Research scrap reaches minister
Three years ago, government officials tried to discredit a critical piece of research that raised concerns about maternity care. The results were never followed up. Why? Michelle Duff reports.
Minister for Women Julie Anne Genter is demanding answers from the Ministry of Health after its apparent attempt to undermine a critical maternity study.
Stuff has revealed how ministry officials aligned with the College of Midwives to discredit the findings of an Otago University study undertaken by Professor Diana Sarfati and Ellie Wernham. The research found differences in outcomes between midwife and doctorled care.
This included the ministry sharing details of plans to cast doubt on the research, drafting a misleading and inaccurate press release obscuring the results, holding meetings with top university figures, and publicly questioning aspects of the study researchers had gone to lengths to explain.
Stuff also revealed the ministry appears not to have followed up on a November 2016 recommendation of the National Maternity Monitoring Group (NMMG) to establish a maternity research programme. In February 2017, the ministry told the NMMG it was considering working with the Health Research Council (HRC) to commission research proposals in maternity, and had discussed research areas. It then said it was forming a group to direct this work. But it did not produce any evidence this work had been done when asked this week.
Genter, who is also associate minister of health in charge of maternity, said she would be questioning Director-General of Health Ashley Bloomfield over the ministry’s treatment of both the Wernham study and Dr Bev Lawton’s 2016 research into perinatal mortality.
She would also be asking for an explanation about the research programme.
‘‘Given the significance of the issues, we need to know we are relying on the very best information, research, and assessment available and I expect the ministry to provide reassurance around that.’’
She acknowledged concerns around the ministry’s handling of the research, and said making sure mothers and babies received the best care was critically important. ‘‘I would certainly want to address any systemic issues having a negative impact on mums and babies.’’
The Wernham study found higher risks of poor outcomes for babies in midwife-led care. It said midwifery-led care could be optimal within well-organised systems, but there was an urgent need to evaluate what made them more or less safe.
Otago University Professor Peter Crampton, then the head of Otago University’s medical school, said the response at the time was disquieting. ‘‘There should have been more high quality research set up to explore the issues that were raised, and we should have been doing this from day one. The chilling effect of the response to the results basically means this hasn’t happened.’’
The ministry this week said it had not underplayed the results of the research.
The College of Midwives now has a new chief executive, Alison Eddy. She said she was not party to communication around the 2016 study, but that the college had entered into discussions in good faith. She was supportive of more research. Childbirth in the main is safe in New Zealand, with figures for mortality comparable to other developed countries like Australia and Britain.
In the months leading up to the release of a study which asked how safe it is to give birth in New Zealand, health officials were busy.
As a courtesy, researchers from Otago University had advised the Ministry of Health well in advance the study looking into maternity care outcomes would be coming out. Closer to the date, they provided an advance copy to the department.
The study found evidence to suggest all babies were not being born equal. Those in midwife-led care were at risk of poorer outcomes than babies in doctor-led care. The authors, Diana Sarfati and Ellie Wernham, were careful to point out their support for a midwifery-led system.
However, their conclusions were clear: the current way maternity care is provided in New Zealand is not as good as it could be.
‘‘It may well be that midwife-led care is optimal within the context of well-organized systems,’’ the authors wrote.
‘‘However, there is an urgent need to establish which aspects of those systems potentially make that care more, or less, safe.’’
In the months they knew about the study – and the nine weeks they had a copy of it – ministry officials did little to suggest they would take its findings seriously. Instead, an investigation by
Stuff has found the ministry actively worked to try and obscure the results. Communications in the months before the study’s release show staffers worked on how to avoid ‘‘fallout,’’ and in one case shared plans to discredit the study ahead of its release with industry body the College of Midwives.
The ministry this week rejected suggestions it underplayed the findings of the study.
But documents obtained under the Official Information Act show attempts to spin the results of the study and avoid the spotlight on the safety of the system, into which 60,000-odd babies are born each year. These were met with stiff resistance from Otago University.
Ministry officials took the unusual step of meeting with Professor Peter Crampton, then the head of Otago University’s Medical School and the pro-vice chancellor of health sciences. In an interview with Stuff, Crampton said it was clear the ministry felt the study was flawed. He disagreed, backing the university’s research.
The study made national and international headlines. The College of Midwives head Karen Guilliland and the Ministry of Health’s head of child and youth health Pat Tuohy openly questioned its findings. Two health academics from the University of Auckland issued their own media release pointing out perceived defects in the study.
