I inevitably talked myself into a solution and sure enough, in the middle of a sentence, I realised that all I wanted was for Sam to stop promoting the MDA with the full weight of his charm. We needed to explain that we were not rushing in with a pre-determined plan but first consulting widely.
I also realised I wanted to push back on the critics. Development and empowerment were easy to recommend but much harder to deliver on the ground and required serious long-term commitment. Short-term solutions were still better than rhetoric.
I got off the phone with a measure of hope.
•
Later I learned that senior doctors in the Northern Territory had discussed the ivermectin MDA proposal and had raised concerns about the large-scale use of ivermectin.
At the time, ivermectin was not approved by the Therapeutic Goods Administration (TGA) to be used for scabies in Australia. So even though the drug had been approved for use against the worm strongyloides and was widely considered very safe, the fact that it had not been approved for scabies and there were still questions about its safety at the extremes of age (the foetus, the very young and the very old) was fuelling my gaping doubts. The precautionary principle dictates that if safety is unknown, caution is appropriate unless overwhelming benefits are clear. The MDA would dose an entire population, the majority of whom would not have scabies at the time.
Internationally recognised infectious disease specialist Professor Richard Manis had also raised his concern about the unregulated use of ivermectin. There had been questions at one stage about whether the drug, which was a neurotoxin, could cross the blood–brain barrier in certain situations and cause adverse effects. He argued for the compilation of safety data from developed countries where there were robust systems in place to monitor adverse effects after the drug had entered the market. As a result some Northern Territory clinicians were understandably reticent to take part in the program.
Developed by MSD for the control of parasites in veterinarian and agricultural use, ivermectin had not been widely registered for human use by the company due to the small market value of the diseases it targeted. Scabies and parasitic worms, which were predominantly issues of developing countries and disadvantaged settings, affected populations with little ability to pay.
Manufacturers have little incentive to conduct clinical trials or pay for the drug registration process for the many neglected diseases with large public health implications but small market values. This results in so-called orphan drugs with no manufacturer to shepherd them through to the market.
MSD had understood the corporate social responsibility (CSR) value of releasing the drug for wider use in the developing world and had donated geographically restricted licences for its use in onchocerciasis (river blindness) to the World Health Organisation (WHO). As patent activists pushed companies to spend millions to test and register orphan drugs important to developing world populations, holding onto ivermectin was potentially a financial liability. Donating the licence for ivermectin (or Mectizan) to the WHO was a smart financial and CSR move. It was also the right thing to do.
So the drug was not licensed in Australia for use in scabies, and the full gamut of adult and paediatric trials that a drug manufacturer would normally submit for approval from regulators such as the US Federal Drug Administration (FDA) and Australia’s TGA, had not been done.
The Aboriginal sub-committee of the Pharmaceutical Benefits Advisory Committee had asked MSD in 2004 to submit a formal TGA application for ivermectin to be licensed for use in scabies. There was no doubt a simple oral tablet would be a more convenient treatment than a whole-body cream, and convenience usually increases compliance.
In response, MSD had hired a consultant to develop a TGA application, but the submission was sent back even before formal review because it did not have all the information required by the TGA. By now it seemed the project for a drug with little market potential had been buried.
As we moved from the highly controlled clinical trial on Galiwin’ku to a program deployed on a large scale, there was a real possibility of accidentally dosing a pregnant woman or a child under the age of five. If nothing else, until the drug’s safety and efficacy in scabies had been appropriately recognised by the TGA, mass deployment of the drug lacked legitimacy as our primary strategy and would drop a new philanthropic organisation into dangerous waters. We had to wait for the Galiwin’ku trial to complete and push MSD to submit to the TGA any safety data it had available from other developed countries.
•
However, momentum was building for the ivermectin MDA, in part due to reporting in the national press.
ABC Stateline featured a story about the Galiwin’ku MDA and the One Disease ambition to take it across Australia. There were also stories in the Sydney Morning Herald and other national broadsheets. Journalists did not ask for details on how a ubiquitous parasite could be eliminated from a wide geographic region without a vaccine or a means to change the rate at which infections spread (the reproductive rate).
But I obsessed about these risks. This was normal for me and served me and the populations I had worked with well—it meant a focus on first doing no harm. What was not normal for me was a rising fear that we should not be entering this space at all.
At one of the nutrition programs I worked on in Niger in western Africa, women and children walked up to three days to take advantage of the services we offered. There was such a dearth of health care that almost anything was better than nothing. But that was not the case in Arnhem Land where the population had been subjected to an unceasing procession of studies and programs.
As I packed to fly to Galiwin’ku I had palpable doubts about the wisdom of running yet another program. Richard Trudgen, author of Why warriors lie down and die, argues a loss of control over people’s lives underlies a lot of the poor health he saw in the Yolngu. Even if scabies rates went down, would a large-scale, timeline-driven program imposed on people leave them feeling even less in control of their lives? Would we be able to live up to the guiding medical principle of primum non nocere (‘to first do no harm’).
