs more bad news.
Boxes of tamoxifen will carry a new ³black box² warning about a recently-identified risk of uterine sarcoma, a rare and aggressive cancer. Black boxes are used to draw attention to serious and potentially life-threatening problems. The USA Food and Drug Administration (FDA) warning on the drug is aimed at women who have not had breast cancer but are at high risk, and at women who have had an early form of cancer of the milk ducts.
Uterine sarcoma is estimated to occur in 0.17 women per 1,000 a year who take tamoxifen. In women not taking the drug, there are only up to 0.02 cases per thousand. Since 1978 when the drug was first sold in the USA, 159 cases of uterine sarcoma worldwide have been reported in users.

New NECAHR members

The National Ethics Committee on Assisted Human Reproduction has new members. The current committee membership is:
Prof Sylvia Rumball (Chair), assistant to the Vice Chancellor (equity and ethics) Massey University, has extensive international and local experience on ethics committees including as a member of the UNESCO International Bioethics Committee.
Philippa Cunningham, barrister, also a trained general nurse. Assistant legal counsel at Cartwright Inquiry and on Cartwright Monitoring Committee.
Ken Daniels, Associate Professor in Social Work at the University of Canterbury, has been researching and writing in the field of assisted human reproduction for 24 years.
Christine Forster, Auckland GP, her specialist interest areas are womenıs health and reproduction, past chair of the Abortion Supervisory Committee.
Prof Gareth Jones, Professor of Anatomy at the University of Otago. Has an active interest in bioethical issues particularly in the areas of embryology and developmental biology/neurology.
Alastair Gunn, Associate Professor in the Department of Philosophy at the University of Waikato, member of ethics committees.
Beverley Lawton, Ngati Porou iwi and Hauiti hapu, Research Fellow in the Department of General Practice at the Wellington Medical School, co-principle investigator on the Aotearoa Womenıs Health Initiative/WISDOM study of long-term use of HRT.
Helene Leaf, Te Hikutu hapu, Whirinaki, Hokianga and Ngapuhi iwi, Maori lay member and chairperson on the Auckland Health and Disability Ethics Committee X for 6 years.
Anne Robertson, consultant obstetrician and gynaecology, health professional member of the Manawatu-Whanganui Ethics Committee since 1996
Christine Rogan, Health Promotion Advisor for the Alcohol Healthwatch Trust, formery Development Officer for the New Zealand Infertility Society. Ms Rogan is the consumer representative on the Committee.
Barbara Nicholas, Director-General of Healthıs representative, currently employed as Senior Advisor (Services Research), Health Services, Ministry of Health. She holds a PhD in bioethics.

NECAHR has a new web site www.moh.govt.nz/necahr

No consensus but much discussion on routine HIV testing in pregnancy

A recent WHA seminar showed the lack of agreement on routine HIV testing in pregnancy among health practitioners, consumer groups and organisations working with high-prevalence communities, but it was a good opportunity to hear different viewpoints
The July seminar was the first public event to bring together all the interested groups since it became known in 2001 that National Womenıs Hospital was considering the introduction of routine HIV testing.
Participants raised many concerns about the issue in workshops, including issues around informed consent, the lack of cost/benefit analysis of routine screening, the relevative priority of the issue compared with other health needs, and resource constraints, especially time and training resources for health professionals in maternity care.
Speakers did agree that the current policy of offering HIV testing to pregnant women at high or uncertain risk was not being implemented. The Ministry of Health introduced the interim policy in 1997, but a recent study found that up to 80% of maternity providers rarely or never assess HIV risk in their antenatal clients. MOH Team Leader John Boyd summarised the main barriers identified in the research -

  • The personal nature of the questions
  • A reluctance to provoke anxiety in pregnant women
  • The low prevalence of HIV among women
  • Privacy concerns.