Still, the message from the ministry was that it would be followed up. On the day the study hit the news, ministry maternity advisor Bronwyn Pelvin told Radio New Zealand the National Maternity Monitoring Group would consider the research and the next steps.
Sarfati had been expecting to attend a meeting of the group. But the day after the story broke, Pelvin emailed Sarfati to tell her the group’s agenda was now full.
‘‘This is a shame ... It would seem very important for the committee to have a good grasp of it,’’ Sarfati wrote, in response.
‘‘I would be extremely concerned if it was dismissed or the findings minimised on invalid methodological grounds. Ours is high quality, robust research and none of the issues raised publicly by either the ministry or the college in any way explain the findings.’’
No further research was commissioned.
The study fell from the headlines; Sarfati went back to cancer research, and former midwife Wernham is in her last year of training to be a doctor.
But Crampton, who has had oversight of hundreds of studies in more than four decades in academia, can’t forget.
‘‘I’ve never seen anything quite like it. The extent to which [the researchers] felt beaten up and traumatised by the experience was way outside of the normal,’’ he says.
‘‘There should have been more high quality research set up to explore the issues that were raised, and we should have been doing this from day one.
‘‘The chilling effect of the response to the results basically means this hasn’t happened.
‘‘In my view, this was more about the management of a contentious issue than a policy engagement with important findings.
‘‘If this area is too hard to research, then this is a big problem.’’
While all research was vulnerable to critique, the authors had been clear about the limitations of the research and to ignore the results was a mistake, he says.
‘‘The [ministry’s] response implied a problematising of the research in a way I found very unusual and disquieting. They viewed the results as highly problematic, and my general sense was that there was a considerable effort to explain them away.’’
THE RESEARCH
Most babies born in this generation are under the care of midwives. Around 93 per cent of prospective parents have a midwife as their lead maternity carer, which entitles them to a series of consultations during the pregnancy, attendance during the birth, and six weeks of postnatal care. If the pregnancy and labour are uncomplicated, then a woman might never see a doctor outside of her first GP appointment.
This has not always been the case. Before 1990, maternity care was provided by a mixture of GPs, obstetricians and midwives. Midwives were not allowed to practise alone. A campaign for autonomy in the late 80s – driven by the women’s movement and a push to de-medicalise childbirth – led to a new law, introduced by then Minister of Health Helen Clark, that gave midwives the right to practise independently.
The way the model was designed made it practically impossible for GPs to continue to provide maternity care. Most withdrew, and midwives now look after the vast majority of pregnancies.
Since 2005, the worst outcomes for mother and baby have been reported on by the Perinatal and Maternal Mortality Review Committee. It’s hard to compare across countries, but the PMMRC say New Zealand’s outcomes are similar to other countries like Australia and the United Kingdom. Giving birth here is, in the main, safe.
However, while neonatal death rates have been declining in these countries since 2007, ours has remained stagnant. The most recent report, in July 2018, highlighted a racial bias which means Ma¯ ori, Pasifika and Indian babies are less likely to survive or be resuscitated.
Problems with midwife shortages – particularly in rural and low-income areas – and an unsustainable working model for midwives which means long working hours, burnout, and insufficient pay have been long identified as issues.
Wernham and Sarfati’s study was the first ever to take an overarching look at the safety of babies within the current system. The differences she and Sarfati found were not small; across the five-year study of more than 244,000 babies, they found those in doctorled care had lower chances of poor birth outcomes.
This included 55 per cent less chance of oxygen deprivation during delivery, 39 per cent lower odds of neonatal encephalopathy, and 48 per cent less chance of a low Apgar score, a measure of a baby’s wellbeing after delivery.
There was also a lower rate of stillbirth and newborn babies dying under medical-led care. This link was statistically weak due to the small number of baby deaths in the five years covered – 1.84 per 1000 births for midwife-led care (410 total deaths, from 20 weeks gestation to the first 27 days of life) and 1.31 per 1000 births for doctor-
led care (27 total deaths) – but it was there.
Of course, comparing women with midwives as their lead maternity carer to those who have doctors is not necessarily fair.
After all, doctors – counting GPs and obstetricians – look after less than ten per cent of mums. It is very possible the types of mothers they see are different – mums who smoke might be more likely to see a midwife, while healthier mums might pay for a private obstetrician, for example.
The researchers knew these things could effect the results. So they used a mathematical model to account for factors like smoking, age, ethnicity, deprivation, and weight. ‘‘Women are not comparable, but the design adjusted for that,’’ says Otago University epidemiologist and emeritus professor Charlotte Paul, who has reviewed the research. ‘‘The authors restricted their population to women who were having single births and term births to make them more alike. Then they collected information on characteristics that differed between the groups and statistically adjusted for them. The results remained.’’