4
FIRST TRIP TO GALIWIN’KU
In early April 2011 I arrived on tiny Elcho Island, barely off the coast of northern Australia. My tiny plane landed on the dirt strip and dropped me off at the gate of the airport where a small group of people sat on wooden benches under a tin shelter, waiting to take the return flight to Darwin. I was met by Annie Trent, the nurse and PhD student coordinating the pilot ivermectin mass drug administration (MDA) of the Northern School of Medical Research (NSMR), and she drove me to her makeshift operational centre housed in an airconditioned sea container.
Annie travelled to Galiwin’ku frequently to oversee the MDA and today I watched her set up marquees, organise staff to complete consent forms and take blood, siphon women off into a tent for pregnancy screening and monitor the ingestion of ivermectin for every Yolngu over the age of five years, except for those with positive pregnancy tests. She had been given permission by the Human Research Ethics Committee to test and treat every single Yolngu on the island and the surrounding satellite homeland communities where many families had second homes. Young children and pregnant women were treated with scabicide creams instead of ivermectin.
My clothes clung to me in the sticky heat and I could feel the red dust, gritty on my skin, as I tried not to get in the way of the frenzied activity. The cognitive dissonance had been building inside me and I told myself to stop ruminating and concentrate, but as the afternoon wore on I began to feel disoriented.
Annie was efficient and confident. When somebody didn’t turn up she simply moved to plan B. She chatted to me as she worked, trying to cover everything she thought I might need to know in order to expand the program across east Arnhem Land. To her it seemed simple and straightforward but I began to feel as though I were watching Annie through a fog.
Although it was professional, organised and efficient, the Galiwin’ku NSMR study
did not seem to be a valuable template in building bridges for sustained action. The Galiwin’ku clinic manager, Brett, was staunchly against the project, and the homeland health organisation was not very interested in helping.
The next day I began introducing myself at the local health centre and other vital community agencies, such as the school and shire office.
Each of these agencies were run like local fiefdoms. The managers didn’t care what qualifications I had or about the details of my scabies proposal. One’s worth depended almost entirely upon the number of decades you had survived in remote work without running home to the suburban comfort of a capital city.
Old-time government services managers had open scorn for each new group of aid workers that flew in looking to ‘save’ Aboriginal people. The newbies would soon leave, often with their tails between their legs and their good intentions thoroughly destroyed. Each manager seemed to enjoy taking a punt at the time I would take to break down and fly off home. They tested me at first greeting by going through a laundry list of reasons why the program was not wanted and was not going to work, and why they would not help.
I shifted uncomfortably. Each of the neat offices felt familiar. Other than some local art on the walls and the occasional Yolngu employee I could have been back in Canberra. My sweat began to cool in the airconditioning and I had to peel my jeans from my legs each time I stood up. Nobody who stayed more than a few days on Elcho Island wore long pants.
I spent the next few days helping Annie and the NSMR team with their work and getting to know the community staff involved in the program. When the MDA trial ended, I was to hire the same staff to work on our program. But a sense of desperation settled upon me as I imagined deploying this MDA across 30,000 square kilometres of sparsely populated country to reach 10,000 people. A slow, thudding ache stretched across my temples.
It wasn’t the logistics of dosing 10,000 people; I had been part of disease outbreak teams that reached a million people in a matter of weeks with vaccines that required cold chains (continuous refrigeration) in far more remote settings. An ivermectin MDA would be relatively simple.
No, I was beginning to realise that the biggest obstacle would be the baggage of past failed programs: the politics and the difficulties in building the relationships required to get the support we needed on the ground. Every single step of the way required agreements that in turn depended on having established long-term relationships. I knew I could find all the help and expertise I needed but I wondered what hope I had of sticking to the NSMR program timelines when time here was measured in units of trust, and past programs had trained people to be extremely wary.
Relationships with community staff and community leaders were vital but even before we could reach them we had to get past the gatekeepers of remote communities: the clinic, shire, school, homeland organisation and community and government officials who had control over the entry permits, accommodation, vehicles and the community workforce that was essential to open doors and connect with families in language. Each had the clout to stand in the way of newcomers.
•
Annie covered these local gatekeepers during her running commentary: ‘Be careful of the managers of the shire, clinic and other agencies. They can make or break your work and can do so over personal differences. You’ll have to get their support for your work so you’ll want to get the politics right.’
Towards the end of my first week on Elcho Island, Brett, the manager of the Galiwin’ku clinic, had organised a training session for staff. Semi-regular healthy skin days had been run in the Northern Territory for decades and in some communities had been documented as reducing scabies rates. Oliver Sinclair, a regional environmental health officer, would also be attending to offer his support to the group of Aboriginal community and health workers preparing for their next healthy skin day. I tagged along as well. But things did not go smoothly.