Epidemiologist Nigel Dickson, of the AIDS Epidemiology Group at the University of Otago, told the seminar that around seven pregnant women each year are estimated to have undiagnosed HIV, a rate of 1.2 per 10,000. He cautioned that this is likely to be an underestimate and will change as the HIV epidemic evolves. This estimate is higher than the number of pregnant women diagnosed with HIV - 18 women had 19 pregnancies in the four years to 2001.
An average of one in four children born to untreated HIV positive mothers will contract the infection, which means that these undiagnosed mothers will give birth to one or two HIV positive children a year.
The push for routine HIV screening is driven by the preventability of HIV transmission between mother and child and the high emotional and economic cost of treating children with HIV. Lucille Wilkinson, of National Womenıs Hospital in Auckland, said that in the USA Œan enormous reduction in paediatric HIV infectionı had resulted from the universal offer of HIV testing to pregnant women, combined with treatment to prevent HIV transmission to the baby. ŒIdentifying pregnant woman who are HIV positive must become a priority,ı she told the seminar.
Paediatrician Simon Rowley, also of National Womenıs, said treatment for HIV positive children is expensive. Multiple antiretroviral drugs can cost up to $10,000 per child per year, and intravenous antibiotics for serious bacterial infections cost several thousands of dollars an episode.

Treatment for women and babies
Treatment for pregnant women with HIV usually involves multiple antiretroviral drugs to reduce the amount of virus in their bloodstream below detectable levels. Women are given additional drugs around the time of delivery, and a caesarian section is recommended. As breastfeeding can also transmit the virus, bottle-feeding is recommended from birth.
Dr Rowley said that at National Womenıs all babies born to women diagnosed with HIV are treated. They are given antiretroviral drugs in syrup for six weeks after birth, and then antibiotic syrup for another six weeks to prevent pneumonia. The babyıs GP is asked to avoid live vaccines. Babies are tested for HIV regularly, and if they are negative at four months the drug treatment is stopped.
Most developed countries have moved from pregnancy testing based on risk assessment to the universal offer of a test, said Dr Wilkinson. She quoted a UK study of services using the two approaches, which found that a risk assessment policy identified only 16% of HIV positive women, while a universal testing offer picked up 35%. Some overseas research indicated that routine testing diagnoses pregnant women with HIV on average two years earlier than non-pregnant women, enabling them to start treatment earlier, she said.
However, Norma Campbell told the seminar that the recent AGM of the New Zealand College of Midwives did not support routine HIV testing. Midwives, who currently do most routine antenatal screening, do not accept that they are Œnecessarily the appropriate practitioner to be undertaking pre- and post-test counsellingı for HIV, according to the AGM statement. The college was not confident that all factors about HIV screening had been addressed and wanted to see wider public debate, Norma said.
Norma and other speakers were concerned that routine HIV testing would require longer, more difficult antenatal consultations and change the emphasis of care. Nigel Dickson said that one of the arguments for routine testing is that it removes the need for maternity carers to make possibly stigmatising judgements about womenıs risk of HIV.
Sandra Coney of Womenıs Health Action said routine screening would involve testing around 20,000 to 30,000 women a year to prevent the infection of one baby. Screening coverage of more than 90% would be required to detect around seven undiagnosed HIV positive women, she said. ŒItıs hard to see that you could reach this level of screening coverage while respecting womenıs autonomy and not acting coercively. It would only take a few midwives working with high-risk women to not offer testing to make the whole exercise futile.ı
Sandra queried the assumption that ³we have to do universal testing because we didnıt do targeted testing very well. ŒThe very reasons that you didnıt do targeted testing may well be the same reasons why you might not do universal testing well.ı
She stressed the need to see HIV testing as screening which would require the same infrastructure, coordination, quality control and management as any other screening programme if it was to ensure that it reached its goals and minimised harm to healthy women.

Importance of pre-test counselling
Three speakers emphasised the need for careful and detailed pre-test counselling of all people having an HIV test. Kevin Hague, Executive Director of the New Zealand AIDS Foundation, said the NZAF did not have a position on antenatal testing, but that Œappropriate counselling is an essential component of the testing processı.
The HIV Futures NZ study found that 80% of the people sampled had received no pre-test counselling. Kevin said Œthat suggests that thereıs been a shift in peopleıs testing experience from inadequate to woefully inadequate, with more of an emphasis on post-test counsellingı.
He was concerned that discussion about bringing HIV testing into line with other antenatal tests actually meant dispensing with the counselling associated with the test. Pre-test counselling is important, he said, because AIDS remains highly emotionally charged, counselling prepares people for handling a positive result, even having a test for HIV can lead to discriminatory treatment, and for some people a negative result can reinforce unsafe sexual behaviour.
Nikki Denholm and Gerida Birukila, from the HIV/AIDS Refugee Health Education Programme, also stressed the importance of pre-test counselling for a condition that is highly stigmatised in African communities. They advocated testing couples together rather than individually, as whoever tests positive first can be blamed for introducing HIV into a family.
Several speakers were concerned about the cost of routine HIV testing. Kevin Hagueıs Œback-of-the-envelopeı figures suggested a cost of $100 for every negative and $200 for every positive test, assuming around 20 minutes for adequate pre-test counselling. ŒThatıs before any indirect costs like training and monitoring are taken into account. With 68,000 pregnancies a year, thatıs a very substantial, currently unfunded cost.ı
Nigel Dickson said that an efficient perinatal information system was needed to record clinical information such as Œhow many women are being offered and accepting this testı. The UK and other countries carry out anonymous testing of neonatal bloodspots to estimate HIV rates among pregnant women, but he expected this type of monitoring to be contentious in New Zealand. Lynda Williams, Co-ordinator for the Maternity Services Consumer Council, argued that it is Œan unethical and immoral use of scarce health dollars to spend $1 million plus a year on routine HIV screening to prevent one or two babies from being infected. It would do nothing to improve the emotional and physical health of 99.9% of the pregnant women in New Zealand and has the potential to cause a considerable amount of harm.ı