Though maternity was not Sarfati’s usual area, she knew any research critical of the system was likely to be controversial. A year previously her then-Otago University colleague, Dr Bev Lawton, had faced widespread criticism for her study finding the likelihood of a baby dying was higher with a first-year midwife. (The ministry did commission a study to try and replicate this; Auckland University’s Dr Lynn Sadler concluded the difference did not exist if higher-risk pregnancies were accounted for.)
For this reason, Sarfati contacted the ministry well before the study had been accepted for publication in Plos medicine, a high-ranked, peer-reviewed medical journal. Sarfati and Wernham met with Tuohy and Pelvin and went through the results both in person and over email, describing their methods and how they had carefully adjusted for bias.
‘‘In the end it didn’t seem to make much difference at all,’’ says Sarfati, now.
‘‘They had nearly a year to consider their response, and in the end their response was largely to discredit the research.’’
Initial contact between the ministry and Otago University researchers had been positive. In December 2015, Tuohy thanked Sarfati for her ‘‘ethical’’ approach, writing: ‘‘I think with careful handling it could be a catalyst for ongoing quality improvement in the maternity sector.’’
A meeting in June 2016 involved Tuohy, Pelvin, then-College of Midwives chief executive Karen Guilliland and advisor Lesley Dixon, and Sarfati and Wernham.
After this meeting, Sarfati and Wernham sent a joint email to attendees thanking them for the meeting, reiterating their support for a midwifery-led model of care and saying they were on board with avoiding media fallout and criticism of maternity care.
Shortly after this, the Ministry of Health’s communication staff contacted Otago University about ‘‘messaging’’. In the meantime, Pelvin and Guilliland were exchanging emails. ‘‘The Ministry understands that there are NO plans for any press releases to be made regarding the publication of the paper but we, yourselves and the University of Otago will have statements ready in case anybody picks the paper up,’’ Pelvin wrote. ‘‘We are likely to take a systems approach and support the system NZ women have and point to other markers ... my idea would be to raise questions about the women looked after by [obstetricians] compared to midwives and raise any other questions – eg. rurality or anything else they may not have standardised for.’’
But as publication neared, the relationship began to break down. The ministry drafted a misleading media release that questioned the study’s findings and contained inaccuracies, including that the study had found no differences in the death rate for babies who had midwife-led or doctor-led care. Sarfati pushed back against this, telling the ministry the study had been through vigorous scrutiny. She thought it best to push the point it was ‘‘good-quality, robust research’’ rather than argue about the merits of it.
Meanwhile, in mid-September, Sarfati was sent what she was told were notes from the College of Midwives’ national committee meeting, criticising the yet-to-bepublished research. ‘‘New research coming from Auckland midwife doing masters looking at ‘2 models’ of care in NZ that found that it was safer to have an obstetrician LMC. Once again flawed research that based information on wrong assumptions. Watch for publications – College and MOH prepared to address the concerning issues of this poor research,’’ it said.
Sarfati emailed the ministry. ‘‘Obviously this is a major breach of confidentiality. But perhaps more importantly and given all the communication there has been on this issue, it would be a real shame if this was the level of response to this research.’’
In the days before publication, Guilliland made it clear where the college stood. ‘‘We have ... done some investigation of the research and have found several issues with the analysis that makes many of the authors assumptions questionable and we will be vociferous in voicing these,’’ she wrote in an email.
She reiterated her views in a further email, also sent to ministry officials and several college staff. In it, she accused the authors of ‘‘scaremongering,’’ and bias, saying the study had a ‘‘lack of credible analysis and discussion’’ and ignored the better resources available to private obstetricians: ‘‘You do us all a disservice by ignoring these issues especially when you have no idea how to solve it. I remain disturbed at the naivety of the study and the unnecessary undermining in the absence of alternatives.’’
When the study landed in September 2016, the College of Midwives said the comparison between care was unfair, as midwives would look after more young, sick, and rural women. The ministry speculated that contributing factors could include that women under the care of midwives were more likely to be ‘‘younger, overweight, nonEuropean, to have higher deprivation and to smoke’’.
The study was also criticised for counting ‘‘midwife-led care’’ at registration, rather than birth. But Paul says this was the right comparison. ‘‘It’s about the package of care, and you would get bias if you compared them at the time of birth. If a midwife was caring for a mother, and there were some signs of risk where the midwife should really refer, it would always be the doctor with the high risk birth. If midwives referred appropriately, doctors would have more adverse outcomes.’’
