A Plan Without Money is Tragic…

“This is a herculean endeavor,” declared CEO of the American Society for Clinical Pathology (ASCP) E. Blair Holladay on the launch of a telepathology laboratory in Rwanda. Why “herculean”? It was made possible by Partners for Cancer Diagnosis and Treatment in Africa (a coalition announced in 2015 by the US White House and also a Clinton Global Initiative Commitment to Action), led by ASCP and supported by the National Cancer Institute (NCI) and various industry partners. The collaboration of so many stakeholders in itself is a task not to be undertaken by the faint-hearted, but the outcome is a momentous one for a country deemed severely resource-limited: a laboratory with some of the world’s most advanced diagnostic systems, access to thousands of ASCP pathologist members through cloud-based systems, and a capacity of around 1,500 biopsies per day, versus 150 in a whole month previously. It’s understandable why Head of the Rwanda Biomedical Center/National Reference Laboratory, Jean Baptiste Mazarati, believes that “ASCP is giving the gift of life,” to his country.

This particular humanitarian initiative is just one of many that the American society is currently involved, but it demonstrates a clear commitment to improve cancer services in countries with incredibly poor diagnostic capabilities. In fact, ASCP has set itself quite an overall mission: to provide patients in underserved areas of Sub-Saharan Africa and Haiti (Botswana, Rwanda, Uganda, Haiti, Swaziland, Lesotho, and Liberia) with access to rapid cancer diagnostics and appropriate treatment – and within the next three years.

We spoke with ASCP Chief Medical Officer Dan Milner – recently appointed to lead the Partners for Cancer Diagnosis and Treatment in Africa coalition – to find out how he got involved in the gargantuan undertaking, what it takes to ensure sustainability, and what challenges he expects along the way.

When did you first become involved in humanitarian projects?

I began working in Africa in 1997 as a medical student in a rural village in The Gambia alongside an OB/GYN who ran a medical clinic out of his home. My most powerful memory from this experience was the feeling of helplessness because of the lack of diagnostics of any kind for every patient we saw. I greatly enjoyed this first glimpse of Africa, but was determined to return when I could actually make an impact.

My work in Malawi was particularly important to me. From 2000, I worked with Terrie Taylor on an autopsy study of cerebral malaria and continue to work with her for analysis of our robust data set. My exposure to the disease in its most mortal form reinforced my desire to always look for impact in my activities in global health. It was during these visits that I began working with the pathologists at the University of Malawi College of Medicine to review surgical pathology cases. From day one at the scope, almost every case I reviewed was cancer. Some years later, we pulled data from 1997 to 2007 for all surgical pathology and showed that 75 percent of the diagnoses were non-infectious – and most of those were cancer. Again, I felt helpless because I could see the problem: people have cancer, and need a diagnosis and treatment. But my hands were tied, and I could not do anything other than report what I was seeing.

How can we successfully provide service support to resource-limited countries?

There are three key elements that are very simple, but essential for success:

1. Partnerships. You can’t do it alone and you must have buy-in from a country’s partners, including the Ministry of Health (MOH), the pathologists, the hospitals or health centers, and the financial backers for the effort. Each country is unique in terms of who these partners are, which leads to...
2. Assessment. You can’t make an implementation plan without knowing what’s going on in the country. Who is there? What do they have? What do they need? These are questions that have to be answered by the country partners with guidance from external experts so that a culturally and politically acceptable solution can be created. And that needs…
3. Funding. Whether through donations of equipment or money, there must be fiscal support for a project because pathology is expensive – but not so expensive that we cannot justify the cause. In fact, a fully functioning anatomic pathology laboratory is one of the most valuable investments a hospital can make because of the value of tissue diagnostics across so many aspects of medicine. And it has immediate impact. But these are real dollar costs and physical or chemical processes that don’t have “work-arounds.”

Can you tell us about your success story in Rwanda?