Where to from here?
The National Health Committee, which was represented at the seminar, will report to the Ministry on HIV testing in the context of antenatal screening in 2003. The Ministry will advise its testing policy after that. MOH staff are also preparing new HIV/AIDS information for health professionals. John Boyd hopes to commission more research about womenıs needs for information about HIV and infectious diseases and the needs of maternity carers.

The proposal for a trans-Tasman agency to regulate therapeutic products

The proposal to establish a trans Tasman Agency to regulate Œtherapeutic productsı raises interesting and sometimes vexed questions for consumers. Jo Fitzpatrick reports on some of these.
What is the harmonisation project? The goal of harmonisation is to establish an agency responsible for the regulation of therapeutic products in both Australia and New Zealand. Therapeutic products include prescription and over-the-counter medicines, medical devices and comple-mentary health care products - including dietary supplements, herbal and homeo-pathic preparations. New Zealand and Australia would both come under the umbrella of this agency with Œharmonisedı regulations for therapeutic products.
The areas to be covered by the regulations include pre-market testing and safety, approval to market, monitoring, setting quality standards for manufacturers and distributors and most aspects of marketing, labelling, advertising and post-market monitoring.
The level of regulation for each product is to be determined by the perceived degree of risk the product poses for the population. Individual products and manufacturers will all require licenses. A low-risk product may only need to be registered to receive a licence but higher risk products would require more rigorous standards. The agency will be funded by industry bodies to perform these tasks on a fee-for-service basis.
The Governance structure for the agency is a treaty signed and endorsed by health ministers in both countries (the Ministerial Council) and a board of five people including the chief executive. The agency would be answerable to both Parliaments and attorney generals and have offices located in both countries.

How is it supposed to work?
There is an underlying philosophy and a strong push for industry self-regulation models with government oversight by the proposed agency. These involve the industry setting up codes of practice and then monitoring code compliance. The role of the agency would be to oversee these processes and provide mechanisms to deal with breaches and complaints. The arguments for models of self-regulation are that industry pays much of the cost and they create a learning environment where the industry is responsible for setting standards and ensuring appropriate models of behaviour amongst its members. They are based on current NZ models, and in the advertising area are being vigorously promoted by the NZ Advertising Standards Authority, which operates in this way.
Womenıs Health Action has had some experience of laying complaints using these processes with the advertising Code for Therapeutic Products and the Code on Breast Milk Substitutes. Our experience is that agencies in this role get caught up in the process of Œhelpingı industry get it right. Complaints are seen as irritating, and subtle attempts are made to discourage the laying of them. It is not uncommon to receive patronising explanations around your perceived misunderstanding of the code. There is a culture which views findings of code breaches as a Œfailureı of the government body to teach effectively. Complaints procedures are often difficult, tedious and protracted. There is little incentive to complain as penalties are generally limited to a series of wet bus tickets ­ a formal apology, a promise to do better in future, a request to remove an advertisement (often gone for months anyway by the time the deliberation is made.)

