With the early success of their All of Us research program, the National Institutes of Health are well on their way to ushering in an era of precision medicine. Precision marketing will play a critical role in helping this become a commercial reality.
As a 2015 report produced by the National Institutes of Health’s (NIH) Precision Medicine Initiative (PMI) highlights, “The surest path to advancing prevention and treatment of disease has been the detailed understanding of the factors that contribute to health and disease in individual patients.”
And yet, as things stand, the majority of medical treatments — especially pharmacological ones — are developed through clinical trials that largely gauge success and failure based on averages, on how a “typical patient” might benefit from a new drug or device. Granted, this approach does deliver a net benefit — FDA approval would be nowhere to be found if it did not — but as the PMI report points out, there is clearly an opportunity to do better.
Depending on their unique amalgam of disease pathophysiology, environmental exposures, and social, behavioral, and genetic factors, any given patient may experience an adverse outcome as a result of taking a drug that produces positive outcomes for most other patients. Aside from working with a sample size of one — which, needless to say, would be prohibitively impractical — there is no way for clinical researchers to eliminate this unpredictability entirely.
That said, the rise of precision medicine has given clinical researchers and healthcare providers a powerful new tool with which to fine-tune the development and administration of targeted medical treatments. Insofar as it will enable the medical community at large to minimize patient-specific adverse effects, the proliferation of precision medicine has the potential to help improve the net outcomes achieved by nearly every medical treatment.
The promise of precision medicine
The underlying principle of precision medicine — namely, the importance of taking patients’ unique profiles into account — has been informing medical practice for at least a century (think: relying on blood typing to guide blood transfusions). Until recently, however, overcoming the oxymoronicism of “broad-based precision medicine” has been effectively impossible.
Encouragingly, this impossibility has begun to fade away as scientific advances like human genomics, proteomics, and metabolomics and technological advances like machine learning-driven big data analytics have created the conditions of possibility for precision medicine at scale.
Early efforts to incorporate cutting-edge science and technology into precision medicine frameworks have resulted in the development of highly targeted cancer and cystic fibrosis treatments, a more comprehensive understanding of specific patient groups’ hypersensitivities to certain drugs, and even the ability to diagnose previously undiagnosable genetic diseases.
And while these efforts have provided an exciting glimpse of what may well be the future of healthcare, precision medicine remains the exception, not the rule. Accelerating the maturation and adoption of precision medicine will require fostering cross-sector buy-in, planning (and funding) additional research, and increasing a wide variety of stakeholders’ access to accurate, comprehensive patient data.
NIH introduces All of Us
As one of the key components of PMI, NIH’s All of Us research program is taking meaningful steps to address the data access imperative. After a PMI working group developed a framework for All of Us in 2015, NIH began assembling a nationwide consortium of partners capable of supporting the program’s ultimate goal:
[Building a cohort of] one million or more volunteers living in the U.S. [who will] contribute their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of evidence-based and more precise preventative care and medical treatment.
Prior to opening enrollment to the general public in May 2018, PMI enrolled over 25,000 beta-testers in the program. These early participants had their physical measurements taken, provided blood and urine samples for whole genome sequencing, agreed to share their electronic health records, and completed a series of surveys featuring questions about their lifestyle (“Do you have breakfast every morning?”), genetics (“Do you look like your mother?”), and environment (“Do you live near public transportation?”).
As of this past May, over 230,000 people had started the process of enrolling in All of Us, some 142,000 of whom had completed the full protocol established by the beta-testers. With the goal of gathering enough data to start sequencing one million whole genomes by 2023, the pace set by the program’s first year of open enrollment leaves All of Us well-positioned to, at the very least, get close to hitting its target.
Laying the groundwork for the diversification of clinical research
However, the greatest triumph of All of Us’ first trip around the sun was not the sheer volume of enrollees it attracted, but the kinds of enrollees it attracted. The program has made a point of striving for a cohort that “reflect[s] the rich diversity of America, including volunteers of many races and ethnicities, age groups, geographic regions, gender identities, sexual orientations, and health statuses.”
Patient pools for clinical trials have traditionally skewed white, male, and affluent, making the “typical patient” even less representative of the general public than statistical averages would dictate. As such, as University of Arizona Health Sciences Associate VP for Diversity and Inclusion Dr. Francisco Moreno explains, “There are a number of gaps in our understanding of risk factors [and] treatment responses…for specific populations. As the diversity of…the United States continues to increase, our assumptions about what may work for the general population become more and more challenged.”
These “gaps in understanding” to which Dr. Moreno refers can have serious consequences. For instance, as a result of being characterized as “a man’s disease” for most of the history of modern medicine, cardiovascular disease (CVD) continues to go underdiagnosed in American women — this despite the fact that women represented 51 percent of the CVD-related fatalities recorded by the American Heart Association in 2011. Unfortunately, the source of this imbalance is no mystery: while men and women manifest different CVD symptomatologies, the majority of CVD research is conducted on men. Consequently, many women do not experience “typical” symptoms when going into cardiac arrest, and thus go undiagnosed for far too long.
The fact that 80 percent of All of Us enrollees come from backgrounds that have been historically underrepresented in medical research — low-income individuals, individuals of color, individuals from predominantly rural states — is an achievement unto itself, but if researchers are able to leverage this unprecedentedly diverse data into real breakthroughs in precision medicine, we may be on the brink of a truly profound medical revolution.
Precision medicine demands precision marketing
There is absolutely no question that initiatives like All of Us will serve as the cornerstones of any precision medicine revolution, but it bears pointing out that bringing such a revolution to fruition will require contributions from stakeholders across the healthcare spectrum — healthcare marketers included.
As healthcare marketers, our foremost responsibility is facilitating the delivery of the right treatment to the right patient at the right time. Until recent years, the majority of pharmaceutical treatments demanded only that our campaign targeting get close. Even in 2019, few treatments are tailored to specific combinations of disease pathophysiologies, environmental exposures, and social, behavioral, and genetic factors, meaning broad-based marketing approaches have continued to be economically viable — and a key tool in healthcare marketers’ arsenals. But while the exceptions to this rule are rare — think: precision oncology and rare disease treatment — they are quite instructive as to how the healthcare marketing industry as a whole should be preparing for the dawn of the precision medicine era.
For instance, a manufacturer of a rare disease treatment can rarely rely on broad-based television ads to market its product — doing so would be tantamount to using a hammer for a job that calls for a scalpel. The number of patients to whom this manufacturer’s drug is relevant is incredibly small, and the chances that enough of these patients are watching television at any given time are so remote that achieving a satisfactory ROI on television ads would be effectively impossible.
In truth, the best practices for designing and executing marketing campaigns for drugs with minute patient groups are still very much in development — and are constantly being refined. Variants of artificial intelligence like predictive analytics and machine learning and robust measurement and optimization approaches driven by data on real-world outcomes have cleared a path forward, but it now falls to the vanguard of data-driven healthcare marketers to lay down pavement upon which the rest of the industry can follow.
It is hardly hyperbolic to say that the ultimate success of All of Us and other initiatives like it will hinge on the dexterity with which we as healthcare marketers are able to wield these cutting-edge technologies. The reality is that even the most precisely tailored medical treatment will never be economically viable — and thus will never deliver on its full promise — unless the right patients and healthcare providers are made aware of it in a timely way.
Society at large stands to benefit immensely from the maturation of precision medicine, but any pharmaceutical company planning on operating in this emerging space must accept that status quo marketing will soon no longer be sufficient. Precision medicine demands precision marketing, and it is incumbent upon all of us to work together to build the scientific, technological, and social infrastructure necessary to produce the best possible health outcomes for every American.