Otago University's Tony Dowell and Dr Nikki Turner. Photo / NZ Doctor
Covid vaccinator training scheme raises conflict of interest questions, writes Kate MacNamara.
A spousal relationship at the heart of the Ministry of Health’s $16.5 million contract to educate the army of vaccinators to administer the new Pfizer Covid-19 vaccine raised red flags over the conflict of interest at the time but went ahead nevertheless.
In mid-2020, the ministry asked the Immunisation Advisory Centre (IMAC) — part of the University of Auckland — to put together a plan to roll out Covid-19 vaccinator education and training to both experienced healthcare workers such as registered nurses and GPs, and also to thousands of new provisional vaccinators, not otherwise trained in any clinical care.
A contract for the work was signed in February 2021, and it contained a considerable evaluation component, worth more than $2m the Weekend Herald understands. Health New Zealand (Te Whatu Ora) declined to release the value under the provisions of the Official Information Act (OIA), citing commercial sensitivity.
Most of that evaluation work was ultimately subcontracted by the University of Auckland to the University of Otago. A second subcontract went to the National Institute for Health Innovation (NIHI), also housed at the University of Auckland. All of the evaluation work was overseen by Otago’s Dr Tony Dowell, who, additionally and as a direct contractor to IMAC, helped shape the evaluation requirements decided upon in the first place. IMAC’s medical director, Dr Nikki Turner, is married to Dowell.
A series of emails between Turner and other university officials appear to suggest that the Dowell’s extensive involvement in the evaluation of IMAC’s work was contentious. The contract, within the small world of tight, and often publicly funded university budgets, was enormous, as was the need to win and keep public trust. The work would underpin a nationwide drive to vaccinate the vast majority of the New Zealand population with a new medicine.
But there are lingering questions about elements of that vaccinator training and education. And particularly, about whether New Zealand’s vaccinators, many of them not previously schooled in principles such as informed consent, received enough training to understand that the small risk of the heart condition myocarditis, once known, was one that required express disclosure to patients.
In the early hours of November 17, 2021, 26-year-old Rory Nairn died of myocarditis, at home and without seeking medical help, 12 days after receiving his first dose of the Pfizer vaccine. Following an inquest last September, the Coroner made the interim finding that Nairn’s fatal heart condition was vaccine-induced. By November 2021, myocarditis was a known, rare risk of the Pfizer vaccine.
The inquest heard that Nairn received no advice about myocarditis in advance of his vaccination by a Dunedin pharmacist and that vaccinators were subject to a complicated and confusing stream of vaccine information, updates and directives from various sources. The pharmacist said she didn’t know that myocarditis could be deadly.
The Coroner, Sue Johnson, has confirmed both that she requested written evidence from IMAC and that material written by IMAC, which was delivered to vaccinators, forms part of her ongoing inquiry into the circumstances of Nairn’s death. Her final report will consider whether his death could have been prevented and is likely to make recommendations.
In early October 2020, New Zealand signed its first vaccine deal with Pfizer, and a few weeks later IMAC and university officials were hashing out their approach to a huge vaccinator training contract with their client, the Ministry of Health.
Emails provided to the Weekend Herald from this time appear to show that Turner was pivotal in driving and developing the evolving contract and that she pushed hard to include Dowell in that work. In addition, dates show that she pressed ahead in working with Dowell well before the university had any system in place to manage the conflict (no documented system was ever put in place).
This has to pass the front page of NZ Herald and with the size it is now and the space its focused on, we have to manage the risk. The relationship is too close and others reduce the professional exposure for all.
But the closeness of the spousal relationship and the value of the contract, as well as the significance of the work, produced tensions.
On October 23, Toni Lamming, executive director of business units and part of the leadership team at the University of Auckland’s business arm, UniServices, and Turner traded emails. In those messages, Lamming pressed Turner to consider options other than, or in addition to, working with Dowell. All IMAC contracts ran through UniServices.
Turner wrote: “Thanks Toni — when we talked about it earlier we decided it was appropriate to continue to use Tony Dowell to help us develop the evaluation part of this proposal — he has considerable expertise in this patch and is currently undertaking an extensive multimillion $ mental health programme evaluation (Piki) with Ministry funding so he is very familiar with Ministry contracts and evaluation. So we have been developing this section today.”
Lamming replied with concern and some prescience: “Thanks Nikki — when we talked it was [a] much smaller role. Things change this week. We have a strong capability in UoA/AUL in this space who are also working on Covid-19 evaluation work. I would like Chris [Bullen, NIHI director] and Karen [Carter, NIHI general manager] involved in the evaluation — NIHI does this as its core capability and works a lot with MoH as well. We have well-proven systems so they need to work together.
“This has to pass the front page of NZ Herald and with the size it is now and the space its [sic] focused on, we have to manage the risk. The relationship is too close and others reduce the professional exposure for all.