Food for thought
A related agency following a similar model is the Australia New Zealand Food Authority (ANZFA) which was relaunched in Sydney in July this year as FSANZ (Food Standards Australia New Zealand). According to the press release from Trish Worth, the Australian Parliamentary Secretary, New Zealand was represented at the relaunching by Te Kumete Maori (a Maori food bowl) and it is unclear whether there were any New Zealand people present. One of the recurring concerns New Zealanders voice about the proposed new drug agency is the potential for a loss of sovereignty and control.
FSANZ is not a reassuring model in this regard as Australians dominate. The governance structure includes Australian states so that NZ is one voice in 22 or 23 on bodies such as the Ministerial Council and the Food Regulations Standing Committee; the Board of 12 has 3 New Zealanders. The organisational structure is heavily Australian with an Australian managing director who has four general managers reporting to him. Three of these have functional responsibilities related to the agencyıs work and the fourth is called simply general manager ­ New Zealand.
The Ministerial Council for the therapeutic product agency is more balanced but includes only two health ministers ­ one each for Australia and New Zealand. The proposed board is also very small with only five members and a built-in bias towards Australia. In cases of disagreement, the Australian health minister makes decisions on board members and three of the board members must be Australian residents. The agency is set up under Australian law and becomes an Australian agency in the event of dissolution.
In our submission, we suggest:

  • a larger Ministerial Council while retaining the principle of equal country representation;
  • inclusion of consumer representatives from both countries on the board;
  • the removal of Australian residential requirements;
  • a statutory obligation to consult with the community;
  • including consumer participation in decision making bodies and processes.

We also suggest basing the agency in New Zealand, making it a New Zealand responsibility and ensuring that while functions are shared evenly between the two countries, some are carried out in both.

The current status
The agenda for a trans-Tasman Agency is well advanced and it unlikely that we will be able to change the fact of it, although it may be possible to have some impact on the form. (See box: Time line for the Joint Therapeutic Goods Agency) The agenda has been pushed by Government officials working alongside selected Œstakeholdersı. For the most part stakeholders have been industry representatives and officials. The participation of New Zealand consumers in the process has been sparse and mixed. We have been represented variously by Grey Power, the Consumersı Institute and Womenıs Health Action. Australian consumers have been represented by Consumer Health Forum (http://www.chf.org.au/).

More concerns about the proposal
Drug regulation
All aspects of drug approval and monitoring are covered. Currently these aspects are handled in New Zealand by Medsafe, a business unit of the Ministry of Health, and by a number of committees made up of New Zealand doctors, usually of a high calibre. Drug monitoring in New Zealand is undertaken by the Centre for Adverse Reactions Monitoring (CARM) based at the University of Otago. Over the years, CARM has had difficulties in its relationship with the Ministry which has attempted to take it over, but the system is valued by doctors and it enjoys a world-wide reputation for having one of the highest reporting rates of adverse events in the world. Part of the reason for the relative success of the CARM system is its perceived independence from the Ministry.
The local Medicines Adverse Reactions Committee plays a role in advising Medsafe if it needs to take action over harms caused by drugs. Issues often have a New Zealand-specific dimension. For example, Medsafe took steps to warn women and doctors about the dangers of 3rd generation oral contraceptives, which were used in large numbers here (150,000 women). In Australia no such action was taken as it was not seen as a major issue because only 5,000 Australian women were using these OCs.
There are considerable concerns that if these functions are not locally run, the reporting rates of adverse events will fall, and that a trans-Tasman agency will be less accessible and less responsive to specifically NZ issues.
Complementary health care
The proposal includes complementary health care products and this is causing concern. Some members of the complementary health care industry argue that choice will be restricted and costs will escalate. (See www.choices.org.nz) Fears of excessive restrictive regulation are exacerbated by an existing Australian regime which is seen as draconian. The industry worked with government to produce a bill suited to New Zealand covering Œcomplementariesı but this has been shelved. New Zealand comple-mentaries are worried that they are seen as minor players/junior partners who will be subsumed and bullied by Australia and multinational companies who have already met the Australian requirements; and that real consumer and local industry representation is not involved in ongoing planning and implementation. Certainly representatives from the complementary sector at the advertising meetings are multinationals who are seen to have a trans-Tasman focus. The complementary sector also needs to be treated as a legitimate player within the field and allowed to make self determining decisions within the context of the agency. There is a feeling that they are essentially snake oil merchants and past experience has seen them targeted disproportionately. A recent revealing example has been the response to kavakava compared to the responses to HRT drugs. The alternative is to lobby to pull complementary medicines out of this framework altogether.

