When Science Fails: The Promise and Limits of Precision Medicine

Featured

For centuries, humans have used science to explain their world. From the principles that suspend the planets in orbit to the relational pull of predator and prey, we turn to science to both examine and rationalize the experience of life. But does our reliance on science have a limit, particularly in medicine, where the “why” of disease can often escape scientific explanation?

For example, historically, medicine has poorly understood why one person gets sick and another doesn’t, particularly for complicated illnesses like cancer, diabetes, or heart disease, where multiple factors contribute to risk. Similarly, it’s been difficult to pinpoint why one medication works well for one person but not another.

And in the case of social determinants of health, medicine has yet to chart the physiology of disadvantage. That means, while we know poor people tend to be sicker, we don’t fully understand how poverty and discrimination manifest physiologically to produce disease; although there are exciting theories about stress hormones and organ function.

And so the why has evaded us, until now.

In January 2015, President Obama invested $215 million in a national Precision Medicine Initiative to use what science knows about the human genome to personalize the way doctors diagnose and treat disease.

The idea is that by using a wide range of biomedical information — including molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters, physicians and scientists will have new tools to understand disease and determine the treatments that work best for each individual’s illness and DNA.

With such a sizable investment from the Obama administration and the partnership of trusted institutions in the scientific community including the National Institutes of Health (NIH), National Cancer Institute, and the Food and Drug Administration, this Precision Medicine Initiative promises to improve the diagnostic strength and treatment success of modern medicine. The significance of that promise cannot be underestimated.

But as we turn to science to answer the elusive why, we have to be mindful of where science has failed in the past. This is to set reasonable expectations but also to avoid repeating past mistakes. So as we move forward, here are 2 things to keep in mind.

First, as we narrow our focus from the population to the individual, it may be easy to overlook the way certain diseases are disproportionately prevalent in certain communities. If we then, limit our evaluation to the individual, their DNA, and their illness, we may miss the aggregate data that compels us to also investigate disease at the community level, where local resources and public policy may profoundly shape disease patterns and prevalence. Which is to say, while some disease is best explained from the lens of a microscope, other disease is best appreciated with a panoramic view of the environmental conditions in which that disease persists.

Second, to capture enough data to understand the human genome, the NIH and its collaborators are aiming to enroll 1 million American volunteers in the Precision Medicine research cohort. But a study published in 2014 found that non-whites account for less than 5% of clinical trial participants. More specifically, of the 10,000 clinical trials reviewed in that data, only 150, or less than 2%, focused on a racial or ethnic minority population.

So, if the Precision Medicine cohort is anything like the clinical trial cohorts from the past, women, minorities, and the elderly may be underrepresented; not to mention undocumented “non-Americans” who are generally excluded from scientific research. That means, while some patients will receive care uniquely tailored to them, women, minorities, the elderly, and the undocumented, may get care that was studied, tested, and developed, mostly for young white men. So as we endeavor to improve our understanding of human biology and disease, we have to make demonstrated efforts to enroll those science has historically forgotten.

Probing the human genome for the answers to medicine’s greatest questions will almost certainly lead to innovations and improvements in the health of our population. But as with most innovations, without careful and thoughtful execution, the impact may be limited. In Precision Medicine, we risk continued exclusion of certain populations from the benefits of science. This is when science fails, when it is unable to capture the breadth and meaning of the human experience. So if Precision Medicine does not couple its inquiry into DNA and disease with an equally rigorous examination of the biologic imprint of social stress, poverty, and discrimination, we may be no why-ser, than when we started.

Advertisements

Is Scalability Overrated?

Featured

Scalability is the end goal of nearly every tech start-up, systems innovation, and teenager you-tubing their cat – it’s going viral, business-style. And traditionally, it’s been seen as a marker of relevance and success. Growth is good, right?

But in healthcare systems transformation, do we lose something meaningful when we measure the value of our work by its national impact?

Take Iora Health, a new healthcare venture out of Massachusetts that contracts with large companies and insurance plans to provide care for employees or insured patients. Iora clinics have a for-profit model and are seeking to capitalize on saving money. They charge companies and insurance plans monthly fees and in turn endeavor to keep their patients out of hospitals and emergency rooms, the most expensive places to receive care. If they successfully prevent costly services, and save their company or insurance plan money, they take a percentage of those savings as profit.

The Iora model is essentially beefed up the primary care services offered in the comfort of a patient’s community, sometimes even as convenient as a local shopping center. They argue that by providing health coaches, lower doctor-to-patient ratios, around-the-clock availability, excellent customer service, and unlimited visits per patients, they can effectively manage most chronic illness before it progresses and requires hospitalization or emergency services. Now, nothing they are offering is particularly new, as primary care practices across the country are considering or implementing similar strategies. But what is intriguing, is their plan for growth.

As The New York Times recently wrote, Iora’s “ultimate goal is hundreds of practices across the country, a kind of Starbucks for healthcare.” And as their CEO Dr. Rushika Fernandopulle stated, “Building one good practice is mildly interesting, because a few people have done that. But how do you scale that across the country? That’s much harder.”