“This is going to the Dean [Dean of Medical Science John Fraser] and DVCR [Deputy Vice-Chancellor Research James Metson] for signoff given the spend and size of it and brand exposure.”
In subsequent emails, Turner noted that it was her intention to work with NIHI as well as Dowell. Both Turner and Lamming declined to speak to the Weekend Herald.
At this time, Dowell was already working directly with Turner and helping to develop and shape the evaluation component of the MoH contract that would ultimately be awarded (in large measure) to Dowell’s university, for work that would fall under his oversight.
And it was with Dowell’s help that IMAC and the ministry decided on a heavily collaborative kind of evaluation which they described as “embedded”. UniServices said this kind of evaluation was never intended as an independent or outside type audit.
In May 2021, UniServices subcontracted the University of Otago to provide qualitative evaluation of IMAC’s training through January 2023. NIHI was subcontracted to do quantitative evaluation. And Dowell, a professor of primary healthcare at Otago, held overall academic leadership over both strands of the work. Both subcontracts were awarded without a competitive process.
Dowell and Otago more generally have expertise in health contract evaluation, but they are not the only experienced providers in the country. Others include the consultancies Allen + Clarke and Synergia.
The Weekend Herald requested correspondence related to the conflict of interest between Dowell and Turner from the University of Auckland. The above exchange, and others, were within the scope of the request but all were withheld in full, either to protect the sharing of free and frank opinion or to protect legal privilege.
The Weekend Herald obtained some of this correspondence and has agreed to provide the source with anonymity. The source expressed dismay over the conflict between the spouses, particularly in light of the large part IMAC’s vaccinator training played in the Government’s pandemic response. In 2021 and 2022, millions of New Zealanders received vaccination in the shadow of government mandates, and sometimes under the threat of losing jobs, schooling, housing, social contact and more.
Several sources told the Weekend Herald that Turner was viewed as the “rainmaker” for the ministry contract and powerful within government circles; overriding her wishes would have been very difficult, they said. Their identities have been withheld as they feared that speaking out would affect their careers.
In recent years Turner, who is also a GP and a professor in the Department of General Practice and Primary Care at the University of Auckland, has been in the thick of the Government’s pandemic response. She sits on a number of Covid response committees, and since last year has chaired the Government’s Strategic Covid-19 Public Health Advisory Group, which reports directly to Health Minister Ayesha Verrall. Turner and Verrall are friends, and Turner was present at Parliament to support Verrall when she made her maiden speech in December 2020.
Dowell’s direct work for IMAC began in mid-October 2020 and finished in January 2021, according to UniServices CEO Andy Shenk. Shenk said Dowell was paid $11,200 “in his personal capacity as a consultant” to help design the evaluation component of the ministry contract.
This work appears to have taken place with no written agreement at all. Shenk said that either a contract didn’t exist or that it could not be found. Dowell declined to speak to the Weekend Herald.
Shenk said, “the requirement to design the programme for the ministry was done at speed at a time when there was constantly new Covid-19 information, settings and situations. UniServices supplemented the team with trusted individuals who could support IMAC and UniServices to shape and cost the work.”
He said Turner was not involved in authorising payment to Dowell.
Shenk also confirmed that UniServices was aware of the spousal relationship and that discussions were held on November 13, 17 and 23 between Toni Lamming and “each of the spouses” regarding “the conflict of interest situation and how this would be managed going forward”. He said that while, “steps were put in place to manage the potential conflict, these were not documented in a formal management plan due to the speed with which everything was being carried out”.
Turner was not involved in any budget or contract negotiations with Otago, Shenk said, and she was formally distanced from involvement in the development and implementation component and did not attend meetings about evaluation throughout the contract.
He confirmed that the award of the evaluation subcontracts to both Otago and NIHI were made without contest, and again cited the difficult circumstances of the pandemic.
“We remain of the view that we put together an appropriate team to develop and conduct the embedded monitoring and evaluation,” Shenk said.
UniServices is now “reviewing and refreshing” its conflict of interest policy and procedures.
There is no record of a disclosure of the spousal relationship between Turner and Dowell to the Ministry of Health.
Shenk said it was verbally disclosed at a meeting on November 27, 2020, but no formal minutes were created and an informal record of the meeting does not note that the conflict was disclosed.
He said, however, that a senior IMAC member, not Turner, has, “a clear recollection of the meeting and is sure the ministry did not raise any concerns about the spousal relationship”.
The ministry was unable to corroborate this version of events. A spokesperson said the Weekend Herald’s questions would need to be considered under the OIA and Health New Zealand responded that no such information could be found.
The ministry contracted IMAC’s work in two parts. In December 2020, the ministry provided $500,000 on an urgent basis to allow IMAC to begin preparatory work and a main contract followed in February 2021, worth an additional $16.54m excluding GST. It ran from December 1, 2020, to December 31, 2022.