Worrying omissions
The proposed scheme covers a huge range of products and activities so there are efforts to exclude certain categories of product from the system. The tension arises around what should be included in pre-vetting processes and what can be left to be picked up in complaints processes. The exclusions relate to Œlow-riskı products (devices and complementaries) with the suggestion that they can be registered without any pre-vetting. Exclusions can also relate to categories of people. There is a proposal that advertisements to health professionals would be exempt from pre-vetting procedures The assumption is that problems will manifest themselves in the complaints system.
Womenıs Health Action has difficulty with some of the proposed exclusions. We were delighted to see that medical devices, such as unmedicated IUDs, breast implants, hip joints, pacemakers, heart valves, and so on, would be regulated. At present there is no regulation of these, even though this has been promised since a Ministry IUD Advisory Committee recommended action in 1986. Devices implanted or placed in the body can do serious damage before people complain or the problem is identified. There is no justification for treating devices differently than medicines.
We disagree in principle with excluding advertising for health professionals. We believe advertising is advertising no matter the audience. This is compounded by the broad definition of health professional being proposed by the Health Professional Competence Assurance Bill and the experience with direct-to-consumer advertising in New Zealand. We donıt believe that advertising is an effective medium for communicating quality information. Our recent HRT education campaign has revealed HRT prescribing practices which suggest that doctors need serious education and some oversight.

Consumer participation
Womenıs Health Action has been involved in the Expert Committee on advertising ­ partly because we have an active interest in direct-to-consumer advertising. We dis-covered the existence of the Experts Committee during our research for a paper on direct-to-consumer advertising. We were invited to attend the Expert Committee meeting in Auckland. At that meeting a number of participants commented they were pleased to see a New Zealand consumer representative. This meeting was being chaired by an Australian consumer representative who had been told there were no interested New Zealand consumers. We were then invited to attend a follow-up meeting in Sydney as New Zealand consumer representative.
WHA had a lively discussion about whether we would accept the offer of an airfare to Sydney on the basis that we were consumer representatives. We have some firmly held views and principles on consumer representation and felt uncomfortable about the issues of accountability around this process.(cf, www.womens-health.org.nz/consrep.htm) We had effectively inserted ourselves into the process at a late stage and, while consumers, did not feel we had done so as consumer representatives. There seemed to have been no clear strategy for the inclusion of New Zealand consumers built into the process. In New Zealand, there is no mechanism for engaging consumer groups at a national level and no consumer reference group available to nominate suitable people who will report back to the community. We have identified the need for this and have put forward funding proposals to establish a consumer network. These have not been funded. Our decision to accept was made because

  • We had an interest in the area and were well acquainted with the issues
  • The Experts Committee had few New Zealand voices and fewer consumer voices
  • The meeting would provide us with an opportunity to identify key issues for NGOs and consumers and report back to the community.

When we rang to accept the invitation, Medsafe made endorsement from the community a condition of funding. This was a difficult request given the problems outlined above, and was complicated by a one week timeframe in which to achieve this. We felt this request revealed a poor understanding of the community and the accepted processes for securing representational endorsement. We would like to thank National Council of Women, Platform, Grey Power, the Federation of Womenıs Health Councils and Auckland Womenıs Health Council for their written endorsement. We are currently preparing a report for these groups on the Sydney meeting. It will be available for general distribution and a copy will also be sent to Medsafe for distribution.
Consumers need to have their interests appropriately addressed in the governance and management of an agency dealing with drugs and therapeutic products. Decisions and processes have implications for the elderly, mental health consumers and groups such as AIDs survivors who have contact with heavy duty pharmaceuticals as part of their everyday lives. It is important that consumers have the opportunity to do this themselves and that consumer representatives have the ability to solicit input and report back to these communities. There is provision throughout the harmonisation proposal for consumer representation in the governance structure and on committees in the work of the agency. Australia has two accredited consumer advocacy groups but there is no such body in New Zealand. This means that when NZ consumer participation is proposed, there are a range of solutions to meeting the need. They range from ill-defined Œlayı participants to a nominee from the New Zealand Consumers Institute. Womenıs Health Action finds none of the suggested Œconsumerı representatives satisfactory. We would like a truly representative platform and a system of accountability and are working towards this. The first step is a consumer email list.

