Since graduating from medical school in 1978, I’ve seen medicine and healthcare change in unimaginable ways for the better. However, one of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of common chronic diseases (CCDs), combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How can it be that our prowess in technology is not translating into better health and longevity for the American public? (Photo: Courtesy)
Source: Food & Drug Administration
By: Robert M. Califf, MD, Commissioner of Food and Drugs
Chronic Disease Day, marked earlier this month, originated in part from the recognition of these trends, now resulting in a serious state of affairs: 7 of the 10 leading causes of death in the U.S. are CCDsExternal Link Disclaimer. But the recognition of the importance of chronicity of disease is a relatively new issue. The focus of my early career was heart attacks, which at that time killed about 50% of those affected. Today, due to advances in treatments for heart attacks that have transformed the field of cardiology with significant support from U.S. Food and Drug Administration policies supporting innovation and evidence generation, the vast majority of people survive heart attacks. However, many of these survivors go on to develop chronic conditions like heart failure. Chronic diseases of the heart, lung, kidneys, liver, and metabolism (such as obesity and diabetes) account for the vast majority of deaths in this country. Even many patients with cancer now can often expect to be long term survivors, although many cancer survivors continue to have chronic manifestations of the cancer or related diseases.
In fact, most Americans have multiple CCDsExternal Link Disclaimer. Some CCDs like heart disease have seen important advances in care. Unfortunately others, such as chronic obstructive pulmonary disease (COPD), have fewer therapeutic options. Moreover, while our health system continues to function well for many acute conditions, its ability to prevent and manage chronic conditions over a long period of time is often limited.
Environmental and social factors are strongly tied to CCDs. The U.S. has very high rates of diet related diseases such as cardiovascular disease, diabetes, obesity and certain cancers: in fact there are 42 countries with lower rates of diet related diseasesExternal Link Disclaimer than the U.S. Further, 28 million Americans continue to smoke cigarettes. The FDA has regulatory authority over tobacco products and significant responsibility for food safety and nutrition. Therefore, it is critical that we take an agency-wide approach towards understanding and addressing chronic conditions.
CCDs, like many other health conditions, disproportionately impact some already disadvantaged communities and individuals. In particular, people who are Black, indigenous, low-income, less educated, or rural, face a higher burden of CCDs, in part due to greater exposure to their risk factors. For example, asthma rates in the U.S. are highest among Black children and adults to a large degree because they are more likely to live in homes and communities with more irritants and pollutionExternal Link Disclaimer. Rural Americans are much more likely to live in healthcare deserts – for example, a study published just this weekExternal Link Disclaimershowed that 86% of rural counties in the U.S. don’t have a single cardiologist practicing in them, even though these very communities experienced greater death rates from heart disease.
The FDA oversees regulatory pathways that have brought revolutionary treatments for CCDs to Americans. In many cases creative regulatory strategies have accelerated development and led industry to productive new interventions, and in many cases the evidence-based rejection of ineffective interventions has paved the way for effective therapies. These treatments span drugs, biologics and medical devices, including digital and AI-enabled devices. The continued reduction in death and disability from tobacco products under FDA regulation is a major public health triumph and better information about nutrition combined with food safety measures provides a foundation for good health for a lifetime. For all this progress, however, the promise of these advances has fallen short of what could be achieved.
Gaps in evidence generation explain part of the gap between the tremendous growth in effective medical products and our lagging health outcomes. Interventions for chronic diseases need to be studied in large diverse populations with a comorbidity burden similar to the indicated population over a follow-up period reflecting the chronic nature of the condition and the duration of treatment. This can be challenging and expensive. The FDA’s centers have launched several programs intended to simplify clinical trials and streamline them with routine patient care. One recent example is the Streamlined Trials Embedded in clinical Practice (STEP) Demonstration from CDER’s Center for Clinical Trial Innovation (C3TI). Further, given the high prevalence of CCDs in some communities, we hope the recent release of the FDA’s draft guidance on diversity action plans will stimulate more sponsors to perform studies in populations more representative of those that the indicated conditions affect.
Another major gap is appropriate use of FDA approved therapies, with most patients not receiving the best available treatments for their chronic conditions. The effective use of medical interventions is also dependent on evidence generally not required for FDA approval—regarding, for example, comparative effectiveness, and long-term outcomes. Cost is another barrier to broader use of many novel therapies. This complex problem, thus, will require stakeholders from across the ecosystem to come together with a common goal: to improve and extend the life of Americans with chronic diseases by increasing access to evidence-based treatments, reducing use of expensive and ineffective interventions relative to alternatives, and the creation of an ecosystem able to collect evidence guiding these decisions at low cost in the post-market setting.
The primary mission of the FDA is to protect “the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.” But it also includes “advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.” I hope that as we continue our work, we’ll look for opportunities to enable innovation in stalled areas in chronic disease.
I also hope you will reach out to your loved ones who live with chronic diseases and offer them your support. Chronic diseases are a major priority for me personally, and for the FDA as an institution, but it will take all of us to play a part in helping stem this rising burden.
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