The Good, the Bad and the Different

“The Good, the Bad and the Different,” the title of a recent educational program and research project by the University of Arizona School of Pharmacy in collaboration with and sponsored by the National Pharmaceutical Council, that examines what happens when a person’s response to a treatment doesn’t follow the expected plot.

The story line in any spaghetti western generally follows a predictable plot. There are a few shoot outs between the good guys and the bad guys, some business deals along the way, and the good guy usually prevails at the end.

But when it comes to health care where real lives are at stake, the plot is not always linear or predictable. Instead of looking like “The Good, the Bad and the Ugly,” health care is often like “The Good, the Bad and the Different.”

That’s also the title of a recent educational program and research project by the University of Arizona School of Pharmacy in collaboration with and sponsored by the National Pharmaceutical Council that examines what happens when a person’s response to a treatment doesn’t follow the expected plot. According to the papers,

“In health care, patients commonly report ‘this medication doesn’t work for me,’ or physicians switch therapies because of nonresponse. Basic pharmacology and clinical studies typically evaluate a medication’s efficacy in a controlled setting, among patients with a narrowly circumscribed set of inclusion and exclusion criteria, and tend to report the ‘average’ or mean treatment response. Yet, this average does not ensure that all patients will have the identical response to therapy. In fact, there is a range of both therapeutic benefits and harms, and no 2 patients will respond exactly the same way.
“…consequently, treatment decisions applied in a ‘one size fits all’ fashion, based on the average response, may lead to suboptimal clinical, humanistic and economic outcomes for patients, providers and health care decision makers. This central tendency approach may result in substantial benefits for some patients, little benefit for many, and harm for a few patients.”

To assist decision-makers in evaluating published research studies to determine when clinically relevant differences exist, this project outlines a variety of tools and resources. In particular, it provides two checklists to help decision-makers identify patient differences within and across different studies.

Image removed.

In addition to the project, published as four papers in the Journal of Managed Care and Specialty Pharmacy, the information is available via four seminars on the University of Arizona School of Pharmacy website. The additional papers provide a case example of how Medicare used evidence of patient differences, or heterogeneity, of treatment effects to make population-based decisions on health care coverage; identify considerations for managing heterogeneity in prescription drug benefits based upon necessity and fairness; and evaluate the impact of the educational program upon completion and again 6 months later.

Instead of shooting wildly at a treatment solution,

“An understanding of the sources of heterogeneity and how to recognize and evaluate these differences will assist pharmacy and medical managers in assessing the relevance and impact of differences between individuals, populations, and clinical studies. Over time, our understanding of biological differences (pharmacogenetic, pharmacodynamic, and pharmacokinetic) will evolve, and the methods used to predict response to treatment will improve, leading to better decision making. In the interim, gaining a better understanding and appreciation of the differences among patients, subpopulations, and studies will serve to optimize health for the population as well as for individual patients.”

Recognizing the impact of these differences can help to make the “plot” of their treatment more predictable for many patients. And just as we assumed that Clint Eastwood, as Blondie, would prevail at the end of “The Good, the Bad and the Ugly” and ride off into the sunset, understanding health care differences also can help patients and providers prevail over their health challenges and help them to avoid unintended health consequences. 

For additional information, view our infographics on individual treatment effects and read The Myth of Average: Why Individual Patient Differences Matter.