For more information on the harmonisation project, the official website is: www.jtaproject.govt.nz To be included on the Consumer email list for updates on the agency and/or a copy of the Womenıs Health Action submission, contact: fitzpatrickj@womens-health.org.nz

Time Line for the Joint Therapeutic Goods Agency

1993:
Memorandum of Understanding signed by the regulators in both countries (the Therapeutic Goods Agency in Australia and Medsafe in New Zealand) to allow for co-operation and information exchange.

1998:
Trans-Tasman Mutual Recognition Act was signed with therapeutic goods were specifically exempted.

1999:
New Zealand and Australian health ministers agree that harmonisation of regulatory requirements for therapeutic products was likely to be the best option under the Trans-Tasman Mutual Recognition Arrangement (TTMRA). The health ministers, with their trade and commerce colleagues, put a project to explore the viability of establishing a joint trans-Tasman therapeutic regulator as a priority on the TTMRA work programme.

December 2000:
In principle agreement to the establishment of an agency by the NZ Cabinet, subject to negotiation of satisfactory governance arrangements

July 2001:
In principle agreement by the Australian Government.

July 2001 to March 2002:
Policy development ­ focus meetings with industry groups, identification of options for regulation, consultations with trans-Tasman officials in Medsafe and TGA regarding governance and accountability options.

June 2002:
Discussion document released for submissions.

Late 2002:
Report back to ministers and governments for policy approval and legislation drafting instructions.

2003:
Passage of legislation through select committees and Parliaments. Signing of Treaty between the Governments

2004:
New Agency opens itsı doors

Sexual boundaries update

Jo Fitzpatrick reports on progress with the Medical Councilıs policies on sexual misconduct by doctors.
In December last year, the NZ Medical Council received an external evaluation report of its sexual boundary policy and processes. The report recommended over 100 changes to Council policy and these are under constant review and action by the Council. Updates on progress are posted on the Medical Council website and the second one went up in mid-September.
The Medical Council is revising its current statement on chaperones and has consulted with nursing groups and medical students to get their perspectives on acting as chaperones as a preliminary step in the process. They have started drafting a new statement and will be inviting comments from interested people. To register an interest, contact Chris Aitcheson on caitcheson@mcnz.org.nz. Ph 04 381 6793.
A related issue is that of developing a protocol related to third party complaints. These are third party reports of an alleged breach of boundaries by a doctor made by people who do not wish to be identified. Obvious examples of people who would make this type of complaint are practice nurses and other doctors who work alongside the doctor who is the subject of the complaint. Such complaints may be genuine or malicious and the protocol needs to deal with both possibilities.
There are plans for a widely promoted 0800 number to receive complaints and enquiries. This is due in September this year and the number will be advertised. The Council has also developed a Guide for Patients which includes some general information about sexual boundary issues. Currently , these issues are dealt with in detail in the publication ³Trust in the Doctor-Patient Relationship² and once current policies and processes in this area are updated a new series of pamphlets will be developed to deal with these issues.
The Medical Council will be making strong submissions on the Health Professionals Competency Assurance Bill and, in particular, on the Complaints Assessments Committees that are based on their own. They are unhappy with a requirement for the appointment of a legal assessor as this is optional in their system and they want an appeal process for complaints decisions rather than going straight to judicial review. They would also like the power to suspend a doctor when there is serious risk to patient safety.
The Medical Council has met with the Health and Disability Commissioner to review complaint recording practices with a view to standardising the process so that comparisons and analyses can be done across these organisations. They are also working with the Medical Practitioners Disciplinary Tribunal to ensure better monitoring of doctors working under disciplinary conditions.

Judge rules on third generation pills

A USA judge has ruled that third generation contraceptive pills carry no higher risk of venous thromboembolism (VTE) than second generation pills, ending a group action suit brought by 99 women against three manufacturers.
The women, who had strokes, pulmonary embolisms and deep vein thromboses, argued that the newer pills were defective products under the Consumer Protection Act.
Both sides had agreed that the case would fail unless the women could prove a more than twofold risk for the newer products. The judge reached his conclusion after reviewing the studies and testimony from 10 expert witnesses, and halted the trial eight weeks early.
The most compelling evidence was a Cox regression analysis on data from a Transnational Research Group study on oral contraceptives. The original transnational study found a relative VTE risk of about 1.7 for the newer pills. However the analysis included full lifetime oral contraceptive exposure for over 90% of the subjects and found no association between third generation pills and any increased risk of VTE.
The judgement is unlikely to resolve the controversy, which has raged since a UK safety committee issued a warning letter about the new pills in 1995. The judgement is available online at www.courtservice. gov.uk.

