News and Insights
Slow Medicine or Failure to Accept Proven Therapy?
November 13, 2024
This is a new voice from a new position at FINN Partners, that of Chief Health Affairs Counselor. I have been a practicing cardiologist and an academic physician for fifty years. I have run a laboratory of vascular biology, taught a thousand students, been a dean in two countries, run a foundation to keep healthcare human, and practiced for decades at the famous Thursday Night Cardiac Clinic at Bellevue Hospital in NYC.
When I started in cardiology, we had no specific therapy for heart attacks, in fact the foundational Scandinavian Simvastatin Survival Study (4S) wouldn’t be published for twenty years. AIDS did not yet exist, we didn’t have any advanced imaging, and the human genome would not be sequenced until 2003. It’s been quite a time and a wonderful journey, experiencing these events that have shaped my optimistic perspective on biomedicine and health.
The pace of invention in medicine implied above has not slackened. When the Spanish flu of 1918-19 killed 1 in 10 of the 500 million people who were infected worldwide, we had no ability to create a vaccine. But by the time we had to deal with Covid-19, it only took nine months to invent the first mRNA vaccine—an inconceivably short span of time (1).
While we have travelled so far from the time of smallpox, with clinical research in randomized, controlled trials honed to prove safety and efficacy of innovative health interventions, acceptance and use of proven therapies may take decades. Multiple factors interact in complex ways such that with the average time to bring a new therapy to the clinic is about 17 years (2,3).
The culture of the doctor-patient relationship in America explains much of this and it is described brilliantly in all its intricacy in Lewis Grossman’s Choose Your Medicine: Freedom of Therapeutic Choice in America (4). Despite the golden age of trust in health and science following WWII, when the war had been won (by physics) and the age of antibiotics ushered in by the general availability of penicillin, public trust in medicines and medical providers has always been low and difficult to sustain. In his book, Grossman lays out the freedoms that make our citizens question and balk at both new and proven therapies. After 250 years of continuous doubt in who they are and what they offer, clinicians themselves are often more than cautious about adopting and prescribing new drugs and devices.
In addition to this significant cultural inhibition, a multitude of other factors also contribute to the slow uptake of proven therapies, in the United States and around the world. These include disease severity, patient preference, patient influence on other patients, prescriber characteristics, therapeutic modality, regulatory limitations, costs, reimbursement, the proliferation of guidelines for use and others (3,5). All of these are further impacted by inequities in distribution and access to health services. There are major consequences to the sluggish implementation of appropriate therapy and, as a consequence, too many patients never receive the care they need to protect, improve, or save their lives.
Antihypertensives provide a clear example of the danger sluggish adoption presents to individuals and societies. While safe and effective antihypertensive medications were introduced over 50 years ago, the World Health Organization (WHO) estimates that 7.5 -9.5 million excess deaths occur each year due to hypertension. Similarly, today about 40% of the adult U.S. population with high cholesterol goes untreated and globally there are an estimated 4.5 million deaths annually due to high cholesterol. These deaths occur despite the inclusion of simvastatin in the ACC/AHA guidelines more than 11 years ago, after the publication of the landmark 4S trial 20 years ago.
As a more contemporary example, it was about 25 years ago that Paul Ridker and colleagues began proving that generalized, low-grade inflammation was a co-factor for atherosclerosis and its complications (6). But, as discussed recently by Eric Topol and despite available agents, inflammation is not generally recognized or treated as a preventive measure of high impact (7). Collectively, the ongoing loss of life across multiple indications in which proven interventions exist demonstrate that data alone are not enough to improve health outcomes. Changing behavior — patients’, providers’, payers’ and policy makers’ — is also essential.
We are not helpless to improve the speed of implementation of new medicines and devices. There are legions of health practitioners, patients, and organizations who are working toward the acceleration of the uptake of proven therapies. The individual approaches that have been identified systematically are known and detailed in the sources identified above.
With the advent of Implementation Science (IS), knowledge and evidence-based interventions from clinical trials can be more effectively integrated into routine health care settings, reaching the prescribers and patients needing new therapies every day (2, 8, 9). Still, there are barriers to overcome at the individual, health care institutional, community, regional and national level. Leveraging existing tools, such as the NASSS (Nonadoption, Abandonment, and Challenges to the Scale-Up, Spread, and Sustainability of Health and Care Technologies) framework adopted at Oxford University, can help with the adoption or integration of technological innovations in health and social care (10).
Despite these initiatives, one thing is clear; modern marketing and communications are among the most powerful solutions to improve the trust and uptake of evidence-based research and medicines. For example, interdisciplinary teams can use digital techniques to identify microgeographic neighborhoods and tailor messages for community, regional, national, or global distribution. This could help fulfill the goal of IS and ensuring evidence-based science is routine practice.
Twenty years from proof to appropriate use is not acceptable. The excess morbidity and mortality of non-adoption of drugs and devices are ruinous. To speed the flow of breakthroughs to patients. We must follow the watchwords attributed to Goethe and used by the National Academy of Medicine: Knowing is not enough; we must apply. Willing is not enough; we must do.
We can – and must – fix this.
Citations
- Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med2020;383:1920-1931.
- Balas EA, Boren SA. Managing Clinical Knowledge for Health Care Improvement. Yearbook of Medical Informatics. (1)65-70, 2000.
- Medlinskiene K, Tomlinson J, Marques I, Richardson S, Stirling K, Petty D. Barriers and facilitators to the uptake of new medicines into clinical practice: a systematic review. BMC Health Services Research. 21(1):1198, 2021
- Grossman, Lewis A. Choose Your Medicine: Freedom of Therapeutic Choice in America. Oxford: Oxford University Press, 2021.
- Lublóy A. Factors affecting the uptake of new medicines: a systematic literature review BMC Health Services Research 2014, 14:469.
- Ridker PM, Brown NJ, Vaughan DE, Harrison DG, Mehta JL. Established an emerging plasma biomarker in the prediction of first atherothrombotic events. Circulation. 109(25 Suppl 1):IV6-19, 2004.
- Topol E. The Big Miss: Inflammation and Cardiovascular Disease. The need for routine assessment and suppression of inflammation. Ground Truths, June 9, 2024; https://erictopol.substack.com/p/the-big-miss-inflammation-and-cardiovascular.
- Olson M and Rootkin L. The triple win – implementation science benefits patients, healthcare systems and industry alike. J Comp Eff Res 11:639-642, 2022.
- Smith MY, Gaglio B, Anatchkova M. The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review. Health Research Policy and Systems 2024, 22:17.
- Greenhalgh T, Wherton J, Papoutsi C et al. Beyond adoption: A New framework for theorizing and evaluating nonadoption, abandonment, and challenges to the scale-up, spread, and sustainability of health and care technologies. J Med Internet Res 2017; 19 e367:1; http://www.jmir.org/2017/11/e367/.
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