As a faculty member at the Brigham and Women’s Hospital (BWH), I served as the liaison for Partners in Health (PIH) cases – biopsies from patients in PIH sites around the world that came to the Brigham for pro bono processing and review. We began with a trickle – a few cases a month at the most would be sent, which began to expand linearly and then exponentially as we became the primary diagnostic force for Rwanda and Haiti. By 2011, it was clear to the whole team (PIH/Dana-Farber Cancer Centers/BWH) that something had to be done for both Haiti and Rwanda from within. Cholera had just hit Haiti, and one of my mentors and funders, Larry Shulman from the Dana-Farber Cancer Institute (DFCI), sent myself and a colleague, Jim Pepoon (a pathology technical expert), to Rwanda to assess the situation. Six months later, a fully functioning anatomic pathology lab was opened. And now, it also has immunohistochemistry and telepathology, allowing us to bring a four- to six-month turnaround time down to five days. What I learned most from this experience was the following (a phrase that I recite frequently): “Money without an implementation plan is useless; an implementation plan without money is tragic.” We can turn the useless into the useful by rectifying this tragedy and acting for impact.

How do you ensure project sustainability?

The Partners for Cancer Diagnosis and Treatment in Africa initiative includes a medical education steering committee, as well as partners whose main mission is education. As noted earlier, an assessment of a country’s current and future needs for staffing is part of the process. Plus, we work with in-country schools and partners to ensure that there is a plan in motion to create the sustained workforce needed to do the work going forward. In a similar process (once again working closely with funders and in-country partners), ASCP creates sustainable budgets to support pathology work by making the business case for pathology, illuminating potential public-private partnerships, and working directly with the MOH of a given country to prioritize and value pathology services.

Let’s look at the sustainable delivery of telepathology services as an example. The initial stage of the project includes funding and delivery of equipment from our technical partners in parallel with the support of a team of up to 15 ASCP pathologists per country, who provide diagnostic support. The equipment itself has a finite life (~10 years or less), so we envision our involvement with a given country to be ~10 years. During that time, we monitor the plan and provide opportunities for training and education for the workforce. In addition, each country must have a national cancer plan, which should include pathology services across multiple sites. Wherever possible, ASCP will assist with the implementation through training, partner connections, and field-based support. The end goal is for there to be enough centers of excellence in cancer care to support 100 percent of a country’s population.

What are the main challenges when setting up a program in a resource-limited country?

We do encounter some locked doors. The key to these doors may be approval from a governmental agency, funding, personnel training, weather conditions, disease control, and so on. Sometimes these are predictable, so we do our best to get the keys in advance; for example, we work directly with the MOH when possible. Others cannot be foreseen (for example, the cholera outbreak in Haiti) and require patience and interim solutions until we can get back on track with our implementation plan. But, going back to my essential elements, if you have partners, have done an assessment, and have the funding, everyone actually wants the project to move forward and shares a common interest in finding the keys as quickly as possible. Without partners, assessments, and funding, the keys are likely lost to you forever and the project stops.

Is support from industry sufficient?

We need more support from many partners to help with all aspects of capacity, including equipment, personnel, and infrastructure – so industry is not alone. But we do need everything for standard pathology, including grossing hoods, tissue processors, embedding stations, microtomes, slide stainers and coverslippers. We need microscopes. We need storage equipment for blocks and slides. We need computers and software to manage the laboratory. We need reporting systems to get the diagnoses back to the patients and care givers.

It’s important to recognize that equipment needs must be balanced by what is most efficient – not just by what is cost-efficient. As an example, if you walked into a microbiology laboratory today, you would see lots of hoods, incubators, storage for biochemical tests, antibiotic discs, microscopes, and so on – the bulk of which would be for the identification of bacteria. You might also see a mass spec and/or an automated biochemical reader. If I were building a microbiology laboratory in a resource-limited setting, I would start with a mass spec and an automated biochemical reader. Those two pieces of equipment alone can provide an identification and antibiotic resistance pattern for more than 99 percent of bacterial infections, and they work on fungi, too. By leapfrogging the incremental older pieces and jumping directly to the most efficient current system, we can make massive improvements and have a great impact in resource-limited settings. Molecular tests that dictate therapy for cancers are another example. In our current iteration of the project, we are working with standard laboratories to use telepathology to provide diagnostics. But tomorrow, a tool could come along that solves cancer diagnostics for a certain group (breast or cervix, for example), and we would consider adopting that technology if its impact can be measured.