Privy Council allows Patient A case

A Privy Council decision has allowed Patient A (³Jane²) to take another case for exemplary damages against Dr Michael Bottrill for misreading her cervical smear results.
Janeıs first case against Dr Bottrill, before the inquiry, was unsuccessful.
The grounds of the council decision have not been released, but it overturns an earlier Court of Appeal decision that stopped Jane from having a new trial in light of the ministerial inquiry into the pathologistıs under-reporting of smears in Gisborne. The court decided by a majority that Jane needed to prove that Dr Bottrill was aware of the risk his conduct posed to her and deliberately or recklessly took that risk. The court found that the evidence did not go that far.
As well as Janeıs case, there is now a class action by 41 Gisborne women also seeking exemplary damages of $50,000 each from Dr Bottrill, the government and the health authority.
The Court of Appeal had previously commented that punishment of outrageous behaviour can be achieved by a modest penalty. The only previous award of exemplary damages against a health professional in New Zealand was for $10,000 in 1998.

Exercise most effective at preventing falls

A Melbourne study of more than 1,000 older people living at home has found that a weekly exercise programme was the most effective of three interventions at preventing falls.
The research, by the Accident Research Centre at Monash University, compared group-based exercise with home hazard management and vision improvement in a randomised controlled trial of over 70-year-olds in good health.
The reduction in falls among participants assigned to the exercise intervention seemed to be associated with improved balance. Neither home hazard management nor treatment of poor vision significantly effected falls.
However, exercise combined with home hazard management and improved vision produced the strongest effect, an estimated 14% reduction in falls. Seven people needed to be treated with the three interventions combined to prevent one fall a year.
Ref: BMJ 2002; 325:128

Hip fractures lower than predicted

The number of hip fractures in New Zealand from 1988 to 1999 was fewer than predicted in a major 1990 study, but researchers do not understand the reasons.
In 1990 it was predicted that hip fractures would increase from 2,000 in 1987 to 4,000 in 2011. However, a Wellington School of Medicine team found that 1999 figures were 20% less than this prediction as the hip fracture rate between 1989 and 1998 dropped significantly for all women over 65.
The research group speculated that four factors could have contributed to this ­

  • Osteoporosis prevention measures such as diets rich in calcium and vitamin D, and increased weight bearing exercise
  • Strategies to prevent falls and fractures in older people, including risk assessments of their homes and installation of hand rails, lighting, arm rests and other measures
  • A higher use of HRT, bisphosphonates or selective oestrogen receptor agonists
  • Population changes, including a 2.4% increase in the 65+ age group and a 4.6% decrease in the 85+ age group on that predicted in 1990.

Ref: NZMJ 2001;114:154-56

Breast screening decreases mastectomy rates

An observational study of the breast screening programme in Florence, Italy, found that the rate of breast conserving surgery increased significantly with screening, while the rate of mastectomy declined significantly.
Researchers at the Centre for the Study and Prevention of Cancer in Florence studied the results of the breast cancer screening programme in the city from 1990 to 1996. In this time almost 60,000 women aged 50 to 69 years were invited to have a prevalence mammography and subsequent screens every two years.
An average of 60% of women in that age group took part. Identification of early disease and breast conserving surgery peaked in 1993 as the mobile screening units completed the prevalence mammography.
In 1990 the rate of mastectomy was 1.08 per thousand women, whereas in 1996 it was 0.62. The rates of breast conserving surgery were 1.18 per thousand in 1990 and 1.87 per thousand in 1996.
This finding contradicts the view of authors of a recent Cochrane review of mammographic screening, who concluded that screening increased the number of mastectomies by around 20%, mainly as a result of over-diagnosis. The Florence researchers will follow these figures to find out whether the results are maintained.
Ref: BMJ 2002;325:418

