Patients as Markets

Or, How to Make Money from the Bearers of Amyloid Plaques

Writing for The Hastings Center, Adriane Fugh-Berman argues that we shouldn’t give symptom-free people medications for Alzheimer’s disease. Why would anyone even think to do that? Well, if you can intervene earlier in the disease, maybe you can prevent symptoms. However, that idea stands on shaky ground:

The Alzheimer’s Association, in fact, recently proposed new diagnostic criteria that define Alzheimer’s “biologically,” using plasma biomarkers for amyloid plaque. Astoundingly, the association recommends that someone with abnormal amyloid biomarkers be diagnosed with Alzheimer’s – regardless of whether the person has memory loss or any other symptoms of Alzheimer’s.

The assumption is that people with plaque in their brains will eventually develop symptoms, and if they live their whole lives without ever developing cognitive issues then they just didn’t live long enough to experience their preprogrammed decline. This is not only wrong, but dangerous. Many people ages 65 and older have significant amounts of amyloid plaque, yet never have cognitive impairment. The connection between plaque and Alzheimer’s is unclear – while amyloid is a hallmark of Alzheimer’s, there is insufficient evidence to support the theory that it actually causes the disease.

This chasing after amyloid fits C. Thi Nguyen’s definition of value capture and subsequent value collapse. Some metric or marker takes the place of something more meaningful because it’s easier to measure, track, or digest by scientific inquiry or by a bureaucracy, and then it becomes the sole focus of activity. The presence of amyloid tells us nothing about how much support someone’s caregiver has; whether they have behavioral disturbances of dementia; whether they enjoy their forgetful days; whether their friends or children still visit them. The list goes on.

Pharmaceutical companies pour billions of dollars into designing medications that budge the surrogate marker’s needle without much thought about considering what really matters. This is more easily studied and fits more neatly within the biologically reductionistic disease model we currently have.

This isn’t new. It’s been going on in other fields for years. In the world of oncology, surrogate markers like progression-free survival (PFS), disease-free survival (DFS), and radiologic response rate have dominated research agendas and clinical decision-making. Oncologists may recommend cancer-targeted interventions that will influence their surrogate markers, even if the markers aren’t linked with any meaningful goal the patient actually has. The patient thinks they’re getting something that will help, whereas the oncologist is just doing what they do. The impulse to collapse values into measurable metrics has metastasized to how we’re seeing and treating dementia.

Regardless of the pathophysiology of Alzheimer’s disease, “the pharmaceutical industry would love to target cognitively normal people who have amyloid plaque because that’s a huge market–30%-to-50% of older individuals.”

For clinicians, this frame might be unsettling, but we need to see it. It encloses how health systems, pharmaceutical companies, and governments think about people in certain ways. When someone goes to see their doctor, they don’t just step into the role of patient; they’re also a customer. Sometimes, also, they’re a resource. Other times, they’re a liability.

Direct-to-consumer advertising attempts to subvert the therapeutic relationship by offering people medical interventions before clinicians can weigh in on whether it’s right for this person or not. People watching these commercials are possible customers before they ever become patients; indeed, the path to welcoming them as a customer is by making them a patient. There’s a deep interest in expanding the reach of a diagnosis to turn more people into patients and thus into customers.

That would be the implication of diagnosing asymptomatic people with Alzheimer’s disease with the aim of treating them. That might be the right move if some surrogate marker were clearly correlated with cognitive and functional decline and intervening on that surrogate marker actually modified the disease course to a substantial degree and without disproportionate burdens. We have yet to see any intervention do that yet, so it’s premature to suggest that we broaden diagnostic criteria for Alzheimer’s disease. Understood charitably, this might just be a lapse in judgment by people in the throes of optimism - we haven’t had a new drug in this space in a long time. But understood more realistically, we see an attempt to create a new, fruitful market.

Patients aren’t just customers, though. They’re also resources and liabilities. Let me speak to a domain with which I’m most familiar. In the USA, hospices are paid at a per diem rate for each patient they enroll. If a hospice agency spends less than that, they get to keep the extra money; if they spend more, well, too bad. Knowing what kinds of patients enroll in hospice, you might guess that some incur a greater cost to a hospice agency than others. Given that hospices are required to paid for all medications, services, and equipment related to the admitting diagnosis, this provides an impetus for why things like chemotherapy are disallowed, even if they’re presumably palliative in nature. They’re just too expensive.¹

For many patients on hospice, the most resource-intensive times are at admission (staff getting to know this person, deploying equipment, titrating medications) and shortly before death (staff are more involved, symptoms increase and you’re adjusting medications again). If you’re running a hospice agency where the average length of stay is only three days for highly symptomatic or complex patients, you’re likely to incur heavy costs. Contrast that with a hospice agency whose average length of stay is 3-5 months, where they may have some time to collect the per diem rate without much cost. There is a risk at the other end: if too many people survive to be discharged alive, Medicare may come knocking to collect money they determine the hospice agency has collected spuriously or even fraudulently. So there’s a sweet spot of length of stay in hospice admissions to keep an agency solvent.

I’m not a community hospice medical director, so I thankfully don’t need to reckon with these realities. But realities they are. Patients may or may not actually be seen as “resources” and “liabilities,” but as they’re considered and discussed, that’s what they become. Decisions about their enrollment and discharge are not only predicated on their own clinical needs but the requirements of the hospice benefit and the needs and resilience of the hospice agency.

Although I don’t work in the health insurance industry, you know these same calculations factor in there. A health insurance company wouldn’t be able to stay afloat if it only took on so-called “high risk” patients, paying out large sums for complex, expensive health conditions and had no one in their pool from whom they were just collecting premiums.

These two challenges - that of value collapse and of transforming patients into customers/resources/liabilities - are hidden snares of technological development in medicine. They show why Marc Andreessen’s Techno-Optimist Manifesto is too optimistic. He fails to account for the way that the tail can too often wag the dog. Not only that, but the resources required to handle technology wisely and well aren’t technically developed. There’s nothing in the market that constrains the fanaticism of pharmaceutical companies chasing after irrelevant surrogate markers; we’ve seen this in oncology, and we’re seeing it in dementia.

Is there anything we can do to change this? I don’t think so. As long as we live in a world in which money can be made or lost on people’s health, their roles will shift among that of patient, customer, resource, and liability. I think it helps to recognize with as much clarity as possible what institutions and systems are prioritizing which roles. We need to be honest with ourselves, for example, that some surrogate markers in some disease states with some therapies are not prioritizing a patient’s health but something else, whether it be a clinician’s anxiety, a biologically reductionistic myth, or a company’s bottom line. For those of us who work most closely with people to restore and support their health, we’re probably best positioned to behold them in their humanity. Who they are is far more than any one role they inhabit. We can advocate for institutions and systems that serve them as people.

1. This is made clearer in the care of veterans who can receive “concurrent care.” They receive hospice services paid for by Medicare, for example, and then can receive palliative cancer-directed therapy through a Veterans Affairs hospital. Because the therapy is paid for by VA, and not be Medicare, the hospice has no problem enrolling this person.