Five minutes into the session, after I had been introduced as ‘a researcher from that ivermectin MDA being run by the Northern School’, Bruce, a male health worker, raised his hand. He said he was asking a question on behalf of Wakanawuy, a quiet, sharp-eyed Aboriginal health worker with decades of experience in the clinic and a seasoned organiser of healthy skin days. The man said Wakanawuy (who was also present at the meeting) had told him to ask whether she and the other Aboriginal clinic staff had to work with me and the Northern mob on this ivermectin MDA. After he posed the question for her, Wakanawuy finished off by saying she didn’t need me or any other outsider to tell her how to control scabies as they had been running healthy skin days for years, that worked just fine, and they didn’t want to be part of another Northern School research project.
‘They just come here, do their studies, get their certificates and PhDs and we get nothing!’ she complained.
I wanted to disappear.
Brett, clearly delighted, stopped the training session and turned to me for a response. I blurted out something about my visit being part of a new program but that my first objective was to come and listen to what community leaders and staff felt was the best way to reduce scabies and the resulting health conditions. I said my first task was to filter back to Sam and the organisers of the project the thoughts of staff and families on the ground, so I was keen to hear their concerns. I also clarified that my program was not a research project and that a key partner was Miwatj Health, the local Aboriginal-controlled health organisation. My words rang hollow in my ears given the momentum that was behind the MDA and the timelines for dosing that I was expected to follow. After the session I retreated to my sparse container room and flopped onto my bed.
The more Tanya and I researched and the more we learned the more we realised that the scabies program was never going to be just about scabies. There is no neutral ground in the Aboriginal health space.
Australia has been settled for at least 40,000 years but some claim the continent was populated as far back as 120,000 years ago.
Much of Yolngu history is stored in the heads and hearts of those who lived through it or learned the songs and stories from their ancestors. Macassan fishermen visited and traded with the Yolngu for centuries, so the people of east Arnhem were skilled diplomats and traders. But they were unprepared for the arrival of pastoralists in the late 1800s, who began clearing out Aboriginal clans to make way for grazing.
Large swathes of Arnhem Land remained untouched by the new arrivals until the early 1900s when missionaries gathered Yolngu together into mission settlements away from traditional lands. Eradication had given way to paternalism. By the 1930s the government had introduced its assimilation policies, separating children from parents, and parents from their own sense of agency. Assimilation became integration and in 1962 Aboriginal Australians became entitled to vote. The 1980s introduced a period of self-determination but in 2007 the government’s new intervention policy suspended the Commonwealth’s Racial Discrimination Act 1975 and took compulsory leases over many communities. After tens of thousands of years developing specialised expertise and agency in their own context, the rules of the game for the Yolngu had radically changed six times in two generations.
I was lying on my bed in a cramped sea container when I should have been learning how to run a scabies mass dosing program, because by forging ahead with this MDA I was convinced I would be adding my weight to the burden of despair that belongs to people who have little control over their lives.
I pulled out my smartphone, flicking blankly through names and messages. I had better phone coverage on this remote island than I had in much of New South Wales. I had snuck into my ‘donger’ to hide but it was early afternoon and I should have been at work so I turned on my laptop to look at emails.
I had called Tanya the night before and told her we were supposed to be a team and I needed her input. When she asked what I needed, I told her the steering committee wanted an operations plan. She had sat down at the computer, a blank screen in front of her, and started writing. I soon realised
my request had been absurd, but I was drowning up there.
One of Tanya’s greatest talents is dreaming up visions of possible futures but even she knew there wasn’t much anyone could plan, yet. Everybody spoke about community consultation and engagement but so far that part hadn’t happened. It didn’t matter if the plan was designed in the airconditioned offices of world experts or in her parents’ cosy lounge room late one night far from Arnhem Land by somebody who had never once been there, because nobody knew what the people who suffered from scabies wanted to do about it. And the Yolngu had lived through enough programs to know when somebody was really ready to listen and when they were already on their final draft of the operations plan.
Later that afternoon I skulked into the office and sat at my laptop, looking busy. When everybody else had left and Annie was packing up I looked up.
‘Annie, I don’t know how you do this: this frenetic pace, juggling fifty things at once and the constant opposition to our work, but never losing your cool. I just can’t . . .’
‘Hey, we had a great day! It’s all about the people, just keep that in focus and you’ll be fine.’
I nodded dumbly, unable to look at her.
‘Listen,’ Annie sat down beside me. ‘The clinics are the health service providers, and the shire looks after the houses and maintenance issues. For a healthy community you rely on good living conditions, right? So if the scabies program could just come in and get the scabies rates down then the health services and shire could absorb the rest of the work.’
‘Isn’t that sort of what Nicky was saying?’ Nicky Walker was the expert who was advising Annie on the environmental component of the Farewell Scabies program, but she had just withdrawn her support because the program seemed focused on a medical ‘magic-bullet’ model.
I ran my fingers through my hair. Almost to myself I said, ‘Sam told you to think big and so on top of the national eliminate scabies MDA idea you put washing machines, new beds and environmental stuff into the plan and then Nicky got interested. Then Miwatj, the regional health service, signed on because of the environmental components and the practical benefits to families. And then the Northern Territory Department of Health agreed to get on board.’
A Doctor's Dream Page 3