Hard, yes. But meaningful, I’m not so sure.

See, Iora’s foundation is venture capital and their business model aims to create a revenue stream providing services most clinics cannot afford; because most financial incentives in healthcare favor hospital and emergency visits. On the surface, it’s a win for doctors because many physicians want to provide comprehensive care, and it’s a win for patients, because Iora is paying to provide a care experience consumers want. But what about low-income populations? They lose here.

To maintain the for-profit status that supports their model, Iora Health purposefully doesn’t take patients off the street, the uninsured, or the unemployed for that matter, I guess unless some unemployed individuals are buying insurance with a plan they contract with. And yet, Iora says their model is going to “transform healthcare” and scale across the US.

When 5.5% of the population is unemployed and more than 1 in 7 live below the poverty line, how is this model “transforming” the system for everyone? The truth is, it’s not.

So I return to my initial question, do we lose something meaningful when we measure the value of our work by its national impact?

In Iora’s case, as with many clever and highly specialized health systems innovations, I think we do. Iora’s business model is what drives their innovation, but it is also what makes their services irrelevant in populations that don’t qualify or need their comprehensive care. It doesn’t make what they are doing any less valuable, but it does mean they may not find significance with every population. In addition, since their model excludes populations already under-served by the healthcare system, their national dissemination may actually threaten access to care for low-income families.

Healthcare is a complicated enterprise where the needs of the consumer are variable and evolve overtime. That diversity of need and resource distribution defines the challenge in our current system. And in the end, that variability may be too complex for a one-size-fits-all, Starbucks model.

Perhaps healthcare doesn’t need cookie cutter solutions imposed on populations with distinct assets and needs. Perhaps just like politics, all healthcare transformation is local and finds meaning in its local application, not its national prominence.

We all know ideas with traction and those that find their way to a national stage are exciting. But I think there is something to be said for offering a unique service to a distinct population, and doing that well for the long-term. So instead of looking for the next big thing, the actual big thing is made up of small things that are changing the way each of us experience our healthcare.

The Arc of Injustice: How Racism Kills

Featured

The tragic deaths of Oscar Grant, Michael Brown, Eric Garner, Tamir Rice, Walter Scott, and untold others, deeply grieve our national conscience. But more black men die in America from heart disease than from police brutality, and we never mention those parallel realities in the same breath, let alone collectively mourn those dead.

Why is that?

Because it’s not just that African-Americans have higher rates of heart disease and its related risk factors. It’s that being black IS a risk factor for dying from heart disease in America. Yet few connect the dots between black death by police and black death by disease, although both disproportionately take of black lives.

Just look at the data.

Evidence shows African-Americans have a shorter life expectancy and higher rates of illness and disease than any other racial or ethnic group in the country. Even black babies are more than twice as likely to die before their 1st birthday than other infants in the US. Considering America’s overall infant mortality rate ranks behind its first world peers, that finding is far from benign. In fact, it makes African-American babies less likely to survive the first 12 months of life, than babies born in Botswana, Cuba, or Kuwait; to name a few of the 94 countries who have better infant mortality rates than black newborns in the United States.

And these gaps are far from new. Back in 2004 Congress asked the Institute of Medicine to investigate these racial disparities. After reviewing more than 100 studies,

“The committee was struck by the consistency of the research findings [that] indicated minorities are less likely than whites to receive needed services, including clinically necessary procedures.”

For almost every disease studied, black patients received less effective care than white patients, including routine treatments for common health problems; from cancer and diabetes to, you guessed it, heart disease.

Now, I know what you’re thinking. Just because African-Americans are disproportionately sicker and die younger, doesn’t mean common medical practice added to the disparity, right?

Wrong. Titled Unequal Treatment, the authors concluded,

“(Al)though myriad sources contribute to these disparities, evidence suggests bias, prejudice, and stereotyping on the part of healthcare providers may contribute to differences in care. “

There is something about being black in America, that places African-Americans at increased risk of death; and that something is a quantifiable systemic bias.

So while it is important to scrutinize policing practices that disproportionately harass and kill black males, we must also critically appraise equity in health and healthcare.

How else will we explore the extent of the injustice weathered by Eric Garner who ultimately died of a heart attack? Police training may prevent his unprovoked asphyxiation, but it would do little to address an already shortened lifespan. And yes, the banned chokehold and subsequent failure to indict seemed unjust, on the surface. But is it right to invoke Garner’s haunting last words as a rally cry, if we ignore the inequity that may have pulsed beneath the surface?

And how can we learn from Darren Wilson’s description of Michael Brown as a “demon…bulking up to run through the shots, like it [made] him mad that I [shot] him”? Could the former officer’s misinterpretation of anguish, on the face of a black youth who sustained multiple gunshots, be related to medicine’s well-documented racial disparities in pain management? Because in healthcare, data indicates black children and adults are less likely to have their pain accurately perceived and appropriately treated; and this mistreatment limits medicine’s ability to protect and serve black patients well.