Karin Lasthuizen is a professor and Brian Picot Chair in Ethical Leadership at Victoria University of Wellington. In her opinion, the conflict of interest issues started at the outset: “I think the problem with this contract begins right at the very beginning, when the MoH goes to the University of Auckland and gives them a very big contract for everything, the delivery of this education and training and the evaluation of that work, which brings the University of Auckland into a position to subcontract its own evaluation work.
“Frankly, I find this form of embedding remarkable ... It would have been much better if the MoH had taken responsibility for outsourcing the evaluation itself. Because there’s always the risk that an organisation wants its reviewers to be kindly critical and that doesn’t look good in the public eye, whether or not the review has actually been sugar-coated.
“If the ministry had separated the vaccinator training contract and the evaluation component and awarded them separately, it might well have avoided these conflicts entirely: both the inherent conflict in the assignment and the potential nepotism.”
Lasthuizen’s view was that, even if Otago was still awarded the evaluation contract by the ministry: “we would have a clearer reason why the work went there and no suspicions would be raised that this is a husband-and-wife arrangement that seems to have been made at the kitchen table, and we could have kept our distance from the private lives of two renowned experts who turn out to be married to each other.”
Lasthuizen was also incredulous that neither the University of Auckland nor the Ministry of Health could provide documented disclosure of the conflict.
“Bureaucracies document things, that’s what they do. From what I understand, they knew there was a [potential] conflict of interest and I’m just amazed that there is no documentation anywhere. It’s very, very strange, and I don’t think it’s explained by the pressure of the crisis. Documentation is just in the basic DNA of these big organisations, especially public agencies.”
Set against the urgency of responding to the Covid pandemic, Lasthuizen said public trust also needed to be maintained, “even or maybe I should say especially in a crisis where far-reaching measures are being imposed on citizens ...”
IMAC’s vaccinator education and training still forms part of an ongoing coronial inquiry and may be considered in others.
The Government’s safety monitoring board has identified four deaths involving vaccine-related myocarditis, or where vaccine-related myocarditis cannot be ruled out. Two of these are awaiting a coroner’s determination. Seventeen other deaths have not been assessed due to insufficient information and a further two remain under investigation.
The big picture is that these deaths have taken place in the context of the administration of some 12 million doses of the Pfizer vaccine. Viruses also cause myocarditis, and the risk of myocarditis from Covid-19 itself is greater than that of the vaccine.
But vaccinators have an obligation to describe both the risks and the benefits of vaccination to patients before treatment. This typically takes the form of a conversation. There are ethical reasons for this and also the pragmatic likelihood that a patient who knows what symptoms to watch for is better equipped to know if they should seek treatment. Myocarditis is eminently treatable.
In a brief text exchange, the Weekend Herald asked Turner about the risk of myocarditis and the medical principle of informed consent. Turner confirmed that, “yes, vaccinators inform vaccinees of the potential for what signs to look out for — and yes, vaccinators are meant to inform of the risks [and] that is in the [IMAC] training and I understand it has been included [in vaccinator training] since the early international signals”. She declined further questions, saying she didn’t give the training but rather provided clinical advice.
Replying on Turner’s behalf, Shenk told the Weekend Herald that “although Dr Turner is usually able to provide public expert comment on vaccine-related matters ... the questions on myocarditis and consent may relate to broader matters that have previously been, or could still be, the subject of a coroner’s inquiry. We therefore do not feel it would be appropriate for us to comment on these.”
IMAC’s message to vaccinators about warning patients of the risk of myocarditis was unambiguous in its December 2021 “toolkit”, a booklet designed to help frontline vaccinators “on the day”.
Under the heading “Important Reminder”, it stipulated: “in order to gain informed consent from a consumer, the vaccinator must confirm the person has received adequate information about the vaccine, including benefits, the common side effects and the rare but serious adverse events, including anaphylaxis and myocarditis for mRNA vaccine ...” This version of the toolkit was released shortly after Rory Nairn’s death, and prior versions gave no such specific direction. The Weekend Herald has not made an exhaustive survey, but could find no instances, before December, where other IMAC material provided such clear direction to vaccinators, many of whom were trained before myocarditis was a known risk.
What is clear is that the risk was known, at least at a high level, months earlier. In June and July, the US Food and Drug Administration and the European Medicines Agency updated the product information for the Pfizer vaccine and indicated that myocarditis and pericarditis should be listed as side-effects. Medsafe also issued an alert.
Dr Samantha Murton, the president of the Royal New Zealand College of General Practitioners, accepted that including myocarditis in consent conversations could have come sooner. “But the trick”, she said, “is that at any time in responding to Covid, things could have been done better.”
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