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On behalf of the Diabetes Patient Advocacy Coalition (DPAC) and the Diabetes Leadership Council (DLC), we would like to bring your attention to some concerns we have with recent changes at the U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH), and how these changes are misaligned with the goal of the administration to address chronic diseases, including diabetes, in our country.
The Diabetes Patient Advocacy Coalition (DPAC) is an alliance of people with diabetes, caregivers, patient advocates, health professionals, and others working together to support public policy initiatives to improve the lives of all 38 million Americans with diabetes. As an organization run by and for people with diabetes, DPAC seeks to ensure quality of and access to care, medications, and devices for people living with diabetes. The Diabetes Leadership Council (DLC) unites former leaders of national diabetes organizations, dedicated to securing effective, affordable, health care for every person with diabetes.
We are concerned about the cancellation of funding for the Diabetes Prevention Program Outcomes Study (DPPOS), which is the long-term follow-up study of the Diabetes Prevention Program (DPP) at the National Institutes of Health (NIH). This is a 30-year nationwide study of program participants, and its cancellation means a loss of a decade’s worth of important findings and progress on diabetes prevention as well as a new understanding of Alzheimer’s disease and associated dementia in people with diabetes.
This research is being conducted at 30 institutions in 21 states and impacts tens of millions of Americans with diabetes and prediabetes. In 1996, in order to better address the growing problems of prediabetes and Type 2 diabetes, Congress authorized the National DPP, a public-private initiative that provides the framework for type 2 diabetes prevention efforts in the United States. The NDPP has been critical in changing the lives of people with diabetes through evidence-based research.
The DPPOS is a long-term follow-up study of the original study cohort, currently focused on studying Alzheimer’s disease and dementia along with the long-term effects of diabetes prevention on other health conditions including cancer, heart disease, stroke, nerve damage, kidney damage, and eye disease. This long-term study includes over 31,000 surviving participants.
This study is a critical source of information about long-term diabetes prevention. Over 38.4 million people in the U.S. had diabetes as of 2021, 11.6% of the population, and many more have prediabetes.
We appreciate the administration’s focus on chronic disease prevention. Research provided by the DPP and DPPOS is critical to this mission. Preventing the onset and appropriately treating diabetes helps reduce other chronic conditions associated with diabetes, like heart and kidney disease. In turn, this helps to control healthcare costs by reducing the incidence of some of the most costly diseases and complications. According to the CDC, the direct and indirect costs of treating diagnosed cases of diabetes was $413 billion in 2022.
It is imperative that this work continue in order to better our understanding of diabetes, improve prevention, and enhance treatment for people diabetes. We urge continued funding for public-private partnerships that support the National DPP and DPPOS and other diabetes research programs, which serve to further the goal of addressing chronic disease and make America healthier.
We are similarly concerned by the recent termination of additional National Institutes of Health’s (NIH) grants which could impact overall patient health by reducing research into important treatments and medical cures; but could also immediately impact specific patients currently in active clinical trials.
Diabetes is associated with numerous comorbid conditions including cardiovascular disease and related complications; kidney disease; nerve damage; and diabetic retinopathy. Obesity is one of these comorbid conditions of Type 2 diabetes which leaves these Americans vulnerable to more than 200 other serious health conditions including heart disease, high blood pressure, and stroke. The continuation of research into many related diseases and integrity of clinical trials is crucial to the diabetes community.
It has come to our attention that an extensive list of more than 51 pages of grants have been completely and suddenly cut off from funding. These grants total potentially more than $2.4 billion in funding for research and at least 678 research projects including studies across a multitude of critical disease states such as cancer, diabetes, strokes, cardiac health, Alzheimer’s, pregnancy, and mental health.
Ending these studies so abruptly violates science-based review processes, putting the results of these studies at risk. Further, this action wastes the money that has been invested into these projects by stopping them before the results are in, meaning there will be no tangible output from the efforts that have already taken place and the money that has already been spent.
It is our concern not only that valuable research is being put at risk, which in the long run could worsen patient health outcomes and harm the potential for advances in treatment and prevention of these diseases, but also that in the short-term patients currently involved in these terminated studies could be harmed. There has been no clarity on how many of the grants and studies terminated were in active clinical trials, or that there is any process for appeal or exception for studies at this critical stage.
Suddenly halting treatments for patients taking experimental medications could lead to patient harms or even cost people their lives.
Further, we are concerned that termination of these grants will lead patients to be skeptical of participating in clinical trials in the future, threatening all future clinical research and medical advancement.
We respectfully request that NIH provide a response to the following questions via email or a meeting with us:
1. How has interruption of funding of the DPPOS interrupted critical diabetes research, when and how will funding be restored to ensure the money and time spent on this research is not wasted and continues in order to provide insight into the best ways to treat and prevent diabetes?
2. How many of the canceled NIH grants include active clinical trials?
3. How many patients are participating in active clinical trials that have been abruptly stopped due
to the termination of NIH grants?
4. Is there an appeal or exceptions process in place at the NIH for situations where a terminated NIH grant is expected to or has impacted the health of patients in an ongoing clinical trial? If so, what is this process and how has it been communicated?
5. What is the internal process being used to evaluate whether a grant will be terminated, and what factors are being considered in this process? Is risk to patients being considered as a part of this process?
Thank you for your consideration of our concerns. We would like to collaborate with HHS, NIH, and the administration to address chronic disease, including diabetes, and work toward a healthier America through prevention and treatment. Research is critical to this shared goal. We strongly urge you to take necessary action to ensure that patients enrolled in clinical trials through the NIH are not put at risk and that the crucial research being conducted to help patients is continued.