In reality, the threat of police violence that endangers black lives is intimately related to the threat of death and disease that disproportionately burdens communities of color. These are not isolated issues. Together, they tell of a nation that remains profoundly influenced by race, from the mandates of justice to the delivery of healthcare. In time, that influence ceases to publicly alarm. So while some black deaths are made a media spectacle, the vast majority go unacknowledged and unaddressed; the collective impact of which subtly normalizes inequity and codifies injustice.

In the end, there will be no justice without accountability. To save black lives, we have to change how we think about black life – not just how or if, it matters, but where and when, it is most at risk. Now the arc of injustice includes the well-intentioned and malicious alike, each of whom may harbor attitudes and preferences that ripple across systems and threaten the lives of people of color. These threats expose the reality that racism kills and the death toll is much greater than you think.

Fighting for Failing Care: How Hospital Closures May Impact the Safety Net

Featured

In the post-Affordable Care Act healthcare landscape, sweeping hospital closures have created new barriers to access in a system already criticized for its fragmentation and saturation. Looking back over the past 20 years, urban hospitals, and urban trauma centers in particular, bore the brunt of this impact, closing at the highest rates in the country. Now, evidence suggests the impact of urban hospital closures may disproportionately affect those living in poverty, racial and ethnic minorities, and the uninsured.

This concerning trend begs an important question:

If urban hospitals are a trusted point of access for low-income communities of color, does their closure undermine the national safety net OR does it create opportunities to deploy lower-cost, higher-quality delivery models for vulnerable populations?

To answer this question, let’s look at the contentious 2007 closure of Martin Luther King Jr. Harbor Hospital in Los Angeles.

As a bit of background, MLK-Harbor opened in the wake of the 1965 Watts riots and general unrest regarding the lack of sufficient public investment in communities of color in South Central (now termed South LA). The hospital was to provide healthcare in one of the poorest and most violent neighborhoods in LA. At the time of its closure, it remained the only public hospital to serve a large part of South LA, treating more trauma patients than almost all other hospitals in the region. Its closure was prompted by a series of egregious medical errors that eventually threatened the hospital’s accreditation.

Mounting quality concerns aside, what was most notable about its closure, was the staunch community protest. In the face of unquestionably dangerous medical practices, the community rallied to protect their safety net; even garnering the support of Congresswoman Maxine Waters, who rose to the cause’s defense in 2004. Despite their efforts, the trauma center was shut down in 2004 and the general acute care hospital closed thereafter in 2007.

So why would a community fight for the failing care of their discredited hospital? Is the safety net worth protecting when it is offering poor care or is the community’s advocacy tacit admission that poor care is better than no care at all? And ultimately, does “no care” threaten the safety net or does it provide an opportunity for something better?

Let’s dissect these questions piece by piece.

First, it is a basic human instinct to protect what you perceive as yours. Even if what you have is broken. Now superimpose on that instinct, a history of having no say in what is taken from you; a history of abandonment by public institutions charged with investing in your community infrastructure; and a history of displacement driven largely by resource scarcity and discrimination. When viewed in this structural context, the motivations to fight to protect resources become obvious.

Second, let’s explore the idea of fighting for “failing” or “poor” care. Here, the assumption is that low-income communities of color either don’t understand or don’t want, quality. Why else would they protest the closure of a bad hospital, right? In this case, I think we’ve got the assumption wrong. Americans love a deal. We want more for less. Whether it’s super-sizing our french fries or buying into the housing market at the right time, we want quality and we want it at a bargain price. In this way, quality is an American value that translates across the economic spectrum. But sometimes, “the deal” trumps quality. So the real question is, what is the “deal”?

In the case of MLK-Harbor, if there is not another medical facility near your home and public transportation is unreliable, or if you are uninsured and you cannot afford a second opinion, or if the medical specialty you need is only available at your local provider; then the deal is access, the deal is cost-savings, the deal is specialization. This is why low-income populations are vulnerable. Because their lack of resources offers them a bad deal, around which there is little leverage.

So it is not that poor care is better than no care. It is that no care should no longer be an option, but for many, that is the deal they are left with. So as engineers of the system, we have to create something better.

And herein lies the answer to our initial question. It does both.

Because urban hospitals are a trusted point of access for low-income communities of color, their closure undermines the national safety net AND creates opportunities to deploy lower-cost, higher-quality delivery models for vulnerable populations.

In attempting to forge a better healthcare system in the midst of our broken one, every failure is an opportunity for improvement.* As the Affordable Care Act re-organizes the medical landscape into regionalized, micro-systems that are accountable for local populations, it provides the opportunity to consider our past failures and the global impact of shifting costs and shifting care on the vulnerable.

The tension between eliminating inefficiency, maintaining quality, and controlling cost while elevating the voice of the community and prioritizing the needs of the under-served, remains. These are the challenges that loom at the forefront of a healthcare system that seeks to cut costs and maximize quality for all. But this is a cause worth fighting for and I’m all in. Are you with me?

* To see how MLK-Harbor (now MLK Community) is improving their system to re-open in 2015, click the link.