Unwanted pregnancies in New Zealand

Six out of ten pregnancies in a New Zealand cohort of women under 25 were unwanted, according to interviews from 1998.
The cohort was made up of 966 participants in the Dunedin Multi-disciplinary Health and Development Study, born between April 1972 and March 1973. The results of the interviews were analysed by researchers at the Otago School of Medicine.
Of the women, 173 (36%) had experienced 289 pregnancies by the time they were 25. Twenty-nine percent (142) of the men had caused 225 pregnancies by that age, and 73% had not wanted their partner to get pregnant.
The proportion of unwanted pregnancies dropped as the cohort got older. Among women, 85% of pregnancies before age 18 were unwanted, compared to 47% in 23 to 24-year-olds. Pregnancies were also much more likely to be wanted if the parents were in an ongoing relationship at the time of conception, and this increased with the length of the relationship. For women the first pregnancy was less wanted than the second, but for men the pregnancy number was not important.
Not surprisingly, more wanted pregnancies resulted in live births, and more unwanted pregnancies resulted in abortion.
For women, unwanted pregnancies were more likely to be due to contraception not being used than to it failing. Those not in an ongoing relationship at the time of conception were less likely to use contraception.
People with unwanted pregnancies said they didnıt use contraception because they didnıt think about it, they had used alcohol, the male partner did not want to use a condom, women could not afford contraception or had concerns about side effects.
The authors concluded that most New Zealanders in their early twenties are sexually active but do not want a pregnancy. They suggest that interventions to prevent unwanted pregnancies need to be aimed at a wider age range, and there should be as much emphasis on preventing pregnancies outside established relationships as among teenagers.
Ref: NZMJ 2002;115:155-59

Women have less haemoglobin

A major study of more than 25,000 people in the USA has found that mean haemoglobin concentrations are lower in women than in men at any age over 26, and this is not due to iron deficiency.
The study, by researchers at the Scripps Research Institute in California, assessed white people in good health and excluded patients with diseases that might influence blood haemoglobin concentrations. It found an approximate difference of 10 grams per litre in mean haemoglobin concentrations at any given transferrin saturation or serum ferritin concentration.
The only other menstruating primates to have sex differences in haemoglobin values are macaques.
Ref: BMJ 2002;325:137

Obstetric intervention rates and ethnicity

Maori and Pacific women who gave birth at National Womenıs Hospital in Auckland from 1992 to 1999 had much lower rates of induction, prelabour caesarean section and operative vaginal delivery than other women, according to hospital researchers.
This supports a 1999 Ministry of Health report that showed a relationship between lower rates of obstetric procedures and Maori or Pacific ethnicity.
However, caesarean delivery rates for Maori and Pacific women at National Womenıs did not differ in total from those of other women. The lower rate of prelabour caesareans for Maori and Pacific women was offset by higher rates of emergency caesarean.
A hospital research team studied more than 43,000 first births of single children at the hospital, which were not preceded by previous caesarean section. Ten percent of mothers were Maori and 19% Pacific.
They controlled for factors including first or subsequent birth; maternal age, smoking; public or private patients; caregiver; hypertension; diabetes and preterm births. They were unable to control for maternal weight or the time of epidural analgesia. They concluded that lower rates of epidural analgesia for Maori and Pacific women may partly explain the lower rate of operative vaginal delivery.
Ref: NZMJ 2002; 115:36-9

Hysterectomy associated with urge incontinence

Women contemplating hysterectomy should be warned that the operation is associated with an increased risk of urinary incontinence, according to a Dutch study.
In 1999, 1,626 women aged 35 to 75 completed self-report questionnaires. The odds ratio for urge incontinence was 1.93 for the 209 women who had had a hysterectomy although the operation did not significantly increase the likelihood of stress incontinence.
The Utrecht University Medical Centre researchers attributed the effect to the surgeryıs impact on the detrusor muscle.
Ref: Br J Obstet Gynaecol 2002;109:149-54

Studies exaggerate breast cancer risk

The lifetime risk of developing breast cancer in individuals who have the BRCA1 and BRCA2 mutations might have been exaggerated in previous studies, according to USA research.
Early studies of the mutations examined high-risk families with multiple cases of breast cancer, resulting in very high estimates of 71 to 85% of carriers of the mutation developing breast cancer by age 70 years.
Recent studies used data from family members of women with breast cancer who were identified from population-based incident cases. This led to substantially lower estimates. However, the researchers at the Memorial Sloan-Kettering Cancer Center in New York said this is also subject to bias as all risk factors for breast cancer are over-represented in incident cases of breast cancer.
So they analysed eight studies of the development of breast cancer in patients with the mutation who were unselected on the basis of family history of cancer, and found there was substantial difference in the risk of breast cancer among individuals.
They concluded that a womanıs risk of developing breast cancer is associated with other risk factors as well as the mutation.
Ref: J Natl Cancer Inst 2002; 94:1221-26