However, no single partner can provide sufficient numbers of any one item to meet all of the needs. We also need clinicians to be trained to identify cancer; surgeons to be able to biopsy or remove lesions; oncologists to be able to act on our diagnosis; and a cadre of ancillary health workers to support and care for our patients. Again, we have identified partners, but do not have enough to cover what we could do.

We either need to recruit more of the same kind of partners to expand what we can do, or publish what we are doing in a “how to” manner, so that others can create and execute similar approaches. After all, this not a competition nor a process to seek glory; it’s about providing care for people who need it, which we have a moral obligation to do.

How easy is it to recruit pathologist volunteers?

Telepathology has made it possible for many more people to be involved in these projects than previously. And although technical expertise is also needed on the ground, pathologists can provide a great deal of support remotely. ASCP pathologists and laboratory professionals also tend to have an overwhelming enthusiasm to do what’s right and to support patient care anywhere in the world. What more motivation does anyone need to get involved in an effort than to know that a project will save lives?

Your goal is for all cancer patients in Africa to have access to cancer diagnostics and treatment. How can this ambitious objective be achieved?

It requires functioning anatomic pathology laboratories with rapid turnaround time and accurate diagnostics, which ASCP plans to provide directly, with the support of its telepathology network. It also requires health systems that allow us to i) find patients, ii) screen patients, iii) biopsy patients, iv) understand diagnoses, and v) treat patients. These components are assisted by ASCP members’ talents, but also require a large, ever-growing group of partners from all aspects of the cancer spectrum, including clinicians, oncologists, surgeons, radiologists, Ministers of Health, Ministers of Finance, and the people of a given region.

For each site in the regions of Africa that we serve, we have three key goals to achieve:

1. that very first slide is scanned and viewed by a pathologist in the US from a new site
2. all slides will have a diagnosis, receiving average, within five days of collection 
3. the percentage of patients receiving treatment increases in line with the population covered by a given lab.

Our long-term goal is to show a reduction in mortality from malignancy in any given region – but that’s in no way easy. At first, we will expect mortality rates from cancer to increase, simply because patients who would not have previously presented to a doctor will show up (and likely at a late disease stage). As the systems are built and communities are educated about cancer, people should start presenting at earlier stages and mortality will start to drop very quickly – but it might take 5–10 years to get there.

How did it feel to be appointed CMO of ASCP?

As I have told my CEO several times, “this is my dream job.” Many people talk about leaving their mark on the world, which I find to be self-centered and not in the least humanitarian. I am, at heart, a humanitarian devoted to the elimination of poverty and equity across all human populations. I want to have an impact and know that my actions, activities, and interactions are saving people’s lives. Those people may never know what I (or the thousands of other people involved in this or other projects) have done to impact their life. But they have their life to live, which is hugely satisfying. Having the ability to focus on global health with our members and to work with them on a daily basis to create this and other programs is truly remarkable. Every day, I remind myself that I cannot take this work for granted and must give it my best – how low is the probability of me being in this role and in a position to do the things that we can do?

Having grown up in a small town in Alabama, I experienced poverty at an early age, both directly and indirectly. My father’s generosity, despite our own unstable financial situation, was an inspiration to me and left a very strong impression. I feel happy in my heart and comfortable in my skin when I can say, “I saw what was happening, and I did the best I could do to make it right.” That may be buying a meal for a homeless person, delivering school supplies to an orphanage in Malawi, or creating a diagnostics system for patients in Africa. But in all those settings, I feel the natural need to reach out and help others as best I can within my abilities at all times.

If you could fast-forward 10 years, where should we be?

I want a mother of three in rural Angola to notice a lump in her left breast and think to herself, “Oh, no big deal. I’ll go to the doctor this afternoon. He can take a piece of this lump and tell me what it is later this week.” I want pathology to be an afterthought. And that’s not that I want people to take it for granted, but rather I want them to understand its value and know that they have – and deserve – equal access to the care that they need.