In the weeks after publication, Pelvin emailed a ministry colleague dismissing the study and its data as ‘‘unreliable’’ and saying she had ‘‘no clue’’ how researchers obtained their results.
Tuohy sent a reassuring email to Guilliland saying that the study contained ‘‘major methodological flaws’’ and would ‘‘soon be consigned to the back pages.’’
Independent policy analyst and researcher Dr Jess BerentsonShaw co-directs think-tank The Workshop and is the author of
A Matter of Fact: Talking truth in a post-truth world.
She says the midwifery-led maternity model was a major policy change which, like many in New Zealand, was never evaluated.
‘‘We should always be exploring what models of care are working best for the people they are supposed to serve – mothers, babies, families – and that includes midwives themselves. We can’t shy away from it, shut it down, or pretend it doesn’t exist,’’ Berentson-Shaw says.
In maternity, with its historic power dynamics of a women-led profession fighting for autonomy, questions about the system were often not considered objectively. ‘‘There’s this feeling that you can’t critique maternity care without critiquing midwives. How has it got so unconstructive? How has this happened to the point that we cannot have a conversation about standards of care?
‘‘If we do this well, everyone wins. The evidence shows us midwife-led care can be really safe care, and if this is not always happening in New Zealand, how can we make sure the outcomes we know are possible are happening?’’
Guilliland has retired from the College of Midwives. New chief executive Alison Eddy says the college entered discussions with researchers in good faith. ‘‘Given previous experience, we also expressed concerns that the media may misinterpret the paper to criticise midwives and maternity care, potentially creating unnecessary anxiety in women and their families. The College of Midwives believes that there is an inherent gender bias that characterises some media representations of midwifery and maternity services negatively.’’
The college maintains the Wernham study used a ‘‘lower-level quality of evidence’’ with limitations because of its retrospective design..
However, Eddy agrees further research is necessary, to ‘‘more fully understand what is influencing the findings and unpick the reasons for these differences.’’ The under-valuing of midwifery, lack of maternity funding, higher-risk pregnancies and poverty undoubtedly has an impact, she says.
While Eddy wasn’t party to correspondence about the study, she says the college had the right to ‘‘constructively criticise and review research that ... is likely to mislead and cause unnecessary anxiety and distress’’.
Crampton says the only time he has seen such a highly sensitised response to a study in his career was when young researcher Neil Pearce found evidence asthma drug Fenoterol was causing an epidemic of deaths in the 1980s. In Pearce’s case, the drug makers set out to discredit the study and the government was slow to act.
Though Sarfati never spoke to the National Maternity Monitoring Group (NMMG) it did consider the study and recommend the ministry develop a ‘‘co-ordinated maternity research programme that recognises the need for improvements within an already high-quality ... system.’’
In February 2017, the ministry told the NMMG it was considering working with the Health Research Council (HRC) to commission research proposals in maternity, and had discussed research areas. It was forming a group to direct this work.
But two years later, in response to questions from Stuff, the ministry would not say if it had done any of this. Instead, it pointed to Lynn Sadler’s study, commissioned before the Wernham study by the last government, as covering off questions raised by the research. Sadler’s study is also a retrospective design.
‘‘We support the findings of Sadler ... that is, that graduate midwives in New Zealand provide safe care when comparing their performance with more experienced midwives. The message is that pregnant women in New Zealand can have confidence in our midwives. When compared internationally, New Zealand women receive excellent care.’’
Asked if it felt properly able to assess research without undue influence, the ministry said its advisors are constantly working with sector groups and researchers."The free and frank exchange of ideas and information is essential to developing better understandings within the sector. We believe our advisors fulfil their obligations in this regard."Its meetings with university staff were not unusual. ‘‘We respect their work and value our relationships with them as with other tertiary institutions. Regular meetings are part of all those relationships.’’
Sarfati doesn’t know what she could have done differently. ‘‘It was so draining and exhausting and seemed to have so little effect, and it was so stressful personally. It had a big impact on Ellie and me for quite a long time, and despite all our efforts it had no impact at all.
‘‘All we were trying to do was evaluate this major policy change that had happened. We have a really unique system in New Zealand, and the research they use to support it is based on systems completely different to ours. It was an attempt to look at that.
‘‘It suggested there were problems, which isn’t to say the entire system should be thrown away, but you need to address them like any professional group should.’’ THE AFTERMATH THE BREAK DOWN